[Federal Register Volume 83, Number 55 (Wednesday, March 21, 2018)]
[Notices]
[Pages 12385-12386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05635]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2015-0814; FRL-9974-40]
Pesticides; Guidance for Pesticide Registrants on the
Determination of Minor Use
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of availability.
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SUMMARY: The Agency is announcing the availability of a Pesticide
Registration Notice (PR Notice) entitled, ``Determination of Minor Use
under Federal Insecticide, Fungicide, and Rodenticide Act Section
2(ll).'' This PR Notice was signed by the Agency on March 7, 2018 and
is identified as PR Notice 2018-1. 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 PR Notice, which
supersedes PR Notice 97-2, provides guidance to the registrant as to
how EPA determines a ``minor use.'' EPA seeks to identify and encourage
the registration of pesticides for minor uses to protect communities
from harmful pests. This PR Notice revises the method used by EPA for
evaluating ``sufficient economic incentive'' under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). This PR Notice
explains how qualitative information may be used to inform the
quantitative analysis and interpret the results, and clarifies that the
United States Department of Agriculture's (USDA) most recent Census of
Agriculture is the appropriate source for data on acreage in the U.S.
to establish a minor use under the acreage definition in FIFRA
2(ll)(1).
FOR FURTHER INFORMATION CONTACT: Derek Berwald, Biological and Economic
Analysis Division, MC 7503P, Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (703) 308-8115; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. 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
responsible for the initial or continuing registration of pesticides.
Entities that register pesticides with EPA's OPP typically fall under
the NAICS Code 325300--Pesticide, Fertilizer, and Other Agricultural
Chemical Manufacturing. This action may also be of interest to persons
using pesticides on sites that may be considered ``minor'' including
persons engaged in crop and livestock production, and persons engaged
in pest control in residential, commercial, and municipal areas
including control of public health pests, and to the public in general.
Since other entities may also be interested, the Agency has not
attempted to describe all the specific
[[Page 12386]]
entities that may be affected by this action.
B. How can I get copies of this document and other relevant
information?
The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2015-0814, is available either electronically
though http://www.regulations.gov or in hard copy at the OPP Docket in
the Environmental Protection Agency Docket Center, (EPA/DC) EPA West
William Jefferson Clinton Bldg., Room 3334, 1301 Constitution Ave. NW,
Washington, DC 20460-0001. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is (202) 566-1744, and the
telephone number for the OPP Docket is (703) 305-5805.
II. What guidance does this PR Notice provide?
FIFRA defines a minor use of a pesticide as either a use on a crop
grown on 300,000 acres or less in the United States or a use that lacks
sufficient economic incentive to seek or maintain a registration but
has private or social value. This PR Notice provides guidance to the
registrant concerning the method used to determine if a use site is a
``minor use'' as defined by FIFRA 2(ll). In particular, the PR Notice
describes the method for determining if the use ``does not provide
sufficient economic incentive.'' To date, EPA's interpretation of
economic minor use in section 2(ll)(2) has been shaped by guidance
provided in PR Notice 97-2. However, the approach outlined in PR Notice
97-2 does not consider critical factors that influence the incentives
for registration.
EPA published and requested public comment on the draft Economic
Minor Use PR Notice on June 6, 2016 (81 FR 38704). EPA received
comments from seven entities. Most commenters were broadly supportive
of the endeavor to improve upon PR Notice 97-2. Commenters supported
the new process to qualify for minor use registration under FIFRA as
more appropriate and simple by clarifying and updating economic
definitions and treating registration of a pesticide as an investment.
The Agency appreciates the comments provided by the public, and the
Agency's responses to the comments for the draft PR Notice can be found
at regulations.gov using docket ID number EPA-HQ-OPP-2015-0814.
This final PR Notice describes the revised approach to evaluate
``sufficient economic incentive.'' It explicitly considers (1) the
difference in time between incurring costs of generating data for
registration and obtaining revenue from product sales, (2) the multiple
years over which revenue is generated, and (3) the costs of producing
and distributing the product. The PR Notice provides suggestions about
the data that can be used to conduct the analysis. Finally, the PR
Notice explains how qualitative information may be used to inform the
quantitative analysis and interpret the results. It also clarifies that
the most recent USDA Census of Agriculture is the appropriate source
for data on acreage in the U.S. to establish a minor use under the
acreage definition in FIFRA section 2(ll)(1).
Registrants will typically seek to demonstrate that a site is a
minor use in the context of requesting an extension of the exclusive
use period for data submitted in support of a registration under FIFRA
section 3(c)(1)(F)(ii) or a new exclusive use period for data submitted
to support a registration under FIFRA section 3(c)(1)(F)(vi). These
clauses are intended to provide incentives to registrants to obtain
registrations for uses that might otherwise go unfulfilled because they
offer low returns because of low demand.
The information collection activities associated with the
activities described in this PR Notice are already approved by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq. The corresponding Information Collection
Request (ICR) document for the Application for New and Amended
Pesticide Registration has been assigned EPA ICR number 0277.16 and is
approved under OMB control number 2070-0060.
III. Do PR Notices contain binding requirements?
The PR Notice about the determination of a minor use 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.
Authority: 7 U.S.C. 136 et seq.
Dated: March 7, 2018.
Richard P. Keigwin, Jr.,
Director, Office of Pesticide Programs.
[FR Doc. 2018-05635 Filed 3-20-18; 8:45 am]
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