APHIS-2008-0023-0001

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					                                                                                                                                  Thursday,
                                                                                                                                  October 9, 2008




                                                                                                                                  Part IV

                                                                                                                                  Department of
                                                                                                                                  Agriculture
                                                                                                                                  Animal and Plant Health Inspection
                                                                                                                                  Service

                                                                                                                                  7 CFR Part 340
                                                                                                                                  Importation, Interstate Movement, and
                                                                                                                                  Release Into the Environment of Certain
                                                                                                                                  Genetically Engineered Organisms;
                                                                                                                                  Proposed Rule
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                                            60008                 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules

                                            DEPARTMENT OF AGRICULTURE                                 Reading Room: You may read any                      Kansas City, MO, on October 30, 2008;
                                                                                                    comments that we receive on this                      and Riverdale, MD, on November 13,
                                            Animal and Plant Health Inspection                      docket in our reading room. The reading               2008. Each public forum will be held
                                            Service                                                 room is located in room 1141 of the                   from 4 p.m. to 7 p.m., local time.
                                                                                                    USDA South Building, 14th Street and                     Meeting Locations: The public forums
                                            7 CFR Part 340                                          Independence Avenue, SW.,                             will be held at the following locations:
                                                                                                    Washington, DC. Normal reading room                      USDA Riverside, Oklahoma City
                                            [Docket No. APHIS–2008–0023]
                                                                                                    hours are 8 a.m. to 4:30 p.m., Monday                 Memorial Conference Rooms B, C, and
                                            RIN 0579–AC31                                           through Friday, except holidays. To be                D, 4700 River Road, Riverdale, MD,
                                                                                                    sure someone is there to help you,                    20737. For directions or facilities
                                            Importation, Interstate Movement, and                   please call (202) 690–2817 before                     information, call (301) 734–8010.
                                            Release Into the Environment of                         coming.                                                  Walter A. Buehler Alumni & Visitors
                                            Certain Genetically Engineered                            Other Information: Additional                       Center, Alpha Gamma Rho Hall,
                                            Organisms                                               information about APHIS and its                       University of California, Davis, CA,
                                            AGENCY:  Animal and Plant Health                        programs is available on the Internet at              95616. For directions or facilities
                                            Inspection Service, USDA.                               http://www.aphis.usda.gov.                            information, call (530) 754–9195 or visit
                                                                                                    FOR FURTHER INFORMATION CONTACT:                      http://www.alumnicenter.ucdavis.edu/.
                                            ACTION: Proposed rule; notice of public
                                                                                                    Biotechnology Regulatory Services,                       Hilton Kansas City Airport, Shawnee
                                            forums.                                                                                                       Room A, 8801 NW 112th Street, Kansas
                                                                                                    APHIS, 4700 River Road Unit 147,
                                            SUMMARY: We propose to revise our                       Riverdale, MD 20737–1236; (301) 734–                  City, MO, 64153. For directions or
                                            regulations regarding the importation,                  5710.                                                 facilities information, call (816) 891–
                                            interstate movement, and environmental                    For information about the public                    8900 or visit http://www.hiltonkci.com/
                                            release of certain genetically engineered               forums, contact: Dr. T. Clint Nesbitt,                .
                                            organisms in order to bring the                         BRS, APHIS, 4700 River Road Unit 147,                 Table of Contents
                                            regulations into alignment with                         Riverdale, MD 20737–1238; (301) 734–
                                                                                                                                                          I. Introduction
                                            provisions of the Plant Protection Act.                 5673.                                                 II. Background
                                            The revisions would also update the                     SUPPLEMENTARY INFORMATION:                               A. APHIS Role in Federal Regulation of
                                            regulations in response to advances in                  Public Forums                                               Genetically Engineered Organisms
                                            genetic science and technology and our                                                                           B. Current Regulations in 7 CFR part 340
                                            accumulated experience in                                  In order to provide additional                        C. Plant Protection Act Authority to
                                            implementing the current regulations.                   opportunities for the public to comment                     Regulate Plant Pests, Noxious Weeds,
                                                                                                    on the proposed rule, APHIS will hold                       and Biological Control Organisms
                                            This is the first comprehensive review
                                                                                                    public forums in three locations: Davis,              III. Proposed Rule
                                            and revision of the regulations since                                                                            A. Proposed Regulatory Scope (§ 340.0
                                            they were established in 1987. This rule                CA; Kansas City, MO; and Riverdale,
                                                                                                                                                                Scope and General Restrictions)
                                            would affect persons involved in the                    MD (see Meeting Locations below).                        1. Genetically Engineered Organisms
                                            importation, interstate movement, or                    These informal forums are designed to                       Subject to 7 CFR part 340
                                            release into the environment of                         engage interested individuals from the                   2. Deleting the List of Organisms Which
                                            genetically engineered plants and                       public and elicit comments related to                       Are or Contain Plant Pests
                                            certain other genetically engineered                    the proposed rule. The format will                       3. Regulating Whole Organisms, Parts, and
                                            organisms.                                              consist of informational posters and                        Nonliving Products
                                                                                                    comment stations. Attendees will be                      B. Permits for Authorizing Importation,
                                            DATES: We will consider all comments                    able walk through the forum during the                      Interstate Movement, and Release Into
                                            that we receive on or before November                   open hours and interact with other                          the Environment of Certain GE
                                            24, 2008. We will also consider                                                                                     Organisms
                                                                                                    attendees and APHIS personnel. Short                     1. Elimination of the Notification
                                            comments made at public forums to be                    welcoming remarks will be given by
                                            held in Davis, CA; Kansas City, MO; and                                                                             Procedure
                                                                                                    APHIS personnel at 4:30 p.m. and again                   2. Revisions to Permit Procedures
                                            Riverdale, MD.                                          at 6 p.m. (local time), but there is no set              3. Permit Types and Environmental
                                            ADDRESSES: You may submit comments                      schedule for each poster station, so the                    Release Categories (§ 340.2(b))
                                            by any of the following methods:                        public may come and go at any time                       4. Permit Application Information
                                              • Federal eRulemaking Portal: Go to                   during the forum period. Participants                       Requirements (§ 340.2(c))
                                            http://www.regulations.gov/fdmspublic/                  will have the opportunity, if desired, to                5. Permit Conditions (§ 340.3)
                                            component/                                              record brief oral comments with a court                  6. Elimination of Courtesy Permits
                                            main?main=DocketDetail&d=APHIS-                                                                                  C. Conditional Exemptions from Permit
                                                                                                    reporter or to submit comments in
                                                                                                                                                                Requirement (§ 340.4, § 340.5)
                                            2008-0023 to submit or view comments                    writing, following directions provided                   D. Petitions for Nonregulated Status
                                            and to view supporting and related                      at the comment stations. A transcript of                    (§ 340.6)
                                            materials available electronically.                     the oral comments and a copy of any                      E. Compliance, Enforcement, and Remedial
                                              • Postal Mail/Commercial Delivery:                    written comments submitted at the                           Action (§ 340.7)
                                            Please send two copies of your comment                  public forums will be placed in the                      1. Ensuring Compliance with Permits and
                                            to Docket No. APHIS–2008–0023,                          rulemaking record and will be available                     Exemption Activities
                                            Regulatory Analysis and Development,                    for public inspection.                                   2. Low Level Presence of Regulated GE
                                            PPD, APHIS, Station 3A–03.8, 4700                          The purpose of these public forums is                    Plants in Seed or Grain
                                            River Road Unit 118, Riverdale, MD                      to allow the public a venue in which to                  F. Administrative Changes
                                            20737–1238. Please state that your                      interact with APHIS representatives and                  1. Confidential Business Information
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                                                                                                                                                                (§ 340.8)
                                            comment refers to Docket No. APHIS–                     to allow APHIS to solicit further                        2. Time Frames for APHIS Action on
                                            2008–0023.                                              information from the public. Comments                       Permit Applications and Petitions
                                              • Public Forums. Written and oral                     received at these public forums will be                  3. Duration Period for Permits
                                            comment will be accepted at three                       added to this Docket.                                    G. Definitions and Miscellaneous Changes
                                            public forums held during the comment                      Dates: The public forums will be held              IV. Required Analyses
                                            period. See Public Forums below.                        in Davis, CA, on October 28, 2008; in                    A. National Environmental Policy Act



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                                                                  Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules                                                  60009

                                               B. Executive Order 12866 and Regulatory              status, and the resulting progeny which               that address many of the considerations
                                                 Flexibility Act                                    could contain multiple GE traits still                outlined in Section 10204.
                                               C. Executive Order 12372                             retains nonregulated status.                            APHIS is also aligning this proposed
                                               D. Executive Order 12988                                                                                   rule with recommendations arising from
                                                                                                       The bulk of APHIS-authorized
                                               E. Paperwork Reduction Act
                                                                                                    introductions have been crop plants                   the 2005 audit of the USDA Office of
                                               F. E-Government Act Compliance
                                                                                                    bearing genes which confer resistance to              Inspector General entitled ‘‘Controls
                                            I. Introduction                                         certain insects or tolerance to certain               Over Issuance of Genetically Engineered
                                               The U.S. Department of Agriculture’s                 herbicides. Although the current                      Release Permits.’’
                                            (USDA) Animal and Plant Health                          program has been effective in ensuring                II. Background
                                            Inspection Service (APHIS) regulates the                the safe environmental release,
                                            safe introduction (environmental                        interstate movement, and importation of               A. APHIS Role in Federal Regulation of
                                            release, interstate movement, and                       certain genetically engineered                        Genetically Engineered Organisms
                                            importation) of certain genetically                     organisms, technological advances have                   Under the Coordinated Federal
                                            engineered (GE) organisms under its                     led to new uses and questions about                   Framework for Regulation of
                                            regulations in 7 CFR part 340. The                      how the current regulations and APHIS                 Biotechnology,1 USDA works with the
                                            regulations govern the introduction of                  authorities will be used to maintain                  Food and Drug Administration (FDA)
                                            GE organisms that might be plant pests.                 appropriate oversight. Advances in                    and the Environmental Protection
                                            APHIS has amended the regulations                       technology have created possibilities for             Agency (EPA) to ensure that the
                                            several times in an effort to respond to                new and different traits, such as those               development and testing of
                                            the need for streamlined procedures and                 that would produce a compound for                     biotechnology products occur in a
                                            has established clear procedures to                     pharmaceutical or industrial use. In                  manner that is safe for plant and animal
                                            remove GE organisms that do not pose                    addition, researchers have been                       health, human health, and the
                                            a plant pest risk from obligations under                producing organisms that may not fall                 environment. USDA and EPA are the
                                            the regulation.                                         under the scope of our current                        agencies responsible for protecting U.S.
                                               The APHIS regulations have been                      regulations and are also beginning to                 agriculture and the environment. EPA is
                                            used most frequently for permits and                    focus more on perennial plants, such as               responsible for the human health,
                                            notifications for importation, interstate               grasses or trees, which may be capable                animal health, and environmental safety
                                            movement, or environmental releases of                  of establishing and persisting outside                issues raised by any pesticidal
                                            GE plants, although a smaller number of                 the site of introduction.                             substance produced in genetically
                                            permits have been issued for GE                            APHIS is proposing to revise its                   engineered (GE) organisms. FDA has
                                            microorganisms and insects. To date,                    regulations in order to respond to                    authority over the safety of the whole
                                            APHIS has authorized more than 13,000                   emerging trends in biotechnology, to                  food product other than the pesticidal
                                            environmental releases of GE plants,                    address the current and future needs of               components regulated by EPA.
                                            most of which have been part of the                     the agency, to continue to ensure a high
                                            development of improved crop varieties                  level of environmental protection, to                 B. Current Regulations in 7 CFR Part
                                            for agriculture. These controlled                       improve regulatory processes so that                  340
                                            environmental releases are sometimes                    they are more transparent to                             APHIS administers regulations in 7
                                            referred to as field tests or field trials,             stakeholders and the public, to more                  CFR part 340, ‘‘Introduction of
                                            in recognition of their relationship to                 efficiently use agency resources and to               Organisms and Products Altered or
                                            field tests done in the traditional                     eliminate unnecessary regulatory                      Produced Through Genetic Engineering
                                            development of plant varieties, and in                  burdens.                                              Which are Plant Pests or Which There
                                            this document the terms field test or                      Given the diversity of U.S.                        is Reason to Believe are Plant Pests’’
                                            field trial should be understood to mean                agriculture, the USDA Advisory                        (referred to below as the regulations).
                                            environmental release. In addition to                   Committee on Biotechnology and 21st                   The current regulations govern the
                                            permits and notifications, APHIS has                    Century Agriculture recently in its                   introduction (importation, interstate
                                            completed reviews in response to                        March 2008 consensus report                           movement, or release into the
                                            petitions requesting nonregulated status                encouraged the continuing support of                  environment) of certain GE organisms
                                            under these regulations. To date, APHIS                 coexistence among various agricultural                termed ‘‘regulated articles.’’ Regulated
                                            has granted 74 determinations of                        production systems in U.S. agriculture.               articles are essentially GE organisms
                                            nonregulated status, and all of these                   APHIS concludes that the changes it is                which might pose a risk as a plant pest.
                                            have been for GE plants (more                           proposing will continue to support                       APHIS first promulgated these
                                            information about these is posted at                    coexistence in U.S. agriculture.                      regulations in 1987 under the authority
                                            http://www.aphis.usda.gov/brs/                             In addition, APHIS is proposing                    of the Federal Plant Pest Act of 1957
                                            not_reg.html ). Many of these plants                    changes to the regulations to reflect                 (FPPA) and the Plant Quarantine Act of
                                            have since been used to develop plant                   provisions of the 2008 Farm Bill                      1912 (PQA), two acts that were
                                            varieties that have become part of the                  recently enacted. Section 10204 of Title              subsumed into the Plant Protection Act
                                            options that growers have for                           X of the Food, Conservation, and Energy               (PPA, 7 U.S.C. 7701 et seq.) in 2000,
                                            agricultural production in the United                   Act of 2008 (Farm Bill) requires the                  along with other provisions.
                                            States and other countries. The APHIS                   Secretary of Agriculture to take action                  Under the current regulations, a GE
                                            determinations of nonregulated status                   on each issue identified in the                       organism is a regulated article if it is a
                                            have been for the GE plant(s) and their                 document entitled ‘‘Lessons Learned                   plant pest or if the Administrator has
                                            progeny. The GE plant with                              and Revisions under Consideration for                 reason to believe it is a plant pest; more
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                                            nonregulated status can be used                         APHIS’ Biotechnology Framework,’’ and                 specifically:
                                            subsequently in plant breeding                          where appropriate, promulgate
                                                                                                                                                            1 The Coordinated Framework is described in a
                                            programs or in agriculture just like other              regulations. APHIS is proposing certain
                                                                                                                                                          notice published in the Federal Register on June 26,
                                            plant lines. A GE plant that has received               regulatory changes concerning permit                  1986 (51 FR 23302). The notice may be viewed at
                                            nonregulated status can be bred with                    application information requirements,                 http://www.aphis.usda.gov/brs/fedregister/
                                            another GE plant with nonregulated                      permit conditions, records, and reports               coordinated_framework.pdf.



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                                            60010                 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules

                                              ‘‘if the donor organism, recipient organism,          under notification, which is a                        information about the introduction
                                            or vector or vector agent belongs to any                streamlined procedure. Examples of GE                 sufficient for APHIS to evaluate
                                            genera or taxa designated in § 340.2 and                plants introduced under the notification              eligibility for the procedure and impacts
                                            meets the definition of plant pest, or is an            procedure are those GE plants altered to              on the environment. This information
                                            unclassified organism and/or an organism
                                            whose classification is unknown, or any
                                                                                                    be resistant to certain insects or                    includes information on the plant
                                            product which contains such an organism, or             herbicides. GE plants that do not meet                species, introduced gene(s), location(s),
                                            any other organism or product altered or                the notification eligibility criteria and             and anticipated time frame for the
                                            produced through genetic engineering which              all other GE organisms, such as                       introduction.
                                            the Administrator determines is a plant pest            microbes and insects, must be                            For notifications, the eligibility
                                            or has reason to believe is a plant pest.’’             introduced under the permit procedure                 criteria and the performance standards
                                            (Definition of regulated article, § 340.1)              in current § 340.4. In recent years,                  stated in the regulations must be met,
                                               In other words, APHIS regulates the                  APHIS has processed most notifications                but APHIS does not prescribe how the
                                            introduction (importation, interstate                   and permits through its electronic, e-                performance standards must be met. For
                                            movement, and environmental release)                    permitting system that is accessible by               example, one of the performance
                                            of GE organisms if (1) any of the                       the internet at http://                               standards in § 340.3(c)(5) requires that
                                            recipient, genetic donor, or vector                     www.aphis.usda.gov/permits/                           ‘‘The field trial must be conducted such
                                            organisms are plant pests or of unknown                 learn_epermits.shtml.                                 that (i) The regulated article will not
                                            classification or (2) the Administrator                    In making a regulatory determination               persist in the environment, and (ii) No
                                                                                                    for a permit or notification for a GE                 offspring can be produced that could
                                            has determined or has reason to believe
                                                                                                    organism subject to the part 340                      persist in the environment.’’ The
                                            the GE organism is a plant pest. As
                                                                                                    regulations, APHIS makes such a                       responsible person might meet this
                                            constructed the regulations apply to GE
                                                                                                    determination on whether the actions                  standard in a field trial by isolating the
                                            microorganisms, insects, and other
                                                                                                    under notification or permit are unlikely             regulated GE plants at a sufficient
                                            traditional types of plant pests and to
                                                                                                    to result in the introduction or                      distance to preclude gene flow from the
                                            any GE plants if plant pest organisms
                                                                                                    dissemination of a plant pest. This                   GE plant to sexually compatible plants
                                            (bacterial and viral plant pathogens) are
                                                                                                    determination takes into account                      in the vicinity. Another design protocol
                                            the donor organisms and vector agents
                                                                                                    various risk factors, including, among                might meet the same performance
                                            used in the creation of these GE plants.
                                                                                                    other things, a low risk that the GE                  standard by planting the GE plant at a
                                               Taxa containing ‘‘known plant pests’’                organism or its progeny can persist,                  time in the growing season when
                                            are those listed in current § 340.2.                    reproduce, and establish without human                surrounding plants of the same species
                                            Current regulations also include a                      assistance. Other risk factors that would             would not be biologically capable of
                                            petition procedure (§ 340.5) which                      support an ‘‘unlikely’’ determination                 being fertilized by pollen from the GE
                                            allows petitioners to ask APHIS to add                  would be minimal availability of                      plant (temporal isolation).
                                            or subtract taxa from the list in § 340.2.              suitable hosts or habitats for the                       The regulations in current § 340.3(e)
                                            That list has not been amended since it                 organism and low risk that the organism               specify that the APHIS notification
                                            was established in 1987.                                may cause damage to plants and plant                  procedure must be completed within 30
                                               As defined under the current                         products.                                             days for environmental release and
                                            regulations and the PPA, most plants are                   Regarding the risk of introduction or              importations and within 10 days for the
                                            not plant pests, with the exception of a                dissemination of the GE organism as a                 interstate movement of a regulated
                                            few parasitic plant species, such as                    plant pest, an ‘‘unlikely’’ determination             article. If APHIS completes the review
                                            striga, witchweed, and dodder.                          takes into consideration both the nature              process and finds that all regulatory
                                               The primary procedure for regulation                 of the organism (i.e., low risk that the              requirements have been met, the
                                            under the PPA is the issuance of a                      organism or its progeny can persist,                  notification is authorized in a process
                                            permit, which is an authorization by the                reproduce, establish, and spread                      termed ‘‘acknowledgement,’’ and the
                                            Secretary to move plants, plant                         without human assistance) and any                     applicant can proceed with the
                                            products, biological control organisms,                 additional mitigations that are placed                introduction under the terms of the
                                            plant pests, noxious weeds, or articles                 upon the organism that restrict its                   notification. Notifications are valid for
                                            under conditions prescribed by the                      movement and make its unauthorized                    one year from the date of introduction.
                                            Secretary. The PPA also authorizes the                  introduction or dissemination unlikely.                  Approximately 10% of APHIS
                                            Secretary to determine which classes of                    The notification procedure was first               authorizations are done under the
                                            the above articles must have a permit to                added to the regulations in 1993, and                 permitting procedure. The permitting
                                            be moved. Conditions associated with                    then amended in 1997 to allow a                       procedure, found in § 340.4 of the
                                            those permits can be tailored to achieve                broader range of plant species to be                  current regulation, describes the types
                                            the appropriate level of regulatory                     eligible for the procedure. The                       of permits, information required for
                                            control to make it unlikely that actions                notification procedure was designed to                permit application, the standard permit
                                            under the permit would result in the                    be a streamlined procedure with the                   conditions, and administrative
                                            introduction or dissemination of a plant                eligibility criteria and performance                  information (e.g., time frames, appeal
                                            pest or noxious weed.                                   standards already built into the                      procedure, etc.). Permits include
                                               APHIS currently uses a permit and                    regulations. Over the past decade,                    specific conditions that must be
                                            notification system to authorize                        APHIS has typically authorized 700–                   followed by the permit holder. Standard
                                            importation, interstate movement and                    1200 notifications per year.                          permit conditions are listed in the
                                            release into the environment (currently                    As part of the notification procedure,             regulation, and APHIS can supplement
                                            referred to as ‘‘introductions’’) of certain            applicants must adhere to performance                 these with additional conditions as
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                                            GE organisms. Under the current                         standards set forth by APHIS for proper               necessary. The current regulations
                                            regulations, all regulated articles are                 confinement of the GE plants. The goal                specify the amount of time that APHIS
                                            eligible for the permitting procedure,                  of proper confinement is to ensure that               is allotted for review of complete permit
                                            but only certain plants are eligible for                the GE plants do not persist in the                   applications: 60 days for permits for
                                            the notification procedure. Currently,                  environment. Under the notification                   importation and interstate movement;
                                            most regulated GE plants are introduced                 procedure applicants provide                          120 days for environmental release.


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                                                                  Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules                                           60011

                                               Some regulated articles are                          dissemination of plant pests and                      movement, and importation of
                                            conditionally exempt from the                           noxious weeds.                                        genetically engineered organisms,
                                            requirement for permits when moved                         The current regulations were                       technological advances have led to the
                                            interstate under the conditions                         promulgated under former statutes, i.e.,              possibility of developing GE organisms
                                            stipulated in the regulation. Conditional               the FPPA and PQA, which provide                       that do not fit within the plant pest
                                            exemptions currently exist in the                       USDA authority to regulate articles that              definition, but may cause environmental
                                            regulations for the interstate movement                 present a risk of plant pest introduction             or other types of physical harm or
                                            of certain GE bacteria (Escherichia coli,               or dissemination. In addition to the                  damage covered by the definition of
                                            Bacillus subtilis), fungi (Saccharomyces                provisions of the FPPA and PQA, the                   noxious weed in the PPA. Therefore, we
                                            cerevisiae), as well as the plant species               PPA incorporates authority that                       consider that it is appropriate to align
                                            Arabidopsis thaliana. APHIS                             previously was under the Noxious Weed                 the regulations with both the plant pest
                                            established these conditional                           Act of 1974. In order to best evaluate the            and noxious weed authorities of the
                                            exemptions from interstate movement                     risks associated with these GE                        PPA.
                                            permit by amending the regulations in                   organisms and regulate them when
                                            1988 and 1990.                                                                                                1. Genetically Engineered Organisms
                                                                                                    necessary, APHIS needs to exercise its
                                               APHIS forwards the applications for                                                                        Subject to 7 CFR part 340
                                                                                                    authorities regarding noxious weeds and
                                            all permits, and notifications, with any                biological control organisms, in addition                We are proposing to revise the scope
                                            confidential business information                       to its authority regarding plant pests.               of the regulations in § 340.0 to make it
                                            redacted, to State regulators in the                       The definition of plant pest in the                clear that decisions regarding which
                                            States to which regulated articles will be              PPA is broad and includes living                      organisms are regulated remain science-
                                            moved and/or in which environmental                     organisms that could directly or                      based and take both plant pest and
                                            release is planned. This is done to notify              indirectly injure, damage, or cause                   noxious weed risks into account. The
                                            States of the requested action and to                   disease in any plant or plant product (7              proposed scope of the regulations states
                                            allow States to review and comment on                   U.S.C. § 7702(14)). Under the PPA,                    that genetically engineered organisms
                                            proposed releases or importations or                    organisms which could be plant pests                  whose importation, interstate
                                            movements.                                              include:                                              movement, or release into the
                                               The current regulations also include                    • Protozoans                                       environment would be subject to the
                                            various provisions and prescribed                          • Non-human animals                                regulations are:
                                            standards for containers, marking, and                     • Parasitic plants                                    Genetically engineered plants if:
                                            identity that apply to shipments of                        • Bacteria                                            (i) The unmodified parent plant from
                                            regulated articles. For example, there                     • Fungi                                            which the GE plant was derived is a
                                            are instructions regarding how to label                    • Viruses or viroids                               plant pest or noxious weed, or
                                            containers of imported regulated articles                  • Infectious agents or other pathogens                (ii) The trait introduced by genetic
                                            with the nature of the contents, origin                    • Any article similar to or allied with            engineering could increase the potential
                                            and destination, and other information,                 any of the above articles.                            for the GE plant to be a plant pest or
                                            and detailed instructions on what                          The definition of noxious weed in the              noxious weed, or
                                            materials (plastic, metal, etc.) and                    PPA includes:                                            (iii) The risk that the GE plant poses
                                            dimensions may be used for containers                                                                         as a plant pest or noxious weed is
                                            of regulated articles.                                     * * * any plant or plant product that can
                                                                                                    directly or indirectly injure or cause damage
                                                                                                                                                          unknown, or
                                               Under the current regulations, APHIS                                                                          (iv) The Administrator determines
                                                                                                    to crops (including nursery stock or plant
                                            may also grant ‘‘nonregulated status’’ to               products), livestock, poultry, or other               that the GE plant poses a plant pest or
                                            a GE organism in accordance with the                    interests of agriculture, irrigation, navigation,     noxious weed risk.
                                            procedure described in § 340.6. A                       the natural resources of the United States, the          Genetically engineered non-plant,
                                            determination of nonregulated status                    public health, or the environment. (PPA               non-vertebrate organisms if:
                                            means that the organism is no longer                    § 7702(10))                                              (i) The recipient organism can directly
                                            subject to the part 340 regulations, and                  An important distinction between                    or indirectly injure, cause damage to, or
                                            therefore there is no longer any                        noxious weeds and plant pests is that                 cause disease in plants or plant
                                            requirement for APHIS authorization                     noxious weeds under the PPA are                       products; or
                                            under part 340 for a permit or                                                                                   (ii) The GE organism has been
                                                                                                    always plants or plant products. Plant
                                            notification when the GE organism is                                                                          engineered in such a way that it may
                                                                                                    pests are usually not plants (with the
                                            imported, moved interstate, or released                                                                       increase the potential for it to be a plant
                                                                                                    exception of certain parasitic plants
                                            into the environment.                                                                                         pest: or
                                                                                                    such as dodder, striga, and witchweed),
                                                                                                                                                             (iii) The risk that the GE organism
                                            C. Plant Protection Act Authority to                    but are other types of organisms that
                                                                                                                                                          poses as a plant pest is unknown, or
                                            Regulate Plant Pests, Noxious Weeds,                    harm plants.                                             (iv) The Administrator determines
                                            and Biological Control Organisms                        III. Proposed Rule                                    that the GE organism poses a plant pest
                                              Under the provisions of the PPA,                                                                            risk.
                                            Congress has granted the Secretary of                   A. Proposed Regulatory Scope (§ 340.0                    Under the current regulations, there is
                                            Agriculture authority to develop                        Scope and general restrictions)                       no explicit statement of the relative
                                            regulations in order to detect, control,                  We propose to better align the                      responsibilities of the Administrator
                                            eradicate, suppress, prevent, or retard                 regulations with the PPA authorities in               and regulated parties in determining
                                            the spread of plant pests or noxious                    order to ensure that the environmental                whether an organism met the definition
                                            weeds. The PPA grants the Secretary                     release, importation, or interstate                   for regulated article and therefore would
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                                            authority to regulate the movement into                 movement of GE organisms does not                     be subject to the regulations. Under the
                                            and through the United States of any                    pose a risk of introducing or                         proposed regulations, the responsible
                                            plant, plant pest, plant product,                       disseminating plant pests or noxious                  person for a GE organism could
                                            biological control organism, noxious                    weeds. Although the current program                   correctly apply the criteria in § 340.0 to
                                            weed, article, or means of conveyance,                  has been effective in ensuring the safe               determine whether the GE organism is
                                            in order to prevent the introduction or                 environmental release, interstate                     subject to the regulations. Alternatively,


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                                            60012                 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules

                                            the Administrator could determine any                   the organism to clearly determine the                 movement or environmental release.
                                            GE organism to be regulated after                       potential associated plant pest or                    Therefore, APHIS will offer to consult
                                            determining that the GE plant poses a                   noxious weed risks. Unknown risks                     with a developer of a GE organism
                                            plant pest or noxious weed risk.                        might lead to a determination by the                  regarding whether the GE organism is
                                               In many cases, it will be very                       Administrator that a GE organism                      within the scope of the proposed
                                            straightforward for a responsible person                should be subjected to regulatory                     regulations.
                                            to apply these criteria and determine                   oversight if APHIS lacks familiarity with                After consultation and review of
                                            that a GE organism is subject to the                    the non-transformed recipient organism                available information, the Administrator
                                            regulations. For example, the GE                        or the introduced trait.                              will respond in writing as to whether
                                            organism would clearly be subject to the                   The proposed scope makes it clear                  the Administrator has determined that
                                            regulations if the recipient organism                   that the mere act of genetic engineering              the GE organism is within the scope of
                                            were a plant pest or noxious weed. A GE                 does not trigger regulatory oversight or              the regulations. APHIS plans to make
                                            organism would also clearly be subject                  mean that a GE organism will pose risks               information publicly available by
                                            to the regulations if there was little data             as a plant pest or noxious weed. Instead,             posting and maintaining information on
                                            or previous experience available                        it clarifies that APHIS would subject a               its Web site about the determinations it
                                            concerning the recipient organism’s                     GE organism to regulatory oversight                   makes pursuant to this consultation
                                            plant pest or noxious weed potential, or                based upon known plant pest and                       process to help the public and regulated
                                            the type of modification, with the result               noxious weed risks of the parent                      entities understand which organisms are
                                            that it is difficult to do a reliable                   organisms, or based upon the traits of                subject to the regulations.
                                            evaluation of the risks that the GE                     the GE organism, or based upon the                       We welcome suggestions from the
                                            organism may be a plant pest or noxious                 possibility of unknown risks as a plant               public on the most appropriate ways to
                                            weed.                                                   pest or noxious weed when insufficient                provide administrative guidance to the
                                               In other cases, it may not be readily                information is available.                             public on the issue of which GE
                                            apparent to the responsible person for a                                                                      organisms are within the scope of the
                                            GE organism whether or not the                          Consultation With APHIS Regarding the                 regulations. The Agency is especially
                                            organism falls within the scope of                      Scope of These Regulations                            interested in ways which will balance
                                            § 340.0 and is regulated. For this reason,                 The criteria described in the scope                transparency with the efficient use of
                                            persons who are not sure about whether                  should help developers form a                         Agency resources in conducting
                                            a GE organism falls within the                          reasonable expectation as to whether                  consultations and communicating
                                            regulations or who maintain that a                      their GE organism is within the scope of              information to the public regarding
                                            particular GE organism is not subject to                the regulations, based on the nature of               which GE organisms are within the
                                            the regulations based on their belief that              the parent organisms, the engineered                  scope of the regulations.
                                            it is not an organism within the scope                  traits, and the amount of information
                                                                                                    available regarding the organism and                  Organisms Specifically Excluded From
                                            of § 340.0 may consult with APHIS.
                                               A GE organism may be within the                      similar organisms.                                    the Scope of the Regulations
                                            scope of the regulations based on the                      APHIS anticipates that initially the                  Specifically excluded from the
                                            information available at the time of the                range of GE organisms that the                        proposed regulatory scope are GE
                                            determination, which is usually less                    Administrator may determine to be                     microorganisms that are regulated as
                                            information than is available when the                  covered by the proposed regulatory                    biological control organisms by the EPA
                                            Administrator evaluates, for example,                   scope will be broad. This will be due to              under provisions of the Federal
                                            whether a regulated GE organism should                  both an initial measured                              Insecticide, Fungicide, and Rodenticide
                                            be considered for an exemption from the                 implementation of the revised                         Act (FIFRA). APHIS concludes that
                                            requirement for a permit, or should be                  regulatory oversight as well as to the                there is no need for such GE organisms
                                            considered for a determination of                       application of the scope criteria to the              to be evaluated by both agencies. EPA
                                            nonregulated status (see discussion of                  transformed organisms and recipient                   is already evaluating the environmental
                                            § 340.6 below regarding nonregulated                    traits. Over time, the range of GE                    safety of such organisms with respect to
                                            status). In other words, this scope                     organisms subject to oversight is                     their impact on the entire environment,
                                            determination has one purpose (to                       expected to decrease as APHIS becomes                 including plants. We also propose to
                                            determine whether regulation is                         more familiar with these organisms and                retain an exclusion from the current
                                            necessary at all) and is based on one                   receives information from which it can                regulations for GE microorganisms
                                            level of knowledge about a GE organism,                 reach a conclusion that these GE                      where the recipient microorganism is
                                            while determinations regarding such                     organisms or groups of organisms do not               not a plant pest and which have
                                            things as necessary permit conditions or                present increased or unfamiliar plant                 resulted from the addition of genetic
                                            exemptions or nonregulated status have                  pest or noxious weed risks. Because the               material from a donor organism where
                                            a different purpose and are based on a                  Administrator may make such a                         the material is well characterized and
                                            different level of knowledge about a GE                 determination at any time the                         contains only non-coding regulatory
                                            organism.                                               Administrator receives information that               regions.
                                               It is important to note that while a GE              a GE organism is within the scope,
                                            organism may be within the scope of the                 APHIS expects that developers will seek               Effect of Noxious Weed Authority on
                                            regulations due to certain identified                   early consultation with APHIS on                      the Scope of the Proposed Regulations
                                            plant pest or noxious weed risks, it may                whether the regulatory scope covers                     The definition of noxious weed
                                            also be within the scope of the                         their GE organism. Since it is generally              encompasses plants that pose risks akin
                                            regulations if there is not enough                      necessary for research or business plans              to plant pests, because it includes ‘‘any
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                                            information about the GE organism’s                     to include, as early as possible, elements            plant or plant product’’ that can ‘‘injure
                                            potential plant pest or noxious weed                    addressing regulatory processing,                     or cause damage to crops * * * other
                                            risks to make a decision regarding those                approval, and compliance, it will be in               interests of agriculture * * * or the
                                            risks. At the early stages of developing                the interest of the developers to                     environment’’, but also includes plants
                                            a GE organism, there may not be                         determine the regulatory status of their              that can pose harm to non-plant
                                            sufficient information available about                  GE organism prior to contemplating its                organisms, such as humans. Therefore


