EPA 730-N-02-002
                  UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                 WASHINGTON, D.C. 20460
                                           AU6  20  2002
                                                                                OFFICE OF
                                                                         PREVENTION, PESTICIDES AND
                                                                             TOXIC SUBSTANCES
                          Pesticide Registration (PR) Notice 2002-2

         Notice to Manufacturers, Producers, Formulators and Registrants of Pesticides

Attention:    Persons Responsible for Registration and Reregistration of Pesticide Products

Subject:      Guidance for Submitting Requests for Threshold of Regulation (TOR) Decisions to
              the Office of Pesticide Programs

       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 describes criteria and procedures to be considered in determining
whether a use of a pesticide in a location and manner that has the possibility of resulting in residues
in food is below the threshold of regulation.  As explained in the policy notice, a use may be
below the threshold of regulation 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. The TOR Policy also describes
data that might be used to support a finding that a use is below the threshold of regulation. As
stated in the October 1999 notice, there is no fee for requests for TOR decisions.

       This 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 a pesticide registration action,
pesticide reregistration or tolerance reassessment.  A registrant may submit a request for a TOR
decision on a proposed pesticide use  as part of the Federal Insecticide Fungicide and Rodenticide
Act (FIFRA) section 3 registration process.  A registrant or other person may request a TOR
decision on an existing use during reregistration under FIFRA section 4 or tolerance reassessment
under section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA). A State may request a
TOR decision for a use that the State is considering for registration under 24(c) or as part of a
request for an emergency exemption under FIFRA section 18.
                              .Internet Address (URL)  http://www.epa.gov
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       Standard Operating Procedures (SOPs) provide guidance to EPA staff for processing TOR
requests. The Agency developed the SOP with input from the public. The SOP explains how to
apply the criteria and procedures described in the October 1999 TOR Policy and how evaluation of
a TOR request relates to other aspects of a registration decision, reregistration eligibility decision
or tolerance reassessment.                      !

I.      Section 3 Registrations                  !
                                             !

       Before EPA can register the use of a pesticide in a location and manner that has the
possibility of resulting in residues hi food, EPA must determine whether a tolerance is needed, for
residues in or on the food, and if so, whether a tolerance has been established. Ordinarily, EPA
presumes that use of a pesticide hi the vicinity of growing crops or food produces residues hi the
food for which a tolerance is required. Under the "JTOR Policy, EPA may decide that a tolerance is
not needed in certain cases where a pesticide use in the vicinity of growing crops or food results hi
no detected residues in the food.                j
                                             !
       A registrant may send a letter to EPA asking the Agency to determine whether a proposed
use of a pesticide qualifies as a TOR use for which no tolerance or exemption is required. The
registrant should explain why he believes that the use is below the threshold of regulation and
should attach data to support this position. As described hi the TOR policy, data supporting a TOR
request would usually be of the same type and quality that are ordinarily required to support a
petition for a tolerance. The submission should mjset the format requirements given in PR Notice
86-5. If the TOR request is directed to the Office bf Pesticide Programs' Registration Division, the
submitter should provide information on the priority of the action as  described in PR Notices 98-7
and 97-2.  The TOR request and supporting information should accompany the registrant's
application for registration of the new use under FIFRA section 3.

       The TOR request should be directed to the: product manager or chemical review manager
who will be processing the request. In accordance with PR Notice 2000-4, TOR requests should
be addressed as follows for mail delivery to the Office of Pesticide Programs:
                     Document Processing Desk - TOR
                     Office of Pesticide Programs (7504C)
                     U.S. Environmental Protection Agency
                     Ariel Rios Building       j
                     1200 Pennsylvania Avenue? NW
                     Washington, DC 20460.   I
                                             I
For delivery by courier, use this address:         ;
                     Document Processing Desk - TOR
                     Office of Pesticide Programs (7504C)
                     U.S. Environmental Protection Agency
                     Room 266A, Crystal Mall 2
                     1921 Jefferson Davis Hwy.

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-*<
                                Arlington, VA 22202-4501.

                  EPA will review the request for a TOR decision as described in the SOP for TOR
           determinations and notify the person making the request in writing of the results of the review,
           including, if possible, a determination whether the use meets the standard for pesticide registration
           in FIFRA section 3 (c)(5).

                  +     If EPA determines that a pesticide use is below the threshold of regulation and a
                         tolerance is not required for the use, and also finds that the use does not pose an
                         unacceptable risk under FIFRA 2(bb)(l), the Agency will announce in the Federal
                         Register that it proposes to establish that the use is below the threshold of regulation
                         and request comments on the proposal. After publication of the final TOR
                         determination, EPA will register the use under FIFRA section 3.

                         TOR decisions will also appear in Title 40 of the Code of Federal Regulations
                         (CFR). In the Federal Register of December 27, 2001 (66 FR 66769) EPA created
                         a new subpart hi 40  CFR 180 for Pesticide Chemicals Not Requiring a Tolerance or
                         Exemption from Tolerance. Under this proposal, pesticide uses that are below the
                         threshold of regulation would appear in 40 CFR Part 180.2010.

                  +     If EPA' s review shows that the use exceeds the threshold of regulation and that a
                         tolerance or exemption is required, the registrant or other person may submit a
                         tolerance petition and pay the requisite fees.

