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					                                                                                                                               Friday,
                                                                                                                               November 7, 2008




                                                                                                                               Part II

                                                                                                                               Department of
                                                                                                                               Health and Human
                                                                                                                               Services
                                                                                                                               Food and Drug Administration

                                                                                                                               21 CFR Part 1
                                                                                                                               Prior Notice of Imported Food Under the
                                                                                                                               Public Health Security and Bioterrorism
                                                                                                                               Preparedness and Response Act of 2002;
                                                                                                                               Draft Compliance Policy Guide; ‘‘Sec.
                                                                                                                               110.310 Prior Notice of Imported Food
                                                                                                                               Under the Public Health Security and
                                                                                                                               Bioterrorism Preparedness and Response
                                                                                                                               Act of 2002;’’ Availability; Final Rule and
                                                                                                                               Notice
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                                          66294             Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations

                                          DEPARTMENT OF HEALTH AND                                II. Summary of Significant Changes                         Until Export
                                          HUMAN SERVICES                                          Made to the IFR                                         4. Food Under the Exclusive
                                                                                                     A. What Definitions Apply to This                       Jurisdiction of USDA
                                          Food and Drug Administration                                  Subpart? (§ 1.276)                                5. Additional Exclusions Requested—
                                                                                                     B. What is the Scope of This Subpart?                   General
                                          21 CFR Part 1                                                 (§ 1.277)                                         6. Additional Exclusions Requested—
                                          [Docket No. FDA–2002–N–0233] (formerly                     C. Who is Authorized to Submit Prior                    Special Programs (C–TPAT/FAST)
                                          Docket No. 2002N–0278)                                        Notice? (§ 1.278)                                    and Flexible Alternatives
                                                                                                     D. When Must Prior Notice Be                         7. Additional Exclusions Requested—
                                          RIN 0910–AC41                                                 Submitted to FDA? (§ 1.279)                          Samples
                                                                                                     E. How Must You Submit Prior                         8. Additional Exclusions Requested—
                                          Prior Notice of Imported Food Under
                                                                                                        Notice? (§ 1.280)                                    Mail
                                          the Public Health Security and                             F. What Information Must Be in a                     9. Additional Exclusions Requested—
                                          Bioterrorism Preparedness and
                                                                                                        Prior Notice? (§ 1.281)                              Gifts
                                          Response Act of 2002                                       G. What Must You Do If Information                   10. Additional Exclusions
                                          AGENCY:    Food and Drug Administration,                      Changes After You Have Received                      Requested—Low-Value
                                          HHS.                                                          Confirmation of a Prior Notice From               11. Additional Exclusions
                                          ACTION:   Final rule.                                         FDA? (§ 1.282)                                       Requested—Couriers
                                                                                                     H. What Happens to Food That Is                      12. Additional Exclusion Requested—
                                          SUMMARY: The Food and Drug                                    Imported or Offered for Import                       Gift Packs
                                          Administration (FDA) is issuing a final                       Without Adequate Prior Notice?                    13. Additional Exclusions
                                          regulation that requires the submission                       (§ 1.283)                                            Requested—Household Goods and
                                          to FDA of prior notice of food, including                  I. What Are the Other Consequences                      Unaccompanied Baggage
                                          animal feed, that is imported or offered                      of Failing to Submit Adequate Prior               14. Additional Exclusions
                                          for import into the United States. The                        Notice or Otherwise Failing to                       Requested—Noncommercial Use
                                          final rule implements the Public Health                       Comply With This Subpart?                         15. Additional Exclusions
                                          Security and Bioterrorism Preparedness                        (§ 1.284)                                            Requested—U.S. Goods Returned
                                          and Response Act of 2002 (the                              J. What Happens to Food That Is                      16. Additional Exclusions
                                          Bioterrorism Act), which required prior                       Imported or Offered for Import                       Requested—In-Transit Shipments
                                          notification of imported food to begin                        From Unregistered Facilities That                 17. Additional Exclusions
                                          on December 12, 2003. The final rule                          Are Required to Register Subpart H                   Requested—Diplomatic Pouch
                                          requires that the prior notice be                             of This Part? (§ 1.285)                           18. Additional Exclusions
                                          submitted to FDA electronically via                     III. Comments on the IFR                                   Requested—Seeds for Planting
                                          either the U.S. Customs and Border                         A. General Comments                                  E. Who is Authorized to Submit Prior
                                          Protection (CBP or Customs) Automated                      B. Comments on the Legal Authority                      Notice? (§ 1.278)
                                          Broker Interface (ABI) of the Automated                    C. What Definitions Apply to This                    F. When Must Prior Notice Be
                                          Commercial System (ACS) or the FDA                            Subpart? (§ 1.276)                                   Submitted to FDA? (§ 1.279)
                                          Prior Notice System Interface (FDA                         1. The Act (§ 1.276(a))                              1. IFR Timeframes (2, 4, and 8 hours)
                                          PNSI). The information must be                             2. Calendar Day (§ 1.276(b)(1))                      2. Integration of FDA and CBP
                                          submitted and confirmed electronically                     3. Country From Which the Article                       Timeframes
                                          as facially complete by FDA for review                        Originates (§ 1.276(b)(2))                        3. Phase-In of FDA and CBP
                                          no less than 8 hours (for food arriving                    4. Country From Which the Article is                    Timeframes
                                          by water), 4 hours (for food arriving by                      Shipped (§ 1.276(b)(3))                           4. Prior Notice Confirmation Number
                                          air or land/rail), and 2 hours (for food                   5. FDA Country of Production                         5. 5-Day Maximum Pre-Arrival
                                          arriving by land/road) before the food                        (§ 1.276(b)(4))                                      Limitation
                                          arrives at the port of arrival. Food                       6. Full Address (§ 1.276(b)(6))                      6. International Mail
                                          imported or offered for import without                     7. Grower (§ 1.276(b)(7))                            G. How Must You Submit the Prior
                                          adequate prior notice is subject to                        8. Registration Number                                  Notice? (§ 1.280)
                                          refusal and, if refused, must be held.                        (§ 1.276(b)(13))                                  1. General Comments
                                          Elsewhere in this issue of the Federal                     9. United States (§ 1.276(b)(15))                    2. English Language
                                          Register, FDA is announcing the                            10. You (§ 1.276(b)(16))                             3. Technical Issues Concerning Both
                                          availability of a draft compliance policy                  11. Food (§ 1.276(b)(5))                                Systems
                                          guide (CPG) entitled ‘‘Sec. 110.310 Prior                  12. International Mail (§ 1.276 b)(8))               4. ABI/ACS Interface
                                          Notice of Imported Food Under the                          13. Manufacturer (§ 1.276(b)(9))                     5. PNSI
                                          Public Health Security and Bioterrorism                    14. No Longer in Its Natural State                   6. Security of the Systems
                                          Preparedness and Response Act of                              (§ 1.276(b)(10))                                  7. Contingency Plans
                                          2002.’’                                                    15. Port of Arrival (§ 1.276(b)(11))                 H. What Information Must Be in a
                                                                                                     16. Shipper (§ 1.276(b)(14))                            Prior Notice? (§ 1.281)
                                          DATES: This rule is effective May 6,                       17. Comments Requesting Additional                   1. General Comments
                                          2009.                                                         Definitions                                       2. The Submitter
                                          FOR FURTHER INFORMATION CONTACT:                           18. Summary of the Final Rule                        3. The Transmitter
                                          Laura Draski, Office of Regulatory                         D. What is the Scope of this Subpart?                4. The CBP Entry Type
                                          Affairs (HFC–100), Food and Drug                              (§ 1.277)                                         5. The CBP Entry Identifier (e.g., The
                                          Administration, 5600 Fishers Lane,                         1. Food for an Individual’s Personal                    Customs ACS Entry Number or In-
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                                          Rockville, MD 20857, 866–521–2297.                            Use When Accompanied at Arrival                      Bond Number)
                                          SUPPLEMENTARY INFORMATION:                                 2. Homemade Food Sent as Personal                    6. The Product Identity
                                                                                                        Gift                                              7. Identity of the Manufacturer
                                          Table of Contents                                          3. Food Imported Then Exported                       8. The Grower, If Known
                                          I. Background and Legal Authority                             Without Leaving Port of Arrival                   9. FDA Country of Production


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                                                            Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations                                           66295

                                            10. Shipper                                           VII. Federalism                                         30 days on April 14, 2004 (69 FR
                                            11. The Country From Which the                        VIII. References                                        19763), and for an additional 60 days on
                                               Article is Shipped                                                                                         May 18, 2004 (69 FR 28060), for a total
                                            12. Anticipated Arrival Information                   I. Background and Legal Authority
                                                                                                                                                          of 165 days.
                                            13. The Importer, Owner, Ultimate                        Section 307 of the Bioterrorism Act,
                                                                                                                                                          II. Summary of Significant Changes
                                               Consignee, and U.S. Recipient                      which was enacted on June 12, 2002,
                                            14. Mode of Transportation                                                                                    Made to the IFR
                                                                                                  amended the Federal Food, Drug, and
                                            15. Carrier                                           Cosmetic Act (the act) (section 307 of                     The highlights of how this final rule
                                            16. Planned Shipment Information                      the Bioterrorism Act added section                      compares to the IFR and the rationale
                                            I. What Must You Do If Information                    801(m) to the act (21 U.S.C. 381(m)) and                for certain changes are described briefly
                                               Changes After You Have Received                    amended section 301 of the act (21                      in the following paragraphs and are
                                               Confirmation of a Prior Notice From                U.S.C. 331)) by changing when FDA will                  discussed in more detail later in the
                                               FDA? (§ 1.282)                                     receive certain information about                       preamble.
                                            J. What Happens to Food That Is                       imported foods by requiring the                         A. What Definitions Apply to This
                                               Imported or Offered for Import                     Secretary of Health and Human Services                  Subpart? (§ 1.276)
                                               Without Adequate Prior Notice?                     (the Secretary), after consultation with
                                               (§ 1.283)                                          the Secretary of the Treasury,1 to issue                   We retain the following terms without
                                            1. General Comments                                   an implementing regulation by                           change from the IFR:
                                            2. Inadequate Prior Notice                                                                                       • ‘‘The act;’’
                                                                                                  December 12, 2003, to require prior                        • ‘‘Calendar day;’’
                                               (§ 1.283(a)(1))                                    notification to FDA of food that is                        • ‘‘Country from which the article
                                            3. Status and Movement of Refused                     imported or offered for import into the                 originates;’’
                                               Food (§ 1.283(a)(2))                               United States. Beginning on December                       • ‘‘FDA Country of Production;’’
                                            4. Segregation of Refused Foods                       12, 2003, food importers were required                     • ‘‘Grower;’’
                                               (§ 1.283(a)(3))                                    to provide FDA with advance notice of                      • ‘‘Port of entry;’’ and
                                            5. Costs (§ 1.283(a)(4))                              human and animal food shipments                            • ‘‘United States.’’
                                            6. Export After Refusal (§ 1.283(a)(5))               imported or offered for import.                            FDA made the following changes in
                                            7. Post-Refusal Prior Notice                             FDA and CBP jointly published the                    the final rule:
                                               Submissions (§ 1.283(c))                           proposed prior notice regulation in the                    • We revised the term, ‘‘Country from
                                            8. FDA Review After Refusal                           Federal Register of February 3, 2003 (68                which the article is shipped,’’ to read,
                                               (§ 1.283(d))                                       FR 5428), for comment (proposed rule).                  ‘‘* * * or, in the case of food sent by
                                            9. International Mail (§ 1.283(e))                    On October 10, 2003, FDA and CBP                        international mail, the country from
                                            10. Prohibitions on Delivery and                      issued the prior notice interim final rule              which the article is mailed.’’
                                               Transfer (§ 1.283(f))                              (IFR) (prior notice IFR) (68 FR 58974)                     • We revised the term, ‘‘food,’’ to add
                                            11. Relationship to Other                             (corrected by a technical amendment on                  the phrase, ‘‘except as provided in
                                               Admissibility Decisions (§ 1.283(g))               February 2, 2004; 69 FR 4851). The IFR                  paragraph (b)(5)(i) of this section,’’ in
                                            K. What Are the Other Consequences                    implemented section 307 of the                          the first sentence; and reworded
                                               of Failing to Submit Adequate Prior                Bioterrorism Act, and required that the                 § 1.276(b)(5)(i) to read, ‘‘For purposes of
                                               Notice or Otherwise Failing to                     prior notice be submitted to FDA                        this subpart, food does not include’’.
                                               Comply With This Subpart?                          electronically via either the CBP ABI/                     • We added the term, ‘‘full address,’’
                                               (§ 1.284)                                          ACS or the FDA PNSI. The information                    to the final rule. Full address means the
                                            L. What Happens to Food That is                       must be submitted and confirmed                         facility’s street name and number; suite/
                                               Imported or Offered for Import                     electronically as facially complete by                  unit number, as appropriate; city;
                                               From Unregistered Facilities That                  FDA for review no less than 8 hours (for                Province or State as appropriate; mail
                                               Are Required to Register Under                                                                             code as appropriate; and country.
                                                                                                  food arriving by water), 4 hours (for
                                               Subpart H of This Part? (§ 1.285)                                                                             • We revised the term, ‘‘international
                                                                                                  food arriving by air or land via rail), and
                                            M. Outreach and Enforcement                                                                                   mail,’’ to make the sentence easier to
                                                                                                  2 hours (for food arriving by land via
                                            1. General Outreach and Enforcement                                                                           read, and to add the phrase, ‘‘unless
                                                                                                  road) before the food arrives at the port
                                               Issues                                                                                                     such service is operating under contract
                                                                                                  of arrival. Food imported or offered for
                                            2. Prior Notice Submission Training                                                                           as an agent or extension of a foreign
                                                                                                  import without adequate prior notice is
                                               Program From Flexible Alternative                                                                          mail service,’’ at the end of the
                                                                                                  subject to refusal and, if refused, must
                                               Question 7                                                                                                 definition.
                                                                                                  be held. The IFR responded to                              • We added the term,
                                            3. Requests for Additional Outreach
                                                                                                  comments from the public on the                         ‘‘manufacturer,’’ to the final rule.
                                            4. Enforcement Timeframe
                                                                                                  proposed rule, and established a 75-day                 Manufacturer means the last facility, as
                                            5. Enforcement Penalties
                                                                                                  comment period. In order to ensure that                 that word is defined in § 1.227(b)(2),
                                            N. The Joint FDA-CBP Plan for
                                                                                                  those commenting on the IFR had the                     that manufactured/processed the food.
                                               Increasing Integration and
                                                                                                  benefit of FDA’s outreach and                           A facility is considered the last facility
                                               Assessing the Coordination of Prior
                                                                                                  educational efforts and had experience                  even if the food undergoes further
                                               Notice Timeframes
                                            1. Increased Integration                              with the systems, timeframes, and data                  manufacturing/processing that consists
                                            2. General Comments on the Plan                       elements of the prior notice system,                    of adding labeling or any similar activity
                                          IV. Analysis of Economic Impacts                        FDA reopened the comment period for                     of a de minimis nature. If the food
                                            A. Final Regulatory Impact Analysis                      1 Under the Homeland Security Act of 2002
                                                                                                                                                          undergoes further manufacturing/
                                            B. Small Entity Analysis (or Final                    (Public Law 107–296), the Secretary of the Treasury     processing that exceeds an activity of a
                                               Regulatory Flexibility Analysis)                                                                           de minimis nature, then the subsequent
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                                                                                                  has delegated all relevant Customs revenue
                                            C. Small Business Regulatory                          authorities to the Secretary of Homeland Security       facility that performed the additional
                                               Enforcement Fairness Act of 1996                   who has, in turn, delegated them to the                 manufacturing/processing is considered
                                                                                                  Commissioner of the Bureau of Customs and Border
                                               (SBREFA) Major Rule                                Protection (CBP or Customs). Thus, the Secretary is     the manufacturer.
                                          V. Paperwork Reduction Act of 1995                      issuing this final rule jointly with the Secretary of      • We revised the term, ‘‘no longer in
                                          VI. Analysis of Environmental Impact                    Homeland Security.                                      its natural state,’’ by deleting ‘‘waxed’’


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                                          66296             Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations

                                          from the list of actions that render an                 E. How Must You Submit Prior Notice?                  reasons to use when the registration
                                          article of food still in its natural state for          (§ 1.280)                                             number is not provided.
                                          purposes of this subpart.                                                                                        In the IFR, a registration number is
                                                                                                     FDA revised this provision. Under 21
                                             • We revised the term, ‘‘port of                     CFR 1.280(a)(2) (§ 1.280(a)(2)) of the
                                                                                                                                                        not required for a facility associated
                                          arrival’’ to read ‘‘* * * the water, air, or                                                                  with an article of food if the article is
                                                                                                  IFR, prior notice must be submitted via
                                          land port at which the article of food is                                                                     imported or offered for import for
                                                                                                  PNSI for articles of food that have been
                                          imported or offered for import into the                                                                       transshipment, storage, and export, or
                                                                                                  refused under section 801(m)(1) of the
                                          United States. For an article of food                                                                         further manipulation and export. We
                                                                                                  act. Under the final rule, prior notice for
                                          arriving by water or air, this is the port                                                                    have removed this from the final rule
                                                                                                  articles that have been refused under
                                          of unloading. For an article of food                                                                          and are requiring the registration
                                                                                                  section 801(m) of the act must be                     number of the manufacturer (or the full
                                          arriving by land, this is the port where                submitted through PNSI until such time
                                          the article of food first crosses the                                                                         address of the manufacturer and a
                                                                                                  as ACS or its successor system can                    reason) in all circumstances.
                                          border into the United States. The port                 accommodate such transactions.
                                          of arrival may be different than the port                                                                        In the final rule, we have removed the
                                                                                                     FDA also simplified the IFR                        option provided in the IFR that allows
                                          where consumption or warehouse entry                    provisions pertaining to system outages
                                          or foreign trade zone admission                                                                               the label information in § 101.5 (21 CFR
                                                                                                  at § 1.280(b) through (e) by providing                101.5) to be submitted instead of the
                                          documentation is presented to the U.S.                  the outage notification at one Web
                                          Customs and Border Protection (CBP).’’                                                                        name, address, and registration number
                                                                                                  address (http://www.fda.gov) and stating              of the manufacturer for food sent by an
                                             • We revised the term, ‘‘registration                that FDA will accept prior notice                     individual as a personal gift (i.e., for
                                          number,’’ by changing the phrase,                       submissions in the format it deems                    nonbusiness reasons) to an individual in
                                          ‘‘refers to,’’ to ‘‘means,’’ and by adding              appropriate during the system(s) outage.              the United States. FDA notes, however,
                                          the phrase, ‘‘to a facility,’’ after the
                                                                                                  F. What Information Must Be in a Prior                that under the enforcement policy
                                          word, ‘‘assigned,’’ to clarify that FDA
                                                                                                  Notice? (§ 1.281)                                     proposed in the Prior Notice Final Rule
                                          assigns registration numbers by facility.
                                                                                                                                                        Draft CPG, FDA and CBP should
                                             • We revised the term, ‘‘shipper,’’ by                  FDA revised the following                          typically consider not taking any
                                          adding the phrase, ‘‘or express                         information requirements:                             regulatory action when no prior notice
                                          consignment operators or carriers or                       • Submitter: The IFR states that ‘‘if a            is submitted for food imported or
                                          other private delivery service,’’ after                 registration number is provided, city                 offered for import for noncommercial
                                          ‘‘international mail’’ to clarify that a                and country may be provided instead of                purposes with a noncommercial
                                          shipper is involved with various types                  the full address.’’ For clarity, in the final         shipper, irrespective of the type of
                                          of transactions, and not just                           rule, FDA has revised this phrase to                  carrier.
                                          international mail shipments.                           state that ‘‘if the business address of the              • Shipper: The IFR required the name
                                             • We revised the term, ‘‘you,’’ to                   individual submitting the prior notice is             and address of the shipper and, if the
                                          simplify the last phrase of the definition              a registered facility, then the facility’s            shipper is required to register, the
                                          to ‘‘i.e., the submitter or the transmitter,            registration number, city, and country                registration number assigned to the
                                          if any.’’                                               may be provided instead of the facility’s             shipper’s facility; if a registration
                                                                                                  full address.’’ FDA also deleted the                  number is provided, city and country
                                          B. What is the Scope of This Subpart?                   requirement for providing the
                                          (§ 1.277)                                                                                                     may be provided instead of the full
                                                                                                  submitter’s fax number.                               address. The final rule requires the
                                             We revised this provision and added                     • Transmitter: The IFR states that ‘‘if            name and full address of the shipper, if
                                          ‘‘Articles of food subject to Art. 27(3) of             a registration number is provided, city               the shipper is different from the
                                          The Vienna Convention on Diplomatic                     and country may be provided instead of                manufacturer in order to eliminate
                                          Relations (1961), i.e., shipped as                      the full address.’’ For clarity, in the final         duplicative requirements. If the address
                                          baggage or cargo constituting the                       rule, FDA has revised this phrase to                  of the shipper is a registered facility, the
                                          diplomatic bag’’ to the list of food that               state that ‘‘if the business address of the           submitter may submit the registration
                                          does not require prior notice.                          individual submitting the prior notice is             number of the shipper’s registered
                                                                                                  a registered facility, then the facility’s            facility.
                                          C. Who is Authorized to Submit Prior
                                                                                                  registration number, city, and country                   In the IFR, the shipper’s registration
                                          Notice? (§ 1.278)
                                                                                                  may be provided instead of the facility’s             number was not required for a facility
                                            We retain this provision without                      full address.’’ FDA also deleted the                  associated with an article of food if the
                                          change.                                                 requirement for providing the                         article is imported or offered for import
                                                                                                  transmitter’s fax number.                             for transshipment, storage, and export,
                                          D. When Must Prior Notice Be
                                                                                                     • Manufacturer, for food no longer in              or further manipulation and export. We
                                          Submitted to FDA? (§ 1.279)
                                                                                                  its natural state:                                    have removed this from the final rule
                                            FDA revised this provision. Section                      Under the IFR, the name, address, and              because the shipper’s registration
                                          1.279(b) of the IFR states that, except for             registration number of the manufacturer               number is now optional.
                                          international mail, prior notice may not                must be submitted; if a registration                     • Anticipated arrival information:
                                          be submitted more than 5 calendar days                  number is provided, city and country                  Under the final rule, we removed the
                                          before the anticipated date of arrival at               may be provided instead of the full                   requirement for the identity of the
                                          the anticipated port of arrival. We                     address. The final rule requires the                  anticipated border crossing within the
                                          revised this section to permit prior                    name of the manufacturer and either: (1)              port of arrival because FDA and CBP
                                          notice submissions to be submitted no                   The registration number, city and                     have determined that it is no longer
                                          more than 15 calendar days before the                   country of the manufacturer or (2) both               necessary for purposes of
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                                          anticipated date of arrival for                         the full address of the manufacturer and              communication. For post-refusal
                                          submissions made through the PNSI and                   the reason the registration number is not             submissions, actual date the article
                                          no more than 30 calendar days before                    provided. Publishing elsewhere in this                arrived is now a required data element
                                          the anticipated date of arrival for                     issue of the Federal Register, the Prior              so that FDA knows how long it has been
                                          submission made through the ABI/ACS.                    Notice Final Rule Draft CPG lists the                 since the refused food shipment arrived


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                                                            Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations                                          66297

                                          in the United States and how to connect                 privately owned vehicle from the                      J. What Happens to Food That Is
                                          the refused prior notice to the post-                   planned shipment information and                      Imported or Offered for Import From
                                          refusal prior notice submission for                     added this data element to the section                Unregistered Facilities That Are
                                          shipments where a previously refused                    identifying the carrier of the article of             Required to Register Under Subpart H of
                                          prior notice was filed.                                 food (§ 1.281(a)(16) and (c)(16)).                    This Part? (§ 1.285)
                                             The final rule also includes a new
                                                                                                    Table 2, which appears later in this                   The final rule removes the provision
                                          provision for food arriving by express
                                                                                                  preamble, summarizes the information                  in § 1.285(a) that if food is from a
                                          consignment operator or carrier since
                                          certain information may not be available                required in a prior notice.                           foreign manufacturer that is not
                                          to persons who ship food using an                                                                             registered as required and is imported or
                                                                                                  G. What Must You Do If Information                    offered for import, it is subject to refusal
                                          express consignment operator or                         Changes After You Have Received
                                          courier. If the article of food is arriving                                                                   of admission for failure to provide
                                                                                                  Confirmation of a Prior Notice From                   adequate prior notice. It also deletes the
                                          by express consignment operator or
                                                                                                  FDA? (§ 1.282)                                        text in that provision that states that
                                          carrier, and neither the submitter nor
                                          transmitter is the express consignment                                                                        failure to provide the manufacturer’s
                                                                                                    The IFR required that for prior notices             registration number renders the identity
                                          operator or carrier, and the prior notice               submitted via ABI/ACS, the submitter
                                          is submitted via PNSI, the express                                                                            of the facility incomplete for purposes
                                                                                                  should cancel the prior notice via ACS                of prior notice. The final rule retains,
                                          consignment operator or carrier tracking                by requesting that CBP ‘‘delete’’ the
                                          number may be submitted in lieu of the                                                                        with revisions, the provision that states
                                                                                                  entry. FDA has revised the final rule to              that if food is from a foreign facility that
                                          anticipated arrival information.                        state that the submitter should request
                                             • The name and address of the                                                                              is not registered and is imported or
                                          importer, owner, and ultimate                           that CBP ‘‘cancel’’ the entry. Moreover,              offered for import, it is subject to being
                                          consignee: The IFR required the name                    we changed references to ‘‘PN System                  placed under hold under section 801(l)
                                          and address of the importer, owner, and                 Interface’’ to ‘‘PNSI.’’                              of the act.
                                          ultimate consignee, unless the shipment                 H. What Happens to Food That Is                       III. Comments on the IFR
                                          is imported or offered for import for                   Imported or Offered for Import Without
                                          transshipment through the United States                                                                          FDA received 320 timely submissions
                                                                                                  Adequate Prior Notice? (§ 1.283)                      in response to the IFR. To make it easier
                                          under a Transportation and Exportation
                                          (T&E) entry. In the final rule, FDA is                     The IFR stated that refused food must              to identify comments and FDA’s
                                          inserting the word ‘‘full’’ in front of                 be moved under appropriate custodial                  responses to the comments, the word
                                          ‘‘address’’ to make clear that the                                                                            ‘‘Comment’’ will appear in parentheses
                                                                                                  bond. FDA has revised this paragraph in
                                          complete address is required.                                                                                 before the description of the comment,
                                                                                                  the final rule to state that the refused
                                          Consequently, FDA is revising the                                                                             and the word ‘‘Response’’ will appear in
                                                                                                  food must be moved under appropriate
                                          subsequent text to state that if the                                                                          parentheses before FDA’s response. A
                                                                                                  custodial bond unless immediately                     summary follows which includes a
                                          business address of the importer, owner,                exported under CBP supervision. The
                                          or ultimate consignee is a registered                                                                         description of the appropriate section in
                                                                                                  final rule clarifies that the refused food            the final rule.
                                          facility, then the facility’s registration
                                                                                                  may be held at the port or at a secure
                                          number also may be provided in                                                                                A. General Comments
                                          addition to the facility’s full address.                facility outside the port. FDA also
                                             • Planned shipment information:                      changed the timeframe for notifying                      (Comments) Most comments generally
                                          FDA revised this provision by clarifying                FDA of the hold location from within 24               support the intent of the Bioterrorism
                                          that the required planned shipment                      hours of refusal to before the food is                Act and FDA’s efforts to implement its
                                          information is applicable by mode of                    moved to the hold location. For clarity               provisions with the IFR. Some
                                          transportation and when it exists.                      and consistency throughout the final                  comments commend FDA for revising
                                          Moreover, FDA added a new provision                     rule, we are changing the phrase,                     certain proposed requirements to
                                          in the final rule for the Airway Bill                   ‘‘designated location,’’ to ‘‘designated              address the needs of international trade
                                          number/Bill of Lading number and                        secure facility.’’                                    by shortening timeframes, reducing the
                                          flight number since this information is                                                                       amount of information required to be
                                                                                                     Under the section describing FDA
                                          generally not available to individual                                                                         submitted, and adding a reasonable
                                                                                                  review after refusal, FDA revised the
                                          submitters. The final rule provides that                                                                      amount of flexibility for the submission
                                                                                                  final rule by including the carrier as one            of prior notice based on the mode of
                                          for food arriving by express                            of the entities who can submit a request
                                          consignment operator or carrier when                                                                          transportation in the IFR. However,
                                                                                                  for FDA review. FDA also revised the                  several comments assert that the agency
                                          neither the submitter nor transmitter is
                                                                                                  final rule to delete acceptance of                    has misinterpreted the Bioterrorism Act
                                          the express consignment operator or
                                          carrier, the tracking number can be                     requests for review by mail and express               and some comments suggest that the
                                          submitted in lieu of the Bill of Lading                 courier. We are limiting delivery to fax              final rule should be more consistent
                                          or Airway Bill number and the flight                    and e-mail.                                           with the existing trade practices
                                          number for prior notices submitted via                  I. What Are the Other Consequences of                 established in accordance with CBP.
                                          PNSI.                                                   Failing to Submit Adequate Prior Notice                  (Response) FDA drafted the IFR in
                                             FDA also revised the IFR by deleting                                                                       response to the comments to the
                                                                                                  or Otherwise Failing to Comply With
                                          the requirement to provide the                                                                                proposed rule, the needs of
                                                                                                  This Subpart? (§ 1.284)
                                          Harmonized Tariff Schedule (HTS) code                                                                         international trade, and the continued
                                          since FDA and CBP have determined                         We corrected the word ‘‘federal’’ in                threat of international terrorism and
                                          that the HTS code is no longer critical                                                                       other significant risks to public health
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                                                                                                  the IFR to read ‘‘Federal.’’ We also
                                          for communication with CBP.                             corrected the citation to ‘‘section 303 of            posed by imported food. We also drafted
                                             In the final rule, we deleted the                    the act’’ in the IFR to read ‘‘sections 301           the final rule accordingly.
                                          requirement for the license plate                       and 303 of the act.’’                                    (Comments) Several comments
                                          number (and State or Province that                                                                            support the graduated enforcement
                                          issued the license) for food arriving by                                                                      policy the agency used to implement the


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                                          IFR, noting that this policy facilitated                governing the disclosure of information                  (Comments) Several comments
                                          the transition into compliance with the                 under FOIA, including the disclosure of               acknowledge the importance and value
                                          prior notice requirements. Comments                     confidential business information.                    of FDA’s educational outreach efforts to
                                          ask that FDA provide a similar                          Likewise, the agency’s general policies,              the trade industry through scheduled
                                          transition period after publication of the              procedures, and practices relating to the             outreach and education sessions, port-
                                          final rule during which time submitters                 protection of confidential information                specific flyers, foreign government
                                          may become familiar with new                            received from third parties apply to                  training and Web site communications,
                                          requirements, understand the new                        information received under prior notice.              especially those that summarize certain
                                          procedures and adjust business                          We do not believe rules, policies, or                 compliance data. The comments also
                                          processes and practices.                                procedures specific to prior notice are               applaud the unprecedented efforts the
                                             (Response) After publication of the                  needed.                                               FDA has made in this regard.
                                          IFR, FDA published guidance that                           (Comments) One comment states that                    (Response) FDA and CBP will
                                          included a transition period during                     during the period of enforcement                      continue outreach and education efforts
                                          which we emphasized education to                        discretion, various ports of arrival took             as resources permit. See section III.M
                                          achieve compliance (the December 2003                   different approaches to enforcement and               entitled ‘‘Outreach and Enforcement’’
                                          Prior Notice Interim Final Rule CPG) (68                suggests that FDA ensure that all ports               later in this document for further
                                          FR 69708, December 15, 2003). FDA                       and all officials act in a similar fashion            discussion on this subject.
                                          agrees that implementing a graduated                    to achieve a consistent enforcement                      (Comments) Several comments
                                          enforcement policy using enforcement                    posture. The comment also suggests that               commend FDA for its efforts in
                                          discretion has assisted submitters to                   FDA and CBP conduct ‘‘cross-training’’                developing the prior notice regulation in
                                          become accustomed to the new                            of their officials staffing FDA or CBP                an efficient and effective manner,
                                          requirements. The new requirements of                   help desks.                                           reaching out to affected stakeholders for
                                          the final rule will not take effect until                  (Response) All prior notice field                  input and comment, and acknowledge
                                          180 days after publication. Since the                   operations and procedures are directed                the tremendous effort put forth by the
                                          final rule retains most of the                          by the FDA Prior Notice Center (PNC).                 agency in the development of the
                                          requirements found in the IFR, and with                 The PNC works to ensure a consistent                  regulation. Other comments state that
                                          the 180-day delay in effective date, we                 implementation and enforcement                        the rule lacked real world international
                                          are not implementing a graduated                        program. Since the initial                            business input and will have both
                                          enforcement policy for implementing                     implementation of the prior notice rule,              business and government unable to
                                          the final rule.                                         FDA staff has received additional                     function because of the amount of
                                             FDA and CBP have issued elsewhere                    training and guidance on prior notice                 paperwork generated, which will not
                                          in this issue of the Federal Register a                 requirements.                                         stop a terrorist attack. In particular, one
                                          new CPG (hereinafter the Prior Notice                      (Comments) Several comments                        comment notes that tracing a grower of
                                          Final Rule Draft CPG) that explains our                 acknowledge the efforts of CBP and FDA                a particular shipment is impossible in
                                          proposed policies for enforcing                         to work together to achieve the common                many instances.
                                          violations of this final rule. The draft                goal of securing the imported food                       (Response) FDA and CBP systems
                                          CPG describes the circumstances under                   supply. In particular, comments                       have been able to manage the millions
                                          which FDA and CBP should typically                      congratulate FDA for coordinating with                of prior notice submissions received,
                                          consider not taking any regulatory                      CBP to allow transmission of FDA-                     reviewed, and responded to since
                                          action, the types of violations FDA and                 required information through the ABI to               December 12, 2003. The agencies strove
                                          CBP intend to focus on, and other                       CBP’s ACS. In addition, comments                      to implement the requirements in the
                                          enforcement policies.                                   support the integration and cooperation               Bioterrorism Act in a manner that
                                             (Comments) Several comments thank                    of both agencies in utilizing CBP’s                   required only that information deemed
                                          FDA for providing an opportunity to                     targeting system to efficiently and                   necessary and appropriate to ensure
                                          provide comments on the provisions of                   rapidly spot anomalies in freight                     FDA could meet its statutory obligation
                                          the IFR after a period of active FDA/CBP                crossing our borders; reducing the FDA                to receive, review and respond to prior
                                          enforcement.                                            proposed timeframes for submission of                 notices and target those shipments
                                             (Response) FDA agrees that providing                 prior notice in the advance electronic                needing inspection upon arrival in the
                                          several comment periods following                       information requirements; and the                     United States. Based on FDA’s and
                                          publication of the IFR has permitted                    commissioning of CBP staff to conduct                 CBP’s experience since December 2003,
                                          affected stakeholders an additional                     examinations and investigations. One                  the agencies have revised some of the
                                          opportunity to offer specific and                       comment requests that CBP and FDA                     requirements in the IFR and eliminated
                                          informed comments on the new                            ensure that there are adequate resources              some of the information we no longer
                                          requirements.                                           at ports of arrival to mitigate anticipated           deem necessary (e.g., HTS codes). FDA
                                             (Comments) One comment requests                      delays at border crossings when the rule              notes that the grower of a food in its
                                          that FDA clarify that prior notices                     is enforced. Several comments                         natural state is required only when
                                          submitted to FDA will not be subject to                 anticipated that trade would collapse on              known.
                                          public disclosure under the Freedom of                  December 12, 2003, when the new                          (Comments) One comment suggests
                                          Information Act (5 U.S.C. 552, et seq.)                 regulations took effect.                              that the prior notice IFR is ‘‘functionally
                                          (FOIA) because information contained                       (Response) FDA and CBP are                         redundant’’ because prior notice has
                                          in a prior notice is confidential business              continuously coordinating efforts to                  long been a part of FDA protocol long
                                          information. Alternatively, the comment                 receive, review, and respond to prior                 before the Bioterrorism Act.
                                          requests that FDA develop policies to                   notice submissions. We further note that                 (Response) While FDA agrees that
                                          protect confidential business                           trade continued without significant                   most of the information required by the
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                                          information contained in prior notices                  interruption on December 12, 2003, or                 IFR has been submitted to FDA via CBP
                                          from public disclosure.                                 anytime after that implementation date.               processes for decades, the information
                                             (Response) FDA does not believe this                 Rather, the implementation of the prior               has not been required prior to arrival of
                                          is necessary. FDA already has relatively                notice requirements was relatively                    the food, making prior notice a new,
                                          detailed regulations, in 21 CFR part 20,                smooth.                                               unique, and valuable process.


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                                             (Comments) One comment suggests                      Bioterrorism Act mandates.                            over which both FDA and USDA have
                                          that the IFR was unduly costly, ill-                    Accordingly, we have made a number of                 jurisdiction. For example, both FDA and
                                          considered and generally more harmful                   changes in the final rule that minimize               USDA’s Animal and Plant Health
                                          than useful. An additional comment                      the impact of prior notice requirements               Inspection Service (APHIS) regulate the
                                          believes that the prior notice                          on the food being imported or offered                 importation of fruits and vegetables into
                                          requirements would restrict trade more                  for import into the United States. We                 the United States, although the goal of
                                          than necessary and hopes that the                       also note that the registration                       APHIS’ regulation is to safeguard U.S.
                                          United States will implement the                        requirement applies to domestic                       agriculture and natural resources from
                                          Bioterrorism Act in the least trade-                    facilities, as well as foreign facilities,            the risks associated with the plant pests.
                                          restrictive manner. Another comment                     and that the registration provisions in               Nonetheless, FDA does not believe that
                                          states that despite efforts to comply with              the Bioterrorism Act contain certain                  there is a need to have USDA
                                          the new requirements, massive                           exclusions that apply only to foreign                 implement the prior notice
                                          problems seem to constantly occur.                      facilities. (See e.g., 21 CFR 1.226(a),               requirements for products for which we
                                          Another comment complains about                         which exempts from the requirement to                 share jurisdiction, nor do we believe
                                          accessibility to the Web site, cost and                 register a foreign facility, if food from             that doing so would lead to an efficient
                                          time of the submission procedures,                      such facility undergoes further                       enforcement of the prior notice
                                          language barriers, and complexity of the                manufacturing/processing (including                   requirements. The Bioterrorism Act
                                          information requested.                                  packaging) by another facility outside                mandates that advance notice be given
                                             (Response) FDA disagrees. The prior                  the United States; no similar exclusion               to FDA for any article of food that is
                                          notice process, which allows                            applies to facilities within the Unites               being imported or offered for import
                                          submission of the required information                  States.)                                              into the United States and that the
                                          via either ABI/ACS or PNSI, has been                      (Comments) Other comments suggest                   Secretary receive, review, and
                                          relatively smooth. Although there were                  that the IFR failed to include a provision            appropriately respond to such
                                          some technical problems encountered                     that would ensure that high risk imports              notifications. To accomplish this, FDA
                                          during the early implementation phase,                  arrive at ports staffed by FDA inspection             established the PNC that operates 24
                                          FDA believes that the graduated                         personnel and notes that this could be                hours a day, 7 days a week, to receive,
                                          enforcement process coupled with the                    accomplished by designating particular                review, and respond to these notices as
                                          vigorous education and outreach efforts                 ports of entry for accepting high risk                they are submitted. The purpose of prior
                                          by both the government and the                          products or requiring importers of such               notice is to enable FDA to conduct
                                          industry have supported a relatively                    products to provide longer notice to                  inspections of imported foods at U.S.
                                          smooth transition to the new procedures                 ensure adequate inspection coverage.                  ports upon arrival and target foods that
                                          and have improved compliance with the                     (Response) FDA disagrees. Section                   may pose a significant risk to public
                                          new requirements. FDA also has                          307 of the Bioterrorism Act specifically              health, based on the information
                                          considered its international trade                      prohibits FDA from limiting the port of               submitted.
                                          obligations under various World Trade                   entry by stating, ‘‘Nothing in this                     Prior Notice is submitted
                                          Organization agreements, North                          section may be construed as a limitation              electronically to FDA through either
                                          America Free Trade Agreement, and                       on the port of entry for an article of                Customs’ ABI/ACS or FDA’s PNSI.
                                          other international agreements                          food.’’ We also disagree that certain                 Regardless of the mode of transmission,
                                          throughout the rulemaking development                   shipments require longer timeframes for               the prior notice information will
                                          processes for both the IFR and this final               submission of prior notice to ensure                  undergo both a validation process and a
                                          rule. Both rules are consistent with our                adequate inspection coverage. Under a                 screening in FDA’s Operational and
                                          international obligations.                              Memorandum of Understanding (MOU)                     Administrative System for Import
                                             (Comments) Some comments believe                     between FDA and CBP, published on                     Support (OASIS) for food safety and
                                          there is a disincentive towards product                 January 7, 2004 (69 FR 924), FDA has                  security criteria. If the FDA system does
                                          diversification when exporting articles                 commissioned thousands of CBP                         not indicate that further evaluation of or
                                          of food to the United States because the                officers in ports and other locations to              action on the notice or article of food is
                                          prior notice requirements put them at a                 conduct, on FDA’s behalf, investigations              necessary for prior notice, the system
                                          competitive disadvantage compared to                    and examinations of imported foods.                   will transmit a message through OASIS
                                          shipments that originate in the United                  This helps ensure that there is adequate              to the ABI/ACS interface for CBP that
                                          States.                                                 inspection coverage, including at ports               the article of food may be conditionally
                                             (Response) The requirement for prior                 where FDA does not currently have                     released. However, if additional
                                          notice was established by Congress with                 personnel.                                            evaluation of the prior notice
                                          the passage of the Bioterrorism Act to                                                                        information is necessary, personnel at
                                          improve the ability of the United States                B. Comments on the Legal Authority                    the FDA’s PNC will access the
                                          to prevent, prepare for, and respond to                   (Comments) One comment requests                     information provided and determine if
                                          bioterrorism and other public health                    that FDA delegate authority to the U.S.               that information suggests the potential
                                          emergencies. Section 307 of the                         Department of Agriculture (USDA), as it               for a significant risk to public health.
                                          Bioterrorism Act requires prior notice of               has with CBP, to enable USDA to                         FDA personnel are able to make this
                                          all food imported or offered for import                 implement prior notice requirements on                determination by using their experience
                                          into the United States. FDA is aware of                 products where the USDA shares                        of imported foods, utilizing the
                                          the international trade obligations of the              jurisdiction.                                         expertise within the Center for Food
                                          United States and has considered these                    (Response) FDA disagrees. FDA has                   Safety and Nutrition (CFSAN), the
                                          obligations throughout the rulemaking                   not delegated its authority under section             Center for Veterinary Medicine (CVM),
                                          process for this final rule and the IFR                 801(m) of the act to CBP, although FDA                the inspectional information obtained
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                                          preceding it. Both are consistent with                  has commissioned CBP officers in ports                by the Office of Regulatory Affairs
                                          these international obligations. FDA and                and other locations to conduct, on                    (ORA), and utilizing the expertise of
                                          CBP have actively explored ways to                      FDA’s behalf, investigations and                      CBP staff who are co-located with the
                                          reduce the burden on industry to the                    examinations of imported foods. FDA                   PNC. If FDA determines that a potential
                                          extent feasible while fulfilling the                    recognizes that there are some products               health risk is present, FDA or CBP will


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                                          66300             Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations

                                          examine the food or take other                          made minor revisions to these                         6. Full Address (§ 1.276(b)(6))
                                          appropriate action.                                     definitions. We also added a definition                  The IFR did not have a definition for
                                             Evaluations of imported articles of                  for the term, ‘‘full address,’’ although we           the term, ‘‘full address.’’ However, we
                                          food are made on an article-of-food by                  did not get any comments on this term.                added this term to the final rule for
                                          article-of-food basis. CBP and FDA are                                                                        clarity since this term is used
                                          continuously working together to                        1. The Act (§ 1.276(a))
                                                                                                                                                        throughout the rule. The final rule
                                          incorporate further intelligence gained                   The final rule defines ‘‘the act’’ to               defines ‘‘full address’’ to mean ‘‘the
                                          from this process. The recent addition of               mean ‘‘the Federal Food, Drug, and                    facility’s street name and number; suite/
                                          USDA personnel to assist in the sharing                 Cosmetic Act.’’                                       unit number, as appropriate; city;
                                          of information affecting the safety and                                                                       Province or State as appropriate; mail
                                          security of imported foods will help                    2. Calendar Day (§ 1.276(b)(1))
                                                                                                                                                        code as appropriate; and country.’’
                                          further this effort.
                                             FDA does note that food items that are                 The final rule defines ‘‘calendar day’’             7. Grower (§ 1.276(b)(7))
                                          under the exclusive jurisdiction of the                 to mean ‘‘every day shown on the
                                                                                                  calendar.’’                                              The final rule defines ‘‘grower’’ to
                                          USDA are not subject to the                                                                                   mean ‘‘a person who engages in growing
                                          requirements of prior notice. (See the                  3. Country From Which the Article                     and harvesting or collecting crops
                                          discussion on § 1.277 (scope), discussed                Originates (§ 1.276(b)(2))                            (including botanicals), raising animals
                                          infra.)                                                                                                       (including fish, which includes
                                             (Comments) Another comment                              The final rule defines ‘‘country from              seafood), or both.’’
                                          suggests that to be consistent with the                 which the article originates’’ to mean
                                          Bioterrorism Act, FDA should permit an                  ‘‘FDA Country of Production.’’                        8. Registration Number (§ 1.276(b)(13))
                                          alternative to prior notice for                                                                                  The final rule defines ‘‘registration
                                          administrative flexibility. The                         4. Country From Which the Article is
                                                                                                  Shipped (§ 1.276(b)(3))                               number’’ to mean ‘‘the registration
                                          comments suggest that this could be                                                                           number assigned to a facility by FDA
                                          accomplished by including in the final                     The final rule defines ‘‘country from              under section 415 of the act (21 U.S.C.
                                          rule a provision which states, ‘‘Other                  which the article is shipped’’ to mean                350d) and subpart H of this part.’’ FDA
                                          measures as appropriate that provide an                 ‘‘the country in which the article of food            made a minor change in this definition
                                          equivalent level of assurance of                        is loaded onto the conveyance that                    in the final rule by adding the phrase
                                          compliance with the requirements of                     brings it to the United States or, in the             ‘‘to a facility’’ after the word ‘‘assigned’’
                                          this part.’’                                                                                                  to clarify that FDA assigns registration
                                                                                                  case of food sent by international mail,
                                             (Response) FDA disagrees. Section
                                                                                                  the country from which the article is                 numbers by facility.
                                          801(m) of the act requires the
                                          submission of prior notice for all food                 mailed.’’ For clarity, we revised the last            9. United States (§ 1.276(b)(15))
                                          imported or offered for import into the                 phrase of this definition to change, ‘‘the
                                                                                                  country in which the article will be                     The final rule defines ‘‘United States’’
                                          United States, except as outlined in                                                                          to mean ‘‘the Customs territory of the
                                          § 1.277(b). FDA is to use that                          mailed’’ to ‘‘the country from which the
                                                                                                  article is mailed.’’                                  United States (i.e., the 50 States, the
                                          information to determine whether it                                                                           District of Columbia, and the
                                          should inspect the food upon arrival in                 5. FDA Country of Production                          Commonwealth of Puerto Rico), but not
                                          the United States. Compliance with                      (§ 1.276(b)(4))                                       the Territories.’’
                                          prior notice, therefore, means providing
                                          the required information within the                       The final rule defines ‘‘FDA Country                10. You (§ 1.276(b)(16))
                                          specified timeframes. No other                          of Production’’ to mean, for an article of               The final rule defines ‘‘you’’ to mean
                                          ‘‘measures’’ would ‘‘provide an                         food that is in its natural state, the                ‘‘the person submitting the prior notice,
                                          equivalent level of assurance of                        country where the article of food was                 i.e., the submitter or the transmitter, if
                                          compliance’’ with the prior notice                      grown, including harvested or collected               any.’’ We made a minor change to this
                                          requirements.                                           and readied for shipment to the United                definition by simplifying the last phrase
                                                                                                  States. If an article of food is wild fish,           of the definition to ‘‘i.e., the submitter
                                          C. What Definitions Apply to This                       including seafood that was caught or
                                          Subpart? (§ 1.276)                                                                                            or the transmitter, if any.’’
                                                                                                  harvested outside the waters of the                      FDA received comments on the
                                             Section 1.276 of the IFR provides                    United States by a vessel that is not                 definitions for the following terms in
                                          definitions for the following terms: The                registered in the United States, the FDA              the IFR: food, international mail, no
                                          act, calendar day, country from which                   Country of Production is the country in               longer in its natural state, port of arrival,
                                          the article originates, country from                    which the vessel is registered. If an                 and shipper. FDA also received
                                          which the article is shipped, FDA                       article of food that is in its natural state          comments that recommend that FDA
                                          Country of Production, food, grower,                    was grown, including harvested or                     include additional definitions for the
                                          international mail, no longer in its                    collected and readied for shipment, in a              following terms in the IFR: Carrier,
                                          natural state, port of arrival, port of                 Territory, the FDA Country of                         manufacturer, trip number, and ultimate
                                          entry, registration number, shipper,                    Production is the United States. For an               consignee. FDA responds to these
                                          United States, and you. FDA received                    article of food that is no longer in its              comments in the following paragraphs.
                                          no comments on the definitions for the                  natural state, the country where the
                                          act, calendar day, country from which                   article was made; except that, if an                  11. Food (§ 1.276(b)(5))
                                          the article originates, FDA Country of                  article of food is made from wild fish,                 The IFR defines ‘‘food’’ as having the
                                          Production, grower, and United States,                  including seafood, aboard a vessel, the               meaning given in section 201(f) of the
                                          and thus, the final rule retains the                    FDA Country of Production is the                      act, except that it does not include food
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                                          definitions for these terms that were in                country in which the vessel is                        contact substances as defined in section
                                          the IFR. Although no comments were                      registered. If an article of food that is no          409(h)(6) of the act (21 U.S.C. 348(h)(6))
                                          received on the definitions for ‘‘country               longer in its natural state was made in               or pesticides as defined in 7 U.S.C.
                                          from which the article is shipped,’’                    a Territory, the FDA Country of                       136(u). Examples of food include fruits,
                                          ‘‘registration number,’’ and ‘‘you,’’ we                Production is the United States.                      vegetables, fish, including seafood,


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                                                            Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations                                                    66301

                                          dairy products, eggs, raw agricultural                  direct food additive is not a food contact            to be directed to a food use. This should
                                          commodities for use as food or as                       substance but is a food processing aid,               make it clearer that, as explained in the
                                          components of food, animal feed                         then it would be subject to prior notice.             preamble to the IFR, the determination
                                          (including pet food), food and feed                        (Comments) Two comments ask the                    is not based on the intended use of the
                                          ingredients, food and feed additives,                   FDA to clarify the term, ‘‘reasonably                 article (68 FR 58974 at 58987).
                                          dietary supplements and dietary                         expected to be directed to a food use.’’                 In one of the comments, the seed will
                                          ingredients, infant formula, beverages                  One comment states that seed produced                 ‘‘inevitably’’ contain remnant seed and
                                          (including alcoholic beverages and                      by seed companies is intended to be                   culls that will be diverted to human or
                                          bottled water), live food animals, bakery               used for planting crops, but the                      animal feed. In this case, since at the
                                          goods, snack foods, candy, and canned                   production process inevitably results in              time of import, the seed is reasonably
                                          foods.                                                  remnant or culled seed that is suitable               likely to be directed to a food use, prior
                                             (Comments) One comment asks FDA                      for use as animal feed (and to a far lesser           notice is required. FDA believes this is
                                          to define food contact substances, which                degree, as food for human                             consistent with the purpose of the
                                          are exempt from the requirements of                     consumption), which generally is sold                 Bioterrorism Act. With respect to the
                                          prior notice, to include secondary direct               by the seed company as such. The                      other comment about seeds found
                                          food additives. The comment reasons                     comment states that a similar issue                   ‘‘unsuitable’’ for planting, there is
                                          that secondary direct food additives,                   arises with some crops, such as onions,               insufficient detail in the comment to
                                          many of which are food processing aids,                 for which bulbs sold to farmers may also              determine whether these seeds would
                                          meet the criteria for food contact                      be used as feed or, in limited cases, as              be considered food.
                                          substances as defined in section                        food if they are determined to be                        Nonetheless, we note that the Prior
                                          409(h)(6) of the act (21 U.S.C. 348(h)(6)).             remnant or culled. The comment                        Notice Final Rule Draft CPG, announced
                                          The comment further reasons that                        believes that FDA should provide                      elsewhere in this issue of the Federal
                                          secondary direct food additives meet the                specific limitations on the definitions of            Register, proposes an enforcement
                                          criteria that FDA used in the registration              ‘‘reasonably believes’’ and ‘‘reasonably              policy regarding seeds for planting.
                                          IFR to exclude food contact materials                   expected’’ that take into consideration               Under the draft policy, FDA and CBP
                                          from the requirements of the registration               that the seed produced by seed                        would typically consider not taking any
                                          IFR as they are not ‘‘food for                          companies is intended to be used for                  regulatory action regarding seeds that
                                          consumption’’ in that ‘‘they are not                    planting crops, even though it is                     will be used for cultivation. The policy
                                          intentionally eaten for their taste,                    understood that there inevitably will be              would apply when no more than a small
                                          aroma, or nutritive value’’ (68 FR 58894                some remnant seed and culls. Without                  portion of that seed is diverted from
                                          at 58911).                                              such limitations, the comment believes                cultivation to animal feed or other food
                                             (Response) Some secondary direct                     the rule is unreasonably broad, imposes               use. It would not apply, however, where
                                          food additives meet the definition of                   a burden on seed companies primarily                  the seed is used for the production of
                                          food contact substances as given in                     marketing seeds for planting purposes                 edible sprouts, such as alfalfa seeds for
                                          section 409(h)(6) of the act and,                       that is out of proportion to the                      the production of alfalfa sprouts.
                                          therefore, would not be subject to the                  protective goals of the act, and is subject              (Comments) One comment states that
                                          prior notice requirements                               to widely varying interpretations.                    the Bioterrorism Act regulations do not
                                          (§ 1.276(b)(5)(i)(A)). The comment,                     Another comment notes that the seed                   present a means to provide FDA with
                                          however, asks about secondary direct                    industry’s research and development                   certification that any of the indicated
                                          food additives that are not food contact                activities generate very small amounts                persons (i.e., submitter, transmitter,
                                          substances, for example food processing                 of seed that may be found ‘‘unsuitable’’              manufacturer, grower, shipper,
                                          aids. The IFR concluded that food                       for planting and end up in the food                   importer, owner, or ultimate consignee)
                                          processing aids that are not food contact               supply, and similarly asks for                        do not reasonably believe that an item
                                          substances are subject to prior notice                  clarification of the ‘‘reasonably                     is reasonably expected to be directed to
                                          ‘‘Whether a food processing aid or                      believes’’ and ‘‘reasonably expected’’                a food use prior to arrival at a U.S. port.
                                          ‘indirect additive’ is subject to prior                 language.                                             The comment further states that there is
                                          notice depends upon whether such a                         (Response) In the preamble to the IFR,             no method to avoid classifying their
                                          substance is ‘food’ under this rule. As                 we state that ‘‘FDA will consider a                   products as anything other than those
                                          noted, for purposes of the interim final                product as one that will be used for food             flagged as FD4 2 articles requiring prior
                                          rule, ‘food’ excludes ‘food contact                     if any of the persons involved in
                                          substances’ as defined at section                       importing or offering the product for                   2 HTS codes are ‘‘flagged’’ in ACS as follows to

                                          409(h)(6) of the FD&C Act. Among other                  import (e.g., submitter, transmitter,                 indicate that products are or may be under FDA
                                                                                                                                                        jurisdiction:
                                          things, unlike food processing aids and                 manufacturer, grower, shipper,                          FD0—Indicates that FDA has determined the
                                          ‘indirect additives,’ ‘food contact                     importer, owner, or ultimate consignee)               article, even though subject to FDA’s laws and
                                          substances’ are not ‘intended to have                   reasonably believes that the substance is             regulations, is acceptable for CBP release without
                                          any technical effect in food,’ [section                 reasonably expected to be directed to a               further presentation of prior notice or other entry
                                                                                                                                                        information to FDA.
                                          409(h)(6) of the act]. In addition, ‘food’              food use’’ (68 FR 58974 at 58987). The
                                                                                                                                                          FD1—Indicates that the article may be subject to
                                          excludes pesticides as defined at 7                     purpose of this statement was to explain              FDA jurisdiction, including FDA review under
                                          U.S.C. 136(u). Thus, if the substance is                when an article of food would be subject              801(a) of the act. For products not subject to FDA
                                          not a pesticide and is intended to have                 to prior notice if it is capable of multiple          jurisdiction, a filer can ‘‘Disclaim’’ product from
                                          a technical effect in the food being                    uses. The comments, and our                           FDA notification requirements.
                                                                                                                                                          FD2—Indicates that the article is under FDA
                                          processed, the substance is not exempt                  experience with the IFR, have shown                   jurisdiction and review of entry information by
                                          from the definition of ‘food’ under                     that there is some confusion as to how                FDA under section 801(a) of the act will take place.
                                          § 1.276(b)(5) in the interim final rule.                to determine when a substance that is
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                                                                                                                                                        However, the article is not ‘‘food’’ for which prior
                                          This is a reasonable result in that such                capable of a food use and a nonfood use               notice information is required.
                                          processing aids are intentionally and                   is a ‘‘food’’ for purposes of prior notice.             FD3—Indicates that the article may be subject to
                                                                                                                                                        prior notice under section 801(m) of the act and 21
                                          directly added to ‘traditional’ foods.’’                To clarify, we will consider such a                   CFR Part 1, subpart I. , e.g., the article has both food
                                          (68 FR 58974 at 58986). We continue to                  substance to be ‘‘food’’ for the purpose              and nonfood uses.
                                          hold this view. Thus, if a secondary                    of prior notice if it is reasonably likely                                                          Continued




