97-3518. Propargite; Proposed Revocation of Certain Tolerances  

  • [Federal Register Volume 62, Number 30 (Thursday, February 13, 1997)]
    [Proposed Rules]
    [Pages 6750-6753]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-3518]
    
    
    -----------------------------------------------------------------------
    
    
    ENVIRONMENTAL PROTECTION AGENCY
    40 CFR Parts 180, 185, and 186
    
    [OPP-300432; FRL-5381-9]
    RIN 2070-AC18
    
    
    Propargite; Proposed Revocation of Certain Tolerances
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Proposed Rule.
    
    -----------------------------------------------------------------------
    
    SUMMARY: EPA is proposing to revoke tolerances for residues of the 
    pesticide Propargite in or on the following commodities: apples, dried 
    apple pomace, apricots, cranberries, figs, dried figs, peaches, pears, 
    plums (fresh prunes), strawberries, and succulent beans. EPA is 
    proposing these revocations because the uses associated with the 
    tolerances have been voluntarily deleted from propargite labels by 
    Uniroyal Chemical Company. Uniroyal deleted the uses to address risk 
    concerns raised by EPA.
    DATES: Written comments should be submitted to EPA by April 14, 1997.
    
    ADDRESSES: By mail, submit comments to Public Response and Program 
    Resources Branch, Field Operations Division (7506C), Office of 
    Pesticide Programs, 401 M St., SW., Washington, DC 20460. In person, 
    bring comments to Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis 
    Highway, Arlington, VA.
        Comments and data may also be submitted electronically by sending 
    electronic mail (e-mail) to: 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. Comments and data will also be 
    accepted on disks in WordPerfect in 5.1 file format or ASCII file 
    format. All comments and data in electronic form must be identified by 
    the docket number [OPP-300432]. No Confidential Business Information 
    (CBI) should be submitted through e-mail. Electronic comments on this 
    proposed rule may be filed online at many Federal Depository Libraries. 
    Additional information on electronic submissions can be found in Unit 
    VII. of this document.
    
    FOR FURTHER INFORMATION CONTACT: By mail: Jeff Morris, Special Review 
    and Reregistration Division (7508W), Environmental Protection Agency, 
    401 M St., SW., Washington, DC 20460.
    
    [[Page 6751]]
    
    Office location, telephone number and e-mail address: Special Review 
    Branch, Crystal Station #1, 3rd floor, 2800 Crystal Drive, Arlington, 
    VA 22202, telephone: (703) 308-8029; e-mail: 
    morris.jeffrey@epamail.epa.gov.
    SUPPLEMENTARY INFORMATION:
    
    I. Introduction
    
        Propargite (trade names Omite and Comite) is a pesticide that was 
    registered in 1969 for the control of mites on a number of agricultural 
    commodities and ornamental plants. EPA classifies propargite as a 
    B2 (probable) human carcinogen.
    
    II. Legal Authorization
    
        The Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et 
    seq., as amended by the Food Quality Protection Act of 1996 (FQPA), 
    Pub. L. 104-170, authorizes the establishment of tolerances (maximum 
    residue levels), exemptions from the requirement of a tolerance, 
    modifications in tolerances, and revocation of tolerances for residues 
    of pesticide chemicals in or on raw agricultural commodities and 
    processed foods pursuant to section 408 [21 U.S.C. 346(a), as amended]. 
    Without a tolerance or exemption, food containing pesticide residues is 
    considered to be unsafe and therefore ``adulterated'' under section 
    402(a) of the FFDCA, and hence may not legally be moved in interstate 
    commerce [21 U.S.C. 342]. For a pesticide to be sold and distributed, 
    the pesticide must not only have appropriate tolerances under the 
    FFDCA, but also must be registered under section 3 of the Federal 
    Insecticide, Fungicide, and Rodenticide Act (FIFRA, 7 U.S.C. 136 et 
    seq.).
    
