81 FR 38704 - Pesticides; Draft Guidance for Pesticide Registrants on the Determination of Minor Use

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 114 (June 14, 2016)

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).

[Federal Register Volume 81, Number 114 (Tuesday, June 14, 2016)]
[Notices]
[Pages 38704-38705]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-14037]


-----------------------------------------------------------------------

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Pesticides; Draft Guidance for Pesticide Registrants on the 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.

-----------------------------------------------------------------------

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]
 BILLING CODE 6560-50-P