97-21690. Coat Protein of Potato Virus Y and the Genetic Material Necessary for its Production; Exemption From the Requirement of a Tolerance  

  • [Federal Register Volume 62, Number 158 (Friday, August 15, 1997)]
    [Rules and Regulations]
    [Pages 43653-43657]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-21690]
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    
    40 CFR Part 180
    
    [OPP-300531; FLR-5738-4]
    
    RIN 2070-AB78
    
    
    Coat Protein of Potato Virus Y and the Genetic Material Necessary 
    for its Production; Exemption From the Requirement of a Tolerance
    
    AGENCY: Environmental Protection Agency (EPA).
    ACTION: Final Rule.
    
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    SUMMARY: This rule establishes an exemption from the requirement of a 
    tolerance for residues of the biological pesticide Coat Proteins of 
    Potato Virus Y and the genetic material necessary for its production in 
    or on all raw agricultural commodities. Monsanto Company submitted a 
    petition to EPA under the Federal Food, Drug and Cosmetic Act as 
    amended by the Food Quality Protection Act of 1996 requesting the 
    tolerance exemption. This regulation eliminates the need to establish a 
    maximum permissible level for residues of Coat Proteins of Potato Virus 
    Y and the genetic material necessary for its production.
    DATES: This regulation is effective August 15, 1997. Objections and 
    requests for hearings must be received by EPA on or before October 14, 
    1997.
    ADDRESSES: Written objections and hearing requests, identified by the 
    docket control number [OPP-300531], must be submitted to: Hearing Clerk 
    (1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., 
    Washington, DC 20460. Fees accompanying objections and hearing requests 
    shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA 
    Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O. 
    Box 360277M, Pittsburgh, PA 15251. A copy of any objections and hearing 
    requests filed with the Hearing Clerk identified by the docket control 
    number, [OPP-300531], must also be submitted to: Public Information and 
    Records Integrity Branch, Information Resources and Services Division 
    (7506C), Office of Pesticide Programs, Environmental Protection Agency, 
    401 M St., SW., Washington, DC 20460. In person, bring a copy of 
    objections and hearing requests to Rm. 1132, CM #2, 1921 Jefferson 
    Davis Hwy., Arlington, VA.
        A copy of objections and hearing requests filed with the Hearing 
    Clerk may be submitted electronically by sending electronic mail (e-
    mail) to: opp-docket@epamail.epa.gov. Copies of
    
    [[Page 43654]]
    
    electronic objections and hearing requests must be submitted as an 
    ASCII file avoiding the use of special characters and any form of 
    encryption. Copies of electronic objections and hearing requests will 
    also be accepted on disks in WordPerfect 5.1 file format or ASCII file 
    format. All copies of electronic objections and hearing requests must 
    be identified by the docket number [OPP-300531]. No Confidential 
    Business Information (CBI) should be submitted through e-mail. Copies 
    of electronic objections and hearing requests on this rule may be filed 
    online at many Federal Depository Libraries.
    FOR FURTHER INFORMATION CONTACT: By mail: Linda Hollis, c/o Product 
    Manager (PM) 90, Biopesticides and Pollution Prevention Division 
    (7501W), Environmental Protection Agency, 401 M St., SW., Washington, 
    DC 20460. Office location, telephone number, and e-mail: Rm. 5th fl., 
    CS#1 2800 Crystal Drive, Arlington, VA 22202, (703) 308-8733, e-mail: 
    hollis.linda@epamail.epa.gov
    SUPPLEMENTARY INFORMATION: In the Federal Register of June 25, 1997 (62 
    FR 34281-34283)(FRL-5723-2), EPA issued a notice pursuant to section 
    408(d), of the Federal Food Drug & Cosmetic Act (FFDCA), 21 U.S.C. 
    346a(d), announcing the filing of a pesticide tolerance petition by 
    Monsanto Company, St. Louis, MO. The notice contained a summary of the 
    petition prepared by the petitioner and this summary contained 
    conclusions and arguments to support its conclusion that the petition 
    complied with the Food Quality Protection Act (FQPA) of 1996. The 
    petition requested that 40 CFR part 180 be amended by establishing an 
    exemption from the requirement of a tolerance for residues of the 
    biological pest control agent Coat Protein of Potato Virus Y and the 
    genetic material necessary for its production in or on all raw 
    agricultural commodities.
        There were no comments or requests for referral to an advisory 
    committee received in response to the notice of filing.
        The data submitted in the petition and other material have been 
    evaluated. The toxicology data requirements in support of this 
    exemption from the requirement of a tolerance were satisfied via data 
    waivers from the open scientific literature.
    