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                                          notice, thereby providing no means to                   continuously reviewing and updating                      (Comments) One comment asks FDA
                                          avoid refusal of the goods upon arrival                 the FD flags associated with the HTS                  to define international mail to include
                                          because the prior notice was not filed.                 codes. If you have questions regarding                express carriers. Another comment asks
                                             (Response) FDA disagrees. FDA is                     whether prior notice is required for a                FDA to clarify whether sending an item
                                          continuously reviewing the FD3 and                      particular article of food, contact the               by express delivery will be considered
                                          FD4 flags associated with HTS codes.                    PNC for assistance. Furthermore, we                   ‘‘international mail’’ or ‘‘express
                                          The HTS codes are flagged to indicate                   have established procedures in place to               carrier.’’
                                          which products will (FD4) or may (FD3)                  disclaim articles of food the submitter                  (Response) FDA declines to make the
                                          require prior notice and which product                  believes does not require prior notice.               requested change. The IFR defines
                                          will or may require FDA review under                    This can be accommodated by ABI/ACS                   ‘‘international mail’’ to mean ‘‘foreign
                                          section 801(a) of the act for                           as an affirmation of compliance.                      national mail services’’ and expressly
                                          admissibility; all FDA-regulated                           (Comments) One comment states that                 excluded express carriers, express
                                          products are covered, not just foods. If                the list of HTS codes flagged for prior               consignment operators, or other private
                                          you believe that an item has been                       notice (both FD3 and FD4) (as provided                delivery services from the definition.
                                          incorrectly flagged, you should contact                 by Customs Admin message 03–2605                      We retain this definition in the final
                                          the FDA and provide a statement that                    dated October 31, 2003) contains 762                  rule but revised the wording to make the
                                          explains your rationale. The designation                tariff numbers. The comment asks if this              definition easier to read, and to add the
                                          will be reviewed and action taken to                    is a definitive list at this point,                   phrase, ‘‘unless such service is
                                          correct the flag if deemed appropriate.                 especially since FDA and CBP estimated                operating under contract as an agent or
                                          With respect to the comment about                       the number to be around 2,000.                        extension of a foreign mail service,’’ at
                                          providing certification about the belief                   (Response) This is not a definitive list.          the end of the definition. This phrase
                                          of the ‘‘indicated persons,’’ submitters                FDA and CBP are continuously                          was needed to clarify that a contractor
                                          may disclaim articles of food marked                    reviewing and updating the FD flags                   working for a foreign mail service also
                                          FD3 if the article is not reasonably likely             associated with the HTS codes.                        is included in the definition of
                                          to be directed to a food use by using an                Guidance regarding the HTS flags is                   ‘‘international mail.’’ International mail
                                          affirmation of compliance in ABI/ACS.                   posted at http://www.cfsan.fda.gov/                   is a function of the foreign postal
                                             (Comments) Many comments address                                                                           organizations of sovereign countries
                                                                                                  ~dms/htsguid3.html. The lack of an
                                          the FD flags associated with the HTS                                                                          who are members of the International
                                                                                                  FD3 or FD4 designation does not mean
                                          codes. Two comments state that they are                                                                       Postal Union. International mail
                                                                                                  that prior notice is not required. If the
                                          currently importing a product that was                                                                        shipments generally do not utilize any
                                                                                                  article of food fits the definition of food
                                          flagged FD4, which requires that prior                                                                        of the electronic data transmission
                                                                                                  provided in § 1.276 of the final rule,
                                          notice be submitted for that article.                                                                         systems commonly used by express
                                                                                                  then prior notice is required for that
                                          However, the item is not an article of                                                                        consignment carriers and private
                                                                                                  article of food.
                                          food and the commenter would like the                                                                         delivery services.
                                                                                                     (Final rule) Section 1.276(b)(5) of the               (Final rule) Section 1.276(b)(8) of the
                                          HTS code changed from a FD4 flag to a                   final rule defines ‘‘food’’ as having the
                                          FD3 flag. An additional comment had                                                                           final rule defines ‘‘international mail’’ to
                                                                                                  meaning given in section 201(f) of the                mean foreign national mail services.
                                          concerns about multiple use products,                   act, except that it does not include food
                                          where one use would require prior                                                                             International mail does not include
                                                                                                  contact substances as defined in section              express consignment operators or
                                          notice and another use would not.                       409(h)(6) of the act (21 U.S.C. 348(h)(6))
                                          Another comment states that there is no                                                                       carriers or other private delivery
                                                                                                  or pesticides as defined in 7 U.S.C.                  services unless such service is operating
                                          clear methodology provided to disclaim                  136(u). Examples of food include fruits,
                                          an item beyond the initial FD3                                                                                under contract as an agent or extension
                                                                                                  vegetables, fish, including seafood,                  of a foreign mail service.
                                          designation. The comment recommends                     dairy products, eggs, raw agricultural
                                          that the agency outline the elements of                 commodities for use as food or as                     13. Manufacturer (§ 1.276(b)(9))
                                          a due diligence protocol that would                     components of food, animal feed                          (Comments) Two comments request
                                          become part of the disclaimer process.                  (including pet food), food and feed                   that we define the word
                                          One comment suggested that the data                     ingredients, food and feed additives,                 ‘‘manufacturer.’’ One of these suggests
                                          elements in the prior notice submission                 dietary supplements and dietary                       that we define ‘‘manufacturer’’ to mean
                                          be amended to permit an affirmation                     ingredients, infant formula, beverages                the last entity to conduct a processing
                                          that a substance is not directed for a                  (including alcoholic beverages and                    operation; e.g., including bottling but
                                          food use. This would avoid the article                  bottled water), live food animals, bakery             excluding labeling.
                                          of food from being refused if the prior                 goods, snack foods, candy, and canned                    (Response/Final rule) As discussed in
                                          notice was submitted for a category that                foods.                                                section III.H.7.a of this document, FDA
                                          required prior notice. Another comment
                                                                                                     We revised this definition for clarity             agrees and has added a definition for
                                          wants FDA to develop a method that
                                                                                                  in the final rule by adding the phrase,               manufacturer. Section 1.276(b)(9) of the
                                          would allow the submitter or the
                                                                                                  ‘‘except as provided in paragraph                     final rule defines manufacturer as the
                                          transmitter to disclaim the need for
                                                                                                  (b)(5)(i) of this section,’’ in the first             last facility, as that word is defined in
                                          prior notice at the time of the prior
                                                                                                  sentence; and reworded paragraph                      § 1.227(b)(2) (in the registration rule),
                                          notice transmission.
                                                                                                  (b)(5)(i) to read, ‘‘For purposes of this             that manufactured/processed the food.
                                             (Response) If there is a concern
                                                                                                  subpart, food does not include:’’.                    A facility is considered the last facility
                                          regarding the FD flags associated with
                                                                                                                                                        even if the food undergoes further
                                          the HTS codes, you should contact FDA                   12. International Mail (§ 1.276(b)(8))
                                                                                                                                                        manufacturing/processing that consists
                                          and provide a detailed description of
                                                                                                    The IFR defines ‘‘international mail’’              of adding labeling or any similar activity
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                                          why you believe the HTS code is flagged
                                                                                                  to mean foreign national mail services.               of a de minimis nature. If the food
                                          incorrectly. FDA and CBP are
                                                                                                  International mail does not include                   undergoes further manufacturing/
                                            FD4—Indicates that the article is ‘‘food’’ for
                                                                                                  express carriers, express consignment                 processing that exceeds an activity of a
                                          which prior notice is required under section 801(m)     operators, or other private delivery                  de minimis nature, then the subsequent
                                          of the act and 21 CFR Part 1, subpart I.                services.’’                                           facility that performed the additional


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                                          manufacturing/processing is considered                  the prior notice requirements. In the                 on the vehicle or vessel, then the port
                                          the manufacturer.                                       second edition of ‘‘Questions and                     of arrival definition has not been met for
                                                                                                  Answers Regarding the Interim Final                   these and only these articles. Another
                                          14. No Longer in Its Natural State
                                                                                                  Rule on Prior Notice of Imported Food                 comment reports being told by FDA
                                          (§ 1.276(b)(10))
                                                                                                  (Edition 2)’’ (the prior notice question              representatives that when a ship arrives
                                             The IFR defines ‘‘no longer in its                   and answer guidance document)                         from Europe, only goods ‘‘off loaded’’ in
                                          natural state’’ to mean that ‘‘an article of            available at http://www.cfsan.fda.gov/                that port must be given prior notice
                                          food has been made from one or more                     ~pn/pnqagui2.html, issued May 2004,                   within the timeframes required. If the
                                          ingredients or synthesized, prepared,                   under section B, Definitions, question                ship has food destined to be ‘‘off
                                          treated, modified, or manipulated.                      4.1 of the guidance, we discuss seeds. If             loaded’’ in other ports, prior notice must
                                          Examples of activities that render food                 the seed will be used only for sowing or              be filed for each port in accordance with
                                          no longer in its natural state are cutting,             planting, and not directed to food use,               the timeframes required by the
                                          peeling, trimming, washing, waxing,                     then no prior notice is required and,                 regulations. The comments ask FDA to
                                          eviscerating, rendering, cooking, baking,               therefore, there is no need to determine              clarify this definition.
                                          freezing, cooling, pasteurizing,                        whether the seeds are in their natural                   (Response) FDA agrees to clarify the
                                          homogenizing, mixing, formulating,                      state for the purposes of prior notice.               term, ‘‘port of arrival,’’ as it is a required
                                          bottling, milling, grinding, extracting                    Regarding the other comments, the                  data element in a prior notice and
                                          juice, distilling, labeling, or packaging.              definition for ‘‘no longer in its natural             important for gauging the timeframes for
                                          Crops that have been cleaned (e.g.,                     state’’ in the final rule already states that         prior notice submission. The interim
                                          dusted, washed), trimmed, or cooled                     trimmed or washed produce is still in                 final rule defined ‘‘port of arrival’’ as
                                          attendant to harvest or collection or                   its natural state, if those activities are            ‘‘the water, air, or land port at which the
                                          treated against pests, waxed, or polished               attendant to harvest or collection. This              article of food is imported or offered for
                                          are still in their natural state for                    same definition states that waxing and                import into the United States, i.e., the
                                          purposes of this subpart. Whole fish                    packaging are activities that render food             port where the article of food first
                                          headed, eviscerated, or frozen attendant                no longer in its natural state.                       arrives in the United States.’’ In essence,
                                          to harvest are still in their natural state                (Final Rule) Section 1.276(b)(10) of               the comments ask us to identify the
                                          for purposes of this subpart.’’                         the final rule defines ‘‘no longer in its             point at which an article of food ‘‘first
                                             (Comments) One comment asks FDA                      natural state’’ to mean that ‘‘an article of          arrives’’ in the United States when the
                                          to clarify the term, ‘‘no longer in its                 food has been made from one or more                   food is arriving by water.
                                          natural state’’ by expressly stating that               ingredients or synthesized, prepared,                    The preambles to the proposed rule
                                          seed for sowing or planting that are                    treated, modified, or manipulated.                    and IFR explained that for FDA to be
                                          shucked, sorted and sized remain ‘‘in                   Examples of activities that render food               able to protect U.S. consumers from
                                          their natural state’’ for purposes of prior             no longer in its natural state are cutting,           terrorism or other food-related
                                          notice. Another comment believes that                   peeling, trimming, washing, waxing,                   emergencies, it was important for FDA
                                          activities such as trimming, washing,                   eviscerating, rendering, cooking, baking,             to receive prior notice before the food
                                          waxing, and packaging of produce are                    freezing, cooling, pasteurizing,                      covered by that notice is shipped
                                          part of normal harvesting activities and                homogenizing, mixing, formulating,                    around the country and potentially lost
                                          seeks to clarify that produce that has                  bottling, milling, grinding, extracting               to government oversight (68 FR 5428 at
                                          been trimmed, washed, waxed, and/or                     juice, distilling, labeling, or packaging.            5431 and 68 FR 58974 at 58991). The
                                          packaged is still ‘‘in its natural state.’’             Crops that have been cleaned (e.g.,                   preambles concluded that prior notice
                                             (Response) The IFR defines ‘‘no                      dusted, washed), trimmed, or cooled                   must be given before the food first
                                          longer in its natural state’’ as meaning                attendant to harvest or collection or                 physically appears in the United States
                                          ‘‘an article of food has been made from                 treated against pests, or polished or                 so that FDA can inspect the food upon
                                          one or more ingredients or synthesized,                 packaged are still in their natural state             arrival.
                                          prepared, treated, modified, or                         for purposes of this subpart. Whole fish                 As noted in the comments, some
                                          manipulated. Examples of activities that                headed, eviscerated, or frozen attendant              shipments contain both food and
                                          render food no longer in its natural state              to harvest are still in their natural state           nonfood cargo. If the carrier stops at
                                          are cutting, peeling, trimming, washing,                for purposes of this subpart.’’                       multiple ports, the articles of food may
                                          waxing, eviscerating, rendering,                                                                              remain on board at intermediate ports
                                          cooking, baking, freezing, cooling,                     15. Port of Arrival (§ 1.276(b)(11))                  where nonfood articles are unloaded.
                                          pasteurizing, homogenizing, mixing,                        The IFR defines ‘‘port of arrival’’ to             The articles of food are then unloaded
                                          formulating, bottling, milling, grinding,               mean ‘‘the water, air, or land port at                at one or more subsequent ports. When
                                          extracting juice, distilling, labeling, or              which the article of food is imported or              food is shipped via water and FDA has
                                          packaging. Crops that have been cleaned                 offered for import into the United                    bioterrorism or other public health
                                          (e.g., dusted, washed), trimmed, or                     States, i.e., the port where the article of           emergency concerns about the food, it
                                          cooled attendant to harvest or collection               food first arrives in the United States.              would inspect the food at the point of
                                          or treated against pests, waxed, or                     This port may be different than the port              unloading. This is because before the
                                          polished are still in their natural state               where consumption or warehouse entry                  food is unloaded it would remain on the
                                          for purposes of this subpart. Whole fish                or foreign trade zone admission                       carrier either at a secured port under
                                          headed, eviscerated, or frozen attendant                documentation is presented to the U.S.                CBP authority or in open water,
                                          to harvest are still in their natural state             Customs and Border Protection (CBP).’’                preventing intentional or unintentional
                                          for purposes of this subpart.’’ In the                     (Comments) Two comments ask FDA                    diversion until unloading. The same is
                                          final rule, we are deleting the word                    to clarify what is meant by the term,                 true for food shipped by air. When an
                                          ‘‘waxed’’ in the list of activities that                ‘‘port of arrival.’’ One comment notes                article of food remains on board at one
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                                          render the food still in their natural                  that notwithstanding the definition in                airport to be unloaded at a subsequent
                                          state because this was included in error.               the IFR, FDA representatives have stated              airport, FDA would not need to examine
                                             After publishing the prior notice IFR,               that ‘‘port of arrival’’ means the first              the food until the point where that food
                                          FDA issued guidance in the form of                      port where the articles of food are ‘‘off-            is unloaded. In contrast, when food is
                                          questions and answers to help clarify                   loaded’’ and that if the articles remain              shipped via land, any articles of food


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                                          66304             Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations

                                          remaining on board would travel                         record. Another states that FDA and                   example it would be the company
                                          through the United Stated while outside                 CBP should typically consider not                     having the business contract to export
                                          of secured ports and, therefore, could be               taking any regulatory action when an                  the food; in the second, assuming that
                                          potentially lost to government oversight                article of food is imported or offered for            the producer is sending the food to a
                                          due to off-loading in noncontrolled                     import for noncommercial purposes                     firm in the United States, they (the
                                          areas.                                                  with a noncommercial shipper without                  producer) would be the shipper. It
                                             Therefore, we believe that when an                   prior notice. One of the examples of                  should also be noted that a firm may be
                                          article of food is shipped via water or                 foods imported or offered for import                  both a shipper and a manufacturer with
                                          air, the article ‘‘first arrives’’ at the port          that may be covered by this policy is                 respect to the same product if the
                                          where it is unloaded. When an article of                food in household goods, including                    product is shipped from the point of
                                          food is shipped via land, the article                   military transfers.                                   manufacture to the United States.
                                          ‘‘first arrives’’ at the port where it                     (Final rule) Section 1.276 (b)(11) of              Moreover, we have added the phrase,
                                          crosses the border. We are revising the                 the final rule defines ‘‘port of arrival’’ as         ‘‘or express consignment operators or
                                          definition of ‘‘port of arrival’’ in the                ‘‘the water, air, or land port at which the
                                                                                                                                                        carriers or other private delivery
                                          final rule to clarify this distinction. We              article of food is imported or offered for
                                                                                                                                                        service,’’ after the term, ‘‘international
                                          have added a statement that for an                      import into the United States. For an
                                                                                                                                                        mail,’’ in the definition of ‘‘shipper’’ to
                                          article of food arriving by water or air,               article of food arriving by water or air,
                                          the port of arrival is the port of                      this is the port of unloading. For an                 clarify that a shipper is involved with
                                          unloading. For an article of food                       article of food arriving by land, this is             various types of transactions, and not
                                          arriving by land, the definition now                    the port where the article of food first              just international mail shipments.
                                          states that the port of arrival is the port             crosses the border into the United                       (Final rule) Section 1.276(b)(14) of the
                                          where the article of food first crosses the             States. The port of arrival may be                    final rule defines shipper to mean ‘‘the
                                          border into the United States.                          different than the port where                         owner or exporter of the article of food
                                             (Comments) One comment asks FDA                      consumption or warehouse entry or                     who consigns and ships the article from
                                          to clarify the word ‘‘port.’’ The comment               foreign trade zone admission                          a foreign country or the person who
                                          asks whether the IFR applies to U.S.                    documentation is presented to the U.S.                sends an article of food by international
                                          Navy ships returning to ‘‘port’’ or to a                Customs and Border Protection (CBP).’’                mail or express consignment operators
                                          U.S. Naval Base from outside U.S.                                                                             or carriers or other private delivery
                                          territorial waters. The comment notes                   16. Shipper (§ 1.276(b)(14))
                                                                                                                                                        service to the United States.’’
                                          that U.S. Navy fleet ships always have                     The IFR defines ‘‘shipper’’ to mean
                                          been considered U.S. territory. The                     ‘‘the owner or exporter of the article of             17. Comments Requesting Additional
                                          comment also notes that the CPG states                  food who consigns and ships the article               Definitions
                                          that food entering and then leaving the                 from a foreign country or the person
                                          ‘‘port area’’ is not subject to prior notice            who sends an article of food by                          (Comments) Several comments
                                          and asks FDA to clarify the term, ‘‘port                international mail to the United States.’’            request that we define additional terms
                                          area.’’                                                    (Comments) Two comments request                    in the final rule, including: ‘‘trip
                                             (Response) FDA clarifies that the                    that we clarify the IFR’s definition of               number,’’ ‘‘carrier,’’ and ‘‘ultimate
                                          term, ‘‘port,’’ is not defined but that                 ‘‘shipper.’’ One comment asks whether                 consignee.’’
                                          ‘‘port of arrival’’ and ‘‘port of entry’’ are           the shipper is the person who                            (Response) FDA disagrees. FDA
                                          defined. The term, ‘‘port,’’ as used in the             physically loads the shipment for its                 believes these terms are sufficiently
                                          rule relates to ports identified by CBP.                final journey to the United States, the               clear based on our experience since the
                                          In 19 CFR 101.1 Definitions, ‘‘Port and                 company that has the business contract                initial implementation of the prior
                                          port of entry refer to any place                        to export the food to the U.S. importer,              notice IFR. FDA intends to interpret the
                                          designated by Executive Order of the                    or someone in the middle who removes                  ‘‘ultimate consignee’’ consistent with
                                          President, by order of the Secretary of                 the shipment from temporary storage for               CBP’s use of that term in regards to the
                                          the Treasury, or by Act of Congress, at                 the initial phase of its entire journey to            entry of merchandise, which is
                                          which a Customs officer is authorized to                the United States. Another comment                    contained in paragraph 6.3 of Customs
                                          accept entries of merchandise to collect                asks for clarification as to who is the               Directive No. 3550–079A, June 27, 2001.
                                          duties, and to enforce the various                      shipper when the producer’s shipping
                                                                                                                                                        As stated in that CBP Directive, ‘‘if the
                                          provisions of the Customs and                           platform is involved in the shipment—
                                                                                                                                                        merchandise has not been sold or
                                          navigation laws. The terms ‘port’ and                   the transporter who takes responsibility
                                                                                                                                                        consigned to a U.S. party at the time of
                                          ‘port of entry’ incorporate the                         for the whole shipment or the
                                                                                                                                                        entry or release, then the Ultimate
                                          geographical area under the jurisdiction                producer’s own facility (assuming that
                                                                                                                                                        Consignee at the time of entry or release
                                          of a port director.’’ If CBP changes this               neither would be classified as
                                                                                                                                                        is defined as the proprietor of the U.S.
                                          definition in the future, we will evaluate              ‘‘manufacturer’’)?
                                          whether § 1.276(b)(12) should be revised                   (Response) In the IFR, we defined                  premises to which the merchandise is to
                                          to incorporate those changes. Proposed                  ‘‘shipper’’ based upon the description of             be delivered.’’
                                          policies in the Prior Notice Final Rule                 shipper as it is discussed in CBP’s                   18. Summary of the Final Rule
                                          Draft CPG, would apply to most articles                 proposed rule ‘‘Required Advance
                                          of food on U.S. Navy ships returning to                 Electronic Presentation of Cargo                        Section 1.276 of the final rule defines
                                          ‘‘port’’ or a U.S. Naval Base from outside              Information’’ (July 23, 2003, 68 FR                   the following terms: The act, calendar
                                          U.S. territorial waters. One policy states              43574 at 43577). We have decided to                   day, country from which the article
                                          that FDA and CBP should typically                       continue to use this definition in the                originates, country from which the
                                          consider not taking any regulatory                      final rule. In the examples cited in the              article is shipped, FDA Country of
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                                          action when an article of food is                       comments above, the shipper is                        Production, food, full address, grower,
                                          imported or offered for import for an                   considered to be the entity that arranges             international mail, manufacturer, no
                                          official government purpose without                     or directs the shipment to be sent to the             longer in its natural state, port of arrival,
                                          prior notice, provided that a Federal                   United States, irrespective of who                    port of entry, registration number,
                                          Government agency is the importer of                    physically transports it. In the first                shipper, United States, and you.


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                                                            Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations                                                  66305

                                          D. What is the Scope of this Subpart?                   personal use to include all food                         (Comments) One comment states that
                                          (§ 1.277)                                               products carried in personal baggage; or              if food moves for immediate export 3 (IE)
                                             Section 1.277(a) of the IFR states that              to allow declaration of entry to be made              out of the same port, it is not subject to
                                          the prior notice requirements apply to                  through existing general CBP entry                    prior notice. However, if the food moves
                                          all food for humans and other animals                   declaration procedures.                               on a T&E entry, prior notice is required.
                                                                                                     (Response) FDA disagrees. Prior                    The comment provides a scenario where
                                          that is imported or offered for import
                                                                                                  notice is not required for food that is               a shipment arrives at Los Angeles
                                          into the United States. This covers food
                                                                                                  carried by or otherwise accompanies an                Harbor and then moves to Los Angeles
                                          for use, storage, or distribution in the
                                                                                                  individual entering the United States                 Airport for export. Los Angeles Harbor
                                          United States, and includes food for
                                                                                                  (e.g., food that is in his or her carry-on            and Los Angeles Airport are separate
                                          gifts, trade and quality assurance/
                                                                                                  or checked baggage) when the food is for              ports and each has its own port code
                                          quality control samples, food for
                                                                                                  that individual’s personal use                        assigned by CBP. The comment states
                                          transshipment through the United States
                                                                                                  (§ 1.277(b)(1)). This means that the food             that CBP considers this an IE entry.
                                          to another country, food for future
                                                                                                  is for consumption by the individual or               Similarly, the comment questioned if
                                          export, and food for use in a U.S.
                                                                                                  by the individual’s family and friends                FDA considers this an IE entry as well,
                                          Foreign Trade Zone (FTZ).
                                                                                                  and is not for sale or other distribution.            or if it is considered a T&E entry that
                                             Section 1.277(b) of the IFR sets out
                                                                                                  If the food carried by or otherwise                   requires prior notice.
                                          the exclusions from prior notice. It                                                                             (Response) If the food arrives in and
                                          excludes food for an individual’s                       accompanying an individual is for
                                                                                                  commercial purposes, then prior notice                is exported from the same port, then it
                                          personal use when it is carried by or                                                                         is not subject to prior notice. FDA
                                          otherwise accompanies the individual                    requirements apply.
                                                                                                     As we explained in the IFR preamble,               considers a port to be the same as
                                          when arriving in the United States (i.e.,                                                                     defined by CBP in 19 CFR 101.1; i.e., the
                                                                                                  we do not believe that Congress
                                          for consumption by themselves, family                                                                         term ‘‘port’’ incorporates the
                                                                                                  intended for us to characterize travelers
                                          and friends, not for sale or other                                                                            geographical area under the jurisdiction
                                                                                                  bringing food back from their travels in
                                          distribution); food that was made by an                                                                       of a port director. The geographical
                                                                                                  their personal baggage for their own use
                                          individual in his/her personal residence                                                                      boundaries of the port of Los Angeles-
                                                                                                  as ‘‘shippers’’ for purposes of section
                                          and sent by that individual as a personal                                                                     Long Beach are described in 19 CFR
                                                                                                  801(m) of the act. When there is a
                                          gift (i.e., for nonbusiness reasons) to an                                                                    101.3(b)(1). While Los Angeles Harbor
                                                                                                  commercial purpose involved, there is a
                                          individual in the United States; food                                                                         and Los Angeles Airport are separate for
                                                                                                  ‘‘shipper,’’ i.e., the person or entity on
                                          that is imported then exported without                                                                        CBP management purposes, they are
                                                                                                  whose behalf the traveler is bringing in
                                          leaving the port of arrival until export;                                                                     considered to be within the same port.
                                                                                                  the food. Thus, by its terms, section
                                          and meat food products, poultry                                                                               Accordingly, IE entries may be filed for
                                                                                                  801(m) of the act requires that food
                                          products, and egg products that, at the                                                                       movements between Los Angeles Harbor
                                                                                                  carried by or otherwise accompanying
                                          time of importation, are subject to the                                                                       and Los Angeles Airport followed by
                                                                                                  an individual arriving in the United
                                          exclusive jurisdiction of USDA under                                                                          exportation of the goods. Similarly,
                                                                                                  States that is not for personal use be
                                          the Federal Meat Inspection Act (21                                                                           because such movements would not
                                                                                                  subject to prior notice. Moreover, we
                                          U.S.C. 601 et seq.), the Poultry Products                                                                     leave the port of arrival until export,
                                                                                                  explained that we would potentially
                                          Inspection Act (21 U.S.C. 451 et seq.), or                                                                    prior notice would not be required.
                                                                                                  create a loophole that would defeat the
                                          the Egg Products Inspection Act (21                                                                              (Comments) One comment suggests
                                                                                                  purpose of the prior notice rule if we
                                          U.S.C. 1031 et seq.).                                                                                         that articles of food imported and
                                                                                                  were to exempt all food products carried
                                             FDA received many comments about                                                                           admitted into a FTZ in or adjacent to the
                                                                                                  in personal baggage.
                                          § 1.277(b), which are addressed in order                   (Final rule) Section 1.277(b)(1) of the            port of arrival as ‘‘zone restricted status’’
                                          of the exclusions covered in the IFR:                   final rule continues to state that the rule           merchandise, and then exported from
                                          Food for an individual’s personal use                   does not apply to food for an                         the port of arrival under an IE entry, are
                                          when carried by or otherwise                            individual’s personal use when it is                  sufficiently similar to an IE entry that
                                          accompanying an individual;                             carried by or otherwise accompanies the               the same restrictions as for an IE entry
                                          homemade food; food that is imported                    individual when arriving in the United                would apply if the food were refused
                                          for immediate exportation; and foods                    States.                                               admission under 801(m) of the act. The
                                          under exclusive USDA/Food Safety and                                                                          comment, therefore, recommends that
                                          Inspection Service jurisdiction. The                    2. Homemade Food Sent as Personal                     these articles should be exempt from the
                                          comments concerning requests for                        Gift                                                  prior notice requirements.
                                          additional exclusions from the scope of                    Section 1.277(b)(2) of the IFR                        (Response) The fact that food is for
                                          the prior notice requirements are                       excludes food that was made by an                     admission into an FTZ does not, by
                                          addressed by issue, beginning with                      individual in his/her personal residence              itself, mean that the food is not subject
                                          general comments/requests.                              and sent by that individual as a personal             to the requirements of the prior notice
                                                                                                  gift (i.e., for nonbusiness reasons) to an            regulation (§ 1.277(a)). In the first
                                          1. Food for an Individual’s Personal Use                                                                      instance described in the comments,
                                          When Accompanied at Arrival                             individual in the United States.
                                                                                                     (Comments) No comments were                        where the article of food is imported
                                            Section 1.277(b)(1) of the IFR                        received about this issue.                            and admitted into an FTZ located in the
                                          excludes food for an individual’s                          (Final rule) Section 1.277(b)(2) is                port of arrival and then exported from
                                          personal use when it is carried by or                   retained without change.                              the port of arrival, prior notice is not
                                          otherwise accompanies the individual                                                                          required (§ 1.277(b)(3)). In the second
                                          when arriving in the United States. The                 3. Food Imported Then Exported                        instance, where the article of food is
                                          IFR explains that in this situation there               Without Leaving Port of Arrival Until                 imported and admitted into an FTZ
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                                          was no ‘‘shipper’’ as that term is used                 Export
                                          in section 801(m) of the act.                              Section 1.277(b)(3) of the IFR                       3 Food that is brought to a U.S. port but is then

                                            (Comments) One comment requests                       excludes food that is imported then                   directly exported from that port of arrival is entered
                                                                                                                                                        under a CBP IE entry and subject to the limitations
                                          that FDA expand the exemption for food                  exported without leaving the port of                  of an IE bond. In essence, this food may not leave
                                          carried in to the United States for                     arrival until export.                                 the port of arrival until export.



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                                          66306             Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations

                                          located adjacent to the port of arrival                 does the prior notice for such an article             Note that live food animals are not
                                          and then exported, prior notice would                   of food require the manufacturer’s                    excluded from prior notice under
                                          be required since the food has left the                 registration number.                                  section 801(m)(3)(B) of the act and
                                          port of arrival before export and may not                 (Response) Prior notice is required for             § 1.277(b)(4) or (b)(5) because live food
                                          be subject to the limitations of an IE                  food imported or offered for import into              animals do not fall within the exclusive
                                          bond. An FTZ adjacent to the port of                    the United States before arrival and not              jurisdiction of USDA under the Federal
                                          arrival is considered to be outside the                 when the food is loaded onto a                        Meat Inspection Act or Poultry Products
                                          port of arrival, and therefore not                      passenger ship in the United States.                  Inspection Act. If the live animals are
                                          sufficiently similar to those IE entries                  (Final rule) Section 1.277(b)(3) is                 imported for a nonfood use (i.e., as a
                                          that have never left the port of arrival.               retained without change in the final rule             pet, for show purposes, racing) and are
                                             (Comments) Several comments ask                      and excludes food that is imported then               not reasonably likely to be directed to a
                                          that FDA exempt the airline industry’s                  exported without leaving the port of                  food use, then prior notice is not
                                          food service from the requirements of                   arrival until export.                                 required. USDA/Veterinary Services
                                          prior notice. The comments assert that                  4. Food Under the Exclusive                           inspects imported live animals for
                                          there is no danger to the American                      Jurisdiction of USDA                                  animal health, not human health,
                                          public from this operation. One                                                                               purposes. An FD3 flag associated with
                                          comment suggests that leftover                             The IFR in § 1.277(b)(4), (b)(5), and              breeder livestock means that the
                                          unopened cans of soda, unopened small                   (b)(6) excludes: Meat food products that              livestock may be subject to prior notice
                                          bottles of liquor (to be held in bonded                 at the time of importation are subject to             requirements. If the live animal is not
                                          storage) or other ‘‘dry-stores’’ items on               the exclusive jurisdiction of USDA                    reasonably likely to be directed to a food
                                          flights inbound to the United States and                under the Federal Meat Inspection Act                 use, then the HTS code may be
                                          intended for use on later flights should                (21 U.S.C. 601 et seq.); poultry products             disclaimed because prior notice is not
                                          be exempt from prior notice. In                         that at the time of importation are                   required.
                                          addition, the comment states that it is                 subject to the exclusive jurisdiction of                 (Comments) Some comments had a
                                          not possible to determine at ‘‘wheels                   USDA under the Poultry Products                       concern regarding USDA-regulated
                                          up’’ what will remain upon landing in                   Inspection Act (21 U.S.C. 451 et seq);                products. One comment noted that
                                          the United States. One comment states                   and egg products that at the time of                  USDA-regulated products were
                                          that it is impossible to provide detailed               importation are subject to the exclusive              excluded from the FDA prior notice
                                          information about leftover soda and                     jurisdiction of USDA under the Egg                    rule, but that an HTS codes document
                                          liquor on incoming international                        Products Inspection Act (21 U.S.C. 1031               released on November 20, 2003,
                                          aircraft. One comment proposes the                      et seq). The IFR explains that these are              highlights a number of products that are
                                          addition of the following exception to                  excluded as directed in the Bioterrorism              regulated by USDA. Another comment
                                          § 1.277(b): ‘‘Food that is imported by a                Act.                                                  questions why cattle imported for
                                          shipper operating an aircraft in                           (Comments) Comments state that live                slaughter are coded FD4 and all other
                                          international air transportation, then                  animals including cattle, pig, chickens,              cattle are coded FD3 when the
                                          exported by the same shipper, [as] long                 etc. require prior notice, whereas prior              importation of cattle is under the
                                          as such food remains on board the                       notice is not required for products                   responsibility and jurisdiction of USDA.
                                          aircraft at all times from import to                    exclusively regulated by the Federal                     (Response) Only items that are under
                                          export.’’                                               Meat Inspection Act. The comments                     the exclusive jurisdiction of the USDA
                                             (Response) If the aircraft food is                   recommend that animals regulated                      are excluded from the requirements of
                                          consumed on the international flight or                 exclusively by USDA/Veterinary                        prior notice. Articles of food that are
                                          discarded and is not entered into the                   Services such as live cattle, pigs, and               jointly regulated by FDA and USDA are
                                          United States for use, storage, or                      chickens be exempt from prior notice                  subject to the requirements of prior
                                          distribution or remains on board and is                 because USDA examines them upon                       notice. Live animals raised for food,
                                          exported from the same port into which                  importation. One comment further                      even though not in their final, edible
                                          it arrived, it is outside the scope of the              suggests that live animals requiring                  form, are considered to be food under
                                          regulation and prior notice is not                      prior notice should be those animals                  the act. United States v. Tomahara
                                          required. By contrast, prior notice is                  regulated by FDA, such as turtles, game               Enterprises Ltd., Food Drug Cosm. L.
                                          required for in-flight food that is moved               animals, etc. Another comment asks                    Rep. (CCH) 38,217 (N.D.N.Y. 1983) (live
                                          out of the port of arrival to caterers for              whether prior notice is required for                  calves intended as veal are food) and
                                          use on other international or domestic                  livestock sent to the United States for               United States v. Tuente Livestock, 888
                                          flights (§ 1.277).                                      recreational purposes, but after a                    F. Supp. 1416 (S.D. Ohio 1995) (live
                                             (Comments) One comment questions                     number of years are expected to be                    hogs are food).
                                          whether wines manufactured in a                         slaughtered and enter the food chain as                  (Final rule) Section 1.277(b)(4), (b)(5),
                                          foreign country and present on a                        pet food. One comment asks that FDA                   and (b)(6) of the final rule are retained
                                          passenger ship that may cruise or dock                  exempt breeder livestock not imported                 without change and exclude meat food
                                          in the United States Territorial Sea                    for immediate slaughter and remove                    products that at the time of importation
                                          require prior notice.                                   ‘‘FD3’’ flags from HTS codes that cover               are subject to the exclusive jurisdiction
                                             (Response) If the wine remains on the                breeder livestock to avoid confusion at               of the USDA under the Federal Meat
                                          ship, it does not require prior notice                  the ports of arrival regarding                        Inspection Act (21 U.S.C. 601 et seq.);
                                          (§ 1.277(b)(3)). However, if the wine is                applicability of prior notice                         poultry products that at the time of
                                          offloaded from the ship and leaves the                  requirements.                                         importation are subject to the exclusive
                                          port of arrival in the United States, prior                (Response) FDA disagrees. Live                     jurisdiction of USDA under the Poultry
                                          notice would be required.                               animals, such as poultry and cattle, are              Products Inspection Act (21 U.S.C. 451
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                                             (Comments) One comment asks that if                  food for purposes of prior notice                     et seq.); and egg products that at the
                                          wines are loaded onto a passenger ship                  (§ 1.276(b)(5)(ii)) if the article of food is         time of importation are subject to the
                                          at a U.S. port, but such an article of food             reasonably likely to be directed to a food            exclusive jurisdiction of USDA under
                                          has been previously imported into the                   use (see discussion supra on the                      the Egg Products Inspection Act (21
                                          U.S. to be exported or transshipped,                    definition of food in section III.C.11).              U.S.C. 1031 et seq.).


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                                                            Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations                                          66307

                                          5. Additional Exclusions Requested—                     that food ingredient was exempt from                  that there is a conflict between the
                                          General                                                 prior notice, even if the ingredient is               registration and prior notice
                                             (Comments) One comment states that                   known to be used in food. Other                       requirements. Under the registration
                                          cough drops containing OTC (over-the-                   comments assume that ingredients                      rule, in general, a facility engaged in the
                                          counter) Monograph active ingredients                   lacking an FD3 or FD4 code that are best              manufacturing/processing, packaging, or
                                          are regulated as an over-the-counter                    known as being active ingredients in                  holding of food for consumption in the
                                          drug by the FDA, and therefore, are not                 drugs, but are also used in dietary                   United States must be registered.
                                          subject to prior notice. However, CBP                   supplements, are exempt from prior                    Regardless of whether the facility that
                                          categorizes all cough drops, including                  notice. The comment recommends that                   manufactured the food manufactured it
                                          ones regulated as drugs by the FDA, as                  these codes should be made as complete                for consumption in the United States,
                                                                                                  as possible and that FDA should                       section 801(l) of the act prohibits food
                                          candy subject to regulation by FDA as
                                                                                                  indicate that ingredients without a FD3               that is from an unregistered foreign
                                          food. Therefore, due to this
                                                                                                  or FD4 code may still require prior                   facility from being delivered for
                                          classification by CBP, cough drops
                                                                                                  notice.                                               distribution in the United States until
                                          would require prior notice. In addition,                   (Response) FDA and CBP
                                          another comment asks if                                                                                       the facility is registered. Thus, if the
                                                                                                  continuously evaluate the HTS codes in                owners, operators, or agents in charge of
                                          pharmaceuticals, such as over-the-                      order to attach the appropriate FD3 and
                                          counter drugs, are exempt from prior                                                                          facilities want to ensure these types of
                                                                                                  FD4 designations. However, the lack of                food are not subject to being held under
                                          notice requirements.                                    an FD3 or FD4 designation does not
                                             (Response) CBP classification does                                                                         section 801(l) of the act, they can
                                                                                                  mean that prior notice is not required.               register in accordance with section 415
                                          not identify foods requiring prior notice.              If the article fits the definition of food
                                          However, CBP and FDA have worked                                                                              of the act (21 U.S.C. 350d) (and if the
                                                                                                  provided in § 1.276 of the final rule,                food is for consumption in the United
                                          together to provide indicators; i.e., flags             then prior notice is required for that
                                          associated with HTS codes to indicate                                                                         States, they must register unless the
                                                                                                  article of food. If you believe that an               facility qualifies for an exemption). An
                                          which articles being imported may                       item has been incorrectly flagged, or is
                                          require prior notice submission. The                                                                          importer can likewise ensure that food
                                                                                                  not currently flagged, but should be, you             is not subject to being held under
                                          FD3 flag indicates that the products                    should contact the FDA and provide a
                                          categorized by that HTS code may                                                                              section 801(l) of the act by not
                                                                                                  statement with your suggestion and                    importing or offering for import food
                                          require prior notice submission; those                  basis for the flag designation.
                                          products categorized in those HTS                                                                             that is from an unregistered foreign
                                                                                                     (Comments) One comment believes                    facility.
                                          codes flagged as FD3 that do not require                that there is a conflict between the
                                          prior notice submission may be                          registration (21 CFR part 1, subpart H)                  Throughout this preamble to the final
                                          disclaimed by the filer upon entry. On                  and prior notice IFRs, where the former               rule, we often use the phrase ‘‘food is
                                          the other hand, the FD4 flag indicates                  is based upon the intended use of food                subject to being held’’ in describing our
                                          that the products categorized by that                   (i.e., consumption), and the latter                   enforcement of the registration
                                          HTS code require prior notice                           applies to ‘‘all’’ food. The comment                  requirement through prior notice. Under
                                          submission. FDA has published                           states that this has caused difficulties              section 801(l) of the act, ‘‘[i]f an article
                                          guidance regarding these flags and has                  with the import process by: (1)                       of food is being imported or offered for
                                          published a list of the HTS codes with                  Requiring foreign facilities to register in           import into the United States, and such
                                          FD3 and FD4 flags. The guidance is                      order to meet the prior notice                        article is from a foreign facility for
                                          posted at http://www.cfsan.fda.gov/                     requirements and (2) requiring drug and               which a registration has not been
                                          ~dms/htsguid3.html and the list of                      device establishments to register as food             submitted to the Secretary under section
                                          codes is posted at http://                              facilities in order to facilitate                     415, such article shall be held at the
                                          www.cfsan.fda.gov/~pn/htscodes.html.                    importation of intra-company articles.                port of entry for the article, and may not
                                             The comment asks about such articles                 The comment believes this places an                   be delivered to the importer, owner, or
                                          containing OTC monograph active                         undue burden on drug and device                       consignee of the article, until the foreign
                                          ingredients. HTS Code 3004909176                        establishments and hampers the                        facility is so registered’’ (emphasis
                                          (cough and cold preparations) would                     importation process for articles not                  added). In this situation, the article of
                                          apply to, among other articles, cough                   intended for use in food, as well as for              food is being prevented from moving
                                          suppressants that contain OTC                           food articles not intended for                        forward past the port of arrival because
                                          monograph active ingredients. This HTS                  consumption. The comment suggests                     the food is from a foreign facility that
                                          Code is not flagged for either FD3 or                   that section § 1.277 be changed to read:              has not registered. This situation is
                                          FD4, meaning that prior notice would                    ‘‘This subpart applies to all food                    distinct from a situation where, after
                                          not be required. Candies, which are                     intended for consumption by humans                    FDA reviews the prior notice
                                          food, would fall under different HTS                    and other animals * * *.’’ In addition,               information, the food is held upon
                                          Codes and would be subject to prior                     the comment suggests that the HTS                     arrival for examination because it may
                                          notice.                                                 codes be modified to allow articles                   pose a significant risk to public health,
                                             (Comments) One comment                               designated with a FD3 or FD4 code to                  usually referred to as a ‘‘BT Hold.’’ In
                                          recommends that FDA’s food category                     be disclaimed, with rationale,                        addition, we do not believe that prior
                                          codes for raw materials could be made                   depending on their intended use.                      notice places an undue burden on the
                                          more complete to cover the range of                        (Response) FDA disagrees. FDA                      drug and medical device industry. Items
                                          materials known to be used in products                  disagrees with changing § 1.277 to read               designated with a FD4 code are all
                                          marketed as foods. The comment states                   that prior notice is only required for                believed to be used exclusively in food,
                                          that there are numerous CBP ‘‘Customs                   food that is intended for consumption.                and therefore, require prior notice.
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                                          Codes’’ that do not contain the                         In the preamble to the IFR, FDA noted                 Articles designated by a FD3 code can
                                          appropriate FD3 or FD4 codes and that                   that the determination of whether a                   have food and nonfood uses. These
                                          this causes confusion among the                         substance is ‘‘food’’ is not a question of            items do not require prior notice if the
                                          industry with some groups interpreting                  intended use (See 68 FR 58974 at                      use of the article does not fit the
                                          the lack of an FDA code as meaning that                 58987). Moreover, we do not believe                   definition of food provided in § 1.276 of


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                                          the final rule and may be disclaimed by                 which are inspected by the Canadian                   basic prior notice information that will
                                          the filer as such upon entry.                           Food and Inspection Agency.                           repeat on each prior notice can be
                                             (Comments) One comment states that                      (Response) FDA disagrees. While we                 created and saved for use on subsequent
                                          there is no facility registration                       welcome any additional information                    prior notices. A separate prior notice
                                          requirement for transshippers; however,                 that supports our ability to quickly                  confirmation number is generated for
                                          goods processed under CBP’s Form                        review prior notice submissions and                   each article of food or recipient.
                                          CF7512 (T&Es and ITs) require a prior                   determine which food to inspect at U.S.                  (Comments) One comment requests
                                          notice to be filed. The comment notes                   ports of arrival, the Bioterrorism Act                that FDA exempt highly perishable food
                                          that this cannot be accomplished                        does not provide for blanket exclusions               products. The comment states that
                                          without the corresponding facility                      based on the country from which the                   highly perishable food products, such as
                                          registration number. In addition, T&Es                  food is shipped or the country in which               ice cream, must be delivered in a timely
                                          and ITs do not have a designated                        the food originates. FDA currently is                 manner. A delay in the delivery
                                          submitter. The comment requests that                    reviewing flexible alternative programs               schedule due to holdups at the border
                                          T&E and IT transactions be exempt from                  (e.g., CBP’s Customs-Trade Partnership                could potentially ruin these products,
                                          prior notice.                                           Against Terrorism (C–TPAT), which                     and customers inconvenienced by the
                                             (Response) FDA disagrees that T&E or                 was adopted into law (still as a                      time delay may choose to stop
                                          IT transactions should be exempt from                   voluntary system) by Subtitle B of Title              importing them. A number of comments
                                          the requirements of prior notice. These                 II of the SAFE Port Act of 2006 (Public               request that FDA exempt fresh produce.
                                          articles of food leave the port of arrival              Law 109–347), and Free and Secure                     Several comments note that produce is
                                          prior to exportation from the United                    Trade (FAST) (a voluntary program                     already carefully monitored by CBP and
                                          States or for subsequent movement                       authorized under 19 U.S.C. 1411) ) to                 placed on automatic quarantine for
                                          through the United States prior to entry.               determine their potential for                         mandatory inspection at the first port of
                                             Under § 1.281(a)(9) of the IFR, a                    streamlining the prior notice review                  arrival by USDA/CBP. Other comments
                                                                                                  process, but notes that these programs                state that produce is already subject to
                                          shipper’s (transshipper’s) registration
                                                                                                  do not meet or affect the requirement to              100 percent USDA inspection and
                                          number was not required for a facility
                                                                                                  submit prior notice. Moreover, FDA                    approval prior to release. Another
                                          associated with an article of food if the
                                                                                                  notes that many shipments from Canada                 comment requests that produce be
                                          article is imported for transshipment.
                                                                                                  and Mexico into the United States in                  exempt from the requirement of prior
                                          Under the final rule, if the shipper’s
                                                                                                  fact are transshipments from other                    notice because it already meets the
                                          identity is provided, the shipper’s
                                                                                                  countries, which prior notice
                                          registration number is optional.                                                                              requirements of the Bioterrorism Act.
                                                                                                  submissions identify with the FDA
                                          Therefore, the absence of a shipper’s                                                                         The comment reasons that the purpose
                                                                                                  Country of Production data element.
                                          registration number should not prevent                     (Comments) One comment suggests                    of the prior notification to FDA is to
                                          submission of a prior notice under                      that FDA create a relational database to              provide FDA with the information
                                          either the IFR or final rule. Moreover,                 give unique identification numbers to                 necessary to make a decision (prior to
                                          FDA disagrees with the comment’s                        an importer’s specific items. The                     arrival) for a possible physical
                                          implication that a prior notice requires                comment states that this would speed                  inspection. The comment states that the
                                          a designated submitter. Under § 1.278 of                submission, reduce time to enter the                  CBP Agriculture Specialist performs the
                                          the IFR and final rule, a prior notice                  data, and increase compliance with the                physical inspection (or reviews original
                                          may be submitted by any person with                     regulation. The comment reasons that                  documentation that confirms ‘‘pre-
                                          knowledge of the required information.                  most food importers will bring in the                 inspection’’). Therefore, the comment
                                             (Comments) Several comments                          same product, in the same package,                    reasons, importations of fresh produce
                                          request that FDA generally exempt                       from the same country, over and over.                 are already meeting the requirements of
                                          Canada and Mexico from submitting                       Another comment suggests that a single                the Bioterrorism Act. The comments
                                          prior notice for food shipments. One                    weekly summary of all shipments by a                  further state that because prior notice is
                                          comment requests that FDA exempt                        company to individual consumers or a                  already given for produce, the new
                                          Canada, in keeping with the nature of                   summary of orders received should be                  procedure created by this new
                                          cooperation and shared security risks                   adequate for this type of commerce.                   legislation will only increase costs and
                                          between the United States and Canada,                      (Response) FDA disagrees. Not all                  cause extreme hardship for small
                                          in particular the 30 point border plan.                 importers consistently import the same                business. An additional comment states
                                          The comment reasons that Canadian                       types of food. The Bioterrorism Act                   that their shipments are subject to four
                                          origin food is easily traceable through                 requires submission of prior notice                   levels of inspection: County, State,
                                          existing Canadian registration                          before an article of food is imported or              Federal, Customs and ‘‘Bio Terrorist’’
                                          requirements, while already meeting or                  offered for import into the United                    and reasons that the redundancy is
                                          exceeding United States standards in                    States. A weekly summary as suggested                 wasteful.
                                          some instances. The comment further                     by the comment would not meet this                       (Response) FDA disagrees. Highly
                                          notes that the legislation acknowledges                 requirement, as such a summary would                  perishable foods, like all other foods
                                          the largest threat is from offshore, yet                not provide prior (advance) notice                    that are covered by the final rule, are
                                          the regulations most severely hit                       before the article of food is imported or             subject to prior notice requirements.
                                          continental trade between the United                    offered for import. FDA notes, however,               The timeframes are sufficiently short,
                                          States, Canada, and Mexico. One                         that a number of the software programs                allowing for submission of prior notice
                                          comment suggests that the exemption                     that customs brokers use to file prior                as soon as 2, 4, or 8 hours before arrival
                                          could be limited to shipments of food                   notice and entry submissions with ABI/                in the United States depending on mode
                                          which are under similar security                        ACS do allow for repetitive information               of transportation. While the
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                                          controls, especially small quantity                     to be saved on the filer’s computer and               Bioterrorism Act provides for an
                                          shipments of fish imported via package                  used for future shipments, as                         exclusion for certain types of food, such
                                          delivery. Another comment asks that                     appropriate. Similarly, FDA’s PNSI has                as meat and meat food products subject
                                          FDA exempt goods being imported into                    been designed to accommodate                          to USDA’s exclusive jurisdiction, it does
                                          the United States from companies                        repetitive information, such that the                 not exclude perishable foods generally


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                                                            Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations                                        66309

                                          or foods jointly regulated by USDA and                  article of food imported or offered for               become eligible for expedited
                                          FDA.                                                    import, and food imported or offered for              processing and reduced inspections, but
                                             As we explained in the IFR preamble,                 import by or for select importers will                are not exempt from advance electronic
                                          merely obtaining existing information                   not be excluded from prior notice                     information requirements. (See CBP’s
                                          about the food from other agencies                      requirements. If an importer does not                 advance electronic information rule).
                                          would not guarantee that FDA has the                    import articles of food, then no                      FAST, an acronym for Free and Secure
                                          information required by section 801(m)                  ‘‘exemption’’ would be needed since                   Trade between the United States and
                                          of the act’s prior notice requirements                  prior notice would not apply to such                  Canada, and the United States and
                                          because there is wide variation in the                  imports. The FD flags associated with                 Mexico, is an expedited-clearance
                                          purposes and information required by                    HTS codes are designed to help identify               system designed to improve border
                                          other government programs (68 FR                        which products will require prior                     security without slowing the flow of
                                          58974 at 58992). Moreover, our ability                  notice. If an import is marked FD3 but                legitimate trade across the northern and
                                          to respond to bioterrorism incidents or                 it is not food subject to prior notice, the           southern U.S. borders. FAST processing
                                          other food-related emergencies in a                     importer can disclaim this import and                 is available to importers, carriers and
                                          timely manner may be more difficult if                  prior notice would not need to be                     foreign manufacturers (southern border)
                                          the information is not easily accessible.               submitted.                                            who participate in C–TPAT and who
                                             (Comments) One comment                                                                                     use a FAST-registered driver. The
                                          recommends that the rule be amended                     6. Additional Exclusions Requested—
                                                                                                                                                        initiative builds on the same concepts
                                          to include an exemption from prior                      Special Programs (C–TPAT/FAST) and
                                                                                                                                                        that drove the rapid, post-9/11
                                          notice for organizations that are                       Flexible Alternatives
                                                                                                                                                        construction and implementation of C–
                                          importing FD4 materials for nonfood                        In the explanation of the reduced                  TPAT. FDA and CBP plan to assess the
                                          uses.                                                   timeframes and the relationship of                    feasibility of including the FAST
                                             (Response) FDA disagrees. Items                      special programs to those timeframes,                 timeframes in FDA’s prior notice final
                                          designated with an FD4 code are all                     FDA stated in the IFR that the ‘‘interim              rule, as well as other flexible
                                          believed to be used exclusively in food,                final rule provides for greatly reduced               alternatives raised by comments.
                                          and therefore, food encompassed by an                   timeframes for foods based on mode of                    To assist in this assessment, FDA and
                                          HTS code that is flagged FD4 is subject                 transportation. These timeframes are                  CBP requested comments on several
                                          to prior notice requirements. Moreover,                 what FDA has determined are the                       questions, including three regarding
                                          as discussed previously, FDA provided                   minimum timeframes necessary to allow                 special programs (69 FR 19763 at
                                          extensively its rationale for not limiting              it to satisfy the statutory mandate that              19764):
                                          the prior notice requirements to food for               the timeframes give the agency the time                  C–TPAT/FAST Questions:
                                          consumption in the United States. (See                  it needs to ‘receive, review, and                        (1) Should food products subject to
                                          68 FR 58974 at 58990 and 58991.) As                     respond’ to prior notices. However, FDA               FDA’s prior notice requirements be
                                          FDA noted in the IFR, Congress did not                  is also interested in exploring flexible              eligible for the full expedited processing
                                          explicitly limit the prior notice                       alternatives for submission of prior                  and information transmission benefits
                                          requirement to articles of food that are                notice for foods or firms covered by                  allowed with C–TPAT and FAST? If so,
                                          intended for consumption in the United                  programs of other agencies, such as C–                how should this be accomplished?
                                          States even though it could have done                   TPAT, or imported by other agencies.’’                   (2) If the timeframe for submitting
                                          so as shown in section 415 of the act                   (68 FR 58974 at 58995).                               prior notice for food arriving by land via
                                          (requirement to register food facilities).                 FDA and CBP reopened the comment                   road is reduced to 1 hour consistent
                                          If anyone believes that an HTS code has                 period for the IFR in the Federal                     with the timeframe in the advance
                                          been flagged FD4 in error, they can                     Register of April 14, 2004 (69 FR                     electronic information rule, would a
                                          inform FDA and, if we agree, we will                    19763). On page 19764 of that                         shorter timeframe be needed for
                                          change the flag accordingly.                            publication, FDA and CBP wrote ‘‘In the               members of FAST?
                                             (Comments) Two comments request                      prior notice [interim final rule], we                    (3) Should the security and
                                          that FDA exempt small businesses.                       expressed interest in exploring flexible              verification processes in C–TPAT be
                                             (Response) FDA disagrees. Prior                      alternatives for submission of prior                  modified in any way to handle food and
                                          notice is required for all FDA-regulated                notice for foods or firms covered by                  animal feed shipments regulated by
                                          food that is imported or offered for                    programs of other agencies, such as                   FDA? If so, how?
                                          import. The Bioterrorism Act does not                   CBP’s Customs-Trade Partnership                          The comments received addressing
                                          provide for exclusions based upon the                   Against Terrorism (C–TPAT) and the                    these issues are discussed in the
                                          size or nature of the firms or facilities               Free and Secure Trade (FAST) program,                 following paragraphs in order of the
                                          associated with that importation.                       or food imported by other government                  questions posed in the Federal Register
                                             (Comments) One comment asks FDA                      agencies (68 FR 58974 at 58995). C–                   notice, beginning with comments
                                          to permit an exemption from prior                       TPAT is a government/business                         addressing general issues regarding C–
                                          notice, by importer number, to be                       initiative to increase cargo security                 TPAT and FAST.
                                          recognized in ACS at the time of entry                  while improving the flow of trade.                       a. General comments. (Comments)
                                          transmission, to importers who                          Under this program, businesses must                   Numerous comments address special
                                          demonstrate that their products will not                conduct comprehensive self-                           trade programs, such as C–TPAT and
                                          reasonably be expected to be directed to                assessments of their supply chain using               FAST. These comments recommend
                                          a food use.                                             the security guidelines developed                     that FDA and CBP modify these CBP
                                             (Response) FDA disagrees. Prior                      jointly with CBP, and they must                       programs to reflect the criteria required
                                          notice requirements are associated with                 familiarize companies in their supply                 by FDA and to develop integrated data
                                          food, not the person manufacturing,                     chain with the guidelines and the                     elements for low risk FAST/C–TPAT
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                                          growing, shipping, importing, or owning                 program. These businesses must provide                shipments, which would meet both
                                          the food. A product is food for purposes                CBP with specific and relevant                        agencies’ requirements. The comments
                                          of prior notice if the article of food is               information about their supply chains                 believe it is necessary to have
                                          reasonably likely to be directed to a food              and security practices and procedures.                harmonization between FDA and CBP
                                          use. Prior notice is required for each                  As C–TPAT members, companies may                      for ‘‘low-risk’’ shippers.


