FIFRA Scientific Advisory Panel; Notice of Public Meeting, 34736-34739 [E8-13773]
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34736
Federal Register / Vol. 73, No. 118 / Wednesday, June 18, 2008 / Notices
PP Number
Docket ID Number
PP 7F7302
EPA–HQ–OPP–2008–0381
PP 8G7320
EPA–HQ–OPP–2005–0303
III. What Action is the Agency Taking?
EPA is printing notice of the filing of
pesticide petitions received under
section 408 of the Federal Food, Drug,
and Cosmetic Act (FFDCA), 21 U.S.C.
346a, proposing the establishment or
modification of regulations in 40 CFR
part 180 for residues of pesticide
chemicals in or on various food
commodities. EPA has determined that
the pesticide petitions described in this
notice contain data or information
regarding the elements set forth in
FFDCA section 408(d)(2); however, EPA
has not fully evaluated the sufficiency
of the submitted data at this time or
whether the data support granting of the
pesticide petitions. Additional data may
be needed before EPA rules on these
pesticide petitions.
Pursuant to 40 CFR 180.7(f), a
summary of each of the petitions
included in this notice, prepared by the
petitioner, is included in a docket EPA
has created for each rulemaking. The
docket for each of the petitions is
available on-line at https://
www.regulations.gov.
PP 7F7302. Circle One Global, Inc.
(Circle One), P.O. Box 28, Shellman, GA
39886–0028, proposes to amend the
exemption from the requirement of a
tolerance in 40 CFR 180.1254 for
residues of the fungicide Aspergillus
flavus NRRL 21882 in or on the food
commodity corn. Because this petition
is a request to amend an exemption
from the requirement of a tolerance
without numerical limitations, no
analytical method is required. Contact:
Shanaz Bacchus; telephone (703) 308–
8097; email address:
bacchus.shanaz@epa.gov.
rwilkins on PROD1PC63 with NOTICES
Amendment to Existing Exemption from
Tolerance
PP 8G7320. Montana Microbial
Products, 510 East Kent Ave., Missoula
MT 59801 proposes to amend the
temporary exemption from the
requirement of a tolerance in 40 CFR
180.1269 for residues of the fungicide,
Bacillus mycoides, isolate J, in or on
pecans, potatoes, sugar beets, tomatoes,
and peppers. Because this petition is a
request to amend an exemption from the
requirement of a tolerance without
numerical limitations, no analytical
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Dated: June 12, 2008.
Mary Ellen Radzikowski,
Acting Director, Office of Science Policy.
[FR Doc. E8–13825 Filed 6–17–08; 8:45 am]
List of Subjects
Environmental protection,
Agricultural commodities, Feed
additives, Food additives, Pesticides
and pests, Reporting and recordkeeping
requirements.
BILLING CODE 6560–50–P
Dated: June 6, 2008.
Janet L. Andersen,
Director, Biopesticides and Pollution
Prevention Division, Office of Pesticide
Programs.
[FR Doc. E8–13625 Filed 6–17–08; 8:45 am]
FIFRA Scientific Advisory Panel;
Notice of Public Meeting
BILLING CODE 6560–50–S
SUMMARY: There will be a 3–day
meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act
Scientific Advisory Panel (FIFRA SAP)
to consider and review an evaluation of
the common mechanism of action of
pyrethroid pesticides.
DATES: The meeting will be held on
September 9-11, 2008, from
approximately 8:30 a.m. to 5 p.m,
eastern time.
Comments. The Agency encourages
that written comments be submitted by
August 26, 2008 and requests for oral
comments be submitted by September 2,
2008. However, written comments and
requests to make oral comments may be
submitted until the date of the meeting.
Anyone submitting written comments
after August 26, 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 July 2,
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.
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–ORD–2007–0484; FRL–8582–2]
Board of Scientific Counselors,
National Center for Environmental
Research (NCER) Standing
Subcommittee Meeting—2008
Environmental Protection
Agency (EPA).
