[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: <a href="/cdn-cgi/l/email-protection#6a051a1a470e0509010f1e2a0f1a0b070b0306440f1a0b440d051c"><span class="__cf_email__" data-cfemail="cca3bcbce1a8a3afa7a9b88ca9bcada1ada5a0e2a9bcade2aba3ba">[email protected]</span></a>. 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: <a href="/cdn-cgi/l/email-protection#452924372a2626246b22202a3722200520352428242c296b2035246b222a33"><span class="__cf_email__" data-cfemail="6905081b060a0a08470e0c061b0e0c290c190804080005470c1908470e061f">[email protected]</span></a>.

[[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-D<a href="/cdn-cgi/l/email-protection#bbd4d8d0decffbdecbdad6dad2d795decbda95dcd4cd"><span class="__cf_email__" data-cfemail="2e414d454b5a6e4b5e4f434f4742004b5e4f00494158">[email protected]</span></a>


    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  
------------------------------------------------------------------------
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)-<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 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)-<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  
------------------------------------------------------------------------
Sunflower, hulls...........................................         0.50
Tomato pomace (dry or wet).................................          6.0
Wheat, bran................................................          0.2
------------------------------------------------------------------------


[FR Doc. 95-10612 Filed 4-26-95; 3:36 pm]
BILLING CODE 6560-50-F

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