96-14630. Bifenthrin; Pesticide Tolerance  

  • [Federal Register Volume 61, Number 114 (Wednesday, June 12, 1996)]
    [Rules and Regulations]
    [Pages 29676-29678]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-14630]
    
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    40 CFR Part 180
    
    [PP 5F4485/R2232; FRL-5364-3]
    RIN 2070-AB78
    
    
    Bifenthrin; Pesticide Tolerance
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Final rule.
    
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    SUMMARY: This rule establishes a tolerance for residues of the 
    pesticide bifenthrin in or on the raw agricultural commodity 
    strawberries. The regulation to establish a maximum permissible level 
    for residues of the pesticide was requested in a petition submitted by 
    FMC Corporation.
    
    Effective Date: This regulation becomes effective June 12, 1996.
    
    ADDRESSES: Written objections and hearing requests, identified by the 
    document control number [PP 5F4485/R2232], may be submitted to: Hearing 
    Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
    SW., Washington, DC 20460. A copy of any objections and hearing 
    requests filed with the Hearing Clerk should be identified by the 
    docket control number and submitted to: Public Response and Program 
    Resources Branch, Field Operations Division (7506C), Office of 
    Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
    Washington, DC 20460. In person, bring copy of objections and hearing 
    requests to: Rm. 1132 CM #2, 1921 Jefferson Davis Highway, Arlington, 
    VA 22202. Fees accompanying objections shall be labeled ``Tolerance 
    Petition Fees'' and forwarded to: EPA Headquarters Accounting 
    Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, 
    PA 15251.
        An electronic copy of objections and hearing requests filed with 
    the Hearing Clerk may be submitted to OPP by sending electronic mail 
    (e-mail) to:
    
        opp-docket epamail.epa.gov.
    
        Copies of 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 in 5.1 file 
    format or ASCII file format. All copies of objections and hearing 
    requests in electronic form must be identified by the docket number [PP 
    5F4485/R2232]. 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. Additional information on electronic submissions can be 
    found below in this document.
    
    FOR FURTHER INFORMATION CONTACT: By mail: George T. LaRocca, Product 
    Manager (PM) 13, Registration Division (7505C), Office of Pesticide 
    Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
    DC 20460. Office location, telephone number, and e-mail address: Rm. 
    204, CM #2, 1921 Jefferson Davis Highway, Arlington, VA, (703) 305-
    6100; e-mail: [email protected] epa.gov.
    
    SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the 
    Federal Register of June 15, 1995 (60 FR 31466), which announced that 
    FMC Corporation, 1735 Market Street, Philadelphia, PA 19103, had 
    submitted a pesticide petition (PP 5F4485) to EPA requesting that the 
    Administrator, pursuant to section 408(d) of the Federal Food, Drug, 
    and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), establish a tolerance for 
    the residues of the pyrethroid bifenthrin (2-methyl(1,1-biphenyl)-3-
    yl)methyl-3-(2-chloro-3,3,3-trifluoro-1-propenyl-2,2-
    dimethylcyclopropanecarboxylate) in or on the raw agricultural 
    commodity strawberries at 3.0 parts per million (ppm).
        No comments were received in response to the notice of filing.
        The scientific data submitted in support of this petition and other 
    relevant material have been evaluated. The toxicological and metabolism 
    data considered in support of this tolerance are discussed in detail in 
    a related document published in the Federal Register of June 22, 1994 
    (59 FR 32167).
        A chronic dietary exposure/risk assessment has been performed for 
    bifenthrin using a Reference Dose (RfD) of 0.015 mg/kg of bwt/day. The 
    RfD was based on a No Observed Effect Level (NOEL) of 1.5 mg/kg/day 
    from the 1-year study in dogs and a safety factor of 100. The endpoint 
    effect of concern was intermittent tremors in test animals at the 
    lowest effect level. The chronic exposure analysis was performed using 
    tolerance level residues and 100 percent crop treated information. The 
    current estimated dietary exposure for the
    
    [[Page 29677]]
    
