Department of Agriculture

					                                                                                            Friday,
                                                                                            March 18, 2005




                                                                                            Part II

                                                                                            Department of
                                                                                            Agriculture
                                                                                            Animal and Plant Health Inspection
                                                                                            Service

                                                                                            7 CFR Part 331 and 9 CFR Part 121
                                                                                            Agricultural Bioterrorism Protection Act
                                                                                            of 2002; Possession, Use, and Transfer of
                                                                                            Biological Agents and Toxins; Final Rule




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      13242                Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations

      DEPARTMENT OF AGRICULTURE                               213), and provides for interagency                    listed agents and toxins for use in
                                                              coordination between the two                          domestic or international terrorism or
      Animal and Plant Health Inspection                      departments regarding overlap agents                  for any other criminal purpose;
      Service                                                 and toxins (subtitle C, section 221).                    • Establish procedures to protect
                                                              Subtitle D (section 231) provides for                 animal and plant health, and animal
      7 CFR Part 331 and 9 CFR Part 121                       criminal penalties regarding certain                  and plant products, in the event of a
                                                              biological agents and toxins. For the                 transfer or potential transfer of a listed
      [Docket No. 02–088–4]
                                                              Department of Health and Human                        agent or toxin in violation of the safety
      RIN 0579–AB47                                           Services, the Centers for Disease Control             procedures and safeguard and security
                                                              and Prevention (CDC) has been                         measures established by the Secretary;
      Agricultural Bioterrorism Protection                    designated as the agency with primary                 and
      Act of 2002; Possession, Use, and                       responsibility for implementing the                      • Ensure appropriate availability of
      Transfer of Biological Agents and                       provisions of the Act; the Animal and                 biological agents and toxins for
      Toxins                                                  Plant Health Inspection Service (APHIS)               research, education, and other
      AGENCY:  Animal and Plant Health                        is the agency fulfilling that role for the            legitimate purposes.
                                                              Department of Agriculture (USDA). The                    In an interim rule published in the
      Inspection Service, USDA.
                                                              Criminal Justice Information Services                 Federal Register on December 13, 2002
      ACTION: Final rule.                                                                                           (67 FR 76908–76938, Docket No. 02–
                                                              (CJIS) Division of the Federal Bureau of
      SUMMARY: We are adopting as a final                     Investigation has been designated as the              088–1) and effective on February 11,
      rule, with changes, an interim rule that                agency with primary responsibility for                2003, we established regulations in 7
      established regulations governing the                   implementing the Attorney General’s                   CFR part 331 and 9 CFR part 121
      possession, use, and transfer of                        responsibilities under the Act (i.e., the             governing the possession, use, and
      biological agents and toxins that have                  security risk assessments).                           transfer of biological agents and toxins
      been determined to have the potential to                   In subtitle B (which is cited as the               that have been determined to have the
      pose a severe threat to public health and               ‘‘Agricultural Bioterrorism Protection                potential to pose a severe threat to both
      safety, to animal health, to plant health,              Act of 2002’’ and referred to below as                human and animal health, to animal
      or to animal or plant products. This                    the Act ), section 212(a) provides, in                health, to plant health, or to animal or
      action is necessary to protect animal                   part, that the Secretary of Agriculture               plant products. These CFR parts are
      and plant health, and animal and plant                  (the Secretary) must establish by                     referred to below as the regulations. We
                                                              regulation a list of each biological agent            solicited comments concerning the
      products.
                                                              and each toxin that the Secretary                     interim rule for 60 days ending February
      DATES: Effective Date: The amendments
                                                              determines has the potential to pose a                11, 2003. We received 36 written
      to the list of PPQ select agents and                                                                          comments. They were from academic
                                                              severe threat to animal or plant health,
      toxins in 7 CFR 331.3(b) are effective                                                                        institutions, professional associations,
                                                              or to animal or plant products. The Act
      March 10, 2005. The remaining                                                                                 corporations, nonprofit organizations,
                                                              further requires (under section 213(b))
      provisions of this final rule are effective                                                                   individuals, and representatives of State
                                                              that all persons in possession of any
      April 18, 2005.                                                                                               and Federal Governments. These
                                                              listed biological agent or toxin must,
      FOR FURTHER INFORMATION CONTACT: For                    within 60 days of the publication of that             comments, as well as oral comments
      information concerning the regulations                  regulation, notify the Secretary of such              presented at a public meeting on
      in 7 CFR part 331, contact Dr. Charles                  possession.                                           December 16, 2002, are discussed by
      L. Divan, Senior Agricultural                              In accordance with these statutory                 topic below.
      Microbiologist, Pest Permit Evaluations,                requirements, on August 12, 2002, we                     Also on December 13, 2002, CDC
      Biological and Technical Services, PPQ,                 published in the Federal Register (67                 published in the Federal Register (67
      APHIS, 4700 River Road Unit 133,                        FR 52383–52389, Docket No. 02–082–1)                  FR 76886–76905) an interim rule that
      Riverdale, MD 20737–1236, (301) 734–                    an interim rule that established the                  established the standards and
      8758.                                                   initial lists of biological agents and                procedures governing the possession,
        For information concerning the                        toxins and set out the manner in which                use, and transfer of certain biological
      regulations in 9 CFR part 121, contact                  persons in possession of listed agents                agents and toxins (referred to by CDC as
      Dr. Lee Ann Thomas, Director, Animals,                  and toxins were to provide notice of                  select agents and toxins) (42 CFR part
      Organisms and Vectors, and Select                       such possession.                                      73).
      Agents, VS, APHIS, 4700 River Road                         Section 212 of the Act also required                  On November 3, 2003, APHIS and
      Unit 2, Riverdale, MD 20737–1231,                       the Secretary to provide by regulation                CDC published in the Federal Register
      (301) 734–5960.                                         for the establishment and enforcement                 (68 FR 62218–62221, Docket No. 02–
      SUPPLEMENTARY INFORMATION:                              of standards and procedures governing                 088–3; and 68 FR 62245–62247) interim
                                                              the possession, use, and transfer of                  rules that amended both agencies’
      Background                                                                                                    regulations in order to allow for the
                                                              listed biological agents and toxins in
         On June 12, 2002, the President                      order to protect animal and plant health,             issuance of provisional registration
      signed into law the Public Health                       and animal and plant products.                        certificates for individuals and entities
      Security and Bioterrorism Preparedness                  Specifically, sections 212(b) and (c)                 and provisional grants of access to listed
      and Response Act of 2002 (Pub. L. 107–                  required that the Secretary:                          biological agents and toxins for
      188). Title II of Pub. L. 107–188,                         • Establish and enforce safety                     individuals. These provisional measures
      ‘‘Enhancing Controls on Dangerous                       procedures for listed agents and toxins,              provided additional time for the
      Biological Agents and Toxins’’ (sections                including measures to ensure proper                   Attorney General to complete security
      201 through 231), provides for the                      training and appropriate skills to handle             risk assessments for those individuals
      regulation of certain biological agents                 agents and toxins, and proper laboratory              and entities for which the Attorney
      and toxins by the Department of Health                  facilities to contain and dispose of                  General received, by November 12,
      and Human Services (subtitle A,                         agents and toxins;                                    2003, all of the information required to
      sections 201–204) and the Department                       • Establish and enforce safeguard and              conduct a security risk assessment. We
      of Agriculture (subtitle B, sections 211–               security measures to prevent access to                solicited comments concerning the


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                           Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations                                         13243

      interim rules for 60 days ending January                   • Recombinant nucleic acids that                   entity’s select agents or toxins or with
      2, 2004. We did not receive any                         encode for the functional forms of any                regard to the individuals with access to
      comments by that date.                                  toxin listed in either 7 CFR part 331 or              the select agents or toxins possessed,
         APHIS and CDC collaborated closely                   9 CFR part 121 if the nucleic acids: (1)              used, or transferred by the entity.
      on the December 13, 2002, and                           Can be expressed in vivo or in vitro; or                • An entity will be considered to be
      November 3, 2003, interim rules, as well                (2) are in a vector or recombinant host               an institution of higher education if it is
      as on this final rule and CDC’s final rule              genome and can be expressed in vivo or                an institution of higher education as
      also issued in today’s Federal Register.                in vitro; and                                         defined in section 101(a) of the Higher
      Below is a summary of the changes we                       • Select agents and toxins listed in               Education Act of 1965 (20 U.S.C.
      are making to the regulations in this                   either 7 CFR part 331 or 9 CFR part 121               1001(a)), or is an organization described
      final rule. We refer to the regulations in              that have been genetically modified.                  in 501(c)(3) of the Internal Revenue
      place prior to the effective date of this                  8. We are broadening the scope of the              Code of 1986, as amended (26 U.S.C.
      final rule as the ‘‘interim’’ regulations,              overlap toxin exclusion to cover overlap              501(c)(3)).
      or ‘‘interim’’ 7 CFR 331.4, for example,                toxins under the control of a principal                 14. We are amending the registration
      when we need to distinguish between                     investigator, treating physician or                   sections to provide that a certificate of
      the regulations established by the                      veterinarian, or commercial                           registration will be valid for one
      interim rules of December 2002 and                      manufacturer or distributor.                          physical location (a room, a building, or
      November 2003 and this final rule.                         9. We are amending the exemption                   a group of buildings) where the
                                                              provisions by requiring, as another                   responsible official will be able to
      Summary of Changes Made in Final                        condition of exemption, that the select               perform the responsibilities required in
      Rule                                                    agent or toxin be secured against theft,              this part, for specific select agents or
         1. We are revising the format of the                 loss, or release during the period                    toxins, and for specific activities.
      regulations in 7 CFR part 331 and 9 CFR                 between identification of the agent or                  15. We are amending the registration
      part 121 so that the sections numbers                   toxin and transfer or destruction of such             sections to require that, prior to any
      and, to the extent possible, the section                agent or toxin.                                       change, the responsible official must
      titles and the information contained in                    10. We are amending the exemption                  apply for an amendment to a certificate
      each section is the same in 7 CFR part                  provisions in 9 CFR part 121 by                       of registration by submitting the
      331, 9 CFR part 121, and 42 CFR part                    requiring immediate reporting after                   relevant page(s) of the registration
      73.                                                     identification of specified select agents             application.
         2. We are changing the terms                         and toxins; identification of the other                 16. We are amending the registration
      ‘‘biological agents and/or toxins,’’                    select agents and toxins must be                      sections to provide that an entity must
      ‘‘listed agents and/or toxins,’’ and ‘‘high             reported within 7 calendar days after                 immediately notify APHIS or CDC if it
      consequence livestock pathogens’’ to                    identification.                                       loses the services of its responsible
      ‘‘select agents and toxins’’ or ‘‘select                   11. We are amending the exemption                  official. An entity may continue to
      agents or toxins’’ throughout 7 CFR part                provisions to allow the Administrator to              possess or use select agents or toxins
      331 and 9 CFR part 121. In addition, in                 make exceptions to the timeframes for                 only if it appoints as the responsible
      9 CFR part 121, we are removing the                     transfer or destruction of a select agent             official another individual who has been
      term ‘‘overlap agents’’ each time it                    or toxin, as necessary.                               approved by the Administrator or the
                                                                 12. We are amending the registration               HHS Secretary following a security risk
      appears and adding ‘‘overlap select
                                                              sections to set out a new framework for               assessment by the Attorney General and
      agents and/or toxins’’ in its place.
                                                              submitting registration applications to               who meets the requirements of the
         3. We are changing the title of 7 CFR
                                                              APHIS or CDC.                                         regulations.
      part 331 and 9 CFR part 121 from                           13. We are amending the registration                 17. We are amending the sections
      ‘‘Possession, Use, and Transfer of                      sections in 7 CFR part 331 and 9 CFR                  pertaining to denial, revocation, and
      Biological Agents and Toxins’’ to                       part 121 to provide:                                  suspension of registration by requiring
      ‘‘Possession, Use, and Transfer of Select                  • Federal, State, or local                         that, upon notification of suspension or
      Agents and Toxins.’’                                    governmental agencies, including public               revocation, an individual or entity must:
         4. We are removing Phakopsora                        institutions of higher education, are                   • Immediately stop all use of each
      pachyrhizi and plum pox potyvirus from                  exempt from the security risk                         select agent or toxin covered by the
      the list of PPQ select agents and toxins.               assessment for the entity and the                     revocation or suspension order;
         5. We are removing Newcastle disease                 individual who owns or controls such                    • Immediately safeguard and secure
      virus (VVND) from the list of VS select                 entity.                                               each select agent or toxin covered by the
      agents and toxins and adding Newcastle                     • For a private institution of higher              revocation or suspension order from
      disease virus (velogenic) in its place to               education, an individual will be deemed               theft, loss, or release; and
      make it clear that we are regulating all                to own or control the entity if the                     • Comply with all disposition
      of the velogenic strains.                               individual is in a managerial or                      instructions issued by the Administrator
         6. We are removing Clostridium                       executive capacity with regard to the                 for each select agent or toxin covered by
      botulinum from the list of overlap select               entity’s select agents or toxins or with              the revocation or suspension.
      agents and toxins but we are continuing                 regard to the individuals with access to                18. We are amending the responsible
      to list Botulinum neurotoxin producing                  the select agents or toxins possessed,                official sections to require the
      species of Clostridium.                                 used, or transferred by the entity.                   responsible official to report the
         7. We are adopting CDC’s approach                       • For entities other than institutions             identification and final disposition of
      for genetic elements and, therefore, we                 of higher education, an individual will               any select agent or toxin contained in a
      will consider the following to be select                be deemed to own or control the entity                specimen presented for diagnosis or
      agents and toxins:                                      if the individual: (1) Owns 50 percent or             verification. We are also amending the
         • Nucleic acids that can produce                     more of the entity, or is a holder or                 responsible official section in 9 CFR
      infectious forms of any of the select                   owner of 50 percent or more of its                    121.9 to require the responsible official
      agent viruses listed in either 7 CFR part               voting stock; or (2) is in a managerial or            to report the identification and final
      331 or 9 CFR part 121;                                  executive capacity with regard to the                 disposition of any select agent or toxin


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      13244                    Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations

      contained in a specimen presented for                                  the Administrator or the HHS Secretary                           28. We are amending the section
      proficiency testing.                                                   before he/she works in or visits areas                         pertaining to notification of theft, loss,
         19. We are amending the provisions                                  where select agents or toxins are                              or release in 7 CFR part 331 to require
      relating to access approvals to state that                             handled or stored (e.g., laboratories,                         that APHIS or CDC be notified
      an individual will be deemed to have                                   growth chambers, animal rooms,                                 immediately upon discovery of a release
      access at any point in time if the                                     greenhouses, storage areas, etc.).                             of a select agent or toxin outside of the
      individual has possession of a select                                     24. We are amending the transfer                            primary barriers of the biocontainment
      agent or toxin (e.g., carries, uses, or                                section in 9 CFR 121.16 to set out the                         area and we are amending this section
      manipulates) or the ability to gain                                    requirements for transfer of a select                          in 9 CFR part 121 to require that APHIS
      possession of a select agent or toxin.                                 agent or toxin contained in a specimen                         or CDC be notified immediately upon
         20. We are amending the provisions                                  for proficiency testing.                                       discovery of a release of a select agent
      pertaining to access approval to provide                                  25. We are amending the transfer                            or toxin causing occupational exposure
      that an individual’s access approval                                   sections to provide that, on a case-by-                        or a release outside of the primary
      may be revoked if the individual is                                    case basis, the Administrator may                              barriers of the biocontainment area.
      within any of the categories specified in                              authorize a transfer of a select agent or
                                                                                                                                              29. We are amending the
      the regulations.                                                       toxin not otherwise eligible for transfer
         21. We are amending the security                                                                                                   administrative review sections to allow
                                                                             under the regulations under conditions
      sections to clarify that the security plan                                                                                            an individual to appeal revocation of
                                                                             prescribed by the Administrator.
      must be sufficient to safeguard the select                                26. We are amending the transfer                            access approval.
      agent or toxin against unauthorized                                    sections to provide that an authorization                      Format of the Regulations
      access, theft, loss, or release.                                       for a transfer shall be valid only for 30
         22. We are adding the provisions for                                calendar days after issuance, except that                        APHIS and CDC are revising the
      restricted experiments to 7 CFR part 331                               such an authorization becomes                                  format of the regulations in the final
      and we are amending these provisions                                   immediately null and void if any facts                         rules so that the section numbers and,
      in 7 CFR part 331 and 9 CFR part 121                                   supporting the authorization changes                           to the extent possible, the section titles
      to indicate that these experiments must                                (e.g., change in the certificate of                            and the information contained in each
      be conducted under any conditions                                      registration for the sender or recipient,                      section is the same in 7 CFR part 331,
      prescribed by the Administrator.                                       change in the application for transfer).                       9 CFR part 121, and 42 CFR part 73.
         23. We are amending the training                                       27. We are amending the records                             These changes should make the
      sections to require that information and                               sections to require the maintenance of                         regulations easier to use and facilitate
      training on biocontainment/biosafety                                   an accurate, current inventory for each                        compliance. The chart below sets out
      and security be provided to each                                       toxin held and for each select agent held                      the format of 7 CFR part 331 and 9 CFR
      individual with access approval from                                   in long-term storage (placement in a                           part 121 set by the interim rules (interim
      the Administrator or the HHS Secretary                                 system designed to ensure viability for                        regulations) and the new format for the
      before he/she has access and to each                                   future use, such as in a freezer or                            regulations in 7 CFR part 331 and 9 CFR
      individual not approved for access by                                  lyophilized materials).                                        part 121 (final rule).

                                           Interim regulations                                                                                      Final rule

      331.0    Effective and applicability dates
      121.0    Effective and applicability dates
      331.1    Definitions ....................................................................................    331.1 Definitions.
      121.1    Definitions ....................................................................................    121.1 Definitions.
      331.2    Purpose and scope ......................................................................            331.2 Purpose and scope.
      121.2    Purpose and scope ......................................................................            121.2 Purpose and scope.
      331.3    List of biological agents and toxins .............................................                  331.3 PPQ select agents and toxins.
      121.3    List of biological agents and toxins .............................................                  121.3 VS select agents and toxins.
      331.4    Exemptions ..................................................................................       331.4 [Reserved].
      121.4    Exemptions for overlap agents or toxins .....................................                       121.4 Overlap select agents and toxins.
      331.5    Registration; who must register ...................................................                 331.5 Exemptions.
      121.5    Exemptions for animal agents and toxins ...................................                         121.5 Exemptions for VS select agents and toxins.
      331.6    Registration; general provisions ..................................................                 331.6 [Reserved]
      121.6    Registration; who must register ...................................................                 121.6 Exemptions for overlap select agents and toxins.
      331.7    Denial, revocation, or suspension of registration ........................                          331.7 Registration and related security risk assessments.
      121.7    Registration; general provisions ..................................................                 121.7 Registration and related security risk assessments.
      331.8    Registration; how to register ........................................................              331.8 Denial, revocation, or suspension of registration.
      121.8    Denial, revocation, or suspension of registration ........................                          121.8 Denial, revocation, or suspension of registration.
      331.9    Responsibilities of the responsible official ...................................                    331.9 Responsible official.
      121.9    Registration; how to register ........................................................              121.9 Responsible official.
      331.10    Restricting access to biological agents and toxins ....................                            331.10 Restricting access to select agents and toxins; security risk
                                                                                                                     assessments.
      121.10 Responsibilities of the responsible official .................................                        121.10 Restricting access to select agents and toxins; security risk
                                                                                                                     assessments.
      331.11    Biocontainment and security plan ..............................................                    331.11 Security.
      121.11    Restricting access to biological agents and toxins ....................                            121.11 Security.
      331.12    Training ......................................................................................    331.12 Biocontainment.
      121.12    Biosafety and security plan ........................................................               121.12 Biosafety.
      331.13    Transfer of biological agents and toxins ....................................                      331.13 Restricted experiments.
      121.13    Training ......................................................................................    121.13 Restricted experiments.
      331.14    Records ......................................................................................     331.14 Incident response.
      121.14    Transfer of biological agents and toxins ....................................                      121.14 Incident response.
      331.15    Inspections .................................................................................      331.15 Training.



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                               Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations                                                               13245

                                          Interim regulations                                                                                        Final rule

      121.15    Records ......................................................................................    121.15 Training.
      331.16    Notification in the event of theft, loss, or release of a biological                              331.16 Transfers.
        agent   or toxin.
      121.16    Inspections .................................................................................     121.16 Transfers.
      331.17    Administrative review .................................................................           331.17 Records.
      121.17    Notification in the event of theft, loss, or release of a biological                              121.17 Records.
        agent   or toxin.
      121.18    Administrative review .................................................................           331.18     Inspections.
                                                                                                                  121.18     Inspections.
                                                                                                                  331.19     Notification of theft, loss, or release.
                                                                                                                  121.19     Notification of theft, loss, or release.
                                                                                                                  331.20     Administrative review.
                                                                                                                  121.20     Administrative review.



      General Comments                                                      mechanism and one office of                                       regulations on the scientific community.
         A commenter suggested that APHIS                                   compliance assistance and enforcement                             Several commenters stated that the
      and CDC adopt consistent terminology                                  in order to enhance coordination                                  regulations will limit the free exchange
      when referring to biological agents and                               between APHIS and CDC.                                            of scientific information and make it
      toxins. The commenter pointed out that                                   We agree that APHIS and CDC should                             difficult to recruit foreign researchers
      the regulations use the following terms:                              harmonize the regulations and provide                             and technical workers in areas of short
      biological agents and toxins, select                                  consistent guidance to entities. APHIS                            supply in the United States. Several
      agents and toxins, overlap agents, and                                and CDC have worked closely together                              commenters asserted that the costs of
      high consequence pathogens.                                           to identify and resolve differences                               the regulations (especially the security
         We agree that APHIS and CDC should                                 between the regulations. This final rule                          requirements) will result in the
      use consistent terminology. Therefore,                                is consistent with CDC’s final rule in                            termination of important research
      in this final rule, we are removing the                               both structure and substance. APHIS                               projects and the destruction of
      terms ‘‘biological agents and/or toxins,’’                            and CDC have also established                                     specimens. One commenter stated that
      ‘‘listed agents and/or toxins,’’ and ‘‘high                           procedures that will allow an entity to                           research programs will be terminated
      consequence livestock pathogens’’ each                                interact with only one agency—either                              because researchers will not want to
      time they appear in 7 CFR part 331 and/                               APHIS or CDC—with respect to most                                 deal with the new regulatory
      or 9 CFR part 121 and adding ‘‘select                                 matters involving select agents and                               requirements or their institutions will
      agents and/or toxins’’ in their place. In                             toxins. These changes will ensure the                             not want to be liable for violations of the
      addition, in 9 CFR part 121, we are                                   close coordination of APHIS and CDC                               regulations. This commenter also noted
      removing the term ‘‘overlap agents’’                                  and create a uniform and consistent                               that the costs of adhering to the
      each time it appears and adding                                       approach to the regulation of select                              regulations will limit the money
      ‘‘overlap select agents and/or toxins’’ in                            agents and toxins. APHIS and CDC are                              available for the research. Another
      its place. To reflect this change in                                  also developing a single shared web-                              commenter stated that scientists will
      terminology, we are also changing the                                 based system that will allow the                                  end up spending more time dealing
      title of both parts from ‘‘Possession, Use,                           regulated community to conduct                                    with bureaucratic requirements rather
      and Transfer of Biological Agents and                                 transactions electronically with APHIS                            than working in the laboratory or
      Toxins’’ to ‘‘Possession, Use, and                                    and CDC via a single web portal. By                               supervising their employees.
      Transfer of Select Agents and Toxins.’’                               providing a single web portal, APHIS                                 The Act requires the Secretary to
      In accordance with these changes, we                                  and CDC will be able to interact                                  establish, by regulation, standards and
      will be using the term ‘‘select agent and/                            efficiently and effectively with the                              procedures governing the possession,
      or toxin’’ throughout the preamble of                                 regulated community while reducing                                use, and transfer of listed biological
      this rule. When it is necessary to specify                            the burden on the public. We envision                             agents and toxins in order to protect
      the type of select agent or toxin, we will                            that this system will enable the entity to                        animal and plant health, and animal
      use the following terms: ‘‘PPQ select                                 dynamically communicate with APHIS                                and plant products. In an interim rule
      agent and/or toxin’’ (for the plant agents                            and CDC in a digitally secured                                    published in the Federal Register on
      and toxins), ‘‘VS select agent and/or                                 environment using a single web portal.                            December 13, 2002, and effective on
      toxin’’ (for the animal agents and                                    The web portal will provide a platform                            February 11, 2003, APHIS established
      toxins), or ‘‘overlap select agent and/or                             for electronic exchange of information.                           the regulations required under the Act.
      toxin.’’ Unless otherwise specified, the                              It will allow entities to access data                             To date, the commenters’ concerns
      term ‘‘select agent and/or toxin’’ will                               related to their own registration data                            about the costs or difficulties of
      refer to all agents or toxins listed by                               and allow them to create, amend, and                              complying with the regulations have
      APHIS.                                                                submit registration applications;                                 failed to materialize. Accordingly, we
         One commenter stated that APHIS                                    requests for approvals for transfers,                             are making no changes in response to
      and CDC should harmonize the                                          exemptions, or exclusions; and any                                these comments.
      regulations and provide consistent                                    other required forms without the need                                Several commenters requested that
      guidance to entities. This commenter                                  to print, mail, or e-mail hard copies.                            APHIS and CDC create a grant program
      also recommended close collaboration                                  Hard copy registration materials and                              to assist entities with the costs of
      between the agencies for registration,                                other required forms will still be                                implementing the security
      enforcement, and compliance                                           accepted. The single web portal will be                           requirements.
      assistance. Another commenter                                         available in winter 2005.                                            At this time APHIS is unable to assist
      recommended that APHIS and CDC                                           A number of commenters expressed                               entities with the costs of implementing
      establish one regulatory and reporting                                concern about the effect of the                                   the security requirements because


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      Congress has not appropriated any                       APHIS would store and protect the                     commenter expressed concern that the
      funds to establish such a grant program.                information collected. Another                        data collected for registration or a
      Accordingly, we are making no change                    commenter stated that USDA should                     security risk assessment might be used
      based on these comments.                                ensure that the information collected is              inappropriately by a Federal agency to
         One commenter requested that APHIS                   not available through Freedom of                      assess a proposal for funding. The
      specify in the final rule that it is the                Information Act requests.                             commenter recommended that APHIS,
      regulatory agency for the veterinary                       Section 212(h) of the Act sets forth the           CDC, and the Department of Justice take
      biologics industry.                                     requirements relating to the disclosure               steps to ensure the security and
         An entity in the veterinary biologics                of information by APHIS and other                     confidentiality of submitted
      industry may be regulated by APHIS                      Federal agencies. Specifically, section               information.
      and/or CDC, depending on the agent or                   212(h)(1) provides that the specified                   In accordance with the Act, the
      toxin that it possesses, uses, or                       Federal agencies may not disclose under               information submitted by an individual
      transfers—overlap select agents and                     5 U.S.C. 552 any of the following: (1)                as part of a security risk assessment may
      toxins are regulated by both APHIS and                  Any registration or transfer                          only be used to determine if an
      CDC, while VS select agents and toxins                  documentation, permits issued prior to                individual is a restricted person under
      are regulated only by APHIS. For this                   the enactment of the Act, or information              18 U.S.C. 175b or is reasonably
      reason, we are making no change in                      derived therefrom to the extent that it               suspected by any Federal law
      response to this comment.                               identifies the agent or toxin possessed,              enforcement or intelligence agency of
         A commenter stated that the                          used, or transferred by a specific person             (1) committing a crime set forth in 18
      regulations should be revoked and                       or discloses the identity or location of              U.S.C. 2332b(g)(5), (2) knowing
      replaced with prohibitions on owning,                   a specific person; (2) the national                   involvement with an organization that
      working with, or importing any of the                   database or any other compilation of the              engages in domestic or international
      agents or products. This commenter                      registration or transfer information to               terrorism (as defined in 18 U.S.C. 2331)
      recommended that the penalty for                        the extent that such compilation                      or with any other organization that
      possession of a select agent be a fine of               discloses site-specific registration or               engages in intentional crimes of
      $500,000 or imprisonment for up to 25                   transfer information; (3) any portion of              violence, or (3) being an agent of a
      years.                                                  a record that discloses the site-specific             foreign power as defined in 50 U.S.C.
         The Act does not authorize APHIS to                  or transfer-specific safeguard and                    1801. We believe that the Act and other
      prohibit the possession, use, or transfer               security measures used by a registered                applicable Federal laws, such as the
      of biological agents and toxins. Rather,                person to prevent unauthorized access                 Privacy Act, are sufficient to ensure the
      section 212 of the Act directs APHIS to                 to agents and toxins; (4) any notification            confidentiality of the submitted
      establish, by regulation, standards and                 of a theft, loss, or release of an agent or           information. We are making no change
      procedures governing the possession,                    toxin; and (5) any portion of an                      in response to this comment.
      use, and transfer of biological agents                  evaluation or report of an inspection of                A commenter asked how APHIS
      and toxins that have been determined to                 a specific registered person that                     inspectors will mark and protect their
      have the potential to pose a severe                     identifies the agent or toxin possessed               inspection reports. APHIS inspection
      threat to both human and animal health,                 by a specific registered person if the                reports and related documents will be
      to animal health, to plant health, or to                agency determines that public                         protected in accordance with the Act
      animal or plant products. The Act also                  disclosure of the information would                   and agency and departmental policies.
      sets forth the civil and criminal                       endanger animal or plant health, or
                                                                                                                    Economic Impact
      penalties for violations of the Act. For                animal or plant products. We believe
      these reasons, we are making no                         the Act provides sufficient protection                   Several commenters argued that the
      changes based on this comment.                          for the information collected under the               costs of compliance were grossly
         One commenter warned of the                          regulations. Accordingly, we are making               understated in the economic analysis for
      potential for international travelers to                no changes based on these comments.                   the December 2002 interim rule. One
      bring biological ‘‘suitcase bombs’’ into                   A commenter stated the rule should                 commenter stated that the one-time cost
      the United States from countries with                   explicitly state that the security risk               to retrofit existing facilities will easily
      bovine spongiform encephalopathy,                       assessment is confidential.                           exceed $1 million and that recurring
      foot-and-mouth disease, or other exotic                    As previously noted, we believe the                annual costs could top $100,000.
      animal disease pathogens.                               Act provides sufficient protection for                   Although the commenter didn’t
         This commenter appears to be                         the information collected under the                   specify, we believe that the commenter
      concerned about the introduction of                     regulations. We do not believe it is                  is referring to the costs to upgrade
      animal disease pathogens into the                       necessary to state in the regulations that            security. In our December 2002
      United States in the luggage of                         the security risk assessment is                       economic analysis, we provided
      international travelers. This comment is                confidential. Therefore, we are making                estimates of the costs of the interim
      outside the scope of this rulemaking.                   no change based on this comment.                      security requirements. However, we
      However, we note that VS select agents                     Another commenter asserted that the                noted that these estimates may not
      or toxins and overlap select agents or                  information collected by APHIS for the                apply to every entity due to the
      toxins may only be imported into the                    security risk assessment should not be                diversity in existing security levels and
      United States in accordance with 9 CFR                  used more broadly than to determine                   security needs, as well as the various
      parts 121 and 122. We are making no                     who is a ‘‘restricted person.’’ The                   methods of meeting the interim security
      change based on this comment.                           commenter noted that California State                 requirements. In the economic analysis
                                                              law prohibits discrimination in                       in this final rule, we reiterate that the
      Protection of Information Collected by                  employment based upon citizenship                     costs to comply with the security
      APHIS                                                   and prohibits the disclosure of                       requirements are site specific and will
        Several commenters expressed                          citizenship information to a third party              vary accordingly.
      concern about APHIS’ ability to protect                 in a manner that links that information                  Another commenter stated that the
      the information collected under the                     to the individual, except in limited and              interim rule ignored or grossly
      regulations. One commenter asked how                    compelling circumstances. The                         underestimated financial costs,


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                           Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations                                          13247

      including the costs of verifying the                    identifying or confirming the presence                select agent and/or toxin is defined as
      baseline inventory and the costs of                     or characteristics of a select agent or               ‘‘a biological agent or toxin that is listed
      responding to lost vial reports. The                    toxin provided that such analysis is                  in 9 CFR 121.4 and 42 CFR 73.4.’’ We
      commenter estimated that the one-time                   directly related to protecting the public             are also adding definitions for VS and
      cost to verify the baseline inventory will              health or safety, animal health or animal             VS select agent and/or toxin in § 121.1.
      be $2 million with recurring costs of                   products, or plant health or plant                    VS is defined as ‘‘the Veterinary
      about $1 million per year. The                          products.’’ Verification is defined as                Services Programs of the Animal and
      commenter also estimated that it will                   ‘‘the demonstration of obtaining                      Plant Health Inspection Service’’ and VS
      cost about $5 million per year to                       established performance (e.g., accuracy,              select agent and/or toxin is defined as
      respond to reports of lost vials of select              precision, and the analytical sensitivity             ‘‘a biological agent or toxin listed in
      agents because the response would                       and specificity) specifications for any               § 121.3.’’
      require, at least, a verification of the                procedure used for diagnosis.’’ In                       One commenter claimed that the term
      inventory.                                              addition, in 9 CFR 121.1, we are                      ‘‘entity’’ is subject to interpretation. The
         In response to this comment, the                     amending the definition of proficiency                commenter stated that it does not make
      economic analysis in this final rule                    testing. Proficiency testing is defined as            sense for a large multi-campus
      provides more information about the                     ‘‘the process of determining the                      university to base cumulative limits on
      costs of the inventory recordkeeping                    competency of an individual or                        toxins or the designation of the
      requirements. In this final rule, we                    laboratory to perform a specified test or             responsible official on the entity when
      estimate that it would cost an entity                   procedure.’’ Finally, we are deleting the             the actual labs are separated by
      $7,200 to create a baseline inventory                   definition for diagnostic laboratory in               hundreds of miles. Another commenter
      (assuming an average of 10 freezers and                 both sections and we are deleting the                 stated the definition of ‘‘entity’’ should
      3 toxin containers per entity). Assuming                definition for clinical laboratory in 9               be amended to permit a responsible
      that registered entities would have to re-              CFR 121.1. These changes will clarify                 official to discharge his or her
      inventory one-half of their freezers each               the exemption provisions and help to                  responsibilities at several adjacent
      year to maintain an accurate and current                ensure that APHIS and CDC consistently                addresses.
      inventory, we estimate the total yearly                 apply these provisions.                                  These issues are addressed below in
      inventory cost for all affected entities to                To be consistent with CDC’s                        the registration section. We are making
      be $274,000. Finally, in the event of a                 definitions, we are adopting CDC’s                    no change to the definitions section in
      theft or loss, we expect an entity would                definitions for HHS Secretary and HHS                 7 CFR 331.1 and 9 CFR 121.1 based on
      conduct an inventory of the affected                    select agent and/or toxin in both                     these comments.
      storage freezer or toxin container. We                  sections in this final rule. HHS                         One commenter recommended that
      estimate that such an inventory would                   Secretary is defined as ‘‘the Secretary of            APHIS and CDC adopt a common
      cost $560 per occurrence.                               the Department of Health and Human                    definition for the term ‘‘responsible
                                                              Services or his or her designee, unless               official.’’ The commenter noted that
      Effective and Applicability Dates                       otherwise specified.’’ HHS select agent               APHIS defines the term ‘‘responsible
        Interim 7 CFR 331.0 and 9 CFR 121.0                   and/or toxin is defined as ‘‘a biological             official’’ but CDC does not. The
      provided that the regulations in each                   agent or toxin listed in 42 CFR 73.3.’’               commenter stated that APHIS indicates
      part became effective on February 11,                      A commenter suggested that APHIS                   a responsible manager should be the
      2003. To minimize the disruption of                     and CDC adopt consistent terminology                  responsible official for an entity, while
      research or educational projects, both                  when referring to biological agents and               CDC would allow a biosafety officer to
      sections also provided additional time                  toxins. As previously noted, in this final            assume this role. The commenter stated
      for individuals and entities to reach full              rule we are adopting the terms ‘‘select               that, in general, a biosafety officer
      compliance with the regulations in each                 agents and/or toxins’’ and ‘‘overlap                  would not have direct control over
      part (i.e., a phase-in period). Finally, as             select agents and/or toxins.’’ To reflect             either the affected staff or budgets in
      established in the November 3, 2003,                    this change in terminology, we are                    order to ensure compliance with the
      interim rule, both sections provided for                adding several additional definitions to              regulations.
      the issuance of provisional certificates                the regulations.                                         We agree that APHIS and CDC should
      of registration and provisional grants of                  In 7 CFR 331.1 and 9 CFR 121.1, we                 adopt a common definition for the term
      access for individuals under certain                    are adding a definition for the term                  ‘‘responsible official.’’ Accordingly, we
      conditions.                                             select agent and/or toxin. However, due               are amending the definition for
        A number of commenters requested                      to differences between the plant-related              responsible official in this final rule. In
      clarification of the provisions for the                 regulations in 7 CFR part 331 and the                 7 CFR 331.1 and 9 CFR 121.1, we define
      phase-in period and several commenters                  animal-related regulations in 9 CFR part              responsible official as ‘‘the individual
      requested additional time to comply                     121, the term select agent and/or toxin               designated by an entity with the
      with certain provisions. Given that all of              is defined differently in both parts. In 7            authority and control to ensure
      the dates in 7 CFR 331.0 and 9 CFR                      CFR 331.1, select agent and/or toxin is               compliance with the regulations in this
      121.0 have passed, the sections are no                  defined as ‘‘a biological agent or toxin              part.’’ CDC is adopting the same
      longer applicable and the issues raised                 listed in § 331.3’’ while in 9 CFR 121.1              definition in its final rule.
      by the commenters are moot.                             it is defined as ‘‘unless otherwise                      A commenter stated that APHIS
      Accordingly, in this final rule, we are                 specified, all of the biological agents               should clarify the term ‘‘facility.’’ The
      removing 7 CFR 331.0 and 9 CFR 121.0.                   and toxins listed in §§ 121.3 and 121.4.’’            commenter said the term appears to
                                                              The latter definition takes into account              refer to a complete building or complex
      Definitions                                             the fact that overlap select agents and               in some parts of the rule but to an
         In 7 CFR 331.1 and 9 CFR 121.1, we                   toxins are also regulated under 9 CFR                 individual laboratory/room in other
      define the terms used in the regulations.               part 121.                                             parts of the rule.
      We are adding definitions of diagnosis                     In 9 CFR 121.1, we are removing the                   APHIS uses the term ‘‘facility’’ in the
      and verification in both sections in this               definition for overlap agent or toxin and             definition for diagnostic laboratory in 7
      final rule. Diagnosis is defined as ‘‘the               adding a definition for overlap select                CFR 331.1 and in the definitions for
      analysis of specimens for the purpose of                agent and/or toxin in its place. Overlap              clinical laboratory and diagnostic


