[Federal Register Volume 60, Number 58 (Monday, March 27, 1995)]
[Rules and Regulations]
[Pages 15683-15686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-7586]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 186
[PP 1F3952, PP 1F3985, PP 2F4100, and FAP 1H5607/R2120; FRL-4945-8]
RIN 2070-AB78
Lambda-Cyhalothrin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes tolerances for residues of the synthetic
pyrethroid lambda-cyhalothrin in or on the raw agricultural commodities
(RACs) tomatoes, cabbage, broccoli, head lettuce, dry bulb onion, and
garlic and in or on the processed food/feed tomato pomaces. Zeneca,
Inc., requested this regulation to establish maximum permissible levels
for residues of the insecticide.
EFFECTIVE DATE: This regulation becomes effective March 27, 1995.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 1F3952, PP 1F3985, PP 2F4100, and FAP
1H5607/R2120], 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 document 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 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: 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 and telephone number: Second Floor, Crystal
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA 22202, (703)-305-
6100; e-mail: LaRocca.George@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued notices, published in the Federal
Registers of April 3, 1991 (56 FR 13642), December 13, 1991 (56 FR
65080), and June 10, 1992 (57 FR 24644), which announced that Zeneca,
Inc., (formerly ICI Americas, Inc.), 1800 Concord Pike, Wilmington, DE
19897, had submitted pesticide petitions (PPs) 1F3952, 1F3985, 2F4100
and food/feed additive petition (FAP) 1H5607 to EPA requesting that the
Administrator, pursuant to sections 408(d) and 409(b) of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d) and 348(b),
establish tolerances for residues of the insecticide lambda-cyhalothrin
[1--(S),3-2--(Z)]-()-cyano-(3-
phenoxyphenyl)methyl 3-(2-chloro-3,3,3-trifluoro-1-propenyl)-2,2-
dimethylcyclopropanecarboxylate] in or on the raw agricultural
commodities (RACs) tomatoes at 0.06 part per million (ppm); cabbage at
0.4 ppm; broccoli at 0.4 ppm; lettuce (head) fresh, with wrapper leaves
at 2.0 ppm; lettuce (head) fresh, without wrapper leaves at 0.3 ppm;
dry bulb onions and garlic at 0.1 ppm; tomato pomaces (wet) at 0.6 ppm;
and tomato pomaces (dry) at 4.0 ppm. EPA considers lettuce with wrapper
leaves as the raw agricultural commodity not without wrapper leaves.
Therefore, a proposed tolerance of 2.0 ppm for lettuce (head) is the
correct commodity definition for tolerance purposes.
On June 29, 1994, Zeneca, Inc., requested that certain petitions be
amended by increasing the proposed tolerances for the RAC tomatoes (PP
1F3952) to 0.1 and by deleting the proposed tolerance on wet tomato
pomace (1H5607) since there is no distinction between wet and dry
pomace, and increasing the proposed feed additive tolerance to 6.0 ppm
for tomato pomaces. (See the Federal Register of August 24, 1994 (59 FR
43580).)
Currently, tolerances for lambda-cyhalothrin have been established
as combined residues of parent and its epimer without expressing the
chemical identification of the epimer since an analytical method to
distinguish parent from epimer was not available at the time. There are
now validated methods to distinguish parent from epimer, and the
tolerances will now be expressed as the combined residues of lambda-
cyhalothrin and its epimer. In addition, EPA has concluded that
although the Chemical Abstract Services (CAS) names for lambda-
cyhalothrin and its epimer are more compact, to a chemist the
structures are more easily derived from the IUPAC names. Therefore, the
IUPAC nomenclature will replace the CAS names in this and future
regulations for lambda-cyhalothrin. The [[Page 15684]] correct IUPAC
names for lambda-cyhalothrin and its epimer are as follows: Lambda-
cyhalothrin, a 1:1 mixture of (S)--cyano-3-phenoxybenzyl-(Z)-
(1R,3R)-3- (2-chloro-3,3,3-trifluoroprop-1-enyl) -2,2-
dimethylcyclopropanecarboxylate and (R)--cyano-3-
phenoxybenzyl-(Z)-(1S,3S) -3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate. Epimer of lambda-cyhalothrin, a 1:1
mixture of (S)--cyano-3-phenoxybenzyl-(Z)-(1S,3S)-3-(2-chloro-
3,3,3- trifluoroprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate and
(R)- -cyano-3-phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro-3,3,3-
trifluoroprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate.
The scientific data submitted in the petition and other relevant
material have been evaluated. The toxicological data considered in
support of the tolerance include:
1. A metabolism study in rats demonstrated that distribution
patterns and excretion rates in multiple oral dose studies are similar
to single-dose studies. Accumulation of unchanged compound in fat upon
chronic administration. Otherwise, rapidly metabolized and excreted.
