99-1250. Kuraray America, Inc.; Pesticide Tolerance Petition Filing  

  • [Federal Register Volume 64, Number 12 (Wednesday, January 20, 1999)]
    [Notices]
    [Pages 3092-3096]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 99-1250]
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    
    [PF-845; FRL-6043-8]
    
    
    Kuraray America, Inc.; Pesticide Tolerance Petition Filing
    
    AGENCY: Environmental Protection Agency (EPA).
    
    
    [[Page 3093]]
    
    
    ACTION: Notice.
    
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    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-845, must 
    be received on or before February 19, 1999.
    ADDRESSES: By mail submit written comments to: Information and Records 
    Integrity Branch, Public Information and Services Divison (7502C), 
    Office of Pesticides Programs, Environmental Protection Agency, 401 M 
    St., SW., Washington, DC 20460. In person bring comments to: Rm. 119, 
    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. 119 at the 
    address given above, from 8:30 a.m. to 4 p.m., Monday through Friday, 
    excluding legal holidays.
    
    FOR FURTHER INFORMATION CONTACT: Bipin Gandhi, 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. 707A, 
    Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA 22202, 
    (703) 308-8380; e-mail: gandhi.bipin@epamail.epa.gov.
    SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition as 
    follows 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-845] (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 5.1/6.1 file format or 
    ASCII file format. All comments and data in electronic form must be 
    identified by the docket control number (PF-845) 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: January 12, 1999.
    
    Peter Caulkins,
    
    Acting Director, Registration Division, Office of Pesticide Programs.
    
    Summary of Petition
    
        The petitioner summary of the pesticide petition is printed below 
    as required by section 408(d)(3) of the FFDCA. The summary of the 
    petition was prepared by the petitioner and represents the views of the 
    petitioner. EPA is publishing the petition summaries verbatim without 
    editing them in any way. The petition summary announces the 
    availability of a description of the 9analytical methods available to 
    EPA for the detection and measurement of the pesticide chemical 
    residues or an explanation of why no such method is needed.
    
     Kuraray America, Inc.
    
     PP 8E4949
    
         EPA has received a pesticide petition (PP 8E4949) from Kuraray 
    America, Inc., 200 Park Avenue, New York, N.Y. 10166-3098, proposing 
    pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act, 
    21 U.S.C. 346a(d), to amend 40 CFR 180.1001(c) and (e) to establish an 
    exemption from the requirement of a tolerance as a pesticide inert 
    ingredient in or on raw agricultural commodities for polyvinyl acetate, 
    sulfoxyl group modified sodium salt (Vinylon VF-HP-2) in or on the raw 
    agricultural commodities. EPA has determined that the petition contains 
    data or information regarding the elements set forth in section 
    408(d)(2) of the FFDCA; 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.
    
