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Tralomethrin; Pesticide Tolerances
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: August 16, 1995 (Volume 60, Number 158)]
[Proposed Rules]
[Page 42494-42496]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16au95-45]
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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 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, [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:
larocca.george@epamail.epa.gov.
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 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.
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