[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.G[email protected].

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  
------------------------------------------------------------------------
                                                                        
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