    A. Toxicological Profile
    
         Polyvinyl acetate, sulfoxyl group modified, sodium salt conforms 
    to the definition of polymer given in 40 CFR 723.250(b), except that it 
    is biodegradable under the stability test conditions and is water 
    soluble.
        1. Polyvinyl acetate, sulfoxyl group modified, sodium salt is not 
    cationic or potentially cationic.
        2. Polyvinyl acetate, sulfoxyl group modified, sodium salt contains 
    as an integral part of it's composition at least two of the required 
    atomic elements, and does not contain elements above permitted levels 
    or any elements not permitted by the atomic element limitation.
        3. Polyvinyl acetate, sulfoxyl group modified, sodium salt is not 
    manufactured or imported from monomers and/or other reactants that are 
    not already included on the TSCA Chemical Substance Inventory.
        4. Polyvinyl acetate, sulfoxyl group modified, sodium salt has a 
    number average molecular weight 10,000 Dalton (typical 
    number average molecular weight of 62,800 Dalton) and maximum oligomer 
    contents of 0.00% <500 and="" 0.0%="">< 1,000.="" 5.="" stability:="" polymers="" cannot="" be="" manufactured="" under="" the="" amended="" tsca="" exemption="" if="" they="" substantially="" degrade,="" decompose,="" or="" depolymerize,="" or="" are="" designed="" (or="" can="" be="" reasonably="" anticipated)="" to="" substantially="" degrade,="" decompose="" or="" depolymerize="" prior="" to,="" during="" or="" after="" use.="" this="" exclusion="" includes="" polymers="" with="" such="" properties="" after="" disposal.="" a="" similar="" exclusion="" was="" made="" a="" part="" of="" the="" original="" tsca="" [[page="" 3094]]="" exemption="" rule="" because="" it="" is="" not="" feasible="" for="" epa="" to="" anticipate="" all="" possible="" breakdown="" products="" that="" could="" result="" from="" polymers="" otherwise="" eligible,="" and="" it="" is="" therefore="" not="" possible="" for="" epa="" to="" define="" precisely="" in="" advance="" which="" polymers="" with="" this="" property="" are="" intrisically="" safe.="" polymers="" that="" otherwise="" satisfy="" all="" the="" criteria="" of="" the="" tsca="" exemption="" may="" still="" be="" intrinsically="" safe="" even="" if="" they="" are="" designed="" or="" reasonably="" anticipated="" to="" break="" down="" prior="" to,="" during,="" or="" after="" use,="" depending="" upon="" the="" extent="" to="" which="" they="" break="" down="" and="" the="" nature="" of="" any="" persistent="" break-down="" products.="" kurary="" america,="" inc.="" conducted="" tests="" on="" the="" stability="" of="" the="" polyvinyl="" acetate,="" sulfoxyl="" group="" modified,="" sodium="" salt="" polymer="" and="" found="" it="" to="" be="" biodegradable="" under="" the="" test="" conditions.="" polyvinyl="" acetate,="" sulfoxyl="" group="" modified,="" sodium="" salt="" is="" not="" a="" water-absorbing="" polymer,="" and="" therefore="" is="" not="" excluded="" from="" eligibility="" for="" the="" amended="" tsca="" exemption.="" the="" exclusion="" in="" the="" amended="" polymer="" exemption="" rule="" is="" intended="" primarily="" to="" address="" concerns="" for="" ``super="" absorbent''="" polymers="" or="" ``super="" slurpers'',="" which="" have="" the="" capacity="" to="" absorb="" 60="" to="" 100="" times="" their="" own="" mass="" of="" water,="" yet="" not="" dissolve.="" polyvinyl="" acetate,="" sulfoxyl="" group="" modified,="" sodium="" salt="" does="" not="" fall="" within="" this="" exclusion="" because="" it="" dissolves="" in="" water="" rather="" than="" absorbing="" it.="" based="" on="" conformance="" to="" the="" criteria="" for="" tsca="" polymer="" exemption,="" polymers="" can="" be="" anticipated="" to="" have="" no="" mammalian="" toxicity="" from="" dietary,="" inhalation="" or="" dermal="" exposure.="" the="" polyvinyl="" acetate,="" sulfoxyl="" group="" modified,="" sodium="" salt="" polymer="" conforms="" with="" all="" the="" criteria="" except="" that="" it="" is="" biodegradable.="" this="" characteristic="" of="" biodegradability="" is="" not="" anticipated="" to="" have="" any="" impact="" on="" mammalian="" toxicity="" from="" dietary,="" inhalation="" or="" dermal="" exposure,="" but="" rather="" is="" a="" factor="" which="" serves="" to="" diminish="" the="" possibility="" of="" exposure.