[Federal Register Volume 60, Number 121 (Friday, June 23, 1995)]
[Proposed Rules]
[Pages 32643-32645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15428]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 185
[OPP-300391; FRL-4962-7]
RIN 2070-AC18
Clethodim; Pesticide Tolerance and Food Additive Regulation
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA proposes to establish an import tolerance and a food
additive regulation, respectively, for residues of the herbicide
clethodim ((E)-()-2-[1-[[(3-chloro-2-
propenyl)oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-
cyclohexen-1-one) and its metabolites containing the 2-cyclohexen-1-one
moiety in or on the raw agricultural commodity potatoes and the food
additive commodities potato flakes and granules. EPA is issuing this
proposal on its own initiative pursuant to a project to harmonize
certain tolerances and food additive regulations with those established
by the Canadian government.
DATES: Comments, identified by the document control number [OPP-
300391], must be received on or before July 24, 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 4:30 p.m., Monday through Friday, excluding legal
holidays.
Comments and data may also be submitted electronically 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 in 5.1 file format or ASCII file
format. All comments and data in electronic form must be identified by
the docket number [OPP-300391]. No Confidential Business Information
(CBI) should be submitted through e-mail. Electronic comments 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.
FOR FURTHER INFORMATION CONTACT: By mail: Joanne Miller, Product
Manager (PM) 23, Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St. SW., Washington,
DC 20460. Office location and telephone number: Rm. 237, CM #2, 1921
Jefferson Davis Highway, Arlington, VA 22202, (703)-305-6224; e-mail:
miller.joanne@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: On its own initiative and pursuant to
section 408(e) of the Federal Food, Drug, and Cosmetic Act by (FFDCA),
21 U.S.C. 346a(e), EPA is proposing to amend 40 CFR 180.458 by
establishing an import tolerance for residues of the herbicide
clethodim and its metabolites containing the 2-cyclohexen-1-one moiety
in or on the raw agricultural commodity potatoes at 0.5 part per
million (ppm); and to add new Sec. 185.1075 (40 CFR 185.1075) by
establishing a food additive regulation for residues of the herbicide
clethodim and its metabolites containing the 2-cyclohexen-1-one moiety
in or on the food additive commodity potato granules and potato flakes
at 1 part per million (ppm). Clethodim residues on potatoes grown in
Canada and imported into the United States have been identified as a
Canada-United States Trade Agreement (CUSTA) irritant. The Agency has
reviewed Canadian crop field trial residue data and determined that
they are adequate to support an import tolerance. All relevant
materials have been evaluated. The toxicological data considered in
support of the proposed tolerances and food additive regulation
include:
1. Several acute toxicology studies placing the technical-grade
herbicide in Toxicity Category II for primary dermal irritation,
Toxicity Category III for oral and inhalation toxicity and primary eye
irritation, and Toxicity Category IV for dermal toxicity.
2. A 2-year rat chronic toxicity/carcinogenicity study found the
compound to be noncarcinogenic to rats under the conditions of the
study. The systemic no-observed-effect level (NOEL) was 500 ppm
(approximately 19 mg/kg/day), and the systemic lowest-observed-effect
level (LOEL) was 2,500 ppm (approximately 100 mg/kg/day) based on the
observed body weight gain, the increases in liver weights, and the
presence of centrilobular hepatic hypertrophy.
3. An 18-month mouse carcinogencity study which showed the compound
to be noncarcinogenic to mice under the conditions of the study. The
systemic NOEL was 200 ppm (approximately 30 mg/kg/day), and the
systemic LOEL was 1,000 ppm (approximately 150 mg/kg/day) based on
treatment-related effects on survival, red cell mass, absolute and
relative liver weights, and microscopic findings in liver and lung.
4. A 1-year feeding study in dogs with a systemic NOEL of 1 mg/kg/
day in both sexes and a LOEL of 75 mg/kg/day based on increased
absolute and relative liver weights, and alterations in hematology and
clinical chemistry.
5. A developmental toxicity study in rats with a developmental and
maternal NOEL and LOEL of 100 and 350 mg/kg/day, respectively. The LOEL
for developmental toxicity was based on reductions in fetal body weight
and increases in skeletal anomalies.
