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Lambda-Cyhalothrin (Zeneca; Coopers). April 28, 1995. Proposed Tolerances. Federal Register.
http://www.epa.gov/docs/fedrgstr/EPA-PEST/1995/April/Day-28/pr-237.html
[Federal Register: April 28, 1995] ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180, 185 and 186
[PP 1F3992, 2F4109, 2F4114, 7F3488, 7F3560, 9F3770, FAP 7H3560 and 7H5543/P615;
FRL-4951-9]
RIN 2070-AC18
Pesticide Tolerances for Lambda-Cyhalothrin
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
SUMMARY: EPA proposes to establish 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, 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 increase tolerances in milk, fat, 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 under the Federal Food, Drug and Cosmetic Act (FFDCA) proposing tolerances and regulations to establish maximum permissible levels for residues of the insecticide.
DATES: Comments, identified by the document control numbers, [PP 1F3992, 2F4109, 2F4114, 7F3488, 7F3560, 9F3770, FAP 7H3560 and 7H5543/ P615], must be received on or before May 30, 1995.
ADDRESSES: By mail, submit written comments to: Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs,
Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington, DC 20460.
In person, bring comments to: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington,
VA 22202. 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). Information so marked 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.
Comments and data may also be submitted electronically 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 in 5.1 file
format or ASCII file format. All comments and data in electronic form must be
identified by the docket number [1F3992, 2F4109, 2F4114, 7F3488, 7F3560, 9F3770,
FAP 7H3560 and 7H5543/P615]. No CBI should be submitted through e-mail. 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.
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 Hwy., Arlington, VA 22202, (703)-305- 6100; e-mail: larocca.george@epamail.epa.gov.
[[Page 20947]]
SUPPLEMENTARY INFORMATION: EPA issued notices, published in the Federal Registers of March 18, 1987 (52 FR 8527), November 25, 1987 (52 FR 45238), November 1, 1989 (54 FR 46119), 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 7F3488, 7F3560, 1F3992, 2F4109, 2F4114, 7H3560, and 7H5543 and that Coopers Animal Health, Inc., P.O. Box 419167, Kansas City, MO 64141-0167, had submitted PP 9F3770 to EPA requesting that the Administrator, pursuant to sections 408(d) and 409(b) of the FFDCA, 21 U.S.C. 346a(d) and 348(e), establish tolerances and food/feed additive regulations for residues of the pyrethroid lambda-cyhalothrin in or on the raw agricultural commodities (RACs) soybeans at 0.01 part per million (ppm); poultry meat, fat, and meat byproducts (mbyp) (PP 7F3488); wheat grain at 0.01 ppm, sunflower seeds at 0.03 ppm; sweet corn at 0.01 ppm; poultry meat and mbyp at 0.01 ppm (PP 7F3560); sorghum grain at 0.2 ppm; milk at 0.1 ppm; meat of cattle, goats, horses, and sheep at 0.04 ppm, fat at 2.0 ppm, liver at 0.1 ppm and kidney at 0.1 ppm (PP 1F3992); corn grain (field, pop, and seed) at 0.05 ppm, corn fodder at 3.0 ppm, corn silage at 1.0 ppm and corn grain dust at 0.1 ppm (PP 2F4109); peanut hulls and peanut nutmeats at 0.05 ppm; peanut hulls and peanut nut meats at 0.05 (PP 2F4114); cattle meat and mbyp at 0.1 ppm; cattle fat at 1.0 ppm from direct dermal treatment of cattle (PP 9F3770); sunflower hulls at 0.7 ppm; and sunflower oil at 0.05 ppm (PP 7H5543).
The tolerance expression for lambda-cyhalothrin has been revised and now includes
combined residues of parent compound and its epimer. (See the Federal Register
of March 27, 1995 (60 FR 15683).) The correct commodity expression for peanut
nut meat is peanuts. Corn silage is covered under the commodities for corn fodder
and forage. Based upon submitted residue data and because residues in corn grain
were nondetected, EPA concluded that a tolerance in/on corn grain dust is not
required. Since residues concentrate when corn grain is processed into flour,
EPA concluded that a food additive tolerance of 0.15 ppm for corn grain flour
is required.
At the request of Zeneca Ag products, EPA issued in the Federal Register of
March 5, 1992 (57 FR 10353), an amendment to PP 7F3560 to increase the proposed
tolerance level for the insecticide in or on wheat grain to 0.03 and proposed
establishing tolerances for residues of the insecticide lambda cyhalothrin in
or on the RACs wheat forage at 2.0 ppm and wheat straw at 2.0 ppm, and the document
amended FAP 7H5543 by adding the processed commodity wheat bran at 0.2 ppm and
wheat shorts, germ at 0.05 ppm.
