97-12914. American Cyanamid Company; Pesticide Tolerance Petition Filing  

  • [Federal Register Volume 62, Number 95 (Friday, May 16, 1997)]
    [Notices]
    [Pages 27025-27027]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-12914]
    
    
    -----------------------------------------------------------------------
    
    ENVIRONMENTAL PROTECTION AGENCY
    
    [PF-735; FRL-5717-8]
    
    
    American Cyanamid Company; Pesticide Tolerance Petition Filing
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Notice.
    
    -----------------------------------------------------------------------
    
    SUMMARY: This notice announces the initial filing of a pesticide 
    petition proposing the establishment of regulations for residues of a 
    certain pesticide chemical in or on various food commodities.
    DATES: Comments, identified by the docket control number PF-735, must 
    be received on or before June 16, 1997.
    ADDRESSES: By mail submit written comments to: Public Response and 
    Program Resources Branch, Field Operations Divison (7505C), Office of 
    Pesticides Programs, Environmental Protection Agency, 401 M St., SW., 
    Washington, DC 20460. In person bring comments to: Rm. 1132, CM #2, 
    1921 Jefferson Davis Highway, Arlington, VA.
        Comments and data may also be submitted electronically by following 
    the instructions under ``SUPPLEMENTARY INFORMATION.'' No confidential 
    business information should be submitted through e-mail.
        Information submitted as a comment concerning this document may be 
    claimed confidential by marking any part or all of that information as 
    ``Confidential Business Information'' (CBI). CBI should not be 
    submitted through e-mail. Information marked as CBI will not be 
    disclosed except in accordance with procedures set forth in 40 CFR part 
    2. A copy of the comment 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. All written 
    comments will be available for public inspection in Rm. 1132 at the 
    address given above, from 8:30 a.m. to 4 p.m., Monday through Friday, 
    excluding legal holidays.
    
    FOR FURTHER INFORMATION CONTACT: Amelia M. Acierto, Registration 
    Support Branch, Registration Division (7505W), Office of Pesticide 
    Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
    DC 20460. Office location, telephone number, and e-mail address: Rm. 4-
    W60, Crystal Station #1, 2800 Jefferson Davis Highway, Arlington, VA 
    22202, (703) 308-8375; e-mail: acierto.amelia@epamail.epa.gov.
    SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition as 
    follows
    
    [[Page 27026]]
    
    proposing the establishment and/or amendment of regulations for 
    residues of certain pesticide chemical in or on various food 
    commodities under section 408 of the Federal Food, Drug, and Comestic 
    Act (FFDCA), 21 U.S.C. 346a. EPA has determined that this petition 
    contains data or information regarding the elements set forth in 
    section 408(d)(2); however, EPA has not fully evaluated the sufficiency 
    of the submitted data at this time or whether the data supports 
    granting of the petition. Additional data may be needed before EPA 
    rules on the petition.
        The official record for this notice of filing, as well as the 
    public version, has been established for this notice of filing under 
    docket control number [PF-735] (including comments and data submitted 
    electronically as described below). A public version of this record, 
    including printed, paper versions of electronic comments, 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 official record is located at the address in 
    ``ADDRESSES'' at the beginning of this document.
        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. Comment and data 
    will also be accepted on disks in Wordperfect 5.1 file format or ASCII 
    file format. All comments and data in electronic form must be 
    identified by the docket number PF-735 and appropriate petition number. 
    Electronic comments on this notice may be filed online at many Federal 
    Depository Libraries.
    
    List of Subjects
    
        Environmental protection, Agricultural commodities, Food additives, 
    Feed additives, Pesticides and pests, Reporting and recordkeeping 
    requirements.
    
        Dated: May 7, 1997.
    
    James Jones,
    
    Acting Director, Registration Division, Office of Pesticide Programs.
    
    Summaries of Petitions
    
        Petitioner summaries of the pesticide petitions are printed below 
    as required by section 408(d)(3) of the FFDCA. The summaries of the 
    petitions were prepared by the petitioners and represent the views of 
    the petitioners. EPA is publishing the petition summaries verbatim 
    without editing them in any way. The petition summary announces the 
    availability of a description of the analytical methods available to 
    EPA for the detection and measurement of the pesticide chemical 
    residues or an explanation of why no such method is needed.
    