    III. Regulatory Background
    
        EPA published a Registration Standard for propargite in 1986, and 
    FIFRA reregistration is ongoing. Through the reregistration process, in 
    1992 EPA received from Uniroyal Chemical Company, the sole propargite 
    registrant in the United States, a voluntarily submitted market basket 
    survey examining residue levels in selected commodities in a nation-
    wide cross section of grocery stores. The survey attempted to better 
    reflect propargite residues in these commodities as purchased by 
    consumers. Uniroyal's market basket survey, as well as other sampling 
    data used by EPA, indicated propargite residues on certain foods such 
    as apples and peaches that were far below tolerance levels but 
    nevertheless resulted in dietary risks of concern for those foods. 
    Based on this and other information, EPA conducted an intensive dietary 
    risk assessment and concluded that long-term exposure to propargite 
    posed an unreasonable dietary cancer risk to persons who consume 
    propargite-treated foods.
    
    A. Use Deletions
    
        EPA discussed its risk findings with Uniroyal, and Uniroyal 
    responded in an April 5, 1996 letter by requesting, among other things, 
    voluntary deletion of the following uses from all applicable propargite 
    labels: apples, apricots, cranberries, figs, green beans, lima beans, 
    peaches, pears, plums (including plums grown for prune production), and 
    strawberries. EPA agreed to this request, and the deletions were 
    announced in a Federal Register notice dated May 3, 1996 (61 FR 19936) 
    (FRL-5367-4). EPA received comments both supporting and opposing the 
    use deletions; those comments were considered prior to the requested 
    use deletions taking effect on August 1, 1996. The comments are 
    available in the public record under docket number OPP-64029. As part 
    of its use-deletion agreement with EPA, Uniroyal also agreed not to 
    challenge revocation of tolerances for any of the deleted uses.
    
    B. Previous Actions
    
        EPA previously proposed to revoke the apple and fig tolerances 
    listed under 40 CFR 180.259, because apples and figs had or needed food 
    additive regulations (FAR) that were prohibited by the Delaney clause. 
    Under EPA's coordination policy, EPA proposed to revoke the tolerances 
    for apples and figs (61 FR 8174, March 1, 1996) (FRL-5351-6). On March 
    22, 1996, EPA issued a final rule, subject to objections, revoking the 
    FARs for dried figs and tea, also on grounds that the FARs violated the 
    Delaney clause (61 FR 11994)(FRL-5357-7). The propargite registrant 
    filed objections to the ``induces cancer'' ground for the final 
    revocation and requested a hearing. Those revocations were stayed. In 
    the same notice, EPA revoked the FAR for raisins because it was not 
    needed. However, the August 3, 1996 enactment of the FQPA removed 
    pesticides from coverage under FFDCA section 409 and the Delaney 
    clause. Therefore, the proposed and final revocations based on Delaney 
    clause grounds have no basis in law. Accordingly, EPA published a 
    notice in the Federal Register (61 FR 50684, September 26, 1996)(FRL-
    5397-4) withdrawing the proposed and final revocations for apples and 
    figs that were premised on the Delaney clause.
        The dried apple pomace tolerance listed under 40 CFR 186.5000 was 
    proposed for revocation on September 21, 1995 (60 FR 49142)(FRL-4977-3) 
    on the ground that dried apple pomace is no longer listed on Table 1 of 
    Series 860--Residue Chemistry Test Guidelines (formerly Table II of 
    Subdivision O of EPA's Pesticide Assessment Guidelines), and therefore 
    a tolerance is not needed.
    
