94-21358. Microbial Pesticides; Experimental Use Permits and Notifications; Final Rule ENVIRONMENTAL PROTECTION AGENCY  

  • [Federal Register Volume 59, Number 169 (Thursday, September 1, 1994)]
    [Unknown Section]
    [Page 0]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 94-21358]
    
    
    [[Page Unknown]]
    
    [Federal Register: September 1, 1994]
    
    
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    Part V
    
    
    
    
    
    Environmental Protection Agency
    
    
    
    
    
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    40 CFR Part 172
    
    
    
    
    Microbial Pesticides; Experimental Use Permits and Notifications; Final 
    Rule
    ENVIRONMENTAL PROTECTION AGENCY
    
    40 CFR Part 172
    
    [OPP-50668B; FRL-4752-7]
    RIN 2070-AB77
    
     
    Microbial Pesticides; Experimental Use Permits and Notifications
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Final rule.
    
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    SUMMARY: This notice promulgates an amendment to the experimental use 
    permit (EUP) regulations for pesticides that was proposed on January 
    22, 1993. These regulations clarify the circumstances under which an 
    EUP is presumed not to be required and implement a screening procedure 
    that requires notification to EPA before initiation of small-scale 
    testing of certain microbial pesticides. This notification scheme 
    implements provisions of the EPA policy statement published in the 
    Federal Register of June 26, 1986, with modifications.
    
    DATES: This final rule is effective October 31, 1994.
    
    FOR FURTHER INFORMATION CONTACT: By mail: Evert K. Byington, Chief, 
    Science Analysis and Coordination Staff, Environmental Fate and Effects 
    Division (7507C), Environmental Protection Agency, 401 M St., SW., 
    Washington, DC 20460. Office location and telephone number: Rm. 1016A, 
    Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, (703-305-
    6307).
    
    SUPPLEMENTARY INFORMATION: Section 5 of the Federal Insecticide, 
    Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136c, and 40 CFR part 
    172 provide for issuance by the Agency of experimental use permits 
    (EUPs) for the testing of new pesticides or new uses of existing 
    pesticides. Such permits are generally issued for large-scale testing 
    of pesticides.
        Large-scale tests under 40 CFR part 172 include any terrestrial 
    application on a cumulative total of more than 10 acres of land or any 
    aquatic application on more than 1 surface acre of water. EPA has 
    generally presumed that testing on up to 10 acres of land or 1 surface 
    acre of water (``small-scale test'') would not require EUPs. However, 
    the Agency believes that small-scale tests in the environment with some 
    microbial pesticides may pose sufficiently different risk 
    considerations from conventional chemical pesticides that a closer 
    evaluation at the small-scale testing stage may be warranted. 
    Therefore, the Agency is amending 40 CFR part 172 to require 
    notification before initiation of small-scale testing in the 
    environment of certain microbial pesticides so that EPA may determine 
    whether these tests should be conducted under an EUP. This rule 
    codifies the notification provisions of the Agency's policy statement 
    of June 26, 1986 (51 FR 23302), with modifications.
    
    I. Authority and Background
    
    A. Statutory and Regulatory Authority
    
        These regulations are promulgated under sections 3(a), 5, 8, and 25 
    of FIFRA. Section 5 governs the issuance of EUPs; section 3(a), 7 
    U.S.C. 136a(a), allows the Agency to regulate unregistered pesticides 
    that are not subject to an EUP in order to prevent unreasonable adverse 
    effects on the environment; section 8, 7 U.S.C. 136f, gives the Agency 
    authority to require recordkeeping; and section 25, 7 U.S.C. 136w, 
    gives EPA the authority to issue regulations and to exempt pesticides 
    from regulation under FIFRA.
        Section 5 of FIFRA provides that any person wishing to test a 
    pesticide may apply for an EUP. As stated in the preamble proposing the 
    issuance of the original regulations under section 5 (39 FR 11306, 
    March 27, 1974), ``The purpose behind section 5 is to facilitate the 
    generation of data necessary to support an application for registration 
    under section 3 and yet provide sufficient regulatory control to 
    prevent adverse environmental effects.'' An EUP issued pursuant to 
    section 5 authorizes limited use of a pesticide on a limited number of 
    acres, under specific and controlled conditions, to develop the 
    necessary data.
        EPA will issue an EUP only if issuance of such a permit will not 
    cause unreasonable adverse effects on the environment. Similarly, EPA 
    may revoke an existing EUP if it determines that the terms and 
    conditions of the permit are inadequate to avoid unreasonable adverse 
    effects, 7 U.S.C. 136c; 40 CFR 172.10. Section 2(bb) of FIFRA, 7 U.S.C. 
    136(bb), defines ``unreasonable adverse effects on the environment'' as 
    ``any unreasonable risk to man or the environment, taking into account 
    the economic, social, and environmental costs and benefits of use of 
    [the] pesticide.''
        When the EUP regulations, 40 CFR part 172, were originally 
    promulgated (40 FR 18782, April 30, 1975), the Agency recognized that 
    the development of an effective pesticide, culminating in registration, 
    is a multi-stage process that warrants a scaling in the level of 
    oversight by EPA. EPA therefore set forth procedures that would ``. . 
    .place experimental programs under reasonable constraints without 
    imposing burdens unrelated to needed protection of human health and the 
    environment'' (39 FR 11307, March 27, 1974). The final regulations 
    included a presumption that EUPs would not be required for most small-
    scale tests (40 CFR 172.3). However, the regulations also explicitly 
    recognized that a wide variety of testing situations may arise and that 
    a flexible regulatory approach is needed to deal with these situations.
    
    B. Historical Development
    
        The Agency recognizes that there has been a long history of safe 
    use of microbial pesticides. With respect to small-scale testing of 
    most microbial pesticides, the Agency believes that the likelihood that 
    such tests will result in significant adverse impacts on human health 
    or the environment is sufficiently low that Agency oversight is 
    unnecessary. Thus, the Agency believes that, in most instances, small-
    scale tests with microbial pesticides should continue to be excluded 
    from the requirement for an EUP.
        However, since the issuance of the original EUP regulations, new 
    and different microbial pesticides have been developed that warrant a 
    closer review before being excluded from the EUP requirements at the 
    small-scale testing stage. In amending the EUP regulations, the 
    Agency's goal is to set forth a system that focuses on the 
    characteristics and risks of the product, protects human health and the 
    environment, establishes a screening mechanism that does not unduly 
    impede potentially beneficial research, and is designed to accommodate 
    rapid advances in biotechnology.
        In 1984, EPA issued an interim policy statement entitled 
    ``Microbial Pesticides: Interim Policy on Small-Scale Field Testing'' 
    (49 FR 40659, October 17, 1984). This statement announced that the 
    presumption in the 1975 EUP regulations (40 CFR 172.3) would not 
    automatically apply to tests using genetically altered and 
    nonindigenous microbial pesticide products and that the Agency should 
    be notified before initiation of any such testing. Since 1984, the 
    Agency has used this notification scheme to evaluate small-scale tests 
    involving genetically altered and/or nonindigenous microbial pesticides 
    for possible risk to human health or the environment and to determine 
    whether EUPs would be required before the tests could be initiated.
        Subsequent to publication of the Interim Policy, this same basic 
    position was published for comment in EPA's section of the Office of 
    Science and Technology Policy (OSTP) ``Proposal for a Coordinated 
    Framework for Regulation of Biotechnology'' (49 FR 50856, December 31, 
    1984). The final OSTP statement of policy was published on June 26, 
    1986 (51 FR 23302, June 26, 1986). In the 1986 Policy Statement, the 
    Agency stated its intention to codify the major elements of the 
    notification procedure in the EUP regulations (40 CFR part 172).
        EPA published a proposal to amend its EUP regulations on January 
    22, 1993 (58 FR 5878). The proposal reflected changes in the 1986 
    Policy position made in response to public comments, the 
    recommendations of the FIFRA Scientific Advisory Panel (SAP) and the 
    EPA Biotechnology Science Advisory Committee (BSAC), and Federal 
    biotechnology policy statements.
        Specifically influencing the Agency's proposal were the 
    ``Principles for Federal Oversight of Biotechnology: Planned 
    Introduction into the Environment of Organisms with Modified Hereditary 
    Traits'' (55 FR 31118), and the policy announcement (57 FR 6753) 
    entitled ``Exercise of Federal Oversight Within Scope of Statutory 
    Authority: Planned Introductions of Biotechnology Products Into the 
    Environment.''
        The Agency received 19 comments in response to the notice of 
    proposed rulemaking published on January 22, 1993 (58 FR 5878). These 
    comments were received from trade associations, business firms, public 
    interest groups, scientific researchers, State and Federal agencies, 
    and others. Unit IV of this preamble summarizes and responds to the 
    significant issues raised in these comments.
    
    II. Summary of Proposed Rule
    
        The proposed rule set out a scheme for codifying the Agency 
    procedure, under which EPA has been operating from 1984, of screening 
    planned small-scale tests to evaluate the potential for adverse effects 
    on human health or the environment and allowing EPA to determine 
    whether an EUP would be required for the test. The proposed rule added 
    a Subpart C, ``Notification for Certain Genetically Modified Microbial 
    Pesticides,'' to the existing EUP regulations (40 CFR part 172). The 
    Agency proposed that its review of a notification would be completed 
    within 90 days. At the conclusion of the review, the Agency could make 
    one of the following determinations: Approve the test without requiring 
    an EUP; approve the test without requiring an EUP as long as certain 
    modifications in the proposed test plan are incorporated; require 
    additional information; require an EUP for the test; or disapprove the 
    test because of the potential for unreasonable adverse effects.
        The proposed rule requested comment on two options (Options 1 and 
    3) for defining which microbial pesticides would be subject to the 
    notification requirement. A third option was also discussed (Option 2), 
    but only for illustrative and comparative purposes. The Agency's goal 
    in setting forth these options was to discuss alternative approaches to 
    identifying those microbial pesticides having the greatest potential to 
    pose risks, or those where sufficient information and knowledge are 
    lacking about the potential risk when the microbial pesticide is 
    introduced into the environment. In the proposal, EPA indicated its 
    preference for Option 1.
        Under Option 1, the Agency proposed that the Agency be notified 
    before initiation of small-scale testing with microbial pesticides 
    ``whose pesticidal properties have been enhanced or imparted by the 
    introduction of genetic material that has been deliberately modified.'' 
    Key terms in Option 1 were defined as follows:
        1. ``Deliberately modified'' means the directed addition, 
    rearrangement, or removal of a nucleotide sequence(s) to or from 
    genetic material.
        2. ``Introduction of genetic material'' means the movement of a 
    nucleotide sequence(s) into a microorganism, regardless of the 
    technique used.
        3. ``Pesticidal property'' means a characteristic exhibited by a 
    microorganism that contributes to the intentional use of the 
    microorganism to prevent, destroy, repel, or mitigate a pest or to act 
    as a plant regulator, defoliant, or desiccant.
        In Option 3, EPA proposed notification for ``Indigenous microbial 
    pesticides for which specific pesticidal activities have been created 
    or increased by deliberate processes or techniques.''
        Under Option 3, notification would not be required for microbial 
    pesticides whose pesticidal activities have been increased, but which 
    are unlikely to pose a greater risk in the test site environment, in 
    terms of increased host range, competitiveness, survivability, or 
    genetic mobility, compared to the microorganism(s) from which they were 
    derived, and notification would not be required for microorganisms 
    whose phenotype has been changed only by the microorganism's 
    introduction into a new environment, but which are unlikely to pose a 
    greater risk in the test site environment resulting from an increase in 
    host range, competitiveness, survivability, or genetic mobility.
        Key terms used in Option 3 were defined as follows:
        1. ``Pesticidal activities,'' for the purpose of this option, means 
    hazard characteristics expressed by the microorganism, which is the 
    active ingredient, that prevent, repel, destroy, or mitigate a pest or 
    act as a plant growth regulator, defoliant, or desiccant through toxin 
    production, infectivity, pathogenicity, or virulence. Pesticidal 
    activities do not include non-cytotoxic modes of action such as those 
    brought about by niche exclusion, substrate competition, or nutrient 
    sequestration.
        2. ``Created'' means the microorganism has been given a pesticidal 
    activity that is not part of the normal genetic complement of the 
    species in nature.
        3. ``Increased pesticidal activity'' means an augmentation of a 
    pesticidal activity that can be shown to be part of the normal genetic 
    complement of the species in nature.
        4. ``Deliberate processes or techniques'' means the intentional 
    movement of the microorganism to a new environment or a change in the 
    genetic information of the microorganism resulting from natural 
    breeding, selection for spontaneous mutations, chemical or physical 
    mutagenesis, transduction, transformation, conjugation, cell fusion, 
    recombinant DNA or other genetic manipulations.
        5. ``Test site environment'' means the immediate test site and the 
    area surrounding the test site to which the microorganism or its 
    genetic material may reasonably be expected to be dispersed.
        6. ``Genetic mobility'' means the horizontal movement [i.e., from 
    the genome of one species to the genome of another] of genetic 
    material.
        The Agency also requested comment on specific administrative 
    aspects of implementation of the scope of coverage.
        Under any option, the Agency proposed to no longer require 
    notifications for any naturally occurring nonindigenous microbial 
    pesticides. EPA based its decision on its experience since 1984 with 
    the assessment of these types of microbial pesticide products at the 
    small-scale testing stage and its belief that continued imposition of 
    the notification requirement for these microbial pesticides would 
    constitute unnecessary duplicative oversight of research and 
    development with that of the U.S. Department of Agriculture Animal and 
    Plant Health Inspection Service (USDA/APHIS).
        The proposed rule also provided, at Sec. 172.45, that testing 
    conducted in a facility with adequate containment and inactivation 
    controls would not be subject to the notification requirement. 
    Responsibility for selection and use of adequate containment and 
    inactivation controls would lie with the researcher or institution 
    conducting the test.
        The proposed rule contained a discussion of the kinds of data and 
    information to be submitted in a notification at Sec. 172.48. 
    Procedures for claiming data and information provided to the Agency in 
    a notification as confidential business information (CBI) were proposed 
    in Sec. 172.46(d).
        A mechanism for designating, in the future, generic exemptions from 
    the requirement for notification prior to testing at the small-scale 
    stage was proposed at Sec. 172.52. Using this mechanism, certain 
    subgroups of microbial pesticides, otherwise subject to notification 
    would, on the basis of scientific knowledge and experience, be added to 
    a list of exemptions from the notification requirement.
        The Agency also proposed to revise Sec. 172.3 to clarify its 
    rationale for presuming that an EUP is not required prior to small-
    scale testing with most pesticides. The Agency would modify the 
    language of the rule to clarify that the determination of whether an 
    EUP is required is based on risk considerations, rather than on a 
    definitional presumption about whether the substance is a pesticide. 
    Whether a substance is a pesticide, and therefore under the 
    jurisdiction of FIFRA, is governed by the definition in section 2(u) of 
    FIFRA; whether a pesticide should be regulated under FIFRA is governed 
    by risk/benefit considerations.
        EPA proposed, at Secs. 172.57 and 172.59, means to address 
    situations where small-scale tests covered in Subpart C result in 
    unanticipated and untoward effects. Section 172.57 was proposed to 
    address situations where a person using a microbial pesticide in small-
    scale testing obtains information concerning the potential for 
    unreasonable adverse effects. This section would require a person to 
    submit such information to EPA within 30 days so that the Agency could 
    evaluate the information and take any necessary action to minimize the 
    potential for adverse effects. In situations where threat of harm to 
    human health or the environment is immediate and serious, 
    Sec. 172.59(a) sets out the manner in which EPA would act immediately 
    to prevent adverse impacts.
        The provisions set forth in proposed Subpart C Secs. 172.43 through 
    172.59 for the review of small-scale tests of certain microbial 
    pesticides would not affect the already established Agency procedures 
    for the review of pesticides for EUPs or for registration purposes.
    
