81 FR 38704 - Pesticides; Draft Guidance for Pesticide Registrants on the Determination of Minor Use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

Page Range		38704-38705
FR Document		2016-14037

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 Issue 114 (Tuesday, June 14, 2016)

[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]


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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Pesticides; Draft Guidance for Pesticide Registrants on the 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]
 BILLING CODE 6560-50-P

Federal Register / Vol. 81, No. 114 / Tuesday, June 14, 2016 / Notices 38705

exclusive use period for data submitted Proposed Statement of Policy Regarding ADDRESSES: You may submit comments,
in support of a registration under FIFRA the Public Disclosure of Closed identified by Docket No. CDC–2016–
section 3(c)(1)(F)(ii) or a new exclusive Enforcement Files 0052 by any of the following methods:
use period for data submitted to support Other Rulemaking • Federal eRulemaking Portal:
a registration under FIFRA section REG 2016–02: Draft Interim Final Regulations.gov. Follow the instructions
3(c)(1)(F)(vi). These clauses are Rules and Explanation and for submitting comments.
intended to provide incentives to Justification: Civil Money Penalty • Mail: Leroy A. Richardson,
registrants to obtain registrations for Inflation Adjustments Information Collection Review Office,
uses that might otherwise go unfulfilled Proposed Revisions to Forms 3, 3P, Centers for Disease Control and
because they offer low returns because 3X, 6 and Instructions Prevention, 1600 Clifton Road NE., MS–
of low demand. Management and Administrative D74, Atlanta, Georgia 30329.
The information collection activities Matters Instructions: All submissions received
associated with the activities described must include the agency name and
Individuals who plan to attend and
in this PR Notice are already approved Docket Number. All relevant comments
require special assistance, such as sign
by the Office of Management and received will be posted without change
language interpretation or other
Budget (OMB) under the Paperwork to Regulations.gov, including any
reasonable accommodations, should
Reduction Act (PRA), 44 U.S.C. 3501 et personal information provided. For
contact Shawn Woodhead Werth,
seq. The corresponding Information access to the docket to read background
Secretary and Clerk, at (202) 694–1040,
Collection Request (ICR) document for documents or comments received, go to
at least 72 hours prior to the meeting
the Application for New and Amended Regulations.gov.
date.
Pesticide Registration has been assigned PERSON TO CONTACT FOR INFORMATION:
Please note: All public comment should be
EPA ICR number 0277.16 and is submitted through the Federal eRulemaking
Judith Ingram, Press Officer, Telephone: portal (Regulations.gov) or by U.S. mail to the
approved OMB control number 2070– (202) 694–1220.
0060. address listed above.
Shawn Woodhead Werth, FOR FURTHER INFORMATION CONTACT: To
III. Do PR Notices contain binding
Secretary and Clerk of the Commission. request more information on the
requirements?
[FR Doc. 2016–14077 Filed 6–10–16; 11:15 am] proposed project or to obtain a copy of
The PR Notice about the BILLING CODE 6715–01–P the information collection plan and
determination of a minor use is instruments, contact the Information
intended to provide guidance to EPA Collection Review Office, Centers for
personnel and decision-makers and to Disease Control and Prevention, 1600
pesticide registrants. While the DEPARTMENT OF HEALTH AND Clifton Road NE., MS–D74, Atlanta,
requirements in the statutes and Agency HUMAN SERVICES Georgia 30329; phone: 404–639–7570;
regulations are binding on EPA and the Email: omb@cdc.gov.
applicants, this PR Notice is not binding Centers for Disease Control and
SUPPLEMENTARY INFORMATION: Under the
on either EPA or pesticide registrants, Prevention
Paperwork Reduction Act of 1995 (PRA)
and EPA may depart from the guidance (44 U.S.C. 3501–3520), Federal agencies
where circumstances warrant and [60 Day–16–16AQM; Docket No. CDC–2016–
must obtain approval from the Office of
without prior notice. Likewise, pesticide 0052]
Management and Budget (OMB) for each
registrants may assert that the guidance collection of information they conduct
is not appropriate generally or not Proposed Data Collection Submitted
for Public Comment and or sponsor. In addition, the PRA also
applicable to a specific pesticide or requires Federal agencies to provide a
situation. Recommendations
60-day notice in the Federal Register
Authority: 7 U.S.C. 136 et seq. AGENCY: Centers for Disease Control and concerning each proposed collection of
Dated: May 31, 2016. Prevention (CDC), Department of Health information, including each new
and Human Services (HHS). proposed collection, each proposed
Jack E. Housenger,
ACTION: Notice with comment period. extension of existing collection of
Director, Office of Pesticide Programs.
information, and each reinstatement of
[FR Doc. 2016–14037 Filed 6–13–16; 8:45 am] SUMMARY: The Centers for Disease previously approved information
BILLING CODE 6560–50–P Control and Prevention (CDC), as part of collection before submitting the
its continuing efforts to reduce public collection to OMB for approval. To
burden and maximize the utility of comply with this requirement, we are
FEDERAL ELECTION COMMISSION government information, invites the publishing this notice of a proposed
general public and other Federal data collection as described below.
Sunshine Act Meetings agencies to take this opportunity to Comments are invited on: (a) Whether
comment on proposed and/or the proposed collection of information
AGENCY: Federal Election Commission.
continuing information collections, as is necessary for the proper performance
DATE AND TIME: Thursday, June 16, 2016 required by the Paperwork Reduction of the functions of the agency, including
at 10:00 a.m. Act of 1995. This notice invites whether the information shall have
PLACE: 999 E Street NW., Washington, comment on the Presidential Youth practical utility; (b) the accuracy of the
DC (Ninth Floor). Fitness Program (PYFP) Evaluation. The agency’s estimate of the burden of the
srobinson on DSK5SPTVN1PROD with NOTICES

STATUS: This Meeting will be open to Evaluation will be conducted in proposed collection of information; (c)
the public. approximately 11 middle schools ways to enhance the quality, utility, and
ITEMS TO BE DISCUSSED: implementing the PYFP and 11 match clarity of the information to be
Correction and Approval of Minutes for comparison schools and will focus on collected; (d) ways to minimize the
May 19, 2016 both process and outcome measures. burden of the collection of information
Draft Advisory Opinion 2016–05: DATES: Written comments must be on respondents, including through the
Huckabee for President, Inc. received on or before August 15, 2016. use of automated collection techniques

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Document Created: 2016-06-14 02:58:42
Document Modified: 2016-06-14 02:58:42

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.
Dates		Comments must be received on or before August 15, 2016.
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
FR Citation		81 FR 38704