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                                          66310             Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations

                                            Many comments contend that the IFR                    products will incur increased                         issue and develop a protocol for food
                                          does not take into account the Canada-                  complexity, increased cost, and will be               products that are currently ineligible for
                                          United States Smart Border Plan (SBP).                  subject to making errors. This comment                any FAST benefits.
                                          A key element of the SBP is the FAST                    suggests that firms who routinely send                   A few comments request that C–TPAT
                                          bilateral arrangements. Under the C–                    products across the border could                      should be open to all foreign operators
                                          TPAT and the Canadian Partnerships in                   provide prior notice on a quarterly                   willing to participate and that
                                          Protection (PIP) programs, companies                    basis. The facility would track the                   companies participating in C–TPAT
                                          approved by both countries have                         number of shipments each quarter and                  should be exempt from the procedures
                                          invested in specific counter-terrorism                  update FDA with any changes to the                    under the Bioterrorism Act. These
                                          and supply-chain integrity measures,                    anticipated amounts. These shipments                  comments encourage partnerships
                                          and are therefore, accorded more                        would be permitted to cross the border                between the U.S. and E.U. similar to C–
                                          expedited treatment at the Canada-U.S.                  without waiting, but still could be                   TPAT, which would facilitate trade in
                                          border in recognition of the lower risk                 subjected to FDA or CBP inspection.                   food and feed between the E.U. and U.S.
                                          they present.                                              Another comment questions the cost,                and avoid delays at the U.S. border,
                                            The comments recommend that FDA                       benefits, etc. of these programs for small            especially with respect to perishable
                                          recognize foods imported under these                    companies. In addition, a few comments                products. In addition, one comment
                                          programs as low risk and to afford them                 address the creation of similar programs              suggests that food transporters should
                                          benefits, such as reduced information                   and/or the expansion of the current                   be allowed eligibility in C–TPAT and
                                          requirements for each shipment;                         programs. One comment requests that                   FAST to ensure that all transporters
                                          reduced timeframes for providing prior                  FDA permit the use of Line Release (i.e.,             operate on a level playing field.
                                          notice; reduced clearance time at the                   an automated system designed to release                  One comment notes that C–TPAT is
                                          border; and reduced number of                           and track repetitive shipments) for food              not currently offered to Canadian
                                          verifications of information. The                       shipments arriving by rail. The                       manufacturers unless they are an
                                          comments further urge FDA and CBP to                    comment states that their member                      Importer of Record for U.S. Customs’
                                          permit importers who are participants                   railroads participate in C–TPAT and it                purposes.
                                          in C–TPAT and FAST to comply with                       would be discriminatory to permit the                    Finally, one comment expresses
                                          their prior notice obligations in a                     use of an expedited clearance system for              concern that any motor carrier who is
                                          manner that does not undermine the                      motor carriers, but not rail                          not Pre-Arrival Processing System
                                          benefits of participation in these                      transportation.                                       (PAPS)-certified may be required to
                                          programs. The comments contend that                        One comment urges FDA to begin                     present the prior notice confirmation
                                          C–TPAT and FAST improve U.S.                            working with all interested parties to                number upon arrival at the border, even
                                          security on a number of levels,                         identify criteria for qualification and               if prior notice was submitted through
                                          including reducing the risk of                          participation in a program like C–TPAT,               ACS. The comment states that truck
                                          bioterrorism, and help to focus limited                 FAST, and others as it applies to prior               drivers are generally unable to obtain
                                          border resources on higher risk cargo.                  notice. The comment suggests that                     the prior notice confirmation number
                                          The comments suggest that FDA and                       participation might hinge on the                      prior to arrival given the short distance
                                          CBP therefore should be careful not to                  submission and verification of                        between Canada and the United States
                                          remove incentives for participation in                  documentation evidencing the                          and the fact that prior notice is not
                                          these programs by making importation                    implementation of, and continued                      generally submitted until after the
                                          of food items more cumbersome than                      adherence to, validated supply chain                  trucker has left with the load. The
                                          other types of entries. Otherwise, the                  risk management techniques. The                       comment states that requiring PAPS
                                          comments contend prior notice will                      comment believes that there would be                  authorization as a way to avoid delays
                                          dilute a key advantage offered to FAST/                 mutual benefits of such a program. FDA                is to mandate that truck companies
                                          C–TPAT participants, thereby                            could reallocate its resources to closer              become C–TPAT certified or otherwise
                                          weakening the incentive to join the                     review and examination of shipments                   comply with the designation
                                          program. The companies participating                    from those importers that do not                      requirements. The comment notes that
                                          in these programs have made a                           participate in the program and, thus,                 this is not possible, sometimes for cost
                                          substantial commitment to improving                     have not demonstrated the same level of               reasons alone. The comment also has
                                          security by putting in place appropriate                commitment to food safety and                         similar concerns regarding the PAPS-
                                          security systems, and submitting to                     shipment security as participating                    program at the Southern border.
                                          periodic review of those systems by                     importers do. Program participants                       (Response) While FDA welcomes the
                                          CBP.                                                    would benefit from the agency’s                       additional information provided by C–
                                            The comments believe that these                       recognition of their commitment to                    TPAT and FAST, these programs would
                                          programs strengthen FDA’s ability to                    safety and security, which presumably                 require relatively significant changes to
                                          meet the objectives of the prior notice                 would be reflected in more efficient and              be useful in helping us carry out the
                                          rule. They contend that this is achieved                timely processing of their entries at the             prior notice program. The purpose of
                                          in two ways: (1) Through the rigorous                   border. In that regard, the comment                   prior notice is to help identify food that
                                          security screening that participants                    suggests that the agency consider                     potentially poses a significant health
                                          must comply with in order to obtain a                   extending to participating low risk                   risk to the American public and to
                                          low-risk status; and (2) by removing                    importers the option of submitting a                  deploy resources to the port of arrival so
                                          low-risk shipments from the queue,                      single prior notice for all entries in a              that inspections can be conducted
                                          FAST/C–TPAT work to shrink the                          mixed load container or truck. FDA                    before the shipment enters the United
                                          number of shipments that must be                        product codes for all line entries would              States. Information about the
                                          screened, thereby ‘‘freeing up’’ FDA                    continue to be available to FDA through               manufacturing facility is used in
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                                          officials to focus limited resources on                 FDA’s existing OASIS system.                          conducting this risk assessment. The C–
                                          higher risk shipments.                                     Another comment hopes that the                     TPAT assessment, however, does not
                                            One comment states that a firm                        multiple U.S. agencies (FDA,                          always include the food manufacturing/
                                          having to manage its systems to track C–                Department of Homeland Security, and                  processing operations. Even when it
                                          TPAT products and non-C–TPAT                            USDA) could collectively address this                 does, C–TPAT focuses on security risks


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                                                            Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations                                        66311

                                          whereas the prior notice program                        time and money, while leading to a                    comments noted that if the primary
                                          considers all health and safety risks to                more predictable supply chain. CBP                    benefits of the C–TPAT program were
                                          the food, such as unintentional                         continues to explore additional benefits,             removed, FDA would create a
                                          contamination. Moreover, unlike PNC                     which can be afforded members who                     disincentive for C–TPAT participation
                                          reviewers, the CBP Supply Chain                         meet or exceed the minimum-security                   that would ultimately reduce the
                                          Specialists who conduct the validation                  criteria.’’                                           security of the articles covered by the
                                          assessments for C–TPAT are not                             The document also states that ‘‘CBP                Bioterrorism Act. Finally, the comments
                                          necessarily trained in assessing the                    employs a risk management approach in                 note that these benefits are necessary to
                                          potential risks associated to food                      screening and targeting, and such                     avoid duplication and inconsistent
                                          products and neither FDA nor CBP has                    shipments, as well as those from                      application of prior notice requirements
                                          the resources to fund the extensive                     unknown or less established entities,                 for shipments that meet the stringent
                                          training that would be required to do so.               receive higher scrutiny from CBP. The                 FAST criteria.
                                          Because knowing that a firm                             agency does not disclose ATS targeting                   (Response) FDA continues to use a
                                          participates in C–TPAT does not assist                  rules.’’                                              risk-based approach for determining
                                          FDA in conducting its food safety                          (Comments) Several comments                        which foods to inspect for the purposes
                                          review, we have decided not to provide                  suggest that FDA should not establish a               of admissibility. FDA will continue to
                                          special treatment in terms of reduced                   duplicative program, but should                       work with CBP and acknowledges that
                                          prior notice information requirements or                incorporate additional factors or criteria            the additional information provided by
                                          reduced timeframes based on C–TPAT                      necessary for prior notice into existing              C–TPAT participation could be helpful
                                          participation.                                          programs.                                             in this risk-based assessment. In CBP’s
                                             It is important to note that                            (Response) FDA agrees that it is                   March 25, 2005, FAQ document cited
                                          participation in C–TPAT does not affect                 generally preferable not to establish                 previously, CBP states that
                                          the information requirements of CBP’s                   duplicative programs. Thus, while we                  ‘‘[u]nsolicited shipments will
                                          advance electronic information rules;                   have determined not to provide C–                     understandably lie outside the
                                          the same information is required                        TPAT members with special treatment                   capability of the importer to ensure
                                          regardless of C–TPAT participation.                     in terms of reduced prior notice                      security. CBP employs a risk
                                          However, successful participation in C–                 information requirements or reduced                   management approach in screening and
                                          TPAT does affect the frequency of CBP                   timeframes, we will continue exploring                targeting, and such shipments, as well
                                          cargo and trade examination. FDA                        use of these programs in making                       as those from unknown or less
                                          likewise uses a risk-based approach in                  decisions regarding which products to                 established entities, receive higher
                                          selecting foods for examination at the                  inspect for the purposes of admissibility             scrutiny from CBP.’’ FDA agrees with
                                          border for security and food safety                     (801(a) decisions).                                   this statement.
                                          reasons. FDA, thus, is continuing to                       b. Special programs.                                  (Comments) Numerous comments
                                          explore with CBP and industry use of                       i. Should food products subject to                 provide suggestions on how to
                                          these programs in making decisions                      FDA’s prior notice requirements be                    accomplish processing/transmission
                                          regarding which products to inspect for                 eligible for the full expedited processing            benefits for C–TPAT and FAST
                                          the purposes of admissibility (801(a)                   and information transmission benefits                 participants. Many of the comments cite
                                          decisions).                                             allowed with C–TPAT and FAST? If so,                  a need for better harmonization and
                                             Comments addressing which foreign                    how should this be accomplished?                      streamlining between FDA and CBP.
                                          operators are eligible for participation in             (Comments) Numerous comments assert                   Suggestions from the comments include:
                                          FAST and C–TPAT are outside the                         that businesses that participate in the C–               • Enhance coordination between CBP
                                          scope of this rule. CBP stated in a                     TPAT and FAST programs should be                      and FDA, allowing trained CBP/FDA
                                          document entitled ‘‘Frequently Asked                    eligible for processing/transmission                  officers to process food shipments
                                          Questions Regarding Minimum Security                    benefits. These comments contend that                 through the FAST lane, and allowing
                                          Criteria for Importers,’’ dated March 25,               importers, carriers and drivers who have              FAST importers using a FAST driver
                                          2005, (CBP’s March 25, 2005,                            been approved for C–TPAT and FAST                     and carrier importing food and/or feed
                                          Frequently Asked Questions (FAQ)                        already have been deemed to be ‘‘low                  products to submit prior notice to both
                                          document) (available at http://                         risk’’ by CBP. Importers and carriers                 the CBP and FDA through the existing
                                          www.cbp.gov/xp/cgov/trade/cargo_                        have had to demonstrate supply chain                  CBP/FDA interface.
                                          security/ctpat/security_criteria/criteria_              security controls, and drivers have been                 • Allow for integrated targeting
                                          importers/questions.xml (FDA has                        subjected to rigorous background                      processes, including a reduction in the
                                          verified the Web site address, but FDA                  screening. Companies have made the                    risk targeting factors for food shipments,
                                          is not responsible for any subsequent                   security investments and have bolstered               as well as other product categories,
                                          changes to the Web site after this                      their operations to provide the requisite             which would translate into expedited
                                          document publishes in the Federal                       security and integrity of their trade                 processing, reduced exams and other
                                          Register)), that ‘‘C–TPAT remains a                     transactions. The federal governments of              benefits for food import shipments
                                          voluntary, incentive based partnership.                 the United States and Canada have                     under the program.
                                          However, once a company commits to                      encouraged FAST participation on the                     • Integrate the CBP and FDA data
                                          the C–TPAT program, there are specific                  grounds that it will mean expedited                   systems to allow for one filing of the
                                          program requirements that must be                       border crossings and reduced                          required information. The C–TPAT
                                          adhered to by the company to qualify                    information requirements. By allowing                 certification process delves into the
                                          for C–TPAT benefits, which are                          food to move through the FAST                         critical aspects of a company’s handling
                                          significant. C–TPAT importers are six                   ‘‘stream’’ in the same manner as other                and documentation procedures, and
                                          times less likely to undergo a security                 products, FDA would demonstrate the                   requires a company to demonstrate it
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                                          related cargo examination, and four                     commitment to harmonization that                      has good process controls in place
                                          times less likely to be subject to a trade              industry has long encouraged and                      throughout the supply chain.
                                          related examination, than non-C–TPAT                    would provide an incentive for                           • Modify the CBP and FDA systems
                                          members. These significantly fewer                      additional participation in the C–TPAT                for the receipt of advance notice and
                                          cargo examinations help save importers                  and FAST programs. In addition, the                   prior notice to ‘‘flag’’ importation under


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                                          66312             Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations

                                          C–TPAT and FAST. These notices                          CBP Advance Electronic Information                    caution that additional FDA inspection
                                          should receive priority attention for                   Rule, the time element for FAST                       would be redundant. Many of these
                                          entry and clearance purposes.                           participants is 30 minutes. The                       comments state that C–TPAT is a well-
                                             • Establish an MOU between FDA                       comments state that to have two                       thought-out program and that with its
                                          and CBP to allow the sharing of                         different time standards for the same                 current security profile requirements
                                          necessary information with the                          mode of transportation only serves to                 and present followup verification
                                          understanding of the program applicant.                 create confusion. The comments believe                systems, the program is already well
                                             • Implement a shorter prior notice                   that any harmonization of FDA and CBP                 suited to handle human and animal
                                          timeframe for C–TPAT members.                           security programs would assist the                    food shipments. The comments suggest
                                             • Reduce data element reporting by                   orderly flow of trade at the border                   that FDA should rely on CBP’s
                                          virtue of having successfully passed the                crossing points.                                      successful programs and avoid
                                          C–TPAT validation process. Product                         The comments contend that the key                  ‘‘recreating the wheel’’ or imposing new
                                          information (HTS code, product code,                    premise behind the FAST program is                    and potentially inconsistent criteria on
                                          manufacturer’s registration numbers,                    that low-risk parties should receive                  food companies. The comments further
                                          etc.) should be part of the pre-filed                   expedited treatment at the border,                    contend that food safety and product
                                          information profiles under FAST.                        freeing up enforcement resources to                   integrity is already an integral part of
                                             Finally, one comment suggests the                    concentrate on parties of higher or                   the industry’s own internal policies,
                                          following:                                              unknown risk, which is why the                        which have always been concerned and
                                             (1) A statement of proof of acceptance               timeframes CBP adopted are shorter for                accountable for the safety and security
                                          (e.g., copy of acceptance letter from                   FAST than for other shipments. If FDA                 of their products without regard to the
                                          CBP) into the C–TPAT and/or FAST                        adopted the 30 minute timeframe, it                   more recent border security program.
                                          programs;                                               would demonstrate a commitment to
                                             (2) A detailed statement/description                                                                       Therefore, companies certified under C–
                                                                                                  harmonizing with CBP, and prevent a                   TPAT have made the critical security
                                          of policies and procedures in place for
                                                                                                  situation whereby FAST requirements                   investments and have bolstered their
                                          meeting FDA prior notice requirements.
                                                                                                  vary depending on the type of                         operations to provide the requisite
                                          This submission should follow the
                                                                                                  commodity being transported. Finally,                 security and integrity of their trade
                                          format of the supply chain
                                                                                                  one comment believes that to ensure                   transactions, regardless of the
                                          questionnaire information submitted to
                                                                                                  consistency with FAST and CBP’s                       commodities (food or nonfood products)
                                          CBP as part of the C–TPAT application
                                                                                                  Automated Commercial Environment                      that are shipped. Another comment
                                          process and should be considered as an
                                                                                                  (ACE),4 prior notice should be required               stresses that FDA should not impose
                                          addendum to the original submission;
                                                                                                  and calculated from the port of entry                 additional conditions of participation
                                          and
                                             (3) FDA should notify the importer in                and not the first point of arrival, as is             for FAST members because the
                                          writing of: (a) its acceptance/agreement                currently the case.                                   requirements for FAST participation
                                                                                                     (Response) Harmonized timeframes                   imposed by CBP provide adequate
                                          with the importer’s FDA prior notice
                                                                                                  could facilitate the orderly flow of trade            assurance that expedited clearance is
                                          procedures; or (b) additional questions
                                                                                                  traffic at the borders. Advance screening             appropriate.
                                          to be answered or data to be provided
                                                                                                  of consistent information also would aid                 (Response) FDA agrees with the
                                          to meet FDA requirements for
                                                                                                  in reducing the review time. However,                 statement in CBP’s March 25, 2005,
                                          acceptance into the FDA prior notice
                                                                                                  as we discuss later in section II.F of this           FAQ document that says ‘‘For C–TPAT
                                          ‘‘C–TPAT/FAST’’ program.
                                             (Response) As we discussed                           document (‘‘When must prior notice be                 to ensure its continued viability,
                                          previously, we have determined not to                   submitted to FDA? (§ 1.279)’’), we are                effectiveness, and relevance, the
                                          provide C–TPAT members with special                     maintaining the timeframes that are in                program must continue to evolve—as
                                          treatment in terms of reduced prior                     the IFR. These timeframes represent the               the terrorist threat and the nature of
                                          notice information requirements or                      minimum amount of time FDA needs to                   global trade evolves. The impetus for
                                          reduced timeframes. FDA, however, is                    meet the statutory responsibility to                  strengthening the existing security
                                          continuing to explore with CBP and                      receive, review, and respond to prior                 guidelines is to provide more detail to
                                          industry use of these programs in                       notice submissions. Our assessment of                 the membership on the expectations of
                                          making decisions regarding which                        the timeframes and review times                       the program, and to assist CBP in
                                          products to inspect for the purposes of                 showed that we would not be able to                   defining a more consistent baseline for
                                          admissibility (801(a) decisions).                       reduce the timeframes to correspond to                minimal program requirements and
                                             ii. If the timeframe for submitting                  those used by CBP for land and air                    better-defined C–TPAT benefits.’’ The
                                          prior notice for food arriving by land via              shipments.                                            issue of how to modify the processes is
                                          road is reduced to 1 hour consistent                       iii. Should the security and                       discussed in the next comments and
                                          with the timeframe in the advance                       verification processes in C–TPAT be                   responses.
                                          electronic information rule, would a                    modified in any way to handle food and                   (Comments) Numerous comments
                                          shorter timeframe be needed for                         animal feed shipments regulated by                    provide suggestions on how to modify
                                          members of FAST? (Comments) One                         FDA? If so, how? (Comments) Four                      the security/verification processes of C–
                                          comment suggests that the timeframe for                 comments respond that the security/                   TPAT/FAST. These include:
                                          submitting prior notice of one hour is                  verification processes of C–TPAT/FAST                    • FDA should investigate security
                                          fine, even for express deliveries.                      should be modified for food. Fourteen                 plans with actual physical inspections
                                          Another comment believes that                           comments respond that the process                     of the facilities prior to allowing
                                          reducing the timeframes for submission                  should not be modified for food. Most                 participation in the programs.
                                          of prior notice would not sufficiently                  comments suggest that the current                        • FDA should verify that other
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                                          expedite the clearance of product for                   validation processes are sufficient and               countries’ regulatory systems for food
                                          participants of FAST. However, an                         4 The ACE system will replace the current ABI/
                                                                                                                                                        production and safety are equivalent to
                                          overwhelming majority of the comments                   ACS, as well as combine other CBP entry functions
                                                                                                                                                        those of the United States. The agency
                                          favor reducing the timeframe for FAST                   and transactions. Prior Notice submissions will be    should also perform on-site audits and
                                          participants to 30 minutes. Under the                   compatible with ACE.                                  inspection of production facilities


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                                          before a food manufacturer or carrier                      c. Flexible alternatives. In the Federal           alternatives. Several comments state
                                          can be certified.                                       Register document to reopen the                       that any flexible alternatives should be
                                             • It should be mandatory for food                    comment period, FDA and CBP also                      incorporated into existing programs
                                          manufacturers to provide notice                         requested comment on the following                    because the duplication of security
                                          concerning any changes in the                           questions regarding flexible alternatives             programs and division of limited
                                          manufacturing processes or supplies, as                 (69 FR 19763 at 19764):                               resources are not in the best interest of
                                          well as those that may affect physical                     • If timeframes are reduced in FDA’s               our security goals and the protection of
                                          and personnel security. In addition, the                prior notice final rule, would other                  public health.
                                          current requirements that manufacturers                 flexible alternatives for participants in                (Response) FDA believes that
                                          periodically review the security                        FAST or for food imported by other                    additional flexible alternatives should
                                          commitment of their service providers                   agencies be needed?                                   be incorporated into existing programs
                                          to detect weakness or potential                            • In considering flexible alternatives             when appropriate and feasible. FDA
                                          weaknesses in security should be                        for food imported by other government                 will continue to work with CBP and
                                          altered to require that: (1) The review is              agencies, what factors or criteria should             acknowledges that the additional
                                          conducted on an annual basis and (2) a                  FDA consider when examining                           information provided by other programs
                                          certification that the review has been                  alternatives? Should participation be                 such as C–TPAT could be helpful for
                                          conducted.                                              voluntary? If so, should FDA consider                 purposes of admissibility decisions.
                                             • FDA and CBP should work together,                  inspection of companies in the supply                    i. If timeframes are reduced in FDA’s
                                          along with the trade community, to                      chain from the manufacturer to those                  prior notice final rule, would other
                                          identify potential areas where the C–                   who may hold the product, including                   flexible alternatives for participants in
                                          TPAT security and verification                          reviews of their security plans to                    FAST or for food imported by other
                                          processes can or should be modified.                    determine what procedures are in place                agencies be needed? (Comments)
                                          CBP and FDA should coordinate these                     to prevent infiltration of their facilities           Several comments encourage
                                                                                                  as a condition of participation?                      incorporation of prior notice
                                          processes to address the additional
                                          concerns of the FDA in order to allow                      • In considering flexible alternatives             requirements into the C–TPAT and
                                                                                                  for submission of prior notice, should                FAST programs. Most comments
                                          C–TPAT/FAST members expedited
                                                                                                  FDA consider additional means of                      caution that additional requirements
                                          processing of food and feed shipments
                                                                                                  ensuring that all companies subject to                should not be added as separate
                                          in addition to CBP shipments.
                                                                                                  the Registration of Food Facilities                   programs, but that FDA should
                                             • C–TPAT requirements should                                                                               recognize participants in the existing
                                          encompass any industry and food                         Interim Final Rule ((68 FR 58894,
                                                                                                  October 10, 2003) (21 CFR part 1,                     programs for expedited review and
                                          specific security measures into C–                                                                            processing of prior notice. One
                                          TPAT’s checklist.                                       subpart H)), have an updated
                                                                                                  registration on file with FDA that has                comment further suggests that
                                             • These processes must be more                                                                             participation in C–TPAT and FAST
                                                                                                  been verified?
                                          comprehensive. There are no questions                      • Are there conditions of                          should also ensure expedited 801(a)
                                          on the Supply Chain Security Profile                    participation that FDA should consider;               admissibility processing. Another
                                          Questionnaire to specify the type of                    e.g., inspections of companies in the                 comment suggests that CBP be solely
                                          freight being hauled. In addition, there                supply chain from the manufacturer to                 responsible for administering both the
                                          are no opportunities in the                             those who may hold the product, or                    FDA and CBP requirements of C–TPAT
                                          questionnaire to indicate different                     reviews of their security plans to                    and FAST.
                                          locations to which a company is                         determine what procedures are in place                   (Response) As we discussed
                                          shipping regularly, or insurance a                      to prevent infiltration of their facilities?          previously, we have determined not to
                                          company has to cover those states.                         • Should the food product category                 provide C–TPAT members with special
                                             (Response) FDA notes that CBP has                    be considered as a criteria or element of             treatment in terms of reduced prior
                                          continued to expand the C–TPAT                          expedited prior notice processing or                  notice information requirements or
                                          program, which now includes minimum                     other flexible alternatives? If so, should            reduced timeframes. FDA, however, is
                                          security criteria for importers who                     certain foods be excluded from                        continuing to explore with CBP and
                                          participate in C–TPAT. FDA also notes                   expedited prior notice processing? If so,             industry use of these programs in
                                          that as of July 10, 2006, CBP has                       what should be the basis for                          making decisions regarding which
                                          received over 11,000 C–TPAT                             determining which foods should be                     products to inspect for the purposes of
                                          applications of which 6,089 have been                   excluded?                                             admissibility (801(a) decisions).
                                          certified and 2,973 have been validated                    • If FDA adopts reduced timeframes                    FDA disagrees with the comment’s
                                          (certified members provide a complete                   in the prior notice final rule, should                suggestion that CBP be solely
                                          security profile that is screened by CBP,               FDA phase in the shorter timeframes as                responsible for administering both the
                                          while validated members also undergo a                  CBP phases in the advance electronic                  FDA and CBP requirements for these
                                          complete validation of their security                   information rule?                                     programs, as the expertise related to
                                          profile that includes an on-site visit to                  • Should FDA offer a prior notice                  food safety and possible additional
                                          the company to review the submitted                     submission training program for                       participation requirements that address
                                          security profile, followed by a physical                submitters and transmitters, including                food safety resides in FDA. Accordingly,
                                          verification of security measures). There               brokers, to ensure the accuracy of the                FDA and CBP will continue to consider
                                          are limited resources at this time to add               data being submitted?                                 how to administer FAST and C–TPAT
                                          new significant program requirements to                    This section will address the                      programs so that they could apply to
                                          meet FDA’s needs under the                              comments to each of those questions                   FDA regulated products.
                                          Bioterrorism Act and verify that those                  introduced in the Federal Register of                    ii. In considering flexible alternatives
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                                          procedures have been incorporated. The                  April 14, 2004, beginning with general                for food imported by other government
                                          two agencies will continue to explore                   comments.                                             agencies, what factors or criteria should
                                          the feasibility of the approaches                          (Comments) One comment said that if                FDA consider when examining
                                          recommended in the comments in the                      the final rule is refined, then it is not             alternatives? Should participation be
                                          future.                                                 necessary to offer additional flexible                voluntary? If so, should FDA consider


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                                          66314             Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations

                                          inspection of companies in the supply                   CFR part 1, subpart H. FDA also agrees                company’s ability to meet the program
                                          chain from the manufacturer to those                    it would be efficient to conduct the                  standards set by the particular
                                          who may hold the product, including                     verification as part of the C–TPAT                    government agency.
                                          reviews of their security plans to                      validation process, but neither FDA nor                  (Response) FDA agrees in part that no
                                          determine what procedures are in place                  CBP has the resources to do so at this                product category distinctions should be
                                          to prevent infiltration of their facilities             time.                                                 made. However, FDA acknowledges that
                                          as a condition of participation?                           iv. Are there conditions of                        some foods are more susceptible to
                                          (Comments/Response) There were no                       participation that FDA should consider;               terrorism and food safety problems than
                                          comments addressing flexible                            e.g., inspections of companies in the                 others, regardless of the processes
                                          alternatives for food imported by other                 supply chain from the manufacturer to                 within the supply chain. But if we were
                                          government agencies. However, FDA                       those who may hold the product, or                    to make product category distinctions,
                                          has considered imported shipments of                    reviews of their security plans to                    such actions could be disruptive to
                                          foods for official U.S. federal                         determine what procedures are in place                transportation (e.g., we may need to
                                          government use and our draft policy for                 to prevent infiltration of their facilities?          segregate products) and may make such
                                          enforcing prior notice in these situations              (Comments) Most comments suggest                      products targets for terrorism since such
                                          is contained in the Prior Notice Final                  that other conditions, such as inspection             products may be eligible for special
                                          Rule Draft CPG that is announced                        of other companies in the supply chain                (e.g., expedited) treatment.
                                          elsewhere in this issue of the Federal                  would be unnecessary and a repetition                    vi. If FDA adopts reduced timeframes
                                          Register. Under the draft policy, FDA                   of effort with little return on investment.           in the prior notice final rule, should
                                          and CBP should typically consider not                   Another comment states that to begin a                FDA phase in the shorter timeframes as
                                          taking any regulatory action when an                    process of examining the security plans               CBP phases in the advance electronic
                                          article of food is imported or offered for              and procedures of foreign food facilities             information rule? (Comments/Response)
                                          import for an official government                       would be tremendously expensive, call                 Comments addressing phase-in of
                                          purpose, provided that a Federal                        into question the validity of the prior               timeframes are found under the
                                          Government agency is the importer of                    notice and registration requirements                  discussion of § 1.279 ‘‘When must prior
                                          record.                                                 already in place, and the efficacy of the             notice be submitted to FDA.’’
                                             (Comments) Many comments advise                      targeting tools FDA employs.                             vii. Should FDA offer a prior notice
                                          that voluntary participation enhances                      (Response) We agree that adding                    submission training program for
                                          the success of these programs.                          conditions for C–TPAT participation                   submitters and transmitters, including
                                             (Response) C–TPAT is a voluntary,                    and validating them to meet the purpose               brokers, to ensure the accuracy of the
                                          incentive based partnership. As we                      of the Bioterrorism Act would be                      data being submitted? (Comments/
                                          continue exploring use of the C–TPAT                    extremely expensive and potentially                   Response) Most comments support
                                          and FAST programs in making                             only benefit a small number of those                  additional training for submitters and
                                          decisions regarding which products to                   entities subject to this rule. We do not              transmitters. Additional discussion of
                                          inspect for the purposes of admissibility               believe that this is the best use of our              training is found under section III. M
                                          (801(a) decisions), it will be based on                 limited resources at this time,                       (Outreach and Enforcement) of this
                                          the assumption that participation                       particularly as we have not experienced               document.
                                          should remain voluntary.                                significant impacts on the flow of trade              7. Additional Exclusions Requested—
                                             iii. In considering flexible alternatives            as a result of the timeframes in the rule             Samples
                                          for submission of prior notice, should                  since the IFR took effect on December
                                          FDA consider additional means of                        12, 2003.                                                (Comments) Numerous comments
                                          ensuring that all companies subject to                     v. Should the food product category                request an exclusion from the
                                          the Registration of Food Facilities                     be considered as a criteria or element of             requirements of prior notice for samples
                                          Interim Final Rule ((68 FR 58894,                       expedited prior notice processing or                  used in trade fairs, market research,
                                          October 10, 2003) (21 CFR part 1,                       other flexible alternatives? If so, should            market testing, and laboratory analyses
                                          subpart H)), have an updated                            certain foods be excluded from                        (i.e., quality analysis/quality control
                                          registration on file with FDA that has                  expedited prior notice processing? If so,             (QA/QC) samples, scientific research,
                                          been verified? (Comments) Several                       what should be the basis for                          compositional analyses, research and
                                          comments reiterate that it is not                       determining which foods should be                     development, standard of identity
                                          necessary for FDA to provide flexible                   excluded? (Comments) While one                        confirmation testing or quality
                                          alternatives that exceed or augment                     comment asserts that the food product                 comparison testing). The comments
                                          CBP’s existing programs, including a                    category be considered an important                   state that QA/QC samples are clearly not
                                          requirement to have an updated and                      element of expedited processing, most                 destined for consumption and will
                                          verified registration on file with FDA.                 other comments state that no product                  never enter the food chain or be
                                          However, another comment believes                       category distinctions should be made.                 consumed by the general public, thereby
                                          that companies eligible to participate in               One comment states that to allow items                placing samples in a low-risk category.
                                          low-risk programs should have an                        imported under food product categories                In addition, the comments note that
                                          updated registration and that                           to qualify for expedited prior notice                 these samples are often imported in very
                                          verification of that registration would be              could easily lead to abuse of the system              small quantities for a specific purpose.
                                          useful in determining low-risk status.                  intended to protect us from terrorist                 Samples used for organoleptic analyses
                                          Another comment assumes that                            attack. Other comments suggest that all               will be consumed in very small
                                          verification of registration with FDA                   food products be treated in the same                  quantities as part of the analytic
                                          should have been conducted under                        manner and be subject to the same                     procedures in a laboratory setting. In the
                                          CBP’s current validation aspect of the                  regulations. Most comments state that                 case of trade samples, the comments
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                                          C–TPAT program.                                         no product should be specifically                     contend that although the food will be
                                             (Response) FDA agrees that                           included or excluded from                             consumed, the consumption is minor
                                          participants designated as low risk                     participation, but that the criteria for              and is contained within a controlled
                                          should have an updated and verified                     participation should be focused solely                environment, such as a test kitchen or
                                          registration of all facilities subject to 21            on attributes of the company and a                    trade booth.


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                                             In addition, the comments suggest                    would not be subject to prior notice                  Law 107–188.) Moreover, we have had
                                          some ways in which the burdens for                      requirements. In addition, if the sample              incidents where small quantities of
                                          submitting prior notice for samples                     is in a form that is not an article of food,          samples that had been consumed caused
                                          could be less cumbersome. These                         such as a slurry of lettuce for pesticide             serious illness or death. For example, in
                                          recommendations include:                                analysis, then prior notice requirements              the preamble to the IFR, FDA noted that
                                             • Exempt all samples or some subset                  would not apply. But where a sample is                ‘‘in the summer of 2003, FDA received
                                          of samples, e.g., analytical, research,                 food, as defined under prior notice, the              a report from a poison control center in
                                          consumer complaint;                                     sample is not excluded from the final                 country T concerning the acute
                                             • Set a limit of the quantity of                     rule even if it is imported or offered for            poisoning of 9 men (one died) from
                                          samples in each shipment and do not                     import for quality assurance, research or             ingestion of an herbal fermented wine.
                                          require prior notice for quantities below               analysis purposes only, not for human                 Symptoms occurred within minutes.
                                          this limit;                                             or animal consumption and not for                     Reports indicated that this product may
                                             • Exempt samples from the                            resale. However, as outlined in the Prior             have been exported to the United States
                                          requirement to provide the                              Notice Final Rule Draft CPG, FDA’s and                in small quantities for test marketing in
                                          manufacturer’s registration number;                     CBP’s enforcement discretion policy                   restaurants. This underscores the
                                             • Include a field in the prior notice in             would apply to these foods, under                     importance of FDA receiving prior
                                          which a filer can indicate that the                     which FDA and CBP should typically                    notice of all food imported or offered for
                                          item(s) is a sample, and eliminate                      consider not taking any regulatory                    import.’’ (68 FR 58974 at 58993.)
                                          certain data elements if this field is                  action when there is no prior notice and
                                          flagged (i.e., registration number);                                                                          8. Additional Exclusions Requested—
                                                                                                  the food is a sample not intended for
                                             • Allow a single prior notice without                human or animal consumption.                          Mail
                                          registration numbers for commingled                        Samples of food are considered to be                  (Comments) One comment sought
                                          shipments of many small sample items                    for quality assurance, research or                    better information regarding the sending
                                          falling under the same or similar FDA                   analysis purposes, rather than human or               of food products as international
                                          product codes;                                          animal consumption, when they are in                  packages or bringing food products into
                                             • Allow shippers to provide a pre-                   small quantities (i.e., quantities                    the United States personally in their
                                          approved list of customers who may                      consistent with the quality assurance,                baggage.
                                          receive samples in a particular month,                  research, or analysis purposes) and the                  (Response) Information on the
                                          on a monthly basis in lieu of filing                    entire sample is used up by the analysis,             sending of food through international
                                          individual prior notices;                               destroyed after analysis, or destroyed                mail can be found at: http://
                                             • Specify procedures in the final rule               following a reasonable retention period               www.cfsan.fda.gov/~pn/pnmail.html.
                                          for clearly identifying samples, such as                after analysis. The analysis may include              Food products for personal use brought
                                          the inclusion of a statement on the                     sensory examination, such as                          into the United States that accompanies
                                          airway bill of lading that says: ‘‘Quality              organoleptic examination for                          an individual are not subject to the
                                          Evaluation and Research and                             determining tea quality or detecting the              requirements of prior notice
                                          Development Use Only—Resale                             presence of histamines. Evidence that                 (§ 1.277(b)(1)).
                                          Prohibited;’’ and                                       an article of food is for quality                        (Comment) One comment questions
                                             • Provide a limited exemption for                    assurance, research, or analysis                      whether express couriers, such as EMS,
                                          intra-corporate (within the same                        purposes only might include, among                    FEDERAL EXPRESS, DHL, and TNT, are
                                          company) samples.                                       other evidence, markings on the food                  considered ‘‘international mail.’’
                                             One comment requests that FDA                        and shipping documents.                                  (Response) Section 1.276(b)(8) of the
                                          exempt foods for exhibit at trade shows                    FDA disagrees with the comments                    final rule defines international mail to
                                          and food samples. The comment reasons                   that suggest that prior notice should                 mean foreign national mail services and
                                          that these foods are not intended for                   only be required for food, including                  further states that international mail
                                          consumption in the United States, but                   samples, that is intended for                         does not include express consignment
                                          are imported for ‘‘show’’ and sampling                  consumption. In the preamble to the                   operators or carriers or other private
                                          at the trade shows, not for later general               IFR, FDA discussed extensively its                    delivery services unless such service is
                                          consumption. The comment further                        rationale for not limiting the prior                  operating under contract as an agent or
                                          reasons that the quantity involved with                 notice requirements to food for                       extension of a foreign mail service.
                                          each shipment is minuscule, usually no                  consumption in the United States. (See                Therefore, if food items are shipped
                                          more than five hundred consumer units,                  68 FR 58974 at 58990 and 58991.) This                 through one of these services and the
                                          which is too small a quantity to pose a                 rationale still holds. FDA also disagrees             food items are not otherwise excluded
                                          potential national security threat.                     with the comments that state samples                  from prior notice requirements, prior
                                             Another comment states that there                    should be exempted from prior notice if               notice is required.
                                          should be a de minimus provision for                    the consumption of the samples is                        (Comments) One comment questions
                                          samples from known shippers/importers                   minor and is contained within a                       if the rule applies to the military postal
                                          that is ‘‘cross-referenced’’ by shipper                 controlled environment, such as a test                service, which is a subsidiary of the
                                          facility registration, manufacturer                     kitchen or trade booth, or the quantity               United States Postal Service that
                                          facility registration, importer facility                involved with each shipment is                        operates overseas.
                                          registration, low value, and low weight.                minuscule, such that it ‘‘is too small a                 (Response) If the military post offices
                                             (Response) Many samples of food,                     quantity to pose a potential national                 are located outside of the United States,
                                          including those for test marketing, are                 security threat.’’ The purpose of the                 as defined for the purposes of prior
                                          ‘‘articles of food imported or offered for              Bioterrorism Act is not limited to                    notice, articles of food would be subject
                                          import,’’ as stated in section 801(m) of                terrorist activity or other national                  to the requirements of prior notice
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                                          the act. If, however, the samples are                   security threats; its purpose is ‘‘[t]o               (§ 1.277(a)).
                                          items that are in such early stages of                  improve the ability of the United States                 (Comments) One comment states that
                                          research and development that they                      to prevent, prepare for, and respond to               the costs and resource implications of
                                          cannot yet be considered food under                     bioterrorism and other public health                  FDA applying this type of approach to
                                          § 1.276(b)(5) of the final rule, they                   emergencies’’ [emphasis added]. (Public               single-piece, person-to-person,


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                                          66316             Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations

                                          international mailings of manufactured                     In addition, the comments suggest                  submission of the express consignment
                                          food products may outweigh any                          that: (1) Private persons should be                   operator or carrier tracking number in
                                          perceived benefits. FDA’s current                       excluded from prior notice; (2) the                   lieu of anticipated arrival and certain
                                          approach to prior notice forces the U.S.                requested information should be limited               planned shipment information. Thus,
                                          Postal Service (USPS), FDA, and CBP to                  to some key-information, such as the                  we do not believe the final rule should
                                          dedicate substantial resources simply to                submitter and the type of food; (3) all               be revised to expand the definition of
                                          attempt effective implementation of                     mail services, including express                      international mail to include express
                                          these regulations. The comment asks                     carriers, should fall under the definition            consignment operators or carriers or
                                          that FDA: (1) Exempt these single-piece,                of ‘‘international mail;’’ and (4) FDA                other private delivery services.
                                          personal use mailings from prior notice;                should provide on their Web site                         FDA also does not agree the prior
                                          (2) allow CBP to continue using its time-               dedicated information for companies                   notice requirements should not apply to
                                          tested strategies for screening and                     and consumers about international mail,               low-value shipments, as neither the
                                          selections of items from mail shipments                 in different languages.                               Bioterrorism Act nor experience with
                                          arriving at the first port of entry; (3)                   (Response) The act does not exempt                 samples support this approach. See
                                          allow the delivery of mail items                        noncommercial shipments with a                        FDA’s responses to comments
                                          containing food, even if the contents are               noncommercial shipper. FDA explained                  previously under section III.D.7 of this
                                          not accompanied by prior notice                         this position in the preamble to the IFR              document ‘‘Additional Exclusions
                                          confirmation numbers to the U.S.                        (See 68 FR 58992) and believes that this              Requested—Samples’’ for further
                                          address, as long as the U.S. authorities                rationale is still valid. However, under              discussion on this point.
                                          find no problem with the contents at                    the Prior Notice Final Rule Draft CPG,                   (Comments) A few comments suggest
                                          border inspection; and (4) work in close                when food is purchased or otherwise                   that FDA modify the existing
                                          coordination with CBP and USPS to                       acquired by an individual for                         procedures for commercial shipments
                                          promote more clarity of understanding                   nonbusiness purposes and sent to an                   arriving by international mail. The
                                          on the procedures for packages where                    individual with a noncommercial
                                                                                                                                                        comments state that complying with the
                                          the majority of the contents are not food               shipper, FDA and CBP would typically
                                                                                                                                                        requirements of FDA’s prior notification
                                          items. The comment states that these                    consider not taking regulatory action if
                                                                                                                                                        procedure results in an unbearable
                                          policies will need to be uniformly                      prior notice is not submitted. This
                                                                                                                                                        workload for mail order companies,
                                          applied, and also must ensure that                      proposed enforcement discretion policy
                                                                                                                                                        which sometimes mail thousands of
                                          proper accountability is provided to the                would be continued from the Prior
                                                                                                                                                        packages at one time, with each package
                                          mailers and recipients whose mailed                     Notice Interim Final Rule CPG.
                                                                                                     Express consignment operators or                   requiring a prior notice. The comments
                                          items might have been refused, seized,
                                                                                                  carriers or other private delivery                    suggest that manufacturers submit their
                                          or destroyed.
                                                                                                  services, unless such service is                      company information and product
                                             Another comment requests an
                                          exemption for manufactured food                         operating under contract as an agent or               information for similar items once and
                                          products that are sent via international                extension of a foreign mail service, are              then add the different recipients’
                                          mail for noncommercial purposes. Some                   not considered international mail. (See               addresses at the end.
                                          comments complain that the required                     § 1.276(b)(8) of the final rule). The IFR                (Response) FDA’s PNSI has been
                                          data are very complex for the average                   created a category for international mail             designed to accommodate repetitive
                                          customer and the system is not very                     because the rule imposed slightly                     information so that the basic prior
                                          customer-friendly, entries take a long                  different requirements for such imports.              notice can be created and saved, and
                                          time, and each single item has to have                  For example, given the nature of                      each U.S. recipient can be added at the
                                          a separate prior notice.                                international mail imports, prior notice              end of each subsequent prior notice. A
                                             A few comments state that most of the                required the planned date of mail                     separate prior notice confirmation
                                          required information, such as the                       instead of the anticipated arrival                    number is generated for each article of
                                          manufacturer’s registration number, is                  information; it required the                          food (and recipient). Similarly, a
                                          not available to private persons, and                   identification of the recipient instead of            number of the software programs that
                                          therefore, not available to international               the importer, owner, and consignee; and               customs brokers use to file prior notice
                                          mail and mail by express carriers. The                  it did not require the mode of                        and entry submissions with ABI/ACS do
                                          comments note that this is particularly                 transportation, carrier, planned                      allow for repetitive information to be
                                          problematic, since FDA does not                         shipment information, and hold                        saved on the filer’s computer and used
                                          provide information on registration of                  information. In addition, for                         for future shipments, as appropriate.
                                          facilities to private parties. The                      international mail the prior notice must              9. Additional Exclusions Requested—
                                          comments further note that a business                   be submitted before the article of food               Gifts
                                          relationship between the buyer of the                   has been sent in order to allow the prior
                                          goods (e.g., a private person), the mail                notice confirmation number to                            (Comments) Several comments
                                          service and the manufacturer will in                    accompany the package. We do not                      recommend that FDA expand the
                                          general not be present. In addition, the                believe these changes are relevant for                exemption already provided for
                                          comments state that to file prior notice,               shipments arriving by express                         homemade food products sent as gifts
                                          Internet access and knowledge of the                    consignment operators or carriers or                  (§ 1.277(b)(2)) or food items carried in
                                          English language is required. The                       other private delivery services. For                  for ‘‘personal consumption’’
                                          comments contend that mail users will                   example, if the express carrier submits               (§ 1.277(b)(1)) to include all gifts,
                                          have to bear unreasonable disadvantages                 the prior notice, it will be able to                  regardless of mode of transportation,
                                          and unequal treatment. The comments                     include the mode of transportation,                   that are intended for personal use.
                                          argue that this seems disproportionate                  carrier, and other data elements not                  Another comment asks for clarification
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                                          because most shipments are of low                       included in the international mail                    regarding food articles sent as gifts to
                                          value. Therefore, the comments suggest                  category. In situations where the                     persons in the United States for
                                          that FDA simplify the prior notice                      submitter and/or transmitter is not the               personal consumption. This comment
                                          requirements through FDA’s PNSI for                     express consignment operator or carrier,              believes that prior notice is only
                                          mail users.                                             the final rule now allows the                         required for food articles that will be


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                                          distributed or traded in the United                     explained in the IFR (68 FR 58974 at                  anticipated arrival information and/or
                                          States.                                                 58993). However, under the proposed                   planned shipment information and if,
                                             (Response) If the food was made by an                enforcement discretion policy,                        among other criteria, the prior notice
                                          individual in his/her personal residence                described in the Prior Notice Final Rule              includes the shipment’s tracking
                                          and sent by that individual as a personal               Draft CPG, when food is sent by an                    number in lieu of the required
                                          gift (i.e., for nonbusiness reasons) to an              individual for noncommercial purposes                 anticipated arrival information and/or
                                          individual in the United States, prior                  with a noncommercial shipper without                  planned shipment information. A
                                          notice is not required (§ 1.277(b)(2)).                 prior notice, regardless of the article’s             person shipping food into the United
                                          Other food products sent by an                          value, FDA and CBP should typically                   States via an express courier will have
                                          individual and imported for                             consider not taking any regulatory                    access to the tracking number to use in
                                          noncommercial purposes with a                           action.                                               lieu of the flight number or other
                                          noncommercial shipper are not                             (Comments) Two comments                             planned shipment information. FDA has
                                          excluded from prior notice                              recommend that FDA consider                           incorporated this policy in § 1.281 of the
                                          requirements. FDA explained this                        incorporating into the final rule a                   final rule, which allows the submitter
                                          position in the preamble to the IFR (See                limited exemption for very small                      and/or transmitter to submit the express
                                          68 FR 58992) and believes that this                     quantities of food. One of those                      consignment operator or carrier tracking
                                          rationale is still valid. However, under                comments considers a small quantity to                number in lieu of anticipated arrival
                                          the Prior Notice Final Rule Draft CPG,                  be under 80 pounds or less than 100                   and certain planned shipment
                                          when gifts are shipped by an individual                 bottles.                                              information as long as neither the
                                          for nonbusiness reasons to an individual                  (Response) FDA disagrees and will                   submitter nor transmitter is the express
                                          without prior notice, FDA and CBP                       not place a weight or quantity                        consignment operator or carrier and
                                          should typically consider not taking                    restriction on the requirements for prior             prior notice is submitted via PNSI.
                                          regulatory action. This proposed policy                 notice. ‘‘Small quantity’’ shipments are
                                          would apply regardless of the mode of                   clearly subject to the terms of section               12. Additional Exclusion Requested—
                                          transportation.                                         801(m) of the act as they are ‘‘articles of           Gift Packs
                                                                                                  food imported or offered for import.’’                   (Comments) One comment requests
                                          10. Additional Exclusions Requested—                    Similar to low-value articles of food,                clarification of the interpretation
                                          Low-Value                                               small quantity shipments can pose the                 pertaining to gift baskets. The comment
                                            (Comments) Many comments request                      same threat level to the U.S. food supply             states it is unclear whether prior notice
                                          a de minimis exemption from prior                       as do articles of food that arrive in larger          is based upon the description of the
                                          notice for all low value shipments (less                quantities. If we were to exempt small                entire gift basket as an entity, which is
                                          than $200). The comments assert that                    quantity food shipments, small                        currently the case for CBP entry
                                          the prior notice requirements can be                    quantities of poisoned food (with the                 processing, or on the individual items
                                          quite onerous for small shipments and                   potential to do a high level of damage)               within the basket. One comment asks
                                          that low value shipments of prepared                    could be imported into the United                     FDA to exempt gift baskets because they
                                          food sent from and to individuals for                   States without prior notice, thereby                  are ‘‘no-risk.’’
                                          their personal use are of little risk to the            negating the purpose of the Bioterrorism                 (Response) Under the final rule, a gift
                                          U.S. food supply, especially relative to                Act.                                                  pack is not considered a single article of
                                          the individual size and large number of                                                                       food (e.g., a gift pack consisting of four
                                          commercial shipments entering the                       11. Additional Exclusions Requested—                  articles of food would require four prior
                                          country. One comment states that a low                  Couriers                                              notice submissions). This is because a
                                          value exemption from prior notice for                      (Comments) One comment reports                     gift pack is not manufactured/processed
                                          shipments under $200, whether for                       that many of the express couriers refuse              as a single product, but is packed by
                                          personal or commercial use, would be                    to do the necessary paperwork for                     consolidating a variety of articles of
                                          consistent with CBP’s de minimis                        shipments being sent via their services.              food into a unit, with or without other
                                          exemption. In addition, one comment                     Therefore, the manufacturers are                      nonfood articles. However, FDA and
                                          states that foreign individuals shipping                required to submit prior notice.                      CBP are proposing to continue their
                                          low value gifts to the United States will               However, the manufacturer does not                    enforcement discretion policy for gift
                                          not know the Bioterrorism Act’s                         have the necessary information needed                 packs, which the agencies first
                                          requirements and will not be able to                    to complete the form, such as flight                  announced in their March 2005 CPG
                                          obtain the manufacturer’s phone and                     number, departure and arrival time, etc.              (March 4, 2005; 70 FR 10657). Under
                                          registration numbers. The comment                       The comment suggests that express                     that policy, ‘‘FDA and Customs Border
                                          states that these numbers are not readily               courier shipments should be treated in                Protection (CBP) staff should typically
                                          available to the consumer when                          the same manner as mail shipments.                    consider not taking regulatory action if
                                          products are purchased in small                            (Response) FDA disagrees but has                   there is a prior notice violation because
                                          quantities. One comment requests an                     modified the rule to address the                      a single prior notice is submitted for a
                                          exemption for small dollar value mail-                  underlying concern. Food imported or                  gift pack and the identity of the facility
                                          order sales to U.S. customers ($100 or                  offered for import via these private                  that packed the gift pack is submitted in
                                          less) since the prior notice system is                  delivery services are subject to prior                lieu of the identity of the
                                          difficult and costly to implement for                   notice, which must be submitted within                manufacturer(s), provided that the gift
                                          this type of business.                                  the timeframe of the applicable mode of               pack is purchased or otherwise acquired
                                            (Response) FDA disagrees. Low-value                   transportation—water, air, or land                    by an individual and imported or
                                          shipments are clearly subject to the                    (§ 1.279). In the prior notice CPG                    offered for import for nonbusiness
                                          terms of section 801(m) of the act as                   published in November 2004 (November                  purposes.’’
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                                          they are ‘‘articles of food imported or                 9, 2004; 69 FR 64959), FDA and CBP                       There is no CBP rule or regulation,
                                          offered for import.’’ Moreover, low-                    stated that they generally would                      nor is there a General Rule of
                                          value articles of food can pose the same                consider not taking regulatory action if              Interpretation (GRI) under which gift
                                          threat level to the U.S. food supply as                 the prior notice is inadequate because it             packs are classified. In the case of ‘‘gift
                                          do articles of food that cost more, as we               does not include the required                         packs’’ that contain multiple products,


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                                          CBP tries to classify the gift pack using               employed by NATO Headquarters,                        food imported or offered for import for
                                          the concept of a set. That is, if the                   Supreme Allied Commander                              noncommercial purposes with a
                                          products included in a gift pack are part               Transformation Atlantic and their                     noncommercial shipper without prior
                                          of a common activity, the gift pack may                 immediate families be granted an                      notice, irrespective of the type of carrier.
                                          be classified under the HTS code that is                exemption from prior notice. The                      Under the proposed policy, FDA and
                                          most applicable. However, CBP does not                  comment contends that these                           CBP should typically consider not
                                          consider eating to be a common activity,                individuals have undergone an intense                 taking any regulatory action when an
                                          even when all items in a gift pack are                  screening process prior to being selected             article of food is imported or offered for
                                          to be consumed. Therefore, unless there                 for a NATO position. One comment                      import for noncommercial purposes
                                          has been an applicable CBP ruling,                      requests that FDA exempt Department                   with a noncommercial shipper without
                                          entries of gift packs should be declared                of Defense active duty military and                   prior notice. The noncommercial
                                          to CBP using the HTS code for each item                 civilian personnel unaccompanied                      shipper, under this policy, would be an
                                          included within the gift pack. This                     baggage and household good shipments.                 individual (e.g., the individual delivers
                                          principle applies even when there are                      (Response) Section 801(m) of the act               the food to a post office or common
                                          food and nonfood items in the pack                      does not authorize an exclusion from                  carrier for delivery to self, family
                                          (e.g., a soup mug and a can of soup) as                 prior notice for food imported as part of             member, or friend for nonbusiness
                                          well as for make-your-own gift packs                    unaccompanied baggage or food                         purposes).
                                          (e.g., if you created a gift pack by                    included as part of a shipment of                        When a business ships a food, it is for
                                          personally selecting individual items                   personal household goods. Therefore,                  a commercial or business purpose. The
                                          from a list of available products).                     food contained in household goods and                 situation as described in this comment,
                                                                                                  accompanied baggage are subject to                    therefore, would not meet the criteria
                                          13. Additional Exclusions Requested—                    prior notice requirements.                            covered by the enforcement discretion
                                          Household Goods and Unaccompanied                          However, a proposed enforcement                    policy since the shipper is a business.
                                          Baggage                                                 discretion policy in the Prior Notice                    (Comments) One comment requests
                                             (Comments) Many comments suggest                     Final Rule Draft CPG would apply to                   that private persons should be excluded
                                          that the final rule exempt                              most or all of the household goods and                from the requirements of prior notice.
                                          unaccompanied food that is included in                  unaccompanied baggage shipments                       The comment states that commercially-
                                          a shipment of personal household                        described in the comments. Under the                  produced food imported for the
                                          goods, if the food is owned by and                      proposed policy, FDA and CBP should                   personal use of an individual, even if
                                          intended to be consumed by the shipper                  typically consider not taking any                     included in a shipment of personal
                                          of the household goods, their family or                 regulatory action when an article of food             effects, should not require prior notice.
                                          friends, and if the food is not to be                   is imported or offered for import for                    (Response) Section 801(m) of the act
                                          offered for sale or distribution. In                    noncommercial purposes with a                         does not authorize a broad exclusion
                                          addition, several comments suggest that                 noncommercial shipper without prior                   from prior notice for food imported or
                                          food contained in unaccompanied                         notice. We consider food in household                 offered for import by private persons.
                                          baggage should be exempt from the                       goods, including military and civilian                Therefore, food that is commercially
                                          requirements of prior notice. The                       transfers, to be food imported or offered             produced that is imported for the
                                          comments state that the owner of the                    for import for a noncommercial                        personal use of an individual, as
                                          food never changes, and that there is no                purpose. This enforcement discretion                  described in the comment, would be
                                          sale or transfer of the goods. The                      policy would be a continuation of the                 subject to this final rule.
                                          comments believe that shipping food                     policy in effect since FDA issued the                    However, we are proposing an
                                          items contained in household goods or                   June 2004 Prior Notice Interim Final                  enforcement discretion policy in the
                                          unaccompanied baggage to the United                     Rule CPG (June 29, 2004, 69 FR 38906).                Prior Notice Final Rule Draft CPG for
                                          States is equivalent to carrying the items                                                                    food imported or offered for import for
                                          in baggage for personal use. The                        14. Additional Exclusions Requested—                  noncommercial purposes with a
                                          comments further state that household                   Noncommercial Use                                     noncommercial shipper, irrespective of
                                          goods are even more personal than food                     (Comments) One comment asserts that                the type of carrier without prior notice.
                                          accompanying a traveler because                         shipments for personal consignment                    Under the proposed policy, FDA and
                                          although it travels from one personal                   when sent from a business are, by                     CBP should typically consider not
                                          residence to another, it remains part of                definition, noncommercial, due to the                 taking any regulatory action when an
                                          the same household or home. The                         fact they are purchased for personal use              article of food is imported or offered for
                                          comments suggest that FDA not require                   and not for resale. The comment                       import for noncommercial purposes
                                          as many data elements for these types of                suggests that FDA define                              with a noncommercial shipper without
                                          shipments, and allow a minimum                          noncommercial shipments to include                    prior notice. This policy would cover
                                          amount of food/consumables to be                        any consignment to an individual for                  the food described in the comment,
                                          imported without prior notice. The                      personal, noncommercial use, as exempt                commercially produced food imported
                                          comments believe that it will be                        from the requirements of prior notice,                for the personal use of an individual, as
                                          unnecessarily tedious and exhaustive                    regardless of whether the shipper is a                long as the shipper is noncommercial.
                                          for individuals to input the required                   business entity or an individual.                     This enforcement policy would
                                          information into the FDA PNSI, and that                    (Response) FDA disagrees. As we                    continue the policy initially announced
                                          it is unreasonable to ask individuals to                described in the IFR, there is no basis               in our June 2004 Prior Notice Interim
                                          destroy or leave behind hundreds of                     in the statute for an exemption based on              Final Rule CPG. The draft CPG describes
                                          dollars of canned goods.                                shipments that are for personal use,                  a noncommercial purpose as one where
                                             Additionally, one comment suggests                   regardless of whether the shipper is a                the food is purchased or otherwise
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                                          that persons on duty in the United                      commercial or noncommercial (i.e., an                 acquired by an individual for
                                          States as members of the armed forces                   individual) entity (68 FR 58974 at                    nonbusiness purposes, and a
                                          of a North Atlantic Treaty Organization                 58992). However, we are proposing an                  noncommercial shipper is one where
                                          (NATO) or Partnership for Peace or                      enforcement discretion policy in the                  the shipper is an individual (e.g., the
                                          civilian component attached to or                       Prior Notice Final Rule Draft CPG for                 individual delivers the food to a post


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                                          office or common carrier for delivery to                noncommercial purposes, such as small                 United States’’ (§ 1.277(a)), regardless of
                                          self, family member, or friend for                      shipments for personal use, with a                    whether it was initially a U.S. export
                                          nonbusiness purposes, i.e., not for sale,               noncommercial shipper without prior                   that was refused by a foreign
                                          resale, barter, business use, or                        notice. However, this proposed                        government. We would require prior
                                          commercial use). Examples of foods                      enforcement discretion policy would                   notice for these shipments even if entry
                                          imported or offered for import that may                 not extend to situations where the                    is not required by CBP. In these cases,
                                          be covered by this noncommercial                        shipper is a commercial entity (e.g., a               we recommend that prior notice be
                                          category are: (1) Food in household                     retail store, an Internet company, etc.).             submitted via PNSI.
                                          goods, including military and civilian
                                                                                                  15. Additional Exclusions Requested—                  16. Additional Exclusions Requested—
                                          transfers; (2) food purchased by a
                                                                                                  U.S. Goods Returned                                   In-Transit Shipments
                                          traveler and mailed or shipped to the
                                          traveler’s U.S. address by the traveler,                   (Comments) A few comments request                     (Comments) Several comments
                                          not the commercial establishment; and                   exemptions for unadulterated U.S.                     request that in-transit shipments be
                                          (3) gifts purchased at a commercial                     goods being returned. The comments                    excluded from the prior notice
                                          establishment and shipped by the                        state that these items do not pose an                 requirements. The comments express
                                          purchaser, not the commercial                           adequate threat to the nation’s food                  concern that submitting prior notice for
                                          establishment.                                          supply. In addition, these comments                   such shipments presents a tremendous
                                             (Comments) One comment suggests                      indicate that it is not possible to provide           burden on industry. Companies may
                                          that older wines already owned by a                     the manufacturer’s registration number                seek to avoid the potential cost and
                                          U.S. individual and imported solely for                 for merchandise that was manufactured                 disruption by diverting freight to other
                                          personal consumption be exempt from                     in the United States and then exported                routes rather than use transshipment
                                          prior notice. Another comment provides                  overseas, where the merchandise can be                facilities through U.S. territory for
                                          an example of an individual who owns                    purchased and then shipped back to the                destinations in Mexico and Canada.
                                          a wine cellar overseas and arranges for                 United States. The comments state that                   The comments note that requiring
                                          cases of wine to be sent to him/herself                 the original manufacturer in the United               prior notice for shipments not intended
                                          in the United States for personal                       States will not provide their registration            for consumption in the United States
                                          consumption.                                            number in these scenarios.                            appears to be beyond the statutory
                                             (Response) As discussed previously,                     (Response) FDA disagrees. As                       authority provided by the Bioterrorism
                                          there is no basis in section 801(m) of the              discussed in the IFR, FDA believes that,              Act. The comments reason that in-
                                          act to exclude food imported or offered                 for the purpose of section 801(m) of the              transit shipments are under strict CBP
                                          for import for personal use. Although                   act, the phrase ‘‘imported or offered for             regulations and control by the carrier
                                          this importation is subject to the                      import into the United States’’ applies               with respect to movement and are
                                          provisions of this final rule, if the wine              to articles of food of U.S. origin that are           secured by a bond, and thus, the food
                                          is imported or offered for import by an                 ‘‘reimported’’ back into the United                   cannot be diverted to enter the U.S. food
                                          individual for noncommercial purposes                   States (68 FR 58974 at 58990). FDA                    supply.
                                          and shipped by himself to himself using                 believes that this interpretation, and the               (Response) FDA disagrees. The IFR
                                          a noncommercial shipper without prior                   underlying rationale for it, are still                contains FDA’s rationale and legal
                                          notice, the proposed enforcement                        valid. We also believe, as explained in               support for determining that for the
                                          discretion policy in the Prior Notice                   the IFR, that section 801(m) of the act               purpose of section 801(m) of the act, the
                                          Final Rule Draft CPG would apply.                       does not authorize us to exclude ‘‘low-               phrase, ‘‘imported or offered for import
                                          Under the proposed policy, FDA and                      risk’’ food shipments from prior notice               into the United States,’’ applies to
                                          CBP generally should typically consider                 requirements (68 FR 58974 at 58993).                  articles of food of U.S. origin that are
                                          not taking regulatory action when an                       The inability to submit the                        ‘‘reimported’’ back into the United
                                          article of food is imported or offered for              manufacturing facility’s registration                 States, as well as to food that transits the
                                          import for noncommercial purposes                       number is not a valid reason for                      United States (See 68 FR 58974 at
                                          with a noncommercial shipper without                    excluding such a shipment from prior                  58990). FDA continues to believe this
                                          prior notice.                                           notice requirements. However, we are                  determination is correct and is not
                                             (Comments) One comment suggests                      revising § 1.281(a)(6) of the final rule to           convinced it should be revised.
                                          that small shipments of nominal value                   provide flexibility in submitting the                 Moreover, the comment implies that
                                          for personal, noncommercial use should                  identity of the manufacturer. In addition             these shipments should be exempt from
                                          be exempted from the requirements of                    to the name of the manufacturer, the                  prior notice requirements since the
                                          prior notice. The comment states that                   submitter may submit either the                       shipments are under strict CBP control
                                          the express industry handles many of                    registration number, city, and country of             and are secured by a bond, i.e., that
                                          these shipments now, which include                      the manufacturer, or both the full                    these shipments are low-risk. However,
                                          purchases from a growing number of                      address of the manufacturer and the                   section 801(m) of the act does not
                                          Internet-based sellers. The comment                     reason why the registration number is                 authorize an exemption for articles of
                                          asserts that these small shipments for                  not provided.                                         food that are ‘‘low risk’’ or covered by
                                          personal use do not qualify as a risk to                   (Comments) One comment requests                    programs of other agencies, such as CBP
                                          the domestic food supply, and should                    that FDA provide clear direction                      or foreign government regulatory
                                          be exempt from prior notice.                            whether prior notice is required for food             authorities.
                                             (Response) As we discussed                           shipments of U.S. products that are                      (Comments) One comment requests
                                          previously, section 801(m) of the act                   returned to the United States after                   that the final rule exempt foreign-to-
                                          does not authorize an exclusion for                     refusal by a foreign government.                      foreign transit mail; i.e., mail shipments
                                          small quantity or low-value shipments.                     (Response) FDA requires prior notice               that simply transit the United States for
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                                          FDA notes that under the Prior Notice                   for an article of food that has been                  delivery in a third country. The
                                          Final Rule Draft CPG, FDA and CBP                       exported from the U.S. and is being                   comment reasons that these items are
                                          should typically consider not taking                    ‘‘reimported’’ back into the U.S., as we              not intended for U.S. consumption (i.e.,
                                          regulatory action when an article of food               consider such a shipment as being                     not intended for a U.S. recipient);
                                          is imported or offered for import for                   ‘‘imported or offered for import into the             represent the transfer of universal