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                                                                   Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules                                              60013

                                            evaluation of noxious weed risk                           The distinction between a weed and                  impacts warrant its listing as a noxious
                                            expands what we can consider, while                     a noxious weed warrants emphasis.                     weed.
                                            still including those risks examined                    ‘‘Weeds,’’ in the broadest sense of the                 APHIS currently lists 98 aquatic,
                                            under the plant pest approach. When                     word, could include any plant growing                 terrestrial, or parasitic plant taxa as
                                            considering risks associated with a GE                  where and/or when it is unwanted; even                noxious weeds. The species included in
                                            plant, we would continue to consider                    plants that are desirable in some settings            the list illustrate the kinds of plants
                                            whether it can harm plants, as well as                  may be considered weeds in others. In
                                            whether it can cause the other types of                                                                       APHIS considers to be sufficiently
                                                                                                    a narrower sense, weeds are invasive,                 invasive, damaging, and difficult to
                                            physical harm or damage described in                    often non-native, plants which impact
                                            the definition for noxious weed.                                                                              control to be deemed noxious weeds.
                                                                                                    natural and managed ecosystems, often                 Table 1 describes some specific
                                               The first consideration in determining
                                                                                                    with significant negative consequences                examples from the Federal noxious
                                            if a plant is a noxious weed is
                                                                                                    due to lost yields, changes in                        weed list and the kinds of impacts
                                            identifying what direct injury or damage
                                            (physical harm) the plant causes. If                    management practices, altered herbicide               noxious weeds can have, to illustrate
                                            direct harm or damage is established,                   use, etc. Only a fraction of these                    the types of effects APHIS will be
                                            the next consideration is to evaluate any               problematic weeds are considered to be                looking for when evaluating whether GE
                                            indirect damage the plant may cause to                  so invasive, so harmful, and so difficult             plants reviewed under part 340 have
                                            interests of agriculture, irrigation,                   to control that Federal regulatory                    any potential noxious weed traits. The
                                            navigation, the natural resources of the                intervention to prevent their                         experience and precedents developed
                                            United States, the public health, or the                introduction or dissemination is                      by the APHIS–PPQ noxious weed
                                            environment. In general, federally listed               justified, and these are the focus of the
                                                                                                                                                          program provide a guide for the
                                            noxious weeds are plants that are likely                regulatory controls placed on them by
                                                                                                                                                          regulation of plants that may be noxious
                                            to be aggressively invasive, have                       APHIS. However, any weed, and
                                                                                                                                                          weeds, and we intend to apply it to the
                                            significant negative impacts, and are                   virtually any plant or plant product, can
                                                                                                                                                          consideration of GE plants in the same
                                            extremely difficult to manage or control                be evaluated by APHIS to determine
                                                                                                                                                          way.
                                            once established.                                       whether its characteristics and potential

                                                                      TABLE 1—EXAMPLES OF IMPACTS CAUSED BY FEDERALLY LISTED NOXIOUS WEEDS
                                                    Impact                        Description of impact                                                  Example species

                                            Lost productivity of      Noxious weeds may directly compete               Cogongrass (Imperata cylindrica) infests over 20 crop species; it releases
                                              crop fields.              with crop plants for limited resources,          chemicals into the soil that suppress crop growth and causes damaging
                                                                        dramatically reducing yields.                    puncture wounds to plant roots, bulbs, and tubers. Other examples include
                                                                                                                         Benghal dayflower (Commelina benghalensis), red rice (Oryza spp.), and
                                                                                                                         kikuyugrass (Pennisetum clandestinum).
                                            Parasitic damage to       Parasitic plants can cause significant           Federally listed noxious parasitic plants include the dodders (Cuscuta spp.)—
                                              crops.                    reductions in yield by attaching them-           with common names like strangleweed, devil’s-guts, hellbine, and witch’s
                                                                        selves to a host plant, removing nutri-          hair—and witchweed (Striga spp.), which causes devastating losses in corn,
                                                                        ents and ultimately killing it.                  sorghum, and rice.
                                            Reduced productivity      Grazing animals may avoid noxious                Serrated tussock (Nassella trichotoma) has heavily infested large areas, leaving
                                              of pasture.               weeds and consume the more favor-                them completely incapable of supporting livestock.
                                                                        able pasture species, resulting in in-
                                                                        creased noxious weed populations at
                                                                        the expense of more favorable spe-
                                                                        cies. Noxious weeds may also
                                                                        outcompete desirable pasture spe-
                                                                        cies.
                                            Injury to humans or       Many noxious weeds are toxic, harming            Cape tulip (Homeria spp.) contains a cardiac glycoside, which can be fatal to
                                               livestock.               humans or livestock either when con-             livestock. Contact with giant hogweed (Heracleum mantegazzianum) causes
                                                                        sumed or by direct contact.                      painful skin blisters. Three-cornered jack (Emex australis) and devil’s thorn
                                                                                                                         (Emex spinosa) both bear spiny fruits that can cripple or cause injury to live-
                                                                                                                         stock or other animals.
                                            Unchecked over-           Noxious weeds may be capable of                  Mile-a-minute vines (Mikania cordata and M. micrantha) can entirely smother
                                              growth.                   completely dominating the landscape              fields and forests in a dense, tangled mass of vines. A single plant of the
                                                                        and preventing the use of cultivated             aquatic weed giant salvinia (Salvinia spp.) can blanket 40 square miles in 3
                                                                        or pasture lands for agriculture.                months, and produce an underwater mat 3 feet thick.
                                            Physical obstruc-         Growth rate and habit of some noxious            Certain mesquites (Prosopis spp.), jointed prickly pear (Opuntia aurantiaca),
                                              tions.                    weeds may physically hamper the                  and African boxthorn (Lycium ferocissimum) form impenetrable thickets filled
                                                                        movement of livestock and humans,                with thorns or needles, blocking the movement of grazing animals, injuring
                                                                        or interfere with navigation of water-           them or preventing access to food and water.
                                                                        ways.
                                            Disruption of water       Aquatic noxious weeds may disrupt                Notable examples include hydrilla (Hydrilla verticillata), giant salvinia (Salvinia
                                              flow.                     water flow, adversely affecting irriga-          spp.), and Chinese waterspinach (Ipomoea aquatica). Dense mats of oxygen
                                                                        tion, drainage and flood control ca-             weed (Lagarosiphon major) can completely shut down operation of hydro-
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                                                                        nals, city water intakes, and rec-               electric plants.
                                                                        reational water use.




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                                            60014                  Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules

                                                             TABLE 1—EXAMPLES OF IMPACTS CAUSED BY FEDERALLY LISTED NOXIOUS WEEDS—Continued
                                                    Impact                        Description of impact                                                  Example species

                                            Habitat alteration .....   Noxious weeds may severely alter                Infestation of lakes and ponds with hydrilla (Hydrilla verticillata) can alter aquat-
                                                                        water quality by changing oxygen                  ic ecosystems so drastically that native plants are entirely eliminated, ren-
                                                                        and nutrient content, may dramati-                dering the habitat unsuitable for fish and other wildlife.
                                                                        cally lower local water tables, or
                                                                        could so significantly outcompete or
                                                                        overgrow other vegetation resulting in
                                                                        a complete ecological shift of the
                                                                        habitat.



                                               As discussed above, APHIS’                           may be a noxious weed because it poses                consider when concluding that a GE
                                            determination that a plant is a noxious                 a public health risk when growing in the              organism is not a plant pest. We
                                            weed is based on notable physical harm                  environment, APHIS considers toxicity                 envision providing additional
                                            or injury caused by the plant. The                      and other food safety information,                    information on the Administrator’s
                                            elements of the noxious weed definition                 including the type reviewed by EPA and                interpretation on such criteria at the
                                            include a number of interests that might                FDA. In the case of GE plants, APHIS                  time of the final rule or in subsequent
                                            be damaged by noxious weeds including                   would not assess the safety of the GE                 administrative guidance.
                                            not only plants but irrigation,                         plant for human or animal
                                                                                                                                                          GE Vertebrate Animals Do Not Fall
                                            navigation, the natural resources of the                consumption, but would consider
                                                                                                                                                          Within the Scope of the Regulations
                                            United States, the public health, the                   available information about toxicity and
                                            environment and interests of                            other food safety information in                         Although the PPA definition of plant
                                            agriculture. Often APHIS quantifies the                 assessing noxious weed risk posed by                  pest includes the potential for a
                                            physical harm or injury in terms of                     the plants growing in the environment.                nonhuman, vertebrate animal to be
                                            economic losses. Loss in commodity                         It should be noted, moreover, that                 considered a plant pest, APHIS decided
                                            value due to the presence of noxious                    most GE plants that APHIS has been                    at this time that there are no
                                            weeds in seeds, for example, is a                       regulating in the past, such as varieties             demonstrated risks or pending GE
                                            consequence of the anticipated physical                 of GE corn and soybeans modified with                 animal developments indicating that it
                                            damage that would be caused if the seed                 common agronomic traits, do not                       is necessary for the proposed
                                            containing a noxious weed were                          qualify as ‘‘noxious weeds’’. But with                regulations to evaluate vertebrate GE
                                            distributed and planted; the economic                   the increasing diversity of both                      animals as potential plant pests.
                                            loss is never simply the result of market               agronomic and non-agronomic traits                    Because other statutory authorities exist
                                            preference to have commodities free of                  being engineered into plants it is                    for addressing GE animals, APHIS could
                                            certain noxious weed seeds in and of                    appropriate to place regulatory controls              guard against any plant pest risks that
                                            itself, in the absence of any potential                 upon GE plants proportionate to the                   might be presented by GE vertebrate
                                            physical damage or harm. APHIS does                     likelihood that they may present a                    animals without directly regulating
                                            not consider significant economic                       noxious weed risk until the potential                 them under the regulations in part 340.
                                            effects alone that are not linked to                    risk can be appropriately evaluated.                  On the other hand, we propose to
                                            physical damage to be sufficient to                                                                           regulate GE invertebrate animals under
                                                                                                    How Non-Plant, Non-Vertebrate GE                      part 340 because many classes of
                                            determine a plant is a noxious weed.
                                                                                                    Organisms Fall Within the Scope of the                invertebrates include known plant pests
                                               Certainly, some noxious weeds can
                                                                                                    Regulations                                           (e.g., insects, arachnids, nematodes,
                                            cause physical harm to the health of
                                            humans or livestock and other animals.                     The proposed revision of the                       gastropods, etc.).
                                            In general, these impacts occur when                    regulations retains control for potential
                                                                                                    plant pest risks posed by non-plant,                  How GE Biological Control Organisms
                                            individuals come into direct contact
                                                                                                    non-vertebrate GE organisms. We would                 (BCOs) Fall Within the Scope of the
                                            with the noxious plants or plant parts,
                                                                                                    continue to explicitly use the plant pest             Regulations
                                            which may cause physical injury or are
                                            toxic or otherwise harmful when                         provisions of the PPA for regulating                    The PPA defines biological control
                                            consumed. Conceivably, noxious weeds                    non-plant, non-vertebrate GE organisms                organism (BCO) as ‘‘any enemy,
                                            growing in crop fields could potentially                which align with the taxa listed in the               antagonist, or competitor used to control
                                            threaten public health, for example, if                 PPA definition of plant pest. In its                  a plant pest or noxious weed’’ (7 U.S.C.
                                            toxic parts of the noxious weeds are                    reviews of GE non-plant and non-                      7702(2)). The PPA gives the authority to
                                            harvested and inadvertently enter the                   vertebrate species, APHIS will continue               regulate plant pests and noxious weeds,
                                            food supply. If such toxic or otherwise                 to assess GE insects, fungi, bacteria, and            not specifically biocontrol organisms.
                                            harmful noxious weed parts were found                   other non-plant, non-vertebrate                       APHIS recognizes that BCOs may have
                                            in food and caused the food to be                       organisms for their potential to pose                 the potential to affect populations of
                                            ‘‘adulterated’’ within the meaning of the               risks as plant pests.                                 noxious weeds or plant pests, or become
                                            FFDCA, FDA could take regulatory                           The scope of the regulations as                    plant pests themselves. To fall within
                                            action against the food.                                defined above makes it clear that it is               the scope of the proposed regulations,
                                               Whereas APHIS has no direct role in                  the Administrator, and not the public,                the GE BCO would have to pose a threat
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                                            evaluating the safety of foods, the                     who determines whether a non-plant                    as a plant pest or noxious weed. There
                                            agency plays an important supporting                    organism is within or outside the                     are relatively few examples today of GE
                                            role in safeguarding the food supply by                 proposed scope of the Part 340                        BCOs, but these may become more
                                            protecting the health of plants and                     regulations. APHIS welcomes public                    common in the future. For example,
                                            animals at the farm level. When                         comment on the proposed concise                       some researchers are developing GE
                                            evaluating whether a particular GE plant                criteria that the Administrator would                 biological control pink bollworms that


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                                                                  Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules                                           60015

                                            are sterile, which achieve their                        a plant pest or noxious weed, we would                and therefore would not require permits
                                            controlling effect by reducing the ability              consider the most up-to-date pest                     for these activities.
                                            of fertile, non-GE pink bollworms to                    information maintained by PPQ. This                      The PPA defines a noxious weed as
                                            produce offspring. Such GE pink                         information is more specific than the                 encompassing both plants and plant
                                            bollworm BCOs would fall within the                     information in the list of plant pest taxa            products. A plant product is defined as
                                            scope of the proposed regulation,                       in the current regulations, and should                ‘‘any flower, fruit, vegetable, root, bulb,
                                            because they are plant pests. Although                  be more useful and reliable than static               seed, or other plant part that is not
                                            there are currently no examples of using                lists of taxa. APHIS welcomes public                  included in the definition of plant; or
                                            GE plants as BCOs, such a GE plant                      comment on deletion of the taxa list and              any manufactured or processed plant or
                                            would be evaluated under the proposed                   preferred sources of plant pest and                   plant part.’’ APHIS has regulated GE
                                            regulations to evaluate whether it is a                 noxious weed information for use under                organisms under part 340 for over 20
                                            noxious weed or a plant pest.                           the proposed regulations.                             years, and there is no strong evidence to
                                              Currently, the federal regulation of                     With deletion of this list from the                suggest the need to regulate nonliving
                                            microbial BCOs is regulated by EPA                      regulations, there is also no longer a                (nonviable) plant products in most
                                            under FIFRA, and this covers GE as well                 need for the procedure currently                      cases. However, if in a specific case the
                                            as non-GE microorganisms used to                        described in § 340.5 for amending this                importation, interstate movement, or
                                            mitigate the effect of pests. Unlike the                list.                                                 environmental release of nonliving
                                            PPA, which limits the definition of BCO                                                                       products of a GE plant may pose
                                            only to organisms used to control plant                 3. Regulating Whole Organisms, Parts,                 noxious weed risks, APHIS has clear
                                            pests and noxious weeds, FIFRA covers                   and Nonliving Products                                authority to address those risks by
                                            microorganisms used as biological                          APHIS proposes to clarify the                      imposing permit conditions on the
                                            control for any pest. APHIS considers it                regulated status of nonliving plant                   handling of such nonliving products of
                                            duplicative to have these regulations                   products in the regulations. First, the               the GE organism in the permit issued for
                                            include GE microbial BCOs under its                     PPA defines a plant pest only as any                  the associated living GE organism. The
                                            scope since FIFRA already adequately                    living stage of any of the articles                   proposed regulations state clearly in
                                            covers them, so APHIS is proposing that                 specifically named in the plant pest                  § 340.3(b) that the Administrator may
                                            the regulatory scope language in                        definition that can directly or indirectly            also assign permit conditions addressing
                                            § 340.0(d) would explicitly exclude GE                  injure, cause damage to, or cause                     nonliving plant materials associated
                                            microorganisms if they are already being                disease in any plant or plant product.                with or derived from GE organisms
                                            regulated as BCOs by EPA under FIFRA.                   Moreover, APHIS does not consider                     when such conditions are needed to
                                            We are proposing to only regulate GE                    most GE organisms or parts of GE                      make it unlikely that the nonliving
                                            BCO macro-organisms that fall under                     organisms which cannot reproduce to                   materials would pose a noxious weed
                                            the proposed regulatory scope (APHIS–                   present a risk as plant pests or noxious              risk. APHIS invites consultation from
                                            PPQ currently regulates the macro-                                                                            any person considering a movement or
                                                                                                    weeds.
                                            organism non-GE BCOs used to control                                                                          release of nonliving materials derived
                                                                                                       Conversely, we would regulate
                                            plant pests and noxious weeds pursuant                                                                        from a GE organism who is uncertain as
                                                                                                    importation, interstate movement and
                                            to other regulations). APHIS welcomes                                                                         to whether it would be regulated.
                                                                                                    release into the environment of GE
                                            public comment on this aspect of its
                                                                                                    seedlings, seeds, tubers, cuttings, bulbs,            B. Permits for Authorizing Importation,
                                            proposal.
                                                                                                    spores, etc., because there is a                      Interstate Movement and Release Into
                                            Intrastate Movements of GE Organisms                    reasonable, albeit small, possibility of              the Environment of Certain GE
                                            Between Contained Facilities and                        reproduction, establishment, and spread               Organisms
                                            Activities in Contained Facilities Do Not               if these were deliberately or accidentally
                                            Fall Within the Scope of the Regulations                released into the environment without                 1. Elimination of the Notification
                                                                                                    authorization.                                        Procedure
                                              Under the current regulations, certain
                                            GE organisms are only regulated by                         Viable pollen from GE plants                          APHIS first added the notification
                                            APHIS if they are imported, moved                       imported, moved interstate, or released               procedure to the regulations in 1993 as
                                            interstate, or released into the                        into the environment would be subject                 an administratively streamlined
                                            environment. The regulations do not                     to the regulations because such                       procedure for certain GE plants that met
                                            govern intrastate movements between                     movements of pollen can reasonably                    the eligibility criteria described in the
                                            contained facilities such as laboratories,              lead to genomes becoming established                  regulation. Rather than using
                                            nor do they govern such activities as                   in the environment. Similarly, in                     customized requirements, like the
                                            creating GE organism in a contained                     circumstances where an article                        permit conditions used for the
                                            research laboratory. The proposed                       incidentally contains viable pollen,                  permitting procedure, the notification
                                            revision does not change this aspect of                 during movement, APHIS would                          procedure uses generalized performance
                                            the regulations.                                        consider the movement regulated. There                standards that are described in the
                                                                                                    are many cases, however, when pollen                  regulation itself. The use of the
                                            2. Deleting the List of Organisms Which                 may be present but is no longer capable               performance standards that do not vary
                                            Are or Contain Plant Pests                              of producing offspring, e.g., nonviable               from one notification to the next is one
                                               In § 340.2 of the current regulations,               or immature pollen. In such cases,                    of the ways that the more rapid
                                            there is a list of taxa that are considered             APHIS would not require permits under                 administrative turnaround was
                                            to be plant pests. Under the proposed                   this part. The commercial distribution                achieved. In some ways, the term
                                            scope, this list is not needed because we               of cut flowers is one pollen movement                 ‘‘notification’’ has been misleading to
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                                            would not use taxonomic classification                  situation that APHIS has considered in                the public, since they do not realize that
                                            of donor and recipient organisms to                     light of the regulations, especially in               sending a notification does not mean
                                            determine if a GE organism is regulated.                cases where the flowers are grown in                  automatic authorization by APHIS.
                                            When in the course of evaluating a GE                   other countries then imported only as                    APHIS reviews notifications to verify
                                            organism APHIS considers whether a                      cut flowers. APHIS considers these                    that the GE plant meets the eligibility
                                            donor or recipient species is likely to be              circumstances to pose little, if any risk,            criteria, and also evaluates whether the


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                                            60016                 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules

                                            proposed importation, interstate                        providing the responsible person with                 implemented under the notification
                                            movement or environmental release can                   flexibility in how the standard is met,               procedure, because under the current
                                            be done in a manner that meets the                      e.g., allowing for appropriate change in              regulations APHIS does not have the
                                            performance standards described in the                  protocols used during the growing                     ability to attach conditions to
                                            regulation. In many ways, these APHIS                   season. However, there are some                       notifications. This provides additional
                                            evaluations for notifications are very                  disadvantages in not specifically                     justification for APHIS to propose the
                                            similar to those done for permit                        enumerating the specific measures that                elimination of the notification
                                            applications, but the notification                      constitute compliance with the                        procedure. The APHIS proposal to
                                            procedure relies on applicants agreeing                 regulations. The permitting procedure                 eliminate the notification procedure is
                                            to meet the performance standards                       does not have this disadvantage,                      an effective way to address several of
                                            described in the regulation rather than                 because the permit conditions specify                 the provisions of the Farm Bill, such as
                                            submitting an application for APHIS                     which actions need to be taken by the                 the changes to the requirements for
                                            review describing the specific measures                 responsible person to be in compliance.               recordkeeping and reporting.
                                            they will employ for the activity (as is                   APHIS considered revising the
                                                                                                    performance standards and retaining the               2. Revisions to Permit Procedures
                                            the case for permits). With permits, but
                                            not with notifications, APHIS can                       notification procedure, but this would                   APHIS proposes to reorganize the
                                            accept the proposed measures or add to                  not have remedied its shortcomings,                   regulations to improve the clarity of the
                                            them and the result is a set of binding                 especially the lack of specificity that is            permit application and evaluation
                                            customized permit conditions.                           a necessity of using broadly applicable,              procedures. The proposed change is
                                               Because the notification procedure                   performance standards in the                          more a reorganization than substantive
                                            uses only the performance standards in                  regulations.                                          change, and should enhance the
                                            the regulations, it is more                                Under the proposed regulations where               transparency of the regulations to the
                                            administratively streamlined, but the                   all authorizations will be done under a               public. The permitting procedure will
                                            general nature of the standards has                     permitting procedure, the permit                      continue to identify and obtain
                                            made it difficult for APHIS inspectors to               conditions will provide more specific                 information relevant to evaluating the
                                            determine if a notification holder is in                information about what procedures the                 risks associated with a proposed
                                            compliance and can also make                            permit holder must follow in order to be              importation, interstate movement, or
                                            enforcement more difficult. For                         in compliance. In the proposed rule, we               release into the environment, and
                                            example, under the current regulations,                 are describing in detail the types of core            determine and document whether, and
                                            one of the performance standards for                    permit conditions that will be imposed,               under what conditions, the activity
                                            notifications relevant to environmental                 plus the additional permit conditions                 should be allowed. The proposed
                                            releases states that: ‘‘The field trial must            that the Administrator can place upon                 regulations related to the issuance of
                                            be conducted such that (1) the regulated                the permit holder in order to make it                 permits are divided into two sections.
                                            article will not persist in the                         unlikely that actions under the permit                The first is proposed § 340.2, Procedure
                                            environment, and (2) no offspring can                   would result in the introduction or                   for permits, which describes permit
                                            be produced that could persist in the                   dissemination of a plant pest or noxious              types, the procedure for permit
                                            environment.’’ Conversely, specific                     weed.                                                 application (including information
                                            conditions which APHIS places on                           In view of the above discussion,                   requirements), and the Agency’s
                                            permits are unambiguous, easy to verify                 APHIS has determined that it would                    administrative actions for permits. The
                                            at inspection, and easier to enforce. A                 have more flexible, risk-appropriate                  second is proposed § 340.3, Permit
                                            specific permit condition that could be                 oversight, better regulatory enforcement              conditions, which describes the general
                                            used to address just part of the                        and improved transparency if all                      types of conditions that APHIS may add
                                            performance standard described above                    regulated importations, interstate                    to a permit, and the obligations of the
                                            might read: ‘‘After final harvest of the                movements, and releases into the                      responsible person after permit
                                            GE corn plants covered under this                       environment are authorized under the                  issuance.
                                            environmental release permit, the site                  permitting procedure. The use of the                     APHIS is proposing explicit
                                            will be monitored every 4 weeks for the                 permitting procedure in lieu of                       procedures for amendment, transfer of
                                            emergence of volunteer corn seedlings                   notifications is also necessary for APHIS             responsibility, and revocation of permits
                                            for one year, and any emerging                          to address some of the                                in order to establish clear regulatory
                                            volunteer plants will be devitalized                    recommendations arising from the OIG                  procedures that can increase efficiency
                                            before they produce pollen. Records of                  Report and the provisions of the 2008                 yet maintain adequate safety. Currently
                                            the monitoring and management of                        Farm Bill. For example, the OIG                       the APHIS administrative practices to
                                            volunteers must be maintained by the                    recommendations have led to proposed                  amend, transfer, and revoke permits
                                            permit holder and made available to                     provisions in the regulations that will               have not been explicit in the regulation,
                                            APHIS upon request.’’                                   enable APHIS to add permit conditions                 and this addition will provide increased
                                               APHIS employs performance                            to require additional reports during the              transparency and efficiency.
                                            standards in many of its regulations,                   course of an environmental release, the                  The proposed changes organize the
                                            where appropriate. For example, we                      submission of notices to APHIS if the                 regulations to more clearly reflect the
                                            propose to employ a performance                         permit holder decides not to conduct                  procedural steps in the application,
                                            standard in another part of this                        the environmental release, and 7-day,                 evaluation, and issuance of a permit (see
                                            proposal, container requirements for                    pre-plant notices in the case of GE                   Figure 1). First, the different types of
                                            shipments of GE organisms. In that case,                plants engineered to produce                          permits (importation, interstate
                                            it is possible to employ a                              pharmaceutical or industrial substances.              movement, and environmental release)
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                                            straightforward standard that the                       The last recommendation is already                    are described in § 340.2(b), as are new
                                            container must not break or leak when                   being implemented as a permit                         subcategories of environmental release
                                            subjected to ordinary handling in                       condition, because all of these                       permits. Second, the types of
                                            transportation. The use of performance                  authorizations are done under the                     information that must be submitted with
                                            standards under the notification                        permitting procedure. The OIG                         a permit application are described in
                                            procedure has some benefits, such as                    recommendations cannot be                             § 340.2(c). The permit type, as well as


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                                                                       Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules                                                                 60017

                                            the nature of the environmental release                             conditions to permits, which is also                                 Figure 1. Schematic of activities
                                            (if the permit is for a release), affect the                        dependent upon permit type and release                             associated with issuance and
                                            application information requirements.                               category, is described in § 340.3. Each of                         enforcement of permits, showing
                                            Third, § 340.2(d) outlines the procedural                           these permit-related sections of the                               associated sections of the proposed
                                            and administrative steps of issuing a                               proposed regulations is discussed                                  regulation.
                                            permit. Finally, the attachment of                                  below.


                                                                                                 Permit Types and Environmental Release Categories (§ 340.2(b))
                                                                                                                               ↓
                                                                                                   Application Information Requirements, by Type (§ 340.2(c))
                                                                                                                               ↓
                                                                                                            Permit Evaluation Procedures (§ 340.2(d))
                                                                                                                               ↓
                                                                                                           Assignment of Permit Conditions (§ 340.3)
                                                                                                                                ↓
                                                                                                 Compliance, Enforcement, and Remediation Activities (§ 340.7)
                                            3. Permit Types and Environmental                                   generalized ‘‘performance standards’’                              and import permits. In general,
                                            Release Categories (§ 340.2(b))                                     described in the regulation and                                    deliberate release of GE organisms into
                                                                                                                therefore do not vary from one                                     the environment presents a greater risk
                                              As discussed above in the background                              notification to the next. Currently,                               of introducing or disseminating plant
                                            section, APHIS currently uses two                                   approximately 90% of APHIS                                         pests and noxious weeds, and thus
                                            procedures—notification and permits—                                authorizations are done under the                                  requires more careful oversight, than
                                            to authorize the importation, interstate                            notification procedure.                                            shipments of GE organisms into and
                                            movement and release into the                                         Under the proposed system, which                                 across the country in secure containers.
                                            environment of GE organisms                                         would eliminate notifications, APHIS                               Of the three permit types, only
                                            considered to be regulated articles                                 would continue to issue three types of                             environmental release permits would be
                                            under this part. The permitting                                     permits—interstate movement,                                       differentiated into broad risk-related
                                            procedure can be used for all regulated                             importation, and environmental release.                            categories by the Administrator. This
                                            articles, but the notification procedure                            The procedures for the first two types of                          categorization would occur prior to the
                                            can be used only for certain GE plants                              permits are relatively straightforward,                            detailed and specific APHIS evaluation
                                            that meet the eligibility criteria                                  and the conditions usually required for                            of an individual permit application.
                                            described in the regulations. Whereas                               these permits address risks that are very                          Table 2 summarizes the relationship of
                                            permits are issued with explicit permit                             similar from one shipment to another.                              the three permit types and categories
                                            conditions which must be met by the                                 We propose only minor adjustments to                               that pertain to environmental release
                                            permit holder, notifications have                                   the procedures for interstate movement                             permits.

                                                                TABLE 2—PROPOSED PERMIT TYPES AND CATEGORIES FOR ENVIRONMENTAL RELEASE PERMITS
                                                                         Type                                                                                                                           Use

                                            Importation permit ..............................................                                                                      For securely moving a GE organism into the
                                                                                                                                                                                     United States.
                                            Interstate Movement ...........................................                                                                        For securely moving a GE organism from any
                                                                                                                                                                                     State into or through any other State.
                                            Environmental Release:* ....................................        Release   Category   A .........................................   For releases into the environment, outside the
                                                                                                                Release   Category   B .........................................     constraints of physical containment that are
                                                                                                                Release   Category   C ........................................      found in a laboratory, contained green-
                                                                                                                Release   Category   D ........................................      house, fermenter, other contained structure,
                                                                                                                Release   Category   E (non-plants) ....................             or secure shipment.
                                              * In some cases, an environmental release permit may also incorporate permits for importation or interstate movement when such movements
                                            are incidental to the environmental release.