="" b.="" aggregate="" exposure="" the="" agency="" has="" maintained="" that="" polymers="" meeting="" the="" polymer="" exemption="" criteria="" (as="" described="" previously="" for="" polyvinyl="" acetate,="" sulfoxyl="" group="" modified,="" sodium="" salt),="" will="" present="" minimal="" risk="" to="" human="" health="" when="" used="" as="" inert="" ingredients="" in="" pesticide="" products="" applied="" to="" food="" crops.="" epa="" has="" also="" established="" exemptions="" from="" tolerance="" for="" polymeric="" materials="" used="" as="" pesticide="" inert="" ingredients="" that="" it="" considers="" to="" be="" intrinsically="" safe="" based="" on="" the="" fact="" that="" they="" are="" listed="" on="" the="" tsca="" inventory="" or="" meet="" the="" requirements="" of="" the="" amended="" tsca="" polymer="" exemption="" and="" are="" thereby="" not="" subject="" to="" the="" requirements="" of="" pre-manufacturing="" notification.="" non-dietary="" exposure.="" based="" on="" the="" conformance="" of="" polyvinyl="" acetate,="" sulfoxyl="" group="" modified,="" sodium="" salt="" to="" the="" definition="" of="" a="" polymer="" given="" in="" 40="" cfr="" 723.250(b),="" as="" well="" as="" the="" criteria="" that="" are="" used="" to="" identify="" low="" risk="" polymers,="" epa="" can="" conclude="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" to="" the="" u.s.="" population="" will="" result="" from="" non-dietary="" exposures="" to="" it.="" c.="" cumulative="" effects="" section="" 408(b)(2)(d)(v)="" of="" ffdca="" requires="" that,="" when="" considering="" whether="" to="" establish,="" modify,="" or="" revoke="" a="" tolerance="" or="" tolerance="" exemption,="" the="" agency="" consider="" ``available="" information''="" concerning="" the="" cumulative="" effects="" of="" a="" particular="" chemical's="" residues="" and="" ``other="" substances="" that="" have="" a="" common="" mechanism="" of="" toxicity''.="" in="" the="" case="" of="" the="" polyvinyl="" acetate,="" sulfoxyl="" group="" modified,="" sodium="" salt,="" the="" lack="" of="" expected="" toxicity="" of="" this="" substances="" based="" on="" its="" conformance="" to="" the="" definition="" of="" polymers="" as="" given="" in="" 40="" cfr="" 723.250(b),="" as="" well="" as="" the="" criteria="" that="" identify="" low="" risk="" polymers,="" results="" in="" no="" expected="" cumulative="" effects.="" a="" cumulative="" risk="" assessment="" is="" therefore="" not="" necessary.="" d.="" safety="" determination="" 1.="" u.s.="" population.="" as="" a="" matter="" of="" policy,="" epa="" has="" in="" the="" past="" established="" exemptions="" from="" tolerance="" for="" polymeric="" materials="" used="" as="" pesticide="" inert="" ingredients="" that="" it="" considers="" to="" be="" intrinsically="" safe="" based="" on="" the="" fact="" that="" they="" are="" listed="" on="" the="" tsca="" inventory="" or="" meet="" the="" requirements="" of="" the="" amended="" tsca="" polymer="" exemption="" and="" are="" thereby="" not="" subject="" to="" the="" requirements="" of="" pre-manufacturing="" notification.="" the="" agency="" has="" maintained="" that="" polymers="" meeting="" the="" polymer="" exemption="" criteria="" will="" present="" minimal="" risk="" to="" human="" health="" when="" used="" as="" inert="" ingredients="" in="" pesticide="" products="" applied="" to="" food="" crops.="" 2.="" infants="" and="" childen.="" ffdca="" section="" 408="" provides="" that="" epa="" shall="" supply="" an="" additional="" tenfold="" margin="" of="" safety="" for="" infants="" and="" children="" in="" the="" case="" of="" threshold="" effects="" where="" pre-="" and/or="" postnatal="" toxicity="" are="" found="" or="" there="" is="" incompleteness="" of="" the="" data="" base,="" unless="" epa="" concludes="" that="" a="" different="" margin="" of="" safety="" will="" be="" safe="" for="" infants="" and="" children.="" margins="" of="" safety="" are="" incorporated="" into="" epa="" risk="" assessments="" either="" directly="" through="" the="" use="" of="" margin="" of="" exposure="" (moe)="" analysis="" or="" through="" using="" uncertainty="" (safety)="" factors="" in="" calculating="" a="" dose="" level="" that="" poses="" no="" appreciable="" risk="" to="" humans.