

[Federal Register: March 14, 2007 (Volume 72, Number 49)]
[Notices]               
[Page 11867-11870]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14mr07-48]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0186; FRL-8118-7]

 
FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: There will be a 3-day meeting of the Federal Insecticide, 
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to 
consider and

[[Page 11868]]

review guidance on test methods for demonstrating the efficacy of 
antimicrobial products for inactivating Bacillus anthracis spores on 
environmental surfaces.

DATES: The meeting will be held on July 17-19, 2007, from 8:30 a.m. to 
5 p.m., Eastern time.
    Comments. The Agency encourages that written comments be submitted 
by July 3, 2007 and requests for oral comments be submitted by July 10, 
2007. However, written comments and requests to make oral comments may 
be submitted until the date of the meeting. For additional 
instructions, see Unit I.C. of the SUPPLEMENTARY INFORMATION.
    Nominations. Nominations of candidates to serve as ad hoc members 
of the FIFRA SAP for this meeting should be provided on or before March 
26, 2007.
    Special Accommodations. For information on access or services for 
individuals with disabilities, and to request accommodation of a 
disability, please contact the Designated Federal Official (DFO) listed 
under FOR FURTHER INFORMATION CONTACT at least 10 days prior to the 
meeting to give EPA as much time as possible to process your request.

ADDRESSES: The meeting will be held at the Environmental Protection 
Agency Conference Center, Lobby Level, One Potomac Yard (South Bldg.), 
2777 Crystal Dr., Arlington, VA 22202.
    Comments. Submit your comments, identified by docket ID number EPA-
HQ-OPP-2007-0186, by one of the following methods:
      Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments. Your use of 
the Federal eRulemaking Portal to submit comments to EPA electronically 
is EPA's preferred method for receiving 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'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 telephone number is (703) 305-5805.
    Instructions. Direct your comments to docket ID number EPA-HQ-OPP-
2007-0186. If your comments contain any information that you consider 
to be CBI or otherwise protected, please contact the DFO listed under 
FOR FURTHER INFORMATION CONTACT to obtain special instruction before 
submitting your comments. 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 a docket index 
available in regulations.gov. To access the electronic docket, go to 
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket 

Search.'' Insert the docket ID number where indicated and select the 
``Submit'' button. Follow the instructions on the regulations.gov web 
site to view the docket index or access available documents. Although 
listed in a docket 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 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 
telephone number is (703) 305-5805.
    Nominations, Requests to Present Oral Comments, and Requests for 
Special Accommodations. Submit nominations to serve as an ad hoc member 
of the FIFRA SAP, requests for special seating accommodations, or 
requests to present oral comments to the DFO listed under FOR FURTHER 
INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT: Joseph E. Bailey, DFO, Office of 
Science Coordination and Policy (7201M), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone 
number: (202) 564-2045; fax number: (202) 564-8382; e-mail addresses: 
bailey.joseph@epa.gov.


SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. This action may, 
however, be of interest to persons who are or may be required to 
conduct testing of chemical substances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA), FIFRA, and the Food Quality Protection Act of 
1996 (FQPA). Since other entities may also be interested, 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 DFO 
listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    When submitting comments, remember to:
    1. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
     2. 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.
    3. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    4. Describe any assumptions and provide any technical information 
and/or data that you used.
    5. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.

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    6. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    7. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    8. Make sure to submit your comments by the comment period deadline 
identified.

