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lactofen (Cobra) Proposed Pesticide Tolerance 2/96

[Federal Register: February 14, 1996 (Volume 61, Number 31)]
[Notices]               
[Page 5771-5772]
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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 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).
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:
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                                   Parts per                            
          Commodity                 million          Expiration date    
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Cottonseed...................        0.05............December 31, 1996
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