    I. Risk Assessment and Statutory Findings
    
        New section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an 
    exemption from the requirement for a tolerance (the legal limit for a 
    pesticide chemical residue in or on a food) only if EPA determines that 
    the tolerance is ``safe.'' Section 408(c)(2)(ii) defines ``safe'' to 
    mean that ``there is a reasonable certainty that no harm will result 
    from aggregate exposure to the pesticide chemical residue, including 
    all anticipated dietary exposures and all other exposures for which 
    there is reliable information.'' This includes exposure through 
    drinking water and in residential settings, but does not include 
    occupational exposure. Section 408(c)(2)(B) requires EPA to give 
    special consideration to exposure of infants and children to the 
    pesticide chemical residue in establishing a tolerance and to ``ensure 
    that there is a reasonable certainty that no harm will result to 
    infants and children from aggregate exposure to the pesticide chemical 
    residue***.'' EPA performs a number of analyses to determine the risks 
    from aggregate exposure to pesticide residues. First, EPA determines 
    the toxicity of pesticides. Second, EPA examines exposure to the 
    pesticide through food, drinking water, and through other exposures 
    that occur as a result of pesticide us in residential settings.
    
    II. Toxicological Profile
    
        Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
    available scientific data and other relevant information in support of 
    this action and considered its validity, completeness and reliability 
    and the relationship of this information to human risk. EPA has also 
    considered available information concerning the variability of the 
    sensitivities of major identifiable subgroups of consumers, including 
    infants and children.
        Additionally, section 408(b)(2)(D)(v) requires that, when 
    considering whether to establish, modify, or revoke a tolerance, the 
    Agency consider ``available information'' concerning the cumulative 
    effects of a particular pesticide's residues and ``other substances 
    that have a common mechanism of toxicity.'' All available information 
    indicates that viral coat proteins in food have no human toxicity and 
    EPA is not aware of any other substances within or outside of the food 
    supply that might have a common mechanism of human toxicity with 
    residues of viral coat proteins produced in plants as part of a plant-
    pesticide.
        Data waivers were requested for acute toxicity, genotoxicity, 
    reproductive and developmental toxicity, subchronic toxicity and 
    chronic toxicity data. The data waivers were accepted based on the long 
    history of mammalian consumption of the entire plant virus particle in 
    foods, without causing any deleterious human health effects [See OPP-
    300367A; FRL-5716-6]. Virus-infected plants currently are and have 
    always been a part of both the human and domestic animal food supply 
    and there have been no findings which indicate that plant viruses are 
    toxic to humans and other vertebrates. Further, plant viruses are 
    unable to replicate in mammals or other vertebrates, thereby 
    eliminating the possibility of human infection. More importantly, 
    however, this tolerance exemption will apply to that portion of the 
    viral genome coding for the whole coat protein and any subcomponent of 
    the coat protein expressed in the plant. This component alone is 
    incapable of forming infectious particles.
        The genetic material necessary for the production of the plant-
    pesticides active and inert ingredients are the nucleic acids (DNA) 
    which comprise (1) genetic material encoding these viral coat proteins 
    and their regulatory regions. ``Regulatory regions: are the genetic 
    material that control the expression of the genetic material encoding 
    the proteins, such as promoters, terminators, and enhancers. DNA is 
    common to all forms of plant and animal life and the Agency knows of no 
    instance where these nucleic acids have been associated with toxic 
    effects related to their consumption as a component of food. These 
    ubiquitous nucleic acids as they appear in the subject plant-
    pesticide's inert ingredient have been adequately characterized by the 
    applicant and supports EPA's conclusion that no mammalian toxicity is 
    anticipated from dietary exposure to the genetic material necessary for 
    the production of the coat protein of Potato Virus Y and inert plant 
    pesticidal ingredients.
    
