[Federal Register Volume 61, Number 97 (Friday, May 17, 1996)]
[Proposed Rules]
[Pages 24911-24913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12350]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 186
[PP 1E4020 and FAP 2H5619/P655; FRL-5364-2]
RIN 2070-AC18
Tau-fluvalinate; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish tolerances for residues of the
insecticide tau-fluvalinate in or on the raw agriculture commodities
(RAC) apples, oriental pears, and kiwi, to increase the tolerance for
the insecticide tau-fluvalinate in or on the RAC fat of cattle and to
change the chemical nomenclature in the tolerance. The proposed
regulations to establish the maximum permissible levels for residues of
the pesticide were requested pursuant to a petition submitted by Sandoz
Agro, Inc.
DATES: Comments, identified by the docket control number [PP 1E4020/
P655], must be received on or before June 17, 1996.
ADDRESSES: By mail, submit written comments 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 comments to: Rm. 1132 CM #2,
1921 Jefferson Davis Highway, Arlington, VA 22202.
Comments and data may also be submitted to OPP by sending
electronic mail (e-mail) to: 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. Comments 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 [PP 1E4020/P655]. Electronic comments on this proposed
rule may be filed online at many Federal Depository Libraries.
Additional information on electronic submissions can be found below in
this document.
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 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 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
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.
202, CM #2, 1921 Jefferson Davis Highway, Arlington, VA 22202, (703)
305-6100, e-mail: larocca.george.gov.epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Registers of December 13,
1991 (56 FR 65080) and June 10, 1992 (57 FR 24644), EPA issued rules
that gave notice that Sandoz Agro., Inc. (formerly Sandoz Crop
Protection Corp), 1300 East Touhy Ave., Des Plaines, Illinois 60018-
[[Page 24912]]
3300, had submitted food/feed additive petition (FAP) 2H5619 proposing
to amend 40 CFR parts 185 and 186 by establishing food/feed additive
regulations under section 409 of the Federal, Food, Drug and Cosmetic
Act (21 U.S.C. 348) for the insecticide tau-fluvalinate {(RS)-
-cyano-3-phenoxybenzyl N-(2-chloro-
,,-trifluoro-p-tolyl)-D-valinate (formerly
known as (--RS,2R)-fluvalinate {RS)--cyano-3-
phenoxybenzyl (R)-2{2-chloro-4-(triflurormethyl)anilino}-3-
methylbutanoate}) in or on apple pomace, dry and wet, from imported
apples at 2.0 parts per million (ppm) and hops, dry from imported hops
at 15.0 ppm. At the same time Sandoz Agro., Inc. also submitted a
pesticide petition (PP) 1E4020 proposing to establish tolerances under
408(e) for the insecticide tau-fluvalinate in or on the RACs apples
imported from France, Chile and New Zealand at 0.4 ppm; Nashi imported
from New Zealand at 0.4 ppm, and Kiwi imported from New Zealand at 0.5
ppm.
There were no comments or requests for referral to an advisory
committee received in response to the proposed rule.
On April 22, 1994, Sandoz Agro., Inc. requested voluntary
withdrawal of their petition to establish tolerances in hops without
prejudice to future filing. In the same letter and at the request of
EPA they proposed to increase tolerances for the RACs fat of cattle to
0.1 ppm (previously established at 0.01 ppm), increase the proposed
tolerance for apples to 0.5 ppm, and revise the commodity name
``nashi'' to ``oriental pears'' since it is the term used in the Codex
Classification of Food and Animal Feeds published in the Code of
Federal Regulations. The need for the increased cattle fat tolerance
arises from the feeding of wet apple pomace to cattle raised outside
the U.S. and then importing the cattle fat into the U.S.
With respect to the feed additive proposal for apple pomaces (wet/
dry) the Agency no longer considers dry apple pomace a feed item,
therefore tolerances are not required for this commodity (based on
EPA's latest revision (unpublished) to Table II of the Pesticide
Assessment Guidelines, Subdivision O (Residue Chemistry) titled ``Raw
Agricultural and Processed Commodities and Livestock Feeds Derived from
Field Crops''). With respect to wet apple pomace, the Agency has
concluded that the proposed cattle fat tolerance of 0.10 ppm and
currently established tolerances in the meat, meat by-products and milk
of cattle at 0.01 ppm are adequate to cover the residues expected from
the proposed tolerance on apples. Since economics and perishability
dictate that wet apple pomace will not likely be imported into the U.S.
