[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="">