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

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

 [Federal Register: August 28, 2002 (Volume 67, Number 167)]
[Notices]
[Page 55253-55254]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28au02-100]

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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0165; FRL-7190-5]

 
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.

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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: (703) 308-9341; fax number: (703) 305-5884; e-mail 
address: Prunier.Vivian@epa.gov.

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/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 (703) 305-5805.

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

[[Page 55254]]

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.

[FR Doc. 02-21753 Filed 8-27-02; 8:45 am]
BILLING CODE 6560-50-S

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