[Federal Register Volume 59, Number 61 (Wednesday, March 30, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-7369]
[[Page Unknown]]
[Federal Register: March 30, 1994]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
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.
-----------------------------------------------------------------------
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.
* * * * *
(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:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cottonseed................................................. 0.05
------------------------------------------------------------------------
[FR Doc. 94-7369 Filed 3-29-94; 8:45 am]
BILLING CODE 6560-50-F