    III. Summary of Final Rule
    
        The Agency has determined that Option 1 of the proposed rule 
    provides a scope of coverage which best addresses potential risks 
    presented by certain categories of small-scale testing with microbial 
    pesticides. It does so by focusing the notification requirement on 
    tests involving microbial pesticides with the potential for presenting 
    new and different hazards or exposures to humans or the environment on 
    the basis of simple and directly addressable criteria that form the 
    scope definition. This final rule significantly reduces the number of 
    notifications that will be sent to EPA relative to existing EPA policy. 
    Thus, Option 1 as it appears in the proposed rule will become part of 
    Subpart C to be added to the existing EUP regulations in 40 CFR part 
    172.
        In the proposed rule, EPA provided a rationale for, and requested 
    comment on, the scientific merit of adding a categorical exemption to 
    proposed Option 1 for microorganisms modified solely by rearrangement 
    or deletion of nucleotide sequences within a single genome. Public 
    comment supported this approach. Thus, at Sec. 172.45(d) of the 
    regulatory text, EPA specifically exempts a category of microbial 
    pesticides otherwise captured by the scope of the requirements, by 
    adding the following language.
        ``Microbial pesticides resulting from deletions or rearrangements 
    within a single genome that are brought about by the introduction of 
    genetic material.''
        Key terms are defined as follows:
        1. ``Single genome'' means the sum total of chromosomal and 
    extrachromosomal genetic material of an isolate and any descendants 
    derived under axenic culture conditions from that isolate.
        2. ``Microbial pesticides resulting from rearrangements'' means 
    microbial pesticides resulting from translocations or inversions.
        With regard to nonindigenous microbial pesticides, the Agency, 
    through discussions with USDA/APHIS and its own investigations, has not 
    been able to identify any category of nonindigenous microorganisms 
    potentially used as a pesticide that are not covered by APHIS 
    authorities. However, in response to public comment, Subpart C 
    contains, in Sec. 172.45(c), a provision that EPA require 
    notifications, at the small-scale testing stage, for nonindigenous 
    microbial pesticides that have not been acted upon by USDA (i.e., 
    either by issuing or denying a permit or determining that a permit is 
    unnecessary; or a permit is not pending with USDA).
        In the final rule, testing conducted in a facility with adequate 
    containment and inactivation controls will not be subject to the 
    notification requirements. Responsibility for selection and use of 
    adequate containment and inactivation controls lies with the researcher 
    or institution conducting the research and can be based on available 
    guidance. In the proposed rule, the Agency asked for public comment on 
    whether minimal recordkeeping to document the selection and use of 
    containment and inactivation controls should be required. Public 
    comment favored this proposal and at 40 CFR 172.45(e) contains language 
    to this effect.
        Section 172.46 describes the format of a notification and when and 
    where to submit the notification. A provision for claiming data and 
    information provided in a notification as CBI is included in 
    Sec. 172.46(d). Section 172.48 identifies the data and information to 
    be included in a notification. Section 172.50 indicates the time (90 
    days) the Agency allows itself to review and respond to a notification.
        Section 172.52 describes a process petitioners may use to request 
    exemption of specific microbial pesticides or categories of microbial 
    pesticides from the notification requirement.
        Sections 172.57 and 172.59 are included to enable the Agency to 
    address situations where small-scale tests covered by Subpart C result 
    in unanticipated and untoward effects.
        The Agency has revised 40 CFR 172.3 to clarify its rationale for 
    presuming that an EUP is not required prior to small-scale testing with 
    most pesticides. In response to public comment on the proposed rule, 
    EPA has revised the proposed text of Sec. 172.3 to clarify that the 
    applicability of EUP requirements will be based upon risk/benefit 
    considerations, and to include testing of new uses of registered 
    pesticides.
    
    IV. Response to Comments
    
        EPA received a total of 19 comments on its proposal to amend its 
    EUP regulations for microbial pesticides (58 FR 5878, January 22, 
    1993). A detailed analysis of the public comments was prepared by EPA 
    and is available in the public record (``Analysis of Comments, 40 CFR 
    part 172 Microbial Pesticides; Experimental Use Permits and 
    Notification; Proposed Rule. 58 FR 5878.'' Docket Control Number OPP-
    50668A).
        The following organizations or individuals provided comments on the 
    proposed rule: S. Abramson; American Council on Science and Health 
    (ACSH); American Farm Bureau Federation (AFBF); The American 
    Phytopathological Society (APS); Council for Responsible Genetics 
    (CRG); DuPont Agricultural Products (DuPont); Ecogen, Inc.; 
    Environmental Defense Fund (EDF); M. Goettel; Industrial Biotechnology 
    Association (IBA); D. Keppel; Massachusetts Audubon Society (MAS); 
    Mycogen, Inc.; National Audubon Society (NAS); National Wildlife 
    Federation (NWF); Novo Nordisk Bioindustrials (NNB); U.S. Department of 
    Agriculture National Agriculture Pesticide Impact Assessment Program 
    (USDA/NAPIAP); Wisconsin Department of Agriculture, Trade, and Consumer 
    Protection (WDATCP); A. Wood.
    
