05-21365. Oxydemeton-methyl Interim Reregistration Eligibility Decision and Amendment

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the availability of EPA's Interim Reregistration Eligibility Decision (IRED) for the organophosphate pesticide oxydemeton-methyl (ODM) and the ODM IRED Amendment document. The Agency's risk assessments and other related documents also are available in the ODM Docket (docket number OPP-34167), and on the ODM reregistration website located at http://www.epa.gov/​oppsrrd1/​op/​odm.htm. ODM is a systemic, organophosphate insecticide/acaracide registered on terrestrial food crops (vegetable, field, tree fruit, and nut crops) and terrestrial non-food sites (ornamental uses). EPA has reviewed ODM through the public participation process that the Agency uses to involve the public in developing pesticide reregistration and tolerance reassessment decisions. Through these programs, EPA is ensuring that all pesticides meet current health and safety standards.

FOR FURTHER INFORMATION CONTACT:

Katie Hall, Special Review and Reregistration Division (7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; fax number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket identification (ID) number OPP-2005-0281. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is [phone].

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/​fedrgstr/​.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/​edocket/​ to view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

II. Background

A. What Action is the Agency Taking?

Under section 4 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is reevaluating existing pesticides to ensure that they meet current scientific and regulatory standards. EPA has completed an IRED for the organophosphate pesticide, ODM under section 4(g)(2)(A) of FIFRA. ODM is a systemic, organophosphate insecticide/acaricide used to control many insects, primarily aphids, mites, and thrips. Registered use sites include terrestrial food crops (vegetable, field, tree fruit, and nut crops) and terrestrial non-food sites (ornamental uses). The ODM IRED presents the Agency's conclusions on the risks posed by exposure to ODM alone; however, section 408(b)(2)(D)(v) of the Federal Food, Drug, and Cosmetic Act (FFDCA) directs the Agency also to consider available information on the cumulative risk from substances sharing a common mechanism of toxicity. Because the organophosphate pesticides share a common mechanism of toxicity, cholinesterase inhibition, the Agency will evaluate the cumulative risk posed by this group before making final reregistration eligibility decision on individual organophosphates.

During the pendency of the organophosphate cumulative assessment, the Agency is proceeding with risk assessments and interim risk management for individual organophosphate pesticides. EPA has determined that, but for the cumulative risk assessment, the data base to support ODM reregistration is substantially complete and that products containing ODM are eligible for reregistration, provided the risks are mitigated in the manner described in the ODM IRED and ODM IRED Amendment. Upon submission of any required product-specific data under FIFRA section 4(g)(2)(B) and any necessary changes to the registration and labeling (either to address concerns identified in the IRED or as a result of product-specific data), and after assessing organophosphate cumulative risks, EPA will make a final reregistration decision under FIFRA section 4(g)(2)(C) for products containing ODM. When the Agency finalizes decisions for ODM and other organophosphate pesticides, further risk mitigation may be required for ODM.

EPA must review tolerances and tolerance exemptions that were in effect when the Food Quality Protection Act was enacted in August 1996, to ensure that these existing pesticide residue limits for food and feed commodities meet the safety standard established by the new law. Tolerances are considered reassessed once the safety finding has been made or a revocation occurs. EPA has reviewed and made the requisite safety finding for the ODM tolerances, pending completion of the organophosphate cumulative assessment.

Although the ODM IRED was signed on August 5, 2002, certain components of the document, which did not affect the final regulatory decision, were undergoing final editing at that time. These components, including the list of additional generic data requirements, summary of labeling changes, appendices, and other relevant information, have been added to the ODM IRED document. In addition, subsequent to signature, EPA identified several minor errors and ambiguities in the document. These additions or changes do not alter the conclusions documented in the 2002 ODM IRED. Label language and use parameters for use of ODM on lettuce were altered based on submission of additional information that affected the risk conclusions for this use. Label changes are described in detail in the “Label Changes Summary Table” in section V.D. of the ODM IRED and in the “Amendment to the 2002 Oxydemeton-methyl IRED,” which are included in the public docket for ODM.

EPA is applying the principles of public participation to all pesticides undergoing reregistration and tolerance reassessment. The Agency's Pesticide Tolerance Reassessment and Reregistration; Public Participation Process, published in the Federal Register on May 14, 2004 (69 FR 26819) (FRL-7357-9), explains that in conducting these programs, EPA is tailoring its public participation process to be commensurate with the level of risk, extent of use, complexity of issues, and degree of public concern associated with each pesticide. Due to its uses, risks, and other factors, ODM was reviewed through the full 6-Phase public participation process. Through this process, EPA worked extensively with stakeholders and the public to reach the regulatory decisions for ODM.

The reregistration program is being conducted under Congressionally mandated time frames, and EPA recognizes the need both to make timely decisions and to involve the public. Since all issues related to this pesticide were resolved through consultations with stakeholders before issuing the ODM IRED Amendment, the Agency is issuing the ODM IRED and ODM IRED Amendment without a comment period. Decisions presented in this IRED may be supplemented by further risk mitigation measures when EPA concludes its cumulative assessment of the organophosphate pesticides.

B. What is the Agency's Authority for Taking this Action?

Section 4(g)(2) of FIFRA as amended, directs that, after submission of all data concerning a pesticide active ingredient, “the Administrator shall determine whether pesticides containing such active ingredient are eligible for reregistration,” before calling in product-specific data on individual end-use products and either reregistering products or taking other “appropriate regulatory action.”

Section 408(q) of the FFDCA, 21 U.S.C. 346a(q), requires EPA to review tolerances and exemptions for pesticide residues in effect as of August 2, 1996, to determine whether the tolerance or exemption meets the requirements of section 408(b)(2) or (c)(2) of the FFDCA. This review is to be completed by August 3, 2006.

List of Subjects

• Environmental protection
• Pesticides and pests

Dated: October 19, 2005.

Debra Edwards,

Director, Special Review and Reregistration Division, Office of Pesticide Programs.