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lambda-cyhalothrin (Karate, Force) Time-Limited Tolerance--Final Rule 6/95



40 CFR Parts 180, 185, and 186
[PP 1F3992, 2F4109, 2F4114, 7F3488, 7F3560, 9F3770, FAP 7H3560 and 
      7H5543/R2143; FRL-4960-6]
RIN 2070-AB78
Lambda Cyhalothrin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This document establishes time-limited tolerances with an 
expiration date of November 15, 1997, for residues of the synthetic 
pyrethroid lambda-cyhalothrin in or on the raw agricultural commodities 
(RACs) soybeans; wheat, forage, hay, straw, and grain dust; sweet corn; 
sunflower, seeds and forage; sorghum grain and dust; corn (grain, field 
and pop); corn fodder and forage; peanuts; meat, fat, and meat 
byproducts (mbyp) and eggs of poultry and increased tolerances in milk, 
fat, and meat and mbyp of cattle, goats, hogs, horses, and sheep; and in 
or on the processed food/feed items corn grain flour, sunflower hulls,
sunflower oil, and wheat bran. Zeneca Ag Products, Inc., and Coopers Animal
Health, Inc., submitted petitions to EPA requesting these regulations pursuant
to the Federal Food, Drug and Cosmetic Act (FFDCA).

EFFECTIVE DATE: This regulation becomes effective July 5, 1995.

ADDRESSES: Written objections and hearing requests, identified by the 
document control number, [PP 1F3992, 2F4109, 2F4114, 7F3488, 7F3560, 
9F3770, FAP 7H3560, and 7H5543/R2143], may be submitted to: Hearing 
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
SW., Washington, DC 20460. Fees accompanying objections and hearing 
requests shall be labeled "Tolerance Petition Fees" and forwarded to: 
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), 
P.O. Box 360277M, Pittsburgh, PA 15251. 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.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of 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 
1F3992, 2F4109, 2F4114, 7F3488, 7F3560, 9F3770, FAP 7H3560, and 7H5543/
R2143]. No Confidential Business Information (CBI) should be submitted 
through e-mail. Electronic copies of 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), Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location and telephone number: Second Floor, Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-6100; e-mail: 
                 larocca.george.epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 28, 1995 
(60 FR 20946), EPA issued a proposed rule that gave notice of a 
proposed amendment to 40 CFR parts 180, 185, and 186 to establish 
various time-limited tolerances and food/feed additive regulations, to 
expire on November 15, 1997, for residues of the pyrethroid lambda-
cyhalothrin. The proposal was issued pursuant to petitions submitted to 
EPA under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 346a(d) 
and 348(e)) by Zeneca, Inc. (formerly ICI Americas, Inc.), 1800 Concord 
Pike, Wilmington DE 19897 (PP 7F3488, 78F3560, 1F3992, 2F4109, 2F4114, 
7H3560, and 7H5543) and by Coopers Animal Health, Inc., P.O. Box 
419167, Kansas City, MO 64141-0167 (PP 9F3770).
    There were no comments or requests for referral to an advisory 
committee received in response to the proposed rule.
    The data submitted with the proposal and other relevant material 
have been evaluated and discussed in the proposed rule. Based on the 
data and information considered, the Agency concludes that the time-
limited tolerances and food/feed additive regulations will protect the 
public health. Therefore, the tolerances and food/feed additive 
regulations 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 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 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).
     A record has been established for this rulemaking under docket 
number [PP 1F3992, 2F4109, 2F4114, 7F3488, 7F3560, 9F3770, FAP 7H3560, 
and 7H5543/R2143] (including any objections and hearing requests 
submitted electronically as described below). A public version of this 
record, including printed, paper versions 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, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Written objections and hearing requests, identified by the document 
control number [PP 1F3992, 2F4109, 2F4114, 7F3488, 7F3560, 9F3770, FAP 
7H3560, and 7H5543/R2143], may be submitted to the Hearing Clerk 
(1900), Environmental Protection Agency, Rm. 3708, 401 M St., SW., 
Washington, DC 20460.
    A copy of electronic objections and hearing requests filed with the 
Hearing Clerk can be sent directly to EPA at:
                     opp-Docket@epamail.epa.gov


    A copy of electronic objections and hearing requests filed with the 
Hearing Clerk 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 any objections and hearing requests 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 objections and hearing requests 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, Oct. 4, 1993), the Agency 
must determine whether the regulatory action is "significant" and 
therefore subject to review by the Office of Management and Budget 
(OMB) and the requirements of the Executive Order. Under section 3(f), 
the order defines a "significant regulatory action" as an action that 
is likely to result in 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 referred to 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 the rights and obligations of recipients 
thereof; 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 the 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: June 5, 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 amending Sec. 180.438, by revising the table therein, to read 
as follows:

Sec. 180.438   Lambda-cyhalothrin; tolerance for residues.