    III. Aggregate Exposures
    
        In examining aggregate exposure, FFDCA section 408 directs EPA to 
    consider available information concerning exposures from the pesticide 
    residue in food and all other non-occupational exposures, including 
    drinking water from groundwater or surface water and exposure through 
    pesticide use in gardens, lawns, or buildings (residential and other 
    indoor uses).
        1. Dietary exposure--a. Food. The use of viral coat protein 
    mediated resistance will not result in any new dietary exposure to 
    plant viruses. Entire infectious particles of Potato Virus Y, including 
    the coat protein component, are found in the fruit, leaves and stems of 
    most plants. Viruses are ubiquitous in the agricultural environment at 
    levels higher than will be present in transgenic
    
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    plants. Virus infected food plants have historically been a part of the 
    human and domestic animal food supply with no observed adverse effects 
    to human health and infants and children upon consumption. Therefore, 
    the lack of toxicity associated with plant viruses and the history of 
    contamination of the food supply by virus coat proteins provides a 
    scientific rationale for exempting from the requirement of a tolerance 
    transgenic plants expressing virus coat proteins and leads the Agency 
    to conclude that the use of Coat Protein of Potato Virus Y and the 
    genetic material necessary for its production will not pose a dietary 
    risk of concern under normal conditions. Moreover, there is no evidence 
    which indicates that adverse effects due to aggregate exposure of viral 
    coat proteins (with substances outside the food supply) through 
    dietary, non-food oral, dermal and inhalation occurs. This conclusion 
    is suppported by the EPA's Scientific Advisory Panel's discussion 
    regarding the Agency's Regulatory approach for plant pesticides which 
    concluded:
        i. The levels of virus in the agricultural environment are much 
    higher than those levels present in transgenic plants.
        ii. The existing contamination of the current food supply provides 
    a scientific rationale for exempting from the requirement of a 
    tolerance transgenic plants which express viral coat proteins.
        b. Drinking water exposure. Potential non-occupational exposures in 
    drinking water is negligible. Viral coat proteins produced in plants as 
    part of a plant-pesticide are an integral part of the living tissue of 
    the plant. As such, these components are subject to degradation and 
    decay, a process which occurs fairly rapidly. Viral coat proteins 
    produced in plants as part of a plant-pesticide do not persist in the 
    environment or bioaccumulate. The rapid turnover of these substances in 
    the environment limits their ability to present anything other than a 
    very negligible exposure in drinking water drawn from either surface or 
    groundwater sources.
        2. Other non-occupational exposure. Other non-occupational exposure 
    of engineered coat proteins via residential and indoor uses, e.g., uses 
    around homes, parks, recreation areas, athletic fields and golf 
    courses, will be minimal to non-existent as the coat protein is 
    expressed only within the plant tissues.
        a.  Dermal exposure. Due to the nature of viral coat proteins 
    produced in plants as part of a plant-pesticide, exposure through any 
    route (i.e., dermal, respiratory) other than dietary is unlikely to 
    occur. Physical contact with the plant or raw agricultural food from 
    the plant may present some limited opportunity for dermal exposure. 
    However, on a per person basis, the potential amounts involved in this 
    exposure is negligible in comparison to exposure through the dietary 
    route. Additionally, viral coat proteins produced in plants as part of 
    a plant-pesticide are unlikely to cross the barrier provided by the 
    skin.
        b. Inhalation exposure. The occurrence of respiratory exposure of 
    viral coat proteins produced in plants as part of a plant-pesticide is 
    negligible in comparison to potential exposure through the dietary 
    route. In some cases, viral coat proteins may be present in pollen, 
    thus affording exposure to those individuals in areas exposed to wind-
    blown pollen. However, it is unlikely that exposure to the pollen is 
    equivalent to exposure to viral coat proteins produced in plants as 
    part of a plant-pesticide. Viral coat proteins, when present in pollen, 
    will likely be integrated into the tissue of pollen grain and are 
    unlikely to cross the barrier provided by the mucous membrane of the 
    respiratory tract and thus are not additive to dietary exposure. 
    Moreover, exposure through inhalation via wind-blown pollen occurs to 
    the whole virus particle and there is no evidence which suggests that 
    exposure to whole plant viruses by wind-blown pollen results in any 
    adverse effects. Therefore, it is unlikely that exposure to pollen that 
    may contain viral coat proteins produced in plants as part of a plant-
    pesticide would result in adverse effects.
    
