[Federal Register Volume 60, Number 55 (Wednesday, March 22, 1995)]
[Proposed Rules]
[Pages 15109-15111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-6932]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 3E4241/P607; FRL-4941-1]
RIN 2070-AC18
Imazethapyr; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish tolerances with regional
registration for the sum of the residues of the herbicide imazethapyr,
as its ammonium salt, and its metabolite in or on the raw agricultural
commodities lettuce and endive. The Interregional Research Project No.
4 (IR-4) requested this proposed regulation.
DATES: Comments, identified by the document control number, [PP 3E4241/
P607], must be received on or before April 21, 1995.
ADDRESSES: By mail, submit written comments 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 comments to: Rm. 1132, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA 22202.
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 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 may be disclosed publicly by EPA without prior notice. All
written comments will be available for public inspection in Rm. 1132 at
the address given above, from 8 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail: Hoyt L. Jamerson,
Registration Division (7505W), Office of Pesticide Programs,
Environmental Protection [[Page 15110]] Agency, 401 M St., SW.,
Washington, DC 20460. Office location and telephone number: Sixth
Floor, Crystal Station #1, 2800 Jefferson Davis Hwy., Arlington, VA
22202, (703)-308-8783.
SUPPLEMENTARY INFORMATION: The Interregional Research Project No. 4
(IR-4), New Jersey Agricultural Experiment Station, P.O. Box 231,
Rutgers University, New Brunswick, NJ 08903, has submitted pesticide
petition (PP) 3E4241 to EPA on behalf of the vegetable growers of
Florida. The petition requests that the Administrator, pursuant to
section 408(e) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a(e), amend 40 CFR 180.447 by establishing tolerances with
regional registration for residues of the herbicide imazethapyr, 2-
[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-
ethyl-3-pyridine carboxylic acid, as its ammonium salt, and its
metabolite, 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-
imidazol-2-yl]-5-(1-hydroxyethyl-3-pyridine carboxylic acid), free and
conjugated, in or on the raw agricultural commodities lettuce (head and
leaf) and endive (escarole) at 0.1 part per million (ppm). The
petitioner proposed that use of imazethapyr on lettuce and endive be
limited to Florida based on the geographical representation of the
residue data submitted. Additional residue data will be required to
expand the area of usage. Persons seeking geographically broader
registration should contact the Agency's Registration Division at the
address provided above.
The scientific data submitted in the petition and other relevant
material have been evaluated. The toxicological data considered in
support of the proposed tolerances include:
1. Several acute toxicology studies placing technical-grade
imazethapyr in Toxicity Category III and Toxicity Category IV.
2. A 1-year feeding study with dogs fed diets containing 0, 1,000,
5,000, or 10,000 part per million (ppm) with a systemic no-observed-
effect level (NOEL) of 1,000 ppm (25 milligrams (mg)/kilogram (kg)/day)
based on decreased packed cell volume, hemoglobin, and erythrocytes in
the blood of female dogs at the 5,000-ppm (125 mg/kg/day) dose level.
3. A 78-week carcinogenicity study in mice fed diets containing 0,
1,000, 5,000 or 10,000 ppm (equivalent to 0, 150, 750, or 1,500 mg/kg/
day) with a systemic NOEL of 5,000 ppm based on decreased body weight
gain in both sexes at the 10,000-ppm dose level. No carcinogenic
effects were observed under the conditions of the study.
4. A 2-year chronic feeding/carcinogenicity study in rats fed diets
containing 0, 1,000, 5,000, or 10,000 ppm (equivalent to 0, 50, 250, or
500 mg/kg/day) with no treatment-related systemic or carcinogenic
effects observed under the conditions of the study.
5. A multi-generation reproduction study in rats fed diets
containing 0, 1,000, 5,000, or 10,000 ppm (equivalent to 0, 50, 250, or
500 mg/kg/day) with no treatment-related systemic or reproductive
effects observed under the conditions of the study.
6. Developmental toxicity studies in rats and rabbits with no
developmental toxicity observed under the conditions of the studies at
dose levels up to and including the highest dose tested (1,125 mg/kg/
day in rats and 1,000 mg/kg/day in rabbits).
7. Mutagenicity studies include gene mutation assays in bacteria
cells (negative) and Chinese hamster ovary cells (no dose-response);
structural chromosomal aberration assays in vivo in rat bone marrow
cells (negative) and in vitro in Chinese hamster ovary cells (positive
without activation at levels toxic to cells and negative with
activation); and other genotoxic effects (did not induce unscheduled
DNA synthesis in rat hepatocytes cultured in vitro).
The reference dose (RfD) for imazethapyr is established at 0.25 mg/
kg body weight/day. The RfD is based on a NOEL of 25 mg/kg/day
established in the 1-year feeding study in dogs and an uncertainty
factor of 100. The theoretical maximum residue contribution (TMRC) from
existing uses and the proposed uses on lettuce and endive utilizes less
than 1 percent of the RfD for the general population and all 22
subgroup populations for which EPA routinely conducts dietary risk
assessments. This is a worst-case estimate of dietary exposure which
assumes tolerance level residues and treatment of the total production
acreage of the commodities. The dietary risk assessment indicates that
there is minimal risk from the establishment of the proposed tolerances
for lettuce and endive.
The nature of residues in lettuce and endive is adequately
understood for the purposes of establishing the proposed tolerances. An
adequate analytical method is available for enforcement purposes. The
enforcement methodology has been submitted to the Food and Drug
Administration for publication in the Pesticide Analytical Manual, Vol.
II (PAM II). Because of the long lead time for publication of the
method in PAM II, the analytical methodology is being made available in
the interim to anyone interested in pesticide enforcement when
requested from: Calvin Furlow, Public Response and Program Resources
Branch, Field Operations Divisions (7506C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm. 1132, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-5937.
No secondary residues are expected to occur in meat, milk, poultry,
or eggs from this action since lettuce and endive are not considered
livestock feed commodities.
There are currently no actions pending against the continued
registration of this chemical.
Based on the information and data considered, the Agency has
determined that the tolerances established by amending 40 CFR 180.447
would protect the public health. Therefore, it is proposed that the
tolerances be established 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 any of the
ingredients listed herein, may request within 30 days after publication
of this document in the Federal Register that this rulemaking proposal
be referred to an Advisory Committee in accordance with section 408(e)
of the FFDCA.
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
document control number, [PP 3E4241/P607]. All written comments filed
in response to this petition will be available in the Public Response
and Program Resources Branch, at the address given above from 8 a.m. to
4 p.m., Monday through Friday, except legal holidays.
Under Executive Order 12866 (58 FR 51735, Oct. 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
[[Page 15111]] 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 (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: March 8, 1995.
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. In Sec. 180.447, by adding new paragraph (d), to read as
follows:
Sec. 180.447 Imazethapyr, ammonium salt; tolerance for residues.
* * * * *
(d) Tolerances with regional registration, as defined in
Sec. 180.1(n) of this chapter, are established for the sum of residues
of the herbicide imazethapyr, 2-[4,5-dihydro-4-methyl-4-(1-
methylethyl)-5-oxo-1H-imidazol-2-yl]-5-ethyl-3-pyridine carboxylic
acid, as its ammonium salt, and its metabolite, 2-[4,5-dihydro-4-
methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-(1-hydroxyethyl)-3-
pyridine carboxylic acid, both free and conjugated, in or on the
following raw agricultural commodities:
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Parts per
Commodity million
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Endive (escarole).......................................... 0.1
Lettuce (head and leaf).................................... 0.1
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[FR Doc. 95-6932 Filed 3-21-95; 8:45 am]
BILLING CODE 6560-50-F
