[Federal Register Volume 60, Number 168 (Wednesday, August 30, 1995)]
[Proposed Rules]
[Pages 45115-45117]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-21515]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 4E4311 and 4E4358/P625; FRL-4970-7]
RIN 2070-AC18
2-(2-Chlorophenyl)Methyl-4,4-Dimethyl-3-Isoxazolidinone;
Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish tolerances for residues of the
herbicide 2-(2-chlorophenyl)methyl-4,4-dimethyl-3-isoxazolidinone (also
referred to in this document as clomazone) in or on the raw
agricultural commodities cabbage, cucumbers, and summer squash. The
proposed regulation to establish maximum permissible levels
[[Page 45116]]
for residues of the herbicide was requested in petitions submitted by
the Interregional Research Project No. 4 (IR-4).
DATES: Comments, identified by the document control number [PP 4E4311
and 4E4358/P625], must be received on or before September 29, 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. Comments and data may
also be submitted to OPP 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 5.1 file format or ASCII
file format. All comments and data in electronic form must be
identified by the docket number [PP 4E4311 and 4E4358/P625]. 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 ``SUPPLEMENTAL INFORMATION'' section of this
document.
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 should not be submitted
through e-mail. Information marked as CBI 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 4:30 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 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; e-mail:
Jamerson.Hoyt@epamail.epa.gov.
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
petitions (PP) 4E4311 and 4E4358 to EPA on behalf of the named
Agricultural Experiment Stations. These petitions request 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 180.425 by
establishing tolerances for residues of the herbicide clomazone in or
on the certain raw agricultural commodities as follows:
1. PP 4E4311. Petition submitted on behalf of Agricultural
Experiment Stations of Arkansas, California, Florida, Georgia,
Kentucky, New York, North Carolina, Oregon, Texas, Washington, and
Wisconsin proposing a tolerance for cabbage at 0.05 part per million
(ppm). The petition was subsequently revised to propose a tolerance for
cabbage at 0.1 ppm.
2. PP 4E4358. Petition submitted on behalf of Agricultural
Experiment Stations of Arkansas, Kentucky, Michigan, New Jersey, North
Carolina, Tennessee, Virginia, Washington, and Wisconsin proposing a
tolerance for cucumber and summer squash at 0.1 ppm.
The scientific data submitted in the petitions and other relevant
material have been evaluated. The toxicological data considered in
support of the proposed tolerances include:
1. A 1-year feeding study in dogs, which were fed diets containing
100, 500, 2,500, and 5,000 ppm, with a no-observed-effect level (NOEL)
of 500 ppm (equivalent to 12.5 milligrams (mg)/kilogram (kg)/day). An
increase in the absolute and relative liver weights in male and female
dogs was observed at the 2,500-ppm dose level (equivalent to 62.5 mg/
kg/day).
2. A development toxicity study in rats with NOEL's for maternal
and developmental toxicity of 100 mg/kg/day. Maternal toxicity
(decreased locomotion, genital stain, and runny eyes) and developmental
toxicity (increased incidence of delayed ossification) were observed in
rats at the 300-mg/kg/day dose level.
3. A developmental toxicity study in rabbits, which were given the
test chemical by gavage at doses of 30, 240, and 700 ppm, with NOEL's
for maternal and developmental toxicity of 240 mg/kg/day. Maternal
toxicity (decrease in body weight) and developmental toxicity (increase
in number of fetal resorptions) were observed in rabbits at the 700-mg/
kg/day dose level.
4. A 2-year feeding/carcinogenicity study in rats, which were fed
diets containing 20, 100, 500, 1,000, and 2,000 ppm, with a systemic
NOEL of 100 ppm (equivalent to 4.3 mg/kg/day) based on elevated
cholesterol, absolute and relative liver weights, and the incidence of
liver cytomegaly. There were no carcinogenic effects observed under the
conditions of the study at any dosage level tested.
5. A 2-year feeding/carcinogenicity study in mice, which were fed
diets containing 20, 100, 500, 1,000 and 2,000 ppm, with a NOEL of 100
ppm (equivalent to 15 mg/kg/day) for systemic effects based on an
increase in white blood cell count. The study was negative for
carcinogenic effects at all dosage levels tested.
6. Mutagenic studies: including unscheduled DNA synthesis,
negative; reverse mutation (two studies in Salmonella), both negative
with/without activation; point mutation (CHO/HGPT), weakly positive
without activation; and in vivo cytogenetic (chromosomal aberration),
negative for mutagenicity.
The reference dose (RfD), based on the 2-year feeding study in rats
(NOEL of 4.3 mg/kg/day) and using an uncertainty factor of 100, is
calculated to be 0.043 mg/kg of body weight (bw)/day. The theoretical
maximum residue contribution (TMRC) from existing tolerances and the
proposed tolerances for cabbage, cucumber, and summer squash are
calculated to be 0.000055 mg/kg/day, which utilizes less than 1 percent
of the RfD for the U.S. population. The TMRC for nonnursing infants
(the population subgroup most highly exposed) also utilizes less than 1
percent of the RfD. EPA concludes that established tolerances and the
proposed tolerances for clomazone pose a negligible dietary risk to
humans.
The nature of the residue in plants is adequately understood. An
adequate analytical method (gas-liquid chromatography) is available for
enforcement purposes. The analytical method for enforcing these
tolerances has been published in the Pesticide Analytical Manual, Vol.
II (PAM II). There is no reasonable expectation that secondary residues
will occur in milk, eggs, or meat of livestock and poultry since there
are no livestock feed items associated cabbage, cucumbers, and summer
squash.
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 part 180
would protect the public health. Therefore, it is
[[Page 45117]]
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.
A record has been established for this rulemaking under docket
number [PP 4E4311 and 4E4358/P625] (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 rulemaking, 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, 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 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: August 11, 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. 180.425, by adding and alphabetically inserting the
entries for cabbage, cucumber, and squash, summer, to read as follows:
Sec. 180.425 2-(2-Chlorophenyl)methyl-4,4-dimethyl-3-isoxazolidinone;
tolerances for residues.
* * * * *
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Parts per
Commodity million
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Cabbage.................................................... 0.1
* * * * *
Cucumber................................................... 0.1
* * * * *
Squash, summer............................................. 0.1
* * * * *
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[FR Doc. 95-21515 Filed 8-29-95; 8:45 am]
BILLING CODE 6560-50-F