                                               The proposed sorting system for                                  grouped into four categories, as                                   conceivable releases into tiers
                                            environmental release permits includes                              described below.                                                   representing discrete levels of risk.
                                            five categories: Four for releases of GE                               APHIS considered a tiered permitting                            There are a large number of risk factors
                                            plants (Categories A–D) and one for                                 system which would sort proposed                                   that contribute to the overall risk
                                            releases of all other GE organisms                                  environmental releases of plants into a                            associated with any given release. These
                                            (Category E). Releases of GE non-plant                              number of risk-based categories. Lowest                            factors include reproductive biology and
                                            organisms (Category E) would be placed                              risk releases would be assigned to Tier                            growth habit of the species, potential for
                                            into a single category and reviewed on                              1, slightly higher risk releases in Tier 2,                        gene flow to other species, phenotype
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                                            a case-by-case basis. APHIS considered                              and so on. In such a system, tier                                  engineered into the organism,
                                            the creation of smaller risk-related                                assignment is analogous to a risk rating.                          familiarity with the genetic material
                                            subcategories for non-plants, but APHIS                             In developing the specifics of                                     used, safety of any expressed products,
                                            has received too few permit applications                            implementing such a system in the                                  scale of the release, location, duration,
                                            to warrant the creation of these smaller                            regulations, however, APHIS found that                             experience, and compliance history of
                                            groupings. Releases of plants would be                              it was challenging to pre-assign all                               the applicant, proximity to threatened


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                                            60018                 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules

                                            and endangered species, and other                       weed. Secondary factors, which in some                species fall into each group by
                                            factors.                                                instances may change the initial                      publishing lists in guidance.
                                               Sorting proposed releases considering                categorization, include: how the                         Similarly, with regard to the factor for
                                            all relevant factors would lead to an                   recipient plant is commonly used (e.g.,               potential harm caused by introduced
                                            unwieldy system with many risk-based                    as a food or feed crop); the impact of the            traits, APHIS proposes to group traits
                                            categories, and would essentially                       engineered trait on the fitness of the GE             engineered into plants into four simple
                                            require a full risk assessment prior to                 plant; and, the degree of uncertainty                 groupings based upon the definitions of
                                            assigning a proposed release to the                     associated with the trait and its possible            plant pest and noxious weed. The
                                            appropriate risk category. Consequently,                impacts.                                              groups are listed in order of increasing
                                            it would be nearly impossible for                          Regarding the persistence factor,                  potential hazard of the engineered trait:
                                            applicants and the public to predict the                APHIS proposes to group plant species                    • Low:
                                            risk tier to which a proposed release                   according to the risk of persistence of                  Æ Any new proteins or substances
                                            would be assigned.                                      the plant or its progeny in the                       produced are unlikely to be toxic or
                                               APHIS proposes that the permitting                   environment without human                             otherwise cause serious harm to
                                            system for environmental release                        intervention. Based upon the growth                   humans, vertebrate animals, or
                                            permits would assign releases into                      habit of the plant species and presence               invertebrate organisms upon
                                            administrative categories based upon                    of wild relatives in the United States,               consumption of or contact with the
                                            two primary risk-related factors                        APHIS proposes to sort all plants into                plant or plant parts; and
                                            described below, so that the categories                 four groups, listed in order of increasing               Æ No morphological changes which
                                            would identify the general types of                     persistence risk:                                     could cause mechanical injury or
                                            releases of plants which share broadly                     • Low: Populations of the recipient                damage; and
                                            similar risks and management issues.                    plant are unlikely to persist in the                     Æ Introduced sequences are known
                                            This initial administrative sorting                     environment without human                             not to result in plant disease, and
                                            would be followed by an evaluation that                 intervention, and the recipient plant has             confers no or very low increased disease
                                            fully characterized the risk of the                                                                           susceptibility.
                                                                                                    no interfertile wild relatives in the
                                            proposed release, which would then be                                                                            An example would include
                                                                                                    United States. Examples include corn,
                                            the primary basis for adding necessary                                                                        expression of well characterized
                                                                                                    soybeans, and cotton (except in certain
                                            permit conditions. APHIS concludes                                                                            proteins known not to be toxic or
                                                                                                    areas).
                                            that such a system could appropriately                                                                        harmful, such as a marker gene that
                                                                                                       • Moderate: Populations of the
                                            sort most releases into groupings that                                                                        does not pose a food or feed safety
                                                                                                    recipient plant are known to be weakly
                                            are alike enough that they could usually                                                                      concern, or expression of viral genes
                                            be treated similarly initially, in terms of             persistent in the environment without
                                                                                                    human intervention, or the recipient                  where it is demonstrated that no protein
                                            application information requirements                                                                          is produced
                                                                                                    plant has interfertile wild relatives in
                                            and evaluation of potential risks. In                                                                            • Moderate:
                                            most cases the initial groupings would                  the United States. Examples include
                                                                                                                                                             Æ Any new proteins or substances
                                            also result in a similar level of oversight             alfalfa, beets, canola, rice, and tomato.
                                                                                                                                                          produced are unlikely to be toxic or
                                            of the release and conditions attached to                  • High: Populations of the recipient
                                                                                                                                                          otherwise cause serious harm to humans
                                            the permit-but any final determination                  plant are known to be strongly
                                                                                                                                                          or vertebrate animals upon consumption
                                            of the permit category, oversight and                   persistent in the environment without
                                                                                                                                                          of or contact with the plant or plant
                                            permit conditions would depend on the                   human intervention, or the recipient
                                                                                                                                                          parts ; or
                                            results of the APHIS evaluation.                        plant has interfertile wild relatives in                 Æ Novel resistance to the application
                                               Using this approach, there is no prior               the United States which are aggressive                of an herbicide; or
                                            conclusion that every release within the                colonizers. Examples include creeping                    Æ Has novel ability to cause
                                            same category poses the same level of                   bentgrass, poplar, sorghum, and                       mechanical injury or damage; or
                                            risk. Likewise, releases in different                   sunflower.                                               Æ Produces proteins or substances
                                            categories do not necessarily pose                         • Severe: The recipient plant is a                 that are associated with plant disease
                                            greatly different risks. For this reason,               Federally-listed noxious weed or is                   that are not prevalent or endemic in the
                                            APHIS would not refer to these                          known to be similarly aggressive in its               area of release, or that confer an
                                            groupings as ‘‘tiers,’’ as this implies an              ability to colonize and persist in the                increased susceptibility to disease.
                                            incremental increase in risk from tier to               environment without human                                Examples include expression of new
                                            tier, but would instead label them as                   intervention. Examples include hydrilla               CRY proteins, ,mechanisms of herbicide
                                            ‘‘categories’’ which are lettered and not               and kudzu.                                            tolerance (e.g., CP4–EPSPS, which
                                            numbered.                                                  These aspects of plant biology and                 confers glyphosate tolerance), and
                                               APHIS developed the proposed                         growth habit are broad indicators of the              production of viral movement proteins.
                                            sorting scheme by first examining the                   increasing likelihood that the plant or                  • High:
                                            types of releases that typically are                    its progeny can reproduce and spread                     Æ Any new proteins or substances
                                            authorized under its current regulations.               without human intervention.                           produced may be toxic or to otherwise
                                            APHIS then modified the categories to                   ‘‘Interfertile wild relatives’’ includes              cause serious harm to humans or
                                            make them more explicitly connected to                  both wild relatives in the traditional                vertebrate animals, upon consumption
                                            plant pest and noxious weed risks.                      sense, as well as feral populations of the            of or contact with the plant or plant
                                               The two primary factors APHIS                        same species persisting outside                       parts; or
                                            identified as most relevant to define its               agroecosystems. The distinction                          Æ Produces an infectious entity which
                                            sorting system for environmental release                between ‘‘weakly persistent’’ and
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                                                                                                                                                          can cause disease in plants.
                                            permits were the (1) ability of the                     ‘‘strongly persistent,’’ is intended to                  Examples include mercury hyper-
                                            unmodified recipient plant species to                   mean survival without human                           accumulators or production of some
                                            persist in the wild and (2) potential of                intervention for one or very few                      pharmaceutical compounds.
                                            the engineered trait to cause harm,                     generations (weakly persistent) versus                   • Severe:
                                            injury, or damage, as described in the                  several to many generations (strongly                    Any new proteins or substances
                                            definitions of plant pest and noxious                   persistent). APHIS will clarify which                 produced are known or likely to be


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                                                                            Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules                                                                       60019

                                            highly toxic or fatal to humans or                                           resistance to an herbicide is included in                            categories (see Table 3). Once
                                            vertebrate animals, upon consumption                                         the ‘‘moderate’’ category due to the                                 environmental releases of GE plants
                                            of or contact with the plant or plant                                        impacts the trait could have on the                                  have been sorted into the permit
                                            parts.                                                                       ability to manage the plant or its                                   categories shown in Table 3, we will
                                               These aspects of the engineered trait                                     progeny.                                                             review and evaluate the information
                                            are related to harms or damages                                                The proposed use of plant growth                                   submitted by the applicant to determine
                                            associated with plant pests or noxious                                       habit and trait harm or injury as the two                            oversight and permit conditions. The
                                            weeds. This takes into consideration (1)                                     main factors for the initial sorting of                              information requested from applicants
                                            the harmfulness of any substances                                            environmental releases into categories                               will not be limited to these factors and
                                            produced, (2) the possibility of creating                                    uses the two factors to roughly                                      is, in fact, designed to allow us to
                                            morphological changes that would                                             approximate ‘‘exposure’’ and ‘‘hazard,’’                             evaluate any of the risks associated with
                                            cause physical injury, and (3) the                                           respectively. Thus, using a combination                              noxious weeds and plant pests. In some
                                            likelihood of increasing plant disease,                                      of these two factors alone, we propose                               instances, our review may result in a
                                            either due to risk of creating novel pests                                   the following initial sorting of plant-trait                         change to the release category
                                            or increased inoculum source. Novel                                          combinations into release permit                                     assignment of a GE plant.

                                             TABLE 3—INITIAL SORTING INTO ADMINISTRATIVE PERMIT CATEGORIES (A, B, C, AND D) FOR ENVIRONMENTAL RELEASES
                                                OF GE PLANTS, BASED UPON PERSISTENCE RISK OF THE RECIPIENT PLANT SPECIES AND POTENTIAL HARM OR DAM-
                                                AGE OF THE ENGINEERED TRAIT

                                                                                                                                                                                         Potential harm or damage of engineered trait
                                                                                                     Persistence *
                                                                                                                                                                                        Low           Moderate      High         Severe

                                            Low ..................................................................................................................................       A               A            C             D
                                            Moderate ..........................................................................................................................          A               B            C             D
                                            High ..................................................................................................................................      B               B            C             D
                                            Severe ..............................................................................................................................        D               D            D             D
                                               * Persistence risk of the recipient plant species.


                                               The sorting system above presumes                                         species sorted into any one of the                                   current system. However, it will be
                                            that there is sufficient scientific                                          proposed groupings, however, APHIS                                   much clearer to the public what types
                                            information available about the GE plant                                     has concluded that in most instances                                 of oversight will be applied broadly
                                            to support the categorization. For                                           the engineered trait would not alter the                             within each category. As we discussed
                                            example, the phenotype conferred by                                          likelihood of persistence enough to                                  above, oversight and permit conditions
                                            inserted sequences and the growth habit                                      warrant a change in initial release                                  with each category will be similar,
                                            of the plant species in the U.S. must be                                     category. However, in cases where the                                though not necessarily identical, for any
                                            well-characterized and based upon                                            engineered trait significantly alters plant                          plant within the category. Category D
                                            direct empirical observation of the                                          growth habit, metabolism, or                                         was created to acknowledge the
                                            genetic construct in the recipient plant                                     reproduction to increase the likelihood                              possibility that some proposed releases
                                            species. In cases where less (or nothing)                                    of persistence in the environment,                                   may pose a very high risk of introducing
                                            is known about phenotype of the                                              APHIS could change the release                                       a highly persistent or harmful plant into
                                            engineered trait in the recipient plant                                      category accordingly. Examples of such                               the environment. To date, APHIS has
                                            species-such as inference based upon                                         changes might include converting an                                  never been requested to allow releases
                                            sequence similarity, protein structure                                       annual species to a perennial or                                     that would fall into this category. If an
                                            modeling, or observation of the genetic                                      converting a plant with C3 metabolism                                applicant were to propose a Category D
                                            construct in other species-the release                                       to crassulacean acid metabolism (CAM).                               release, APHIS would only authorize
                                            category may be changed (from A to B                                            The proposed category system should                               such releases after imposing extremely
                                            or B to C) as a result of this uncertainty.                                  provide a simple, transparent way for                                strict levels of oversight akin to high
                                            Similarly, lack of familiarity with the                                      APHIS review information in                                          security quarantine far exceeding that of
                                            plant species’ behavior in the U.S. or the                                   applications to initially sort releases                              Category C that would ensure that the
                                            techniques needed to mitigate the                                            into broad, risk-related categories,                                 GE plants could not persist in the
                                            likelihood of its persistence could also                                     which can then be more efficiently                                   environment. The information
                                            change the release category.                                                 assessed for the actual risks posed by                               requirements, permit conditions, and
                                               APHIS considered whether to adjust                                        the release. However, it should be                                   general levels of oversight associated
                                            the categories table to acknowledge that                                     emphasized that the categories are                                   with each release Category are discussed
                                            an engineered trait could affect                                             intended only for initial sorting, and                               below.
                                            (enhance or detract from) the other                                          other factors are taken into account in                                 This simple sorting system places GE
                                            factor axis, namely the persistence risk                                     the APHIS evaluation when determining                                plants into categories and provides a
                                            of the nonmodified recipient plant.                                          the specific permit conditions.                                      relatively clear, simple rationale for
                                            Engineered traits such as resistance to                                         APHIS intends that release Category A                             placement in a given category. What
                                            biotic or abiotic stresses could                                             will be associated with a level of                                   follows is a series of illustrations of
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                                            theoretically increase the fitness of the                                    regulatory oversight similar to                                      common plant-trait combinations and
                                            plant, and thereby increase the                                              environmental release notifications                                  the release categories to which they
                                            likelihood that it will persist in the                                       under the current system, and                                        would be assigned:
                                            environment without human assistance.                                        Categories B and C with a level of                                      • Category A:
                                            Considering the range of persistence                                         regulatory oversight similar to various                                 Æ Bt corn producing CRY1ab toxin.
                                            risks posed by all of the different plant                                    permits that have been issued under the                              The plant is unlikely to persist in the


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                                            60020                 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules

                                            environment and the safety of the                       would fall in Category C, and would                   details about how the engineered traits
                                            protein has been assessed by the EPA.                   carry the same level of oversight as                  might be harmful.
                                               Æ Soybeans engineered with                           current permits for PMPI.
                                                                                                                                                          5. Permit Conditions (§ 340.3)
                                            glyphosate tolerance conferred by CP4–
                                                                                                    4. Permit Application Information                        Conditions are specific practices or
                                            EPSPS. While herbicide tolerance poses
                                                                                                    Requirements (§ 340.2(c))                             requirements that an applicant must
                                            a ‘‘moderate’’ hazard, soybean has no
                                            interfertile wild relatives in the U.S..                   In the proposed regulations, we                    follow upon issuance of a permit. Under
                                               • Category B:                                        provide greater detail about the basic                the current regulation, the permit
                                               Æ Corn producing a new CRY protein.                  application information requirements                  conditions are described in the same
                                            The plant is unlikely to persist and the                that need to be addressed in all permit               section as the permit procedure itself. In
                                            novel CRY protein is likely to be toxic                 applications, as well as additional basic             the proposed revision, the permit
                                            to some species that live or feed on the                information required for each permit                  conditions are enumerated in a separate
                                            plant (normally Category A), but its                    type and the categories in the case of                section (§ 340.3) to accommodate the
                                            food/feed safety is only inferred from                  environmental release permits. Under                  additional details to describe conditions
                                            similarity to other CRY proteins.                       the current regulation, certain areas                 for the three permit types as well as the
                                               Æ Random ‘‘knock-out’’ or antisense                  where APHIS routinely needs                           categories of environmental release
                                            libraries of soybean lines. While the                   information from the applicant do not                 permits.
                                            lines may not likely produce novel                      become apparent until the applicant                      The use of permits and permit
                                            proteins or substances (Category A),                    submits the permit application (and                   conditions gives APHIS and the
                                            because of the uncertainty associated                   APHIS subsequently follows up for                     responsible person a clearer
                                            with the impacts of genetic engineering                 additional information). Some of the                  understanding as to what actions must
                                            on these lines, they would be treated as                information requirements related to                   be taken for the permit holder to comply
                                            Category B. Well-characterized lines                    recordkeeping, reporting, and                         with the regulation. In the proposed
                                            taken from such libraries that do not                   contractual arrangements among the                    regulation, APHIS has strived to provide
                                            produce new proteins would likely be                    permit holder and agents are new to the               as much transparency and predictability
                                            treated as Category A.                                  regulation and reflect, in part, certain              as possible about permit conditions
                                               Æ Kentucky bluegrass engineered                      provisions of the 2008 Farm Bill and                  while retaining sufficient flexibility so
                                            with glyphosate resistance conferred by                 also align with recommendations of                    that the regulations will be adaptable in
                                            CP4–EPSPS. Herbicide resistance is a                    USDA’s OIG 2005 Report. For example,                  a broad range of cases.
                                            ‘‘moderate’’ hazard and bluegrass has                   the OIG recommendations have led to                      Permits will be issued with the core
                                            interfertile wild relatives in the U.S.                 provisions that will enable APHIS to                  permit conditions described in
                                               Æ Pines producing an enzyme to                       require geographic coordinates for the                § 340.3(a), which are a minimum set of
                                            enhance paper production. Pines are                     locations of environmental releases.                  basic conditions for importation,
                                            persistent and have interfertile wild                      The differences between the                        interstate movement, and release. The
                                            relatives in the United States.                         information required for an application               Administrator may add to these
                                               • Category C:                                        under the current regulations versus the              conditions additional or expanded
                                               Æ Poplar engineered to produce                       proposed regulations may be seen by                   conditions when necessary to make it
                                            enzymes for heavy metal                                 comparing current § 340.4 to proposed                 unlikely that actions under the permit
                                            bioremediation.                                         § 340.2(c). Both the current and                      would result in the introduction or
                                               • Category D:                                        proposed application procedures                       dissemination of a plant pest or noxious
                                               Æ Any Federally listed noxious weed                  require information characterizing the                weed.
                                            that has been genetically engineered;                   nature of the GE organism, including                     The Administrator will assign the
                                            any GE plant producing a vertebrate                     detailed molecular biology information                permit conditions in a manner that is
                                            toxin.                                                  about the expression of the introduced                commensurate with the risk of the
                                                                                                    genetic material. They also both require              individual proposed movement or
                                            Permits for Environmental Releases of                   information about the type of movement                release. Additional or expanded permit
                                            Plants Making Pharmaceutical and                        and/or release planned. The proposed                  conditions may include, but are not
                                            Industrial (PMPI) Compounds                             rule requires more detail in some of                  limited to, specific requirements for:
                                               APHIS considered whether to                          these areas, and more description of the              reproductive, cultural, spatial, temporal
                                            continue to issue environmental release                 applicant’s plans and methods to                      controls; monitoring; post-termination
                                            permits for GE plants engineered to                     prevent unauthorized releases, and to                 land use; site security or access
                                            produce pharmaceutical and industrial                   respond to unauthorized releases if they              restrictions; and management practices
                                            compounds if the GE plant species is                    occur. This information is used in part               such as training of personnel involved
                                            the same as, or sexually compatible                     by APHIS to formulate the specific                    in the release.
                                            with, a species commonly used for food                  permit conditions. In cases where the                    The proposed description of permit
                                            or feed. APHIS concludes that the                       permit is for environmental release, and              conditions elaborates on the ‘‘standard’’
                                            proposed permitting procedure and the                   would be in permit categories C or D                  permit conditions found in the current
                                            use of stringent permit conditions can                  according to the table in § 340.2(b)(3), a            regulations, and the additional detail is
                                            continue to effectively minimize the                    greater level of detail would be required             designed to better communicate with
                                            risks that may be associated with the                   for almost all aspects of the activity,               potential applicants what the
                                            environmental release of such GE                        including the recipient organism, the                 requirements are likely to be for their
                                            plants. APHIS will continue to impose                   inserted gene(s), site location and                   particular permit, and will better
                                            permit conditions that take into account                management practices, and training and                support administration of the program,
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                                            the issues related to the safety of                     communication among the permit                        including compliance and enforcement.
                                            proteins or other substances that these                 holder and agents involved in the                        In the current regulation, only
                                            plants have been engineered to produce.                 activity covered under the permit. This               ‘‘standard’’ permit conditions are
                                            Based upon APHIS experience to date,                    information would also address the                    described, and APHIS has the authority
                                            many releases of GE plants producing                    capability of the organism to persist or              to place other conditions upon the
                                            pharmaceutical or industrial substances                 spread in the environment, or include                 permit as deemed necessary by the


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                                                                  Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules                                          60021

                                            Administrator. The proposal for permit                  acknowledgement from the applicant                    conditions for import and interstate
                                            conditions will be more transparent to                  prior to permit issuance that they are                movement permits have been placed in
                                            the public and this transparency will                   aware of and consent to the permit                    the section for permit conditions, rather
                                            better facilitate planning by researchers,              conditions. To verify that applicants are             than retaining them in a separate section
                                            especially those who have not                           aware of and willing to abide by the                  as in the current regulations. The
                                            previously received permits from                        conditions, APHIS proposes to add an                  performance-based standards we are
                                            APHIS.                                                  additional administrative step in the                 proposing incorporates a simple
                                               The proposed required core permit                    permit procedure in § 340.2(d)(6) to                  performance standard in our proposed
                                            conditions consolidate six primary areas                support administration of the program.                definition of secure shipment, discussed
                                            addressed in different parts of the                     We are proposing to require that                      below: ‘‘Shipment of a package of
                                            current regulations to ensure                           applicants agree prior to permit                      sufficient strength and integrity to
                                            compliance with the regulation and to                   issuance that they will comply with all               withstand leakage of contents, shocks,
                                            make it unlikely that the permitted                     the permit conditions. Eventually,                    pressure changes, and other conditions
                                            activity will result in the introduction                APHIS would build this feature into the               incident to ordinary handling in
                                            and dissemination of a plant pest or                    existing ePermits system, and in the                  transportation.’’ APHIS is also
                                            noxious weed: Identity, shipment,                       interim it would provide alternative                  proposing to require applicants to
                                            unauthorized dissemination,                             mechanisms, such as e-mail                            provide their proposed methods of
                                            communication and training, records,                    communications, to implement this step                secure shipment, and APHIS will
                                            reports and notices. APHIS intends the                  of the permitting procedure.                          specify the methods of secure shipment
                                            list of specific condition areas we                        APHIS is also proposing to clarify in              as a permit condition.
                                            propose in § 340.3 to be used for all                   § 340.2(h) of the regulations the                        APHIS proposes to eliminate the
                                            permits we issue as they apply to                       procedure to be used when amendment                   marking and identity requirements for
                                            importation, interstate movement, and                   of existing permit conditions is sought               imports of GE organisms as a separate
                                            release into the environment. The                       by the responsible person or required by              section of the regulations (current
                                            required permit conditions listed in                    APHIS, as well as the procedure for                   § 340.7). As with the container standard
                                            § 340.3 represent the permit conditions                 transfer of an existing permit to a                   issue discussed above, appropriate
                                            that we propose to apply for any type                   different responsible person.                         labeling and related requirements would
                                            of permit. Listing them in the                             As with the current regulations,                   be highly individual depending on the
                                            regulations should provide applicants                   APHIS is retaining the flexibility to                 organism, type of permit, and other
                                            with the ability to plan their activities               modify permit conditions as needed                    conditions.
                                            with knowledge of the primary                           under individual circumstances.                          APHIS is proposing to include
                                            requirements for all activities that                    Proposed § 340.3 will increase                        relevant tribal officials when it provides
                                            would have to be met to comply with                     transparency, yet still allow sufficient              copies of permit applications to state
                                            the regulations.                                        adaptability of the regulations for the               regulatory officials. The current
                                               For environmental release permits,                   full range of permit applications APHIS               regulations state that APHIS provides
                                            proposed § 340.3(a)(4)(iii)(F) would also               expects to receive today and in the                   this information to state regulatory
                                            require the permit holder to notify                     future. APHIS recognizes that                         officials.
                                            APHIS seven days prior to initiation of                 transparency and predictability for
                                                                                                                                                          6. Elimination of Courtesy Permits
                                            the release if the release is Category C                applicants must be balanced with
                                            or D. For all Categories, permit holders                maintaining Agency flexibility and                       APHIS is also proposing to eliminate
                                            are required to notify APHIS if they do                 adaptability for years to come under                  the issuance of courtesy permits.
                                            not conduct the release.                                these regulations. APHIS encourages the               Courtesy permits have been part of the
                                               The current regulations require                      public to comment on the choices we                   regulations since their inception in
                                            environmental release permit holders to                 are proposing here, and we welcome                    1987, but in an effort to better allocate
                                            submit field test reports to APHIS                      suggestions for alternative approaches.               APHIS resources, APHIS is proposing to
                                            within 6 months after termination of a                     APHIS is proposing to revise the                   remove this regulatory feature. The
                                            field test. Under proposed § 340.3(a), the              current sections of the regulations for               current regulations provide the ability
                                            requirement simply states that the                      container requirements for shipments of               for APHIS to issue ‘‘courtesy permits,’’
                                            responsible person shall submit reports                 GE organisms (§ 340.8) and marking and                in order to facilitate the movement of
                                            to APHIS at the times specified in the                  identity requirements for imports of GE               organisms which are outside the scope
                                            permit conditions and containing the                    organisms (§ 340.7). Rather than the                  of these regulations, but whose
                                            information specified in the permit                     highly prescriptive approach in the                   movement might otherwise be hindered
                                            conditions.                                             current regulation, we will use an                    because of their similarity to organisms
                                               APHIS is also proposing revision of                  approach that is performance based and                regulated under these regulations. The
                                            the regulations to clarify the procedure                can be adapted to the activity that is                issuance of courtesy permits has
                                            it would use for amendment of permit                    being performed. This should provide                  generated confusion in the public and
                                            conditions, transfer of a permit to a                   greater efficiency for the public as well             especially in the research community.
                                            different responsible person, and                       as APHIS, yet still achieve the necessary             The application form for courtesy
                                            revocation of an existing permit. Each of               level of containment during shipments.                permits is identical to the application
                                            these additions to the regulations reflect              We have reorganized this information in               for other types of permits, and the
                                            current administrative practices and the                the regulations so that the requirements              courtesy permit itself looks like other
                                            incorporation of these into the                         are associated with the related activity              permits. This has led to the widespread
                                            regulations will make the overall system                under the proposed regulation. For                    misunderstanding by some researchers
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                                            more transparent.                                       example, the shipping requirements for                that courtesy permits are actually
                                               Currently, APHIS attaches conditions                 interstate movements under the                        required for the movement of certain
                                            to permits at the moment the permit is                  conditional exemption have the                        organisms, or that issuance of a courtesy
                                            issued to the applicant. Under the                      requisite shipping conditions stipulated              permit removes the requirement for
                                            current regulations, the permitting                     in the section for conditional                        applicants to have other authorizations
                                            procedure does not include a formal                     exemptions. Likewise, the shipping                    which may be required, under plant


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                                            60022                 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules

                                            pest regulations such as those found at                    The current regulations provide for                would provide an adaptable means of
                                            7 CFR part 330. APHIS commits                           conditional exemptions from the                       ensuring that the regulatory oversight is
                                            significant resources to the issuance of                requirement for permits for the                       proportional to the risks posed by
                                            these courtesy permits for the                          interstate movement of certain GE                     specific activities with GE organisms.
                                            movement of organisms which are not                     strains of the microorganisms                            Proposed § 340.5 describes the
                                            subject to the provisions of part 340.                  Escherichia coli, Saccharomyces                       procedure whereby a petitioner would
                                            APHIS will work with researchers and                    cerevisiae, and Bacillus subtilis, and the            seek a determination by the
                                            relevant government regulatory officials                plant Arabidopsis thaliana in § 340.2(b),             Administrator that the importation,
                                            to facilitate the transition.                           and these conditional exemptions are                  interstate movement, and/or release into
                                               APHIS will also be available for                     being retained under the proposed                     the environment of a GE organism is not
                                            consultation by persons who formerly                    regulations. Conditional exemptions                   subject to the requirement to have a
                                            used courtesy permits and other persons                 from permit have been part of the                     permit under this part. We propose that
                                            moving similar non-regulated articles, to               regulations since the first exemption                 the Administrator’s decision to approve
                                            discuss how to facilitate their                         was established in 1988 (for the                      an exemption would be based upon a
                                            movement. We also encourage the                         interstate movement of certain GE                     determination that the exemption from
                                            public to comment on the proposed                       microorganisms), with the addition of                 the requirement for a permit, when
                                            elimination of courtesy permits and                     another conditional exemption, through                conducted with the associated
                                            how APHIS should work with persons                      rulemaking, in 1990 for certain types of              conditions, is unlikely to result in the
                                            moving organisms for which we might                     GE Arabidopsis thaliana, one of the                   introduction or dissemination of a plant
                                            formerly have issued courtesy permits.                  most commonly used plants for                         pest or noxious weed. APHIS
                                            C. Conditional Exemptions From Permit                   scientific studies and which is                       anticipates that creating this new
                                            Requirement (§ 340.4)                                   frequently distributed among                          petition procedure to allow approval of
                                                                                                    researchers. The essential conditions for             additional conditional exemptions
                                               The PPA allows the Secretary to                      each of these conditional exemptions                  would enhance its ability to customize
                                            create ‘‘exceptions’’ to the permit                     address the following: (1) Species of the
                                            requirement when the Secretary deems                                                                          regulatory oversight to be proportional
                                                                                                    GE organism, (2) the types of genetic                 to any risks associated with importation,
                                            that a permit is not necessary. That is,                modifications that are allowed or
                                            these regulated activities are allowed,                                                                       interstate movement, or release into the
                                                                                                    prohibited for the GE organism, and (3)               environment of a GE organism.
                                            under certain conditions, without                       the manner in which the GE organism
                                            seeking prior authorization via permit.                                                                          Under the proposed procedure,
                                                                                                    is shipped interstate. The existing                   petitioners have the flexibility to
                                            The current APHIS regulations contain                   conditional exemptions for the
                                            such PPA exceptions, but they are                                                                             propose various types of conditional
                                                                                                    interstate movement of microorganisms                 exemptions from the requirement for a
                                            referred to as ‘‘exemptions’’ in the                    were based on APHIS’ conclusion that
                                            regulations. The current regulations                                                                          permit: The proposal can be for one or
                                                                                                    the exemption from the requirement for
                                            include conditional exemptions from                                                                           more permit types (importation,
                                                                                                    permits for interstate movement of these
                                            the requirement for interstate movement                                                                       interstate movement, or release into the
                                                                                                    microorganisms would ‘‘not present a
                                            permits. These conditional exemptions                                                                         environment). In addition, the petitioner
                                                                                                    risk of the introduction or dissemination
                                            were established in the regulations                                                                           can propose the relevant conditions.
                                                                                                    of a plant pest’’ (53 FR 12910, p.12910).
                                            during the first few years after the                       The existing conditional exemptions                The Administrator may approve the
                                            regulations were first promulgated. The                 for E. coli, Bacillus subtilis,                       proposed conditional exemption as
                                            last conditional exemption was                          Saccharomyces cerevisiae and                          submitted in the petition, or the
                                            established in the regulations in 1990                  Arabidopsis thaliana are being retained               Administrator may impose alternatives
                                            for the interstate movement of GE plants                in the proposed regulations. APHIS has                to the requested exemption and
                                            of the species Arabidopsis thaliana as                  no information that would indicate that               conditions. The Administrator would
                                            long as the conditions described in the                 such conditional exemption would be                   review the scientific information and
                                            regulations are met.                                    result in the introduction and                        evaluate potential risks relevant to the
                                               In its proposed revision to the                      dissemination of a plant pest or noxious              proposal, then make the relevant
                                            regulations, APHIS is retaining the                     weed. The text of the conditional                     documents (proposal and any
                                            existing conditional exemptions from                    exemption is being updated to place the               supporting information) available to the
                                            interstate movement. We are also                        shipping requirements with the other                  public for review and comment prior to
                                            proposing a new regulatory procedure                    conditions associated with the                        the Administrator’s decision.
                                            that would enable APHIS to approve                      exemption, instead of the current                        The information needed for a petition
                                            new conditional exemptions more                         regulatory organization that has the                  for conditional exemption would
                                            efficiently than using the procedure of                 shipping requirements in a separate                   depend on the nature of the exemption
                                            notice and comment rulemaking for                       section of the regulation.                            requested and the proposed conditions
                                            each individual exemption. This can be                     In addition to the existing conditional            for exemption. For example, conditional
                                            a transparent and efficient way to                      exemptions, APHIS is proposing a                      exemptions for the interstate movement
                                            provide regulatory relief. This new                     transparent and efficient petition                    of narrowly-defined groups of organisms
                                            procedure for approving conditional                     procedure in § 340.5 whereby the                      with restrictive associated conditions
                                            exemptions is described in § 340.5, and                 Administrator may approve additional                  might require considerably less
                                            it incorporates transparent steps                       conditional exemptions from permit                    information to justify than exemptions
                                            including scientific review, public                     without having to amend the                           for broadly defined groups of organisms
                                            input, and adaptability when APHIS                      regulations. This procedure would                     or less restrictive associated conditions.
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                                            establishes the conditions relevant to                  provide for a scientific review by APHIS              In making its determination, APHIS
                                            the specific conditional exemption.                     as well as the opportunity for public                 would consider all relevant information,
                                            Conditional exemptions, by their nature,                review and comment on the scientific                  including information in the scientific
                                            will always include conditions and                      basis for the proposed exemption and                  literature, copies of unpublished
                                            continued APHIS oversight to ensure                     the conditions associated with the                    studies, and reviews by other regulatory
                                            that the conditions are met.                            exemption. The proposed procedure                     agencies.


