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FIFRA Scientific Advisory Panel; Notice of Public Meeting

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[Federal Register: July 23, 2008 (Volume 73, Number 142)]
[Notices]
[Page 42796-42798]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jy08-42]


[[Page 42796]]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0550; FRL-8375-3]

FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: There will be a 4-day meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to
consider and review selected issues associated with the risk assessment
process for pesticides with persistent, bioaccumulative and toxic
characteristics.

DATES: The meeting will be held on October 28 - 31, 2008, from
approximately 8:30 a.m. to 5:00 p.m, eastern time.
    Comments. The Agency encourages that written comments be submitted
by October 14, 2008 and requests for oral comments be submitted by
October 21, 2008. However, written comments and requests to make oral
comments may be submitted until the date of the meeting, but anyone
submitting written comments after October 14, 2008 should contact the
Designated Federal Official (DFO) listed under FOR FURTHER INFORMATION
CONTACT. 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
August 4, 2008.
    Special accommodations. For information on access or services for
individuals with disabilities, and to request accommodation of a
disability, please contact the 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 S. Crystal Dr., Arlington, Virginia 22202.
    Comments. Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2008-0550, 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'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-
2008-0550. 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 instructions 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
website 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 Facility telephone number is (703) 305-5805.
    Nominations, requests to present oral comments, and requests for
special accommodations Submit nominations to serve as ad hoc members 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: Myrta R. Christian, DFO, Office of
Science Coordination and Policy (7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001;
telephone number: (202) 564-8498; fax number: (202) 564-8382; e-mail
addresses: christian.myrta@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

[[Page 42797]]

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.
    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-2008-0550 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 October
14, 2008, to provide the FIFRA SAP the time necessary to consider and
review the written comments. Written comments are accepted until the
date of the meeting, but anyone submitting written comments after
October 14, 2008 should contact the DFO listed under FOR FURTHER
INFORMATION CONTACT. Anyone submitting written comments at the meeting
should bring 30 copies for distribution to the FIFRA SAP.
    2. Oral comments. The Agency encourages that each individual or
group wishing to make brief oral comments to the FIFRA SAP submit their
request to the DFO listed under FOR FURTHER INFORMATION CONTACT no
later than October 21, 2008, 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 the 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 open and
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: toxicity, residue-based toxicity
approaches, bioaccumulation, persistence, long-range transport,
sediment dynamics and general risk assessment methodology. 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 August 4, 2008. 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. Although 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 8 to 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 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 website
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 EPA's 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

[[Page 42798]]

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 FQPA, established a
Science Review Board consisting of at least 60 scientists who are
available to the Scientific Advisory Panel on an ad hoc basis to assist
in reviews conducted by the Scientific Advisory Panel. As a peer review
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

    This Scientific Advisory Panel meeting will address selected
scientific issues associated with assessing the potential ecological
risks resulting from use of a pesticide active ingredient which has
persistent, bioaccumulative, and toxic (PBT) characteristics. EPA will
pose specific charge questions to the SAP on issues involving:
     The range and combination of characteristics of
persistence, bioaccumulation, and toxicity that should employ a
modified approach to ecological risk assessment;
     The need for changes to the conceptual model used to
evaluate the potential ecological effects of pesticides with varying P
and B characteristics;
     Toxicity endpoints and methods OPP should consider when
assessing pesticides with varying P and B characteristics;
     Pathways of potential exposure that should be considered
in assessing the ecological risks of a pesticide with varying P and B
characteristics;
     Data and model(s) appropriate for estimating and
characterizing bioaccumulation and estimating steady and non-steady
state pesticide residue concentrations in biota;
     Data and model(s) appropriate for estimating and
characterizing environmental fate in soil, water and sediment; andData
and model(s) most appropriate for assessing exposure to biota through
multiple pathways.
    Office of Pesticides Programs (OPP) has recently completed
ecological risk assessments on several pesticides with varying P and B
characteristics. OPP will draw on information and analyses from these
assessments to illustrate the evolving approach OPP is using to address
selected issues and how differences across chemicals - for example, in
terms of data, characteristics, and available models - influence OPP's
approaches. This meeting with the SAP is the first of what OPP
anticipates will be several meetings over the next few years to improve
OPP's evolving approach to evaluating pesticides with varying P and B
characteristics.

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-October 2008. 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 website or may be
obtained from the OPP Regulatory Public Docket at http://
www.regulations.gov.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: July 16, 2008.
Elizabeth Resek,
Acting Director, Office of Science Coordination and Policy.
[FR Doc. E8-16738 Filed 7-22-08; 8:45 am]

BILLING CODE 6560-50-S

 
 


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