    IV. Safety Factors
    
        Rather than relying on available animal experimentation data to 
    support a tolerance exemption for viral coat proteins, EPA relied on 
    the long history of safe human consumption of food containing plant 
    viruses as the appropriate information base for this tolerance 
    exemption. Because the EPA did not rely on animal data, determination 
    of appropriate safety factors to be used in a human risk assessment was 
    not considered.
    
    V. Infants and Children
    
        Consistent with section 408(b)(2)(C) of the FFDCA, EPA has assessed 
    the available information about consumption patterns among infants and 
    children, special susceptibility of infants and children to pesticide 
    chemical residues and the cumulative effects on infants and children of 
    the residues and other substances with a common mechanism of toxicity. 
    Based on all available information, the Agency concludes that viral 
    coat proteins produced in plants as part of a plant-pesticide are 
    ubiquitous in foods, including those foods consumed by infants and 
    children. Moreover, there is no reason to believe that plant viral coat 
    proteins are likely to occur in different amounts in foods, consumed by 
    children and infants. Children are exposed as part of a normal diet to 
    viral coat proteins and there is no evidence which indicates that viral 
    coat proteins would have a diferent effect on children than on adults. 
    Further, there is no evidence which suggests that such exposure to 
    either adults or infants and children leads to any harm.
    
    VI. Other Considerations
    
        1. Endocrine disrupters. The Agency has no informtion to suggest 
    that Coat Proteins of Potato Virus Y and the genetic material necessary 
    for its production will have an effect on the immune and endocrine 
    systems. The Agency is not requiring information on the endocrine 
    effects of this biological pesticide at this time; Congress has allowed 
    3 years after August 3, 1996, for the Agency to implement a screening 
    program with respect to endocrine effects.
        2.  Analytical method. The Agency proposes to establish an 
    exemption from the requirement of a tolerance without any numerical 
    limitation; therefore, the agency has concluded that an analytical 
    method is not required for enforcement purposes for Coat Protein of 
    Potato Virus Y and the genetic material necessary for its production.
    
    VII. Determination of Safety for U.S. Population, Infants and 
    Children
    
        For the U.S. population, including infants and children, Potato 
    Virus Y Coat Protein and the genetic material necessary for its 
    production has no known adverse effects. Extensive use and experience 
    show the safety of foods containing viral coat proteins. There has been 
    no evidence in the many years of human experience with the growing and 
    consumption of food from plants containing viral coat proteins which 
    indicates that adverse effects due to aggregate exposure through the 
    dietary, non-food oral, dermal and inhalation routes occur. Therefore, 
    EPA concludes that there is reasonable certainty that no harm will 
    result to the U.S. population from aggregate exposure to residues of 
    viral coat proteins produced in plants as part of a plant-pesticide 
    including all anticipated dietary exposures and all other exposures for 
    which there is reliable information. The Agency has arrived at this 
    conclusion because, as discussed above, no toxicity to mammals has been 
    observed for coat
    
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    protein of Potato Virus Y and the genetic material necessary for its 
    production. Thus, a tolerance for this Coat Protein of Potato Virus Y 
    and the genetic material necessary for its production is not necessary 
    to protect the public health. Therefore, 40 CFR part 180 is amended as 
    set forth below.
    