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      13248                Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations

      laboratory in 9 CFR 121.1. The term                     paragraph (a) in both sections since it is            pharmacotherapies and prophylaxis to
      does not appear elsewhere in the                        no longer necessary.                                  treat and prevent any illness caused by
      regulations. Accordingly, we are making                                                                       the agent or toxin; and (4) any other
                                                              List of Biological Agents and Toxins
      no change based on this comment.                                                                              criteria the Secretary considers
         A commenter recommended that                            In accordance with the Act, interim 7              appropriate to protect animal or plant
      APHIS define the term ‘‘access’’ to mean                CFR 331.3 and 9 CFR 121.3 listed                      health, or animal or plant products.
      actual, physical contact with the agent                 certain biological agents and toxins.                    We do not believe it is necessary to
      or the realistic opportunity for same.                     Section 212(a)(2) of the Act requires              provide a summary of the risk
         This issue is addressed below in the                 that the lists of biological agents and               assessment data that supports the listing
      sections relating to security risk                      toxins be reviewed and republished                    of each select agent or toxin in order to
      assessments and security. We are                        biennially, or more often as needed, and              heighten awareness of the risk
                                                              revised as necessary. In addition, the                characteristics of such agents and toxins
      making no change to the definitions in
                                                              Act requires that, when determining                   and promote safe practice and
      7 CFR 331.1 or 9 CFR 121.1 based on
                                                              whether to include an agent or toxin,                 proficiency in handling of such agents
      this comment.
                                                              the Secretary shall consult with                      and toxins. Information about the risk
         One commenter stated that 9 CFR
                                                              appropriate Federal departments and                   characteristics of a select agent or toxin
      121.1 should define the term ‘‘exotic’’ so
                                                              agencies and with scientific experts                  and safe handling practices is available
      that the term can be removed from the                   representing appropriate professional
      list of agents.                                                                                               in scientific literature and other
                                                              groups.                                               publications (e.g., the CDC/NIH
         This issue is addressed below in the                    This final rule serves as APHIS’
      section relating to the lists of VS and                                                                       publication, ‘‘Biosafety in
                                                              republication of the lists of select agents           Microbiological and Biomedical
      overlap select agents and toxins.                       and toxins in 7 CFR 331.3 and 9 CFR                   Laboratories’’). For these reasons, we are
      Therefore, we are making no change to                   121.3, and in newly designated 9 CFR                  making no change based on this
      the definitions in 9 CFR 121.1 in                       121.4. As part of APHIS’ review of the                comment.
      response to this comment.                               lists of agents and toxins, we reviewed                  Interim 7 CFR 331.3(a) (newly
      Purpose and Scope                                       current scientific information and                    designated § 331.3(b)) listed the
                                                              studies and consulted with other                      biological agents and toxins that have
         Interim 7 CFR 331.2 and 9 CFR 121.2                  Federal agencies. We also reviewed and                been determined to pose a severe threat
      set out the purpose and scope of the                    considered the comments to the                        to plant health or to plant products
      regulations. Specifically, 7 CFR 331.2(a)               December 2002 interim rule on the lists               (PPQ select agents and toxins).
      stated that part 331 sets forth the                     of agents and toxins.                                    In this final rule, we are removing
      requirements for possession, use, and                      As previously noted, in this final rule,           Phakopsora pachyrhizi, also known as
      transfer of biological agents or toxins                 we are amending the structure of both                 Asian soybean rust, from the list of PPQ
      that have been determined to have the                   parts to be consistent with CDC’s select              select agents and toxins. Asian soybean
      potential to pose a severe threat to plant              agent regulations. In 9 CFR part 121, we              rust has been introduced into the United
      health or plant products, while 9 CFR                   are creating separate sections for the                States by natural means and now it
      121.2(a) stated that part 121 sets forth                lists of VS select agents and toxins and              would have virtually no impact if used
      the requirements for possession, use,                   overlap select agents and toxins—                     as a weapon of terrorism. Asian soybean
      and transfer of biological agents or                    §§ 121.3 and 121.4, respectively. We are              rust was detected in the United States
      toxins that have been determined to                     also adding a new paragraph (a) to 7                  in November 2004. All available
      have the potential to pose a severe                     CFR 331.3, containing introductory text,              evidence suggests that spores were
      threat to both human and animal health,                 so that the format of the section is                  blown into the United States during a
      or to animal health or animal products.                 consistent with the format in 9 CFR                   series of hurricanes in 2004. Detection
      Both sections noted that the purpose of                 121.3 and 9 CFR 121.4.                                surveys indicate that it is present in at
      the regulations is to ensure the safe                      One commenter recommended that                     least nine southeastern States; however,
      handling of such agents or toxins, and                  APHIS include in the regulations a                    USDA is conducting additional surveys
      to protect against the use of such agents               summary of the risk assessment data                   to determine the full extent of the
      or toxins in domestic or international                  that supports the listing of each agent               introduction. Because Asian soybean
      terrorism or for any other criminal                     and toxin. The commenter stated that                  rust has a host range of more than 90
      purpose.                                                the data will heighten awareness of the               plant species and its spores disperse
         In this final rule, we are amending                  risk characteristics of the listed agents             naturally on wind currents, this disease
      both sections to clarify that each part                 and will promote safe practice and                    will continue to spread naturally and it
      implements the provisions of the                        proficiency in handling such agents.                  cannot be controlled effectively. We
      Agricultural Bioterrorism Protection Act                   APHIS does not include risk                        expect that this disease will quickly
      of 2002. Furthermore, we are amending                   assessment data in the regulations;                   reach the full extent of its ecological
      9 CFR 121.2 to clarify that overlap select              rather, such information is discussed in              range in the United States. As a result,
      agents and toxins are subject to                        a rule’s preamble. As noted in the                    there is an urgent need for timely
      regulation by both APHIS and CDC.                       preamble of the August 2002 interim                   research on effective means to manage
         In interim 7 CFR 331.2 and 9 CFR                     rule, the Act requires APHIS to consider              the disease in the United States. For all
      121.2, paragraphs (b) and (c)                           the following criteria in determining                 of these reasons, we are removing
      summarized the regulatory                               whether to list an agent or toxin: (1) The            Phakopsora pachyrhizi from the list of
      requirements. Since these provisions are                effect of exposure to the agent or toxin              PPQ select agents and toxins. However,
      already set forth in other sections of the              on animal or plant health, and on the                 we note that a permit will still be
      regulations, we believe it is unnecessary               production and marketability of animal                required for importation or interstate
      to summarize them in these sections.                    or plant products; (2) the pathogenicity              movement of Asian soybean rust (7 CFR
      Therefore, in this final rule, we are                   of the agent or the toxicity of the toxin             part 330).
      removing paragraphs (b) and (c) in 7                    and the methods by which the agent or                    A commenter claimed that, pursuant
      CFR 331.2 and 9 CFR 121.2, and                          toxin is transferred to animals or plants;            to the rules of the International Code of
      removing the paragraph designation for                  (3) the availability and effectiveness of             Nomenclature of Bacteria, two bacteria


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                           Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations                                          13249

      have been renamed; thus, Liberobacter                   States, where potatoes are commercially               For these reasons, we are making no
      africanus should be Candidatus                          grown, because it is intolerant of                    change in response to this comment.
      Liberobacter africanus, and Liberobacter                freezing and does not generally survive                  Several commenters questioned the
      asiaticus should be Candidatus                          winters in regions with sustained                     inclusion of malignant catarrhal fever
      Liberobacter asiaticus.                                 temperatures below 20 °F. The                         virus (exotic) on the list of select agents.
         We agree. Therefore, in this final rule,             commenter claimed that, even if the                   One commenter stated the disease
      we are replacing the entry for                          bacterium became established, it is                   malignant catarrhal fever virus is caused
      Liberobacter africanus with Candidatus                  unlikely to cause an economically                     be a variety of herpes viruses, none of
      Liberobacter africanus and replacing                    damaging disease outbreak in the                      which is known as malignant catarrhal
      Liberobacter asiaticus with Candidatus                  climactic conditions characteristic of                fever virus. The commenter stated that
      Liberobacter asiaticus. In addition, we                 North America. The commenter went on                  Alcelaphine herpesvirus type 1 infects
      are placing Candidatus Liberobacter                     to note that the bacterium has been                   most wildebeest and spreads to
      africanus and Candidatus Liberobacter                   repeatedly introduced into the United                 domestic cattle causing malignant
      asiaticus on separate lines in order to                 States without impact.                                catarrhal fever in Africa. The
      make it clear that each one is a select                    APHIS has determined that Ralstonia                commenter argued that malignant
      agent.                                                  solanacearum, race 3, biovar 2, has the               catarrhal fever virus (exotic) should be
         One commenter argued that plum pox                   potential to pose a severe threat to plant            replaced with Alcelaphine herpesvirus
      potyvirus should not be listed as a select              health or plant products. The bacterium               type 1. Another commenter argued that
      agent because it is only naturally                      is known to attack a number of                        the biological features of malignant
      transmitted by aphids, and, without the                 economically significant hosts (e.g.,                 catarrhal fever viruses prevent them
      insect vector to transmit the disease                   geraniums and tomatoes), not just                     from being effective bioterror agents.
      from one plant to another, the                          potatoes. Some of the known hosts are                 The commenter noted that Alcelaphine
      possibility of the virus being used as a                grown in greenhouses (e.g., geraniums),               herpesvirus type 1 can only be
      weapon of terrorism is extremely small.                 which protect them from local climatic                transmitted by parenteral injection and
      The commenter stated that laboratory                    conditions, and some hosts are grown in               cow-to-cow transmission does not occur
      research of this agent, in the absence of               fields throughout the United States (e.g.,            under natural conditions. This
      its natural vector and only known                       tomatoes and potatoes). With regard to                commenter also argued that it is
      means of transmission, poses little to no                                                                     misleading to label malignant catarrhal
                                                              potatoes, scientific data indicate the
      risk to plant health or plant products.                                                                       fever as ‘‘exotic’’ since it is present
                                                              potential range of the bacterium would
         We agree that plum pox potyvirus                                                                           wherever there are wildebeests, from
      (PPV) has limited potential as a weapon                 include the potato-growing regions in
                                                              the United States. Ralstonia                          zoos to exotic game farms.
      of terrorism given its biological                                                                                We agree that clarification is needed
      characteristics. PPV is not easily                      solanacearum, race 3, biovar 2, occurs
                                                                                                                    with regard to the term malignant
      transmitted and does not spread easily.                 in Europe as far north as the 56th
                                                                                                                    catarrhal fever virus. Accordingly, in
      The natural host range is limited to                    parallel (southern Scandinavia), which
                                                                                                                    this final rule we are replacing the entry
      plants in the genus Prunus (e.g., plums                 parallels regions of Canada.
                                                                                                                    for malignant catarrhal fever virus with
      and other stone fruits). The natural                    Furthermore, there are a number of wild               malignant catarrhal fever virus
      spread of the disease requires insect                   hosts that would contribute to the                    (Alcelaphine herpesevirus type 1).
      vectors (aphids), and is a complex                      spread of the bacterium if it were                    However, we disagree that the biological
      biological process, and artificial spread               introduced into the United States. For                features of malignant catarrhal fever
      requires grafting, which is labor                       these reasons, we are making no                       viruses prevent them from being
      intensive and time-consuming. PPV is                    changes based on this comment.                        effective bioterror agents. Malignant
      not spread by pollen or seed. While                        Interim 9 CFR 121.3(d) (newly                      catarrhal fever virus (Alcelaphine
      systemic treatments are not completely                  designated § 121.3(b)) listed the                     herpesevirus type 1) causes severe
      effective at mitigating the disease,                    biological agents and toxins that have                disease in cattle, and it may be possible
      destruction of infected trees mitigates                 been determined to have the potential to              for the virus to be transmitted from cow
      the effects of the disease, removal of the              pose a severe threat to animal health or              to cow. Currently, this virus is not
      diseased trees and other susceptible                    to animal products (VS select agents and              found in U.S. cattle populations, and a
      hosts removes the source of infection,                  toxins).                                              widespread outbreak of the disease
      and transmission can be halted by                          A commenter asserted that listing                  would likely result in widespread
      removing host material from the area.                   Japanese encephalitis virus (JEV) as a                animal movement restrictions that could
      Furthermore, most strains of PPV attack                 select agent will negatively impact                   be long term, at least with respect to
      only a few varieties of stone fruits,                   research on this disease, as well as on               exports. We are making no change in
      which limits the affect of an outbreak on               West Nile virus and dengue virus. This                response to this comment.
      the production and marketability of                     commenter stated that there does not                     One commenter suggested that
      stone fruits. For these reasons, in this                appear to be sufficient justification for             Newcastle disease virus (VVND) be
      final rule, we are removing plum pox                    making Japanese encephalitis virus a                  replaced with Newcastle disease virus
      potyvirus from the list of PPQ select                   select agent.                                         (velogenic). The commenter stated the
      agents and toxins. However, we note                        We disagree that there is insufficient             background information indicated that
      that PPV continues to be a quarantine                   justification for listing Japanese                    only velogenic strains are to be
      pest under the domestic plant                           encephalitis virus as a VS select agent.              regulated; however, the acronym VVND
      regulations (7 CFR 301.74 through                       The virus can cause severe disease in                 indicates viscerotropic, velogenic
      301.74–5).                                              horses and swine for which there is no                Newcastle disease.
         Another commenter asserted that                      effective treatment and no domestically                  In the December 2002 interim rule, we
      Ralstonia solanacearum, race 3, biovar                  available veterinary vaccine. While the               replaced the entry for Newcastle disease
      2, should not be listed as a select agent.              select agent regulations may affect                   virus (exotic) with Newcastle disease
      This commenter stated that the                          research on JEV, we expect it will have               virus (VVND) to make it clear that we
      bacterium is unlikely to become                         a negligible effect on associated research            are regulating only velogenic strains.
      established in the northern United                      on West Nile virus and dengue virus.                  Viscerotropic, velogenic Newcastle


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      13250                Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations

      disease (VVND) is a velogenic strain. To                intentionally introduced into people,                 genome and can be expressed in vivo or
      ensure that we are regulating all of the                horses, or other domestic animals, there              in vitro; and
      velogenic strains, in this final rule we                would be little or no chance of spread                   • Select agents and toxins listed in
      are replacing the entry for Newcastle                   to cause an adverse agricultural event.               either 7 CFR part 331 or 9 CFR part 121
      disease virus (VVND) with Newcastle                        We agree that Coxiella burnetii,                   that have been genetically modified.
      disease virus (velogenic).                              Coccidioides immitis, and Francisella                    Another commenter stated that
         A commenter stated the distinction                   tularensis are endemic, widespread, and               interim 9 CFR 121.3(c) and 121.3(f)
      between domestic and exotic vesicular                   easily isolated from natural sources.                 conflict—§ 121.3(c) seems to include
      stomatitis virus cannot be justified                    However, these factors are not sufficient             fragments, while § 121.3(f) exempts
      scientifically. Therefore, it would be                  reason to remove these agents from the                them. The commenter pointed out that
      more logical to list all vesicular                      list of overlap select agents and toxins.             all genetic elements that cause disease
      stomatitis viruses except specific                      Furthermore, we disagree that there is                can be fragmented into pieces that
      viruses that are generally recognized as                little risk of an adverse agricultural                cannot cause disease, but that can be
      attenuated (e.g., the VSV-Indiana Lab                   event involving Eastern equine                        reconstituted simply and quickly.
      strain).                                                encephalitis virus because it can cause                  We believe the changes in this final
         We do not believe it is necessary to                 high mortality in horses, and there is no             rule will address the differences
      regulate all strains of vesicular                       mandatory vaccination program in the                  identified by this commenter.
      stomatitis virus, especially those strains              United States. We are making no                       Accordingly, we are making no change
      that have limited morbidity and                         changes based on this comment.                        based on this comment. However, we
      mortality in the United States.                            A commenter stated that it is                      note that fragments are not subject to the
      Therefore, we are making no change                      pointless to regulate trichothecenes                  regulations until reconstituted.
      based on this comment.                                  such as T–2 toxin as select agents if                    One commenter asked if cDNA is
         Interim 9 CFR 121.3(b) (newly                        highly toxigenic strains of the toxin-                regulated. This commenter also asked
      designated § 121.4(b)) listed the                       producing organism are not also                       how sequence data of select agents will
      biological agents and toxins that have                  regulated.                                            be protected, since it can be used to
      been determined to have the potential to                   We are regulating T–2 toxin, and not               make a select agent.
      pose a severe threat to both human and                  the organism that produces it, because                   A cDNA fragment will be subject to
      animal health, to animal health, or to                  we believe the toxin has the potential to             the regulations if it can produce either
      animal products (overlap select agents                  pose a severe threat to public health and             an infectious form of toxin or a select
      and toxins).                                            safety, to animal health, and to animal               agent. Sequence data of select agents is
         Several commenters pointed out that                  products. Accordingly, we are making                  already in the public domain, and
      Clostridium botulinum is listed in the                  no change in response to this comment.                APHIS cannot protect this information.
      APHIS regulations but not in the CDC                       Interim 7 CFR 331.3(c)(2), 9 CFR                   However, we note that an individual or
      regulations.                                            121.3(c), and 9 CFR 121.3(f)(2) (newly                entity that uses sequence data to
         APHIS inadvertently listed both                      designated 7 CFR 331.3, 9 CFR 121.3,                  produce an infectious agent or toxin
      Clostridium botulinum and Botulinum                     and 9 CFR 121.4) set out the provisions               will be subject to the select agent
      neurotoxin producing species of                         for genetic elements.                                 regulations. We are making no changes
      Clostridium as overlap agents in the                       One commenter stated there are                     based on this comment.
      December 2002 interim rule. We always                   differences between the APHIS and CDC                    Interim 7 CFR 331.3(b) and 9 CFR
      intended to only list Botulinum                         regulations regarding genetic elements.               121.3(e) stated that any biological agent
      neurotoxin producing species of                         For example, the regulations seem to                  or toxin that is in its naturally occurring
      Clostridium in order to be consistent                   imply that no bacterial sequences are                 environment will not be subject to the
      with CDC. Accordingly, we are                           regulated, except those from animal                   requirements of either part, provided
      removing Clostridium botulinum from                     agents.                                               that the biological agent or toxin has not
      the list of overlap select agents and                      We agree. In the interim regulations,              been intentionally introduced,
      toxins in this final rule.                              CDC provided that infectious viral                    cultivated, collected, or otherwise
         A number of commenters argued that                   sequences of HHS and overlap select                   extracted from its natural source.
      overlap agents that are endemic,                        agents are regulated, while APHIS                        To be consistent with CDC, we are
      widespread, and easily isolated from                    provided that infectious viral sequences              adopting the phrase ‘‘excluded from the
      natural sources should not be included                  of overlap agents are regulated and                   requirements of this part’’ in place of
      in the list of overlap select agents. For               infectious viral and bacterial sequences              the phrase ‘‘will not be subject to the
      these reasons, one commenter                            of PPQ and VS select agents are                       requirements of this part.’’ Thus, in this
      recommended that Francisella                            regulated. To resolve these differences,              final rule, newly designated 7 CFR
      tularensis and Coxiella burnetii be                     in this final rule we are adopting CDC’s              331.3(d)(1), 9 CFR 121.3(d)(1), and 9
      removed from the list of overlap agents.                approach for genetic elements.                        CFR 121.4(d)(1) state that a select agent
      Several commenters stated that                          Specifically, newly designated 7 CFR                  or toxin that is in its naturally occurring
      Coccidioides immitis should not be                      331.3, 9 CFR 121.3, and 9 CFR 121.4                   environment is excluded from the
      included in the list of overlap select                  provide that the following will be                    requirements of the regulations,
      agents because it is endemic in                         considered select agents and toxins:                  provided that the agent or toxin has not
      California’s Central Valley and is found                   • Nucleic acids that can produce                   been intentionally introduced,
      in many areas of the southwest. Another                 infectious forms of any of the select                 cultivated, collected, or otherwise
      commenter argued that Coxiella burnetii                 agent viruses listed in either 7 CFR part             extracted from its natural source.
      should be removed from the overlap list                 331 or 9 CFR part 121;                                   One commenter stated that the
      because ‘‘it is so ubiquitous in nature                    • Recombinant nucleic acids that                   naturally occurring environment of a
      that its identification as a select agent is            encode for the functional forms of any                virus is its host. The commenter pointed
      meaningless.’’ One commenter argued                     toxin listed in either 7 CFR part 331 or              out that Coxiella burnetii can be found
      that Eastern equine encephalitis virus                  9 CFR part 121 if the nucleic acids: (1)              in milk samples and asked if the truck
      should be removed from the overlap list                 Can be expressed in vivo or in vitro; or              moving milk to a processing plant
      because it is endemic and even if it were               (2) are in a vector or recombinant host               would be subject to the regulations or if


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                           Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations                                         13251

      the milk sample submitted to a                          interim 9 CFR 121.3(f) (newly                         nonviable agents and genetic elements.
      laboratory for mastitis testing would be                designated 9 CFR 121.3(d)(2) and                      We note that permits may contain
      subject to the regulations as the milk                  121.4(d)(2)) provided that nonviable                  restrictions that extend beyond the
      sample is being collected.                              agents or fixed tissues that are, bear, or            expiration of the permit if the agent/
         Coxiella burnetii that is contained in               contain listed agents or toxins will not              genetic element is not destroyed. If so,
      milk in a truck or in a diagnostic sample               be subject to the requirements of the                 an individual or entity would be
      is considered to be in its naturally                    part because they do not have the                     required to obtain a new permit as long
      occurring environment as long as it has                 potential to pose a severe threat to both             as the nonviable agent or genetic
      not been intentionally introduced,                      human and animal health, or to animal                 element is possessed by the permittee.
      cultivated, collected, or otherwise                     health or animal products.                               A commenter asked if a positive chain
      extracted from its natural source. We are                  In this final rule, we are amending                reaction (PCR) test done on formalin
      making no changes in response to these                  both sections to clarify that these                   fixed tissue that detects Eastern equine
      comments.                                               provisions apply to nonviable agents                  encephalitis virus would be exempt
         Another commenter stated that the                    and nonfunctional toxins. These                       because it is nonviable.
      regulations suggest that an agent found                 changes will make the provisions in the                  This comment is not entirely clear.
      in the lymph node of a slaughtered                      APHIS and CDC regulations consistent.                 We believe the commenter is asking
      animal (found on histopathology but not                    A commenter requested clarification                about the reporting requirements for
      cultivated or extracted) is in its                      of the terms ‘‘nonviable’’ and                        identifications of a select agent or toxin.
      naturally occurring environment and,                    ‘‘nonfunctional’’ select agents or toxins.            If Eastern equine encephalitis virus is
      therefore, exempt from notification.                    The commenter noted that some                         identified from formalin tissue, an
         This comment appears to combine the                  organisms can survive in nature, others               individual or entity must report the
      requirements for exclusions and                         only under lab conditions, and others                 identification to APHIS in accordance
      exemptions. A select agent or toxin that                not under any conditions.                             with either newly designated 9 CFR
      has not been intentionally introduced,                     A nonviable agent is not capable of                121.6 or 121.9, whichever is applicable.
      cultivated, collected, or otherwise                     replicating, infecting a plant or animal,             However, nonviable overlap select
      extracted from its natural source is                    or causing disease, while a                           agents or nonfunctional toxins are
      considered to be in its naturally                       nonfunctional toxin is not able to                    excluded from the regulations (newly
      occurring environment and, therefore,                   produce a toxic effect. These terms are               designated 9 CFR 121.4(d)(2)). We are
      excluded from the requirements of the                   generally understood in the scientific                making no changes in response to this
      regulations. The exemption provisions                   community, and we do not believe that                 comment.
      for overlap select agents and toxins are                further clarification is needed in the                   Interim 9 CFR 121.3(f)(3) provided an
      set forth in newly designated 9 CFR                     regulations. Therefore, we are making                 exclusion from the regulations for
      121.6. Histopathology alone is not a                    no change in response to this comment.                ‘‘[o]verlap toxins under the control of a
      definitive identification of a select                      Footnotes in interim 9 CFR 121.3                   principal investigator (or equivalent), if
      agent. However, a select agent that has                 stated that the importation and                       the total aggregate amount does not, at
      been identified by a histopathology                     interstate movement of nonviable agents               any time, exceed the following amounts:
      method that has been validated would                    and genetic elements are subject to the               0.5 mg of Botulinum neurotoxins (types
      need to be reported to APHIS or CDC in                  permit requirements under 9 CFR part                  A–G), 100 mg of Clostridium perfringens
      accordance with the regulations. We are                 122.                                                  epsilon toxin, 100 mg of Shigatoxin, 5
      making no changes in response to this                      One commenter asked why a permit                   mg of Staphylococcal enterotoxins, and
      comment.                                                is needed for nonviable agents and                    1,000 mg of T–2 toxin.
         A commenter stated that any naturally                genetic elements that are excluded from                  APHIS and CDC have determined that
      occurring organism expressing a                         regulation under 9 CFR part 121. The                  this exclusion is too narrow and has the
      Shigatoxin should be specifically                       commenter argued that nonviable agents                unintended consequence of requiring
      excluded from the list of select agents                 and genetic elements that are not                     treating physicians or veterinarians and
      and toxins.                                             capable of causing disease do not meet                commercial manufacturers or
         As previously noted, we are                          the definition of ‘‘organism’’ in part 122.           distributors that possess, use, or transfer
      regulating the toxin and not the                        Another commenter requested                           otherwise excluded toxins to register.
      organisms that produce the toxin.                       clarification of the permit requirement               Accordingly, in this final rule, we are
      Therefore, it is not necessary to exclude               for nonviable agents or fixed tissues.                broadening the scope of the overlap
      from the requirements of the regulations                The commenter stated that the provision               toxin exclusion to cover overlap toxins
      any naturally occurring organism                        seems to suggest that, for as long as you             under the control of a principal
      expressing a Shigatoxin. However, we                    retain the tissues, you would need to get             investigator, treating physician or
      note that Shigatoxin under the control                  yearly interstate transport permits even              veterinarian, or commercial
      of a principal investigator, treating                   though no further receipt/transport is                manufacturer or distributor (newly
      physician or veterinarian, or                           taking place.                                         designated § 121.4(d)(3)). To be
      commercial manufacturer or distributor                     The regulations in 9 CFR part 122                  consistent with CDC, we are also
      is excluded from the requirements of 9                  pertain to the movement of organisms                  removing the words ‘‘(types A–G)’’ after
      CFR part 121 if the aggregate amount                    and vectors. A nonviable agent or                     Botulinum neurotoxins.
      does not, at any time, exceed 100 mg                    genetic material could serve as a vector                 One commenter requested that APHIS
      (newly designated 9 CFR 121.4(d)(3)).                   of a disease agent through ineffective or             clarify that there is no limit to the
         Interim 7 CFR 331.3(c)(1) (newly                     insufficient processing methods, and,                 amount of overlap toxins an individual
      designated 7 CFR 331.3(d)(2)) provided                  therefore, require a permit for                       or entity may possess or use, as long as
      that nonviable agents that are, bear, or                importation or interstate movement.                   the amount of toxin under the control of
      contain listed agents or toxins will not                However, since a permit may not always                each principal investigator does not
      be subject to the requirements of the                   be required, in this final rule we are                exceed the specified amounts.
      part because they do not have the                       revising the footnotes so that, in newly                 We believe that newly designated
      potential to pose a severe threat to plant              designated 9 CFR 121.3 and 121.4, they                § 121.4(d)(3) clearly indicates that the
      health or plant products. Similarly,                    state that a permit may be needed for                 exclusion is based upon the amount of


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      13252                Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations

      overlap toxin under the control of a                       One commenter claimed that the                     vaccine strain of Brucella abortus
      principal investigator, treating                        microbiological community, not just                   available for the critical need of quality
      physician or veterinarian, or                           government agency representatives,                    control, without registration of the
      commercial manufacturer or distributor.                 must be involved in the process for                   laboratory.
      Therefore, we are making no change                      excluding attenuated strains. The                        An attenuated strain of a select agent
      based on this comment.                                  commenter recommended the                             may be excluded from the requirements
         Another commenter asked if the toxin                 establishment of a broadly                            of regulations based upon a
      amounts refer to quantities of isolated                 representative group to act as an                     determination that the attenuated strain
      toxin (i.e., toxin that has been extracted              advisory body to APHIS and CDC. This                  does not pose a severe threat to plant
      and is separate from the cell) or toxin                 commenter also stated that the                        health or plant products (newly
      that is in the process of being produced                regulations should state that                         designated 7 CFR 331.3(e)) or to public
      by living cells and may increase in                     determinations regarding overlap agents               health and safety, to animal health, or
      quantity. The commenter stated that                     require the concurrence of APHIS and                  animal products (newly designated 9
      measuring the exact quantities of a toxin               CDC.                                                  CFR 121.3(e) and 121.4(e)). Once an
      can only reasonably be achieved if the                     APHIS may exclude attenuated strains               attenuated strain of a select agent has
      toxin has been isolated from the cell.                  of select agents or toxins after                      been excluded, it may be used for
         We agree that an exact measurement                   consultation with subject matter                      quality control or for other purposes, as
      of a toxin can only reasonably be                       experts, including those in the                       long as its virulence is not restored or
      achieved if the toxin has been isolated                 microbiology community. For overlap                   enhanced. To date, a number of
      from the cell. The amounts listed in                    select agents and toxins, APHIS may                   attenuated strains have been excluded,
      newly designated § 121.4(d)(3) refer to                 exclude attenuated strains after                      including Bacillus anthracis Sterne,
      the amount of toxin that has been                       consultation with subject matter experts              pX01∂pX02¥ and Brucella abortus
      isolated from the cell, not the amount of               and CDC. We do not believe it is                      strain RB51 (vaccine strain). For these
      toxin that is being produced in living                  necessary to include these                            reasons, we are making no change in
      cells. We are making no change based                    administrative procedures in the                      response to this comment.
                                                              regulations. Accordingly, we are making                  One commenter asked if the TC–83
      on this comment.
                                                              no change based on this comment.                      vaccine strain of Venezuelan equine
         Interim 9 CFR 121.3(g) (newly                           A commenter stated that APHIS                      encephalitis is subject to the
      designated §§ 121.3(e) and 121.4(e))                    should specify the criteria for exclusion             regulations. The commenter pointed out
      provided a procedure by which an                        of attenuated strains because the current             that the CDC regulations specifically
      individual or entity may request a                      standard (‘‘poses a severe threat’’) is               exclude this strain from regulation but
      determination by the Administrator that                 insufficiently specific.                              the APHIS regulations do not.
      an attenuated strain of a biological agent                 The Act requires APHIS to regulate                    Both APHIS and CDC have excluded
      does not pose a severe threat to both                   the possession, use, and transfer of                  the TC–83 vaccine strain of Venezuelan
      human and animal health, or to animal                   biological agents and toxins that have                equine encephalitis virus from the
      health or animal products.                              been determined to pose a severe threat               requirements of the regulations. We note
         In this final rule, we are adding this               to public health and safety, to animal                that a current list of exclusions is
      provision to 7 CFR 331.3 so that the                    health, to plant health, or to animal or              available on the Internet at http://
      regulations in part 331 are consistent                  plant products. Thus, the Act                         www.aphis.usda.gov/programs/
      with the regulations in 9 CFR part 121.                 establishes the standard by which                     ag_selectagent/index/html. We are
      We are also amending both parts to                      APHIS may exclude an attenuated strain                making no change based on this
      clarify the requirements and streamline                 (i.e., the strain does not pose a severe              comment.
      the process for excluding an attenuated                 threat). We are making no change to the                  To address concerns raised by Federal
      strain of a select agent or toxin.                      regulations in response to this comment.              law enforcement agencies related to
      Specifically, paragraph (e) in 7 CFR                       A commenter asserted that the                      seizures (i.e., possession) of select
      331.3, 9 CFR 121.3, and 9 CFR 121.4                     excluded attenuated strains should be                 agents or toxins, in this final rule we are
      provides that an individual or entity                   listed in the regulations so that an entity           adding a new paragraph (f) to 7 CFR
      may apply for an exclusion by                           may be able to determine if an agent is               331.3, 9 CFR 121.3, and 9 CFR 121.4 to
      submitting a written request and                        excluded before registering the strain                address situations in which the select
      supporting scientific information. A                    and installing any additional security.               agents or toxins have been identified
      written decision granting or denying the                   APHIS is not including the lists of                prior to seizure. In the event that a
      request will be issued and the exclusion                excluded attenuated strains of select                 Federal law enforcement agency seizes
      will be effective upon notification of the              agents or toxins in the regulations                   a suspected select agent or toxin or
      applicant. Exclusions will be published                 because any change to the lists of                    unknown material, this material will be
      periodically in the notice section of the               exclusions would require rulemaking.                  regarded as a specimen presented for
      Federal Register and will be listed on                  To minimize the potential delays related              diagnosis or verification and, therefore,
      the Internet at http://                                 to rulemaking, in this final rule we are              will not be subject to the regulations
      www.aphis.usda.gov/programs/                            providing that exclusions will be                     until it has been identified as a select
      ag_selectagent/index.html. Paragraph (e)                published periodically in the notices                 agent or toxin.
      also provides that, if an excluded                      section of the Federal Register and will                 Paragraph (f) provides that any select
      attenuated strain is subjected to any                   be listed on the Internet at http://                  agent or toxin seized by a Federal law
      manipulation that restores or enhances                  www.aphis.usda.gov/programs/                          enforcement agency will be excluded
      its virulence, the resulting select agent               ag_selectagent/index.html. We believe                 from the requirements of the regulations
      or toxin will be subject to the                         these measures will provide sufficient                during the period between seizure of the
      requirements of each part. This has                     notice to the public.                                 agent or toxin and the transfer or
      always been the way the exclusion for                      A commenter stated that the                        destruction of such agent or toxin
      attenuated strains has been interpreted;                exclusion for attenuated strains would                provided that:
      however, we are adding this provision                   not make agents such as the Sterne                       • As soon as practicable, the Federal
      to both parts to facilitate compliance.                 strain of Bacillus anthracis and the                  law enforcement agency transfers the


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                           Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations                                         13253

      seized agent or toxin to an entity eligible             other entities (for PPQ and VS select                 www.aphis.usda.gov/programs/
      to receive such agent or toxin or                       agents and toxins). Specifically,                     ag_selectagent/index/html.
      destroys the agent or toxin by a                        paragraph (a) in newly designated 7 CFR                  A commenter asserted that clinical or
      recognized sterilization or inactivation                331.5 and paragraphs (a) and (b) in                   diagnostic laboratories should be
      process;                                                newly designated 9 CFR 121.5 and 121.6                required to secure the agent or toxin
        • The Federal law enforcement                         make clear that laboratories and other                prior to transfer or destruction.
      agency safeguards and secures the                       entities must meet the exemption                         We agree. Taking into account the
      seized agent or toxin against theft, loss,              requirements for each select agent or                 risks posed by select agents and toxins
      or release and reports any theft, loss, or              toxin contained in a specimen that it                 and the security requirements for
      release of such agent or toxin; and                     possesses, uses, or transfers. This                   registered entities, it is reasonable to
        • The Federal law enforcement                         change takes into account situations in               require that a clinical or diagnostic
      agency reports the seizure of the select                which a diagnostic laboratory or other                laboratory or other entity secure the
      agent or toxin to APHIS or CDC.                         entity could be registered for a select               agent or toxin prior to transfer or
        This provision will allow Federal law                 agent or toxin but still meet the                     destruction. Furthermore, we believe it
      enforcement agencies to conduct certain                 exemption requirements for other select               is reasonable to require that a clinical or
      law enforcement activities (e.g.,                       agents or toxins contained in specimens.              diagnostic laboratory or other entity
      collecting evidence from a laboratory                   We are also amending both parts to                    report any theft, loss, or release of a
      crime scene) without being in violation                 clarify that, as a condition of exemption,            select agent or toxin prior to transfer or
      of the regulations. We note, however,                   clinical or diagnostic laboratories and               destruction. Therefore, newly
      that this provision does not authorize                  other entities must transfer a select                 designated 7 CFR 331.5, 9 CFR 121.5,
      the seizure of a select agent or toxin by               agent or toxin in accordance with the                 and 9 CFR 121.6 require, as another
      a Federal law enforcement agency;                       transfer requirements in each part                    condition of exemption, that the select
      rather, it establishes the conditions                   (newly designated 7 CFR 331.16 and 9                  agent or toxin be secured against theft,
      under which a Federal law enforcement                   CFR 121.16, respectively) or destroy the              loss, or release during the period
      agency may seize a select agent or toxin                agent or toxin on-site by a recognized                between identification of the agent or
      without violating the regulations.                      sterilization or inactivation process.                toxin and transfer or destruction of such
      Seizure of a select agent or toxin by a                                                                       agent or toxin, and that any theft, loss,
                                                                 In this final rule, we are also deleting
      Federal law enforcement agency would                                                                          or release of such agent or toxin be
                                                              in both parts the requirement that the
      have to be in accord with that agency’s                                                                       reported.
                                                              identification of a select agent or toxin                Another commenter argued that the
      statutory authority.
                                                              be reported to appropriate authorities                exemptions for clinical and diagnostic
      Exemptions                                              when required by Federal, State, or local             laboratories should require, at the very
         Interim 7 CFR 331.4, 9 CFR 121.4, and                law (interim 7 CFR 331.4, 9 CFR 121.4,                least, that employees of such labs be
      9 CFR 121.5 (newly designated 7 CFR                     and 9 CFR 121.5). Because this                        subject to security risk assessments by
      331.5, 9 CFR 121.5, and 9 CFR 121.6) set                provision merely indicates that                       the Attorney General.
      out exemptions.                                         additional reporting requirements may                    The Act does not require security risk
         Interim 9 CFR 121.4(a) provided that                 exist under Federal, State, or local law,             assessments for employees of entities
      clinical or diagnostic laboratories and                 it is not necessary to include this                   that are exempt from registration under
      other entities possessing, using, or                    provision in the regulations. It is the               the regulations (section 212(e)). We
      transferring overlap agents or toxins that              entity’s responsibility to be familiar                believe that the conditions for
      are contained in specimens presented                    with all legal requirements for select                exemption in this final rule provide
      for diagnosis or verification will be                   agents and toxins.                                    adequate safeguard and security
      exempt from the requirements of part                       In addition, newly designated 9 CFR                measures to protect animal and plant
      121, provided that the identification of                121.5 and 121.6 require immediate                     health, and animal and plant products.
      such agents or toxins is immediately                    reporting after identification for                    Accordingly, we are making no change
      reported to APHIS or CDC, and to other                  specified select agents and toxins;                   based on this comment.
      appropriate authorities when required                   identification of the other select agents                One commenter requested that APHIS
      by Federal, State, or local law; and,                   and toxins must be reported within 7                  define the term ‘‘identification.’’ The
      within 7 days after identification, such                calendar days after identification. This              commenter asked if a PCR positive
      agents or toxins are transferred or                     change will reduce the reporting burden               reaction constituted identification or
      inactivated, and APHIS Form 2040 is                     on the public while continuing to                     simply detection. This commenter also
      submitted to APHIS or CDC. Interim 7                    provide information that will help us to              wondered if an entity must report an
      CFR 331.4(a) and 9 CFR 121.5(a)                         identify outbreaks and to monitor                     identification done on a nonviable
      contained similar exemption provisions                  activities related to select agents and               organism.
      for diagnostic laboratories (the term                   toxins.                                                  If a PCR test is recognized in the
      clinical laboratories is not applicable to                 Finally, we are deleting footnote 1 in             scientific community as an
      the plant-related regulations in 7 CFR                  interim 7 CFR 331.4 (newly designated                 identification method, then a result
      part 331 or the animal-related                          7 CFR 331.5) because this information is              utilizing this test must be reported. If
      regulations in 9 CFR part 121).                         contained in the transfer section in this             not, reporting is not required. An
      Exemption provisions for laboratories                   final rule (newly designated § 331.16).               individual or entity must report an
      and other entities that perform                         We are also deleting the application and              identification done on a nonviable
      proficiency testing were set out in                     contact information contained in                      organism in accordance with the
      interim 9 CFR 121.4(b) and 121.5(b).                    footnotes in interim 7 CFR 331.4, 9 CFR               regulations. We require this reporting in
         In this final rule, we are amending                  121.4, and 9 CFR 121.5 because                        order to obtain surveillance information
      both parts to clarify the exemption                     addresses and telephone numbers are                   about select agents or toxins. We are
      provisions related to clinical or                       subject to change. Information about the              making no changes in response to this
      diagnostic laboratories and other                       submission of forms, notices, and                     comment.
      entities (for overlap select agents and                 requests for exemptions or exclusions is                 Several commenters argued that the
      toxins) and diagnostic laboratories and                 available on the Internet at http://                  requirement to transfer an agent or toxin


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      13254                Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations

      within 7 calendar days of identification                331.5(a), 9 CFR 121.5(a), and 9 CFR                   by order determines that additional
      was unrealistic. One commenter stated                   121.6(a)) do not require mandatory                    regulation is necessary to protect animal
      that delays in transfer approval by                     inactivation of a select agent or toxin.              health, or animal products, an
      APHIS or CDC could result in delays in                  To qualify for an exemption, an                       individual or entity possessing, using,
      shipping the samples. Several                           individual or entity must satisfy the                 or transferring products that are, bear, or
      commenters expressed concern about                      conditions for exemption, including                   contain agents or toxins will be exempt
      this deadline due to the unreliability of               transferring or destroying the select                 from the requirements of this part if the
      shippers. Another commenter stated                      agent or toxin within 7 calendar days of              products have been cleared, approved,
      that it is unreasonable and                             identification unless directed otherwise              licensed, or registered pursuant to:
      counterproductive to require diagnostic                 by the Administrator or HHS Secretary.                   (1) The Federal Food, Drug, and
      labs to destroy or transfer select agents               However, an individual or entity could                Cosmetic Act (21 U.S.C. 301 et seq.);
      within 7 days after identification. The                 continue to hold a select agent or toxin                 (2) Section 351 of the Public Health
      commenter said that some labs may                       if it registers with APHIS or, for overlap            Service Act (42 U.S.C. 262);
      process hundreds or thousands of                        select agents and toxins, if it registers                (3) The Virus-Serum-Toxin Act (21
      samples each week and generate large                    with APHIS and CDC. While we                          U.S.C. 151–159); or
      numbers of select agent isolates, and                   recognize that the select agent                          (4) The Federal Insecticide,
      transferring these isolates to a qualified              regulations may have an effect on                     Fungicide, and Rodenticide Act (7
      lab within 1 week will be very difficult                internal quality assurance procedures,                U.S.C. 131 et seq.).
      and costly. The commenter claimed that                  lengthening the time that a diagnostic                   In this final rule, newly designated
      most labs will simply destroy the                       laboratory or other entity can possess a              §§ 121.5(d) and 121.6(c) clarify that the
      isolates and that such destruction will                 sample without being registered is                    product is exempt from the
      result in the loss of valuable scientific               inconsistent with the intent of the Act.              requirements of the regulations. This
      material.                                               We are making no changes based on this                change is designed to address those
         Based on information provided by                     comment.                                              situations in which an entity produces
      CDC and APHIS’ National Veterinary                         One commenter asked if diagnostic                  an exempt product but conducts other
      Services Laboratories (NVSL), and                       facilities could preregister for potential            activities that would require registration
      taking into consideration the risks posed               isolates they might obtain from future                under this part.
      by select agents and toxins, we believe                 diagnostic cases. The commenter stated                   A commenter requested that APHIS
      that 7 days will provide ample time                     the regulations suggest that a facility has           and CDC provide a list of agents
      after identification to destroy the agent               to have the agent before it can register.             exempted under the Federal laws listed
      or toxin, or to make transfer                           The commenter stated that, once an                    in interim 9 CFR 121.4(c) so that
      arrangements and to transfer the agent                  agent is isolated, it appears that the                investigators would know if the agents
      or toxin. However, in this final rule, we               facility would only have 7 days to                    they possess or wish to study are
      are amending newly designated 7 CFR                     become registered before it would have                exempt.
      331.5(a) and 9 CFR 121.5(a) to allow the                to destroy or transfer the agent. The                    It is not administratively feasible for
      Administrator to make exceptions to                     commenter noted that even the process                 APHIS to maintain a list of select agents
      these timeframes, as necessary. We are                  to amend a certificate of registration                exempted under the Federal laws
      also amending newly designated 9 CFR                    would likely take longer than 7 days.                 described above. The regulations
      121.6(a) to allow the Administrator or                     The regulations do not preclude                    provide sufficient information for an
      the HHS Secretary to make exceptions                    preregistration for a select agent or                 individual or entity to determine if the
      to these timeframes for overlap select                  toxin. A certificate of registration may              agents they possess or wish to study are
      agents or toxins, as necessary. Finally,                be issued to an entity as long as the                 exempt. Accordingly, we are making no
      we are making similar changes to newly                  entity meets the regulatory requirements              changes based on this comment.
      designated 9 CFR 121.5(b) and 9 CFR                     for such agent or toxin, even if the entity              In interim 9 CFR 121.5(c), we
      121.6(b) to allow for exceptions to the                 does not currently possess that                       provided that an individual or entity
      timeframes for proficiency testing,                     particular agent or toxin.                            receiving diagnostic reagents and
      which require that an agent or toxin be                    The regulations (interim 7 CFR                     vaccines that are, bear, or contain select
      transferred or destroyed within 90                      331.4(b) and 9 CFR 121.5(f); newly                    agents or toxins that are produced at
      calendar days of receipt.                               designated 7 CFR 331.5(b) and 9 CFR                   USDA diagnostic facilities will be
         Another commenter recommended a                      121.5(f)) provide that the Administrator              exempt from the requirements of part
      longer holding period for agents and                    may grant exemptions from the                         121.
      toxins before mandatory inactivation—                   requirements of 7 CFR part 331 and 9                     A commenter stated that agents
      30 to 45 days instead of 7 days—because                 CFR part 121 upon a showing of good                   approved by APHIS’ Center for
      the destruction of isolates of select                   cause and a determination that such an                Veterinary Biologics for use in USDA
      agents after only 7 days is counter to                  exemption is consistent with protecting               licensed facilities should be exempt
      good quality control in labs, which often               animal or plant health or animal or                   from the requirements of the rule.
      specifies that isolates and specimens be                plant products.                                          We disagree. We included this
      kept for 30 days, and labs often have                      A commenter stated that APHIS                      provision in the regulations in order to
      cases pending for at least 30 days                      should establish timelines for                        exempt products, not agents, that would
      awaiting additional results. The                        responding to requests for exemptions.                be cleared, approved, licensed, or
      commenter went on to note that it is                    APHIS is committed to processing                      registered pursuant to the Virus-Serum-
      good lab practice to maintain the                       requests for exemptions in a timely                   Toxin Act (21 U.S.C. 151–159), but for
      original sample until a case is complete,               manner. We do not believe it is                       the fact that they are produced by
      and labs often maintain samples so that                 necessary to include in the regulations               USDA. In order to clarify that this
      additional testing can be done as                       timelines for responding to requests for              exemption applies to products, in this
      needed.                                                 exemptions. Therefore, we are making                  final rule, newly designated 9 CFR
         The exemption provisions in interim                  no change based on this comment.                      121.5(c) provides that diagnostic
      7 CFR 331.4(a), 9 CFR 121.4(a), and 9                      Interim 9 CFR 121.4(c) and 121.5(d)                reagents and vaccines that are, bear, or
      CFR 121.5(a) (newly designated 7 CFR                    provided that, unless the Administrator               contain VS select agents or toxins that


