[Federal Register Volume 60, Number 158 (Wednesday, August 16, 1995)]
[Proposed Rules]
[Pages 42494-42496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20011]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP 6F3436/P624; FRL 4968-8]
RIN 2070-AC18


Tralomethrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes that time-limited tolerances be 
established with an expiration date of November 15, 1997, for the 
combined residues of the insecticide tralomethrin and its metabolites 
cis-deltamethrin and trans-deltamethrin in or on the raw agricultural 
commodities (RACs) leaf lettuce, head lettuce, broccoli, and 
sunflowers. The proposed tolerances would establish the maximum 
permissible levels for residues of the insecticide in or on the 
commodities. The AgrEvo USA Co. requested these tolerances pursuant to 
the Federal Food, Drug and Cosmetic Act (FFDCA).

DATES: Comments identified by the docket number, [PP 6F3436/P624], must 
be received on or before September 15, 1995.

ADDRESSES Submit written comments by mail 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 comments to: Public Docket, Rm. 
1132, Crystal Mall #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 as 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 will be included in the public docket by EPA without prior 
notice. The public docket is available for public inspection in Rm. 
1132 at the above address, from 8 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: opp [email protected]. 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, [PP 6F3436/P624]. No Confidential Business 
Information (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, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection 

[[Page 42495]]
Agency, 401 M St., SW., Washington, DC 20460. Office location and 
telephone number: Second Floor, CM #2, 1900 Jefferson Davis Hwy., 
Arlington, VA 22202, (703)-305-6100; e mail: 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of October 29, 1986 
(51 FR 39576), EPA issued a notice that AgrEvo USA Co. (formerly 
Roussel Uclaf of Paris, France; U.S. Agent: Hoechst-Roussel Agri-Vet 
Co.), Little Falls Center One, 2711 Centerville Rd., Wilmington, DE 
19808, had submitted pesticide petition (PP 6F3436) to EPA proposing to 
amend 40 CFR part 180 by establishing a regulation pursuant to the 
Federal Food, Drug and Cosmetic Act (21 U.S.C. 346a and 371), to 
establish tolerances for residues of the pyrethroid tralomethrin [(S)-
alpha-cyano-3-phenoxybenzyl-(1R,3S)-2,2-dimethyl-3-[(RS)-1,2,2,2-
tetrabromoethyl]-cyclopropane carboxylate] and its metabolites cis-
deltamethrin [(S)-alpha-cyano-3-phenoxybenzyl(1R,3R)-3-(2,2-
dibromovinyl)-2,2-dimethylcyclopropanecarboxylate] and trans-
deltamethrin [(S)-alpha-cyano-3-phenoxybenzyl(1S,3R)-3-(2,2-
dibromovinyl)-2,2-dimethylcyclopropanecarboxylate] in or on the 
following raw agricultural commodities (RACs): broccoli at 0.50 part 
per million (ppm); broccoli, Chinese (gai lon), broccoli, and raab 
(rapini) at 3.50 ppm; Brussels sprouts at 3.50 ppm; cabbage at 0.10 
ppm; cabbage, Chinese (bok choy, napa) at 3.50 ppm; cabbage, Chinese 
mustard (gai choy) at 3.50 ppm; cauliflower at 3.50 ppm; collards at 
3.50 ppm; kale at 3.50 ppm; kohlrabi at 3.50 ppm; lettuce, head at 0.50 
ppm; lettuce, leaf at 2.50 ppm; mustard greens at 3.50 ppm; sunflower 
seeds at 0.05 (N); and rape greens at 3.50 ppm.
    On May 21, 1990, AgrEvo USA Co. submitted a request to amend the 
subject petition by deleting the proposed tolerance for the entire 
brassica (cole) leafy vegetable crop group except broccoli. Tolerances 
were proposed for broccoli at 0.50 ppm, leaf lettuce at 3.0 ppm, and 
head lettuce at 0.50 ppm. On July 20, 1993, AgrEvo USA Co. submitted a 
request to increase the proposed tolerance level of the insecticide and 
its metabolites in or on the RAC head lettuce to 1.00 ppm.
    The scientific data submitted in the petitions and other relevant 
material have been evaluated. The toxicological and metabolism data and 
analytical methods for enforcement purposes considered in support of 
these tolerances are discussed in detail in related documents published 
in the Federal Register of September 18, 1985 (50 FR 37581). In 
addition, mutagenicity studies were submitted and considered in support 
of these tolerances. Based on the studies submitted (an unscheduled DNA 
synthesis study in rat primary hepatocytes and a chromosome aberration 
study in Chinese hamster ovary cells), tralomethrin is not considered 
mutagenic.
    A dietary exposure/risk assessment was performed for tralomethrin 
using a Reference Dose (RfD) of 0.0075 mg/kg/ bwt/day, based on a no-
observed-effect level (NOEL) of 0.75 mg/kg bwt/day and an uncertainty 
factor of 100. The NOEL was determined in a 2-year rat-feeding study. 
The endpoint effect of concern was decreased body weight. The 
Theoretical Maximum Residue Contribution (TMRC) from established 
