[Federal Register Volume 77, Number 52 (Friday, March 16, 2012)]
[Notices]
[Pages 15750-15751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-6432]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0681; FRL-9332-4]


Final Test Guidelines; OCSPP 810 Series; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is announcing the availability of the final test 
guidelines for Series 810--Product Performance Test Guidelines, 
specifically public health uses of antimicrobial agents (OCSPP 
810.2000), sterilants (OCSPP 810.2100), disinfectants (OCSPP 810.2200), 
and sanitizers (OCSPP 810.2300). 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 to develop data for submission to the Agency under 
the Toxic Substances Control Act (TSCA), the Federal Insecticide, 
Fungicide and Rodenticide Act (FIFRA), and section 408 of the Federal 
Food, Drug and Cosmetic (FFDCA). As guidance documents, the test 
guidelines are not binding on either EPA or any outside parties.

FOR FURTHER INFORMATION CONTACT: For general information contact: 
Melissa Chun, Regulatory Coordination Staff (7101M), Office of Chemical 
Safety and Pollution Prevention, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-1605; email address: [email protected].
    For technical information contact: Michele E. Wingfield, 
Antimicrobials Division (7510P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (703) 308-6349; email 
address: [email protected].
    FIFRA information contact: Communications Services Branch (7506P), 
Field and External Affairs Division, Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (703) 305-5017; fax 
number: (703) 305-5558.

SUPPLEMENTARY INFORMATION:

I. Introduction

    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 TSCA (15 
U.S.C. 2601 et seq.), FIFRA (7 U.S.C. 136 et seq.), and section 408 of 
the FFDCA (21 U.S.C. 346a).
    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 provide guidance for conducting the test, and are also used 
by EPA, the public, and the companies that are subject to data 
submission

[[Page 15751]]

requirements under TSCA, FIFRA, and/or FFDCA.

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 chemical substances under TSCA, FFDCA, 
and/or FIFRA, the Agency has not attempted to describe all the specific 
entities that may be affected by this action. If you have any questions 
regarding the applicability of this action to a particular entity, 
consult the appropriate person listed under FOR FURTHER INFORMATION 
CONTACT.

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

    1. Docket for this document. EPA has established a docket for this 
action under docket identification (ID) number EPA-HQ-OPP-2009-0681. 
Publicly available docket materials are available either in the 
electronic docket at http://www.regulations.gov, or, if only available 
in hard copy, at the Office of Pesticide Programs (OPP) Regulatory 
Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. 
Crystal Dr., Arlington, VA. The hours of operation of this Docket 
Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding 
legal holidays. The Docket Facility telephone number is (703) 305-5805.
    2. Electronic access to 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. What action is EPA taking?

    EPA is announcing the availability of the final test guidelines for 
Group B--Product Performance Test Guidelines for Public Health Uses of 
Antimicrobial Agents in OCSPP Series 810--Product Performance Test 
Guidelines:
    1. General Considerations for Public Health Uses of Antimicrobial 
Agents (OCSPP 810.2000).
    2. Sterilants--Efficacy Data Recommendations (OCSPP 810.2100).
    3. Disinfectants for Use on Hard Surfaces--Efficacy Data 
Recommendations (OCSPP Guideline 810.2200).
    4. Sanitizers for Use on Hard Surfaces--Efficacy Data 
Recommendations (OCSPP 810.2300).
    These final test guidelines address efficacy testing for 
antimicrobial agents intended to be used on hard, inanimate, 
environmental surfaces and which bear label claims as sterilants, 
disinfectants, and sanitizers.
    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. Alternatives to the 
recommendations described in the test guidelines may be proposed, and 
the Agency will assess them for appropriateness on a case-by-case 
basis.

IV. How were these test guidelines developed?

    The product performance guidelines for antimicrobial agents were 
last updated in 1982 under the ``Pesticide Assessment Guidelines--
Subdivision G, Product Performance.'' Since then, the Agency has 
presented several issues at two separate meetings of the FIFRA 
Scientific Advisory Panel (SAP) related to the conduct of studies for 
antimicrobial agents (the first meeting September 9-10, 1997, announced 
in the Federal Register issue of July 14, 1997 (62 FR 37584) (FRL-5731-
4) and the second meeting July 17-19, 2007, announced in the Federal 
Register issue of March 14, 2007 (72 FR 11867) (FRL-8118-7). 
Information and recommendations regarding these two FIFRA SAPs can be 
found at the Office of Science and Coordination and Policy's Web site 
at http://www.epa.gov/scipoly/sap/index.htm. The test guidelines were 
also published for comment in the Federal Register issue of January 
2010 (75 FR 4380) (FRL-8437-2) and revised based on comments received 
from industry. In addition to formatting changes to incorporate the 
test guidelines into the OCSPP 810 Series, EPA has added sections that 
incorporate new guidelines and clarifications from other guidance 
documents. In particular, data recommendations for testing against the 
spore formers Bacillus anthracis and Clostridium difficile have been 
added.

List of Subjects

    Environmental protection, Antimicrobials, Chemical testing, Test 
guideline.

    Dated: March 5, 2012.
James Jones,
Acting Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2012-6432 Filed 3-15-12; 8:45 am]
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