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clethodim (Select) Proposed Pesticide Tolerance and Food Additive Regulation 6/95

[Federal Register: June 23, 1995 (Volume 60, Number 121)]
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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.
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SUMMARY: EPA proposes to establish an import tolerance and a food 
additive regulation, respectively, for residues of the herbicide 
clethodim ((E)-(<plus-minus>)-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 
 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: 
Sec. 180.458   Clethodim ((E)-(<plus-minus>)-2-[1-[[(3-chloro-2-
propenyl)oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-
cyclohexen-1-one); tolerances for residues.
    *        *        *        *        *
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                                                              Parts per 
                         Commodity                             million  
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                  *        *        *        *        *                 
Potatoes...................................................          0.5
                                                                        
                  *        *        *        *        *                 
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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)-(<plus-minus>)-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)-(<plus-minus>)-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:
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                                                              Parts per 
                            Food                               million  
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Potato flakes1\...........................................          1.0
Potato granules1\.........................................          1.0
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1\There are no U.S. registrations as of (date of publication of final  
  rule) for clethodim on potatoes.