[Federal Register Volume 60, Number 82 (Friday, April 28, 1995)]
[Proposed Rules]
[Pages 20946-20949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-10612]
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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.
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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]
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
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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
[[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
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)--
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 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 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)--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 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 feed commodities:
------------------------------------------------------------------------
Parts per
Food million
------------------------------------------------------------------------
Sunflower, hulls........................................... 0.50
Tomato pomace (dry or wet)................................. 6.0
Wheat, bran................................................ 0.2
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[FR Doc. 95-10612 Filed 4-26-95; 3:36 pm]
BILLING CODE 6560-50-F