2. A 12-month feeding study in dogs fed dose (by capsule) levels of
0, 0.1, 0.5, 3.5 milligrams(mg)/kilogram (kg)/day with a no-observed-
effect level (NOEL) of 0.1 mg/kg/day. The lowest-observed-effect-level
(LOEL) for this study is established at 0.5 mg/kg/day based upon
clinical signs of neurotoxicity ataxia, muscle tremors, convulsions.
3. A developmental toxicity study in rats given gavage doses of 0,
5, 10, and 15 mg/kg/day with no developmental toxicity observed under
the conditions of the study. Developmental NOEL is greater than 15 mg/
kg/day. Maternal NOEL and LOEL are established at 10 and 15 mg/kg/day,
respectively. Reduced body weight and food consumption were observed
during the dosing period.
4. A developmental toxicity study in rabbits given gavage doses of
0, 3, 10, and 30 mg/kg/day with no developmental toxicity observed
under the conditions of the study. The maternal NOEL and LOEL are
established at 10 and 30 mg/kg/day, respectively (decreased body weight
gain was observed during the dosing period). The developmental NOEL is
30 mg/kg/day (highest dose tested).
5. A three-generation reproduction study in rats fed diets
containing 0, 10, 30, and 100 ppm with no developmental toxicity
observed at 100 ppm, highest dose tested. The maternal NOEL and LOEL
for the study are established at 30 (1.5 mg/kg/day) and 100 ppm (5 mg/
kg/day), respectively, based upon decreased parental body weight gain.
The reproductive NOEL and LOEL are established at 30 (1.5 mg/kg/day)
and 100 ppm (5 mg/kg/day), respectively, based on decreased pup weight
gain during weaning.
6. A 24-month chronic feeding/carcinogenicity study with rats fed
diets containing 0, 10, 50, and 250 ppm. The NOEL was established at 50
ppm and LOEL at 250 ppm. Reduced body weight gain was observed at 250
ppm in both sexes throughout the study. The animals could have
tolerated higher dose levels; however, the Agency considered the high
dose to be approaching an adequate dose for a negative carcinogenicity
study. There were no carcinogenic effects observed under the conditions
of the study.
7. A carcinogenicity study in mice fed dose levels of 0, 20, 100,
or 500 ppm (0, 3, 15, or 75 mg/kg/day) in the diet for 2 years. A
systemic NOEL was established at 100 ppm and systemic LOEL at 500 ppm
based on decreased body weight gain in males throughout the study at
500 ppm. The Agency has determined that the chemical was not tested at
a sufficiently high dose level for carcinogenicity testing in female
mice. In addition, due to an equivocal finding for mammary tumors in
females (1/52, 0/52, 7/52, 6/52), the Agency classified the chemical as
a Group D carcinogen.
8. The following genotoxicity tests were negative: a gene mutation
assay (Ames), a chromosomal aberration study in rodents, an in vito
cytogenetics assay, and a gene mutation study in Lymphoma cells.
The acceptable Reference Dose (RfD) based on a NOEL of 0.1 mg/kg/
body weight/day from the chronic dog study and a safety factor of 100
is 0.001 mg/kg/body weight/day. A chronic dietary exposure/risk
assessment has been performed for lambda-cyhalothrin using the above
RfD. Available information on anticipated residues and percent crop
treated was incorporated into the analysis to estimate the Anticipated
Residue Contribution (ARC). The ARC is generally considered a more
realistic estimate than an estimate based on tolerance level residues.
The ARC from established tolerances and the current and pending actions
are estimated to be 0.000192 mg/kg/bwt/day and utilize 19.24 per cent
of the RfD for the U.S. population. The ARC for children, aged 1 to 6
years old, and nonnursing infants (subgroups most highly exposed)
utilizes 32 and 58 percent of the RfD, respectively. Generally
speaking, the Agency has no cause for concern if anticipated residues
contribution for all published and proposed tolerances is less than the
RfD.
The metabolism of the chemical in plants and livestock is
adequately understood for this use. Any secondary residues occurring in
meat and meat by products will be covered by the existing tolerances.
There is no reasonable expectation of finite residues in poultry
commodities; therefore, no tolerances are necessary at this time.
An adequate analytical method (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 any one 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., Washington, DC
20460. Office location and telephone number: Rm. 1132, CM #2, 1921
Jefferson Davis Hwy., Arlington VA 22202, (703)-305-5232.