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                           Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations                                        13255

      are produced at USDA diagnostic                         the Attorney General. We are making no                other required forms without the need
      facilities will be exempt from the                      change based on this comment.                         to print, mail, or e-mail hard copies.
      requirements of this part.                                 One commenter requested that USDA                  Hard copy registration materials and
         The regulations (interim 9 CFR                       and CDC consider a single                             other required forms will still be
      121.4(e); newly designated § 121.6(e))                  clearinghouse for registration of select              accepted. The single web portal will be
      provide that the Administrator may                      agents. The commenter said the rules                  available in winter 2005.
      exempt an individual or entity from the                 require an entity that possesses only                    Several commenters requested more
      requirements of the part for 30 days if                 human and animal/plant agents (no                     information about the registration
      it is necessary to respond to a domestic                overlaps) to register separately with                 process. One commenter asked how
      or foreign agricultural emergency                       each agency; however, this would place                long will it take to receive a certificate
      involving an overlap agent or toxin.                    an undue burden on the entity by                      of registration after all the paperwork
      This exemption may be extended for an                   requiring dual registration packages and              has been submitted. The commenter
      additional 30 days.                                     safety/security plans. Another                        urged APHIS to promptly process
         One commenter argued that the 30-                    commenter recommended that APHIS                      registration applications so as not to
      day special exemption granted during                    indicate what an entity can do to assist              disrupt valuable research and impede
      an emergency is insufficient to deal                    or mitigate conflict between APHIS and                academic planning. Another commenter
      with a foreign animal or outbreak                       CDC on registration applications for                  suggested that APHIS add information
      emergency. This commenter stated that                   overlap agents.                                       to the final rule to indicate when an
      neither exotic Newcastle disease or the                    To simplify the registration process               entity should submit renewal
      low pathogenic avian influenza                          and minimize the burden on the public,                applications (i.e., at least 90 days prior
      outbreaks were resolved in 60 days.                     APHIS and CDC have established a                      to expiration).
                                                              framework by which individuals and                       We are committed to promptly
         Section 212(g)(1)(D) of the Act sets
                                                              entities with various combinations of                 processing initial registration
      forth the exemption for agricultural
                                                              select agents and toxins may submit                   applications and renewal applications.
      emergencies involving overlap select
                                                              their registration applications to either             The time needed to process a
      agents and toxins. The Act specifies that
                                                              APHIS or CDC. For instance, to apply                  registration application and issue a
      such exemptions may not exceed 60                       for a certificate of registration for only            certificate of registration depends on the
      days. Accordingly, we are making no                     PPQ or VS select agents or toxins, or for             complexity and completeness of the
      changes based on this comment.                          PPQ and VS select agents or toxins, an                application. However, to provide more
      Registration                                            individual or entity must submit the                  guidance about the submission of
                                                              registration application package to                   renewal applications, we recommend
        Interim 7 CFR 331.5, 331.6, and 331.8                 APHIS. However, to apply for a                        that the registration application and the
      and 9 CFR 121.6, 121.7, and 121.9                       certificate of registration for overlap               information necessary to conduct the
      (newly designated 7 CFR 331.7 and 9                     select agents or toxins, overlap select               required security risk assessments be
      CFR 121.7) set out registration                         agents or toxins and any combination of               submitted at least 8 weeks prior to the
      requirements and procedures.                            PPQ or VS select agents or toxins, or                 expiration of the date of the certificate
        One commenter stated that the                         HHS select agents or toxins and any                   of registration.
      regulations do not contemplate or                       combination of PPQ or VS select agents                   Interim 7 CFR 331.6(b)(1) and 9 CFR
      address a situation where an entity has                 or toxins, an individual or entity must               121.7(b)(1) (newly designated 7 CFR
      employees that possess, use, or transfer                submit the registration application                   331.7 and 9 CFR 121.7) indicated that,
      select agents at locations owned and                    package to APHIS or CDC, but not both.                as one of the conditions of registration,
      controlled by another entity. The                       In this final rule, we are amending both              the owner or controller of an entity must
      commenter stated that it is a nonprofit                 sections to set out this new framework                be approved by APHIS following a
      organization that provides medical                      for submitting registration applications              security risk assessment by the Attorney
      research personnel to Federal agencies.                 (newly designated 7 CFR 331.7(d) and 9                General.
      The commenter asserted that the                         CFR 121.7(d)).                                           A commenter asked who would be
      regulations and the registration                           As previously discussed, APHIS and                 deemed to own or control the entity in
      application should be revised to require                CDC are also developing a single shared               the context of an academic institution.
      registration for the entity that owns or                web-based system that will allow the                  Another commenter thought the phrase
      controls the location where agents and                  regulated community to conduct                        ‘‘individual who controls the facility’’
      toxins are used and stored.                             transactions electronically with either               meant the senior administrators to
        This final rule requires that, unless                 agency via a single web portal. By                    whom the responsible official reports
      exempted under the regulations, an                      providing a single web portal, APHIS                  and not the members of the Board of
      individual or entity that possesses, uses,              and CDC will be able to interact                      Trustees.
      or transfers select agents or toxins must               efficiently and effectively with the                     The determination of who is an owner
      register with APHIS or, for overlap                     regulated community while reducing                    or controller of an academic institution
      select agents or toxins, APHIS and CDC.                 the burden on the public. We envision                 (i.e., institution of higher education)
      The regulations provide for both                        that this system will enable the entity to            depends on whether it is a public or
      individuals and entities, even though                   dynamically communicate with APHIS                    private institution of higher education.
      we expect that most registrants will be                 and CDC in a digitally secured                        Federal, State, or local governmental
      entities. Using the example given by the                environment using a single web portal.                agencies, including public institutions
      commenter, the Federal agency that                      The web portal will provide a platform                of higher education, are exempt from
      possesses, uses, or transfers select                    for electronic exchange of information.               the security risk assessment for the
      agents or toxins would be required to                   It will allow entities to access data                 entity and the individual who owns or
      register and restrict access to such                    related to their own registration data                controls such entity. However, for a
      agents or toxins to only those                          and allow them to create, amend, and                  private institution of higher education,
      individuals approved by the                             submit registration applications;                     an individual will be deemed to own or
      Administrator or HHS Secretary                          requests for approvals for transfers,                 control the entity if the individual is in
      following a security risk assessment by                 exemptions, or exclusions; and any                    a managerial or executive capacity with


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      13256                Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations

      regard to the entity’s select agents or                 more of the entity, or is a holder or                 deleting this provision in both sections.
      toxins or with regard to the individuals                owner of 50 percent or more of its                    In addition, we are amending newly
      with access to the select agents or toxins              voting stock; or (2) is in a managerial or            designated 7 CFR 331.7(f) and 9 CFR
      possessed, used, or transferred by the                  executive capacity with regard to the                 121.7(f) to clarify that the issuance of a
      entity. We consider an entity to be an                  entity’s select agents or toxins or with              certificate of registration may be
      institution of higher education if it is an             regard to the individuals with access to              contingent upon inspection or
      institution of higher education as                      the select agents or toxins possessed,                submission of additional information,
      defined in the Higher Education Act of                  used, or transferred by the entity.                   such as the security plan,
      1965 (20 U.S.C. 1001(a)) or an                             • An entity will be considered to be               biocontainment/biosafety plan, incident
      organization described in the Internal                  an institution of higher education if it is           response plan, or any other documents
      Revenue Code of 1986 (26 U.S.C.                         an institution of higher education as                 required to be prepared under each part.
      501(c)(3)). Because entities that meet                  defined in section 101(a) of the Higher               These changes will make the APHIS and
      this criteria do not have an owner, the                 Education Act of 1965 (20 U.S.C.                      CDC regulations consistent.
      individual(s) in control of the entity                  1001(a)), or is an organization described                In interim 7 CFR 331.5(b) and 9 CFR
      must be approved by the Administrator                   in 501(c)(3) of the Internal Revenue                  121.6(b), we provided that each entity
      or the HHS Secretary following a                        Code of 1986, as amended (26 U.S.C.                   must designate an individual to be its
      security risk assessment by the Attorney                501(c)(3)).                                           responsible official and that this
      General. For all other entities, an                        Finally, we are adding a footnote to 7             individual must have the authority and
      individual will be deemed to own or                     CFR 331.7 and 9 CFR 121.7 to clarify                  control to ensure compliance with the
      control the entity if the individual: (1)               that more than one individual may meet                regulations. Furthermore, in interim 7
      Owns 50 percent or more of the entity,                  the criteria for ownership or control of              CFR 331.6(c) and 9 CFR 121.7(d), we
      or is a holder or owner of 50 percent or                an entity.                                            provided that a certificate of registration
      more of its voting stock, or (2) is in a                   Interim 7 CFR 331.6(b)(2) and 9 CFR                will be valid for only the specific agents
      managerial or executive capacity with                   121.7(b)(2) provided that APHIS may                   or toxins and specific activities and
      regard to the entity’s select agents or                 issue a certificate of registration if,               locations listed on the certificate.
      toxins or with regard to the individuals                among other things, the Administrator                    One commenter stated an entity
      with access to the select agents or toxins              approves an entity’s biosafety,                       should be able to apply for a single
      possessed, used, or transferred by the                  containment, and security.                            certificate of registration to cover
      entity.                                                    In drafting this provision, we                     activities at all buildings on a campus
         To clarify the requirements for owners               intended to stress to the regulated                   or site under the control and authority
      or controllers of an entity, we are                     community the importance of the                       of the responsible official, which would
      making several changes to the                           biosafety, containment, and security                  include both contiguous and dispersed
      registration sections in this final rule.               requirements. However, we did not                     sites within a local geographical area.
      We are making clear that the individuals                intend to suggest that an individual or               The commenter stated that it is overly
      must be approved by the Administrator                   entity did not have to meet the other                 burdensome to require separate
      or HHS Secretary based on a security                    requirements of the regulations. Since                registrations for each general physical
      risk assessment by the Attorney General                 the issuance of a certificate of                      location (defined as a building or a
      (7 CFR 331.7(c)(1) and 9 CFR                            registration is an administrative action              complex of buildings at a single mailing
      121.7(c)(1)). We are also moving the                    taken by APHIS, it is not necessary to                address). The commenter claimed that
      information contained in footnote 4 in                  include this provision in the                         the administrative and control functions
      interim 7 CFR 331.6 and footnote 7 in                   regulations. Accordingly, we are                      at research and academic institutions
      interim 9 CFR 121.7 to a new paragraph                  deleting this provision in both sections.             are efficiently managed by a centralized
      in both sections, 7 CFR 331.7(c)(2) and                    Interim 7 CFR 331.6(b)(3) and 9 CFR                department responsible for more than
      9 CFR 121.7(c)(2), which states that                    121.7(b)(3) provided that APHIS may                   one physical location. Similarly, a
      Federal, State, or local governmental                   issue a certificate of registration if,               commenter stated that the provisions
      agencies, including public institutions                 among other things, the Administrator                 concerning location should be amended
      of higher education, are exempt from                    determines that the individual or entity              to cover a single administrative
      the security risk assessment for the                    seeking to register has a lawful purpose              organization under a single responsible
      entity and the individual who owns or                   to possess, use, or transfer agents or                official. Another commenter requested
      controls such entity. In addition, we are               toxins.                                               that the final regulations allow
      adding the following paragraphs to both                    One commenter stated that it is                    campuses to designate responsible
      7 CFR 331.7 and 9 CFR 121.7 to clarify                  unclear how APHIS will determine if                   officials with responsibility for an entire
      who will be deemed to own or control                    the entity has an unlawful purpose to                 campus.
      an entity and to indicate the criteria by               possess, use, or transfer select agents.                 APHIS designed these provisions to
      which an entity will be considered an                   The commenter asked what information                  ensure that the responsible official has
      institution of higher education:                        APHIS will use to make this                           the requisite authority and control to
         • For a private institution of higher                determination.                                        ensure compliance with the select agent
      education, an individual will be deemed                    To determine whether an entity has a               regulations. We reasoned that a
      to own or control the entity if the                     lawful purpose to possess, use, or                    responsible official would be better able
      individual is in a managerial or                        transfer select agents or toxins, APHIS               to ensure compliance with the
      executive capacity with regard to the                   will consider the information contained               regulations if he/she managed only one
      entity’s select agents or toxins or with                in the registration application and any               general physical location. While we still
      regard to the individuals with access to                other information available to APHIS                  believe that to be true, we recognize that
      the select agents or toxins possessed,                  about the entity. This determination                  some responsible officials will be able to
      used, or transferred by the entity.                     will be made on a case-by-case basis.                 ensure compliance for an entire campus
         • For entities other than institutions               However, since this is an administrative              or business complex. Therefore, in this
      of higher education, an individual will                 action taken by APHIS, it is unnecessary              final rule, the registration sections
      be deemed to own or control the entity                  to include this provision in the                      (newly designated 7 CFR 331.7(g) and 9
      if the individual: (1) Owns 50 percent or               regulations. Accordingly, we are                      CFR 121.7(g)) provide that a certificate


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      of registration will be valid for one                   who meets the requirements of the                     to possess, use, or transfer listed agents
      physical location (a room, a building, or               regulations.                                          or toxins. In addition, interim 7 CFR
      a group of buildings) where the                            Interim 7 CFR 331.6(e) and 9 CFR                   331.7(a)(4) and 9 CFR 121.8(a)(4)
      responsible official will be able to                    121.7(f) stated that a responsible official           provided that APHIS may deny an
      perform the responsibilities required in                who wishes to discontinue possessing,                 application for registration or revoke
      this part, for specific select agents or                using, or transferring an agent or toxin              registration if the responsible official is
      toxins, and for specific activities. We                 may inactivate the agent or toxin or he/              an individual who handles or uses
      believe this change will provide more                   she may transfer the agent or toxin to a              listed agents or toxins and he/she does
      flexibility and guidance to entities                    registered entity. Both sections further              not have the necessary training or skills
      seeking to register.                                    provided that APHIS must be notified 5                to handle such agents or toxins. To be
         In interim 7 CFR 331.6(d) and 9 CFR                  business days prior to a planned                      consistent with CDC, we are deleting
      121.7(e), we provided that a certificate                inactivation so that APHIS may have the               these provisions in this final rule.
      of registration may be amended to                       opportunity to observe the inactivation.                 Interim 7 CFR 331.7(a)(5) provided
      reflect changed circumstances and that                     One commenter asked when APHIS                     that APHIS may deny an application for
      the responsible official must                           will observe the destruction of a select              registration or revoke registration if the
      immediately notify APHIS of such                        agent. Another commenter asked if a                   entity does not meet the containment
      changes in circumstances that occur                     responsible official for a diagnostic                 and security requirements prescribed by
      after submission of the application for                 laboratory is required to notify APHIS 5              the Administrator, while interim 9 CFR
      registration or after receipt of a                      business days prior to destroying a                   121.8(a)(5) provided that APHIS may
      certificate of registration.                            select agent or toxin.                                deny an application for registration or
         A commenter said that it is unclear                     In the final rule, we are deleting these           revoke registration if the entity does not
      how great a change would require                        paragraphs and simply providing that a                meet the biosafety, containment, and
      notification of APHIS or CDC. The                       certificate of registration will be                   security requirements prescribed by the
      commenter suggested that investigators                  terminated upon the written request of                Administrator. In addition, interim 7
      should instead submit annual reports of                 the entity if the entity no longer                    CFR 331.7(a)(6) provided that APHIS
      projects done and projects planned.                     possesses or uses any select agents or                may deny an application for registration
      Another commenter stated that there is                  toxins and no longer wishes to be                     or revoke registration if there are
      no specific information in the                          registered (newly designated 7 CFR                    egregious or repeated violations of the
      regulations about what information                      331.7(j) and 9 CFR 121.7(j)). This change             containment or security requirements,
      must be reported and what constitutes                   should eliminate any confusion between                while interim 9 CFR 121.8(a)(6)
      immediately (i.e., within 24 hours). The                this reporting requirement and the                    provided that APHIS may deny an
      commenter indicated that, if the entire                 reporting requirements for diagnostic                 application for registration or revoke
      registration application must be                        exemptions.                                           registration if there are egregious or
      resubmitted, then APHIS should allow a                     The regulations (interim 7 CFR                     repeated violations of the biosafety,
      minimum of 7 to 10 business days.                       331.6(f) and 9 CFR 121.7(g); newly                    containment, or security requirements.
         To clarify the requirements for                      designated 7 CFR 331.7(k) and 9 CFR                      In drafting these provisions, we
      amending a registration application and                 121.7(k)) state that a certificate of                 wished to stress to the regulated
      a certificate of registration, in this final            registration will be valid for a maximum              community the importance of the
      rule we are deleting the provisions of                  of 3 years.                                           biosafety, containment, and security
      interim 7 CFR 331.6(d) and 9 CFR                           A commenter recommended that                       requirements. However, we never
      121.7(e). In their place, we are adding a               certificates of registration be valid for 5           intended to suggest that an entity did
      new paragraph (e) in newly designated                   years to be consistent with the security              not have to meet the other requirements
      7 CFR 331.7 and 9 CFR 121.7 that                        risk assessments, simplify paperwork                  of each part. Therefore, we are
      requires the responsible official to                    requirements for the entity, and reduce               amending these provisions in this final
      provide prompt notification of any                      cost to government.                                   rule to provide that an application may
      changes in the registration application                    We believe it is reasonable to provide             be denied or a certificate of registration
      by submitting the relevant page(s) of the               that a certificate of registration will be            revoked or suspended if the individual
      registration application. In addition, we               valid for a maximum of 3 years. A 3-                  or entity does not meet the requirements
      are adding a new paragraph (h) in both                  year registration period takes into                   of the applicable part (newly designated
      sections to require that, prior to any                  consideration the burden on the public                7 CFR 331.8(a)(3) and 9 CFR
      change, the responsible official must                   and the risks posed by select agents and              121.8(a)(3)). These changes will clarify
      apply for an amendment to a certificate                 toxins. In addition, it is consistent with            the registration requirements and make
      of registration by submitting the                       APHIS’ permit systems and other                       both sections consistent with CDC’s
      relevant page(s) of the registration                    established programs for laboratory                   regulations.
      application. Finally, to clarify the                    certification or registration (e.g., Clinical            In addition, in this final rule, we are
      requirements for when an entity loses                   Laboratory Improvement Amendments                     clarifying the actions an entity must
      the services of its responsible official,               (CLIA) and the College of American                    take in the event that APHIS suspends
      we are adding a new paragraph (i) in                    Pathologists (CAP)), which are generally              or revokes a certificate of registration.
      both sections to require an entity to                   valid for 2 to 3 years. Accordingly, we               Specifically, we are adding a paragraph
      immediately notify APHIS or CDC if it                   are making no change based on this                    to require that, upon notification of
      loses the services of its responsible                   comment.                                              suspension or revocation, an individual
      official. These paragraphs also provide                                                                       or entity must: (1) Immediately stop all
      that an entity may continue to possess                  Denial, Revocation, and Suspension of                 use of each select agent or toxin covered
      or use select agents or toxins only if it               Registration                                          by the revocation or suspension order;
      appoints as the responsible official                      Interim 7 CFR 331.7(a)(3) and 9 CFR                 (2) immediately safeguard and secure
      another individual who has been                         121.8(a)(3) provided that APHIS may                   each select agent or toxin covered by the
      approved by the Administrator or the                    deny an application for registration or               revocation or suspension order from
      HHS Secretary following a security risk                 revoke registration if the responsible                theft, loss, or release; and (3) comply
      assessment by the Attorney General and                  official does not have a lawful purpose               with all disposition instructions issued


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      by the Administrator for each select                       One commenter stated that the APHIS                CFR 121.15, 7 CFR 331.17 and 9 CFR
      agent or toxin covered by the revocation                and CDC regulations should have the                   121.17, and 7 CFR 331.19 and 9 CFR
      or suspension (newly designated 7 CFR                   same responsibilities for the responsible             121.19). This change will allow the
      331.8(b) and 9 CFR 121.8(b)).                           official and that these responsibilities              responsible official to delegate certain
        In a footnote to interim 7 CFR                        should be better defined.                             responsibilities. For instance, interim 7
      331.7(a)(5) and 9 CFR 121.8(a)(5), we                      We agree that the APHIS and CDC                    CFR 331.14(a) and 9 CFR 121.15(a)
      indicated that APHIS may provide                        regulations should contain the same                   stated that the responsible official must
      technical assistance and guidance on                    provisions for the responsible official.              maintain complete, up-to-date records
      the biosafety, containment, and security                Therefore, in this final rule, we are                 of information necessary to give an
      requirements. A commenter requested                     amending newly designated 7 CFR                       accounting of all of the activities related
      information on when and to what                         331.9(a) and 9 CFR 121.9(a) to require                to listed agents or toxins. In this final
      degree APHIS will provide such                          that an individual or entity required to              rule, we are amending the regulations to
      assistance.                                             register under each part designate an                 require the individual or entity to
        As discussed below in the                             individual to be the responsible official.            maintain such records (newly
      biocontainment/biosafety and security                   Paragraph (a) further requires that the               designated 7 CFR 331.17 and 9 CFR
      sections, in this final rule we are                     responsible official:                                 121.17).
      providing a list of documents in each                      • Be approved by the Administrator                    Interim 7 CFR 331.9(b) and 9 CFR
      part that an entity should consider in                  or the HHS Secretary following a                      121.10(b) (newly designated 7 CFR
      developing a biocontainment/biosafety                   security risk assessment by the Attorney              331.9 and 9 CFR 121.9) required the
      or security plan. We recommend that an                  General;                                              responsible official for a diagnostic
      entity review these documents before                       • Be familiar with the requirements of             laboratory, or other entity possessing,
      contacting APHIS for technical                          this part;                                            using, or transferring listed agents or
                                                                 • Have the authority and                           toxins that are contained in specimens
      assistance. We will provide technical
                                                              responsibility to act on behalf of the                presented for diagnosis to immediately
      assistance and guidance upon request.
                                                              entity;                                               report the identification of such agents
        Interim 7 CFR 331.7(b) and 9 CFR                         • Ensure compliance with the                       or toxins to the Administrator and to
      121.8(b) provided that APHIS may                        requirements of this part; and                        other appropriate authorities when
      summarily revoke or suspend                                • Ensure that annual inspections are               required by Federal, State, or local law.
      registration for any of the reasons set                 conducted for each laboratory where                   Furthermore, both paragraphs provided
      forth in each section.                                  select agents or toxins are stored or used            that the Administrator may require less
        To clarify the provisions for denial,                 in order to determine compliance with                 frequent reporting during agricultural
      suspension, and revocation of                           the requirements of this part. The                    emergencies or outbreaks, or in endemic
      registration, in this final rule, we are                results of each inspection must be                    areas.
      deleting interim paragraph (b) in both                  documented, and any deficiencies                         In this final rule, we are amending
      sections and simply providing that an                   identified during an inspection must be               newly designated 7 CFR 331.9(c) and 9
      application may be denied or a                          corrected.                                            CFR 121.9(c) to require the responsible
      certificate of registration revoked or                     In addition, we are deleting the                   official to report the identification and
      suspended for the reasons set forth in                  provision for the alternate responsible               final disposition of any select agent or
      each section (newly designated 7 CFR                    official(s) from the registration section             toxin contained in a specimen for
      331.8(a) and 9 CFR 121.8(a)).                           and adding it to the responsible official             diagnosis or verification. In addition, we
        Interim 7 CFR 331.7(d) and 9 CFR                      section (newly designated 7 CFR                       are adding a new paragraph (d) to 9 CFR
      121.9(d) provided that the denial of an                 331.9(b) and 9 CFR 121.9(b)). These                   121.9 to require the responsible official
      application for registration, revocation                changes will make the APHIS and CDC                   to report the identification and final
      of registration, and suspension of                      regulations consistent.                               disposition of any select agent or toxin
      registration may be appealed under each                    A commenter recommended that                       contained in a specimen presented for
      part. In this final rule, newly designated              APHIS add the following language to                   proficiency testing. This information
      7 CFR 331.8(c) and 9 CFR 121.8(c)                       the regulations: ‘‘This does not preclude             will help us to identify outbreaks and to
      provide that the denial of an application               the assignment of activities in                       monitor activities related to select
      for registration and revocation of                      §§ 121.10(a)(1) through 121.10(a)(8) to               agents and toxins.
      registration may be appealed under each                 other individuals, provided the                          We are also amending newly
      part. Furthermore, both paragraphs                      activities are performed or supervised                designated 9 CFR 121.9(c) to require the
      provide that any denial of an                           by a person approved under § 121.11                   responsible official to immediately
      application for registration or revocation              and the results are reviewed and                      report the identification of specified
      of a certificate of registration will                   approved by the Responsible Official or               select agents and toxins with a report of
      remain in effect until a final agency                   Alternate Responsible Official.’’ The                 the final disposition of the agent or
      decision has been rendered. These                       commenter stated that it would be                     toxin due within 7 calendar days after
      changes will clarify the status of an                   inappropriate for the responsible official            identification. The responsible official
      application for registration or a                       to participate in the actual transferring             must report the identification and final
      certificate of registration during the                  of an agent or to perform data entry to               disposition of the other select agents
      appeal process.                                         maintain records.                                     and toxins within 7 calendar days after
                                                                 In response to this comment, in this               identification. This will make the
      Responsibilities of the Responsible                     final rule we are amending the                        reporting requirements for registered
      Official                                                regulations to provide that the                       entities consistent with those in the
        To facilitate compliance with the                     individual or entity required to register             exemption sections (newly designated 9
      regulations, the regulations (interim 7                 under each part, and not the responsible              CFR 121.5 and 121.6). Finally, we are
      CFR 331.9 and 9 CFR 121.10; newly                       official, must provide training, maintain             deleting in both sections the
      designated 7 CFR 331.9 and 9 CFR                        records, and provide notice of theft,                 requirement that the identification of a
      121.9) set out the responsibilities of the              loss, or release of select agents or toxins           select agent or toxin be reported to
      responsible official.                                   (newly designated 7 CFR 331.15 and 9                  appropriate authorities when required


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                           Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations                                          13259

      by Federal, State, or local law (interim                assessments conducted by the Attorney                 judgments about an individual’s need to
      7 CFR 331.9(b) and 9 CFR 121.10(b)).                    General.                                              handle agents and the adequacy of their
      This change corresponds to a similar                       To obtain a security risk assessment,              training and skills is a matter for the
      change made in the exemption sections                   an individual or entity must submit a                 responsible official, not APHIS. This
      (interim 7 CFR 331.4, 9 CFR 121.4, and                  completed FBI Form FD–961 and two                     commenter recommended that APHIS
      9 CFR 121.5).                                           legible fingerprint cards, printed by a               rely upon the responsible official to
         One commenter requested                              local law enforcement agency, to the                  make informed judgments about an
      clarification of the diagnostic                         Criminal Justice Information Services                 individual’s need for access and their
      exemptions and the provisions of                        (CJIS) Division of the Federal Bureau of              proficiency in handling select agents
      interim 9 CFR 121.10(b) requiring the                   Investigation. Fingerprint cards and FBI              and toxins. One commenter noted the
      responsible official for a diagnostic                   Form FD–961 may be obtained by                        term ‘‘access’’ is used to describe two
      laboratory to report identifications. The               calling (304) 625–4900. FBI Form FD–                  distinct situations—access to select
      commenter noted that exempt                             961 is also available on the Internet at              agents and toxins by individuals who
      diagnostic laboratories are not required                http://www.fbi.gov/terrorinfo/                        are authorized to handle and use them,
      to have a responsible official.                         bioterrorfd961.htm. It would be                       and approved entry to an area where
         The reporting requirements in interim                impractical to include this information               select agents or toxins are present by
      9 CFR 121.10(b) (newly designated 7                     in the regulations because the Attorney               individuals who are not authorized to
      CFR 331.9(c) and 9 CFR 121.9(c))                        General determines the information and                handle or use such agents or toxins.
      pertain to registered diagnostic                        processes required for a security risk                Several commenters recommended that
      laboratories. The regulations require                   assessment. Accordingly, we are making                APHIS define the term ‘‘access’’ as the
      that both exempt and registered entities                no change based on these comments.                    ‘‘ability to gain physical control of select
                                                                 One commenter recommended that                     agents and toxins.’’ Another commenter
      report the identification of a select agent
                                                              security risk assessments be completed                suggested the word ‘‘access’’ be changed
      or toxin. We adopted these reporting
                                                              within 2 weeks. Another commenter                     to ‘‘handle or use’’ throughout the
      requirements because this information
                                                              stated that a person should be permitted              regulations. The commenter noted that
      will help us to identify outbreaks and to
                                                              to work with select agents or toxins                  many people may have access to a
      monitor activities related to select
                                                              under the direct supervision of an                    containment space but never handle or
      agents and toxins. Accordingly, we are
                                                              approved person if the individual                     use agents or toxins. Similarly, one
      making no change in response to this
                                                              subject to the background check suffers               commenter argued that the regulations
      comment.
                                                              a delay in excess of 10 working days.                 are conceptually flawed because they
      Restricting Access/Security Risk                           Security risk assessments are
                                                                                                                    focus on restricting access to the
      Assessments                                             conducted by the Attorney General, not
                                                                                                                    laboratory rather than to the select agent
                                                              APHIS. The time required to complete
        Interim 7 CFR 331.10 and 9 CFR                                                                              or toxin. The commenter said that
                                                              a security risk assessment depends on
      121.11 stated that an individual may not                                                                      numerous individuals need to access lab
                                                              the completeness of the application and
      have access to listed agents and toxins                                                                       space for a variety of reasons and that
                                                              the results of the database search. In
      unless approved by APHIS or, for                                                                              it is unnecessary and burdensome to
                                                              general, a security risk assessment may
      overlap agents, APHIS or CDC. Both                                                                            require that they be continually escorted
                                                              be completed in 45 days. However, in
      sections provided that APHIS will grant,                                                                      or undergo security risk assessments.
                                                              certain cases, additional time may be
      limit, or deny access approval and,                                                                           Another commenter recommended that
                                                              needed to verify the results of the
      interim 9 CFR 121.11, provided that                                                                           APHIS define the term ‘‘entry,’’ which
                                                              database search. We are making no
      APHIS or CDC will make this                                                                                   would refer to admission of unapproved
                                                              changes based on these comments.
      determination for overlap agents or                        A commenter asserted that personnel                individuals into an area where select
      toxins. Interim 7 CFR 331.10 and 9 CFR                  screening should include, at a                        agents and toxins are present.
      121.11 further provided that the                        minimum, a criminal background check,                    In the December 2002 interim rule, we
      responsible official is responsible for                 credit check, and random drug                         provided that an individual may not
      ensuring that only approved individuals                 screening.                                            have access to listed agents or toxins
      within the entity have access to agents                    In accordance with the Act, each                   unless approved by APHIS or, for
      or toxins.                                              individual identified by the responsible              overlap agents or toxin, APHIS or CDC.
        In this final rule, we are amending                   official must undergo a security risk                 We required access approval for each
      these sections to clarify that an                       assessment. The Act does not require a                individual with a legitimate need to
      individual must be approved for access                  credit check or random drug screening.                handle or use agents or toxins, and the
      by the Administrator or the HHS                         However, this does not preclude an                    necessary training and skills to handle
      Secretary following a security risk                     entity from having more stringent                     such agents or toxins. We continue to
      assessment by the Attorney General                      personnel screening for individuals                   believe that individuals that handle or
      (newly designated 7 CFR 331.10 and 9                    with access to select agents or toxins.               use select agents or toxins must be
      CFR 121.10). In addition, we are                        Accordingly, we are making no changes                 approved for such access. However, we
      deleting the provision that the                         based on this comment.                                agree with the commenters that access
      responsible official is responsible for                    Interim 7 CFR 331.10(b) and 9 CFR                  approval should also be required for
      ensuring that only approved individuals                 121.11(b) required the responsible                    individuals who have the ability to gain
      have access to select agents or toxins.                 official to request access approval for               possession. Therefore, this final rule
      This change will make it clear that the                 only those individuals who have a                     provides that an individual will be
      registrant and the individual are                       legitimate need to handle or use listed               deemed to have access at any point in
      responsible for ensuring that the                       agents or toxins, and who have the                    time if the individual has possession of
      individual does not have access to any                  appropriate training and skills to handle             a select agent or toxin (e.g., carries, uses,
      select agent or toxin unless approved by                such agents and toxins.                               or manipulates) or the ability to gain
      the Administrator or the HHS Secretary.                    APHIS received a number of                         possession of a select agent or toxin
        Several commenters requested                          comments dealing with the term                        (newly designated 7 CFR 331.10(b) and
      information about the security risk                     ‘‘access.’’ A commenter stated that                   9 CFR 121.10(b)). In addition, we are


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      13260                Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations

      requiring in both sections that each                       Section 212(e) of the Act requires that               • The Administrator determines that
      individual with access to select agents                 registered persons provide access to                  the individual does not have a
      or toxins have the appropriate                          select agents and toxins to only those                legitimate need to handle listed agents
      education, training, and/or experience                  individuals that have a legitimate need               or toxins;
      to handle or use such agents or toxins                  to handle or use such agents and toxins,                 • The individual does not have the
      (newly designated 7 CFR 331.10(c) and                   and that those individuals undergo a                  necessary training and skills to handle
      9 CFR 121.10(c)). However, in this final                security risk assessment by the Attorney              listed agents or toxins; or
      rule, we are removing the requirement                   General. The Act provides no exemption                   • The Administrator determines that
      that the responsible official submit                    for Federal clearances. Accordingly, we               such action is necessary to protect plant
      information about an individual’s                       are making no change based on this                    health or plant products, or animal
      training and skills to APHIS (interim 7                 comment.                                              health or animal products.
      CFR 331.10(e) and 9 CFR 121.11(e)).                        The regulations (interim 7 CFR                        In this final rule, newly designated 7
      These changes will make it clear that                   331.10(f) and 9 CFR 121.11(f); newly                  CFR 331.10(f) and 9 CFR 121.10(f)
      the registered individual or entity, and                designated 7 CFR 331.10(e) and 9 CFR                  provide that an individual’s access
      not APHIS, is responsible for ensuring                  121.10(e)) provide that the access                    approval may be denied, limited, or
      that an individual with access to select                approval process for individuals may be               revoked if the individual is a restricted
      agents or toxins has the appropriate                    expedited upon request by the                         person under 18 U.S.C. 175b or is
      education, training, and/or experience                  responsible official and a showing of                 reasonably suspected by any Federal
      to handle such agents or toxins.                        good cause.                                           law enforcement or intelligence agency
                                                                 Several commenters stated that                     of committing a crime set forth in 18
         Several commenters argued that
                                                              APHIS and the Attorney General should                 U.S.C. 2332b(g)(5), knowing
      access approval should be portable from
                                                              establish timelines for responding to                 involvement with an organization that
      entity to entity, from location to
                                                              requests for expedited review for                     engages in domestic or international
      location, and from project to project for
                                                              security risk assessments.                            terrorism (as defined in 18 U.S.C. 2331)
      the duration of the valid period. A
                                                                 We do not believe it is necessary to               or with any other organization that
      commenter stated that delays in access
                                                              establish timelines for responding to                 engages in intentional crimes of
      approval could be avoided if an
                                                              requests for expedited review for                     violence, or being an agent of a foreign
      individual’s approval was portable.                                                                           power as defined in 50 U.S.C. 1801.
                                                              security risk assessments. In our
      Another commenter asked if an                                                                                 This has always been the way these
                                                              experience, an expedited security risk
      individual will need a new security risk                                                                      provisions have been interpreted;
                                                              assessment can be completed within a
      assessment if he or she has already been                                                                      however, we are making this change to
                                                              week, barring any complications.
      cleared at one entity but will visit                                                                          both sections for clarification purposes.
                                                              Therefore, we are making no change
      another entity to conduct research.                                                                              To be consistent with a change made
                                                              based on this comment.
         We do not believe it is necessary to                    Another commenter asked what                       in the section pertaining to denial,
      make an individual’s access approval                    constituted ‘‘good cause’’ for expedited              revocation, or suspension of registration
      portable in order to avoid delays in such               review of access approval. This                       (newly designated 7 CFR 331.8 and 9
      approval. The Administrator or the HHS                  commenter asserted that Federal                       CFR 121.8), in this final rule we are
      Secretary may grant access approval to                  clearances should be a reason for                     deleting the provision that the
      an individual following a security risk                 expedited review.                                     Administrator may deny, limit, or
      assessment by the Attorney General. A                      This final rule cites several examples             revoke an individual’s access approval
      security risk assessment may be                         of good cause to expedite a security risk             if the individual does not have a
      completed in 45 days unless additional                  assessment (e.g., public health or                    legitimate need to handle select agents
      time is needed to verify the database                   agricultural emergencies, national                    or toxins. In addition, we are deleting
      search results. However, in recognition                 security, a short-term visit by a                     the provision pertaining to an
      of the need for flexibility for visiting                prominent researcher). We do not                      individual’s training and skills to be
      researchers, APHIS, CDC, and the                        believe that a Federal clearance alone is             consistent with CDC’s regulations.
      Attorney General have developed                         sufficient reason to expedite a security                 A commenter stated that limited
      procedures by which an approved                         risk assessment. Thus, we are making no               access, whereby the individual can only
      individual may visit another registered                 change in response to this comment.                   handle or use the agent or toxin under
      entity without having to undergo                           Interim 7 CFR 331.10(h) and 9 CFR                  the direct supervision of an approved
      another security risk assessment by the                 121.11(h) provided that APHIS may                     individual, is impractical. The
      Attorney General. Specific guidance on                  deny or limit access of an individual to              commenter noted that each faculty
      these procedures is available on the                    agents or toxins if:                                  member, postdoctoral fellow, or student
      Internet at http://www.aphis.usda.gov/                     • The Attorney General identifies the              who is a member of a research team is
      programs/ag_selectagent/index/html.                     individual as a restricted person under               expected to make significant,
      We note that an individual who ceases                   18 U.S.C. 175b;                                       independent contributions to research;
      to be employed by the entity at which                      • The Attorney General identifies the              also, it would be too burdensome for
      he/she originally received access                       individual as reasonably suspected by                 institutions to track whether individuals
      approval must obtain new access                         any Federal law enforcement or                        have full or limited access. The
      approval through his/her new employer.                  intelligence agency of (1) committing a               commenter stated that provisions for
      We are making no changes to the                         crime set forth in 18 U.S.C. 2332b(g)(5),             limited access would be unnecessary if
      regulations in response to these                        (2) knowing involvement with an                       the regulations included a precise
      comments.                                               organization that engages in domestic or              definition of access.
         A commenter asserted that the L or Q                 international terrorism (as defined in 18                Section 212(e)(2) of the Act provides
      clearances (or their equivalent) granted                U.S.C. 2331) or with any other                        for limited access approval. The
      in Department of Energy laboratories                    organization that engages in intentional              Administrator will determine what
      should be considered synonymous with                    crimes of violence, or (3) being an agent             constitutes limited access on a case-by-
      the security risk assessment, and,                      of a foreign power as defined in 50                   case basis. The determination will take
      therefore, approved.                                    U.S.C. 1801;                                          into consideration all of the facts at


