[Federal Register Volume 61, Number 50 (Wednesday, March 13, 1996)]
[Proposed Rules]
[Pages 10297-10298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5889]



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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[PP 5E4521/P644; FRL-5353-7]
RIN 2070-AB18


Clomazone; Proposed Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed Rule.

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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: [email protected]. 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 
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). CBI should not be 
submitted through e-mail. Inforrnation 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-
mail: Jamerson.H[email protected].
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 l-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/
kg/day).
    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 RfD.
    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).

[[Page 10298]]

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 beans.
    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 
the FFDCA.
    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:
    opp-D[email protected]


    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 
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 2495O).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: February 29, 1996.

Peter Caulkins,

Acting 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. Section 180.425 is amended by revising the section heading and 
in the table by adding alphabetically the entry for bean, snap to read 
as follows:


Sec. 180.425 Clomazone; tolerances for residues.

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                                                                  Parts 
                          Commodities                              per  
                                                                 million
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Bean, snap.....................................................     0.05
                                                                        
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[FR Doc. 96-5889 Filed 3-12-96; 8:45 am]
BILLING CODE 6560-50-F