E6-4837. Ethoprop, Addendum to the Interim Reregistration Eligibility Decision

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the availability of an Addendum to EPA's 2001 Interim Reregistration Eligibility Decision (IRED) for the organophosphate pesticide, ethoprop. The Agency's risk assessments and other related documents also are available in the ethoprop Docket. The 2001 IRED for ethoprop described the Agency's interim reregistration decision on granular formulated products. A decision on the emulsifiable concentrate (EC) formulation was deferred until the registrant submitted additional exposure data. The Agency has received and reviewed the additional data, and the review is available in the ethoprop Docket. This addendum to the 2001 IRED for ethoprop includes the regulatory decision on the EC formulation of ethoprop. EPA has reviewed ethoprop 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:

Jacqueline Guerry, 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 a docket for this action under Docket identification number (ID) EPA-HQ-OPP-2002-0269; FRL-7772-9. Publicly available docket materials are available either electronically through http://www.regulations.gov or in hard copy 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/​.

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 completed an IRED for the organophosphate pesticide ethoprop in 2001 that presented an interim reregistration eligiblity decision for granular formulated products. The decision on the emulsifiable concentrate (EC) formulation was deferred until the registrant submitted additional occupational exposure information on the EC formulation. The Agency's review of the exposure data is available in the ethoprop docket. The addendum to the ethoprop IRED, signed on February 25, 2006, presents the Agency's conclusions on the risks posed by exposure to EC formulations of ethoprop 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, the Agency will evaluate the cumulative risk posed by this group before making final reregistration eligibility decisions 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 ethoprop reregistration is substantially complete and that products containing ethoprop, in addition to the grandular formulators, EC formulations are eligible for reregistration provided the risks are mitigated in the manner described in the 2001 IRED and in the 2006 Addendum to the IRED or by another means that achieves equivalent risk reduction. Upon submission of any required product specific data under 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 section 4(g)(2)(C) for products containing ethoprop. When the Agency finalizes decisions for ethoprop and other organophosphate pesticides, further risk mitigation may be required for ethoprop.

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, ethoprop 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 ethoprop.

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. In this case, no additional comment period is needed because the 2001 ethoprop IRED was reviewed through the full 6-phase public participation process, and all issues related to this pesticide were resolved through consultations with stakeholders and the submission of data allowing the Agency to conclude the decision on the EC formulation. The Agency, therefore, is issuing the 2006 ethoprop addendum to the IRED without a comment period. Decisions presented in the IRED and in the addendum to the 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.”

List of Subjects

• Environmental protection
• Pesticides and pests

Dated: March 28, 2006.

Debra Edwards,

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