(either from apples processed overseas or treated apples imported and
processed in the U.S.) the establishment of a tolerance for the animal
feed item wet apple pomace will not be necessary. On July 25, 1995,
Sandoz Agro., Inc. withdrew FAP 2H5619 and their request for a feed
additive tolerance on wet apple pomace. Further, they amended the
tolerance on oriental pears by increasing it to 0.5 ppm to be
consistent with the tolerance level on apples.
Sandoz Agro., Inc. submitted a letter dated October 19, 1994,
requesting a name change of fluvalinate to ``tau-fluvalinate'' and a
change in chemical nomenclature from (--RS,2R)-fluvalinate
{RS)--cyano-3-phenoxybenzyl (R)-2{2-chloro-4-
(triflurormethyl)anilino}-3-methyl-butanoate}) to tau-fluvalinate
{(RS)--cyano-3-phenoxybenzyl N-(2-chloro-
,,-trifluoro-p-tolyl)-D-valinate for all
products registered in the United States (U.S.). This name has appeared
on pesticide registrations in Europe since 1989 and reflects the half
resolved form of fluvalinate. It is an approved American National
Standards Institute (ANSI), British Standards Institute (BSI), and
International Organization for Standardization (ISO) name. EPA
concludes that the name of tau-fluvalinate is a useful means of
distinguishing the half resolved fluvalinate from the completely
racemic mixture, and therefore proposes to revise the current chemical
name under 40 CFR 180.427 and 186.3400 to read as follows: tau-
fluvalinate {(RS)--cyano-3-phenoxybenzyl N-(2-chloro-
,,-trifluoro-p-tolyl)-D-valinate.
The data submitted in support of this tolerance and other relevant
material have been reviewed. 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 August 3, 1989
(54 FR 31972).
A chronic dietary exposure analysis was performed for tau-
fluvalinate using a reference dose (RfD) of 0.01 mg/kg-bwt/day based on
a no-observable effect level (NOEL) of 1.0 mg/kg- bwt/day from a 2-year
rat feeding study with an uncertainty factor of 100. The end point
effect of concern was decreased body weight gain in both sexes. The
Theoretical Maximum Residue Contribution (TMRC) from established
tolerances utilizes 1.6% of the RfD for the U.S. population and 7.0% of
the RfD for the subpopulation most highly exposed, non-nursing infants
(<1 yr).="" establishing="" the="" new="" tolerances="" would="" utilize="" 4.9%="" of="" the="" rfd="" for="" the="" u.s.="" population="" and="" 48.3%="" for="" non-nursing="" infants=""><1 yr).="" if="" the="" new="" tolerances="" are="" approved,="" the="" total="" percentages="" of="" the="" rfd="" utilized="" for="" the="" u.s.="" population="" and="" non-nursing="" infants="">< 1yr)="" are="" 6.5%="" and="" 55.4%,="" respectively.="" generally="" speaking,="" epa="" has="" no="" cause="" for="" concern="" if="" total="" residue="" contribution="" for="" published="" tolerances="" is="" less="" than="" the="" rfd.="" epa="" concludes="" that="" the="" chronic="" dietary="" risk="" of="" tau-="" fluvalinate,="" as="" estimated="" by="" the="" dietary="" risk="" assessment,="" does="" not="" appear="" to="" be="" of="" concern.="" the="" metabolism="" of="" the="" chemical="" in="" animals="" for="" this="" use="" is="" adequately="" understood.="" an="" adequate="" analytical="" method,="" gas-liquid="" chromatography,="" 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="" resources="" branch,="" field="" operations="" divisions="" (7506c),="" office="" of="" pesticide="" programs,="" 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.="" there="" are="" presently="" no="" u.s.="" registrations="" for="" use="" of="" the="" insecticide="" tau-fluvalinate="" on="" apples,="" oriental="" pears,="" and="" kiwis.="" based="" on="" the="" above="" information,="" the="" agency="" concludes="" that="" the="" tolerances="" established="" by="" amending="" 40="" cfr="" part="" 180="" would="" protect="" the="" public="" health.="" therefore,="" it="" is="" proposed="" that="" the="" tolerances="" be="" established="" as="" set="" forth="" below.="" interested="" persons="" are="" invited="" to="" submit="" written="" comments="" on="" the="" proposed="" regulation.