[Federal Register Volume 86, Number 51 (Thursday, March 18, 2021)]
[Notices]
[Pages 14750-14751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05628]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2017-0693 and EPA-HQ-OPP-2019-0161; FRL-10019-54]


Final Test Guidelines; OCSPP Series 810--Product Performance Test 
Guidelines; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing the 
availability of the final product performance test guidelines for fire 
ants and invertebrate pests of pets. These test guidelines are part of 
a series of test guidelines established by the Office of Chemical 
Safety and Pollution Prevention (OCSPP) for use in testing pesticides 
and chemical substances. The test guidelines serve as a compendium of 
accepted scientific methodologies and protocols for testing that are 
intended to provide data to inform regulatory decisions. These test 
guidelines, which are identified as OCSPP Test Guideline 810.3100 and 
810.3300, provide guidance for conducting a study to determine 
pesticide product performance against fire ants and invertebrate pests 
of pets, respectively, and are used by EPA, the public, and companies 
that submit data to EPA.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (703) 305-7090; email address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Introduction

    EPA is announcing the availability of the following final test 
guidelines: OCSPP Test Guideline 810.3100: Treatments for Imported Fire 
Ants and 810.3300: The Efficacy of Topically Applied Pet Products 
Against Certain Invertebrate Pests.
    These test guidelines are part of a series of test guidelines 
established by OCSPP for use in testing pesticides and chemical 
substances to develop data for submission to the Agency under the 
Federal Food, Drug, and Cosmetic Act (FFDCA) section 408 (21 U.S.C. 
346a), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
(7 U.S.C. 136 et seq.), and the Toxic Substances Control Act (TSCA) (15 
U.S.C. 2601 et seq.). The test guidelines serve as a compendium of 
accepted scientific methodologies and protocols that are intended to 
provide data to inform regulatory decisions under TSCA, FIFRA, and/or 
FFDCA.
    The test guidelines are used by EPA, the public, and companies that 
are subject to data submission requirements under TSCA, FIFRA, and/or 
FFDCA. As guidance documents, the test guidelines are not binding on 
either EPA or any outside parties, and EPA may depart from the test 
guidelines where circumstances warrant and without prior notice. At 
places in this guidance, the Agency uses the word ``should.'' In this 
guidance, use of ``should'' with regard to an action means that the 
action is recommended rather than mandatory. The procedures contained 
in the test guidelines are recommended for generating the data that are 
the subject of the test guideline, but EPA recognizes that departures 
may be appropriate in specific situations. You may propose alternatives 
to the recommendations described in the test guidelines, and the Agency 
will assess them for appropriateness on a case-by-case basis.

II. 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 or may be 
required to conduct testing of pesticides and chemical substances for 
submission to EPA under TSCA, FIFRA, and/or FFDCA, the Agency has not 
attempted to describe all the specific entities that may be affected by 
this action.

B. How can I get copies of this document and other related information?

    1. Docket for this document. The dockets for this action, 
identified by docket identification (ID) numbers EPA-HQ-OPP-2017-0693 
and EPA-HQ-OPP-2019-0161, are available at http://www.regulations.gov 
or at the Office of Pesticide Programs Regulatory Public Docket (OPP 
Docket) in the Environmental Protection Agency Docket Center (EPA/DC), 
West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. 
NW, Washington, DC 20460-0001. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Due to the public health emergency, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.
    2. Electronic access to the OCSPP test guidelines. To access OCSPP 
test guidelines electronically, please go to http://www.epa.gov/ocspp/pubs/frs/home/testmeth.htm. You may also access the test guidelines in 
http://www.regulations.gov, grouped by series under docket ID numbers: 
EPA-HQ-OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159 and EPA-HQ-OPPT-
2009-0576.

III. Overview

A. What action is EPA taking?

    EPA is announcing the availability of final test guidelines under 
Series 810.3100 entitled ``Treatments for Imported Fire Ants'' and 
identified as OCSPP Test Guideline 810.3100, and Series 810.3300 
entitled ``The Efficacy of Topically Applied Pet Products Against 
Certain Invertebrate Pests'' and identified as OCSPP Test Guideline 
810.3300. These revised guidelines replace the original versions 
published in 1998. The guidelines provide recommendations for the 
design and execution of studies to evaluate the performance of 
pesticide products intended for use against fire ants and invertebrate 
pests of pests, such as fleas, ticks, and mosquitoes, in connection 
with registration of pesticide products under the FIFRA (7 U.S.C. 136, 
et seq.).

B. How were these final test guidelines developed?

    EPA-registered pesticide products are an important part of pest 
management programs for pests of pets and premises. The Agency 
developed the product performance test guidelines to standardize the 
approaches to testing methods to ensure the quality and validity of the 
efficacy data for these types of products. The Agency attended 
entomology conferences, consulted with leading academics, and reviewed 
peer-reviewed scientific journal articles on topics related to the 
guideline to draft the original document. Further, EPA sought advice 
and recommendations from FIFRA Scientific Advisory Panels (SAPs) and 
the public. The SAP meetings, held on May 8-10, 2018, and June 11-14, 
2019, were announced in the Federal Register issues of January 26, 2018 
(83 FR 3704) (FRL-9972-65) and April 15, 2019 (84 FR 15214) (FRL-9991-
80), respectively. These guidelines

[[Page 14751]]

have been revised based on comments from the SAPs and the public. The 
revisions to the fire ant guideline include the expansion of the 
guideline applicability to other ants in the Solenopsis saevissima 
complex, removal of the need to test in multiple geographically 
distinct locations and with both social forms of fire ants, inclusion 
of additional options for both field and laboratory test designs, and 
decreasing the number of ants needed for laboratory tests. The 
revisions to the pet product guideline include decreasing the number of 
animals used for tick testing, simplifying the tick test data 
collection categories, removing dead pest counts in favor of live pest 
counts, and revising the negative control for shampoo treatments from a 
placebo control to an untreated control. The Agency is also making 
available in the dockets the Response to Comments documents that 
address issues raised in the public comment submissions.

C. Do guidance documents contain binding requirements?

    As guidance, the test guidelines are not binding on the Agency or 
any outside parties, and the Agency may depart from it where 
circumstances warrant and without prior notice. While EPA has made 
every effort to ensure the accuracy of the discussion in the guidance, 
the obligations of EPA and the regulated community are determined by 
statutes, regulations, or other legally binding documents. In the event 
of a conflict between the discussion in the guidance document and any 
statute, regulation, or other legally binding document, the guidance 
document will not be controlling.

IV. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders 
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders. This unit addresses those requirements that apply to 
a guidance document.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    The Office of Management and Budget (OMB) determined that the final 
test guideline documents are not significant regulatory actions under 
Executive Order 12866 (58 FR 51735, October 4, 1993). The final 
guidelines were not, therefore, submitted to OMB for review under 
Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

    These test guidelines do not create paperwork burdens that require 
additional approval by OMB under the PRA, 44 U.S.C. 3501 et seq. The 
information collection activities associated with pesticide 
registration are already approved by OMB under OMB Control No. 2070-
0060.

    Authority: 7 U.S.C. 136 et seq.; 15 U.S.C. 2601 et seq.; 21 
U.S.C. 301 et seq.

    Dated: March 10, 2021.
Michal Freedhoff,
Acting Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2021-05628 Filed 3-17-21; 8:45 am]
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