     American Cyanamid Company
    
    PP 3E4216
    
        EPA has received a pesticide petition (PP) PP 3E4216 from American 
    Cyanamid Company, Agricultural Research Division, P.O. Box 400, 
    Princeton, NJ, 08543-0400. The petition proposes, pursuant to section 
    408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 
    346a, to amend 40 CFR part 180 to exempt the residues of 2,2'-(1,2-
    ethenediyl)bis[5-[[4-[bis(2-hydroxyethyl)amino]-6-phenylamino]-1,3,5-
    triazin-2-yl]amino]-benzenesulfonate from the requirement of a 
    tolerance when used as inert ingredient (adjuvant and UV absorber/
    protectant) in pesticide formulations applied to growing crops. EPA has 
    determined that the petition contains data or information regarding the 
    elements set forth in section 408(d)(2); however, EPA has not fully 
    evaluated the sufficiency of the submitted data at this time or 
    determined whether the data supports granting of the petition. 
    Additional data may be needed before EPA rules on the petition.
        The petitioner is proposing the exemption from the requirement of a 
    tolerance for 2,2'-(1,2-ethenediyl)bis[5-[[4-[bis(2-
    hydroxyethyl)amino]-6-phenylamino]-1,3,5-triazin-2-yl]amino]-
    benzenesulfonate (CAS Reg. No. 4404-43-7), a stilbene fluorescent 
    whitening agent (FWA), to be used as an inert ingredient in 
    biopesticide formulations intended for use on food and/or feed crops. 
    USDA has patented the use of FWAs as adjuvants in pesticide 
    formulations (U.S. Patent No. 5,124,149) and the petitioner has 
    submitted an application to license this technology. The petitioner 
    states that FDA has previously approved the use of related stilbenes 
    (4,4'-bis(2-benzoxazolyl)stilbene, CAS Reg. No. 1533-45-5; 4-(2-
    benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl)stilbene, CAS Reg. No. 5242-
    49-9; and 4,4'-bis(5-methyl-2-benzoxazolyl)stilbene, CAS Reg. No. 2397-
    00-4) as indirect food additives for use in food-contact polymers [21 
    CFR 178.3297].
    
    A. Residue Chemistry
    
        The petitioner notes that the nature and magnitude of the residue 
    and analytical methods to determine residue levels are not required by 
    EPA at this time. The favorable toxicology profile of 2,2'-(1,2-
    ethenediyl)bis[5-[[4-[bis(2-hydroxyethyl)amino]-6-phenylamino]-1,3,5-
    triazin-2-yl]amino]-benzenesulfonate and other FWAs in combination with 
    a negligible increase in expected exposure from the proposed use as an 
    inert ingredient in biopesticides amounts to an insignificant 
    incremental risk to the public health.
    
    B. Toxicological Profile
    
        The petitioner notes that stilbene fluorescent whitening agents 
    have been commercially available for nearly 60 years in the textile, 
    paper and detergent industries and more recently available as FDA-
    approved indirect food additives. Thus, an extensive body of reliable 
    information has been generated on the toxicology of the stilbene class 
    of chemistry. This complete data base has been developed by industry, 
    academia, and government agencies both in the United States and 
    overseas and can be found in numerous publications on FWAs. The 
    petitioner provides the following toxicological data in support of the 
    submission:
        The acute oral LD50 in rats for 2,2'-(1,2-
    ethenediyl)bis[5-[[4-[bis(2-hydroxyethyl)amino]-6-phenylamino]-1,3,5-
    triazin-2-yl]amino]-benzenesulfonate reported in the literature is 
    14,500 mg/kg body weight while the acute dermal toxicity is reported to 
    be > 2,000 mg/kg body weight in rabbits. In a single 4 hour exposure 
    acute inhalation study with a related stilbene, no sign of intoxication 
    or mortality to rats at a concentration of 1.65 mg/L was determined 
    (LC50 >1.65 mg/L).
        In 2-year chronic feeding studies with a related FWA compound, a 40 
    ppm no observable adverse eEffect level [NOAEL] was established for the 
    rat based upon slightly increased female mortality (unsupported by 
    pathological findings) and a 2,000 ppm NOAEL (highest dose tested) was 
    established for the dog. Additionally, the United States Department of 
    Health and Human Services' National Toxicology Program technical report 
    (TR 412) of 2-year toxicology and carcinogenesis studies using a 
    related stilbene compound concluded there was no evidence of 
    carcinogenic activity attributed to the molecule when fed to rats and 
    mice at up to 25,000 ppm and 12,500 ppm, respectively.
        Based on a review of available data, the petitioner believes that 
    FWAs are not genotoxic, not carcinogenic, and do not cause reproductive 
    or developmental effects when tested in
    
    [[Page 27027]]
    
    mammals and that there is also no evidence to suggest that FWAs exhibit 
    estrogenic properties.
    