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                                                                  Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules                                            60023

                                               APHIS foresees many advantages to                    (seeds, fruit with seeds, nonviable                   concluding that the GE organism ‘‘poses
                                            the proposed procedure, including                       products like flour, etc.).                           no more of a plant pest risk than its non-
                                            scientific rigor, public involvement, and                  However, at this time APHIS is not                 genetically engineered counterpart,’’
                                            regulatory efficiency. APHIS would                      proposing such criteria in the                        ‘‘will not pose a plant pest risk’’; or that
                                            continue to provide to the public the                   regulation. APHIS does not rule out the               there is ‘‘no plant pest risk,’’ or ‘‘no
                                            relevant scientific information under                   possibility of developing such a                      direct or indirect plant pest effects.’’
                                            consideration, its environmental                        criterion-based system in the future. We              Regardless of the phrases used in its
                                            analysis, and the rationale for its                     welcome comments from the public on                   determination of nonregulated status to
                                            determination. The public would also                    this issue.                                           date, APHIS has applied the same basic
                                            retain its ability to provide comments to                  We are also proposing regulatory                   evaluation criteria to each
                                            the agency prior to a decision approving                procedures whereby the Administrator                  determination to conclude that the GE
                                            a new exemption. APHIS decisions                        may revoke any exemption under this                   organism is unlikely to pose a plant pest
                                            regarding these newly approved                          part after it is approved. As proposed,               risk and therefore is not subject to the
                                            conditional exemptions would be                         the Administrator may revoke any                      part 340 regulations.
                                            published in the Federal Register and                   exemption if the Administrator receives                  APHIS is proposing revisions to
                                            maintained on a list accessible to the                  information subsequent to approving                   § 340.6 that will clarify the petition
                                            public.                                                 the exemption and makes a                             procedure, information requirements for
                                               In evaluating whether to approve a                   determination based upon this                         petitions, and the standard upon which
                                            new conditional exemption, APHIS                        information that the circumstances have               the Administrator will make a
                                            would carefully consider issues related                 changed such that the exemption is                    determination that a GE organism is
                                            to enforceability of the conditional                    likely to result in the introduction or               approved for nonregulated status. Under
                                            exemption when proposing to approve a                   dissemination of a plant pest or noxious              the current regulations, the basic
                                            conditional exemption. Unlike permit                    weed. A revocation may not be                         standard for a determination of
                                            conditions, which are binding on the                    appealed. However, any person may file                nonregulated status of a GE organism
                                            specific responsible person, the                        a new petition in accordance with                     has been related to plant pest risk. In
                                            conditions associated with the                          § 340.5 regarding the same or similar                 § 340.6(b)(4) of this proposed rule, we
                                            exemption would apply to anyone who                     organisms covered by the exemption if                 are proposing to apply a similar basic
                                            conducts the activity under the                         new information relevant to the                       standard derived from the proposed
                                            conditional exemption. Before granting                  revocation becomes available.                         regulatory scope in § 340.0(a), namely,
                                            such a conditional exemption, APHIS                        In addition to this procedure for                  whether the GE organism is unlikely to
                                            would take into consideration the                       completely revoking an exemption so it                be a plant pest or noxious weed.
                                            likelihood that such conditions would                   would be unavailable for use by any                      The current regulations also have a
                                            be followed and the consequences if                     person, we propose to add a provision                 provision at § 340.6 to extend a
                                            they are not.                                           in paragraph (e) of the conditional                   determination of nonregulated status
                                               Conditional exemptions could be                      exemptions section, § 340.4, under                    and grant nonregulated status to a GE
                                            used, for example, for the importation of               which the Administrator may revoke the                organism based on the similarity of the
                                            certain GE commodities. A person could                  right of an individual person to use an               GE organism to an antecedent GE
                                            petition for an exemption from all                      exemption without revoking the                        organism that has already granted
                                            permits for shipments of a particular GE                exemption for other persons. The                      nonregulated status (§ 340.6(e)
                                            commodity grain under the condition                     Administrator could revoke an                         ‘‘Extensions to determinations of
                                            that the grain is not grown, but will only              individual’s right to use an exemption                nonregulated status’’). This provision
                                            be moved for direct use as food, feed, or               after determining that the person or any              has been in the APHIS regulations since
                                            for processing. The proposed procedure                  agent of the person has failed to comply              1997 and has been used fifteen times to
                                            to approve new exemptions would be                      at any time with any provision of this                grant nonregulated status to additional
                                            sufficiently adaptable that it can                      part.                                                 GE plants based on similarity to their
                                            consider approving exemptions for the                                                                         antecedents. This existing ‘‘extension
                                            shipment of certain GE commodities                      D. Petitions for Nonregulated Status                  procedure’’ was designed for APHIS to
                                            that would take into account any                        (§ 340.5)                                             take into account the previous
                                            conditions necessary to make it unlikely                   The current regulations include a                  evaluation conducted by APHIS and
                                            to result in the introduction and                       procedure by which anyone may                         thereby afford the potential for
                                            dissemination of plant pests or noxious                 petition APHIS to grant ‘‘nonregulated                expedited evaluations of a petition for
                                            weeds.                                                  status’’ to a GE organism, which means                extension. The extension procedure has
                                               APHIS considered proposing specific                  it would no longer be subject to the                  some administrative aspects which are
                                            criteria in the regulations that the                    regulations in part 340. This                         streamlined but in practice the APHIS
                                            Agency would use when evaluating                        nonregulated status is different from                 scientific reviews for extensions are
                                            potential risks of imported GE                          that of regulated articles that might be              similar to those of the antecedent
                                            commodities which are viable                            conditionally exempt from the                         organism.
                                            propagules such as grains like corn,                    requirement for a permit when moved                      Some members of the public have
                                            wheat, etc. APHIS considered that such                  interstate (following the conditions                  misunderstood the nature of the
                                            a criterion-based system in the                         specified in the regulations).                        extension procedure, believing that
                                            regulations might allow APHIS to                           Published APHIS decisions made                     APHIS has not conducted a thorough
                                            conduct expedited reviews of imports                    under the current regulations have used               scientific review. Some members of the
                                            that met the specified criteria. APHIS                  different ways to express the basic                   public have misconstrued the term
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                                            considered criteria such as whether the                 standard ‘‘unlikely to pose a plant pest              ‘‘extension’’ to conclude that an
                                            GE plant had undergone a safety review                  risk’’ in determining whether to grant                extension would extend the duration of
                                            in a foreign country, whether APHIS                     nonregulated status to a specific GE                  nonregulated status (nonregulated status
                                            had granted nonregulated status to                      organism. In its determinations, APHIS                is not granted with an expiration date).
                                            something similar, and the likelihood                   has conveyed the basic standard of                       For these reasons, APHIS is proposing
                                            that the commodity could be propagated                  ‘‘unlikely to pose a plant pest risk’’ by             to eliminate the extension procedure in


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                                            60024                 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules

                                            the regulation. APHIS sees no advantage                 be appealed. However, any person may                  E. Compliance, Enforcement, and
                                            to retaining the distinction in the                     file a new petition in accordance with                Remedial Action (§ 340.7)
                                            regulations between reviews for                         § 340.5 or § 340.6 regarding the same or
                                                                                                                                                          1. Ensuring Compliance With Permits
                                            antecedents and reviews for subsequent                  similar organisms covered by the
                                                                                                                                                          and Exemption Activities
                                            petitions for extensions. Because the                   revocation if new information relevant
                                            proposed revisions for petition for                     to the revocation becomes available.                     In recent years, APHIS has
                                            nonregulated status provide a high                                                                            strengthened its program in order to
                                                                                                    Treatment of GE Organisms That Have                   improve permit holders’ compliance
                                            degree of flexibility, a separate
                                                                                                    Been Granted Nonregulated Status                      with the regulations, to augment the
                                            extension procedure is not needed in
                                            the regulation. Review of petitions                        Although the APHIS evaluations of                  approaches used to prevent or remediate
                                            under the proposed regulations will rely                GE plants that would be conducted                     potential risks to plant health, and to
                                            on previous evaluations of similar GE                   under the proposed regulatory changes                 utilize appropriate enforcement
                                            organisms when they exist. APHIS                        will evaluate some additional factors                 strategies. This proposal provides an
                                            foresees that some evaluations for                      because of consideration of noxious                   opportunity to set forth the compliance
                                            nonregulated status may require less                    weed risks, APHIS nonetheless                         and enforcement requirements and the
                                            time if previous evaluations have                       considers this proposed revision to be                tools and administrative practices
                                            addressed the issues relevant to a new                  sufficiently consistent with the criteria             APHIS may employ as part of an
                                            petition for nonregulated status.                       evaluated in making determinations of                 integrated approach to prevent the
                                               In § 340.6 we propose some revisions                 nonregulated status to date under the                 introduction or dissemination of plant
                                            to the information that the                             current regulations. For this reason,                 pests and noxious weeds, and to
                                            Administrator may require a petitioner                  APHIS is proposing that all previous                  support overall administration of the
                                            to submit in consideration of the                       determinations of nonregulated status                 program. These matters are addressed in
                                            particular petition. In the current                     made since the early 1990s under the                  proposed § 340.7, ‘‘Compliance,
                                            regulation, the information needs are                   part 340 regulations will be                          enforcement, and remedial actions.’’
                                            described largely with respect to                       automatically approved for                            These proposed regulatory changes also
                                            evaluating GE plants, but APHIS                         nonregulated status under the revisions               reflect certain provisions of the 2008
                                            foresees that other GE organisms may                    proposed here. The history of safe use                Farm Bill and align with
                                            also be suitable candidates. This                       of these nonregulated GE plants in                    recommendations of USDA’s OIG.
                                            provision may become more important                     agriculture in the United States and                     APHIS seeks to clarify that it will use
                                            as new commercial applications of                       other countries gives APHIS confidence                the full range of enforcement authorities
                                            biotechnology emerge and new types of                   that it is appropriate to retain                      and penalties granted under the PPA. As
                                            information are needed to properly                      nonregulated status under the revised                 described above, APHIS issues permits
                                            assess the risks associated with new                    regulations for all those GE plants                   with specific conditions or requirements
                                            types of GE organisms. In all of the                    which have been granted nonregulated                  placed upon the responsible person.
                                            nonregulated status requests processed                  status under the existing regulations.                Proposed § 340.7 clarifies the
                                            to date, the subject organisms and the                  Many of these GE plants have been                     requirement for compliance with these
                                            alterations involved did not present                    incorporated into plant breeding                      conditions, as well as the approaches
                                            unanticipated or completely novel                       programs and been used to develop                     available to APHIS to verify compliance.
                                            approaches and APHIS was able to                        hundreds of crop varieties that have                  Such conditions may include
                                            make a determination based on                           been widely and safely used in                        requirements for the responsible person
                                            information in the petitions. When                      agriculture around the world.                         to establish and maintain records
                                            needed, APHIS obtained additional                          We also note that although the                     related to the permit, as well as allowing
                                            information from petitioners, in a                      addition of the term ‘‘noxious weed’’ is              APHIS to review those records. This
                                            consultation process similar to the one                 new to the proposed regulation,                       section underscores APHIS’ ability to
                                            proposed.                                               previous evaluations for determinations               conduct inspections and audit records
                                               We are also proposing a regulatory                   of nonregulated status considered the                 related to the regulated activities.
                                            procedure whereby the Administrator                     concept of plant pest risk in a broad                    In this proposed rule, the
                                            may revoke a previous approval of                       context that included consideration of                requirements for record retention are
                                            nonregulated status. This is consistent                 potential weediness. The evaluations                  being increased. Records indicating that
                                            with the existing regulations and                       considered, inter alia, whether the                   a GE organism that was imported or
                                            policies that the Administrator may                     unmodified plant was a weed, whether                  moved interstate reached its intended
                                            place a deregulated GE organism back                    the GE plant was a weed, and whether                  destination must be retained for at least
                                            under the regulations if the                            the interbreeding of the GE plant with                2 years after completion of importation
                                            Administrator concludes that the GE                     sexually compatible plant species                     or interstate movement, and all other
                                            organism poses a plant pest risk. As                    would result in offspring that would be               records must be retained for at least 5
                                            proposed, the Administrator may revoke                  weeds. In each case in which APHIS                    years after completion of all obligations
                                            any approval of nonregulated status if                  granted nonregulated status to date,                  required under a relevant permit or
                                            the Administrator receives information                  APHIS reached the conclusion that in                  exemption. APHIS is also proposing
                                            subsequent to approval that the GE                      each instance that the potential for                  changes to the nature of the records that
                                            organism is likely to be a plant pest or                weediness was unlikely to occur. In the               are required, a topic discussed in greater
                                            noxious weed. If the Administrator                      case of some petitions for nonregulated               detail in section E of this document, ‘‘E.
                                            revokes an approval for nonregulated                    status in which the GE plants were                    Paperwork Reduction Act.’’ Changes
                                            status, the Administrator may approve                   engineered with sequences derived from                include a requirement to maintain
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                                            for the same GE organism an exemption                   plant viruses, APHIS also considered in               records for activities done under a
                                            from the requirement for permit in                      its reviews whether the genetic                       conditional exemption, as well as
                                            accordance with § 340.5. The                            modification was unlikely to result in a              contracts and other information related
                                            revocation, its effective date, and the                 new plant pest, in this case a plant virus            to agreements between the responsible
                                            reasons for it will be published in the                 (through mechanisms such as                           person and all agents that conduct
                                            Federal Register. A revocation may not                  recombination or transencapsidation).                 activities subject to this part.


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                                                                  Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules                                           60025

                                               In a previous section of this proposal               need to review not only any written                   handling of the organisms, articles, or
                                            we discussed the types of records                       contracts, but also any written                       means of conveyances.
                                            proposed as core permit conditions in                   agreements among researchers,
                                                                                                                                                          2. Low Level Presence of Regulated GE
                                            § 340.3. We also propose to add certain                 developers, or other parties that are
                                                                                                                                                          Plants in Seed or Grain
                                            recordkeeping requirements to § 340.7                   sharing performance of tasks required
                                            that would apply not just to responsible                by the permit for a field trial.                         On March 29, 2007, APHIS published
                                            persons exercising permits, but to all                     The proposed regulations would                     a Federal Register notice titled ‘‘Policy
                                            responsible persons and their agents                    allow APHIS to require these types of                 on Responding to the Low-Level
                                            engaged in the importation, interstate                  records. As APHIS considered the types                Presence of Regulated Genetically
                                            movement, or release into the                           of records needed to support the                      Engineered Plant Materials’’ (72 FR
                                            environment of any GE organism that is                  regulations it became apparent that                   14649–14651; Docket No. APHIS–2006–
                                            subject to this part, including persons                 regulations could not specify in a ‘‘one              0167. This notice described how APHIS
                                            utilizing the conditional exemptions                    size fits all’’ fashion all record                    responds when low levels of regulated
                                            from permits.                                           requirements that might be needed.                    GE plant materials occur in commercial
                                               In recent years, APHIS has accrued a                 Therefore, we propose to add those                    seeds or grain that may be used for food
                                            great deal of experience in enforcing the               detailed record requirements of truly                 or feed. This issue was also addressed
                                            regulations and investigating possible                  general applicability in § 340.3 and                  in the DEIS in Issue 7. Both of these
                                            violations of them. This experience has                 § 340.7. However, we also propose in                  documents described how APHIS has
                                            helped us identify specific types of                    § 340.3 that we would continue to                     addressed these occurrences in the past,
                                            records that may not be required by the                 impose any necessary additional record                and how the Agency intends to address
                                            current regulations, but that are                       requirements appropriate to each permit               them in the future. We are proposing to
                                            necessary for effective enforcement of                  situation as individual permit                        amend the current regulations to
                                            the proposed regulations.2 For example,                 conditions.                                           explicitly incorporate APHIS’ low level
                                            in investigations of field trials we have                  Proposed § 340.7 also outlines the                 presence policy.
                                            found that we could not always obtain                   possible consequences of failure to                      As described in the DEIS, APHIS
                                            detailed maps for each planting area                    comply with the regulations, including                proposes to establish criteria under
                                            used during each season of the trial.                   denial of future permits; revocation of               which the occurrence of a low level
                                            This information is important for the                   current permits; destruction, treatment,              presence (LLP) of GE plant materials in
                                            efficient enforcement of the regulations.               and removal of GE organisms; issuance                 seeds or grain may not be cause for
                                            We also found that sometimes records of                 of penalties; and a means to settle                   agency remedial action. APHIS would
                                            actual field trial operations over time                 alleged civil violations prior to the                 still retain discretion to order corrective
                                            were not sufficient to confirm that the                 issuance of an administrative complaint.              or remedial actions in situations that
                                            procedures, equipment, and safeguards                      Under this proposal, every person                  meet the non-actionable criteria, when
                                            APHIS approved for a field trial were                   whose activities are within the scope of              the Administrator determines remedial
                                            actually employed. That is, while                       the regulations must comply with all the              action is needed to make the LLP
                                            existing records could generally confirm                requirements of this part. Moreover, a                unlikely to result in the introduction or
                                            plans to use, for example, certain                      responsible person can be held liable for             dissemination of a plant pest or noxious
                                            cleaning equipment or procedures at                     the violation of any requirement of this              weed. We propose to list criteria and
                                            certain intervals, or to conduct plantings              part by any agent working for the                     describe possible enforcement actions in
                                            on certain dates, the records did not                   responsible person (including persons                 the regulations to improve transparency
                                            confirm that plans were actually carried                contracted to conduct or carry out the                regarding how APHIS would respond to
                                            out on the approved dates. We also                      environmental release on their own or                 LLP in most instances. APHIS will not
                                            found that records for some field trials                on leased properties).                                predetermine a specific level that is
                                            did not identify which staff members or                    We propose to address remediation                  considered non-actionable as far as
                                            contractors were responsible for                        authority and procedures to a greater                 taking some remedial and/or
                                            performing which duties, either during                  degree of detail than the current                     enforcement action because this
                                            a field test or in the event of an                      regulations. In proposed §§ 340.7(e) and              determination should always be made
                                            unauthorized release that triggered the                 (g) we explicitly state that the APHIS                case-by-case. These criteria are intended
                                            field test contingency plan. When                       Administrator has the authority to take               to apply only to APHIS’ decision to take
                                            responsibilities cannot be linked to                    remedial actions in the event that an                 or order remedial action in the event
                                            specific individuals, it makes it very                  incident requires such actions. We also               that LLP occurs. The proposed criteria
                                            difficult to investigate possible                       specify that the APHIS Administrator                  are listed within the section describing
                                            violations. Another gap in necessary                    has the authority to order remedial                   the Administrator’s ability to take or
                                            records we discovered through                           action by others. These orders could                  order remedial actions. Regardless of
                                            experience was the absence of clear                     take the form of an Administrative                    whether APHIS considers the LLP
                                            written records of the responsibilities of              Order, Emergency Action Notification,                 actionable with regard to remediation,
                                            different organizations, when several                   or similar regulatory instrument.                     any violations of the regulations or
                                            different entities were involved in a                   Additional information about these                    permit conditions could still result in
                                            field trial. During investigations we may               types of orders and related procedures                any of the compliance and enforcement
                                                                                                    are provided in administrative guidance               actions listed in the regulations,
                                              2 Details of investigations that have led APHIS to    on the APHIS Web site. The                            including imposing civil penalties.
                                            propose expanded records requirements may be            consequence for failure to abide by the                  APHIS is proposing a new provision
                                            found in the ‘‘Lessons Learned’’ document cited                                                               in the regulations that would reflect the
                                                                                                    orders of the Administrator is also
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                                            above, and in investigation report documents on the
                                            APHIS Web site, e.g., ‘‘2007 Report of LibertyLink      described in proposed § 340.7, linking                current policy cited above. The
                                            Rice Incidents’’ (http://www.aphis.usda.gov/            remediation to enforcement.                           provision describes the criteria APHIS
                                            newsroom/content/2007/10/content/printable/                Finally, APHIS has clarified in the                will use when determining that a LLP
                                            RiceReport10-2007.pdf) and ‘‘Transcript of
                                            Technical Briefing on Rice Investigation’’ (http://
                                                                                                    proposed regulations that in the event of             event would be non-actionable with
                                            www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB          a permit revocation, it may act or order              regard to remediation, namely when the
                                            ?contentidonly=true&contentid=2007/10/0285.xml).        action of the responsible person in the               criteria support a conclusion that the


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                                            60026                 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules

                                            LLP is unlikely to result in the                        2. Time Frames for APHIS Action on                    to eliminate the current restrictions in
                                            introduction or dissemination of a plant                Permit Applications and Petitions                     the regulation on the duration of
                                            pest or noxious weed. Because the                          Current regulations specify time                   permits for interstate movement and
                                            criteria are safety-based, they will be                 frames within which APHIS must take                   importation. The proposed regulations
                                            used for incidents of low level presence                certain actions, such as issuing permits,             will remove the requirements that
                                            originating domestically (e.g., from field              acknowledging notifications or issuing                interstate movement permits are only
                                            testing) as well as any low level                       decisions on petitions to grant                       valid for one year from the date of
                                            presence that might be detected in                      nonregulated status. APHIS experience                 issuance, and that importation permits
                                            import shipments that may contain                       in the last several years has shown that              must be obtained for each individual
                                            organisms subject to regulation.                        the time required to complete these                   importation. These changes should give
                                              APHIS also considered two additional                  actions has increased beyond the time                 APHIS the flexibility to issue these
                                            criteria, which we have not adopted in                  frames originally stipulated in the                   permits with suitable durations to meet
                                            the proposed rule. First, we considered                 regulations in 1987 (permits) and 1993                the individual circumstances.
                                            a criterion that would require that the                 (petitions for nonregulated status). As               G. Definitions and Miscellaneous
                                            genetic material be introduced into the                 stated in the current regulation, APHIS               Changes
                                            plant using a method that has been                      is obligated to give its reply in the                   APHIS proposes to change certain
                                            demonstrated to result in integration of                stipulated time, even if required                     definitions in § 340.1 of the regulations,
                                            the new sequences into the plant                        procedures are not yet complete.                      to add certain new definitions, and to
                                            genome, as defined in § 340.1. We did                   Therefore, APHIS proposes to include in               remove definitions for terms that are
                                            not include this criterion in our                       § 340.2(d) of the regulations a statement             defined in the PPA or that no longer
                                            proposal because its relevance in the                   that APHIS will generally respond in                  appear in the regulations.
                                            LLP context is unclear. A second                        the time frames indicated. APHIS
                                            criterion considered was that the genetic               believes it is important to continue to               Revised Definitions
                                            material engineered into the GE plant                   meet the indicated time frames                          APHIS proposes to change the
                                            does not encode substances with whose                   whenever possible, but the most                       definitions of the following terms in
                                            function APHIS is unfamiliar. APHIS                     important thing is to communicate the                 § 340.1:
                                            did not adopt this criterion since it is                actual status of reviews and procedures                 Release into the environment would
                                            redundant with the proposed criteria                    with applicants rather than be obligated              read ‘‘Dispersal beyond the constraints
                                            that will be used, i.e., that the function              to reach a decision in a certain number               of a contained facility or secure
                                            of the introduced genetic sequences is                  of days despite the complexities                      shipment. Synonymous with the term
                                            known and that key food safety issues                   involved with a review. APHIS is                      environmental release.’’
                                            have been addressed.                                    particularly seeking comment on this                    Secure shipment is a new term
                                              The DEIS, in Issue 7, Alternative 3,                  proposed change from persons with                     defined below. By adding reference to
                                            proposed that APHIS would also                          experience under the current time                     secure shipment in this definition, we
                                            consider the LLP safety criteria when                   frames.                                               clarify the distinction between
                                            deciding whether to issue a permit for                  3. Duration Period for Permits                        environmental release and shipments
                                            environmental release, and what type                                                                          for importation and interstate
                                            and severity of permit conditions to                       Under the current regulations,                     movement; any such movements which
                                            assign to the release permit. In its                    notifications for environmental release               are not done by secure shipment
                                            evaluation of permit applications,                      and interstate movement are valid for                 constitute an environmental release.
                                            APHIS does plan to refer to the LLP                     one year, and the duration period for a                 Responsible person would read ‘‘The
                                            criteria, as described above.                           permit issued for an environmental                    person who has control and will
                                                                                                    release is not specified. Currently                   maintain control over a GE organism
                                            F. Administrative Changes                               interstate movement permits are only                  during its importation, interstate
                                            1. Confidential Business Information                    valid for one year from the date of                   movement, or release into the
                                                                                                    issuance, and a new import permit must                environment and assures compliance
                                               APHIS is proposing a new § 340.8 to                  be obtained for each imported shipment.               with all conditions contained in any
                                            provide further guidance on the manner                     APHIS will continue to retain the                  applicable permit or exemption as well
                                            in which confidential business                          flexibility of the permitting procedure to            as other requirements in this part. A
                                            information (CBI) will be addressed in                  authorize environmental release permits               responsible person shall be at least 18
                                            the implementation of these regulations.                that can be effective for any appropriate             years of age and be a legal resident of
                                            This change will support the overall                    time period. In some cases, it may be                 the United States or designate an agent
                                            administration of the program. The                      most efficient to authorize                           who is at least 18 years of age and a
                                            proposed § 340.8 cites the relevance of                 environmental release permits that are                legal resident of the United States.’’ The
                                            the Freedom of Information Act (FOIA)                   valid for more than a single year. In                 change from the former definition is the
                                            and exemptions from releasing                           such cases, APHIS can retain adequate                 addition of ‘‘at least 18 years of age,’’
                                            information pursuant to FOIA, namely,                   oversight by performing periodic                      added to prevent possible enforcement
                                            5 U.S.C. 552(b)(4), and states that APHIS               inspections and requiring periodic                    difficulties.
                                            may exempt from disclosure to the                       reports. Experience has revealed
                                            public trade secrets and commercial or                  situations where field tests lasting more             New Definitions
                                            financial information obtained from a                   than one year are essential. For                         APHIS proposes to add definitions of
                                            person that are privileged or                           example, some environmental releases                  the following new terms:
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                                            confidential. Proposed § 340.8 also                     of GE fruit trees may take several years                 Confidential business information,
                                            states how persons wishing to protect                   to evaluate the fruit production that                 CBI would read ‘‘Information such as
                                            confidential business information                       often does not begin for several years                trade secrets or commercial or financial
                                            should communicate with APHIS in                        after planting.                                       information that may be exempt from
                                            permit applications, petitions, or other                   In order to provide greater flexibility            disclosure under Exemption 4 of the
                                            submissions to APHIS.                                   and efficiency, APHIS is also proposing               Freedom of Information Act (FOIA),


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                                                                  Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules                                          60027

                                            because disclosure could reasonably be                  interests of agriculture, irrigation,                 eliminate the term regulated article
                                            expected to cause substantial                           navigation, the natural resources of the              partly because the use of the term
                                            competitive harm. USDA regulations on                   United States, the public health, or the              ‘‘article’’ in current part 340 is not
                                            how the agency will handle CBI and                      environment.’’ This is the definition for             consistent with usage in the PPA, which
                                            how to determine what information may                   noxious weed found in the PPA.                        uses the term article to mean ‘‘any
                                            be exempt from disclosure under FOIA                       Recipient organism would read ‘‘The                material or tangible object that could
                                            (5 U.S.C. 552) are found at 7 CFR                       organism that will receive the genetic                harbor plant pests or noxious weeds’’—
                                            § 1.12.’’ We propose to add this                        material from a donor organism in the                 that is, things like packing materials,
                                            definition because APHIS has often                      process of genetic engineering (once the              shipping containers, commodities,
                                            been asked to clarify what is and is not                organism is engineered it is referred to              etc.—and not a plant pest or noxious
                                            CBI, and how it is handled. The                         as the genetically engineered (GE)                    weed itself. Under the current
                                            definition describes typical types of CBI,              organism).’’ This definition is needed to             regulation, however, regulated article
                                            and the language in proposed § 340.8                    properly distinguish organisms and                    refers exclusively to certain GE
                                            describes how persons submitting                        their traits in comparisons of GE                     organisms. Furthermore, under both the
                                            documents to APHIS can request that                     organisms to the same organisms prior                 PPA and part 340, ‘‘articles’’ are not
                                            identified information be treated as CBI.               to transformation.                                    regulated, but rather their importation,
                                            There is also additional guidance on CBI                   State or tribal regulatory official                interstate movement or environmental
                                            contained in administrative guidance on                 would read ‘‘State or tribal official with            release is regulated. For these reasons,
                                            the APHIS Web site regarding document                   responsibilities for plant health, or any             the term ‘‘regulated article’’ in the
                                            preparation for part 340 requests.                      other duly designated State or tribal                 current regulations is both inconsistent
                                            However, it is important to realize that                official, in the State or on the tribal               with the terminology of the PPA and
                                            in actual situations where someone                      lands where the importation, interstate               difficult for the public to comprehend.
                                            submits a FOIA request for particular                   movement, or release into the                            We also propose to remove the
                                            information, the APHIS FOIA Officer                     environment is to take place.’’ This term             definition for introduction. APHIS
                                            makes the ultimate determination as to                  is used in reference to consultations                 currently uses the term in part 340 to
                                            whether particular information shall be                 with States and tribes under the                      denote certain kinds of activities that
                                            released, in accordance with the                        regulations.                                          fall within the scope of the regulation,
                                            standards of FOIA, Executive Order                         Secure shipment would read                         namely importation, interstate
                                            12600, and 7 CFR 1.12.                                  ‘‘Shipment in a container or a means of               movement, and release into the
                                               Contingency plan would read ‘‘A                      conveyance of sufficient strength and                 environment. The PPA, however, does
                                            written plan stating how the responsible                integrity to withstand leakage of                     not specifically define the term
                                            person will respond in the event of the                 contents, shocks, pressure changes, and               introduction. Therefore, to avoid
                                            unauthorized environmental release of                   other conditions incident to ordinary                 confusion, instead of using the term
                                            GE organisms.’’ We propose to define                    handling in transportation.’’                         introduction to define the different
                                            this new term to describe a document                       We propose to add the following two                types of regulated activities, APHIS will
                                            mentioned in both the permit                            definitions to make it clear that, when               instead refer to these specific activities
                                            application information requirements                    the Administrator authorizes it, a                    themselves in the regulations, namely,
                                            section (§ 340.2(c)) and the permit                     signature required under the regulations              the importation, interstate movement
                                            conditions section (§ 340.3).                           may be an electronic signature and a                  and release into the environment.
                                               Exempt, exempted, exemption would                    written document required under the
                                            read ‘‘A determination by the                           regulations (e.g., a permit application)              Miscellaneous Changes
                                            Administrator that the importation,                     may be an electronic document.                          We also propose to make minor
                                            interstate movement, and/or release into                   Signature, signed would read ‘‘The                 miscellaneous changes to the
                                            the environment of an organism or class                 discrete, verifiable symbol of an                     regulations to improve their clarity and
                                            of organisms described in § 340.0(a) is                 individual which, when affixed to a                   remove redundancies. For example, in
                                            not subject to the requirement to have                  writing with the knowledge and consent                addition to adding the definition for CBI
                                            a permit under this part. An exemption                  of the individual, indicates a present                discussed above, we are consolidating
                                            from one type of permit (e.g., interstate               intention to authenticate the writing.                requirements concerning CBI, formerly
                                            movement) does not remove remaining                     This includes electronic signatures                   contained in several sections of the
                                            obligations to obtain other permits                     when authorized by the Administrator.’’               regulations, into proposed § 340.8.
                                            under this part.’’ We propose to add this                  Write, writing, written would read
                                            definition for the term exemption to                    ‘‘Any document or communication                       IV. Required Analyses
                                            refer to situations where a regulated                   required by this part to be in writing                A. National Environmental Policy Act
                                            movement is exempt from the                             may also be provided by electronic
                                            requirement for a permit. The proposed                  communication when authorized by the                     On January 23, 2004 (69 FR 3271),
                                            definition is based on language in Sec.                 Administrator.’’                                      APHIS published a notice of intent to
                                            411(b)(1) of the PPA (7 U.S.C. 7711(c)),                                                                      prepare a draft environmental impact
                                            titled ‘‘Exception to permit                            Deletion of Definitions                               statement (DEIS) in accordance with the
                                            requirement,’’ which authorizes the                       We propose to remove the following                  National Environmental Policy Act in
                                            Secretary to issue regulations to allow                 definitions from the regulations:                     connection with the regulations at 7
                                            the movement of specified plant pests                   courtesy permit, expression vector,                   CFR part 340 and potential changes to
                                            without further restriction if the                      introduce or introduction, regulated                  those regulations. This notice identified
                                            Secretary finds that a permit is not                    article, stably integrated, vector or                 potential issues and alternatives to be
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                                            necessary.                                              vector agent, and well-characterized and              studied and requested public comment
                                               Noxious weed would read ‘‘Any plant                  contains only non-coding regulatory                   to shape the scope of the DEIS.
                                            or plant product that can directly or                   regions.                                                 On July 17, 2007, APHIS published
                                            indirectly injure or cause damage to                      These definitions would be removed                  the DEIS evaluating regulatory
                                            crops (including nursery stock or plant                 because the terms would no longer be                  alternatives under consideration and
                                            products), livestock, poultry, or other                 used in the regulations. We propose to                solicited public comment on the DEIS


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                                            60028                 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules

                                            (72 FR 39021–39025). The                                comments on the DEIS, which will be                      Consideration of the DEIS comments
                                            Environmental Protection Agency                         discussed fully when we publish a final               led APHIS to refine and reorganize some
                                            published a separate notice on July 13,                 environmental impact statement (FEIS).                of the regulatory alternatives it
                                            2007, soliciting public comment on the                  The DEIS and the comments on it were                  considered. Therefore, the presentation
                                            DEIS (72 FR 38576–38577). The notices                   used by APHIS to inform decision                      and discussion of the alternatives
                                            sought comments on the quality of our                   makers and aid the design of this                     proposed in this proposal do not exactly
                                            analysis of potential environmental                     proposal. Information from the DEIS                   match those described in the DEIS. The
                                            effects of the alternatives under                       comments, along with information from                 differences are primarily a matter of
                                            consideration, and also sought views on                 many other sources, including certain                 reorganizing and realigning some
                                            how each alternative would affect areas                 provisions of the 2008 Farm Bill and                  material and their corresponding
                                            such as the overall effectiveness of our                recommendations from USDA’s OIG,                      regulatory alternatives, using more
                                            biotechnology program, its operational                  was used to inform the drafters of this               descriptive terms in some criteria listed
                                            efficiency, industry compliance issues,                 proposed rule about the issues                        in the alternatives, and choosing
                                            or other issues that would be associated                perceived to be involved in and                       between regulatory alternatives that fall
                                            with the implementation of an                           addressed by the rulemaking. We will                  within the analysis of the DEIS.
                                            alternative.                                            respond to all DEIS comments in detail                Accordingly, the DEIS is still consistent
                                               The major elements of this proposed                  in the FEIS since the agency action                   and applicable as an analysis of the
                                            rule were accurately described in the                   (revising the regulations in part 340) is             potential environmental effects of the
                                            alternatives contained in the DEIS and                  still subject to change based on                      proposed action. However, we are
                                            their potential environmental effects                   comments and information received on                  interested in receiving comments on
                                            were analyzed in the DEIS. Table 4                      this proposed rule, and thus we cannot                whether any of the proposed regulatory
                                            below provides a comparison between                     provide definitive and final comment                  alternatives in this document do not
                                            the proposed changes to part 340 and                    responses until we issue the FEIS and                 appear to have been adequately
                                            the DEIS. We received numerous                          the final rule.                                       addressed within the DEIS.