="" due="" to="" the="" low="" expected="" toxicity="" of="" polyvinyl="" acetate,="" sulfoxyl="" group="" modified,="" sodium="" salt,="" a="" safety="" factor="" analysis="" is="" not="" required="" in="" assessing="" the="" risk.="" for="" the="" same="" reasons="" the="" additional="" safety="" factor="" is="" unnecessary.="" e.="" analysis="" of="" tsca="" polymer="" exemption="" applicability="" 1.="" polymer="" definition.="" in="" order="" to="" apply="" the="" criteria="" of="" the="" polymer="" exemption,="" it="" is="" essential="" that="" the="" chemical="" identity="" of="" polymer="" be="" established="" precisely,="" if="" possible.="" in="" the="" case="" of="" polyvinyl="" acetate,="" hydrolyzed,="" sulfonate-modified="" sodium="" salt="" (vinylon="" vf-hp-2),="" the="" precursors="" are="" simple="" chemicals="" that="" can="" be="" fully="" characterized="" and="" their="" reaction="" products="" are="" clearly="" defined.="" under="" the="" amended="" tsca="" polymer="" exemption,="" a="" substance="" must="" meet="" the="" definition="" of="" a="" polymer,="" which="" is:="" a="" chemical="" substance="" that="" consists="" of="" not="" less="" than="" 50.0%="" (a="" simple="" majority)="" of="" polymer="" molecules="" and="" less="" than="" 50.0%="" of="" molecules="" with="" the="" same="" molecular="" weight,="" wherein="" the="" polymer="" molecules="" are="" distributed="" over="" a="" range="" of="" molecular="" weights="" and="" the="" differences="" among="" polymer="" molecules="" are="" primarily="" due="" to="" differences="" in="" the="" number="" of="" internal="" monomer="" units.="" polyvinyl="" acetate,="" sulfoxyl="" group="" modified,="" sodium="" salt="" satisfies="" the="" polymer="" definition.="" 2.="" exclusions:="" 40="" cfr="" 723.250(d)--i.="" unreviewed="" reactants.="" under="" the="" amended="" tsca="" polymer="" exemption,="" a="" manufacturer="" or="" importer="" is="" not="" allowed="" to="" commercialize="" a="" polymer="" if="" any="" one="" or="" more="" of="" the="" reactants="" used="" or="" incorporated="" at="" two="" weight="" percent="" or="" more="" are="" not="" listed="" on="" the="" tsca="" inventory="" or="" manufactured="" under="" an="" applicable="" exemption="" to="" section="" 5="" of="" tsca.="" all="" monomers="" and="" other="" reactants="" involved="" in="" manufacturing="" polyvinyl="" acetate,="" sulfoxyl="" group="" modified,="" sodium="" salt="" are="" listed="" on="" the="" tsca="" inventory.="" ii.="" positively="" charged="" polymers.="" cationic="" or="" potentially="" cationic="" polymers="" are="" excluded="" under="" paragraph="" (d)(1)="" from="" the="" tsca="" polymer="" exemption="" unless="" the="" charge="" density="" is="" sufficiently="" low="" or="" the="" polymer="" is="" a="" non-dispersible,="" non-soluble="" solid.="" polyvinyl="" acetate,="" sulfoxyl="" group="" modified,="" sodium="" salt="" is="" not="" cationic="" or="" potentially="" cationic.="" iii.="" atomic="" element="" limitations.="" the="" exclusion="" at="" (d)(2)="" limits="" the="" identities="" of="" atomic="" elements="" in="" the="" composition="" of="" polymers="" eligible="" for="" the="" tsca="" exemption.="" all="" such="" polymers="" must="" contain="" as="" an="" integral="" part="" of="" their="" composition="" two="" or="" more="" of="" the="" atomic="" [[page="" 3095]]="" elements,="" carbon,="" hydrogen,="" nitrogen,="" oxygen,="" silicon="" and="" sulfur.="" the="" specific="" monatomic="" counter="" ions,="">+, Mg+2, 
    Al+3, K+ and Ca+2 are permitted. 
    Chlorine, bromine, and iodine are permitted whether they are covalently 
    bonded to carbon or as the specific monatomic counter ions, Cl-, Br- 
    and I-. Fluorine must be covalently bound to carbon. Lithium, boron, 
    phosphorus, titanium, manganese, iron, nickel, copper, zinc, tin, or 
    zirconium are permitted at less than 0.20 weight percent alone or in 
    any combination. No other atomic elements are permitted and other 
    exclusions may apply.
        Polyvinyl acetate, sulfoxyl group modified, sodium salt contains at 
    least two of the required atomic elements, and it does not contain 
    elements above permitted levels or any elements not permitted by this 
    limitation.
        iv. Instability. Polymers cannot be manufactured under the amended 
    TSCA exemption if they substantially degrade, decompose, or 