    overall U.S. population resulting from established tolerances is 
    0.002641 mg/kg of bwt/day, which represents 17.6 percent of the RfD, 
    and for non-nursing infants (< 1="" yr="" old)="" the="" subgroup="" population="" exposed="" to="" the="" highest="" risk="" the="" estimated="" dietary="" exposure="" is="" 0.008183,="" which="" represents="" 54.6="" percent="" of="" the="" rfd.="" the="" current="" action="" will="" increase="" the="" exposure="" for="" the="" overall="" u.s.="" population="" to="" 0.002745="" mg/kg="" of="" bwt/day="" or="" 18.3="" percent="" of="" the="" rfd="" and="" for="" non-nursing="" infants="">< 1="" yr="" old)="" to="" 0.008265="" mg/kg="" of="" bwt/day="" or="" 55.1="" percent="" of="" the="" rfd.="" generally="" speaking,="" the="" agency="" has="" no="" concern="" if="" for="" all="" published="" and="" proposed="" tolerances="" dietary="" exposure="" is="" less="" than="" the="" rfd.="" because="" there="" was="" a="" sign="" of="" developmental="" effects="" seen="" in="" animal="" studies,="" the="" agency="" used="" the="" rat="" developmental="" toxicity="" study="" with="" a="" maternal="" noel="" of="" 1="" mg/kg/day="" to="" assess="" acute="" dietary="" exposure="" and="" determine="" a="" margin="" of="" exposure="" (moe)="" for="" the="" overall="" u.s.="" population="" and="" certain="" subgroups.="" since="" the="" toxicological="" end-point="" pertains="" to="" developmental="" toxicity,="" the="" population="" group="" of="" concern="" for="" this="" analysis="" is="" women="" age="" 13="" and="" above,="" the="" subgroup="" which="" most="" closely="" approximates="" women="" of="" child-bearing="" age.="" the="" moe="" is="" calculated="" as="" the="" ratio="" of="" the="" noel="" to="" the="" exposure.="" for="" this="" analysis="" the="" agency="" calculated="" the="" moe="" for="" women="" age="" 13="" and="" above="" to="" be="" 200.="" generally="" speaking,="" moe's="" greater="" than="" 100="" for="" data="" derived="" from="" animal="" studies="" are="" regarded="" as="" showing="" no="" appreciable="" risk.="" the="" metabolism="" of="" the="" chemical="" in="" plants="" and="" animals="" for="" the="" use="" is="" adequately="" understood.="" secondary="" residues="" occurring="" in="" livestock="" and="" their="" by-products="" are="" not="" expected="" since="" there="" are="" no="" known="" animal="" feed="" stock="" uses="" for="" strawberries.="" adequate="" analytical="" methodology="" (gas="" liquid="" chromatography="" with="" an="" electron="" capture="" detector)="" is="" available="" for="" enforcement="" purposes.="" the="" enforcement="" methodology="" has="" been="" submitted="" to="" the="" food="" and="" drug="" administration="" for="" publication="" in="" the="" pesticide="" analytical="" manual,="" vol.="" ii="" (pam="" ii).="" because="" of="" the="" long="" lead="" time="" for="" publication="" of="" the="" method="" in="" pam="" ii,="" the="" analytical="" methodology="" is="" being="" made="" available="" in="" the="" interim="" to="" anyone="" interested="" in="" pesticide="" enforcement="" when="" requested="" from="" calvin="" furlow,="" public="" response="" and="" program="" resource="" branch,="" field="" operations="" division="" (7506c),="" office="" of="" pesticide="" programs,="" u.s.="" environmental="" protection="" agency,="" 401="" m="" st.,="" sw.,="" washington,="" dc="" 20460.="" office="" location="" and="" telephone="" number:="" rm.="" 1132,="" cm="" #2,="" 1921="" jefferson-davis="" hwy.,="" arlington,="" va="" 22202,="" (703)="" 305-5232.="" the="" tolerances="" established="" by="" amending="" 40="" cfr="" part="" 180="" will="" be="" adequate="" to="" cover="" residues="" in="" or="" on="" strawberries.="" the="" pesticide="" is="" considered="" useful="" for="" the="" purposes="" which="" it="" is="" sought="" and="" capable="" of="" achieving="" the="" intended="" physical="" or="" technical="" effect.="" there="" are="" presently="" no="" actions="" pending="" against="" the="" continued="" registration="" of="" this="" chemical.="" based="" on="" the="" information="" and="" data="" considered,="" the="" agency="" has="" determined="" that="" the="" tolerance="" established="" by="" amending="" 40="" cfr="" part="" 180="" would="" protect="" the="" public="" health.="" therefore,="" the="" tolerance="" is="" established="" as="" set="" forth="" below.="" any="" person="" adversely="" affected="" by="" this="" regulation="" may,="" within="" 30="" days="" after="" publication="" of="" this="" document="" in="" the="" federal="" register,="" file="" written="" objections="" and/or="" request="" a="" hearing="" with="" the="" hearing="" clerk,="" at="" the="" address="" given="" above="" (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="" issue(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="" 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="" issue(s)="" in="" the="" manner="" sought="" by="" the="" requestor="" would="" be="" adequate="" to="" justify="" the="" action="" requested="" (40="" cfr="" 178.32).