[Federal Register Volume 66, Number 194 (Friday, October 5, 2001)]
[Notices]
[Pages 51040-51042]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-25044]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00795; FRL-6790-2]


Pesticides; Draft Guidance for Pesticide Registrants on 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.

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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

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Ave., NW., Washington, DC 20460; telephone number: (703) 308-9341; fax 
number: (703) 308-5884; e-mail address: [email protected].

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 (202) 
401-0527 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

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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 (703) 305-5805.

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 (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], 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.

[FR Doc. 01-25044 Filed 10-4-01; 8:45 am]
BILLING CODE 6560-50-S