    A. Scope of Coverage
    
        In its proposal, EPA requested comment on two approaches to scope 
    of coverage. EPA's preferred option, Option 1, represents a 
    ``centralized'' approach to regulation. That is, EPA defined in Option 
    1 the specific microbial pesticides subject to the notification 
    requirement. To arrive at Option 1, EPA performed an initial assessment 
    of the potential risk presented by certain categories of small-scale 
    testing with microbial pesticides to determine which microbial 
    pesticides need not be subject to the notification requirement. The 
    Option 1 language was then drafted to describe those microbial 
    pesticides which could not generically be exempted from the 
    notification requirement. EPA would perform the review of the risks and 
    benefits of the subject microbial pesticides on a case-specific basis. 
    The language used to describe the microbial pesticides subject to 
    notification consisted of three fairly straightforward and specific 
    criteria that could be answered by either a ``yes'' or ``no.''
        Option 3, on the other hand, is an option based on a 
    ``decentralized'' approach. That is, based on general criteria supplied 
    by EPA, the researcher conducts a comprehensive evaluation of the 
    microbial pesticide and the proposed test and makes a determination of 
    whether a test would be subject to EPA notification review. Those 
    microbial pesticides the researcher determines would be subject to 
    notification would be reviewed by EPA on a case-specific basis. The 
    criteria used to determine whether the test would be subject to 
    notification are greater in number and would not usually be answered by 
    either a simple ``yes'' or ``no.'' Rather, researchers would use their 
    judgement to determine whether EPA should be notified.
        A total of 16 comments were received on the question of the 
    relative merits of the two options. Fifteen commenters supported Option 
    1. One commenter (ACSH) supported Option 3 unequivocally. Of the 15 
    commenters supporting Option 1, seven (NWF, M. Goettel, NAS, Ecogen, 
    IBA, NNB, and AFBF) supported the option unequivocally; eight (EDF, 
    MAS, CRG, A. Wood, WDATCP, Mycogen, APS, and USDA/NAPIAP) supported the 
    option but suggested modifications to the scope of coverage. Seven 
    (Ecogen, NWF, CRG, EDF, WDATCP, MAS, and NAS) of the 15 commenters 
    supporting Option 1 specifically voiced opposition to Option 3. All 
    seven were opposed to a decentralized approach per se; two (MAS and 
    CRG) of these seven identified major concerns with the language of the 
    scope of coverage of Option 3. Among the 15 who supported Option 1, two 
    (AFBF and APS) saw some advantages to a decentralized approach; and 1 
    of these 2 (APS) requested that EPA reconsider a decentralized approach 
    in 3 years.
        Commenters who supported Option 1 but suggested modifications to 
    the language of the scope of coverage can be grouped into three 
    categories based on the extensiveness of the suggested modifications. 
    In the first group, five commenters (EDF, MAS, CRG, A. Wood, and 
    WDATCP) suggested that the definition of ``deliberately modified'' be 
    changed to include all genetic material that is introduced and not, as 
    currently set forth in Option 1, only that genetic material that has 
    experienced ``directed addition, rearrangement, or removal of a 
    nucleotide sequence(s) to or from genetic material.'' In the second 
    group, one of the seven commenters (Mycogen) requested a broad scope of 
    coverage. Specifically, this commenter suggested that the Agency adopt 
    the centralized approach with the following scope language, 
    ``Indigenous microbial pesticides for which specific pesticidal 
    activities have been created or increased by deliberate processes or 
    techniques.'' In the third group, two commenters suggested a somewhat 
    different direction. USDA/NAPIAP suggested that ``biological control 
    agents'' be differentiated from ``microbial pesticides'' and that 
    microbial biological control agents be exempted from the notification 
    requirement. The EPA proposal did not make such a differentiation. The 
    other commenter (APS) offered a suggestion that ``[a] modification to 
    Option 1 might be considered for potential exemption or to allow 
    initiation of experiments simultaneously with notification in the case 
    of rearrangements or deletions within a single genome that result in 
    phenotypes comparable to those observed in natural populations.''
        EPA Response: EPA agrees with the comments supporting Option 1 and 
    has adopted Option 1 in the final rule. EPA believes that a centralized 
    approach is the more efficient and protective approach to small-scale 
    testing of microbial pesticides at this time.
        EPA believes the scope of coverage of Option 1 creates a structure 
    wherein the assessment of whether a test is subject to notification to 
    EPA is made on the basis of simple and directly addressable criteria 
    that form the scope definitions. Under this approach, all interested 
    parties (e.g., industry, researchers, public interest groups, and EPA) 
    would, in most instances, conclude from a reading of the definitions 
    alone whether a test involving a specific microbial pesticide is 
    subject to the notification requirement. In addition, this final rule 
    significantly reduces the number of notifications that will be sent to 
    EPA relative to existing EPA policy.
        EPA believes Option 1 appropriately focuses attention on microbial 
    pesticides with (1) new or different hazard traits; and, (2) the 
    potential to present new or different exposures, e.g., organisms which 
    heretofore might not have been exposed to a particular substance might 
    now be exposed to that substance through the microbial pesticide. EPA 
    judges pesticides in these categories to present relatively greater 
    potential for risk than those microbial pesticides EPA would no longer 
    subject to the notification requirement.
        EPA has examined the eight comments suggesting modification of the 
    Option 1 language; however, EPA does not believe any of the suggested 
    modifications are warranted. EPA believes the word ``directed'' in the 
    definition of ``deliberately modified'' as proposed in Option 1 
    addresses what appears to be the primary concerns of the majority of 
    commenters. From their letters, three commenters (EDF, CRG, and WDATCP) 
    appear to believe that some types of microbial pesticides EPA intends 
    to be captured for notification under Option 1, would not be captured. 
    EDF, for example, noted that an ``unmodified scorpion gene would not 
    require notification'' under Option 1. WDATCP made a similar point 
    using a wasp toxin gene as an example.
        EPA believes that the Option 1 language in its proposal of January 
    22, 1993, would capture such microbial pesticides, because some type of 
    ``directed'' modification would have to be made in the development of 
    these microbial pesticides. In the examples mentioned by EDF and 
    WDATCP, appropriate regulatory sequences would have to be added 
    directly to the nucleotide sequences encoding the structural gene for 
    the toxin, and this complete genetic construct introduced into the 
    recipient microorganism, in order to be expressed in the recipient 
    microorganism. Inserted structural genes lacking appropriate regulatory 
    sequences have an extremely low probability of being expressed. Without 
    appropriate regulatory sequences, the only possibility for an 
    introduced gene to be expressed is if it accidentally inserts in a 
    position on the microorganism's chromosome adjacent to appropriate 
    regulatory genes. However, an introduced gene is unlikely to insert by 
    chance at a position adjacent to sequences necessary for expression by 
    the recipient microorganism. EPA is not aware of any reports in the 
    scientific literature documenting that this can occur, and no examples 
    of such genetic modifications were provided in public comments on the 
    proposed rule.
        An additional technical problem would arise as a result of the 
    extreme difficulty of identifying and isolating, without the use of 
    marker genes, microorganisms appropriately expressing the desired 
    introduced pesticidal traits. The use of marker genes entails 
    ``directed'' modification. Without marker genes, the time required for 
    researchers to test thousands, if not millions, of individual microbial 
    isolates to identify the microorganism that has undergone the rare 
    event of insertion of a pesticidal trait is not practical.
        To summarize, it is technically extremely difficult to introduce an 
    ``unmodified'' scorpion or wasp gene into a microorganism to create a 
    novel microbial pesticide. Directed addition of nucleotide sequences 
    would be necessary for either selection of the modified microorganism 
    or proper expression of the gene encoding the pesticide.
        EPA has not modified the rule to incorporate the suggestion 
    (Mycogen) to broaden the scope to all genetically altered microbial 
    pesticides by utilizing a scope of coverage for all ``indigenous 
    microbial pesticides for which specific pesticidal activities have been 
    created or increased by deliberate processes or techniques.'' EPA's 
    experience, in the past 10 years, in reviewing notifications for small-
    scale testing with genetically altered microbial pesticides has allowed 
    the Agency to conclude that certain of these microbial pesticides need 
    not be subject to the notification process. EPA believes the scope of 
    coverage in the final rule addresses the appropriate category of 
    microbial pesticides, while excluding from notification microbial 
    pesticides similar to those likely to occur in microbial populations in 
    nature. Laboratory-generated microbial pesticides similar to those 
    likely to occur in nature are not likely to present new hazard or 
    exposure issues when tested at small-scale, with the possible exception 
    of certain nonindigenous microbial pesticides as discussed below.
        EPA has determined not to take the suggestion that ``biological 
    control agents'' be differentiated from ``microbial pesticides.'' Since 
    EPA did not propose such a distinction in the proposed rule, the 
    distinction cannot be incorporated into this final rule. Moreover, such 
    a modification would require substantive changes in regulations and 
    guidance that are not related to this rulemaking; changes that EPA does 
    not believe are warranted. FIFRA applies to all pesticides, whether 
    they be microbial pesticides or other types of biological control 
    agents. EPA does not know of any risk-based reason to create two 
    separate categories that should be treated differently. The commenter 
    has not provided sufficient support for the suggestion that 
    microorganisms that act by means of competitive displacement pose low 
    risk. Little data either supporting or disproving this contention exist 
    in the literature. Competitive displacement interactions among 
    microorganisms can be mediated by microbial toxins, and such toxins can 
    raise concerns for effects on nontarget organisms.
        With regard to the comment suggesting that deletions or 
    rearrangements within a single genome be handled either as exemptions 
    or as post-card notifications, the Agency believes this suggestion 
    could be handled under the exemption provision of Sec. 172.52, and the 
    Agency's determination is discussed under unit E, ``Exemption 
    Process,'' of this final rule.
    
    B. Administrative Aspects of Implementation of Scope of Coverage
    
        EPA requested comment on four administrative aspects of 
    implementation of scope of coverage. These four administrative 
    procedures could apply to both Options 1 and 3, but are more relevant 
    to Option 3. The four procedures are: (1) Guidance from EPA on the 
    considerations used in making a determination of whether a 
    microorganism is covered by the scope; (2) documentation of the 
    determination; (3) review of the determination by a third party; and, 
    (4) retention of the records of the determination.
        Six respondents commented on this issue. Three comments (AFBF, 
    WDATCP, and MAS) were received supporting the need for Agency guidance 
    on considerations relevant to determining whether a microbial pesticide 
    is subject to the notification requirement.
        Three commenters (EDF, NAS, and NWF) stated that, if Option 3 were 
    adopted, a third-party review procedure would not adequately protect 
    human health and the environment. One comment (AFBF) was received 
    suggesting that third-party review would strengthen a process where 
    researchers make a determination of whether a microorganism is covered 
    by the scope in terms of consistency, ensuring the correct 
    determination, and addressing the concerns of the public. One comment 
    (AFBF) was received supporting the retention of records.
        Two commenters (MAS and AFBF) stated that if Option 3 were chosen 
    by EPA, documentation of the considerations used in making a 
    determination of whether a microorganism is covered by the scope should 
    be required.
        EPA Response: EPA will implement in the final rule the scope of 
    coverage described in its proposed Option 1. EPA believes that 
    researchers' laboratory notebooks routinely include the types of 
    information considered in making a determination of whether a 
    microorganism is covered by the notification requirement set forth in 
    Option 1. Although researchers are not required to develop and maintain 
    records specifically supporting a determination of whether a 
    microorganism is covered by this notification requirement, researchers' 
    laboratory notebooks or other documentation would be treated by EPA as 
    records.
        Because of the sufficiently straightforward nature of the language 
    of Option 1, third-party review would add little to the determination, 
    and this is not judged by EPA to be necessary for Option 1. In terms of 
    guidance to submitters, the Agency believes that the selection of 
    Option 1 obviates the need for extensive guidance. The criteria 
    contained in Option 1 are fairly straightforward and the selection 
    criteria set forth in the scope definition, as well as the rationale 
    discussion in Unit III of the proposed rule, provide sufficient 
    guidance. Developers of microbial pesticides may also consult with the 
    Agency for guidance on notification requirements, including whether a 
    particular microbial pesticide is subject to the notification 
    requirement.
    
    C. Nonindigenous Microbial Pesticides
    
        Since 1984, EPA has had in place policies that require notification 
    to EPA for small-scale testing of all genetically altered and 
    nonindigenous microbial pesticides. ``Nonindigenous microorganism'' was 
    defined in the 1986 ``Coordinated Framework for Regulation of 
    Biotechnology'' (51 FR 23302, June 26, 1986), which stated that a 
    microorganism would be considered to be nonindigenous to ``any one of 
    the geographic areas listed below if it is isolated from outside that 
    area: (1) The continental United States, including Alaska, and the 
    immediately adjoining countries (i.e., Canada and Mexico); (2) The 
    Hawaiian Islands; (3) The Caribbean Islands including Puerto Rico and 
    the U.S. Virgin Islands.'' EPA stated in the proposed rule that 
    ``nonindigenous'' microbial pesticides should no longer be subject to 
    the notification requirement because they are adequately regulated by 
    another Federal agency. In the proposed rule, EPA requested comment on 
    whether a category could be identified consisting of nonindigenous 
    microbial pesticides that pose a potential for significant risk to 
    human health or the environment, when used in testing at small-scale, 
    that are not otherwise reviewed by another Federal agency. Three 
    commenters (IBA, NNB, and Ecogen) supported EPA's proposal to exclude 
    nonindigenous microbial pesticides from the scope of coverage. Four 
    other commenters (MAS, EDF, A. Wood, and ACSH) opposed omitting 
    nonindigenous microbial pesticides from the scope of coverage of this 
    rule. Two among this second group of commenters (MAS and EDF) stated 
    that the Agency should consider covering those nonindigenous microbial 
    pesticides not regulated by other Federal agencies. These commenters 
    asked the Agency to provide a more detailed analysis of how other 
    Federal agencies' authorities would apply to nonindigenous 
    microorganisms, and ensure safe use. The other two commenters opposed 
    to omitting nonindigenous microbial pesticides from the scope of 
    coverage (A. Wood and ACSH) believed that all microbial pesticides 
    should be reviewed before initial field testing.
        EPA Response: The Agency believes that the vast majority, if not 
    all, of nonindigenous microorganisms (some of which are microbial 
    pesticides) are addressed by the regulatory authorities of USDA/APHIS. 
    Nonindigenous microorganisms that may have direct or indirect plant 
    pest or adverse animal health effects are regulated by USDA/APHIS. 
    Under its authorities (Federal Plant Pest Act, U.S.C. 150aa et. seq.; 
    Plant Quarantine Act, 7 U.S.C. 151 et. seq.; Federal Noxious Weed Act, 
    7 U.S.C. 2801 et. seq.; and several animal quarantine statutes, 21 
    U.S.C. 111, 114, 134), and pursuant to its responsibilities under the 
    National Environmental Policy Act (NEPA) 42 U.S.C. 4321 et seq., USDA/
    APHIS considers the human health and environmental impacts associated 
    with nonindigenous microorganisms that have plant pest potential or are 
    animal pests. USDA/APHIS has issued regulations at 7 CFR part 330 which 
    regulate the importation and interstate movement of plant pests 
    including provisions on the port of entry, inspection, emergency 
    measures, and the information needed in applications for permits to 
    move plant pests.
        EPA believes that small-scale tests involving naturally occurring 
    nonindigenous microbial pesticides, that have been acted upon by USDA 
    (i.e., either by issuing or denying a permit or determining that a 
    permit is unnecessary; or a permit is not pending with USDA), are 
    adequately regulated and thus are unlikely to cause any significant 
    impact on the environment. Another measure of oversight is provided by 
    the U.S. Public Health Service, which regulates the importation and 
    subsequent distribution of microorganisms that are of human health 
    concern.
        EPA's preferred option in the proposed rule was to exclude, based 
    on its analysis of USDA/APHIS regulatory authorities, nonindigenous 
    microbial pesticides from the notification requirement. However, EPA 
    also stated that it would consider reviewing nonindigenous microbial 
    pesticides that pose a potential for significant risk to human health 
    or the environment when used in testing at small-scale and that are not 
    otherwise reviewed by another Federal agency, provided that a category 
    of such microorganisms can be identified. However, the Agency explained 
    that it was not aware of the existence of such a category of 
    nonindigenous microbial pesticides.
        In this final rule EPA will require notification, at small-scale 
    field testing, for nonindigenous microbial pesticides that have not 
    been acted upon by USDA (i.e., either by issuing or denying a permit or 
    determining that a permit is unnecessary; or a permit is not pending 
    with USDA), even though at this time no microbial pesticides may be 
    described by this category. EPA believes this approach will ensure that 
    all nonindigenous microbial pesticides, testedat small-scale, will be 
    reviewed by a Federal agency. EPA believes this cautious approach 
    addresses the concerns raised in public comments and the comments of 
    the SAP (see proposed rule at 58 FR 5878), both of which suggested a 
    similar approach.
        The Agency will, under its EUP and registration authority, continue 
    to regulate nonindigenous microbial pesticides prior to any use at more 
    than 10 acres of land or 1 surface acre of water.
    