="" a="" record="" has="" been="" established="" for="" this="" rulemaking="" under="" docket="" number="" [pp="" 5f4485/r2232]="" (including="" comments="" and="" data="" submitted="" electronically).="" a="" public="" version="" of="" this="" record,="" including="" printed,="" paper="" version="" of="" electronic="" comments,="" which="" does="" not="" include="" any="" information="" claimed="" as="" cbi,="" is="" available="" for="" inspection="" from="" 8="" a.m.="" to="" 4:30="" p.m.,="" monday="" through="" friday,="" excluding="" legal="" holidays.="" the="" public="" record="" is="" located="" in="" room="" 1132="" of="" the="" public="" response="" and="" program="" resources="" branch,="" field="" operations="" division="" (7506c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" crystall="" mall="" #2,="" 1921="" jefferson="" davis="" highway,="" arlington,="" va.="" the="" official="" record="" for="" this="" rulemaking,="" 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="" rulemaking="" 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="" document.="" under="" executive="" order="" 12866="" (58="" fr="" 51735,="" october="" 4,="" 1993),="" 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="" sector="" of="" the="" economy,="" productivity,="" competition,="" jobs,="" the="" environment,="" public="" health="" or="" safety,="" or="" state,="" local="" or="" tribal="" governments="" or="" communities="" (also="" known="" as="" ``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="" not="" ``significant''="" and="" is="" therefore="" not="" subject="" to="" omb="" review.="" 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="" 1993),="" entitled="" enhancing="" the="" intergovernmental="" partnership,="" or="" special="" considerations="" as="" required="" by="" executive="" order="" 12898="" (59="" fr="" 7629,="" february="" 16,="" 1994).="" pursuant="" to="" the="" requirements="" of="" the="" regulatory="" flexibility="" act="" (pub.="" l.="" 96-354,="" 94="" stat.="" 1164,="" 5="" u.s.c.="" 601-612),="" the="" administrator="" has="" determined="" that="" regulations="" establishing="" new="" tolerances="" or="" raising="" tolerance="" levels="" or="" establishing="" exemptions="" from="" tolerance="" requirements="" do="" not="" have="" a="" significant="" [[page="" 29678]]="" economic="" impact="" on="" a="" substantial="" number="" of="" small="" entities.="" a="" certification="" statement="" to="" this="" effect="" was="" published="" in="" the="" federal="" register="" of="" may="" 4,="" 1981="" (46="" fr="" 24950).="" list="" of="" subjects="" in="" 40="" cfr="" part="" 180="" environmental="" protection,="" administrative="" practice="" and="" procedure,="" agricultural="" commodities,="" pesticides="" and="" pests,="" reporting="" and="" recordkeeping="" requirements.="" dated:="" may="" 28,="" 1996.="" stephen="" l.="" johnson,="" director,="" registration="" division,="" office="" of="" pesticide="" programs.="" therefore,="" 40="" cfr="" part="" 180="" is="" amended="" to="" read="" as="" follows:="" part="" 180--[amended]="" 1.="" the="" authority="" citation="" of="" part="" 180="" continues="" to="" read="" as="" follows:="" authority:="" 21="" u.s.c.="" 346a.="" 2.="" section="" 180.442="" is="" amended="" by="" redesignating="" and="" revising="" the="" current="" introductory="" text="" and="" commodity="" table="" as="" paragraph="" (a)="" and="" adding="" a="" new="" paragraph="" (b)="" to="" read="" as="" follows:="" sec.="" 180.442="" bifenthrin;="" tolerances="" for="" residues.="" (a)="" tolerances,="" to="" expire="" november="" 15,="" 1997,="" are="" established="" for="" residues="" of="" the="" pyrethroid="" bifenthrin,="" (2-methyl(1,1-biphenyl)-3-="" yl)methyl-3-(2-chloro-3,3,3-trifluoro-1-propenyl)-2,2-="" dimethylcyclopropanecarboxylate,="" in="" or="" on="" the="" following="" commodities:="" *="" *="" *="" *="" *="" (b)="" tolerances,="" are="" established="" for="" residue="" of="" the="" pyrethroid="" bifenthrin,="" (2-methyl(1,1-biphenyl)-3-yl)methyl-3-(2-chloro-3,3,3-="" trifluoro-1-propenyl)-2,2-dimethylcyclopropanecarboxylate,="" in="" or="" on="" the="" following="" commodity:="" ------------------------------------------------------------------------="" commodity="" parts="" per="" million="" ------------------------------------------------------------------------="" strawberries..............................="" 3.00="" ------------------------------------------------------------------------="" [fr="" doc.="" 96-14630="" filed="" 6-11-96;="" 8:45="" am]="" billing="" code="" 6560-50-f="">

Document Information

Effective Date:
6/12/1996
Published:
06/12/1996
Department:
Environmental Protection Agency
Entry Type:
Rule
Action:
Final rule.
Document Number:
96-14630
Dates:
This regulation becomes effective June 12, 1996.
Pages:
29676-29678 (3 pages)
Docket Numbers:
PP 5F4485/R2232, FRL-5364-3
RINs:
2070-AB78
PDF File:
96-14630.pdf
CFR: (1)
40 CFR 180.442