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                                          service obligation mail between                         United States if the express carrier, for             under which FDA and CBP should
                                          sovereign governmental entities; and are                example, chooses to consolidate                       typically consider not taking regulatory
                                          items from foreign mailers who would                    shipments going to South America in                   action when prior notice is not
                                          not know when to submit the required                    Florida. The proposed enforcement                     submitted.
                                          prior notice data as they do not always                 discretion policy in the Prior Notice                    (Comments) Another comment
                                          know whether their mail dispatches will                 Final Rule Draft CPG states that FDA                  suggests that the FDA work
                                          be transiting the United States.                        and CBP should typically consider not                 cooperatively with CBP such that
                                             (Response) As we explained in the                    taking any regulatory action when an                  transshipments that follow the CBP
                                          IFR and elsewhere in this notice, food                  article of food is imported or offered for            transshipment procedures are not
                                          that is not intended for U.S.                           import and the carrier is an express                  required to enter additional information
                                          consumption is still within the scope of                consignment operator or carrier; neither              for FDA prior notice purposes, and that
                                          ‘‘imported or offered for import’’ (68 FR               the submitter nor transmitter is the                  shipments that may pose a risk are
                                          58974 at 58991) and is subject to prior                 express consignment operator or carrier;              identified through the CBP process. The
                                          notice requirements. However, we                        and the importer, owner, or recipient/                comment also states that the current
                                          understand that in the case of foreign-                 consignee is not located in the United                requirements in the agreement for
                                          to-foreign mail, the sender does not                    States.                                               secure in-transit procedures could be
                                          have control over the transportation                       (Comments) Several comments                        modified to meet the objective of the
                                          route that the foreign-to-foreign                       request that FDA exempt shipments of                  prior notice IFR to prevent the entry of
                                          shipment will transit. Therefore, we are                food that move from Canada to Canada                  products that have been intentionally
                                          proposing an enforcement discretion                     under bond by rail through Northern                   adulterated. Shipments that follow the
                                          policy in the Prior Notice Final Rule                   Maine. These comments note that such                  proposed secure in-transit procedures
                                          Draft CPG that would address this                       shipments moving by rail in bond                      would not be distributed in the United
                                          situation. Under that policy, FDA and                   cannot be delivered to points within the              States and would be of minimal risk to
                                          CBP should typically consider not                       United States, must move from Canada                  human or animal security and safety.
                                          taking any regulatory action when an                    to Canada, and that the food products in              The comment also suggests that FDA
                                          article of food is imported or offered for              trailers on rail cars cannot be diverted              can achieve certainty of safety of
                                          import via international mail without                   to enter the U.S. food supply. The                    overseas shipments that are transiting to
                                          prior notice and there is no U.S.                       comments state that having to submit                  the United States through Canada by
                                          recipient.                                              prior notice puts the U.S. rail carriers at           conducting examinations at the first
                                             (Comments) Comments filed by                         a competitive disadvantage when                       point of arrival in North America and
                                          express carriers request that FDA                       competing for Canadian rail business.                 through the expansion of existing
                                          exempt all non-U.S. destination                         Other comments request that FDA                       bilateral harmonized risk screening and
                                          shipments from the requirement to                       exempt shipments of food that move                    lockout sharing systems to
                                          provide prior notice. The comments                      from Canada to Canada by marine and                   accommodate additional high-risk
                                          note that the shipment is in the custody                trucking companies. The comments                      commodities.
                                          of the express carrier at all times and the             reason that their Canada to Canada in-                   (Response) CBP’s secure in transit
                                          risk of diversion from the highly-                      transit shipments move in sealed                      procedures cannot substitute for the
                                          controlled environment in which                         containers and that providing detailed                submission of prior notice for in transit
                                          express shipments move, particularly                    information for products that are never               shipments because they do not meet the
                                          in-bond shipments, is low. The                          going to enter the U.S. food supply is a              requirements of the Bioterrorism Act,
                                          comments also reason that foreign                       hardship to U.S. businesses.                          such as providing FDA with certain
                                          shippers and foreign consignees do not                     (Response) FDA disagrees. The                      specified information. The information
                                          submit the required prior notice data                   Bioterrorism Act does not create any                  in a prior notice is necessary for FDA to
                                          because they are, by design, not aware                  exemptions for this situation and                     determine whether it should examine
                                          that their shipments will transit the                   therefore, there is no basis for excluding            the food at the U.S. port of arrival. In
                                          United States on their way to a third                   such business operations from prior                   addition, section 801(m) of the act does
                                          country because express carriers do not                 notice requirements. The preamble to                  not authorize an exemption for articles
                                          disclose flight routes of packages either               the IFR provides our rationale for                    of food that are covered by programs of
                                          to shippers or consignees due to                        determining that food that transits the               other agencies, such as CBP, even if
                                          security concerns. If prior notice must                 United States falls under the scope of                those programs would ‘‘prevent the
                                          be submitted, express carriers will be                  this rule (68 FR 58974 at 58990) and we               entry of products that have been
                                          required to make the customers aware of                 continue to hold this view. Moreover,                 intentionally adulterated.’’
                                          routes, nullifying this simple but                      the comment implies that these                           (Comments) One comment notes that
                                          effective security precaution.                          shipments should be exempt from prior                 there are many ocean containers
                                             (Response) As described in the                       notice requirements because they pose a               crossing into the United States for
                                          previous comment, prior notice applies                  relatively low risk by moving by rail, in             transshipment purposes and prior
                                          to food imported or offered for import                  bond, and/or under seal. Even if such                 notice is not being submitted. The
                                          notwithstanding that the food is not                    food shipments are a low risk, as                     comment asks how to ensure that ocean
                                          intended for U.S. consumption.                          discussed elsewhere in this notice,                   containers that arrive in Canada or
                                          However, we recognize that, when                        section 801(m) of the act does not                    Mexico and cross into the United States
                                          shipping via express carrier or other                   authorize a ‘‘low risk’’ exemption.                   by rail have prior notice submitted in a
                                          private delivery service, the sender does               However, the proposed guidance in the                 timely fashion, or submitted at all, when
                                          not have control over the transportation                Prior Notice Final Rule Draft CPG                     shippers are not always aware of when
                                          route that the foreign-to-foreign                       (which would continue the policy                      the containers are due to cross or on
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                                          shipment will transit. For example, a                   established in the March 2005 revision                which train.
                                          person in Europe intends to mail an                     to the Prior Notice Interim Final Rule                   (Response) FDA addressed this issue
                                          article of food to South America via an                 CPG) addresses imported food arriving                 in the IFR when it allowed any person
                                          express carrier. This person has no                     from and exiting to the same country. It              with knowledge of the required
                                          control over the package entering the                   describes the situations and conditions               information to submit prior notice. In


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                                                            Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations                                        66321

                                          § 1.285 of the proposed prior notice rule                  (Response) Whether seeds are subject               confusion regarding who is responsible
                                          (68 FR 5428, February 3, 2003), FDA                     to prior notice depends on whether the                for submitting prior notice. This causes
                                          provided that a purchaser or importer of                seeds meet the definition of food. Some               particular problems for carriers of in-
                                          an article of food who resides or                       seeds, such as sesame seeds for baking                bond cargo transiting the United States.
                                          maintains a place of business in the                    or as a garnish, are food for which prior             The comment suggests that exempting
                                          United States or an agent thereof was                   notice must be submitted to FDA before                in-bond shipments from prior notice
                                          authorized to submit prior notice. FDA                  the seed is imported or offered for                   would allow carriers to move the
                                          further proposed that if the article of                 import into the United States. Some                   shipment without having to submit
                                          food is imported for in-bond movement                   seeds are capable of both food and                    prior notice and permit the broker at the
                                          through the United States for export, the               nonfood uses, such as seeds that are                  port of entry, who does get the
                                          prior notice must be submitted by the                   sometimes processed into cooking oil                  necessary documents, to properly
                                          arriving carrier or, if known, the carrier              and other times processed into                        submit the prior notice. (Response) FDA
                                          making the in-bond entry. Many                          industrial-use oil. As discussed                      disagrees that there is confusion
                                          comments to the proposed rule objected                  elsewhere in this document, FDA                       regarding who is responsible for
                                          to the limitation that only a person who                considers such seed to be food for the                submitting prior notice. The IFR and
                                          resides or maintains a place of business                purpose of prior notice if the seed is                this final rule expressly state in § 1.278
                                          in the United States can submit the                     reasonably likely to be directed to a food            that any person with knowledge of the
                                          prior notice. In addition, comments                     use. Even when seed is for a nonfood                  required information may submit the
                                          pointed out that under some                             use, such as seeds for growing flowers,               prior notice. FDA provided this
                                          circumstances, the U.S. importer or                     if a small portion of that seed is                    flexibility as to who could submit prior
                                          purchaser or carrier would not have all                 reasonably likely to be directed for use              notice in response to comments that
                                          the information required by prior notice,               in animal feed, prior notice would be                 FDA received on the proposed rule,
                                          but that other entities, e.g., the foreign              required. Because seeds, including                    which urged FDA not to limit who
                                          manufacturer/ processor, shipper, or                    seeds for planting, may be subject to                 could file prior notice to either a
                                          exporter, would have the required                       prior notice under section 801(m) of the              purchaser or importer of an article of
                                          information. Many comments stated that                  act, we believe they are properly flagged             food who resides or maintains a place
                                          entities other than U.S. firms or carriers              as FD3.                                               of business in the United States or an
                                          should be allowed to submit prior                          Nonetheless, we note that the draft                agent thereof, or to the arriving carrier
                                          notice.                                                 Prior Notice Final Rule CPG, announced                or the carrier making the in-bond entry
                                            In response, FDA modified this                        elsewhere in this issue of the Federal                if the article of food is imported for in-
                                          provision in the IFR and removed the                    Register, proposes an enforcement                     bond movement through the United
                                          restriction on who can submit prior                     policy regarding seeds for planting.                  States for export. (See 68 FR 58974 at
                                          notice. Accordingly, § 1.278 of the IFR                 Under the draft policy, FDA and CBP                   58994.) Comments to the proposed rule
                                          provides that any person with                           should typically consider not taking any              also pointed out that under some
                                          knowledge of the required information                   regulatory action regarding seeds that                circumstances, the U.S. importer or
                                          may submit prior notice to FDA. FDA                     will be used for cultivation if they are              purchaser or carrier would not have all
                                          has retained this provision in the final                imported or offered for import without                the information required by prior notice,
                                          rule.                                                   prior notice. The policy would apply                  but that other entities, e.g., the foreign
                                                                                                  when no more than a small portion of                  manufacturer/ processor, shipper, or
                                          17. Additional Exclusions Requested—                    that seed is diverted from cultivation to
                                          Diplomatic Pouch                                                                                              exporter, would have the required
                                                                                                  animal feed or other food use. It would
                                                                                                                                                        information. Many comments stated that
                                             We have determined that prior notice                 not apply, however, where the seed is
                                                                                                                                                        entities other than U.S. firms or carriers
                                          does not apply to food in diplomatic                    used for the production of edible
                                                                                                                                                        should be allowed to submit prior
                                          pouches because Art. 27(3) of The                       sprouts, such as alfalfa seeds for the
                                                                                                                                                        notice. In response, FDA modified this
                                          Vienna Convention on Diplomatic                         production of alfalfa sprouts.
                                                                                                                                                        provision in the IFR and removed the
                                          Relations (1961) states that: ‘‘The
                                                                                                  E. Who is Authorized to Submit Prior                  limitation on who can submit prior
                                          diplomatic bag shall not be opened or
                                                                                                  Notice? (§ 1.278)                                     notice.
                                          detained.’’
                                             (Final Rule) Section 1.277(b)(7) of the                 Section 1.278 of the IFR states that                  (Response) FDA disagrees that there is
                                          final rule adds a new exclusion to the                  prior notice may be submitted by any                  confusion regarding who is responsible
                                          rule: ‘‘Articles of food subject to Art.                person with knowledge of the required                 for submitting prior notice. The IFR and
                                          27(3) of The Vienna Convention on                       information and identifies this person as             this final rule expressly state in § 1.278
                                          Diplomatic Relations (1961), i.e.,                      the submitter. The IFR also states that               that any person with knowledge of the
                                          shipped as baggage or cargo constituting                the submitter also may use another                    required information may submit the
                                          the diplomatic bag.’’                                   person to transmit the required                       prior notice. FDA provided this
                                                                                                  information on his/her behalf and                     flexibility as to who could submit prior
                                          18. Additional Exclusions Requested—                    identifies the person who transmits the               notice in response to comments that
                                          Seeds for Planting                                      information as the transmitter. The IFR               FDA received on the proposed rule,
                                             (Comments) One comment requests                      also states that the submitter and                    which urged FDA not to limit who
                                          that FDA exempt imported seed that is                   transmitter may be the same person.                   could file prior notice to either a
                                          destined solely for planting purposes,                     (Comments) Several comments note                   purchaser or importer of an article of
                                          even if small amounts found unsuitable                  that carriers often do not have access to             food who resides or maintains a place
                                          for planting will end up in the food                    the information required to classify                  of business in the United States or an
                                          supply. The comment also requests that                  articles in the FDA system (the                       agent thereof, or to the arriving carrier
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                                          the FD3 flags be removed from HTS                       commercial invoice and packing list)                  or the carrier making the in-bond entry
                                          codes that cover seed for sowing or                     because it is proprietary information                 if the article of food is imported for in-
                                          planting or, alternatively, to clarify that             that the owners of the goods will not                 bond movement through the United
                                          FD3 flagged HTS codes may be                            want to give to intermediaries in the                 States for export. (See 68 FR 58974 at
                                          ‘‘disclaimed’’ at entry.                                transportation chain. Also, there is                  58994.) Comments to the proposed rule


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                                          66322             Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations

                                          also pointed out that under some                        notice has the appropriate and correct                of admission. Other consequences under
                                          circumstances, the U.S. importer or                     information.                                          the act for those who fail to comply with
                                          purchaser or carrier would not have all                    (Comments) One comment suggests                    the prior notice requirements, such as
                                          the information required by prior notice,               that it is improper for a carrier to require          by submitting inaccurate or untimely
                                          but that other entities, e.g., the foreign              the shipper to submit prior notice when               notice, are described in § 1.284.
                                          manufacturer/processor, shipper, or                     the shipper is not shipping goods into                   (Final rule) Section 1.278 of the final
                                          exporter, would have the required                       the United States, but the carrier                    rule states that prior notice may be
                                          information. Many comments stated that                  unilaterally moves the goods through                  submitted by any person with
                                          entities other than U.S. firms or carriers              their hub in the United States, thereby               knowledge of the required information
                                          should be allowed to submit prior                       causing the shipment to enter the                     and identifies this person as the
                                          notice. In response, FDA modified this                  United States. Another comment notes                  submitter. The final rule also states that
                                          provision in the IFR and removed the                    that the data elements required in a                  the submitter may use another person to
                                          limitation on who can submit prior                      prior notice are not available to the                 transmit the required information on
                                          notice.                                                 shipper, inferring that it is not possible            his/her behalf and identifies the person
                                             Accordingly, § 1.278 of the IFR                      for a shipper to submit prior notice.                 who transmits the information as the
                                          provides that any person with                              (Response) Neither the IFR nor this                transmitter. The final rule also states
                                          knowledge of the required information                   final rule specifies who must file prior              that the submitter and transmitter may
                                          may submit prior notice to FDA. FDA                     notice. Rather, the rule provides that                be the same person.
                                          noted in the preamble to the IFR that                   any person with knowledge of the
                                                                                                  required information may submit prior                 F. When Must Prior Notice Be Submitted
                                          any person may now take responsibility
                                                                                                  notice to FDA. Accordingly, it is not for             to FDA? (§ 1.279)
                                          for submitting prior notice for a
                                          particular article of food, as long as that             FDA to say whether it is proper for a                    Section 801(m)(2)(A) of the act states
                                          person can provide all the required                     carrier to require a shipper to submit                that FDA shall by regulation prescribe
                                          information. This person is referred to                 prior notice as a condition of shipment,              the time of submission of the
                                          as the submitter in the IFR. The IFR also               as that is a matter between two                       notification in advance of importation
                                          states that the submitter may use                       contracting parties. We note that the                 or the offering of the food for import,
                                          another person to transmit the required                 Prior Notice Final Rule Draft CPG                     which period shall be no less than the
                                          information to FDA. For ease of                         proposes an enforcement policy for                    minimum amount of time necessary for
                                          reference, the person who transmits the                 foreign-to-foreign mail. Under the                    the Secretary to receive, review, and
                                          prior notice is referred to as the                      proposed policy, if there is no prior                 appropriately respond to such
                                          transmitter in the IFR. FDA has retained                notice FDA and CBP should typically                   notification, and any timeframe FDA
                                          these provisions in the final rule. FDA                 consider not taking any regulatory                    adopts in the final rule must be justified
                                          further notes that to the extent that there             action in the case of international mail              under this standard. Section 1.279(a) of
                                          is confusion, the parties to the                        where the recipient is not in the United              the IFR requires FDA to receive prior
                                          transaction may want to consider a                      States since the sender does not have                 notice and confirm it for review no less
                                          means for identifying which party is                    control over the transportation route                 than 2 hours before arriving at the port
                                          responsible for submitting prior notice                 that the foreign-to-foreign mail will                 of arrival by land via road, no less than
                                          as part of their business arrangements                  transit.                                              4 hours before arriving at the port of
                                          (e.g., within their contract).                             (Comments) One comment asks                        arrival by air and land via rail, and no
                                             (Comments) Several comments note                     whether there are any prior notice                    less than 8 hours before arriving at the
                                          that problems arise because the IFR                     obligations to fulfill if the exporter is             port of arrival by water. We explained
                                          creates no particular obligation on any                 not required to register with the FDA                 in the preamble to the IFR that the
                                          particular party within the distribution                under the Bioterrorism Act (21 CFR part               ‘‘interim final rule provides for greatly
                                          system to submit prior notice. One                      1, subpart H).                                        reduced timeframes for foods [from
                                          comment states that because prior                          (Response) Prior notice and                        what we had proposed] based on mode
                                          notice can be submitted by any person                   registration are separate obligations                 of transportation. These timeframes are
                                          who has the information, there are many                 under different regulations and with                  what FDA has determined are the
                                          cases of duplicate prior notices filed by               differing applicability. For example,                 minimum timeframes necessary to allow
                                          different parties for the same shipment.                registration applies to facilities that               it to satisfy the statutory mandate that
                                          Another comment suggests that FDA                       manufacture, process, pack or hold food               the timeframes give the agency the time
                                          select one party to be responsible,                     that will be consumed by humans or                    it needs to ‘receive, review, and
                                          suggesting the appropriate party would                  animals in the United States. By                      respond’ to prior notices.’’ (68 FR 58974
                                          be either the exporter or the importer-                 comparison, prior notice generally                    at 58995)
                                          broker.                                                 applies to FDA-regulated food being                      Under § 1.279(b) of the IFR, prior
                                             (Response) Please see the response to                imported or offered for import into the               notice may not be submitted more than
                                          the previous comments. FDA’s proposed                   United States, regardless of whether it               5 calendar days before arrival, except in
                                          rule did specify a limited class of                     will be consumed in the United States                 the case of food imported or offered for
                                          individuals who could provide prior                     and regardless of whether the exporter                import by international mail. Under
                                          notice and this limitation received                     must register.                                        § 1.279(c) of the IFR, if the article of
                                          significant adverse comment.                               (Comments) One comment asks for                    food is arriving by international mail,
                                          Accordingly, both the IFR and this final                clarification of the legal responsibility of          the prior notice must be submitted
                                          rule provide that any person with                       the submitter.                                        before the food is sent to the United
                                          knowledge of the required information                      (Response) Among the requirements                  States.
                                          may submit the prior notice (§ 1.278).                  of the final rule, the prior notice                      Section 1.279(d) of the IFR provides
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                                          FDA notes that the parties to a                         information must be accurate and                      that the time of submission is fixed and
                                          transaction can elect to take steps                     timely. As described in § 1.283, if an                the prior notice time will start for
                                          among them to identify which party                      article of food is imported or offered for            purposes of determining if prior notice
                                          should submit the prior notice and                      import and the notice is inaccurate or                is timely when the prior notice
                                          ensure that the party submitting prior                  untimely, the food is subject to refusal              submission is confirmed by FDA for


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                                          review. FDA will confirm a prior notice                 Electronic Information Rule implements                receive, review, and respond to all prior
                                          once all required information has been                  the provisions of section 343(a) of the               notice submissions with reduced
                                          submitted and confirmed as facially                     Trade Act of 2002, as amended by the                  timeframes for land and air consistent
                                          complete. For example, if the                           Maritime Transportation Security Act of               with CBP’s rule; and implement
                                          information submitted failed to include                 2002. The relevant timeframes provided                necessary changes and make
                                          an FDA Product Code, the system will                    in the Advance Electronic Information                 appropriate adjustments to ensure we
                                          not provide a confirmation for that prior               Rule are as follows:                                  could receive, review, and respond to
                                          notice. The transmitter has an                             • For arrival by land via road at ports            all prior notice submissions with
                                          opportunity to correct the rejected                     that are fully equipped to accommodate                reduced timeframes before issuing the
                                          information. When the information is                    CBP’s Advance Electronic Information                  final rule, consistent with our obligation
                                          corrected, transmitted, and determined                  Rule, no later than 1 hour prior to the               to ensure that any timeframe selected is
                                          to be facially valid, the system will then              arrival of the truck at the border, or for            sufficient to receive, review, and
                                          notify the transmitter and provide the                  Free and Secure Trade (FAST)                          respond to prior notice submissions, as
                                          prior notice confirmation number.                       participants, 30 minutes;                             set out in section 801(m)(2)(A) of the
                                             Under § 1.279(e) of the IFR, the prior                  • For arrival by land via rail at ports            act. We also emphasized that ‘‘the
                                          notice confirmation number must                         that are fully equipped to accommodate                evaluation of whether to reduce the
                                          accompany any article of food arriving                  CBP’s Advance Electronic Information                  timeframes for prior notice review will
                                          by international mail. Under § 1.279(f),                Rule, no later than 2 hours prior to the              depend on the level of compliance
                                          a copy of the confirmation (with the                    arrival of the train at the border; For               industry achieves during the
                                          prior notice confirmation number) must                  arrival by air, no later than the                     assessment. If we are unable to make
                                          accompany any article of food carried                   departure time (‘‘wheels up’’) of the                 such an assessment, our intended
                                          by or otherwise accompanying an                         aircraft from any foreign port or place in            timeframe for issuing a prior notice final
                                          individual (unless excluded under                       North America, including locations in                 rule may be delayed.’’
                                          § 1.277(b)(1)), and be provided to CBP or               Mexico, Central America, South
                                                                                                                                                           Comments received on the prior
                                          FDA upon arrival. Additionally, under                   America (from north of the Equator
                                                                                                                                                        notice IFR addressed the timeframes
                                          § 1.279(g) the prior notice confirmation                only), the Caribbean, and Bermuda, and
                                                                                                                                                        required in the IFR, as well as
                                          number must accompany any article of                    from other areas into ports that are fully
                                                                                                  equipped to accommodate CBP’s                         integration of those timeframes with the
                                          food for which the prior notice was
                                                                                                  Advance Electronic Information Rule no                timeframes covered by CBP’s advance
                                          submitted through the FDA PNSI when
                                                                                                  later than 4 hours prior to the arrival of            electronic information rule. Comments
                                          arriving in the United States and must
                                                                                                  the aircraft in the United States.                    also covered the IFR’s requirement that
                                          be provided to CBP and FDA upon
                                                                                                     On April 14, 2004, FDA and CBP                     prior notice must be submitted at least
                                          arrival.
                                             We further stated in the IFR’s                       announced their ‘‘Joint FDA-CBP Plan                  5 days prior to arrival. We respond to
                                          preamble that we also were interested in                for Increasing Integration and Assessing              the issue of timeframes for submitting
                                          exploring flexible alternatives for                     the Coordination of Prior Notice                      prior notice here, and respond to the
                                          submission of prior notice for foods or                 Timeframes’’ (69 FR 19765), which the                 other questions raised in our Joint
                                          firms covered by programs of other                      agencies amended in August 2004                       Implementation Plan and April 14,
                                          agencies, such as C–TPAT, or imported                   (http://www.cfsan.fda.gov/~pn/                        2004, reopening of the comment period
                                          by other agencies. We explained that                    pnplan2.html). As stated in the plan                  later in this preamble.
                                          FDA and CBP would publish a plan,                       regarding the agencies’ assessment of                 1. IFR Timeframes (2, 4, and 8 hours)
                                          including an implementation schedule,                   reduced timeframes ‘‘FDA and CBP
                                          to achieve the goal of a uniform,                       continuously are assessing the                           (Comments) One comment asks FDA
                                          integrated system, and to coordinate                    completeness of prior notice                          to permit prior notice to be submitted at
                                          timeframes for import prior notice                      submissions received as well as the                   the port of entry, instead of at the port
                                          information while fulfilling the                        amount of time necessary to receive,                  of arrival, in order to align the prior
                                          Bioterrorism Act mandates for air and                   review, and respond to those                          notice process with long-standing,
                                          truck modes of transportation with                      submissions requiring a human review.                 existing CBP clearance processes and
                                          timeframes finalized by CBP when they                   However, that process is not yet                      infrastructures at the port of entry. The
                                          finalize their rule entitled ‘‘Required                 complete, as we are currently operating               comment reasons that since according to
                                          Advance Electronic Presentation of                      under the enforcement policies outlined               FDA’s own estimates, 80 to 90 percent
                                          Cargo Information’’ (the Advance                        in the Prior Notice Compliance Policy                 of prior notice data will be filed by the
                                          Electronic Information Rule) (68 FR                     Guide (CPG). See Compliance Policy                    ABI filer, it is logical that prior notice
                                          58995). On December 5, 2003, CBP                        Guide Sec. 110.310—Prior Notice of                    should be filed at the same port where
                                          issued the Advance Electronic                           Imported Food Under the Public Health                 clearance entry is filed. The comment
                                          Information Rule (68 FR 68140), which                   Security and Bioterrorism Preparedness                also suggests that FDA may want to
                                          requires CBP to receive, by way of a                    and Response Act of 2002. (Issued                     consider a two-step process for
                                          CBP-approved electronic data                            December 15, 2003, and revised June                   submitting prior notice, under which
                                          interchange system, information                         and August 2004; http://www.fda.gov/                  the CBP ‘‘ACI data’’ is accepted as the
                                          pertaining to cargo before the cargo is                 ora under Compliance References.) We                  first step, filed at port of arrival as part
                                          either brought into or sent from the                    currently do not receive prior notice for             of the ‘‘ACI data,’’ followed by complete
                                          United States by any mode of                            all shipments.’’                                      prior notice in its current form, filed as
                                          commercial transportation (water, air,                     In our plan, we also stated that we                a second step at the port of entry, i.e.,
                                          rail, or truck). The cargo information                  would assess existing procedures and                  concurrent with the clearance entry.
                                          required is that which is reasonably                    staffing needed to receive, review, and               Another comment suggests that to
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                                          necessary to enable high-risk shipments                 respond to the prior notices submitted                ensure consistency with ACE, the prior
                                          to be identified for purposes of ensuring               in accordance with the Prior Notice IFR;              notice should be required and
                                          cargo safety and security and preventing                identify what changes to work practices               calculated from the port of entry and not
                                          smuggling under the laws enforced and                   and staffing would be necessary to                    the first point of arrival, as is currently
                                          administered by CBP. The Advance                        determine if FDA could continue to                    the case.


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                                             Another comment recommends that                      December 3, 2003, FDA has                             prior notice timeframe for imported
                                          to fully achieve the FDA-CBP goal of                    commissioned thousands of CBP                         food arriving by water with the CBP
                                          coordinating timeframes, FDA should                     officers in ports and other locations to              advanced electronic information rule
                                          adopt the ‘‘point of entry,’’ rather than               conduct, on FDA’s behalf, investigations              timeframe of 24 hours prior to loading
                                          the ‘‘point of arrival’’ in the United                  and examinations of imported foods.                   on the vessel. The reasons for
                                          States to measure the timeliness of the                 This unprecedented FDA-CBP                            recommending that prior notice
                                          prior notice filing. CBP’s ‘‘point of                   collaboration significantly strengthens               timeframes be the same as CBP’s
                                          entry’’ is well known to importers and                  the implementation of the Bioterrorism                advanced electronic information
                                          its use for purposes of the Bioterrorism                Act to ensure the security of imported                timeframes for food arriving by air and
                                          Act not only will alleviate unnecessary                 foods, particularly with respect to                   land are that it would minimize the
                                          confusion, but also will facilitate the                 implementing the prior notice rule.                   complexity of the process by presenting
                                          stream of U.S. commerce without                         Building on FDA’s and CBP’s long                      a more streamlined flow of information
                                          compromising food safety.                               history of close cooperation, the MOU                 and avoid unnecessary duplication,
                                             The comment also states that with the                upgrades the two agencies’ teamwork in                result in fewer errors, provide better
                                          growing partnership between FDA and                     training, day-to-day operations, and                  compliance rates, allow for fewer
                                          CBP, FDA’s concern regarding limited                    information sharing. As part of the                   disruptions at the border, significantly
                                          personnel should no longer be an issue                  MOU, FDA and CBP have provided                        reduce the burden on the trade
                                          now that FDA and CBP collectively are                   specialized training for the                          community without creating additional
                                          using their respective enforcement                      commissioned CBP employees who                        security risks, and allow operators at
                                          officials for this joint endeavor.                      carry out this work, and both agencies                close border points to load and verify
                                             (Response) FDA discussed the ‘‘port                  have expanded their existing                          truck loads and travel routes prior to
                                          of entry/port of arrival’’ issue                        cooperative arrangements to directly                  submitting notice. One comment
                                          extensively in the preamble to the IFR                  share information affecting the safety                suggested that there is no basis for
                                          and is not persuaded by the comments                    and security of imported foods,                       concluding that more time is needed for
                                          that its initial position should be                     including co-locating FDA’s PNC with                  food shipments than for other
                                          changed (See 68 FR 58974 at 58988).                     CBP staff. Although the FDA and CBP                   shipments. Another comment states that
                                          The Bioterrorism Act established that                   partnership benefits the prior notice                 utilizing one system and one set of
                                          prior notice be provided by a specified                 process in many ways, this partnership                timelines should provide adequate
                                          period of time in advance of the time of                does not mean that the PNC no longer                  notice to FDA and improve compliance
                                          the importation of the article of food                  would have staffing concerns such that                with the prior notice requirements.
                                          involved or the offering of the food for                the prior notice timeframes could be                     (Response) The timeframes
                                          import, which period shall be no less                   reduced, as the comment implies. Please               established in the final rule represent
                                          than the minimum amount of time                         see the discussion later in this                      the minimum amount of time FDA
                                          necessary for the Secretary to receive,                 document regarding ‘‘Integration of FDA               needs to meet our statutory
                                          review, and appropriately respond to                    and CBP timeframes’’ for further                      responsibility to receive, review, and
                                          such notification, but may not exceed 5                 discussion on reducing timeframes.                    respond to prior notice submissions. In
                                          days. That means that prior notice must                    (Comments) One comment noted that                  accordance with our Joint
                                          be submitted before the article of food                 the time difference between their                     Implementation Plan, we evaluated the
                                          arrives in the United States. Moreover,                 country and the United States makes it                feasibility of conducting prior notice
                                          we explained in the IFR that the overall                difficult for the agent to start submitting           reviews in a reduced time period in an
                                          purpose of the Bioterrorism Act is to                   prior notice immediately upon the                     effort to more closely harmonize the
                                          improve the ability of the United States                receipt of necessary information.                     submissions with CBP timeframes. As
                                          to prevent, prepare for, and respond to                 Therefore, some food transported by air,              part of our assessment, we analyzed
                                          bioterrorism and other public health                    as well as by water, has actually missed              data regarding prior notices we received
                                          emergencies, thereby making essential                   the appointed timeframe. The comment                  in the first 9.75 months of fiscal year
                                          the ability to examine or hold a suspect                requests that prior notice be accepted                (FY) 2005—specifically from prior
                                          article of food when it first arrives at a              until immediately before the arrival of               notices received and responded to by
                                          port of entry in the United States, rather              the food.                                             the PNC between October 1, 2004, and
                                          than later at the port where CBP will                      (Response) FDA disagrees. FDA’s                    July 23, 2005. Based on the results of
                                          process the entry. Thus, the final rule                 PNSI is available 24 hours a day to                   our assessment, in the final rule we
                                          uses the term ‘‘port of arrival’’ rather                submit prior notice. The timeframes                   have maintained the timeframes that are
                                          than ‘‘port of entry’’ as the food may not              established in the final rule are the                 in the IFR:
                                          arrive at the port of entry until long after            minimum amount of time that FDA                          • If the article of food is arriving by
                                          it has arrived in the United States. In                 needs to receive, review, and respond to              land by road, no less than 2 hours before
                                          addition, CBP’s advance electronic                      prior notice submissions.                             arriving at the port of arrival;
                                          information rule also requires notice in
                                                                                                  2. Integration of FDA and CBP                            • If the article of food is arriving by
                                          advance of ‘‘arrival’’ in the United                                                                          land by rail, no less than 4 hours before
                                                                                                  Timeframes
                                          States, and not at ‘‘entry.’’                                                                                 arriving at the port of arrival;
                                             The IFR and final rule define ‘‘port of                 (Comments) One comment states that                    • If the article of food is arriving by
                                          arrival’’ and ‘‘port of entry.’’ Neither,               ‘‘no shorter timeframes should be                     air, no less than 4 hours before arriving
                                          however, use the terms ‘‘point of                       allowed.’’ However, the remainder of                  at the port of arrival; and
                                          arrival’’ or ‘‘point of entry.’’ FDA could              the comments addressing consistency of                   • If the article of food is arriving by
                                          not find reference to ‘‘point of entry’’ in             timeframes between FDA and CBP                        water, no less than 8 hours before
                                          CBP rules or regulations.                               recommend that FDA timeframes for                     arriving at the port of arrival.
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                                             FDA does agree that FDA’s staffing at                imported food arriving by air and land                   FDA and CBP established these
                                          certain U.S. ports is much less of an                   be reduced and be consistent with those               timeframes for the IFR based on the
                                          issue. Under an MOU between FDA and                     set forth by CBP in their advanced                    information available at the time. By
                                          CBP signed by the respective                            electronic information rule. No                       necessity, though, these decisions
                                          commissioners of both agencies on                       comments recommend aligning the                       regarding timeframes were not informed


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                                          by actual experience in operating the                   notice review are discussed in more                   diminishing returns. When a shipment
                                          prior notice program. We now have that                  detail below.                                         must undergo intensive review, PNC
                                          experience, and the information gained                     To implement the Prior Notice IFR,                 staff members are reviewing databases
                                          during our assessment shows that the                    FDA established the PNC that operates                 and sorting through information to
                                          minimum timeframes for submitting                       24 hours a day, 7 days a week, all days               determine whether the shipment poses
                                          prior notices contained in the IFR                      of the year to receive, review, and                   a potential threat. Reviewing one source
                                          closely match the minimum time                          adequately responds to these notices as               of information leads to other sources of
                                          necessary for FDA to receive, review,                   they are submitted. PNC staff is also                 information to investigate. It would not
                                          and respond to the prior notices. During                responsible for responding in real-time               necessarily be effective to expend, for
                                          the assessment period, FDA was able to                  (by e-mail, fax, or telephone) to                     example, five staff members on one
                                          receive, review, and respond to almost                  inquiries they receive from affected                  intensive review at the start because not
                                          all notices within the established                      parties about pending prior notices and/              all sources of information for review are
                                          timeframes. In a relatively small number                or operational issues.                                known at the beginning of an intensive
                                          of situations, FDA was not able to make                    The purpose of prior notice is to help             review. Doubling or tripling staff, as
                                          a decision regarding whether to inspect                 identify food that potentially poses a                discussed in Option 2B of the Final
                                          the food at the port of arrival by the end              significant health risk to the American               Regulatory Impact Analysis of this
                                          of the timeframe. In these situations,                  public and to deploy resources to the                 document, also would result in a
                                          when the food arrived at the port of                    port of arrival so that inspections can be            significant amount of unused office
                                          arrival, it was delayed while FDA                       conducted before the shipment ever                    space and equipment during the slowest
                                          completed its review. The number of                     enters the United States. Regardless of               time periods. Staffing at increased levels
                                          such shipments, however, has been                       whether a prior notice is submitted                   at all times would result in wasteful
                                          relatively low, and the resulting impact                electronically to FDA through CBP’s                   unproductive staff waiting for
                                          on government resources and the flow                    ABI/ACS or FDA’s PNSI, the prior                      shipments to arrive.
                                          of traffic at ports has not been                        notice information undergoes a
                                                                                                                                                           Moreover, the constant
                                          significant. Thus, we do not believe we                 validation process and is then screened
                                                                                                                                                        unpredictability of the submission times
                                          should increase the timeframes to                       against food safety and security criteria.
                                                                                                     If the results of our initial validation           for high risk prior notices requiring the
                                          account for this relatively small number                                                                      shortest timeframe review (2 hours for
                                                                                                  indicate that the prior notice
                                          of outliers whose review takes longer                                                                         food arriving by land via road) is a
                                                                                                  requirements have been met and the
                                          than the IFR’s timeframes.                                                                                    significant issue. The exact busiest
                                                                                                  results of our screening indicate that the
                                             Our assessment also shows that,                      shipment does not appear to be a                      times are variable, and are very difficult
                                          because the IFR’s timeframes closely                    potential bioterrorism or significant                 to predict on a daily basis. In addition,
                                          match the minimum time necessary for                    public health threat, the submission is               PNC targeting for high risk shipments
                                          FDA to receive, review, and respond to                  considered to have satisfied prior notice             also varies based on contemporaneous
                                          the prior notices, those timeframes                     requirements and the associated article               targeting intelligence and changing risk
                                          could not be significantly reduced. If we               of food is allowed to proceed for further             assessment strategies. Having constant
                                          were to change the timeframes to be                     processing, including FDA admissibility               two to three times the number of staff
                                          consistent with those of CBP’s advance                  review under section 801(a) of the act.               to cover those short bursts of time when
                                          electronic information rule, not only                   Alternatively, if the results of the initial          the highest volume of high risk
                                          would this go against the statutory                     screening of the prior notice information             shipments, with the lowest timeframes
                                          standard for setting the timeframes, but                indicate there is a potential bioterrorism            are at their peak would be inefficient
                                          it would also significantly increase the                or other significant public health threat,            and wasteful.
                                          number of shipments where FDA would                     the prior notice undergoes additional                    In addition, it has been suggested that
                                          not be able to decide whether it should                 intensive review by the PNC using other               the PNC reduce their time frames and
                                          examine the food at the port of arrival                 databases and sources of information to               hold only those shipments it needs
                                          by the end of the timeframe. Based on                   determine whether the article of food                 more time to review. There are two very
                                          current and projected staffing levels in                should be held at the port of arrival for             significant reasons why this would be
                                          the PNC, such shipments would be                        examination or should be allowed to                   impractical. First, from a security
                                          delayed at the port of arrival until FDA                proceed into 801(a) status for                        perspective, doing so would result in
                                          has either completed its review or                      admissibility review. PNC personnel                   holding only potential high risk
                                          decided to examine or not examine the                   make this determination using their                   shipments at the border and would
                                          food at the port of arrival without the                 experience with imported foods and the                make PNC targeting strategies widely
                                          benefit of a complete review. FDA could                 expertise within FDA’s CFSAN for                      visible and predictable to both those
                                          expend additional resources to increase                 human food or FDA’s CVM for animal                    involved in legitimate trade, and those
                                          capacity to review and reduce the                       feed, the inspectional information                    with nefarious pursuits looking to
                                          timeframe, but it would be at                           obtained by FDA’s ORA, and the                        exploit weaknesses in U.S. food cargo
                                          considerable cost to assist a small                     expertise of CBP. FDA’s goal is to                    security. Second, the holding of high
                                          number of shipments that have                           complete its review within the 2, 4, or               risk shipments at the port would cause
                                          difficultly meeting these timeframes. In                8 hour timeframe for submitting prior                 logistical challenges for port operators,
                                          the nearly 4 years since the end of the                 notice so that the review is complete                 and would almost certainly have a
                                          transition enforcement period for the                   before the shipment arrives at the port               negative impact on all food and nonfood
                                          interim final rule, very few shipments                  of arrival. If the intensive review takes             shipments processed through those
                                          have arrived without prior notice and as                longer than the timeframe and the                     ports. In contrast, with the current PN
                                          such, the timeframes are both                           shipment arrives at the port of arrival,              timeframes which have been in place for
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                                          reasonable, and economically efficient.                 then FDA may delay the shipment at the                more than 4W years, these logistical
                                          The prior notice review process,                        port of arrival until its review is                   challenges have been almost
                                          information from our assessment, and                    completed. FDA could increase staffing                nonexistent, and PNC targeting
                                          the consequences of reducing the                        at the PNC in order to decrease                       strategies are virtually transparent to the
                                          timeframes for conducting the prior                     timeframes, but the effect has                        import trade.


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                                             The other factor to consider is the                  FDA received the prior notice and                     timeframes, as we do not know how
                                          tremendous growth of imported foods                     confirmed it for review. Using data                   many articles of food arriving in the
                                          year to year (approximately 14 percent                  collected on articles of food arriving by             United States subject to the prior notice
                                          growth over the past 4 years), which far                land via truck and car during our                     requirements are from FAST and C–
                                          exceeds what FDA projected in the IFR.                  assessment period, the PNC expended                   TPAT participants. Moreover, there are
                                          FDA has been able to maintain the                       an average of 61 minutes to receive,                  other impediments to integrating prior
                                          existing timeframes without adversely                   review, and make a decision on whether                notice with the C–TPAT and FAST
                                          impacting trade. Given that we continue                 or not a shipment should be refused or                programs. These are discussed in
                                          to expect imports to increase in volume,                held for examination under section                    section III.D.6 of this document
                                          FDA does not believe that reducing                      801(m) of the act, or allowed to proceed              (‘‘Additional Exclusions Requested—
                                          timeframes is warranted. For all the                    into 801(a) status for admissibility                  Special Programs (C–TPAT/FAST) and
                                          above reasons, FDA believes that its                    review. The PNC completed about 99                    Flexible Alternatives’’).
                                          current and projected staffing levels are               percent of its intensive reviews of prior                We also conducted a similar
                                          sufficient and appropriate, and the                     notices submitted for land/road border                assessment on prior notices submitted
                                          timeframes are both reasonable, and                     arrivals within 120 minutes of receiving              for articles of food arriving by air
                                          economically efficient.                                 and confirming the prior notice for                   between October 1, 2004, and July 23,
                                             FDA receives approximately 167,000                   review. Only about 57 percent of the                  2005. The IFR requires prior notices for
                                          prior notices each week. The                            intensive reviews were completed                      these shipments to be submitted and
                                          distribution of prior notices by mode of                within 1 hour. Reviews for the                        confirmed for review at least 4 hours
                                          transportation during our assessment                    remaining 43 percent (8,900 prior                     before the food arrives at the U.S. port
                                          that were flagged by the initial screening              notices for the assessment period, or                 of arrival. If the timeframes for articles
                                          and that received an intensive prior                    more than 10,000 for FY 2005) took                    of food arriving by air during our
                                          notice review by the PNC is as follows:                 longer. If the timeframe were set at 1                assessment period had been reduced to
                                                                                                  hour for these articles of food instead of            ‘‘wheels up,’’ the PNC would not have
                                              TABLE 1.—PROPORTION OF PRIOR                        the IFR’s 2 hours, the PNC would have                 completed approximately 21 percent of
                                              NOTICES FLAGGED AT THE INITIAL                      had to either delay the food at the port              the intensive prior notice reviews for
                                                                                                  of arrival until it completed its review              articles of food with flight times less
                                              SCREENING, BY MODE OF TRANS-
                                                                                                  or decide whether to examine the food                 than 3 hours. These articles of food
                                              PORTATION
                                                                                                  at the port or arrival without the benefit            (2,700 for our assessment period, or an
                                            Truck                                     27.6%       of a complete review, based on current                estimated 3,230 for FY 2005) also would
                                                                                                  and projected staffing levels in the PNC.             have been subject to cargo delays and/
                                            Car                                         2.9%                                                            or increased cargo examinations, based
                                                                                                     FDA does not have data to accurately               on current and projected staffing levels
                                            Air                                       17.6%       analyze the impact of changing the                    in the PNC.
                                                                                                  timeframe to 30 minutes for FAST                         Neither FDA nor CBP have sufficient
                                            Rail                                        0.8%      participants because FAST membership                  personnel or resources to accommodate
                                                                                                  is not one of the data elements that we               the number of additional cargo delays
                                            Sea                                       39.2%       currently require in a prior notice                   and/or food shipment examinations that
                                            Mail                                      11.1%       submission. FDA instead did the                       would result under either 60- or 30-
                                                                                                  analysis based on the total number of                 minute timeframes for articles of food
                                            Other                                       0.8%      prior notices submitted that the PNC                  arriving by land by road. This would
                                                                                                  could review based on a timeframe of 30               include the significant additional
                                            As indicated, a significant portion                   minutes. The PNC completed less than                  personnel and resources needed to
                                          (approximately 31 percent) of the prior                 10 percent of its intensive reviews of                track, facilitate, and coordinate the
                                          notices reviewed by the PNC on a daily                  prior notices submitted for land/road                 evaluation and/or examination of the
                                          basis are land/road border entries,                     border arrivals within 30 minutes of                  delayed cargo. Coordination of the
                                          which under the IFR are subject to                      receiving and confirming the prior                    handling of delayed shipments is a
                                          submission timeframes of at least 2                     notice for review. If the timeframe for all           resource intensive process that can last
                                          hours before arrival. On average, during                articles of food arriving by land by truck            for multiple days per shipment, and
                                          the assessment period, the PNC                          and car during our assessment period                  includes communicating with both FDA
                                          conducted intensive security reviews on                 had been 30 minutes (i.e., the                        and CBP personnel at the border, and
                                          225 to 250 prior notices per day from all               timeframes for FAST participants)                     the brokers/filers and importers
                                          modes of transportation, which means                    instead of 2 hours, the PNC would not                 involved in the shipment.
                                          that, on average, the PNC conducted                     have completed approximately 68                          To handle the extra work, the PNC
                                          intensive security reviews on about 77                  percent of its intensive reviews (over                would need to shift its personnel based
                                          prior notices (31 percent of 250) each                  14,000 during the assessment period,                  on current and projected staffing levels
                                          day that are subject to the 2–hour                      which equates to approximately 16,000                 in the PNC, resulting in fewer staff being
                                          timeframe. Moreover, the prior notices                  for FY 2005 of the land/road border                   available to review prior notices for all
                                          are not evenly distributed over an 8                    prior notices) within the applicable                  categories of shipments including
                                          hour shift or 24–hour day. The actual                   timeframe. As a result, the PNC would                 shipments arriving by water. The PNC’s
                                          dispersal pattern of the prior notice                   have had to either delay the food at the              current approximate average time for
                                          submissions is not uniform; an                          port of arrival until it completed its                the PNC intensive review for shipments
                                          overwhelming majority of prior notice                   review or decide whether to examine                   arriving by water is 5 hours, which is
                                          submissions arrive between a certain                    the food at the port of arrival without               within the 8 hour submission
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                                          12–hour period.                                         the benefit of a complete review, based               timeframe. We would expect, based on
                                            The amount of time the PNC has                        on current and projected staffing levels              our assessment, that the time taken
                                          needed for its intensive review has                     in the PNC. This assessment is an                     away from prior notice review work for
                                          ranged from 20 minutes to 315 minutes                   overestimate of the number of articles of             the increase in coordination due to the
                                          (5 hours and 25 minutes) from when                      food that would be eligible for FAST                  increase in delays and examinations for


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                                          land and air shipments would increase                   number of intensive reviews to continue               CBP is planning to bring its ACE system
                                          the time needed to complete intensive                   to increase relative to the assessment                on line in the next few years, which will
                                          review of prior notices for shipments                   period, resulting in even more food                   accommodate prior notice submissions
                                          arriving by water by 25 percent at the                  shipments that would be delayed or                    and eliminate or change ABI/ACS and
                                          minimum. As a result, over 7,000                        held for examination under shortened                  PNSI prior notice submissions. FDA
                                          shipments by water during our                           timeframes.                                           will continue to assess and pursue the
                                          assessment period (estimated as 7,370                      We did not get any comments asking                 integration of timeframes as policies,
                                          for FY 2005) would have been delayed                    us to coordinate the timeframes for                   processes, and strategic IT systems are
                                          at the port of arrival while the PNC                    articles of food arriving by water in our             improved. FDA believes that the most
                                          completed its intensive review and                      prior notice rule (8 hours before arrival)            opportune time for coordinating
                                          determined whether the shipment in                      with those in CBP’s rule (24 hours                    timeframes will coincide with the
                                          fact presented a significant health                     before arrival). We received one                      startup of CBP’s ACE. We will
                                          threat, based on current and projected                  comment asking us to reduce the time                  determine at that time or after ACE is
                                          staffing levels in the PNC.                             for articles arriving by water. We stated             operational whether the prior notice
                                             In setting the timeframes, the act                   in the preamble to the IFR ‘‘In                       timeframes should and can be reduced
                                          provides that we may consider, among                    determining the actual timeframes for                 further. Until that time, the timeframes
                                          other considerations, the effect on                     submission of prior notice for each                   for submission of prior notice will
                                          commerce (section 801(m)(2)(A) of the                   mode of transportation, FDA considered                remain the same in the final rule as
                                          act). Assuming current and projected                    the need to provide sufficient time for               issued under the IFR (see § 1.279).
                                          PNC resources, lowering the timeframes                  the agency to review and respond to the
                                          to 60 or 30 minutes would likely result                 information submitted, as well as the                 3. Phase-In of FDA and CBP Timeframes
                                          in delays at the border, not only for                   current ability of the food industry to                  When FDA reopened the comment
                                          those shipments delayed for intensive                   provide the information required within               period for the IFR on April 14, 2004 (see
                                          review longer than the timeframe, but                   the stated timeframe given the                        69 FR 19763), FDA asked Flexible
                                          also for other shipments passing                        differences in lead time before arrival               Alternative Question 6: ‘‘If FDA adopts
                                          through the port, especially at the                     among different modes of                              reduced timeframes in the prior notice
                                          busiest land border ports where traffic                 transportation. We determined that                    final rule, should FDA phase in the
                                          lanes, parking, and inspection facilities               information for shipments whose                       shorter timeframes as CBP phases in the
                                          are extremely limited. In some ports, the               transport time is measured in days or                 advance electronic information rule?’’
                                          lack of holding facilities could result in              weeks (e.g., ocean shipments) is                         (Comments) Most comments
                                          an increase in trucks being turned                      available further in advance of arrival               recommend integration of the phase-in
                                          around at the border. As we have                        than shipments whose transport time is                of reduced timeframes in association
                                          mentioned above, there have been a                      measured in hours (e.g., land and air                 with CBP’s schedule to promote
                                          relatively small number of situations                   shipments.) Staggered prior notice                    consistency between the programs,
                                          where FDA was not able to make a                        submission timeframes will allow FDA                  reduce errors, and minimize disruption
                                          decision regarding whether to inspect                   reviewers to direct additional resources              of supply chains through conflicting
                                          the food at the port of arrival by the end              to shipments with short transport times               requirements. However, one comment,
                                          of the timeframe, causing a small                       and to defer review of shipments with                 in addition to recommending adherence
                                          number of shipments to be delayed                       longer transport times. Based on these                to CBP’s phase-in schedule, also notes
                                          when it arrived at the port of arrival.                 considerations, FDA established the                   that they would not want FDA to delay
                                          Since the impact of these small number                  prior notice timeframes in the interim                adopting a reduced timeframe for
                                          of delays on trade has not been                         final rule to associate with the mode of              submitting prior notice merely because
                                          significant, continuing to maintain that                transportation.’’ (69 FR at 58995). We                CBP is not yet ready to implement the
                                          the current IFR timeframes is the most                  continue to hold this view for                        counterpart provisions of its advance
                                          efficient use of resources.                             shipments arriving by water in light of               notice programs. In addition, they state
                                             Thus, based on current and projected                 our assessment for articles of food                   that the deadlines are minimum
                                          resources and other high-priority                       arriving by land and air.                             periods, and any shipper can provide
                                          activities FDA is addressing, reducing                     For all of the previously stated                   more notice of imports, to FDA, CBP or
                                          the timeframes would lead to an                         reasons, we did not reduce the                        both, than the minimum timeframes in
                                          increase in delays at the ports of arrival,             timeframes for submitting prior notice                either regulation. They recommend that
                                          causing FDA to shift some resources                     in the final rule for any mode of                     FDA should shorten its lead times to
                                          away from conducting intensive reviews                  transportation, as these timeframes still             match those in the CBP regulations,
                                          of prior notices so they can conduct the                are the minimum amount of time FDA                    even if the CBP requirements are not yet
                                          coordination and other activities                       needs to fulfill its statutory obligation to          in place. Another comment states that
                                          necessary for these delayed shipments.                  receive, review and respond to prior                  the phase-in plan, which is a port-by-
                                          The shift in resources away from                        notices while having the minimal                      port implementation according to a time
                                          conducting intensive reviews would, in                  impact on trade.                                      schedule, would be very problematic to
                                          turn, further increase the number of                       (Comments) One comment suggests                    industry. The comment further explains
                                          shipments that are delayed because FDA                  that it would be preferable for FDA to                that systems and operations do not
                                          has not been able to finish its intensive               harmonize the prior notice timelines to               necessarily have the flexibility to switch
                                          review within the applicable                            the future ACE transmission timelines,                on by individual site or location and the
                                          submission timeframe. This ultimately                   ensuring consistency and compliance of                current plan would introduce
                                          would cause a delay in getting cargo to                 the trade community and efficiencies in               complication and confuse the trade
                                          its final destination, which would have                 both agency and industry workforces.                  community. The comment recommends
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                                          an adverse impact on trade.                                (Response) FDA agrees that                         further discussion with CBP and FDA as
                                             Moreover, the number of prior notices                timeframes for submission of prior                    to development of a more viable and
                                          identified for intensive review has                     notice may be further evaluated in light              achievable implementation plan.
                                          increased over time, as intelligence and                of new trade programs such as ACE,                       (Response) This issue is moot, as the
                                          other risks are identified. We expect the               when it is implemented and in effect.                 final rule retains the timeframes


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                                          established in the IFR, for the                         prior notice confirmation number must                 shipment allowed to proceed. This
                                          previously stated reasons.                              accompany any article of food for which               would not be the case if there was only
                                                                                                  the prior notice was submitted through                one prior notice confirmation number
                                          4. Prior Notice Confirmation Number
                                                                                                  the FDA PNSI when arriving in the                     for the entire shipment.
                                             (Comments) One comment asks for                      United States and must be provided to
                                          clarification regarding when the prior                                                                        5. 5-Day Maximum Pre-Arrival
                                                                                                  CBP and FDA upon arrival. How
                                          notice confirmation number is required                                                                        Limitation
                                                                                                  persons importing or offering for import
                                          to accompany the food.                                  food into the United States choose to                    (Comments) Many comments
                                             (Response) The prior notice                          comply with this requirement is a                     requested that prior notice be allowed to
                                          confirmation number must accompany                      private matter (e.g., persons may decide              be submitted more than 5 days before
                                          any article of food arriving by                         to specify these obligations in the                   arrival. This would allow exporters to
                                          international mail, when the food is                    contract between the exporting                        complete their documentation at the
                                          carried by or otherwise accompanying                    company and the carriers to ensure that               same time the bill of lading and health
                                          an individual, or when the prior notice                 the logistics are worked out in advance).             certification is usually completed in the
                                          was submitted via FDA’s PNSI.                              (Comments) Comments stated that the                case of food shipped by water. One
                                             Under § 1.279(e), the prior notice                   data requirements should be reassessed                comment contends that the 5 day limit
                                          confirmation number must accompany                      to simplify and make the requirements                 does not reflect the variable and
                                          any article of food arriving by                         more manageable. The comment states                   unpredictable nature of transport and
                                          international mail. Under § 1.279(f), a                 that one data element should link all                 does not reflect a risk-based approach to
                                          copy of the confirmation (with the prior                information secured by prior notice,                  a potential bioterrorism threat. Another
                                          notice confirmation number) must                        which would be beneficial for locating                comment contends that the limitation of
                                          accompany any article of food carried                   shipments in the event of a possible                  the timeframe to 5 days is problematic
                                          by or otherwise accompanying an                         crisis. The comments suggest that FDA                 and is due to a misinterpretation of the
                                          individual (unless excluded under                       use bill of lading numbers as a single                statute. The comment asserts that the
                                          § 1.277 (b)(1)), and be provided to CBP                 reference point because all shipments                 statutory language does not preclude a
                                          or FDA upon arrival. Additionally,                      that are moved are repeatedly covered                 party from voluntarily providing prior
                                          under § 1.279(g) the prior notice                       by this number. This would render the                 notice more than 5 days in advance. The
                                          confirmation number must accompany                      prior notice confirmation number                      comment also maintains that 10 days
                                          any article of food for which the prior                 currently used redundant.                             prior to arrival would provide the
                                          notice was submitted through the FDA                       (Response) FDA does not agree that                 necessary flexibility for their industry.
                                          PNSI when arriving in the United States                 the waybill/Bill of Lading can be used                A foreign government, apparently
                                          and must be provided to CBP and FDA                     as a single reference point for all                   assuming that prior notice must be
                                          upon arrival.                                           shipments instead of the prior notice                 submitted by the foreign shipper or
                                             (Comments) One comment asked FDA                     confirmation number. A Bill of Lading                 exporter, recommends that the time
                                          to confirm whether it is sufficient for an              number is not always assigned to a                    should be extended because it may take
                                          ocean carrier to have the prior notice                  shipment at the time of prior notice                  the shipment 2 weeks to reach a U.S.
                                          confirmation number on arrival or                       submission. For certain shipments, such               port.
                                          whether they are required to have the                   as those sent by international mail, no                  (Response) In response to the
                                          actual prior notice confirmation also.                  Bill of Lading may exist. Thus, FDA has               concerns raised by the comments, we
                                             (Response) Under § 1.279(e), the prior               determined that it is better to use a                 have revised § 1.279(b) to allow
                                          notice confirmation number must                         unique confirmation number provided                   submission of prior notice more than 5
                                          accompany any article of food arriving                  by the FDA system to transmitters.                    days before arrival (except for articles of
                                          by international mail. Additionally,                       (Comments) One comment notes that                  food imported or offered for import by
                                          under § 1.279(g) the prior notice                       a separate prior notice is required for               international mail). Specifically, this
                                          confirmation number must accompany                      each distinct food product and a prior                provision permits prior notice
                                          any article of food for which the prior                 notice confirmation number is returned                submissions to be submitted no more
                                          notice was submitted through the FDA                    for each prior notice. Therefore, if a                than 30 calendar days before the
                                          PNSI when arriving in the United States                 shipment consists of multiple food                    anticipated date of arrival for
                                          and must be provided to CBP and FDA                     products, the carrier would have                      submissions made through ABI/ACS
                                          upon arrival. Therefore, although a prior               multiple prior notice confirmations                   and no more than 15 calendar days
                                          notice confirmation number is required,                 upon arrival. The comment states                      before the anticipated date of arrival for
                                          the final rule does not require that the                multiple prior notice confirmations do                submissions made through PNSI. Due to
                                          actual prior notice confirmation has to                 not align well with the commercial                    system limitations, the timeframes
                                          be supplied for food arriving by ocean                  realities of international trade, where               between ABI/ACS and PNSI are not
                                          carrier.                                                the focus is on the entire shipment, not              identical. Also, because of the way ABI/
                                             (Comments) One comment states that                   the individual components. The                        ACS is programmed, when prior notice
                                          when food arrives in the United States,                 comment recommends that FDA                           is submitted through ABI/ACS, the prior
                                          the carrier should present a copy of the                provide a prior notice confirmation                   notice confirmation number cannot be
                                          prior notice confirmation and the food                  number that encompasses the entire                    provided more than 5 calendar days
                                          to CBP. The comment asks if the                         shipment.                                             before the anticipated date of arrival.
                                          submitter should send the prior notice                     (Response) FDA disagrees. The carrier                 Please note that if any of the prior
                                          confirmation to the carrier company or                  could be carrying articles of food for                notice information, except the
                                          to the vessel that transported the food to              different submitters or recipients. If it             anticipated arrival information, the
                                          the United States.                                      was necessary to hold an article of food,             estimated quantity, or the planned
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                                             (Response) As stated previously,                     the entire shipment would be held                     shipment information, changes after
                                          § 1.279(e) requires the prior notice                    under the above scenario suggested by                 FDA has confirmed the prior notice
                                          confirmation number to accompany any                    the comment. Under the final rule, the                submission for review, the prior notice
                                          article of food arriving by international               article of food that is subject to a hold             must be resubmitted, as provided by
                                          mail. Additionally, under § 1.279(g) the                can be offloaded and the rest of the                  § 1.282(a). The resubmission must be