    C. Aggregate Exposure
    
        The petitioner believes that 2,2'-(1,2-ethenediyl)bis[5-[[4-[bis(2-
    hydroxyethyl)amino]-6-phenylamino]-1,3,5-triazin-2-yl]amino]-
    benzenesulfonate and stilbene FWAs in general are extensively used as 
    optical brighteners both domestically and internationally. 
    Approximately 30 million pounds are used annually in the United States 
    alone with the majority being used in detergents to enhance the color 
    of laundered clothing. Other uses of stilbenes include incorporation 
    into textiles, paper, paint, and plastics (some of which are used in 
    the food industry). In comparison, the proposed use of 2,2'-(1,2-
    ethenediyl)bis[5-[[4-[bis(2-hydroxyethyl)amino]-6-phenylamino]-1,3,5-
    triazin-2-yl]amino]-benzenesulfonate as an inert ingredient in 
    pesticide formulations is not expected to exceed 250,000 pounds 
    annually (< 1%="" of="" the="" total="" fwa="" use="" in="" the="" united="" states).="" the="" petitioner="" believes="" that="" potential="" routes="" of="" non-occupational="" exposure="" to="" fwas="" currently="" include="" non-dietary="" (i.e.,="" potential="" dermal="" exposure="" via="" contact="" with="" laundered="" clothing)="" and="" dietary="" sources="" (i.e.,="" potential="" consumption="" in="" drinking="" water,="" in="" fish,="" and="" as="" residue="" of="" detergents="" adhering="" to="" dishes="" and="" cutlery)="" and="" consequently,="" the="" proposed="" inert="" ingredient="" use="" of="" 2,2'(1,2-ethenediyl)bis[5-[[4-[bis(2-="" hydroxyethyl)amino]-6-phenylamino]-1,3,5-triazin-2-yl]amino]-="" benzenesulfonate="" is="" not="" expected="" to="" significantly="" increase="" the="" aggregate="" exposure="" to="" fwas.="" d.="" cumulative="" effects="" the="" petitioner="" believes="" that="" data="" show="" that="" the="" diaminostilbene-="" disulfonic="" acid="" class="" of="" fwas="" is="" relatively="" non-toxic="" to="" mammals="" and,="" in="" addition,="" the="" proposed="" use="" of="" 2,2'-(1,2-ethenediyl)bis[5-[[4-[bis(2-="" hydroxyethyl)amino]-6-phenylamino]-1,3,5-triazin-2-yl]amino]-="" benzenesulfonate,="" a="" member="" of="" this="" class="" of="" chemistry,="" will="" not="" significantly="" increase="" the="" us="" population's="" exposure="" to="" fwas.="" thus,="" the="" petitioner="" believes="" that="" there="" is="" no="" expectation="" of="" significant="" incremental="" risk="" due="" to="" the="" use="" of="" 2,2'-(1,2-ethenediyl)bis[5-[[4-="" [bis(2-hydroxyethyl)amino]-6-phenylamino]-1,3,5-triazin-2-yl]amino]-="" benzenesulfonate="" as="" an="" inert="" ingredient="" in="" pesticide="" formulations.="" e.="" safety="" determination="" the="" petitioner="" considered="" that="" toxicology="" studies="" conducted="" with="" 2,2'-(1,2-ethenediyl)bis[5-[[4-[bis(2-hydroxyethyl)amino]-6-="" phenylamino]-1,3,5-triazin-2-yl]amino]-benzenesulfonate="" and="" other="" compounds="" in="" the="" stilbene="" class="" of="" chemistry="" show="" there="" is="" reasonable="" certainty="" that="" no="" harm="" to="" the="" u.s.="" population="" will="" result="" from="" aggregate="" exposure="" to="" fwa="" residue="" including="" all="" anticipated="" dietary="" exposures="" and="" all="" other="" non-occupational="" exposures="" for="" which="" there="" is="" reliable="" information.="" experimental="" investigations="" show="" that="" the="" likelihood="" of="" fwas="" constituting="" a="" danger="" to="" human="" health="" is="" so="" minimal="" as="" to="" be="" completely="" negligible.="" the="" petitioner="" notes="" that="" there="" is="" no="" information="" available="" to="" indicate="" that="" children="" or="" infants="" would="" be="" more="" sensitive="" than="" adults="" to="" any="" toxic="" effect="" associated="" with="" exposure="" to="" 2,2'-(1,2-="" ethenediyl)bis[5-[[4-[bis(2-hydroxyethyl)amino]-6-phenylamino]-1,3,5-="" triazin-2-yl]amino]-benzenesulfonate.="" f.="" international="" tolerances="" there="" are="" no="" codex="" maximum="" residue="" levels="" established="" for="" residues="" of="" 2,2'-(1,2-ethenediyl)bis[5-[[4-[bis(2-hydroxyethyl)amino]-6-="" phenylamino]-1,3,5-triazin-2-yl]amino]-benzenesulfonate="" on="" food="" or="" feed="" crops.="" [fr="" doc.="" 97-12914="" filed="" 5-15-97;="" 8:45="" am]="" billing="" code="" 6560-50-f="">

Document Information

Published:
05/16/1997
Department:
Environmental Protection Agency
Entry Type:
Notice
Action:
Notice.
Document Number:
97-12914
Dates:
Comments, identified by the docket control number PF-735, must be received on or before June 16, 1997.
Pages:
27025-27027 (3 pages)
Docket Numbers:
PF-735, FRL-5717-8
PDF File:
97-12914.pdf