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clethodim (Select) Pesticide Tolerance and Food Additive Regulation 8/95

Date: Wed, 9 Aug 1995 09:45:56 -0400
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To: Multiple recipients of list <epa-pest@unixmail.rtpnc.epa.gov> Subject: Clethodim; Pesticide Tolerance and Food Additive Regulation X-Comment: U.S. EPA FEDERAL REGISTER PESTICIDE documents 
[Federal Register: August 9, 1995 (Volume 60, Number 153)] [Rules and Regulations]
[Page 40503-40505]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov] 
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 185
[OPP-300391A; FRL-4967-5]
RIN 2070-AB78
Clethodim; Pesticide Tolerance and Food Additive Regulation 
AGENCY: Environmental Protection Agency (EPA). 
ACTION: Final rule.
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SUMMARY: EPA is establishing 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 rule on its own initiative pursuant to a project to harmonize certain tolerances and food additive regulations with those established by the Canadian government. 
EFFECTIVE DATE: This regulation becomes effective August 9, 1995. 
ADDRESSES: Written objections and hearing requests, identified by the document control number, [OPP-300391A], may be submitted to: Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington, DC 20460. Fees accompanying objections and hearing requests shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and hearing requests filed with the Hearing Clerk should be identified by the document control number and submitted 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 copy of objections and hearing requests to: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202.
A copy of objections and hearing requests filed with the Hearing Clerk may also be submitted electronically by sending electronic mail (e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and hearing requests must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Copies of objections and hearing requests will also be accepted on disks in WordPerfect in 5.1 file
[[Page 40504]]
format or ASCII file format. All copies of objections and hearing requests in electronic form must be identified by the docket number [OPP-300391A]. No Confidential Business Information (CBI) should be submitted through e-mail. Electronic copies of objections and hearing requests on this 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), Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: Rm. 259, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-6224; e-mail: miller.joanne@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of June 23, 1995 (60 FR 32643), EPA issued a proposed rule giving notice that on its own inititative and pursuant to section 408(e) of the FFDCA, 21 U.S.C. 346a, it was issuing a proposal 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 Canadian-United States Trade Agreement (CUSTA) irritant. EPA has reviewed Canadian crop field trial residue data and determined that they are adequate to support an import tolerance.
The data submitted with the proposal and other relevant material have been evaluated and discussed in the proposed rule. Based on the data and information considered, the Agency concludes that the tolerance will protect the public health. Therefore, the tolerance and food additive regulation are established as set forth below. 
Any person adversely affected by this regulation may, within 30 days after publication of this document in the Federal Register, file written objections and/or request a hearing with the Hearing Clerk, at the address given above (40 CFR 178.20). A copy of the objections and/ or hearing requests filed with the Hearing Clerk should be submitted to the OPP docket for this rulemaking. The objections submitted must specify the provisions of the regulation deemed objectionable and the grounds for the objections (40 CFR 178.25). Each objection must be accompanied by the fee prescribed by 40 CFR 180.33(i). If a hearing is requested, the objections must include a statement of the factual issue(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established, resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issue(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).
A record has been established for this rulemaking under docket number [OPP-300391A] (including any objections and hearing requests 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. 
Written objections and hearing requests, identified by the document control number [OPP-300391A], may be submitted to the Hearing Clerk (1900), Environmental Protection Agency, Rm. 3708, 401 M St., SW., Washington, DC 20460.
A copy of electronic objections and hearing requests filed with the Hearing Clerk can be sent directly to EPA at: 
opp-Docket@epamail.epa.gov.
A copy of electronic objections and hearing requests filed with the Hearing Clerk 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 any objections and hearing requests 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 objections and hearing requests 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 review by the Office of Management and Budget (OMB) and the requirements of the Executive Order. Under section 3(f), the order defines a ``significant regulatory action'' as an action that is likely to result in 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 referred to 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 the rights and obligations of recipients thereof; 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 the 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. 
[[Page 40505]]
Dated: July 27, 1995.
Daniel M. Barolo,
Director, Office of Pesticide Programs.
Therefore, 40 CFR parts 180 and 185 are 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. 
* * * * *
------------------------------------------------------------------------ 
Parts per
Commodity	million
------------------------------------------------------------------------ 
*	*	*	*	*
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: 
------------------------------------------------------------------------ 
Parts per
Food	million
------------------------------------------------------------------------ 
Potato flakes1\...........................................	1.0
Potato granules1\.........................................	1.0
------------------------------------------------------------------------ 1\There are no U.S. registrations as of August 9, 1995. 
[FR Doc. 95-19529 Filed 8-8-95; 8:45 am] BILLING CODE 6560-50-F