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                                          confirmed by FDA for review no less                     confirmation number, must accompany                   1. General Comments
                                          than 2, 4, or 8 hours before arriving at                any article of food that is subject to this
                                          the port of arrival, with the minimum                   subpart when it is carried by or                         (Comments) One comment suggests
                                          time depending on the mode of                           otherwise accompanies an individual                   that FDA should have CBP collect and
                                          transportation (§ 1.279(a)). If prior                   when arriving in the United States. The               review all prior notices with one prior
                                          notice is resubmitted, the previous prior               copy of the confirmation must be                      notice submission timeframe for all
                                          notice should be cancelled (§ 1.282(b),                 provided to CBP or FDA upon arrival.                  agencies.
                                          (c)).                                                     Under § 1.279(g), the prior notice                     (Response) FDA disagrees. The
                                                                                                  confirmation number must accompany                    Bioterrorism Act, while providing for
                                          6. International Mail                                                                                         the ability to commission other agencies
                                                                                                  any article of food for which the prior
                                             (Comments) There were no comments                    notice was submitted through the FDA                  to help implement the provisions of the
                                          received regarding the timeframes                       PNSI when the article arrives in the                  Bioterrorism Act, specifies that the
                                          established for prior notice covering                   United States and must be provided to                 Secretary is to receive prior notice for
                                          food arriving by international mail.                    CBP or FDA upon arrival.                              all food imported or offered for import
                                             (Response) FDA retained the                                                                                into the United States. FDA personnel
                                          timeframes for submission of prior                      G. How Must You Submit the Prior                      are trained and knowledgeable about the
                                          notice for food arriving by international               Notice? (§ 1.280)                                     risks and hazards involving food
                                          mail that are in the IFR.                                  Section 1.280 of the IFR required that             products under its jurisdiction and have
                                             (Final rule) The final rule at § 1.279(a)            prior notice must be submitted                        the expertise to review the prior notice
                                          requires that you must submit prior                     electronically to FDA in the English                  submissions. The integration of prior
                                          notice to FDA and the prior notice                      language, except that an individual’s                 notice submission timeframes is
                                          submission must be confirmed by FDA                     name, the name of a company, and the                  discussed earlier in this document
                                          for review as follows: If the article of                name of a street may be submitted in a                under the discussion for § 1.279.
                                          food is arriving by land by road, no less               foreign language. All information,                       (Comments) Several comments
                                          than 2 hours before arriving at the port                including these items, must be                        suggest allowing the option of
                                          of arrival; if the article of food is                   submitted using the Latin (Roman)                     submitting prior notice by fax or mail
                                          arriving by land by rail, no less than 4                alphabet. The IFR provided for two                    because not everyone has Internet
                                          hours before arriving at the port of                    methods of electronic submission of                   capability, access to a computer, or
                                          arrival; if the article of food is arriving             prior notice: (1) The CBP ABI/ACS; or                 proficiency in English. One comment
                                          by air, no less than 4 hours before                     (2) FDA PNSI at http://                               asks that they be allowed to continue
                                          arriving at the port of arrival; or if the              www.access.fda.gov.                                   sending prior notice by fax (as is
                                          article of food is arriving by water, no                   The IFR required submission of prior               allowed during certain contingency
                                          less than 8 hours before arriving at the                notice via FDA’s PNSI for articles of                 situations). Several other comments
                                          port of arrival.                                        food imported or offered for import by                suggest that international mail shippers
                                             Under § 1.279(b), except in the case of                                                                    are at a disadvantage because many mail
                                                                                                  international mail, other transaction
                                          an article of food imported or offered for                                                                    customers have no access to the
                                                                                                  types that cannot be made through ABI/
                                          import by international mail, prior                                                                           Internet, the pre-notification system is
                                                                                                  ACS, and articles of food that have been
                                          notice may be submitted no more than                                                                          not customer-friendly, entries take a
                                                                                                  refused under section 801(m)(1) of the
                                          30 calendar days before the anticipated                                                                       long time, and the data requirements are
                                                                                                  act and 21 CFR part 1, subpart I.
                                          date of arrival for submissions made                                                                          too complex and difficult for customers
                                          through ABI/ACS and no more than 15                        The IFR also provided for
                                                                                                  contingencies if certain systems were                 to determine.
                                          calendar days before the anticipated
                                                                                                  not working, e.g., a custom broker’s or                  (Response) FDA does not agree that a
                                          date of arrival for submissions made
                                                                                                  self-filer’s system, ABI/ACS, PNSI, or                process for manual transmission is
                                          through PNSI.
                                             Under § 1.279(c), if the article of food             OASIS. The IFR required that prior                    needed, except on a contingency basis.
                                          is arriving by international mail, the                  notice must be submitted through PNSI                 FDA believes that persons engaged in
                                          prior notice must be submitted before                   if a custom broker’s or self-filer’s system           international commerce have, or can get,
                                          the article of food is sent to the United               or if the ABI/ACS interface is not                    access to the Internet. If the Internet is
                                          States.                                                 working. The IFR also required that                   not accessible by the submitter, he or
                                             Under § 1.279(d), FDA will provide                   prior notice must be submitted via e-                 she can use a customs broker to submit
                                          notification that the prior notice has                  mail or fax if PNSI or OASIS is not                   prior notice through ABI/ACS or
                                          been confirmed for review with a reply                  working. The IFR did not exempt any                   another person to transmit prior notice
                                          message that contains a prior notice                    specific categories of food articles from             through the FDA PNSI. Allowing
                                          confirmation number. The prior notice                   prior notice if systems are not                       manual transmission would not give
                                          will be considered submitted and the                    performing.                                           adequate time for FDA personnel to
                                          prior notice review time will start when                   In August 2004, FDA and CBP                        receive, review, and respond, unless the
                                          FDA has confirmed the prior notice for                  published guidance covering a                         timeframes for prior notice in the final
                                          review.                                                 Contingency Plan for System Outages.                  rule were greatly extended. Thus,
                                             Under § 1.279(e), the prior notice                   This guidance can be accessed at http://              manual transmission will be used only
                                          confirmation number must accompany                      www.cfsan.fda.gov/~pn/pndguid.html.                   as a contingency alternative.
                                          any article of food arriving by                         Comments addressing contingencies                        FDA also notes that the data quality
                                          international mail. The prior notice                    will be discussed later in this section.              of manual systems is usually less than
                                          confirmation number must appear on                         Comments regarding how to submit                   satisfactory, because no automated data
                                          the Customs Declaration that                            prior notice are addressed according to               validation takes place during data entry.
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                                          accompanies the package. We provide                     issue: General comments; comments                     The U.S. Government has a strong
                                          CN22 or CN23 or a U.S. equivalent as                    about the ABI/ACS and PNSI systems,                   commitment to reducing paper-based
                                          examples of the Customs Declaration.                    including technical issues and security               processes and moving toward e-
                                             Under § 1.279(f), a copy of the                      of the systems; and comments about                    commerce for all business transactions.
                                          confirmation, including the prior notice                contingencies.                                        Accordingly, under the final rule, paper-


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                                          based submissions will not be allowed,                     FDA again notes that it has                        determination and the admissibility
                                          except on a contingency basis.                          compliance policies that address some                 determination.)
                                             In response to the comment that                      of the concerns raised by the comments.                  (Comments) One comment suggests
                                          international mail shippers are                         Its compliance policy under the IFR had               the agencies should synchronize the
                                          disadvantaged, FDA also notes that it                   been that ‘‘FDA and CBP should                        different filing systems so as to ensure
                                          has compliance policies to address this                 typically consider not taking any                     that all notices can be made via
                                          situation. Its compliance policy under                  regulatory action when an article of food             Automated Manifest System (AMS).
                                          the IFR had been that ‘‘FDA and CBP                     is imported or offered for import for                 Other comments request FDA to
                                          should typically consider not taking any                non-commercial purposes with a non-                   coordinate prior notice with CBP’s AMS
                                          regulatory action when an article of food               commercial shipper’’ without prior                    to eliminate duplication of data
                                          is imported or offered for import for                   notice. This applied to all such food                 submissions.
                                          non-commercial purposes with a non-                     subject to prior notice, including food                  (Response) FDA disagrees. No
                                          commercial shipper’’ without prior                      shipped by international mail. The Prior              interface currently exists between AMS
                                          notice. This applied to all such food                   Notice Final Rule Draft CPG, announced                and the existing interface with FDA’s
                                          subject to prior notice, including food                 elsewhere in this issue of the Federal                OASIS through the ABI/ACS entry
                                          shipped by international mail. The Prior                Register, would continue that                         processes, which means FDA does not
                                          Notice Final Rule Draft CPG, announced                  enforcement policy. FDA believes that                 have access to AMS data. FDA and CBP
                                          elsewhere in this issue of the Federal                  this proposed compliance policy should                have discussed interfacing with AMS
                                          Register, would continue that                           not be extended to food that is imported              for manifest data and determined that
                                          enforcement policy.                                     or offered for import for commercial                  the general cargo data in AMS are not
                                                                                                  purposes or with a noncommercial                      suitable to accommodate the detailed
                                             (Comments) One comment suggests
                                                                                                  shipper without prior notice. Mail                    information requirements of section
                                          that instead of submitting prior notice
                                                                                                  shipments associated with a commercial                801(m) of the act. For example, AMS
                                          via PNSI, mail shippers be allowed to
                                                                                                  purpose pose a higher risk with respect               does not collect the country of origin. In
                                          complete an alternate form requiring
                                                                                                  to ability to reach a greater number of               addition, its collection of the identities
                                          minimal information that is similar to
                                                                                                  people, and most commercial entities                  of the article of food and its
                                          the Customs Declaration form in the
                                                                                                  already are familiar with submitting                  manufacturer differs from the way those
                                          native language to be completed at the                                                                        are collected under the prior notice
                                          post office. This comment argues that                   information to FDA and CBP.
                                                                                                                                                        interim final and final rules in such a
                                          the current requirements are too                           (Comments) One comment proposes a
                                                                                                                                                        way that the data would not meet our
                                          cumbersome for the average consumer.                    two-step process for filing prior notice,
                                                                                                                                                        needs in carrying out the purpose of
                                          Similarly, another comment suggests                     whereby FDA would accept the same
                                                                                                                                                        section 801(m) of the act.
                                          that FDA accept Customs Declaration                     data submitted for CBP ABI to satisfy                    (Comments) One comment urges FDA
                                          Forms CN22 and CN23 in lieu of                          the prior notice requirements at the first            to upgrade its systems to coincide with
                                          submitting prior notice via PNSI for                    port of arrival. Then, after accepting ABI            normal commercial flow times and
                                          mail shippers. This comment argues                      data at the port of arrival, complete                 recommends that FDA consider the
                                          that such forms are much easier to                      prior notice data would be filed at the               approach used by the Census Bureau,
                                          complete and are official documents                     port of entry as step two of the process.             i.e., providing a range of automated
                                          prescribed by the Universal Postal                      The comment contends that utilizing                   filing options for meeting electronic
                                          Convention and are used around the                      ABI data for prior notice at the port of              filing requirements by offering an
                                          world. In the alternative, this comment                 arrival would allow faster processing,                Internet application, a direct link for
                                          suggests that FDA accept data submitted                 which is a significant issue considering              certified filers, and a personal computer
                                          by mail shippers via PNSI in a                          FDA’s concern about timely processing                 (PC)-based application.
                                          condensed form determined by the                        of prior notice under a shorter time                     (Response) FDA provides two
                                          foreign government’s postal agency.                     schedule. This more complete data                     methods for submitting prior notice:
                                             (Response) FDA disagrees. Section                    would be filed concurrent with the CBP                One via ABI/ACS (a PC-based link for
                                          801(m) of the act requires the prior                    clearance entry, and therefore provide                certified filers) and another via PNSI (an
                                          notice submission to contain certain                    FDA with the level of data desired,                   Internet-based application). Prior notice
                                          data elements, such as the identity of                  while removing the issue of time                      is not required to be filed at a specific
                                          the article of food, manufacturer and                   constraints under a reduced schedule                  time or during specific hours of the day,
                                          shipper of the article, grower, country                 measured against the port of arrival.                 but may be submitted 24 hours/day, 365
                                          from which the article originates,                         (Response) FDA disagrees. The                      days of the year. The rule requires FDA
                                          country from which the article is                       purpose of section 801(m) of the                      to receive the prior notice before the
                                          shipped, and the anticipated port of                    Bioterrorism Act is to ensure that FDA                food arrives in the United States, and
                                          entry of the article. Customs Declaration               has sufficient information before arrival             the time frame is based on the mode of
                                          Forms are not adequate substitutes for                  so it can determine what foods to                     transportation (see § 1.279).
                                          providing this information to FDA since                 inspect at the border. Therefore, all                    (Comments) One comment suggests
                                          such forms do not typically require this                information required for prior notice                 that FDA participate in the International
                                          kind of comprehensive information.                      must be submitted prior to arrival, not               Trade Data System (ITDS), which
                                          Likewise, allowing a foreign                            just a portion of the information.                    provides for one-window filing of trade-
                                          government’s postal agency to                              Additional information may be                      related information by motor carriers
                                          determine which information to submit                   required after arrival and for entry                  and other parties through CBP’s ACE
                                          to FDA also does not guarantee that we                  admissibility decisions. That process is              system, to more effectively execute its
                                          will receive the information required by                completed after arrival for those foods               Bioterrorism Act mission.
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                                          section 801(m) of the act. Therefore,                   offered for consumption in the United                    (Response) FDA is actively
                                          FDA has not provided an alternative                     States. (See 68 FR 58974 at 58976 in the              participating in the development of
                                          form of prior notice submission for food                preamble to the IFR for additional                    CBP’s ACE system and has long been a
                                          arriving by mail for commercial                         discussion about the relationship and                 participant in the ITDS. However, ACE
                                          purposes.                                               differences between the prior notice                  is not yet a complete reality and prior


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                                          notice requirements have been in effect                 this time. The cost of updating the                   3. Technical Issues Concerning Both
                                          since December 12, 2003. FDA is                         translations as new versions of the                   Systems
                                          working with CBP and others in the                      system are developed would also be                       (Comments) One comment suggests
                                          international trade community to ensure                 substantial. In addition, FDA notes that              that both systems provide a link to HTS
                                          that the prior notice requirements are                  other import documents required by                    codes.
                                          reflected in ACE once ACE is fully                      FDA and by CBP must be filed in                          (Response) FDA agrees. Both PNSI
                                          operational.                                            English. Therefore, FDA does not plan                 and ABI/ACS provide a link to HTS
                                             (Comments) One comment notes that                    to program PNSI in other languages and                codes. FDA also has provided guidance
                                          exporters use different kinds of
                                                                                                  the final rule will continue to require               regarding HTS codes and a companion
                                          transmission formats to send prior
                                                                                                  submission of prior notice in the                     list of HTS codes flagged with prior
                                          notice-related information to importers
                                                                                                  English language.                                     notice indicators. The guidance is
                                          or brokers in the United States. The
                                                                                                     FDA and CBP nonetheless have taken                 posted at http://www.cfsan.fda.gov/
                                          comment further states that since none
                                                                                                  into account many of the concerns                     ~dms/htsguid3.html and the updated
                                          of its member companies have received
                                                                                                                                                        list is posted at http://
                                          any notice from FDA requesting changes                  referenced in the comments. For
                                                                                                                                                        www.cfsan.fda.gov/~pn/htscodes.html.
                                          in content or formatting of the                         example, the final rule does not apply
                                                                                                                                                           (Comments) One comment states that
                                          transmitted information, they assume                    to homemade foods shipped from an                     railroads will not load cargo until a
                                          that FDA is satisfied with their                        individual to an individual in the                    prior notice confirmation number is
                                          industry’s approach to regulatory                       United States (see § 1.277, Scope,
                                          compliance. In the event that FDA                                                                             provided, and a prior notice
                                                                                                  discussed supra). In addition, the                    confirmation number cannot be
                                          requires a change to format or content                  agencies’ compliance policy under the
                                          of the reporting now conducted, the                                                                           provided without complete planned
                                                                                                  IFR had been that ‘‘FDA and CBP                       shipment information, including a
                                          comment requests that FDA notify                        should typically consider not taking any
                                          companies well in advance of any such                                                                         railcar number.
                                                                                                  regulatory action when an article of food                (Response) FDA notes that, while this
                                          requested change.
                                             (Response) FDA receives prior notice                 is imported or offered for import for                 situation seemed to be an issue early in
                                          information via ABI/ACS or PNSI. FDA                    non-commercial purposes with a non-                   the implementation of the prior notice
                                          expects that the transmitted information                commercial shipper’’ without prior                    IFR, it is our understanding and
                                          discussed in the comment is submitted                   notice. This applied to all such food                 experience that the rail industry has
                                          to FDA via one of these two methods in                  subject to prior notice, including food               now changed business practices to
                                          the proper format. If the information is                shipped by international mail. The Prior              address this concern. FDA received only
                                          inaccurate, the food is subject to refusal.             Notice Final Rule Draft CPG, announced                one comment on this issue and has not
                                          Customs brokers are notified using                      elsewhere in this issue of the Federal                received any other feedback to suggest
                                          typical procedures regarding any                        Register, would continue that                         this matter is still of concern. A check
                                          changes relating to the rule that require               enforcement policy.                                   with a large rail shipping company
                                          an IT change to ABI/ACS, including a                                                                          revealed that the restrictions for loading
                                                                                                     (Comments) One comment requests                    cargo are not at issue; i.e. rail cars can
                                          90-day lead time before implementation                  that other pieces of the prior notice
                                          of the IT change. FDA also provides                                                                           be physically loaded with shipments
                                                                                                  system also be available in other                     containing food prior to obtaining prior
                                          tutorials on its Web site that explain
                                                                                                  languages, such as the tutorials for                  notice (Ref. 1). Therefore, the prior
                                          changes to PNSI (see http://
                                          www.cfsan.fda.gov/~pnts/pnsitut.html).                  determining the FDA product code.                     notice filer does have the ability to
                                                                                                  Another comment suggests that FDA                     obtain the rail car number in order to
                                          2. English Language                                     provide foreign governments and trade                 file prior notice. The rail company did
                                             (Comments) Many comments suggest                     organizations with a detailed outline of              however indicate that rail cars are not
                                          that FDA program PNSI in other                          the ‘‘prior notice form’’ with                        connected/added/attached to the U.S.
                                          languages, such as Japanese, Korean,                    explanations of the individual                        in-bound train until the rail company
                                          German, and Spanish. These comments                     requirements so that they could be                    receives documentation that prior notice
                                          state that ‘‘mail users’’ must rely on                  translated into a foreign language and                has been filed.
                                          PNSI to submit prior notice, and in                     provided to affected companies.                          (Comments) One comment states that
                                          many cases, English may not be the                         (Response) While many of the                       the FDA Help Desk, and other methods
                                          native language for many of these users                                                                       now established for resolution of
                                                                                                  documents regarding prior notice
                                          and puts them at a disadvantage, e.g.,                                                                        operational issues, simply are not
                                                                                                  requirements have been translated into
                                          foreign filers experience higher burdens                                                                      yielding a workable ‘‘fix’’ to the ‘‘kinks’’
                                                                                                  other languages, the PNSI tutorials
                                          and are frequently being timed out of                                                                         in the new PNSI/ABI system. Another
                                                                                                  (available at http://www.cfsan.fda.gov/               comment recommends the
                                          PNSI because it takes them longer to
                                                                                                  ~pnts/pnsitut.html) and the FDA                       establishment of a system for swift
                                          complete a prior notice. One comment
                                          argues that a reason for noncompliance                  Harmonized Tariff Schedule Codes                      resolution of technical and operational
                                          of prior notice requirements is the                     guidance (available at http://                        problems for both systems.
                                          inability to understand English well                    www.cfsan.fda.gov/~dms/                                  (Response) FDA agrees and has
                                          enough to submit prior notice via PNSI.                 htsguid3.html) have not been translated.              established an FDA Help Desk to deal
                                             (Response) FDA agrees that a system                  FDA intends to continue translating                   with technical issues involving PNSI.
                                          available in multiple languages would                   these and other prior notice documents                Questions and concerns about
                                          be advantageous for some users.                         as resources permit. Documents that are               operational, rather than technical,
                                          However, the agency has assessed the                    available in other languages are posted               problems involving prior notice should
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                                          feasibility of providing and maintaining                at http://www.cfsan.fda.gov/~mow/                     be directed to FDA’s PNC. While the
                                          PNSI in multiple languages, and has                     internat.html. Foreign governments and                FDA PNC is available 24 hours a day,
                                          determined that the cost of developing                  trade organizations are welcome to                    7 days a week to respond to operational
                                          translations into one or more additional                translate these documents and provide                 issues, it is not equipped to resolve
                                          languages cannot be accommodated at                     them to affected companies.                           technical issues involving PNSI or ABI.


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                                          However, the PNC has a process in                       take an hour or more to receive the prior             OA Record,5 as has always been done
                                          place to handle calls involving technical               notice confirmation number that is                    for FDA disclaims.
                                          issues and will forward those calls to                  needed to move the cargo. Another                        (Comments) One comment believes
                                          the Help Desk. CBP also has a well-                     comment states that there have been                   there is a problem with the in-bond
                                          established system of client                            several instances when the confirmation               system. The comment states that if it is
                                          representatives to deal with technical                  response has been delayed and asks                    assumed that a shipment arrives in Los
                                          problems involving ABI/ACS. CBP                         FDA to improve the timeliness of this                 Angeles, but is destined for in-bond
                                          client representatives are available to                 response.                                             travel to New York, the shipment is
                                          assist users with ABI issues. ABI                                                                             subject to prior notice upon arrival. In
                                          operational issues are the sole                            (Response) Generally, for prior notice             order to properly comply with CBP
                                          responsibility of CBP.                                  submission via PNSI, the user should                  requirements, the arrival date is entered
                                             (Comments) One comment states that                   receive their confirmation number                     based upon the expected arrival date in
                                          the systems go down from time to time,                  immediately upon submission of the                    New York. The data exchange between
                                          and all the time-consuming entry-work                   correctly completed form. For those                   CBP and FDA is then triggered by the
                                          has to be repeated.                                     prior notices submitted via ABI on the                New York arrival date rather than the
                                             (Response) PNSI has been enhanced                    anticipated date of arrival, users can                Los Angeles arrival date. The comment
                                          to allow copying and saving of prior                    expect to receive a response message                  is concerned that prior notice could be
                                          notices within a Web entry and copying                  (confirmation number or rejection)                    transmitted in a timely manner to CBP,
                                          of a Web entry, with or without the                     within 15 minutes of submission. For                  but be held up due to computer
                                          associated prior notices. Copying allows                ABI submissions submitted prior to the                programming, making the prior notice
                                          you to avoid repetitive data entry for                  anticipated date of arrival, users can                untimely. The brokers have fixed this
                                          similar Web Entries and associated Prior                expect to receive their response message              problem in the short term by inputting
                                          Notices. You also may cancel a Web                                                                            the Los Angeles arrival date in both
                                                                                                  no later than midnight (Eastern Time)
                                          Entry and then copy it, to correct errors                                                                     places for prior notice purposes and
                                                                                                  on the anticipated date of arrival.
                                          in a Web Entry you have already                                                                               then changing it after prior notice has
                                          completed. Instructions for copying a                      (Comments) One comment states that
                                                                                                                                                        concluded.
                                          Web entry prior notice are available on                 there are glitches in the software that                  (Response) The anticipated arrival
                                          FDA’s Web site at http://                               has been released. The comment notes                  date is a requirement of prior notice and
                                          www.cfsan.fda.gov/~pn/                                  that perfume is a nonfood product that                is independent of CBP entry
                                          pnstep2.html#copywe. ABI users are                      is subject to FDA’s 801(a) jurisdiction,              requirements. The Bioterrorism Act
                                          responsible for their own software and                  but it does not require prior notice.                 requires submission of prior notice
                                          its capability to save and/or copy                      However, in a procedures memorandum                   before the food arrives in the United
                                          information that has not been                           from CBP, it appears that if you disclaim             States, and not upon arrival as stated in
                                          transmitted.                                            FDA in FD3, it is disclaimed for all                  the comment. Therefore, in the example
                                             (Comments) One comment urges FDA                     purposes. Similarly, if you acknowledge               provided, prior notice is required before
                                          to harmonize their efforts with CBP with                FDA jurisdiction in FD3, then prior                   the article of food arrives in Los Angeles
                                          respect to the prior notification of food               notice must be submitted whether or not               notwithstanding any other CBP entry
                                          articles and to work with CBP to                        the importation involves food.                        requirements.
                                          integrate its joint administration and
                                                                                                     (Response) We have provided                           For ABI entries requiring prior notice,
                                          enforcement of prior notice for both CBP
                                                                                                  instructions describing how to disclaim               the filer must enter separate dates for
                                          and FDA. One comment recommends
                                                                                                  an article for prior notice, while still              purposes of entry and prior notice. The
                                          that both the FDA and CBP systems be
                                                                                                  sending information required for FDA                  filer enters an anticipated arrival date at
                                          simplified to allow for both a decrease
                                                                                                  801(a) admissibility. The instructions                the entry header level for CBP. For
                                          in data entry time and a more efficient
                                                                                                  were included in at least four separate               purposes of prior notice, the filer also
                                          method for multiple data entries.
                                                                                                  ABI Administrative Messages issued by                 enters the anticipated arrival date as an
                                             (Response) FDA agrees and is
                                                                                                                                                        affirmation of compliance code ‘‘ADA.’’
                                          continuously working with CBP to make                   CBP beginning in March 2004 (e.g.,
                                                                                                                                                        Therefore, there should not be a
                                          the administration and enforcement of                   Administrative Message 04–0586, dated
                                                                                                                                                        problem with choosing which date to
                                          prior notice as integrated and efficient                March 24, 2004). If merchandise marked
                                                                                                                                                        submit as raised by the comment.
                                          as possible. Both agencies recognize that               FD3 in the Tariff Record is subject to                   (Comments) One comment suggests
                                          ACE, when initiated, will allow for a                   prior notice and 801(a) reporting                     that the systems provide a drop down
                                          more harmonized process.                                requirements, the required prior notice
                                             With respect to multiple data entries,                                                                     list of reasons that provide an
                                                                                                  and 801(a) information should be                      explanation for the absence of the
                                          PNSI does offer several features that                   transmitted. In cases where 801(a)
                                          make prior notice data entry faster and                                                                       registration number.
                                                                                                  information is required, and prior notice                (Response) FDA agrees. In the
                                          reduce the amount of redundant data                     information is not required, filers
                                          entry, such as the Copy Web Entry                                                                             November 2004 revision of the CPG that
                                                                                                  should transmit the ‘‘PN disclaimer’’                 explained how FDA intended to enforce
                                          feature, Copy Prior Notice feature, and                 (PND) and the information required for
                                          other shortcuts. Please refer to Time                                                                         the prior notice IFR, a list of reasons
                                                                                                  801(a). In this case, the PND Affirmation             was provided as Appendix 1, Reason
                                          Saving Tips from the FDA PNC for PNSI
                                                                                                  of Compliance (AofC) code must be the                 Codes for Registration Number of
                                          (http://www.cfsan.fda.gov/~pn/
                                                                                                  first AofC code recorded (FD01 Record-                Manufacturer Not Provided. This list of
                                          pntips.html) for a description of these
                                                                                                  Positions 20–22) in the ABI                           reasons is available in both PNSI and
                                          features. Many private ABI software
                                          programs also have features that provide                transmission. The PND affirmation does                ABI/ACS, and the reasons are available
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                                          a means for multiple data entries.                      not require a qualifier. If the                       as a drop down menu in PNSI. ACS is
                                             (Comments) Several comments                          merchandise marked FD3 represents an
                                          express concern about the timeliness of                 article exempt from all FDA reporting                   5 This is a ‘‘Conditional Other Government

                                                                                                                                                        Agency Declaration’’ input record that provides a
                                          receipt of the prior notice confirmation                requirements, the line should be                      code indicating that there are/are not other
                                          number. One comment states that it can                  disclaimed using the FD0 marker in the                government agency review requirements.



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                                                            Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations                                         66333

                                          programmed in ‘‘batch mode’’ which                         (Comments) One comment points out                  who contracts with a filer who is
                                          does not lend itself to drop down                       that some problems with electronic                    licensed and approved by CBP to use
                                          menus. CBP also has issued                              submission of prior notice are being                  ABI/ACS. The submitter provides the
                                          Administrative Messages to ABI filers in                encountered by virtue of the fact that                filer with the information necessary to
                                          December 2004 and March 2005                            not all brokers interact with FDA in a                transmit a complete prior notice through
                                          concerning these reason codes. The                      completely electronic environment. ABI                ABI/ACS to FDA. This process is often
                                          Prior Notice Final Rule Draft CPG that                  allows for the fully electronic                       used to combine the prior notice and
                                          is announced elsewhere in this issue of                 transmission of CBP and FDA data, but                 entry processes and many importers and
                                          the Federal Register provides an                        ‘‘dual mode’’ brokers must also submit                foreign exporters find this to be the most
                                          updated list of reasons to be used in                   information to FDA in paper form. The                 advantageous process. FDA and CBP
                                          certain limited situations when the                     comment recommends that FDA                           provided the ability to use ABI/ACS in
                                          manufacturer’s facility registration                    encourage all brokers to participate in               response to comments to the proposed
                                          number is not provided in a prior notice                paperless electronic processing.                      rule. As expected, the ABI/ACS process
                                          submission.                                                (Response) ‘‘Dual mode’’ filers are                is used in around 83 percent of prior
                                             (Comments) One comment                               those who must submit paper entries                   notice transmissions. PNSI was
                                          recommends that the required data                       when transmitting entry information for               developed for those submissions that
                                          elements be identified so that shippers                 FDA admissibility consideration.                      cannot be accommodated by ABI/ACS,
                                          will know which elements are                            However, for prior notice, any customs                and for those who choose not to use a
                                          mandatory and which are not.                            broker or self-filer, including ‘‘dual                customs broker for prior notice
                                             (Response) In the preamble to the IFR,               mode’’ filers, may transmit using ABI/                submissions, and these transmissions
                                          FDA provided a table of the data                        ACS or PNSI.                                          represent about 17 percent of the total
                                                                                                     (Comments) One comment urges that                  prior notice submissions.
                                          elements for reference describing in
                                                                                                  for rail intermodal shipments between                    (Comments) One comment asks that
                                          which situations the information is
                                                                                                  points in Canada where the                            the customs broker be allowed access to
                                          mandatory (68 FR 58974 at 58980). The
                                                                                                  transportation transits the United States,            all pertinent information by electronic
                                          preamble of this final rule also contains
                                                                                                  FDA should agree that data submitted to               means in order to reduce the amount of
                                          table 2 which describes the information
                                                                                                  the CBP via AMS constitutes advance                   paperwork required by the prior notice
                                          requirements. FDA also notes that PNSI
                                                                                                  notice under the FDA regulations.                     process.
                                          is programmed such that if a data                          (Response) FDA disagrees. Under                       (Response) The means by which the
                                          element does not apply, the data                        section 801(m) of the act, FDA, not CBP,              submitter provides the transmitter with
                                          element is not requested during the                     must receive prior notice. Furthermore,               the required information is a matter of
                                          prior notice submission process.                        no interface currently exists between                 communication between the submitter
                                             (Comments) One comment states that                   AMS and the existing interface with                   and transmitter. The final rule neither
                                          when a prior notice confirmation                        FDA’s OASIS through the ABI/ACS                       requires nor precludes processes the
                                          number is submitted to CBP and FDA,                     entry processes, which means FDA does                 parties select to handle these
                                          it is sometimes returned with a different               not have access to AMS data. FDA and                  communications.
                                          prior notice confirmation number. The                   CBP have discussed interfacing with                      (Comments) Several comments
                                          comment asks why this is and what                       AMS for manifest data and determined                  request that the agencies change the
                                          happens to the original prior notice                    that the general cargo data in AMS are                process for resubmission of prior notice
                                          confirmation number.                                    not suitable to accommodate the                       after the original prior notice or entry
                                             (Response) FDA acknowledges that                     detailed information requirements of the              has been cancelled and when prior
                                          this problem occurred in the early stages               prior notice rule. For example, AMS                   notice is submitted after the food is
                                          of prior notice; however, we have                       does not collect the country of origin. In            already in the United States. One
                                          rectified the situation. When we                        addition, its collection of the identities            comment asks that the system interface
                                          received a report concerning this prior                 of the article of food and its                        be modified so that the resubmission
                                          notice confirmation number problem,                     manufacturer differs from the way those               automatically cancels the original.
                                          we immediately modified our software                    data points are collected under the prior             Another comment suggests that in the
                                          to prevent the reported problem from                    notice final rule in such a way that the              case where the foods are already in the
                                          reoccurring.                                            data would not meet our needs in                      United States and the CBP entry has had
                                          4. ABI/ACS Interface                                    carrying out the purpose of section                   to be cancelled and resubmitted, it
                                                                                                  801(m) of the act.                                    should not be necessary to repeat the
                                             (Comments) One comment states that                      (Comments) One comment reports                     prior notice filing; filing entry should be
                                          the ABI system has been proven to be                    that foreign exporters are obliged to use             sufficient. Another suggests that when
                                          the most efficient means for meeting the                FDA’s PNSI as they cannot register as                 the second entry is made, CBP allow for
                                          prior notice time requirements.                         users of CBP’s ABI. The comment                       submission of the previous prior notice
                                             (Response) FDA agrees that for many                  contends that these exporters, not being              confirmation number rather than the
                                          submitters, the ABI interface is the most               able to combine prior notice and a                    creation of a new prior notice with an
                                          efficient means for providing prior                     customs declaration for import in one                 accompanying new prior notice
                                          notice, as it allows the data to be saved               operation, will be in a disadvantaged                 confirmation number. Other comments
                                          and used for entry purposes. FDA also                   position compared to U.S. importers                   suggest that ABI submission of prior
                                          acknowledges that not all submitters                    because the foreign exporter, after                   notice be allowed for food in the United
                                          have a custom broker, nor does ABI                      having completed his prior notice, will               States. An additional comment states
                                          accommodate all transactions subject to                 receive a prior notice confirmation                   that CBP entry can be made for articles
                                          prior notice (e.g., food imported by                    number, which he then has to transmit                 of food that are already in the United
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                                          international mail or inside personal                   to his U.S. importer or customs broker.               States without adequate prior notice.
                                          baggage not for personal use).                             (Response) FDA disagrees. Prior                    Another comment recommends that
                                          Accordingly, the final rule continues to                notice may be submitted electronically                FDA consider allowing the submission
                                          provide for electronic submission of                    through either ABI/ACS or PNSI.                       of prior notice through the ABI interface
                                          prior notice via either ABI/ACS or PNSI.                Typically, ABI/ACS is used by a person                even when that prior notice will not be


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                                          66334             Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations

                                          timely. Finally, one comment suggests                   requirements) and current system                      system, which is how the majority of
                                          that a new prior notice should not be                   configurations can make it impossible to              prior notices are being transmitted,
                                          required when errors are made and that                  comply with both CBP and prior notice                 requires the name and country and does
                                          an easier way should be created to                      requirements. The comment                             not provide the SCAC option.
                                          provide for corrections.                                recommends that CBP and FDA create a                     (Response) FDA disagrees. The SCAC
                                             (Response) In the case of a prior                    procedure in ABI/ACS that allows the                  or International Air Transportation
                                          notice submitted after the food has                     CBP entry to be generated, but not filed,             Association (IATA) codes can be
                                          arrived, the prior notice is inadequate                 at the time a prior notice is submitted.              transmitted via ABI/ACS via an
                                          because of no prior notice and the food                    Another comment states that filers are             Affirmation of Compliance. The CBP
                                          may be refused. The post-refusal prior                  insisting on submitting the entry                     requirement to provide the name and
                                          notice (i.e., the prior notice submitted                information to CBP via ABI at the same                country of the carrier is for purposes
                                          after arrival) may only be submitted via                time that they are submitting the prior               other than prior notice.
                                          PNSI until such time as ACS or its                      notice information to the FDA. This                      (Comments) Several comments
                                          successor system can accommodate                        apparently creates situations where the               recommend an interface between the
                                          such transactions. The changes to the                   food is loaded and ready for shipment                 CBP manufacturer identity (MID) codes
                                          system requested by the comments                        before there is a form of electronic                  and the FDA food facility registration
                                          cannot be accommodated since such                       release and this situation negates CBP’s              numbers. Specific recommendations
                                          revisions would require programming                     Customs-Trade Partnership Against                     include that: (1) CBP allow the MID
                                          changes to ACS, which CBP is currently                  Terrorism (C–TPAT) and the Free and                   system to be updated via prior notice
                                          only maintaining, and not enhancing                     Secure Trade (FAST) program                           submissions; (2) FDA develop an
                                          since its replacement system (ACE) is                   requirements. The proximity of certain                interface with CBP that allows for
                                          being developed.                                        border points means that although the                 validation and coordination of data
                                             (Comments) One comment suggests                      timeframe has been met with CBP for                   between these two systems; (3) ABI
                                          that because errors in the ABI system                   electronic release via CBP’s PAPS, it is              provide a notification to the filer if the
                                          need to be corrected in a timely manner                 difficult to meet the present timeframes              information from the MID does not
                                          to facilitate transmission of prior notice,             of the prior notice as the filer takes a              match the facility registration
                                          CBP should be required to be available                  longer time to submit both entries via                information on file with FDA; and (4)
                                          24 hours a day, 7 days a week to allow                  ABI.                                                  the agencies permit incorrect and
                                          for correction of these clerical errors.                   (Response) We disagree. Prior notice               duplicate MID information to be
                                             (Response) Inasmuch as the filer has                 and entry need not be made at the same                corrected though a secure CBP system.
                                          submitted a certified summary that the                  time. Prior notice is a precondition of               Another comment recommends the
                                          filer wishes to change, the cancellation                entry and must be made first but may                  establishment of a system that validates
                                          of the entry is more than just a simple                 be done independently of the entry by                 data and resolves any conflict between
                                          correction to an ABI transmission. This                 use of FDA’s PNSI or CBP’s ‘‘WP’’                     CBP and FDA data.
                                          change requires review because it affects               transaction in ABI. These systems allow                  (Response) With respect to correcting
                                          the integrity of cargo release.                         for an independent submission of prior                and updating MIDs, CBP does not
                                          Accordingly, any corrections to certified               notice even if no entry has been filed.               believe it is possible to eliminate all
                                          entry information must be done during                   The entry filer may then provide the                  differences between MIDs and related
                                          normal business hours.                                  prior notice confirmation number to                   FDA manufacturing facility registration
                                             (Comments) Several comments                          CBP as part of the entry. The entry will              numbers. The same manufacturer may
                                          suggest that PNSI, in its validation                    be validated in the CBP/FDA interface                 have numerous MIDs, and conversely, a
                                          processes, should include a check to see                and will be allowed if the prior notice               MID may identify more than one
                                          if other notices are already on file for                has been completed. The importer and                  manufacturer due to the nature of the
                                          the same article and that a warning                     filer may make a business decision to                 algorithm that is employed.
                                          message should be established to                        file the prior notice with the entry, and                With respect to the comment that asks
                                          indicate a duplicate prior notice is being              FDA and CBP’s systems can                             that FDA develop an interface with CBP
                                          filed.                                                  accommodate this practice.                            to allow for validation and coordination
                                             (Response) FDA disagrees. The prior                     Because the entry and prior notice                 of data, FDA and CBP currently
                                          notice submission process allows for                    submissions may be completed                          exchange facility data electronically as
                                          transmission through either ABI/ACS or                  independently, the timeframes are                     part of the prior notice and 801(a)
                                          PNSI. The prior notice confirmation                     dependent on how the parties at interest              processes. CBP sends FDA the MID and
                                          number is unique to a transmission                      choose to file entry and prior notice:                facility information (including
                                          through either system but cannot be                     The one-step (prior notice with entry) or             registration number, when applicable).
                                          matched against other transmissions at                  two-step (independent prior notice                    FDA performs edits to ensure that the
                                          this time. Programming PNSI to locate                   followed by entry) process. This allows               MID matches the firm represented by
                                          duplicate prior notices would require a                 them to meet both timeframes, which                   the registration number. In certain cases,
                                          considerable amount of resources,                       represent two agencies, two processes,                FDA will reject a prior notice
                                          which would yield minimal benefit                       and two different sets of requirements.               submission that does not match a MID
                                          since the submitter would know about                       (Comments) One comment contends                    submission. Filers will receive an ABI
                                          the duplicate submission after                          that the lack of uniformity between the               rejection communication identifying the
                                          transmitting the prior notice.                          PNSI and CBP requirements for                         mismatch when this occurs. Once the
                                             (Comments) Several comments                          transmission of carrier information                   facility and all other required
                                          request resolution of a PN/ABI system                   causes confusion to filers and FDA/CBP                information has been received and
                                          interface obstacle that requires that CBP               staff. The comment contends that                      validated, FDA will confirm the prior
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                                          entry and prior notice be made at the                   providing the Standard Carrier                        notice submission.
                                          same time. The comment contends that                    Abbreviated Code (SCAC) code for the                     (Comments) Several comments
                                          prior notice must be submitted before                   carrier in lieu of the carrier’s name and             suggest that when a prior notice is
                                          entry can be made (e.g., for quota class                country is only available when                        transmitted via ABI/ACS and confirmed
                                          merchandise subject to CBP ‘‘live entry’’               transmitting via PNSI because the CBP                 for review by FDA, the data should be


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                                                            Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations                                        66335

                                          moved from ACS to OASIS regardless of                   Automated Commercial Environment,                     systematic screening to assist FDA in
                                          the estimated time of arrival (ETA) date.               which will replace ACS.                               making admissibility decisions.
                                             (Response) The ABI/ACS system is                        (Comments) One comment                                (Comments) Several comments
                                          not configured to certify information nor               recommends that for a short trial period,             request extension of the time one is
                                          transfer information to FDA in real-time                the full prior notice edits, with warning             permitted to be logged into a session
                                          as PNSI does. ACS is programmed to                      messages, should be turned on without                 using PNSI. Comments state that it is
                                          collect data in batch mode and does not                 rejection of CBP entry processing. The                difficult to complete entering data
                                          transmit the data to FDA                                comment reasons that this would be a                  before the system times out. Several
                                          instantaneously. Therefore, prior notices               method of alerting ABI/ACS                            comments suggest that completing the
                                          submitted via PNSI will continue to                     transmitters to errors without                        process in time was difficult for many
                                          receive a real-time system response                     jeopardizing the movement of the food.                persons whose native language is not
                                          when the prior notice is confirmed for                  Another comment suggests that a                       English.
                                          review by FDA. However, prior notices                   significant reason for a high rate of                    (Response) For security reasons, PNSI
                                          submitted via ABI/ACS will continue to                  noncompliance on data submissions is                  is currently configured with a 30-minute
                                          be transmitted in a batch mode and to                   the lack of the automated systems’                    time-out. FDA notes that Internet
                                          receive systematic confirmation                         capability to advise filers of data                   commerce systems are typically
                                          responses in the pre-arranged                           inadequacies.                                         configured with a similar, or more
                                          timeframes developed by CBP. For those                     (Response) The systems provide for                 stringent, time-out setting. FDA also
                                          prior notices submitted via ABI on the                  error messages to be transmitted to filers            notes that the time-out setting applies
                                          anticipated date of arrival, users can                  that identify the reasons for errors in               only to a period of user inactivity; no
                                          expect to receive a response message                    prior notice submissions that can be                  limit is set on the total amount of time
                                          (confirmation number or rejection)                      determined during the data entry                      the user may be logged into a particular
                                          within 15 minutes of submission. For                    process (e.g., certain required data                  session, nor is there a limit to the
                                          ABI submissions submitted prior to the                  elements are missing or product code                  amount of time taken to prepare and
                                          anticipated date of arrival, users can                  submitted is invalid). Over time, the                 save or submit a specific Web entry or
                                          expect to receive a response message no                 agencies have seen the prior notice                   prior notice. Users are ‘‘timed-out’’ only
                                          later than midnight (Eastern Time) on                   rejection rate go down. Both agencies                 if their session remains inactive for
                                          the anticipated date of arrival, i.e., the              have been providing industry with                     longer than the time-out setting.
                                          message generally is sent before 11:59                  information regarding error messages.                    Users may also save their entry while
                                          p.m. on the day before the anticipated                     (Comments) One comment points out                  it is partially completed. The data are
                                          date of arrival.                                        that the PNSI Web portal has changed                  retained and will be available when the
                                             (Comments) Several comments state                    to allow multiple containers to be                    user logs back into the system.
                                          that although PNSI is designed to not                   reported against a single prior notice                   (Comments) Several comments
                                          require changes in the location of the                  line but that CBP has not changed their               express concern about the capacity of
                                          anticipated port of arrival (thus allowing              specifications to allow more than a                   the FDA computer systems to process
                                          a shipment to be diverted to a port other               single container to be reported on a                  the volume of submissions. These
                                          than the intended port of arrival                       prior notice line in ABI. The comment                 comments suggest that the system needs
                                          transmitted in the prior notice), the CBP               recommends that this change to the                    additional capacity to meet the loads
                                          ABI system precludes the CBP entry                      FDA Web portal be communicated to                     expected when full enforcement is
                                          from being accepted at other than the                   CBP so they may change their ABI                      instituted. Several comments also
                                          reported port of entry. When this                       specifications.                                       believe that performance issues (e.g.,
                                          occurs, the CBP entry and original prior                   (Response) ABI currently allows filers             slow response) are hampering their
                                          notice must be deleted and a new entry                  to submit multiple container numbers                  usage of the system.
                                          must be submitted with a new prior                      per FDA line by sending multiple FD05                    (Response) FDA recognizes these
                                          notice creating a new timeframe. The                    records containing affirmation of                     concerns and is committed to providing
                                          comments recommend that the                             compliance code ‘‘CNO.’’ The first                    systems that will meet user needs. FDA
                                          requirement be consistently applied and                 affirmation goes in the FD01 record,                  designed the prior notice systems to
                                          that the ABI/ACS system be revised to                   with subsequent affirmations in the                   process a volume of users far in excess
                                          allow for changes to the port of entry                  FD05 record which can be repeated as                  of the projected usage. Prior to
                                          without causing cancellation of the CBP                 often as necessary. Filers are able to                implementation, FDA thoroughly tested
                                          entry.                                                  submit multiple records using the                     the performance of its system against
                                             (Response) FDA disagrees. The prior                  affirmation of compliance code ‘‘CNO’’                loads in excess of that anticipated.
                                          notice rule does not require a new prior                and provide a different container                     These tests have shown the system
                                          notice when the anticipated port of                     number in each record.                                capable of maintaining acceptable
                                          arrival changes after the prior notice has                                                                    response even at these loads. Currently,
                                          been confirmed for review by FDA. CBP                   5. PNSI                                               FDA handles approximately 167,000
                                          does require cancellation of entry                         (Comments) One comment suggests                    prior notices each week and could
                                          documentation for entry purposes when                   that to more effectively screen                       handle a much higher volume without
                                          the port of entry changes. The                          shipments entering the United States,                 a capacity problem.
                                          cancellation of an electronic ABI entry                 FDA must work to integrate OASIS with                    Many factors influence the
                                          for CBP results in the cancellation of                  the prior notice system.                              responsiveness of an Internet based
                                          any associated prior notices filed with                    (Response) FDA’s OASIS has always                  system, including factors beyond the
                                          the entry in ABI. Amending ABI/ACS to                   been an integral part of the prior notice             FDA’s control, such as the user’s
                                          allow amendments, such as when the                      process as OASIS provides for internal                computer system (hardware, software,
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                                          port of entry changes, would entail                     systematic screening of prior notice                  and Internet connection) and traffic on
                                          substantial and costly revisions to the                 submissions in order to assist the                    the Internet as a whole. Since prior
                                          system; such technical changes are not                  agency in making a determination                      notice was implemented in December
                                          cost-effective or a good use of limited                 regarding inspection of the food at the               2003, FDA has carefully monitored both
                                          resources given the development of the                  border. OASIS also provides for                       PNSI and OASIS system usage and


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                                          performance. During this period, no                     additional system would be significant.               required for an article of food that
                                          issues related to load on these systems                 Therefore, FDA is not prepared to                     requires prior notice. The comment
                                          have been identified. FDA has worked                    undertake the development of a batch                  questions why the FDA Web Portal does
                                          to resolve specific issues, such as                     system at this time; following                        not accept an entry number when a CBP
                                          hardware failures, which have                           completion of any system upgrades that                entry is required and known at the time
                                          hampered system performance and                         will be released in conjunction with                  of filing prior notice. Another comment
                                          availability for short periods.                         implementation of the final rule, FDA                 recommends that the Web Portal
                                             FDA and CBP also have increased the                  will reassess the need for and feasibility            software be redesigned in order for filers
                                          capacity of the communications link                     of developing a batch submission                      to receive the relevant entry identifier
                                          between their systems to ensure that                    system. FDA notes that some submitters                information with the prior notice
                                          additional bandwidth is available for                   have created their own internal                       confirmation number.
                                          future increases in load. FDA continues                 programs that are designed to organize                  (Response) FDA disagrees. PNSI does
                                          to monitor its system and to test for                   data in ‘‘batch’’ mode, which in turn                 accept the CBP entry number. If there is
                                          performance as the system is upgraded                   submits their prior notices to PNSI in                no entry number or other entry
                                          and enhanced. Users may obtain current                  rapid succession.                                     identifier, PNSI will provide a system-
                                          system status information for PNSI at                      (Comments) One comment states that                 generated entry identifier to the prior
                                          the FDA Industry Systems home page                      they frequently ship the same article of              notice submission. We also posted
                                          (http://www.access.fda.gov) and are                     food in multiple containers. The                      guidance on FDA’s Web site at http://
                                          requested to contact the Help Desk if                   comment believes that since there is                  www.cfsan.fda.gov/~pn/pnentgui.html
                                          they encounter any performance issues                   only one article of food, only one prior              that describes the entry types and the
                                          currently not identified on the system                  notice should be required. The comment                entry identifiers. (See also discussion
                                          status page.                                            notes that the FDA Web Portal only                    infra on the CBP entry identifier in
                                             (Comments) Several comments                          allows the input of one container per                 section III.H.5 of this document.)
                                          recommend that FDA develop an                           prior notice; therefore, they have to                   (Comments) Several comments
                                          alternate system that supports batch                    submit multiple prior notices instead of              express concern about system outages
                                          submission of prior notices. The                        only one. The comment requests that                   for PNSI and/or ABI. These comments
                                          comments suggest that a batch system                    the FDA Web Portal be changed to allow                suggest that one or both systems had not
                                          would save submitters a vast amount of                  for the input of multiple containers per              been available for extended periods in
                                          input time and allow the agency faster                  article of food.                                      the past or were frequently unavailable.
                                          processing capability. The comments                        (Response) FDA agrees. The FDA Web                 Comments also recommend that FDA
                                          also assert that a batch system would                   Portal has been changed to allow                      provide an alternate method, such as
                                          reduce the costs incurred due to double                 multiple containers to be reported                    facsimile, for submission during periods
                                          entry between the user’s existing                       against a single prior notice line in the             when the systems are not available. One
                                          systems, e.g., for order entry and filing               above situation.                                      comment notes that PNSI has not been
                                          with FDA. One comment proposes that                        (Comments) One comment states that                 functioning properly. The comment
                                          they be given a defined quantity of                     most of their orders contain multiple                 states that the System Status update
                                          registration numbers at their disposal                  food items in one box and the process                 pages indicates that the system is
                                          for printing onto their dispatch labels                 of filing prior notice in PNSI for each               operating as ‘‘normal,’’ but the system is
                                          (presumably by registration number                      item is very time consuming because                   really down.
                                          they are referring to the prior notice                  one can only enter one item at a time.                  (Response) FDA recognizes that
                                          confirmation number). The comment                       The comment suggests updating PNSI to                 system outages could have the potential
                                          says they would like a fully automated                  allow users to enter multiple items on                to disrupt trade. To minimize outages,
                                          process, where all data relevant for prior              one screen (i.e., the user creates a Web              FDA has built redundancy into these
                                          notice would be created and then                        entry for each shipment and the system                computer systems (e.g., multiple servers
                                          transmitted electronically to CBP and                   then allows them to specify all items in              and backup systems) and, to the extent
                                          FDA, instead of the current procedure of                that shipment on one screen).                         possible, combined planned
                                          manual input of all details.                               (Response) A prior notice contains                 maintenance activities to be
                                             (Response) FDA agrees that a                         information on not just the article of                accomplished during a single outage.
                                          mechanism to facilitate batch/fully                     food being imported, but also the                     Planned outages are scheduled for a
                                          automated filing would provide some                     facilities related to that article such as            timeframe with the minimum possible
                                          advantage to certain filers. However,                   the manufacturer, shipper, owner and                  impact to users and notice is provided
                                          FDA believes that the existing systems                  ultimate consignee. Since this                        as far in advance as possible, allowing
                                          (PNSI and ABI) currently provide                        information can be unique for each                    users to plan their access to the system.
                                          substantial capabilities in this area.                  article, it must be provided for each                 System status information, including
                                          PNSI offers several features that make                  article individually. PNSI does offer                 planned outages, is posted at http://
                                          prior notice data entry faster and                      several features that make prior notice               www.access.fda.gov and at http://
                                          reduces the amount of redundant data                    data entry faster and reduce the amount               www.cfsan.fda.gov/~furls/fisstat.html.
                                          entry such as the Copy Web Entry                        of redundant data entry such as the                   Users are requested to contact the Help
                                          feature, Copy Prior Notice feature and                  Copy Web Entry feature, Copy Prior                    Desk if any performance issues not
                                          other shortcuts. Please refer to Time                   Notice feature and other shortcuts.                   identified on the system status page are
                                          Saving Tips from FDA’s PNC for PNSI                     Please refer to Time Saving Tips from                 encountered.
                                          (http://www.cfsan.fda.gov/~pn/                          FDA’s PNC for PNSI (http://                             FDA also provides alternate options
                                          pntips.html) for a description of these                 www.cfsan.fda.gov/~pn/pntips.html)                    for users to file prior notice during
                                          features. ABI software can often provide                for a description of these features.                  system outages. Filers who use CBP’s
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                                          similar copying features, depending on                     (Comments) One comment states that                 ABI/ACS system can utilize PNSI when
                                          the ABI software package used by the                    FDA’s Web Portal does not accept the                  ABI, ACS, and/or OASIS are
                                          transmitter.                                            input of CBP entry numbers. The                       unavailable. In addition, FDA has
                                             FDA also recognizes that the                         comment further states that there are                 provided a method for filing via
                                          resources to develop and maintain an                    times when an entry number is not                     facsimile or e-mail when PNSI is


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                                          unavailable for an extended period (see                 as well as to changing business                       the Help Desk using the telephone
                                          the Contingency Plan for System                         requirements.                                         number or e-mail provided at http://
                                          Outages at http://www.cfsan.fda.gov/                       (Comments) One comment asks if                     www.cfsan.fda.gov/~furls/helpf.html.
                                          ~pn/pndguid.html). These contingency                    PNSI will provide guidance on
                                                                                                  formatting of the information for                     6. Security of the Systems
                                          plans are designed to ensure that the
                                          flow of trade is not interrupted when                   identification of the submitter,                         (Comments) One comment suggests
                                          system outages cannot be avoided (see                   transmitter, and manufacturer. The                    that FDA create a mechanism whereby
                                          also the discussion on contingency                      comment is concerned that PNSI may                    interested parties may assert protection
                                          plans below).                                           only accept certain formatting, without               from public disclosure under FOIA for
                                             (Comments) One comment notes that                    providing guidance to the submitter,                  information contained in prior notices
                                          companies continue to report technical                  thereby, causing problems with PNSI                   that they believe is confidential
                                          difficulties when using PNSI, including                 accepting and processing prior notice.                business information.
                                          the inability to access reliable technical                 (Response) PNSI is supported by                       (Response) We believe that there is no
                                          advice through the hot-line. Another                    several tutorials and help screens which              need to create such a mechanism
                                          comment indicates that the waiting time                 lead the user through correct inputting               because the agencies would review the
                                          for the helpline is very long, with a                   of data.                                              prior notice information to determine if
                                          minimum wait time of 15 minutes.                           (Comments) Several comments                        it is protected by a FOIA exemption
                                                                                                  address specific issues with the PNSI                 before disclosure to the public.
                                             (Response) FDA has made a number
                                                                                                  software (potential ‘‘bugs’’) or                         (Comments) One comment states that
                                          of enhancements and has fixed several
                                                                                                  suggestions for enhanced capabilities.                in order to complete the PNSI
                                          issues with earlier releases of PNSI.
                                                                                                  Examples include questions about the                  submission, several security settings on
                                          FDA also continues to work to provide
                                                                                                  completeness of the lists of values                   their respective computers had to be
                                          the best possible service addressing
                                                                                                  (drop-down lists), issues with browser                disabled.
                                          technical issues through the Help Desk.
                                                                                                  settings and compatibility, and                          (Response) PNSI is designed to work
                                          Users are encouraged to continue to                     suggestions for additional bar code                   with the browsers listed at http://
                                          contact the Help Desk for technical                     printouts.                                            www.access.fda.gov/, using standard
                                          assistance. The Help Desk is available                     (Response) FDA welcomes user                       settings. PNSI requires that the browser
                                          Monday through Friday from 7:30 a.m.                    suggestions for improvements to the                   be set to accept cookies. FDA does not
                                          to 11 p.m. Eastern Time. Users may                      PNSI system. Discrepancy reports are                  believe that these settings present a
                                          leave a message or send e-mail at other                 investigated thoroughly to ensure the                 security risk to users. Users are
                                          times, which will be addressed on the                   system meets both FDA’s requirements                  encouraged to contact the Help Desk for
                                          next business day.                                      and user needs to the extent possible.                assistance with specific issues regarding
                                             (Comments) Several comments                          Suggested improvements are also                       access and system settings.
                                          address the complexity of PNSI. The                     prioritized and reviewed by a Change
                                          comments state that the system requires                 Control Board who continue to                         7. Contingency Plans
                                          the complete re-creation of all data for                determine appropriate and feasible                       In § 1.280(b), (c), (d), and (e) of the
                                          each prior notice even when shipments                   improvements to the system. FDA                       IFR, FDA requires that if a custom
                                          are repetitive with minimal variables in                encourages users to continue to contact               broker’s or self-filer’s system is not
                                          information; that the full address should               the Help Desk with any technical                      working or if the ABI/ACS interface is
                                          not be necessary for registered facilities;             questions, issues, or suggestions.                    not working, prior notice must be
                                          and that PNSI should allow submitters                      (Comments) One comment suggests                    submitted through PNSI. It further states
                                          to save and store data for replication or               that PNSI should be revised to create a               that if the PNSI is not working and/or
                                          provide for self-populating fields. One                 view screen similar to the printed                    OASIS is not working, FDA will issue
                                          comment, however, notes that their                      confirmation with all the information in              an Internet notification, and submission
                                          users have had relatively little problem                one place before submission. The                      of prior notice must be by e-mail or by
                                          using PNSI.                                             comment also suggests that when                       facsimile to FDA. FDA posts the e-mail
                                             (Response) FDA continues to provide,                 creating a prior notice for different                 or facsimile information on its Web site.
                                          to the extent possible, a ‘‘user-friendly’’             commodities, the system should not                    The prior notice information will only
                                          PNSI application. Several features have                 have all commodities default onto prior               be accepted at the posted e-mail or
                                          been added since the initial release                    notice, but should allow the user to use              facsimile locations if FDA determines
                                          (PNSI 1.0) to assist users, including a                 a check box to choose a commodity,                    that PNSI or OASIS is not working.
                                          feature that allows users to copy                       rather than to cancel the commodity.                     On August 12, 2004, FDA and CBP
                                          individual prior notices and Web                           (Response) FDA agrees. The PNSI                    published guidance covering a
                                          Entries, with or without the associated                 software has been enhanced to provide                 Contingency Plan for System Outages
                                          prior notices. Where possible, lists of                 a screen that includes all of the                     (see http://www.cfsan.fda.gov/~pn/
                                          standard values (e.g., entry types, SCAC                information about the prior notice prior              pndguid.html/). FDA and CBP identified
                                          & IATA Codes, firm types, quantity and                  to a transmitter completing the                       seven potential system downtime
                                          packaging descriptions) are provided to                 submission step. PNSI also has been                   scenarios that could impact
                                          facilitate entry of these values. These                 enhanced to allow copying of prior                    transmission, confirmation, and
                                          enhancements minimize the need for                      notices within a Web Entry and copying                processing of prior notice submissions
                                          users to enter repetitive information.                  of a Web Entry, with or without the                   and developed alternative submission
                                          Similar to the IFR, the prior notice final              associated prior notices. A user thus can             options for each of the identified
                                          rule does not require the full address in               copy a Web Entry with all associated                  scenarios.
                                          all cases. When a registration number is                prior notices, then use the cancel                       (Comments) One comment states that
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                                          provided, name, city and country can                    function to remove any prior notices not              FDA and CBP need to formulate and
                                          usually be provided instead of the name                 required for the new entry.                           communicate a realistic contingency
                                          and full address (e.g., § 1.281(a)(6)).                    FDA welcomes any additional                        plan for commercial importations that
                                          FDA continues to work to enhance the                    comments or suggestions on how to                     takes into account CBP ABI downtime,
                                          system, in response to user comments,                   improve PNSI; these can be submitted to               FDA OASIS downtime, and broker


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                                          downtime. Two comments express                          various contingencies, the final rule has             that the usual flow of goods should be
                                          concern that contingency plans include                  also been revised by stating that FDA                 allowed to continue unhindered, with
                                          a dependency on PNSI and their                          will accept prior notice submissions in               the paperwork sorted out afterwards.
                                          experience has shown that PNSI was                      the format it deems appropriate during                One comment further suggests that
                                          intended for the casual importer and                    the system(s) outage.                                 rather than providing for PNSI as a
                                          never intended for commercial                              FDA has posted information on the                  contingency system when ABI is down,
                                          operations. The comment states that                     Systems Status Web site located at                    prior notice submissions should
                                          significant delays will be experienced if               http://www.cfsan.fda.gov/~furls/                      function according to all other
                                          80 percent of the transactions are                      fisstat.html regarding system downtime                submissions processed through ABI
                                          suddenly routed from the ABI/ACS                        that states ‘‘Most problems will be                   when CBP declares either a ‘‘national
                                          system to the PNSI system.                              temporary. Try accessing the system                   snow day’’ or ‘‘power outage.’’ The
                                             (Response) FDA is committed to                       again in 15 minutes.’’ This site also                 comment recommends that if ABI is not
                                          providing systems that will meet user                   provides information about scheduled                  working, the shipment should be
                                          needs. FDA designed PNSI to process a                   maintenance, which states that                        allowed to proceed, pending later
                                          volume of users far in excess of the                    ‘‘Periodically FDA Industry Systems                   issuance of a prior notice confirmation
                                          projected usage, and tested performance                 will need to undergo maintenance and                  via ABI.
                                          at these volumes. As noted previously,                  upgrades. All scheduled maintenance                      (Response) FDA does not agree that if
                                          FDA and CBP published guidance                          will take place on Saturdays 3 a.m. to                ABI is not working the shipment should
                                          covering a Contingency Plan for System                  8 a.m. Eastern Time (Saturday 8 a.m. to               be allowed to proceed. In that instance,
                                          Outages (see http://www.cfsan.fda.gov/                  1 p.m. GMT). If you are having trouble                prior notice can, and therefore should,
                                          ~pn/pndguid.html/) and anyone may                       accessing FDA Industry Systems during                 be submitted via PNSI.
                                          submit comment on it.                                   that time, please try again after 8 a.m.                 In all contingency situations, except
                                             (Comments) One comment suggests                      Eastern Time on Saturday (1 p.m.                      for power failure, some electronic
                                          that FDA and CBP provide guidance                       GMT).’’ This site also provides a status              means of prior notice submission is
                                          that defines an appropriate timeframe to                history of the system.                                required, either by PNSI, e-mail, or fax.
                                          wait for prior notice confirmation before                  (Comments) One comment suggests                    However, in the case of a localized or
                                          assuming the system is down and/or                      that FDA should develop and publish a                 regional power failure, the Contingency
                                          that resubmission is required.                          form that could be used if it were ever               Plan guidance recommends that filers
                                             (Response) Generally, for prior notice               necessary to file prior notice by fax. The            should submit the required prior notice
                                          submissions via PNSI, the user should                   comment asserts that a form also would                information to FDA at the port of
                                          receive a confirmation number                           assist importers in gathering the                     arrival, or if there is no FDA officer at
                                          immediately upon submission of the                      information necessary to file a prior                 a given port, to CBP via a paper copy
                                          correctly completed form. For those                     notice and also would clear up the                    of the prior notice e-mail contingency
                                          prior notices submitted via ABI on the                  confusion that currently exists in                    form (FDA 3540) at the time of cargo
                                          anticipated date of arrival, users can                  foreign countries. The comment believes               release.
                                          expect to receive a response message                    that it was obvious that FDA                             (Comments) One comment explains
                                          (confirmation number or rejection)                      contemplated issuing a form when it                   that various companies are organizing
                                          within 15 minutes of submission. For                    first proposed the prior notice                       contingency plans whereby the prior
                                          ABI submissions submitted prior to the                  regulations and complains that no                     notice confirmation number will be
                                          anticipated date of arrival, users can                  explanation has been given by FDA for                 included in the delivery order, which
                                          expect to receive a response message no                 not producing the form.                               then will be faxed to the office of the
                                          later than midnight (Eastern Time) on                      (Response) FDA disagrees. A form to                steamship line at the port of entry so
                                          the anticipated date of arrival, i.e., the              be used during contingencies is posted                that the requisite paperwork is in hand
                                          message generally is sent before 11:59                  on FDA’s Web site only when an                        when the product is offloaded from the
                                          p.m. on the day before the anticipated                  applicable system outage is                           carrier. The comment further explains
                                          date of arrival.                                        encountered. During a system outage                   that this contingency plan takes into
                                             The FDA/CBP Contingency Plan                         when fax submissions are being                        account the unique circumstances posed
                                          states that ‘‘notice advising of any                    accepted, FDA will publish the fax                    by transporting goods by steamship line
                                          available downtime specifics will be                    telephone number for the PNC at http://               insofar as the customs broker or
                                          posted at http://www.access.fda.gov,                    www.access.fda.gov, http://                           purchaser may not always be able to
                                          http://www.fda.gov, http://                             www.fda.gov, http://www.cfsan.fda.gov/                send the prior notice confirmation
                                          www.cfsan.fda.gov/~furls/fisstat.html,                  ~furls/fisstat.html, and http://                      number to the carrier prior to the
                                          and http://www.cfsan.fda.gov/~pn/                       www.cfsan.fda.gov/~pn/pnoview.html,                   carrier’s arrival. The comment asserts
                                          pnoview.html, and through messages in                   as well as through messages in ABI/                   that the procedure satisfies FDA’s
                                          ABI/ACS (see 21 CFR 1.280(d)).’’                        ACS. Fax transmission is not allowed                  requirements that the prior notice
                                          Section 1.280(c), (d), and (e) of the IFR               except when posted and submitted                      confirmation number must accompany
                                          also lists three of these four Web sites                during PNSI downtimes or specified                    the food when it ‘‘arrives in the United
                                          to advise of system downtimes, and                      emergencies. FDA believes that if the                 States’’ and be provided to CBP or FDA
                                          specifies in what form prior notice                     form was available and posted even as                 ‘‘upon arrival.’’ The comment further
                                          should be submitted during certain                      a reference, there is the potential for               urges FDA to include this course of
                                          system outages (i.e., e-mail or fax). In                misuse or confusion. Our experience                   action in its guidance documents.
                                          order to simplify the Web addresses for                 with use of the fax form is that                         (Response) FDA agrees that the
                                          these notifications and the instructions                submitters will continue to fax the form              described scenario satisfies the
                                          for submitting prior notice when PNSI                   even after they have been instructed that             requirement under § 1.279(g) that the
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                                          or OASIS is not working, the final rule                 the form will not be accepted.                        prior notice confirmation number must
                                          has been revised by providing the                          (Comments) Some comments express                   accompany any article of food for which
                                          outage notification at one Web address                  concern that submission of all prior                  the prior notice was submitted through
                                          (http://www.fda.gov). In order to                       notices relies on electronic systems                  PNSI when the article arrives in the
                                          provide more flexibility to respond to                  (even the fax). The comments suggest                  United States and must be provided to