6. A developmental toxicity study in rabbits with a maternal
toxicity NOEL and LOEL of 25 and 100 mg/kg/day, respectively. Maternal
toxicity was manifested as clinical signs of toxicity and reduced
weight gain and food consumption during treatment. Developmental
toxicity was not observed, and therefore the developmental toxicity
NOEL was 300 mg/kg/day (HDT).
7. A two-generation reproduction study in the rat with a parental
toxicity NOEL and LOEL of 500 and 2,500 ppm (51 and 263 mg/kg/day),
respectively, based on reductions in body weight in males, and
decreased food consumption in both generations. The NOEL for
[[Page 32644]] reproductive toxicity was 2,500 ppm (263 mg/kg/day,
HDT).
8. A mutagenicity test with Salmonella Ames assay showed
nonmutagenicity in three strains. Clethodim imine sulfone was negative
for reverse gene mutation in Salmonella and E. coli exposed up to
10,000 ug/plate with or without activation. Clethodim was negative for
chromosomal damage in bone marrow cells of rats treated orally up to
toxic doses (1,500 mg/kg).
The dietary risk exposure analysis used a RfD of 0.01 mg/kg/body
weight(bw)/day based on a NOEL of 1.0 mg/kg/bw/day and a safety factor
of 100. The proposed use on potatoes for the U.S. population results in
an Anticipated Residue Contribution (ARC) of 0.000571 mg/kg/bw/day,
which represents 6% of the RfD. For nonnursing infants less than one
year old, the ARC for the use on potatoes is 0.000860 mg/kg/bw/day, or
9% of the RfD.
The nature of the residue is adequately understood. A common moiety
analytical method (gas chromatograph with a flame photometric detector
in the sulfur mode) and a compound-specific confirmatory method are
available for enforcement purposes. Prior to publication in the
Pesticide Analytical Manual, Vol. II, both methods are available in the
interim to anyone interested in pesticide enforcement. They can be
requested from: Calvin Furlow, Public Response and Program Resources
Branch, Field Operations Division (7506C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M. St. SW., Washington,
DC 20460. Office location and telephone number: Crystal Mall #2, Rm.
1132, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-5232.
Any secondary residues occurring in milk, eggs, or meat of
livestock and poultry will be covered by the established tolerances for
these commodities.The pesticide is considered useful for the purpose
for which the tolerance is sought. 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 parts 180
and 185 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 notice 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, [OPP-300391]. 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
4:30 p.m., Monday through Friday, except legal holidays.
A record has been established for this rulemaking under docket
number [OPP-300391] (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 Parts 180 and 185
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Food additives, Pesticides and pests,
Reporting and recordkeeping requirements.
Dated: June 15, 1995.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
herefore, it is proposed that 40 CFR parts 180 and 185 be amended
as follows:
PART 180--[AMENDED]
1. In part 180:
a. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
b. By amending Sec. 180.458 in the table therein by adding and
alphabetically inserting the commodity potatoes, to read as
follows: [[Page 32645]]
Sec. 180.458 Clethodim ((E)-()-2-[1-[[(3-chloro-2-
propenyl)oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-
cyclohexen-1-one); tolerances for residues.
* * * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Potatoes................................................... 0.5
* * * * *
------------------------------------------------------------------------
PART 185--[AMENDED]
2. In part 185:
a. The authority citation for part 185 continues to read as
follows:
Authority: 21 U.S.C. 346a and 348.
b. By adding new Sec. 185.1075, to read as follows:
Sec. 185.1075 Clethodim ((E)-()-2-[1-[[(3-chloro-2-
propenyl)oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-
cyclohexen-1-one).
Food additive tolerances are established for the combined residues
of the herbicide clethodim ((E)-()-2-[1-[[(3-chloro-2-
propenyl)oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-
cyclohexen-1-one) and its metabolites containing the 2-cyclohexen-1-one
moiety in or on the following processed foods:
------------------------------------------------------------------------
Parts per
Food million
------------------------------------------------------------------------
Potato flakes\1\........................................... 1.0
Potato granules\1\......................................... 1.0
------------------------------------------------------------------------
\1\There are no U.S. registrations as of (date of publication of final
rule) for clethodim on potatoes.
[FR Doc. 95-15428 Filed 6-20-95; 1:50 pm]
BILLING CODE 6560-50-F