C. How May I Participate in this Meeting?

    You may participate in this meeting by following the instructions 
in this unit. To ensure proper receipt by EPA, it is imperative that 
you identify docket ID number EPA-HQ-OPP-2007-0186 in the subject line 
on the first page of your request.
    1. Written comments. The Agency encourages that written comments be 
submitted, using the instructions in ADDRESSES, no later than July 3, 
2007, to provide FIFRA SAP the time necessary to consider and review 
the written comments. However, written comments are accepted until the 
date of the meeting. Persons wishing to submit written comments at the 
meeting should contact the DFO listed under FOR FURTHER INFORMATION 
CONTACT and submit 30 copies. There is no limit on the extent of 
written comments for consideration by FIFRA SAP.
    2. Oral comments. The Agency encourages that each individual or 
group wishing to make brief oral comments to FIFRA SAP submit their 
request to the DFO listed under FOR FURTHER INFORMATION CONTACT no 
later than July 10, 2007, in order to be included on the meeting 
agenda. Requests to present oral comments will be accepted until the 
date of the meeting and, to the extent that time permits, the Chair of 
the FIFRA SAP may permit the presentation of oral comments at the 
meeting by interested persons who have not previously requested time. 
The request should identify the name of the individual making the 
presentation, the organization (if any) the individual will represent, 
and any requirements for audiovisual equipment (e.g., overhead 
projector, 35 mm projector, chalkboard). Oral comments before FIFRA SAP 
are limited to approximately 5 minutes unless prior arrangements have 
been made. In addition, each speaker should bring 30 copies of his or 
her comments and presentation slides for distribution to the FIFRA SAP 
at the meeting.
    3. Seating at the meeting. Seating at the meeting will be on a 
first-come basis.
    4. Request for nominations to serve as ad hoc members of the FIFRA 
SAP for this meeting. As part of a broader process for developing a 
pool of candidates for each meeting, the FIFRA SAP staff routinely 
solicits the stakeholder community for nominations of prospective 
candidates for service as ad hoc members of the FIFRA SAP. Any 
interested person or organization may nominate qualified individuals to 
be considered as prospective candidates for a specific meeting. 
Individuals nominated for this meeting should have expertise in one or 
more of the following areas: Microbiology, disinfectant and sporicidal 
efficacy testing, cellular biology/morphology of bacterial spores and 
statistics. Nominees should be scientists who have sufficient 
professional qualifications, including training and experience, to be 
capable of providing expert comments on the scientific issues for this 
meeting. Nominees should be identified by name, occupation, position, 
address, and telephone number. Nominations should be provided to the 
DFO listed under FOR FURTHER INFORMATION CONTACT on or before March 26, 
2007. The Agency will consider all nominations of prospective 
candidates for this meeting that are received on or before this date. 
However, final selection of ad hoc members for this meeting is a 
discretionary function of the Agency.
    The selection of scientists to serve on the FIFRA SAP is based on 
the function of the panel and the expertise needed to address the 
Agency's charge to the panel. No interested scientists shall be 
ineligible to serve by reason of their membership on any other advisory 
committee to a Federal department or agency or their employment by a 
Federal department or agency except the EPA. Other factors considered 
during the selection process include availability of the potential 
panel member to fully participate in the panel's reviews, absence of 
any conflicts of interest or appearance of lack of impartiality, 
independence with respect to the matters under review, and lack of 
bias. Though financial conflicts of interest, the appearance of lack of 
impartiality, lack of independence, and bias may result in 
disqualification, the absence of such concerns does not assure that a 
candidate will be selected to serve on the FIFRA SAP. Numerous 
qualified candidates are identified for each panel. Therefore, 
selection decisions involve carefully weighing a number of factors 
including the candidates' areas of expertise and professional 
qualifications and achieving an overall balance of different scientific 
perspectives on the panel.
    In order to have the collective breadth of experience needed to 
address the Agency's charge for this meeting, the Agency anticipates 
selecting approximately 10 ad hoc scientists. FIFRA SAP members are 
subject to the provisions of 5 CFR part 2634, Executive Branch 
Financial Disclosure, as supplemented by the EPA in 5 CFR part 6401. In 
anticipation of this requirement, prospective candidates for service on 
the FIFRA SAP will be asked to submit confidential financial disclosure 
information which shall fully disclose, among other financial 
interests, the candidate's employment, stocks and bonds, and, where 
applicable, sources of research support. The EPA will evaluate the 
candidates financial disclosure form to assess whether there are 
financial conflicts of interest, appearance of a lack of impartiality 
or any prior involvement with the development of the documents under 
consideration (including previous scientific peer review) before the 
candidate is considered further for service on the FIFRA SAP. Those who 
are selected from the pool of prospective candidates will be asked to 
attend the public meetings and to participate in the discussion of key 
issues and assumptions at these meetings. In addition, they will be 
asked to review and to help finalize the meeting minutes. The list of 
FIFRA SAP members participating at this meeting will be posted on the 
FIFRA SAP web site at http://epa.gov/scipoly/sap or may be obtained from the OPP Regulatory Public Docket at http://www.regulations.gov.