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                                          CBP or FDA upon arrival. FDA does not                      (Final rule) The final rule in § 1.280(a)          1.281(a) covers general information
                                          believe, however, that it is necessary to               requires that prior notice must be                    requirements which apply to all
                                          include this specific business practice                 submitted electronically to FDA in the                shipments except those arriving by
                                          in its guidance documents, as there are                 English language, except that an                      international mail; section 1.281(b)
                                          various means that private entities may                 individual’s name, the name of a                      covers limited information requirements
                                          choose to use to comply with the                        company, and the name of a street may                 for food arriving by international mail;
                                          regulation.                                             be submitted in a foreign language. All               and section § 1.281(c) covers
                                             As described in the contingency plan                 information, including these items,                   information requirements for food
                                          guidance, if prior notice already has                   must be submitted using the Latin                     refused under section 801(m) of the act
                                          been submitted via ABI/ACS prior to an                  (Roman) alphabet.                                     (e.g., food that has already arrived in the
                                          interface outage, and confirmation from                    Section 1.280(a)(1) and (a)(2) of the              United States).
                                          FDA already has been received, then the                 final rule provides for two methods of                   The preamble to the IFR discusses the
                                          submitter may proceed with prior notice                 electronic submission of prior notice: (1)            term, ‘‘an article of food,’’ and states
                                          using the standard process under the                    The CBP Automated Broker Interface of                 that ‘‘the description of an ‘article’ of
                                          following scenarios:                                    the Automated Commercial System                       food is not the same as the definition of
                                             • ACS, OASIS, and PNSI are all                       (ABI/ACS); or (2) The FDA PN System                   ‘food’ in § 1.276(b)(5). An ‘article’ refers
                                          operational, but the link between ACS                   Interface (PNSI) at http://                           to a single food that is associated with
                                          and OASIS is down on FDA’s or CBP’s                     www.access.fda.gov. We corrected a                    the same complete FDA Product Code,
                                          side of the system interface;                           reference in paragraph (a) to state that              the same package size, and the same
                                             • ACS, PNSI, and the link between                    unless § 1.280(c) applies, prior notice               manufacturer or grower. These
                                          ACS and OASIS are operational, but                      must be submitted through either ABI/                 requirements are found in the
                                          OASIS is non-operational;                               ACS or PNSI.                                          information required in the IFR in
                                             • ACS and the link between ACS and                      The final rule requires submission of              § 1.281(a)(5), (a)(6), or (a)(7) and again in
                                          OASIS are operational, but OASIS is                     prior notice via PNSI for articles of food            § 1.281(b) and (c)’’ (68 FR 58974 at
                                          non-operational and PNSI is non-                        imported or offered for import by                     59003).
                                          operational or unavailable due to                       international mail, and other transaction                The comments are discussed in order
                                          Internet service interruptions;                         types that cannot be made through ABI/                of the information requirement in the
                                             • OASIS, PNSI and the link between                   ACS. Prior notice for articles of food                IFR, beginning with comments generally
                                          ACS and OASIS are operational but                       that have been refused under section                  addressing the information
                                          ACS is non-operational; or                              801(m)(1) of the act must be submitted                requirements.
                                             • ACS is non-operational, PNSI is                    through PNSI until such time as ACS or
                                          non-operational or unavailable due to                                                                         1. General Comments
                                                                                                  its successor system can accommodate
                                          Internet service interruptions, and                     such transactions.                                       (Comments) Several comments
                                          OASIS and the link between ACS and                         The final rule also provides for                   express concern that the IFR requires
                                          OASIS are either operational or non-                    contingencies if involved systems were                significantly more information than the
                                          operational.                                            not working, e.g., a custom broker’s or               Bioterrorism Act requires and ask that
                                             The standard process does not                        self-filer’s system, ABI/ACS, PNSI, or                FDA reduce the number of data
                                          include presentation of the prior notice                OASIS. The final rule requires that prior             elements. One comment notes that the
                                          confirmation number to FDA or CBP                       notice must be submitted through PNSI                 Bioterrorism Act names only six or
                                          upon arrival if the prior notice was                    if a customhouse broker’s or self-filer’s             seven specific items that must be
                                          submitted by ABI/ACS.                                   system or if the ABI/ACS interface is not             provided. One comment indicates that
                                             If prior notice already has been                     working. The final rule states that if                the information required for prior notice
                                          submitted via ABI/ACS and                               PNSI or OASIS is not working, FDA will                is far in excess of that required in the
                                          confirmation from FDA has not been                      post prominent notification and                       Codex Committee on Food Import and
                                          received prior to the interface outage,                 instructions at http://www.fda.gov. FDA               Export Inspection and Certification
                                          FDA and CBP recommend that rather                       will accept prior notice submissions in               Systems Guidelines for Generic Official
                                          than resubmitting via PNSI, submitters                  the format it deems appropriate during                Certificate Formats and the Production
                                          should provide to CBP officers, at the                  the system(s) outage. The final rule does             and Issuance of Certificates (CAC/GL
                                          time of cargo release, an endorsed                      not exempt any specific categories of                 38–2001). One comment adds that the
                                          (signed) copy of the ABI transmission or                food articles from prior notice if systems            required information far exceeds what is
                                          some other evidence adequate to show                    are not performing.                                   necessary to enable FDA to identify
                                          that prior notice has been submitted via                                                                      articles of food that need to be
                                          ABI/ACS.                                                H. What Information Must Be in a Prior                inspected. Another comment suggests
                                             If prior notice has been submitted via               Notice? (§ 1.281)                                     that some of the information required
                                          PNSI prior to the system outage and a                      The Bioterrorism Act requires the                  for a prior notice is already ‘‘covered’’
                                          confirmation number already has been                    submission to the Secretary of a notice               by the registration requirement of
                                          received, the confirmation number must                  providing the identity of each of the                 section 305 of the Bioterrorism Act (see
                                          accompany the article of food                           following: The article; the manufacturer              the Registration of Food Facilities Under
                                          (§ 1.279(g)). In addition, FDA and CBP                  and shipper of the article; if known                  the Public Health Security and
                                          recommend that the submitter also                       within the specified period of time that              Bioterrorism Preparedness and
                                          provide the PNSI confirmation page,                     notice is required to be provided, the                Response Act of 2002 interim final rule,
                                          including the prior notice confirmation                 grower of the article; the country from               21 CFR part 1, subpart H, confirmed 70
                                          number and time stamp, to CBP officers                  which the article originates; the country             FR 57505, October 3, 2005), so FDA will
                                          for cargo release. If the prior notice                  from which the article is shipped; and                already have this information. Another
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                                          confirmation page is not provided, this                 the anticipated port of entry for the                 comment suggests that the prior notice
                                          may delay cargo release while the CBP                   article.                                              could be simplified, thus reducing the
                                          officer contacts FDA for verification of                   The IFR requires in § 1.281(a), (b), and           possibility of errors and potential trade
                                          the prior notice confirmation number(s)                 (c) that specific information be                      disruptions, by quoting the registration
                                          and time of submission.                                 submitted in prior notice: Section                    number and only adding information


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                                          66340             Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations

                                          specific to a particular shipment. One                  of the Bioterrorism Act that FDA receive              multiple entities that may be involved
                                          comment notes that CBP’s data fulfill                   information about a shipment before it                in a traditional commercial importation.
                                          FDA’s needs; therefore, the IFR’s                       arrives in the United States.                         The final rule does not require an entry
                                          duplicate system is a waste of resources,                  FDA also does not agree that some of               identifier because international mail
                                          and FDA should use CBP’s system.                        the prior notice information is already               will always receive a system-generated
                                             (Response) FDA disagrees with the                    ‘‘covered’’ by the food facility                      identifier, as international mail
                                          comments that ask for a reduction in the                registration requirement. For example,                shipments cannot be submitted via ABI/
                                          number of required data elements. FDA                   facilities typically provide general                  ACS. Because the port of entry and time
                                          has selected those data elements that                   product categories as part of the                     and date of entry are completely subject
                                          will allow FDA to meet its statutory                    registration process. This generalized                to the international mail process, the
                                          obligation to receive, review, and                      information would not provide the                     IFR requires only that the submitter
                                          respond to prior notices efficiently and                identity of the article being imported or             identify the date of shipment, i.e., the
                                          effectively. In addition to the                         offered for import and, therefore, would              date the food is shipped, which
                                          Bioterrorism Act’s requirements of the                  not meet the prior notice requirements                provides the most information possible
                                          identities of the article of food, the                  as defined in section 801(m) of the act.              to satisfy the anticipated port of entry.
                                          manufacturer and shipper, the grower, if                Therefore, we do not agree that some of               Moreover, since international mail is
                                          known, the country from which the                       the registration information could be                 always in the custody of CBP until it is
                                          article originates, the country from                    used to meet the prior notice                         released for delivery to the recipient, no
                                          which the article is shipped, and the                   information needs. Moreover, a facility’s             additional shipment information is
                                          anticipated port of entry for the article,              registration contains all of the general              necessary for communication between
                                          FDA determined that certain additional                  food product categories the facility                  FDA and CBP.
                                          information is required for efficient                   manufactures, processes, packs or holds;                 FDA also disagrees that information,
                                          enforcement of the Bioterrorism Act,                    and would not allow FDA to know                       such as the entry type and identifier, the
                                          primarily for the means of identifying                  specifically which article of food is the             port of entry, and the FDA Product Code
                                          the article of food and effective                       subject of the prior notice, which                    should be eliminated from the prior
                                          enforcement of refusals. For example,                   precludes an effective assessment of                  notice requirements. The anticipated
                                          the identification of the individual and                risk.                                                 port of entry is specifically required by
                                          the firm, if applicable, submitting the                    (Comments) Several comments                        the statute and FDA has determined that
                                          prior notice is needed so that FDA                      recommend that the limited information                the best possible method of determining
                                          knows who is responsible for the                        requirements associated with food                     product identity is the FDA Product
                                          information in the prior notice and can                 arriving by international mail in                     Code. We have eliminated the HTS code
                                          communicate with them when                              § 1.281(b) be applied to all importations.            in the final rule because it has not been
                                          necessary via mail, phone, or e-mail.                   One comment suggests that by                          a necessary factor for enhancing
                                          The information also is necessary to                    eliminating such data as the entry type               communication between FDA and CBP
                                          follow up when audits, inspections, or                  and identifier, the port of entry, the FDA            for the purpose of inspection at the port
                                          enforcement are necessary. Therefore,                   Product code, and the HTS code, all                   of arrival. However, the entry type and
                                          FDA does not agree with one of the                      prior notices could be submitted via                  identifier are critical elements in
                                          comment’s assertions that the prior                     FDA’s PNSI at an earlier time. The                    communications between FDA and CBP
                                          notice rule should only require the                     comment further asserts that the                      so that the appropriate food is either
                                          registration number and other                           requirement for these types of data is                held at the port of arrival as appropriate,
                                          information specific to a particular                    the primary reason that 80 to 90 percent              or allowed to proceed.
                                          shipment.                                               of prior notices are submitted via ABI/                  FDA also disagrees with the
                                             The goals of the Bioterrorism Act and                ACS rather than PNSI. Another                         suggestion that the manufacturer and
                                          the Codex Committee differ, and thus,                   comment reasons that as the                           facility registration numbers are not
                                          the requirements of the prior notice rule               manufacturer and facility identification              provided for homemade food or postal
                                          will differ from that of the Codex                      numbers are not provided for                          shipments and, therefore, should not be
                                          Committee on Food Import and Export                     homemade food or postal shipments,                    required for other types of shipments.
                                          Inspection and Certification Systems.                   the necessity of providing this                       The IFR excludes homemade food from
                                          The purpose of prior notice is to enable                information for other types and modes                 prior notice requirements entirely, and
                                          FDA to conduct inspections of imported                  should be examined. Another comment                   this exclusion also is in the final rule.
                                          foods at U.S. ports upon arrival and                    recommends that the notification                      Both the IFR and the final rule require
                                          target foods that may pose a significant                procedure should be simplified, and                   submission of the identity of the
                                          risk to public health, based on the                     that the data elements should be limited              manufacturer and the manufacturer’s
                                          information submitted. The Codex                        to the minimum, such as the shipper’s                 registration number in the prior notice
                                          Committee on Food Import and Export                     name and its contact point, the food                  for food arriving by international mail.
                                          Certification and Inspection Systems is                 facility registration number, and food                   FDA agrees with the comments that
                                          charged with developing principles and                  product codes.                                        prior notice requirements should be
                                          guidelines for food import and export                      (Response) FDA disagrees. The type of              limited to the minimum, and has
                                          certification and inspection systems.                   information required for prior notice                 selected those data elements that will
                                             We also do not agree with the                        submissions of food arriving by                       allow FDA to expeditiously meet its
                                          comment’s assertion that FDA should                     international mail are limited because of             statutory obligation to receive, review,
                                          use CBP’s data to fulfill FDA’s needs                   the process by which international mail               and respond to prior notices. FDA,
                                          under the Bioterrorism Act. Information                 enters the United States. For                         however, does not agree with the
                                          that is submitted at the time of CBP                    international mail shipments, the IFR                 comments that the shipper’s name and
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                                          entry processing is not useful for prior                and the final rule requires the                       its contact point, the registration
                                          notice as this information can be                       identification of the U.S. recipient                  number of food facility, and food
                                          submitted or changed after the food has                 rather than the importer, owner, or                   product codes are the only data
                                          already arrived in the United States and                ultimate consignee because mail is sent               elements FDA needs to fulfill this
                                          thus does not fulfill the express intent                only to a U.S. recipient rather than the              mandate. In addition to the Bioterrorism


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                                          Act requirements of the identities of the               accommodate the detailed information                  requirements. The comment particularly
                                          article of food, the manufacturer and                   requirements of section 801(m) of the                 focuses on FAST and C–TPAT and
                                          shipper, the grower, if known, the                      act. For example, its collection of the               recommends that prior notice
                                          country from which the article                          identities of the article of food and its             submissions for those participating in
                                          originates, the country from which the                  manufacturer differs from the way those               these programs should be subject to
                                          article is shipped, and the anticipated                 are collected under the prior notice                  fewer information requirements.
                                          port of entry for the article, FDA                      interim final and final rules in such a                  (Response) FDA disagrees. All of the
                                          determined that certain additional                      way that the data would not meet our                  information required in a prior notice is
                                          information is required for efficient                   needs in carrying out the purpose of                  necessary for determining what articles
                                          enforcement of the Bioterrorism Act,                    section 801(m) of the act.                            to inspect upon arrival and otherwise
                                          primarily for the means of identifying                     (Comments) Many comments suggest                   carrying out section 801(m) of the act.
                                          the article of food and effective                       that submitters consolidate similar prior             The information is initially screened
                                          enforcement of refusals.                                notices into one prior notice based on a              electronically in order to expedite the
                                            FDA also notes that it is not                         variety of reasons, e.g., one prior notice            PNC’s review. If less information is
                                          surprising that 80 to 90 percent of prior               per consignee with all food products                  provided, regardless of whether the food
                                          notices are submitted via ABI/ACS.                      consolidated; one prior notice per                    is covered by some other program, then
                                          Numerous comments on the proposed                       shipment with all information                         the result of that screening would be
                                          rule urged FDA to use the existing ACS–                 consolidated; one prior notice per                    less reliable. This issue is discussed
                                          OASIS interface between CBP and FDA                     commodity regardless of the quantity,                 further in section III.D.6.a of this
                                          to accept prior notice information. As                  size, color or species; one prior notice              document (‘‘Additional Exclusions
                                          stated in the IFR, FDA and CBP agreed                   per bill of lading; one prior notice per              Requested—Special Programs (C–TPAT/
                                          with the recommendation that the                        truck or conveyance and one prior                     FAST) and Flexible Alternatives—
                                          agencies provide a single point of data                 notice for the same food type regardless              General Comments’’)
                                          entry for CBP and FDA for as many                       of brand.                                                (Comments) Two comments refer to
                                          kinds of entries as possible, and                          (Response) The Bioterrorism Act                    submission of ‘‘blanket’’ prior notices;
                                          modified our systems to allow prior                     requires notice for each article of food              one referencing repetitive shipments of
                                          notice to be filed by either CBP’s ABI/                 and requires in that notice, for each                 analytical samples and the other
                                          ACS or FDA’s PNSI beginning with the                    article of food, certain information. As              suggesting a summary of daily
                                          December 12, 2003, effective date of the                stated in the IFR, an ‘‘article’’ refers to           shipments.
                                          IFR. FDA also noted at that time that it                a single food that is associated with the                (Response) FDA disagrees that it
                                          expected approximately 90 percent of                    same complete FDA Product Code, the                   should change its approach from the
                                          prior notice submissions for all                        same package size, and the same                       IFR. As stated in the preamble to the IFR
                                          importations of foods to be transmitted                 manufacturer or grower (68 FR 58974 at                (see 68 FR at 59003), an article of food
                                          by a customs broker or self-filer through               59003). This is consistent with how                   is a unique item related to a specific
                                          the ABI/ACS interface to FDA. (See 68                   entry is filed with CBP. An article of                manufacturer or grower and a specific
                                          FR 58974 at 58976, October 10, 2003.)                   food is a unique item related to a                    process or size. All of these pieces of
                                          Since implementation, this estimate has                 specific manufacturer or grower and a                 information are critical for a risk-based
                                          proven true, as approximately 83                        specific process or size. All of these                assessment of the food. FDA currently
                                          percent of all prior notices are filed                  pieces of information are critical for a              receives most of this information from
                                          through the ABI/ACS interface.                          risk-based assessment of the food. The                customs brokers or self-filers via ABI/
                                            (Comments) Several comments                           ABI/ACS system provides the capability                ACS. The ABI/ACS system also
                                          suggest that all prior notice information               to submit information for multiple food               provides the capability to submit
                                          requirements that are duplicative of                    items as lines in a single entry, when                information for multiple food items as
                                          information requirements for CBP via                    entry level information is consistent for             lines in a single entry, when entry level
                                          AMS for Advanced Electronic                             a number of articles in a shipment. For               information is consistent for a number
                                          Information or in ABI/ACS for Entry                     example, shipment level information,                  of articles in a shipment. For example,
                                          should be eliminated. One comment                       such as estimated time of arrival, can be             shipment level information, such as
                                          recommends that prior notice be aligned                 captured once for all articles within a               estimated time of arrival, can be
                                          with CBP ‘‘ACI’’ rules, for both timing                 shipment. The ability to minimize data                captured once for all articles within a
                                          and data elements. The comment                          entry by copying specific information                 shipment. The ability to minimize data
                                          believes that this could lead to a                      from one article, or line, to another                 entry by copying specific information
                                          possible reduction in data elements.                    depends upon the sophistication of the                from one article, or line, to another
                                            (Response) FDA disagrees.                             software being used by the submitter to               depends upon the sophistication of the
                                          Information that is submitted for CBP                   create the submission to CBP. The FDA                 software being used to create the
                                          entry processing is not useful for prior                PNSI allows for simplified submission                 submission to CBP. The FDA PNSI is
                                          notice as this information can be                       of similar articles of food by allowing               designed to allow for simplified
                                          submitted or changed after the food                     the submitter to easily repeat common                 submission of similar articles of food by
                                          already has arrived in the United States                information (e.g., FDA product code,                  allowing the submitter to easily repeat
                                          and prior notice is required before the                 manufacturer, etc.) while entering                    common information (e.g., FDA product
                                          food arrives.                                           different quantities (e.g., amount and                code, manufacturer, etc.) while entering
                                            Moreover, no interface currently                      package size). Both systems thus                      different quantities (e.g., amount and
                                          exists between AMS and the existing                     significantly reduce the amount of                    package size). Both systems will thus
                                          interface with FDA’s OASIS through the                  repetitive entry. The prior notice                    significantly reduce the amount of
                                          ABI/ACS entry processes, which means                    requirements in the IFR or the final rule             repetitive entry of information while
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                                          FDA does not have access to AMS data.                   do not require the submission of the                  preserving the identity of each article of
                                          FDA and CBP have discussed                              brand for the article of food.                        food. Moreover, the purpose of prior
                                          interfacing with AMS for manifest data                     (Comments) One comment suggests                    notice is for FDA to receive, prior to
                                          and determined that the general cargo                   that different programs should not                    arrival, information about each article of
                                          data in AMS are not suitable to                         require different information                         food being imported or offered for


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                                          66342             Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations

                                          import for the purpose of enabling such                 with the submitter. See section III.J.1 of            notice IFR are silent regarding which
                                          article to be inspected at ports of entry               this document regarding inadequate                    person(s) will be contacted by FDA and/
                                          into the United States. Receiving                       prior notice (§ 1.283(a)(1)) for a                    or CBP when an issue or problem arises
                                          blanket prior notices would not provide                 discussion of communication of                        regarding a prior notice and urges FDA
                                          the necessary information nor would a                   refusals.                                             to clarify that in refusal circumstances,
                                          daily summary, which by definition                         (Comments) One comment suggests                    the agency will contact the person who
                                          would be after-the-fact, not prior to                   that there should be an option to                     submitted the prior notice (i.e., the
                                          arrival.                                                identify whether or not the submitter is              submitter or the transmitter.) The
                                                                                                  C–TPAT certified.                                     comment further states that due to his
                                          2. The Submitter                                           (Response) As we previously                        or her knowledge and/or access to the
                                             In § 1.281(a)(1), (b)(1), and (c)(1), the            explained in the discussion under our                 necessary information, as well as the
                                          IFR requires submission of the name of                  assessment of timeframes (see section                 implicit authority and responsibility for
                                          the individual submitting the prior                     III.F of this document), C–TPAT                       properly filing the prior notice, the
                                          notice and his/her business address,                    participation will not affect timeframes,             submitter or transmitter typically will
                                          telephone number, fax number, e-mail                    the amount of information required to                 be in the best position to take corrective
                                          address, and the name and address of                    be submitted under prior notice, or                   action as expeditiously as possible.
                                          the submitting firm, if applicable. If a                decisions made during the prior notice                   (Response) FDA agrees. The
                                          registration number is provided, city                   review process. Thus, the costs to                    identification of the individual or the
                                          and country may be provided instead of                  submitters and the government of                      firm, if applicable, transmitting the prior
                                          the full address.                                       submitting such information would not                 notice is needed so that FDA knows
                                             (Comments) Several comments assert                   provide benefits. FDA will continue to                who is responsible for transmitting the
                                          that it is duplicative and unnecessary to               coordinate with CBP for administration                information in the prior notice and can
                                          require not only the corporate name and                 of C–TPAT as it applies to FDA-                       communicate with them when
                                          address of the submitter but an                         regulated products, particularly as it                necessary via mail, phone, fax, or e-
                                          individual’s name, telephone number,                    relates to admissibility decisions under              mail. Moreover, the information
                                          fax number and e-mail address as well.                  section 801(a) of the act. However, the
                                          The comments contend that this                                                                                submitted must provide sufficient
                                                                                                  prior notice final rule will not require              information to enable FDA to
                                          information already should exist in the                 that the submitter self-declare as C–
                                          FDA registration database and that the                                                                        communicate questions, concerns, or
                                                                                                  TPAT certified or not C–TPAT certified.               enforcement information with the
                                          name of the submitting firm should be                      (Comments) One comment asks if it is
                                          sufficient. The comments assert that in                                                                       transmitter. See section III.J.1 of this
                                                                                                  possible for a submitter to have his/her              document regarding inadequate prior
                                          today’s job market, individuals change                  legal residence in the country of origin.
                                          jobs more frequently, thereby making                                                                          notice (§ 1.283(a)(1)) for a discussion of
                                                                                                     (Response) Neither the IFR nor the
                                          the maintenance of this level of                                                                              communication of refusals.
                                                                                                  final rule limits the residence or
                                          specificity in a database time consuming                location of the submitter. Section 1.278                 (Comments) Some comments ask if
                                          with minimal benefit.                                   of the final rule states that any person              FDA would clarify what distinguishes
                                             However, another comment states that                 with the knowledge of the required                    the submitter from a transmitter and if
                                          the regulatory provisions in the prior                  information may submit a prior notice.                it is possible for an authorized
                                          notice IFR are silent regarding which                      (Final rule) The final rule requires in            transmitter to have his/her legal
                                          person(s) will be contacted by FDA and/                 § 1.281(a)(1), (b)(1), and (c)(1) the                 residence in the USA.
                                          or CBP when an issue or problem arises                  submission of the name of the                            (Response) The submitter is any
                                          regarding a prior notice and urge FDA                   individual submitting the prior notice                person with knowledge of the required
                                          to clarify that in refusal circumstances,               and his/her business address, telephone               information. The transmitter is the
                                          the agency will contact the person who                  number, and e-mail address, and the                   person who transmits the required
                                          submitted the prior notice (i.e., the                   name and address of the submitting                    information on behalf of the submitter.
                                          submitter or the transmitter.) The                      firm, if applicable. We reworded the last             The submitter and transmitter may be
                                          comment further states that by reason of                sentence of these paragraphs for clarity              the same person. (See § 1.278) The final
                                          his or her knowledge and/or access to                   to state that if the business address of              rule does not limit the residence or
                                          the necessary information, as well as                   the individual submitting the prior                   location of the transmitter.
                                          having the implicit authority and                       notice is a registered facility, then the                (Final rule) If the prior notice is
                                          responsibility to properly file the prior               facility’s registration number, city, and             transmitted by a person other than the
                                          notice, the submitter or transmitter                    country may be provided instead of the                submitter, the final rule in § 1.281(a)(2),
                                          typically will be in the best position to               facility’s full address.                              (b)(2), and (c)(2) requires the name of
                                          take corrective action as expeditiously                                                                       the individual and firm, if applicable,
                                          as possible.                                            3. The Transmitter                                    transmitting the prior notice on behalf
                                             (Response) FDA has determined that                      Section 1.281(a)(2), (b)(2), and (c)(2)            of the submitter and his/her business
                                          a fax number is not necessary for                       of the IFR requires the submission of the             address, telephone number, fax number,
                                          communication with the submitter.                       identity of the transmitter, if different             and e-mail address. We reworded the
                                          However, the identification of the                      from the submitter. The IFR requires the              last sentence of these paragraphs for
                                          individual and the firm, if applicable,                 name of the individual and firm, if                   clarity to state that if the business
                                          submitting the prior notice is needed so                applicable, transmitting the prior notice             address of the individual transmitting
                                          that FDA knows who is responsible for                   on behalf of the submitter and his/her                the prior notice is a registered facility,
                                          the information in the prior notice and                 business address, and phone number,                   then the facility’s registration number,
                                          can communicate with them when                          fax number, and e-mail address. If a                  city, and country may be provided
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                                          necessary via mail, phone, or e-mail.                   registration number is provided, city                 instead of the facility’s full address.
                                          The information submitted must                          and country may be provided instead of
                                                                                                                                                        4. The CBP Entry Type
                                          provide sufficient information to enable                the full address.
                                          FDA to communicate questions,                              (Comments) A comment states that                     Section 1.281(a)(3), (b)(3), and (c)(3)
                                          concerns, or enforcement information                    the regulatory provisions in the prior                of the IFR require submission of the


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                                          entry type, which for § 1.281(b)(3) will                for use of the house air waybill as a CBP                There is guidance posted on FDA’s
                                          be a mail entry.                                        identifier.                                           Web site at http://www.cfsan.fda.gov/
                                             (Comments) Two comments ask for                         (Response) FDA disagrees. The CBP                  ~pn/pnentgui.html that describes the
                                          clarification of the CBP entry type data                entry identifier information is necessary             entry types and the entry identifiers
                                          element and request a list of all of the                for proper identification of the                      (§ 1.281(a)(4) and (c)(4)) associated with
                                          options for entry type.                                 information in a prior notice with the                those entry types.
                                             (Response) FDA needs this                            appropriate articles for inspection. The                 (Final rule) The final rule requires in
                                          information both for screening to                       submission of the entry identifier also is            § 1.281(a)(4) and (c)(4) the CBP entry
                                          identify the appropriate articles for                   critical for matching the prior notice to             identifier (e.g., CBP entry number or in-
                                          inspection and for communication                        the corresponding CBP entry, which is                 bond number), if available.
                                          between the FDA and CBP staff at the                    necessary to assess the adequacy of the
                                                                                                                                                        6. The Product Identity
                                          port. Also, the entry type determines                   prior notice when shipments arrive and
                                                                                                  are presented for review.                                Section 801(m)(1) of the Bioterrorism
                                          which entry identifiers should be used
                                                                                                     For in-bond entries and FTZ                        Act requires that a prior notice must
                                          (entry number, in-bond number) to
                                                                                                  admissions, and for prior notices                     contain the identity of the article of food
                                          identify the shipment. In addition, the
                                                                                                  submitted through the FDA PNSI, an                    being imported or offered for import.
                                          CBP entry type tells us if the article of
                                                                                                  entry identifier is critical for matching             Section 1.281 (a)(5), (b)(4), and (c)(5) of
                                          food is for consumption in the United
                                                                                                  the prior notice to the corresponding                 the IFR requires the identity of the
                                          States or is for export or other uses.
                                                                                                  CBP entry if a consumption entry is                   article of food being imported or offered
                                             Some examples of CBP entry types                                                                           for import, as follows: the complete
                                                                                                  submitted so FDA and CBP can ensure
                                          are: consumption entries, warehouse                                                                           FDA product code; the common or
                                                                                                  that prior notice requirements were
                                          entries, and temporary importation                                                                            usual name or market name; the
                                                                                                  satisfied. FDA does not agree that the
                                          bond entries. Each of these types has a                                                                       estimated quantity of food that will be
                                                                                                  waybill/Bill of Lading can be used as a
                                          designated CBP code. For prior notice                                                                         shipped, described from largest
                                                                                                  CBP identifier, nor do we believe that
                                          submissions made through ABI/ACS,                                                                             container to smallest package size; and
                                                                                                  there is a problem with obtaining a CBP
                                          the entry type will consist of the CBP                                                                        the lot or code numbers or other
                                                                                                  identifier. If the submitter does not have
                                          entry code specific for that type of entry;                                                                   identifier of the food if required by the
                                                                                                  a CBP identifier, a system-generated
                                          e.g., ‘‘01’’ for a consumption entry, ‘‘21’’            entry identifier can be provided upon                 act or FDA regulations; e.g., low-acid
                                          for a warehouse entry, ‘‘23’’ for a                     request. The Airway Bill number and                   canned foods, at § 113.60(c) (21 CFR
                                          temporary importation bond entry, etc.                  Bill of Lading number is a separate data              113.60(c)); acidified foods, at § 114.80(b)
                                          These codes are ones customs brokers                    element found in the planned shipment                 (21 CFR 114.80(b)); and infant formula,
                                          and self-filers provide to CBP at entry.                information (§ 1.281(a)(17)(i)). A Bill of            at § 106.90 (21 CFR 106.90).
                                             For prior notice submissions made                    Lading number is not always assigned to                  (Comments) One comment suggests
                                          through the FDA PNSI, applicable entry                  a shipment at the time of prior notice                that the definition of ‘‘article of food’’
                                          types will be provided for selection in                 submission. For certain shipments, such               should be amended to eliminate
                                          a drop-down menu; e.g., consumption,                    as those sent by international mail, no               quantity and product code as
                                          IT, T&E, mail, FTZ, etc. Explanations of                Bill of Lading may exist. Thus, FDA has               distinguishing factors that require a
                                          the different entry types are available on              determined that we cannot allow for the               separate prior notice and that separate
                                          PNSI to help the transmitter choose the                 use of the house air waybill number as                prior notices should be based on the
                                          right one. There also is guidance posted                a CBP identifier.                                     uniformity of entry level food data. The
                                          on FDA’s Web site located at http://                       (Comments) Two comments request                    comment further asserts that the
                                          www.cfsan.fda.gov/~pn/pnentgui.html                     clarification of the CBP entry identifier             integrity, or lack thereof, of the food
                                          that describes the entry types and the                  data element and where it can be                      product will not be compromised based
                                          entry identifiers (§ 1.281(a)(4) and (c)(3))            located.                                              on the product type, size and/or
                                          associated with those entry types.                         (Response) For transmitters                        quantity.
                                             (Final Rule) The final rule in                       submitting prior notice with CBP entry                   (Response) FDA disagrees. FDA
                                          § 1.281(a)(3), (b)(3), and (c)(3) requires              information through the ABI/ACS                       continues to believe that estimated
                                          submission of the entry type. For                       interface, the CBP entry number                       quantity, including base units and total
                                          articles arriving by international mail                 assigned by CBP is also the entry                     quantity, is a necessary component of
                                          (§ 1.281(b)(3)), the entry type will                    identifier. For customs brokers or self-              product identity. This information is
                                          always be a mail entry.                                 filers submitting prior notice for a food             important for communications with
                                                                                                  entering the United States as an IT                   FDA and CBP staff at the border and for
                                          5. The CBP Entry Identifier (e.g., the
                                                                                                  entry, a T&E entry, or FTZ admission,                 examinations to determine whether the
                                          Customs ACS Entry Number or In-Bond
                                                                                                  the CBP in-bond number or FTZ                         amount ordered matches the amount
                                          Number)
                                                                                                  admission number assigned by CBP also                 received. For example, as discussed in
                                            Sections 1.281(a)(4) and (c)(4) of the                is the entry identifier. If prior notice is           the preamble to the IFR, if more was
                                          IFR require the submission of the CBP                   being submitted through PNSI, the entry               received than was ordered, FDA
                                          entry identifier (e.g., CBP entry number                identifier will depend on the entry type              guidance recommends an investigation
                                          or in-bond number), if available. This                  and the reason for the Web submission.                to determine the cause of the
                                          requirement does not apply to articles                  If available to the transmitter (e.g., the            discrepancy as additional and unwanted
                                          arriving by international mail, nor to                  prior notice is for a CBP entry but the               articles may have been added to
                                          those carried by or accompanying an                     ABI/ACS interface is not available), the              intentionally contaminate the shipment
                                          individual, unless entry is otherwise                   CBP entry number must be used. When                   (68 FR 58974 at 59005). If less product
                                          required by CBP and an associated CBP                   appropriate, the in-bond number must                  is received than ordered or than
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                                          entry identifier has been assigned. In                  be used as the entry identifier. If one of            shipped, some of the product may have
                                          these cases, the FDA PNSI will apply a                  the entry identifiers described above                 been intentionally diverted. Moreover,
                                          system-generated entry identifier.                      does not exist, the transmitter can                   the agency’s risk-based decisions are
                                            (Comments) One comment suggests                       request a system-generated entry                      based upon the food type and size of
                                          that PNSI should be modified to allow                   identifier.                                           that product as many foods are


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                                          66344             Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations

                                          processed differently and the health-                   to CBP using the HTS code for each item               Moreover, the HTS code has never been
                                          based problems result from these                        included with the gift pack. This would               sufficient for FDA admissibility
                                          differences. For example, a                             apply even when there are food and                    decisions; at entry, the FDA product
                                          manufacturer may have two different                     nonfood items in the pack; e.g. a soup                code has been required on FDA-
                                          low acid canned food (LACF)                             mug and a can of soup, as well as for                 regulated products. Therefore, the FDA
                                          production lines that are used for filling              make-your-own gift packs; e.g., if you                product code should be familiar to most
                                          and sealing different size cans. A                      created a gift pack by selecting                      submitters of prior notice. Prior notice
                                          problem with pulling a vacuum on one                    individual items from a list of available             requires that we now get this
                                          LACF line may cause the food in those                   products.                                             information before arrival of the article
                                          size cans to become adulterated; this                      The final rule requires a prior notice             of food into the United States.
                                          would not apply to the cans sealed on                   submission for each article of food. As                  (Comments) One comment asserts that
                                          the other LACF line. FDA would be able                  we explained in the preamble to the                   FDA has issued an interim final
                                          to target shipments from this                           IFR, an ‘‘article’’ refers to a single food           regulation that requires prior notice
                                          manufacturer for the size cans that may                 that is associated with the same                      needlessly. The comment provides an
                                          similarly be adulterated. As stated                     complete FDA Product Code, the same                   example of a container containing red
                                          previously, the PNSI system also allows                 package size, and the same                            wine, under 14 percent alcohol and in
                                          for automatic repeating of like                         manufacturer or grower (68 FR 58974 at                multiple varietals and sizes from the
                                          information (e.g., identity of the                      59003). Moreover, the ‘‘packer’’ of a gift            same manufacturing facility and asserts
                                          manufacturer), which decreases                          pack is not the facility that                         that multiple prior notice submissions
                                          repetitive entry of information that is                 manufactured/processed the food pack.                 should not be required.
                                          the same for multiple articles of food                  Therefore, each article of food in a gift                (Response) FDA disagrees. For prior
                                          within a shipment. This also can be                     pack must be covered by a separate                    notice to accomplish its intended
                                          accomplished with submission via ABI/                   prior notice. However, the Prior Notice               purpose and help FDA protect
                                          ACS, dependent on the filer’s own                       Final Rule Draft CPG, published                       American consumers, a prior notice
                                          software.                                               elsewhere in this issue of the Federal                must be submitted for each article of
                                             (Comments) One comment requests                      Register, describes our proposed                      food. If the food is identified by a single
                                          clarification of the interpretation                     enforcement policy for gift packs                     FDA product code, size, and
                                          pertaining to gift packs. The comment                   purchased or otherwise acquired by an                 manufacturer, then only one prior
                                          asserts that CBP currently processes gift               individual and imported or offered for                notice is required. Currently there are
                                          packs according to the description of the               import for nonbusiness purposes. This                 only seven FDA product code
                                          entire gift pack as an entity. The                      draft guidance states that for these types            designations covering wine: White/still,
                                          comment asks if prior notice is required                of gift packs FDA and CBP staff should                red/still, rose/still, naturally carbonated
                                          on the individual items within the gift                 typically consider not taking regulatory              sparkling, artificially carbonated
                                          pack. Another comment recommends                        action if there is a prior notice violation           sparkling, Champagne, and wine
                                          that FDA show flexibility and further                   because a single prior notice is                      coolers. The identity of the size of the
                                          develop policies that do not create                     submitted for a gift pack and the                     article of food is covered under the
                                          excessive costs for exporters who are                   identity of the facility that packed the              requirement to submit the estimated
                                          shipping multiple food products in the                  gift pack is submitted in lieu of the                 quantity of the article of food (see
                                          same package.                                           identity of the manufacturer(s) and/or                § 1.281(a)(5)(iii), (b)(4)(iii), and
                                             (Response) A gift pack may contain                   grower(s) for each article of food within             (c)(5)(iii)). In the previous example,
                                          various articles of food subject to prior               the gift pack.                                        although the shipment contains only red
                                          notice requirements. In addition, a gift                   (Comments) One comment states that                 wine from the same manufacturer, there
                                          pack may also contain various nonfood                   the regulations should require a separate             are different sizes of bottles within the
                                          articles that are not subject to prior                  prior notice for each HTS number in the               container and each package size
                                          notice requirements. A package with                     container and that a detailed description             requires a separate prior notice. The
                                          multiple food products, though not a                    of the product is not necessary.                      reason is that a problem in sealing one
                                          gift pack, is another example of various                   (Response) FDA disagrees. For prior                size bottle of wine, but not the other size
                                          articles of food. A prior notice is                     notice to accomplish its intended                     bottles, may result in serious adverse
                                          required for each article of food, even                 purpose and help FDA protect                          health consequences. As we explained
                                          when multiple articles of food are                      American consumers, a more precise                    in the preamble to the IFR, FDA believes
                                          designated as a gift pack or are                        description of the product is necessary               that package size is necessary and part
                                          otherwise packaged together.                            than that provided by the HTS number.                 of product identity. Moreover, the base
                                             There is no CBP rule or regulation nor               As we explained in the preamble to the                unit of measure is a characteristic of
                                          is there a General Rule of Interpretation               IFR, although the HTS codes are                       product identity and is thus necessary
                                          (GRI) under which gift packs are                        currently utilized by CBP and FDA to                  for effective review of the prior notice
                                          classified for tariff purposes. In the case             identify generally which imports are                  information. Base unit is critical to
                                          of ‘‘gift packs’’ that contain multiple                 subject to an FDA admissibility review,               processing safety requirements and is
                                          products, for entry purposes, CBP will                  these codes are often not sufficient to               particularly important when evaluating
                                          try to classify the gift pack using the                 specifically identify a product for FDA               the safety of low-acid canned foods (68
                                          concept of a set. That is, if the products              decisionmaking. For example, in many                  FR 58974 at 59005).
                                          included in a gift pack are part of a                   cases, the tariff code does not describe                 (Comments) One comment requests
                                          common activity, the gift pack may be                   how the product was processed (e.g.,                  that a single prior notice should cover
                                          classified under the HTS code that is                   commercially sterile or shelf-stable) or              one commodity and alternately suggests
                                          most applicable. However, CBP does not                  how the product is packaged. Thus,                    that a single prior notice be required for
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                                          consider eating to be a common activity                 several products that FDA considers                   each FDA Product Code. As an example,
                                          even when all items in a gift pack are                  different from each other (because these              the comment suggests that a separate
                                          to be consumed. Therefore, unless there                 differences affect the potential safety of            prior notice is required for each size of
                                          has been an applicable CBP ruling,                      the food) may be combined under one                   apples in a load with 10 sizes of apples
                                          entries of gift packs should be declared                HTS code. (See 68 FR 58974 at 59004.)                 representing one FDA Product Code.


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                                                            Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations                                         66345

                                          Another comment suggests that all                       synonyms for foods covered by the same                that will be shipped, described from
                                          products covered by the same FDA                        product code designations; e.g., Rice                 largest container to smallest package
                                          product code should require a single                    Flour (FDA Product Code 02C–01) has                   size and for articles of food that have
                                          prior notice entry.                                     the synonyms of Bot Gao (Vietnamese                   been refused under section 801(m) of
                                             (Response) A separate prior notice is                rice flour), Harina De Arroz (Latin                   the act in § 1.281(c)(5)(iii), the quantity
                                          required for each article of food                       American rice flour), and Joshinko                    of food that was shipped, described
                                          represented in a shipment or a load. In                 (Japanese fine, white rice flour, used to             from largest container to smallest
                                          the example of different sizes of apples,               make taffy-like sweets). At this time due             package size.
                                          because apples are identified by one                    to resource constraints, FDA does not                    (Comments) Several comments
                                          FDA Product Code, and assuming that                     plan to translate the FDA Product Code                recommend elimination of the
                                          all the apples represent the same                       Builder into foreign languages. A                     submission of quantity for each article
                                          grower, if known, and the remainder of                  product code builder tutorial is                      of food, and recommend that such
                                          the required information is the same for                available at http://www.cfsan.fda.gov/                situations involving various sizes and
                                          all the apples, then one prior notice                   ~pn/pcb-tut.html.                                     quantities of similar articles of food
                                          would be sufficient. However, if the                       As stated previously (see the                      (e.g., same FDA product code and same
                                          articles of food represent the same FDA                 discussion on the identity of the article             manufacturer) be covered by one prior
                                          product code but contain different                      of food being imported or offered for                 notice submission.
                                          package sizes, then these are different                 import), a gift pack is not a single article             (Response) FDA disagrees. FDA
                                          articles of food and a separate prior                   of food, but multiple articles of food                continues to believe that quantity is a
                                          notice is required for each.                            packed together. Each article of food in              necessary component of product
                                             (Comments) One comment states that                   a gift pack must be covered by a                      identity. FDA also believes that package
                                          prior notice would need to be submitted                 separate prior notice with an FDA                     size is a necessary part of product
                                          for each brand, and then each bottle size               product code for each article. However,               identity. The base unit of measure is a
                                          and format.                                             FDA is proposing an enforcement policy                critical characteristic of product identity
                                             (Response) In response to comments                   whereby FDA should typically not take                 and is thus necessary for effective
                                          to the proposed rule, FDA determined                    regulatory action if a single prior notice            review of the prior notice information.
                                          that the brand is not critical for risk-                is submitted for a gift pack. More details            Base unit also is critical to processing
                                          based screening and the IFR did not                     about this proposed enforcement policy                safety requirements and is particularly
                                          require identification of the brand of the              are described in the Prior Notice Final               important when evaluating the safety of
                                          article of food. This determination has                 Rule Draft CPG, published elsewhere in                low-acid canned foods. Both base unit
                                          been retained in the final rule.                        this issue of the Federal Register.                   and total quantity (which includes
                                          Identification of the size of the article of               b. The common or usual or market                   knowing the smallest ‘‘package size’’)
                                          food is covered under the requirement                   name. The IFR in § 1.281(a)(5)(ii),                   are necessary for response (examination)
                                          to submit the estimated quantity of the                 (b)(4)(ii), and (c)(5)(ii) requires the               and communication with FDA and CBP
                                          article of food (see § 1.281(a)(5)(iii),                submission of the common or usual                     staff at the port. As noted in FDA’s
                                          (b)(4)(iii), and (c)(5)(iii)).                          name or market name of the article of                 ‘‘Food Security Preventive Measures
                                             a. The complete FDA product code.                    food as an element of the identity of the             Guidance for Importers’’ (‘‘Guidance for
                                          FDA’s product code is a unique numeric                  article of food. (See 21 CFR 102.5 for                Industry, Importers and Filers, Food
                                          code currently used by FDA and                          additional information about common                   Security Preventive Measures
                                          customs brokers and self-filers to                      or usual names.)                                      Guidance,’’ March 2003), these elements
                                          describe food products, as well as other                   (Comments) Several comments ask for                are also critical for food security
                                          products regulated by FDA. The IFR                      clarification about the appropriate                   examinations to determine if the
                                          requires in § 1.281(a)(5)(i), (b)(4)(i), and            common, usual, or market name to use                  amount ordered is the amount received.
                                          (c)(5)(i), the complete FDA Product                     for specific products and for guidance                For example, if more was received than
                                          Code be submitted.                                      concerning specific types of products.                was ordered, the guidance recommends
                                             (Comments) Several comments ask for                  One comment asks if a sufficient                      an investigation to determine the cause
                                          clarification about the appropriate FDA                 common, usual, or market name would                   of the discrepancy, as additional and
                                          product code to use for specific                        be the name or names of products listed               unwanted articles may have been added
                                          products and for guidance concerning                    in the FDA Product Code Builder.                      to intentionally contaminate the
                                          specific types of products. Several                        (Response) The final rule does not                 shipment. If less is received than
                                          comments request that the FDA Product                   attempt to clarify appropriate common,                ordered or than shipped, some of the
                                          Code Builder be translated into various                 usual, or market names for specific                   food may have been intentionally
                                          foreign languages. Two comments                         products. The FDA Product Code                        diverted. Both base unit and total
                                          request clarification regarding the                     Builder contains many synonyms,                       quantity are currently data elements that
                                          appropriate product code for gift packs.                which are common, usual, or market                    can be submitted via ABI/ACS to
                                          One comment requests that submitters                    names, for foods covered by the same                  OASIS.
                                          be advised of the correct product code                  product code designations; e.g., FDA                     (Comments) One comment asks for
                                          for foods subject to prior notice                       Product Code 16A—4 Ocean Perch is                     clarification as to the requirements in
                                          requirements.                                           also known as Pacific Perch, Red Perch,               § 1.281(a)(5)(iii) and (b)(4)(iii) for
                                             (Response) The final rule does not                   Red Rockfish, and Rosefish. Therefore,                estimated quantity and the requirement
                                          attempt to clarify appropriate coding for               anyone needing information about the                  in § 1.281(c)(5)(iii) for the actual
                                          specific products. The FDA product                      appropriate common, usual or market                   quantity.
                                          codes are frequently updated, revised                   name to use should consult the FDA                       (Response) The requirement for
                                          and changed. The active codes are                       Product Code Builder, which is                        providing estimated quantity in
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                                          available in the FDA Product Code                       accessible at http://www.cfsan.fda.gov/               § 1.281(a)(5)(iii) and (b)(4)(iii) apply to
                                          Builder at http://                                      ~pn/pcb-tut.html.                                     those prior notices provided in
                                          www.accessdata.fda.gov/SCRIPTS/                            c. The estimated quantity of food. The             accordance with the requirements in the
                                          ORA/PCB/PCB.HTM. The FDA Product                        IFR in § 1.281(a)(5)(iii) and (b)(4)(iii)             final rule; i.e., those submitted before
                                          Code Builder also contains many                         requires the estimated quantity of food               the food arrives at the port of arrival in


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                                          66346              Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations

                                          the United States as required in § 1.279.               not require that a prior notice be                    the smallest package size. For articles of
                                          The requirement for providing the                       cancelled and resubmitted if the                      food that have been refused under
                                          actual quantity in § 1.281(c)(5)(iii)                   estimated quantity changes after                      section 801(m) of the act, the final rule
                                          applies only to those articles of food                  confirmation.                                         in § 1.281(c)(5)(iii) requires submission
                                          refused under section 801(m) of the act,                   d. The lot or code numbers or other                of the quantity of food that was shipped,
                                          i.e., prior notices submitted after the                 identifier. The IFR in § 1.281(a)(5)(iv),             described from largest container to
                                          article of food has arrived at the port of              (b)(4)(iv), and (c)(5)(iv) requires the               smallest package size. The final rule in
                                          arrival without adequate prior notice                   submission of the lot or code numbers                 § 1.281(a)(5)(iv), (b)(4)(iv), and (c)(5)(iv)
                                          and has been refused. In this case, since               or other identifier of the food if required           requires the submission of lot or code
                                          the article of food already has arrived,                by the act or FDA regulations; e.g., low-             numbers or other identifiers for articles
                                          the quantity is set and the actual                      acid canned foods, at § 113.60(c);                    of food if required to bear such numbers
                                          quantity can be determined and                          acidified foods, at § 114.80(b); and                  by the act or by FDA regulations.
                                          submitted in the post-refusal prior                     infant formula, at § 106.90.
                                                                                                     (Comments) One comment requests                    7. Identity of the Manufacturer
                                          notice.
                                             (Comments) One comment asserts that                  clarification concerning when a lot or                   Section 801(m)(1) of the act states that
                                          a slide entitled ‘‘Article of Food vs.                  code number or other identifier is                    a prior notice must contain the identity
                                          Shipment of Food’’ in an FDA                            required for an article of food.                      of the manufacturer of the article of food
                                          presentation about the IFR provides a                      (Response) The lot or code numbers                 being imported or offered for import.
                                          conflict of interpretation about the                    are the identification numbers or code                Section 1.281(a)(6), (b)(5), and (c)(6) of
                                          requirement to provide the estimated                    of a production lot, which can more                   the IFR requires that prior notice for an
                                          quantity. The comment asserts that the                  specifically identify a product for                   article of food that is no longer in its
                                          illustration suggests a separate prior                  screening and examination purposes                    natural state include the name and
                                          notice is required for each and asks that               and for communication within FDA and                  address of the manufacturer and the
                                          FDA clarify this presentation.                          with CBP and the manufacturer, etc. For               registration number assigned to the
                                             (Response) The illustration in                       example, recalls involving serious                    facility that is associated with the article
                                          question (see http://www.cfsan.fda.gov/                 health risks are often associated with a              of food. The IFR further states that a
                                          ~dms/fsbtac17/sld014.htm) provides                      specific production lot, such as                      registration number is not required for
                                          the following example:                                  counterfeit infant formula or under-                  a facility associated with an article of
                                                                                                  processed canned food. FDA screening                  food if the article is imported or offered
                                            TABLE 1A.—‘‘ARTICLE OF FOOD’’ VS.                     can target these food products for                    for import for transshipment, storage,
                                                                                                  examination based on information of                   and export, or further manipulation and
                                                   SHIPMENT OF FOOD1                              public health emergencies or recalls in               export. The IFR also provides that if the
                                          Tuna    24/12 oz.      2,000           Company 1        foreign countries.                                    article of food is sent by an individual
                                                    cans           cases                             FDA regulations require lot/code                   as a personal gift (i.e., for nonbusiness
                                                                                                  identifiers for certain foods. Currently,             reasons) to an individual in the United
                                          Tuna    48/6 oz.       1,000           Company 1        low acid canned foods, acidified foods,               States, he or she may provide the name
                                                    cans           cases                          and infant formula are required to bear               and address of the firm that appears on
                                                                                                  lot codes or other identifiers (see                   the label under 21 CFR 101.5 instead of
                                          Tuna    24/12 oz.      300 cases       Company 2        § 113.60(c) (low-acid canned foods);
                                                    cans                                                                                                the name, address, and registration
                                                                                                  § 114.80(b) (acidified foods); and                    number of the manufacturer. If a
                                          Tuna    6/66 oz.       2,400           Company 3        § 106.90 (infant formula low-acid                     registration number is provided, city
                                                    cans           cases                          canned foods)). The interim final and                 and country may be provided instead of
                                            1 One shipment; 4 different products; 4 prior
                                                                                                  final rules require lot/code or other                 the full address.
                                          notices
                                                                                                  identifiers only for these kinds of                      FDA received many comments on the
                                                                                                  articles of foods. Many other foods may               requirement to provide the name,
                                             FDA reiterates that the previously                   have lot or code identifiers that are not             address and registration number, when
                                          shown chart illustrates a situation with                required by FDA regulation; submission                applicable, as the identity of the
                                          four different articles of food, each                   of these identifiers is optional under the            manufacturer. For ease in discussing
                                          requiring a separate prior notice. The                  final rule.                                           these comments, we are presenting the
                                          example provides three different                           Submission of the required lot/code                issues they raise into the following
                                          manufacturers of the canned tuna; thus,                 identifier is accommodated by ABI/ACS                 general categories:
                                          canned tuna from each of these                          as an affirmation of compliance or                       • Does ‘‘the manufacturer’’ in section
                                          manufacturers requires a separate prior                 through PNSI as a production identifier.              801(m) of the act mean the place where
                                          notice submission. Further, the 12                      ACS currently allows for submission of                the food was actually manufactured or
                                          ounce (oz) cans and the 6 oz cans                       more than one affirmation of                          can it include other entities? What if
                                          manufactured by Company 1 are                           compliance per article of food. PNSI                  more than one entity was involved in
                                          different sizes and thus are different                  also accepts more than one lot identifier             the manufacture of the article of food?
                                          articles of food. Accordingly, each                     per article of food.                                     • Does FDA have the authority to
                                          requires a separate prior notice                           (Final rule) The final rule requires in            require the registration number of the
                                          submission.                                             § 1.281(a)(5)(i), (b)(4)(i), and (c)(5)(i) the        manufacturer of the article of food being
                                             The final rule continues to require                  complete FDA product code. The final                  imported or offered for import as a data
                                          submission of the estimated quantity of                 rule in § 1.281(a)(5)(ii), (b)(4)(ii), and            element in prior notice?
                                          food that will be shipped, described                    (c)(5)(ii) requires the submission of the                • Assuming FDA can require the
                                          from largest container to smallest                      common or usual name or market name                   manufacturer’s registration number in a
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                                          package size. A prior notice will not be                of the article of food as an element of               prior notice submission, should FDA
                                          inadequate if the estimated quantity                    the identity of the article of food. The              continue to do so in the final rule and/
                                          changes between the confirmation of                     final rule in § 1.281(a)(5)(iii) and                  or should FDA provide an alternative
                                          prior notice and the time of arrival.                   (b)(4)(iii) requires the estimated quantity           means for submitters to provide the
                                          Similar to the IFR, the final rule does                 described from the largest container to               identity of the manufacturer? and


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                                                            Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations                                        66347

