FIFRA Scientific Advisory Panel; Notice of Public Meeting, 76639-76641 [E8-29977]
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Federal Register / Vol. 73, No. 243 / Wednesday, December 17, 2008 / Notices
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not affect the final regulatory decision,
were undergoing final editing at that
time. These components, including the
list of additional generic data
requirements, summary of labeling
changes, appendices, and other relevant
information, have been added to the
flumetralin RED document.
EPA is applying the principles of
public participation to all pesticides
undergoing reregistration and tolerance
reassessment. The Agency’s Pesticide
Tolerance Reassessment and
Reregistration; Public Participation
Process, published in the Federal
Register on May 14, 2004, (69 FR 26819)
(FRL–7357–9) explains that in
conducting these programs, EPA is
tailoring its public participation process
to be commensurate with the level of
risk, extent of use, complexity of issues,
and degree of public concern associated
with each pesticide. Due to its uses,
risks, and other factors, flumetralin was
reviewed through the modified 4–Phase
process. Through this process, EPA
worked extensively with stakeholders
and the public to reach the regulatory
decisions for flumetralin.
The reregistration program is being
conducted under congressionally
mandated time frames, and EPA
recognizes the need both to make timely
decisions and to involve the public. The
Agency is issuing the flumetralin RED
for public comment. This comment
period is intended to provide an
additional opportunity for public input
and a mechanism for initiating any
necessary amendments to the RED. All
comments should be submitted using
the methods in ADDRESSES, and must be
received by EPA on or before the closing
date. These comments will become part
of the Agency Docket for flumetralin.
Comments received after the close of the
comment period will be marked ‘‘late.’’
EPA is not required to consider these
late comments.
The Agency will carefully consider all
comments received by the closing date
and will provide a Response to
Comments Memorandum in the Docket
and regulations.gov. If any comment
significantly affects the document, EPA
also will publish an amendment to the
RED in the Federal Register. In the
absence of substantive comments
requiring changes, the flumetralin RED
will be implemented as it is now
presented.
B. What is the Agency’s Authority for
Taking this Action?
Section 4(g)(2) of FIFRA, as amended,
directs that, after submission of all data
concerning a pesticide active ingredient,
the Administrator shall determine
whether pesticides containing such
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18:58 Dec 16, 2008
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active ingredient are eligible for
reregistration, before calling in product
specific data on individual end-use
products and either reregistering
products or taking other ‘‘appropriate
regulatory action.’’
List of Subjects
Environmental protection, Pesticides
and pests.
Dated: December 11, 2008.
Peter Caulkins,
Acting Director, Special Review and
Reregistration Division, Office of Pesticide
Programs.
[FR Doc. E8–29972 Filed 12–16–08; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2008–0859; FRL–8392–9]
FIFRA Scientific Advisory Panel;
Notice of Public Meeting
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Notice.
SUMMARY: There will be a 2–day meeting
of the Federal Insecticide, Fungicide,
and Rodenticide Act Scientific Advisory
Panel (FIFRA SAP) to consider and
review Scientific Issues Associated with
Designating a Prion as a ‘‘Pest’’ under
the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), and Related
Efficacy Test Methods.
DATES: The meeting will be held on
March 31 and April 1, 2009, from
approximately 8:30 a.m. to 5 p.m,
eastern time.
Comments. The Agency encourages
that written comments be submitted by
March 17, 2009, and requests for oral
comments be submitted by March 24,
2009. However, written comments and
requests to make oral comments may be
submitted until the date of the meeting,
but anyone submitting written
comments after March 17, 2009, 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
December 29, 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
PO 00000
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76639
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, VA 22202.
Comments. Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2008–0859, by
one of the following methods:
• Federal eRulemaking Portal:
https://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–2008–
0859. 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 https://
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 email. 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
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Federal Register / Vol. 73, No. 243 / Wednesday, December 17, 2008 / Notices
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 https://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 https://
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 address:
christian.myrta@epa.gov.
SUPPLEMENTARY INFORMATION:
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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
VerDate Aug<31>2005
18:58 Dec 16, 2008
Jkt 217001
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.
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–2008–0859 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 March 17,
2009, 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 March 17, 2009,
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 March 24, 2009, in order to
be included on the meeting agenda.
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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 firstcome 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,
antimicrobial efficacy testing, prions
(TSE agents). 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 December 31, 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
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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 https://epa.gov/scipoly/sap or
may be obtained from the OPP
Regulatory Public Docket at https://
www.regulations.gov.
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18:58 Dec 16, 2008
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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
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
EPA is developing a Notice of
Proposed Rulemaking (NPRM) that
describes how EPA proposes to revise
its regulations to include ≥prion≥ in the
definition of ≥pests≥ that fall under the
jurisdiction of FIFRA. The work group
for the NPRM drafted a ≥white paper≥
entitled, ≥Scientific Information
Concerning the Issue of Whether Prions
Are a ‘Pest’ under the Federal
Insecticide, Fungicide, and Rodenticide
Act.≥ The purpose of this paper was to
provide the work group with sound
knowledge about the scientific issues
that are relevant to the proposed rule.
