[Federal Register Volume 81, Number 114 (Tuesday, June 14, 2016)]
[Notices]
[Pages 38704-38705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14037]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2015-0814; FRL-9946-13]
Pesticides; Draft Guidance for Pesticide Registrants on the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 and seeking
public comment on a draft Pesticide Registration Notice (PR Notice)
entitled ``Determination of Minor Use under Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), section 2(ll).'' 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 draft PR
Notice would update section 5 of PR Notice 97-2 and provide guidance to
the registrant as to how the 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 draft PR Notice revises
the method used by EPA for evaluating ``sufficient economic incentive''
under FIFRA. The draft PR Notice explains how qualitative information
may be used to inform the quantitative analysis, interpret the results,
and clarifies that the most recent United States Department of
Agriculture (USDA) Census of Agriculture is the appropriate source for
data on acreage in the United States to establish a minor use under the
acreage definition in FIFRA 2(ll)(1).
DATES: Comments must be received on or before August 15, 2016.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2015-0814, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.
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?
You may be potentially affected by this action if you are
responsible for the initial or continuing registration of pesticides.
Entities that register pesticides with EPA's Office of Pesticide
Programs typically fall under the North American Industry
Classification System (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 many entities may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes 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 docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
C. How can I get copies of this document and other related information?
A copy of the draft PR Notice is available in the docket under
docket identification (ID) number EPA-HQ-OPP-2015-0814.
II. What guidance does this PR notice provide?
FIFRA defines a minor use of a pesticide as either (1) a use on a
crop grown on 300,000 acres or less in the United States or (2) a use
that lacks sufficient economic incentive to seek or maintain a
registration but has private or social value. This draft 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 draft 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 ignores critical factors that influence the
incentives for registration.
This draft PR Notice describes the revised approach to evaluate
``sufficient economic incentive'' which addresses these factors. 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 draft PR
Notice provides suggestions about the data that can be used to conduct
the analysis. Finally, the draft 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 United States to establish a minor use under the acreage definition
in FIFRA section 2(ll)(1).
Registrants will typically seek to demonstrate a site is a minor
use in the context of requesting an extension of the
[[Page 38705]]
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 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: May 31, 2016.
Jack E. Housenger,
Director, Office of Pesticide Programs.
[FR Doc. 2016-14037 Filed 6-13-16; 8:45 am]
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