    depolymerize, or are designed (or can be reasonably anticipated) to 
    substantially degrade, decompose or depolymerize prior to, during or 
    after use. This exclusion includes polymers with such properties after 
    disposal, for example, in a waste water treatment plant. A similar 
    exclusion was made a part of the original TSCA exemption 
    rule1. This provision is present in the amended rule, 
    because it is not feasible for EPA to anticipate all possible breakdown 
    products that could result from polymers otherwise eligible, and it is 
    therefore not possible for EPA to define precisely in advance which 
    polymers with this property are intrinsically safe. Polymers that 
    otherwise satisfy all the criteria of the TSCA exemption, may still be 
    intrinsically safe even if they are designed or reasonably anticipated 
    to break down prior to, during, or after use, depending upon the extent 
    to which they break down and the nature of any persistent bread-down 
    products.
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        \1\ 49 FR 46066 November 21, 1984.
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        Kuraray America, Inc. conducted tests on the stability of the VF-
    HP-2 polymer and found it to be biodegradable under the test 
    conditions. In a study using aerobic soil microorganisms from a 
    municipal water treatment plant, the VF-HP-2 polymer, the polyvinyl 
    acetate, hydrolyzed, sulfonate-modified sodium salt, was found to 
    biodegrade with a half life of 30 days. For comparison in the same 
    study, the degradation of closely related WSP material, hydrolyzed 
    polyvinyl acetate, for which an exemption from tolerance is already 
    established, was determined. This polymer was found to degrade with a 
    half life of 12 days. Aniline was used as a reference (positive 
    control) and found to degrade with a half life of around 5 days.
        In the study, biological oxygen demand (B.O.D.) of a water solution 
    of the polymer was used as a measure of the extent of degradation. This 
    assay measures the total degradation of organic matter in solution. 
    There was no indication in the study that the biodegradation of the VF-
    HP-2 polymer would be less than complete (C CO2, H 
    H2O, N NO2, S SO3, Na 
    Na2O), leading to the persistence of any breakdown products. 
    Complete biodegradation in the environment is a desirable property for 
    any ingredient in pesticide formulations. After an acclimation period, 
    the rate of degradation of VF-HP-2 polymer appeared the same as 
    hydrolyzed polyvinyl acetate, which EPA has already judged to be safe. 
    It is therefore reasonable to establish an exemption from tolerance for 
    the VF-HP-2 polymer as WSP for pesticides on the basis that it 
    otherwise qualifies for the TSCA exemption and is intrinsically safe.
        v. High molecular weight, water-absorbing polymers. Water-absorbing 
    polymers are excluded from eligibility for the amended TSCA exemption. 
    A water-absorbing polymer is defined as one ``that is capable of 
    absorbing its own weight of water'' and has a number-average molecular 
    weight (NAMW) equal to or greater than 10,000. As discussed in the 
    preamble of the amended polymer exemption rule2, the 
    exclusion is intended primarily to address concerns for ``super 
    absorbent'' polymers or ``super slurpers.'' The exclusion responds to 
    information received under section 8(e) of TSCA for a water-absorbing 
    polyacrylate. The polymer in question had a NAMW of about 1,000,000 and 
    could absorb about 100 times its own mass of water. EPA set the 
    exclusion two orders of magnitude below these levels. ``Super 
    slurpers'' have the capacity to absorb 60 to 100 times their own mass 
    of water, yet not dissolve. Clearly, polyvinyl acetate, sulfoxyl group 
    modified, sodium salt does not fall within this exclusion because it 
    dissolves in water rather than absorbing it3.
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        \2\ 60 FR 16319-16320 March 29, 1995.
        \3\ In the Federal Register notice that established a broad 
    generic exemption from tolerance for acrylate polymers, described 
    earlier in this volumn, EPA'S Office of Pesticide Programs stated: 
    ``Water soluble (sic) polymers in this molecular weight range 