    VIII. Objections and Hearing Requests
    
        The new FFDCA section 408(g) provides essentially the same process 
    for persons to ``object'' to a regulation for an exemption from the 
    requirement of a tolerance issued by EPA under new section 408(d) as 
    was provided in the old section 408 and in section 409. However, the 
    period for filing objections is 60 days, rather than 30 days. EPA 
    currently has procedural regulations which governs the submission of 
    objections and hearing requests. These regulations will require some 
    modification to reflect the new law. However, until those modifications 
    can be made, EPA will continue to use those procedural regulations with 
    appropriate adjustments to reflect the new law.
        Any person may, by October 14, 1997, file written objections to any 
    aspect of this regulation and may also request a hearing on those 
    objections. Objections and hearing requests must be filed with the 
    hearing clerk, at the address given under the ``ADDRESSES'' section (40 
    CFR 178.20). A copy of the objections and/or hearing requests filed 
    with the hearing clerk should be submitted to the OPP docket for this 
    rulemaking. The objections submitted must specify the provisions of the 
    regulation deemed objectionable and the grounds for the objections (40 
    CFR 178.25). Each objection must be accompanied by the fee prescribed 
    by 40 CFR 180.33(i). If a hearing is requested, the objections must 
    include a statement of the factual issues(s) on which a hearing is 
    requested, the requestor's contentions on such issues, and a summary of 
    any evidence relied upon by the objector (40 CFR 178.27). A request for 
    a hearing will be granted if the Administrator determines that the 
    material submitted shows the following: There is a genuine and 
    substantial issue of fact; there is a reasonable possibility that 
    available evidence identified by the requestor would, if established 
    resolve one or more of such issues in favor of the requestor, taking 
    into account uncontested claims or facts to the contrary; and 
    resolution of the factual issues(s) in the manner sought by the 
    requestor would be adequate to justify the action requested (40 CFR 
    178.32). Information submitted in connection with an objection or 
    hearing request may be claimed confidential by marking any part or all 
    of that information as CBI. Information so marked will not be disclosed 
    except in accordance with procedures set forth in 40 CFR part 2. A copy 
    of the information that does not contain CBI must be submitted for 
    inclusion in the public record. Information not marked confidential may 
    be disclosed publicly by EPA without prior notice.
    
    IX. Public Docket
    
        A record has been established for this rulemaking under docket 
    control number [OPP-300531]. A public version of this record, which 
    does not include any information claimed as CBI, is available for 
    inspection from 8:30 a.m. to 4 p.m., Monday through Friday, excluding 
    legal holidays. The public record is located in Room 1132 of the Public 
    Information and Records Integrity Branch, Information Resources and 
    Services Division (7506C), Office of Pesticide Programs, Environmental 
    Protection Agency, Crystal Mall #2, 1921 Jefferson Davis Highway, 
    Arlington, VA 22202.
        Electronic comments can be sent directly to EPA at:
        opp-docket@epamail.epa.gov
    
        Electronic comments must be submitted as an ASCII file avoiding the 
    use of special characters and any form of encryption.
        The official record for this rulemaking, as well as the public 
    version, as described above, is kept in paper form. Accordingly, in the 
    event there are objections and hearing request, EPA will transfer any 
    copies of objections and hearing requests received electronically into 
    printed, paper form as they are received and will place the paper 
    copies in the official rulemaking record. The official rulemaking 
    record is the paper record maintained at the Virginia address in 
    ``ADDRESSES'' at the beginning of this document.
    