After evaluation of the wheat processing study, EPA concluded that the residues
in midlings, shorts, germs resulting from the product use rate are no greater
than the proposed tolerance on whole wheat grain, and thus no food/feed additive
tolerances are required for the processed commodities wheat, shorts and germs.
In June 29, 1994, Zeneca, Inc., requested that certain petitions be amended
by increasing the proposed tolerances for the RACs corn, forage (PP 2F4109)
to 6.0 ppm; corn, sweet (kernel + kernel with husk removed (k + kwhr)) (PP 7F3560)
to 0.05 ppm; sorghum, grain (PP 1F3992) to 0.2 ppm; establish tolerance for
sorghum, grain dust (PP 1F3992) at 1.5 ppm; corn grain flour (FAP 7H5543) at
0.15 ppm; increase tolerance for sunflower, seeds (PP 7F3560) to 0.2 ppm; establish
proposed tolerance in or on wheat hay and grain dust (PP 7F3560) at 2.0 ppm;
increase the tolerance for milk, fat (reflecting 0.2 ppm in whole milk) to 5.0
ppm; meat mbyp of cattle, goats, hogs, horses, and sheep to 0.2 ppm; fat of
cattle, goats, hogs, horses, and sheep to 3.0 ppm; meat, fat, mbyp and eggs
of poultry to 0.01 ppm, and processed food/feed items sunflower, hulls (FAP
7H5543) to 0.5 ppm and sunflower, oil (7H5543) to 0.3 ppm. In a letter dated
February 10, 1995, Zeneca Ag Products requested that a tolerance be established
in or on sunflower, forage (PP 7F3560) at 0.2 ppm.
The scientific data submitted in the petitions and other relevant material have
been evaluated. The toxicological data considered in support of the tolerances
have been discussed in the Federal Register published March 29, 1995 (58 FR
15683). 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 pending action 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 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., Washington, DC 20460. Office location and telephone
number: Rm. 1132, CM #2, 1921 Jefferson Davis Highway, 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.
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. Because of the conditional
status of the registration, tolerances have been established for lambda-cyhalothrin
on a [[Page 20948]] time-limited 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 present from use during the period of conditional
registration. To be consistent with the conditional registration and extension
on cotton, the Agency is proposing to issue a conditional registration with
an expiration date of November 15, 1996, and establishing a time-limited tolerance
on field corn, peanuts, sorghum, soybeans, sweet corn, sunflowers, wheat including
livestock meat, fat and milk and processed commodities with an expiration date
of November 15, 1997, to cover residues expected to result from use during the
period of conditional registration. There are currently no actions pending against
the continued registration of this chemical and its epimer. The pesticide is
considered useful for the purposes which it is sought and capable of achieving
the intended physical or technical effect. Based on the information and data
considered, the Agency has determined that the tolerances established by amending
40 CFR parts 180, 185, and 186 would protect the public health. Therefore, it
is proposed that the tolerances be established as set forth below. Any person
who has registered or submitted an application for registration of a pesticide,
under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) as amended,
which contains any of the ingredients listed herein, may request within 30 days
after publication of this notice in the Federal Register that this rulemaking
proposal be referred to an Advisory Committee in accordance with section 408(e)
of the FFDCA.
Interested persons are invited to submit written comments on the proposed regulation.
Comments must bear a notation indicating the document control numbers, [PP 1F3992,
2F4109, 2F4114, 7F3488, 7F3560, 9F3770, and FAP 7H3560 and 7H5543/P615]. 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. 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). A record has been established
for this rulemaking under docket number [1F3992, 2F4109, 2F4114, 7F3488, 7F3560,
9F3770, FAP 7H3560 and 7H5543/P615] (including any comments and data 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 p.m., Monday through
Friday, excluding legal holidays. The public record is located in Rm. 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 can
be sent directly to EPA at: 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. 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.
List of Subjects in 40 CFR Parts 180, 185, 186
Environmental Protection, Administrative practice and procedure, Agricultural commodities, Food additives, Feed additives, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: April 21, 1995.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that chapter I of title 40 of the Code of Federal Regulations be amended as follows:
PART 180--[AMENDED]
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
[[Page 20949]]
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
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.
Parts per
Food million
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)-<greek-a>-cyano- 3-phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)- 2,2-dimethylcyclopropanecarboxylate and (R)-<greek-a>-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)-<greek-a>-cyano-3-phenoxybenzyl-(Z)-(1S,3S)-3-(2- chloro-3,3,3-trifluoroprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate and (R)-<greek-a>-cyano-3-phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro-3,3,3- trifluoroprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate in or on the following feed commodities:
Parts per
Food million
[FR Doc. 95-10612 Filed 4-26-95; 3:36 pm] BILLING CODE 6560-50-F