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                           Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations                                        13261

      hand and be commensurate with the                          • Has been adjudicated as a mental                 the burden on the public and the fact
      risks posed by the select agent or toxin.               defective or has been committed to any                that the Act allows for approvals to be
      We are making no change based on this                   mental institution;                                   valid for up to 5 years. We believe that
      comment.                                                   • Is an alien (other than an alien                 these timeframes are reasonable and
         One commenter argued that the                        lawfully admitted for permanent                       consistent with the requirements of the
      Attorney General should allow the                       residence) who is a national of a country             Act. We do not believe that it will be
      research community to comment on                        as to which the Secretary of State,                   easier for the regulated community if
      how the definition of ‘‘restricted                      pursuant to section 6(j) of the Export                the renewals are concurrent and can be
      person’’ will be interpreted and applied.               Administration Act of 1979 (50 U.S.C.                 sent at one time. Access approvals are
      This commenter stated that, while the                   App. 2405(j), section 620A of chapter 1               granted by the Administrator or the
      Attorney General is bound by statutory                  of part M of the Foreign Assistance Act               HHS Secretary on a rolling basis due to
      language in the respective categories,                  of 1961 (22 U.S.C. 2371), or section                  frequent staff changes at entities and
      interpretation will be required to make                 40(d) of chapter 3 of the Arms Export                 variations in the time it takes for the
      the definitions operational. For                        Control Act (22 U.S.C. 2780(d)), has                  Attorney General to conduct an
      instance, the commenter asked if a                      made a determination (that remains in                 individual’s security risk assessment. If
      scientist who has fled political                        effect) that such country has repeatedly              APHIS adopted the same timeframe for
      persecution in another country, and                     provided support for acts of                          registration and access approval, it is
      who may therefore have an outstanding                   international terrorism; or                           likely that some individuals in an entity
      foreign arrest warrant, would be                           • Has been discharged from the                     would have to renew their access
      considered a restricted person. Another                 Armed Services of the United States                   approvals in a much shorter timeframe
      commenter recommended that the                          under ‘‘dishonorable conditions.’’                    than other individuals in the same
      Administrator reserve the authority, in                    Based on the foregoing, we are making              entity. We believe this would cause
      exceptional circumstances, to allow                     no change in response to this comment.                undue burden on the public.
      individuals deemed ineligible to have                      Interim 7 CFR 331.10(g) and 9 CFR                  Accordingly, we are making no changes
      access to select agents and toxins for a                121.11(g) provided that APHIS will                    based on this comment.
      limited time. The commenter stated that                 notify the responsible official if an                    The regulations (interim 7 CFR
      it is in the national interest to take a                individual is granted full or limited                 331.10(k) and 9 CFR 121.11(l); newly
      nuanced approach that takes into                        access, or denied access to listed agents             designated 7 CFR 331.10(i) and 9 CFR
      account the contributions the individual                or toxins. Both sections further provided             121.10(j)) require immediate notification
      may be able to make to the country. This                that APHIS will notify the individual if              when an individual’s access to agents or
      commenter stated there should be an                     he/she is denied access or is granted                 toxins is terminated by the entity and
      opportunity for individuals and their                   only limited access.                                  the reasons therefore.
      sponsoring institutions to make the                        Several commenters recommended                        A commenter requested clarification
      argument that an individual has                         that any entities or individuals denied               as to what constitutes ‘‘immediately.’’
      exceptional talent and insight that                     access to select agents and toxins be                 The commenter stated that large entities
      should be used to advance research, and                 notified of the reasons for the denial;               would find it difficult to provide written
      that an individual does not present a                   otherwise, they are unable to make a                  notices within 24 hours. The commenter
      security risk, even if he or she meets the              meaningful request for an                             recommended that APHIS require an
      criteria for a restricted person.                       administrative review.                                initial notification by phone or fax
         The statutory requirements are clear,                   APHIS will provide written notice of               within 72 hours that is followed up by
      and it is not necessary for the research                any denial, limitation, or revocation of              a written notice within 7 business days.
      community to assist in the                              access approval, including the reason(s)                 The regulations do not require written
      interpretation and application of the                   therefore. However, since this is an                  notice of a termination of access. Notice
      term ‘restricted person.’ In accordance                 administrative action ‘‘taken’’ by                    of a termination of access may be
      with the Act, the Administrator may                     APHIS, it is unnecessary to include this              provided by telephone, fax, or e-mail.
      limit or deny access to PPQ and VS                      information in the regulations.                       We are making no change in response to
      select agents and toxins to individuals                 Accordingly, we are deleting this                     this comment.
      whom the Attorney General has                           paragraph in both sections in this final
                                                                                                                    Security
      identified as a ‘‘restricted person’’ under             rule.
      18 U.S.C. 175b. Furthermore, the                           The regulations (interim 7 CFR                        Interim 7 CFR 331.11 required that an
      Administrator must deny access to                       331.10(j) and 9 CFR 121.11(k); newly                  individual or entity develop and
      overlap select agents and toxins to                     designated 7 CFR 331.10(h) and 9 CFR                  implement a Biocontainment and
      individuals whom the Attorney General                   121.10(i)) provide that access approval               Security Plan. Interim 9 CFR 121.12
      has identified as a ‘‘restricted person.’’              is valid for a maximum of 5 years.                    contained similar requirements for a
      According to 18 U.S.C. 175b, ‘‘the term                    One commenter recommended that                     Biosafety and Security Plan. In both
      ‘‘restricted person’’ means an individual               APHIS reconsider the timeframes for                   sections, paragraph (a)(2) stated that the
      who:                                                    renewal of registration packages (3                   security systems and procedures must
         • Is under indictment for a crime                    years) and access approval (5 years).                 be designed according to a site-specific
      punishable for a term exceeding 1 year;                 The commenter stated that it would be                 risk assessment and provide graded
         • Has been convicted in any court of                 easier for the regulated community if                 protection in accordance with the threat
      a crime punishable by imprisonment for                  the renewals were concurrent and could                posed by the agent or toxin. Both
      a term exceeding 1 year;                                be sent at one time.                                  sections also set out the types of
         • Is a fugitive from justice;                           In establishing the timeframe for                  information that should be contained in
         • Is an unlawful user of any                         registration, we took into consideration              the security plan.
      controlled substance (as defined in                     the risks of the select agents and toxins                A commenter asserted that biological
      section 102 of the Controlled Substances                and the fact that APHIS’ permits are                  lab security should be administered by
      Act (21 U.S.C. 802));                                   valid for a similar timeframe, while, in              only one Federal agency (i.e, the
         • Is an alien illegally or unlawfully in             establishing the timeframe for access                 Department of Homeland Security) to
      the United States;                                      approvals, we took into consideration                 ensure consistency.


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        Section 212(b) of the Act requires                    interagency groups and security experts               little experience in this area and should
      APHIS to establish and enforce                          to draft a document that will provide                 be clarified. A commenter suggested
      safeguard and security measure to                       additional guidance about the security                that APHIS replace the phrase ‘‘risks
      prevent access to select agents and                     required for select agents and toxins.                associated with those vulnerabilities are
      toxins for use in domestic or                           This document will be available in                    mitigated’’ with the phrase
      international terrorism or for any other                spring 2005. We will provide this                     ‘‘consequences associated with those
      criminal purpose. In addition, the Act                  guidance document to the regulated                    vulnerabilities are mitigated.’’
      provides for interagency coordination                   community when it is available.                          In response to these comments, in this
      between APHIS and CDC regarding                            A commenter stated that the                        final rule we are deleting this text in
      overlap select agents and toxins. As                    regulations should clearly distinguish                both sections and adding in its place the
      discussed below, APHIS and CDC have                     between lab security and entity security,             requirement that an entity’s security
      amended the regulations so that the                     especially for large academic settings                plan be sufficient to safeguard the select
      security requirements are identical and                 where a secure lab may coexist with                   agent or toxin against unauthorized
      APHIS and CDC have established                          educational and research labs.                        access, theft, loss, or release (newly
      procedures to ensure consistent                            We disagree. The security regulations              designated 7 CFR 331.11(a) and 9 CFR
      regulation of select agents and toxins.                 are designed to prevent unauthorized                  121.11(a)). In addition, we are amending
      For these reasons, we are making no                     access, theft, loss, or release of select             both sections to require that the security
      change in response to this comment.                     agents and toxins. The regulations                    plan be designed according to a site-
        A commenter recommended that                          require that an entity’s security plan be             specific risk assessment and provide
      APHIS and CDC adopt identical security                  designed according to a site-specific risk            graded protection in accordance with
      provisions. Several commenters asked                    assessment. Such a risk assessment                    the risk of the select agent or toxin,
      whose security, inspection, and                         would take into consideration the                     given its intended use. We believe these
      compliance standards will be used for                   security needed for a select agent lab in             changes will clarify the requirements
      overlap agents—APHIS’ or CDC’s. These                   a large academic setting. Therefore, we               and make the text in this section
      commenters also asked what will                         are making no change based on this                    consistent with other sections in the
      happen if APHIS and CDC do not                          comment.                                              regulations (e.g., biocontainment/
      concur.                                                    One commenter asked what                           biosafety).
        Both the APHIS and CDC select agent                   constituted an adequate description of                   One commenter recommended that
      regulations apply to overlap select                     safety and security in the required                   entities be required to comply with
      agents and toxins. To eliminate                         plans. Another commenter asked who                    Appendix F of the BMBL as well as the
      confusion about whose security                          will judge the adequacy of a security                 specific USDA manuals cited in the
      standards will be used for overlap select               plan.                                                 rule. The commenter stated that this
      agents and toxins, we are amending the                     A security plan must be sufficient to              would mandate the use of state-of-the-
      security sections in this final rule so                 safeguard the select agent or toxin                   art approaches for safety and security. A
      that the APHIS and CDC security                         against unauthorized access, theft, loss,             commenter stated that the security
      requirements are identical (newly                       or release. APHIS or CDC will determine               regulations are inadequate (i.e., key
      designated 7 CFR 331.11 and 9 CFR                       if a security plan is adequate. We are                locks and key control) and
      121.11). These changes are discussed in                 making no changes in response to these                recommended that the pathogens be
      detail below. We believe these changes                  comments.                                             secured with a modern access control
      will help to ensure consistent regulation                  The introductory text in interim 7                 system. Another commenter stated that
      of select agents and toxins by APHIS                    CFR 331.11(a)(2) and 9 CFR 121.12(a)(2)               the regulations should specify minimum
      and CDC, including compliance                           stated that the security systems and                  security standards. The commenter
      inspections. We note that compliance                    procedures must be designed according                 recommended the following: (1) A
      inspections for security will be based on               to a site-specific risk assessment and                minimum of three levels of access
      the regulations and that inspectors will                must provide graded protection in                     control (e.g., access to the building,
      be looking for security that provides                   accordance with the threat posed by the               access to the wing of the building, and
      graded protection commensurate with                     agent or toxin. Both sections further                 access to the laboratory); (2) a minimum
      the risk of the select agent or toxin,                  provided that the site-specific risk                  of two levels of access control with
      given its intended use.                                 assessment should involve a threat                    video surveillance; (3) a minimum of
        Several commenters expressed                          assessment and risk analysis in which                 one level of access control with security
      concern that the regulations do not                     threats are defined, vulnerabilities                  personnel; and (4) a minimum of one
      provide for preclearance of security                    examined, and risks associated with                   level of access control with an alarm
      plans before an entity invests in a                     those vulnerabilities identified. Both                system with off-site monitoring.
      security system.                                        sections also stated that the security                   On the other hand, several
        In this final rule, we recommend that                 systems and procedures must be                        commenters recommended a
      an individual or entity consider the                    tailored to address site-specific                     performance standard for compliance
      following document when developing a                    characteristics and requirements,                     with the regulations. One commenter
      security plan—‘‘Laboratory Security and                 ongoing programs, and operational                     stated that Appendix F of the BMBL
      Emergency Response Guidance for                         needs and must mitigate the risks                     does not provide appropriate guidance
      Laboratories Working With Select                        identified.                                           for developing a performance-based
      Agents,’’ in Morbidity and Mortality                       A commenter suggested replacing the                security program because it implies the
      Weekly Report. An individual or entity                  phrase ‘‘in accordance with the threat                need for a rigorous security program
      should review this document before                      posed by the agent’’ with the phrase ‘‘in             applicable uniformly to all biosafety
      contacting APHIS for technical                          accordance with the consequences                      levels. The commenter noted that overly
      assistance. We will provide technical                   posed by the agent or toxin.’’ Another                prescriptive requirements will impede
      assistance and guidance upon request.                   commenter pointed out that the terms                  the development of effective and
      However, in recognition of the                          ‘‘risk assessment,’’ ‘‘threat assessment,’’           affordable plans and will result in
      commenters’ concerns, we note that                      ‘‘vulnerability assessment,’’ and                     constraining the availability of select
      APHIS and CDC are working with                          ‘‘threats’’ are confusing to those with               agents and toxins for the legitimate


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                           Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations                                       13263

      purposes specified in the Act. Another                     Interim 7 CFR 331.11(a)(2)(iii) and 9              are performing a specifically authorized
      commenter stated that toxins should not                 CFR 121.12(a)(2)(iii) required that the               function during hours required to
      be subject to the same biocontainment                   security plan describe, among other                   perform that job.
      and security measures as viruses,                       things, cybersecurity.                                   In its final rule, CDC is amending the
      bacteria, fungi, and plant pathogens                       One commenter recommended that                     comparable provision in its rule in
      (which are capable of replication). The                 the term cybersecurity be replaced with               response to comments. To be consistent
      commenter suggested a two-tiered                        ‘‘information and cybersecurity.’’ The                with CDC’s regulations, we are making
      approach, with a higher level of security               commenter also recommended spelling                   a corresponding change in this final
      and biocontainment for materials that                   out the assets that should be protected               rule. Specifically, we are amending both
      can be propagated. Similarly, a                         and how they are to be protected.                     sections to provide that an entity may
      commenter stated the security                              In this final rule, we are amending                allow access only to individuals with
      requirements should recognize that not                  these provisions by removing the word                 access approval from the Administrator
      all listed agents are equal from a                      ‘‘cybersecurity’’ and adding in its place             or the HHS Secretary (newly designated
      weaponization perspective; therefore, a                 the words ‘‘information systems                       7 CFR 331.11(d)(1) and 9 CFR
      set of graded protection requirements                   control’’ (newly designated 7 CFR                     121.11(d)(1)).
      should be established so that the most                  331.11(c)(1) and 9 CFR 121.11(c)(1)).                    Interim 7 CFR 331.11(a)(2)(iv)(B) and
      dangerous pathogens and the most                        This change is consistent with changes                9 CFR 121.12(a)(2)(iv)(B) required that
      likely to be weaponized are protected at                made throughout this final rule to                    individuals who are not approved under
      higher levels than the majority of the                  ensure that information about select                  §§ 331.10 or 121.11, respectively, be
      select agents.                                          agents and toxins is protected.                       allowed to conduct routine cleaning,
                                                                 Interim 7 CFR 331.11(a)(2)(iv) and 9               maintenance, repairs, and other non-
         Because different select agents and
                                                              CFR 121.12(a)(2)(iv) provided that, with              laboratory functions only when escorted
      toxins pose differing degrees of risk, we
                                                              respect to areas containing listed agents             and continually monitored.
      believe it would be counterproductive
                                                              or toxins, an entity or individual must                  A commenter requested clarification
      to attempt to prepare a detailed list of
                                                              adhere to the specified security                      of the terms ‘‘escorting’’ and
      prescriptive requirements for entities
                                                              requirements or implement measures to                 ‘‘continually monitored.’’
      (i.e., a ‘‘one size fits all’’ design                                                                            These terms are commonly
                                                              achieve an equivalent or greater level of
      standard). Therefore, the regulations                   security.                                             understood and do not require further
      contain performance standards for                          Two commenters requested                           clarification in the regulations.
      biocontainment/biosafety, security, and                 clarification of the term ‘‘area’’ with               However, upon further review, we are
      incident response that take into account                regard to large multi-use laboratories.               amending these provisions to make it
      the risks presented by a particular agent               One commenter stated there is little                  clear that an individual who is not
      or toxin, given its intended use.                       benefit in terms of security to require               approved for access by the
         With regard to security, newly                       access control, specialized training, and             Administrator or the HHS Secretary may
      designated 7 CFR 331.11 and 9 CFR                       personnel background checks for                       conduct routine cleaning, maintenance,
      121.11 require each individual or entity                individuals who are only sharing lab                  repairs, and other activities not related
      required to register under each part to                 space with individuals working with                   to select agents or toxins only when
      develop and implement a written                         select agents or toxins. Another                      continuously escorted by an approved
      security plan. This security plan must                  commenter suggested that the                          individual (newly designated 7 CFR
      be designed according to a site-specific                regulations should be flexible enough to              331.11(d)(2) and 9 CFR 121.11(d)(2)).
      risk assessment and must provide                        allow local solution of this issue (i.e.,                Interim 7 CFR 331.11(a)(2)(iv)(C) and
      graded protection in accordance with                    allowing the entity to designate a                    9 CFR 121.12(a)(2)(iv)(C) required
      the risk of the select agent or toxin,                  portion of the lab as a select agent area             entities and individuals to control
      given its intended use. In addition,                    for which use and entry restrictions                  access to containers where listed agents
      newly designated 7 CFR 331.11 and 9                     would be governed by the regulations).                and toxins are stored by requiring that
      CFR 121.11 require the individual or                    A commenter recommended that, where                   such containers be locked when not in
      entity to adhere to specified security                  labs are used intermittently for select               the direct view of an approved
      requirements or implement measures to                   agent research, free access be permitted              individual and by using other
      achieve an equivalent or greater level of               when select agents and toxins are not in              monitoring measures, as needed.
      security. We believe these security                     use and when the agents/toxins are                       One commenter stated that the
      provisions provide enough flexibility                   secured in a safe or other secured                    phrase, ‘‘when not in direct view of an
      and specificity to allow an individual or               storage.                                              approved individual,’’ implies that
      entity to develop and implement a                          As previously noted, the security                  these areas do not need to be secured
      security plan that will safeguard the                   requirements are designed to prevent                  when an authorized person is present,
      select agent or toxin against                           unauthorized access, theft, loss, or                  and that this is inappropriate. The
      unauthorized access, theft, loss, or                    release of select agents and toxins. We               commenter said that an area containing
      release.                                                believe the regulations provide enough                select agents should be secure at all
         However, in recognition of the                       flexibility for an entity to determine the            times and that only authorized persons
      commenters’ concerns, we reiterate that                 best way to accomplish this goal.                     should have access to a freezer. The
      APHIS and CDC are working with                          However, since the term ‘‘area’’ appears              commenter stated that an individual
      interagency groups and security experts                 to be confusing, in this final rule we are            should not bear the burden of being
      to draft a document that will provide                   deleting the phrase ‘‘with respect to                 responsible for the security of the
      additional guidance about the security                  areas containing listed agents or toxins’’            freezer. Another commenter argued that
      required for select agents and toxins.                  (newly designated 7 CFR 331.11(d) and                 this requirement is unnecessarily
      This document will be available in                      9 CFR 121.11(d)).                                     stringent and is not feasible in many
      spring 2005. The 5th edition of the                        Interim 7 CFR 331.11(a)(2)(iv)(A) and              labs. This commenter recommended
      BMBL, which is under development,                       9 CFR 121.12(a)(2)(iv)(A) stated that an              that the agent or toxin be under the
      will provide additional guidance on                     entity must allow unescorted access                   direct control of an individual, meaning
      laboratory security.                                    only to those approved individuals who                that an unauthorized person could


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      approach the agent or toxin without                     HHS Secretary, including chain-of-                    entities should consider in developing
      coming into the view of approved staff.                 custody documents and provisions for                  and implementing a performance-based
      A commenter stated there is no need to                  safeguarding against theft, loss, or                  safety plan. On the other hand, several
      require locked containers. The                          release (newly designated 7 CFR                       commenters urged APHIS and CDC to
      commenter noted that a freezer that is                  331.11(d)(5) and 9 CFR 121.11(d)(5)).                 develop joint biosafety guidelines for
      located outside an access-controlled                    This change is consistent with the                    select agents that would supplant the
      area should be locked, while a freezer                  recordkeeping requirements in newly                   BMBL and NIH Guidelines.
      that is located inside such an area need                designated 7 CFR 331.17 and 9 CFR                       In this final rule, we are retaining the
      not be locked.                                          121.17.                                               existing performance standard but we
         We agree that containers where select                   To be consistent with CDC’s                        are providing a list of references that an
      agents and toxins are stored must be                    regulations, we are adding a new                      individual or entity should consider in
      secured against unauthorized access at                  paragraph (d)(8) in 7 CFR 331.11 and 9                developing its biocontainment/biosafety
      all times. Accordingly, we are amending                 CFR 121.11 that requires an individual                plan (newly designated 7 CFR 331.12(c)
      both sections to state that an entity must              or entity to separate areas where select              and 9 CFR 121.12(c)). This change
      control access to containers by requiring               agents and toxins are stored or used                  should provide more guidance on
      that freezers, refrigerators, cabinets, and             from the public areas of the building.                acceptable biosafety practices.
      other containers be secured against                        One commenter stated that the BMBL
                                                              and NIH Guidelines require labs to post               Restricted Experiments
      unauthorized access (newly designated
      7 CFR 331.11(d)(3) and 9 CFR                            biohazard signs on access doors that list                In interim 9 CFR 121.10(c), we
      121.11(d)(3)).                                          the agents present in the lab, which may              provided that the responsible official
         Interim 7 CFR 331.11(a)(2)(iv)(D) and                compromise lab security.                              must ensure that the following
      9 CFR 121.12(a)(2)(iv)(D) required the                     In this final rule, 9 CFR 121.12                   experiments are not conducted unless
      inspection of all packages upon entry                   (Biosafety) provides that an individual               approved by the Administrator, after
      and exit.                                               or entity should consider the BMBL and                consultation with experts: (1)
         Several commenters stated that it is                 NIH Guidelines when developing a                      Experiments utilizing recombinant DNA
      not practical to require inspection of all              biosafety plan. However, it is the                    that involve the deliberate transfer of a
      packages upon entry and exit, that doing                entity’s responsibility to determine if               pathogenic trait or drug resistance trait
      so provides almost no security value,                   posting biohazard signs on access doors               to biological agents that are not known
      and that doing so may be unsafe. One                    would compromise lab security. We are                 to acquire the trait naturally, if such
      commenter asked if the requirement                      making no change based on this                        acquisition could compromise the use of
      applied to packages of agents being                     comment.                                              the drug to control disease agents in
      shipped/received or if it applied to                                                                          humans, veterinary medicine, or
                                                              Biocontainment/Biosafety                              agriculture; and (2) experiments
      briefcases, backpacks, etc. Another
      commenter asked if sharps containers or                    Interim 7 CFR 331.11 required                      involving the deliberate formation of
      Petri dishes must be inspected.                         individuals and entities to develop and               recombinant DNA containing genes for
         We agree that it is not practical to                 implement a Biocontainment and                        the biosynthesis of toxins lethal for
      require inspection of all packages upon                 Security Plan that is commensurate with               vertebrates at an LD50<100 ng/kg body
      entry and exit. Therefore, in this final                the risk of the agent or toxin, given its             weight.
      rule, we are amending both sections to                  intended use. It also required that the                  We adopted this provision in the
      require that an entity inspect all                      containment procedures be sufficient to               December 2002 interim rule in order to
      suspicious packages before they are                     contain the agent or toxin (e.g., physical            be consistent with CDC and to address
      brought into or removed from an area                    structure and features of entity, and                 concerns about laboratory manipulation
      where select agents or toxins are used or               operational and procedural safeguards).               of microbes that alter their
      stored (newly designated 7 CFR                          Interim 9 CFR 121.12 contained similar                characteristics (e.g., increased virulence,
      331.11(d)(4) and 9 CFR 121.11(d)(4)).                   requirements for a Biosafety and                      pathogenicity, or host range; alter mode
         Interim 7 CFR 331.11(a)(2)(iv)(E) and                Security Plan.                                        of transmission or route of transmission)
      9 CFR 121.12(a)(2)(iv)(E) required an                      In this final rule, newly designated 7             and increase the risks to human, animal,
      entity to establish a protocol for intra-               CFR 331.12 requires that an individual                or plant health. At the time, we did not
      entity transfers, including provisions for              or entity develop and implement a                     believe it was necessary to require
      ensuring that the packaging and                         written biocontainment plan that is                   approval for experiments involving
      movement is conducted under the                         commensurate with the risk of the select              recombinant DNA of PPQ select agents
      supervision of an approved individual.                  agent or toxin, given its intended use.               because these experiments are regulated
         A commenter stated that the                          Newly designated 9 CFR 121.12                         under 7 CFR part 340. However, we are
      requirement for a protocol for intra-                   contains similar requirements for a                   adding this provision to 7 CFR part 331
      entity transfers is vague and inadequate.               biosafety plan. The titles and provisions             in this final rule to ensure that these
      The commenter suggested that intra-                     of the plans are different because the                experiments are covered and to provide
      entity movement of select agents should                 select agents and toxins listed in 7 CFR              consistency in the select agent
      follow a documented chain of custody                    331.3 do not pose a severe threat to                  regulations.
      process that minimizes any possibility                  human health and, therefore, it is                       To facilitate compliance with these
      of diversion.                                           unnecessary to require that the plant-                requirements, in this final rule we are
         We agree. Therefore, in this final rule,             related plan address personnel safety                 moving these provisions to a new
      we are amending both sections to                        and health.                                           section in each part titled, ‘‘Restricted
      require entities to establish a protocol                   Several commenters stated that the                 experiments’’ (7 CFR 331.13 and 9 CFR
      for intra-entity transfers, including                   biosafety section in the final rule should            121.13, respectively), and we are adding
      chain of custody documentation and                      reference existing Department of Health               a footnote to both sections that indicates
      provisions for ensuring that packaging                  and Human Services guidelines and                     that guidance on the requirements for
      and movement is conducted under the                     current Occupational Safety and Health                experiments involving recombinant
      supervision of an individual with access                Administration (OSHA) regulations as                  DNA may be obtained from the
      approval from the Administrator or the                  authoritative codes of practice that                  publication, ‘‘NIH Guidelines for


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      Research Involving Recombinant DNA                        One commenter stated that interim 9                 required to address personnel safety and
      Molecules.’’ Moreover, 7 CFR 331.13                     CFR 121.10(c)(1) (newly designated                    health, containment, inventory control,
      provides that these experiments must be                 § 121.13(a)) is open to interpretation                and notification of managers and
      conducted under conditions prescribed                   and, therefore, needs to be more                      responders. In addition, the plans were
      by the Administrator, and that the                      specific. This commenter also suggested               required to address bomb threats, severe
      Administrator may revoke approval to                    that the restricted experiment                        weather (floods, hurricanes, tornadoes),
      conduct these experiments, or suspend                   provisions should contain an exception                earthquakes, power outages, and other
      or revoke a certificate of registration, if             for small scale in vitro experiments.                 natural disasters or emergencies.
      the individual or entity fails to comply                  We disagree that this provision needs                  A commenter stated that the
      with the requirements of that part. A                   to be more specific. However, we note                 requirements for APHIS’ incident
      corresponding provision in 9 CFR                        that additional guidance on the                       response plan and CDC’s emergency
      121.13 provides for consultation with                   requirements for experiments involving                response plan should be the same.
      the HHS Secretary. This has always                      recombinant DNA may be obtained from                     We agree. Therefore, the revised
      been the way we have interpreted all of                 APHIS or the NIH Guidelines. We also                  incident response sections in this final
      these requirements; however, we are                     disagree that the restricted experiment               rule (newly designated 7 CFR 331.14
      adding these provisions to both sections                provisions should contain an exemption                and 9 CFR 121.14) are consistent with
      for clarity.                                            for small scale in vitro experiments.                 the incident response section in CDC’s
         One commenter stated that the                        APHIS included these provisions in the                final rule. In this final rule, we are
      inclusion of the words ‘‘pathogenic                     regulations to ensure that these                      adding the CDC requirement that an
      trait’’ establishes an additional class of              experiments are conducted only if safe                incident response plan must be
      experiments that require approval from                  to do so. The commenter provided no                   coordinated with any entity-wide plans.
      the Administrator. The commenter                        information to indicate that small scale              To ensure that such plans are available
      recommended that the APHIS and CDC                      in vitro experiments are safe and,                    for review by an entity’s employees, we
      requirements be identical.                              therefore, should be exempted from the                are also requiring that the plans be kept
         We agree. Accordingly, we are                        restricted experiment provisions.                     in the workplace and made available to
      deleting the words ‘‘pathogenic trait’’ in              Accordingly, we are making no changes                 employees for review. In addition, as
      both sections of this final rule (newly                 in response to this comment.                          described below in response to a request
      designated 7 CFR 331.13(a)(1) and 9                       A commenter stated that an entity                   for clarification of the term ‘‘incidents,’’
      CFR 121.13(a)).                                         utilizes the deliberate formation of                  we are clarifying the types of incidents
         One commenter stated that the                        antibiotic resistance as a common                     and information that must be included
      regulations should be amended to refer                  research tool and that the restricted                 in the plan. Finally, we are adding the
      to the NIH Guidelines rather than list                  experiments provisions will limit this                CDC requirement that the response
      the types of experiments that are                       standard research practice. The                       procedures account for the hazards
      restricted in the regulations. The                      commenter noted that transposon                       associated with the select agent or toxin
      commenter noted that the NIH                            insertion libraries are common                        and appropriate actions to contain such
      Guidelines are subject to change and the                experimental creations used to generate               agent or toxin.
      regulations would not be as current as                  gene knockouts and study the effect on                   A commenter requested clarification
      the guidelines and more difficult to                    expression and phenotype; however,                    of the term ‘‘incidents.’’ In this final
      amend, if necessary.                                    this often results in an array of genomes             rule, newly designated 7 CFR 331.14
         One of the reasons APHIS included                    containing antibiotic resistance markers              and 9 CFR 121.14 require that the
      these provisions in the regulations was                 used for selection and screening. The                 incident response plan fully describe
      to ensure that these categories of                      commenter argued that this common                     the entity’s response procedures for
      experiments are conducted only if safe                  practice should not need approval and                 theft, loss, or release of a select agent or
      to do so. By including these provisions                 that it is too burdensome on the entity               toxin, inventory discrepancies, security
      in the regulations, we are providing                    to obtain approval for each of several                breaches (including information
      notice to the public and establishing                   thousand insertional mutants that                     systems), severe weather and other
      enforceable regulatory requirements.                    would be created for a single genome.                 natural disasters, workplace violence,
      APHIS would have difficulty enforcing                     As previously noted, APHIS included                 bomb threats and suspicious packages,
      the provisions of the NIH Guidelines. If                these provisions in the regulations to                and emergencies such as fire, gas leak,
      it becomes necessary to revise the list of              ensure that these experiments are                     explosion, power outage, etc.
      restricted experiments, we will initiate                conducted only if safe to do so. We                      One commenter stated that the
      rulemaking and provide notice and                       believe the manipulation of a select                  reference to ‘‘inventory control’’ is
      opportunity for public comment. For                     agent in order to create antibiotic                   ambiguous and needs to be defined.
      these reasons, we are making no change                  resistance increases the risks to human,                 We agree that the term ‘‘inventory
      based on this comment.                                  animal, or plant health and, therefore,               control’’ is not clear. Therefore, we are
         A commenter suggested that the NIH                   warrants APHIS’ approval. We are                      deleting the reference to inventory
      recombinant advisory committee be                       making no change based on this                        control in this final rule. However, we
      designated to review the restricted                     comment.                                              are retaining the requirement that an
      experiments.                                                                                                  incident response plan describe the
         We do not believe it is necessary to                 Incident Response
                                                                                                                    entity’s response procedures for
      designate the NIH recombinant advisory                    In interim 7 CFR 331.11(a)(3) and 9                 inventory discrepancies.
      committee to review applications to                     CFR 121.12(a)(3), we required that the
      conduct restricted experiments. The                     Biocontainment and Security Plan/                     Training
      Administrator of APHIS will approve                     Biosafety and Security Plan include                     Interim 7 CFR 331.12 (newly
      such experiments after consultation                     incident response plans for containment               designated § 331.15) required the
      with subject matter experts and, for                    breach, security breach, inventory                    responsible official to provide
      overlap select agents and toxins, CDC.                  violations, non-biological incidents                  appropriate training in containment and
      Accordingly, we are making no changes                   such as workplace violence, and                       security procedures to all individuals
      based on this comment.                                  cybersecurity breach. These plans were                with access to listed agents and toxins,


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      while interim 9 CFR 121.13 (newly                          One commenter recommended that                     effectively monitor proficiency testing
      designated § 121.15) required the                       APHIS adopt the CDC provisions in                     activities.
      responsible official to provide                         interim 42 CFR 73.13(d) that allows an                   In addition, we are amending both
      appropriate training in biosafety,                      entity to certify that personnel have                 sections to provide that the recipient
      containment, and security procedures to                 been trained.                                         must immediately notify APHIS or CDC
      all individuals with access to listed                      In interim 42 CFR 73.13(d), CDC                    if a package containing a select agent or
      agents and toxins. Both sections                        provided that, in lieu of initial training            toxin has been damaged to the extent
      required the responsible official to                    for those individuals already involved                that a release of the select agent or toxin
      provide information and training to an                  in handling select agents or toxins, the              may have occurred (newly designated 7
      individual at the time the individual is                responsible official may certify that an              CFR 331.16(f) and 9 CFR 121.16(g)).
      assigned to work with a listed agent and                individual has the required knowledge,                These changes will make the APHIS and
      toxin, and to provide refresher training                skills, and abilities to safely carry out             CDC regulations consistent.
      annually.                                               the duties and responsibilities. CDC                     Both sections (newly designated 7
         A commenter requested clarification                  included this provision to minimize the               CFR 331.16(g) and 9 CFR 121.16(h)) also
      about the training requirements. This                   disruption of research or educational                 provide that an authorization for a
      commenter wondered what would be                        projects that were under way as of the                transfer shall be valid only for 30
      considered appropriate training, what                   effective date of the December 2002                   calendar days after issuance, except that
      qualifications an individual would need                 interim rule. CDC is deleting this                    such an authorization becomes
      to train others, and who decides if the                 provision in its final rule. For this                 immediately null and void if any facts
      training is adequate. Another                           reason, we are making no change based                 supporting the authorization change
      commenter recommended that APHIS                        on this comment.                                      (e.g., change in the certificate of
      revise the training provisions to require                                                                     registration for the sender or recipient,
                                                              Transfer of Biological Agents and                     change in the application for transfer).
      training for approved individuals
                                                              Toxins                                                This change is intended to ensure
      working with select agents and toxins
      and unapproved individuals working in                      Interim 7 CFR 331.13 and 9 CFR                     timely transfers of select agents and
      or visiting areas where select agents and               121.14 (newly designated 7 CFR 331.16                 toxins and provide notice to the public
      toxins are handled or stored. The                       and 9 CFR 121.16) set out the transfer                that APHIS may terminate a transfer
      commenter suggested that such training                  requirements and procedures. In this                  authorization under certain
      may be modified according to the needs                  final rule, we are amending newly                     circumstances.
      of the individual, the work they will do,               designated 7 CFR 331.16 and 9 CFR                        One commenter stated that the
      and their potential exposure. A                         121.16 to clarify the transfer provisions.            regulations should provide for transfer
      commenter noted that APHIS’ training                    Specifically, we are amending both                    of agents and toxins from an
      requirements cover fewer staff than                     sections by providing that, in addition               unregistered entity to a registered entity
      CDC’s training requirements (i.e., only                 to any permit required under the                      to prevent destruction of valuable
      those individuals handling the agents or                regulations, a transfer of a select agent             historical, archival, and educational
      toxins). The commenter recommended                      or toxin may be authorized if: (1) The                materials.
      that the APHIS and CDC requirements                     sender has a certificate of registration                 We agree. Accordingly, in this final
      be consistent.                                          that covers the agent or toxin to be                  rule, we are amending the transfer
         In response to these comments, in this               transferred and meets the requirements                provisions in interim 7 CFR 331.13 and
      final rule we are amending both sections                of each part, meets the exemption                     9 CFR 121.14 to provide that, on a case-
      to require that an individual or entity                 requirements for the select agent or                  by-case basis, the Administrator may
      provide information and training on                     toxin to be transferred, or is transferring           authorize a transfer of a select agent or
      biocontainment/biosafety and security                   the select agent or toxin from outside of             toxin, not otherwise eligible for transfer
      to each individual with access approval                 the United States and meets all import                under each part, under conditions
      from the Administrator or the HHS                       requirements, and (2) at the time of                  prescribed by the Administrator (newly
      Secretary before he/she has such access                 transfer, the recipient has a certificate of          designated 7 CFR 331.16(c) and 9 CFR
      (newly designated 7 CFR 331.15(a) and                   registration that includes the select                 121.16(c)).
      9 CFR 121.15(a)). We are also requiring                 agent or toxin to be transferred and                     One commenter maintained that
      that an individual or entity provide                    meets all of the requirements of each                 APHIS should permit hand-carried
      training to each individual not approved                part (newly designated 7 CFR 331.16(b)                transfers of select agents or toxins with
      for access by the Administrator or the                  and 9 CFR 121.16(b)). This information                the same reporting requirements already
      HHS Secretary before he/she works in or                 was contained in the interim rule but                 described in the regulations.
      visits areas where select agents or toxins              the final rule more clearly sets out the                 Given the risks posed by select agents
      are handled or stored (e.g., laboratories,              requirements for the sender and                       and toxins, we do not believe that hand-
      growth chambers, animal rooms,                          recipient. We are also amending the                   carried transfers of such agents or toxins
      greenhouses, storage areas, etc.). The                  transfer provisions in 9 CFR 121.16 to                is consistent with the intent of the Act.
      training must address the particular                    provide that a select agent or toxin                  By prohibiting hand-carried transfers,
      needs of the individual, the work they                  contained in a specimen for proficiency               we ensure that select agents or toxins
      will do, and the risks posed by the                     testing may be transferred without prior              are packaged appropriately and that
      select agents or toxins. Finally, refresher             authorization from APHIS or CDC                       there is documentary evidence of the
      training must be provided annually                      provided that, at least 7 calendar days               transfer (e.g., tracking numbers,
      (newly designated 7 CFR 331.15(b) and                   prior to the transfer, the sender reports             confirmation of delivery, etc). We are
      9 CFR 121.15(b)). These changes will                    to APHIS or CDC the select agent or                   making no changes based on this
      make the APHIS and CDC regulations                      toxin to be transferred and the name and              comment.
      consistent. We note the training should                 address of the recipient. This change, in                One commenter stated that the
      be provided by an individual who has                    conjunction with the reporting                        requirement that APHIS or CDC approve
      the appropriate training and skills.                    requirements for identifications of select            transfers between entities is highly
      APHIS will determine if an individual’s                 agents or toxins in 9 CFR 121.5, 121.6,               likely to produce unreasonable delays.
      training is adequate.                                   and 121.9, will allow us to more                      The commenter suggested that the