    IV. Current Proposal
    
        This notice proposes to revoke the following tolerances established 
    under sections 408 and 409 of FFDCA (as a matter of law, these 
    tolerances are now all considered to be under section 408) for residues 
    of the pesticide propargite (2-(p-tert-butylphenoxy) cyclohexyl 2-
    propynyl sulfite) in or on the following commodities listed under 40 
    CFR 180.259, 185.5000, and 186.5000:
        Under Sec. 180.259: apples, 3 parts per million (ppm); apricots, 7 
    ppm; beans, succulent, 20 ppm; cranberries, 10 ppm; figs, 3 ppm; 
    peaches, 7 ppm; pears, 3 ppm; plums (fresh prunes), 7 ppm; 
    strawberries, 7 ppm.
        Under Sec. 185.5000: figs, dried, 9 ppm.
        Under Sec. 186.5000: apple pomace, dried, 80 ppm.
        EPA is proposing these revocations because the registrant requested 
    that the uses associated with the above tolerances be formally deleted 
    from all of its propargite registrations, and those uses have been 
    deleted. End-use propargite labels no longer list as registered uses 
    the commodities associated with these tolerances. It is EPA's general 
    practice to revoke tolerances where the associated pesticide use has 
    been deleted from all FIFRA labels. See 40 CFR 180.32(b).
        An additional ground for revoking the dried apple pomace tolerance 
    is that dried apple pomace is no longer listed on Table 1 of Series 
    860--Residue Chemistry Test Guidelines, because it is no longer 
    considered to be a significant livestock feed item and therefore does 
    not require a feed additive regulation. Documentation explaining EPA's 
    conclusions on what animal feeds are significant has been included in 
    the public record.
        Propargite degrades in soil with a half-life of less than 60 days. 
    Based on this lack of persistence, there is no expectation of 
    unavoidable residues.
        Codex maximum residue limits exist for propargite. Propargite is a 
    candidate for Codex re-evaluation, but review has not yet been 
    scheduled. EPA requests comments on whether residues are present in or 
    on imported commodities.
    
    V. Effective Dates of Proposed Tolerance Revocations
    
        Prior to the amendment of the FFDCA, it was generally the practice 
    of
    
    [[Page 6752]]
    
    EPA in similar instances to establish an effective date for each 
    tolerance revocation that takes into consideration the time needed for 
    legally treated food to pass entirely through the channels of trade. 
    That is no longer necessary because under section 408(l)(5), food 
    lawfully treated will not be rendered adulterated despite the lack of a 
    tolerance so long as the residue on the food complies with the 
    tolerance in place at the time of treatment.
        At this time, EPA estimates that legally treated commodities should 
    clear the channels of trade within 3 years of issuance of a final order 
    revoking these tolerances. This is based on a preliminary EPA estimate 
    that food processors attempt to deliver their products to grocery 
    stores within 2 years of production, and that the products in general 
    remain on store shelves for less than 1 year. EPA also estimates that 
    no fresh market commodities are expected to be in the channels of trade 
    3 years after treatment with propargite. However, because it is 
    important to FDA as the agency that monitors residues in food to have 
    accurate information regarding the length of time required for each 
    affected commodity to move through commerce, EPA specifically requests 
    comment from growers, processors, and other interested parties on this 
    matter. The procedure for filing comments is described below in unit VI 
    of this preamble.
    
    VI. Public Comment Procedures
    
        EPA invites interested persons to submit written comments, 
    information, or data in response to this proposed rule. After 
    consideration of comments, EPA will issue a final rule. Such rule will 
    be subject to objections. Failure to file an objection within the 
    appointed period will constitute waiver of the right to raise in future 
    proceedings issues resolved in the final rule.
        Comments must be submitted by April 14, 1997, and must bear a 
    notation indicating the docket number [OPP-300432]. Three copies of the 
    comments should be submitted to either location listed under ADDRESSES 
    at the beginning of this notice.
        Information submitted as a comment concerning this notice may be 
    claimed confidential by marking any or all of that information as CBI. 
    EPA will not disclose information so marked, except in accordance with 
    procedures set forth in 40 CFR part 2. A second copy of such comments, 
    with the CBI deleted, also must be submitted for inclusion in the 
    public record. EPA may publicly disclose without prior notice 
    information not marked confidential.
    
