[Federal Register Volume 61, Number 114 (Wednesday, June 12, 1996)]
[Rules and Regulations]
[Pages 29674-29676]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14629]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 5F4522/R2237; FRL-5367-8]
RIN 2070-AB78
Imidacloprid; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This rule establishes a tolerance for residues of the
insecticide (1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine) and its metabolites in or on leafy green vegetables.
Bayer Corporation (formerly Miles, Inc.) requested this regulation to
establish these maximum permissible levels for residues of the
insecticide.
EFFECTIVE DATE: This regulation became effective May 28, 1996.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [PP 5F4522/R2237], may be submitted to: Hearing
Clerk (A-110), 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
[[Page 29675]]
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 Hwy., 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.
FOR FURTHER INFORMATION CONTACT: By mail: Dennis H. Edwards, Jr.,
Product Manager (PM) 19, 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. 207, CM #2, 1921 Jefferson Davis Highway, Arlington, VA,
(703) 305-6386, e-mail: edwards.dennis@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued a notice in the Federal Register
of July 26, 1995 (60 FR 38333) (FRL-4958-2), which announced that Bayer
Corporation, 8400 Hawthorn Road, P.O. Box 4913, Kansas City, MO 64120-
0013, had submitted pesticide petition 5F4522 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 tolerances
for residues of the insecticide 1-[(6-chloro-3-pyridinyl)methyl]-N-
nitro-2-imidazolidinimine in or on leafy green vegetables (including
amaranth; arrugual; chervil; chrysanthemum, edible-leaved;
chrysanthemum, garland; corn salad; cress, garden; cress upland;
dandelion; dock; endive; orach; parsley; purslane, garden; purslane,
winter; radicchio, (red chicory; spinach; spinach, New Zealand; and
spinach vine). There were no comments or request for referral to an
advisory committee received in response to this notice of filing.
All relevant materials have been evaluated. The toxicology data
considered in support of the tolerance include:
1. A three-generation rat reproduction study with a no-observed-
effect level (NOEL) of 100 ppm (8 mg/kg/bwt); rat and rabbit
developmental toxicity studies were negative at doses up to 30 mg/kg/
bwt and 24 mg/kg/bwt, respectively.
2. A 2-year rat feeding/carcinogenicity study that was negative for
carcinogenic effects under the conditions of the study and had a NOEL
of 100 ppm (5.7 mg/kg/bwt in male and 7.6 mg/kg/bwt female) for
noncarcinogenic effects that included decreased body weight gain in
females at 300 ppm and increased thyroid lesions in males at 300 ppm
and females at 900 ppm.
3. A 1-year dog feeding study with a NOEL of 1,250 ppm (41 mg/kg/
bwt).
4. A 2-year mouse carcinogenicity study that was negative for
carcinogenic effects under conditions of the study and that had a NOEL
of 1,000 ppm (208 mg/kg/day).
There is no cancer risk associated with exposure to this chemical.
Imidacloprid has been classified under ``Group E'' (no evidence of
carcinogenicity) by EPA's OPP/HED's Reference Dose (RfD) Committee.