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                           Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations                                         13267

      regulations be revised to require that                  collections or to all infectious materials            accurate, have controlled access, and
      APHIS respond within an appropriate                     generated. Another commenter stated                   can be verified for authenticity. We do
      interval (e.g., 1 to 2 days).                           that keeping track of vials is a waste of             not believe it is necessary to require that
         We do not expect the transfer                        Federal resources.                                    an entity mark and protect all of its
      requirements in the regulations to                         We agree that the requirements for                 records at the ‘‘Official Use Only’’ level
      produce unreasonable delays. The                        inventory records are unclear. To                     to satisfy this requirement. Therefore,
      requirement for approval prior to a                     provide clarification and to be                       we are not implementing this
      transfer of a select agent or toxin is not              consistent with CDC’s approach, in this               suggestion.
      a new requirement, nor is it                            final rule the inventory recordkeeping                   One commenter suggested that all
      unreasonable given the risks posed by                   requirements in both parts (newly                     transfer forms be securely stored for 5
      select agents or toxins. The transfer                   designated 7 CFR 331.17 and 9 CFR                     years, instead of 3 years. Taking into
      requirements for select agents and                      121.17) require the maintenance of an                 consideration the burden on the public
      toxins incorporate the permit                           accurate, current inventory for each                  and APHIS’ investigational needs, we
      requirements under the plant pest                       select agent held in long-term storage                believe that it is reasonable to require
      regulations in 7 CFR part 330 and the                   (placement in a system designed to                    that all records, including transfer
      organisms and vectors regulations in 9                  ensure viability for future use, such as              forms, be maintained for 3 years.
      CFR part 122, which require APHIS’                      in a freezer or lyophilized materials)                Accordingly, we are making no change
      approval prior to transfer. We are                      and for each toxin held. The provisions               based on this comment.
      making no changes based on this                         for select agents and toxins are different
                                                                                                                    Inspections
      comment.                                                to account for the differences between
         A commenter asserted that the                        select agents and toxins; we do not                     Interim 7 CFR 331.15(a) provided that
      transfer provisions are incompatible                    believe it is feasible to record quantities           any APHIS inspector must be allowed,
      with biosecurity. The commenter stated                  of replicating organisms (i.e., select                without previous notification, to enter
      that they require the principal                         agents). In addition, we are providing                and inspect the entire premises, all
      investigator to prohibit access to the                  more information about the types of                   materials and equipment, and all
      material up to the point of shipment,                   information that must be included in                  records required to be maintained by the
      after which the package is handled by                   the inventory records for each select                 regulations, while interim 9 CFR
      a host of individuals out of the control                agent or toxin. For example, an                       121.16(a) contained a similar provision
      of the responsible official or the                      inventory for a select agent must                     for APHIS or CDC inspectors.
      principal investigator. Several                         include the name and characteristics of                 To be consistent with CDC’s
      commenters expressed concern about                      the agent, the quantity acquired from                 regulations, newly designated 7 CFR
      the U.S. Department of Transportation’s                 another entity, where stored, when                    331.18(a) and 9 CFR 121.18(a) provide
      labeling requirements for packages                      moved from storage and by whom,                       that APHIS, without prior notification,
      containing select agents or toxins. These               purpose of use, transfer records, etc.,               must be allowed to inspect any site at
      commenters pointed out that the                         while an inventory for a toxin must                   which activities regulated under each
      labeling requirements clearly indicate                  include the name and characteristics of               part are conducted and must be allowed
      which packages should be stolen. One                    the toxin, the quantity acquired from                 to inspect and copy any records relating
      commenter recommended eliminating                       another entity, the initial and current               to the activities covered under each
      the requirement for external labeling.                  quantity, where stored, when moved                    part.
      This commenter also recommended                         from storage and by whom, transfer                      Interim 7 CFR 331.15(b) provided
      adding tamper-indicating procedures in                  records, etc.                                         that, prior to issuing a certificate of
      the packaging so that the recipient                        Interim 7 CFR 331.14(a)(4) and 9 CFR               registration, APHIS may inspect and
      would know the package had been                         121.15(a)(4) required an individual or                evaluate the premises and records to
      tampered with.                                          entity to maintain accurate and current               ensure compliance with the regulations
         These issues are outside the scope of                inventory records (including source and               and the biosafety, containment and
      this rulemaking. Accordingly, we are                    characterization data).                               security requirements. Interim 9 CFR
      making no changes based on these                           One commenter recommended that                     121.16(b) contained a similar provision
      comments.                                               APHIS define the terms                                for APHIS or CDC inspectors.
                                                              ‘‘characterization data’’ and ‘‘accurate.’’             In this final rule, we are removing the
      Records                                                 To clarify the term ‘‘characterization                phrase ‘‘and the containment and
        Interim 7 CFR 331.14 and 9 CFR                        data,’’ in this final rule we are providing           security requirements’’ (newly
      121.15 required the responsible official                examples of the characterization                      designated 7 CFR 331.18(b)) and
      to maintain complete, up-to-date                        information that should be maintained                 removing the phrase ‘‘and the biosafety,
      records of information necessary to give                by the entity for each select agent (e.g.,            containment, and security
      an accounting of all of the activities                  strain designation, GenBank Accession                 requirements’’ (newly designated 9 CFR
      related to listed agents and toxins. Such               number, etc.). The term ‘‘accurate’’ is               121.18(b)). These phrases are
      records must be maintained for 3 years                  commonly defined as free from mistakes                unnecessary since we already state in
      and produced upon request to APHIS                      or errors. We do not believe it is                    both sections that, prior to issuing a
      inspectors and appropriate Federal,                     necessary to define this term in the                  certificate of registration, APHIS may
      State, and local law enforcement                        regulations.                                          inspect and evaluate an entity’s
      authorities.                                               A commenter suggested that all                     premises and records to ensure
        A commenter stated that the                           records should be marked and protected                compliance with the regulations.
      requirements for inventory records of                   at the ‘‘Official Use Only’’ level.                     A commenter requested additional
      select agents are unclear. The                             To be consistent with CDC’s                        information about compliance
      commenter pointed out that research                     regulations, in this final rule newly                 inspections. In particular, the
      labs generate and destroy material on a                 designated 7 CFR 331.17 and 9 CFR                     commenter asked what level of training
      daily, if not hourly, basis. The                        121.17 require an entity to implement a               and security clearances would be
      commenter wondered if the inventory                     system to ensure that all records and                 required for inspectors and whether
      requirement pertained to stock                          databases created under each part are                 there would be separate inspectors to


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      13268                Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations

      assess the biosafety and security                       a written report within 7 days. The                   exposed worker may be so concerned
      requirements. The commenter also                        regulations further provided that APHIS               about needing to report an accident to
      asked what standards will be used by                    will notify relevant Federal, State, and              APHIS that he or she may decide not to
      the inspectors to assess compliance with                local authorities, and the public, if                 inform anyone of a potential exposure,
      the regulations.                                        necessary. In § 121.17(b), we                         resulting in an immediate risk to the
        APHIS inspectors will have the                        additionally provided that, if the release            person and a possible risk to the
      appropriate training and security                       involves an overlap agent or toxin, we                population.
      clearances (at least a security risk                    will also notify the Secretary of Health                Given the risks associated with select
      assessment) to inspect and evaluate an                  and Human Services.                                   agents and toxins, we believe it is
      entity’s premises and records to ensure                   In this final rule, newly designated 7              necessary to be notified of all
      compliance with the regulations. APHIS                  CFR 331.19(b) requires that APHIS or                  occupational exposures. It is the entity’s
      inspectors will use the standards                       CDC be notified immediately upon                      responsibility to ensure that its
      established in the regulations and                      discovery of a release of a PPQ select                employees comply with these reporting
      published guidelines (e.g., BMBL) to                    agent or toxin outside the primary                    requirements. For these reasons, we are
      determine compliance. While we expect                   barriers of the biocontainment area                   making no changes based on these
      that, normally, only one inspector will                 while 9 CFR 121.19(b) requires that                   comments.
      be needed to conduct an inspection,                     APHIS or CDC be notified immediately
                                                                                                                    Administrative Review
      occasionally more than one inspector                    upon discovery of a release of a VS or
      may be needed to evaluate an entity’s                   overlap select agent or toxin causing                   Interim 7 CFR 331.17 and 9 CFR
      biosafety, containment, and security.                   occupational exposure or a release                    121.18 provided that an individual or
        APHIS and CDC will coordinate                         outside the primary barriers of the                   entity may appeal a denial or revocation
      inspections to minimize the burden on                   biocontainment area. The requirement                  of registration. In addition, these
      the entity. This coordination will ensure               for notification of a release outside of              sections provided that an individual
      that inspections by APHIS and CDC are                   the primary barriers of the                           who has been denied access to listed
      not duplicative. However, additional                    biocontainment area is a clarification.               agents or toxins or who has been
      inspections may be required under                       This is how we have always interpreted                granted only limited access to listed
      certain circumstances. For instance,                    the provision regarding release outside               agents or toxins may appeal that
      another inspection may be required for                  the biocontainment area; however, we                  decision. Both sections set out the
      amendments to a certificate of                          are making this change to make it clear               process for an administrative review.
      registration (e.g., addition of a                       to the public. In 9 CFR 121.19(b), we are               In this final rule, the administrative
      laboratory) or to satisfy APHIS’ permit                 adding the provision for occupational                 review sections also provide that an
      requirements.                                           exposure to be consistent with CDC’s                  individual or entity may appeal the
                                                              regulations. We did not include this                  suspension of registration. This
      Notification in the Event of Theft, Loss,                                                                     provision was included in the sections
      or Release                                              provision in 7 CFR 331.19 because PPQ
                                                              select agents and toxins do not pose a                on denial, revocation, and suspension of
         Interim 7 CFR 331.16(a) and 9 CFR                    severe threat to human health and,                    registration (interim 7 CFR 331.7 and 9
      121.17(a) required the responsible                      therefore, it is unnecessary to address               CFR 121.8) but was inadvertently not
      official to orally notify APHIS and                     personnel safety and health. In both                  included in interim 7 CFR 331.17 and
      appropriate Federal, State, or local law                sections, we are also specifying the                  9 CFR 121.18 (newly designated 7 CFR
      enforcement agencies immediately upon                   information that must be reported to                  331.20 and 9 CFR 121.20). In addition,
      discovery of a theft or loss of listed                  APHIS or CDC. We believe these                        we are amending both sections to allow
      agents or toxins. We also required that                 changes will clarify the requirements for             an individual to appeal revocation of
      the oral notification be followed by a                  notification of a release.                            access approval. This change
      written report within 7 days. In this                     Finally, we are deleting the provision              corresponds to a change in newly
      final rule, newly designated 7 CFR                      that APHIS will notify relevant Federal,              designated 7 CFR 331.10 and 9 CFR
      331.19(a) and 9 CFR 121.19(a) provide                   State, and local authorities, and the                 121.10 that allows revocation of an
      that thefts or losses must be reported to               public in the event a release poses a                 individual’s access approval in the
      APHIS or CDC. In addition, these                        threat to animal health or animal                     event that an individual becomes a
      paragraphs clarify that thefts or losses                products. This is an administrative                   restricted person under 18 U.S.C. 175b
      must be reported even if the select agent               action taken by APHIS and it is                       or is reasonably suspected by any
      or toxin is subsequently recovered or                   unnecessary to include this information               Federal law enforcement or intelligence
      the responsible parties are identified.                 in the regulations.                                   agency of committing a crime set forth
      These changes will make the APHIS and                     A commenter requested clarification                 in 18 U.S.C. 2332b(g)(5), knowing
      CDC regulations consistent. Finally, we                 of the term ‘‘unintentional release.’’ The            involvement with an organization that
      are specifying the information that must                commenter stated that it can be                       engages in domestic or international
      be reported to APHIS or CDC (newly                      interpreted to include any exposure or                terrorism (as defined in 18 U.S.C. 2331)
      designated 7 CFR 331.19(a) and 9 CFR                    release at any biosafety level.                       or with any other organization that
      121.19(a)). We believe this change will                   The term ‘‘unintentional release’’ is               engages in intentional crimes of
      clarify the requirements for notification               not used in either the interim                        violence, or being an agent of a foreign
      of theft or loss of select agents and                   regulations or this final rule. Therefore,            power as defined in 50 U.S.C. 1801.
      toxins.                                                 we are making no change based on this                   A commenter stated that the final rule
         Interim 7 CFR 331.16(b) and 9 CFR                    comment.                                              should include provisions for entities
      121.17(b) provided that the responsible                   Several commenters urged APHIS to                   and individuals to appeal security risk
      official must orally notify APHIS                       exempt from notification those                        assessment decisions or seek
      immediately upon discovery that a                       accidents (i.e., releases) that take place            exemptions for legitimate research.
      release of a listed agent or toxin has                  entirely within biosafety labs where the                The regulations already allow an
      occurred outside the biocontainment                     select agent is being handled at the                  individual who has been denied access
      area. We also required that the oral                    appropriate biosafety level. One                      to select agents or toxins or who has
      notification of a release be followed by                commenter went on to state that an                    been granted only limited access to such


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                           Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations                                             13269

      agents or toxins to appeal that decision                aspect of the final rule relieves                          public health and safety, to animal
      (interim 7 CFR 331.17 and 9 CFR                         restrictions and thus may be made                          health, to plant health, or to animal and
      121.18; newly designated 7 CFR 331.20                   effective less than 30 days after                          plant products. The Act also requires
      and 9 CFR 121.20). However, in                          publication in the Federal Register.                       that the Secretary of Agriculture
      accordance with the Act, an entity may                  Accordingly, the Administrator of the                      establish and enforce standards and
      not appeal the denial or limitation of an               Animal and Plant Health Inspection                         procedures governing the possession
      individual’s access to select agents or                 Service has determined that the                            and use of the listed biological agents
      toxins. The regulations do not provide                  amendments made to 7 CFR 331.3(b) in                       and toxins, including the establishment
      exemptions for research. However, we                    this rule should be effective upon                         and enforcement of safety requirements
      note that an individual’s access to PPQ                 signature. The remaining provisions of                     for the transfer of listed agents and
      select agents or toxins and VS select                   this final rule will become effective 30                   toxins; the establishment and
      agents or toxins may be limited or                      days after date of the rule’s publication                  enforcement of safeguard and security
      denied if an individual is a restricted                 in the Federal Register.                                   measures to prevent access to listed
      person under 18 U.S.C. 175b. In                                                                                    agents and toxins for use in domestic or
                                                              Executive Order 12866 and Regulatory
      addition, an individual’s access to PPQ                                                                            international terrorism or other criminal
                                                              Flexibility Act
      select agents or toxins, VS select agents                                                                          purpose; and the establishment of
      or toxins, or overlap select agents or                    This rule has been reviewed under                        procedures to protect animal and plant
      toxins may be limited or denied if an                   Executive Order 12866. The rule has                        health, and animal and plant products,
      individual is reasonably suspected by                   been determined to be significant for the                  in the event of a transfer in violation of
      any Federal law enforcement or                          purposes of Executive Order 12866 and,                     the established safety and security
      intelligence agency of committing a                     therefore, has been reviewed by the                        measures. APHIS has the primary
      crime set forth in 18 U.S.C. 2332b(g)(5),               Office of Management and Budget.                           responsibility for implementing the
      knowing involvement with an                               For this rule, we have prepared an                       provisions of the Act within USDA. VS
      organization that engages in domestic or                economic analysis. The economic                            select agents and toxins are those that
      international terrorism (as defined in 18               analysis provides a cost-benefit analysis,                 have been determined to have the
      U.S.C. 2331) or with any other                          as required by Executive Order 12866,                      potential to pose a severe threat to
      organization that engages in intentional                as well as an analysis on the potential                    animal health or animal products. PPQ
      crimes of violence, or being an agent of                economic effects of this final rule on                     select agents and toxins are those that
      a foreign power as defined in 50 U.S.C.                 small entities, as required under 5                        have been determined to have the
      1801. For these reasons, we are making                  U.S.C. 603. The economic analysis is                       potential to pose a severe threat to plant
      no changes based on this comment.                       summarized below. Copies of the full                       health or plant products. Overlap select
                                                              analysis are available by contacting the                   agents and toxins are those that have
      Miscellaneous                                           person listed under FOR FURTHER                            been determined to pose a severe threat
        We are also making minor,                             INFORMATION CONTACT.                                       to public health and safety, to animal
      nonsubstantive changes to the                                                                                      health, or to animal products. Overlap
      regulations to correct misspellings and                 Background
                                                                                                                         select agents and toxins are subject to
      internal references, reflect changes to                   Certain pathogens or toxins produced                     regulation by both APHIS and CDC,
      the form numbers, ensure a consistent                   by biological organisms that are released                  which has the primary responsibility for
      format in both parts, and eliminate                     intentionally or accidentally can result                   implementing the provisions of the Act
      redundancy.                                             in disease, wide-ranging and devastating                   for the Department of Health and
        Therefore, for the reasons given in the               impacts on the economy, disruption to                      Human Services.
      interim rule and in this document, we                   society, diminished confidence in
      are adopting the interim rule as a final                public and private institutions, and                       Benefits of the Rule
      rule, with the changes discussed in this                large-scale loss of life.                                     This rule will require registration,
      document.                                                 The Public Health Security and                           biocontainment/biosafety, incident
        This final rule also affirms the                      Bioterrorism Preparedness and                              response and security measures for the
      information contained in the interim                    Response Act of 2002 (Pub. L. 107–188),                    possession, use, and transfer of the
      rule concerning Executive Orders 12372                  provides for the regulation of certain                     select agents and toxins listed in 7 CFR
      and 12988.                                              biological agents 1 and toxins 2 that have                 part 331 and 9 CFR part 121. This rule
                                                              the potential to pose a severe threat to                   is intended to prevent the misuse of
      Effective Date
                                                                                                                         those select agents and toxins, and will
         For the reasons discussed in the                       1 Any microorganism (including, but not limited          therefore reduce the potential for those
      Supplementary Information section of                    to, bacteria, viruses, fungi, rickettsiae, or protozoa),   pathogens to harm humans, animals,
      this rule, we have determined that it is                or infectious substance, or any naturally occurring,
                                                              bioengineered, or synthesized component of any
                                                                                                                         animal products, plants or plant
      no longer necessary to include                          such microorganism or infectious substance,                products in the United States. Should
      Phakopsora pachyrhizi (Asian soybean                    capable of causing: (1) Death, disease or other            any select agent or toxin be
      rust) and plum pox potyvirus on the list                biological malfunction in a human, an animal, a            intentionally introduced into the United
      of PPQ select agents and toxins.                        plant, or another living organism; (2) deterioration
                                                              of food, water, equipment, supplies, or material of
                                                                                                                         States, the consequences would be
      Therefore, this final rule amends 7 CFR                 any kind; or (3) deleterious alteration of the             significant. Some of these select agents
      331.3(b) by removing P. pachyrhizi and                  environment.                                               have the potential to cause ailment and
      plum pox potyvirus from that list.                        2 The toxic material or product of plants, animals,      death in humans. Direct losses in
      Making these amendments to 7 CFR                        microorganisms (including, but not limited to,             agriculture could occur as a result of the
                                                              bacteria, viruses, fungi, rickettsiae, or protozoa), or
      331.3(b) effective immediately will                     infectious substances, or a recombinant or
                                                                                                                         exposure, such as death or debility of
      relieve restrictions we no longer find                  synthesized molecule, whatever their origin and            affected production animals, or yield
      warranted and aid ongoing research into                 method of production, and includes: (1) Any                loss in plants. Industry could also be
      effective means of managing Asian                       poisonous substance or biological product that may         affected through the imposition of
                                                              be engineered as a result of biotechnology produced
      soybean rust in the United States.                      by a living organism; or (2) any poisonous isomer
                                                                                                                         domestic and foreign quarantines,
      Pursuant to the provisions of 5 U.S.C.                  or biological product, homolog, or derivative of           which result in a loss of markets. The
      553, we have determined that this                       such a substance.                                          Federal and State Governments would


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      13270                Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations

      also incur costs associated with                         diminished confidence in public and                   private commercial enterprises, 28
      eradication and quarantine enforcement                   private institutions, and possible loss of            percent are government, and 1 percent
      to prevent further spread, and in the                    life. The perpetrators would have the                 are non-profit.
      case of intentional introduction—law                     advantage of controlling the time of                    The level of security at the entities
      enforcement. In addition, there is the                   introduction of the agent, introducing                that possess, use or transfer select agents
      potential for a disruption in the                        agents into remote or highly susceptible              and toxins is currently very diverse,
      domestic food supply, whether through                    areas, multiple introductions of the                  ranging from a locked freezer to a lock
      contamination, consumer perception, or                   same agent, or simultaneous release of                on the door to razor wire perimeter
      both. Past food safety incidents have                    different agents. Intentional                         fencing, a guard post, locks or coded
      shown that consumer perceptions (both                    introductions permit an increased                     entry, and visitor escorts.
      domestic and international) about an                     probability of survival of a pathogen, the            Exemptions and Exclusions From the
      implicated food product and about the                    use of highly virulent strains and high               Rule
      producing country or sector’s ability to                 concentrations of inoculum, and precise
      produce safe food are slow to recover                    timing of release to coincide with                       A number of exclusions and
      and can have a lasting influence on food                 maximal colonization potential.6                      exemptions from the rule exist that
      demand and global trade.3 As such, the                                                                         reduce the number of entities that
      benefits associated with the rule are the                Costs of the Rule                                     otherwise might have been affected by
      avoided losses to the animals or plants                     The rule is intended to ensure that                this rule. For example, nonviable select
      that could be attacked by these                          any entity that possesses, uses or                    agents and nonfunctional toxins are
      organisms, and their products and                        transfers a select agent or toxin is                  excluded from the requirements of this
      markets.                                                 registered and has safeguard,                         rule. Some attenuated strains of a select
         The costs associated with outbreaks                   containment, and disposal requirements                agent or toxin may be excluded based
      can be very high as is demonstrated by                   that are commensurate with the risk of                on a determination that the strain does
      natural outbreaks associated with select                 that agent or toxin. Affected entities                not pose a severe threat to animal health
      agents that have occurred. For example,                  vary widely, and therefore, the                       or to animal products. In addition,
      it has been estimated that the losses to                 biosafety/biocontainment, incident                    overlap toxins are excluded if they are
      agriculture and the food chain from the                  response and physical security situation              under the control of a principal
      recent foot-and-mouth disease (FMD)                      will vary widely from one entity to                   investigator, treating physician or
      outbreak in the United Kingdom (UK),                     another, as will the specific changes that            veterinarian, or commercial
      including the costs compensated by the                   will need to occur at a given entity to               manufacturer or distributor and the
      government, amount to about £3.1                         comply with this rule.                                aggregate amount does not, at any time,
      billion ($4.7 billion). In 1999, it was                                                                        exceed certain amounts.
      estimated that the potential impacts of                  Affected Entities                                        In addition, a number of exemptions
      an FMD outbreak in California alone                        Entities that possess, use, or transfer             also exist. In particular, exemptions
      would be between $8.5 and $13.5                          VS, PPQ or overlap select agents or                   cover diagnostic laboratories and others
      billion.4 Also, a bovine spongiform                      toxins will be affected by this rule.                 when select agents and toxins contained
      encephalopathy (BSE) crisis occurred in                  Because of the nature of some of these                in a specimen are presented for
      the UK (which has a cattle industry                      entities and some of the select agents or             diagnosis or verification and proficiency
      about one-tenth the size of that in the                  toxins they possess, APHIS and CDC                    testing. Diagnostic reagents and
      United States) in 1996. It has been                      share common regulatory authority.                    vaccines that are, bear, or contain VS
      estimated 5 that the total resource costs                However, APHIS and CDC have                           select agents or toxins that are produced
      to the UK economy as a result of BSE                     established procedures that will allow                at USDA diagnostic facilities are also
      in the first 12 months after the onset of                an entity to interact with only one                   exempt from the requirements. For the
      the 1996 crisis were in the range of £740                agency—either APHIS or CDC—with                       most part, products that are, bear, or
      million to £980 million ($1.2 billion to                 respect to all matters involving select               contain VS or overlap select agents or
      $1.5 billion), or just over 0.1 percent of               agents and toxins. This analysis                      toxins are exempt from the requirements
      the gross domestic product of the                        considers only those entities for which               if the products have been cleared,
      United Kingdom. In addition to these                     APHIS is considered the primary                       approved, licensed, or registered under
      losses, the UK lost its entire export                    regulatory agency.7                                   a number of Federal statutes.
      market for beef following the crisis.                      The affected entities are primarily                 Experimental products and
         The above cited consequences relate                   research and diagnostic facilities. They              investigational products can also be
      to natural or accidental introduction.                   include Federal, State, and university                exempted.
      Deliberate introduction greatly increases                laboratories, and private commercial                     In addition, the Administrator may
      the probability of an agent or toxin                     and non-profit enterprises. Currently,                grant exemptions from the applicability
      becoming established and causing wide-                   there are 76 8 academic, commercial,                  of the regulations as they apply to VS or
      ranging and devastating impacts on the                   State and Federal government facilities               PPQ select agents and toxins if the
      economy, disruption to society,                          that have applied for a certificate of                Administrator determines that such
                                                               registration from APHIS for PPQ, VS,                  exemptions are consistent with
         3 Buzby, J.C. Effects of food-safety perceptions on
                                                               and/or overlap agents and toxins.                     protecting animal or plant health, or
      food demand and global trade. Changing Structure         Approximately 34 percent of these                     animal or plant products. While an
      of Global Food Consumption and Trade/WRS–01–                                                                   entity will not be exempt if it keeps a
      1. Economic Research Service/USDA.                       entities are academic, 37 percent are
         4 Ekboir, J.M. Potential impact of foot-and-mouth
                                                                                                                     positive control of a select agent or
      disease in California: the role and contribution of          6 NationalResearch Council.                       toxin, alternatives will exist. If an entity
      animal health surveillance and monitoring services.          7 Thoseentities for which the CDC is considered   decides to keep a positive control of a
      Davis, CA: Agricultural Issues Center, Division of       the primary regulatory agency are considered in       select agent or toxin, it will have to
      Agriculture and Natural Resources, University of         conjunction with the CDC rule.
      California, Davis, 1999.                                   8 Thus far, APHIS has received 148 applications
                                                                                                                     register and may need to make changes
         5 DTZ Pieda Consulting. Economic Impact of BSE        for registration or exemption. Of those, 72 were      to its operations in order to do so.
      on the UK economy. A Report commissioned by the          exempt, have been shifted to CDC, been withdrawn,        Those not specifically exempted have
      UK Agricultural Departments and HM Treasury.             or denied.                                            to submit an exemption application if


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                           Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations                                                    13271

      they wish to become exempt. Thus far,                   Investigation, and collecting and                      will be required.11 It is estimated that
      APHIS has received 34 exemption                         providing the required information. The                re-applying for registration will require
      applications, and anticipates receiving                 checks will require that individuals                   3 hours with one PI (2.67 managerial
      an additional one per year. It is                       provide identifying information. In                    hours and between 0.33 and 2.97
      estimated that applying for an                          addition, this information will need to                technical hours) or $253 to $436 per
      exemption requires 1.17 hours (0.17                     include fingerprints. It is estimated that             entity to collect and provide the
      managerial hours at $86.09 per hour 9,                  this cost will be $5 to $30 per set for                required information. The total cost of
      and 1 technical hour at $69.34 per                      those done on paper. It may cost up to                 re-application is estimated at $21,000
      hour), or $84 per exemption application.                $50 per set for electronic prints, but                 every 3 years based on the 76 entities
      Based on the number of exemption                        these could be processed far more                      currently applying for registration, and
      applications received, the total initial                quickly. A given entity could expect to                the number of PIs at the entities.
      cost is estimated to have been $2,900,                  spend between $50 and $5000 obtaining                    As a condition of registration, an
      while the yearly cost for new applicants                and submitting fingerprints, with                      individual or entity must develop and
      would be about $100. Exemptions are                     between 10 and 100 employees needing                   implement a written security plan that
      valid for a maximum of 3 years;                         fingerprints per entity. To the extent                 provides graded protection in
      therefore the costs of applying for an                  that there is staff turnover at an entity,             accordance with the risk of the select
      exemption would recur every 3 years.                    these costs could be recurring. With a                 agent or toxin, given its intended use.
         Remaining exempt under this rule                     total of 2,300 security risk assessments               The plan must describe inventory
      will require the submission of the                      to be performed initially, and an average              control procedures, physical security
      proper paperwork dealing with                           fingerprinting cost of $27.50 per                      and information systems control. The
      identifications and the transfer or                     individual, the total cost of obtaining                individual or entity must also develop
      destruction of select agents and toxins.                fingerprints would be $63,250. With                    and implement a written biosafety/
      Registered diagnostic laboratories will                 1,300 new assessments to be performed                  biocontainment plan that is
      also be required to report identifications              yearly, the annual cost of obtaining                   commensurate with the risk of the agent
      of select agents and toxins when                        fingerprints could be expected to be                   or toxin, given its intended use. It is
      presented for diagnosis. The number of                  $37,750. APHIS may request the                         estimated that the development of the
      these identifications can vary widely in                Attorney General to expedite an                        biosafety/biocontainment plan may take
      a given year, climbing dramatically                     individual’s security risk assessment                  20 managerial hours and 40 technical
      when outbreaks occur. However, during                   upon request by the responsible official               hours at a given entity for a cost of
      agricultural emergencies or outbreaks,                  and a showing of good cause. APHIS                     $4,500. However, many entities will
      or in endemic areas, the Administrator                  expects to receive 20 of these requests                already have this type of plan in place
      may require less frequent reporting.                    initially and 13 a year thereafter. These              and in writing. For example, under the
      APHIS expects to receive an average of                  requests are expected to take 0.5                      plant pest permit system, standard
      1,000 notifications of identifications                  managerial hours, or $43 per                           operating procedures at an entity are
      from diagnostic laboratories in a given                 occurrence. This gives a total cost of                 already required to be submitted. Also,
      year. It is estimated that complying with               $1,000 in the first year, and $560 a year              university safety officers generally
      the notification requirements will                      thereafter.                                            require that safety requirements be in
      require 1 hour (0.17 managerial hours                      It is estimated that it will take a total           writing. If we conservatively assume
      and 0.83 technical hours), or $72 per                   of 3 managerial hours and 0.75 technical               that one-half of the 76 affected entities
      notification. Based on 1,000                            hours for a complete form with one                     need to develop these plans the total
      notifications, the estimated total cost is              principal investigator (PI) plus 0.75                  cost would be $171,000. The
      $72,000 per year.                                       technical hours per additional PI.                     development of the physical security
                                                              Affected entities have between 1 and 9                 plan would most likely take place as a
      Registration
                                                              PIs.10 It is, therefore, estimated to take             part of the site-specific entity security
         Under this rule, unless exempted an                  3 managerial hours and between 0.75                    assessment required under the rule (see
      individual or entity shall not possess,                 and 6.75 technical hours to complete                   Security).
      use, or transfer any select agent or toxin              the registration package, at a cost of                   As a further condition of registration,
      without a certificate of registration                   between $310 and $726 per entity.                      an individual or entity must develop
      issued by APHIS or CDC. The                             Based on the number of PIs at the 76                   and implement a written incident
      registration process is designed to                     entities currently applying for                        response plan. The incident response
      obtain critical information concerning                  registration, the total cost of registration           plan must fully describe the entity’s
      individuals or entities in possession of                is estimated to be $29,000. APHIS                      response procedures for releases, theft
      certain agents or toxins, as well as the                expects to receive 8 new applications                  or loss of a select agent or toxin,
      specific characteristics of the agents and              for registration in a given year, with a               inventory discrepancies, security
      toxins. Information to determine that                   total cost of $3,300 per year. It is                   breaches (including information
      individuals and entities seeking to                     estimated that 75 percent of entities will             systems), severe weather and other
      register have a lawful purpose to                       amend their registrations twice in a                   natural disasters, workplace violence,
      possess, use, or transfer agents or toxins              given year. These amendments are                       bomb threats and suspicious packages,
      will also be required as part of the                    estimated to take 1 managerial hour, or                and emergencies such as fire, gas leak,
      registration process. This will involve                 $86 per amendment. Based on 76                         explosion, power outage, etc. The
      security risk assessments by the                        registrations this gives a cost of $9,800.             response procedures must account for
      Criminal Justice Information Services                   In addition, because registrations will be             hazards associated with the select agent
      (CJIS) Division of the Federal Bureau of                valid for up to 3 years, re-application
                                                                                                                        11 To minimize the administrative burden
        9 For purposes of this analysis we use estimates           10 Based                                          associated with this new registration program,
                                                                          on information from the registration
      of an average hourly respondent labor rate              applications, 40 percent of the registered entities    initially APHIS will assign expiration dates ranging
      (including fringe and overhead) of $86.09 for           have 1 PI, 30 percent have 2 PIs, 11 percent have      from 24 to 36 months to stagger the dates for
      managerial staff, and $69.34 for technical staff.       3 PIs, 6 percent have 4 PIs, 3 percent have 5 PIs,     renewing registration. Upon renewal, it is expected
      Based on the 2000 Occupational Employment               3 percent have 6 PIs, 3 percent have 7 PIs, and 1      that all certificates of registration will be valid for
      Statistics Survey, Bureau of Labor Statistics.          percent have 9 PIs.                                    3 years.



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      13272                Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations

      or toxin and appropriate actions to                     plant pest permit system. Under this                  agents are held can be considerable.
      contain such agent or toxin. It is                      rule, the biosafety and containment                   USDA has recently upgraded, or is
      estimated that the development of the                   procedures at an entity must be                       currently upgrading, security at a
      incident response plan may take 10                      sufficient to contain the agent or toxin              number of its own entities, including
      managerial hours and 25 technical                       (e.g., physical structure and features of             laboratories. While these costs are not a
      hours at a given entity for a cost of                   the entity, and operational and                       result of this rule, they are illustrative
      $2,600. However, many entities will                     procedural safeguards).                               of the spending that can be necessary to
      already have similar plans in place and                    Acquiring adequate biosafety and                   upgrade security. By department policy,
      in writing, i.e., as part of compliance                 containment measures can be costly. For               all USDA biosafety level 3 (BSL–3)
      with health and safety regulations. If we               example, as a result of work related to               laboratories are required to meet
      conservatively assume that one-half of                  anthrax testing at APHIS’ National                    physical security requirements. The
      the 76 affected entities need to develop                Veterinary Services Laboratories, a                   level of security mandated in this policy
      these plans, the total cost would be                    portion of the laboratories’ air handling             meets or exceeds the levels required in
      $99,000.                                                system had to be replaced at a cost of                this rule. For example, upgrades at
                                                              $75,000. However, the biosafety and                   NVSL in Ames, IA were completed in
      Transfer                                                containment requirements contained in                 2002 at a cost of $550,077 ($6.63/ft2,
         Under this rule, select agents and                   this rule should require little change at             83,000ft 2 total area). Installations of
      toxins may only be transferred to                       affected entities. USDA permits 12 cover              electronic security components can
      individuals or entities registered to                   the importation and interstate                        include closed circuit television (CCTV)
      possess, use, or transfer that particular               movement of agents and toxins. Prior to               (cameras, VCR, and control equipment),
      agent or toxin. However, the sender may                 the implementation of the December                    intrusion detection system (IDS) (access-
      be an individual or entity exempt from                  2002 interim rule, these permits already              control card-readers, card-keys,
      the requirements of this rule, or an                    required the biosafety and containment                operating computer and software), all
      individual or entity located outside the                level to be commensurate with the risk                cabling associated with the security
      United States. In addition, APHIS may                   associated with the pathogen covered in               system, and integrating the system with
      authorize transfers for select agents or                the permit. Therefore, to the extent that             the off-site monitoring. Other security
      toxins that would not otherwise be                      affected entities are already permittees,             related expenses that could be needed at
      eligible for transfer. Transfer must occur              the biosafety and containment                         a given entity following an entity
      only with prior authorization,                          requirements in this rule will have                   security assessment include entry
      notification of receipt by the recipient,               already been required at those entities.              control equipment (x-ray, metal
      and notification of overdue or damaged                  Before the enactment of the Act, there                detectors). Other features would entail
      shipments. APHIS expects there to be a                  may have been entities operating legally              yearly recurring costs (i.e., off-site
      total of 130 transfers in a given year. It              outside the permit system, but who are                monitoring, an equipment maintenance
      is estimated that complying with the                    not exempt from this rule. The rule may               agreement, and guard service).
      transfer requirements will require 1.75                 involve additional biosafety or                          The security systems and standard
      hours (0.17 managerial hours and 1.58                   containment burdens for those entities,               operating procedures must be designed
      technical hours), or $124 for each                      but the extent of these burdens cannot                according to a site-specific risk
      transfer. This gives a total cost of                    be estimated.                                         assessment. This site-specific risk
      $16,000 per year.                                                                                             assessment is completed to determine
                                                              Security
      Biosafety/Biocontainment                                                                                      the existing security status and needs of
                                                                The rule will require that any entity
         Biosafety and containment                                                                                  a specific entity. The cost of a security
                                                              where select agents and toxins are held
      requirements ensure that the                                                                                  assessment of a laboratory is based
                                                              adequately provide for the physical
      combination of work practices and                                                                             largely on the required expertise and
                                                              security of the premises. These
      physical containment are designed to                                                                          would be somewhat dependant on the
                                                              requirements are intended to ensure the
      reduce the risks of working with                                                                              size of the entity. At APHIS laboratories
                                                              appropriate levels of protection against,
      infectious material and the degree of                                                                         these assessments have ranged from
                                                              theft or loss of select agents or toxins,
      protection is proportional to the risk                                                                        $17,000 to $25,000 per location.13 Many
                                                              and other acts that may cause
      associated with the agent. Higher                                                                             affected entities will have had entity
                                                              unacceptable adverse impacts on
      biosafety levels (BSL) correspond to                    national security or on the health of the             security assessments done in another
      greater degrees of protection. For                      public or the environment. The security               context prior to the interim rule on
      example, at a BSL–3 laboratory, more                    systems and standard operating                        select agents and toxins, or will need far
      emphasis is placed on primary and                       procedures must be sufficient to                      less extensive and therefore expensive
      secondary barriers to protect personnel                 safeguard the select agent or toxin                   assessments.
                                                                                                                       Electronic security may need to be a
      in contiguous areas, the community,                     against unauthorized access, theft, or
                                                                                                                    major part an entity’s physical security.
      and the environment from exposure to                    loss. The security systems and standard
                                                                                                                    Based on average actual security system
      potentially infectious aerosols. Also,                  operating procedures must be designed
                                                              according to a site-specific risk                     installations for APHIS facilities, a cost
      because there is special concern for
                                                              assessment and must provide graded                    per square foot for electronic security
      reducing the risk of environmental
                                                              protection in accordance with the risk of             upgrades was developed.14 The security
      exposure to pathogens of concern to
      agriculture, BSL–3-Ag adds filtration of                the select agent or toxin, given its                  needs and existing systems at these
      supply and exhaust air, sewage                          intended use.                                         entities varied. The matrix cost per
      decontamination, exit personnel                           The costs of providing security at                  square foot includes: CCTV; IDS;
      showers, and entity integrity testing.                  entities where the select toxins and                  integration; perimeter protection;
      While the BSL terminology is not                                                                              design; construction; and construction
                                                                12 Prior to the enactment of the Public Health
      formally used in relation to laboratories                                                                       13 Robert Rice, Security Manager, APHIS select
                                                              Security and Bioterrorism Response Act of 2002,
      working with plant agents or toxins, a                  USDA issued permits for importation and interstate    agent program.
      parallel philosophy of matching pest                    movement of agents and toxins, including those          14 Robert Rice, Security Manager, APHIS select

      risk to biocontainment is used in the                   now listed in 7 CFR part 331 and 9 CFR part 121.      agent program.



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                            Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations                                               13273

      management, but not biometric                            Small laboratories in larger buildings                 This rule will require that all
      technology. The cost per square foot                     are unlikely to need access controlled               information resources related to select
      assumes single story entities and has                    gates, a security fence, or even guard               agents and toxins have an appropriate
      been adjusted for laboratory type                        service (although a university or                    level of protection in the system that is
      entities. For buildings under 80,000 ft2                 commercial entity may already have a                 used to acquire, store, manipulate,
      the average cost/ft 2 is $8.71. In addition,             security force which would be                        manage, move, control, display, switch,
      there is an adjustment factor for                        considered in assessing security needs).             interchange, receive or transmit that
      retrofitting existing buildings. It should               Larger entities will inevitably have more            information. Most affected entities have
      be noted that for very small entities, the               and different security needs than small              a variety of compelling reasons,
      cost/ft 2 can be considerably higher.15 It               ones. These entities naturally have more             including regulatory requirements,19 for
      should also be noted that these costs per                points of access and are more likely to              already protecting information.
      ft 2 are based on security installations of              need features such as fences or gates to
                                                                                                                    Other Costs
      state-of-the-art technology. In addition                 control access. In addition, the costs
      to the entity security assessment and                    themselves are very site specific; there                All individuals with access to select
      access control discussed above, a given                  can be literally hundreds of variables               agents or toxins are required to have the
      entity could need none, some, or all of                  that will influence cost at a specific site.         appropriate education, training and/or
      the following to maintain its physical                   The variation begins with the needs of               experience to handle or use such agents
      security. Entry control equipment                        the individual entity (views of which                or toxins. In addition, additional
      includes x-ray—small unit ($28,000 per                   can differ from administration, scientist,           training may be needed to familiarize
      unit), x-ray—large unit ($40,000 per                     and physical security points of view)                staff with changes resulting from the
      unit), and metal detector(s) ($20,000 per                and is influenced by the characteristics             rule. This requirement may necessitate
      unit). Other features would entail yearly                of the site—for example, linked areas                that affected entities provide additional
      recurring costs. Off-site monitoring                     are in different buildings, on opposite              training. It is not known the extent to
      ($10,000 to $45,000 per year); an                        sides of a fire wall, etc. Generally labor           which training may be needed at
      equipment maintenance agreement                          for installation (approximately $96/hour             affected entities, and therefore the cost
      ($12,000 to $30,000 per year); and guard                 in Washington, DC for installation work              of providing that training is not known.
      service—unarmed ($30.00/hr per                           on electronic access control) 17 is the              However, the National Center for Import
      security post), armed ($35.00/hr per                     most expensive and variable cost of                  and Export (NCIE) within APHIS
      security post), and a supervisor ($40.00/                these systems.                                       Veterinary Services has a laboratory
      hr).16 Following September 11, 2001,                        A review of 20 security plans of                  biosafety class to train inspectors. In FY
      more comprehensive security packages                     registered entities gives an indication of           2002, APHIS spent $35,480 on
      have been (or will be) added to APHIS                    the nature of security present at affected           participant and speaker travel, speaker
      facilities including many of these                       entities. It also gives an indication of the         honoraria, and equipment and supplies
      additional features. There are, however,                 nature of improvements to security that              to train 18 inspectors, or about $2,000
      alternatives to the specific services that               have occurred since the implementation               each. If we assume that each of affected
      can greatly reduce costs and could be                    of the interim rule, or are planned, or              entities will have similar expenditures,
      acceptable depending on the security                     will need to occur at affected entities.             and must train 25 individuals 20 the
      needs of a given entity, e.g., remote                    All showed a good base of security. In               training cost would be $50,000 per
      monitoring and response to alarms                        fact, a number require no improvement                entity or $3.8 million for all 76 entities.
      instead of on-site guard service. Also, an               under this rule. Improvements that have              It should be noted that most of the
      entity may have some or all of the                       already occurred or have been                        APHIS training cost is in travel. To the
      services already included in an overall                  recommended include installing                       extent that training at affected entities
      facility operational and maintenance                     intrusion detection systems, installing              can occur on-site, the cost per
      plan. An example would be a laboratory                   or expanding CCTV surveillance, card-                individual could be reduced.
      holding select agents or toxins that is                  key access control and standard locks.                  The rule requires that a registered
      part of an academic institution where                    Often an entity’s standard operating                 entity maintain complete records
      support services are already incurred by                 procedures for security sufficiently                 concerning activities related to select
      the academic institution, e.g., campus                   serve in place of a limited number or                agents or toxins. This includes an
      police for security response.                            lack of electronic controls. Because                 accurate, current inventory for each
         Because security needs are site-                      many of the affected entities deal with              select agent held in long-term storage. It
      specific and the rule allows for site-                   select agents or toxins in an area that is           is estimated that it would take eight
      specific security solutions, the                         fully contained in a larger structure, the           technical hours to complete an
      approaches and applications will be                      lack of entry control equipment may not              inventory of a freezer containing select
      varied. The above physical security                      affect the level of graded protection. It            agents or a toxin container. Assuming
      components, and others, may have to be                   should also be noted that only that                  that there are on average 10 freezers,
      added in various quantities (including                   portion of a given entity affected by
      none) to meet the specific security                      select agent or toxin operations is                  Robert Rice, Security Manager, APHIS select agent
                                                                                                                    program.
      needs of an entity. The entities covered                 required to be secured under this rule.                19 Among others: Presidential Decision Directive
      in this rule can and do vary from a small                On average, academic entities had 5,560              63, Critical Infrastructure Protection; the Computer
      laboratory contained within a larger                     square feet, commercial entities 2,894               Security Act of 1987 (Public Law (PL) 100–235); the
      facility to large dedicated buildings to                 square feet, and government entities                 Computer Fraud and Abuse Act (18 U.S.C. Sec.
                                                                                                                    1030 [1993]); Office of Management and Budget
      large groups of buildings and land.                      4,848 square feet to be secured.18                   (OMB) Circular No. A–123, Management
                                                                                                                    Accountability and Control; Appendix III of OMB
        15 Equivalent security needs at two buildings can        17 Christian Lee, Physical Security Specialist,
                                                                                                                    Circular No. A–130, Management of Federal
      have significant differences in cost per ft 2. For       USDA–APHIS–FMD–ESB. Personal                         Information Resources; FED–STD–1037A, ‘‘An
      example, the need for one $1000 video camera             communication.                                       Electronic Means for Communicating Information;
      would add $1 to the ft 2 cost of a 1000 ft 2 facility,     18 Based on a review of 20 security plans for      and the Electronic Communications Privacy Act (18
      but only $0.1 to a 10,000 ft 2 one.                      select agents or toxins submitted to APHIS. The      U.S.C. 2701).
        16 Robert Rice, Security Manager, APHIS select         review covered a broad spectrum of security plans,     20 The average number of individuals needing

      agent program.                                           and type of entity. Plans were reviewed at random.   security risk assessments per entity.