                                             • Questions Seeking Clarification.                   ‘‘the manufacturer’’ in section 801(m) of             mean the place where the food was
                                             a. Does ‘‘the manufacturer’’ in section              the act. In construing the prior notice               actually manufactured/processed (i.e.,
                                          801(m) of the act mean the place where                  provision of the Bioterrorism Act, FDA                the site-specific manufacturing facility).
                                          the food was actually manufactured or                   is confronted with the question of                    We believe that this interpretation is
                                          can it include other entities? What if                  whether Congress has directly spoken to               reasonable and consistent with the goals
                                          more than one entity was involved in                    the precise question presented                        of the Bioterrorism Act.
                                          the manufacture of the article of food?                 (‘‘Chevron step one’’). Chevron, U.S.A.,                 In considering whether it is
                                          (Comments) Section 1.281(a)(6) of the                   Inc. v. NRDC, Inc., 467 U.S. 837, 842                 reasonable to interpret the manufacturer
                                          IFR requires the submission of the                      (1984). To find no ambiguity, Congress                as being the actual place where the food
                                          identity of the manufacturer of each                    must have clearly manifested its                      was manufactured, we considered the
                                          article of food no longer in its natural                intention with respect to the particular              language and purpose of the prior notice
                                          state. Several comments recommend                       issue. Young v. Community Nutrition                   provision, as well as the other
                                          that the final rule define ‘‘the                        Institute, 476 U.S. 974, 980 (1986). If               provisions of the Bioterrorism Act. The
                                          manufacturer.’’ Some comments note                      Congress has spoken directly and                      purpose of the Bioterrorism Act is ‘‘to
                                          that for ‘‘gray market’’ or ‘‘parallel                  plainly, the agency must implement                    improve the ability of the United States
                                          market’’ importations (food purchased                   Congress’s unambiguously expressed                    to prevent, prepare for, and respond to
                                          outside the manufacturer’s distribution                 intent. Chevron, 467 U.S. at 842–843. If,             bioterrorism and other public health
                                          chain and imported to the United                        however, the Bioterrorism Act is silent               emergencies’’ (Public Law 107–188).
                                          States), the only identifiable product                  or ambiguous as to the meaning of ‘‘the               The prior notice provision contributes
                                          information is that which is on the                     manufacturer,’’ FDA may define this                   to this goal by providing the agency
                                          product itself. The comments suggest                    term in a reasonable fashion (‘‘Chevron               with the information it needs to
                                          that in lieu of the name, address, and                  step two’’). Chevron, 467 U.S. at 842–                determine whether, due to significant
                                          registration number of the manufacturer                 843; FDA v. Brown & Williamson                        concerns about an article of imported
                                          of the food, the prior notice submission                Tobacco Corp., 529 U.S. 120, 132                      food, it should inspect the food upon
                                          should include the name and address of                  (2000).                                               arrival in the United States. Having the
                                          the entity that appears on the label on                    We have determined that in enacting                identity of the actual place where the
                                          the food. A comment notes that while                    section 801(m) of the act, Congress did               food was manufactured (i.e., the site-
                                          this information is not as detailed as                  not clearly manifest its intention with               specific manufacturing facility) will
                                          that required for other imports, it                     respect to the meaning of ‘‘the                       inform these risk-based decisions much
                                          relieves importers of ‘‘gray market’’                   manufacturer.’’ When an article of food               better than having the identity of the
                                          foods from having to provide                            is made from one or more raw                          packer or distributor or even the name
                                          information that in most instances                      ingredients, there could be several                   and address of the manufacturer’s
                                          would never be available to them. Other                 entities involved in its manufacture. For             principal place of business.
                                          comments suggest that shipments of                      example, boxed macaroni and cheese                       Information about the manufacturer
                                          gifts to individuals but with a                         might involve preparing the dried                     contributes to FDA’s inspection
                                          commercial purpose, such as business                    macaroni, preparing the dried cheese,                 decisions under prior notice in two
                                          gifts to generate goodwill among                        combining these materials, and                        principal ways. One way is that when
                                          colleagues, should be permitted to                      packaging and labeling the finished                   FDA receives intelligence regarding
                                          reference the manufacturer’s name and                   product. Where multiple steps are                     potential areas of concern about food
                                          address as shown on the label in lieu of                carried out by multiple entities, the act             shipments, this intelligence is often
                                          the registration number of the                          does not directly and plainly set forth               linked to a site-specific manufacturing
                                          manufacturer.                                           which entity or entities Congress                     facility. For example, FDA received
                                             Several comments request that FDA                    intended as the manufacturer to be                    intelligence regarding alleged
                                          provide guidance regarding how to                       submitted as part of the prior notice.                contamination with a harmful chemical
                                          complete prior notice for imported food                 Another question regarding ‘‘the                      substance of certain imported food
                                          from multiple manufacturing facilities.                 manufacturer’’ whose answer is not                    products from a certain specific foreign
                                          One comment suggests that the final                     clearly manifested in the act is whether              manufacturing facility. FDA flagged
                                          rule should define the manufacturer as                  the manufacturer means the specific                   shipments from this facility for further
                                          the last entity to conduct a processing                 facility where the article is                         PNC review, and subsequently
                                          operation; e.g., including bottling, but                manufactured or the entity that owns, or              recommended the examination and
                                          excluding labeling. Another comment                     contracts with, the manufacturing                     sampling of several shipments from the
                                          provides an example of wine that is                     facility. Additionally, Congress did not              site specific facility due to the
                                          produced and bottled at winery ‘‘X’’ and                plainly address whether the entity listed             significant public health threat posed by
                                          sent to winery ‘‘B’’ for labeling, which                on a product’s label could be considered              the articles of food. Because the identity
                                          sends the wine to another facility for                  the manufacturer. The entity listed on a              of the site-specific manufacturing
                                          storage, which then transfers the wine to               product’s label can be, as provided by                facility was included in the prior
                                          the freight forwarder ‘‘F’’ who stores                  21 CFR 101.5, the packer or distributor.              notices, FDA was able to match the
                                          and consolidates the wine with other                    Additionally, under that regulation, the              intelligence with the relevant food
                                          wines for shipment to the United States.                label may state the principal place of                shipments, without affecting the
                                          Another comment provides an example                     business of the manufacturer, packer, or              importation of similar products from
                                          of fresh fruit that is processed in one                 distributor in lieu of the actual place               other manufacturers. If prior notice only
                                          facility in a foreign country and then is               where the food was manufactured or                    included the name and address listed on
                                          transported to one or several other                     packed or is to be distributed, unless the            the label, FDA could not have
                                          facilities that re-palletize the fruit,                 statement would be misleading.                        confidence that it could flag shipments
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                                          resulting in a finished pallet containing                  For the reasons given in the following             of the food manufactured at the specific
                                          boxes that have been packaged at                        paragraphs, we have determined that,                  facility, either for further PNC review or
                                          several packing facilities.                             for purposes of section 801(m) of the                 for inspection. Matching a third-party
                                             (Response) These comments address,                   act, the phrase, ‘‘the identity of the                distributor or packer with the actual
                                          directly or indirectly, the meaning of                  manufacturer,’’ should be interpreted to              manufacturer that FDA wants to flag


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                                          based on intelligence would be very                     distributor would be much less                        would have a detrimental impact on
                                          difficult and time consuming, and may                   meaningful than one based on the actual               trade), in many situations FDA may not
                                          even be impossible to do with the                       manufacturer because the actual                       be able to ascertain the identity of each
                                          information available to the agency. If                 manufacturer has much more control                    of the firm’s manufacturing facilities.
                                          prior notice included the principal                     over the product’s quality and security               Alternatively, FDA could attach a risk to
                                          place of business of the manufacturer                   than the product’s distributor.                       the headquarters location, but doing so
                                          (e.g., the corporate headquarters                          For example, when researching the                  would result in a less meaningful prior
                                          location) instead of the site-specific                  site-specific manufacturer listed in a                notice risk assessment and may result in
                                          manufacturing facility, FDA’s ability to                prior notice to investigate potential                 articles of food being assigned a lower
                                          correctly target shipments would not be                 security concerns, FDA found                          or higher risk than they should have
                                          much better. More often than not, when                  information in a government database                  based on the specific manufacturing
                                          FDA receives intelligence regarding a                   suggesting the facility had ties to                   facility.
                                          manufacturer, it is specific to the site-               terrorism. Based on this and other                       Our interpretation of ‘‘the
                                          specific manufacturing facility and not                 information, FDA decided to examine                   manufacturer’’ to mean the actual place
                                          just the manufacturer’s corporate                       the product covered by the prior notice.              where the food was manufactured also
                                          identity. In these situations, if the prior             If the name and address of a different                furthers the purposes of the
                                          notice that has been submitted contains                 firm, such as the distributor, had been               Bioterrorism Act by helping to ensure
                                          only corporate-level information, FDA                   provided in the prior notice instead, it              that imported food is from registered
                                          would have to target every relevant                     is unlikely that FDA’s research would                 facilities. Under section 801(l) of the act,
                                          shipment from every plant the firm                      have turned up this association and                   food that is imported or offered for
                                          owns or contracts with, which could be                  unlikely that this shipment would have                import is subject to being held if it ‘‘is
                                          dozens, or even hundreds. As a result,                  been flagged for inspection. In its                   from a foreign facility for which a
                                          much time would be spent                                experience under the IFR, when prior                  registration has not been submitted to
                                          unnecessarily reviewing many                            notice has not included the identity of               [FDA] under section 415’’ of the act.
                                          shipments that may not be of interest                   the actual manufacturer, FDA has had to               FDA checks the information about the
                                          but whose risk could not be discounted                  attempt to determine the site-specific                site-specific manufacturing facility
                                          based on the supplied manufacturer                      manufacturer by using alternative                     provided in prior notice to verify that
                                          information.                                            means such as inspection, contacting                  facility’s registration status. If the prior
                                                                                                  the submitter, and/or contacting the                  notice provided only the name and
                                             The other way information about the                  firm listed on the label, a process that              address listed on the label of the food
                                          manufacturer contributes to FDA’s                       in some cases has taken days and even                 rather than the actual manufacturing
                                          inspection decisions under prior notice                 weeks. The only other way to be sure                  facility, FDA would have no practicable
                                          is the agency’s use of this information                 that the subject article of food is not a             means to readily determine whether the
                                          during its manual review of a prior                     threat is to have the food stopped and                manufacturing facility is registered. As
                                          notice. Regardless of the reason a                      examined at the port of arrival to                    explained previously, the name and
                                          shipment is flagged for manual review                   determine if it is a threat. Stopping                 address on the label could be, for
                                          by the PNC, the identity of the                         shipments while FDA conducts                          example, the distributor or the parent
                                          manufacturer is one of the key elements                 additional research or an inspection                  company of the facility.
                                          FDA relies on in further assessing the                  would require significant agency                         Collecting information regarding the
                                          potential risk a shipment poses to the                  resources and could create inefficiencies             manufacturing facility of an imported
                                          United States. FDA does this by using                   for the agency, CBP, industry, and                    product and its registration status goes
                                          the identity of manufacturer, as                        consumers as food shipments back-up at                back to well before prior notice. As part
                                          provided in prior notice, to gather                     the border.                                           of the admissibility review process for
                                          additional information from a variety of                   Similarly, if the prior notice included            the various types of imported goods it
                                          sources, such as FDA’s and other                        the principal place of business of the                regulates, FDA collects, among other
                                          government agencies’ databases and                      manufacturer rather than the specific                 information, the ‘‘FDA Manufacturer’’
                                          research using publicly available                       manufacturing facility, this information              and applicable registration numbers.
                                          information. For example, FDA will                      is likely to be too broad to be helpful,              (See, for example, 70 FR 69576,
                                          often try to determine whether the                      particularly if it is a large company.                November 16, 2005.)
                                          article of food being imported is                       Each manufacturing facility is different,                The Bioterrorism Act expanded the
                                          consistent with the type or types of food               in terms of its employees, the food it                registration requirement with respect to
                                          the facility usually makes and ships to                 manufactures for the United States, its               food facilities. New section 415 of the
                                          the United States, whether the facility’s               manufacturing processes, and its                      act requires domestic and foreign
                                          owners, agents, or workers have                         security standards and procedures. One                facilities that manufacture, process,
                                          potential ties to security concerns, and                location of a company may have a                      pack, or hold food for human or animal
                                          whether FDA has found problems with                     higher standard for the security of its               consumption in the United States to be
                                          prior shipments from the facility. The                  employees and manufacturing processes                 registered with FDA, unless the facility
                                          more closely that this information is                   than another location. In those cases                 is exempted. Under new section 801(1)
                                          tied with the site-specific manufacturing               where the parent company owns or                      of the act, food from a foreign facility
                                          facility, the more reliable the risk                    contracts with multiple manufacturing                 that has not registered under section 415
                                          assessment will be. If prior notice could               facilities, FDA would have to determine               of the act is subject to being held until
                                          include the name and address of the                     the risk associated with each of these                the foreign facility has registered. It
                                          firm on the label (in lieu of the site                  facilities to ensure our review is                    could be argued that FDA should make
                                          specific manufacturer), and this firm is                adequate. Because FDA is under strict                 its determination about the food
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                                          the product’s distributor, then FDA                     timeframes to review, assess risk, and                manufacturing facility’s registration
                                          would be able to gather additional                      respond to the prior notices, conducting              status as part of the entry and
                                          information about the distributor but                   such wide-ranging research is not                     admissions process. The reason it is
                                          not the manufacturer. A risk assessment                 practical. Not only would this be                     necessary to make this determination at
                                          based on information concerning the                     prohibitively time-consuming (which                   the time FDA is reviewing prior notice


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                                          is that if the article of food is held under            facility registration provision, section              are shipped by an individual to an
                                          section 801(l) of the act, it may not be                415(b)(3) of the act, and our                         individual.
                                          delivered to the importer, owner, or                    implementing rule, 21 CFR part 1,                        Given the importance of having the
                                          consignee and cannot be moved under                     subpart H (see specifically §§ 1.227(b)(2)            site-specific manufacturer, we are also
                                          bond under section 801(b) of the act.                   and 1.226(a)). It also is consistent with             proposing a change to the CPG regarding
                                          Operationally, the only way to                          the definition of FDA manufacturer                    the identity of the manufacturer. The
                                          implement these movement restrictions                   collected as part of the entry and                    Prior Notice Interim Final Rule CPG had
                                          is to conduct the registration status                   admissibility process, which states that              a policy that covered situations where,
                                          review before entry is filed, which is                  if more than one party processed the                  after a good faith effort, the person
                                          when the prior notice review is                         article, then the manufacturer is the last            submitting prior notice did not know
                                          conducted.                                              party who substantially transformed the               the name and address of the facility that
                                             The comments recommending that                       product. (See, for example, 70 FR 69576,              manufactured the food. It stated that if
                                          the prior notice rule be expanded to                    November 16, 2005.)                                   the submitter provided certain
                                          allow the identity of the entity shown                     Applying this definition to the                    alternative information, such as the
                                          on the product label in lieu of the                     example pertaining to wine in the                     identity of the facility’s headquarters,
                                          identity of the manufacturer are                        comments, the manufacturer for                        FDA and CBP should typically consider
                                          generally based on the argument that                    purposes of prior notice would be                     not taking any regulatory action despite
                                          information about the manufacturer,                     winery ‘‘X’’ since this is the facility that          this noncompliance with the prior
                                          especially its registration number, is not              produced and bottled the wine. The                    notice requirements. The Prior Notice
                                          always available to the submitter, such                 other facilities involved in this example             Final Rule Draft CPG does not continue
                                          as when food is purchased outside the                   perform either manufacturing activities               this policy because, as described above,
                                          manufacturer’s distribution chain. The                  of a de minimis nature, such as labeling,             FDA and CBP believe that knowing the
                                          statute indicates that Congress                         or other activities not related to                    identity of the facility involved in the
                                          considered the issue of whether it                      manufacturing, such as storing and                    food’s production is critical to ensuring
                                          would be difficult or impossible to                     consolidating the wine. Thus, although                that FDA can effectively target food for
                                          provide the identity of the manufacturer                some of these facilities might have to                inspection at the border upon arrival
                                          but chose to require it nonetheless.                    register with FDA as required by 21 CFR               and can effectively determine whether
                                          Among the data required by prior notice                 part 1, subpart H as holders or packers               food should be held because it is from
                                          are the identity of the manufacturer and,               of food intended for consumption in the               an unregistered manufacturing facility.
                                          for food in its natural state, the identity             United States, the facilities in the                     Accordingly, section 1.276(b)(9) of the
                                          of the grower, if known. Section 801(m)                 example other than winery ‘‘X’’ are not               final rule defines manufacturer for the
                                          of the act expressly provides that the                  considered the last facility under the                purpose of prior notice submission as
                                          identity of the grower does not need to                 prior notice final rule’s definition of               the last facility, as that word is defined
                                          be submitted if it is not known within                  ‘‘manufacturer.’’ Regarding the                       in § 1.227(b)(2), that manufactured/
                                          the prior notice timeframes; however,                   comment on fresh fruit, FDA assumes                   processed the food. A facility is
                                          the act does not include this exemption                 that the comment is using the term                    considered the last facility even if the
                                          for the identity of the manufacturer.                   ‘‘processed’’ to mean an activity (such               food undergoes further manufacturing/
                                          This indicates that this information                    as treatment against pests or polishing)              processing that consists of adding
                                          about the manufacturer must be                          that leaves the food still in its natural             labeling or any similar activity of a de
                                          submitted regardless of any potential                   state, as explained in the definition of              minimis nature. If the food undergoes
                                          difficulties in obtaining it. With respect              ‘‘no longer in its natural state’’ under              further manufacturing/processing that
                                          to the comments that were concerned                     § 1.276(b)(10). Although subsequent                   exceeds an activity of a de minimis
                                          about situations where the person                       facilities palletize the fruit, these would           nature, then the subsequent facility that
                                          submitting prior notice does not know                   not be manufacturers because they only                performed the additional
                                          the registration number of the                          pack the food and packing is not                      manufacturing/processing is considered
                                          manufacturer, as discussed elsewhere in                 considered manufacturing/processing.                  the manufacturer. We have removed in
                                          this preamble, FDA and CBP are                          Under this scenario, no information for               the final rule the option that was in the
                                          modifying the final rule such that the                  any manufacturers would be required                   IFR to provide the label information in
                                          identity of the manufacturer can be                     for the prior notice. Instead, under                  § 101.5 instead of the name, address,
                                          submitted as the name of the                            § 1.281(a)(7) of the final rule, the prior            and registration number of the
                                          manufacturer and either the registration                notice would require the name and                     manufacturer for food sent by an
                                          number, city, and country of the                        address of the grower, if known.                      individual as a personal gift (i.e., for
                                          manufacturer, or both the full address of                  Consistent with the interpretation that            nonbusiness reasons) to an individual in
                                          the manufacturer and the reason the                     the identity of the manufacturer requires             the United States. Unless excepted
                                          registration number is not provided.                    site-specific information, we are                     elsewhere in the regulation, the identity
                                             Regarding situations where multiple                  removing the provision in the IFR                     of the manufacturer must be submitted
                                          steps are carried out by multiple                       stating that if the article of food is sent           for an article of food that is no longer
                                          entities, we have determined that ‘‘the                 by an individual as a personal gift to an             in its natural state.
                                          manufacturer’’ can reasonably be                        individual in the United States, then the                b. Does FDA have the authority to
                                          interpreted to mean the last facility that              name and address of the firm that                     require the registration number of the
                                          manufactured/processed the article. A                   appears on the label could be submitted               manufacturer of the article of food being
                                          facility is the last facility that                      instead of the identity of the facility that          imported or offered for import as a data
                                          manufactured/processed the food if the                  manufactured the food. We note,                       element in prior notice? (Comments)
                                          food does not undergo further                           however, that under the enforcement                   Many comments state that the
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                                          manufacturing/processing, other than                    policy contemplated in the Prior Notice               Bioterrorism Act does not require
                                          the addition of labeling or any similar                 Final Rule Draft CPG, FDA and CBP                     registration numbers to be submitted in
                                          activity of a de minimis nature. This                   would typically consider not taking                   prior notice. Some comments further
                                          interpretation is based on the definition               regulatory action when no prior notice                assert that the statute clearly states that
                                          of a foreign manufacturer under the food                is submitted with respect to gifts that               the ‘‘identity of the manufacturer’’ must


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                                          be included for prior notice but it does                   Another comment states that the U.S.               of entry for the article, and may not be
                                          not allude to nor require the registration              Congress placed the burden upon the                   delivered to the importer, owner, or
                                          number. Another comment explains that                   FDA to ensure that a facility’s owner,                consignee of the article, until the foreign
                                          if Congress intended FDA to require the                 operator or agent in charge complies                  facility is so registered. In the preamble
                                          registration number, it would have                      with the registration requirements                    to the IFR, we described how we would
                                          specifically articulated this requirement               established under the Bioterrorism Act                use registration in concert with prior
                                          as it did in section 321 of the                         and while it is reasonable for the FDA                notice to carry out our responsibilities
                                          Bioterrorism Act for drug and device                    to request that importers assist them in              under section 801(l) of the act
                                          imports. The comment concludes that                     this task by asking for facility                      ‘‘Registration is designed to work in
                                          the failure of the Congress to include                  registration numbers on prior notice                  concert with prior notice at the border,
                                          registration numbers in the enumerated                  submissions, the agency must not                      as reflected in new section 801(l) of the
                                          statutory elements of prior notice is                   condition lawful entry on the provision               FD&C Act, which provides that food
                                          powerful evidence that Congress did not                 of this number that may, for a variety of             from facilities that must register may not
                                          intend for FDA to require it. Another                   reasons, be unavailable to the importer.              be admitted into distribution for
                                          comment states that the act does not                       Another comment claims that FDA                    consumption in the United States unless
                                          prescribe how the identity of the                       has no jurisdiction to enforce the                    the relevant facilities have been
                                          manufacturer must be provided, and                      registration requirements upon the                    registered. To enforce section 801(l) of
                                          therefore Congress has not spoken to                    affected foreign facilities. Another                  the FD&C Act as intended by Congress,
                                          this issue. Accordingly, FDA is entitled                comment asserts that domestic food                    FDA has determined that it must review
                                          to deference in crafting a permissible                  manufacturers are not faced with this                 registration status of manufacturers and
                                          construction of the statutory                           dilemma because they are already                      shippers as part of prior notice. The
                                          requirements.                                           within the United States, and there are               information provided by registration
                                             One comment notes that all wineries                  no equivalent requirements to verify                  will allow FDA to check prior notice
                                          producing wine for consumption in the                   that domestic foods are produced at                   submissions against registration data to
                                          United States are required under section                facilities that are properly registered               confirm the identity. Moreover, the
                                          415 of the Bioterrorism Act to provide                  with FDA.                                             information provided by prior notice
                                                                                                     (Response) FDA’s position remains                  submissions can serve as a crosscheck
                                          to FDA their name, the street addresses
                                                                                                  that it has the authority to require the              as to whether these facilities are
                                          of their facilities and the trade names
                                                                                                  registration of the manufacturer as a                 registered as required and have
                                          under which they do business. It further
                                                                                                  data element in prior notice. Under                   provided the necessary updates * * *.
                                          states that as long as the importer
                                                                                                  section 801(m) of the act, prior notice               FDA does not agree that it should
                                          provides the name and address of the                    must include the identity of the
                                          manufacturer of the wine, this will be                                                                        confirm registration without requiring
                                                                                                  manufacturer. The manufacturer’s
                                          sufficient for FDA to identify whether                                                                        that the number be submitted. Each
                                                                                                  registration number is an identifier, just
                                          the manufacturer is registered with the                                                                       registered facility will be assigned a
                                                                                                  as, for example, Employer Identification
                                          FDA, and that additionally requiring the                                                                      unique registration number by FDA.
                                                                                                  numbers, Social Security numbers, and
                                          importer to furnish a registration                                                                            Thus, the registration number will help
                                                                                                  driver’s license numbers are regularly
                                          number is unnecessary to implement                                                                            identify the manufacturer. Without a
                                                                                                  used to help identify establishments and
                                          the Bioterrorism Act.                                                                                         registration number, it may be difficult
                                                                                                  individuals. Such numerical identifiers
                                             Another comment asserts that the                                                                           to determine exactly which registered
                                                                                                  are much better for matching than name
                                          obligation to verify that the                                                                                 facility to associate with the article:
                                                                                                  and address information alone. For
                                          manufacturer of a food article imported                                                                       Different firms may have the same or
                                                                                                  example, names and addresses often do
                                          or offered for import into the United                   not have standardize formats, there can               similar names and more than one firm
                                          States is registered, or is required to do              be alternative spellings and                          may operate from a particular location.’’
                                          so, is an obligation imposed upon the                   abbreviations, and misspellings are not               (68 FR 58974 at 59001). FDA continues
                                          FDA by Congress under the Bioterrorism                  uncommon. In addition, many facilities                to believe that it should use the
                                          Act, not upon the importer. The                         have similar names, even facilities in                information in prior notice to verify the
                                          comment further asserts that for FDA to                 the same country or city. Unique                      manufacturer’s registration status, and
                                          shift its burden to importers who are not               identifiers are all the more important                that the registration number is the
                                          related to the facilities required to be                given the high volume of prior notices                simplest and fastest way for us to do
                                          registered is, at the very least, unjust                that FDA needs to process, FDA’s goal                 this. FDA further notes that it verifies
                                          and certainly was not the intent of                     of processing them expeditiously, and                 the registration status of both domestic
                                          Congress. The comment further states                    the need to ensure that FDA can                       and foreign facilities. FDA’s procedures
                                          that FDA has the ability and access to                  accurately flag shipments of potential                for enforcing the registration
                                          the information necessary to verify                     concern.                                              requirements for domestic facilities are
                                          registration status of manufacturers;                      As contemplated by the Registration                explained in FDA’s ‘‘Compliance Policy
                                          unaffiliated importers do not. Another                  of Food Facilities rule, § 1.241(c), FDA              Guide—Guidance for FDA Staff,
                                          comment asserts that FDA’s overly                       also uses the identity of the                         Registration of Food Facilities Under the
                                          broad interpretation of the prior notice                manufacturer collected as part of prior               Public Health Security and Bioterrorism
                                          provision of the Bioterrorism Act results               notice to ensure that imported food is                Preparedness and Response Act of
                                          in an anticompetitive business                          from registered facilities. Section 801(l)            2002.’’ See http://www.cfsan.fda.gov/
                                          environment that is contrary to the                     of the act, which was enacted as part of              ~furls/cpgreg2.html.
                                          spirit of the Bioterrorism Act. Another                 the Bioterrorism Act, states that if an                  c. Assuming FDA can require the
                                          comment emphasizes that to enforce the                  article of food is being imported or                  manufacturer’s registration number in a
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                                          registration requirement through the                    offered for import into the United                    prior notice submission, should FDA
                                          means of prior notice requirements,                     States, and such article is from a foreign            continue to do so in the final rule and/
                                          which affect persons that are completely                facility for which a registration has not             or should FDA provide an alternative
                                          unrelated to the party responsible for                  been submitted under section 415 of the               means for submitters to provide the
                                          registering the facility, is inappropriate.             act, such article shall be held at the port           identity of the manufacturer other than


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                                                            Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations                                        66351

                                          the registration number? (Comments)                     may seek to import food products from                 therefore already have a strong incentive
                                          Several comments recommend                              manufacturers whose registration                      to register with the FDA, since that is
                                          elimination of the registration number                  number is unknown or which are not                    the only way their products can gain
                                          as a requirement for identifying the                    required to register with FDA.                        entry into the United States.
                                          manufacturer of a food no longer in its                    Other comments recommend                              Other comments suggest inspection of
                                          natural state. One comment suggests                     alternatives to the requirement to                    a food shipment to ensure its safety
                                          that inclusion of a food facility                       submit the manufacturer’s registration                when the prior notice submission lacks
                                          registration number does not ensure the                 number. The most commonly                             the required registration number, rather
                                          legitimacy of the shipment and that a                   recommended alternative to submission                 than refusal of that food as an
                                          black market for certain foods could                    of the manufacturer’s registration                    acceptable alternative. The comments
                                          result if registration numbers continue                 number is to allow submitters to                      state that this approach will avoid
                                          to be required for prior notice. Many                   identify the manufacturer by providing                situations where shipments are rejected
                                          others comments recommend                               the name and address of the facility                  while still preserving FDA’s regulatory
                                          elimination of the requirement for the                  with an accompanying reason as to why                 discretion. Another comment states that
                                          manufacturer’s registration number in                   the registration number was not                       importers who obtain food from parties
                                          various situations:                                     submitted. One comment specifically                   other than the original food
                                             • The food facility is not required to               recommends a drop-down menu that                      manufacturers are willing to bear the
                                          register because ingredients or finished                allows the submitter to explain the                   burden of increased inspections when
                                          goods manufactured by it are not                        reason for the lack of a registration                 they do not provide a manufacturer’s
                                          consumed in the United States, and thus                 number, such as ‘‘product was not                     registration number in the prior notice.
                                          it has no registration number;                          obtained from the manufacturer.’’ The                 Other comments agree that the
                                             • The manufacturer that has gone out                 comment reasons that this optional                    manufacturer’s registration number
                                          of business and does not have a facility                approach allows FDA to continue to                    should be required in prior notice
                                          registration number;                                    require registration numbers, but does                submissions, but that the prior notice
                                             • Samples for:                                       not per se invalidate a prior notice                  should not be deemed inadequate (i.e.,
                                             Any reason/any type of sample;                       based on the absence of this single piece             the food should not be refused under
                                             Any product samples not intended for                 of information. Another comment                       801(m) of the act) if the manufacturer is
                                               public consumption or for retail                   suggests that the submitter affirm that it            identified by name and address of the
                                               sale;                                              believes, to the best of its knowledge,               facility and a reason for lack of
                                             Quality control;                                     that the manufacturer is registered with              submission of the manufacturer’s
                                             Research;                                            FDA. One comment recommends that                      registration number is provided.
                                             Analytical samples that are not                      only the manufacturer’s name for a                       Another comment suggests that the
                                               intended for human or animal                       ‘‘gray market’’ food should be sufficient             final rule should be amended to provide
                                               consumption;                                       for the prior notice when the submitter               that the prior notice only need to
                                             Quality assurance samples that will                  does not know the manufacturer’s                      include such information about the
                                               be used for taste testing or quality               registration number.                                  manufacturers of older vintage wines
                                               control that includes human                           Another comment asserts that FDA                   that is readily available to the importer,
                                               consumption;                                       must consider alternative means for                   together with registration numbers for
                                             • Fine wines;                                        ensuring that all facilities subject to the           all persons who have owned the wine
                                             • Registration numbers of the parties                Registration of Food Facilities Rule (21              and all facilities that have stored the
                                          in possession of the wine over the past                 CFR part 1, subpart H) have an updated                wine over the preceding 2 years.
                                          2 years;                                                registration on file with FDA that has                   One comment suggests that FDA
                                             • All wines and distilled spirits,                   been verified. The comment further                    permit the importation of quality
                                          when a registration number is not                       suggests that taking such action will                 assurance samples that will be used for
                                          available;                                              allow the FDA to ensure that the                      taste testing or quality control that
                                             • Wine produced more than 5 years                    regulations are not implemented in a                  includes human consumption without
                                          prior to the date of its import (the year               manner that prevents the lawful import                the facility registration number of the
                                          of production is typically indicated on                 of safe and healthy food products based               foreign manufacturer or processor. The
                                          the bottle’s label, and label approvals                 solely upon the unavailability of the                 comment further suggests that in lieu of
                                          are required under U.S. Tax and Trade                   confidential facility registration number.            the registration number, the prior notice
                                          Bureau regulations);                                    Several comments assert that                          should include the manufacturer’s name
                                             • All food produced prior to                         confirmation that a facility is registered            and location along with the
                                          December 12, 2003;                                      can be made without obtaining the                     identification of the person sending the
                                             • All food sent into the country for                 registration number of the facility.                  samples.
                                          the personal consumption of the                            One comment states that, though FDA                   While most comments state that the
                                          recipient and not for business use or                   has indicated that it wants the new                   name and address of the manufacturer
                                          redistribution;                                         facility registration requirement to be               could be submitted in prior notice, one
                                             • Gifts arriving in the United States                enforced through the prior notice                     comment states that re-sellers will not
                                          from one individual to another in a                     regime, enforcement can be                            normally supply the name of their
                                          business setting; and                                   accomplished without requiring that the               supplier or the name of the
                                             • Consumer-to-consumer shipments.                    facility registration numbers be                      manufacturer of a particular product to
                                             Some comments state that the                         included in the prior notice. With the                their customers. The comment asserts
                                          requirement to provide the                              name and address of the manufacturer                  that supplying the name of the
                                          manufacturer’s registration number in                   included, FDA can look up the                         manufacturer would allow that
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                                          the prior notice is overly burdensome                   manufacturer in its database of                       customer to circumvent the re-seller and
                                          and unreasonable for some segments of                   registered manufacturers. If the                      attempt to make direct contact with the
                                          the food industry. The comments                         manufacturer has not registered, then                 supplier or manufacturer, thus taking
                                          suggest that there are numerous                         the FDA could deny entry to the articles              business away from the re-seller.
                                          legitimate reasons that food companies                  of food in question. The manufacturers                Another comment states that if only the


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                                          66352             Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations

                                          name of the manufacturer is submitted                   the fact that the manufacturing facility              submitted when no manufacturer
                                          in a prior notice, the prior notice should              submitted as part of prior notice might               registration number is provided:
                                          not be considered inadequate.                           not be registered. At best this matching                 • Situations where the facility is out
                                             Other comments support requiring the                 process may take significantly longer                 of business, as stated in § 1.235(a);
                                          registration number of the original                     (depending on the number of                              • Private residence, as stated in
                                          processor on prior notice submissions,                  manufacturers, products, and other                    § 1.227(b)(2);
                                          particularly when a third-party is                      factors involved), impeding FDA’s                        • The facility is a restaurant, as
                                          exporting the product to the United                     ability to complete its review within the             defined in § 1.227(b)(10), and qualifies
                                          States. One comment further                             prior notice timeframes. At worst, a                  for the restaurant exemption in
                                          recommends that FDA should revise its                   facility mismatch will result in FDA                  § 1.226(d);
                                          rules regarding the use of registration                 conducting its risk assessment based on                  • The facility is a retail food
                                          numbers in general, and in the prior                    incorrect information.                                establishment, as defined in
                                          notice rule in particular, to protect                      The information provided in a                      § 1.227(b)(11), and qualifies for the retail
                                          legitimate buyers and distributors from                 registration thus enables FDA to better               food establishment exemption in
                                          unauthorized ‘‘gray market’’ imports.                   assess risk of the product itself, as it              § 1.226(c);
                                          Several comments suggest that the                                                                                • The facility is a nonprocessing
                                                                                                  gives the PNC more information upon
                                          manufacturer’s registration number                                                                            fishing vessel, as stated in § 1.226(f);
                                                                                                  which to base its assessment. PNC                        • Nonbottled drinking water
                                          should be required and that only the                    reviewers use the registration
                                          registration number be submitted, not                                                                         collection and distribution
                                                                                                  information to verify whether the                     establishment, as stated in § 1.227(b)(2);
                                          the name and country. Additionally,                     articles of food in the shipment match
                                          some comments suggest that if                                                                                    • The manufacturer satisfies the
                                                                                                  the food product categories that the                  definition of ‘‘farm’’ in § 1.227(b)(3), and
                                          manufacturer and facility registration                  owner, operator, or agent-in-charge of
                                          numbers are provided and the numbers                                                                          qualifies for the farm exemption in
                                                                                                  the facility listed in the site-specific              § 1.226(b); or
                                          provided are specific to a particular                   facility’s registration with FDA. The
                                          facility location, the requirement to                                                                            • The submitter is unable to
                                                                                                  registration information also provides                determine the registration number of the
                                          complete the address information                        alternate names for a facility, lists the
                                          should be removed to avoid duplication                                                                        manufacturer. The full address of the
                                                                                                  parent company and subsidiaries of the                manufacturer has been provided by the
                                          of information.                                         facility, verifies addresses, and provides
                                             (Response) To effectively implement                                                                        submitter.
                                                                                                  the identity of the officers of the facility             The Prior Notice Final Rule Draft CPG
                                          the prior notice and registration
                                                                                                  and/or their U.S. Agents. This                        that is announced elsewhere in this
                                          provisions in the Bioterrorism Act, the
                                                                                                  additional information may identify                   issue of the Federal Register lists these
                                          final rule requires the registration
                                          number of the manufacturer or, if the                   potential terrorist threats (e.g., a facility         reasons to use when the registration
                                          registration number is not provided, the                and/or facility official has ties with a              number is not provided and describes
                                          facility’s full address and reason the                  terrorist organization). Not providing                our proposed enforcement policies.
                                          registration is not provided. Reasons for               the registration number in a prior notice                As discussed previously, without the
                                          not providing a registration number                     leads to prolonged or incomplete                      registration number, it will be more
                                          include, for example, the manufacturing                 searches, which in turn could lead to                 difficult and/or may take more time for
                                          facility is out of business; the                        additional cargo delays or examinations               us to verify the identity of the
                                          manufacturing facility is a private                     at the port of arrival as the PNC                     manufacturing facility and its
                                          residence and thus is not a ‘‘facility’’ for            completes its intensive review (see                   registration status and to determine
                                          the purposes of the registration                        earlier discussion under timeframes).                 whether the article of food is subject to
                                          requirements; and the submitter is                      We also note that registered facilities               being held under section 801(l) of the
                                          unable to determine the registration                    generally do not make their registration              act. Thus, it is in the interest of the
                                          number of the manufacturing facility.                   numbers public, so they generally have                parties involved in the import to
                                             Matching of facilities is vital for                  to be obtained directly from the                      provide the manufacturer’s name and
                                          making an initial assessment on the                     manufacturer or its designee during the               registration number, and not simply the
                                          accuracy of the prior notice; assessing                 importation process as part of                        manufacturer’s name and full address,
                                          the risk of the associated article of food              completing a prior notice. Thus it is                 because the registration number will
                                          based on the associated manufacturing                   harder to falsify registration information            help us process the shipment more
                                          facility, its operations, and history of                than the facility’s name and address,                 expeditiously. The submitter should
                                          importations; and verifying registration                deterring the submission of false                     exercise a reasonable amount of effort to
                                          status. Without the registration number,                manufacturer identification information.              obtain and provide the registration
                                          PNC reviewers have to conduct this                         In some cases, the registration number             number before using the reason ‘‘the
                                          matching using the name and address                     of the manufacturer is not available to               submitter is unable to determine the
                                          submitted in a prior notice. Due to the                 the submitter, and therefore, we have                 registration number of the
                                          potential for human error during data                   revised the rule to provide an alternate              manufacturer.’’
                                          input or deviations in the spelling or                  means for satisfying the requirement to                  FDA does not agree with the
                                          format of a facility’s name, address or                 provide the identity of the site-specific             comments asserting that the registration
                                          city, FDA may incorrectly think it has                  manufacturer in prior notices. For                    number is sufficient by itself to
                                          found a match between the facility                      purposes of the prior notice final rule,              ‘‘identify’’ a facility in a prior notice
                                          described in the prior notice and a                     the identity of the manufacturer is the               submission. The additional information
                                          facility in the registration database.                  name of the manufacturer and either: (1)              is needed to verify that the registration
                                          Similarly, the facility described in the                The registration number, city, and                    number, which is comprised of eleven
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                                          prior notice may be close, but not exact,               country of the manufacturer or (2) both               digits, is accurate. Without additional
                                          to several facilities listed in the                     the full address of the manufacturer and              information, there is a significant
                                          registration database, causing                          the reason the registration number is not             possibility of typographical errors,
                                          uncertainty as to which, if any, is the                 provided (see § 1.281(a)(6), (b)(5), (c)(6)).         leading to misidentification of facilities,
                                          correct match. This is complicated by                   One of the following reasons may be                   which could lead to foods being stopped


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                                                            Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations                                        66353

                                          at the port for inadequate prior notice                 submitter may submit either the                       shoppers are hired to collect company
                                          and registration. There also is the                     manufacturer’s registration number,                   trademark products, package these
                                          possibility of someone entering data in                 city, and country or both the                         according to company-established
                                          an attempt to ‘‘guess’’ at a registration               manufacturer’s full address and the                   protocol, enclose purchase information
                                          number. Having identifying information                  reason why the registration number is                 and ship these to designated
                                          in addition to the registration number                  not provided.                                         laboratories in the United States. and
                                          helps prevent such guessing. Having                        d. Questions seeking clarification.                the shoppers often have no way of
                                          this confirmatory information also                         i. Designation of grower. (Comments)               knowing the identity of the specific
                                          allows us to notify submitters of a                     Two comments state that they are                      manufacturing facility. One comment
                                          mismatch before the prior notice is                     exempt from the registration                          states that it is not likely that a
                                          accepted and confirmed for review,                      requirements because they are farms;                  manufacturer’s registration number
                                          which allows them to correct any                        however, they want guidance regarding                 would be available for competitive
                                          inadvertent errors before the food                      the steps these farms should follow to                product samples and for finished
                                          arrives at the port, where it otherwise                 ensure that their products move through               product samples used for evaluation
                                          may be subject to refusal for an                        the prior notice system without delays                purposes, as well as for articles used for
                                          inadequate (inaccurate) prior notice.                   at the port.                                          research and development purposes.
                                             If the prior notice does not contain                    (Response) If the article of food is no            The comment states that the registration
                                          either the manufacturer’s registration                  longer in its natural state, such that the            number does not fall under the Freedom
                                          number or the reason and name and full                  identity of the manufacturer is required,             of Information Act and in some cases,
                                          address, the food is subject to refusal of              the submitter can submit a reason for                 the manufacturer’s facility may not be
                                          admission under section 801(m)(1) of                    why the registration number was not                   required to register since the article of
                                          the act for failure to provide adequate                 provided; i.e., facility is a grower, meets           food was not intended for consumption
                                          prior notice, as the identity of the                    farm exemption. These reasons also are                in the United States. Another comment
                                          manufacturer is incomplete. The food                    listed in the Prior Notice Final Rule                 provides the example of when a
                                          also may be subject to a hold under                     Draft CPG announced elsewhere in this                 consumer expresses a concern about
                                          section 801(l) of the act if the food is                issue of the Federal Register. If the                 either the quality or safety of a
                                          from a foreign manufacturer that is not                 article of food is in its natural state, the          purchased food, and the consumer is
                                          registered under section 415 of the act.                identity of the manufacturer is not                   instructed to ship that product to the
                                             In response to comments from those                   required and the systems will know that               U.S.-based franchise company
                                          who are importing food from a facility                  they do not need to verify the                        laboratory for a timely analytical
                                          that is not registered because food                     manufacturing facility’s registration                 assessment.
                                          manufactured by it is not intended to be                status.                                                  (Response) We have revised the final
                                          consumed in the United States, FDA                         ii. Manufacturer cancels registration.             rule such that the identity of the
                                          notes that these shipments are subject to               (Comments) A comment asks what                        manufacturer must include the name of
                                          hold under 801(l) of the act. Under                     designation is appropriate for the                    the manufacturer and either the
                                          section 801(l) of the act, food is subject              scenario where at the time of production              registration number, city, and country of
                                          to being held if it is imported or offered              the manufacturing/processing facility                 the manufacturer or both the full
                                          for import into the United States and it                was legitimately registered with the                  address of the manufacturer and the
                                          is from a foreign facility that has not                 FDA, but cancelled its registration prior             reason the registration number is not
                                          registered. This provision applies                      to the importer submitting prior notice.              provided. Relevant to these comments,
                                          regardless of whether the food was                         (Response) If the manufacturing                    one of the reasons for not providing the
                                          intended for consumption in the United                  facility still is operational, but chooses            registration number is that the submitter
                                          States at the time it was manufactured,                 to cancel its registration with FDA, then             is unable to determine it. However, as
                                          for example where an article of food is                 the food from this facility is subject to             described above, if the article of food is
                                          made in Country X for consumption in                    refusal under 801(l) of the act. As stated            from an unregistered facility, it is
                                          Country X, but is purchased by a third                  therein, ‘‘If an article of food is being             subject to being held under section
                                          party who re-labels the product for                     imported or offered for import into the               801(l) of the act. Moreover, without the
                                          import and resale in the United States.                 United States, and such article is from               registration number, it will be more
                                             (Comments) One comment                               a foreign facility for which a registration           difficult and/or may take more time for
                                          recommends that inter-company gifts be                  has not been submitted to [FDA], such                 FDA to verify the identity of the
                                          exempt from the requirement to provide                  article shall be held at the port of entry            manufacturing facility and its
                                          the manufacturer’s registration number                  for the article, and may not be delivered             registration status. As a result, the food
                                          on the prior notice because these items                 to the importer, owner, or consignee of               may be delayed until the verification is
                                          have no commercial value and are sent                   the article, until the foreign facility is so         completed.
                                          as business gifts. The comment suggests                 registered.’’ If the facility has canceled               While the final rule requires prior
                                          that FDA use the same approach for                      its registration because it has gone out              notice, including the identity of the
                                          business and nonbusiness gifts, by                      of business, then this reason may be                  manufacturer, for shipments of samples,
                                          allowing a listing of the manufacturer’s                entered on the prior notice.                          under the enforcement policy proposed
                                          name and address as it appears on the                      iii. Identity of manufacturer for                  in the Prior Notice Final Rule Draft CPG,
                                          product’s label.                                        samples. (Comments) One comment                       FDA and CBP should typically consider
                                             (Response) The provisions in the final               states that there are some circumstances              not taking any regulatory action with
                                          rule regarding the registration number                  involving market survey and consumer                  respect to prior notice violations when
                                          are being revised, and these revised                    complaint samples where the                           an article of food is imported or offered
                                          provisions apply to both business and                   manufacturing facility is unknown to                  for import for quality assurance,
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                                          nonbusiness shipments. The final rule                   the submitter of prior notice and the                 research or analysis purposes only, not
                                          no longer allows for submission of the                  manufacturing facility may not have a                 for human or animal consumption
                                          name and address as it appears on the                   registration number because it does not               without prior notice.
                                          label in any situation. However, the rule               do business in the United States. One                    iv. U.S. manufacturer of product
                                          also is being changed such that the                     comment provides the example of when                  being imported. (Comments) Two


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                                          66354             Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations

                                          comments express concern that FDA                       encourages the agency to allow                        unable to determine the registration
                                          would reject a prior notice for imported                American importers to query a database                number of the manufacturer, the
                                          food that contains a U.S. manufacturing                 that would do nothing more than                       submitter may provide a reason along
                                          facility and that facility’s registration               confirm whether the details provided                  with the name and full address of the
                                          number.                                                 are accurate. Another comment suggests                manufacturer.
                                             (Response) Both ABI/ACS and PNSI                     that FDA make the registration database                 (Final rule) Section 1.281(a)(6), (b)(5),
                                          accept the identity of a manufacturing                  available to authorized customs brokers               and (c)(6) of the final rule requires for
                                          facility from any internationally                       only.                                                 an article of food that is no longer in its
                                          recognized country designation,                            (Response) FDA does not intend to                  natural state, the identity of the
                                          including the United States. FDA                        direct registered food facilities to                  manufacturer, as follows: the name of
                                          recognizes that some food imported into                 divulge their registration numbers on                 the manufacturer; and either the
                                          the U.S. is manufactured in the U.S.,                   documents or upon request. However,                   registration number, city, and country of
                                          exported, and then re-imported. Prior                   FDA does agree that guidance regarding                the manufacturer or both the full
                                          notice applies to these articles of food                divulging registration numbers and                    address of the manufacturer and the
                                          and identification of the U.S. facility as              prior notice submissions may help to                  reason the registration number is not
                                          the manufacturer is correct.                            clarify the process, and provided this                provided.
                                             v. Require manufacturer to reveal or                 guidance in our ‘‘Guidance for Industry,
                                          conceal the registration number.                                                                              8. The Grower, if Known
                                                                                                  Questions and Answers Regarding
                                          (Comments) Two comments recommend                       Registration of Food Facilities Final                    The Bioterrorism Act requires the
                                          that FDA compel manufacturers to                        Guidance’’ available at http://                       submission of the identity of the grower
                                          divulge their food facility registration                www.cfsan.fda.gov/~dms/ffregui4.html.                 of the article, if that identity is known
                                          numbers upon inquiry. Another                              vi. Exporting facility. (Comments) One             within the specified period of time that
                                          comment requests that FDA issue                         comment requests that FDA                             notice is required to be provided.
                                          guidance stating that: FDA does not                     accommodate the importation of                        Section 1.281(a)(7), (b)(6), and (c)(7) of
                                          require the registration number on                      previously manufactured food products                 the IFR requires for an article of food
                                          commercial documents; the inclusion of                  that were purchased at retail outlets                 that is in its natural state, submission of
                                          a registration number on commercial                     outside the United States and                         the name and growing location address
                                          documents will not facilitate clearance                 recommends that FDA require only the                  of the grower, if known. If the submitter
                                          by CBP or FDA of the shipment; and                      registration number of the exporting                  does not know the identity of the grower
                                          FDA recommends that companies reveal                    facility and information identifying the              or, if the article has been consolidated,
                                          this confidential information once only                 company responsible for the product.                  and the submitter does not know the
                                          in a formal letter and ensure by all                    The comment reasons that this                         identity of any of the growers, the
                                          possible means that their customer (e.g.,               information, along with other identity                submitter may provide the name and
                                          distributor, importer, or customs broker)               information required by prior notice,                 address of the firm that has consolidated
                                          also respect the confidentiality of this                should be sufficient for FDA and CBP to               the articles of food from different
                                          information. One comment cautions                       make risk decisions about a particular                growers or different growing locations.
                                          about reported abusive and misleading                   import.                                                  (Comments) One comment asks that
                                          declaration of a registration number in                    (Response) FDA disagrees. The                      the requirement to identify the grower
                                          a prior notice for shipments that are                   Bioterrorism Act requires the identity of             not be mandatory in the final rule and
                                          unconnected with the food facility that                 the manufacturer as well as the shipper.              suggests exempting the growers and
                                          actually owns that registration number.                 The identity of the shipper or the                    providing the information of growers on
                                          Another comment suggests that FDA                       exporting facility alone is not sufficient            a voluntary basis. Another comment
                                          should revise both the prior notice and                 to satisfy the requirements of the statute.           asserts that it is virtually impossible to
                                          registration rules to clarify that those                The facility that manufactured the food               identify each grower once grain is
                                          doing business with the owner of a                      must be identified.                                   commingled at the country elevator.
                                          facility should not and have no reason                     vii. Food imported or offered for                     (Response) The Bioterrorism Act
                                          to demand the facility registration                     import for transshipment, storage, and                requires the identity of the grower, if
                                          number.                                                 export, or further manipulation and                   known, in the submission of prior
                                             Several comments suggest that FDA                    export. In the IFR, a registration number             notice. Therefore, we cannot eliminate
                                          provide a means for importers and                       is not required for a facility associated             the requirement to provide the identity
                                          others to verify a facility’s registration,             with an article of food if the article is             of the grower in all cases, as suggested
                                          even if such verification does not                      imported or offered for import for                    by the comment. If the identity of the
                                          disclose any information beyond                         transshipment, storage, and export, or                grower is not known at the time of
                                          affirmation or denial. One comment                      further manipulation and export. We                   submission of the prior notice, and the
                                          suggests that FDA compare                               have removed this exception in the final              food has been consolidated, then the
                                          Manufacturer Identity (MID) data                        rule because we have determined that                  submitter may, but is not required to,
                                          submitted through ABI/ACS to the FDA                    section 801(m) of the act requires the                provide the name and address of the
                                          Food Facility Registration database and                 identity of the manufacturer for food                 consolidator (§ 1.281(a)(7), (b)(6), and
                                          notify the transmitter of a MID                         imported or offered for import into the               (c)(7)).
                                          mismatch while keeping actual                           United States, regardless of whether that                (Comments) Another comment states
                                          registration information secure. The                    food will be consumed in the United                   that a single shipment of fresh fruit may
                                          comment reasons that this process                       States. Likewise, under section 801(l) of             represent hundreds of growers, all of
                                          would give the submitter and                            the act, food is subject to being held if             whom are known by the submitter of the
                                          transmitter of a prior notice a                         it is imported or offered for import into             prior notice. The comment asserts that
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                                          noncompliance alert and also would                      the United States and it is from a foreign            requiring submission of an individual
                                          alert the agency of possible additional                 facility that has not registered. This                prior notice for each article represented
                                          intensive review requirements even                      provision applies even if the food is not             by a single grower seems unnecessarily
                                          before the prior notice submission has                  for consumption in the United States.                 burdensome. The comment suggests that
                                          been completed. Another comment                         As noted previously, if the submitter is              in lieu of requiring identification of all


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                                          known growers in the prior notice, the                  assuming the imports for each grower                  manufacturing/processing step that
                                          rule should require the submitter of the                are distinctly packaged.                              exceeds an activity of a de minimis
                                          prior notice to retain a complete list of                  (Final rule) Section 1.281(a)(7), (b)(6),          nature.
                                          growers and to make this list available                 and (c)(7) of the final rule requires for               (Final rule) The final rule retains
                                          to FDA for inspection and copying upon                  an article of food that is in its natural             without change the provisions in
                                          request.                                                state, the submission of the name and                 § 1.281(a)(8), (b)(7), and (c)(8) of the IFR.
                                             (Response) We do not agree. Periodic                 growing location address of the grower,
                                                                                                                                                        10. Shipper
                                          access, inspection, and copying of a                    if known. If the submitter does not
                                          complete listing of all growers of an                   know the identity of the grower or, if the               The Bioterrorism Act requires the
                                          article of food does not satisfy the                    article has been consolidated and the                 submission of the identity of the shipper
                                          requirement to identify the grower of                   submitter does not know the identity of               of the article. The IFR at § 1.281(a)(9),
                                          the article of food, if known, within the               any of the growers, the name and                      (b)(8), and (c)(9) requires that the
                                          specified period of time that notice is                 address of the firm that has consolidated             shipper be included in a prior notice.
                                          required to be provided. FDA responded                  the articles of food from different                   The IFR defines shipper (§ 1.277(b)(12))
                                                                                                  growers or different growing locations                as the owner or exporter who consigns
                                          to a similar comment in the prior notice
                                                                                                  may be submitted.                                     and ships the article of food from a
                                          IFR and explained that FDA does not
                                                                                                                                                        foreign country or the person who sends
                                          agree that a list would satisfy the                     9. FDA Country of Production                          an article of food in international mail
                                          statutory requirement, as it would not
                                                                                                     The Bioterrorism Act requires the                  to the United States.
                                          tell FDA which grower was associated                                                                             (Comments) One comment states that
                                                                                                  submission of the identity of the
                                          with the particular article of food as                                                                        the FDA has augmented section 307 of
                                                                                                  country from which the article
                                          envisioned by the statute (68 FR 58974                                                                        the Bioterrorism Act to require not only
                                                                                                  originates. The IFR in § 1.281(a)(8),
                                          at 59006). We affirm the view here.                                                                           supply chain party identification but
                                                                                                  (b)(7) and (c)(8), requires that a prior
                                             (Comments) One comment requests                      notice contain the FDA Country of                     also the registration number of the
                                          that FDA reconsider the requirement to                  Production of the article of food being               shipper. The comment further states
                                          submit the names of multiple growers,                   imported or offered for import into the               that the requirement to submit the
                                          if known, in the prior notice. The                      United States. As set out in the IFR                  shipper’s registration number is easily
                                          comment notes that submitters of prior                  definition at § 1.276(b)(4), the FDA                  met. There were no other comments
                                          notices must provide separate notices                   Country of Production is, for an article              received on this issue.
                                          for each grower in the case of                          of food in its natural state, the country                (Response) We revised certain
                                          consolidated shipments (if the growers                  where the article of food was grown,                  sections pertaining to the identity of the
                                          are known), which it asserts is onerous                 including harvested or collected and                  shipper. The IFR required the
                                          and costly for exporters of consolidated                readied for shipment to the United                    registration number of the shipper, if the
                                          shipments of horticulture products. The                 States. If, however, an article of food is            shipper is required to be registered. The
                                          comment believes that the proposed                      wild fish, including seafood, that was                final rule requires the identity of the
                                          recordkeeping rules will cause the                      caught or harvested outside the waters                shipper only if the shipper is different
                                          names of the growers to be recorded and                 of the United States by a vessel that is              from the manufacturer. Moreover, the
                                          available and the prior notice                          not registered in the United States, the              final rule eliminates the requirement to
                                          information is a duplication of effort.                 FDA Country of Production is the                      submit the registration number of the
                                          The comment asks that, for consolidated                 country in which the vessel is                        shipper, if the shipper is required to be
                                          shipments, FDA permit the submission                    registered. For a food that is no longer              registered, and made the submission of
                                          of one prior notice providing the name                  in its natural state, the FDA Country of              the registration number optional. The
                                          of the consolidator or one notice with                  Production is the country where the                   identity of the shipper in the final rule
                                          the names of all the growers.                           article of food was made. However, if an              is satisfied by submission of the name
                                             (Response) FDA disagrees. Adding the                 article of food is made from wild fish,               and full address of the shipper.
                                          capability to accept a list of growers                  including seafood, that was made                         (Final rule) The final rule in
                                          would add considerable complexity to                    aboard a vessel, the FDA Country of                   § 1.281(a)(9), (b)(8), and (c)(9) requires
                                          both the data entry software (PNSI and/                 Production is the country in which the                the name and full address of the
                                          or ABI) and the screening programs.                     vessel is registered. The IFR also                    shipper, if the shipper is different from
                                          FDA responded to a similar comment in                   provides that the FDA Country of                      the manufacturer. If the address of the
                                          the prior notice IFR and explained that                 Production of food grown and harvested                shipper is a registered facility, the
                                          FDA does not agree that a list would                    or collected or made in a U.S. Territory              submitter may submit the registration
                                          satisfy the statutory requirement, as it                is the United States.                                 number of the shipper’s registered
                                          would not tell FDA which grower was                        (Comments) One comment asks what                   facility.
                                          associated with the particular article of               is required as the country of production                 FDA revised this requirement to
                                          food as envisioned by the statute (68 FR                in a case where spirits are exported in               require the shipper’s information only
                                          58974 at 59006). And as we explained                    bulk to a third-country for local bottling            when the shipper is different from the
                                          in the previous response, periodic                      and subsequent export from that third-                manufacturer in order to eliminate
                                          access, inspection, and copying of a                    country for consumption in the United                 duplicative requirements. Moreover, we
                                          complete listing of all growers of an                   States.                                               eliminated the requirement to provide
                                          article of food does not satisfy the                       (Response) For a food that is no longer            the registration number of the shipper,
                                          requirement to identify the grower of                   in its natural state (e.g. spirits), the FDA          if the shipper is required to be
                                          the article of food, if known, within the               Country of Production is the country                  registered, and made the submission of
                                          specified period of time that notice is                 where the article of food was made (e.g.              the registration number optional.
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                                          required to be provided. FDA notes that                 bottled). For an article of food that                    In the IFR, the shipper’s registration
                                          users of PNSI can create a prior notice                 undergoes multiple manufacturing                      number is not required for a facility
                                          for one grower, copy that prior notice,                 steps, as in this comment, the FDA                    associated with an article of food if the
                                          and edit just the grower information and                Country of Production would be country                article is imported or offered for import
                                          the quantity and packaging information,                 where the last facility performs a                    for transshipment, storage, and export,


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                                          or further manipulation and export. We                  border. The coordination procedures                   OASIS regardless of the estimated time
                                          have removed this exception in the final                between FDA and CBP should not be                     of arrival date.
                                          rule since the shipper’s registration                   construed to mean that arrival                           (Response) Such changes to the ABI
                                          number is now optional.                                 information is no longer important nor                system are not feasible at this time given
                                                                                                  that we will not, whenever possible,                  resource constraints, and the
                                          11. The Country From Which the Article                  conduct necessary inspections at the                  development of CBP’s new Automated
                                          is Shipped                                              port. Moreover, FDA’s working with                    Commercial Environment. Moreover,
                                             The Bioterrorism Act requires the                    CBP personnel does not negate our need                CBP transfers information to FDA at 8
                                          submission of the identity of the                       for anticipated time and date of arrival              p.m. on the day before arrival for truck
                                          country from which the article is                       since headquarters and field staff still              shipments and 9 p.m. on the day before
                                          shipped. The IFR requires in                            need to know when articles of food plan               arrival for air shipment. Information is
                                          § 1.281(a)(10) and (c)(10) submission of                to arrive.                                            transferred to FDA on the same day if
                                          the identity of the country from which                     (Comments) One comment states that                 that information is submitted the same
                                          the article is shipped. In § 1.281(b)(9),               the arrival information should be linked              day as anticipated arrival of the
                                          the IFR requires submission of the                      to the ABI entry filing at the port of                shipment. CBP and FDA believe that
                                          identity of the country from which the                  entry because the FDA prior notice                    this is sufficient for meeting the
                                          article is shipped (i.e., mailed).                      requirement is inconsistent with the                  timeframes for receipt, review, and
                                             (Comments) There were no comments                    existing entry clearance processes of                 response to prior notice submission.
                                          received on this issue.                                 CBP. The comment contends that                           (Comments) Two comments address
                                             (Final Rule) The final rule retains                  requiring prior notice at the port of                 the difficulty of obtaining exact arrival
                                          without change the provisions in                        arrival will result in severe disruption to           information, including a specific time of
                                          § 1.281(a)(10), (b)(9), and (c)(10) of the              flight schedules, with the possible                   arrival for air shipments, because many
                                          IFR.                                                    consequence of aircraft offload for any               airlines are often closed at night. The
                                                                                                  affected food shipment for which prior                comment also states that including a
                                          12. Anticipated Arrival Information
                                                                                                  notice was not submitted.                             specific date and time for arrivals by
                                             Section 1.281(a)(11) of the IFR                         (Response) FDA disagrees. The                      ocean vessel is difficult.
                                          requires the submission of anticipated                  Bioterrorism Act requires notification                   (Response) FDA disagrees. From
                                          arrival information to include the                      about articles of food prior to arrival in            FDA’s standpoint, ‘‘time of arrival’’
                                          anticipated port of arrival and                         the United States. Although prior notice              relates to when the food will first
                                          anticipated border crossing; the                        and entry information can be submitted                become available for examination at the
                                          anticipated date on which the article of                together through ABI/ACS, prior notice                port. For vessels, this would be when
                                          food will arrive at the anticipated port                cannot be substituted by the entry                    the vessel docks in the port. For planes,
                                          of arrival; and the anticipated time of                 process, which legally can occur well                 this would be when the plane lands. For
                                          that arrival. In § 1.281(c)(11), the IFR                after the food has arrived in the United              land vehicles, such as trucks, buses, and
                                          requires the submission of the actual                   States. Since implementation of the IFR,              trains, this would be when they cross
                                          port of arrival. Anticipated arrival                    FDA and CBP have noted no severe                      the border. FDA believes that someone
                                          information is not required for food                    disruptions, including to flight                      involved in importing or offering for
                                          arriving by international mail.                         schedules due to lack of prior notice of              import an article of food has an
                                             A prior notice will not be inadequate                some articles of food within an aircraft,             indication of anticipated arrival into the
                                          if the anticipated port of arrival, the                 truck, or vessel load. FDA points out                 United States of that food and can
                                          anticipated date of arrival, or the                     that in December 2003, CBP issued and                 inform the submitter and/or transmitter
                                          anticipated time of arrival changes                     began implementation of the Advance                   of the prior notice. FDA also emphasizes
                                          between the time of confirmation of                     Electronic Cargo Information rule,                    that the information being requested is
                                          prior notice and the time of arrival, as                which also requires information about                 ‘‘anticipated’’ information, not ‘‘exact’’
                                          provided by § 1.282(a) of the IFR.                      cargo before it arrives in the United                 or ‘‘specific’’ information as the
                                             The anticipated arrival information                  States and allows for prohibition of                  comment incorrectly describes.
                                          must specify the anticipated port of                    landing authorization if such                            (Final rule) FDA and CBP have
                                          arrival and, if there is more than one                  information is not provided in advance                determined that for the purposes of
                                          border crossing location within that                    of arrival. (See 19 CFR 122.12(c)                     communication, the identity of the
                                          port, the specific anticipated border                   (international airports), 19 CFR                      border crossing within the port of
                                          crossing where the food will be brought                 122.14(d)(4) (landing rights airports);               arrival is no longer necessary. Therefore,
                                          into the United States.                                 and 19 CFR 122.15(a) (user fee                        that information is not required in the
                                             (Comments) One comment suggests                      airports).)                                           final rule. The final rule requires in
                                          the elimination of the anticipated arrival                 (Comments) One comment                             § 1.281(a)(11) the anticipated arrival
                                          information as a data element. Another                  recommends that FDA ask CBP to                        information, including the anticipated
                                          comment suggests that in light of the                   change their ABI system to provide for                port of arrival, the anticipated date on
                                          MOU between FDA and CBP, arrival                        port diversion functionality. The                     which the article of food will arrive at
                                          data are no longer important, as CBP can                comment acknowledges that, although                   the anticipated port of arrival, and the
                                          provide the personnel to conduct the                    the FDA prior notice system is designed               anticipated time of that arrival. If the
                                          necessary inspections.                                  to allow a shipment to be diverted to a               article of food is arriving by express
                                             (Response) Section 801(m) of the act                 port other than the intended port of                  consignment operator or carrier, and
                                          requires the submission of the identity                 entry reported in the prior notice, CBP’s             neither the submitter nor transmitter is
                                          of the anticipated port of entry for the                ABI system precludes the CBP entry                    the express consignment operator or
                                          article of food, therefore, this data                   from being accepted at other than the                 carrier, and the prior notice is submitted
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                                          element cannot be eliminated. The                       reported port of entry. Another                       via PNSI, the express consignment
                                          anticipated time and date of arrival are                comment requests that when a prior                    operator or carrier tracking number may
                                          needed for planning resources because                   notice is transmitted via either the Cargo            be submitted in lieu of the anticipated
                                          it relates to when the food will first                  or Border Cargo Selectivity application,              arrival information. This revision is
                                          become available for examination at the                 the data should be moved from ACS to                  being made because anticipated arrival


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                                          information is often not available to                   full address. Providing the registration              to the entry of merchandise. In a case
                                          people who ship food using an express                   number will facilitate FDA’s review.                  where a customer or consignee has not
                                          consignment operator or courier (see                    The identity of the importer is not                   been identified, as described in the
                                          also the discussion in section III.E of                 required for an article of food that is               previous comment, the public storage
                                          this document describing the shipper as                 imported or offered for import for                    warehouse where the merchandise will
                                          it relates to who is authorized to submit               transshipment through the United States               be delivered and stored should be
                                          prior notice). For food that has been                   under a T&E entry.                                    identified as the ultimate consignee in
                                          refused under section 801(m) of the act,                   b. Owner. (Comments) One comment                   the prior notice submission.
                                          § 1.281(c)(11) of the final rule requires               asks that FDA clarify what it means by
                                                                                                                                                           (Final rule) Section 1.281(a)(14) and
                                          the port of arrival. We revised this                    owner and provide examples.
                                                                                                     (Response) In the preamble to the IFR,             (c)(14) of the final rule requires the
                                          provision in the final rule to require the
                                                                                                  in response to a comment, we explained                name and full address of the ultimate
                                          actual date on which the article of food
                                                                                                  that the ‘‘owner’’ is the entity who owns             consignee. FDA is continuing to require
                                          arrived at the port of arrival. This
                                          information is important for shipments                  the article of food at the time of arrival            the identity of the ultimate consignee so
                                          where no previous prior notice was filed                (68 FR 58974 at 59011). However, if a                 that FDA can take steps to ensure that
                                          so that FDA knows how long it has been                  prior notice is given after the article is            food refused admission under section
                                          since the refused food shipment arrived                 refused under section 801(m)(1) of the                801(m) of the act is not delivered to the
                                          in the United States. For shipments                     act, then the owner is the entity who                 ultimate consignee illegally. FDA is
                                          where a previously refused prior notice                 owns the article of food at the time the              inserting the word ‘‘full’’ in front of
                                          was filed, the actual arrival date will                 prior notice is submitted (Id.).                      ‘‘address’’ in the final rule to make clear
                                          help FDA to connect the refused prior                      (Final rule) The final rule in                     that the complete address is required.
                                          notice to the post-refusal prior notice                 § 1.281(a)(13) and (c)(13) requires the               Consequently, FDA is revising the
                                          submission. Anticipated arrival                         name and full address of the owner if                 subsequent sentence to state that if the
                                          information is not required for food                    different from the importer or ultimate               business address of the ultimate
                                          arriving by international mail.                         consignee. FDA is continuing to require               consignee is a registered facility, then
                                                                                                  the identity of the owner so that FDA                 the facility’s registration number also
                                          13. The Importer, Owner, Ultimate                       can take steps to ensure that food                    may be provided in addition to the
                                          Consignee, and U.S. Recipient                           refused admission under section 801(m)                facility’s full address. The identity of
                                             In § 1.281(a)(12) and (c)(12), the IFR               of the act is not delivered to the owner              the ultimate consignee is not required
                                          requires the name and address of the                    illegally. FDA is inserting the word                  for an article of food that is imported or
                                          importer. In § 1.281(a)(13) and (c)(13),                ‘‘full’’ in front of ‘‘address’’ in the final         offered for import for transshipment
                                          the IFR requires the name and address                   rule to make clear that the complete                  through the United States under a T&E
                                          of the owner if different from the                      address is required. Consequently, FDA                entry.
                                          importer or ultimate consignee. In                      is revising the subsequent sentence to
                                                                                                                                                           d. U.S. recipient. (Comments) There
                                          § 1.281(a)(14) and (c)(14), the IFR                     state that if the business address of the
                                                                                                                                                        were no comments received on this
                                          requires the name and address of the                    owner is a registered facility, then the
                                                                                                                                                        issue.
                                          ultimate consignee. However, the                        facility’s registration number may be
                                          identity of the importer, owner, and                    provided in addition to the owner’s full                 (Final rule) The identity of the
                                          ultimate consignee are not required for                 address. The identity of the owner is not             importer, owner, or ultimate consignee
                                          an article of food that is imported or                  required for an article of food that is               is not required for an article of food that
                                          offered for import for transshipment                    imported or offered for import for                    is imported or offered for import via
                                          through the United States under a T&E                   transshipment through the United States               international mail. Instead, the final rule
                                          entry.                                                  under a T&E entry.                                    requires in § 1.281(b)(11) the name and
                                             The identity of the importer, owner,                    c. Ultimate consignee. (Comments)                  address of the U.S. recipient. FDA is
                                          or ultimate consignee is not required for               One comment states that the ultimate                  continuing to require the identity of the
                                          an article of food that is imported or                  consignee, as defined by CBP (Customs                 U.S. recipient so that FDA can take
                                          offered for import via international mail.              Directive No. 3550–079A), is not                      steps to ensure that food refused
                                          Instead, § 1.281(b)(11) of the IFR                      necessarily the party to whom the                     admission under section 801(m) of the
                                          requires the name and address of the                    merchandise is delivered and asks who                 act is not delivered to the U.S. recipient
                                          U.S. recipient.                                         is the ultimate consignee for purposes of             illegally.
                                             a. Importer. (Comments) There were                   this rule. Another comment notes that
                                          no comments received on this issue.                     there are a number of manufacturers in                14. Mode of Transportation
                                             (Final rule) The final rule in                       Canada who ship their product to public                 Section 1.281(a)(15) and (c)(15) of the
                                          § 1.281(a)(12) and (c)(12) requires the                 warehouses in the United States to have               IFR requires submission of the identity
                                          name and full address of the importer.                  product available on a just-in-time basis             of the mode of transportation.
                                          FDA continues to require the identity of                for their customers. The comment states
                                          the importer so that FDA can take steps                 that at the time the product crosses the                (Comments) There were no comments
                                          to ensure that food refused admission                   border, it is still the property of the               received on this issue.
                                          under section 801(m) of the act is not                  manufacturer and it does not have a                     (Final rule) The final rule retains
                                          delivered to the importer illegally. FDA                specific customer (consignee) in the                  without change the provisions in
                                          is inserting the word ‘‘full’’ in front of              United States other than the                          § 1.281(a)(15) and (c)(15) of the IFR. The
                                          ‘‘address’’ in the final rule to make clear             manufacturer because the consignee is                 mode of transportation data element is
                                          that the complete address is required.                  still to be determined. The comment                   necessary to calculate whether prior
                                          Consequently, FDA also is revising the                  asks for guidance as to how to comply                 notice is timely, as well as for
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                                          subsequent sentence of this paragraph to                and fill out the prior notice for these               identification of the article of food at the
                                          state that if the business address of the               types of shipments.                                   time of arrival for the purposes of
                                          importer is a registered facility, then the                (Response) FDA intends to interpret                planning examinations and
                                          facility’s registration number also may                 the ‘‘ultimate consignee’’ consistent                 communicating with CBP for
                                          be provided in addition to the facility’s               with CBP’s use of that term in regards                enforcement and examination.