                  +    . If the use exceeds the threshold of regulation and the Agency determines that the
                         use does not meet the requirements of section 408 of the FFDCA, EPA will advise
                         the person making the request that it cannot register the use under FIFRA.

                  ^     If the use is below the threshold of regulation with respect to potential exposure and
                         risk from any residue theoretically present hi the food, but the Agency finds in its
                         review of the pesticide registration application that the pesticide use poses an
                         unacceptable risk under FIFRA section 2(bb)(l)  such as unacceptable risks to
                         workers or non-target organisms or from pesticide residues in drinking water 
                         EPA will neither establish the use as a TOR use nor register the use unless the risk
                         can be reduced to acceptable levels.

           II.    Section 24(c) Registrations

                  Under section 24(c) of FIFRA, a State may provide for registration for additional uses of
           federally registered pesticides formulated for distribution and use within that State to meet  special
           local needs if EPA has not previously denied, disapproved or canceled the use. A State may not
           issue a registration for a food or feed use unless EPA has established a tolerance or exemption
           under 408 for residues of the pesticide on food or feed.

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       A State may ask EPA to make a TOR determination for a use of a pesticide. The State
should explain why it believes that the use is below the threshold of regulation and should attach
data to support this position.  Data supporting a TOR request should be of the same type and
quality that are ordinarily required to support a petition for a tolerance. To avoid conflict with the
requirements of FIFRA section 24(c)(3), the State should not register the use until EPA has
notified the State of its decision on the TOR decision request.

III.    Section 18 Emergency Exemptions

       Section 18 of FIFRA authorizes EPA to allow States or Federal agencies to use a pesticide
for an unregistered use for a limited time (no longer than one year) if EPA determines that
emergency conditions exist. When a State identifijes a problem situation which currently registered
pesticides will not alleviate, the State lead agency ^usually the State department of agriculture) may
apply to EPA for a Section 18 emergency exemption for a particular use. The FFDCA requires
EPA to establish time-limited tolerances for pesticides used under an emergency exemption.

       The State may ask EPA to determine whether the use is below the threshold of regulation
or EPA may conduct such a review on its own initiative.  If EPA finds that the emergency use is
below the threshold of regulation, a time-limited tolerance would not be required. EPA would
document this finding in the memorandum notifying the State of the outcome of its review of the
request for an emergency exemption. However, because of the time-limited nature of the
emergency exemption, EPA would grant the exemption but would not propose to establish the
emergency use as a TOR use in Part 180 of the Code of Federal Regulations.
                                             j
IV.    Reregistration                          ;
                                             i
       Before EPA can determine whether a pesticide use is eligible for reregistration under
section 4 of FIFRA, EPA must determine whether a tolerance is required for residues resulting
from the use, and if so, whether an existing tolerance may remain in effect or be modified or if a
new tolerance can be established under section 408 of the FFDCA.  Ordinarily, EPA will presume
mat a pesticide applied to - or in the vicinity of- crops or food will result in residues and that a
tolerance must be established. If a registrant or other person believes that such a use qualifies as a
TOR use and that a tolerance is not required, he may ask the Agency to make a TOR decision
during reregistration. The registrant or other person should send the request to the address given in
Unit I of this notice. The TOR decision request should explain why the use qualifies as a TOR use
and should be supported by the kind and quality of data generally required to support a tolerance.
Such requests should be made as early as possible!in the reregistration process.

       EPA will review the request for a TOR depision as described in the  SOP for TOR
determinations. EPA will respond to this TOR request in its preliminary risk assessment or, if the
TOR request is submitted late in the reregistrationj process, as part of its consideration of public
comments on the preliminary risk assessment.
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       +     If the review shows that the use is below the threshold of regulation and is eligible
              for reregistration under FIFRA section 4, the Agency will announce in the Federal
              Register its proposal to establish the use as a TOR use and to revoke any existing
              tolerance for the use. After reviewing and responding to comments, EPA will issue
              a final determination of the TOR status of the use and any existing tolerance for the
              use.  TOR decisions will also appear in Title 40 of the Code of Federal Regulations
              (CFR), as described above.

       +     If the use exceeds the threshold of regulation, EPA will continue to review the use
              and any associated tolerances or exemptions.  It will follow established
              reregistration procedures for this review.

V.     Non-Binding Statement

       This PR Notice provides guidance to EPA and to pesticide registrants. This notice is not
binding on either EPA or pesticide registrants, and EPA may depart from the guidance provided in
individual circumstances. Likewise, pesticide registrants may assert that the guidance is not
appropriate for a specific pesticide or situation.

VI.    For Further Information

       If you have questions about the Threshold of Regulation Policy, please contact Vivian
Prunier, Policy and Regulatory Support Branch, Field and External Affairs Division (7506C),
Office of Pesticide Programs, U.S. EPA, Ariel Rios Building, 1200 Pennsylvania Avenue, NW.,
Washington D.C., 20460, phone:703-308-9341, fax:703-304-5884, e-mail:
prunier.vivian@epa.gov.

       If you have questions about preparing a TOR submission for a specific use, contact the
Product Manager who handles pesticide registration matters for the pesticide or the Chemical
Review Manager who handles the reregistration case for the pesticide.
                                   Signed:
                                   Marcia E. Mulkey, Director
                                   Office of Pesticide Programs, (7501C)
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