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      13274                Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations

      and 3 toxin containers at a given                       result of this rule, the impact on the                      The portion of an affected entity
      registered entity, it would cost $7,200                 progress of scientific knowledge is                       where select agents or toxins are
      per entity to create this baseline                      unknown and likely unknowable.                            handled and that needs to be secure
      inventory. Based on 76 registered                       However, the consequences of not                          tends to be small. A review of 20
      entities, the baseline inventory would                  securing select agents and toxins could                   security plans of registered entities
      cost a total of $548,000. The inventory                 be extreme.                                               show an average of 4,449 ft2 to be
      will have to be verified periodically.                                                                            secured. Seventy percent of the entities
      Assuming that the registered entities                   Costs to APHIS
                                                                                                                        have less than 5,000 ft2 to be secured,
      would have to re-inventory one-half of                    The rule will also involve costs to                     20 percent between 5,000 and 10,000 ft2
      their freezers each year to maintain an                 APHIS. The rule will require the                          to be secured, and 10 percent more than
      accurate and current inventory, yields a                government to process entity                              10,000 ft2 to be secured.23
      yearly inventory cost of $274,000.                      registrations, notifications of                             For the purpose of assessing the
         Other record keeping includes copies                 identification of agents and toxins,                      impact of the security requirements of
      of the biosafety/biocontainment,                        exemption applications, transfer                          the rule, we make the following
      security and incident response plans, a                 applications, theft/loss notifications and                assumptions based on the available
      list of individuals with access to select               appeals, perform inspection and                           information:
      agents and toxins, training records,                    compliance activities, provide technical                    • 70 percent of affected entities have
      inventory records, permits and transfer                 assistance for compliance to affected                     an area to be secured of approximately
      documents, security records, and                        entities, develop and maintain a                          5,000 ft2,
      incident reports. It is estimated that                  database covering select agents and                         • 20 percent of affected entities have
      complying with the record keeping                       toxins, develop and maintain a secure                     an area to be secured of approximately
      requirements will require 10 hours per                  space for the database, and obtain                        7,500 ft2,
      PI (3 managerial and 7 technical hours                  security clearances. The FY2004 budget                      • 10 percent of affected entities have
      per PI), between 10 and 90 hours per                    for the APHIS select agent and toxin                      an area to be secured of approximately
      entity per year or $745 to $6,700 per                   program is $4.3 million. User fees to                     15,000 ft2, and
      entity. The total cost of yearly record                 offset government costs will not be                         • Because entities will have varying
      keeping is estimated to be $132,000                     collected by APHIS under this rule.                       levels of existing security, security
      based on the current number of affected                                                                           needs, and methods of meeting those
      entities, and the number of PIs at those                Potential Impact of This Rule                             needs, the average security upgrades in
      entities.                                                                                                         APHIS facilities is used as a proxy for
         The rule also requires oral notification               Approximately 70 percent of research
                                                              & development (commercial and non-                        upgrades at these entities. (The proxy is
      immediately upon discovery of the theft                                                                           based on upgrading to state-of-the-art
      or loss of select agents or toxins,                     profit laboratories dealing with human,
                                                              animal and/or plant agents), biological                   equipment, which may or may not be
      followed by a written report within 7
                                                              (except diagnostic) manufacturing,                        used at a given entity).
      days. This is also the requirement for
                                                              diagnostic manufacturing,                                   Using an average budget estimate for
      the discovery that a release of a select
                                                              pharmaceutical manufacturing, and                         upgrading the electronic portion of a
      agent or toxin has occurred outside of
                                                              other private establishments affected by                  security system and the average area to
      the containment area of the entity.
                                                              this rule have fewer than 20 employees,                   secure by type of entity, we get
      APHIS expects there to be two
                                                              and another 15 percent have between 20                    estimates of the budget necessary to
      notifications of theft, loss or release in
                                                              and 49 employees.21 Plant laboratories                    make these upgrades. Based on a budget
      a given year. It is estimated that
                                                              (Federal, commercial, State, and                          estimate of $10.25/square foot,24 an
      complying with these theft, loss and
      release notification requirements will                  academic) tend to be very small, with                     entity with 5,000 ft2 to secure by
      require one hour (0.17 managerial hours                 fewer than 10 individuals having access                   installing electronic security
      and 0.83 technical hours), or $72 for                   to select agents or toxins. Veterinary                    countermeasures would need to budget
      each occurrence, for a total cost of $144               diagnostic laboratories (commercial,                      $51,250, an entity with 7,500 ft2 to
      per year. It is assumed that an incident                State or university) and university                       secure would need to budget $76,875,
      of theft or loss will also require a                    research laboratories likely have fewer                   and one with 15,000 ft2 to secure would
      thorough inventory of the affected                      than 100 employees.22 Federal entities                    need to budget $153,750.
      storage freezer or toxin container, at a                covered by the rule will be affected by                     To obtain an aggregate cost estimate
      cost of $560 per occurrence, for a yearly               the registration requirements but should                  we apply these budget estimates based
      total of $1,120.                                        not have to make alterations due to the                   the size distribution of those entities.
         An individual or entity may appeal a                 biosafety, containment and security                       Applying a budget cost of $51,250 to the
      denial, revocation, or suspension of                    requirements of the rule.                                 70 percent of affected entities that have
      registration under this part. An                                                                                  5,000 ft2 to secure gives a cost of $2.7
      individual may appeal a denial,                            21 1997 Economic Census. Department of                 million. Applying a budget cost of
      limitation, or revocation of access                     Commerce, Census Bureau.                                  $76,875 to the 20 percent of affected
      approval under this part. APHIS expects
                                                                 22 AAVLD provided information on 10 veterinary         entities that have 7,500 ft2 to secure
                                                              diagnostic laboratories. These laboratories ranged in     gives a cost of $1.2 million. Applying a
      there to be one appeal in a given year.                 size form 11 to 100 employees including faculty,
      It is estimated that complying with the                 staff (part- and full-time), and students. In addition,
                                                                                                                        budget cost of $153,750 to the 10
      appeal requirements will require 2                      the AAVLD president estimated that diagnostic             percent of affected entities that have
      managerial hours and 2 technical hours,                 laboratories in general would likely have between         15,000 ft2 to secure gives a cost of $1.2
                                                              6 and 80 employees. According to Dr. Denise               million.
      or $311 for each occurrence.                            Spenser, USDA–APHIS, university research on
         Another potential cost of the rule is                select agents likely involves fewer than 100
      on the pace and quantity of research on                 individuals (3 to 5 principal investigators out of           23 Based on a review of 20 security plans of

      select agents and toxins. If an entity                  about 25 faculty members in each of 3 or 4                affected entities.
                                                              departments—microbiology (veterinary                         24 The baseline estimated cost/ft2 of $8.71/ft2 for
      chooses not to continue work with                       microbiology), chemistry, and physiology, 3 to 5 (20      facilities less than 30,000 ft2 in size, plus an
      select agents or toxins to avoid the                    at most) investigators, technicians, and students in      adjustment of 17.7% for retrofitting existing
      expenditures that will be required as a                 each laboratory).                                         structures.



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                           Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations                                        13275

         It should be noted that as indicated                 of a guard that is the most important                 entities need to develop new plans. The
      above, utilizing APHIS’’ costs as a proxy               factor. Therefore, unarmed guards                     security plan would be developed as
      implies that all entities have baseline                 would most likely be used. At most, a                 part of the entity security assessment
      levels of electronic security similar to                given entity would need a single                      discussed above. It is estimated that
      that of APHIS facilities and will upgrade               unarmed guard on duty 24 hours a day.                 developing an incident response plan
      to state-of-the-art technology. However,                The majority of affected entities will                will cost $2,500 per plan for a total of
      a review of security plans at affected                  rely on off-site monitoring, campus or                $99,000 if one-half of the affected
      entities shows that an upgrade state-of-                local police, or existing guard presence.             entities need to develop new plans. The
      the-art systems is not necessary or likely              Therefore, we assume that the 70                      cost to registrants associated with the
      in most cases. Therefore, this proxy                    percent of entities with less than 5,000              individual security risk assessments is
      likely overstates the true cost of                      ft2 to secure would add no additional                 in obtaining fingerprints of individuals
      electronic security at these entities.                  guard service, the 20 percent with                    in the entity needing security screening.
         In addition to electronic security, an               between 5,000 and 10,000 ft2 to secure                The average entity could expect to
      entity could need none, some, or all of                 would add an additional guard 12 hours                spend $825 obtaining fingerprints
      the following:                                          per day at a cost of $135,050 per year,               initially with a total for all entities of
         • Entity security assessment,                        and the 10 percent with more than                     $63,250, and $470 annually for a total
      including developing a security plan as                 10,000 ft2 to secure would add an                     of $35,750. It is estimated that
      per the rule. Assuming that the 70                      additional guard 24 hours per day at a                developing a baseline inventory of
      percent of entities with less than 5,000                cost of $270,100 per year, giving a total             select agents and toxins at affected
      ft2 to secure spend $17,000, the 20                     annual cost of $814,000.25                            entities would cost $7,200 per entity for
      percent with between 5,000 and 10,000                      This rule will involve other costs to              a total of $548,000, and the yearly
      ft2 to secure spend $21,000, and the 10                 the regulated community. It is estimated              inventory cost will be $3,600 per entity
      percent with more than 10,000 ft2 to                    that complying with the exemption and                 for a total of $274,000. Other
      secure spend $25,000 on these                           notification requirements will have a
                                                                                                                    recordkeeping is estimated at $1,742 per
      assessments gives a total cost of $1.4                  total cost of $75,000 per year, $84 for
                                                                                                                    entity for a total of $132,000 per year.
      million.                                                each exemption application and $72 for
                                                                                                                    The estimated cost associated with
         • Entry control equipment; includes                  each notification of identification. The
                                                                                                                    training is $50,000 per entity for a total
      x-ray—small unit ($28,000 per unit), x-                 rule will also involve the costs
                                                                                                                    of $3.8 million. The estimated total cost
      ray—large unit ($40,000 per unit), and                  associated with the registration
                                                                                                                    associated with notifications of theft,
      metal detector(s) ($20,000 per unit).                   requirements. It is estimated that it will
                                                                                                                    loss and release of select agents or
      Based on available information, we                      cost each entity $380 to collect and
                                                                                                                    toxins is $72 per occurrence for a total
      assume that 8 affected entities would                   provide the required information, for a
                                                                                                                    of $144 per year. In addition, it is
      need to add entry control equipment as                  total cost of $29,000. Registration
                                                              amendments are expected to cost                       assumed that an incident of theft or loss
      a result of this rule. We further assume                                                                      will also require a thorough inventory of
      that each of those entities would spend                 $10,000 per year, $172 per occurrence.
                                                              In addition, it is estimated that it will             the affected storage freezer or toxin
      an average of $30,000 on that equipment                                                                       container, $560 per occurrence at a
      for a total cost of $240,000.                           cost each entity $277 for a total of
                                                              $21,000 to collect and provide the                    yearly total cost of $1,120. The
         • Off-site monitoring can range from                                                                       estimated total cost associated with
      $10,000 to $45,000 per year. Assuming                   required information for re-application.
                                                              Complying with the requirements                       appeals under this rule is estimated to
      that the 70 percent of entities with less                                                                     be $311 per year. The estimated cost
                                                              concerning the transfer of select agents
      than 5,000 ft2 to secure spend $10,000,                                                                       associated with expedited reviews
                                                              and toxins could cost $248 per
      the 20 percent with between 5,000 and                                                                         under this rule is estimated to be $43
                                                              occurrence or $16,000 per year. The rule
      10,000 ft2 to secure spend $27,500, and                                                                       per occurrence for a total of $1,000
                                                              could also entail costs for any needed
      the 10 percent with more than 10,000 ft2                                                                      initially and $560 per year thereafter.
                                                              upgrades to biosafety and containment,
      to secure spend $45,000 on this off-site
                                                              and information systems control. These                   The costs to APHIS include
      monitoring gives a total cost of $1.3
                                                              costs are expected to be small. To the                processing entity registrations,
      million.
                                                              extent that affected entities are already             notifications of identification of agents
         • Equipment maintenance agreements
                                                              permittees, the biosafety and                         and toxins, exemption applications,
      can range in cost from $12,000 to                       containment requirements of the new                   transfer applications, theft/loss
      $30,000 per year. Assuming that the 70                  act will have already been required at                notifications, appeals, performing entity
      percent of entities with less than 5,000                those entities. Affected entities have a              inspections and providing technical
      ft2 to secure spend $12,000, the 20                     variety of compelling reasons, including              assistance for compliance to affected
      percent with between 5,000 and 10,000                   legislation, for already protecting                   entities, developing and maintaining a
      ft2 to secure spend $21,000, and the 10                 information. The rule also requires that              database covering select agents and
      percent with more than 10,000 ft2 to                    biosafety/biocontainment, security, and               toxins, developing and maintaining a
      secure spend $30,000 on these                           incident response plans be developed. It              secure space to house the database, and
      maintenance agreements gives a total                    is estimated that the development of the              obtaining security clearances. The FY
      cost of $1.2 million.                                   biosafety/biocontainment plan could                   2004 budget for the APHIS select agent
         • Guard Service. Unarmed ($30.00/hr                  cost $4,500 per plan or a total of                    and toxin program is $4.3 million.
      per security post), armed ($35.00/hr per                $171,000 if one-half of the affected
      security post), and a supervisor ($40.00/                                                                        Costs of the various components
      hr). When the site-specific security                      25 Robert Rice, Security Manager, APHIS select
                                                                                                                    associated with the rule are summarized
      needs call for guards, it is the presence               agent program.                                        in the following table.




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      13276                       Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations

                                                                           TABLE 1.—SUMMARY OF POTENTIAL COSTS 1
                                                       Costs                                                                        One-time costs                                          Recurring costs

      Exemptions from the Rule:
          Application ........................................................................................       $2,900.
          Re-application ..................................................................................          ........................................................   $2,900.
          Notifications of identification ............................................................               ........................................................   $72,000/yr.
      Registration:
          Application ........................................................................................       $29,000.
          Re-application ..................................................................................          ........................................................   $21,000 every 3 yrs.
          Amendments ....................................................................................            ........................................................   $10,000/yr.
          Biosafety/Biocontainment Plan ........................................................                     $171,000.
          Incident Response plan ...................................................................                 $99,000.
          Fingerprinting associated with SRAs ...............................................                        $63,250 ..........................................         $35,750/yr.
          Security plan/entity security assessment .........................................                         $17,000 to $25,000 per entity.
                                                                                                                     $1.4 million.
      Transfer ...................................................................................................   ........................................................   $16,000/yr.
      Physical security procedures: 2
          Electronic Security (cameras, card-readers, etc.) ...........................                              $51,250 for 5,000 ft 2.
                                                                                                                     $76,875 for 7,500 ft 2.
                                                                                                                     $153,750 for 15,000 ft 2.
                                                                                                                     $5.1 million.
            Entry control (x-ray, metal detector) ................................................                   $30,000 each.
                                                                                                                     $240,000.
            Off-site monitoring ............................................................................         ........................................................   $10,000 to $45,000 per entity.
                                                                                                                                                                                $1.3 million/yr.
            Maintenance agreement ..................................................................                 ........................................................   $12,000 to $30,000 per entity.
                                                                                                                                                                                $1.2 million/yr.
            Guard service ...................................................................................        ........................................................   $0 to $270,100 per entity.
                                                                                                                                                                                $814,000/yr.
      Other costs:
          Training ............................................................................................      $3.8 million.
          Baseline inventory ............................................................................            $548,000.
          Periodic inventory .............................................................................           ........................................................   $274,000/yr.
          Recordkeeping .................................................................................            ........................................................   $132,000/yr.
          Theft/loss/release
          Notification ........................................................................................      ........................................................   $144/yr.
          Additional inventory ..........................................................................            ........................................................   1,120/yr.
          Appeals ............................................................................................       ........................................................   $311/yr.
          Expedited reviews ............................................................................             $1,000 ............................................        $560/yr.

               Total ..........................................................................................      $11.5 million ..................................           $3.9 million.
      Costs to APHIS:
          Budget for select agent program .....................................................                      ........................................................   $4.3 million.
         1 Unless otherwise   noted, these are total costs for all affected entities.
         2 Because security   needs are site-specific and the rule allows for site-specific security solutions, the approaches and applications will be var-
      ied. Actual additional physical security measures added will vary (including none) based on the current level of security and the specific security
      needs of a given entity. The electronic security costs assumes 70 percent of facilities are 5,000 ft 2, 20 percent of facilities are 7,500 ft 2, and 10
      percent of facilities are 15,000 ft 2. The entry control equipment cost assumes 8 entities need such equipment. The off-site monitoring and main-
      tenance agreement costs assume all affected entities need some monitoring. The guard service cost assumes entities would need, on average,
      from 0 to 24 additional hours daily of unarmed guard service.


        For all affected entities, estimates of                                  security measures may have to be added                                      consider the economic impact of rules
      the various one-time costs associated                                      in various quantities (including none) to                                   on small entities. Those entities most
      with this rule total $11.5 million and                                     meet the specific security needs of an                                      likely to be impacted by the rule are
      the estimates of the annual recurring                                      entity. In fact, the security plans                                         those laboratories and other institutions
      costs total $3.9 million. The above is                                     submitted under the December 2002                                           conducting research and related
      given to provide perspective on the                                        interim rule shows that the need for                                        activities that involve the use of select
      magnitude of the potential costs                                           additional security measures is limited                                     agents and toxins. Most affected entities
      associated with this rule. The costs                                       in many cases. Also, some of the                                            (other than Federal or State
      shown here are likely overstated,                                          impacts of the rule are somewhat offset                                     governmental entities) would be
      however, due to conservative                                               by previous requirements, such as                                           considered part of NAICS code 541710,
      assumptions used in the absence of                                         permit requirements in place prior to                                       ‘‘Research and Development in the
      better information. The entities covered                                   the implementation of the December                                          Physical, Engineering, and Life
      in this rule can and do vary from a small                                  2002 interim rule. The flexibility in the                                   Sciences.’’ Some affected entities would
      laboratory contained within a larger                                       rule also allows for site-specific needs to                                 be considered part of NAICS 541940,
      facility to large dedicated buildings to                                   be met in the most cost effective manner                                    ‘‘Veterinary Services,’’ NAICS 611310,
      large groups of buildings and land.                                        possible.                                                                   ‘‘Colleges, Universities and Professional
      Because security needs are site-specific                                   Regulatory Flexibility Analysis                                             Schools,’’ NAICS 325412
      and the rule allows for site-specific                                                                                                                  ‘‘Pharmaceutical Preparation
      security solutions, the approaches and                                       The Regulatory Flexibility Act                                            Manufacturing,’’ NAICS 325413 ‘‘In-
      applications will be varied. Physical                                      requires that the Agency specifically                                       Vitro Diagnostic Substance


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      Manufacturing,’’ and NAICS 325414,                      the establishment and enforcement of                  potential for a disruption in the
      ‘‘Biological Product (except Diagnostic)                safeguard and security measures to                    domestic food supply, whether through
      Manufacturing.’’                                        prevent access to listed agents and                   contamination, consumer perception, or
         The Small Business Administration                    toxins for use in domestic or                         both. Such a disruption can have a
      (SBA) has established guidelines for                    international terrorism or other criminal             lasting influence on food demand and
      determining when establishments are to                  purpose; and the establishment of                     global trade.
      be considered small under the                           procedures to protect animal and plant                   While the costs associated with this
      Regulatory Flexibility Act. An entity in                health, and animal and plant products,                rule could be considerable, some of
      NAICS 541710, 325413 or 325414 is                       in the event of a transfer in violation of            those impacts are somewhat offset. For
      considered small with 500 or fewer                      the established safety and security                   example, requirements such as USDA
      employees, in 325412 with 750 or fewer                  measures.                                             permit requirements for biosafety and
      employees. An entity in NAICS 611310                       Another alternative would involve                  containment and the mandate to update
      is considered small with annual                         variations to the chosen regulatory                   security at USDA facilities were in place
      receipts/revenues of $6 million or less.                scheme. For example, we could have                    prior to the implementation of the
         While the establishment size                         chosen prescriptive requirements for                  December 2002 interim rule. The
      breakdown in the Economic Census                        meeting the need for security around                  flexibility in the rule also allows for
      does not precisely fit the SBA                          select agents and toxins. We rejected                 site-specific needs to be met in the most
      guidelines, it still shows that the vast                this option. Because different agents and             cost effective manner possible. In
      majority (more than 90 percent) of life                 toxins pose differing degrees risk,                   addition, these costs are greatly
      sciences research & development                         depending on factors such as their                    outweighed by the benefits of
      establishments can be considered small.                 escape potential and availability of a                preventing an unintentional or
      More than 99 percent of biological                      suitable habitat (for plant-related agents)           deliberate introduction of a select agent
      (except diagnostic) manufacturing, more                 and transmission and effect of exposure               or toxin into the United States. The cost
      than 98 percent of diagnostic                           to the agent or toxin (for overlap and                associated with outbreaks can be very
      manufacturing, and at least 94 percent                  animal agents or toxins), we believe that             high as is demonstrated by natural
      of pharmaceutical manufacturing are                     it would be counterproductive to                      outbreaks that have occurred. Deliberate
      considered small. The economic census                   attempt to prepare a detailed list of                 introduction greatly increases the
      does not contain information on the                     prescriptive requirements for entities                probability of a select agent or toxin
      establishment size of veterinary service                (i.e., a ‘‘one size fits all’’ design                 becoming established and causing wide-
      entities. According to data from the U.S.               standard). Rather, we prepared a brief                ranging and devastating impacts on the
      Department of Education, about 31                       set of performance standards that we                  economy, disruption to society,
      percent of reporting postsecondary                      will consider to the degree to which                  diminished confidence in public and
      institutions had revenue of less than $6                they are appropriate to the risks                     private institutions, and possible loss of
      million in fiscal year 1995–96.26                       presented by a particular agent or toxin,             life.
         Based on the available information,                  given its intended use and the location
      this rule is not anticipated to have a                  of the entity. In addition, these                     Paperwork Reduction Act
      substantial impact on a significant                     performance based standards allow for                    The December 2002 interim rule
      number of small entities.                               site-specific needs to be met in the most             established regulations governing the
                                                              cost effective manner possible.                       possession, use, and transfer of
      Alternatives Considered
                                                                                                                    biological agents and toxins that have
         This rule has been prompted by the                   Conclusion                                            been determined to have the potential to
      need to prevent the misuse of select                      This rule is intended to prevent the                pose a severe threat to public health and
      agents and toxins and thereby reduce                    misuse of select agents and toxins, and               safety, to animal health, to plant health,
      the potential for those pathogens to                    thereby reduce the potential for those                or to animal or plant products. This
      harm humans, animals, animal                            pathogens to harm humans, animals,                    final rule includes certain regulatory
      products, plants or plant products in the               animal products, plants or plant                      provisions that differ from those
      United States. In assessing the need for                products in the United States. Should                 included in the December 2002 interim
      this rule, we considered several                        any select agent or toxin be                          rule. Some of those provisions involve
      alternatives to the chosen course of                    intentionally introduced into the United              changes from the information collection
      action.                                                 States, the consequences would be                     requirements set out in the December
         One alternative would be to maintain                 significant. Consequences could include               2002 interim rule, which were approved
      the status quo, where we rely on our                    disruption of markets, difficulties in                by the Office of Management and
      authority to issue permits for the                      sustaining an adequate food and fiber                 Budget (OMB) under OMB control
      importation and interstate movement of                  supply, and the potential spread of                   number 0579–0213 (expires May 31,
      agents and toxins as a basis for any                    disease infestations over large areas. In             2005).
      actions we take to regulate select agents               any animal or plant disease outbreak,                    In a separate notice in today’s issue of
      and toxins. We rejected this option. The                the government would incur the costs of               the Federal Register, APHIS is
      Public Health Security and Bioterrorism                 eradication. Industry would be affected               announcing that the information
      Preparedness and Response Act of 2002                   through the imposition of domestic and                collection and recordkeeping
      (Pub. L. 107–188), requires that the                    foreign quarantines, which would result               requirements included in this final rule
      Secretary of Agriculture establish and                  in a loss of markets and destruction of               have been submitted for emergency
      enforce standards and procedures                        animals/plants if commercial properties               approval to OMB.
      governing the possession and use of the                 are found to be infected with the
      listed biological agents and toxins,                    disease. Even though compensation can                 Government Paperwork Elimination
      including the establishment and                         be paid for the destroyed property,                   Act Compliance
      enforcement of safety requirements for                  repopulating (flocks, herds, fields, etc.)              The Animal and Plant Health
      the transfer of listed agents and toxins;               may be time consuming with additional                 Inspection Service is committed to
                                                              losses from idle capital and lost                     compliance with the Government
        26 IPEDS.                                             markets. In addition, there is the                    Paperwork Elimination Act (GPEA),


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      13278                Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations

      which requires Government agencies in                      Biological agent. Any microorganism                from such samples, for diagnosis,
      general to provide the public the option                (including, but not limited to, bacteria,             verification, or proficiency testing.
      of submitting information or transacting                viruses, fungi, rickettsiae, or protozoa),               State. Any of the several States of the
      business electronically to the maximum                  or infectious substance, or any naturally             United States, the Commonwealth of the
      extent possible. For information                        occurring, bioengineered, or synthesized              Northern Mariana Islands, the
      pertinent to GPEA compliance related to                 component of any such microorganism                   Commonwealth of Puerto Rico, the
      this rule, please contact Mrs. Celeste                  or infectious substance, capable of                   District of Columbia, Guam, the Virgin
      Sickles, APHIS’ Information Collection                  causing:                                              Islands of the United States, or any
      Coordinator, at (301) 734–7477.                            (1) Death, disease, or other biological            other territory or possession of the
                                                              malfunction in a human, an animal, a                  United States.
      List of Subjects                                        plant, or another living organism;                       Toxin. The toxic material or product
      7 CFR Part 331                                             (2) Deterioration of food, water,                  of plants, animals, microorganisms
        Agricultural research, Laboratories,                  equipment, supplies, or material of any               (including, but not limited to, bacteria,
      Plant diseases and pests, Reporting and                 kind; or                                              viruses, fungi, rickettsiae, or protozoa),
                                                                 (3) Deleterious alteration of the                  or infectious substances, or a
      recordkeeping requirements.
                                                              environment.                                          recombinant or synthesized molecule,
      9 CFR Part 121                                             Centers for Disease Control and                    whatever their origin and method of
        Agricultural research, Animal                         Prevention (CDC). The Centers for                     production, and includes:
      diseases, Laboratories, Medical research,               Disease Control and Prevention of the                    (1) Any poisonous substance or
      Reporting and recordkeeping                             U.S. Department of Health and Human                   biological product that may be
      requirements.                                           Services.                                             engineered as a result of biotechnology
                                                                 Diagnosis. The analysis of specimens               produced by a living organism; or
      I Accordingly, 7 CFR part 331 and 9 CFR                 for the purpose of identifying or                        (2) Any poisonous isomer or
      part 121 are revised to read as follows:                confirming the presence or                            biological product, homolog, or
      Title 7—Agriculture                                     characteristics of a select agent or toxin,           derivative of such a substance.
                                                              provided that such analysis is directly                  United States. All of the States.
      I 1. Revise part 331 to read as follows:
                                                              related to protecting the public health or               USDA. The U.S. Department of
      PART 331—POSSESSION, USE, AND                           safety, animal health or animal                       Agriculture.
      TRANSFER OF SELECT AGENTS AND                           products, or plant health or plant                       Verification. The demonstration of
      TOXINS                                                  products.                                             obtaining established performance (e.g.,
                                                                 Entity. Any government agency                      accuracy, precision, and the analytical
      Sec.                                                    (Federal, State, or local), academic                  sensitivity and specificity)
      331.1 Definitions.                                      institution, corporation, company,                    specifications for any procedure used
      331.2 Purpose and scope.                                partnership, society, association, firm,              for diagnosis.
      331.3 PPQ select agents and toxins.                     sole proprietorship, or other legal entity.
      331.4 [Reserved]                                           HHS Secretary. The Secretary of the                § 331.2   Purpose and scope.
      331.5 Exemptions.                                       Department of Health and Human                           This part implements the provisions
      331.6 [Reserved]
      331.7 Registration and related security risk
                                                              Services or his or her designee, unless               of the Agricultural Bioterrorism
           assessments.                                       otherwise specified.                                  Protection Act of 2002 setting forth the
      331.8 Denial, revocation, or suspension of                 HHS select agent and/or toxin. A                   requirements for possession, use, and
           registration.                                      biological agent or toxin listed in 42                transfer of select agents and toxins. The
      331.9 Responsible official.                             CFR 73.3.                                             biological agents and toxins listed in
      331.10 Restricting access to select agents                 Import. To move into, or the act of                this part have the potential to pose a
           and toxins; security risk assessments.             movement into, the territorial limits of              severe threat to plant health or plant
      331.11 Security.                                        the United States.                                    products.
      331.12 Biocontainment.                                     Interstate. From one State into or
      331.13 Restricted experiments.                          through any other State, or within the                § 331.3   PPQ select agents and toxins.
      331.14 Incident response.                                                                                       (a) Except as provided in paragraphs
                                                              District of Columbia, Guam, the Virgin
      331.15 Training.
      331.16 Transfers.                                       Islands of the United States, or any                  (d) and (e) of this section, the
      331.17 Records.                                         other territory or possession of the                  Administrator has determined that the
      331.18 Inspections.                                     United States.                                        biological agents and toxins listed in
      331.19 Notification of theft, loss, or release.            Permit. A written authorization by the             this section have been determined to
      331.20 Administrative review.                           Administrator to import or move                       have the potential to pose a severe
        Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80,           interstate select agents or toxins, under             threat to plant health or to plant
      and 371.3.                                              conditions prescribed by the                          products.
                                                              Administrator.                                          (b) PPQ select agents and toxins:
      § 331.1   Definitions.                                     PPQ. The Plant Protection and                        Candidatus Liberobacter africanus;
        Administrator. The Administrator,                     Quarantine Programs of the Animal and                   Candidatus Liberobacter asiaticus;
      Animal and Plant Health Inspection                      Plant Health Inspection Service.                        Peronosclerospora philippinensis;
      Service, or any person authorized to act                   Responsible official. The individual                 Ralstonia solanacearum, race 3,
      for the Administrator.                                  designated by an entity with the                      biovar 2;
        Animal and Plant Health Inspection                    authority and control to ensure                         Sclerophthora rayssiae var. zeae;
      Service (APHIS). The Animal and Plant                   compliance with the regulations in this                 Synchytrium endobioticum;
      Health Inspection Service of the U.S.                   part.                                                   Xanthomonas oryzae pv. oryzicola;
      Department of Agriculture.                                 Select agent and/or toxin. A biological              Xylella fastidiosa (citrus variegated
        Attorney General. The Attorney                        agent or toxin listed in § 331.3.                     chlorosis strain).
      General of the United States or any                        Specimen. Samples of material from                   (c) Genetic elements, recombinant
      person authorized to act for the                        humans, animals, plants, or the                       nucleic acids, and recombinant
      Attorney General.                                       environment, or isolates or cultures                  organisms:


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         (1) Nucleic acids that can produce                   transfer or destruction of such agent or              section, the Administrator may grant a
      infectious forms of any of the select                   toxin provided that:                                  specific exemption upon a showing of
      agent viruses listed in paragraph (b) of                   (1) As soon as practicable, the Federal            good cause and upon his or her
      this section.                                           law enforcement agency transfers the                  determination that such exemption is
         (2) Recombinant nucleic acids that                   seized agent or toxin to an entity eligible           consistent with protecting plant health
      encode for the functional forms of any                  to receive such agent or toxin or                     or plant products. An individual or
      toxin listed in paragraph (b) of this                   destroys the agent or toxin by a                      entity may request in writing an
      section if the nucleic acids:                           recognized sterilization or inactivation              exemption from the requirements of this
         (i) Can be expressed in vivo or in vitro;            process.                                              part. If granted, such exemptions are
      or                                                         (2) The Federal law enforcement                    valid for a maximum of 3 years;
         (ii) Are in a vector or recombinant                  agency safeguards and secures the                     thereafter, an individual or entity must
      host genome and can be expressed in                     seized agent or toxin against theft, loss,            request a new exemption. If a request for
      vivo or in vitro.                                       or release, and reports any theft, loss, or           exemption is denied, an individual or
         (3) Select agents and toxins listed in               release of such agent or toxin.                       entity may request reconsideration in
      paragraph (b) of this section that have                    (3) The Federal law enforcement                    writing to the Administrator. The
      been genetically modified.                              agency reports the seizure of the select              request for reconsideration must state
         (d) Select agents or toxins that meet                agent or toxin to APHIS or CDC. The                   all of the facts and reasons upon which
      any of the following criteria are                       seizure must be reported within 24                    the individual or entity relies to show
      excluded from the requirements of this                  hours by telephone, facsimile, or e-mail.             that the exemption was wrongfully
      part:                                                   This report must be followed by                       denied. The Administrator will grant or
         (1) Any select agent or toxin that is in             submission of APHIS/CDC Form 4                        deny the request for reconsideration as
      its naturally occurring environment,                    within 7 calendar days after seizure of               promptly as circumstances allow and
      provided that the agent or toxin has not                the select agent or toxin. A copy of the              will state, in writing, the reasons for the
      been intentionally introduced,                          completed form must be maintained for                 decision.
      cultivated, collected, or otherwise                     3 years.
      extracted from its natural source.                         (4) The Federal law enforcement                    § 331.6   [Reserved]
         (2) Nonviable select agents or                       agency reports the final disposition of               § 331.7 Registration and related security
      nonfunctional toxins.                                   the select agent or toxin to APHIS or                 risk assessments.
         (e) An attenuated strain of a select
                                                              CDC by submission of APHIS/CDC Form                      (a) Unless exempted under § 331.5, an
      agent or toxin may be excluded from the
                                                              4. A copy of the completed form must                  individual or entity shall not possess,
      requirements of this part based upon a
                                                              be maintained for 3 years.                            use, or transfer any select agent or toxin
      determination that the attenuated strain
      does not pose a severe threat to plant                  § 331.4    [Reserved]
                                                                                                                    without a certificate of registration
      health or plant products.                                                                                     issued by the Administrator.
         (1) To apply for an exclusion, an                    § 331.5    Exemptions.                                   (b) As a condition of registration, each
      individual or entity must submit a                         (a) Diagnostic laboratories and other              entity must designate an individual to
      written request and supporting                          entities that possess, use, or transfer a             be its responsible official. While most
      scientific information. A written                       select agent or toxin that is contained in            registrants are likely to be entities, in
      decision granting or denying the request                a specimen presented for diagnosis or                 the event that an individual applies for
      will be issued. An exclusion will be                    verification will be exempt from the                  and is granted a certificate of
      effective upon notification of the                      requirements of this part for such agent              registration, the individual will be
      applicant. Exclusions will be published                 or toxin contained in the specimen,                   considered the responsible official.
      periodically in the notice section of the               provided that:                                           (c)(1) As a condition of registration,
      Federal Register and will be listed on                     (1) Unless directed otherwise by the               the following must be approved by the
      the Internet at http://                                 Administrator, within 7 calendar days                 Administrator or the HHS Secretary
      www.aphis.usda.gov/programs/                            after identification, the agent or toxin is           based on a security risk assessment by
      ag_selectagent/index.html.                              transferred in accordance with § 331.16               the Attorney General:
                                                              or destroyed on-site by a recognized                     (i) The individual or entity;
         (2) If an excluded attenuated strain is
                                                                                                                       (ii) The responsible official; and
      subjected to any manipulation that                      sterilization or inactivation process;                   (iii) Unless otherwise exempted under
      restores or enhances its virulence, the                    (2) The agent or toxin is secured                  this section, any individual who owns
      resulting select agent or toxin will be                 against theft, loss, or release during the            or controls the entity.
      subject to the requirements of this part.               period between identification of the                     (2) Federal, State, or local
         (3) An individual or entity may make                 agent or toxin and transfer or                        governmental agencies, including public
      a written request to the Administrator                  destruction of such agent or toxin, and               accredited academic institutions, are
      for reconsideration of a decision                       any theft, loss, or release of such agent             exempt from the security risk
      denying an exclusion application. The                   or toxin is reported; and                             assessments for the entity and the
      written request for reconsideration must                   (3) The identification of the agent or             individual who owns or controls such
      state the facts and reasoning upon                      toxin is immediately reported to APHIS                entity.
      which the individual or entity relies to                or CDC by telephone, facsimile, or e-                    (3) An individual will be deemed to
      show the decision was incorrect. The                    mail. This report must be followed by                 own or control an entity under the
      Administrator will grant or deny the                    submission of APHIS/CDC Form 4                        following conditions: 1
      request for reconsideration as promptly                 within 7 calendar days after                             (i) For a private institution of higher
      as circumstances allow and will state, in               identification. Less stringent reporting              education, an individual will be deemed
      writing, the reasons for the decision.                  may be required during agricultural                   to own or control the entity if the
         (f) Any select agent or toxin seized by              emergencies or outbreaks, or in endemic               individual is in a managerial or
      a Federal law enforcement agency will                   areas. A copy of APHIS/CDC Form 4                     executive capacity with regard to the
      be excluded from the requirements of                    must be maintained for 3 years.
      this part during the period between                        (b) In addition to the exemption                     1 These conditions may apply to more than one

      seizure of the agent or toxin and the                   provided in paragraph (a) of this                     individual.