    X. Regulatory Assessment Requirements
    
        This final rule establishes an exemption from the tolerance 
    requirement under FFDCA section 408(d) in response to a petition 
    submitted to the Agency. The Office of Management and Budget (OMB) has 
    exempted these types of actions from review under Executive Order 
    12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
    1993). This final rule does not contain any information collections 
    subject to OMB approval under the Paperwork Reduction Act (PRA), 44 
    U.S.C. 3501 et seq., or impose any enforceable duty or contain any 
    unfunded mandate as described under Title II of the Unfunded Mandates 
    Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does it require any 
    prior consultation as specified by Executive Order 12875, entitiled 
    Enhancing the Intergovernmental Partnership (58 FR 58093, October 28, 
    1993), or special considerations as required by Executive Order 12898, 
    entitled Federal Actions to Address Environmental Justice in Minority 
    Populations and Low-Income Populations (59 FR 7629), February 16, 
    1994), or require OMB review in accordance with Executive Order 13045, 
    entitled Protection of Children from Environmental Health Risks and 
    Safety Risks (62 FR 19885, April 23, 1997).
        In additions, since tolerance exemptions that are established on 
    the basis of a petition under FFDCA section 408(d), such as the 
    exemption in this final rule, do not require the issuance of a proposed 
    rule, the requirements of the Regulatory Flexibility Act (RFA) (5 
    U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency previously 
    assessed whether establishing tolerances, exemptions from tolerances, 
    raising tolerance levels or expanding exemptions might adversely impact 
    small entities and concluded, as a generic matter, that there is no 
    adverse economic impact. The factual basis for the Agency's generic 
    certification for tolerance actions published on May 4, 1981 (46 FR 
    24950), and was provided to the Chief Counsel for Advocacy of the Small 
    Business
    
    XI. Submission to Congress and the General Accounting Office
    
        Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business 
    Regulatory Enforcement Fairness Act of 1996, the Agency has submitted a 
    report containing this rule and other required information to the U.S. 
    Senate, the U.S. House of Representatives and the Comptroller General 
    of the General Accounting Office prior to publication of the rule in 
    today's Federal Register. This is not a major rule as defined by 5 
    U.S.C. 804(2).
    
    List of Subjects in 40 CFR Part 180
    
        Environmental protection, Administrative practice and procedure, 
    Agricultural commodities, Pesticides and pests, Reporting and 
    recordkeeping requirements.
    
        Dated: August 7, 1997.
    
    Daniel M. Barolo,
    
    Director, Office of Pesticide Programs.
        Therefore, 40 CFR part 180 is amended as follows:
        1. The authority citation for part 180 continues to read as 
    follows:
    
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        Authority: 21 U.S.C. 346a and 371.
    
        2. Section 180.1182 is added to subpart D to read as follows:
    
    
    Sec. 180.1182  Coat Protein of Potato Virus Y and the genetic material 
    necessary for its production; exemption from the requirement of a 
    tolerance.
    
        An exemption fron the requirement of a tolerance is established for 
    residues of the biological plant pesticide Coat Protein of Potato Virus 
    Y and the genetic material necessary for its production in or on all 
    food commodities.
    [FR Doc. 97-21690 Filed 8-14-97; 8:45 am]
    BILLING CODE 6560-50-F
    
    
    

Document Information

Effective Date:
8/15/1997
Published:
08/15/1997
Department:
Environmental Protection Agency
Entry Type:
Rule
Action:
Final Rule.
Document Number:
97-21690
Dates:
This regulation is effective August 15, 1997. Objections and requests for hearings must be received by EPA on or before October 14, 1997.
Pages:
43653-43657 (5 pages)
Docket Numbers:
OPP-300531, FLR-5738-4
RINs:
2070-AB78
PDF File:
97-21690.pdf
CFR: (1)
40 CFR 180.1182