[Federal Register Volume 83, Number 40 (Wednesday, February 28, 2018)]
[Notices]
[Pages 8666-8667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04106]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2015-0276; FRL-9971-08]


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is announcing the availability of the following 810 Series 
final test guidelines: General Considerations for Testing Public Health 
Antimicrobial Pesticides--Guidance for Efficacy Testing, OCSPP Test 
Guideline 810.2000; Sterilants, Sporicides, and Decontaminants--
Guidance for Efficacy Testing, OCSPP Test Guideline 810.2100; and 
Disinfectants for Use on Environmental Surfaces--Guidance for Efficacy 
Testing, OCSPP Test Guideline

[[Page 8667]]

810.2200. 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 is intended to provide data to inform 
regulatory decisions. The test guidelines provide guidance for 
conducting the tests, and are also used by EPA, the public, and 
companies that are subject to data submission requirements under one or 
more statutes.

FOR FURTHER INFORMATION CONTACT: Thao Pham, Antimicrobials Division 
(7510P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, 
Washington, DC 20460-0001; telephone number: 703-308-0125; email 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Introduction

    EPA is announcing the availability of three final test guidelines: 
General Considerations for Testing Public Health Antimicrobial 
Pesticides--Guidance for Efficacy Testing, OCSPP Test Guideline 
810.2000; Sterilants, Sporicides, and Decontaminants--Guidance for 
Efficacy Testing, OCSPP Test Guideline 810.2100; and Disinfectants for 
Use on Environmental Surfaces--Guidance for Efficacy Testing, OCSPP 
Test Guideline 810.2200.
    These final 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 (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 for testing that is 
intended to provide data to inform regulatory decisions under TSCA, 
FIFRA, and/or FFDCA.
    The test guidelines provide guidance for conducting tests, and are 
also 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 particular 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 docket for this action, identified 
by docket identification (ID) number EPA-HQ-OPP-2015-0276, is 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 
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. Please review the visitor instructions and 
additional information about the docket available at http://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, entitled ``Product Performance Test Guidelines'' and 
identified as OCSPP Test Guidelines 810.2000, 810.2100, and 810.2200. 
The OCSPP 810 Test Guideline Series addresses antimicrobial pesticide 
products with public health uses or that bear public health claims for 
which product performance (efficacy) test data are required to be 
submitted to the Agency to support registration or amended 
registration, including, but not limited to the requirements of 40 CFR 
158.2220(a)(2). These guidelines provide an update to the 2012 OCSPP 
Guidelines 810.2000, 810.2100, and 810.2200 and supersede previous 
efficacy testing guidance for sterilants, sporicides, decontaminants, 
and disinfectant products.
    All studies initiated one year after the final publication date 
should utilize the revised guidelines for testing.

B. How was this final test guideline developed?

    The updated test guidelines integrate agency policies and revised 
test methods that have been released after the 2012 publication of the 
810 guideline series. The availability of public draft test guidelines 
for public comment was announced in a June 17, 2015 Federal Register 
notice (80 FR 34638) (FRL-9927-37). The public draft test guidelines 
were placed in the EPA Docket for public access. These final test 
guidelines were reformatted for ease of navigation and reading and 
incorporate changes resulting from the public comments received in 
response to the 2015 public draft test guidelines. The Agency is also 
making available in the docket a Response to Comments document that 
summarizes changes to the 2015 draft guidelines and addresses issues 
raised in the public comment submissions.

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

    Dated: February 6, 2018.
Charlotte Bertrand,
Acting Principal Deputy Assistant Administrator, Office of Chemical 
Safety and Pollution Prevention.
[FR Doc. 2018-04106 Filed 2-27-18; 8:45 am]
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