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clomazone (Command) Proposed Pesticide Tolerance 8/95

[Federal Register: August 30, 1995 (Volume 60, Number 168)]
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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 
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 
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
                                           
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Cucumber...............................0.1
                                           
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Squash, summer.........................0.1
                                           
                  *        *        *      
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