Pesticides; Draft Guidance for Pesticide Registrants on the Determination of Minor Use, 38704-38705 [2016-14037]

Download as PDF 38704 Federal Register / Vol. 81, No. 114 / Tuesday, June 14, 2016 / Notices regulations for transuranic radioactive waste at 40 CFR part 191. Dated: June 3, 2016. Gina McCarthy, Administrator. [FR Doc. 2016–14095 Filed 6–13–16; 8:45 am] BILLING CODE P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPP–2015–0814; FRL–9946–13] Pesticides; Draft Guidance for Pesticide Registrants on the Determination of Minor Use Environmental Protection Agency (EPA). ACTION: Notice of availability. AGENCY: 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: https:// www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) srobinson on DSK5SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:36 Jun 13, 2016 Jkt 238001 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 https:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://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: berwald.derek@epa.gov. 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 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 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 https://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 E:\FR\FM\14JNN1.SGM 14JNN1 Federal Register / Vol. 81, No. 114 / Tuesday, June 14, 2016 / Notices 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. [FR Doc. 2016–14037 Filed 6–13–16; 8:45 am] FEDERAL ELECTION COMMISSION Sunshine Act Meetings Federal Election Commission. Thursday, June 16, 2016 at 10:00 a.m. PLACE: 999 E Street NW., Washington, DC (Ninth Floor). STATUS: This Meeting will be open to the public. ITEMS TO BE DISCUSSED: Correction and Approval of Minutes for May 19, 2016 Draft Advisory Opinion 2016–05: Huckabee for President, Inc. srobinson on DSK5SPTVN1PROD with NOTICES Jkt 238001 [FR Doc. 2016–14077 Filed 6–10–16; 11:15 am] BILLING CODE 6715–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60 Day–16–16AQM; Docket No. CDC–2016– 0052] Proposed Data Collection Submitted for Public Comment and Recommendations The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the Presidential Youth Fitness Program (PYFP) Evaluation. The Evaluation will be conducted in approximately 11 middle schools implementing the PYFP and 11 match comparison schools and will focus on both process and outcome measures. DATES: Written comments must be received on or before August 15, 2016. SUMMARY: BILLING CODE 6560–50–P 19:36 Jun 13, 2016 FOR FURTHER INFORMATION CONTACT: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment period. Dated: May 31, 2016. Jack E. Housenger, Director, Office of Pesticide Programs. VerDate Sep<11>2014 ADDRESSES: AGENCY: Authority: 7 U.S.C. 136 et seq. DATE AND TIME: Proposed Statement of Policy Regarding the Public Disclosure of Closed Enforcement Files Other Rulemaking REG 2016–02: Draft Interim Final Rules and Explanation and Justification: Civil Money Penalty Inflation Adjustments Proposed Revisions to Forms 3, 3P, 3X, 6 and Instructions Management and Administrative Matters Individuals who plan to attend and require special assistance, such as sign language interpretation or other reasonable accommodations, should contact Shawn Woodhead Werth, Secretary and Clerk, at (202) 694–1040, at least 72 hours prior to the meeting date. PERSON TO CONTACT FOR INFORMATION: Judith Ingram, Press Officer, Telephone: (202) 694–1220. Shawn Woodhead Werth, Secretary and Clerk of the Commission. 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. AGENCY: 38705 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 You may submit comments, identified by Docket No. CDC–2016– 0052 by any of the following methods: • Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments. • Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS– D74, Atlanta, Georgia 30329. Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov. Please note: All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above. To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS–D74, Atlanta, Georgia 30329; phone: 404–639–7570; Email: omb@cdc.gov. SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques E:\FR\FM\14JNN1.SGM 14JNN1

Agencies

[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.

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

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: https://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 https://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at https://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: berwald.derek@epa.gov.

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 https://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
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