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-
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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,
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-
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
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
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.
* * * * *
(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-
its metabolites containing the diphenyl ether linkage in or
on the following raw agricultural commodity:
Commodity Parts per
[FR Doc. 94-7369 Filed 3-29-94; 8:45 am]