II. Background

A. Purpose of the FIFRA SAP

    The FIFRA SAP serves as the primary scientific peer review 
mechanism of the EPA, Office of Prevention, Pesticides and Toxic 
Substances (OPPTS), and is structured to provide scientific advice, 
information and recommendations to the EPA Administrator on pesticides 
and pesticide-related issues as to the impact of regulatory actions on 
health and the environment. The FIFRA SAP is a Federal advisory 
committee established in 1975 under FIFRA that operates in accordance 
with requirements of the Federal Advisory Committee Act. The FIFRA SAP 
is composed of a permanent panel consisting of seven members who are 
appointed by the EPA Administrator from nominees provided by the 
National Institutes of Health and the National Science Foundation. 
FIFRA, as amended by the FQPA of 1996, established a Science Review 
Board consisting of at least 60 scientists who are available to the 
FIFRA SAP on an ad hoc basis to assist in reviews conducted by the 
Panel. As a peer review

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mechanism, the FIFRA SAP provides comments, evaluations and 
recommendations to improve the effectiveness and quality of analyses 
made by Agency scientists. Members of the FIFRA SAP are scientists who 
have sufficient professional qualifications, including training and 
experience, to provide expert advice and recommendation to the Agency.

B. Public Meeting

    The FIFRA SAP will meet to consider and review guidance on test 
methods for demonstrating the efficacy of antimicrobial products for 
inactivating Bacillus anthracis (B. anthracis) spores on environmental 
surfaces. EPA regulations require that product performance (efficacy) 
studies be submitted to support registration of an antimicrobial 
product for which public health claims, such as ``disinfect'' or 
``sterilize'' (40 CFR 158.640), are made. In addition, any claim of 
inactivation of a specific microorganism should be supported by valid 
data that demonstrate the efficacy of the product against that 
particular microorganism. At this SAP meeting, the EPA will present 
draft guidance concerning efficacy testing to support a claim that an 
antimicrobial product inactivates B. anthracis spores on inanimate 
environmental surfaces. EPA is seeking the assistance of the FIFRA SAP 
to review and comment on the scientific basis for efficacy data 
requirements to support registration of products that make such claims. 
Specific topics the FIFRA SAP will be asked to consider include 
available qualitative and quantitative sporicidal efficacy test 
methods, the use of various coupon materials to conduct tests, use of 
test surrogates for B. anthracis, and the adequacy of performance 
standards for quantitative sporicidal testing. Further, EPA is seeking 
assistance of the SAP to review and comment on the scientific basis for 
using a ``simulated use test'' for gases and vapors to support 
registration of sterilants and sporicides.

C. FIFRA SAP Documents and Meeting Minutes

    EPA's background paper, related supporting materials, charge/
questions to the FIFRA SAP, FIFRA SAP composition (i.e., members and ad 
hoc members for this meeting), and the meeting agenda will be available 
by mid-June. In addition, the Agency may provide additional background 
documents as the materials become available. You may obtain electronic 
copies of these documents, and certain other related documents that 
might be available electronically, at http://www.regulations.gov and the FIFRA SAP homepage at http://www.epa.gov/scipoly/sap.

    The FIFRA SAP will prepare meeting minutes summarizing its 
recommendations to the Agency approximately 90 days after the meeting. 
The meeting minutes will be posted on the FIFRA SAP web site or may be 
obtained from the OPP Regulatory Public Docket at http://www.regulations.gov
.


List of Subjects

    Environmental protection, Pesticides and pests.


    Dated: March 2, 2007.
Clifford J. Gabriel,
Director, Office of Science Coordination and Policy.
[FR Doc. E7-4276 Filed 3-13-07; 8:45 am]

BILLING CODE 6560-50-S
