clomazone (Command) Proposed Pesticide Tolerance 3/96
[Federal Register: March 13, 1996 (Volume 61, Number 50)]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 5E4521/P644; FRL-5353-7]
Clomazone; Proposed Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed Rule.
SUMMARY: EPA proposes to establish a tolerance 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 commodity snap bean. The proposed regulation to establish
maximum permissible levels for residues of the herbicide was requested
in a petition submitted by the Interregional Research Project No. 4 (IR-4).
DATES: Comments, identified by the document control number [PP 5E4521/P644],
must be received on or before April 12, 1996.
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 Highway, Arlington, VA 22202.
Comments and data may also be submitted to OPP by sending
electronic mail (e-mail) to: firstname.lastname@example.org. 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 5E4521/P644]. Electronic conunents on this proposed
rule may be filed online at many Federal Depository Libraries.
Additional information on electronic submissions can be found below in
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). 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 2046O.
office location and telephone number: Sixth Floor, Crystal Station #1,
28OO Jefferson Davis Highway, Arlington, VA 22202, (703) 308-8783; e-
SUPPLEMENTARY INFORMATION: The Interregional Research Project No. 4
(IR-4), New Jersey Agricultural Experiment Station, P.O. Box 231,
Rutgers University, New Brunswick, NJ O8903, has submitted pesticide
petition (PP) 5E4521 to EPA on behalf of the Agricultural Experiment
Stations of Arkansas, Kentucky, North Carolina, Tennessee, Texas, and
Virginia. This 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 180.425 by establishing a tolerance for
residues of the herbicide clomazone in or on the raw agricultural
commodity snap bean at 0.05 part per million (ppm).
The scientific data submitted in the petition and other relevant
material have been evaluated. The toxicological data considered in
support of the proposed tolerance 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 ppln dose level (equivalent to 62.5 mg/
2. A developmental 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, l,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 tolerance for snap bean is calculated to be 0.000065 mg/kg/
day, which utilizes less than 1 percent of the RfD for the U.S.
population. The TMRC for non-nursing infants (the population subgroup
most highly exposed) also utilizes less than 1 percent of the RfD. EPA
generally has no cause for concern for exposures below 100 percent of
The nature of the residue in plants is adequately understood. An
adequate analytical method is available for enforcement purposes. The
analytical method for enforcing this tolerance 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: there are no livestock feed items associated with snap
There are presently no actions pending against the continued registration
of this chemical.
Based on the information and data considered, the Agency has
determined that the tolerance established by amending 40 CFR part 180
would protect the public health. Therefore, it is proposed that the
tolerance 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 3O days after publication
of this notice in the Federal Register that this rulemaking proposal be
referred to an Advisory Committee in accordance with section 408(e) of
A record has been established for this rulemaking under docket
number [PP 5E4521/P644] (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:
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 (l) 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
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 2495O).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: February 29, 1996.
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be amended as
1. The authority citation for Part 180 continues to read as
Authority: 21 U.S.C. 346a and 371.
2. Section 180.425 is amended by revising the section heading and
in the table by adding alphabetically the entry for bean, snap to read
Sec. 180.425 Clomazone; tolerances for residues.
* * * * *
Bean, snap..................................................... 0.05
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