Document ID: EPA-HQ-OPP-2009-0681-0016
Agency: epa
Document Type: Notice
Title: Draft Harmonized Test Guidelines; Availability
Posted Date: 2011-09-15T04:00Z

[Federal Register Volume 76, Number 179 (Thursday, September 15, 2011)]
[Notices]
[Pages 57031-57033]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23666]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0681; FRL-8879-1]

Draft Harmonized 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 the draft test 
guidelines for Series 810--Product Performance Test Guidelines for 
Public Health Uses of Antimicrobial Agents, concerning specifically 
air, textiles, and water.

DATES: Comments must be received on or before December 14, 2011.

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 Web site 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

[[Page 57032]]

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 harmonized test guidelines. To access the 
harmonized test guidelines electronically, please go to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.'' You may 
also access the harmonized 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.

FOR FURTHER INFORMATION CONTACT: 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; e-mail 
address: wingfield.michele@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; e-mail address: TSCA-Hotline@epa.gov.
    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 numbers: (703) 305-5017 and TDD: 
(202) 554-0551; fax number: (703) 305-5558.

SUPPLEMENTARY INFORMATION:

I. 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, 
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 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.

II. What action is EPA taking?

    EPA is announcing the availability of the draft test guidelines for 
Series 810--Product Performance Test Guidelines for Public Health Uses 
of Antimicrobial Agents:
    1. Disinfectants and Sanitizers for Use on Fabrics and Textiles--
Efficacy Data Recommendations (OCSPP Guideline 810.2400).
    2. Air Sanitizers--Efficacy Data Recommendations (OCSPP Guideline 
810.2500).
    3. Disinfectants for Use in Water--Efficacy Data Recommendations 
(OCSPP Guideline 810.2600).
    These draft test guidelines address efficacy testing for 
antimicrobial agents intended to be used on hard, inanimate, 
environmental surfaces; in the air; and in water, and which bear label 
claims as disinfectants and/or sanitizers. Data from these studies are 
used to support the labeling claims for public health related 
antimicrobial agents.
    As a guidance document, the test guidelines are not binding on 
either EPA or any outside parties. 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. EPA will consider alternatives to the 
recommendations described in the test guidelines on a case-by-case 
basis, after assessing whether the alternative will provide the data 
necessary to inform the regulatory decision that must be made.

III. How were these draft 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 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 SAPs can be found at the Office of Science and Coordination's 
Web site: http://www.epa.gov/scipoly/sap/index.htm. In addition to 
formatting changes to incorporate the guidelines into the OCSPP test 
guideline 810 series, EPA has added sections that incorporate new 
guidelines and clarifications from other guidance documents, and 
comments from the regulated industry. In particular, the waiver for the 
submission of efficacy data for air sanitizers that contain at least 5% 
glycol has been rescinded. Altogether, these draft test 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 40 CFR 158.2220 contains a table 
entitled ``Antimicrobial Product Performance Data

[[Page 57033]]

Requirements,'' which referenced under the ``Guideline Number'' column 
the 91 series of test guidelines. EPA's intention is to replace the 91 
series test guideline designations with the appropriate 810 series test 
guideline designations. Therefore, at the time of the publication of 
the final rule, appropriate references to the 810 series test guideline 
numbers and names will be incorporated into the final rule.

IV. Are there any applicable voluntary consensus standards that EPA 
should consider?

    This notice of availability does not involve a proposed regulatory 
action that would require the Agency to consider voluntary consensus 
standards pursuant to section 12(d) of the National Technology Transfer 
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) 
(15 U.S.C. 272 note). Section 12(d) of NTTAA directs EPA to use 
voluntary consensus standards in its regulatory activities unless to do 
so would be inconsistent with applicable law or otherwise impractical. 
Voluntary consensus standards are technical standards (e.g., materials 
specifications, test methods, sampling procedures, and business 
practices) that are developed or adopted by voluntary consensus 
standards bodies. NTTAA requires EPA to provide an explanation to 
Congress, through OMB, when the Agency decides not to use available and 
applicable voluntary consensus standards when NTTAA directs the Agency 
to do so.
    These test guidelines represent an Agency effort to harmonize the 
test guidelines within OCSPP, as well as to harmonize the OCSPP test 
guidelines with those of OECD. The process for developing and amending 
these test guidelines, which began in 1991, includes public 
participation and the extensive involvement of the scientific 
community, including peer review by SAP and the SAB and other expert 
scientific organizations.
    In the future, these test guidelines could be incorporated into 
regulatory actions taken by EPA under TSCA, i.e., with regard to the 
TSCA section 4 testing program. Although, NTTAA requirements do not 
specifically apply to the issuance of these particular test guidelines, 
EPA invites your comment on whether or not there are any voluntary 
consensus standards that should be considered during the development of 
the final test guidelines or any future regulatory action that may be 
taken under TSCA. Future regulatory actions under TSCA section 4 may 
involve notice and comment rulemaking or negotiated voluntary testing 
enforcement consent agreements/orders/decrees. Nevertheless, However, 
the Agency is interested in whether or not there are any voluntary 
consensus standards that EPA should consider either as part of the 
development of the final test guidelines themselves or in lieu of these 
final test guidelines when the Agency develops any future regulatory 
action that incorporates these test guidelines. Any comments provided 
will assist the Agency in complying with NTTAA by facilitating the 
Agency's identification of voluntary consensus standards that should be 
addressed in the test guideline or considered during the development of 
a proposed regulatory action that incorporates any standards included 
in the final test guidelines. Please submit your comments as directed 
under ADDRESSES.

List of Subjects

    Environmental protection, Antimicrobial agents, Chemicals, 
Harmonized test guidelines, Health and safety.

    Dated: September 7, 2011.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2011-23666 Filed 9-14-11; 8:45 am]
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