="" comments="" must="" bear="" a="" notation="" indicating="" the="" document="" control="" number,="" [pp="" 1e4020/p655].="" all="" written="" comments="" filed="" in="" response="" to="" this="" petition="" will="" be="" available="" in="" the="" public="" response="" and="" program="" resources="" branch,="" at="" the="" address="" given="" above="" from="" 8="" a.m.="" to="" 4="" p.m.,="" monday="" through="" friday,="" except="" legal="" holidays.="" a="" record="" has="" been="" established="" for="" this="" rulemaking="" under="" docket="" number="" [pp="" 1e4020/p655]="" (including="" comments="" and="" data="" submitted="" electronically="" as="" described="" below.="" a="" public="" version="" of="" this="" record,="" including="" printed,="" paper="" version="" of="" electronic="" comments,="" which="" [[page="" 24913]]="" 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,="" crystal="" mall="" #2,="" 1921="" jefferson="" davis="" highway,="" arlington,="" va.="" electronic="" comments="" must="" be="" submitted="" as="" an="" ascii="" file="" avoiding="" the="" use="" of="" special="" characters="" and="" any="" form="" of="" encryption.="" 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="" 28,="" 1993),="" entitled="" enhancing="" the="" intergovernmental="" partnership''="" or="" special="" consideration="" 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="" 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="" parts="" 180="" and="" 186="" environmental="" protection,="" administrative="" practice="" and="" procedure,="" agricultural="" commodities,="" pesticides="" and="" pests,="" reporting="" and="" recordkeeping="" requirements.="" dated:="" may="" 2,="" 1996.="" stephen="" l.="" johnson,="" director,="" registration="" division,="" office="" of="" pesticide="" programs.="" therefore,="" it="" is="" proposed="" that="" 40="" cfr="" part="" 180="" be="" amended="" as="" follows:="" part="" 180--[amended]="" 1.="" in="" part="" 180:="" a.="" the="" authority="" citation="" for="" part="" 180="" continues="" to="" read="" as="" follows:="" authority:="" 21="" u.s.c.="" 346a="" and="" 348.="" b.="" section="" 180.427="" is="" amended="" by="" revising="" the="" section="" heading,="" the="" introductory="" text="" of="" paragraph="" (a),="" revising="" the="" entry="" for="" cattle="" fat="" and="" by="" adding="" and="" alphabetically="" inserting="" the="" commodities="" apples,="" kiwi,="" and="" oriental="" pears="" in="" the="" table="" therein="" paragraph="" (a),="" and="" revising="" the="" introductory="" text="" of="" paragraph="" (b)="" to="" read="" as="" follows:="" sec.="" 180.427="" tau-fluvalinate="">-cyano-3-phenoxybenzyl N-
(2-chloro-,,-trifluoro-p-tolyl)-D-valinate;
Tolerances for residues.
(a) Tolerances are established for residues of the insecticide tau-
fluvalinate {(RS)--cyano-3-phenoxybenzyl N-(2-chloro-
,,-trifluoro-p-tolyl)-D-valinate in or on
the following commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Apples 0.5
Cattle, fat 0.1
* * * * *
Kiwi 0.1
* * * * *
Oriental pears 0.5
* * * * *
------------------------------------------------------------------------
* * * * *
(b) Tolerances with regional registration, as defined in
Sec. 180.1(n) are established for residues of the insecticide tau-
fluvalinate {(RS)--cyano-3-phenoxybenzyl N-(2-chloro-
,,-trifluoro-p-tolyl)-D-valinate in or on
the following commodities:
* * * * *
PART 186--[AMENDED]
2. In part 186:
a. The authority citation for part 186 continues to read as
follows:
Authority: 21 U.S.C. 348.
b. Section 186.3400 is amended by revising the section heading and
introductory paragraph to read as follows:
Sec. 186.3400 Tau-fluvalinate {(RS)--cyano-3-phenoxybenzyl
N-(2-chloro-,,-trifluoro-p-tolyl)-D-
valinate.
A regulation is established to permit residues of the insecticide
taufluvalinate {(RS)--cyano-3-phenoxybenzyl N-(2-chloro-
,,-trifluoro-p-tolyl)-D-valinate in or on
the following commodities:
* * * * *
[FR Doc. 96-12350 Filed 5-16-96; 8:45 am]
BILLING CODE 6560-50-F