                                                             TABLE 4—SUMMARY OF PROPOSED CHANGES TO THE REGULATIONS AND RELATIONSHIP TO DEIS
                                                                Summary of proposed substantive changes to the regulation                                  DEIS issue                   DEIS alternative

                                            Redescription of which GE organisms are subject to the regulations.                                                    1            2 (DEIS preferred alternative)
                                                                                                                                                                                  or 3.
                                            Deletion of the list of plant pest taxa in the regulations and the petition procedure to amend the
                                               list.
                                            Clarification that APHIS has the authority to regulate nonliving materials through permit condi-                       5            2 (DEIS preferred alternative).
                                               tions in cases where such materials may pose a risk as a noxious weed.
                                            Revision of the application information requirements and permit conditions for all permit types.
                                            Elimination of the current notification procedure for importation, interstate movement, and re-                        2            4 (DEIS preferred alternative).
                                               lease into the environment of certain types of GE plants (permitting procedure will be used in-
                                               stead).
                                            Revision of the permitting system for environmental releases:                                                          2            4 (DEIS preferred alternative).
                                                  • Subdivision into 5 categories of permits for environmental releases (4 for GE plants, 1 for                    4            2 (DEIS preferred alternative).
                                                     other GE organisms).
                                                  • Continue strict permit conditions for environmental releases of GE plants engineered to                        6            1 (No action alternative).
                                                     produce compounds intended for pharmaceutical or industrial uses.
                                            Continued use of permits with appropriate conditions for single or multiple year releases.
                                            Creation of new administrative procedures in permitting: (1) The explicit agreement of the re-
                                               sponsible person to comply with regulatory requirements of the permit, (2) amendment of ex-
                                               isting permit conditions, (3) transfer of permits to a different responsible person, and (4) rev-
                                               ocation of a permit.
                                            Elimination of the prescribed shipping container provisions in favor of a performance based ap-                    10               2 (DEIS preferred alternative).
                                               proach specified as permit conditions for importation and interstate movement.
                                            Revision of the existing conditional exemptions for interstate movement such that the shipping
                                               standard is part of the exemption. Addition of a recordkeeping requirement for persons using
                                               the existing conditional exemptions.
                                            Elimination of the option for APHIS to issue courtesy permits for importation, interstate move-
                                               ment, and environmental release of GE organisms which are not subject to the regulation.
                                            Creation of a petition procedure for the Administrator to approve additional conditional exemp-                        3            2 (DEIS preferred alternative).
                                               tions from the requirement for a permit. This also includes a description of administrative                         8            1 (DEIS No Action alternative).
                                               steps if Administrator revokes an exemption, amends the conditions of an exemption, or pro-
                                               hibits a person from using a conditional exemption.
                                            Clarification and revision of the existing petition procedure for determining nonregulated status,
                                               including elimination of the procedure to extend a previous determination of nonregulated sta-
                                               tus, and a description of the administrative steps if Administrator revokes nonregulated status.
                                            Clarification of the actions the Administrator may take related to compliance, enforcement, and
                                               remediation.
                                            Clarification of APHIS approach to the low level presence of regulated GE plants in seed or                            7            3 (DEIS preferred alternative).
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                                               grain.
                                            Definition of Confidential Business Information (CBI) and description of administrative practices
                                               for CBI.




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                                                                  Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules                                           60029

                                               We received approximately 23,000                     public health in APHIS regulations, and               ‘‘weediness of the regulated article’’ (see
                                            comments on the DEIS, of which more                     the noxious weed definition should not                current § 340.6(c)(4)).
                                            than 22,000 were variations of several                  be interpreted so broadly as to provide                  Several DEIS commenters addressed
                                            form letters. There were also several                   APHIS with the legal responsibility or                what characteristics should trigger
                                            lengthy and detailed evaluations of                     authority to determine the food safety of             regulation of a GE organism, or put
                                            environmental, scientific, legal, cultural,             GE crops or to prevent GE crops from                  another way, how to set the scope of
                                            and economic issues raised by the DEIS.                 entering the food supply. The                         organisms subject to regulation. In the
                                            APHIS took all comments related to                      commenters stated that Congress clearly               DEIS, APHIS explored many options
                                            regulatory changes under consideration                  intended the FDA to be responsible in                 including continuing to make its
                                            as we developed the content of this                     this area.                                            decisions primarily based upon the
                                            proposed rule, and altered a number of                     We agree, and this proposal                        transformation event (also sometimes
                                            preliminary ideas for the proposal based                acknowledges FDA authority in the food                referred to as the individual transformed
                                            on comments. We will fully summarize                    safety area. However, it is important that            line, transgenic line or GE line). Some
                                            and address the comments received on                    the regulatory procedures in each                     members of the public refer to this as an
                                            the DEIS in a Final Environmental                       agency dovetail and support each other                event-by-event approach. It is
                                            Impact Statement to be prepared in                      where agency mission areas come in                    sometimes contrasted with a ‘‘trait-
                                            conjunction with the publication of a                   contact. This proposal recognizes this                based’’ approach that focuses more on
                                            final rule. In addition to specific DEIS                need for mutual agency support. When                  the resulting trait or phenotype of the
                                            issues that were discussed above in the                 a permit for environmental release,                   GE organism. In a trait-based approach,
                                            Preamble, the following section                         importation, or interstate movement of a              a regulatory decision for an organism
                                            summarizes and discusses those                          new GE organism is submitted to                       engineered for one phenotype would
                                            comments on the DEIS that were most                     APHIS, we would evaluate whether                      apply equally to other GE organisms if
                                            directly related to the regulatory                      there are any signs that the                          they had the same phenotype or trait,
                                            alternatives discussed in this proposed                 environmental release, importation, or                regardless of whether they were
                                            rule and the ways in which these                        interstate movement of the organism                   engineered with the same genes. APHIS
                                            comments affected development of the                    could present risks to the public health.             invited comment on the relative merits
                                            proposal.                                               If APHIS is concerned that there may be               of the event-by-event approach and the
                                               Many DEIS commenters addressed                       food safety risks associated with the GE              trait-based approach. The current
                                            how the regulations should use the PPA                  organism, we would contact FDA. The
                                                                                                                                                          regulations do not limit APHIS to one
                                            authorities regarding noxious weeds,                                                                          approach or the other. Many readers
                                                                                                    decision on whether or how to regulate
                                            plant pests, and biological control                                                                           equated ‘‘event-by-event’’ with a
                                                                                                    food and feed from the GE organism to
                                            organisms. Most comments on the DEIS                                                                          ‘‘process-based’’ system and likewise
                                                                                                    address food and feed safety risks would
                                            that addressed this issue stated that                                                                         equated ‘‘trait-based’’ regulation with a
                                                                                                    then be FDA’s. On the other hand, it is
                                            APHIS should expand the scope of its                                                                          ‘‘product-based’’ system. Thus many
                                                                                                    also likely that existing food safety
                                            regulatory program beyond plant pests                                                                         comments focused on the relative merits
                                                                                                    evaluations will prove to be useful and
                                            to include both noxious weeds and                                                                             of a product-based system versus a
                                                                                                    relevant to APHIS evaluations of a GE
                                            certain biological control organisms,                                                                         process-based system.
                                                                                                    organism. Food safety concerns are one                   Some suggested that the trigger be
                                            consistent with all of the regulatory
                                                                                                    of several factors APHIS would take into              ‘‘process-based’’, i.e., the process of
                                            authorities of the PPA. The following
                                            opinions were expressed regarding PPA                   account when considering, for example,                modifying the organism by recombinant
                                            authority regarding noxious weeds and                   what types of permit conditions are                   DNA techniques would be the
                                            the meaning of the PPA definition of                    needed for the environmental release of               determinant. Others suggested the
                                            noxious weed.                                           a GE organism, or whether activities                  trigger be ‘‘product-based’’, i.e., the
                                               Very few commenters suggested that                   associated with the organism should                   nature of the resulting product
                                            APHIS biotechnology regulations                         qualify for an exemption from the                     (organism) would be the determinant for
                                            should implement the PPA’s noxious                      permit requirement.                                   whether the organism would be subject
                                            weed definition in its broadest possible                   Several commenters stated that under               to the regulation. Many of the comments
                                            sense. One commenter suggested that                     the current regulations APHIS has                     were not actually related to the basis for
                                            APHIS broadly interpret the phrase                      always considered noxious weed risk, or               the trigger, but rather to the focus of the
                                            ‘‘other interests of agriculture,’’ in the              at least ‘‘weediness.’’ We agree that in              risk assessment, with most stating that
                                            PPA definition of noxious weed such                     practice, when APHIS assesses a GE                    the risk assessments should be based on
                                            that APHIS would consider a plant to be                 plant it has always evaluated the                     the biology of the organism (product-
                                            a noxious weed if it poses solely                       potential weediness of the GE plant in                based), not the technique by which it
                                            economic harm, i.e., in the absence of                  relation to its plant pest potential. In the          was made (process-based). One
                                            physical harm. As explained previously                  context of the PPA, ‘‘weediness’’ is more             commenter believes that the process of
                                            in this proposal, such an interpretation                properly a noxious weed risk                          genetic engineering is a useful trigger,
                                            is not consistent with the PPA, nor with                characteristic than a plant pest one, and             but once regulated, the characteristics of
                                            the manner in which APHIS–PPQ has                       the proposed revision of the regulations              the GE organism should dominate
                                            implemented the noxious weed program                    will more clearly align the regulations               APHIS considerations of safety.
                                            pursuant to the PPA. Many commenters                    with the plant pest and noxious weed                     Those supporting a process-based
                                            suggested that APHIS needed clear                       risk pursuant to the PPA. Current                     approach for identifying which
                                            regulations or policies to describe how                 APHIS regulations and guidance                        organisms should be subject to
                                            it will be evaluating whether GE plants                 directly address the importance of                    regulation stated that each GE organism
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                                            pose threats as noxious weeds. APHIS                    including weediness when evaluating                   can have unintended as well as
                                            agrees and has framed this proposal to                  risks associated with GE organisms. For               intended changes, and that these
                                            clarify the issue for the public.                       example, when the petition procedure                  unintended changes to the organism
                                               Some commenters stated that APHIS                    to grant nonregulated status was added                would require that each individual
                                            should acknowledge limits to its                        to part 340 in 1993, the traits APHIS                 resulting from genetic engineering must
                                            consideration of potential damage to                    listed for evaluation explicitly included             be assessed on a case-by-case basis.


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                                            60030                 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules

                                            Some commenters also suggested that                     material only in certain circumstances,               criteria in the current regulations used
                                            this approach of APHIS assessment of                    based on the risks posed. The few                     to determine eligibility for the
                                            each individual GE organism better                      comments that provided greater detail                 notification process could be preserved
                                            protects the environment and human                      identified toxicity risks and possible                in the new regulations as criteria to
                                            health than an approach that focuses                    persistence in the environment of toxic               identify organisms that should be
                                            primarily on the trait(s) of the GE                     nonviable plant parts or debris as the                exempted from the requirement for a
                                            organism.                                               most significant risk associated with                 permit. One commenter stated that since
                                               Some commenters against process-                     nonliving GE products. A few                          the current ‘‘notification’’ process
                                            based approach stated that this                         commenters also stated that adding a                  involves acknowledgment by APHIS
                                            approach is illogical, on the one hand,                 clear definition of ‘‘nonliving’’ or                  and conditions as well as notification,
                                            to regulate a plant species with no                     ‘‘nonviable’’ would aid the regulations.              changing to a system of low risk permits
                                            known risks only because GE                                APHIS has responded to these                       would be a de facto acknowledgment of
                                            techniques were used to modify it,                      comments in this proposal by not                      the current process. To address these
                                            whereas on the other hand the same                      usually regulating nonliving GE                       issues, APHIS is proposing to eliminate
                                            plant species modified by other                         products, and by providing that when                  notifications and to handle regulated GE
                                            techniques faces no additional                          any control is needed over such a                     organisms that previously would have
                                            regulatory requirements from APHIS.                     product that is associated with a living              been eligible for notifications through a
                                               Those supporting a product-based                     GE organism which is covered by a                     permitting procedure.
                                            regulatory approach stated that it would                permit, due to toxicity or other risks,                  We received a few comments on the
                                            be aligned with the preponderance of                    such controls would be included as                    DEIS generally related to procedures for
                                            scientific opinion on the issue, that the               permit conditions in permits issued for               reviewing permit applications.
                                            characteristics of the organism should                  the associated living GE organism. We                 Comments stated that the role of States
                                            take precedence over the technique of                   propose to provide for this by adding                 in reviewing or approving permit
                                            genetic modification in the APHIS                       the following sentence to paragraph (b)               applications for GE crops has been very
                                            assessment of the organism. APHIS                       of § 340.3, Permit conditions: ‘‘The                  important and useful under the current
                                            agrees that any evaluation of risk should               Administrator may also assign permit                  regulations, and should continue in
                                            be based on the biology of the product.                 conditions addressing nonliving                       future regulations. Comments also
                                               Several commenters suggested that                    materials associated with or derived                  stated the importance of scientific
                                            the definition of regulated article would               from GE plants when such conditions                   integrity in the review process, and
                                            have to be reexamined and possibly                      are needed to make it unlikely that the               emphasized the importance of
                                            redefined to reflect changes in the PPA.                nonliving materials would pose a                      coordinating with other agencies
                                            Commenters also stated that the term                    noxious weed risk.’’                                  (particularly FDA and EPA review)
                                            regulated article was problematic                          We received one DEIS comment                       when issues within their mission area
                                            whether linked to specific taxa in                      directly addressing the issuance of                   arise during APHIS review of
                                            § 340.2, under the current regulations,                 courtesy permits. This comment                        applications.
                                            or linked to plants produced by                         supported retaining use of courtesy                      The proposed changes to the permit
                                            particular technologies. These                          permits, and stated that courtesy                     application procedure address these
                                            commenters emphasized that actions                      permits facilitate the importation of GE              concerns. States would have a
                                            under the regulations usually amount to                 Drosophila melanogaster strains by the                continuing role in application review
                                            an investigation of whether an article                  research community and also ease the                  that is very similar to their existing role,
                                            (GE organism) needs to be regulated,                    workload for APHIS. The continued                     and we have been increasing
                                            and that predefining the subject of the                 issuance of courtesy permits diverts                  interactions with the relevant tribal
                                            investigation as a regulated article                    Agency resources unnecessarily from                   authorities in recent years.
                                            strongly implies that a decision has                    organisms that are within the scope of                   Several comments were peripherally
                                            been made to require some regulatory                    the regulations. We intend to help                    related to the DEIS issue of whether
                                            oversight.                                              develop informational materials for the               APHIS should establish standard or
                                               The proposed elimination of the term                 research community and other agencies                 general permit conditions or what they
                                            ‘‘regulated article’’ would facilitate a                that are aware of courtesy permits to                 should require. These comments
                                            clearer understanding that it is not the                clarify that such permits are not                     emphasized that the purpose of permit
                                            GE organism that is regulated, but rather               required, and to explain this to any                  conditions is to control risks not
                                            the importation, interstate movement, or                persons who contact us requesting                     otherwise controlled, and that permit
                                            release into the environment of the GE                  courtesy permits in the future.                       conditions must be developed in
                                            organism.                                                  Several DEIS comments addressed the                response to careful consideration of the
                                               APHIS determined that eliminating                    notification procedure and supported                  risks presented by the particular
                                            ‘‘introduction’’ as a defined term would                eliminating it. Some comments                         permitted activity. One comment stated
                                            facilitate clearer understanding that the               suggested that the types of organisms                 that APHIS should not require permit
                                            activities subject to the regulations are               formerly eligible for the notification                conditions that have the primary
                                            in fact importation, interstate                         process should instead be handled                     purpose of preventing crops from
                                            movement, and release into the                          through a two-tiered permitting process,              entering the food supply, because
                                            environment.                                            with experimental permits for field                   APHIS does not have the legal authority
                                               In the DEIS, APHIS discussed the                     trials and commercial permits for GE                  or scientific expertise to set them.
                                            need to regulate nonliving products of                  crops that are to be sold in commerce.                   We have taken these views into
                                            GE organisms. The preferred alternative                 Other comments suggested that while                   account in designing this proposed rule.
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                                            was to have a procedure to regulate non-                some organisms might require permits                  Proposed § 340.3 describes the core list
                                            viable material only in certain rare                    with minimal conditions rather than                   of general conditions that APHIS would
                                            circumstances when it might pose a                      notifications, others with even lower                 impose on all permits as well as
                                            risk. Most of the DEIS comments                         risks could be exempted from permit                   additional conditions for specific types
                                            addressing this issue agreed that APHIS                 requirements. These latter comments                   of permits. APHIS is also making it clear
                                            should regulate nonviable GE plant                      also generally suggested that some of the             that APHIS may also add other specific


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                                                                  Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules                                          60031

                                            conditions to a permit upon its                            Several commenters stated that a                   with many other uses for GE plants. Our
                                            issuance. Conditions are specific                       tiered permitting system should be                    approach in this proposed rule
                                            practices or requirements that an                       flexible and allow consideration of any               addresses the other concerns cited by
                                            applicant must follow upon issuance of                  factors that seem relevant, or allow                  DEIS commenters.
                                            a permit. Conditions are added as a                     reclassification of a GE plant from one                  Many commenters were concerned
                                            consequence of the APHIS evaluation in                  tier to another based on additional                   that the outdoor cultivation of GE plants
                                            order to make it unlikely that actions                  characterization information and agency               producing pharmaceutical and
                                            under the permit would result in the                    familiarity with the GE plant. Some                   industrial compounds could be a source
                                            introduction or dissemination of a plant                commenters opposed the development                    of gene flow to nearby non-GE plants or
                                            pest or noxious weed.                                   of a tiered risk-based permitting system              result in the co-mingling of grain with
                                               Several DEIS comments stressed that                  because each transformation event can                 related crop species intended for food or
                                            APHIS needs to do more to ensure that                   have unintended effects that must be                  feed. Risks associated with this scenario
                                            the permit conditions it sets are actually              assessed on a case-by-case basis, rather              may be abated by either of two means:
                                            followed and enforced. The changes to                   than through predefined categories. We                (1) Preventing such gene flow or co-
                                            permit procedures proposed for § 340.2                  have addressed these views in this                    mingling from occurring, or (2)
                                            contribute to that goal by obtaining                    proposed rule by changing the permit                  establishing that if such gene flow or co-
                                            written agreement from the responsible                  tier system described in the DEIS to a                mingling to other plants does occur, it
                                            person that he or she, and all of their                 proposed permit application                           does not present an unacceptable risk of
                                            agents, must comply with all of the                     categorization system that is more                    introducing or disseminating a noxious
                                            permit conditions before issuance of the                flexible than the system described in the             weed.
                                            permit.                                                 DEIS.                                                    Such gene flow can be minimized or
                                               Almost all DEIS comments on                             In the DEIS, APHIS considered                      substantially prevented through permit
                                            containers or marking and identity for                  whether to continue to issue                          conditions developed for environmental
                                                                                                    environmental release permits for GE                  releases of GE pharmaceutical or
                                            regulated articles supported
                                                                                                    plants engineered to produce                          industrial plants. In many cases the
                                            performance standards for containers.
                                                                                                    pharmaceutical and industrial                         genetic and phenotypic characteristics
                                            Most of these commenters made the
                                                                                                    compounds if the GE plant species is                  of the organism also serves to
                                            point that performance criteria are
                                                                                                    the same as, or sexually compatible                   discourage survivability of the plant
                                            generally more adaptable and efficient
                                                                                                    with, a species commonly used for food                away from the intended site as well as
                                            than prescriptive criteria. Some stated
                                                                                                    or feed. APHIS concludes that the                     gene flow to other plants. During the
                                            that shipping research organisms
                                                                                                    permitting procedure with its stringent               review prior to permit issuance, APHIS
                                            interstate in enclosed containers is a
                                                                                                    permit conditions can continue to                     would also always consider the effects
                                            low-risk activity that is very unlikely to
                                                                                                    effectively minimize the risks that may               if the GE plant were likely to spread
                                            result in release, establishment or harm.                                                                     widely, or if large-scale gene flow to
                                                                                                    be associated with the environmental
                                               Some commenters stated that the type                                                                       other plants occurred. A permit for an
                                                                                                    release of such GE plants. APHIS will
                                            of container indicated by performance                                                                         environmental release would not be
                                                                                                    continue to impose appropriate permit
                                            standards must be appropriate to the                    conditions that take into account the                 approved if APHIS concluded there was
                                            level of risk in the tiered permit system               issues related to the public safety of                a likelihood of such events causing any
                                            for the shipped GE organism. One                        proteins or other substances that these               of the types of harm as described in the
                                            commenter requested that APHIS make                     plants have been engineered to produce.               noxious weed definition.
                                            its container standards consistent with                    Numerous commenters supported                         One DEIS comment on the issue of
                                            the International Air Transporters                      banning the outdoor production of                     multiple-year permits stated that
                                            Association (IATA) requirements for                     pharmaceuticals and industrial                        compliance agreements should be used
                                            shipping.                                               substances in food and feed crops. Some               instead of actual multiple-year permits.
                                               The way this proposed rule deals with                stated that food crops should not be                  Another suggested that multiple-year
                                            container standards is consistent with                  used for the production of                            permits should be limited to trait/crop
                                            the above DEIS comments.                                pharmaceuticals and industrial                        combinations not intended for feed or
                                               Most of the commenters addressing                    substances.                                           food use. In contrast, another comment
                                            tiered or categorized permit systems                       Some commenters stated that GE                     stated that APHIS should consider
                                            supported APHIS establishing a tiered                   plants used for the production of                     allowing multi-year permits for any
                                            permitting system for plants based on                   pharmaceuticals and industrial                        product, not just GE pharmaceutical or
                                            criteria that included risk and other GE                substances should be evaluated by                     industrial plants.
                                            organism characteristics. However,                      criteria that are different from those                   Several commenters stated a risk-
                                            commenters also stressed that risk                      used to evaluate crops intended for                   based opposition to multi-year permits
                                            categories should be based on a trait by                food. Other commenters stated that if                 and stated that crops engineered to
                                            species approach, not on the basis of                   such GE industrial plants were made                   produce pharmaceuticals or industrial
                                            individual transformed plant line                       from food crop species, or could spread               compounds should always be regulated
                                            (referred to as ‘‘event-by-event’’ in some              genes to food crop species, they should               under an annually-reviewed permit
                                            of the comments). Some commenters                       be evaluated based on food safety risk,               system.
                                            advised against using limited broad                     not the industrial product’s function,                   This proposed rule addresses the risk-
                                            based categories that include many                      and approved only if they pose no food                based concerns cited by commenters in
                                            different species with different biologies              safety risks. However, with regard to                 the proposed processes for issuing
                                            and different risk factors. Several stated              evaluating food safety, several                       permits and granting exemptions,
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                                            the importance of evaluating permit                     commenters also stated that FDA should                discussed elsewhere in this document.
                                            applications on a case-by-case basis, to                be the agency evaluating these risks.                 We propose to allow multi-year permits
                                            avoid the risk that categorizing permit                    We have not seen evidence suggesting               for any type of regulated activity, when
                                            types could result in approval of risky                 that these types of organisms present                 we determine that appropriate risk-
                                            releases that were inadvertently seen as                unique or uncontrollable risks, or risks              related conditions can be prescribed for
                                            ‘‘routine categories.’’                                 higher than those that may be associated              those activities. We have not seen any


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                                            60032                 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules

                                            convincing evidence, in DEIS comments                   ensuring that the commodities are made                with such incidents, and that beyond
                                            or elsewhere, that limiting use of multi-               non-viable or safeguards are in place to              applying general criteria APHIS should
                                            year permits to certain types of                        ensure that propagation will not occur.               investigate each unauthorized release
                                            organisms would reduce risk or                          Some comments in this group also                      individually and determine actions
                                            otherwise serve the purpose of the                      stated that such exemptions should not                based on the facts surrounding each
                                            regulations.                                            be granted for a GE commodity from any                incident. Some commenters stated that
                                               Of the approximately 67 comments                     country until APHIS has confidence that               any LLP policy should clearly state that
                                            received by APHIS on the interstate                     the country has robust regulatory                     even if an incident was found to be non-
                                            movement exemptions discussion in the                   guidelines and assessment standards                   actionable (i.e., not requiring remedial
                                            DEIS, 30 comments appear to support                     with strong, reliable science and                     action), persons involved would still be
                                            APHIS’ preferred Alternative 2, under                   trustworthy regulatory oversight,                     subject to enforcement actions such as
                                            which APHIS would exempt from                           equivalent in effectiveness to the U.S.               civil penalties if violations of the
                                            permit requirements for interstate                      system.                                               regulations occurred.
                                            movement a class of GE plants or                           One comment included a general                        APHIS has considered all these views
                                            organisms that are well-studied and                     statement that it was important that a                in the development of this proposed
                                            present little or no environmental risk,                petitioner for deregulation or exemption              rule and has attempted to find a
                                            as is currently done for Arabidopsis.                   should work closely with APHIS to                     reasonable balance. It is not warranted,
                                            However, many of these commenters                       develop and evaluate the management                   or practical, to implement a ‘‘zero
                                            suggested that APHIS choose an                          plan under which the subject GE                       tolerance’’ LLP policy. Instead, we
                                            approach that combined this with one                    organism would be grown if deregulated                propose a policy that each LLP incident
                                            or more of the other Alternatives.                      or exempted. APHIS agrees that its                    would be individually investigated, and
                                            Several commenters stated that the                      regulatory approach should include                    APHIS would then make a decision on
                                            regulations should provide a procedure                  working closely with petitioners on                   whether, or what kind of, remedial
                                            for APHIS to consider additional                        their proposals for exemption,                        action is needed. In making this
                                            exemptions from interstate movement                     especially if management plans are part               determination APHIS would use
                                            restrictions on a case-by-case basis.                   of the requisite conditions. APHIS                    established criteria to rate the risks
                                               APHIS has concluded that the most                    would retain some degree of oversight                 involved in the LLP incident. However,
                                            appropriate proposal for the regulations                and could restrict movements of a GE                  these criteria would not fully determine
                                            at this time is to provide a clear and                  organism such that the exemption and                  the APHIS response. In addition to
                                            adaptable procedure whereby it would                    its conditions are unlikely to result in              considering the criteria, APHIS would
                                            use a case-by-case approach to consider                 the introduction or dissemination of a                evaluate any other relevant information
                                            the merits of new exemptions from the                   plant pest or noxious weed. The                       regarding the LLP incident and order
                                            requirement for a permit. The                           proposed procedure to approve                         remedial action if it appears necessary.
                                            procedure, described in proposed                        additional conditional exemptions is                     Also, we propose to clearly state that
                                            § 340.5, would allow for a transparent                  sufficiently adaptable even when the                  regardless of whether APHIS considers
                                            procedure in which APHIS would                          exemption is for all forms of movement                the LLP actionable with regard to
                                            evaluate the proposed exemption, and                    (i.e., importation, interstate movement,              remediation, any violations of the
                                            the public would have an opportunity to                 and environmental release).                           regulations or permit conditions can
                                            review APHIS’ evaluation and provide                       Very few DEIS comments directly                    still result in compliance and
                                            comments prior to APHIS decisions on                    addressed enforcement and compliance.                 enforcement actions for failure to
                                            individual cases. The proposed                          A few comments stated that APHIS                      comply with the regulations.
                                            procedure should provide the benefit of                 regulatory oversight and enforcement of                  One DEIS comment directly
                                            transparency and scientific rigor while                 its regulations in the past have been                 addressed timelines for APHIS to
                                            affording a more streamlined and cost-                  insufficient and have provided                        perform permit- and petition-related
                                            efficient procedure that would not                      inadequate containment of GE crops.                   activities and urged APHIS to continue
                                            require formal amendment of the                         This proposed rule would strengthen                   to define specific timelines for
                                            regulations when each new exemption                     enforcement and compliance and                        regulatory reviews to allow for a
                                            is approved.                                            enhance the effectiveness of the                      predictable regulatory review system.
                                               Several DEIS comments addressed                      regulations.                                          The comment stated that time frames
                                            what criteria in the regulations the                       Comments on the discussion in the                  are especially critical for field trial
                                            Agency could use to determine the level                 DEIS of low level presence ranged from                permitting activities since planting
                                            of risk assessment applied to imported                  suggestions that APHIS should                         occurs during a narrow window each
                                            GE commodities which are viable                         completely prevent such incidents by                  year and a delay of a month or two in
                                            propagules. They fell into two general                  banning all outdoor growth of GE plants               a regulatory decision can result in a year
                                            groups. Both groups stated that any                     to suggestions that LLP is a minor                    delay due to the inability to timely plant
                                            expedited review or exemption for GE                    problem needing only minimal controls,                a field trial.
                                            commodity imports needed to be                          and does not warrant an increased                        We understand the concerns, and
                                            granted based on a review of risk and a                 regulatory burden to control a minor                  have decided to keep the time frames in
                                            determination that the importation                      risk. Some commenters stated that the                 the text of the regulations. However, as
                                            presented no significant risks. Beyond                  preferred alternative in the DEIS                     discussed above, APHIS will view them
                                            that, one group emphasized that                         accepted too high a level of risk. These              as performance goals and will generally
                                            commodity imports were in general                       commenters generally preferred DEIS                   respond in the time frames indicated,
                                            inherently safe, and such an expedited                  alternative 4, which would impose very                rather than be obligated to respond at
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                                            system would be appropriate and would                   strict permit conditions on all                       those times. In recent years, there has
                                            also greatly facilitate international trade.            environmental releases to reduce the                  been an increase in the time required for
                                            The other group was skeptical about                     likelihood of LLP events. Most                        APHIS review due to the increasing
                                            inherent safety of GE commodities and                   commenters agreed that APHIS should                   complexity of issues related to
                                            suggested that exemptions should only                   adopt an LLP policy that recognizes the               environmental effects, new traits, and
                                            be offered when there are procedures                    wide variety of risk levels associated                unfamiliar species. In addition to


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                                                                   Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules                                               60033

                                            retaining general time frames in the                       The benefits associated with the use               commercial production, their
                                            regulations, APHIS intends to discuss                   of some GE crops already in production                production has resulted since 1996 in
                                            time frames with each applicant early in                include higher yields, lower pesticide                decreases in the use of pesticides by 286
                                            the application process, and to the                     costs, and overall savings in                         million kg and in the use of herbicides
                                            extent possible give the applicant                      management time. There are also                       by 51 million kg (Brookes and Barfoot
                                            reliable time estimates based on the                    environmental benefits from reduced                   2008). These declines represent 7.9
                                            nature and complexity of the particular                 pesticide use. Attempts have been made                percent reductions. In terms of
                                            application and current APHIS activities                to quantify the benefits that have                    greenhouse gases, one study estimated
                                            and resources that are expected to affect               occurred as a result of the adoption of               cultivation using no-tillage systems
                                            the application review.                                 GE crops and, according to a recent                   associated with GE crops modified for
                                                                                                    survey, farm-level net economic benefits              herbicide tolerance to reduce fuel use by
                                            B. Executive Order 12866 and
                                                                                                    worldwide from the adoption of GE                     32.52 liters/ha (89 percent) compared to
                                            Regulatory Flexibility Act
                                                                                                    crops were estimated to be $7 billion in              conventional methods, and 14.7 liters/
                                               This proposed rule has been reviewed                 2006 (Brookes and Barfoot 2008). Total                ha (76 percent) compared to reduced
                                            under Executive Order 12866. The rule                   net benefits, 1996–2006, were estimated               tillage methods (Jasa 2002). An
                                            has been determined to be significant                   to be $34 billion. Of this total estimated            American Soybean Association survey 4
                                            for the purposes of Executive Order                     net welfare gains, the United States                  showed significant reductions in tillage,
                                            12866 and, therefore, has been reviewed                 experienced the largest benefit, with                 and therefore in fuel use, by growers of
                                            by the Office of Management and                         $15.8 billion; followed by Argentina,                 glyphosate-tolerant soybeans. The fuel
                                            Budget.                                                 $6.6 billion; China, $5.8 billion; and                reductions were estimated as 1.26
                                               We have prepared an economic                         Brazil, $1.9 billion (Brookes and Barfoot             gallons per acre, or, for the 56 million
                                            analysis for this proposed rule, which is               2008). U.S. farmers’ welfare gains from               acres of glyphosate-tolerant soybeans
                                            summarized below. Copies of the full                    the adoption of biotechnology ranged                  planted in 2001, 70 million gallons of
                                            economic analysis are available by                      from 29 to 42 percent of total net                    fuel saved and associated greenhouse
                                            contacting the person listed under FOR                  welfare gains (Price et al. 2005; Falck-              gas emissions avoided. These fuel-use
                                            FURTHER INFORMATION CONTACT or on the                   Zepeda, Traxler, and Nelson 2000).                    reductions translate into reductions of
                                            Regulations.gov Web site (see                              The high rate of GE crop adoption by               carbon dioxide emissions of 89.44 kg/ha
                                            ADDRESSES above for instructions for                    farmers has been driven by an increase                and 40.43 kg/ha, respectively. Overall in
                                            accessing Regulations.gov). The analysis                in consumption of product developed                   2006, the total carbon dioxide savings
                                            provides a cost-benefit analysis, as                    with the use of GE techniques. However,               associated with the use of GE crops
                                            required by Executive Order 12866, and                  studies that quantify consumers’                      were 1.2 billion kg. This is equivalent to
                                            an analysis of the potential economic                   benefits from the use of biotechnology                removing 540,000 cars from the streets
                                            effects of this final rule on small                     are limited, as most studies tend to                  for a year.
                                            entities, as required by the Regulatory                 focus on the direct adopters of
                                            Flexibility Act.                                        biotechnology, i.e., the producers. Price             Benefits of the Proposed Rule
                                            Background                                              et al. (2006) found consumers do benefit                 The proposed rule would provide
                                                                                                    from the adoption of Bt cotton.                       benefits by establishing more efficient
                                              The adoption of genetically                              Overall, consumers’ gains from the                 regulation of GE organisms and
                                            engineered (GE) crops by farmers                        adoption of various GE crops have been                activities subject to part 340 and by
                                            worldwide has become increasingly                       estimated to range from 4 to 17 percent               continuing to provide a high level of
                                            widespread. The United States,                          of total net welfare gains (Price et al.              protection against risks associated with
                                            Argentina, Brazil, Canada, and China                    2005; Falck-Zepeda, Traxler, and Nelson               these organisms and activities. Benefits
                                            are the major GE crop adopters. In 2008,                2000).                                                would also include improved public
                                            92 percent of soybean, 80 percent of                       Crop producers and consumers are                   understanding of and confidence in
                                            corn, and 86 percent of cotton acreages                 not the only beneficiaries of recent                  APHIS’ biotechnology regulatory
                                            planted in the United States were                       advances in biotechnology. The                        responsibilities, and improved clarity
                                            genetically engineered (USDA NASS,                      providers of biotechnology have also                  and transparency of the regulatory
                                            2008). In addition to the major field                   benefited from the increased adoption of              process. Several amendments of the
                                            crops, GE varieties of papaya, yellow                   GE products. Intellectual property right              proposed rule would improve the
                                            squash, and zucchini were available for                 laws have offered incentives for the                  efficiency of APHIS’ biotech regulatory
                                            commercial production in 2008.                          private sector to invest in research and              process. Particular proposed changes
                                              Worldwide plantings of transgenic                     development of GE products, and as a                  that should improve the efficiency of
                                            crops grew by 12 percent in 2007,                       result, plant breeding expenditures have              the regulations include the elimination
                                            reaching 282.4 million acres in 23                      largely shifted from the public to the                of courtesy permits and the
                                            countries growing biotech crops in                      private sector (Fuglie 2006). As private              establishment of a procedure to evaluate
                                            2007, including 12 developing                           research spending has increased, so has               and grant requests for new exemptions
                                            countries. Over the next decade, use of                 the number of firms engaged in this type              from the requirement that GE organisms
                                            these ‘‘first-generation’’ GE crops, which              of research. However, consolidation and               have a permit to be imported, moved
                                            carry traits such as insect resistance and              mergers during the 1990’s resulted in an              interstate, or released into the
                                            herbicide tolerance, should continue to                 industry dominated by large companies.                environment.
                                            grow while a second generation of crops                 Currently, 80 percent of biotech traits                  Approving new exemptions could be
                                            promises new applications and traits                    that have been approved are owned or                  done without amending the regulations,
                                            such as improved drought tolerance,                     co-owned by four firms (Bayer Crop                    resulting in considerable time savings
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                                            biofuel-related enhancements, and                       Science, DuPont, Monsanto, and
                                            quality and nutritional traits.3                        Syngenta) or their subsidiaries                         4 Cited in Fawcett, Richard and Towery, Dan.

