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lactofen (Cobra) Pesticide Tolerance 3/94

40 CFR Part 180
[PP 9F3798/R2047; FRL-4762-6]
RIN No. 2070-AB78
Pesticide Tolerance for Lactofen (1-(Carboethoxy)Ethyl-5-(2-
Chloro-4-(Trifluoromethyl)Phenoxy)-2-Nitrobenzoate) 
AGENCY: Environmental Protection Agency (EPA). 
ACTION: Final rule.
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SUMMARY: This rule extends 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) to 
December 31, 1995. This regulation was requested by Valent U.S.A. 
Corp. and continues the maximum permissible level for residues 
of the herbicide in or on this RAC. 
EFFECTIVE DATE: This time-limited regulation becomes effective 
on March 30, 1994. 
ADDRESSES: Written objections and requests for a hearing, identified 
by the document control number, [PP 9F3798/R2047], may be submitted 
to: Hearing Clerk (1900), Environmental Protection Agency, Rm. 
3708, 401 M St., SW., Washington, DC 20460. A copy of any objections 
and hearing requests filed with the Hearing Clerk should be 
identified by the document control number and submitted 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 copy of objections and hearing requests to: Rm. 
1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. 
Fees accompanying objections shall be labeled ``Tolerance Petition 
Feeds'' and forwarded to: EPA Headquarters Accounting Operations 
Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, 
PA 15251. 
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 and telephone 
number: Rm. 255, CM #2, 1921 Jefferson Davis Highway, Arlington, 
VA 22202, (703)-305-7830. 
SUPPLEMENTARY INFORMATION: EPA issued a time-limited tolerance 
in the Federal Register of June 14, 1990 (55 FR 24084), under 
section 408(e) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 346a(e)) 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 
on the raw agricultural commodity (RAC) cottonseed at 0.05 part 
per million (ppm). This tolerance was requested by Valent U.S.A. 
Corp. (formerly Chevron Chemical Co.), 1333 N. California Blvd., 
P.O. Box 8025, Walnut Creek, CA 94596-8025, and establishes 
the maximum permissible level for residues of the herbicide 
in or on this RAC.
   This tolerance was issued as a time-limited tolerance because 
EPA required additional information on a cottonseed processing 
study and required animal metabolism studies. 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) Independent Method Evaluation and EPA Method Validation 
of the proposed analytical methodology if tolerances on animal 
commodities are required; (3) a ruminant feeding study; (4) 
An Independent Method Validation and EPA Method Validation of 
revised analytical methodology for cottonseed; and (5) revised 
product labeling. Information was submitted in September 1993 
and, with the exception of the revised Section B which has undergone 
preliminary evaluation, are pending review by the Agency. 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, 1995. The data 
considered in support of the time-limited tolerance can be identified 
in the June 14, 1990 (55 FR 24084) Federal Register.
   There are no pending regulatory actions against the registration 
of this pesticide. The pesticide is useful for the purpose for 
which this tolerance 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. 1128, 1921 Jefferson 
Davis Hwy., Arlington, VA 22202, (703)-305-5805.
   Based on the information cited above, the Agency has determined 
the tolerance established by amending 40 CFR part 180 would 
protect the public health. Therefore, the tolerance is continued 
as set forth below.
   Any person adversely affected by this regulation may, within 
30 days after publication of this document in the Federal Register, 
file written objections and/or request a hearing with the Hearing 
Clerk, at the address given above (40 CFR 178.20). A copy of 
the objections and/or hearing requests filed with the Hearing 
Clerk should be submitted to the OPP docket for this rulemaking. 
The objections submitted must specify the provisions of the 
regulation deemed objectionable and the grounds for the objections 
(40 CFR 178.25). Each objection must be accompanied by the fee 
prescribed by 40 CFR 180.33(i). If a hearing is requested, the 
objections must include a statement of the factual issue(s) 
on which a hearing is requested, the requestor's contentions 
on such issues, and a summary of any evidence relied upon by 
the objector (40 CFR 178.27). A request for a hearing will be 
granted if the Administrator determines that the material submitted 
shows the following: There is a genuine and substantial issue 
of fact; there is a reasonable possibility that available evidence 
identified by the requestor would, if established, resolve one 
or more of such issues in favor of the requestor, taking into 
account uncontested claims or facts to the contrary; and resolution 
of the factual issue(s) in the manner sought by the requestor 
would be adequate to justify the action requested (40 CFR 178.32). 
   Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), 
the Agency must determine whether the regulatory action is ``significant'' 
and therefore subject to review by the Office of Management 
and Budget (OMB) and the requirements of the Executive Order. 
Under section 3(f), the order defines a ``significant regulatory 
action'' as an action that is likely to result in 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 referred to as ``eonomically 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 the 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: March 21, 1994.
Susan H. Wayland,
Acting Director, Office of Pesticide Programs.
   Therefore, 40 CFR part 180 is 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 sec 180.432, by revising paragraph (b), to read as follows:
sec 180.432   Lacotfen; tolerances for residues.
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   (b) A time-limited tolerance, set to expire December 31, 
1993, is extended for 2 years and will now expire December 31, 
1995, 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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                           Commodity                              Parts per   
                                                                   million    
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Cottonseed.....................................................         0.05  
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[FR Doc. 94-7369 Filed 3-29-94; 8:45 am]