Document ID: EPA-HQ-OPP-2009-0681-0001
Agency: epa
Document Type: Notice
Title: Draft Test Guidelines; Notice of Availability and Request for Comments
Posted Date: 2010-01-27T05:00Z

[Federal Register: January 27, 2010 (Volume 75, Number 17)]
[Notices]               
[Page 4380-4381]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27ja10-79]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0681; FRL-8437-2]

 
Draft Test Guidelines; Notice of Availability and Request for 
Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is announcing the availability of four draft test 
guidelines for Product Performance of Public Health Uses of 
Antimicrobial Agents for public review and comment.

DATES: Comments must be received on or before March 29, 2010.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2009-0681, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2009-0681. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
http://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index 
available at http://www.regulations.gov. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, is not placed on the Internet 
and will be publicly available only in hard copy form. 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 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.
    Electronic access to the OPPTS Test Guidelines: To access the OPPTS 
harmonized test guidelines electronically, please go to http://
www.epa.gov/oppts and select ``Test Methods & Guidelines'' on the left 
side navigation menu. You may also access the guidelines in http://
www.regulations.gov grouped by series under dockets ID numbers EPA-HQ-
OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159, and EPA-HQ-OPPT-2009-
0576.

FOR FURTHER INFORMATION CONTACT:  For general 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 numbers: (703) 305-5017 and TDD: (202) 554-0551; fax number: 
(703) 305-5558.
    For technical information contact: Michele Wingfield, 
Antimicrobials Division (7510P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-6349; fax 
number: (703) 305-5620; e-mail address: wingfield.michele@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Introduction

    These draft guidelines are part of a series of test guidelines 
established by the Office of Prevention, Pesticides and Toxic 
Substances (OPPTS) for use in testing pesticides and chemical 
substances to develop data for submission to the Agency under the Toxic 
Substances Control Act (TSCA) (15 U.S.C. 2601, et seq.), the Federal 
Insecticide, Fungicide and Rodenticide Act (FIFRA) (7 U.S.C. 136, et 
seq.), and section 408 of the Federal Food, Drug and Cosmetic (FFDCA) 
(21 U.S.C. 346a).
    The OPPTS test guidelines serve as a compendium of accepted 
scientific

[[Page 4381]]

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 requirements under TSCA, FIFRA, and/or the FFDCA.
    As a guidance document, the test guidelines are not binding on 
either EPA or any outside parties, and the EPA may depart from the test 
guidelines where circumstances warrant and without prior notice. 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 FIFRA and/or FFDCA, 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 technical person listed 
under FOR FURTHER INFORMATION CONTACT.

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 e-mail. 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 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 submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at the estimate.
    vi. Provide specific examples to illustrate your concerns and 
suggested alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

III. Overview

A. What Action is EPA Taking?

    EPA is announcing the availability for public review and comment of 
the following four draft test guidelines under Series 810-Product 
Performance Test Guidelines for Public Health Uses of Antimicrobial 
Agents:

     OPPTS 810.2000 - General Considerations for Public 
Health Uses of Antimicrobial Agents.

     OPPTS 810.2100 - Sterilants - Efficacy Data 
Recommendations.

     OPPTS 810.2200 - Disinfectants for Use on Hard 
Surfaces--Efficacy Data Recommendations.

     OPPTS 810.2300 - Sanitizers for Use on Hard Surfaces--
Efficacy Data Recommendations.

    These 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/or 
sanitizers. Data from these studies are used to support the labeling 
claims for public health related antimicrobial agents.

B. How Were These Test Guidelines Developed?

    The product performance use 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 Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory 
Panel (SAP) (one in September 1997 and the other in July 2007) related 
to the conduct of studies for antimicrobial agents. In addition to 
formatting changes to incorporate the guidelines into the OPPTS 
guidelines series 810, EPA has added sections that incorporate the 
recommendations from the two SAPs, new guidelines and clarifications 
from other guidance documents, and comments from the regulated 
industry. In particular, a new section has been added that describes 
the data to be submitted to support labeling claims against two spore 
forming bacteria, Bacillus anthracis and Clostridium difficile. 
Altogether, these revised guidelines, once final, will represent the 
Agency's current recommendations for conducting studies to support 
antimicrobial pesticide label claims.
    On October 8, 2008, EPA published in the Federal Register a 
proposed rule entitled ``Data Requirements for Antimicrobial 
Pesticides'' (73 FR 59382). Proposed Sec.  158.2220 (40 CFR part 158) 
contains a table entitled ``Antimicrobial Product Performance Data 
Requirements,'' which referenced under the Guidelines Number column the 
91 series of guidelines. EPA's intention is to replace the 91 series 
designations with the appropriate reference to the 810 series 
designations under 810.2000. Therefore, at the time of the publication 
of the final rule, appropriate references to the OPPTS test guideline 
numbers and names will be incorporated into the final data requirement 
regulations.

List of Subjects

    Environmental protection, Chemical testing, Test guidelines.

    Dated: January 15, 2010.
Stephen A. Owens,
Assistant Administrator, Office of Prevention, Pesticides and Toxic 
Substances.

[FR Doc. 2010-1323 Filed 1-26-10; 8:45 am]
BILLING CODE 6560-50-S