Tralomethrin (Scout) - Proposed Pesticide Tolerances 11/97
Date: Wed, 16 Aug 1995 09:52:08 -0400
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Tralomethrin; Pesticide Tolerances X-Comment: U.S. EPA FEDERAL REGISTER
[Federal Register: August 16, 1995 (Volume 60, Number 158)] [Proposed
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 6F3436/P624; FRL 4968-8]
Tralomethrin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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 firstname.lastname@example.org. 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
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@example.com.
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
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
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
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
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:
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.
* * * * *
Lettuce, head.............................................. 1.00
Lettuce, leaf.............................................. 3.00
Sunflower seed............................................. 0.05
[FR Doc. 95-20011 Filed 8-15-95; 8:45 am] BILLING CODE 6560-50-F