02-21753. Pesticides; Guidance for Pesticide Registrants on Submitting Requests for Threshold of Regulation (TOR) Decisions and Standard Operating Procedures (SOP) for Making TOR Decisions

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The Agency is announcing the availability of Pesticide Registration Notice 2002-2 (PR-Notice) Entitled “Guidance for Submitting Requests for Threshold of Regulation (TOR) Decisions.” The Office of Pesticide Programs (OPP) issues PR-Notices to inform pesticide registrants and other interested persons about important policies, procedures and registration-related decisions and to provide guidance to pesticide registrants and OPP personnel. PR-Notice 2002-2 provides guidance concerning procedures to use when a registrant or other person wants the Agency to determine whether a use of a pesticide in a manner that has the possibility of resulting in residues in food qualifies under the Agency's October 27, 1999 “Threshold of Regulation” policy. If EPA concludes a use is below the threshold of regulation, no tolerance or tolerance exemption would be required. The accompanying SOP explains how the Agency will process TOR requests.

FOR FURTHER INFORMATION CONTACT:

Vivian Prunier, Field and External Affairs Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 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. This action may, however, be of interest to those persons who are required to register pesticides under the Federal Fungicide, Insecticide and Rodenticide Act (FIFRA) or to persons who may be interested in ascertaining whether a tolerance or tolerance exemption is required under the Federal Food, Drug and Cosmetic Act (FFDCA) as a condition of FIFRA registration of a pesticide. Since other entities may also 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 Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/​. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/​fedrgstr/​. You may view the PR Notice and the SOP described in this notice on the Office of Pesticide Programs Internet Home Page at http://www.epa.gov/​opppmsd1/​PR_​Notices/​.

2. In person. The Agency has established an official record for this action under docket ID number OPP-2002-0165. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is [phone].

II. Background

In the Federal Register of October 27, 1999 (64 FR 57881), the Environmental Protection Agency (EPA) announced the availability of a document entitled “Threshold of Regulation Policy — Deciding Whether a Pesticide with a Food Use Pattern Needs a Tolerance.” The Threshold of Regulation (TOR) policy listed criteria and procedures for considering whether a tolerance is required for the use of a pesticide. A use may qualify as a TOR use if: (a) Using a reliable and appropriately sensitive analytical method to measure residues in the commodity, no residues are detected in the commodity under the expected conditions of use; and (b) using reasonably protective criteria, the estimated potential risk of any theoretically possible residues in food is not of concern.

In the Federal Register of October 5, 2001 (55 FR 51040), the Agency announced the availability of, and asked for comments on, a draft PR- Notice entitled “Guidance for Submitting Requests for Threshold of Regulation (TOR) Decisions.” The draft PR-Notice would provide guidance on how to submit a request for a TOR decision and would explain how EPA will make TOR decisions in the course of pesticide registration or reregistration. The October 5, 2001 notice also announced the availability of and asked for comments on a draft SOP for the Agency's use in processing TOR requests.

EPA received one comment in response to the October 5, 2001 notice. This comment discussed the TOR policy but did not address the procedures described in either the draft PR-Notice or the draft SOP for implementing the October 1999 Threshold of Regulation policy. Accordingly, it will be addressed in other ways.

III. What Guidance Does this PR-Notice Provide?

This PR-Notice provides guidance to the registrant concerning implementation of the Agency's Threshold of Regulation policy.

PR-Notice 2002-2 advises that a registrant or other person may submit a request for a TOR decision for a new pesticide use as part of FIFRA section 3 registration process or for an existing use during reregistration under FIFRA section 4 or tolerance reassessment under the FFDCA. Before registering a use under FIFRA 24(c), a State may ask EPA to decide whether the use is below the threshold of regulation. A State may request a TOR decision when requesting an emergency exemption under FIFRA section 18.

EPA expects to follow an SOP for processing TOR requests. The SOP is intended to guide EPA reviewers through the review process for TOR decision requests.

IV. Do PR-Notices Contain Binding Requirements?

The PR-Notice discussed in this notice is intended to provide guidance to EPA personnel and decision-makers and to pesticide registrants. While the requirements in the statutes and Agency regulations are binding on EPA and the applicants, this PR-Notice is not binding on either EPA or pesticide registrants, and EPA may depart from the guidance where circumstances warrant and without prior notice. Likewise, pesticide registrants may assert that the guidance is not appropriate generally or not applicable to a specific pesticide or situation.

List of Subjects

• Environmental protection
• Administrative practice and procedure
• Agricultural commodities
• Pesticides and pests

Dated: August 20, 2002.

Marcia E. Mulkey,

Director, Office of Pesticide Programs.