The reference dose (RfD) based on the 2-year rat feeding/
carcinogenic study with a NOEL of 5.7 mg/kg/bwt and 100-fold
uncertainity factor, is calculated to be 0.057 mg/kg/bwt. The
theoretical maximum residue contribution (TMRC) from published uses is
0.008187 mg/kg/bwt/day utilizing 14.4% of the RfD. The proposed
tolerance will increase the TMRC by 0.000172 mg/kg/day representing an
increase in the ADI of 0.3%. Thus, the TMRC will be 0.008358 mg/kg/day
utilizing 14.7% of the RfD. For exposure of the most highly exposed
subgroups in the population, non-nursing infants (< 1="" year="" old),="" the="" tmrc="" for="" the="" published="" and="" proposed="" tolerances="" is="" 0.01547="" mg/kg/day.="" this="" is="" equal="" to="" 27.1%="" of="" the="" rfd.="" dietary="" exposure="" from="" the="" existing="" uses="" and="" proposed="" use="" will="" not="" exceed="" the="" reference="" dose="" for="" any="" subpopulation="" (including="" infants="" and="" children)="" based="" on="" the="" information="" available="" from="" epa's="" dietary="" risk="" evaluation="" system.="" the="" nature="" of="" the="" imidacloprid="" residue="" in="" plants="" and="" livestock="" is="" adequately="" understood.="" the="" residues="" of="" concern="" are="" combined="" residues="" of="" imidacloprid="" and="" it="" metabolites="" containing="" the="" 6-chloropyridinyl="" moiety,="" all="" calculated="" as="" imidacloprid.="" the="" analytical="" method="" is="" a="" common="" moiety="" method="" for="" imidacloprid="" and="" its="" metabolites="" containing="" the="" 6-chloropyridinyl="" moiety="" using="" a="" permanganate="" oxidation,="" silyl="" derivatization,="" and="" capillary="" gc-ms="" selective="" ion="" monitoring.="" there="" is="" also="" a="" compound="" specific="" hplc-uv="" method="" available.="" imidacloprid="" and="" its="" metabolites="" are="" stable="" in="" the="" commodities="" when="" frozen="" for="" at="" least="" 24="" months.="" there="" are="" adequate="" amounts="" of="" geographically="" representative="" crop="" field="" trial="" data="" to="" show="" that="" combined="" residues="" of="" imidacloprid="" and="" its="" metabolites,="" all="" calculated="" as="" imidacloprid="" will="" not="" exceed="" the="" proposed="" tolerance="" when="" use="" as="" directed.="" there="" are="" no="" livestock="" feed="" stuffs="" associated="" with="" the="" commodation="" in="" the="" petition.="" there="" are="" presently="" no="" actions="" pending="" against="" the="" continued="" registration="" of="" this="" chemical.="" this="" pesticide="" is="" considered="" useful="" for="" the="" purposes="" for="" which="" the="" tolerance="" is="" sought.="" based="" on="" the="" information="" and="" data="" considered,="" the="" agency="" has="" determined="" that="" the="" tolerances="" established="" by="" amending="" 40="" cfr="" part="" 180="" will="" protect="" the="" public="" health.="" therefore,="" these="" tolerances="" are="" 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="" to="" the="" regulation="" and="" may="" also="" request="" a="" hearing="" on="" those="" objections.="" objections="" and="" hearing="" requests="" must="" be="" filed="" 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="" a="" 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).="" 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="" [[page="" 29676]]="" ``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.="" 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="" 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="" as="" follows:="" part="" 180--[amended]="" 1.="" the="" authority="" citation="" for="" part="" 180="" continues="" to="" read="" as="" follows:="" authority:="" 21="" u.s.c.="" 346a="" and="" 371.="" 2.="" section="" 180.472(a)="" is="" amended="" by="" revising="" the="" table="" therein="" by="" adding="" and="" alphabetically="" inserting="" the="" following="" commodities="" to="" read="" as="" follows:="" sec.="" 180.472="" 1-[(6-chloro-3-pyridinyl)methyl]-n-2-imidazolidinimine;="" tolerances="" for="" residues.="" (a)="" *="" *="" *="" ------------------------------------------------------------------------="" commodity="" parts="" per="" million="" ------------------------------------------------------------------------="" *="" *="" *="" *="" *="" leafy="" greens="" subgroup="" 3.5="" leafy="" vegetables="" crop="" group="" 3.5="" *="" *="" *="" *="" *="" ------------------------------------------------------------------------="" *="" *="" *="" *="" *="" [fr="" doc.="" 96-14629="" filed="" 6-11-96;="" 8:45="" am]="" billing="" code="" 6560-50-f="">