                                                                                                    (Kalaitzandonakes, Alston, and Bradford               Conservation Tillage and Plant Biotechnology: How
                                              3 Global Status of Commercialized Biotech/GM                                                                New Technologies Can Improve the Environment
                                            Crops, ISAAA Briefs 37–2007, 35–2006, The               2007).                                                By Reducing the Need to Plow. Conservation
                                            International Service for the Acquisition of Agri-         With regard to the beneficial effects              Technology Information Center, West Lafayette,
                                            Biotech Applications, Cornell University.               for the environment of GE plants in                   Indiana.



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                                            60034                 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules

                                            for regulated parties and reducing                      through particularized permit                         rule, and providing staff training that
                                            APHIS’ rulemaking costs. Persons using                  conditions to require only what is                    may be necessary. Because of the new
                                            an exemption would also avoid the                       needed to ensure regulatory compliance                definition of the scope of the
                                            costs and delays associated with                        based on individual cases. This should                regulations, APHIS may devote more
                                            obtaining a permit for each new planned                 contribute to greater efficiency.                     resources to consultations with
                                            movement or release of a GE organism                      The proposed rule’s greater clarity                 regulated parties if they request
                                            covered by the exemption.                               and transparency is expected to enhance               consultation to determine whether
                                               APHIS commits considerable                           the general public’s perception of                    particular GE organisms are or are not
                                            resources to issuing courtesy permits                   APHIS regulation in this area, with                   subject to the regulations. Such
                                            not actually required by or needed to                   associated benefits from increased                    consultation should decrease after the
                                            implement the part 340 regulations.                     support of and compliance with the                    first year or two of implementation, as
                                            These courtesy permits have been                        regulations.                                          such determinations of regulated status
                                            issued to facilitate the movement of GE                   In addition to the information                      accumulate and become the basis for
                                            organisms that are but whose movement                   provided in the regulations, APHIS                    guidance of general applicability.
                                            may be hindered due to their similarity                 proposes to develop new guidance
                                            to organisms that are subject to part 340.              documents to assist in the preparation                Initial Regulatory Flexibility Analysis
                                            By improving public awareness that                      and submission of applications.                          In accordance with the Regulatory
                                            such organisms do not need a permit                                                                           Flexibility Act of 1980 (Pub. L. 96–354),
                                                                                                    Costs of the Proposed Rule
                                            and eliminating the courtesy permit                                                                           this analysis considers the economic
                                            process APHIS would improve                               There are several cost areas associated             impact of the proposed rule on small
                                            efficiency and reduce its regulatory                    with the proposed rule. Costs associated              businesses, small organizations, and
                                            workload, and save time for regulated                   with the proposed rule that regulated                 small governmental jurisdictions.
                                            entities who would no longer make                       entities would incur include costs of                 Section 603 of the Act requires that the
                                            unnecessary courtesy permit requests.                   learning and adapting procedures to                   initial regulatory flexibility analysis
                                               The Agency currently issues                          changed requirements, providing more                  (IRFA) be made available for public
                                            environmental release permits,                          or different information in permit                    comments. This section addresses the
                                            including permits that are used for                     applications, and additional                          IRFA requirements, as stated in Sections
                                            production of pharmaceutical and                        recordkeeping for some entities. The                  603(b) and 603(c) of the Act.
                                            industrial compounds sold in                            additional recordkeeping burden is
                                                                                                    discussed below in the Paperwork                      Reasons Action Is Being Considered
                                            commerce. In general, permits for
                                            releases of plants producing                            Reduction Act section. Annual costs                      APHIS is taking action to amend 7
                                            pharmaceutical or industrial                            resulting from the additional                         CFR part 340, which was promulgated
                                            compounds have been limited to a one-                   recordkeeping may be estimated as the                 in 1987 under the authority of the
                                            year duration. However, the proposed                    salary and associated costs for 640                   Federal Plant Pest Act of 1957 and the
                                            regulations provide a more useful and                   additional hours of recordkeeping                     Plant Quarantine Act of 1912. These
                                            efficient approach to setting appropriate               divided among 160 respondents.                        acts were subsequently subsumed
                                            risk-related conditions in multi-year                     Many provisions of the proposed                     within the Plant Protection Act (PPA) of
                                            environmental release permits. Under                    regulations are revisions of the current              2000, and the proposed revisions would
                                            the proposed system, APHIS would                        regulations, and it is not expected that              bring part 340 in alignment with this
                                            likely increase issuance of multi-year                  familiarization costs would be                        Act. Advances in biotechnology and
                                            environmental release permits, thereby                  substantial. However, estimates of these              accumulation of oversight experience by
                                            reducing the time the regulated entities                costs are not available and therefore                 APHIS have also made it necessary to
                                            need to spend submitting applications                   APHIS invites public comment on the                   revise and update the regulations, and
                                            as well as the time APHIS spends                        costs the regulated community may                     in addition, the 2008 Farm Bill (The
                                            reviewing the permit applications.                      incur with respect to rule                            Food, Conservation, and Energy Act of
                                               APHIS’ biotechnology operations                      familiarization and changes to their                  2008) enacted most recently contains
                                            would be aided by more clarity in terms                 application systems.                                  provisions that need to be incorporated
                                            of required data submissions and                          Costs to APHIS are currently incurred               into the proposed rule. The proposed
                                            administrative procedures. More detail                  in the regulatory assessment and review               changes would improve the regulatory
                                            is provided regarding what applicant                    of submitted materials. Because the new               process by providing greater
                                            information is required for each permit                 permit process is largely similar to the              transparency, flexibility, and efficiency.
                                            application type, and how application                   current process, it is expected that
                                            information relates to the proposed new                 ongoing permit processing costs to                    Objective and Legal Basis for the Rule
                                            permit categories for environmental                     APHIS would remain essentially                          The objectives of this rule are to
                                            release permits. These changes, along                   unchanged. As a start-up cost to change               amend part 340 to provide consistency
                                            with more clearly defined categories for                the permit system to accommodate                      with the PPA authorities and to
                                            the environmental release permits,                      requirements of the proposed rule,                    incorporate updates and improvements
                                            would potentially reduce the time some                  APHIS may potentially incur a one-time                to provide a more efficient regulatory
                                            entities, large or small, spend on an                   additional cost of $500,000. However                  process while controlling potential risk
                                            application or petition process.                        the current system is adaptable to the                to plant health and the environment.
                                            Increased efficiency benefits may be                    new regulations and it is not anticipated             The PPA authorizes the Secretary of
                                            most helpful to smaller companies and                   that there would be any efficiency loss               Agriculture to implement programs and
                                            public sector entities, where GE                        during the transitional period. APHIS                 policies designed to prevent the
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                                            research is generally conducted on a                    would also potentially incur                          introduction and spread of plant pests
                                            much smaller scale than that of large                   incremental costs conducting outreach                 and diseases. Specifically, the Secretary
                                            agri-business enterprises.                              activities for the proposed rule,                     of Agriculture is given the authority
                                               The proposal includes provisions to                  developing guidance documents to                      under the PPA to prevent the
                                            require necessary recordkeeping and                     ensure that the regulated community is                importation or dissemination of plant
                                            reporting but to fine-tune this burden                  familiar with the requirements of the                 pests and noxious weeds. To do so, the


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                                                                  Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules                                         60035

                                            Secretary may regulate the importation,                 (111421); Floriculture Production                     (NAICS 115210); and Support Activities
                                            interstate movement, and release into                   (111422); Tobacco Farming (111910);                   for Forestry (NAICS 115310).
                                            the environment of any plant, plant                     Cotton Farming (111920); Sugarcane                    Establishments in these categories are
                                            product, biological control organism,                   Farming (111930); Hay Farming                         considered small by SBA standards if
                                            noxious weed, article, or means of                      (111940); Sugar Beet Farming (111950);                annual sales are not more than $6.5
                                            conveyance that could potentially                       Peanut Farming (111960); and All other                million. However, neither the Census of
                                            spread plant pests or noxious weeds.                    Miscellaneous Crop Farming (111970).                  Agriculture nor the Economic Census
                                                                                                       Some aspects of animal production                  reports revenue for these
                                            Description and Estimate of the Number                  may be affected because some GE plants                establishments.
                                            of Small Entities Regulated                             are used for animal feeds and may have                  Entities that may be directly affected
                                              The proposed rule may affect a wide                   enhanced nutritional value or other                   by the proposed rule in the
                                            range of public and private                             benefits. In terms of animal production,              Manufacturing Sector are classified
                                            biotechnology research facilities, GE                   potentially affected entities include                 within Ethyl Alcohol Manufacturing
                                            crop and seed production, food                          ones within the following industries:                 (NAICS 325193); Pesticide and Other
                                            processors, grain processors, and paper                 Beef Cattle Ranching and Farming                      Agricultural Chemical Manufacturing
                                            producers that fall into various                        (NAICS 112111); Cattle Feedlots (NAICS                (NAICS 325320); Pharmaceutical
                                            categories of the North American                        112112); Hog and Pig Farming (NAICS                   Preparation Manufacturing (NAICS
                                            Industry Classification System (NAICS).                 112210); Sheep Farming (NAICS                         325412); and Medicinal and Botanical
                                            For the purpose of this analysis and                    112410); Goat Farming (NAICS 112420);                 Manufacturing (NAICS 325411).
                                            following the Small Business                            and Apiculture (NAICS 112910). Except                 Establishments in the Ethyl Alcohol
                                            Administration (SBA) guidelines, the                    for Cattle Feedlots, entities in all of               Manufacturing category are considered
                                            potentially affected entities are                       these industries are considered small by              small if they employ not more than
                                            classified within the following sectors:                SBA standards if annual sales are not                 1,000 persons and those in the category
                                            Agriculture, Forestry, Fishing and                      more than $0.75 million. Cattle Feedlot               of Pesticide and Other Agricultural
                                            Hunting (Sector 11), Manufacturing                      establishments are considered small by                Chemical Manufacturing (NAICS
                                            (Sectors 31–33), Wholesale Trade                        SBA standards if annual sales are not                 325320) are considered small if they
                                            (Sector 42), Retail Trade (Sector 44 and                more than $2 million. According to the                employ not more than 500 persons. For
                                            45), Transportation (Sectors 48 and 49),                2002 Census of Agriculture, 93 percent                both the Pharmaceutical Preparation
                                            and Professional, Scientific and                        of Cattle Feedlot businesses, 99 percent              Manufacturing (NAICS 325412); and
                                            Technical Services (Sector 54).                         of Beef Cattle Ranching and Farming                   Medicinal and Botanical Manufacturing
                                              For the Agriculture, Forestry, Fishing                businesses, 81 percent of Hog and Pig                 (NAICS 325411) categories,
                                            and Hunting sector, the subsectors of                   Farming businesses, 99 percent of Sheep               establishments are considered small if
                                            Crop Production, Animal Production,                     and Goat farming businesses, and 99                   they employ not more than 750 persons.
                                            Forestry and Logging, and Support                       percent of Apiculture businesses are                  According to the 2002 Economic
                                            Activities for Agriculture and Forestry                 considered small.                                     Census, 98 percent of the establishments
                                            are potentially affected by this rule. The                 For the Forestry and Logging                       in the Chemical Manufacturing Sector
                                            proposed rule may affect a wide range                   subsector the potentially affected                    had fewer than 500 employees and 99
                                            of establishments in the Crop                           establishments are classified within                  percent had fewer than 1000. Therefore,
                                            Production category. Establishments in                  Timber Tract Operations (NAICS                        businesses in the chemical
                                            this category are considered small by                   113110); Forest Nursery and Gathering                 manufacturing are predominantly small
                                            SBA standards if annual sales are not                   of Forest Products (NAICS 113210); and                by SBA standards.
                                            more than $0.75 million. According to                   Logging (NAICS 113310).                                 In terms of Wholesale Trade, entities
                                            the 2002 Census of Agriculture, 97                      Establishments in the category of                     that would be potentially affected may
                                            percent of the farming businesses are                   Timber Tract Operations and Forest                    be found in the following categories:
                                            considered small. Potentially affected                  Nursery and Gathering of Forest                       Fresh Fruit and Vegetable Merchant
                                            crop-producing industries, with their                   Products are considered small by SBA                  Wholesalers (NAICS 424480); Other
                                            NAICS codes in parentheses, are as                      standards if annual sales are not more                Grocery and Related Products Merchant
                                            follows: Soybean Farming (111110);                      than $6.5 million and establishments in               Wholesalers (NAICS 424490); Grain and
                                            Oilseed Farming (except soybean)                        the category of Logging are considered                Field Bean Merchant Wholesalers
                                            (111120); Dry Pea and Bean Farming                      small if employment is not more than                  (NAICS 424510); Other Farm Product
                                            (111130); Wheat Farming (111140); Corn                  500. According to the 2002 Survey of                  Raw Material Merchant Wholesalers
                                            Farming (111150); Rice Farming                          Business Owners, 99 percent of                        (NAICS 424590); Farm Supplies and
                                            (111160); Oilseed and Grain                             establishments in the Logging category                Merchant Wholesalers (NAICS 424910);
                                            Combination Farming (111191); All                       are considered small. Neither the                     and Flower, Nursery Stock, and Florists’
                                            Other Grain Farming (111199); Potato                    Census of Agriculture nor the Economic                Supplies Merchant Wholesalers (NAICS
                                            Farming (111211); Other Vegetable                       Census tracks revenue for                             424930). Establishments in the above
                                            (except potato) and Melon Farming                       establishments classified within Timber               categories are considered small by SBA
                                            (111219); Orange Groves (111310);                       Tract Operations and Forest Nursery                   standards if they employ not more than
                                            Citrus (except orange) Groves (111320);                 and Gathering of Forest Products.                     100 persons. According to the 2002
                                            Apple Orchards (111331); Grape                             In terms of Support Activities for                 Survey of Business Owners, 97 percent
                                            Vineyards (111332); Strawberry Farming                  Agriculture and Forestry, the potentially             of the establishments in this category
                                            (111333); Berry (except Strawberry)                     affected establishments are classified                employed fewer than 100 people and
                                            Farming (111334); Tree Nut Farming                      within Cotton Ginning (NAICS 11511);                  are considered small by SBA standards.
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                                            (111335); Fruit and Tree Nut                            Soil Preparation, Planting, and                         Retail Trade, establishments that
                                            Combination Farming (111336); Other                     Cultivating (NAICS 115112); Crop                      would be affected by the rules are in the
                                            Noncitrus Fruit Farming (111337);                       Harvesting (NAICS 115113); Postharvest                following categories: Nursery and
                                            Mushroom Production (111411); Other                     Crop Activities (NAICS 115114); Farm                  Garden Centers (NAICS 444220);
                                            Food Crops Grown Under Cover                            Management Services (115116) Support                  Supermarkets and Other Grocery Stores
                                            (111419); Nursery and Tree Production                   Activities for Animal Production                      (NAICS 445110); Fruit and Vegetable


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                                            60036                 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules

                                            Markets (NAICS 445230); All Other                       Economic Census suggests that 82                       regulation, and APHIS foresees
                                            Specialty Food Stores (NAICS 445299);                   percent of the establishments in this                  additional areas for coordination under
                                            Food (Health) Supplement Stores                         category are considered small, the                     the proposed rule. In particular, APHIS
                                            (NAICS 446191); Warehouse Clubs and                     majority of applicants to APHIS are                    will coordinate with the Food and Drug
                                            Superstores (NAICS 452910); and Florist                 large by SBA standards.5                               Administration (FDA) and the
                                            (NAICS 453110). Establishments in the                                                                          Environmental Protection Agency
                                            Nursery and Garden Center, Fruit and                    Description and Estimate of Compliance                 (EPA). FDA regulates GE organisms
                                            Vegetable Markets, All other Specialty                  Requirement                                            under the authority of the Federal Food,
                                            Food Stores, Food (Health) Supplement                      The proposed rule would require                     Drug and Cosmetic Act and the Public
                                            Stores; and Florist categories are                      additional and modified information                    Health Service Act (42 U.S.C. 262 et
                                            considered small by SBA standards if                    collections through recordkeeping,                     seq.), as appropriate. The EPA regulates
                                            annual sales are not more than $6.5                     reporting, and notifications to APHIS                  plant-incorporated protectants under
                                            million. Supermarkets and Other                         when certain events occur. The                         the Federal Insecticide, Fungicide, and
                                            Grocery Stores are considered small by                  proposed application process requires                  Rodenticide Act (FIFRA) and certain
                                            SBA standards if annual sales are not                   certain new information. The current                   biological control organisms under the
                                            more than $25 million. While the                        and proposed rules both require                        Toxic Substances Control Act (TSCA).
                                            Economic Census reports total annual                    submission of reports following an                     As examples of areas that need
                                            sales, the Census does not provide a                    environmental release or field test, but               coordination, some of the plant-
                                            breakdown of these establishments by                    the proposed requirement is more                       incorporated protectants regulated by
                                            revenue categories.                                     specific about the contents of such                    EPA are also subject to APHIS
                                               In terms of the Transportation sector,               reports. Both the current and proposed                 requirements under the PPA. Also, FDA
                                            the potentially affected entities are in                rules require APHIS to be notified if an               is the primary U.S. agency responsible
                                            the category Farm Product Warehousing                   unauthorized release occurs or if during               for ensuring the safety of commercial
                                            and Storage (NAICS 493130).                             release the GE organism is found to have               food and food additives, and FDA
                                            Establishments in this category are                     characteristics substantially different                authority extends to any nonpesticidal
                                            considered small by SBA standards if                    from those anticipated by the permit.                  substance that may be introduced into a
                                            annual sales are not more than $23.5                    The proposed rule is more specific                     new GE plant and that is expected to
                                            million. However, the Economic Census                   about the types of records that must be                become a component of food. The
                                            reports only total revenue for all                      kept for importations, interstate                      proposed regulations would clarify the
                                            establishments in this category.                        movements, and environmental                           regulatory scope and procedures used
                                               In terms of Professional, Scientific                 releases, where the current regulations                by APHIS relative to these other
                                            and Technical Services, establishments                  left more of these details to be specified             agencies and improve the coordination
                                            in the category of Research and                         only in permit conditions. In terms of                 process.
                                            Development in the Physical,                            record retention requirements, the
                                            Engineering, and Life Sciences (NAICS                                                                          Significant Alternatives to the Rule
                                                                                                    proposed rule spells out a 2-year
                                            54170) may be affected. Establishments                  retention for records indicating that a                   APHIS considered several significant
                                            in this category are considered small by                GE organism imported or moved                          alternatives during development of this
                                            SBA standards if they employ not more                   interstate reached its intended                        proposed rule. We have compared the
                                            than 500 persons. According to 2002                     destination, and a 5-year retention for                selected alternatives to others that were
                                            Economic Census, 82 percent of the                      all other required records. By providing               not selected to evaluate their feasibility
                                            establishments in this category are                     more specific information on what                      and to consider whether any
                                            considered small.                                       records are required, the proposed rule                alternatives provide ways to minimize
                                               Although information was not                         should alleviate some current burden                   significant economic impacts on small
                                            available on the business sizes for all                                                                        entities. We have not identified any
                                                                                                    that may result from persons keeping
                                            potentially affected establishments,                                                                           selected alternative that imposes
                                                                                                    unnecessary records. In addition, APHIS
                                            based on the foregoing information we                                                                          disproportionate costs on small
                                                                                                    has established the Biotechnology
                                            can assume that the majority of the                                                                            businesses, or any non-selected
                                                                                                    Quality Management System (BQMS),
                                            entities that may be affected by the                                                                           alternative that would both achieve the
                                                                                                    which is a voluntary compliance
                                            proposed rule are small by SBA                                                                                 regulatory purposes and reduce costs for
                                                                                                    assistance unit within USDA APHIS.
                                            standards.                                                                                                     small businesses.
                                               Given the aforementioned, a review of                BQMS would facilitate the regulatory                      The selected alternative regarding the
                                            entities that have made application                     efforts of USDA APHIS by conducting                    scope of the regulatory oversight was to
                                            requests to APHIS shows that of the 420                 outreach activities and providing                      add considerations of noxious weed risk
                                            applicants for the last 6 years, 263 were               compliance assistance to the regulated                 in addition to evaluating plant pest
                                            universities and colleges and public and                community. This would lessen any                       risks, and to use genetic transformation,
                                            private research institutions. The                      burden of the proposed rule to the                     coupled with a determination by the
                                            remainder of the applicants fall under                  regulated community.                                   Administrator as to whether a GE
                                            various NAICS classification codes                      Duplication, Overlap, and Conflict With                organism met certain risk-based criteria,
                                            specified above but given time                          Existing Rules and Regulations                         as the trigger for regulation. Other
                                            constraints their business size could not                 APHIS has identified areas where the
                                                                                                                                                           alternatives considered included
                                            be readily determined. We were able to                  proposed rule will need to be closely
                                                                                                                                                           continuing to base the scope of
                                            ascertain that the 263 institutions (63                 coordinated with other Federal rules
                                                                                                                                                           regulation only on plant pest risks, or
                                            percent) are large by SBA standards as                                                                         trying to develop a set of solely trait-
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                                                                                                    and statutory authorities. Coordination
                                            they fall under NAICS code 54170                        has been an important aspect of the
                                                                                                                                                           based criteria that could be used to
                                            Research and Development in Physical                    daily implementation of the current
                                                                                                                                                           predict what articles would be regulated
                                            Science. Establishments in this category                                                                       without the need for determinations by
                                            are considered small by SBA standards                     5 The size determination was made using public       the Administrator. The first of these
                                            if they employ not more than 500                        information about these entities. This information     alternatives could have resulted in costs
                                            persons. Even though the 2002                           was primarily obtained from the entities’ Web sites.   from damages caused by a GE plant with


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                                                                  Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules                                          60037

                                            noxious weed aspects that was not                       requirements included in this proposed                environmental release under permit or
                                            regulated under the plant pest risks                    rule have been submitted for approval to              notification to create and submit to
                                            standard. The second alternative was                    the Office of Management and Budget                   APHIS a field test report, and in many
                                            not considered technically feasible, and                (OMB). The information collection or                  cases the protocol or guidelines would
                                            could also have resulted in costs for                   recordkeeping requirements in current 7               normally be included in these field
                                            persons who erroneously decide their                    CFR part 340 have been approved under                 reports. This proposed change would
                                            GE plant is not within the scope of the                 OMB Control No. 0579–0085. Please                     require that the protocols or guidelines
                                            regulations, but are overruled by a later               send written comments to the Office of                be kept in all cases as distinctly
                                            determination by the Administrator that                 Information and Regulatory Affairs,                   identifiable records, which may cause
                                            the GE plant is regulated.                              OMB, Attention: Desk Officer for                      some increase in recordkeeping burden.
                                               The selected alternative for providing               APHIS, Washington, DC 20503. Please                      In some particular environmental
                                            transparency and predictability to the                  state that your comments refer to Docket              release cases where higher risk levels
                                            permitting system was to establish                      No. APHIS–2008–0023. Please send a                    make it necessary, the proposed rule
                                            permit categories for environmental                     copy of your comments to: (1) Docket                  would allow APHIS to add a special
                                            releases of plants based on newly                       No. APHIS–2008–0023, Regulatory                       permit condition requiring the permit
                                            devised criteria. We also considered                    Analysis and Development, PPD,                        holder to maintain and make available
                                            evaluating all requests for                             APHIS, Station 3A–03.8, 4700 River                    to APHIS written manuals or protocols
                                            environmental release permits on a                      Road Unit 118, Riverdale, MD 20737–                   describing how specified permit
                                            case-by-case basis, without categories.                 1238, and (2) Clearance Officer, OCIO,                conditions will be met, such as
                                            This alternative would have resulted in                 USDA, room 404–W, 14th Street and                     management practices used for the
                                            less predictability for applicants, and                 Independence Avenue SW.,                              environmental release, training,
                                            likely would have increased their costs                 Washington, DC 20250. A comment to                    communications, and identity
                                            for information collection because                      OMB is best assured of having its full                preservation systems. This would be
                                            applications known to be in a particular                effect if OMB receives it within 30 days              used in cases where it is deemed
                                            category can contain less information                   of publication of this proposed rule.                 necessary to provide specific guidance
                                            about non-relevant areas.                                  This proposed rule contains certain                in addition to the proposed general
                                               The selected alternative regarding the               information collection and                            condition for all permits (i.e., that the
                                            duration period for permits was to make                 recordkeeping requirements that would                 holder must keep records related to
                                            multi-year permits for interstate                       apply to persons and their agents                     permitted activities of sufficient quality
                                            movement and importation more                           engaged in the importation, interstate                and completeness to demonstrate
                                            feasible by removing the one-year limit                 movement, or release into the                         compliance with all permit conditions
                                            for interstate movement permits and the                 environment of any GE organism that is                and requirements under this part).
                                            requirement to obtain a new importation                 subject to the regulations. The majority              Another proposed permit condition
                                            permit for each imported shipment. We                   of the requirements would apply to                    would require permit holders to develop
                                            also considered alternatives to maintain                persons moving GE organisms under a                   and keep a written contingency plan to
                                            either the current or alternative specific              permit issued by APHIS, but some                      respond to any unauthorized
                                            time limits for such permits. These                     requirements also apply to persons                    environmental release. Both of these
                                            alternatives would have resulted in                     engaged in regulatory activities with GE              recordkeeping requirements would be
                                            additional costs for applicants who                     organisms even when no permit is                      added because some researchers or
                                            would have to reapply for permits,                      required, e.g., when they are exempted                developers were found to be unclear
                                            rather than having the original permit                  from the interstate movement permit                   about what management and
                                            issued with an appropriate duration.                    requirement.                                          communications practices were needed
                                                                                                       The proposed information and                       to prevent unauthorized releases, and
                                            C. Executive Order 12372                                recordkeeping requirements are found                  also about their responsibilities and the
                                              This program/activity is listed in the                in § 340.3, Permit conditions, and in                 measures they must take in the event of
                                            Catalog of Federal Domestic Assistance                  § 340.7, Compliance, enforcement, and                 an unauthorized release.
                                            under No. 10.025 and is subject to                      remedial action. Permit conditions for                   The proposed procedure to apply for
                                            Executive Order 12372, which requires                   individual permits issued under the                   an environmental release permit
                                            intergovernmental consultation with                     regulations may also require that certain             requires applicants to submit a great
                                            State and local officials. (See 7 CFR part              records relevant to the particular                    deal of information characterizing the
                                            3015, subpart V.)                                       movement must be kept.                                nature of the GE organism, the type of
                                                                                                       The proposed permit conditions for                 movement and release planned, plans
                                            D. Executive Order 12988                                shipments imported or moved interstate                and methods used to prevent
                                              This proposed rule has been reviewed                  include maintaining records of the same               unauthorized releases, and other
                                            under Executive Order 12988, Civil                      types of information that the current                 matters. Most of the same information is
                                            Justice Reform. If this proposed rule is                regulations require to be on the package              obtained through the current
                                            adopted: (1) No State or local laws or                  labeling of such shipments (nature and                application process, which allows the
                                            regulations would be preempted by this                  quantity, sender, destination, permit                 Administrator to require an applicant to
                                            rule; (2) no retroactive effect will be                 number, etc.) We believe that most                    submit any additional information that
                                            given to this rule; and (3) administrative              persons shipping or importing GE                      is needed for adequate evaluation of the
                                            proceedings will not be required before                 organisms already maintain such                       application. The proposed application
                                            parties may file suit in court challenging              records as part of normal business                    procedure is more specific in describing
                                                                                                    practices.                                            what information is required, and may
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                                            this rule.
                                                                                                       The proposed permit conditions for                 result in a slight increase in the amount
                                            E. Paperwork Reduction Act                              environmental releases include keeping                of information submitted with the
                                              In accordance with section 3507(d) of                 records of all protocols or guidelines                average application.
                                            the Paperwork Reduction Act of 1995                     used to direct any environmental                         The reporting burden for permit
                                            (44 U.S.C. 3501 et seq.), the information               release. The current regulations already              holders under the proposed rule would
                                            collection or recordkeeping                             require persons conducting an                         be similar to the burden under the


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                                            60038                 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules

                                            current regulations. In both cases they                 the Agency Information Management                        (3) Is approved for nonregulated
                                            must submit reports of all field tests to               Specialist, at (301) 851–2908.                        status in accordance with § 340.6 or has
                                            APHIS, report any unauthorized                                                                                previously been approved for
                                                                                                    F. E-Government Act Compliance
                                            releases, and submit any additional                                                                           nonregulated status pursuant to former
                                            reports required as individual permit                      The Animal and Plant Health                        regulations under this part, or
                                            conditions in their permits.                            Inspection Service is committed to                       (4) Is excluded in accordance with
                                               The current regulations do not specify               compliance with the E-Government Act                  paragraph (d) of this section.
                                            record retention periods, although some                 to promote the use of the Internet and                   (b) Genetically engineered organisms
                                            permits APHIS issued included specific                  other information technologies, to                    whose importation, interstate
                                            retention requirements as permit                        provide increased opportunities for                   movement, or release into the
                                            conditions. This proposal would require                 citizen access to Government                          environment is subject to the
                                            that records associated with an                         information and services, and for other               regulations in this part are:
                                            importation or interstate shipment must                 purposes. For information pertinent to                   (1) Genetically engineered plants if:
                                            be retained for at least 2 years after                  E-Government Act compliance related                      (i) The unmodified parent plant from
                                            completion of the movement, and all                     to this proposed rule, please contact                 which the GE plant was derived is a
                                            other records (e.g., regarding                          Mrs. Celeste Sickles, the Agency                      plant pest or noxious weed, or
                                            environmental releases) must be                         Information Management Specialist, at                    (ii) The trait introduced by genetic
                                            retained for at least 5 years after                     (301) 851–2908.                                       engineering could increase the potential
                                            completion of all obligations required                                                                        for the GE plant to be a plant pest or
                                                                                                    List of Subjects in 7 CFR Part 340                    noxious weed, or
                                            under a relevant permit or exemption.
                                               We are soliciting comments from the                    Administrative practice and                            (iii) The risk that the GE plant poses
                                            public (as well as affected agencies)                   procedure, Biotechnology, Genetic                     as a plant pest or noxious weed is
                                            concerning our proposed information                     engineering, Imports, Packaging and                   unknown, or
                                                                                                    containers, Permits, Plant diseases and                  (iv) The Administrator determines
                                            collection and recordkeeping
                                                                                                    pests, Noxious weeds, Transportation.                 that the GE plant poses a plant pest or
                                            requirements. These comments will
                                                                                                      Accordingly, we propose to revise 7                 noxious weed risk.
                                            help us:
                                                                                                    CFR part 340 to read as follows:                         (2) Genetically engineered non-plant,
                                               (1) Evaluate whether the proposed
                                                                                                                                                          non-vertebrate organisms if:
                                            information collection is necessary for                                                                          (i) The recipient organism can directly
                                                                                                    PART 340—IMPORTATION,
                                            the proper performance of our agency’s                                                                        or indirectly injure, cause damage to, or
                                                                                                    INTERSTATE MOVEMENT, AND
                                            functions, including whether the                                                                              cause disease in plants or plant
                                                                                                    RELEASE INTO THE ENVIRONMENT
                                            information will have practical utility;                                                                      products; or
                                                                                                    OF CERTAIN GENETICALLY
                                               (2) Evaluate the accuracy of our                     ENGINEERED ORGANISMS                                     (ii) The GE organism has been
                                            estimate of the burden of the proposed                                                                        engineered in such a way that it may
                                            information collection, including the                   Sec.                                                  increase the potential for it to be a plant
                                            validity of the methodology and                         340.0 Scope and general restrictions.                 pest: or
                                            assumptions used;                                       340.1 Definitions.
                                                                                                    340.2 Procedure for permits.
                                                                                                                                                             (iii) The risk that the GE organism
                                               (3) Enhance the quality, utility, and                                                                      poses as a plant pest is unknown, or
                                                                                                    340.3 Permit conditions.
                                            clarity of the information to be                                                                                 (iv) The Administrator determines
                                                                                                    340.4 Conditional exemptions from the
                                            collected; and                                               requirement for a permit for interstate          that the GE organism poses a plant pest
                                               (4) Minimize the burden of the                            movement.                                        risk.
                                            information collection on those who are                 340.5 Petition for new conditional                       (3) Opportunity to consult APHIS.
                                            to respond (such as through the use of                       exemptions from the requirement for a            Any person may contact APHIS to
                                            appropriate automated, electronic,                           permit.                                          discuss how the criteria of this
                                            mechanical, or other technological                      340.6 Petition for nonregulated status.               paragraph apply in the case of a
                                            collection techniques or other forms of                 340.7 Compliance, enforcement, and
                                                                                                                                                          particular GE organism or group of
                                            information technology; e.g., permitting                     remedial action.
                                                                                                    340.8 Confidential business information.              organisms.
                                            electronic submission of responses).                    340.9 Costs and charges.                                 (c) The Administrator may issue
                                               Estimate of burden: Public reporting                                                                       permits for the importation, interstate
                                            burden for this collection of information                 Authority: 7 U.S.C. 7701–7772 and 7781–             movement, or release into the
                                            is estimated to average 2 hours per                     7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and
                                                                                                    371.3.
                                                                                                                                                          environment of certain genetically
                                            response.                                                                                                     engineered organisms described in
                                               Respondents: Public and private                      § 340.0    Scope and general restrictions.            paragraph (a) of this section. These
                                            biotechnology research facilities, GE                      (a) In order to prevent the                        permits may include such requirements
                                            crop and seed producers, food                           unauthorized introduction or                          or conditions as the Administrator
                                            processors, grain processors, and paper                 dissemination of a plant pest or noxious              deems necessary to prevent the
                                            producers that fall into various                        weed, no person shall import, move                    unauthorized introduction or
                                            categories of the North American                        interstate, or release into the                       dissemination of a plant pest or noxious
                                            Industry Classification System.                         environment genetically engineered                    weed. The Administrator may also
                                               Estimated annual number of                           organisms described in paragraph (b) of               designate certain exemptions from the
                                            respondents: 160.                                       this section, unless the importation,                 requirement to obtain permits. The
                                               Estimated annual number of                           interstate movement, or release into the              Administrator may also approve for
                                            responses per respondent: 2.                                                                                  nonregulated status a genetically
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                                                                                                    environment:
                                               Estimated annual number of                              (1) Is authorized under a permit                   engineered organism described in
                                            responses: 320.                                         issued by the Administrator in                        paragraph (a) of this section for which
                                               Estimated total annual burden on                     accordance with § 340.2, or                           a determination has been made by the
                                            respondents: 640 hours.                                    (2) Is exempt from the requirements                Administrator that the organism is
                                               Copies of this information collection                for a permit in accordance with § 340.4               unlikely to be a plant pest or noxious
                                            can be obtained from Celeste Sickles,                   or § 340.5, or                                        weed.