    >10,000 daltons are excluded from the exemption under Sec. 
    723.250(d)....'' 61 FR 6550-6551. The second time in the same notice 
    that EPA/OPP mentions these polymers, they are called ``highly 
    water-obsorbing'', a correct interpretation of the exclusion. Water-
    obsorbing polymers are not water-soluble.
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        3. Conditions: 40 CFR 723.250(e)--i. Polymers of 1,000 < molecular="" weight=""><10,000. to="" qualify="" for="" the="" exemption,="" polymers="" in="" the="" molecular="" weight="" range,="" 1,000="">< mw=""><10,000 must="" also="" always="" have="" a="" molecular="" weight="" distribution="" such="" that="" there="" is="" less="" than="" 25="" weight="" percent="" with="" molecular="" weights="" below="" 1,000="" and="" less="" than="" 10="" weight="" percent="" with="" molecular="" weights="" below="" 500.="" both="" criteria="" must="" be="" simultaneously="" met.="" in="" addition,="" polymers="" that="" meet="" the="" molecular="" weight="" conditions="" of="" 40="" cfr="" 723.250(e)(1)="" are="" subject="" to="" important="" reactive="" functional="" group="" limitations.="" polyvinyl="" acetate,="" sulfoxyl="" group="" modified,="" sodium="" salt="" has="" a="" number="" average="" molecular="" weights="" above="" 10,000="" and="" does="" not="" fall="" within="" the="" condition="" in="" 40="" cfr="" 723.250(e)(1).="" ii.="" polymers="" with="" molecular="" weight=""> 10,000. Polymers with 
    molecular weights of 10,000 or greater must have oligomer contents of 
    less than five weight percent with molecular weights less than 1,000 
    and less than two weight percent with molecular weights less than 500. 
    The properties of polyvinyl acetate, sulfoxyl group modified, sodium 
    salt, supported by GPC molecular weight data, satisfies this condition, 
    as summarized below:
        Typical number-average molecular weight = 62,800
        Maximum oligomer contents = 0.0% < 500,="" 0.0%="">< 1,000="" f.="" conclusions="" on="" the="" tsca="" polymer="" exemption="" criteria="" based="" on="" conformance="" to="" the="" criteria="" described="" above="" for="" tsca="" polymer="" exemption,="" a="" chemical="" can="" be="" anticipated="" to="" have="" no="" mammalian="" toxicity="" from="" dietary,="" inhalation="" or="" dermal="" exposure.="" the="" polyvinyl="" acetate,="" sulfoxyl="" group="" modified,="" sodium="" salt="" polymer,="" polyvinyl="" acetate,="" hydrolyzed,="" sulfonate-modified="" sodium="" salt,="" conforms="" with="" all="" the="" criteria="" except="" that="" is="" biodegradable.="" this="" characteristic="" of="" biodegradability="" is="" not="" anticipated="" to="" have="" any="" impact="" on="" mammalian="" toxicity="" from="" dietary,="" inhalation="" or="" dermal="" exposure,="" but="" rather="" is="" a="" factor="" which="" serves="" to="" diminish="" the="" possibility="" of="" exposure.="" it="" is="" noted="" that="" a="" closely="" related="" wsp="" polymer="" for="" which="" an="" exemption="" from="" tolerance="" has="" already="" been="" established,="" polyvinyl="" acetate,="">4, CASRN 25213-24-5, is also biodegradable.
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        \4\ 49 FR 46066 November 21, 1984.
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        Based on the conformance of polyvinyl acetate, sulfoxyl group 
    modified, sodium salt to the definition of a polymer given in 40 CFR 
    723.250(b), as well as the criteria that
    
    [[Page 3096]]
    
    are used to identify low risk polymers, EPA can conclude that there is 
    a reasonable certainty that no harm to the U.S. population will result 
    from non-dietary exposures to it.
    
    G. International Tolerances
    
        There are no Codex Alimentarius Commission (Codex), Canadian or 
    Mexican residue limits for polyvinyl acetate, sulfoxyl group modified, 
    sodium salt.
    [FR Doc. 99-1250 Filed 1-19-99; 8:45 am]
    BILLING CODE 6560-50-F
    
    
    

Document Information

Published:
01/20/1999
Department:
Environmental Protection Agency
Entry Type:
Notice
Action:
Notice.
Document Number:
99-1250
Dates:
Comments, identified by the docket control number PF-845, must be received on or before February 19, 1999.
Pages:
3092-3096 (5 pages)
Docket Numbers:
PF-845, FRL-6043-8
PDF File:
99-1250.pdf