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Lactofen; Pesticide Tolerance
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[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]
[DOCID:fr14fe96-36]
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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.
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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]
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 346a and 371.
2. Section 180.432, paragraph (b) is revised as follows:
Sec. 180.432 Lactofen; tolerances for residues.
* * * * *
(b) A time-limited tolerance, that expired December 31, 1995, is
renewed for 1 year and will now expire December 31, 1996, 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 in or on the following raw
agricultural commodity:
------------------------------------------------------------------------
Parts per
Commodity million Expiration date
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Cottonseed................... 0.05............ December 31, 1996
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[FR Doc. 96-3020 Filed 2-13-96; 8:45 am]
BILLING CODE 6560-50-F