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                                                                  Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules                                            60039

                                              (d) Genetically engineered                            of organisms described in § 340.0(a) is               cultures, pollen, shrubs, vines, cuttings,
                                            microorganisms that are regulated as                    not subject to the requirement to have                grafts, scions, buds, bulbs, roots, and
                                            biological control organisms under the                  a permit under this part. An exemption                seeds.
                                            Federal Insecticide, Fungicide, and                     from one type of permit (e.g., interstate                Plant pest. Any living stage of any of
                                            Rodenticide Act are not subject to the                  movement) does not remove remaining                   the following that can directly or
                                            regulations in this part. Genetically                   obligations to obtain other permits                   indirectly injure, cause damage to, or
                                            engineered microorganisms where the                     under this part.                                      cause disease in any plant or plant
                                            recipient microorganism is not a plant                     Genetic engineering. The genetic                   product: A protozoan, a nonhuman
                                            pest and which has resulted from the                    modification of organisms by                          animal, a parasitic plant, a bacterium, a
                                            addition of genetic material from a                     recombinant DNA techniques.                           fungus, a virus or viroid, an infectious
                                            donor organism where the material is                       Genetically engineered, GE. A term                 agent or other pathogen, or any other
                                            well characterized and contains only                    applied to organisms that have been                   living stage similar to or allied with any
                                            non-coding regulatory regions are not                   produced by genetic engineering, e.g.,                of these organisms.
                                            subject to the regulations in this part.                GE organisms, GE plants.                                 Plant product. Any flower, fruit,
                                                                                                       Import and importation. To move                    vegetable, root, bulb, seed, or other
                                            § 340.1   Definitions.                                  into, or the act of movement into, the                plant part that is not included in the
                                               Terms used in the singular form in                   territorial limits of the United States.              definition of plant; or any manufactured
                                            this part shall be construed as the                        Inspector. Any employee of the                     or processed plant or plant part.
                                            plural, and vice versa, as the case may                 Animal and Plant Health Inspection                       Recipient organism. The organism
                                            demand. The following terms, when                       Service, U.S. Department of Agriculture,              that will receive the genetic material
                                            used in this part, shall be construed,                  or other person, authorized by the                    from a donor organism in the process of
                                            respectively, to mean:                                  Administrator, in accordance with law                 genetic engineering (once the organism
                                               Administrator. The Administrator of                  to enforce the provisions of this part.               is engineered it is referred to as the
                                            the Animal and Plant Health Inspection                     Interstate movement. Movement from                 genetically engineered (GE) organism).
                                            Service (APHIS) or any other employee                   any State into or through any other                      Release into the environment.
                                            of APHIS to whom authority has been,                    State.                                                Dispersal beyond the constraints of a
                                            or may be, delegated to act in the                         Means of conveyance. Any personal                  contained facility or secure shipment.
                                            Administrator’s stead.                                  property used for, or intended for use                Synonymous with the term
                                               Animal and Plant Health Inspection                   for, the movement of any other personal               environmental release.
                                            Service (APHIS). An agency of the                       property. This specifically includes, but                Responsible person. The person who
                                            United States Department of                             is not limited to, automobiles, trucks,               has control and will maintain control
                                            Agriculture.                                            railway cars, aircraft, boats, freight                over a GE organism during its
                                               Confidential business information,                   containers, and other means of                        importation, interstate movement, or
                                            CBI. Information such as trade secrets or               transportation.                                       release into the environment and
                                            commercial or financial information                        Nonregulated status. A determination               assures compliance with all conditions
                                            that may be exempt from disclosure                      by the Administrator that an organism                 contained in any applicable permit or
                                            under Exemption 4 of the Freedom of                     described in § 340.0(a) is not subject to             exemption as well as other requirements
                                            Information Act (FOIA), because                         any of the regulatory requirements of                 in this part. A responsible person shall
                                            disclosure could reasonably be expected                 this part.                                            be at least 18 years of age and be a legal
                                            to cause substantial competitive harm.                     Noxious weed. Any plant or plant                   resident of the United States or
                                            USDA regulations on how the agency                      product that can directly or indirectly               designate an agent who is at least 18
                                            will handle CBI and how to determine                    injure or cause damage to crops                       years of age and a legal resident of the
                                            what information may be exempt from                     (including nursery stock or plant                     United States.
                                            disclosure under FOIA (5 U.S.C. 552)                    products), livestock, poultry, or other                  Secure shipment. Shipment in a
                                            are found at 7 CFR 1.12.                                interests of agriculture, irrigation,                 container or a means of conveyance of
                                               Contained facility, contained                        navigation, the natural resources of the              sufficient strength and integrity to
                                            structure. A physical structure designed                United States, the public health, or the              withstand leakage of contents, shocks,
                                            to minimize release into the outdoor                    environment.                                          pressure changes, and other conditions
                                            environment. Examples of contained                         Organism. Any active, infective, or                incident to ordinary handling in
                                            structures include, but are not limited                 dormant stage or life form of an entity               transportation.
                                            to, laboratories, containment                           characterized as living, including                       Signature, signed. The discrete,
                                            greenhouses, bioreactors, and                           vertebrate and invertebrate animals,                  verifiable symbol of an individual
                                            fermenters.                                             plants, bacteria, fungi, mycoplasmas,                 which, when affixed to a writing with
                                               Contingency plan. A written plan                     mycoplasma-like organisms, as well as                 the knowledge and consent of the
                                            stating how the responsible person will                 entities such as viroids, viruses, or any             individual, indicates a present intention
                                            respond in the event of the                             entity characterized as living, related to            to authenticate the writing. This
                                            unauthorized environmental release of                   the foregoing.                                        includes electronic signatures when
                                            GE organisms.                                              Permit. A written authorization by the             authorized by the Administrator.
                                               Donor organism. The organism from                    Administrator for the importation,                       State. Any State of the United States,
                                            which genetic material is obtained for                  interstate movement, and/or release into              the District of Columbia, American
                                            transfer to the recipient organism in the               the environment of a GE organism under                Samoa, Guam, Northern Mariana
                                            process of genetic engineering.                         this part.                                            Islands, Puerto Rico, the Virgin Islands
                                               Environmental release. See definition                   Person. Any individual, partnership,               of the United States, and any other
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                                            of Release into the environment.                        corporation, company, joint venture,                  Territories, Possessions, or Districts of
                                               Exempt, exempted, exemption from                     society, association, or other legal                  the United States.
                                            permit. A determination by the                          entity.                                                  State or tribal regulatory official. State
                                            Administrator that the importation,                        Plant. Any plant (including any plant              or tribal official with responsibilities for
                                            interstate movement, and/or release into                part) for or capable of propagation,                  plant health, or any other duly
                                            the environment of an organism or class                 including trees, tissue cultures, plantlet            designated State or tribal official, in the


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                                            60040                 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules

                                            State or on the tribal lands where the                  administrative categories described in                not limited to detailed information on
                                            importation, interstate movement, or                    paragraph (d) of this section. Applicants             how this training will facilitate
                                            release into the environment is to take                 should consult with APHIS prior to                    compliance with conditions imposed
                                            place.                                                  applying for permits in order to obtain               under the permit and any other
                                              United States. All of the States.                     further guidance as to what additional                regulatory requirements under this part;
                                              Write, writing, written. Any document                 information the Administrator may                     and
                                            or communication required by this part                  require to be submitted with the                         (vii) A certification statement signed
                                            to be in writing may also be provided                   application.                                          by the responsible person that certifies
                                            by electronic communication when                           (1) Information required in all permit             that the application information is
                                            authorized by the Administrator.                        applications. Each application must                   correct.
                                                                                                    include all of the following information,                (2) Additional information required in
                                            § 340.2   Procedure for permits.
                                                                                                    and any other information specified for               all applications for importation permits,
                                              (a) General. A permit is required for                 individual types of permits as described              interstate movement permits, and all
                                            the importation, interstate movement, or                in this paragraph:                                    environmental release permits that
                                            release into the environment of any GE                     (i) The name, title, and contact                   include importation or interstate
                                            organism that is subject to this part, as               information (e.g., mailing address, e-                movement.
                                            described in § 340.0, The responsible                   mail, telephone and fax numbers) of the                  (i) The location(s) of the origin(s) and
                                            person seeking a permit for the                         responsible person;                                   destination(s), including information on
                                            importation, interstate movement, or                       (ii) The type of permit sought                     the addresses, and contact details of the
                                            release into the environment of such                    (importation, interstate movement, or                 sender(s) and recipient(s), if different
                                            organisms shall submit a written                        environmental release, and if the permit              from the responsible person.
                                            application for a permit to APHIS in                    is for environmental release, which                      (ii) A description of the method of
                                            accordance with paragraph (c) of this                   category);                                            secure shipment.
                                            section and obtain the permit prior to                     (iii) Information necessary to identify               (iii) A description of the manner in
                                            the importation, interstate movement, or                and characterize the GE organism(s) for               which packaging material, shipping
                                            release into the environment.                           which a permit is sought, including:                  containers, and any other material
                                              (b) Types of permits. The                                (A) The scientific names of all donor              accompanying the GE organism will be
                                            Administrator may issue the following                   and recipient species plus any                        disposed.
                                            three types of permits under this part.                 designations used for the GE                             (3) Additional information required in
                                              (1) Import permit. Import permits are                 organism(s) (e.g., strain, line, variety);            all environmental release permit
                                            for secure shipment via any means of                       (B) The form of the GE organism (e.g.,             applications. Information should
                                            conveyance from outside the United                      seeds, rootstocks, tubers, spores, larvae,            address the persistence risk and
                                            States into contained facilities within                 eggs) and the amount (e.g., numbers,                  potential harm of the GE organism in
                                            the United States.                                      total weight or volume); and a                        the environment, including but not
                                              (2) Interstate movement permit.                       description of any biological material                limited to:
                                            Interstate movement permits are for                     accompanying the GE organism under                       (i) A description of how the
                                            secure shipment via any means of                        permit (e.g., culture medium, or host                 phenotype of the GE organism differs
                                            conveyance from a contained facility in                 organisms, etc.);                                     from the phenotype of the recipient
                                            any State into or through any other State                  (C) The anticipated phenotype of the               organism, particularly with respect to
                                            to another contained facility.                          GE organism and the nature of the                     potential interactions with and its
                                              (3) Environmental release permit.                     inserted sequences or other genetic                   likelihood of persistence in the
                                            Environmental release permits are for                   modification intended to confer the                   environment.
                                            the environmental release of GE                         phenotype;                                               (ii) The location and size of all
                                            organisms. In cases in which                               (D) Intended uses of the GE organism               proposed release sites, including area,
                                            importation and interstate movements                    after the termination of the importation,             geographic coordinates, addresses, and
                                            will occur incidental to an                             interstate movement, or environmental                 contact information of a person at each
                                            environmental release, the importation                  release (e.g., contained research in                  release site, if different from the
                                            and interstate movements will also be                   laboratories or containment                           responsible person. Include information
                                            authorized under the environmental                      greenhouses, culturing, propagation,                  about the ecology and agronomy of each
                                            release permit.                                         breeding, processing for analysis or                  site, including but not limited to:
                                              (c) Permit application information                    manufacture, sale and distribution for                   (A) Presence of any wild or cultivated
                                            requirements. Applicants must submit                    consumption); and                                     species that are sexually compatible
                                            to APHIS sufficient information about                      (E) Description of how the GE                      with the GE organism;
                                            the specific nature of the GE organism                  organism will be marked, labeled, or                     (B) Presence of any Federally-listed
                                            and the particular proposed permit                      otherwise identified during the                       threatened or endangered species that
                                            conditions, so that the Administrator is                importation, interstate movement, or                  could interact with the GE organism
                                            able to consider whether the proposed                   environmental release;                                during the release;
                                            importation, interstate movement, or                       (iv) The proposed time frame                          (C) Presence of any designated critical
                                            release into the environment is likely to               (estimated start and duration) within                 habitat, or habitat proposed for
                                            result in the introduction or                           which the importation(s), interstate                  designation, in the area of the release
                                            dissemination of a plant pest or noxious                movement(s) or environmental                          site; and
                                            weed. The basic information required in                 release(s) will occur;                                   (D) Land use history of the site and
                                            permit applications is described in this                   (v) Description of how permit                      adjacent areas.
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                                            paragraph. The type and level of detail                 requirements will be communicated to                     (iii) A description of the site
                                            needed for the Administrator to issue a                 persons having contact with the GE                    management practices and control
                                            permit may vary by type of permit. For                  organism under permit;                                procedures designed to make it unlikely
                                            environmental releases, application                        (vi) Description of any training given             that there will be unauthorized
                                            information will be used to sort                        to persons having contact with the GE                 introduction or dissemination of the GE
                                            proposed releases of GE organisms into                  organism under permit, including but                  organism beyond the proposed area and


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                                                                            Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules                                                                       60041

                                            the permit time frame of release. Each                                       opportunity, without prejudice, to                                   ability to colonize and persist in the
                                            of the descriptions shall include:                                           revise the application information to                                environment without human
                                               (A) Description of the methods and                                        meet the needs for administrative                                    intervention.
                                            stages of transport of the GE organism                                       processing and scientific review. Once                                  (B) Potential harm or damage of the
                                            from a contained facility to the                                             the Administrator has determined that                                engineered traits, ranked as follows:
                                            environmental release site, and any                                          an application is complete, the                                         (1) Low: Any new proteins or
                                            storage methods used at the site;                                            Administrator will commence review.                                  substances produced are unlikely to be
                                               (B) Description of methods of                                             The APHIS review should generally be                                 toxic or otherwise cause serious harm to
                                            planting, inoculation, or release; any                                       completed within 60 days after it is                                 humans, vertebrate animals, or
                                            reproductive or cultural controls;                                           determined to be complete for                                        invertebrate organisms upon
                                            methods of treatment and harvest used                                        importation and interstate movement                                  consumption of or contact with the
                                            for the GE organism; and a proposed                                          permits, and within 120 days after it is                             plant or plant parts; and
                                            plan for monitoring the site for pests,                                      determined to be complete for
                                            diseases, and effects on other organisms                                                                                                             (i) No morphological changes which
                                                                                                                         environmental release permits.                                       could cause mechanical injury or
                                            during the time the GE organism is                                              (1) Administrative categories for
                                            released;                                                                                                                                         damage; and
                                                                                                                         environmental releases. The
                                               (C) Description of the methods and                                        Administrator will use the following                                    (ii) Introduced sequences are known
                                            stages of transport of the GE organism                                       categories to efficiently administer the                             not to result in plant disease, and
                                            from release site back into contained                                        program and tailor regulatory oversight                              confers no or very low increased disease
                                            facilities, or methods of devitalization at                                  in a manner that is commensurate with                                susceptibility.
                                            the site(s) of the environmental release;                                    risk. Environmental releases of GE                                      (2) Moderate: Any new proteins or
                                               (D) Description of the cleaning,                                          plants are assigned to one of four                                   substances produced are unlikely to be
                                            disinfection, or other methods used to                                       categories (A–D), using the factors                                  toxic or otherwise cause serious harm to
                                            make it unlikely that unauthorized                                           described in (i–iv). A fifth category (E)                            humans or vertebrate animals upon
                                            dissemination of the GE organism into                                        is for environmental releases of all non-                            consumption of or contact with the
                                            the environment could occur via means                                        plant organisms; applications in this                                plant or plant; or
                                            of conveyance and other articles (e.g.,                                      category will be reviewed on a case-by-                                 (i) Novel resistance to the application
                                            planters, harvesters, containers);                                           case basis.                                                          of an herbicide; or
                                               (E) Description of any post-release                                          (i) Initial sorting into categories. The                             (ii) Novel ability to cause mechanical
                                            land use practices, including any                                            Administrator will use the following                                 injury or damage; or
                                            monitoring plans to ensure that the GE                                       factors to initially sort environmental                                 (iii) Produces proteins or substances
                                            organism or its progeny are unlikely to                                      releases into administrative categories.                             that are associated with plant disease
                                            reproduce and disseminate in the                                                (A) Persistence of the nonmodified                                that are not prevalent or endemic in the
                                            environment after the termination of the                                     plant, ranked as follows:                                            area of release, or that confer an
                                            release (e.g., managing volunteer                                               (1) Low: Populations of the recipient                             increased susceptibility to disease.
                                            plants); and                                                                 plant are unlikely to persist in the
                                               (F) Description of the contingency                                                                                                                (3) High: Any new proteins or
                                                                                                                         environment without human                                            substances produced may be toxic or to
                                            plans associated with the release.                                           intervention, and the recipient plant has
                                               (d) Administrator action on permit                                                                                                             otherwise cause serious harm to humans
                                                                                                                         no interfertile wild relatives in the                                or vertebrate animals, upon
                                            applications. An initial review should                                       United States.
                                            generally be completed by APHIS                                                                                                                   consumption of or contact with the
                                                                                                                            (2) Moderate: Populations of the
                                            within 15 days of the receipt of the                                                                                                              plant or plant parts; or
                                                                                                                         recipient plant are known to be weakly
                                            application for importation or interstate                                    persistent in the environment without                                   (i) Produces an infectious entity
                                            movement permits, and within 30 days                                         human intervention, or the recipient                                 which can cause disease in plants.
                                            for environmental release permits. An                                        plant has interfertile wild relatives in                                (4) Severe: Any new proteins or
                                            application will be considered complete                                      the United States.                                                   substances produced are known or
                                            when the Administrator determines that                                          (3) High: Populations of the recipient                            likely to be highly toxic or fatal to
                                            it includes all information required by                                      plant are known to be strongly                                       humans or vertebrate animals, upon
                                            this section and any additional                                              persistent in the environment without                                consumption of or contact with the
                                            information that the Administrator                                           human intervention, or the recipient                                 plant or plant parts.
                                            determines is needed for review. If                                          plant has interfertile wild relatives in                                (C) Environmental releases will be
                                            necessary after its initial evaluation of                                    the United States which are aggressive                               initially sorted into administrative
                                            an application, APHIS will notify the                                        colonizers.                                                          categories A–D as shown in Table 1,
                                            applicant in writing if the submitted                                           (4) Severe: The recipient plant is a                              based upon the persistence risk and
                                            application information is incomplete,                                       Federally-listed noxious weed or is                                  potential harm described in paragraphs
                                            and the applicant will be provided the                                       known to be similarly aggressive in its                              (d)(1)(i)(A) and (B) of this section.

                                             TABLE 1 TO § 340.2(d)(1)—INITIAL SORTING INTO PERMIT ADMINISTRATIVE CATEGORIES (A, B, C, AND D) FOR ENVIRON-
                                                MENTAL RELEASES OF GE PLANTS, BASED UPON PERSISTENCE RISK OF THE RECIPIENT PLANT SPECIES AND POTEN-
                                                TIAL HARM OR DAMAGE OF THE ENGINEERED TRAIT

                                                                                                                                                                                         Potential harm or damage of engineered trait
                                                                                                     Persistence *
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                                                                                                                                                                                        Low           Moderate      High         Severe

                                            Low ..................................................................................................................................       A               A            C             D
                                            Moderate ..........................................................................................................................          A               B            C             D
                                            High ..................................................................................................................................      B               B            C             D




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                                            60042                          Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules

                                             TABLE 1 TO § 340.2(d)(1)—INITIAL SORTING INTO PERMIT ADMINISTRATIVE CATEGORIES (A, B, C, AND D) FOR ENVIRON-
                                                MENTAL RELEASES OF GE PLANTS, BASED UPON PERSISTENCE RISK OF THE RECIPIENT PLANT SPECIES AND POTEN-
                                                TIAL HARM OR DAMAGE OF THE ENGINEERED TRAIT—Continued

                                                                                                                                                                                       Potential harm or damage of engineered trait
                                                                                                    Persistence *
                                                                                                                                                                                      Low           Moderate      High         Severe

                                            Severe ..............................................................................................................................      D               D            D             D
                                               * Persistence risk of the recipient plant species.


                                               (2) Modification of initial sorting                                      Administrator, that the responsible                                    (ii) The Administrator determines that
                                            based upon additional considerations.                                       person and all agents of the responsible                            the responsible person or any agent of
                                            Following initial sorting using the                                         person will comply with the permit                                  the responsible person has failed to
                                            factors described in paragraph (1)(i) of                                    conditions. The Administrator will deny                             comply at any time with any provision
                                            this section, the Administrator may                                         the permit application if the responsible                           of this part. This would include failure
                                            reassign the environmental release to a                                     person does not agree that both the                                 to comply with the conditions of any
                                            different category based upon one or                                        responsible person and all of his or her                            permit issued.
                                            more of the following factors:                                              agents will comply with all of the                                     (f) Notice of revocation. The
                                               (i) How the recipient plant is used;                                     permit conditions.                                                  Administrator may revoke, either orally
                                               (ii) Whether the added trait                                                (ii) If a permit is issued, the permit                           or in writing, any permit which has
                                            significantly alters the persistence risk                                   will include specific permit conditions                             been issued. If the revocation is oral, the
                                            of the GE plant;                                                            required by the Administrator in                                    Administrator will communicate the
                                               (iii) Whether the gene function is                                       accordance with § 340.3. If a permit is                             revocation and the reasons for it in
                                            known and based upon empirical                                              denied, within a reasonable time                                    writing as promptly as circumstances
                                            observation of the added trait in the                                       thereafter the applicant will be informed                           allow.
                                            same species; and                                                           in writing of the reasons why the permit                               (g) Appeal of denial or revocation of
                                               (iv) Any other information the                                           was denied and will be given the                                    permit. Any person who has been
                                            Administrator deems relevant to the risk                                    opportunity to appeal the denial in                                 denied a permit or had a permit revoked
                                            of introduction or dissemination of a                                       accordance with the provisions of                                   may appeal the decision in writing to
                                            plant pest or noxious weed.                                                 paragraph (g) of this section.                                      the Administrator within ten days after
                                               (3) APHIS review and assignment of                                          (e) Denial or revocation of a permit.                            receiving the written notification of the
                                            permit conditions. The Administrator                                        Permits may be denied or revoked in                                 revocation or denial. The appeal shall
                                            will conduct a review and assign                                            accordance with this paragraph.                                     state all of the facts and reasons upon
                                            appropriate permit conditions so that                                          (1) Denial. The Administrator may                                which the person relies to assert that the
                                            the proposed activity will be conducted                                     deny an application for a permit if:                                permit was wrongfully revoked or
                                            in a manner that makes it unlikely to                                          (i) The Administrator cannot                                     denied. The Administrator will grant or
                                            result in the introduction and                                              conclude based on the application that                              deny the appeal, in writing, stating the
                                            dissemination of a plant pest or noxious                                    the actions proposed under the permit                               reasons for the decision as promptly as
                                            weed.                                                                       are unlikely to result in introduction or                           circumstances allow. Upon request of
                                               (4) State or tribal review and                                           dissemination of a plant pest or noxious                            the applicant, a hearing may be held to
                                            comment. The Administrator will                                             weed; or                                                            resolve any conflict as to any material
                                            submit for notice and review a copy of                                         (ii) The Administrator receives                                  fact. Rules of practice concerning such
                                            the permit application and any permit                                       information apart from the application                              a hearing will be adopted by the
                                            conditions to the appropriate state or                                      that precludes a conclusion by the                                  Administrator. This administrative
                                            tribal regulatory official. Comments                                        Administrator that the actions proposed                             remedy must be exhausted before a
                                            received from the state or tribal                                           under the permit would be unlikely to                               person can file suit in court challenging
                                            regulatory official may be considered by                                    result in the introduction or                                       the denial or revocation of a permit.
                                            the Administrator prior to permit                                           dissemination of a plant pest or noxious                               (h) Amendment or transfer of permits.
                                            issuance.                                                                   weed; or                                                            Permits issued under this part may only
                                               (5) Site inspection. Prior to and after                                     (iii) The Administrator determines                               be amended or transferred in
                                            permit issuance, an inspector may                                           that the responsible person or any agent                            accordance with this section.
                                            inspect the sites or the means of                                           of the responsible person has failed to                                (1) Amendment at responsible
                                            conveyance associated with the                                              comply at any time with any provision                               person’s request. Where circumstances
                                            proposed importation, interstate                                            of this part. This would include failure                            have changed so that a responsible
                                            movement, or release into the                                               to comply with the conditions of any                                person desires to have the permit
                                            environment. The responsible person                                         permit issued.                                                      amended, such responsible person must
                                            must allow any such inspections.                                               (2) Revocation. The Administrator                                submit a written justification and
                                               (6) Issuance of a permit. The                                            may revoke a permit if:                                             provide supporting information to
                                            Administrator may issue a permit if the                                        (i) The Administrator receives                                   APHIS. The Administrator will review
                                            Administrator concludes that the                                            information subsequent to issuing a                                 the amendment request, and may amend
                                            actions allowed under the permit are                                        permit and makes a determination based                              the permit. Prior to issuance of an
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                                            unlikely to result in the introduction or                                   upon this information that the                                      amended permit, the responsible person
                                            dissemination of a plant pest or noxious                                    circumstances have changed such that                                must agree in writing that he or she and
                                            weed.                                                                       actions under the permit would be                                   all of his or her agents will comply with
                                               (i) Prior to the issuance of a permit,                                   likely to result in the introduction or                             the amended permit and conditions.
                                            the responsible person must agree in                                        dissemination of a plant pest or noxious                               (2) Amendment initiated by APHIS.
                                            writing, in a manner prescribed by the                                      weed; or                                                            The Administrator may amend any


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                                                                  Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules                                          60043

                                            permit and its conditions at any time,                  the GE organism, keep it distinct from                and any other material accompanying
                                            upon determining that the amendment                     other organisms, and minimize                         the GE organism in such a manner as to
                                            is needed to make it unlikely that                      unintended mixing of the GE organism                  make it unlikely to result in the
                                            actions under the permit would result in                with other organisms. Conditions for                  organism’s unauthorized importation,
                                            the introduction or dissemination of a                  maintaining the identity of the GE                    interstate movement, or release into the
                                            plant pest or noxious weed, or to ensure                organism include, but are not limited to:             environment.
                                            that the permit is in compliance with all                  (A) Marking, labeling, or otherwise                  (ii) Records. In addition to any other
                                            of the requirements of this part. As soon               identifying all GE organisms during the               records required by this section or
                                            as circumstances allow, the                             course of the permit; and                             § 340.7(b), the following records shall be
                                            Administrator will notify the                              (B) Having the ability to account for              maintained:
                                            responsible person in writing of the                    all GE materials associated with the                    (A) Information identifying the
                                            amendment to the permit and the                         permit.                                               general nature and quantity of the
                                            reason(s) for it. The responsible person                   (ii) Communication and training. The               organism being shipped;
                                            must agree in writing to comply with                    responsible person shall effectively                    (B) Name and address of sender,
                                            the permit and conditions as amended                    communicate any and all conditions,                   owner, or person shipping the organism;
                                            before the Administrator will issue the                 activities, actions, and contingency                    (C) Name, address, and telephone
                                            amended permit. If the responsible                      plans associated with the permit to all               number of recipient;
                                            person does not agree in writing to                     his or her agents and any other persons                 (D) Any invoices, packing lists, or
                                            comply with the amended permit and                      participating in permit-related activities,           bills of lading used for the shipment;
                                            conditions, the existing permit will be                 in order to ensure all persons comply                   (E) The shipper’s name and
                                            revoked.                                                with all requirements under this part.                identifying shipper’s mark and number;
                                               (3) Transfer of permits. Permits issued              Conditions for communicating and                      and
                                            through this part may only be                           training include, but are not limited to:               (F) A description of any containers
                                            transferred by the Administrator in                        (A) Establishing, implementing, and                that were used to transport the GE
                                            response to a request by both the                       maintaining the means to effectively                  organisms, and a copy of any label used
                                            responsible person and the proposed                     communicate to all his or her agents and              on these containers during transport.
                                            transferee, or in the case of a deceased                any other persons participating in                      (3) Additional permit conditions for
                                            responsible person, the deceased                        permit-related activities;                            import permits, and environmental
                                            responsible person’s legal representative                  (B) Providing a copy of the permit and             release permits which include
                                            and the proposed transferee. Such                       conditions to all agents involved in a                importation.
                                            transfer may occur if the Administrator                 permit; and                                             (i) Port(s) of Entry. The GE organism
                                            determines that:                                           (C) Training all agents and any other              shall be presented for entry only at a
                                               (i) The proposed transferee meets all                persons participating in permit-related               port(s) specified in the permit.
                                            of the qualifications of a responsible                  activities to effectively conduct tasks                 (ii) Records. In addition to any other
                                            person under this part;                                 required under the permit.                            records required by this section or
                                               (ii) The proposed transferee has                        (iii) Records. In addition to any other            § 340.7(b), the responsible person shall
                                            provided adequate written assurances to                 records required by this section or                   maintain records that identify the
                                            the Administrator that the proposed                     § 340.7(b), records, related to permitted             country and locality where the GE
                                            transferee and all of his or her agents                 activities of sufficient quality and                  organism was collected, developed,
                                            will meet the terms and conditions of                   completeness to demonstrate                           manufactured, reared, cultivated or
                                            the permit, including any outstanding                   compliance with all permit conditions                 cultured.
                                            mitigation requirements or                              and requirements under this part, must                  (4) Additional permit conditions for
                                            commitments under this part, and that                   be maintained.                                        environmental release permits.
                                            the proposed transferee agrees to                          (iv) Notice. The responsible person                  (i) Environmental release controls.
                                            assume all responsibility and liability                 shall notify APHIS orally within 24                   Sufficient controls shall be applied
                                            associated with permit activities and                   hours of discovery, and subsequently in               during the environmental release of the
                                            responsibilities; and                                   writing within 5 business days of                     GE organism to make it unlikely to
                                               (iii) The proposed transferee has                    discovery, in the event of an                         result in the unauthorized release of the
                                            provided such other information as the                  unauthorized importation, interstate                  GE organism into the environment.
                                            Administrator determines is necessary                   movement, or release into the                         Conditions include, but are not limited
                                            to the processing of the request for                    environment of a GE organism regulated                to:
                                            transfer of permit.                                     under this part.                                        (A) Taking adequate precautions as
                                                                                                       (2) Additional permit conditions for               described in the permit to ensure that
                                            § 340.3   Permit conditions.                            interstate movement permits,                          the GE organism is not inadvertently
                                              (a) Core permit conditions. Permits                   importation permits, and environmental                released in transit between contained
                                            will be issued with the permit                          release permits which include either an               facilities and the location of
                                            conditions below, which are a minimum                   interstate movement or importation.                   environmental release;
                                            set of basic conditions. The                               (i) Shipment. The GE organism must                   (B) Developing and being prepared to
                                            Administrator may add additional or                     be transported in such a way as to                    implement a written contingency plan
                                            expanded conditions when necessary to                   minimize the likelihood of the                        to respond to any unauthorized
                                            make it unlikely that actions under the                 unauthorized release of the GE                        environmental release;
                                            permit would result in the introduction                 organism. Conditions include, but are                   (C) Following any and all required
                                                                                                                                                          reproductive, cultural, spatial, and
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                                            or dissemination of a plant pest or                     not limited to:
                                            noxious weed.                                              (A) Ensuring that the GE organism is               temporal controls, such as isolation
                                              (1) Permit conditions for all permit                  transported in such a way that it is a                distances, buffer zones, and flower
                                            types.                                                  secure shipment, as defined in § 340.1;               removal, as described in the permit, and
                                              (i) Identity. The identity of the GE                  and                                                   monitor to ensure that the controls are
                                            organism shall be maintained at all                        (B) Treating or disposing of all                   maintained throughout the duration of
                                            times, in order to maintain control of                  packaging material, shipping containers,              the release;