    D. Testing in Contained Facilities
    
        In the proposed rule, EPA proposed that testing within a contained 
    facility, such as a laboratory or greenhouse, where appropriate 
    containment controls and procedures are employed, would not require 
    notification. The individual or institution conducting the contained 
    research would be given the discretion to select and use procedures and 
    controls appropriate to achieve the ``performance standard'' of 
    adequate containment. EPA requested comment on whether minimal 
    recordkeeping to document the selection and use of containment and 
    inactivation controls should be required.
        Six respondents commented on this issue. None of the six commenters 
    (IBA, NNB, APS, Ecogen, AFBF, and EDF) supported the concept that 
    notification to EPA for contained research is necessary. Two commenters 
    (IBA and NNB) thought the National Institutes of Health (NIH) 
    Guidelines for Research Involving Recombinant DNA Molecules provided 
    suitable guidance and standards for selecting and using procedures and 
    equipment to obtain appropriate containment. One commenter (AFBF) 
    suggested guidance should be based on USDA, NIH, or American Society 
    for Microbiology guidelines.
        Two commenters (AFBF and APS) stated that no additional and 
    specific recordkeeping is necessary beyond what occurs in standard 
    laboratory practice; e.g., laboratory notebooks. One commenter (EDF) 
    strongly supported requiring minimal recordkeeping to document the 
    selection and use of the containment and inactivation controls. In 
    addition, this commenter believed that EPA's proposed performance 
    standard for containment is vague and not protective.
        EPA Response: EPA continues to believe that notification for 
    contained research with microbial pesticides is not necessary. EPA 
    agrees that adequate guidance on selecting appropriate microbiological 
    procedures for achieving adequate containment is available from sources 
    such as the Public Health Service, Centers for Disease Control guidance 
    on the use of etiologic agents and the NIH Guidelines for Research 
    Involving Recombinant DNA Molecules. Selection and use of specific 
    containment and inactivation controls can be based on this available 
    guidance, and EPA does not plan to issue additional guidance at this 
    time. Researchers are reminded that they must keep records documenting 
    selection and use of appropriate containment and inactivation controls. 
    These may be kept in laboratory notebooks. If the NIH Guidelines are 
    used as guidance, the researcher's notebook should indicate the level 
    of containment suggested by the Guidelines and that this guidance was 
    selected and used. In order to clarify that such records should be 
    available for either inspection by EPA or submission to EPA upon the 
    Agency's request, Sec. 172.45(e)(4) of the regulatory text reads as 
    follows: ``Records shall be developed and maintained describing the 
    selection and use of the containment and inactivation controls, 
    including contingency plans for emergency clean-up and test 
    termination, that will be used during the test. These records shall be 
    available for inspection at the test facility. In addition, these 
    records shall be submitted to EPA at EPA's request and within the 
    timeframe specified in EPA's request.'' EPA believes that persons 
    following the NIH Guidelines would keep adequate records as part of 
    normal procedures for informing their Institutional Biosafety Committee 
    of the contained research.
        In the proposed rule, the Agency asked for comment on whether 
    selection of containment and inactivation controls should be approved 
    in writing by an authorized official of the organization. EPA received 
    no specific comments on this provision either in support or opposition. 
    EPA believes that most research organizations follow such a provision 
    on approval by an authorized official as a matter of course. For 
    example, those institutions complying with the NIH Guidelines would 
    meet this provision through the Institutional Biosafety Committee 
    provisions of the Guidelines. EPA therefore has included the provision 
    on approval by an authorized official at Sec. 172.45(e)(3) of the 
    regulatory text.
        In comments on the proposed rule, EDF stated that EPA's performance 
    standard is too vague and not protective because EPA fails to define 
    what is meant by ``adequate'' containment and inactivation controls. 
    EPA believes that it is appropriate to give the individual or 
    institution conducting the testing the discretion to select and use 
    procedures that would achieve adequate containment, based on available 
    guidance, such as the guidance on containment procedures for 
    microorganisms used in research laboratories found in the NIH 
    Guidelines for Research Involving Recombinant DNA Molecules. EPA's 
    approach accepts that the judgement of the individual or institution 
    conducting the research must take into account the many different kinds 
    of microorganisms used in research and the fact that appropriate 
    containment conditions vary depending on the microorganism. EPA 
    believes that experience with contained research with microbial 
    pesticides demonstrates that this approach is adequate in protecting 
    against unreasonable adverse effects to human health and the 
    environment. Thus, EPA has determined that the recordkeeping 
    requirements at Secs. 172.45(e)(3) and 172.45(e)(4) of the regulatory 
    text, along with the procedures for reporting unreasonable adverse 
    effects at Secs. 172.57 and 172.59, are appropriate for the level of 
    risk presented by contained research with microbial pesticides.
    
    E. Exemption Process
    
        The Agency proposed in Sec. 172.52 a process for exempting from the 
    notification requirement certain subgroups of microbial pesticides 
    otherwise captured by the scope of coverage laid out by Option 1. All 
    five comments (AFBF, IBA, NNB, APS, and MAS) received on this issue 
    supported the concept of a mechanism for exemption of microbial 
    pesticides, otherwise captured by the scope of the rule, from the 
    notification requirements. Two commenters (IBA and NNB) suggested as 
    candidates for exemption Bacillus thuringiensis which have been 
    genetically modified through the introduction of genetic material from 
    other strains of Bacillus thuringiensis and/or genetic material for 
    selectable marker genes. One commenter (MAS) suggested changes in the 
    exemption process: a longer public comment period and ``less vague'' 
    qualification criteria. One commenter (APS) suggested in their comments 
    on scope of coverage a somewhat different exemption mechanism than 
    discussed by the Agency in its proposal. The commenter proposed that 
    ``[a] modification to Option 1 might be considered for potential 
    exemption or to allow initiation of experiments simultaneously with 
    notification in the case of rearrangements or deletions within a single 
    genome that result in phenotypes comparable to those observed in 
    natural populations.''
        EPA Response: The Agency has included at Sec. 172.52 a mechanism 
    for exempting, as information warranting such action becomes available, 
    certain subgroups of microbial pesticides from the notification 
    requirement. EPA agrees with the comment (MAS) received concerning the 
    time allowed for public comment on proposed exemptions. EPA will 
    utilize a comment period of 45 days, instead of the proposed 30 days, 
    in order to allow more time for public participation. EPA will still 
    review these petitions within the 180-day timeframe stated in the 
    regulatory text.
        With regard to the comment on the criteria for exemption (MAS), EPA 
    believes that, at this time, it is not possible to generically describe 
    the criteria that will be used for specific exemptions from 
    notification under Sec. 172.52 of the final regulation. EPA believes 
    that petitions for exemption have to be addressed on a case-specific 
    basis. In instances where EPA believes that an exemption is 
    appropriate, EPA will issue a notice of proposed rulemaking in the 
    Federal Register, which will explain the basis for the Agency's 
    proposed decision.
        MAS also asked how the exemptions from notification under 
    Sec. 172.52 would differ from EPA's policy, stated in the proposed 
    rule, of informing submitters on an individual basis when no further 
    notification to EPA was required for specific microbial pesticides. EPA 
    will encourage submitters to use the exemption from notification 
    process to address such situations in the future. Use of the exemption 
    from notification process under Sec. 172.52 will allow the public the 
    opportunity to comment on any exemption petition submitted to EPA.
        In the proposed rule, EPA requested comment on the scientific merit 
    of adding an exemption under Sec. 172.45(d)(1) of the regulatory text 
    for ``. . . microorganisms modified solely by rearrangement (i.e., 
    translocation or inversion) or deletion of nucleotide sequences within 
    a single genome, including its extrachromosomal elements.'' This 
    concept was supported by APS when they suggested a modification of the 
    scope of coverage to exempt small-scale testing of microbial pesticides 
    ``. . . in the case of rearrangements or deletions within a single 
    genome that result in phenotypes comparable to those observed in 
    natural populations.'' An exemption describing this category of 
    microbial pesticides is included at Sec. 172.45(d)(1) of the regulatory 
    text. EPA has gained experience in the review of notifications of such 
    organisms and is persuaded that such microbial pesticides are similar 
    to those that would be likely to occur in microbial populations in 
    nature, since it is known that deletions and rearrangements of genetic 
    material within a single genome occur in microorganisms in nature. The 
    microbial pesticides described by the exemption at Sec. 172.45(d)(1)(i) 
    would, thus, likely be subject to the same constraints as other 
    naturally occurring microbial populations in the environment.
        EPA agrees with the commenters (IBA and NNB) who proposed an 
    exemption for microbial pesticides based on the organism Bacillus 
    thuringiensis that such an exemption may be merited under Sec. 172.52 
    of the regulatory text. After publication of this final rule in the 
    Federal Register, EPA will begin work on developing an exemption for 
    certain genetically modified Bacillus thuringiensis strains as proposed 
    in public comments. EPA requests that individuals supporting this 
    exemption provide to the Agency any information or data on why the 
    specific microbial pesticide or class of microbial pesticides meet the 
    criteria of Sec. 172.3 for small-scale tests of pesticides that do not 
    require an EUP.
    
    F. Notification Process
    
        Proposed Sec. 172.48, included a discussion of the kinds of data 
    and information to be submitted in a notification; e.g., the identity 
    of the microbial pesticide, a characterization of its relevant biology 
    and ecology, a description, if applicable, of how the microbial 
    pesticide has been modified, and a description of the objectives, 
    experimental design, and other relevant parameters of the proposed 
    test. EPA proposed in Sec. 172.46 that Agency review of a notification 
    would be completed within 90 days. Proposed Sec. 172.46 also contained 
    information on where and how to submit a notification.
        Six comments were received on the proposed notification process. 
    Four of the six comments dealt with data requirements. Two of these 
    four commenters (IBA and NNB) agreed with EPA's proposed regulatory 
    text. The third (MAS) requested that EPA require the use of marker and 
    suicide genes in microbial pesticides and also require information be 
    submitted on the management of resistance to pesticides in populations 
    of target organisms. The fourth commenter (WDATCP) offered suggestions 
    on data requirements addressing survival and potential effects on non-
    target organisms. Two of the six comments (IBA and NNB) requested that 
    EPA review notifications in 60 days rather than the 90 days proposed by 
    the Agency. Two commenters (MAS and WDATCP) addressed issues of 
    coordination with State authorities responsible for oversight of 
    microbial pesticides. One commenter (A. Wood) suggested that EPA 
    develop a data base of human health and environmental data generated 
    from field tests of microbial pesticides, including those under 
    notification, in order to improve the data based for future regulatory 
    decisions. One commenter (APS) suggested that EPA change the term 
    ``notification'' to ``screening procedure'' or ``microbial pesticides 
    pre-test review procedure'' because notification is a misnomer.
        EPA Response: In this final rule EPA will implement its proposal of 
    allowing 90 days as the outer limit for review of notifications. Ninety 
    days is required to achieve coordination with State and local 
    authorities and with USDA/APHIS where jurisdictional overlap occurs 
    between EPA and USDA. Ninety days also permits the Agency sufficient 
    time to fully evaluate whether any risk issues are associated with the 
    test and to examine them in detail, including providing the opportunity 
    for public participation in the review of notifications. EPA's goal is 
    to complete reviews of notifications in a timely fashion and, whenever 
    possible, notify submitters of the Agency's decision in less than 90 
    days.
        In terms of the use of marker genes, EPA included, upon the request 
    of the SAP in 1988, a statement in proposed Sec. 172.48 encouraging the 
    use of such genes. EPA is retaining this statement in the final rule. 
    EPA believes use of such genes should be encouraged to facilitate the 
    identification or monitoring of microbial pesticides in the 
    environment. However, EPA will not make use of such genes a mandatory 
    general requirement for all small-scale field tests. EPA has the 
    flexibility to make a determination, on a case-specific basis, of 
    whether the use of marker genes should be required for particular 
    tests; for example, when the use of marker genes for monitoring of a 
    microorganism is judged by EPA to be an appropriate means of risk 
    management for a particular field test. Technical and efficacy 
    considerations can be taken into account on a case-specific basis in 
    determining the relative cost/benefit ratio of using marker genes. EPA 
    believes the requirement that microbial pesticides contain suicide 
    genes is premature because the efficacy of suicide genes in controlling 
    microbial populations in the environment has not been demonstrated to 
    date in the scientific literature.
        The suggestion that EPA include a requirement for a pesticide 
    resistance management plan is beyond the scope of this rule, which 
    addresses only notification for small-scale tests of certain microbial 
    pesticides. The Agency is aware of this issue for all pesticides and is 
    evaluating its approach to resistance management.
        Comments on data requirements included the suggestion that survival 
    of the microbial pesticide in the environment and evaluation of a broad 
    range of potential non-target organisms for adverse effects is 
    important (WDATCP). EPA agrees that information on the survival of a 
    microbial pesticide should be evaluated in a notification and has 
    retained this data requirement in the final rule at Sec. 172.48. EPA 
    will not, however, routinely require in a notification that a broad 
    range of potential non-target organisms be addressed by the submitter. 
    EPA can require testing of effects on potential non-target organisms in 
    a specific notification if the characteristics of a particular 
    microbial pesticide indicate that this is justified. Data requirements 
    for EUPs and registration in Sec. 158.740 describe tests to address 
    non-target effects of microbial pesticides. These requirements utilize 
    single-species testing, which the Agency has found to be the most 
    effective way to address potential for non-target effects.
        The suggestion (A. Wood) that EPA develop a data base of human 
    health and environmental data generated from field tests of microbial 
    pesticides is beyond the scope of this rule which addresses only 
    notification for small-scale testing of certain microbial pesticides. 
    However, applicants submit human health and environmental data as part 
    of the notification, EUP, and registration processes, and the Agency's 
    experience base grows through this process.
        While, as suggested by APS, the term ``screening procedure'' or 
    ``microbial pesticides pre-test review procedure'' may provide a more 
    accurate description of the reporting process described in the proposed 
    rule, the term ``notification'' has been used by EPA since the 
    publication of the 1984 policy statement and is both accepted and 
    understood by interested parties. To change the term now could lead to 
    confusion. EPA, thus, will continue to use the term ``notification'' to 
    describe this process. The notification process described in 
    Sec. 172.46(b) indicates how submissions should be marked to ensure 
    that notifications are properly processed.
    
