01-25044. Pesticides; Draft Guidance for Pesticide Registrants on Submitting Requests for Threshold of Regulation (TOR) Decisions and Draft Standard Operating Procedures for Making TOR Decisions

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of availability.

SUMMARY:

The Agency is announcing the availability of and seeking public comment on a draft Pesticide Registration Notice (PR-Notice) entitled “Guidance for Submitting Requests for Threshold of Regulation (TOR) Decisions.” PR-Notices are issued by the Office of Pesticide Programs (OPP) to inform pesticide registrants and other interested persons about important policies, procedures and registration related decisions, and serve to provide guidance to pesticide registrants and OPP personnel. This particular draft PR-Notice provides guidance to the registrant concerning procedures to use when a registrant or other person wants the Agency to determine whether a use of a pesticide in a location and 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 Agency also seeks public comment on draft Standard Operating Procedures for implementing the TOR policy.

DATES:

Comments, identified by docket control number OPP-00725, must be received on or before December 4, 2001.

ADDRESSES:

Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit V.A. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-00725 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

Vivian Prunier (7506C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: [phone]; fax number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me?

This action is directed to the public in general. Although this action may be of particular interest to those persons who are required to register pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 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 for FIFRA registration of the use of a pesticide in a location and manner that has the possibility of resulting in residues in food may also be interested in this action. 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 information in this notice, consult the person listed under FOR FURTHER INFORMATION CONTACT.

II. What Guidance Does this PR Notice Provide?

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

In the Federal Register of October 27, 1999 (64 FR 57881) (FRL-6388-2), the 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.

b. Using reasonably protective criteria, the estimated potential risk of any theoretically possible residues in food is not of concern.

The draft PR Notice explains how the Agency will implement the October 1999 TOR policy. The draft PR Notice provides guidance on how to submit a request for a TOR decision and explains how EPA will make TOR decisions in the course of pesticide registration or reregistration. A registrant or other person may submit a request for a TOR decision for a new pesticide use as a 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 will follow Standard Operating Procedures (SOPs) for processing TOR requests. You may review and comment on the draft SOP entitled “Implementation of Threshold of Regulation Policy.” The Agency is announcing the availability of and a 60-day comment period on the draft SOP in this Federal Register notice. The draft Standard Operating Procedures are intended to guide EPA reviewers through the review process for TOR decision requests. The draft SOP explains that EPA's review of a TOR decision request must show that the use is below the threshold of regulation and that the use does not result in risks to humans through exposure to pesticide residues in drinking water or occupation exposures or risks to non-target organisms.

As you review the draft guidance, EPA asks you to consider the following questions:

1. Should EPA initiate a review to see whether a use is below the threshold of regulation? In the October 1999 TOR Policy, EPA stated that it would make TOR eligibility decisions in response to requests from registrants or other persons and on its own initiative. As stated in the 1999 TOR Policy, EPA could consider whether a use of a pesticide on or near food that is described in a petition for a tolerance or exemption is below the threshold of regulation. In tolerance reassessment, EPA could consider whether a use of a pesticide on or near food is below the threshold of regulation. As a matter of practice, however, the Agency plans to confine its activity during tolerance assessment or reassessment to determining whether a tolerance can be established or allowed to remain. EPA believes that the public would not benefit if the Agency routinely used its scarce resources to make a further finding -- that there are no detected residues and that the potential risk from any theoretically present residues in the food is below the threshold of regulation and no tolerance or exemption is necessary. Accordingly, as a general practice, EPA will not conduct TOR eligibility reviews on its own initiative. You may wish to comment on EPA's decision not to initiate such reviews.

2. Do EPA's draft procedures for implementing the TOR policy during tolerance reassessment enable registrants or other persons to identify a use that may be below the threshold of regulation? The draft PR Notice and the draft SOP explain that registrants or other persons are responsible for initiating a TOR eligibility review. The draft documents reflect EPA's belief that a person who wants a TOR decision is responsible for developing the case to support such a decision. When reviewing the draft procedures, please look for opportunities for early involvement of a registrant or other person in identifying a use that could potentially qualify as a TOR use.

III. 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.

IV. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

A. Electronically

You may obtain an electronic copy of this Federal Register document using the date of publication from the listing of EPA Federal Register documents at http://www.epa.gov/​fedrgstr/​. You may obtain an electronic copy of this PR-Notice, as well as other PR-Notices, both final and draft, at http://www.epa.gov/​PR_​Notices/​.

B. Fax-on-demand

You may request a faxed copy of the draft Pesticide Registration (PR) Notice entitled “Guidance for Pesticide Registrants on Submitting Requests for Threshold of Regulation (TOR) Decisions,” and the draft “Standard Operating Procedure entitled “Implementation of the Threshold of Regulation Policy,” by using a faxphone to call [phone] and selecting item 6144 and 6145, respectively. You may also follow the automated menu.

C. In person

The Agency has established an official record for this action under docket control number OPP-00725. 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 Highway, Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is [phone].

V. How Do I Submit Comments?

A. How and to Whom Do I Submit Comments?

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-00725 in the subject line on the first page of your response.

1. By mail. Submit your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is [phone].

3. Electronically. You may submit your comments electronically by e-mail to: [e-mail], or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in Wordperfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPP-00725. Electronic comments may also be filed online at many Federal Depository Libraries.

B. How Should I Handle CBI That I Want to Submit to the Agency?

Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified under FOR FURTHER INFORMATION CONTACT.

C. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

5. Provide specific examples to illustrate your concerns.

6. Offer alternative ways to improve the notice.

7. Make sure to submit your comments by the deadline in this notice.

8. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.-

List of Subjects

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

Dated: September 21, 2001.

James Jones,

Acting Director, Office of Pesticide Programs.