* * * * *


------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
Broccoli...................................................      0.4
Cabbage....................................................      0.4
Cattle, fat................................................      3.0
Cattle, meat...............................................      0.2
Cattle, mbyp...............................................      0.2
Corn, grain (field and pop)................................      0.05
Corn, fodder...............................................      1.0
Corn, forage...............................................      6.0
Corn, sweet (K + kwhr).....................................      0.05
Cottonseed.................................................      0.05
Dry bulb onion.............................................      0.1
Eggs.......................................................      0.01
Garlic.....................................................      0.02
Goats, fat.................................................      3.0
Goats, meat................................................      0.2
Goats, mbyp................................................      0.2
Hogs, fat..................................................      3.0
Hogs, meat.................................................      0.2
Hogs, mbyp.................................................      0.2
Horses, fat................................................      3.0
Horses, meat...............................................      0.2
Horses, mbyp...............................................      0.2
Lettuce, head..............................................      2.0
Milk, fat (reflecting 0.2 ppm in whole milk)...............      5.0
Peanuts....................................................      0.05
Peanut, hulls..............................................      0.05
Poultry, fat...............................................      0.01
Poultry, meat..............................................      0.01
Poultry, mbyp..............................................      0.01
Sheep, fat.................................................      3.0
Sheep, meat................................................      0.2
Sheep, mbyp................................................      0.2
Soybeans...................................................      0.01
Sorghum, grain.............................................      0.2
Sorghum, grain dust........................................      1.5
Sunflower, seeds...........................................      0.2
Sunflower,forage...........................................      0.20
Tomatoes...................................................      0.1
Wheat, grain...............................................      0.05
Wheat, forage..............................................      2.0
Wheat, hay.................................................      2.0
Wheat, straw...............................................      2.0
Wheat, grain dust..........................................      2.0
------------------------------------------------------------------------

PART 185--[AMENDED]

    2. In part 185
    a. The authority citation for part 185 continues to read as follows:

    Authority: 21 U.S.C. 346a and 348.

    b. By redesignating Sec. 185.1310 as Sec. 185.3765, by revising the 
heading, and by adding new paragraph (c), to read as follows:

Sec. 185.3765   Lambda-cyhalothrin.

* * * * *

    (c) A tolerance, to expire on November 15, 1997, is established for 
the combined residues of the insecticide lambda-cyhalothrin and its 
epimer expressed as lambda-cyhalothrin, a 1:1 mixture of (S)-alpha-
cyano-3-phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro-3,3,3-trifluoroprop-1-
enyl)-2,2-dimethylcyclopropanecarboxylate and (R)-alpha-cyano-3-
phenoxybenzyl-(Z)-(1S,3S)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate and its epimer of lambda-cyhalothrin, a 
1:1 mixture of (S)-alpha-cyano-3-phenoxybenzyl-(Z)-(1S,3S)-3-(2-
chloro-3,3,3-trifluoroprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate 
and (R)-alpha-cyano-3-phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro-3,3,3-
trifluoroprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate in or on the 
following food commodities:


------------------------------------------------------------------------
                                                              Parts per 
                            Food                               million  
------------------------------------------------------------------------
Corn, grain flour..........................................         0.15
Sunflower, oil.............................................         0.30
Wheat, bran................................................          0.2
------------------------------------------------------------------------


PART 186--[AMENDED]

    3. In part 186
    a. The authority citation for part 186 continues to read as 
follows:

    Authority: 21 U.S.C. 348

    b. By revising Sec. 186.3765, to read as follows:

Sec. 186.3765   Lambda-cyhalothrin.

    A tolerance, to expire on November 15, 1997, is established for the 
combined residues of the insecticide lambda-cyhalothrin and its epimer 
expressed as lambda-cyhalothrin, a 1:1 mixture of (S)-alpha-cyano-3-
phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate and (R)-alpha-cyano-3-phenoxybenzyl-(Z)-
(1S,3S)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-dimethylcyclo 
propanecarboxylate and its epimer of lambda-cyhalothrin, a 1:1 mixture of (S)-
alpha-cyano-3-phenoxybenzyl-(Z)-(1S,3S)-3-(2-chloro-3,3,3-trifluoroprop-1-
enyl)-2,2-dimethylcyclopropanecarboxylate and (R)-alpha-cyano-3-phenoxybenzyl-
(Z)-(1R,3R)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-dimethylcyclo 
propanecarboxylate in or on the following feed commodities:


------------------------------------------------------------------------
                                                              Parts per 
                            Food                               million  
------------------------------------------------------------------------
Sunflower, hulls...........................................     0.50
Tomato pomace (dry or wet).................................     6.0
Wheat, bran................................................     0.2
------------------------------------------------------------------------