    G. Substantiation of Claims for Confidential Information
    
        The Agency requested comment on the proposed requirement 
    (Sec. 172.46(d)) that any claim of confidentiality must be 
    substantiated at the time the claim is made (i.e., ``up-front 
    substantiation''). Specifically, the Agency sought comment on how to 
    achieve the best balance between the burden on industry to provide 
    substantiation before public disclosure becomes an active issue (e.g., 
    in preparation for SAP meetings) and the regulated community's desire 
    to receive timely responses on notifications. This balance must take 
    into consideration the needs of pesticide developers to protect 
    information they believe to be critical to maintaining their 
    competitiveness and the public's need for access to information related 
    to potential environmental or human health effects early enough in the 
    notification review process to provide informed comment before the 
    Agency makes a decision.
        Five respondents (Ecogen, IBA, NNB, EDF, and CRG) commented on 
    EPA's proposed approach on substantiation of CBI claims. All five 
    commenters supported EPA's proposal to require up-front substantiation; 
    three of these commenters (Ecogen, IBA, and NNB) recommended that EPA 
    implement an initial screening process to identify and address 
    expeditiously any CBI issues.
        EPA Response: EPA continues to believe that up-front substantiation 
    of CBI is appropriate and necessary for expeditious decisions on 
    notifications. EPA believes that, given the Agency's procedural 
    requirements for making final CBI determinations, without up-front 
    substantiation, the 90-day response time associated with the 
    notification procedure at Sec. 172.50 would be difficult or impossible 
    to meet if it becomes necessary to resolve a CBI issue before a 
    decision on the notification can be made. Up-front substantiation 
    allows the Agency to make available to the public expurgated copies of 
    each submission and a rationale for any exclusions, and, in necessary 
    cases, to make final determinations of the validity of CBI claims. The 
    Agency does not believe that a formal initial screening process needs 
    to be implemented because a submitter always has the option of 
    consulting with the Agency on these and other issues.
        Two commenters (IBA and NNB) felt that EPA should issue guidance on 
    the types of information that constitute a valid claim of CBI for 
    microbial pesticides. EPA will consider developing such guidance in the 
    future. It may be more useful for the Agency to develop such guidance 
    after gaining more experience in the review of microbial pesticides 
    subject to this final rule.
    
    H. Voluntary Submissions
    
        Although not specifically proposed in the rule, the Agency 
    requested comment on whether, in addition to the notification 
    requirement, EPA should offer the opportunity to obtain review on a 
    voluntary basis, of any microbial pesticide that a company or 
    researchers believes could benefit by such a review, regardless of the 
    scope of coverage for notification in the final rule. The two 
    commenters (IBA and NNB) who offered comment on this issue supported a 
    provision for voluntary submissions, although one commenter (NNB) 
    expressed concern over the burden on Agency resources as a result of 
    the increased number of submissions.
        EPA Response: EPA agrees with the comment that the Agency's 
    resources may be overly burdened by voluntary submissions if developers 
    of microbial pesticides decide to submit notifications for microbial 
    pesticides outside the scope of coverage. Such voluntary reviews could 
    be equivalent to a notification in terms of Agency resources required 
    to conduct a review. After consideration of the public comments on this 
    issue, the Agency believes that it should focus its limited resources 
    on review of notifications of microbial pesticides subject to this 
    rule. However, submitters who are not clear about the reporting status 
    of a microbial pesticide, in terms of the scope of coverage, are 
    encouraged to contact the Agency for guidance on whether a notification 
    is required.
    
    I. Scope of Requirement
    
        Two commenters (Abramson and DuPont) questioned how the proposed 
    changes in Sec. 172.3 affect the relationship between FIFRA sections 5 
    and 12(b)(5) and the definition of pesticide in section 2(u) and how it 
    would affect testing of registered pesticides in a non-registered use. 
    One commenter (DuPont) suggested modifications of the language of 
    proposed Sec. 172.3(c)(1)(i) and Secs. 172.3(c)(1)(iii), 
    172.3(c)(2)(iv), and 172.3(c)(3). The commenter believed such modified 
    language would more clearly state EPA's intent. This commenter also 
    suggested the word ``not'' had inadvertently been omitted from proposed 
    Sec. 172.3(d). In addition, the commenter asserted that proposed 
    Sec. 172.3(e) was impractical, unnecessary, and unwarranted, and would 
    give the Agency new powers.
        EPA Response: As described in the proposed rule, EPA is modifying 
    Sec. 172.3, to clarify that the basis for the presumption concerning 
    the need for an EUP for small-scale testing is based on risk/benefit 
    considerations, rather than on a definitional determination of whether 
    a substance is a pesticide.
        DuPont was concerned that, in revising Sec. 172.3, EPA was 
    modifying the status under FIFRA of a substance being tested, and 
    questioned whether EPA intended to classify all test substances as 
    pesticides.
        As EPA stated in the preamble to the proposal, the determination of 
    whether a substance or mixture of substances is a pesticide is governed 
    by the intent test of FIFRA section 2(u). Once a substance is 
    determined to be a pesticide, the applicability of FIFRA section 5 EUP 
    requirements must still be set out. In other words, EPA must explain 
    under what circumstances an EUP will be required for testing conducted 
    on a pesticide. This determination is separate and distinct from 
    whether the substance is or is not a pesticide. The current language of 
    Sec. 172.3(a) mingles the two determinations, and implies that a 
    pesticidal determination can be made on the same basis as the 
    determination of EUP applicability. In fact, a pesticide determination 
    must be based upon intent under the definition of pesticide in FIFRA, 
    whereas EUP applicability will be based upon risk/benefit 
    considerations only after pesticide status has been attained. The 
    revised Sec. 172.3 only addresses the latter of these two 
    determinations.
        EPA emphasizes, however, that it does not intend to change the 
    status of any testing with respect to EUP applicability. Small-scale 
    testing previously conducted on a ``substance'' not subject to the 
    requirement of an EUP, in most instances, will continue to be permitted 
    on a ``pesticide'' without the requirement for an EUP. As under the 
    existing Sec. 172.3, this final rule will contain a presumption that an 
    EUP is not required for small-scale testing of pesticidal substances. A 
    substance that does not meet the intent test of FIFRA section 2(u) and 
    is therefore not a pesticide would not be covered by FIFRA section 5 
    under any circumstances. In addition, in this final rule, EPA does not 
    intend to change the status of the exemption under section 12(b)(5) of 
    FIFRA which allows the shipping of a pesticidal substance, under the 
    conditions of that section, without being subject to penalty for 
    failure to have a registration or an EUP. Both Abramson and DuPont 
    commented that EPA had omitted reference in its proposal to the status 
    of testing of new uses of registered pesticides that is currently 
    explicitly stated in Sec. 172.3(c). EPA did not intend to preclude such 
    testing. Such testing will continue to be eligible for the presumption 
    that an EUP is not required for certain small-scale testing under the 
    final rule. In response to both these comments, EPA has revised the 
    text of Sec. 172.3(a) to clarify the applicability of EUP requirements 
    as being a risk/benefit determination, and to include testing of new 
    uses of registered pesticides.
        Proposed Sec. 172.3(e) reserved to the Agency the right to require 
    an EUP on a case-by-case basis, notwithstanding the presumptions in 
    earlier paragraphs that EUPs would not be required. DuPont contended 
    that proposed Sec. 172.3(e) would be impractical, unnecessary, 
    unenforceable, and unduly expand the Agency's authority. DuPont's 
    principal concern was that EPA had not set out criteria for making this 
    determination, and that the regulated community could therefore not 
    discern when it was subject to the requirement of an EUP.
        EPA disagrees that the Agency is extending its authority. Rather, 
    it is expressly articulating the authority it has always had to rebut 
    the presumptions, either for specific tests or categories of tests. 
    Section 5 of FIFRA authorizes EPA to require EUPs for all tests, 
    regardless of acreage. EPA has determined, however, that based on risk 
    considerations, EUPs generally are not necessary for small-scale tests 
    conducted using most pesticides. Since the applicability of EUP 
    requirements depends on risk/benefit considerations, EPA believes it is 
    entirely appropriate that the Agency retain this flexibility and be 
    able to make case-by-case determinations of EUP applicability. If EPA 
    has reason to believe that certain small-scale testing should be 
    regulated under an EUP for risk/benefit reasons, it should ensure that 
    appropriate controls are in place before the testing takes place.
        However, in response to DuPont's concern that the regulated 
    community could not determine when an EUP would be required, EPA has 
    revised Sec. 172.3(e) in the final rule to specify that, if EPA 
    determines that an EUP is required, it will notify the affected parties 
    of the need for an EUP. Prior to such notice from the Agency, parties 
    may assume that the presumption that no EUP is required is applicable 
    to their small-scale tests. EPA notes that the provisions of Subpart C 
    are an example of the type of circumstances where EPA has determined 
    that it is appropriate to rebut the presumption that no EUP is 
    required. Where, as in this rulemaking, EPA is rebutting the 
    presumption generically for a category of pesticides or tests, it will 
    use the rulemaking process as the means of notification. In other 
    cases, EPA could choose to notify a producer individually of the need 
    for an EUP. DuPont commented that the language of proposed 
    Sec. 172.3(c), which pertains to testing covering more than one target 
    pest occurring at different times and places, was confusing, and 
    suggested revised text to clarify the intent. EPA recognizes that the 
    proposed language may be confusing and has clarified Secs. 172.3(c)(1) 
    and (c)(2) of the regulatory text. For example, in Sec. 172.3(c)(1), it 
    is generally EPA's intent that testing of a pesticide for one target 
    pest would qualify for the presumption when conducted on no more than 
    10 acres cumulative, including all test locations. When testing for 
    more than one target pest, the presumption again applies to testing on 
    no more than 10 acres per pest, where the testing occurs either in 
    different locations or at different times. Thus, testing for two target 
    pests on the same site, one of which occurs in the spring and the other 
    in the fall, can be conducted without an EUP as long as neither test 
    exceeds 10 acres. Similarly, testing for two pests at the same time, 
    one of which is a pest only in the Southeast United States, and the 
    other in the Southwest, can be conducted without an EUP as long as 
    neither test exceeds 10 acres. However, testing is limited to 10 acres 
    total if more than one target pest is being tested at the same time and 
    same locality.
        EPA has also addressed the comment from DuPont that the use of the 
    term ``crop'' in proposed Sec. 172.3(c)(1)(iii) is confusing when 
    referring to pesticide residues in or on the crop. The confusion could 
    arise because the term ``crop'' does not properly apply to fish and 
    animals, even though these may be the subject of tests involving 
    pesticides. EPA has clarified this language in Sec. 172.3(c)(1)(ii) in 
    the regulatory text by not specifically referring to crops.
        With regard to the comment from DuPont on Sec. 172.3(d), EPA 
    acknowledges that the word ``not'' was inadvertently omitted from 
    proposed Sec. 172.3(d), and the final regulatory text has been 
    corrected.
    