Although the EPA’s NPRM will be
focused also on legal and policy matters
and not exclusively on scientific
discussion, EPA will nevertheless
present this paper to the SAP for review
as to the completeness and accuracy of
its characterization of the scientific
issues. EPA is not asking the SAP to
interpret Congress’ intent in drafting
FIFRA.
In parallel with the NPRM, EPA is
also developing guidance on a test
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76641
protocol for measuring the performance
of antimicrobial pesticides intended to
reduce the infectivity of prions (TSE
agents) on inanimate surfaces (hereafter
referred to as a ≥prion-related claim≥).
This draft document is entitled, ≥EPA
Guidance for Efficacy Test Methods for
Products Bearing Prion-Related Claims.≥
This guidance is needed because the
proposed rule will require that
antimicrobial products with prionrelated claims be supported by valid
efficacy data acceptable to EPA prior to
registration. Although this guidance is
not part of the rulemaking per se, it is
important to the implementation of the
rule, so EPA will present it to the SAP
for comment on the scientific issues.
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-March 2009. 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
https://www.regulations.gov and the
FIFRA SAP homepage at https://
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 https://
www.regulations.gov.
List of Subjects
Environmental protection, Pesticides
and pests.
Dated: December 10, 2008
Elizabeth Resek,
Acting Director, Office of Science
Coordination and Policy.
[FR Doc. E8–29977 Filed 12–16–08; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2008–0766; FRL–8394–9]
Registration Review; Mineral Acids
Docket Opened for Review and
Comment
AGENCY: Environmental Protection
Agency (EPA).
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]]>Agencies
[Federal Register Volume 73, Number 243 (Wednesday, December 17, 2008)]
[Notices]
[Pages 76639-76641]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29977]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2008-0859; FRL-8392-9]
FIFRA Scientific Advisory Panel; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: There will be a 2-day meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to
consider and review Scientific Issues Associated with Designating a
Prion as a ``Pest'' under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), and Related Efficacy Test Methods.
DATES: The meeting will be held on March 31 and April 1, 2009, from
approximately 8:30 a.m. to 5 p.m, eastern time.
Comments. The Agency encourages that written comments be submitted
by March 17, 2009, and requests for oral comments be submitted by March
24, 2009. However, written comments and requests to make oral comments
may be submitted until the date of the meeting, but anyone submitting
written comments after March 17, 2009, 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
December 29, 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, VA 22202.
Comments. Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2008-0859, by one of the following methods:
Federal eRulemaking Portal: https://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-
2008-0859. 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 https://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
[[Page 76640]]
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 https://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 https://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
address: 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 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-2008-0859 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 March 17,
2009, 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 March
17, 2009, 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 March 24, 2009, 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: Microbiology, antimicrobial efficacy
testing, prions (TSE agents). 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 December 31, 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
[[Page 76641]]
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 https://epa.gov/scipoly/sap or may be obtained from the OPP
Regulatory Public Docket at https://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 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
EPA is developing a Notice of Proposed Rulemaking (NPRM) that
describes how EPA proposes to revise its regulations to include
prion in the definition of
pests that fall under the jurisdiction of FIFRA.
The work group for the NPRM drafted a white paper
entitled, Scientific Information Concerning the Issue of
Whether Prions Are a `Pest' under the Federal Insecticide, Fungicide,
and Rodenticide Act. The purpose of this paper was to
provide the work group with sound knowledge about the scientific issues
that are relevant to the proposed rule. Although the EPA's NPRM will be
focused also on legal and policy matters and not exclusively on
scientific discussion, EPA will nevertheless present this paper to the
SAP for review as to the completeness and accuracy of its
characterization of the scientific issues. EPA is not asking the SAP to
interpret Congress' intent in drafting FIFRA.
In parallel with the NPRM, EPA is also developing guidance on a
test protocol for measuring the performance of antimicrobial pesticides
intended to reduce the infectivity of prions (TSE agents) on inanimate
surfaces (hereafter referred to as a prion-related
claim). This draft document is entitled, EPA
Guidance for Efficacy Test Methods for Products Bearing Prion-Related
Claims. This guidance is needed because the proposed rule
will require that antimicrobial products with prion-related claims be
supported by valid efficacy data acceptable to EPA prior to
registration. Although this guidance is not part of the rulemaking per
se, it is important to the implementation of the rule, so EPA will
present it to the SAP for comment on the scientific issues.
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-March 2009. 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 https://
www.regulations.gov and the FIFRA SAP homepage at https://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 https://
www.regulations.gov.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: December 10, 2008
Elizabeth Resek,
Acting Director, Office of Science Coordination and Policy.
[FR Doc. E8-29977 Filed 12-16-08; 8:45 am]
BILLING CODE 6560-50-S