tolerances utilizes less than 1% of the RfD for the U.S. population and 
the subpopulation most highly exposed, females (13+ years, nursing). 
Establishing the new tolerances would utilize 3.7% of the RfD for the 
U.S. population and 5.1% for females (13+ years, nursing). If the new 
tolerances are approved, the total percentages of RfD utilized for the 
U.S. population and females (13+ years, nursing) are 3.8% and 5.2%, 
respectively. Generally speaking, EPA has no cause for concern if total 
residue contribution for published tolerances is less than the RfD. EPA 
concludes that the chronic dietary risk of deltamethrin, as estimated 
by the dietary risk assessment, does not appear to be of concern.
    The nature of the residues in lettuce, broccoli, and sunflowers is 
adequately understood for the establishment of tolerances. An adequate 
analytical method, gas-liquid chromatography, is available for 
enforcement purposes. The enforcement methodology has been submitted to 
the Food and Drug Administration and published in the Pesticide 
Analytical Manual, Vol. II (PAM II).
    The Agency issued a conditional registration for tralomethrin for 
use on cotton with an expiration date of December 31, 1989 (see the 
Federal Register of September 18, 1985 (50 FR 37581)). The conditional 
registration was subsequently amended and extended to November 15, 1996 
(see the Federal Register of February 22, 1995 (60 FR 9785)). The 
registration was amended and extended to allow time for submission and 
evaluation of additional environmental effects data. In order to 
evaluate the effects of the 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 tralomethrin and its 
metabolites on a time-limited basis (until November 15, 1997) on cotton 
and soybeans to cover residues expected to be present from use during 
the period of conditional registration. To be consistent with the 
conditional registration and extension on cotton and soybeans, the 
Agency is proposing to issue a conditional registration with an 
expiration date of November 15, 1996, and establishing a time-limited 
tolerance on broccoli and lettuce (leaf and head lettuce) and 
sunflowers 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 metabolites. The pesticide is 
considered useful for the purposes for which it is sought. Based on the 
information and data considered, the Agency has determined that the 
tolerances established by amending 40 CFR part 180 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 the ingredient 
listed herein, may request within 30 days after the publication of this 
document in the Federal Register that this rulemaking proposal be 
referred to an Advisory Committee in accordance with section 408(e) of 
the Federal Food, Drug, and Cosmetic Act (FFDCA).
    Interested persons are invited to submit written comments on the 
proposed regulation. Comments must bear a notation indicating the 
document control number, [PP 6F3436/P624]. All written comments filed 
in response to this petition will be available in the Public Response 
and Program Resources Branch at the above address from 8 a.m. to 4:30 
p.m., Monday through Friday, except legal holidays.
    A record has been established for this rulemaking under docket 
number [PP 6F3436/R624] (including comments and data submitted 
electronically as described below). A public version of this record, 
including printed, paper 

[[Page 42496]]
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.
    Electronic comments can be sent directly to EPA at:
    opp D[email protected]

    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.
    The Office of Management and Budget has exempted this document from 
the requirement of review pursuant to Executive Order 12866.
    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: July 27, 1995.

Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, it is proposed that 40 CFR part 180 be amended as 
follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 346a and 371.

    2. In 180.422, by revising the table therein, to read as follows:


Sec. 180.422   Tralomethrin; tolerances for residues.

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                                                              Parts per 
                         Commodity                             million  
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Broccoli...................................................         0.50
Cottonseed.................................................         0.02
Lettuce, head..............................................         1.00
Lettuce, leaf..............................................         3.00
Soybeans...................................................         0.05
Sunflower seed.............................................         0.05
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[FR Doc. 95-20011 Filed 8-15-95; 8:45 am]
BILLING CODE 6560-50-F