    J. Submission of Information Regarding Potential Unreasonable Adverse 
    Effects
    
        One comment (WDATCP) was received on the proposal at Sec. 172.57 to 
    require reporting of unreasonable adverse effects. This commenter 
    believed that: (1) Researchers tend to under assess potential impacts; 
    (2) microorganisms may continue to disperse and increase in numbers; 
    and (3) the phrase ``potential unreasonable adverse effects'' should be 
    defined.
        EPA Response: In this final rule, EPA has included Sec. 172.57 as 
    proposed. Section 172.57 applies to all microbial pesticides identified 
    in Sec. 172.45(c), including those subject to the notification 
    requirements and those that are exempt from the notification 
    requirements under Sec. 172.45(d). While EPA has done generic 
    assessment of potential risk in the development of this rule, and 
    concluded that some, but not all, categories of microbial pesticides 
    warrant notification, the Agency cannot foresee all adverse effects to 
    human health or the environment which may arise in specific individual 
    small-scale tests. Section 172.57 is meant to address unforeseeable 
    adverse effects resulting from use of such pesticides. EPA believes 
    that such effects are likely to be extremely rare; however, Sec. 172.57 
    is a means of ensuring that potential risk is addressed and that the 
    Agency's data base is as complete as possible for future tests. 
    Unreasonable adverse effects must be reported if they are directly 
    observed by the submitter or if the submitter has learned through 
    another source that a microbial pesticide has the potential to result 
    in an unreasonable adverse effect.
    
    K. Related Issues Not Specifically Posed for Comment
    
        Two other topics, not specifically posed for comment by EPA in its 
    January 22, 1993 proposal were also raised by commenters. One commenter 
    (D. Keppel) requested that a moratorium be placed on all releases of 
    genetically modified organisms. Two other commenters (IBA and NNB) 
    requested that EPA reorganize the Office of Pesticide Programs (OPP) so 
    as to form a specific branch dealing with biological pesticides.
        EPA Response: EPA believes that its approach to microbial 
    pesticides (i.e., its proposed notification program for small-scale 
    testing, its EUP program for large-scale testing and its registration 
    program) provide adequate protection from unreasonable adverse effects 
    to human health and the environment. The Agency believes there is no 
    evidence from experience with many years of small-scale testing of 
    genetically modified microbial pesticides that would support a request 
    for a moratorium on such tests. EPA, thus, does not believe a 
    moratorium on testing is warranted.
        The issue of OPP internal organization is not an issue which is 
    appropriately addressed through rulemaking and is not considered in 
    this final regulation. OPP is, however, examining mechanisms to 
    introduce efficiencies into its program for biological pesticides.
    
    V. Statutory Requirements
    
        In accordance with FIFRA section 25(a), a draft of this final rule 
    was submitted to the FIFRA SAP, the Secretary of Agriculture (USDA), 
    and the House Committee on Agriculture and Senate Committee on 
    Agriculture, Nutrition, and Forestry for comment.
    
    A. FIFRA Scientific Advisory Panel
    
        A Subpanel of the SAP provided written comments on the draft final 
    rule. No major issues were identified in comments received from the 
    SAP. One comment was received from a Subpanel member noting that the 
    SAP, at its meeting on September 26, 1990 (see 58 FR 5878), raised the 
    issue that certain deletions or rearrangements of genetic material 
    within a single genome could impart or enhance characteristics of 
    potential concern. This commenter questioned EPA's scientific 
    justification for including such an exemption in the final rule, while 
    noting that there is no major problem with such an exemption.
        EPA Response: EPA has included in the regulatory text, at 
    Sec. 172.45(d)(i), an exemption for small-scale testing of microbial 
    pesticides resulting from deletions or rearrangements within a single 
    genome. As stated in Unit IV of this preamble, EPA has gained 
    experience in the review of notifications of such organisms and is 
    persuaded that such microbial pesticides are similar to those that 
    would be likely to occur in microbial populations in nature since 
    deletions and rearrangements of genetic material within a single genome 
    are known to occur in microorganisms in nature. EPA has also taken into 
    consideration a point raised in the SAP report from the meeting on 
    September 26, 1990, which noted that the long-term survival and/or 
    competitiveness of these kinds of microorganisms may be compromised by 
    genetic modifications involving deletions or rearrangements within a 
    single genome. In making a decision on this exemption, EPA considered 
    both the concerns and mitigating factors raised by the SAP, along with 
    public comment. EPA believes that, on balance, these microbial 
    pesticides, when tested at small-scale, would be subject to natural 
    constraints on their populations in the environment.
        Under Sec. 172.57 of the regulatory text, unreasonable adverse 
    effects resulting from microbial pesticides must be reported to EPA. 
    These reporting requirements also apply to the microbial pesticides 
    exempted at Sec. 172.45(d)(i), if any adverse effects should occur.
    
    B. U.S. Congress and U.S. Department of Agriculture
    
        In accordance with FIFRA section 25, a draft of this final rule was 
    submitted in February 1994 to the U.S. Congress and USDA. USDA 
    commented that the final rule simplifies the regulation of small-scale 
    testing of microbial pesticides, focuses on microbial pesticides posing 
    the greatest risk, and reduces the number of notifications to EPA when 
    compared to current policy.
        USDA requested two changes in their comments, both of which EPA 
    agreed to incorporate in the final rule. The first modification 
    pertained to the text in the parentheses in Sec. 172.45(c)(2), which 
    read as follows: ``Nonindigenous microbial pesticides that have not 
    been favorably acted upon by the USDA (i.e., by the granting of a 
    permit or the determination that a permit is necessary).'' The USDA 
    suggested that the phrase ``not favorably acted upon'' may imply that 
    if USDA were to deny a permit because of a plant pest risk, EPA could 
    authorize testing under 40 CFR part 172. To avoid confusion, USDA 
    suggested the language read: ``Nonindigenous microbial pesticides that 
    have not been acted upon by USDA (i.e., either by issuing or denying a 
    permit or determining that a permit is unnecessary; or a permit is not 
    pending with USDA).'' EPA accepted this comment and the regulatory text 
    suggested by USDA appears in the final rule at Sec. 172.45(c)(2).
        Second, USDA pointed out that both the USDA and EPA should consider 
    the effect of the current regulations on the testing and introduction 
    of biological control agents, given the commitment at USDA to the 
    development of more environmentally friendly biological control 
    approaches in agriculture. EPA agrees that it is important to work with 
    USDA on this issue given EPA's authority to regulate pesticides. EPA 
    and USDA will continue discussions on biological control agents and 
    microbial pesticides to ensure that there is appropriate regulation of 
    these applications, while minimizing potentially duplicative reviews 
    and accelerating availability of safer pest management technologies.
        No comments were received from the U.S. Congress during the 60-day 
    comment period.
    
    VI. Public Record
    
        EPA has established a public record for this rulemaking (docket 
    control number OPP-50668A). The record includes all information 
    considered by EPA in developing this final rule. The record includes 
    the following items:
        1. All prior Federal Register Notices, and supporting public 
    dockets, relating to the regulation of microbial pesticides under 
    FIFRA. These include:
        a. The 1984 Statement of Interim Policy on Small-Scale Testing of 
    Nonindigenous and Genetically Altered Microbial Pesticides (49 FR 
    40659, October 17, 1984).
        b. The December 1984 EPA Federal Register Notice on Biotechnology 
    (49 FR 50856, December 31, 1984).
        c. The 1986 Policy Statement (51 FR 23302, June 26, 1986).
        d. ``Biotechnology; Request for Comment on Regulatory Approach,'' 
    (54 FR 7027, February 15, 1989).
        e. The 1993 Proposed Rule for Microbial Pesticides; Experimental 
    Use Permits and Notifications (58 FR 5878, January 22, 1993).
        2. Public comments submitted in response to each of the above 
    Notices and the EPA ``Analysis of Comments, Proposed Rule, FIFRA Part 
    172: Microbial Pesticides; Experimental Use Permits and 
    Notifications.''
        3. ``Principles for Federal Oversight of Biotechnology: Planned 
    Introduction into the Environment of Organisms With Modified Hereditary 
    Traits,'' Office of Science and Technology Policy (55 FR 31118, July 
    31, 1990).
        4. ``Exercise of Federal Oversight Within Scope of Statutory 
    Authority; Planned Introductions of Biotechnology Products into the 
    Environment,'' Office of Science and Technology Policy (57 FR 6753, 
    February 27, 1992).
        5. Reports of all SAP and BSAC meetings pertaining to this rule.
        6. The Regulatory Impact Analysis for this rule.
        7. Support documents and reports, including:
        a. National Research Council. 1989. ``Field Testing Genetically 
    Modified Organisms: Framework for Decisions.'' National Academy Press, 
    Washington, D.C.
        b. Tiedje, J.M., R.K. Colwell, Y.L. Grossman, R.E. Hodson, R.E. 
    Lenski, R.N. Mack, and P.J. Regal. 1989. ``The Planned Introduction of 
    Genetically Engineered Organisms: Ecological Considerations and 
    Recommendations.'' Ecology 70:298-315.
        c. The President's Council on Competitiveness. 1991. Report on 
    National Biotechnology Policy, February 1991.
        8. Records of all communications between EPA personnel and persons 
    outside EPA pertaining to the development of this rule. (This does not 
    include any inter- or intra-agency memoranda, unless specifically noted 
    in the Index of this docket.)
    
    VII. Regulatory Assessment Requirements
    
    A. Executive Order 12866
    
        Under Executive Order (E.O.) 12866, the Agency must determine 
    whether the regulatory action is ``significant'' and therefore subject 
    to all the requirements of the Executive Order (i.e., Regulatory Impact 
    Analysis, review by the Office of Management and Budget (OMB)). Under 
    section 3(f), the order defines ``significant'' as those actions likely 
    to lead to a rule (1) Having an annual effect on the economy of $100 
    million or more, or adversely and materially affecting a section of the 
    economy, productivity, competition, jobs, the environment, public 
    health or safety, or State, local or tribal governments or communities 
    (``economically significant''); (2) creating serious inconsistency or 
    otherwise interfering with an action taken or planned by another 
    agency; (3) materially altering the budgetary impacts of entitlement, 
    grants, user fees, or loan programs; or (4) raising novel legal or 
    policy issues arising out of legal mandates, the President's 
    priorities, or the principles set forth in this Executive Order. 
    Pursuant to the terms of this Executive Order, EPA has determined that 
    this rule is ``significant'' because it raises novel policy issues 
    arising out of legal mandates. As such, this action was submitted to 
    OMB for review, and any comments or changes made in response to OMB 
    suggestions or recommendations have been documented in the public 
    record.
    
    B. Regulatory Flexibility Act
    
        Under the Regulatory Flexibility Act (5 U.S.C. 605 (b)), EPA 
    certifies that this rule will not have a significant economic impact on 
    a substantial number of small businesses. This conclusion is based on 
    the fact that this rule is only the codification, with modification, of 
    relevant operative provisions of the June 26, 1986 Policy Statement. As 
    such, this rule will not create any additional impacts on affected 
    small businesses or other small entities beyond those currently in 
    effect. In fact, this rule will reduce the number and scope of 
    microbial pesticides requiring EPA oversight from those covered under 
    the current policy.
    
    C. Paperwork Reduction Act
    
        The information collection requirements in this final amendment 
    have been submitted for approval to the Office of Management and Budget 
    (OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. An 
    Information Collection Request (ICR) document has been prepared by EPA 
    (ICR No. 0276.07; OMB control No. 2070-0040) and a copy may be obtained 
    from Sandy Farmer, Information Policy Branch (MC-2136); U.S. 
    Environmental Protection Agency; 401 M St., SW.; Washington, DC 20460 
    or by calling (202) 260-2740.
    
    List of Subjects in 40 CFR Part 172
    
        Environmental protection, Intergovernmental relations, Labeling, 
    Pesticides and pests, Recordkeeping and reporting requirements, 
    Research.
    
        Dated: August 19, 1994.
    Carol M. Browner,
    Administrator.
    