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      13280                Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations

      entity’s select agents or toxins or with                agents or toxins, and for specific                     law enforcement or intelligence agency
      regard to the individuals with access to                activities.                                            of:
      the select agents or toxins possessed,                     (h) A certificate of registration may be               (i) Committing a crime set forth in 18
      used, or transferred by the entity.                     amended to reflect changes in                          U.S.C. 2332b(g)(5); or
         (ii) For entities other than institutions            circumstances (e.g., replacement of the                   (ii) Knowing involvement with an
      of higher education, an individual will                 responsible official or other personnel                organization that engages in domestic or
      be deemed to own or control the entity                  changes, changes in ownership or                       international terrorism (as defined in 18
      if the individual:                                      control of the entity, changes in the                  U.S.C. 2331) or with any other
         (A) Owns 50 percent or more of the                   activities involving any select agents or              organization that engages in intentional
      entity, or is a holder or owner of 50                   toxins, or the addition or removal of                  crimes of violence; or
      percent or more of its voting stock; or                 select agents or toxins).                                 (iii) Being an agent of a foreign power
         (B) Is in a managerial or executive                     (1) Prior to any change, the                        as defined in 50 U.S.C. 1801;
      capacity with regard to the entity’s                    responsible official must apply for an                    (3) The individual or entity does not
      select agents or toxins or with regard to               amendment to a certificate of                          meet the requirements of this part; 3 or
      the individuals with access to the select               registration by submitting the relevant                   (4) It is determined that such action
      agents or toxins possessed, used, or                    page(s) of the registration application.2              is necessary to protect plant health or
      transferred by the entity.                                 (2) The responsible official will be                plant products.
         (4) An entity will be considered to be               notified in writing if an application to                  (b) Upon revocation or suspension of
      an institution of higher education if it is             amend a certificate of registration has                a certificate of registration, the
      an institution of higher education as                   been approved. Approval of an                          individual or entity must:
      defined in section 101(a) of the Higher                 amendment may be contingent upon an                       (1) Immediately stop all use of each
      Education Act of 1965 (20 U.S.C.                        inspection or submission of additional                 select agent or toxin covered by the
      1001(a)), or is an organization described               information, such as the security plan,                revocation or suspension order;
      in 501(c)(3) of the Internal Revenue                    biosafety plan, incident response plan,                   (2) Immediately safeguard and secure
      Code of 1986, as amended (26 U.S.C.                     or any other documents required to be                  each select agent or toxin covered by the
      501(c)(3)).                                             prepared under this part.                              revocation or suspension order from
         (5) To obtain a security risk                           (3) No change may be made without                   theft, loss, or release; and
      assessment, an individual or entity must                such approval.                                            (3) Comply with all disposition
                                                                 (i) An entity must immediately notify               instructions issued by the Administrator
      submit the information necessary to
                                                              APHIS or CDC if it loses the services of               for each select agent or toxin covered by
      conduct a security risk assessment to
                                                              its responsible official. In the event that            the revocation or suspension.
      the Attorney General.
                                                              an entity loses the services of its                       (c) Denial of an application for
         (d) To apply for a certificate of
                                                              responsible official, an entity may                    registration and revocation or
      registration for only PPQ select agents or
                                                              continue to possess or use select agents               suspension of registration may be
      toxins, or for PPQ and VS select agents
                                                              or toxins only if it appoints as the                   appealed under § 331.20. However, any
      or toxins, an individual or entity must
                                                              responsible official another individual                denial of an application for registration
      submit the information requested in the
                                                              who has been approved by the                           or revocation or suspension of a
      registration application package
                                                              Administrator or the HHS Secretary                     certificate of registration will remain in
      (APHIS/CDC Form 1) to APHIS. To
                                                              following a security risk assessment by                effect until a final agency decision has
      apply for a certificate of registration for
                                                              the Attorney General and who meets the                 been rendered.
      overlap select agents or toxins, overlap
                                                              requirements of this part.
      select agents or toxins and any                                                                                § 331.9    Responsible official.
                                                                 (j) A certificate of registration will be
      combination of PPQ or VS select agents                                                                           (a) An individual or entity required to
                                                              terminated upon the written request of
      or toxins, or HHS select agents or toxins                                                                      register under this part must designate
                                                              the entity if the entity no longer
      and any combination of PPQ or VS                                                                               an individual to be the responsible
                                                              possesses or uses any select agents or
      select agents or toxins, an individual or                                                                      official. The responsible official must:
                                                              toxins and no longer wishes to be
      entity must submit the information                                                                               (1) Be approved by the Administrator
                                                              registered.
      requested in the registration application                  (k) A certificate of registration will be           or the HHS Secretary following a
      package (APHIS/CDC Form 1) to APHIS                     valid for a maximum of 3 years.                        security risk assessment by the Attorney
      or CDC, but not both.                                                                                          General;
         (e) Prior to the issuance of a certificate           § 331.8 Denial, revocation, or suspension                (2) Be familiar with the requirements
      of registration, the responsible official               of registration.
                                                                                                                     of this part;
      must promptly provide notification of                     (a) An application may be denied or                    (3) Have authority and responsibility
      any changes to the application for                      a certificate of registration revoked or               to act on behalf of the entity;
      registration by submitting the relevant                 suspended if:                                            (4) Ensure compliance with the
      page(s) of the registration application.                  (1) The individual or entity, the                    requirements of this part; and
         (f) The issuance of a certificate of                 responsible official, or an individual                   (5) Ensure that annual inspections are
      registration may be contingent upon                     who owns or controls the entity is                     conducted of each laboratory where
      inspection or submission of additional                  within any of the categories described in              select agents or toxins are stored or used
      information, such as the security plan,                 18 U.S.C. 175b;                                        in order to ensure compliance with the
      biosafety plan, incident response plan,                   (2) The individual or entity, the                    requirements of this part. The results of
      or any other documents required to be                   responsible official, or an individual                 each inspection must be documented,
      prepared under this part.                               who owns or controls the entity is                     and any deficiencies identified during
         (g) A certificate of registration will be            reasonably suspected by any Federal                    an inspection must be corrected.
      valid for one physical location (a room,                                                                         (b) An entity may designate one or
                                                                2 Depending on the change, a security risk
      a building, or a group of buildings)                                                                           more individuals to be an alternate
                                                              assessment by the Attorney General may also be
      where the responsible official will be                  required (e.g., replacement of the responsible
      able to perform the responsibilities                    official, changes in ownership or control of the         3 If registration is denied for this reason, we may

      required in this part, for specific select              entity, new researchers or graduate students, etc.).   provide technical assistance and guidance.



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      responsible official, who may act for the               U.S.C. 2332b(g)(5); knowing                              (1) Allow access only to individuals
      responsible official in his/her absence.                involvement with an organization that                 with access approval from the
      These individuals must have the                         engages in domestic or international                  Administrator or the HHS Secretary;
      authority and control to ensure                         terrorism (as defined in 18 U.S.C. 2331)                 (2) Allow individuals not approved
      compliance with the regulations when                    or with any other organization that                   for access by the Administrator or the
      acting as the responsible official.                     engages in intentional crimes of                      HHS Secretary to conduct routine
        (c) The responsible official must                     violence; or being an agent of a foreign              cleaning, maintenance, repairs, and
      report the identification and final                     power as defined in 50 U.S.C. 1801; or                other activities not related to select
      disposition of any select agent or toxin                   (3) It is determined that such action              agents or toxins only when
      contained in a specimen for diagnosis or                is necessary to protect plant health or               continuously escorted by an approved
      verification.                                           plant products.                                       individual;
        (1) The identification of the select                     (g) An individual may appeal the                      (3) Provide for the control of select
      agent or toxin must be immediately                      Administrator’s decision to deny, limit,              agents and toxins by requiring freezers,
      reported by telephone, facsimile, or e-                 or revoke access approval under                       refrigerators, cabinets, and other
      mail. The final disposition of the agent                § 331.20.                                             containers where select agents or toxins
      or toxin must be reported by submission                    (h) Access approval is valid for a                 are stored to be secured against
      of APHIS/CDC Form 4 within 7 calendar                   maximum of 5 years.                                   unauthorized access (e.g., card access
      days after identification. A copy of the                   (i) The responsible official must                  system, lock boxes);
      completed form must be maintained for                   immediately notify APHIS or CDC when                     (4) Inspect all suspicious packages
      3 years.                                                an individual’s access to select agents or            before they are brought into or removed
        (2) Less stringent reporting may be                   toxins is terminated by the entity and                from an area where select agents or
      required during agricultural                            the reasons therefore.                                toxins are used or stored;
      emergencies or outbreaks, or in endemic                                                                          (5) Establish a protocol for intra-entity
      areas.                                                  § 331.11    Security.                                 transfers under the supervision of an
                                                                 (a) An individual or entity required to            individual with access approval from
      § 331.10 Restricting access to select                                                                         the Administrator or the HHS Secretary,
      agents and toxins; security risk
                                                              register under this part must develop
                                                              and implement a written security plan.                including chain-of-custody documents
      assessments.
                                                              The security plan must be sufficient to               and provisions for safeguarding against
         (a) An individual or entity required to                                                                    theft, loss, or release; and
                                                              safeguard the select agent or toxin
      register under this part may not provide                                                                         (6) Require that individuals with
                                                              against unauthorized access, theft, loss,
      an individual access to a select agent or                                                                     access approval from the Administrator
                                                              or release.
      toxin, and an individual may not access                                                                       or the HHS Secretary refrain from
                                                                 (b) The security plan must be
      a select agent or toxin, unless the                                                                           sharing with any other person their
                                                              designed according to a site-specific risk
      individual is approved by the                                                                                 unique means of accessing a select agent
                                                              assessment and must provide graded
      Administrator or the HHS Secretary                                                                            or toxin (e.g., keycards or passwords);
                                                              protection in accordance with the risk of
      following a security risk assessment by                                                                          (7) Require that individuals with
                                                              the select agent or toxin, given its
      the Attorney General.                                                                                         access approval from the Administrator
         (b) An individual will be deemed to                  intended use. The security plan must be
                                                              submitted upon request.                               or the HHS Secretary immediately
      have access at any point in time if the                                                                       report any of the following to the
      individual has possession of a select                      (c) The security plan must:
                                                                 (1) Describe procedures for physical               responsible official:
      agent or toxin (e.g., carries, uses, or                                                                          (i) Any loss or compromise of keys,
      manipulates) or the ability to gain                     security, inventory control, and
                                                                                                                    passwords, combinations, etc.;
      possession of a select agent or toxin.                  information systems control;
                                                                                                                       (ii) Any suspicious persons or
         (c) Each individual with access to                      (2) Contain provisions for the control             activities;
      select agents or toxins must have the                   of access to select agents and toxins;                   (iii) Any loss or theft of select agents
      appropriate education, training, and/or                    (3) Contain provisions for routine                 or toxins;
      experience to handle or use such agents                 cleaning, maintenance, and repairs;                      (iv) Any release of a select agent or
      or toxins.                                                 (4) Establish procedures for removing              toxin; and
         (d) To apply for access approval, each               unauthorized or suspicious persons;                      (v) Any sign that inventory or use
      individual must submit the information                     (5) Describe procedures for addressing             records for select agents or toxins have
      necessary to conduct a security risk                    loss or compromise of keys, passwords,                been altered or otherwise compromised;
      assessment to the Attorney General.                     combinations, etc. and protocols for                  and
         (e) An individual’s security risk                    changing access numbers or locks                         (8) Separate areas where select agents
      assessment may be expedited upon                        following staff changes;                              and toxins are stored or used from the
      written request by the responsible                         (6) Contain procedures for reporting               public areas of the building.
      official and a showing of good cause                    unauthorized or suspicious persons or                    (e) In developing a security plan, an
      (e.g., agricultural emergencies, national               activities, loss or theft of select agents or         individual or entity should consider the
      security, or a short-term visit by a                    toxins, release of select agents or toxins,           document entitled, ‘‘Laboratory Security
      prominent researcher). A written                        or alteration of inventory records; and               and Emergency Response Guidance for
      decision granting or denying the request                   (7) Contain provisions for ensuring                Laboratories Working with Select
      will be issued.                                         that all individuals with access approval             Agents,’’ in Morbidity and Mortality
         (f) An individual’s access approval                  from the Administrator or the HHS                     Weekly Report (December 6, 2002); 51
      may be denied, limited, or revoked if:                  Secretary understand and comply with                  (No. RR–19):1–6. This document is
         (1) The individual is within any of the              the security procedures.                              available on the Internet at http://
      categories described in 18 U.S.C. 175b;                    (d) An individual or entity must                   www.cdc.gov/mmwr.
         (2) The individual is reasonably                     adhere to the following security                         (f) The plan must be reviewed
      suspected by any Federal law                            requirements or implement measures to                 annually and revised as necessary.
      enforcement or intelligence agency of                   achieve an equivalent or greater level of             Drills or exercises must be conducted at
      committing a crime set forth in 18                      security:                                             least annually to test and evaluate the


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      effectiveness of the plan. The plan must                experiments in paragraph (a) of this                      (9) A list of personal protective and
      be reviewed and revised, as necessary,                  section, or revoke or suspend a                        emergency equipment, and their
      after any drill or exercise and after any               certificate of registration, if the                    locations;
      incident.                                               individual or entity fails to comply with                 (10) Site security and control;
                                                              the requirements of this part.                            (11) Procedures for emergency
      § 331.12    Biocontainment.
                                                                 (c) To apply for approval to conduct                evacuation, including type of
         (a) An individual or entity required to              any of the experiments in paragraph (a)                evacuation, exit route assignments, safe
      register under this part must develop                   of this section, an individual or entity               distances, and places of refuge; and
      and implement a written                                 must submit a written request and                         (12) Decontamination procedures.
      biocontainment plan that is                             supporting scientific information to the                  (d) The plan must be reviewed
      commensurate with the risk of the select                                                                       annually and revised as necessary.
                                                              Administrator. A written decision
      agent or toxin, given its intended use.4                                                                       Drills or exercises must be conducted at
                                                              granting or denying the request will be
      The biocontainment plan must contain                                                                           least annually to test and evaluate the
                                                              issued.
      sufficient information and                                                                                     effectiveness of the plan. The plan must
      documentation to describe the                           § 331.14    Incident response.6                        be reviewed and revised, as necessary,
      containment procedures.                                    (a) An individual or entity required to             after any drill or exercise and after any
         (b) The biocontainment procedures
                                                              register under this part must develop                  incident.
      must be sufficient to contain the select
                                                              and implement a written incident
      agent or toxin (e.g., physical structure                                                                       § 331.15    Training.
                                                              response plan.7 The incident response
      and features of the entity, and                                                                                   (a) An individual or entity required to
                                                              plan must be coordinated with any
      operational and procedural safeguards).                                                                        register under this part must provide
         (c) In developing a biocontainment                   entity-wide plans, kept in the
                                                              workplace, and available to employees                  information and training on
      plan, an individual or entity should
                                                              for review.                                            biocontainment and security to each
      consider the following:
         (1) ‘‘Containment Facilities and                        (b) The incident response plan must                 individual with access approval from
      Safeguards for Exotic Plant Pathogens                   fully describe the entity’s response                   the Administrator or the HHS Secretary
      and Pests’’ (Robert P. Kahn and S.B.                    procedures for the theft, loss, or release             before he/she has such access. In
      Mathur eds., 1999); and                                 of a select agent or toxin; inventory                  addition, an individual or entity must
         (2) ‘‘A Practical Guide to                           discrepancies; security breaches                       provide information and training on
      Containment: Greenhouse Research                        (including information systems); severe                biocontainment and security to each
      with Transgenic Plants and Microbes’’                   weather and other natural disasters;                   individual not approved for access by
      (Patricia L. Traynor ed., 2001).                        workplace violence; bomb threats and                   the Administrator or the HHS Secretary
         (d) The plan must be reviewed                        suspicious packages; and emergencies                   before he/she works in or visits areas
      annually and revised as necessary.                      such as fire, gas leak, explosion, power               where select agents or toxins are
      Drills or exercises must be conducted at                outage, etc. The response procedures                   handled or stored (e.g., laboratories,
      least annually to test and evaluate the                 must account for hazards associated                    growth chambers, animal rooms,
      effectiveness of the plan. The plan must                with the select agent or toxin and                     greenhouses, storage areas, etc.). The
      be reviewed and revised, as necessary,                  appropriate actions to contain such                    training must address the particular
      after any drill or exercise and after any               agent or toxin.                                        needs of the individual, the work they
      incident.                                                  (c) The incident response plan must                 will do, and the risks posed by the
                                                              also contain the following information:                select agents or toxins.
      § 331.13    Restricted experiments.5                                                                              (b) Refresher training must be
                                                                 (1) The name and contact information
        (a) An individual or entity may not                                                                          provided annually.
      conduct the following experiments                       (e.g., home and work) for the individual
                                                              or entity (e.g., responsible official,                    (c) A record of the training provided
      unless approved by and conducted in                                                                            to each individual must be maintained.
      accordance with the conditions                          alternate responsible official(s),
                                                              biosafety officer, etc.);                              The record must include the name of
      prescribed by the Administrator:                                                                               the individual, the date of training, a
        (1) Experiments utilizing recombinant                    (2) The name and contact information
                                                                                                                     description of the training provided,
      DNA that involve the deliberate transfer                for the building owner and/or manager,
                                                                                                                     and the means used to verify that the
      of a drug resistance trait to select agents             where applicable;
                                                                                                                     employee understood the training.
      that are not known to acquire the trait                    (3) The name and contact information
      naturally, if such acquisition could                    for tenant offices, where applicable;                  § 331.16    Transfers.
      compromise the use of the drug to                          (4) The name and contact information                   (a) Except as provided in paragraph
      control disease agents in humans,                       for the physical security official for the             (c) of this section, a select agent or toxin
      veterinary medicine, or agriculture.                    building, where applicable;                            may only be transferred to an individual
        (2) Experiments involving the                            (5) Personnel roles and lines of                    or entity registered to possess, use, or
      deliberate formation of recombinant                     authority and communication;                           transfer that agent or toxin. A select
      DNA containing genes for the                               (6) Planning and coordination with                  agent or toxin may only be transferred
      biosynthesis of toxins lethal for                       local emergency responders;                            under the conditions of this section and
      vertebrates at an LD50<100 ng/kg body                      (7) Procedures to be followed by                    must be authorized by APHIS or CDC
      weight.                                                 employees performing rescue or medical                 prior to the transfer.8
        (b) The Administrator may revoke                      duties;                                                   (b) In addition to any permit required
      approval to conduct any of the                             (8) Emergency medical treatment and                 under part 330 of this chapter, a transfer
        4 Technical assistance and guidance may be
                                                              first aid;                                             may be authorized if:
      obtained by contacting APHIS.
                                                                                                                        (1) The sender:
        5 For guidance, see the NIH publication, ‘‘NIH          6 Nothing in this section is meant to supersede or

      Guidelines for Research Involving Recombinant           preempt incident response requirements imposed           8 The requirements of this section do not apply

      DNA Molecules.’’ This document is available on the      by other statutes or regulations.                      to transfers within a registered entity (i.e., the
      Internet at http://www.aphis.usda.gov/programs/           7 Technical assistance and guidance may be           sender and the recipient are covered by the same
      ag_selectagent/index.html.                              obtained by contacting APHIS.                          certificate of registration).



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         (i) Has at the time of transfer a                    containers, vials, tubes, etc.), date of              access, and can be verified for
      certificate of registration that covers the             acquisition, and the source;                          authenticity.
      particular select agent or toxin to be                    (iii) Where stored (e.g., building,                   (c) All records created under this part
      transferred and meets all the                           room, and freezer);                                   must be maintained for 3 years and
      requirements of this part;                                (iv) When moved from storage and by                 promptly produced upon request.
         (ii) Meets the exemption requirements                whom and when returned to storage and
                                                              by whom;                                              § 331.18   Inspections.
      for the particular select agent or toxin to
      be transferred; or                                        (v) The select agent used and purpose                 (a) Without prior notification, APHIS
         (iii) Is transferring the select agent or            of use;                                               must be allowed to inspect any site at
      toxin from outside of the United States                   (vi) Records created under § 331.16                 which activities regulated under this
      and meets all import requirements.                      (Transfers);                                          part are conducted and must be allowed
         (2) At the time of transfer, the                       (vii) For intra-entity transfers (sender            to inspect and copy any records relating
      recipient has a certificate of registration             and the recipient are covered by the                  to the activities covered by this part.
      that includes the particular select agent               same certificate of registration), the                  (b) Prior to issuing a certificate of
      or toxin to be transferred and meets all                select agent, the quantity transferred,               registration to an individual or entity,
      of the requirements of this part.                       the date of transfer, the sender, and the             APHIS may inspect and evaluate their
         (c) On a case-by-case basis, the                     recipient; and                                        premises and records to ensure
      Administrator may authorize a transfer                    (viii) Records created under § 331.19               compliance with this part.
      of a select agent or toxin not otherwise                (Notification of theft, loss, or release);            § 331.19   Notification of theft, loss, or
      eligible for transfer under this part                     (2) An accurate, current inventory for              release.
      under conditions prescribed by the                      each toxin held, including:
                                                                                                                       (a) An individual or entity must
      Administrator.                                            (i) The name and characteristics;
                                                                                                                    immediately notify APHIS or CDC upon
         (d) To obtain authorization for a                      (ii) The quantity acquired from
                                                                                                                    discovery of the theft or loss of a select
      transfer, APHIS/CDC Form 2 must be                      another individual or entity (e.g.,
                                                                                                                    agent or toxin. Thefts or losses must be
      submitted.                                              containers, vials, tubes, etc.), date of
                                                                                                                    reported even if the select agent or toxin
         (e) The recipient must submit a                      acquisition, and the source;
                                                                (iii) The initial and current quantity              is subsequently recovered or the
      completed APHIS/CDC Form 2 within 2
                                                              amount (e.g., milligrams, milliliters,                responsible parties are identified.
      business days of receipt of a select agent                                                                       (1) The theft or loss of a select agent
      or toxin.                                               grams, etc.);
                                                                                                                    or toxin must be reported by telephone,
         (f) The recipient must immediately                     (iv) The toxin used and purpose of
                                                                                                                    facsimile, or e-mail. The following
      notify APHIS or CDC if the select agent                 use, quantity, date(s) of the use and by
                                                                                                                    information must be provided:
      or toxin has not been received within 48                whom;
                                                                                                                       (i) The name of the select agent or
      hours after the expected delivery time or                 (v) Where stored (e.g., building, room,
                                                                                                                    toxin and any identifying information
      if the package containing the select                    and freezer);
                                                                                                                    (e.g., strain or other characterization
      agent or toxin has been damaged to the                    (vi) When moved from storage and by
                                                                                                                    information);
      extent that a release of the select agent               whom and when returned to storage and
                                                                                                                       (ii) An estimate of the quantity stolen
      or toxin may have occurred.                             by whom, including quantity amount;
                                                                                                                    or lost;
         (g) An authorization for a transfer                    (vii) Records created under § 331.16                   (iii) An estimate of the time during
      shall be valid only for 30 calendar days                (Transfers);                                          which the theft or loss occurred;
      after issuance, except that such an                       (viii) For intra-entity transfers (sender              (iv) The location (building, room)
      authorization becomes immediately null                  and the recipient are covered by the                  from which the theft or loss occurred;
      and void if any facts supporting the                    same certificate of registration), the                and
      authorization change (e.g., change in the               toxin, the quantity transferred, the date                (v) The list of Federal, State, or local
      certificate of registration for the sender              of transfer, the sender, and the recipient;           law enforcement agencies to which the
      or recipient, change in the application                   (ix) Records created under § 331.19                 individual or entity reported, or intends
      for transfer).                                          (Notification of theft, loss, or release);            to report, the theft or loss.
         (h) The sender must comply with all                    (x) If destroyed, the quantity of toxin                (2) A completed APHIS/CDC Form 3
      applicable laws governing packaging                     destroyed, the date of such action, and               must be submitted within 7 calendar
      and shipping.                                           by whom.                                              days.
                                                                (3) A current list of all individuals                  (b) An individual or entity must
      § 331.17    Records.                                    that have been granted access approval                notify APHIS or CDC immediately upon
         (a) An individual or entity required to              by the Administrator or the HHS                       discovery of a release of a select agent
      register under this part must maintain                  Secretary;                                            or toxin outside of the primary barriers
      complete records relating to the                          (4) Information about all entries into              of the biocontainment area.
      activities covered by this part. Such                   areas containing select agents or toxins,                (1) The release of a select agent or
      records must include:                                   including the name of the individual,                 toxin must be reported by telephone,
         (1) An accurate, current inventory for               name of the escort (if applicable), and               facsimile, or e-mail. The following
      each select agent (including viral                      the date and time of entry;                           information must be provided:
      genetic elements, recombinant nucleic                     (5) Accurate, current records created                  (i) The name of the select agent or
      acids, and recombinant organisms) held                  under § 331.9(c) (Responsible official),              toxin and any identifying information
      in long-term storage (placement in a                    § 331.11 (Security), § 331.12                         (e.g., strain or other characterization
      system designed to ensure viability for                 (Biocontainment), § 331.14 (Incident                  information);
      future use, such as in a freezer or                     response), and § 331.15 (Training); and                  (ii) An estimate of the quantity
      lyophilized materials), including:                        (6) A written explanation of any                    released;
         (i) The name and characteristics (e.g.,              discrepancies.                                           (iii) The time and duration of the
      strain designation, GenBank Accession                     (b) The individual or entity must                   release;
      number, etc.);                                          implement a system to ensure that all                    (iv) The environment into which the
         (ii) The quantity acquired from                      records and databases created under this              release occurred (e.g., in building or
      another individual or entity (e.g.,                     part are accurate, have controlled                    outside of building, waste system);


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        (v) The location (building, room) from                § 121.1    Definitions.                               interstate select agents or toxins, under
      which the release occurred; and                            Administrator. The Administrator,                  conditions prescribed by the
        (vi) The number of individuals                        Animal and Plant Health Inspection                    Administrator.
      potentially exposed at the entity;                      Service, or any person authorized to act                 Proficiency testing. The process of
                                                              for the Administrator.                                determining the competency of an
        (vii) Actions taken to respond to the                                                                       individual or laboratory to perform a
                                                                 Animal and Plant Health Inspection
      release; and                                                                                                  specified test or procedure.
                                                              Service (APHIS). The Animal and Plant
        (viii) Hazards posed by the release.                  Health Inspection Service of the U.S.                    Responsible official. The individual
        (2) A completed APHIS/CDC Form 3                      Department of Agriculture.                            designated by an entity with the
      must be submitted within 7 calendar                        Attorney General. The Attorney                     authority and control to ensure
      days.                                                   General of the United States or any                   compliance with the regulations in this
                                                              person authorized to act for the                      part.
      § 331.20    Administrative review.                      Attorney General.                                        Select agent and/or toxin. Unless
        An individual or entity may appeal a                     Biological agent. Any microorganism                otherwise specified, all of the biological
      denial, revocation, or suspension of                    (including, but not limited to, bacteria,             agents or toxins listed in §§ 121.3 and
      registration under this part. An                        viruses, fungi, rickettsiae, or protozoa),            121.4.
      individual may appeal a denial,                         or infectious substance, or any naturally                Specimen. Samples of material from
      limitation, or revocation of access                     occurring, bioengineered, or synthesized              humans, animals, plants, or the
      approval under this part.9 The appeal                   component of any such microorganism                   environment, or isolates or cultures
      must be in writing, state the factual                   or infectious substance, capable of                   from such samples, for diagnosis,
      basis for the appeal, and be submitted                  causing:                                              verification, or proficiency testing.
      to the Administrator within 30 calendar                    (1) Death, disease, or other biological               State. Any of the several States of the
      days of the decision. Where the denial,                 malfunction in a human, an animal, a                  United States, the Commonwealth of the
      revocation, or suspension of registration               plant, or another living organism;                    Northern Mariana Islands, the
      or the denial, limitation, or revocation                   (2) Deterioration of food, water,                  Commonwealth of Puerto Rico, the
      of an individual’s access approval is                   equipment, supplies, or material of any               District of Columbia, Guam, the Virgin
      based upon an identification by the                     kind; or                                              Islands of the United States, or any
      Attorney General, the request for review                   (3) Deleterious alteration of the                  other territory or possession of the
      will be forwarded to the Attorney                       environment.                                          United States.
      General. The Administrator’s decision                      Centers for Disease Control and                       Toxin. The toxic material or product
      constitutes final agency action.                        Prevention (CDC). The Centers for                     of plants, animals, microorganisms
                                                              Disease Control and Prevention of the                 (including, but not limited to, bacteria,
      Title 9—Animals and Animal Products                     U.S. Department of Health and Human                   viruses, fungi, rickettsiae, or protozoa),
                                                              Services.                                             or infectious substances, or a
      I   2. Revise part 121 to read as follows:                 Diagnosis. The analysis of specimens               recombinant or synthesized molecule,
                                                              for the purpose of identifying or                     whatever their origin and method of
      PART 121—POSSESSION, USE, AND                           confirming the presence or                            production, and includes:
      TRANSFER OF SELECT AGENTS AND                           characteristics of a select agent or toxin,              (1) Any poisonous substance or
      TOXINS                                                  provided that such analysis is directly               biological product that may be
      Sec.                                                    related to protecting the public health or            engineered as a result of biotechnology
      121.1 Definitions.                                      safety, animal health or animal                       produced by a living organism; or
      121.2 Purpose and scope.                                products, or plant health or plant                       (2) Any poisonous isomer or
      121.3 VS select agents and toxins.                      products.                                             biological product, homolog, or
      121.4 Overlap select agents and toxins.                    Entity. Any government agency                      derivative of such a substance.
      121.5 Exemptions for VS select agents and               (Federal, State, or local), academic                     United States. All of the States.
           toxins.                                            institution, corporation, company,                       USDA. The U.S. Department of
      121.6 Exemptions for overlap select agents              partnership, society, association, firm,
           and toxins.
                                                                                                                    Agriculture.
      121.7 Registration and related security risk
                                                              sole proprietorship, or other legal entity.              Verification. The demonstration of
           assessments.                                          HHS Secretary. The Secretary of the                obtaining established performance (e.g.,
      121.8 Denial, revocation, or suspension of              Department of Health and Human                        accuracy, precision, and the analytical
           registration.                                      Services or his or her designee, unless               sensitivity and specificity)
      121.9 Responsible official.                             otherwise specified.                                  specifications for any procedure used
      121.10 Restricting access to select agents                 HHS select agent and/or toxin. A                   for diagnosis.
           and toxins; security risk assessments.             biological agent or toxin listed in 42                   VS. The Veterinary Services Programs
      121.11 Security.                                        CFR 73.3.                                             of the Animal and Plant Health
      121.12 Biosafety.                                          Import. To move into, or the act of                Inspection Service.
      121.13 Restricted experiments.                          movement into, the territorial limits of                 VS select agent and/or toxin. A
      121.14 Incident response.
                                                              the United States.                                    biological agent or toxin listed in
      121.15 Training.
      121.16 Transfers.
                                                                 Interstate. From one State into or                 § 121.3.
      121.17 Records.                                         through any other State, or within the
                                                              District of Columbia, Guam, the Virgin                § 121.2   Purpose and scope.
      121.18 Inspections.
      121.19 Notification of theft, loss, or release.         Islands of the United States, or any                     This part implements the provisions
      121.20 Administrative review.                           other territory or possession of the                  of the Agricultural Bioterrorism
        Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80,           United States.                                        Protection Act of 2002 setting forth the
      and 371.4.                                                 Overlap select agent and/or toxin. A               requirements for possession, use, and
                                                              biological agent or toxin that is listed in           transfer of select agents and toxins. The
        9 An entity may not appeal the denial or              § 121.4 and 42 CFR 73.4.                              biological agents and toxins listed in
      limitation of an individual’s access to select agents      Permit. A written authorization by the             this part have the potential to pose a
      or toxins.                                              Administrator to import or move                       severe threat to public health and safety,


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      to animal health, or to animal products.     excluded from the requirements of this                           or release, and reports any theft, loss, or
      Overlap select agents and toxins are         part:                                                            release of such agent or toxin.
      subject to regulation by both APHIS and         (1) Any VS select agent or toxin that                            (3) The Federal law enforcement
      CDC.                                         is in its naturally occurring                                    agency reports the seizure of the select
                                                   environment, provided that the agent or                          agent or toxin to APHIS or CDC.
      § 121.3 VS select agents and toxins.         toxin has not been intentionally                                    (i) The seizure of any of the following
         (a) Except as provided in paragraphs      introduced, cultivated, collected, or                            VS select agents and toxins must be
      (d) and (e) of this section, the             otherwise extracted from its natural                             reported within 24 hours by telephone,
      Administrator has determined that the        source.                                                          facsimile, or e-mail: African horse
      biological agents and toxins listed in          (2) Nonviable VS select agents or                             sickness virus, African swine fever
      this section have the potential to pose      nonfunctional VS toxins.2                                        virus, avian influenza virus (highly
      a severe threat to animal health or to          (e) An attenuated strain of a VS select                       pathogenic), bovine spongiform
      animal products.                             agent or toxin may be excluded from the                          encephalopathy agent, classical swine
         (b) VS select agents and toxins:          requirements of this part based upon a                           fever virus, foot-and-mouth disease
         African horse sickness virus;             determination that the attenuated strain                         virus, Newcastle disease virus
         African swine fever virus;                does not pose a severe threat to animal                          (velogenic), rinderpest virus, and swine
         Akabane virus;                            health or to animal products.                                    vesicular disease virus. This report must
         Avian influenza virus (highly                (1) To apply for an exclusion, an                             be followed by submission of APHIS/
      pathogenic);                                 individual or entity must submit a                               CDC Form 4 within 7 calendar days
         Bluetongue virus (exotic);                written request and supporting                                   after seizure of the select agent or toxin.
         Bovine spongiform encephalopathy          scientific information. A written                                   (ii) For all other VS select agents or
      agent;                                       decision granting or denying the request                         toxins, APHIS/CDC Form 4 must be
         Camel pox virus;                          will be issued. An exclusion will be                             submitted within 7 calendar days after
         Classical swine fever virus;              effective upon notification of the                               seizure of the agent or toxin.
         Cowdria ruminantium (Heartwater);         applicant. Exclusions will be published                             (iii) A copy of APHIS/CDC Form 4
         Foot-and-mouth disease virus;                                                                              must be maintained for 3 years.
                                                   periodically in the notice section of the
         Goat pox virus;                                                                                               (4) The Federal law enforcement
                                                   Federal Register and will be listed on
         Japanese encephalitis virus;
                                                   the Internet at http://                                          agency reports the final disposition of
         Lumpy skin disease virus;
                                                   www.aphis.usda.gov/programs/                                     the select agent or toxin by submission
         Malignant catarrhal fever virus
                                                   ag_selectagent/index.html.                                       of APHIS/CDC Form 4. A copy of the
      (Alcelaphine herpesvirus type 1);
                                                      (2) If an excluded attenuated strain is                       completed form must be maintained for
         Menangle virus;
                                                   subjected to any manipulation that                               3 years.
         Mycoplasma capricolum/M. F38/M.
      mycoides capri (contagious caprine           restores or enhances its virulence, the
                                                                                                                    § 121.4   Overlap select agents and toxins.
      pleuropneumonia);                            resulting select agent or toxin will be
                                                   subject to the requirements of this part.                           (a) Except as provided in paragraphs
         Mycoplasma mycoides mycoides                                                                               (d) and (e) of this section, the
      (contagious bovine pleuropneumonia);            (3) An individual or entity may make
                                                   a written request to the Administrator                           Administrator has determined that the
         Newcastle disease virus (velogenic);                                                                       biological agents and toxins listed in
         Peste des petits ruminants virus;         for reconsideration of a decision
                                                   denying an exclusion application. The                            this section have the potential to pose
         Rinderpest virus;                                                                                          a severe threat to public health and
         Sheep pox virus;                          written request for reconsideration must
                                                   state the facts and reasoning upon                               safety, to animal health, or to animal
         Swine vesicular disease virus;                                                                             products.
         Vesicular stomatitis virus (exotic).      which the individual or entity relies to
                                                   show the decision was incorrect. The                                (b) Overlap select agents and toxins:
         (c) Genetic elements, recombinant                                                                             Bacillus anthracis;
      nucleic acids, and recombinant               Administrator will grant or deny the
                                                   request for reconsideration as promptly                             Botulinum neurotoxins;
      organisms:                                                                                                       Botulinum neurotoxin producing
         (1) Nucleic acids that can produce        as circumstances allow and will state, in
                                                   writing, the reasons for the decision.                           species of Clostridium;
      infectious forms of any of the select                                                                            Brucella abortus;
      agent viruses listed in paragraph (b) of        (f) Any VS select agent or toxin seized
                                                   by a Federal law enforcement agency                                 Brucella melitensis;
      this section. 1
                                                                                                                       Brucella suis;
         (2) Recombinant nucleic acids that        will be excluded from the requirements
                                                   of this part during the period between                              Burkholderia mallei;
      encode for the functional forms of any                                                                           Burkholderia pseudomallei;
      toxin listed in paragraph (b) of this        seizure of the agent or toxin and the
                                                   transfer or destruction of such agent or                            Clostridium perfringens epsilon toxin;
      section if the nucleic acids:                                                                                    Coccidioides immitis;
         (i) Can be expressed in vivo or in vitro; toxin provided that:                                                Coxiella burnetii;
      or                                              (1) As soon as practicable, the Federal
                                                                                                                       Eastern equine encephalitis virus;
         (ii) Are in a vector or recombinant       law enforcement agency transfers the
                                                                                                                       Francisella tularensis;
      host genome and can be expressed in          seized agent or toxin to an entity eligible
                                                                                                                       Hendra virus;
      vivo or in vitro.                            to receive such agent or toxin or
                                                                                                                       Nipah virus;
         (3) VS select agents and toxins listed    destroys the agent or toxin by a
                                                                                                                       Rift Valley fever virus;
      in paragraph (b) of this section that have recognized sterilization or inactivation                              Shigatoxin;
      been genetically modified.                   process.                                                            Staphylococcal enterotoxins;
         (d) VS select agents or toxins that          (2) The Federal law enforcement                                  T–2 toxin;
      meet any of the following criteria are       agency safeguards and secures the                                   Venezuelan equine encephalitis virus.
                                                   seized agent or toxin against theft, loss,                          (c) Genetic elements, recombinant
        1 The importation and interstate movement of VS
                                                                                                                    nucleic acids, and recombinant
      select agents or toxins listed in paragraphs (c)(1)       2 However, the importation and interstate

      through (c)(3) of this section may be subject to the    movement of these nonviable select agents may be
                                                                                                                    organisms:
      permit requirements under part 122 of this              subject to the permit requirements under part 122        (1) Nucleic acids that can produce
      subchapter.                                             of this subchapter.                                   infectious forms of any of the overlap


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      select agent viruses listed in paragraph                restores or enhances its virulence, the               contained in a specimen presented for
      (b) of this section.3                                   resulting overlap select agent or toxin               diagnosis or verification will be exempt
         (2) Recombinant nucleic acids that                   will be subject to the requirements of                from the requirements of this part for
      encode for the functional forms of any                  this part.                                            such agent or toxin contained in the
      overlap toxin listed in paragraph (b) of                  (3) An individual or entity may make                specimen, provided that:
      this section if the nucleic acids:                      a written request to the Administrator                   (1) Unless directed otherwise by the
         (i) Can be expressed in vivo or in vitro;            for reconsideration of a decision                     Administrator, within 7 calendar days
      or                                                      denying an exclusion application. The                 after identification, the agent or toxin is
         (ii) Are in a vector or recombinant                  written request for reconsideration must              transferred in accordance with § 121.16
      host genome and can be expressed in                     state the facts and reasoning upon                    or destroyed on-site by a recognized
      vivo or in vitro.                                       which the individual or entity relies to              sterilization or inactivation process;
         (3) Overlap select agents and toxins                 show the decision was incorrect. The                     (2) The agent or toxin is secured
      listed in paragraph (b) of this section                 Administrator will grant or deny the                  against theft, loss, or release during the
      that have been genetically modified.                    request for reconsideration as promptly               period between identification of the
         (d) Overlap select agents or toxins that             as circumstances allow and will state, in             agent or toxin and transfer or
      meet any of the following criteria are                  writing, the reasons for the decision.                destruction of such agent or toxin, and
      excluded from the requirements of this                    (f) Any overlap select agent or toxin               any theft, loss, or release of such agent
      part:                                                   seized by a Federal law enforcement                   or toxin is reported; and
         (1) Any overlap select agent or toxin                agency will be excluded from the                         (3) The identification of the agent or
      that is in its naturally occurring                      requirements of this part during the                  toxin is reported to APHIS or CDC.
      environment, provided that the agent or                 period between seizure of the agent or                   (i) The identification of any of the
      toxin has not been intentionally                        toxin and the transfer or destruction of              following select agents and toxins must
      introduced, cultivated, collected, or                   such agent or toxin provided that:                    be immediately reported by telephone,
      otherwise extracted from its natural                      (1) As soon as practicable, the Federal             facsimile, or e-mail: African horse
      source.                                                 law enforcement agency transfers the                  sickness virus, African swine fever
         (2) Nonviable overlap select agents or               seized agent or toxin to an entity eligible           virus, avian influenza virus (highly
      nonfunctional overlap toxins.4                          to receive such agent or toxin or                     pathogenic), bovine spongiform
         (3) Overlap toxins under the control                 destroys the agent or toxin by a                      encephalopathy agent, classical swine
      of a principal investigator, treating                   recognized sterilization or inactivation              fever virus, foot-and-mouth disease
      physician or veterinarian, or                           process.                                              virus, Newcastle disease virus
      commercial manufacturer or distributor,                   (2) The Federal law enforcement                     (velogenic), rinderpest virus, and swine
      if the aggregate amount does not, at any                agency safeguards and secures the                     vesicular disease virus. This report must
      time, exceed the following amounts: 0.5                 seized agent or toxin against theft, loss,            be followed by submission of APHIS/
      mg of Botulinum neurotoxins, 100 mg of                  or release, and reports any theft, loss, or           CDC Form 4 within 7 calendar days
      Clostridium perfringens epsilon toxin,                  release of such agent or toxin.                       after identification.
      100 mg of Shigatoxin, 5 mg of                             (3) The Federal law enforcement                        (ii) For all other VS select agents or
      Staphylococcal enterotoxins, and 1,000                  agency reports the seizure of the overlap             toxins, APHIS/CDC Form 4 must be
      mg of T–2 toxin.                                        select agent or toxin to APHIS or CDC.                submitted within 7 calendar days after
         (e) An attenuated strain of an overlap                 (i) The seizure of any of the following             identification.
      select agent or toxin may be excluded                   overlap select agents and toxins must be                 (iii) Less stringent reporting may be
      from the requirements of this part based                reported within 24 hours by telephone,                required during agricultural
      upon a determination that the                           facsimile, or e-mail: Bacillus anthracis,             emergencies or outbreaks, or in endemic
      attenuated strain does not pose a severe                Botulinum neurotoxins, Brucella                       areas.
      threat to public health and safety, to                  melitensis, Francisella tularensis,                      (iv) A copy of APHIS/CDC Form 4
      animal health, or to animal products.                   Hendra virus, Nipah virus, Rift Valley                must be maintained for 3 years.
         (1) To apply for an exclusion, an                    fever virus, and Venezuelan equine                       (b) Diagnostic laboratories and other
      individual or entity must submit a                      encephalitis virus. This report must be               entities that possess, use, or transfer a
      written request and supporting                          followed by submission of APHIS/CDC                   VS select agent or toxin that is
      scientific information. A written                       Form 4 within 7 calendar days after                   contained in a specimen presented for
      decision granting or denying the request                seizure of the overlap select agent or                proficiency testing will be exempt from
      will be issued. An exclusion will be                    toxin.                                                the requirements of this part for such
      effective upon notification of the                        (ii) For all other overlap select agents            agent or toxin contained in the
      applicant. Exclusions will be published                 or toxins, APHIS/CDC Form 4 must be                   specimen, provided that:
      periodically in the notice section of the               submitted within 7 calendar days after                   (1) Unless directed otherwise by the
      Federal Register and will be listed on                  seizure of the agent or toxin.                        Administrator, within 90 calendar days
      the Internet at http://                                   (iii) A copy of APHIS/CDC Form 4                    of receipt, the agent or toxin is
      www.aphis.usda.gov/programs/                            must be maintained for 3 years.                       transferred in accordance with § 121.16
      ag_selectagent/index.html.                                (4) The Federal law enforcement                     or destroyed on-site by a recognized
         (2) If an excluded attenuated strain is              agency reports the final disposition of               sterilization or inactivation process;
                                                              the overlap select agent or toxin by                     (2) The agent or toxin is secured
      subjected to any manipulation that
                                                              submission of APHIS/CDC Form 4. A                     against theft, loss, or release during the
         3 The importation and interstate movement of         copy of the completed form must be                    period between identification of the
      overlap select agents or toxins listed in paragraphs    maintained for 3 years.                               agent or toxin and transfer or
      (c)(1) through (c)(3) of this section may be subject                                                          destruction of such agent or toxin, and
      to the permit requirements under part 122 of this       § 121.5 Exemptions for VS select agents               any theft, loss, or release of such agent
      subchapter.                                             and toxins.
         4 However, the importation and interstate
                                                                                                                    or toxin is reported; and
      movement of these nonviable overlap select agents
                                                                (a) Diagnostic laboratories and other                  (3) The identification of the agent or
      may be subject to the permit requirements under         entities that possess, use, or transfer a             toxin, and its derivative, is reported to
      part 122 of this subchapter.                            VS select agent or toxin that is                      APHIS or CDC. To report the


