83 FR 12385 - Pesticides; Guidance for Pesticide Registrants on the Determination of Minor Use

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 55 (March 21, 2018)

Page Range		12385-12386
FR Document		2018-05635

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).

Federal Register, Volume 83 Issue 55 (Wednesday, March 21, 2018)

[Federal Register Volume 83, Number 55 (Wednesday, March 21, 2018)]
[Notices]
[Pages 12385-12386]
From the Federal Register Online  [www.thefederalregister.org]
[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]
 BILLING CODE 6560-50-P

Federal Register / Vol. 83, No. 55 / Wednesday, March 21, 2018 / Notices 12385

person is not required to respond to a responses. The EPA will consider the ‘‘Determination of Minor Use under
collection of information unless it comments received and amend the ICR Federal Insecticide, Fungicide, and
displays a currently valid OMB control as appropriate. The final ICR package Rodenticide Act Section 2(ll).’’ This PR
number. will then be submitted to OMB for Notice was signed by the Agency on
DATES: Comments must be submitted on review and approval. At that time, the March 7, 2018 and is identified as PR
or before May 21, 2018. EPA will issue another Federal Register Notice 2018–1. PR Notices are issued by
ADDRESSES: Submit your comments, notice to announce the submission of the Office of Pesticide Programs (OPP)
referencing by Docket ID No. EPA–HQ– the ICR to OMB and the opportunity to to inform pesticide registrants and other
OLEM–2018–0102, online using submit additional comments to OMB. interested persons about important
www.regulations.gov (our preferred Abstract: Section 7004(b) of RCRA policies, procedures, and registration
method), by email to rcra-docket@ gives EPA broad authority to provide related decisions, and serve to provide
epa.gov, or by mail to: EPA Docket for, encourage, and assist public guidance to pesticide registrants and
Center, Environmental Protection participation in the development, OPP personnel. This PR Notice, which
Agency, Mail Code 28221T, 1200 revision, implementation, and supersedes PR Notice 97–2, provides
Pennsylvania Ave. NW, Washington, DC enforcement of any regulation, guidance to the registrant as to how EPA
20460. guideline, information, or program determines a ‘‘minor use.’’ EPA seeks to
EPA’s policy is that all comments under RCRA. In addition, the statute identify and encourage the registration
received will be included in the public specifies certain public notices (i.e., of pesticides for minor uses to protect
docket without change including any radio, newspaper, and a letter to communities from harmful pests. This
personal information provided, unless relevant agencies) that EPA must PR Notice revises the method used by
the comment includes profanity, threats, provide before issuing any RCRA EPA for evaluating ‘‘sufficient economic
information claimed to be Confidential permit. The statute also establishes a incentive’’ under the Federal
Business Information (CBI) or other process by which the public can dispute Insecticide, Fungicide, and Rodenticide
information whose disclosure is a permit and request a public hearing to Act (FIFRA). This PR Notice explains
restricted by statute. discuss it. EPA carries out much of its how qualitative information may be
FOR FURTHER INFORMATION CONTACT: RCRA public involvement at 40 CFR used to inform the quantitative analysis
Michael Pease, (5303P), Environmental Parts 124 and 270. and interpret the results, and clarifies
Protection Agency, 1200 Pennsylvania Form Numbers: None. that the United States Department of
Ave. NW, Washington, DC 20460; Respondents/affected entities: Entities Agriculture’s (USDA) most recent
telephone number: 703–308–0008; fax potentially affected by this action are Census of Agriculture is the appropriate
number: 703–308–8433; email address: Businesses and other for-profit. source for data on acreage in the U.S. to
pease.michael@epa.gov. Respondent’s obligation to respond: establish a minor use under the acreage
SUPPLEMENTARY INFORMATION: Mandatory (RCRA 7004(b)). definition in FIFRA 2(ll)(1).
Supporting documents which explain in Estimated number of respondents: 59. FOR FURTHER INFORMATION CONTACT:
detail the information the EPA will be Frequency of response: On occasion. Derek Berwald, Biological and
collecting are available in the public Total estimated burden: 5,614 Burden Economic Analysis Division, MC 7503P,
docket for this ICR. The docket can be is defined at 5 CFR 1320.03(b). Office of Pesticide Programs,
viewed online at www.regulations.gov Total estimated cost: $369,547 (per Environmental Protection Agency, 1200
or in person at the EPA Docket Center, year), which includes $363,866 Pennsylvania Ave. NW, Washington, DC
WJC West, Room 3334, 1301 annualized labor and $5,681 annualized 20460–0001; telephone number: (703)
Constitution Ave. NW, Washington, DC. capital and operation & maintenance 308–8115; email address:
The telephone number for the Docket costs. berwald.derek@epa.gov.
Center is 202–566–1744. For additional Changes in Estimates: The burden
hours are likely to stay substantially the SUPPLEMENTARY INFORMATION:
information about EPA’s public docket,
visit http://www.epa.gov/dockets. same. I. General Information
Pursuant to section 3506(c)(2)(A) of Dated: March 14, 2018. A. Does this action apply to me?
the PRA, the EPA is soliciting comments Barnes Johnson,
and information to enable it to: (i) Director, Office of Resource Conservation and This action is directed to the public
Evaluate whether the proposed Recovery. in general. Although this action may be
collection of information is necessary [FR Doc. 2018–05759 Filed 3–20–18; 8:45 am] of particular interest to those persons
for the proper performance of the BILLING CODE 6560–50–P
who are responsible for the initial or
functions of the Agency, including continuing registration of pesticides.
whether the information will have Entities that register pesticides with
practical utility; (ii) evaluate the ENVIRONMENTAL PROTECTION EPA’s OPP typically fall under the
accuracy of the Agency’s estimate of the AGENCY NAICS Code 325300—Pesticide,
burden of the proposed collection of Fertilizer, and Other Agricultural
information, including the validity of [EPA–HQ–OPP–2015–0814; FRL–9974–40] Chemical Manufacturing. This action
the methodology and assumptions used; may also be of interest to persons using
Pesticides; Guidance for Pesticide
(iii) enhance the quality, utility, and pesticides on sites that may be
Registrants on the Determination of
clarity of the information to be considered ‘‘minor’’ including persons
Minor Use
collected; and (iv) minimize the burden engaged in crop and livestock
sradovich on DSK3GMQ082PROD with NOTICES

of the collection of information on those AGENCY: Environmental Protection production, and persons engaged in pest
who are to respond, including through Agency (EPA). control in residential, commercial, and
the use of appropriate automated ACTION: Notice of availability. municipal areas including control of
electronic, mechanical, or other public health pests, and to the public in
technological collection techniques or SUMMARY: The Agency is announcing general. Since other entities may also be
other forms of information technology, the availability of a Pesticide interested, the Agency has not
e.g., permitting electronic submission of Registration Notice (PR Notice) entitled, attempted to describe all the specific

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Document Created: 2018-03-21 00:45:23
Document Modified: 2018-03-21 00:45:23

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
Contact		Derek Berwald, Biological and Economic Analysis Division, MC 7503P, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
FR Citation		83 FR 12385