        Therefore, 40 CFR part 172 is amended as follows:
    
    PART 172--[AMENDED]
    
        1. The authority citation for part 172 is revised to read as 
    follows:
    
        Authority: 7 U.S.C. 136a, 136c, 136f, 136v, and 136w.
    
        2. By revising Sec. 172.3 to read as follows:
    
    
    Sec. 172.3   Scope of requirement.
    
        (a) An experimental use permit (EUP) is generally required for 
    testing of any unregistered pesticide or any registered pesticide being 
    tested for an unregistered use. However, as described in paragraph (b) 
    of this section, certain of such tests are presumed not to involve 
    unreasonable adverse effects and, therefore, do not require an EUP.
        (b) Except as provided in subpart C of this part or as specifically 
    determined by the Environmental Protection Agency (EPA), it may be 
    presumed that EUPs are not required when:
        (1) The experimental use of the pesticide is limited to:
        (i) Laboratory or greenhouse tests,
        (ii) Limited replicated field trials as described in paragraph (c) 
    of this section to confirm such tests, or
        (iii) Other tests as described in paragraph (c) of this section 
    whose purpose is only to assess the pesticide's potential efficacy, 
    toxicity, or other properties.
        (2) The producer, applicator, or any other person conducting the 
    test does not expect to receive any benefit in pest control from the 
    pesticide's use.
        (c) For purposes of paragraphs (b)(1)(ii) and (b)(1)(iii) of this 
    section, the following types of experimental tests are presumed not to 
    need an EUP:
        (1) A small-scale test involving use of a particular pesticide that 
    is conducted on a cumulative total of no more than 10 acres of land per 
    pest, except that:
        (i) When testing for more than one target pest occurs at the same 
    time and in the same locality, the 10 acre limitation shall encompass 
    all of the target pests.
        (ii) Any food or feed crops involved in, or affected by, such tests 
    (including, but not limited to, crops subsequently grown on such land 
    which may reasonably be expected to contain residues of the tested 
    pesticides) shall be destroyed or consumed only by experimental animals 
    unless an appropriate tolerance or exemption from a tolerance has been 
    established under the Federal Food, Drug, and Cosmetic Act (FFDCA) for 
    residues of the pesticide.
        (2) A small-scale test involving the use of a particular pesticide 
    that is conducted on a cumulative total of no more than 1 surface acre 
    of water per pest, except that:
        (i) When the testing for more than one target pest occurs at the 
    same time and in the same locality, the 1 acre limitation shall 
    encompass all of the target pests.
        (ii) Waters which are involved in or affected by such tests are not 
    used for irrigation purposes, drinking water supplies, or body contact 
    recreational activities.
        (iii) Testing shall not be conducted in any waters which contain or 
    affect fish, shellfish, plants, or animals taken for recreational or 
    commercial purposes and used for food or feed, unless an appropriate 
    tolerance or exemption from a tolerance has been established under the 
    FFDCA for residues of the pesticide.
        (3) Animal treatment tests involving the use of a particular 
    pesticide that are conducted only on experimental animals which will 
    not be used for food or feed, unless an appropriate tolerance or an 
    exemption from a tolerance has been established for animal products and 
    byproducts under the FFDCA for residues of the pesticide.
        (d) The examples in paragraphs (c)(1), (c)(2), and (c)(3) of this 
    section are not all-inclusive and do not preclude testing in larger 
    areas or larger numbers of units if the intended use meets the criteria 
    of paragraph (a) of this section. However, tests which do not come 
    within the examples in paragraphs (c)(1), (c)(2), and (c)(3) of this 
    section, absent a specific determination by EPA to the contrary, 
    require an EUP. Subdivision I of the Pesticide Assessment Guidelines 
    provides guidance on the procedures, data requirements, and general 
    aspects pertaining to the issuance and use of EUPs. Persons intending 
    to conduct tests who are uncertain whether the testing may be conducted 
    without a permit may submit a request for determination to the 
    Registration Division (7505C), Office of Pesticide Programs, 
    Environmental Protection Agency, 401 M St., SW., Washington, DC 20460, 
    Telephone: (703-305-5447). Such a request shall include the information 
    listed in Sec. 172.4(b)(1)(ii) and (b)(1)(iii) and in the case of an 
    unregistered product, the information in Sec. 172.4(b)(3)(i).
        (e) Notwithstanding paragraphs (b) through (d) of this section, EPA 
    may, on a case-by-case basis, require that certain testing of a 
    particular pesticide or class of pesticides be carried out under an 
    EUP, if it is determined that such EPA oversight is warranted. If EPA 
    determines that an EUP is required, it will notify the developer of the 
    pesticide of the need for an EUP and provide opportunity for comment or 
    objections before imposing the requirement.
        (f) No EUP is required for a substance or mixture of substances 
    being put through tests for the sole purpose of gathering data required 
    for approval of such substance or mixture under the FFDCA (21 U.S.C. 
    301 et seq.) as:
        (1) A ``new drug'' (21 U.S.C. sec. 321(p) and sec. 355).
        (2) A ``new animal drug'' (21 U.S.C. sec. 321(w) and sec. 360(b)), 
    or
        (3) An ``animal feed'' (21 U.S.C. sec. 321 (x)) containing a ``new 
    animal drug'' (21 U.S.C. sec. 360(b)).
        (g) Paragraph (f) of this section shall not apply when a purpose of 
    such test is to accumulate information necessary to register a 
    pesticide under section 3 of the Act.
        3. By adding a new subpart C to read as follows:
    Subpart C--Notification for Certain Genetically Modified Microbial 
    Pesticides
    Sec.
    172.43     Definitions.
    172.45     Requirement for a Notification.
    172.46     Submission of a Notification.
    172.48     Data requirements for a Notification.
    172.50     Response to a Notification.
    172.52     Notification exemption process.
    172.57     Submission of information regarding potential 
    unreasonable adverse effects.
    172.59     Enforcement.
    
    Subpart C--Notification for Certain Genetically Modified Microbial 
    Pesticides
    
    
    Sec. 172.43   Definitions.
    
        Terms used in this subpart shall, with the exception of those 
    defined below, have the meaning set forth in the Act and in Sec. 172.1.
        ``Containment and inactivation controls'' means any combination of 
    mechanical, procedural, or biological controls designed and operated to 
    restrict environmental release of viable microorganisms from a 
    facility.
        ``Deliberately modified'' means the directed addition, 
    rearrangement, or removal of nucleotide sequences to or from genetic 
    material.
        ``Introduction of genetic material'' means the movement of 
    nucleotide sequences into a microorganism, regardless of the technique 
    used.
        ``Inversions of genetic material'' means the replacement of an 
    internal section of a chromosome in the reverse orientation.
        ``Microbial pesticide'' means any pesticide whose active ingredient 
    is a microorganism intended for preventing, destroying, repelling, or 
    mitigating any pest, or intended for use as a plant regulator, 
    defoliant, or desiccant.
        ``Microbial pesticides resulting from rearrangements'' means a 
    microbial pesticide resulting from translocations or inversions of 
    genetic material.
        ``Microorganism'' means a bacterium, fungus, alga, virus, or 
    protozoan.
        ``Nonindigenous microbial pesticide'' means a microbial pesticide 
    brought into one of the following geographic areas from outside that 
    area:
        (1) The continental United States, including Alaska, and the 
    immediately adjoining countries (i.e., Canada and Mexico).
        (2) The Hawaiian Islands.
        (3) The Caribbean Islands including Puerto Rico and the U.S. Virgin 
    Islands.
        ``Pesticidal property'' means a characteristic exhibited by a 
    microorganism that contributes to the intentional use of the 
    microorganism to prevent, destroy, repel, or mitigate a pest or to act 
    as a plant regulator, defoliant, or desiccant.
        ``Single genome'' means the sum total of chromosomal and 
    extrachromosomal genetic material of an isolate and any descendants 
    derived under axenic culture conditions from that isolate.
        ``Small-scale test'' means the experimental use of a microbial 
    pesticide in a facility such as a laboratory or greenhouse, or use in 
    limited replicated field trials or other tests as described in 
    Sec. 172.3(c).
        ``Test'' or ``testing'' means any use of a microbial pesticide 
    consistent with section 5 of the Act, including limited replicated 
    field trials and associated activities.
        ``Translocations of genetic material'' means a chromosomal 
    configuration in which part of a chromosome becomes attached to a 
    different chromosome, or inserts in a different location on the same 
    chromosome.
    
    
    Sec. 172.45   Requirement for a Notification.
    
        (a) Who must submit a Notification. Notwithstanding Sec. 172.3, any 
    person who plans to conduct small-scale testing of a type of microbial 
    pesticide identified in paragraph (c) of this section must submit a 
    Notification to EPA and obtain prior approval for either of the 
    following tests:
        (1) Small-scale tests that involve an intentional environmental 
    introduction of that microbial pesticide.
        (2) Small-scale tests performed in a facility without adequate 
    containment and inactivation controls as provided in paragraph (e) of 
    this section.
        (b) Alternative to Notification. In lieu of a Notification, any 
    person required to submit a Notification under paragraph (a) of this 
    section may submit an application for an experimental use permit (EUP) 
    to EPA for approval.
        (c) Small-scale testing that requires a Notification. As provided 
    in paragraph (a) of this section, and notwithstanding any other 
    approval by any governmental entity, EPA review and approval are 
    required prior to the initiation of any small-scale test involving 
    either of the following microbial pesticides:
        (1) Microbial pesticides whose pesticidal properties have been 
    imparted or enhanced by the introduction of genetic material that has 
    been deliberately modified.
        (2) Nonindigenous microbial pesticides that have not been acted 
    upon by the U.S. Department of Agriculture (i.e., either by issuing or 
    denying a permit or determining that a permit is unnecessary; or a 
    permit is not pending with the USDA).
        (d) Small-scale testing that does not require a Notification. (1) 
    Testing conducted with microbial pesticides identified in paragraph (c) 
    of this section, but made exempt pursuant to Sec. 172.52, does not 
    require a Notification. The following microbial pesticides (or classes 
    of pesticides) are exempt from the notification requirement in 
    paragraph (a) of this section:
        (i) Microbial pesticides resulting from deletions or rearrangements 
    within a single genome that are brought about by the introduction of 
    genetic material that has been deliberately modified.
        (ii) [Reserved]
        (2) Testing conducted in a facility with adequate containment and 
    inactivation controls, as provided in paragraph (e) of this section, 
    does not require a Notification.
        (e) Selection and use of containment and inactivation controls. (1) 
    Selection and use of containment and inactivation controls for a 
    particular microbial pesticide shall take into account the following:
        (i) Factors relevant to the microbial pesticide's ability to 
    survive in the environment.
        (ii) Potential routes of release in air, solids, and liquids; in or 
    on waste materials and equipment; in or on people (including 
    maintenance and custodial personnel); and in or on other organisms such 
    as insects and rodents.
        (iii) Procedures for transfer of materials between facilities.
        (iv) Plans for routine or emergency clean-up and test termination.
        (2) For purposes of paragraph (e)(1) of this section, EPA will 
    presume that compliance with the containment provisions of the National 
    Institutes of Health (NIH) ``Guidelines for Research Involving 
    Recombinant DNA Molecules'' (51 FR 16958, May 7, 1986) constitutes 
    selection and use of adequate containment and inactivation controls.
        (3) The selection of containment and inactivation controls shall be 
    approved by an authorized official of the organization that is 
    conducting the test prior to commencement of the test.
        (4) Records shall be developed and maintained describing the 
    selection and use of the containment and inactivation controls, 
    including contingency plans for emergency clean-up and test 
    termination, that will be used during the test. These records shall be 
    available for inspection at the test facility. In addition, these 
    records shall be submitted to EPA at EPA's request and within the time 
    frame specified in EPA's request.
        (5) Subsequent to any EPA review of the containment/inactivation 
    controls selected under paragraph (e)(1) of this section, changes to 
    the controls necessary to prevent unreasonable adverse effects must be 
    made upon EPA request. Failure to comply with EPA's request shall 
    result in automatic revocation of the exemption from the requirement to 
    submit a Notification.
    
    
    Sec. 172.46   Submission of a Notification.
    
