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)

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, 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