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                                            60044                 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules

                                               (D) Cleaning equipment used in the                   for subsequent planned releases to be                    (ii) Do not cause the production of an
                                            environmental release in order to                       done under this permit.                               infectious entity;
                                            remove or devitalize any viable GE                         (E) The responsible person shall                      (iii) Are not carried on an expression
                                            organism the equipment may carry, as                    provide APHIS with a final report that                vector if the cloned genes code for:
                                            described in the permit;                                includes information related to any                      (A) A toxin to plants or plant
                                               (E) Devitalizing or moving into a                    occurrences during the release that                   products, or a toxin to organisms
                                            contained facility any viable GE                        might result in the dissemination of a                beneficial to plants; or
                                            material remaining at the termination of                plant pest or noxious weed.                              (B) Other factors directly involved in
                                            the environmental release, when                            (F) For categories C and D, permit                 eliciting plant disease (e.g., cell wall
                                            applicable, as described in the permit;                 holders shall provide APHIS with                      degrading enzymes; or
                                            and                                                     written notice no less than seven days                   (C) Substances acting as, or inhibitory
                                               (F) Managing and monitoring the area                 prior to the planned initiation of the                to, plant growth regulators.
                                            of release after the termination of the                 release.                                                 (2) Arabidopsis thaliana provided that
                                            environmental release and removing or                      (G) For categories C and D, permit                 the introduced genetic sequences:
                                            devitalizing any GE organisms which                     holders shall provide APHIS with a                       (i) Do not cause the production of an
                                            persist after the release, as required in               report no less than 21 days prior to                  infectious entity;
                                            the permit.                                             release termination (e.g., harvest of GE                 (ii) Are not derived from an animal or
                                               (ii) Records. In addition to any other               plants) that describes the anticipated                human pathogen;
                                            records required by this section or                     date(s) of termination.                                  (iii) Do not encode products that are
                                            § 340.7(b), the following records shall be                 (b) Standard for additional permit                 toxic to vertebrates;
                                            maintained for each release:                            conditions assigned by Administrator.                    (iv) Do not encode products known to
                                               (A) All protocols or guidelines used to              The Administrator will assign the                     or likely to be causal agents of disease
                                            direct any environmental release of the                 permit conditions described above in a                in vertebrates; and
                                            GE organism; and                                        manner that is commensurate with the                     (v) Do not encode products intended
                                               (B) All environmental release reports                risk of the individual proposed release.              for pharmaceutical or industrial use.
                                            for the organism. At a minimum such                     Additional or expanded permit                            (c) Shipping conditions. Organisms
                                            reports must include the APHIS                          conditions may include, but are not                   that meet the criteria described in
                                            reference number for the environmental                  limited to specific requirements for:                 paragraph (b) of this section must be
                                            release, methods of observation used                    Reproductive, cultural, spatial, temporal             shipped as follows:
                                            during the environmental release,                       controls; monitoring; post-termination                   (i) The container and means of
                                            resulting information, and analysis                     land use; site security or access                     conveyance must provide secure
                                            regarding all deleterious effects on                    restrictions; and management practices                shipment to make it unlikely that the
                                            plants, nontarget organisms, or the                     such as training of personnel involved                introduction or dissemination of the
                                            environment, and any notices sent to                    in the release. The Administrator may                 organisms will occur while in transit.
                                            APHIS of any unusual occurrence                         also assign permit conditions addressing                 (ii) The container must contain a
                                            during the environmental release.                       nonliving materials associated with or                document which includes the following
                                               (iii) Reports and Notices. In order for              derived from GE plants when such                      written information:
                                            the Administrator to monitor the                                                                                 (A) Names and contact details for the
                                                                                                    conditions are needed to make it
                                            progress of the environmental release,                                                                        sender and recipient, and
                                                                                                    unlikely that the nonliving materials
                                            and to evaluate compliance with                                                                                  (B) A statement that the contents are
                                                                                                    would pose a noxious weed risk.
                                            required permit conditions, permit                                                                            genetically engineered and are eligible
                                            conditions will include, but are not                    § 340.4 Conditional exemptions from the               for interstate movement without permit
                                            limited to:                                             requirement for a permit for interstate               under this part, but are not exempt from
                                               (A) The responsible person shall                     movement.                                             permit requirements under this part if
                                            submit periodic reports and notices to                     (a) General. Certain GE organisms                  the organism is imported or released
                                            APHIS at the times specified in the                     described in paragraph (b) of this                    into the environment;
                                            permit and containing the information                   section may be moved interstate without                  (iii) The responsible person shall
                                            specified within the permit; and                        a permit under this part, if they meet the            notify APHIS orally within 24 hours of
                                               (B) The responsible person shall                     shipping conditions enumerated in                     discovery, and subsequently in writing
                                            notify APHIS orally within 24 hours of                  paragraph (c).                                        within 5 business days of discovery, in
                                            discovery, and subsequently in writing                     (b) Conditional exemptions from the                the event of an unauthorized release
                                            within 5 business days of discovery, in                 requirement for a permit for interstate               into the environment of a GE organism
                                            the event that the GE organism is found                 movement of certain organisms. A                      regulated under this part.
                                            to have characteristics substantially                   permit for interstate movement will not                  (d) Revocation of an exemption from
                                            different from those listed in the permit               be required for the following genetically             requirement for permit. The
                                            or if any circumstances occur which                     engineered organisms provided that                    Administrator may revoke any existing
                                            may increase the risk of disseminating                  they meet the requirements of this                    conditional exemption. The
                                            a plant pest or noxious weed.                           paragraph and paragraph (c).                          Administrator may revoke a conditional
                                               (C) The responsible person shall                        (1) Escherichia coli genotype K–12                 exemption if the Administrator receives
                                            notify APHIS in writing if the                          (strain K–12 and its derivatives), sterile            information subsequent to approving
                                            authorized release will not be                          strains of Saccharomyces cerevisiae, or               the conditional exemption and makes a
                                            conducted.                                              asporogenic strains of Bacillus subtilis,             determination based upon this
                                               (D) Within 28 days after the initiation              provided that the introduced genetic                  information that the circumstances have
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                                            of the release, the responsible person                  sequences:                                            changed such that the conditional
                                            shall report to APHIS in writing the                       (i) Are maintained on a                            exemption is likely to result in the
                                            final release site coordinates; number of               nonconjugation proficient plasmid, and                introduction or dissemination of a plant
                                            GE organisms actually released; any                     the organism does not contain other                   pest or noxious weed. The revocation,
                                            information related to the expected                     conjugation proficient plasmids or                    its effective date, and the reasons for it
                                            date(s) and quantities of GE organisms                  generalized transducing phages;                       will be published in the Federal


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                                                                  Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules                                          60045

                                            Register. A revocation may not be                       unlikely to result in the introduction or             petitioner which is unfavorable to the
                                            appealed. However, any person may file                  dissemination of a plant pest or noxious              petition.
                                            a new petition in accordance with                       weed. The information shall include the                 (2) Insufficient information. If, upon
                                            § 340.5 regarding the same or similar                   following:                                            initial review of the petition, the
                                            organisms covered by the revocation if                    (i) Description of the biology of the               Administrator concludes that there is
                                            new information relevant to the                         organism prior to genetic engineering.                insufficient information upon which to
                                            revocation becomes available.                             (ii) Detailed description of the genetic            make a determination on the petition,
                                              (e) Revocation of a person’s use of a                 changes made to the organism.                         the petitioner will be sent a written
                                            conditional exemption from                                (iii) Detailed description of the                   notice indicating what additional
                                            requirement for permit. The                             phenotype of the GE organism,                         information may be required.
                                            Administrator may revoke the right of                   including known and potential                            (3) Public notice. The Administrator
                                            any person to use a conditional                         differences from the recipient organism               should generally complete the review of
                                            exemption from the requirement for a                    that could change the likelihood that the             the complete petition within 180 days,
                                            permit under this part after determining                GE organism will pose a risk as a plant               then publish a notice in the Federal
                                            that the person or any agent of the                     pest or noxious weed. Examples of                     Register of the availability of documents
                                            person has failed to comply at any time                 relevant information include, but are                 related to APHIS’ assessment of the
                                            with any provision of this part. This                   not limited to:                                       proposed conditional exemption. This
                                            would include failure to comply with                      (A) Growth habit and reproduction of                notice will specify that comments will
                                            the conditions of any permit or                         the GE organism;                                      be accepted from the public on the
                                            exemption.                                                (B) Potential host range or geographic              proposal.
                                              (1) Appeal of revocation of a person’s                                                                         (4) Petition approval or denial
                                                                                                    area of distribution;
                                            use of a conditional exemption. Any                                                                           standard. The Administrator will assess
                                                                                                      (C) Potential for other organisms to
                                            person who has had the right to use a                                                                         the GE organism and the conditions of
                                                                                                    pose risks as plant pests or noxious                  the requested exemption to determine
                                            conditional exemption revoked may                       weeds if they acquire the trait from the
                                            appeal the decision in writing to the                                                                         whether the requested exemption from
                                                                                                    GE organism (e.g. via sexual                          a permit for importation, interstate
                                            Administrator within ten days after                     reproduction, horizontal gene transfer);
                                            receiving the written notification of the                                                                     movement, or release into the
                                                                                                      (D) Susceptibility of the GE organism               environment would be unlikely to result
                                            revocation. The appeal shall state all of               to disease or damage by pests;
                                            the facts and reasons upon which the                                                                          in the introduction or dissemination of
                                                                                                      (E) Pathogenicity of the GE organism                a plant pest or noxious weed. The
                                            person relies to assert that the use of the             and/or ability of the GE organism to
                                            conditional exemption was wrongfully                                                                          Administrator will also consider
                                                                                                    cause damage or injury to plants or                   whether any conditions not contained
                                            revoked. The Administrator will grant                   plant parts;
                                            or deny the appeal, in writing, stating                                                                       in the petition would be needed to
                                                                                                      (F) Toxicity, allergenicity, and/or                 ensure that the requested exemption
                                            the reasons for the decision as promptly                ability of the GE organism to damage or
                                            as circumstances allow. Upon request of                                                                       would be unlikely to result in the
                                                                                                    injure other organisms;                               introduction or dissemination of a plant
                                            the applicant, a hearing may be held to                   (iv) A detailed description of
                                            resolve any conflict as to any material                                                                       pest or noxious weed. After completing
                                                                                                    proposed condition(s) to be associated                review of the available information and
                                            fact. Rules of practice concerning such                 with the exemption and how the
                                            a hearing will be adopted by the                                                                              any public comments received on it, the
                                                                                                    conditions would make the exemption                   Administrator will furnish to the
                                            Administrator. This administrative                      unlikely to result in the introduction or             petitioner and publish in the Federal
                                            remedy must be exhausted before a                       dissemination of a plant pest or noxious              Register one of the following responses:
                                            person can file suit in court challenging               weed.                                                    (i) Approve a conditional exemption
                                            the revocation.                                           (v) Any relevant experimental                       from requirement for a permit. The
                                            § 340.5 Petition for new conditional                    information, published references, or                 approval of a conditional exemption
                                            exemptions from the requirement for a                   scientific information which support the              from the requirement for a permit will
                                            permit.                                                 conclusions of the petition;                          state which GE organism(s) may be
                                              (a) General. Any person may petition                    (vi) All reports required under                     imported, moved interstate, and/or
                                            to initiate the procedure for establishing              § 340.3;                                              environmentally released without a
                                            a new conditional exemption from the                      (vi) Any information known to the                   permit under this part, as well as the
                                            requirement for a permit under                          petitioner that the GE organism may                   conditions relevant to the exemption.
                                            § 340.0(b)(1) of this part. The                         pose a risk as a plant pest or noxious                The Administrator may also add
                                            Administrator may initiate the                          weed;                                                 additional conditions not proposed in
                                            procedure without filing a petition. All                  (vii) Any other information that the                the petition, if the Administrator
                                            petitions and all actions by the                        Administrator believes to be relevant to              concludes that additional conditions are
                                            Administrator to establish a new                        a determination that the proposed                     needed to ensure that the conditional
                                            conditional exemption will be evaluated                 conditional exemption from the                        exemption would be unlikely to result
                                            according to the standards for petition                 requirement for a permit for the                      in the introduction or dissemination of
                                            approval or denial contained in                         importation, interstate movement, or                  a plant pest or noxious weed.
                                            paragraph (b)(4) of this section.                       release into the environment of the GE                   (ii) Deny a conditional exemption
                                              (b) Petition submission and                           organism is unlikely to result in the                 from requirement for a permit. The
                                            evaluation procedure. To petition for a                 introduction or dissemination of a plant              Administrator will deny a petition if the
                                            new conditional exemption from the                      pest or noxious weed.                                 Administrator cannot conclude that the
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                                            requirement for a permit under this part,                 (viii) A signed certification by the                proposed exemption would be unlikely
                                            a petitioner must submit a written                      petitioner that, to the best knowledge                to result in the introduction or
                                            petition to the Administrator.                          and belief of the petitioner, the petition            dissemination of a plant pest or noxious
                                              (1) The petition must contain                         includes all information on which to                  weed. The Administrator’s written
                                            information that supports a conclusion                  base a determination, and that it                     decision will set forth the reason for the
                                            that use of the conditional exemption is                includes all information known to the                 denial.


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                                            60046                 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules

                                               (c) Appeal of decision. Any person                   a new petition in accordance with this                  (ii) Detailed description of the genetic
                                            whose petition under § 340.5 has been                   section regarding the same or similar                 changes made to the organism.
                                            denied may appeal the decision in                       organisms covered by the revocation if                  (iii) Detailed description of the
                                            writing to the Administrator within ten                 new information relevant to the                       phenotype of the GE organism,
                                            days after receiving the written                        revocation becomes available.                         including known and potential
                                            notification of the decision. The appeal                  (f) Revocation of a person’s use of a               differences from the recipient organism
                                            shall state all of the facts and reasons                conditional exemption from                            that could change the likelihood that the
                                            upon which the person relies to show                    requirement for permit. The                           GE organism is unlikely to be a plant
                                            that the decision should be changed.                    Administrator may revoke the right of                 pest or noxious weed. Examples of
                                            The Administrator will grant or deny                    any person to use a conditional                       relevant information include, but are
                                            the appeal, in writing, stating the                     exemption from the requirement for a                  not limited to:
                                            reasons for the decision as promptly as                 permit under this part after determining                (A) Growth habit and reproduction of
                                            circumstances allow. Upon request of                    that the person or any agent of the                   the GE organism;
                                            the applicant, a hearing may be held to                 person has failed to comply at any time                 (B) Potential host range or geographic
                                            resolve any conflict as to any material                 with any provision of this part. This                 area of distribution;
                                            fact. Rules of practice concerning such                 would include failure to comply with                    (C) Potential for other organisms to
                                            a hearing will be adopted by the                        the conditions of any permit or                       pose risks as plant pests or noxious
                                            Administrator. This administrative                      exemption.                                            weeds if they acquire the trait from the
                                            remedy must be exhausted before a                         (1) Appeal of revocation of a person’s              GE organism (e.g. via sexual
                                            person can file suit in court challenging               use of a conditional exemption. Any                   reproduction, horizontal gene transfer);
                                            the decision.                                           person who has had the right to use a                   (D) Susceptibility of the GE organism
                                               (d) Amending an exemption after                      conditional exemption revoked may                     to disease or damage by pests;
                                            approval. The Administrator may                                                                                 (E) Pathogenicity of the GE organism
                                                                                                    appeal the decision in writing to the
                                            amend conditions to any conditional                                                                           and/or ability of the GE organism to
                                                                                                    Administrator within ten days after
                                            exemption approved under this section.                                                                        cause damage or injury to plants or
                                                                                                    receiving the written notification of the
                                            The Administrator may amend a                                                                                 plant parts;
                                                                                                    revocation. The appeal shall state all of
                                            conditional exemption if the                                                                                    (F) Toxicity, allergenicity, and/or
                                                                                                    the facts and reasons upon which the
                                            Administrator determines based on                                                                             ability of the GE organism to damage or
                                                                                                    person relies to assert that the use of the
                                            information received subsequent to the                                                                        injure other organisms;
                                                                                                    exemption was wrongfully revoked. The                   (iv) Any relevant experimental
                                            approval of the exemption that the
                                                                                                    Administrator will grant or deny the                  information, published references, or
                                            exemption needs to be amended to
                                                                                                    appeal, in writing, stating the reasons               scientific information which support the
                                            ensure that the exemption would be
                                                                                                    for the decision as promptly as                       conclusions of the petition;
                                            unlikely to result in the introduction or
                                                                                                    circumstances allow. Upon request of                    (v) All reports required under § 340.3;
                                            dissemination of a plant pest or noxious
                                                                                                    the applicant, a hearing may be held to                 (vi) Any information known to the
                                            weed, and that additional conditions
                                                                                                    resolve any conflict as to any material               petitioner that the GE organism may
                                            can successfully mitigate that risk. The
                                                                                                    fact. Rules of practice concerning such               pose risk as a plant pest or noxious
                                            Administrator may also amend a
                                            conditional exemption if needed to                      a hearing will be adopted by the                      weed;
                                            ensure that the exemption is in                         Administrator. This administrative                      (vii) Any other information that the
                                            compliance with all of the requirements                 remedy must be exhausted before a                     Administrator believes to be relevant to
                                            of this part. The amended conditional                   person can file suit in court challenging             a determination that the GE organism is
                                            exemption and the reasons for it will be                the revocation.                                       unlikely to be a plant pest or noxious
                                            published in the Federal Register. The                    (2) [Reserved]                                      weed.
                                            addition of conditions may not be                                                                               (viii) A signed certification by the
                                                                                                    § 340.6    Petition for nonregulated status.
                                            appealed. However, any person may file                                                                        petitioner that, to the best knowledge
                                            a new petition in accordance with                         (a) General. Any person may petition                and belief of the petitioner, the petition
                                            paragraph (a) of this section regarding                 to initiate the procedure for approving               includes all information on which to
                                            the same or similar organisms covered                   nonregulated status under this part for               base a determination, and that it
                                            by the amended exemption if new                         a GE organism. The Administrator may                  includes all information known to the
                                            information relevant to the amended                     initiate the procedure without filing a               petitioner which is unfavorable to the
                                            exemption becomes available.                            petition. All petitions and all actions by            petition.
                                               (e) Revocation of an exemption from                  the Administrator to initiate the                       (2) Insufficient information. If, upon
                                            requirement for permit. The                             procedure for approving nonregulated                  initial review of the petition, the
                                            Administrator may revoke any                            status will be evaluated according to the             Administrator concludes that there is
                                            conditional exemption under this                        standards for petition approval or denial             insufficient information upon which to
                                            section. The Administrator may revoke                   contained in paragraph (b)(4) of this                 make a determination on the petition,
                                            a conditional exemption if the                          section.                                              the petitioner will be sent a written
                                            Administrator receives information                        (b) Petition submission and                         notice indicating what additional
                                            subsequent to approving the exemption                   evaluation procedure. To petition for                 information may be required.
                                            and makes a determination based upon                    approval of nonregulated status, a                      (3) Public notice. The Administrator
                                            this information that the circumstances                 petitioner must submit a written                      should generally complete the review of
                                            have changed such that the conditional                  petition to the Administrator.                        the complete petition within 180 days,
                                            exemption is likely to result in the                      (1) The petition must contain                       then publish a notice in the Federal
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                                            introduction or dissemination of a plant                information that supports a conclusion                Register of the availability of documents
                                            pest or noxious weed. The revocation,                   that the GE organism is unlikely to be                related to APHIS’ assessment of the
                                            its effective date, and the reasons for it              a plant pest or noxious weed. The                     proposal for nonregulated status. This
                                            will be published in the Federal                        information shall include the following:              notice will specify that comments will
                                            Register. A revocation may not be                         (i) Description of the biology of the               be accepted from the public on the
                                            appealed. However, any person may file                  organism prior to genetic engineering.                proposal.


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                                                                  Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules                                          60047

                                               (4) Petition approval or denial                      § 340.7 Compliance, enforcement, and                     (iii) Criminal and/or civil penalties,
                                            standard. The Administrator will assess                 remedial action.                                      and
                                            the GE organism to determine whether                       (a) Access for inspection. Inspectors                 (iv) Remedial or other measures as
                                            the GE organism is unlikely to be a plant               shall have access to inspect any relevant             determined appropriate and necessary
                                            pest or noxious weed. After completing                  premises, facility, location, storage area,           by the Administrator.
                                            review of the available information and                 waypoint, materials, equipment, means                    (2) The Administrator may seek a civil
                                            any public comments received on it, the                 of conveyance, and other articles related             penalty as well as impose and require
                                            Administrator will furnish to the                       to importation, interstate movement,                  corrective action plans, remedial
                                            petitioner and publish in the Federal                   and environmental releases of GE                      measures or other measures as
                                            Register one of the following responses:                organisms regulated under this part.                  determined appropriate and necessary
                                               (i) Approve nonregulated status. The                    (b) Access to audit and review                     by the Administrator.
                                            approval of nonregulated status will                    records. Inspectors shall have access to                 (3) Prior to the issuance of a
                                            state which GE organism(s) have been                    audit and review all records required to              complaint seeking a civil penalty, the
                                            determined to have nonregulated status.                 be maintained under this part.                        Administrator may enter into a
                                               (ii) Deny nonregulated status. The                      (c) Required records. Responsible                  stipulation in which the responsible
                                            Administrator will deny a petition if the               persons and their agents engaged in the               person agrees to take certain remedial
                                            Administrator cannot conclude that the                  importation, interstate movement, or                  actions or other measures in addition to
                                            GE organism is unlikely to be a plant                   release into the environment of a GE                  or in lieu of a stipulated civil penalty,
                                            pest or noxious weed. The                               organism subject to the regulations of                in accordance with 7 CFR § 380.10.
                                            Administrator’s written decision will set               this part are required to establish and                  (f) Liability for acts of an agent. For
                                            forth the reason for the denial.                        keep the following records.                           purposes of enforcing this part, the act,
                                               (c) Appeal of decision. Any person                      (1) All records required as a condition            omission, or failure of any agent for a
                                            whose petition under § 340.6 has been                   of a permit or a conditional exemption                responsible person as defined in § 340.1
                                            denied may appeal the decision in                       approved under the procedure                          of this part may be deemed also to be
                                            writing to the Administrator within ten                 described in § 340.5.                                 the act, omission, or failure of the
                                            days after receiving the written                           (2) Address and any other information              responsible person.
                                            notification of the decision. The appeal                needed to identify all contained                         (g) Remedial action. The
                                            shall state all of the facts and reasons                facilities where the GE organism was                  Administrator may hold, seize,
                                            upon which the person relies to show                    stored or utilized, and all locations                 quarantine, treat, apply other remedial
                                            that the decision should be changed.                    where the GE organism was released                    measures to, destroy, or otherwise
                                            The Administrator will grant or deny                    into the environment;                                 dispose of any GE organisms subject to
                                            the appeal, in writing, stating the                        (3) A record identifying which APHIS               this part, in order to ensure the GE
                                            reasons for the decision as promptly as                 permit, if any, authorized the                        organisms are unlikely to result in the
                                            circumstances allow. Upon request of                    importation, interstate movement, or                  dissemination of a plant pest or noxious
                                            the applicant, a hearing may be held to                 release into the environment;                         weed. Accordingly, the Administrator
                                            resolve any conflict as to any material                    (4) A record identifying which                     may order the responsible person for an
                                            fact. Rules of practice concerning such                 exemption under this part, if any,                    active or revoked permit or any other
                                            a hearing will be adopted by the                        authorized the importation, interstate                person, through an Emergency Action
                                            Administrator. This administrative                      movement, or release into the                         Notification or other administrative
                                            remedy must be exhausted before a                       environment; and                                      order, to apply remedial measures to a
                                            person can file suit in court challenging                  (5) Copies of contracts between the                GE organism or means of conveyance
                                            the decision.                                           responsible person and all agents that                carrying a GE organism subject to
                                               (d) Revocation of nonregulated status.               conduct activities subject to this part for           regulation by this part. The
                                            The Administrator may revoke any                        the responsible person, and copies of                 Administrator’s determination of
                                            approval of nonregulated status of a GE                 other records (e.g., e-mails, telephone               whether or not to require or order
                                            organism. The Administrator may                         records) for such agreements made                     corrective and/or remedial action in a
                                            revoke an approval of nonregulated                      without a written contract.                           given situation does not affect,
                                            status if the Administrator receives                       (d) Record retention. Records                      influence, restrict, or in any other way
                                            information subsequent to approving                     indicating that such a GE organism that               limit the Administrator’s determination
                                            the nonregulated status and makes a                     was imported or moved interstate                      on whether or not to seek criminal or
                                            determination based upon this                           reached its intended destination must                 civil penalties or order other
                                            information that the circumstances have                 be retained for at least 2 years after                compliance or enforcement
                                            changed such that the GE organism is                    completion of importation or interstate               requirements as deemed necessary or
                                            likely to be a plant pest or noxious                    movement, and all other records must                  appropriate by the Administrator to the
                                            weed. If the Administrator revokes an                   be retained for at least 5 years after                given situation.
                                            approval for nonregulated status, the                   completion of all obligations required                   (1) Failure of a person to comply with
                                            Administrator may approve for the same                  under a relevant permit or exemption.                 the Administrator’s order for corrective
                                            GE organism an exemption from the                          (e) Enforcement. (1) Failure of any                and/or remedial action authorizes the
                                            requirement for permit in accordance                    person to comply with any of the                      Administrator to take corrective and/or
                                            with § 340.5. The revocation, its                       requirements of this part may result in               remedial action and recover from the
                                            effective date, and the reasons for it will             any or all of the following:                          person the costs of any care, handling,
                                            be published in the Federal Register. A                    (i) Denial of a permit request by that             application of remedial measures,
                                            revocation may not be appealed.                         person;                                               devitalization, or disposal incurred by
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                                            However, any person may file a new                         (ii) After the issuance of a permit,               APHIS in connection with the corrective
                                            petition in accordance with this section                revocation of a permit and destruction,               and/or remedial actions taken.
                                            regarding the same or similar organisms                 treatment, or removal of the GE                          (2) Low level presence (LLP) remedial
                                            covered by the revocation if new                        organism, or other measures as deemed                 action. The Administrator may order
                                            information relevant to the revocation                  appropriate or necessary by the                       remedial action for any unauthorized
                                            becomes available.                                      Administrator;                                        release into the environment of GE


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                                            60048                 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Proposed Rules

                                            organisms, including situations                         or, if sense or antisense genetic                     permit applications, petitions, or other
                                            involving a low-level mixing of GE                      sequences, they are derived from viruses              submissions to APHIS under this part
                                            plants and materials subject to                         prevalent and endemic in the United                   should do so in the following manner.
                                            regulation 1 under this part with                       States that infect plants of the same host            If there are portions of a document
                                            commercial seed and grain. In some LLP                  species and do not encode a functional                deemed to contain trade secret or
                                            situations the Administrator may                        noncapsid gene product responsible for                confidential business information, each
                                            determine not to order remedial action,                 cell-to-cell movement of the virus.                   page containing such information must
                                            if the Administrator determines that the                  (D) The GE plant is not expected to                 be marked ‘‘CBI Copy.’’ A second copy
                                            low-level mixing is unlikely to result in               establish outside of a managed                        of each such document must be
                                            the introduction or dissemination of a                  ecosystem, and has no sexually-                       submitted with all such CBI deleted and
                                            plant pest or noxious weed. These                       compatible, wild relatives in the United              marked on each page where the CBI was
                                            determinations will be made in the                      States;                                               deleted: ‘‘CBI Deleted.’’ In addition,
                                            same way, based on the same factors,                      (E) The GE plant does not produce
                                                                                                                                                          those portions of the document which
                                            regardless of whether the LLP originates                new substances that are known or likely
                                                                                                                                                          are deemed ‘‘CBI’’ must be identified in
                                            domestically or is found in import                      to be toxic to non-target organisms, does
                                                                                                                                                          an attachment to the document, which
                                            shipments that may contain organisms                    not contain genetic sequences from
                                                                                                    animal or human pathogens, and does                   also must justify how each piece of
                                            subject to regulation. The factors the                                                                        information requested to be treated as
                                            Administrator will consider that would                  not encode products known or likely to
                                                                                                    be causal agents of disease in animals or             CBI is a trade secret or is commercial or
                                            support a decision not to order LLP                                                                           financial information and are privileged
                                            remedial action include, but are not                    humans.
                                                                                                      (F) If the GE plant is a food or feed               or confidential.
                                            limited to, determinations that:
                                               (i) A GE plant of the same species                   crop, then at least one of the following              § 340.9    Costs and charges.
                                            expressing nearly identical proteins or                 must be true:
                                            substances has already been approved                      (1) The U.S. Environmental Protection                 The services of the inspector related
                                                                                                    Agency has established a tolerance or an              to carrying out this part and provided
                                            for nonregulated status under this part;
                                                                                                    exemption from tolerance for any plant-               during regularly assigned hours of duty
                                            or
                                               (ii) All of the following statements are             incorporated protectant expressed by                  and at the usual places of duty will be
                                            true with regard to the GE plant or                     the GE plant, or                                      furnished without cost.2 The U.S.
                                                                                                      (2) Key food safety issues of the new               Department of Agriculture will not be
                                            plants subject to the regulations under
                                                                                                    protein or other substance have been                  responsible for any costs or charges
                                            this part.
                                               (A) The function of the introduced                   addressed, or,                                        incident to inspections or compliance
                                                                                                      (3) No new protein or substance is                  with the provisions of this part, other
                                            genetic sequences is known and its
                                                                                                    produced.                                             than for the services of the inspector.
                                            expression in the GE plant is unlikely to
                                            pose plant pest or noxious weed risk;                   § 340.8    Confidential business information.           Done in Washington, DC, this 1st day of
                                               (B) Introduced genetic sequences do                     In accordance with the Freedom of                  October 2008.
                                            not cause the production of an                          Information Act (FOIA) and exemptions                 Charles D. Lambert,
                                            infectious entity;                                      from releasing information pursuant to
                                               (C) Any genetic sequences derived                                                                          Acting Under Secretary for Marketing and
                                                                                                    FOIA, namely, 5 U.S.C. 552(b)(4),                     Regulatory Programs.
                                            from plant viruses are non-coding                       APHIS may exempt from disclosure to
                                            regulatory sequences of known function;                                                                       [FR Doc. E8–23584 Filed 10–6–08; 9:30 am]
                                                                                                    the public trade secrets and commercial
                                                                                                                                                          BILLING CODE 3410–34–P
                                              1 ‘‘Subject
                                                                                                    or financial information obtained from a
                                                         to regulation’’ may include situations
                                            where a GE organism granted nonregulated status
                                                                                                    person that are privileged or                           2 The Department’s provisions relating to

                                            subsequently had that status revoked in accordance      confidential. Persons wishing to protect              overtime charges for an inspector’s services are set
                                            with § 340.6(d).                                        confidential business information in                  forth in 7 CFR part 354.0.
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DOCUMENT INFO