        (a) When to submit a Notification. A Notification shall be 
    submitted for approval at least 90 days prior to the initiation of the 
    proposed test.
        (b) Where to submit a Notification. A Notification shall be 
    submitted to the Registration Division (7505C), Office of Pesticide 
    Programs, Environmental Protection Agency, 401 M St.,SW., Washington, 
    DC 20460, and clearly marked ``ATTN: Biotechnology Notification 
    Review.''
        (c) How to format a Notification. A Notification submitted under 
    this section must comply with the following procedures, but is not 
    required to comply with the format and other provisions governing 
    submission of data in Secs. 158.32 and 158.33 of this chapter. However, 
    because data submitted with the Notification may subsequently be used 
    to support other regulatory actions (e.g., used in EUP or registration 
    applications), it is recommended that such data comply with EPA 
    requirements in Secs. 158.32 and 158.33 of this chapter.
        (1) Each Notification must be accompanied by a transmittal document 
    that clearly identifies the EPA action supported as a Biotechnology 
    Notification Review.
        (2) Five copies of each Notification must be submitted to EPA.
        (3) Any claims of confidentiality for information submitted in the 
    Notification must be made as described in paragraph (d) of this 
    section.
        (d) How to make confidential business information (CBI) claims in a 
    Notification. Although it is strongly recommended that the submitter 
    minimize the amount of data and other information claimed as CBI, a 
    submitter may assert a claim of confidentiality for all or part of the 
    information submitted to EPA in a Notification (See part 2, Subpart B 
    of this chapter). To assert such a claim, the submitter must comply 
    with the following procedures:
        (1) Any claim of confidentiality must accompany the information at 
    the time the information is submitted to EPA. Failure to assert a claim 
    at that time will be considered a waiver of confidentiality for the 
    information submitted, and the information may be made available to the 
    public, subject to section 10(g) of the Act, with no further notice to 
    the submitter.
        (2) Of the five copies of the Notification required by paragraph 
    (c) of this section, four copies must be complete with the information 
    that is claimed confidential clearly marked in the manner described in 
    Sec. 2.203(b) of this chapter. All information claimed as confidential 
    must be deleted from the fifth copy, but it must be otherwise complete. 
    The first page of the fifth copy must be marked ``Contains no 
    information claimed as confidential.'' EPA may include the fifth copy 
    in a public file without further notice. EPA will consider incomplete a 
    Notification containing information claimed as CBI that is not 
    submitted in accordance with this paragraph and will suspend the review 
    period on the Notification until such procedures are followed.
        (3) Any claim of confidentiality must be accompanied, at the time 
    the claim is made, by comments substantiating the claim and explaining 
    why the submitter believes that the information should not be 
    disclosed. The submitter should refer to Sec. 2.204(e)(4) of this 
    chapter for points to address in the substantiation. If such comments 
    are themselves claimed confidential and are marked confidential when 
    submitted to EPA, they will be treated as such in accordance with 
    Sec. 2.205(c) of this chapter. EPA will consider incomplete all 
    Notifications containing information claimed as CBI that are not 
    accompanied by substantiation, and will suspend the review period on 
    such Notifications until the required substantiation is provided.
        (4) EPA will disclose information that is subject to a claim of 
    confidentiality asserted under this section only to the extent and by 
    means of the procedures set forth in section 10 of the Act, in this 
    subpart, and in part 2 of this chapter.
    
    
    Sec. 172.48   Data requirements for a Notification.
    
        This section identifies the data and information to be included in 
    each Notification. When specific information is not submitted, an 
    explanation of why it is not practical or necessary to provide the 
    information is to be provided.
        (a) The identity of the microorganism which constitutes the 
    microbial pesticide including:
        (1) Summary of data supporting the taxonomic designation and its 
    interpretation.
        (2) Means and limit of detection using sensitive and specific 
    methods (e.g., note the use of any markers that are used to distinguish 
    the introduced population from native microorganisms). Introduction 
    into the microbial pesticide of a unique genetic marker is encouraged.
        (b) Description of the natural habitat of the parental strain of 
    the microbial pesticide including information on:
        (1) Physical and chemical features important to growth and survival 
    of the parental strain.
        (2) Biological features of the parental strain that would have an 
    impact on the microbial pesticide (e.g., presence of phages that infect 
    the microorganism).
        (3) Competitors.
        (c) Information on the host range of the microbial pesticide, if 
    any, with an assessment of infectivity and pathogenicity to nontarget 
    organisms.
        (d) Information on survival and the ability of the microbial 
    pesticide to increase in numbers (biomass) in the environment (e.g., in 
    the environment into which the microbial pesticide will be introduced, 
    and in substantially different environments that may be in the 
    immediate vicinity). These data may be derived from the scientific 
    literature or from tests conducted in a laboratory or other containment 
    facility.
        (e) The identity of possible transmission vectors (e.g., insects).
        (f) Data on relative environmental competitiveness compared to the 
    parental strain of the microbial pesticide.
        (g) Description of the methods used to genetically modify the 
    microbial pesticide.
        (h) The identity and location of the gene segments that have been 
    rearranged or inserted/deleted (host source, nature, and, for example, 
    base sequence data, or restriction enzyme map of the genes).
        (i) Information on the control region of the genes, and a 
    description of the new traits or characteristics that are expressed.
        (j) Data on potential for genetic transfer and exchange with other 
    organisms and on genetic stability of any inserted sequences in the 
    microbial pesticide.
        (k) A description of the proposed testing program including:
        (1) The purpose or objectives of the proposed testing.
        (2) Designation of the pest organisms involved (common and 
    scientific names).
        (3) The States in which the proposed program will be conducted.
        (4) The exact location of the test sites (including proximity to 
    residences and human activities, surface water, etc.).
        (5) The crops, fauna, flora, geographical description of sites, 
    modes, dosage rates, frequency, and situation of application on or in 
    which the pesticide is to be used.
        (6) The total amount of pesticide product proposed for use in the 
    testing.
        (7) The method of application.
        (8) A comparison of the natural habitat of the microbial pesticide 
    with the proposed test site.
        (9) The number of acres, structural sites, or animals/plants by 
    State, to be treated or included in the area of experimental use.
        (10) Procedures to be used to protect the test area from intrusion 
    by unauthorized individuals.
        (11) The proposed dates or periods during which the testing program 
    is to be conducted, and the manner in which supervision of the program 
    will be accomplished.
        (12) Description of procedures for monitoring the microbial 
    pesticide within and adjacent to the test site during the test.
        (13) The method of sanitation or disposal of plants, animals, 
    soils, farm tools, machinery etc., that will be exposed to the 
    microbial pesticide during or after the test.
        (14) Means of evaluating potential adverse effects and methods of 
    controlling the microbial pesticide if detected beyond the test area.
        (l) A statement of composition for the formulation to be tested, 
    giving:
        (1) The name and percentage by weight (or other suitable units) of 
    each ingredient, active and inert.
        (2) Production methods.
        (3) Extraneous microorganisms present as contaminants.
        (4) Amount and potency of any toxin present.
        (5) Where applicable, the number of viable microorganisms per unit 
    weight or volume of the product or other appropriate system for 
    designating the quantity of active ingredient.
        (m) Any additional factual information regarding the potential for 
    unreasonable adverse effects on the environment.
    
    
    Sec. 172.50   Response to a Notification.
    
        (a) EPA will review and evaluate each Notification as expeditiously 
    as possible and will make a determination no later than 90 days after 
    receipt of the complete Notification; however, under no circumstances 
    shall the proposed test proceed until the submitter has received notice 
    from EPA of its approval of such test.
        (b) For each Notification, EPA may make the following 
    determinations:
        (1) Require additional information from the submitter to assess the 
    proposed test adequately.
        (2) Approve the proposed test.
        (3) Approve the proposed test provided that the submitter makes 
    certain modifications to the test proposal.
        (4) Require an EUP for the test.
        (5) Disapprove the proposed test because of the potential for 
    unreasonable adverse effects. Such disapproval by EPA shall be 
    considered the equivalent of denial of an EUP and the remedies for such 
    denial provided by Sec. 172.10 are available to the submitter.
        (c) If the proposed test is approved by EPA, then the submitter 
    shall perform the test in the same manner described in the 
    Notification, subject to any requirements imposed under paragraph 
    (b)(3) of this section.
    
    
    Sec. 172.52   Notification exemption process.
    
        (a) Initiation of the exemption process. Pesticides may be added to 
    the list of exemptions in Sec. 172.45(d) by rule at EPA's initiative or 
    in response to a petition submitted in accordance with paragraph (b) of 
    this section.
        (b) Petitions for exemption from the requirement for a Notification 
    --(1) Who may submit a petition. Any person may submit a petition 
    requesting an exemption from the notification requirements of this 
    subpart for a specific microbial pesticide or class of microbial 
    pesticides.
        (2) Where to submit a petition. All petitions shall be submitted to 
    the following location: Registration Division (7507C), Office of 
    Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
    Washington, DC 20460.
        (3) Content of petition. Each petition shall contain the following:
        (i) Name and address of petitioner and name, address, and telephone 
    number of a person who may be contacted for further information.
        (ii) Description of the exemption requested, including the specific 
    microbial pesticide or class of microbial pesticides to be tested under 
    the petition for exemption.
        (iii) Basis for the petitioner's contention that the specific 
    microbial pesticide or class of microbial pesticides meet the criteria 
    of Sec. 172.3 for small-scale tests of pesticides that do not require 
    an EUP.
        (iv) Discussion of the extent to which the microbial pesticide or 
    class of microbial pesticides covered by the petition differ from 
    microbial pesticides that are already registered or subject to an EUP 
    under the Act.
        (4) Administrative action on a petition. EPA will review and 
    evaluate petitions as expeditiously as possible and may request further 
    information from the petitioner to assess the proposed exemption 
    adequately. No later than 180 days after the submission of a petition, 
    or 90 days after the last submission of additional information by the 
    petitioner, whichever is later, EPA will take one of the following 
    actions with respect to the petition:
        (i) Grant the petition and publish a notice of proposed rulemaking 
    in the Federal Register for a 45-day comment period proposing the 
    exemption requested by the petitioner.
        (ii) Grant the petition and publish a notice of proposed rulemaking 
    in the Federal Register for a 45-day comment period proposing an 
    exemption under such terms and conditions as EPA deems appropriate.
        (iii) Deny the petition and provide the petitioner with a written 
    explanation of EPA's decision.
        (5) Confidential business information (CBI) claims. To assert a 
    claim of confidentiality, the petitioner must comply with the 
    applicable procedures in Sec. 172.46(d).
        (6) Supplements, amendments, and withdrawals. The petitioner may 
    supplement, amend, or withdraw his or her petition in writing without 
    EPA approval at any time prior to the granting or denial of the 
    petition under paragraph (b)(4) of this section. The withdrawal of a 
    petition shall be without prejudice to the resubmission of the petition 
    at a later date.
    
    
    Sec. 172.57   Submission of information regarding potential 
    unreasonable adverse effects.
    
        Any person using a microbial pesticide in small-scale testing 
    covered by this subpart who obtains information regarding potential 
    unreasonable adverse effects on health or the environment must within 
    30 days of receipt of such information submit the information to EPA, 
    unless the person has actual knowledge that EPA has been adequately 
    informed of such information. The requirement to submit information 
    applies both to those microbial pesticides subject to the notification 
    requirements under Sec. 172.45(c) and those that are exempt under 
    Sec. 172.45(d).
    
    
    Sec. 172.59   Enforcement.
    
        (a) Imminent threat of substantial harm to health or the 
    environment. The use of a microbial pesticide in small-scale testing 
    covered by this subpart (whether subject to the notification 
    requirements of Sec. 172.45(c) or exempt under Sec. 172.45(d)) in a 
    manner that creates an imminent threat of substantial harm to health or 
    the environment is prohibited, and is considered a violation of section 
    12(a)(2)(S) of the Act.
        (b) EPA response to violations. Under section 14 of the Act, EPA 
    may seek civil or criminal penalties for violations of the Act. Failure 
    to comply with the regulations in this part could result in civil or 
    criminal penalties. Moreover, under sections 14 and 16(c) of the Act, 
    EPA may at any time take appropriate action against violators to 
    prevent or otherwise restrain use of a microbial pesticide in small-
    scale testing if it is determined that:
        (1) Such use would create an imminent threat of substantial harm to 
    health or the environment that is prohibited under paragraph (a) of 
    this section; or
        (2) The terms or conditions on which approval of the testing was 
    granted under this Subpart C are violated.
    [FR Doc. 94-21358 Filed 8-31-94; 8:45 am]
    BILLING CODE 6560-50-F
    
    
    

Document Information

Effective Date:
10/31/1994
Published:
09/01/1994
Entry Type:
Uncategorized Document
Action:
Final rule.
Document Number:
94-21358
Dates:
This final rule is effective October 31, 1994.
Pages:
0-0 (1 pages)
Docket Numbers:
Federal Register: September 1, 1994
CFR: (20)
40 CFR 172.3(a)
40 CFR 172.59(a)
40 CFR 2.203(b)
40 CFR 172.46(b)
40 CFR 2.205(c)
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