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      identification of a select agent or toxin,              the exemption was wrongfully denied.                  § 121.16 or 42 CFR 73.16 or destroyed
      APHIS/CDC Form 4 must be submitted                      The Administrator will grant or deny                  on-site by a recognized sterilization or
      within 90 days of receipt of the agent or               the request for reconsideration as                    inactivation process;
      toxin. A copy of the completed form                     promptly as circumstances allow and                      (2) The agent or toxin is secured
      must be maintained for 3 years.                         will state, in writing, the reasons for the           against theft, loss, or release during the
         (c) Diagnostic reagents and vaccines                 decision.                                             period between identification of the
      that are, bear, or contain VS select                                                                          agent or toxin and transfer or
      agents or toxins that are produced at                   § 121.6 Exemptions for overlap select                 destruction of such agent or toxin, and
      USDA diagnostic facilities will be                      agents and toxins.
                                                                                                                    any theft, loss, or release of such agent
      exempt from the requirements of this                       (a) Clinical or diagnostic laboratories            or toxin is reported; and
      part.                                                   and other entities that possess, use, or                 (3) The identification of the agent or
         (d) Unless the Administrator by order                transfer an overlap select agent or toxin             toxin, and its derivative, is reported to
      determines that additional regulation is                that is contained in a specimen                       APHIS or CDC. To report the
      necessary to protect animal health or                   presented for diagnosis or verification               identification of an overlap select agent
      animal products, products that are, bear,               will be exempt from the requirements of               or toxin, APHIS/CDC Form 4 must be
      or contain VS select agents or toxins                   this part for such agent or toxin                     submitted within 90 calendar days of
      will be exempt from the requirements of                 contained in the specimen, provided                   receipt of the agent or toxin. A copy of
      this part if the products have been                     that:                                                 the completed form must be maintained
      cleared, approved, licensed, or                            (1) Unless directed otherwise by the               for 3 years.
      registered pursuant to:                                 Administrator or the HHS Secretary,                      (c) Unless the Administrator by order
         (1) The Federal Food, Drug, and                      within 7 calendar days after                          determines that additional regulation of
      Cosmetic Act (21 U.S.C. 301 et seq.);                   identification, the agent or toxin is                 a specific product is necessary to protect
         (2) Section 351 of Public Health                     transferred in accordance with § 121.16               animal health or animal products,
      Service Act (42 U.S.C. 262);                            or 42 CFR 73.16 or destroyed on-site by               products that are, bear, or contain
         (3) The Virus-Serum-Toxin Act (21                    a recognized sterilization or inactivation            overlap select agents or toxins will be
      U.S.C. 151–159); or                                     process;                                              exempt from the requirements of this
         (4) The Federal Insecticide,                            (2) The agent or toxin is secured                  part if the products have been cleared,
      Fungicide, and Rodenticide Act (7                       against theft, loss, or release during the            approved, licensed, or registered
      U.S.C. 131 et seq.).                                    period between identification of the                  pursuant to:
         (e) The Administrator may exempt                     agent or toxin and transfer or                           (1) The Federal Food, Drug, and
      from the requirements of this part an                   destruction of such agent or toxin, and               Cosmetic Act (21 U.S.C. 301 et seq.);
      experimental product that is, bears, or                 any theft, loss, or release of such agent                (2) Section 351 of Public Health
      contains a VS select agent or toxin if                  or toxin is reported; and                             Service Act (42 U.S.C. 262);
      such product is being used in an                           (3) The identification of the agent or                (3) The Virus-Serum-Toxin Act (21
      investigation authorized by any Federal                 toxin is reported to APHIS or CDC.                    U.S.C. 151–159); or
      law and the Administrator determines                       (i) The identification of any of the                  (4) The Federal Insecticide,
      that additional regulation under this                   following overlap select agents and                   Fungicide, and Rodenticide Act (7
      part is not necessary to protect animal                 toxins must be immediately reported by                U.S.C. 131 et seq.).
      health or animal products. To apply for                 telephone, facsimile, or e-mail: Bacillus                (d) After consultation with the HHS
      an exemption, an individual or entity                   anthracis, Botulinum neurotoxins,                     Secretary, the Administrator may
      must submit APHIS/CDC Form 5. A                         Brucella melitensis, Francisella                      exempt from the requirements of this
      written decision granting or denying the                tularensis, Hendra virus, Nipah virus,                part an investigational product that is,
      exemption will be issued. The applicant                 Rift Valley fever virus, and Venezuelan               bears, or contains an overlap select
      must notify APHIS when an                               equine encephalitis virus. This report                agent or toxin if such product is being
      authorization for an investigation no                   must be followed by submission of                     used in an investigation authorized by
      longer exists. This exemption                           APHIS/CDC Form 4 within 7 calendar                    any Federal law and the Administrator
      automatically terminates when such                      days after identification.                            determines that additional regulation
      authorization is no longer in effect.                      (ii) For all other overlap select agents           under this part is not necessary to
         (f) In addition to the exemptions                    or toxins, APHIS/CDC Form 4 must be                   protect animal health or animal
      provided in paragraphs (a) through (e) of               submitted within 7 calendar days after                products.
      this section, the Administrator may                     identification.                                          (1) To apply for an exemption, an
      grant a specific exemption upon a                          (iii) Less stringent reporting may be              individual or entity must submit
      showing of good cause and upon his or                   required during agricultural                          APHIS/CDC Form 5.
      her determination that such exemption                   emergencies or outbreaks, or in endemic                  (2) The Administrator will make a
      is consistent with protecting animal                    areas.                                                determination regarding an exemption
      health or animal products. An                              (iv) A copy of APHIS/CDC Form 4                    within 14 calendar days after receipt of
      individual or entity may request in                     must be maintained for 3 years.                       the application and notification that the
      writing an exemption from the                              (b) Clinical or diagnostic laboratories            investigation has been authorized under
      requirements of this part. If granted,                  and other entities that possess, use, or              a Federal law. A written decision
      such exemptions are valid for a                         transfer an overlap select agent or toxin             granting or denying the exemption will
      maximum of 3 years; thereafter, an                      that is contained in a specimen                       be issued.
      individual or entity must request a new                 presented for proficiency testing will be                (3) The applicant must notify APHIS
      exemption. If a request for exemption is                exempt from the requirements of this                  or CDC when an authorization for an
      denied, an individual or entity may                     part for such agent or toxin contained in             investigation no longer exists. This
      request reconsideration in writing to the               the specimen, provided that:                          exemption automatically terminates
      Administrator. The request for                             (1) Unless directed otherwise by the               when such authorization is no longer in
      reconsideration must state all of the                   Administrator or the HHS Secretary,                   effect.
      facts and reasons upon which the                        within 90 days of receipt, the agent or                  (e) The Administrator may exempt an
      individual or entity relies to show that                toxin is transferred in accordance with               individual or entity from the


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      13288                Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations

      requirements of this part for 30 calendar               to own or control the entity if the                   able to perform the responsibilities
      days if it is necessary to respond to a                 individual is in a managerial or                      required in this part, for specific select
      domestic or foreign agricultural                        executive capacity with regard to the                 agents or toxins, and for specific
      emergency involving an overlap select                   entity’s select agents or toxins or with              activities.
      agent or toxin. The Administrator may                   regard to the individuals with access to                 (h) A certificate of registration may be
      extend the exemption once for an                        the select agents or toxins possessed,                amended to reflect changes in
      additional 30 days. An individual or                    used, or transferred by the entity.                   circumstances (e.g., replacement of the
      entity may apply for this exemption by                     (ii) For entities other than institutions          responsible official or other personnel
      submitting APHIS/CDC Form 5. A                          of higher education, an individual will               changes, changes in ownership or
      written decision granting or denying the                be deemed to own or control the entity                control of the entity, changes in the
      exemption will be issued.                               if the individual:                                    activities involving any select agents or
        (f) Upon request of the Secretary of                     (A) Owns 50 percent or more of the                 toxins, or the addition or removal of
      Health and Human Services, the                          entity, or is a holder or owner of 50                 select agents or toxins).
      Administrator may exempt an                             percent or more of its voting stock; or                  (1) Prior to any change, the
      individual or entity from the                              (B) Is in a managerial or executive                responsible official must apply for an
      requirements of this part for 30 calendar               capacity with regard to the entity’s                  amendment to a certificate of
      days if the Secretary of Health and                     select agents or toxins or with regard to             registration by submitting the relevant
      Human Services has granted an                           the individuals with access to the select             page(s) of the registration application.6
      exemption for a public health                           agents or toxins possessed, used, or                     (2) The responsible official will be
      emergency involving an overlap select                   transferred by the entity.                            notified in writing if an application to
      agent or toxin. The Administrator may                      (4) An entity will be considered to be             amend a certificate of registration has
      extend the exemption once for an                        an institution of higher education if it is           been approved. Approval of an
      additional 30 days.                                     an institution of higher education as                 amendment may be contingent upon an
                                                              defined in section 101(a) of the Higher               inspection or submission of additional
      § 121.7 Registration and related security               Education Act of 1965 (20 U.S.C.
      risk assessments.                                                                                             information, such as the security plan,
                                                              1001(a)), or is an organization described             biosafety plan, incident response plan,
         (a) Unless exempted under § 121.5, an                in 501(c)(3) of the Internal Revenue                  or any other documents required to be
      individual or entity shall not possess,                 Code of 1986, as amended (26 U.S.C.                   prepared under this part.
      use, or transfer any VS select agent or                 501(c)(3)).                                              (3) No change may be made without
      toxin without a certificate of registration                (5) To obtain a security risk                      such approval.
      issued by the Administrator. Unless                     assessment, an individual or entity must                 (i) An entity must immediately notify
      exempted under § 121.6 or 42 CFR 73.6,                  submit the information necessary to                   APHIS or CDC if it loses the services of
      an individual or entity shall not possess,              conduct a security risk assessment to                 its responsible official. In the event that
      use, or transfer any overlap select agent               the Attorney General.                                 an entity loses the services of its
      or toxin without a certificate of                          (d) To apply for a certificate of                  responsible official, an entity may
      registration issued by the Administrator                registration for only VS select agents or             continue to possess or use select agents
      and the HHS Secretary.                                  toxins, or for VS and PPQ select agents               or toxins only if it appoints as the
         (b) As a condition of registration, each             or toxins, an individual or entity must               responsible official another individual
      entity must designate an individual to                  submit the information requested in the               who has been approved by the
      be its responsible official. While most                 registration application package
      registrants are likely to be entities, in                                                                     Administrator or the HHS Secretary
                                                              (APHIS/CDC Form 1) to APHIS. To                       following a security risk assessment by
      the event that an individual applies for                apply for a certificate of registration for
      and is granted a certificate of                                                                               the Attorney General and who meets the
                                                              overlap select agents or toxins, overlap              requirements of this part.
      registration, the individual will be                    select agents or toxins and any                          (j) A certificate of registration will be
      considered the responsible official.                    combination of PPQ or VS select agents
         (c)(1) As a condition of registration,                                                                     terminated upon the written request of
                                                              or toxins, or HHS select agents or toxins             the entity if the entity no longer
      the following must be approved by the
                                                              and any combination of PPQ or VS                      possesses or uses any select agents or
      Administrator or the HHS Secretary
                                                              select agents or toxins, an individual or             toxins and no longer wishes to be
      based on a security risk assessment by
                                                              entity must submit the information                    registered.
      the Attorney General:
         (i) The individual or entity;                        requested in the registration application                (k) A certificate of registration will be
         (ii) The responsible official; and                   package (APHIS/CDC Form 1) to APHIS                   valid for a maximum of 3 years.
         (iii) Unless otherwise exempted under                or CDC, but not both.
                                                                 (e) Prior to the issuance of a certificate         § 121.8 Denial, revocation, or suspension
      this section, any individual who owns                                                                         of registration.
      or controls the entity.                                 of registration, the responsible official
         (2) Federal, State, or local                         must promptly provide notification of                   (a) An application may be denied or
      governmental agencies, including public                 any changes to the application for                    a certificate of registration revoked or
      accredited academic institutions, are                   registration by submitting the relevant               suspended if:
                                                              page(s) of the registration application.                (1) The individual or entity, the
      exempt from the security risk
                                                                 (f) The issuance of a certificate of               responsible official, or an individual
      assessments for the entity and the
                                                              registration may be contingent upon                   who owns or controls the entity is
      individual who owns or controls such
                                                              inspection or submission of additional                within any of the categories described in
      entity.
         (3) An individual will be deemed to                  information, such as the security plan,               18 U.S.C. 175b;
                                                              biosafety plan, incident response plan,                 (2) The individual or entity, the
      own or control an entity under the
                                                              or any other documents required to be                 responsible official, or an individual
      following conditions: 5
         (i) For a private institution of higher              prepared under this part.
                                                                                                                      6 Depending on the change, a security risk
      education, an individual will be deemed                    (g) A certificate of registration will be
                                                                                                                    assessment by the Attorney General may also be
                                                              valid for one physical location (a room,              required (e.g., replacement of the responsible
        5 These conditions may apply to more than one         a building, or a group of buildings)                  official, changes in ownership or control of the
      individual.                                             where the responsible official will be                entity, new researchers or graduate students, etc.)



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      who owns or controls the entity is                         (b) An entity may designate one or                 following a security risk assessment by
      reasonably suspected by any Federal                     more individuals to be an alternate                   the Attorney General.
      law enforcement or intelligence agency                  responsible official, who may act for the                (b) An individual will be deemed to
      of:                                                     responsible official in his/her absence.              have access at any point in time if the
         (i) Committing a crime set forth in 18               These individuals must have the                       individual has possession of a select
      U.S.C. 2332b(g)(5); or                                  authority and control to ensure                       agent or toxin (e.g., carries, uses, or
         (ii) Knowing involvement with an                     compliance with the regulations when                  manipulates) or the ability to gain
      organization that engages in domestic or                acting as the responsible official.                   possession of a select agent or toxin.
      international terrorism (as defined in 18                  (c) The responsible official must                     (c) Each individual with access to
      U.S.C. 2331) or with any other                          report the identification and final                   select agents or toxins must have the
      organization that engages in intentional                disposition of any select agent or toxin              appropriate education, training, and/or
      crimes of violence; or                                  contained in a specimen presented for                 experience to handle or use such agents
         (iii) Being an agent of a foreign power              diagnosis or verification.                            or toxins.
      as defined in 50 U.S.C. 1801;                                                                                    (d) To apply for access approval, each
                                                                 (1) The identification of any of the
         (3) The individual or entity does not                                                                      individual must submit the information
                                                              following select agents or toxins must be             necessary to conduct a security risk
      meet the requirements of this part; 7 or                immediately reported by telephone,
         (4) It is determined that such action                                                                      assessment to the Attorney General.
                                                              facsimile, or e-mail: African horse                      (e) An individual’s security risk
      is necessary to protect animal health or                sickness virus, African swine fever
      animal products.                                                                                              assessment may be expedited upon
                                                              virus, avian influenza virus (highly                  written request by the responsible
         (b) Upon revocation or suspension of                 pathogenic), Bacillus anthracis,
      a certificate of registration, the                                                                            official and a showing of good cause
                                                              Botulinum neurotoxins, bovine                         (e.g., public health or agricultural
      individual or entity must:                              spongiform encephalopathy agent,
         (1) Immediately stop all use of each                                                                       emergencies, national security, or a
                                                              Brucella melitensis, classical swine                  short-term visit by a prominent
      select agent or toxin covered by the                    fever virus, foot-and-mouth disease
      revocation or suspension order;                                                                               researcher). A written decision granting
                                                              virus, Francisella tularensis, Hendra                 or denying the request will be issued.
         (2) Immediately safeguard and secure                 virus, Newcastle disease virus
      each select agent or toxin covered by the                                                                        (f) An individual’s access approval for
                                                              (velogenic), Nipah virus, Rift Valley                 VS select agents or toxins may be
      revocation or suspension order from                     fever virus, rinderpest virus, swine
      theft, loss, or release; and                                                                                  denied, limited, or revoked if:
                                                              vesicular disease virus, and Venezuelan                  (1) The individual is within any of the
         (3) Comply with all disposition                      equine encephalitis virus. The final                  categories described in 18 U.S.C. 175b;
      instructions issued by the Administrator                disposition of the agent or toxin must be                (2) The individual is reasonably
      for each select agent or toxin covered by               reported by submission of APHIS/CDC                   suspected by any Federal law
      the revocation or suspension.                           Form 4 within 7 calendar days after                   enforcement or intelligence agency of
         (c) Denial of an application for                     identification. A copy of the completed               committing a crime set forth in 18
      registration and revocation of                          form must be maintained for 3 years.                  U.S.C. 2332b(g)(5); knowing
      registration may be appealed under                                                                            involvement with an organization that
                                                                 (2) To report the identification and
      § 121.20. However, any denial of an                                                                           engages in domestic or international
                                                              final disposition of any other select
      application for registration or revocation                                                                    terrorism (as defined in 18 U.S.C. 2331)
                                                              agent or toxin, APHIS/CDC Form 4 must
      of a certificate of registration will                                                                         or with any other organization that
                                                              be submitted within 7 calendar days
      remain in effect until a final agency                                                                         engages in intentional crimes of
                                                              after identification. A copy of the
      decision has been rendered.                                                                                   violence; or being an agent of a foreign
                                                              completed form must be maintained for
      § 121.9   Responsible official.                         3 years.                                              power as defined in 50 U.S.C. 1801; or
                                                                 (3) Less stringent reporting may be                   (3) It is determined that such action
        (a) An individual or entity required to                                                                     is necessary to protect animal health or
      register under this part must designate                 required during agricultural
                                                              emergencies or outbreaks, or in endemic               animal products.
      an individual to be the responsible                                                                              (g) For overlap select agents or toxins,
      official. The responsible official must:                areas.
                                                                                                                    an individual’s access approval will be
        (1) Be approved by the Administrator                     (d) The responsible official must                  denied or revoked if the individual is
      or the HHS Secretary following a                        report the identification and final                   within any of the categories described in
      security risk assessment by the Attorney                disposition of any select agent or toxin              18 U.S.C. 175b. An individual’s access
      General;                                                contained in a specimen presented for                 approval may be denied, limited, or
        (2) Be familiar with the requirements                 proficiency testing. To report the                    revoked for the reasons set forth in
      of this part;                                           identification and final disposition of a             paragraphs (f)(2) through (f)(3) of this
        (3) Have authority and responsibility                 select agent or toxin, APHIS/CDC Form                 section.
      to act on behalf of the entity;                         4 must be submitted within 90 calendar                   (h) An individual may appeal the
        (4) Ensure compliance with the                        days of receipt of the agent or toxin. A              Administrator’s decision to deny, limit,
      requirements of this part; and                          copy of the completed form must be                    or revoke access approval under
        (5) Ensure that annual inspections are                maintained for 3 years.                               § 121.20.
      conducted for each laboratory where                                                                              (i) Access approval is valid for a
      select agents or toxins are stored or used              § 121.10 Restricting access to select
                                                              agents and toxins; security risk                      maximum of 5 years.
      in order to determine compliance with                                                                            (j) The responsible official must
                                                              assessments.
      the requirements of this part. The                                                                            immediately notify APHIS or CDC when
      results of each inspection must be                         (a) An individual or entity required to            an individual’s access to select agents or
      documented, and any deficiencies                        register under this part may not provide              toxins is terminated by the entity and
      identified during an inspection must be                 an individual access to a select agent or             the reasons therefore.
      corrected.                                              toxin, and an individual may not access
                                                              a select agent or toxin, unless the                   § 121.11   Security.
           registration is denied for this reason, we may
        7 If                                                  individual is approved by the                           (a) An individual or entity required to
      provide technical assistance and guidance.              Administrator or the HHS Secretary                    register under this part must develop


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      and implement a written security plan.                  and provisions for safeguarding against               Biomedical Laboratories.’’ This
      The security plan must be sufficient to                 theft, loss, or release; and                          document may be obtained from the
      safeguard the select agent or toxin                        (6) Require that individuals with                  U.S. Government Printing Office. It is
      against unauthorized access, theft, loss,               access approval from the Administrator                also available on the Internet at http://
      or release.                                             or the HHS Secretary refrain from                     www.aphis.usda.gov/programs/
         (b) The security plan must be                        sharing with any other person their                   ag_selectagent/index.html.
      designed according to a site-specific risk              unique means of accessing a select agent                 (2) The Occupational Safety and
      assessment and must provide graded                      or toxin (e.g., keycards or passwords);               Health Administration (OSHA)
      protection in accordance with the risk of                  (7) Require that individuals with                  regulations in 29 CFR 1910.1200 and
      the select agent or toxin, given its                    access approval from the Administrator                1910.1450.
      intended use. The security plan must be                 or the HHS Secretary immediately                         (3) The ‘‘NIH Guidelines for Research
      submitted upon request.                                 report any of the following to the                    Involving Recombinant DNA
         (c) The security plan must:                          responsible official:                                 Molecules.’’ This document is available
         (1) Describe procedures for physical                    (i) Any loss or compromise of keys,                on the Internet at http://
      security, inventory control, and                        passwords, combinations, etc.;                        www.aphis.usda.gov./programs/
      information systems control;                               (ii) Any suspicious persons or                     ag_selectagent/index.html.
         (2) Contain provisions for the control               activities;                                              (d) The plan must be reviewed
      of access to select agents and toxins;                     (iii) Any loss or theft of select agents           annually and revised as necessary.
         (3) Contain provisions for routine                   or toxins;                                            Drills or exercises must be conducted at
      cleaning, maintenance, and repairs;                        (iv) Any release of a select agent or              least annually to test and evaluate the
         (4) Establish procedures for removing                toxin; and                                            effectiveness of the plan. The plan must
      unauthorized or suspicious persons;                        (v) Any sign that inventory or use
                                                                                                                    be reviewed and revised, as necessary,
         (5) Describe procedures for addressing               records for select agents or toxins have
                                                                                                                    after any drill or exercise and after any
      loss or compromise of keys, passwords,                  been altered or otherwise compromised;
                                                                                                                    incident.
      combinations, etc. and protocols for                    and
      changing access numbers or locks                           (8) Separate areas where select agents             § 121.13   Restricted experiments.9
      following staff changes;                                and toxins are stored or used from the                  (a) An individual or entity may not
         (6) Contain procedures for reporting                 public areas of the building.                         conduct a restricted experiment with a
                                                                 (e) In developing a security plan, an              VS select agent or toxin unless approved
      unauthorized or suspicious persons or
                                                              individual or entity should consider the              by and conducted in accordance with
      activities, loss or theft of select agents or
                                                              document entitled, ‘‘Laboratory Security              any conditions prescribed by the
      toxins, release of select agents or toxins,
                                                              and Emergency Response Guidance for                   Administrator. In addition, an
      or alteration of inventory records; and
         (7) Contain provisions for ensuring                  Laboratories Working with Select                      individual or entity may not conduct a
      that all individuals with access approval               Agents,’’ in Morbidity and Mortality                  restricted experiment with an overlap
      from the Administrator or the HHS                       Weekly Report (December 6, 2002); 51                  select agent or toxin unless approved by
      Secretary understand and comply with                    (No. RR–19):1–6. This document is                     and conducted in accordance with any
      the security procedures.                                available on the Internet at http://                  conditions prescribed by the
         (d) An individual or entity must                     www.cdc.gov/mmwr.                                     Administrator and the HHS Secretary.
                                                                 (f) The plan must be reviewed                        (b) Restricted experiments:
      adhere to the following security
                                                              annually and revised as necessary.                      (1) Experiments utilizing recombinant
      requirements or implement measures to
                                                              Drills or exercises must be conducted at              DNA that involve the deliberate transfer
      achieve an equivalent or greater level of
                                                              least annually to test and evaluate the               of a drug resistance trait to select agents
      security:
         (1) Allow access only to individuals                 effectiveness of the plan. The plan must              that are not known to acquire the trait
      with access approval from the                           be reviewed and revised, as necessary,                naturally, if such acquisition could
      Administrator or the HHS Secretary;                     after any drill or exercise and after any             compromise the use of the drug to
         (2) Allow individuals not approved                   incident.                                             control disease agents in humans,
      for access by the Administrator or the                  § 121.12    Biosafety.                                veterinary medicine, or agriculture.
      HHS Secretary to conduct routine                                                                                (2) Experiments involving the
                                                                 (a) An individual or entity required to
      cleaning, maintenance, repairs, and                                                                           deliberate formation of recombinant
                                                              register under this part must develop
      other activities not related to select                                                                        DNA containing genes for the
                                                              and implement a written biosafety plan
      agents or toxins only when                                                                                    biosynthesis of toxins lethal for
                                                              that is commensurate with the risk of
      continuously escorted by an approved                                                                          vertebrates at an LD50 <100 ng/kg body
                                                              the select agent or toxin, given its
      individual;                                                                                                   weight.
                                                              intended use.8 The biosafety plan must                  (c) The Administrator may revoke
         (3) Provide for the control of select                contain sufficient information and
      agents and toxins by requiring freezers,                                                                      approval to conduct any of the
                                                              documentation to describe the biosafety               experiments in paragraph (b) of this
      refrigerators, cabinets, and other                      and containment procedures.
      containers where select agents or toxins                                                                      section, or revoke or suspend a
                                                                 (b) The biosafety and containment
      are stored to be secured against                                                                              certificate of registration, if the
                                                              procedures must be sufficient to contain
      unauthorized access (e.g., card access                                                                        individual or entity fails to comply with
                                                              the select agent or toxin (e.g., physical
      system, lock boxes);                                                                                          the requirements of this part.
                                                              structure and features of the entity, and               (d) To apply for approval to conduct
         (4) Inspect all suspicious packages                  operational and procedural safeguards).
      before they are brought into or removed                                                                       any of the experiments in paragraph (b)
                                                                 (c) In developing a biosafety plan, an
      from an area where select agents or                                                                           of this section, an individual or entity
                                                              individual or entity should consider the
      toxins are used or stored;                                                                                    must submit a written request and
                                                              following:
         (5) Establish a protocol for intra-entity               (1) The CDC/NIH publication,                         9 For guidance, see the NIH publication, ‘‘NIH
      transfers under the supervision of an                   ‘‘Biosafety in Microbiological and                    Guidelines for Research Involving Recombinant
      individual with access approval from                                                                          DNA Molecules.’’ This document is available on the
      the Administrator or the HHS Secretary,                   8 Technical assistance and guidance may be          Internet at http://www.aphis.usda.gov/programs/
      including chain-of-custody documents                    obtained by contacting APHIS.                         ag_selectagent/index.html.



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                           Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations                                          13291

      supporting scientific information. A                    least annually to test and evaluate the                  (iii) Is transferring the select agent or
      written decision granting or denying the                effectiveness of the plan. The plan must              toxin from outside of the United States
      request will be issued.                                 be reviewed and revised, as necessary,                and meets all import requirements.
                                                              after any drill or exercise and after any                (2) At the time of transfer, the
      § 121.14    Incident response.10                        incident.                                             recipient has a certificate of registration
         (a) An individual or entity required to                                                                    that includes the particular select agent
      register under this part must develop                   § 121.15    Training.
                                                                                                                    or toxin to be transferred and meets all
      and implement a written incident                           (a) An individual or entity required to            of the requirements of this part.
      response plan.11 The incident response                  register under this part must provide                    (c) A select agent or toxin that is
      plan must be coordinated with any                       information and training on biosafety                 contained in a specimen for proficiency
      entity-wide plans, kept in the                          and security to each individual with                  testing may be transferred without prior
      workplace, and available to employees                   access approval from the Administrator                authorization from APHIS or CDC
      for review.                                             or the HHS Secretary before he/she has                provided that, at least 7 calendar days
         (b) The incident response plan must                  such access. In addition, an individual               prior to the transfer, the sender reports
      fully describe the entity’s response                    or entity must provide information and                to APHIS or CDC the select agent or
      procedures for the theft, loss, or release              training on biosafety and security to                 toxin to be transferred and the name and
      of a select agent or toxin; inventory                   each individual not approved for access               address of the recipient.
      discrepancies; security breaches                        by the Administrator or the HHS                          (d) On a case-by-case basis, the
      (including information systems); severe                 Secretary before he/she works in or                   Administrator may authorize a transfer
      weather and other natural disasters;                    visits areas where select agents or toxins            of a select agent or toxin not otherwise
      workplace violence; bomb threats and                    are handled or stored (e.g., laboratories,            eligible for transfer under this part
      suspicious packages; and emergencies                    growth chambers, animal rooms,                        under conditions prescribed by the
      such as fire, gas leak, explosion, power                greenhouses, storage areas, etc.). The                Administrator.
      outage, etc. The response procedures                    training must address the particular                     (e) To obtain authorization for a
      must account for hazards associated                     needs of the individual, the work they                transfer, APHIS/CDC Form 2 must be
      with the select agent or toxin and                      will do, and the risks posed by the                   submitted.
      appropriate actions to contain such                     select agents or toxins.12                               (f) The recipient must submit a
      agent or toxin.                                            (b) Refresher training must be
         (c) The incident response plan must                                                                        completed APHIS/CDC Form 2 within 2
                                                              provided annually.                                    business days of receipt of a select agent
      also contain the following information:
         (1) The name and contact information                    (c) A record of the training provided              or toxin.
      (e.g., home and work) for the individual                to each individual must be maintained.                   (g) The recipient must immediately
      or entity (e.g., responsible official,                  The record must include the name of                   notify APHIS or CDC if the select agent
      alternate responsible official(s),                      the individual, the date of training, a               or toxin has not been received within 48
      biosafety officer, etc.);                               description of the training provided,                 hours after the expected delivery time or
         (2) The name and contact information                 and the means used to verify that the                 if the package containing the select
      for the building owner and/or manager,                  employee understood the training.                     agent or toxin has been damaged to the
      where applicable;                                                                                             extent that a release of the select agent
                                                              § 121.16    Transfers.
         (3) The name and contact information                                                                       or toxin may have occurred.
      for tenant offices, where applicable;                      (a) Except as provided in paragraphs                  (h) An authorization for a transfer
         (4) The name and contact information                 (c) and (d) of this section, a select agent           shall be valid only for 30 calendar days
      for the physical security official for the              or toxin may only be transferred to                   after issuance, except that such an
      building, where applicable;                             individuals or entities registered to                 authorization becomes immediately null
         (5) Personnel roles and lines of                     possess, use, or transfer that agent or               and void if any facts supporting the
      authority and communication;                            toxin. A select agent or toxin may only               authorization change (e.g., change in the
         (6) Planning and coordination with                   be transferred under the conditions of                certificate of registration for the sender
      local emergency responders;                             this section and must be authorized by                or recipient, change in the application
         (7) Procedures to be followed by                     APHIS or CDC prior to the transfer.13                 for transfer).
      employees performing rescue or medical                     (b) In addition to any permit required                (i) The sender must comply with all
      duties;                                                 under part 122 of this subchapter, a                  applicable laws governing packaging
         (8) Emergency medical treatment and                  transfer may be authorized if:                        and shipping.
      first aid;                                                 (1) The sender:
         (9) A list of personal protective and                                                                      § 121.17   Records.
                                                                 (i) Has at the time of transfer a
      emergency equipment, and their                          certificate of registration that covers the              (a) An individual or entity required to
      locations;                                              particular select agent or toxin to be                register under this part must maintain
         (10) Site security and control;                      transferred and meets all the                         complete records relating to the
         (11) Procedures for emergency                        requirements of this part;                            activities covered by this part. Such
      evacuation, including type of                                                                                 records must include:
                                                                 (ii) Meets the exemption requirements
      evacuation, exit route assignments, safe                                                                         (1) An accurate, current inventory for
                                                              for the particular select agent or toxin to
      distances, and places of refuge; and                                                                          each select agent (including viral
         (12) Decontamination procedures.                     be transferred; or
                                                                                                                    genetic elements, recombinant nucleic
         (d) The plan must be reviewed                                                                              acids, and recombinant organisms) held
                                                                 12 For guidance, see the CDC/NIH publication,
      annually and revised as necessary.                                                                            in long-term storage (placement in a
                                                              ‘‘Biosafety in Microbiological and Biomedical
      Drills or exercises must be conducted at                Laboratories.’’ This document is available on the     system designed to ensure viability for
                                                              Internet at http://www.aphis.usda.gov/programs/       future use, such as in a freezer or
        10 Nothing in this section is meant to supersede      ag_selectagent/index.html.                            lyophilized materials), including:
      or preempt incident response requirements                  13 The requirements of this section do not apply
      imposed by other statutes or regulations.               to transfers within a registered entity (i.e., the
                                                                                                                       (i) The name and characteristics (e.g.,
        11 Technical assistance and guidance may be           sender and the recipient are covered by the same      strain designation, GenBank Accession
      obtained by contacting APHIS.                           certificate of registration).                         number, etc.);


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      13292                Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations

        (ii) The quantity acquired from                       (Responsible official), § 121.11 or 42                discovery of a release of a select agent
      another individual or entity (e.g.,                     CFR 73.11 (Security), § 121.12 or 42 CFR              or toxin causing occupational exposure
      containers, vials, tubes, etc.), date of                73.12 (Biosafety), § 121.14 or 42 CFR                 or a release of a select agent or toxin
      acquisition, and the source;                            73.14 (Incident response), and § 121.15               outside of the primary barriers of the
        (iii) Where stored (e.g., building,                   or 42 CFR 73.15 (Training); and                       biocontainment area.
      room, and freezer);                                       (6) A written explanation of any                       (1) The release of a select agent or
        (iv) When moved from storage and by                   discrepancies.                                        toxin must be reported by telephone,
      whom and when returned to storage and                     (b) The individual or entity must                   facsimile, or e-mail. The following
      by whom;                                                implement a system to ensure that all                 information must be provided:
        (v) The select agent used and purpose                 records and databases created under this                 (i) The name of the select agent or
      of use;                                                 part are accurate, have controlled
        (vi) Records created under § 121.16 or                                                                      toxin and any identifying information
                                                              access, and that their authenticity may               (e.g., strain or other characterization
      42 CFR 73.16 (Transfers);                               be verified.
        (vii) For intra-entity transfers (sender                                                                    information);
                                                                (c) All records created under this part
      and the recipient are covered by the                                                                             (ii) An estimate of the quantity
                                                              must be maintained for 3 years and
      same certificate of registration), the                                                                        released;
                                                              promptly produced upon request.
      select agent, the quantity transferred,                                                                          (iii) The time and duration of the
      the date of transfer, the sender, and the               § 121.18    Inspections.                              release;
      recipient; and                                            (a) Without prior notification, APHIS                  (iv) The environment into which the
        (viii) Records created under § 121.19                 must be allowed to inspect any site at                release occurred (e.g., in building or
      or 42 CFR 73.19 (Notification of theft,                 which activities regulated under this                 outside of building, waste system);
      loss, or release);                                      part are conducted and must be allowed                   (v) The location (building, room) from
        (2) An accurate, current inventory for                to inspect and copy any records relating              which the release occurred; and
      each toxin held, including:                             to the activities covered by this part.
        (i) The name and characteristics;                                                                              (vi) The number of individuals
                                                                (b) Prior to issuing a certificate of               potentially exposed at the entity;
        (ii) The quantity acquired from
                                                              registration to an individual or entity,                 (vii) Actions taken to respond to the
      another individual or entity (e.g.,
                                                              APHIS may inspect and evaluate the                    release; and
      containers, vials, tubes, etc.), date of
                                                              premises and records to ensure
      acquisition, and the source;                                                                                     (viii) Hazards posed by the release.
        (iii) The initial and current quantity                compliance with this part.
                                                                                                                       (2) A completed APHIS/CDC Form 3
      amount (e.g., milligrams, milliliters,                  § 121.19    Notification of theft, loss, or           must be submitted within 7 calendar
      grams, etc.);                                           release.                                              days.
        (iv) The toxin used and purpose of                       (a) An individual or entity must
      use, quantity, date(s) of the use and by                immediately notify APHIS or CDC upon                  § 121.20    Administrative review.
      whom;                                                   discovery of the theft or loss of a select              An individual or entity may appeal a
        (v) Where stored (e.g., building, room,               agent or toxin. Thefts or losses must be              denial, revocation, or suspension of
      and freezer);                                           reported even if the select agent or toxin            registration under this part. An
        (vi) When moved from storage and by
                                                              is subsequently recovered or the                      individual may appeal a denial,
      whom and when returned to storage and
                                                              responsible parties are identified.                   limitation, or revocation of access
      by whom, including quantity amount;
        (vii) Records created under § 121.16                     (1) The theft or loss of a select agent            approval under this part.14 The appeal
      or 42 CFR 73.16 (Transfers);                            or toxin must be reported by telephone,               must be in writing, state the factual
        (viii) For intra-entity transfers (sender             facsimile, or e-mail. The following                   basis for the appeal, and be submitted
      and the recipient are covered by the                    information must be provided:                         to the Administrator within 30 calendar
      same certificate of registration), the                     (i) The name of the select agent or                days of the decision. Where the denial,
      toxin, the quantity transferred, the date               toxin and any identifying information                 revocation, or suspension of registration
      of transfer, the sender, and the recipient;             (e.g., strain or other characterization               or the denial, limitation, or revocation
        (ix) Records created under § 121.19 or                information);                                         of an individual’s access approval is
      42 CFR 73.19 (Notification of theft, loss,                 (ii) An estimate of the quantity stolen            based upon an identification by the
      or release);                                            or lost;                                              Attorney General, the request for review
        (x) If destroyed, the quantity of toxin                  (iii) An estimate of the time during               will be forwarded to the Attorney
      destroyed, the date of such action, and                 which the theft or loss occurred;                     General. The Administrator’s decision
      by whom.                                                   (iv) The location (building, room)                 constitutes final agency action.
        (3) A current list of all individuals                 from which the theft or loss occurred;                  Done in Washington, DC, this 10th day of
      that have been granted access approval                  and                                                   March, 2005.
      by the Administrator or the HHS                            (v) The list of Federal, State, or local           Bill Hawks,
      Secretary;                                              law enforcement agencies to which the                 Under Secretary for Marketing and Regulatory
        (4) Information about all entries into                individual or entity reported, or intends             Programs.
      areas containing select agents or toxins,               to report, the theft or loss.                         [FR Doc. 05–5063 Filed 3–17–05; 8:45 am]
      including the name of the individual,                      (2) A completed APHIS/CDC Form 3
                                                                                                                    BILLING CODE 3410–34–P
      name of the escort (if applicable), and                 must be submitted within 7 calendar
      the date and time of entry;                             days.                                                   14 An entity may not appeal the denial or
        (5) Accurate, current records created                    (b) An individual or entity must                   limitation of an individual’s access to select agents
      under § 121.9 or 42 CFR 73.9                            immediately notify APHIS or CDC upon                  or toxins.




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