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                                          15. Carrier                                             vehicle as the carrier, when applicable,              the final rule contains a table of
                                             Section 1.281(a)(16) and (c)(16) of the              is such a critical factor in the                      information required at the end of this
                                          IFR requires the SCAC or IATA code of                   identification of the article of food for             section (table 2 of this document). Each
                                          the carrier which is, or will be, carrying              examination and communication, that                   information requirement listed in the
                                          the article of food from the country from               we have included this information in                  table 2 of this document is annotated to
                                          which the article is shipped to the                     § 1.281(a)(16) and (c)(16) of the final               indicate when that information is
                                          United States, or if codes are not                      rule.                                                 required.
                                                                                                     Section 1.281(a)(16) and (c)(16) of the               (Comments) One comment suggests
                                          applicable, then the name and country
                                                                                                  final rule requires the identity of the               an additional requirement for planned
                                          of the carrier.
                                                                                                  carrier by submission of the SCAC or                  shipment information. The comment
                                             (Comments) Several comments ask for
                                                                                                  IATA code of the carrier which is, or                 suggests that a number assigned through
                                          clarification of identification of the
                                                                                                  will be, carrying the article of food from            CBP’s PAPS be required and that the
                                          carrier and provide examples of when
                                                                                                  the country from which the article is                 PAPS number could be added after the
                                          the article of food is transferred from
                                                                                                  shipped to the United States to the port              prior notice is submitted, but before the
                                          one carrier to another both prior to
                                                                                                  of arrival, or if these codes are not                 truck arrives at the border. The
                                          arrival in the United States and after
                                                                                                  applicable, then the name of the carrier.             comment asserts that this amendment of
                                          arrival in the United States.                           If the carrier is a privately owned                   a confirmed prior notice, would greatly
                                             (Response) In the prior notice
                                                                                                  vehicle, the final rule requires the                  decrease a truck’s waiting time at the
                                          proposed rule, we had proposed to
                                                                                                  submission of the license plate number                border and aid in quickly clearing
                                          require the identity of each carrier or
                                                                                                  of the vehicle and the State or Province              trucks through CBP.
                                          transporter firm that transports the                    that issued the license plate number.                    (Response) PAPS is a CBP border
                                          article of food from the country from                   Identification of the carrier is not                  cargo release mechanism that utilizes
                                          which the article was shipped into the                  required for an article of food that is               barcode technology to expedite the
                                          United States. We agree with the                        imported or offered for import via                    release of commercial shipments. FDA
                                          comments we received to the proposed                    international mail.                                   at this time has no plans to utilize PAPS
                                          rule that asked FDA to eliminate the                       Identification of the carrier is                   in reviewing prior notices or otherwise
                                          requirement to identify multiple                        necessary to enable FDA and CBP to                    administering the prior notice program,
                                          carriers, and revised the proposed                      identify the appropriate article of food              and therefore, FDA is not adding the
                                          provisions to require in the IFR the                    for inspection or holding when the food               PAPS number as an additional data
                                          submission of the identity of the carrier               arrives in the United States. FDA notes               element.
                                          that is or will be carrying the article of              that a carrier typically is a different firm             (Comments) One comment requests
                                          food from the country from which the                    than the shipper. The broker or self-filer            clarification as to whether the
                                          article is shipped to the United States.                currently submits carrier information to              additional requirement for planned
                                          In doing so, FDA acknowledged the                       ABI/ACS when entry is made, and it                    shipment information, as applicable
                                          suggestion that the only pertinent                      later is transmitted to OASIS.                        (carrier, vessel name, voyage flight
                                          carrier is the one arriving at the U.S.                                                                       numbers and bill of lading number),
                                          port. The final rule clarifies that the                 16. Planned Shipment Information                      will require a resubmission of prior
                                          carrier is the carrier which is, or will be,               In § 1.281(a)(17) and (c)(17), the IFR             notice when those details change due to
                                          carrying the article of food from the                   requires submission of planned                        transportation arrangements outside of
                                          country from which the article is                       shipment information as it exists when                the control of the supplier.
                                          shipped to the United States to the port                the prior notice is submitted. FDA                       (Response) When we issued the IFR,
                                          of arrival.                                             recognized that some of this information              we recognized that some of this
                                             (Final rule) FDA and CBP have                        may change after the prior notice has                 information may change after the prior
                                          determined that identity of the country                 been submitted and addressed this in                  notice has been submitted, and
                                          of the carrier is not necessary when the                the IFR in § 1.282(a), which specifies                addressed this in § 1.282(a) of the IFR,
                                          SCAC or IATA codes are not provided;                    when changes require resubmission to                  which specifies when changes require
                                          the name alone of the carrier is                        FDA.                                                  resubmission to FDA. If planned
                                          sufficient for communication between                       Many comments addressed the                        shipment information required in
                                          the two agencies. However, FDA and                      planned shipment information. These                   § 1.281(a)(17) changes after you receive
                                          CBP have determined that the license                    comments are discussed in order of                    notice that FDA has confirmed your
                                          plate number of a privately owned                       appearance of the specific data elements              prior notice submission for review, you
                                          vehicle as well as the State or Province                in the IFR and preceded by a discussion               are not required by the IFR to resubmit
                                          that issued the license plate number is                 of general comments.                                  prior notice. The final rule retains this
                                          necessary for such communication.                          a. General comments. (Comments)                    provision.
                                             While identity of the license plate                  One comment suggests that a complete                     b. Airway bill number(s) and bill of
                                          number and State or Province that                       list of ABI mandatory and optional data               lading number(s)—§ 1.281(a)(17)(i) and
                                          issued the license is needed to identify                elements be immediately published via                 (c)(17)(i). (Comments) One comment
                                          the carrier of the food at the port of                  the CBP Administrative Message                        stated that FDA should simplify the data
                                          arrival, it is more properly categorized                system. The comment asserted that                     requirements and make the
                                          as part of the identity of the carrier than             some planned shipment information,                    requirements more manageable. The
                                          as part of the identity of the planned                  such as the vessel carrier flag, is not               comment states that one data element
                                          shipment information. Therefore, the                    necessary when the carrier code is                    should link all information secured by
                                          requirement for the submission of the                   submitted.                                            prior notice, which would be beneficial
                                          license plate number (and State or                         (Response) The ‘‘vessel carrier flag’’ is          for locating shipments in the event of a
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                                          Province that issued the license) for                   not part of the planned shipment                      possible crisis. The comment suggests
                                          food arriving by privately owned                        information. For food arriving by ocean               that the waybill/bill of lading number be
                                          vehicle has been moved to § 1.281(a)(16)                vessel, the vessel name and voyage                    utilized as a single reference point
                                          and (c)(16). FDA has found that the                     number are part of the planned                        because all shipments that are moved
                                          identification of the privately owned                   shipment information. The preamble to                 are repeatedly covered by this number.


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                                                            Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations                                        66359

                                             (Response) FDA does not agree that                   regarding examination of that article of              entering the United States. One
                                          the waybill/Bill of Lading can be used                  food prior to arrival of that food. It is             comment recommends elimination of
                                          as a single reference point for all                     one of the means that FDA and CBP use                 the mandatory requirement for trip
                                          shipments instead of the prior notice                   to match the prior notice review to the               number.
                                          confirmation number. A Bill of Lading                   food when it arrives at the port; e.g.,                  (Response) FDA disagrees. Land
                                          number is not always assigned to a                      what conveyance is carrying the article               carriers use the ‘‘Trip’’ number to
                                          shipment at the time of prior notice                    of food. The final rule will continue to              signify a train number, bus route
                                          submission. For certain shipments, such                 require the vessel name and voyage                    number, and/or a truck route number.
                                          as those sent by international mail, no                 number for food arriving by ocean                     This number normally designates a
                                          Bill of Lading may exist. Thus, FDA has                 vessel. As we discussed in the preamble               repetitive route between two locations
                                          determined that it is better to use a                   to the IFR, while we are dedicated to                 (e.g., Washington, DC to New York, NY)
                                          unique confirmation number provided                     increasing information sharing                        and may signify the specific truck, bus,
                                          by the FDA system to transmitters.                      capabilities with other agencies, it is               or train route (e.g., Train # 138 or Bus
                                             (Final rule) The Airway Bill                         generally difficult to have the required              # 4411). This information is necessary
                                          number(s) or Bill of Lading number(s)                   information readily accessible if we                  for communication between FDA and
                                          have been valuable information for                      need to coordinate with other agencies                CBP, and thus, the final rule continues
                                          identification, examination and                         or governments to obtain from them the                to require a trip number for food
                                          communication; however, this                            information necessary to respond to                   arriving by truck, bus, or rail.
                                          information is generally not available to               bioterrorism incidents or other food-                    (Final rule) Section 1.281(a)(17)(iv)
                                          an individual submitter of an article of                related emergencies (68 FR 58974 at                   and (c)(17)(iv) of the final rule requires
                                          food that is arriving via express                       58992).                                               submission of the trip number for food
                                          consignment operator or carrier. The                       (Final rule) Section 1.281(a)(17)(ii)              arriving by truck, bus, or rail, as
                                          express consignment operator or carrier                 and (c)(17)(ii) of the final rule requires            applicable to the mode of transportation
                                          tracking number is available to those                   submission of the vessel name and                     and when it exists. This information is
                                          individuals who send an article of food                 voyage number for food arriving by                    not required for an article of food that
                                          via express courier. Therefore, we have                 ocean vessel, when they exist.                        is imported or offered for import via
                                          amended the final rule to allow the                        d. Flight number—§ 1.281(a)(17)(iii)               international mail.
                                          submission of the express consignment                   and (c)(17)(iii). (Comments) There were                  f. Container number(s)—
                                          operator or carrier tracking number in                  no comments received on this issue.                   § 1.281(a)(17)(v) and (c)(17)(v).
                                          lieu of the Airway Bill or Bill of Lading                  (Final rule) The final rule requires the           (Comments) One comment suggests that
                                          numbers when the article of food is                     flight number for food arriving by air                FDA should allow for multiple
                                          arriving by express consignment                         carrier. The flight number has been                   container submissions on one prior
                                          operator or carrier and the submitter is                valuable information for identification,              notice.
                                          not the express consignment operator or                 examination and communication;                           (Response) Multiple container
                                          carrier.                                                however, this information is generally                numbers can be submitted for one prior
                                             Section 1.281(a)(17)(i) and (c)(17)(i) of            not available to an individual submitter              notice on screen via PNSI submission or
                                          the final rule requires submission of the               of an article of food that is arriving via            through use of multiple qualifiers for
                                          Bill of Lading number(s) or the Airway                  express consignment operator or carrier.              the Affirmation of Compliance code for
                                          Bill number(s), as applicable to the                    The express consignment operator or                   container number via ABI/ACS
                                          mode of transportation and when it                      carrier tracking number is available to               submission.
                                          exists. This information is not required                those individuals who send an article of                 (Final rule) Section 1.281(a)(17)(v)
                                          for an article of food that is imported or              food via express consignment operator                 and (c)(17)(v) of the final rule requires
                                          offered for import via international mail               or carrier. Therefore, § 1.281(a)(17)(iii)            the identification of container numbers
                                          or when carried by or otherwise                         and (c)(17)(iii) of the IFR have been                 for food arriving as containerized cargo
                                          accompanying an individual when                         amended to allow the submission of the                by water, air, or land, as applicable to
                                          entering the United States. For food                    express consignment operator or carrier               the mode of transportation and when it
                                          arriving by express consignment                         tracking number in lieu of the flight                 exists. This information is not required
                                          operator or carrier when the submitter is               number when the article of food is                    for an article of food that is imported or
                                          not the express consignment operator or                 arriving by express consignment                       offered for import via international mail
                                          carrier, the tracking number may be                     operator or carrier and the submitter is              or when carried by or otherwise
                                          submitted in lieu of the Bill of Lading                 not the express consignment operator or               accompanying an individual when
                                          or Airway Bill number.                                  carrier.                                              entering the United States.
                                             c. Vessel name and voyage number—                       e. Trip number—§ 1.281(a)(17)(iv) and                 g. Car number—§ 1.281(a)(17)(vi) and
                                          § 1.281(a)(17)(ii) and (c)(17)(ii).                     (c)(17)(iv). (Comments) Several                       (c)(17)(vi). (Comments) No comments
                                          (Comments) One comment asks the                         comments request clarification of the                 were received on this issue.
                                          purpose of this requirement because the                 definition of trip numbers. One                          (Final rule) The final rule retains the
                                          vessel name and voyage number are                       comment reasons that the load tender                  provisions of the IFR and requires
                                          provided to other U.S. agencies, such as                numbers or manifest numbers should be                 submission of the identity of the car
                                          CBP and U.S. Coast Guard, at an even                    used as trip numbers for food arriving                number for food arriving by rail, when
                                          earlier stage than required for the prior               by truck because loads are tendered to                it exists. This information is not
                                          notice.                                                 carriers with these numbers, and the                  required for an article of food that is
                                             (Response) The planned shipment                      carrier uses the numbers for billing                  imported or offered for import via
                                          information is necessary to ensure the                  reference. Another comment reasons                    international mail or when carried by or
                                          effective enforcement of section 801(m)                 that trip number appears to refer to a                otherwise accompanying an individual
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                                          of the act. Submission of the vessel                    number that relates to the particular trip            when entering the United States.
                                          name and voyage number in prior notice                  or journey rather than the vehicle.                      h. License plate number and State or
                                          associates that information with the                    Another comment asserts that the trip                 Province—§ 1.281(a)(17)(vii) and
                                          article of food and enables FDA to                      number should identify the conveyance,                (c)(17)(vii). (Comments) No comments
                                          effectively communicate with CBP                        everything onboard a trailer or container             were received on this issue.


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                                          66360             Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations

                                             (Final rule) FDA has determined that                 communication between FDA and CBP                     operator or carrier and the submitter is
                                          while identity of the license plate                     and that the identification of the HTS                not the express operator or carrier;
                                          number and State or Province that                       would assist CBP in the efficient                        • For food arriving by truck, bus, or
                                          issued the license is needed to identify                processing of prior notice through ACS.               rail, the trip number;
                                          the carrier of the food at the port of                  We also thought that, for prior notices                  • For food arriving as containerized
                                          arrival, it is more properly categorized                submitted through the FDA’s PNSI, the                 cargo by water, air, or land, the
                                          as part of the identity of the carrier than             HTS numbers were needed to ensure                     container number(s) (not applicable to
                                          as part of the identity of the planned                  that the data collected from the CBP                  food carried by or otherwise
                                          shipment information. Therefore, the                    entry when it is transmitted through                  accompanying an individual); and
                                          requirement for the submission of the                   ABI/ACS could be matched to prior                        • For food arriving by rail, car
                                          license plate number (and State or                      notice. We have found that the HTS                    number (not applicable to food carried
                                          Province that issued the license) for                   code is neither critical for                          by or otherwise accompanying an
                                          food arriving by privately owned                        communication with CBP nor for                        individual).
                                          vehicle has been moved to § 1.281(a)(16)                identification of the food for                           We also added the phrase ‘‘to the
                                          and (c)(16). The final rule requires the                examination purposes. Accordingly, we                 mode of transportation and when it
                                          submission of the license plate number                  have removed the requirement to submit                exists’’ after ‘‘as applicable’’ in the
                                          of the vehicle and the State or Province                the HTS code as a part of prior notice                opening sentence of § 1.281(a)(17) and
                                          that issued the license plate number, if                planned shipment information.                         (c)(17) to clarify that the data elements
                                          the carrier is a privately owned vehicle.                  (Comments) One comment suggests                    under planned shipment information
                                          By including the identification of the                  that FDA and CBP upgrade the flags                    are applicable by mode of transportation
                                          privately owned vehicle as a carrier                    associated with HTS numbers. The                      and when the data element exists. For
                                          information requirement, when                           comment also states that prior notice                 example, rail car number, container
                                          applicable, you must resubmit the prior                 cannot be submitted through ABI/ACS if                number, and train trip number may be
                                          notice in accordance with this subpart                  the HTS code does not have a FDA flag.                applicable for rail shipments, and vessel
                                          (see § 1.282) if the privately owned                    One comment states that FDA should                    name, voyage number, and container
                                          vehicle information changes after the                   not rely solely upon HTS flags to                     number may be applicable for food
                                          prior notice has been confirmed by FDA                  implement the prior notice                            arriving by ocean vessel.
                                          for review. Identification of the license               requirements.                                            The final rule does not require that
                                          plate number and State or Province that                    (Response) FDA agrees and monitors                 prior notice be cancelled and
                                          issued the license is not required for an               and updates the HTS flags. Guidance                   resubmitted if this planned shipment
                                          article of food that is imported or                     about the HTS flags is posted at http://              information changes after FDA has
                                          offered for import via international mail.              www.cfsan.fda.gov/~dms/                               confirmed the prior notice for review. A
                                             i. Harmonized tariff schedule (HTS)                  htsguid3.html. Prior notice can be                    prior notice will not be inadequate if
                                          codes—§ 1.281(a)(17)(viii) and                          submitted on any product because of                   any of the planned shipment
                                          (c)(17)(viii). (Comments) One comment                   intended use, regardless of the HTS flag.             information changes between the
                                          suggests the use of the HTS codes in                    Not having a FDA flag associated with                 confirmation of prior notice and the
                                          lieu of FDA product codes and asserts                   the HTS code does not prevent                         time of arrival.
                                          that the HTS codes provide all the                      submission of prior notice via ABI/ACS                   j. Refused articles. (Comments) One
                                          information that the FDA would need                     or PNSI.                                              comment requests clarification of the
                                          for prior notice.                                          (Final rule) Section 1.281(a)(17) and              process for resubmission if a prior
                                             (Response) The HTS codes often are                   (c)(17) of the final rule requires                    notice is refused for reasons other than
                                          not sufficient to specifically identify a               submission of the following planned                   failure to satisfy prior notice
                                          product for FDA decisionmaking. For                     shipment information, as applicable,                  requirements. The comment asks once
                                          example, in many cases, the tariff code                 based on the mode of transportation:                  the failure is rectified, should
                                          does not describe how the product was                      • Bill of lading number(s), Airway                 companies use the PNSI or ABI/ACS to
                                          processed (e.g., commercially sterile or                bill number(s), or express consignment                resubmit the load for clearance?
                                          shelf-stable) or how the product is                     operator or carrier tracking number                      (Response) A food may be refused
                                          packaged, which is indicated in the                     when the article of food is arriving by               under 801(m) of the act only if it is
                                          Process Indicator Code (PIC) element of                 express consignment operator or carrier               imported or offered for import with
                                          FDA’s product code. Several products                    and the submitter is not the express                  inadequate prior notice; i.e., no prior
                                          that FDA considers different from each                  consignment operator or carrier (not                  notice, untimely prior notice, or
                                          other (because these differences affect                 applicable to food carried by or                      inaccurate prior notice. To resolve a
                                          the potential safety of the food) may be                otherwise accompanying an individual);                refusal, prior notice or a revised prior
                                          combined under one HTS code.                               • For food arriving by ocean vessel,               notice must be submitted via PNSI until
                                          Therefore, the HTS codes do not                         vessel name and voyage number;                        such time as ACS or its successor
                                          provide all the information that is                        • For food arriving by air carrier,                system can accommodate such
                                          required to identify the food.                          flight number or the express                          transactions.
                                             Additionally, at the time that FDA                   consignment operator or carrier tracking                 The following table 2 summarizes the
                                          and CBP issued the IFR, we believed                     number when the article of food is                    information required under § 1.281(a),
                                          that the HTS code was needed for                        arriving by express consignment                       (b), and (c):
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                                                              Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations                                         66361

                                                                                   TABLE 2.—PRIOR NOTICE INFORMATION REQUIRED BY CATEGORY
                                                   Information             Transshipment           Carried By or Ac-     Food Not in Nat-        Food in Natural             Mail      After Section
                                                                                                    companying an           ural State               State                           801(m) of the Act
                                                                                                       Individual                                                                         Refusal

                                            § 1.281 paragraph(s)              (a) and (c)                  (a)                    (a)                  (a)                   (b)            (c)

                                          Submitter                                 Y                       Y                     Y                     Y                     Y             Y

                                          Transmitter                               Y                       Y                     Y                     Y                     Y             Y

                                          Entry type                                Y                       Y                     Y                     Y                     Y             Y

                                          Entry identifier                          Y                       Y                     Y                     Y                     N             Y

                                          FDA product code                          Y                       Y                     Y                     Y                     Y             Y

                                          Common, usual, or                         Y                       Y                     Y                     Y                     Y             Y
                                            market name

                                          Estimated quantity                        Y                       Y                     Y                     Y                     Y           Actual

                                          Lot/Code #                                Y                       Y                     Y                     N                     Y             Y

                                          Manufacturer                              Y                       Y                     Y                     N                     Y             Y

                                          Grower, if known                          Y                       Y                     N                     Y                     Y             Y

                                          Country of production                     Y                       Y                     Y                     Y                     Y             Y

                                          Shipper                                   Y                       Y                     Y                     Y                     Y             Y

                                          Country from which arti-                  Y                       Y                     Y                     Y                     Y             Y
                                            cle is shipped

                                          Port of arrival                    Anticipated1            Anticipated1           Anticipated1           Anticipated1               N           Actual1

                                          Date of arrival                    Anticipated1            Anticipated1           Anticipated1           Anticipated1               N           Actual

                                          Time of arrival                    Anticipated1            Anticipated1           Anticipated1           Anticipated1               N             N

                                          Date of mailing                           N                      N                      N                     N              Anticipated          N

                                          Importer                                  N                       Y                     Y                     Y                     N             Y

                                          Owner                                     N                       Y                     Y                     Y                     N             Y

                                          Ultimate consignee                        N                       Y                     Y                     Y                     N             Y

                                          U.S. recipient                            N                      N                      N                     N                     Y             N

                                          Mode of transport                         Y                       Y                     Y                     Y                     N             Y

                                          Carrier                                   Y                       Y                     Y                     Y                     N             Y

                                          Bill of lading/airbill              Planned1                     N                 Planned1               Planned1                  N           Actual1

                                          Vessel/Voyage                           Planned              Planned                Planned                Planned                  N           Actual

                                          Flight #                            Planned1                 Planned1              Planned1               Planned1                  N           Actual1

                                          Trip #                                  Planned              Planned                Planned                Planned                  N           Actual

                                          Container #                             Planned                  N                  Planned                Planned                  N           Actual

                                          Car #                                   Planned                  N                  Planned                Planned                  N           Actual

                                          Hold information                          N                      N                      N                     N                     N             Y
                                            1 If the article of food is arriving by express consignment carrier or operator, and the submitter and/or transmitter is not the express consign-
                                          ment operator or carrier, and the prior notice is submitted via the FDA PNSI, the express consignment operator or carrier tracking number may
                                          be submitted in lieu of this information.
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                                          66362             Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations

                                          I. What Must You Do If Information                      prior notice submissions that have been               sensitive and must be shipped in a
                                          Changes After You Have Received                         confirmed by FDA for review because                   temperature controlled environment.
                                          Confirmation of a Prior Notice From                     CBP also needs finality so it can                     The comments note that clerical errors
                                          FDA? (§ 1.282)                                          complete its own screening of the entry.              in the prior notice may not be corrected,
                                             In § 1.282 (a)(1) of the IFR, if any of              Therefore, to keep the timeframes as                  and if an error is discovered after a CBP
                                          the information required in § 1.281(a)                  short as possible, we are not permitting              entry is certified, the entry must be
                                          except the quantity information, the                    changes to prior notice without                       cancelled. According to the comments,
                                          anticipated arrival information, or the                 restarting the clock.                                 if CBP is not available to cancel the
                                                                                                     Moreover, we believe that the prior                entry (e.g., the shipment arrives over the
                                          planned shipment information, changes
                                                                                                  notice information required by the final              weekend), the delay may cause the
                                          after FDA has confirmed the prior notice
                                                                                                  rule should be sufficiently fixed to be               shipment to be destroyed. The
                                          submission for review, you must
                                                                                                  submitted within the timeframes. The                  comments request that FDA and CBP
                                          resubmit prior notice. For food arriving
                                                                                                  final rule allows for estimates for some              find a way to address this problem,
                                          by international mail, if any of the                    information—estimated quantity,                       either by allowing clerical revisions
                                          information required in § 1.281(b),                     anticipated arrival information, and                  after the entry has been certified,
                                          except the anticipated date of mailing,                 planned shipment information—and                      permitting entry deletions under certain
                                          changes after FDA has confirmed the                     changes to any of these data elements                 circumstances, or ensuring CBP
                                          prior notice submission for review, you                 does not require that the prior notice be             availability on a 24 hours/7 days a
                                          must resubmit prior notice.                             resubmitted.                                          week/365 days a year schedule.
                                             The IFR also states that the original                   (Comments) Some comments request                      (Response) Because we reduced the
                                          prior notice should be cancelled in PNSI                that FDA create a mechanism to allow                  timeframes for submitting prior notice
                                          or if originally submitted via ABI/ACS,                 correction of errors in a manner that                 in the IFR to the least amount of time
                                          the entry should be deleted.                            does not restart the prior notice clock.              that we need to meet our statutory
                                             (Comments) Some comments request                     One comment requests the final rule                   responsibility to receive, review, and
                                          that FDA revisit the concepts outlined                  provide for correction of errors within               respond to prior notice submissions, the
                                          in §§ 1.289 through 1.294 of the                        the timeframe of the 2-, 4-, or 8–hour                IFR did not provide for amendments or
                                          proposed rule, which allowed                            deadline. The comments suggest that a                 updates. The timeframes in the final
                                          amendments to be made to product                        streamlined process, possibly through                 rule also provide the least amount of
                                          identity, estimated quantity, and arrival               electronic means, of making clerical                  time we need to receive, review and
                                          information, without having to cancel                   corrections or correcting errors in timely            respond to prior notice submissions and
                                          the entry and resubmit the prior notice                 filed prior notice should be a permanent              therefore, the final rule also does not
                                          under a new entry. The comments                         feature of the integrated FDA-CBP                     provide for amendments or updates.
                                          contend that such amendments were                       process. Some comments contend that                   The use of ABI/ACS precludes
                                          acceptable and would not taint the                      without the opportunity to correct the                amendments and updates without
                                          adequacy of a prior notice or                           error post-submission, shippers may                   substantial and costly revisions to the
                                          compromise food security, if the                        find their shipments frozen in an                     system; such technical changes are not
                                          amendments are made within the                          extended period of delay, which would                 cost-effective or a good use of limited
                                          applicable 2-, 4-, or 8–hour timeframes                 frustrate the purpose of the FDA-CBP                  resources given the development of the
                                          per mode of transportation at issue. The                Integration Plan that is aimed at                     Automated Commercial Environment,
                                          comments suggest that amendments                        reducing such timeframes. Comments                    which will replace ACS. Changes to
                                          allow for a degree of flexibility in the                also suggest this would create an                     ABI/ACS submissions that have been
                                          prior notice system and acknowledge a                   unintended legislative loop between the               electronically transmitted to FDA’s
                                          well-known fact in the industry that this               two regulatory frameworks meant by the                OASIS and confirmed by FDA for
                                          type of information may change after                    Integration Plan to be seamlessly and                 review are not feasible because CBP also
                                          prior notice has been submitted. Some                   efficiently integrated.                               needs finality so it can complete its own
                                          comments suggest that allowing the                         Some comments object to the IFR’s                  screening of the entry.
                                          submitter or filer to update or correct                 requirements because after the CBP                       Changes to confirmed prior notice
                                          information provided in a prior notice                  entry or entry summary has been                       submissions, other than those relating to
                                          will facilitate the steady flow of prior                certified, there currently is no                      estimated quantity, anticipated arrival
                                          notice submissions, without                             mechanism for making corrections,                     information, and planned shipment
                                          jeopardizing the security and safety of                 including corrections of simple clerical              information, must be processed by
                                          the food supply.                                        errors, without canceling the entry and               resubmission of prior notice unless the
                                             (Response) Unlike the proposed rule,                 submitting a new entry. Comments state                article of food will not be offered for
                                          the IFR does not allow for amendments                   that the requirement to cancel and                    import or imported into the United
                                          relating to the product identity. After                 resubmit a prior notice when submitted                States. The responsibility is on
                                          considering the comments on whether                     information changes or to correct a                   submitters to provide accurate prior
                                          the final rule should allow amendments,                 clerical error creates additional work in             notice to FDA, and we encourage
                                          and based on our experience with the                    an already overburdened environment.                  affected parties to take appropriate
                                          IFR, we believe the approach in the IFR                 According to the comments, in the air                 measures to verify entries for accuracy
                                          is sound. The reduced timeframes in the                 and truck environment where cargo is                  before sending. FDA notes that both ABI
                                          IFR, which are continued in the final                   processed on weekends and at off-hour                 and PNSI systems allow for correction
                                          rule, provide very little leeway in the                 operations, CBP is unavailable to                     of errors that are revealed by the
                                          time FDA has to receive, review, and                    process these entry cancellations. The                systems’ validation process. In PNSI, a
                                          respond to the prior notice submissions.                comments state that in such                           PN confirmation number will not be
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                                          Moreover, the timeframes are based, in                  circumstances, cargo could be forced                  provided if it detects errors in the
                                          part, on not receiving amendments                       into refused status due to CBP’s                      submitted data.
                                          because allowing amendments would                       inability to act in a timely manner.                     Moreover, FDA notes that if CBP is
                                          increase the review time. In addition,                     Similarly, other comments state that               unavailable to cancel a prior notice,
                                          ACS cannot accommodate changes in                       many imported articles of food are time               submitters can create and submit new


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                                                            Federal Register / Vol. 73, No. 217 / Friday, November 7, 2008 / Rules and Regulations                                        66363

                                          replacement entries and prior notices                   prior notice should be cancelled and a                and could be subject to civil penalties.
                                          using either ABI or a combination of                    prior notice with the correct information             The comment recommends that the
                                          ABI and PNSI even when the original                     must be submitted. Changes to other                   prior notice system allow custom entry
                                          entry has not yet been cancelled.                       information (i.e., estimated quantity,                numbers to be updated after the customs
                                          However, the submitter should cancel                    anticipated arrival information, and                  entry has been filed by the customs
                                          the previously submitted inaccurate ABI                 planned shipment information) do not                  brokers and that any penalty
                                          entry (via request to CBP) at the first                 require the submitter to re-submit a                  considerations be deferred under these
                                          chance possible to avoid subsequent                     revised prior notice.                                 circumstances.
                                          administrative and operational                             (Comments) Some comments suggest                      (Response) The type of updates
                                          problems with entry release. This is a                  that entry deletions, rather than                     recommended by this comment is not
                                          revision to the IFR in that § 1.282(c) of               cancellations, should be permitted for                necessary because prior notice can be
                                          the final rule uses the correct term                    legitimate reasons.                                   submitted without a customs entry
                                          ‘‘cancel’’ versus ‘‘delete’’ when                          (Response) FDA believes the comment                number. In the situation described,
                                          describing what CBP should be                           misunderstands § 1.282(c) of the IFR                  where prior notice must be submitted
                                          requested to do in this case. When an                   because that provision states, ‘‘If you               before entry can be filed, prior notice
                                          entry is ‘‘deleted’’ versus ‘‘cancelled’’ in            submitted the prior notice via ABI/ACS,               may be submitted using PNSI without a
                                          ABI, the filer is able to re-use the                    you should cancel the prior notice via                CBP entry identifier (e.g., a CBP entry
                                          original entry number. However, PNSI                    ACS by requesting that CBP delete the                 number). PNSI will provide a system-
                                          will reject a prior notice submission that              entry’’ (emphasis added). However, the                generated entry identifier. Once a
                                          attempts to re-use a previous entry                     final rule now recommends that if you                 customs broker is secured during
                                          number. Therefore, we revised the final                 cancelled a prior notice submitted via                normal business hours to file the entry,
                                          rule to provide for cancellation of the                 ABI/ACS, you should cancel the prior                  the prior notice confirmation number(s)
                                          entry, rather than deletion of an entry.                notice via ACS by requesting that CBP                 can be given to the broker who can
                                             (Comments) Some comments request                     cancel, rather than delete, the entry                 affiliate the prior notice(s) to the
                                          that FDA and CBP develop a process for                  (§ 1.282(c)). When an entry is ‘‘deleted’’            customs entry via the ABI submission.
                                          reviewing amendments that do not                        versus ‘‘cancelled’’ in ABI, the filer is                (Comments) Some comments request
                                          affect the security of the cargo in less                able to re-use the original entry number.             clarification on what happens to the
                                          than the full eight hours, so that the                  However, PNSI will reject a prior notice              food if the information relating to
                                          shipments’ release from the port is not                 submission that attempts to re-use a                  product identity, estimated quantity, or
                                          delayed unduly.                                         previous entry number. Therefore, we                  anticipated arrival changes after prior
                                             (Response) The requirements for                      revised the final rule to provide for                 notice is submitted.
                                          amendments set forth in the proposed                    cancellation of the entry, rather than                   (Response) The final rule requires that
                                          rule were eliminated from the IFR. This                 deletion of an entry.                                 if required information (except
                                          final rule provides that if required                       (Comments) One comment requested                   estimated quantity, anticipated arrival
                                          information (except estimated quantity,                 clarification regarding whether the                   information, including the anticipated
                                          anticipated arrival information,                        additional requirement for planned                    date of mailing, and planned shipment
                                          including the anticipated date of                       shipment information as applicable                    information) changes after FDA has
                                          mailing, and planned shipment                           (carrier, vessel name, voyage flight                  confirmed prior notice for review, the
                                          information) changes after FDA has                      numbers, and bill of lading number)                   prior notice must be resubmitted. As we
                                          confirmed prior notice for review, the                  will necessitate a resubmission when                  explained in the preamble to the IFR,
                                          prior notice should be cancelled and a                  those details change due to                           ‘‘FDA proposed to allow changes to
                                          prior notice with the correct information               transportation arrangements outside the               certain information in the prior notice
                                          must be submitted. The reduced                          control of the supplier.                              after a prior notice was submitted.
                                          timeframes in the IFR, which are                           (Response) No. The final rule does not             * * *. Some comments stated that if the
                                          continued in the final rule, provide very               require resubmission of prior notice if               timeframe for submitting prior notice
                                          little leeway in the time FDA has to                    the planned shipment information                      was changed, i.e., shortened to 4 hours
                                          receive, review, and respond to the prior               changes after prior notice has been                   for land and air and 8 hours for water,
                                          notice submissions. Moreover, the                       submitted and confirmed for review by                 then amendments and updates would
                                          timeframes are based, in part, on not                   FDA.                                                  not be necessary. * * * FDA agrees
                                          receiving amendments because allowing                      (Comments) One comment notes that                  with the comments that state that if the
                                          amendments would increase the review                    part of the process of completing a prior             deadline for submission of prior notice
                                          time. In addition, ACS cannot                           notice is to obtain a CBP entry number,               were reduced, amendments and updates
                                          accommodate changes in prior notice                     which many firms use a customs broker                 would not be necessary. FDA has
                                          submissions that have been confirmed                    to do. The comment states that this                   chosen timeframes that provide it with
                                          by FDA for review because CBP also                      works well in most cases, but can create              very little leeway in the time it has to
                                          needs finality so it can complete its own               problems for products arriving by boat.               ‘receive, review and respond’ to the
                                          screening of the entry. Because we are                  The comment further states that of all                prior notice submissions. Thus, we
                                          maintaining the IFR timeframes in the                   the modes of transportation, boats are                concluded that we could no longer
                                          final rule, it is difficult to accommodate              the most unpredictable and can arrive                 permit changes to prior notice without
                                          amendments.                                             earlier or later than expected. Early                 restarting the clock. In addition, the use
                                             (Comments) Some comments state                       arrivals pose a problem because of the                of ABI/ACS precludes amendments and
                                          that changes to prior notice should be                  8 hour notice period and the relatively               updates: changes to ABI/ACS
                                          required for material changes only.                     short timeframe in which a company                    submissions that have been
                                          Materiality would need to be                            learns of an impending early arrival.                 electronically transmitted to FDA’s
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                                          determined.                                             Given the fact that customs brokers may               OASIS and confirmed by FDA for
                                             (Response) We agree. The final rule                  not work a 24–hour, 7-day per week                    review are not feasible because CBP also
                                          requires that, if certain required                      schedule, prior notice shipments that                 needs finality so it can complete its own
                                          information changes after FDA has                       arrive on the weekend, holiday, or after              screening of the entry. Therefore, the
                                          confirmed prior notice for review, the                  normal business hours will be filed late              interim final rule does not allow for


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                                          changes to a prior notice after the                     accommodate such transactions, post-                     (Comments) Some comments ask if
                                          transmitter has been notified that FDA                  refusal prior notice must be submitted                there are any measures that importers
                                          has confirmed the prior notice for                      via PNSI (see § 1.280(a)(2)).                         should undertake to avoid delays at the
                                          review.’’ (68 FR 58974 at 59013 and                       (Final Rule) Section 1.282 of the final             port of entry.
                                          59014)                                                  rule requires that if required                           (Response) FDA advises that most
                                             We retain this view and therefore,                   information (except estimated quantity,               delays based on inaccurate and
                                          changes in product identity require                     anticipated arrival information,                      untimely submission of prior notice are
                                          resubmission of a prior notice with the                 including the anticipated date of                     avoidable and recommends that
                                          correct information. We do not require                  mailing, and planned shipment                         importers focus on measures to increase
                                          resubmission of a prior notice if the                   information) changes after FDA has                    accurate and timely submissions of
                                          estimated quantity, anticipated arrival                 confirmed prior notice for review, the                prior notice.
                                          information, including the anticipated                  prior notice should be cancelled and a                   (Comments) Some comments state
                                          date of mailing, and planned shipment                   prior notice with the updated                         that the ‘‘Category 3’’ refusal and fine
                                          information changes, because these data                 information must be submitted.                        provision is excessive for a shipment
                                          elements are not firm in the first place.                                                                     showing up at the border in advance of
                                          Moreover, such changes would not alter                  J. What Happens to Food That Is                       the 2-hour timeframe elapsing and FDA
                                          FDA’s ability to review the prior notice                Imported or Offered for Import Without                should consider lowering the penalty
                                          or to examine the food.                                 Adequate Prior Notice? (§ 1.283)                      for this type of offense. Other comments
                                             (Comments) Some comments request                        The IFR in § 1.283 identifies                      request clarification about what will
                                          that FDA maintain the flexibility, as                   consequences and procedures for failure               happen to trucks that arrive too early,
                                          provided by the IFR, to provide                         to provide adequate prior notice and                  i.e., will they be turned away or will
                                          anticipated port arrival information for                describes the requirements and                        they be allowed to wait in the
                                          date and time of arrival and point of                   procedures for various situations.                    compound?
                                          crossing. The comments state that this                     The comments received will be                         (Response) Section 1.283(a)(1)(iii) of
                                          flexibility is critical for minimizing                  discussed below in the order each issue               the final rule provides that if an article
                                          trade disruption and note that times of                 appears in § 1.283 of the IFR, proceeded              of food arrives early (i.e., before the
                                          arrival and entry locations often change                by comments generally addressing                      prior notice time has elapsed), its arrival
                                          and importers need the flexibility to                   consequences.                                         will not be considered untimely if FDA
                                          accommodate these unanticipated                                                                               already has reviewed the prior notice,
                                                                                                  1. General Comments                                   determined its response to the prior
                                          changes without refiling entry
                                          information.                                               (Comments) Some comments suggest                   notice, and advised CBP of that
                                             (Response) Section 1.281(a)(11),                     that enforcement actions should be                    response. However, if FDA has not
                                          which requires anticipated arrival                      based on levels of culpability (e.g.,                 reviewed the prior notice submission
                                          information, has been revised in the                    negligent, grossly negligent, and                     and responded to CBP before the food
                                          final rule. The requirement to provide                  fraudulent), number of infractions, and               arrives, the food is subject to refusal. As
                                          the identity of the border crossing                     seriousness of infractions.                           noted previously, in determining
                                          within the anticipated port of arrival has                 (Response) FDA and CBP take various                whether to refuse the food, assess a CBP
                                          been eliminated in the final rule. As                   considerations, such as the seriousness               civil monetary penalty, or take other
                                          with the IFR, in the final rule, changes                of the violation, into account when                   regulatory action, we will take into
                                          in anticipated port of arrival,                         deciding whether to take an                           account the seriousness of the violation
                                          anticipated date of arrival, and                        enforcement action in response to                     and other considerations. Trucks
                                          anticipated time of arrival do not                      violations of the prior notice rule and,              arriving before FDA has processed the
                                          require cancellation and resubmission                   if so, what actions to take. For areas in             prior notice will be handled as
                                          of the prior notice.                                    which we have established enforcement                 appropriate under the individual
                                             (Comments) Some comments suggest                     policies for prior notice, these are                  circumstances.
                                          that the requirement that all prior notice              contained in, and communicated to the                    (Comments) Some comments state
                                          data be transmitted via the PNSI portal                 public through a Compliance Policy                    that the implementation plan for the
                                          after the prior notice time limitations or              Guide (CPG). Elsewhere in this issue of               prior notice rule must include a
                                          refusal will increase the load on this                  the Federal Register, we are announcing               contingency plan to ensure that border
                                          limited system. The comments state that                 the availability of the Prior Notice Final            traffic can still be cleared and does not
                                          the PNSI system capacity must be                        Rule Draft CPG, which describes our                   come to a standstill as new systems are
                                          dramatically increased before the                       proposed enforcement policies for the                 put in place and problems are resolved.
                                          August 2004 full enforcement deadline                   final rule.                                           Comments point out that it is essential
                                          in order to ensure that legitimate trade                   (Comments) Some comments request                   for FDA and CBP to have appropriate
                                          is not impacted due to a failure of the                 clarification on the penalties for                    mechanisms and procedures in place
                                          system.                                                 inadvertent errors, such as clerical                  (such as referral to a secondary
                                             (Response) FDA does not agree that                   errors, in the prior notice submission.               inspection, where appropriate) so that
                                          post-refusal prior notice submissions                      (Response) As described in the                     border congestion is not increased by
                                          have or will impact or overload PNSI.                   previous response, FDA and CBP take                   the application of the rules.
                                          PNSI has operated effectively since the                 into account the nature of the violation                 Some comments request clarification
                                          IFR took effect and has sufficient                      in determining how to respond to prior                on arrangements between FDA and CBP,
                                          capacity for any increase in submissions                notice violations. The validation process             the Canada Border Services Agency, and
                                          after the effective date of this final rule.            built into ABI and PNSI should assist in              the bridge authorities to address issues
                                          FDA has carefully monitored both PNSI                   catching inadvertent errors, such as                  surrounding refusal of entry due to
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                                          and OASIS system usage and                              clerical errors, because the systems will             missing or incomplete prior notice
                                          performance. No issues related to load                  not accept data with certain errors. This             information. The comments indicate
                                          on PNSI have been identified since the                  validation process then allows the                    that the relevant agencies on both sides
                                          IFR took effect. Until such time as ACS                 submitter to correct errors before final              of the border should have a plan in
                                          or its successor system can                             submission of prior notice data.                      place to deal with the inevitable


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                                          problems posed by larger volumes of                     means to resolve the refused admission                certain actions, including refusals,
                                          returning trucks to ensure that busy                    status.                                               routinely notifying these and other
                                          border crossings do not become a ‘‘no                     (Response) Both the IFR and the final               parties about a refusal would take
                                          man’s’’ land. Some comments indicate                    rule provide for a response to an 801(m)              limited staff resources away from other
                                          that local staff at busy border crossings,              refusal to be provided to FDA by mail,                functions, such as reviewing prior
                                          such as the Peace Bridge and                            e-mail, fax, or courier. FDA will respond             notices. FDA will try to notify other
                                          Ambassador Bridge, have indicated that                  in kind, as we have not experienced any               parties (e.g., submitter), in addition to
                                          trucks will be turned back for missing/                 problems as a result of this flexibility.             the carrier, if feasible, and we often do
                                          incomplete prior notice if secure storage               2. Inadequate Prior Notice (§ 1.283(a)(1))            contact these other parties as resources
                                          cannot be arranged. Comments suggest                                                                          allow. FDA notes that for the future
                                          that CBP could stamp a shipping                            (Comments) Several comments                        migration of ABI/ACS to the ITDS/ACE
                                          document (such as the bill of lading)                   request that FDA notify the submitter,                environment, FDA has requested the
                                          ‘‘Refused—BTA’’ or implement                            filer, importer, or ultimate consignee,               ability to provide electronic prior notice
                                          procedures that CBP had in place for                    either in lieu of or in addition to the               ‘‘refusal’’ messaging. This capability
                                          refused trucks prior to the Bioterrorism                carrier, about inadequacies in a prior                does not currently exist. If electronic
                                          Act.                                                    notice submission that result in refusal              prior notice refusal messaging is in
                                                                                                  of the food. The comments state that the              place, it would significantly reduce the
                                             Some comments suggest that carriers
                                                                                                  carrier is not in a position to resolve the           resources required to notify ITDS
                                          should be permitted a variety of options
                                                                                                  problem when the article of food is                   participants of these refusals.
                                          when and if they are advised that one
                                                                                                  refused. The comments note that the                      (Comments) Some comments express
                                          or more products within a shipment
                                                                                                  carrier has temporary possession of the               concern that trucking companies that
                                          have been refused due to a failure to
                                                                                                  product, has minimal vested interest in               pick up FDA-regulated freight in Canada
                                          have an adequate prior notice.
                                                                                                  the shipment, particularly if is                      or Mexico bound for the United States
                                          According to the comments, these
                                                                                                  offloaded, and has little, if any,                    cannot ascertain that the importer,
                                          options may include, permission to hold
                                                                                                  resources or incentive to resolve the                 shipper, or customs broker has filed the
                                          the cargo at the border while the proper
                                                                                                  refusal. However, according to the                    appropriate prior notice. The comments
                                          information is submitted to the FDA and                 comments, the exporter, importer, or
                                          before mandatory notice of intended                                                                           ask what form of proof FDA (or other
                                                                                                  ultimate consignee has an ownership                   border regulatory agencies) will
                                          destination for delivery; returning the                 interest in the refused food and a strong
                                          cargo to the exporting facility directly;                                                                     consider acceptable in order to release
                                                                                                  economic incentive to resolve the                     the motor carrier from responsibility if
                                          holding the cargo at a designated                       refusal swiftly, or to export or destroy
                                          carrier’s closest facility; and/or holding                                                                    the prior notice was not filed
                                                                                                  the refused food if the prior notice                  appropriately. The comments state that
                                          the cargo at a designated FDA holding                   defects cannot be corrected. The
                                          facility, not necessarily a general order                                                                     it is not clear whether FDA will supply
                                                                                                  comments state that delaying                          an official document that the importer,
                                          bonded warehouse, near the port of                      notification to the submitter, importer,              shipper, or customs broker would issue
                                          entry.                                                  and ultimate consignee, unduly hinders                to the motor carrier to assure the carrier
                                             (Response) FDA and CBP have not                      the resolution of the problem.                        that prior notice has been filed.
                                          experienced any major disruptions in                       One comment specifies that the filer                  (Response) Under § 1.279(d) of the
                                          border traffic as a result of the                       of the prior notice, who is in most cases             final rule, FDA notifies the submitter
                                          implementation of the IFR in December                   the importer, supplier, owner of the                  when the prior notice has been
                                          2003. The agencies also have not made                   merchandise, or a representative of one               confirmed for review, with a message
                                          any significant revisions to the IFR in                 of these entities, should be notified                 containing a prior notice confirmation
                                          this final rule that cause us to believe                directly, without any intermediate                    number. Section 1.279(g) of the final
                                          there will be major disruptions in trade                communication, so that the filer may                  rule requires that the prior notice
                                          once the provisions in this final rule                  promptly take corrective action and                   confirmation number must accompany
                                          take effect, particularly since we are                  mitigate any possible adverse regulatory              any article of food for which the prior
                                          providing a 180-day period between                      and commercial consequences. Some                     notice was submitted through PNSI
                                          publication of this rule and the effective              comments request that FDA or CBP                      when the article arrives in the United
                                          date of its provisions. This period of                  notify the General Order Manager                      States and must be provided to CBP or
                                          time should allow for full                              (GOM) when a shipment has been                        FDA upon arrival. To address the
                                          understanding by affected parties of the                rejected or denied entry and also                     concern in the comments, carriers may
                                          requirements of the final rule.                         provide the rationale for that decision.              consider, as a matter of business
                                             We also note that the automated                         (Response) FDA disagrees. The IFR                  practice, requesting from their
                                          validation process in ABI and PNSI will                 does not require FDA or CBP to provide                customers proof of confirmation of prior
                                          catch most missing and incomplete                       notice about a refusal, and we continue               notice submission prior to transporting
                                          submissions before refusal because the                  to believe this is appropriate. As an                 the food to the United States, even when
                                          systems will not accept submissions                     operational matter, the carrier would                 there is no requirement to provide the
                                          with certain errors or omissions. If                    have to be notified of the refusal. The               confirmation number to CBP or FDA
                                          refusal does occur, the carrier will have               carrier can then notify others, such as               upon arrival.
                                          the option to segregate refused food                    the entity that hired the carrier to                     (Comments) Some comments request
                                          from the rest of the shipment                           transport the article of food, that there             clarification on whether information for
                                          (§ 1.283(a)(3)), the option to export after             is a problem with the prior notice. It                FDA clearance will be allowed to be
                                          refusal with CBP concurrence                            would be resource-intensive for FDA or                transmitted via ABI, PNSI or either, for
                                          (§ 1.283(a)(5)), and the option to have                 CBP to assume responsibility for                      a shipment of food that will be entered
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                                          refused food held at the port of entry,                 notifying various other entities of the               after the arrival of a vessel or an aircraft.
                                          unless directed otherwise by CBP or                     refusal. FDA notes that, although we                  Comments ask what error message will
                                          FDA (see § 1.283(a)(1)).                                collect the contact information for the               be sent back to the transmitter for entry
                                             (Comments) Some comments                             submitter and transmitter, which we                   that is untimely filed, e.g., will the
                                          recommend establishing an electronic                    could use to contact parties about                    transmitter receive a refused admission


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                                          status or some other error message? In                  58931, October 10, 2003), section 305 of                 (Comments) Some comments ask
                                          addition, comments ask what the                         the Bioterrorism Act states that FDA’s                whether an entry of food would be
                                          mechanism is for communicating with                     list of registered facilities and                     subject to detention if the product code
                                          the carrier on the disposition of the                   registration documents FDA receives                   does not precisely reflect the nature of
                                          prior notice. The comment states that                   under the rule are not subject to                     the product.
                                          carriers cannot view the FDA ‘‘may                      disclosure under FOIA. Furthermore,                      (Response) The final rule requires the
                                          proceed’’ messages in CBP’s AMS, and                    section 305 of the Bioterrorism Act                   submission of accurate information that
                                          the ABI participant (usually the customs                provides that any information derived                 is submitted in the prior notice,
                                          broker) is responsible for                              from the list of facilities or registration           including the product code, which is
                                          communicating freight holds to the                      documents that would disclose the                     required in § 1.281 (a)(5)(i), (b)(4)(i), and
                                          various parties involved, including                     identity or location of a specific                    (c)(5)(i) of the final rule. If the product
                                          importers, container freight stations                   registered person is not subject to                   code does not accurately identify the
                                          (CFS), and truckers.                                    disclosure under FOIA. This does not                  food, the food is subject to refusal.
                                             (Response) FDA clarifies that if an                  preclude the registered facility from                 Section 1.283(a)(1)(ii) of the final rule
                                          article of food subject to prior notice                 disclosing its registration number, such              states that if prior notice has been
                                          requirements arrives in the United                      as to the submitter or others with whom               submitted and confirmed by FDA for
                                          States and prior notice has not been                    it has a business relationship.                       review, but upon review of the notice or
                                          received for review by FDA in the                          (Comments) Some comments request                   examination of the article of food, the
                                          timeframes prescribed in the final rule,                that FDA clarify the penalties for                    notice is determined to be inaccurate,
                                          the food is subject to refusal under                    inadequate prior notice. One comment                  the food is subject to refusal of
                                          section 801(m) of the act, unless FDA                   asks about the consequences when                      admission under section 801(m)(1) of
                                          already reviewed the prior notice,                      foods are accidentally shipped without                the act.
                                          determined its response, and advised                    meeting the prior notice requirements,
                                                                                                                                                        3. Status and Movement of Refused
                                          CBP of that response. See also the                      i.e. can they be transshipped?
                                                                                                     (Response) Prior notice is required for            Food (§ 1.283(a)(2))
                                          discussion above regarding
                                          communication of refusal status.                        food imported or offered for import into                 (Comments) Some comments request
                                             (Comments) One comment requests                      the United States, including shipments                that FDA clarify the process for food
                                          clarification as to how transmitters may                intended for transshipment. If adequate               that is refused and later deemed to be
                                          confirm the validity and existence of                   prior notice is not provided, the food is             admissible.
                                          registration numbers provided by the                    subject to refusal. Refused food must be                 (Response) Section 1.283 of the final
                                          shippers, importers, and carriers. The                  held, in accordance with the provisions               rule identifies the consequences and
                                          comment states that the transmitter                     of § 1.283(a), unless CBP concurrence is              procedures for food that is refused
                                          might bring in goods based on                           obtained for export and the food is                   because of inadequate prior notice. If
                                          erroneous, but good faith information.                  immediately exported from the port of                 the refused food is not immediately
                                             (Response) FDA will identify                         arrival under CBP supervision. An                     exported with CBP concurrence, it is
                                          anomalies in the initial submission of                  article of food that has been refused is              considered general order merchandise
                                          registration numbers based on review of                 considered general order merchandise                  and must be held until adequate prior