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Lactofen (Valent). February 14, 1996. Proposed Pesticide Tolerance. Federal Register.
http://www.epa.gov/docs/fedrgstr/EPA-PEST/1996/February/Day-14/pr-539.html
[Federal Register: February 14, 1996 (Volume 61, Number 31)] [Proposed Rules]
[Page 5726-5728]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP-9F3798/P642; FRL-5349-1]
RIN 2070-AC18
Lactofen; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
SUMMARY: This document proposes to renew a time-limited tolerance for residues of the herbicide lactofen, 1-(carboethoxy)ethyl-5-[2-chloro-4- (trifluoromethyl)phenoxy]-2-nitrobenzoate, and its metabolites containing the diphenyl ether linkage on the raw agricultural commodity (RAC) cottonseed at 0.05 part per million (ppm). The tolerance would establish the maximum permissible level of residues of the herbicide in or on this RAC. The Valent USA Corp. requested this tolerance pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA). The time-limited tolerance would expire on December 31, 1996.
DATES: Comments identified by the docket number, [PP 9F3798/P642], must be received on or before March 15, 1996.
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. In person,
bring comments to: Public Docket, Rm. 1132, Crystal Mall #2, 1921 Jefferson
Davis Highway, Arlington, VA. 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 9F3798/P642]. 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 in the SUPPLEMENTARY INFORMATION unit of this document.
FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller, Product Manager (PM 23), Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location, telephone number, and e-mail address: Rm. 237, CM #2, 1921 Jefferson Davis Highway, Arlington, VA, (703)-305- 6224; e-mail: miller.joanne@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of June 14, 1990 (55 FR
24084), EPA established a time-limited tolerance under section 408 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 346a) for residues of the herbicide
lactofen, 1-(carboethoxy)ethyl-5-[2-chloro-4- (trifluoromethyl)phenoxy]-2-nitrobenzoate,
and its associated metabolites containing the diphenyl ether linkage in or on
the raw agricultural commodity (RAC) cottonseed at 0.05 ppm. This tolerance
was requested by Valent U.S.A. Corp., 1333 North California Blvd., P.O. Box
8025, Walnut Creek, CA 94596-805, and establishes the maximum permissible level
for residues of the herbicide in or on this RAC. The tolerance was issued as
a time-limited tolerance because EPA required animal metabolism studies and
additional information on the cottonseed processing study. EPA's review of the
processing study resulted in a preliminary determination that concentration
does not occur in processed food, but additional information on the study was
required to confirm that determination. Information was submitted and the determination
was confirmed. The animal metabolism studies were required to determine the
likelihood of secondary residues in meat, fat, milk, poultry, and eggs.
The animal metabolism studies were received at the Agency in September 1992
and placed into review. The Agency completed an evaluation of the animal metabolism
studies in March 1993, and concluded that the nature of the residue in animals
was tentatively adequately understood. For the purposes of this tolerance with
an expiration date, the Agency determined
[[Page 5727]]
that finite residues in animal commodities would be minimal from the use of
lactofen on cotton, based on results of metabolism studies. However, for the
proposed permanent tolerance, additional information was required.
This included the following: (1) Further characterization of metabolites from
animal metabolism studies; (2) a ruminant feeding study; (3) independent Method
Evaluation and EPA Method Validation of the proposed analytical methodology
if tolerances on animal commodities are required; (4) an Independent Method
Validation and EPA Method Validation of revised analytical methodology for cottonseed;
and (5) revised product labeling. The ruminant feeding study, Independent Method
Validation of the revised analytical methodology for cottonseed and other information
were received at the Agency in September 1993 and January 1994, and placed in
review. The Agency completed an evaluation of this information in May 1995,
and concluded that the nature of the residue in animals is adequately understood,
pending receipt of additional information on the ruminant feeding study. However,
Agency review identified the following additional deficiencies: (1) Based on
the results of the ruminant feeding study, a tolerance of 0.02 ppm is required
for the lactofen metabolite PPG-2838 in or on ruminant meat byproducts, as well
as an Independent Method Validation and EPA Method Validation of the proposed
analytical methodology for this metabolite in or on meat byproducts; (2) revised
analytical methodology for cottonseed and a revised Section F proposing to raise
the tolerance for cottonseed to 0.25 ppm are required; (3) residue data for
cotton gin byproducts are required as a result of recent revisions to the Residue
Chemistry Guidelines (Subdivision O of the Pesticide Assessment Guidelines).
On December 7, 1995, Valent submitted a response to these deficiencies, excluding
the newly required residue data for cotton gin byproducts.
The company's response has been placed in review. Since Agency review has not
been completed, it is inappropriate to establish a permanent tolerance at this
time. Nevertheless, the Agency believes that the existing data support an extension
of the time-limited tolerance to December 31, 1996. The data considered in support
of the time-limited tolerance are identified in the Federal Register of June
14, 1990 (55 FR 24084).
There are no pending regulatory actions against the registration of this pesticide.
The pesticide is considered useful for the purposes for which it is sought.
Adequate analytical methodology (gas chromatography) is available for enforcement
purposes. Prior to its publication in the Pesticide Analytical Manual, Vol.
II, the enforcement methodology is being made available in the interim to anyone
who is interested in pesticide residue enforcement when requested from: By mail,
Calvin Furlow, Public Response and Program Resource Branch, Field Operations
Division (7506C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. Office location and telephone number:
Crystal Mall #2, Rm. 1132, 1921 Jefferson Davis Highway, Arlington, VA, (703)-305-5805.
Based on the information and data considered, the Agency concludes that the
proposed tolerance will protect the public health. Therefore, it is proposed
that the tolerance be continued 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 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 docket control number, [PP 9F3798/P642).
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 proposal under docket number (PP 9F3798/P642) (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-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
proposal, 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.
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 the rights and obligations of recipients thereof;
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).
[[Page 5728]]
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: February 6, 1996.
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]
2. Section 180.432, paragraph (b) is revised as follows:
Sec. 180.432 Lactofen; tolerances for residues.
Parts per
Commodity million Expiration date
[FR Doc. 96-3020 Filed 2-13-96; 8:45 am] BILLING CODE 6560-50-F