    VII. Public Record
    
        A record has been established for this notice under docket number 
    [OPP-300432] (including comments and data submitted electronically as 
    described below). A public version of this record, including printed, 
    paper versions of electronic comments, that 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 Rm. 1132 of the Public Response and Program 
    Resources Branch, Field Operations Division (7506C), Office of 
    Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 
    1921 Jefferson Davis Highway, Arlington, VA.
        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 notice, as well as the public version, 
    as described above will be kept in paper form. Accordingly, EPA will 
    transfer all comments received electronically into printed, paper form 
    as they are received and will place the paper copies in the official 
    record, which will also include all comments submitted directly in 
    writing. The official rulemaking record is the paper record maintained 
    at the address in ``ADDRESSES'' at the beginning of this notice.
    
    VIII. Regulatory Assessment Requirements
    
        Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
    action is not a ``significant regulatory action'' and, since this 
    action does not impose any information collection requirements subject 
    to approval under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., 
    it is not subject to review by the Office of Management and Budget. In 
    addition, this action does not impose any enforceable duty, or contain 
    any ``unfunded mandates'' as described in Title II of the Unfunded 
    Mandates Reform Act of 1995 (Pub. L. 104-4), or require prior 
    consultation as specified by Executive Order 12875 (58 FR 58093, 
    October 28, 1993), entitled Enhancing the Intergovernmental 
    Partnership, or special considerations as required by Executive Order 
    12898 (59 FR 7629, February 16, 1994).
        Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), the 
    Administrator has determined that there will be no economic impacts 
    from revocation of the tolerances in this notice, because the 
    registrant has cancelled the uses. Despite the revocation, commodities 
    legally treated under FIFRA and consistent with the tolerance in place 
    at time of treatment are allowed by the statute to clear the channels 
    of trade. Therefore, EPA certifies that this action will not have a 
    significant impact on a substantial number of small entities.
    
    List of Subjects
    
    40 CFR Part 180
    
        Environmental protection, Administrative practice and procedure, 
    Agricultural commodities, Pesticides and pests, Reporting and 
    recordkeeping requirements.
    
    40 CFR Part 185
    
        Food additives, Pesticide and pest.
    
    40 CFR Part 186
    
        Animal feeds, Pesticide and pest.
    
        Dated: January 31, 1997.
    
    Daniel M. Barolo,
    
    Director, Office of Pesticide Programs.
        Therefore, it is proposed that 40 CFR parts 180, 185, and 186 be 
    amended to read as follows:
    
    PART 180--[Amended]
    
        1. In part 180:
        a. The authority citation for part 180 continues to read as 
    follows:
        Authority: 21 U.S.C. 346a and 371.
    
    Sec. 180.259 [Amended]
    
        b. In Sec. 180.259, the table in paragraph (a) is amended by 
    removing the entries for apples; apricots; beans, succulent; 
    cranberries; figs; peaches; pears; plums (fresh prunes); and 
    strawberries.
    
    PART 185--[AMENDED]
    
        2. In part 185:
        a. The authority citation for part 185 continues to read as 
    follows:
        Authority: 21 U.S.C. 348.
    
    Sec. 185.5000 [Amended]
    
        b. Section 185.5000 is amended by removing the entry for ``Figs, 
    dried.''
    
    PART 186--[AMENDED]
    
        3. In part 186:
        a. The authority citation for part 186 continues to read as 
    follows:
        Authority: 21 U.S.C. 348.
    
    
    [[Page 6753]]
    
    
    
    Sec. 186.5000 [Amended]
    
        b. Section 186.5000 is amended by removing the entry for ``Apple 
    pomace, dried.''
    
    [FR Doc. 97-3518 Filed 2-12-97; 8:45 am]
    BILLING CODE 6560-50-F
    
    
    

Document Information

Published:
02/13/1997
Department:
Environmental Protection Agency
Entry Type:
Proposed Rule
Action:
Proposed Rule.
Document Number:
97-3518
Dates:
Written comments should be submitted to EPA by April 14, 1997.
Pages:
6750-6753 (4 pages)
Docket Numbers:
OPP-300432, FRL-5381-9
RINs:
2070-AC18
PDF File:
97-3518.pdf
CFR: (3)
40 CFR 180.259
40 CFR 185.5000
40 CFR 186.5000