The Agency issued a conditional registration for lambda-cyhalothrin
for use on cotton with an expiration date of August 30, 1990 (see the
Federal Register of May 24, 1988 (53 FR 18558)). The conditional
registration was subsequently amended and extended to November 15, 1996
((see the Federal Register of February 22, 1995 (60 FR 9783)). The
registrations were amended and extended to allow time for submission
and evaluation of additional environmental effects data. In order to
evaluate the effects of the synthetic pyrethroids on fish and aquatic
organisms and its fate in the environment, additional data were
required to be collected and submitted during the period of conditional
registration. Such requirements included a sediment bioavailability and
toxicity study and a small-plot runoff study that must be submitted to
the Agency by July 1, 1996. Due to the conditional status of the
registration, tolerances have been established for lambda-cyhalothrin
on a temporary basis (until November 15, 1997) on cottonseed, meat, fat
and meat-byproducts of hogs, horses, cattle, goats, sheep and milk to
cover residues expected to be present from use during the period of
conditional registration. [[Page 15685]] To be consistent with the
conditional registration status of lambda-cyhalothrin on cotton the
Agency is establishing these tolerances with an expiration date of
November 15, 1997.
There are currently no actions pending against the continued
registration of this chemical. The pesticide is considered useful for
the purposes which it is sought, and the pesticide is considered
capable of achieving the intended physical or technical effect. Based
on the information and data considered, the Agency has determined that
the tolerances for the RACs will protect the public health and are in
accordance with the terms of the proposed food additive tolerance for
tomato pomaces and will be safe. Therefore, 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 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
``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 Parts 180 and 186
Environmental Protection, Administrative practice and procedure,
Agricultural commodities, Feed additives, Pesticides and pests,
Reporting and recordkeeping requirements.
Dated: March 21, 1995.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, chapter I of Title 40 of the Code of Federal Regulations
is 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 371.
b. By revising Sec. 180.438, to read as follows:
Sec. 180.438 Lambda-cyhalothrin; tolerances for residues.
Tolerances to expire on November 15, 1997, are established for the
combined residues of the pyrethroid lambda-cyhalothrin and its epimer
expressed as: Lambda-cyhalothrin, a 1:1 mixture of (S)--cyano-
3-phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro-3,3,3- trifluoroprop-1-enyl)-
2,2- dimethylcyclopropanecarboxylate and (R)--cyano-3-
phenoxybenzyl-(Z)-(1S,3S)-3-(2-chloro-3,3,3- trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate and its epimer expressed as epimer of
lambda-cyhalothrin, a 1:1 mixture of (S)--cyano-3-
phenoxybenzyl-(Z)-(1S,3S)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate and (R)--cyano-3-
phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro-3,3,3- trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate, in or on the following raw
agricultural commodities:
------------------------------------------------------------------------
Parts per
Commodity million
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Broccoli................................................... 0.4
Cabbage.................................................... 0.4
Cattle, fat................................................ 0.02
Cattle, meat............................................... .01
Cattle, mbyp............................................... .01
Cottonseed................................................. 0.05
Dry bulb onion............................................. 0.1
Garlic..................................................... 0.1
Goats, fat................................................. 0.02
Goats, meat................................................ .01
Goats, mbyp................................................ .01
Hogs, fat.................................................. .01
Hogs, meat................................................. .01
Hogs, mbyp................................................. .01
Horses, fat................................................ 0.02
Horses, meat............................................... .01
Horses, mbyp............................................... .01
Lettuce, head.............................................. 2.0
Milkfat (reflecting 0.01 ppm in whole milk)................ 0.25
Sheep, fat................................................. 0.02
Sheep, meat................................................ .01
Sheep, mbyp................................................ .01
Tomatoes................................................... 0.1
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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. By adding new Sec. 186.3765, to read as follows:
Sec. 186.3765 Lambda-cyhalothrin.
A tolerance to expire on November 15, 1997, of 6.0 parts per
million is established for residues of the insecticide lambda-
cyhalothrin and its epimer expressed as: Lambda-cyhalothrin, a 1:1
mixture of (S)--cyano-3-phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro-
3,3,3 trifluoroprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate and
[[Page 15686]] (R)--cyano-3-phenoxybenzyl-(Z)-(1S,3S)-3-(2-
chloro-3,3,3 trifluoroprop-1-enyl)- 2,2-dimethylcyclopropanecarboxylate
and its epimer, a 1:1 mixture of (S)--cyano-3-phenoxybenzyl-
(Z)-(1S,3S)-3-(2-chloro-3,3,3 trifluoroprop-1-enyl)- 2,2-
dimethylcyclopropanecarboxylate and (R)--cyano- 3-
phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro-3,3,3 trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate in tomato pomace (dry, wet) resulting
from application of the insecticide to tomatoes.
[FR Doc. 95-7586 Filed 3-23-95; 11:47 am]
BILLING CODE 6560-50-F