ACTION: Notice of Cancellation of
Meeting.
AGENCY:
Amendment to Exemption from
Tolerance
VerDate Aug<31>2005
method is required. Contact: Susanne
Cerrelli, telephone: (703) 308–8077; and
email address:
cerrelli.susanne@epa.gov.
SUMMARY: The Environmental Protection
Agency, Office of Research and
Development (ORD), announces the
cancellation of a meeting of the Board
of Scientific Counselors (BOSC)
National Center for Environmental
Research (NCER) Standing
Subcommittee. This meeting, a
teleconference June 24, 2008, was
announced in a Federal Register Notice
published on Friday, May 30, 2008
(Volume 73, Number 105, page 31116).
The purpose of this meeting was to
discuss the subcommittee’s draft letter
report and NCER’s next charge
question(s), and it will be rescheduled
at a later date.
FOR FURTHER INFORMATION CONTACT: The
Designated Federal Officer via mail at:
Susan Peterson, Mail Code 8104–R,
Office of Science Policy, Office of
Research and Development,
Environmental Protection Agency, 1200
Pennsylvania Avenue, NW.,
Washington, DC 20460; via phone/voice
mail at: (202) 564–1077; via fax at: (202)
565–2911; or via e-mail at:
peterson.susan@epa.gov.
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ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2008–0489; FRL–8369–1]
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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Federal Register / Vol. 73, No. 118 / Wednesday, June 18, 2008 / Notices
Comments. Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2008–0489, 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’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–
0489. 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
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
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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 https://
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
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:
Joseph E. Bailey, DFO, Office of Science
Coordination and Policy (7201M),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; 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
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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–2008–0489 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 August 26,
2008, to provide the 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. Anyone submitting
written comments after August 26, 2008
should contact the DFO listed under FOR
FURTHER INFORMATION CONTACT. There is
no limit on the extent of written
comments for consideration by 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
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FOR FURTHER INFORMATION CONTACT no
later than September 2, 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 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: Pyrethroid pesticides;
voltage-sensitive sodium channels;
mode of action analysis; motor activity
and functional observational battery;
and dose Response modeling. 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 July 2, 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
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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 10 ad hoc scientists.
The 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
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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 (OPTS) 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
Pyrethroid pesticide usage has
increased in the past decade in
agricultural and residential settings. The
Office of Pesticide Programs is in the
early stages of evaluating the potential
risks from increased exposure to these
pesticides. As part of this evaluation,
OPP is developing an analysis of the
toxicity profiles of these pesticides and
is evaluating whether or not some or all
of the pyrethroid pesticides share a
common mechanism of action (i.e.,
those pesticides that produce a common
toxic effect by a common mechanism of
toxicity). The Agency will be seeking
the Scientific Advisory Panel’s advice
on a set of scientific issues raised in a
draft science policy document
proposing to establish a common
mechanism group for the pyrethroid
pesticides. The proposed grouping may
include two or more sub-groups.
Establishing a common mechanism
group is the first stage toward
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Federal Register / Vol. 73, No. 118 / Wednesday, June 18, 2008 / Notices
developing a cumulative risk
assessment as required under the Food
Quality Protection Act. Pending the
outcome of this panel review, the
Agency may begin work on the
cumulative risk assessment for those
pyrethroid pesticides that are
determined to share a common
mechanism. The Agency will be seeking
advice from the SAP on the following
areas related to the toxicity of the
pyrethroid pesticides:
1. Interpretation of in vivo motor
activity and functional observational
battery;
2. Interpretation of recent in vitro
literature studies involving sodium,
calcium, and chloride channels;
3. Structural and functional
similarities among these chemicals; and
4. The variability of animal studies
conducted by different routes of
administration and vehicles (e.g.,
dietary admix or corn oil vehicle
gavage).
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-August. 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
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Environmental protection, Pesticides
and pests.
Dated: June 12, 2008.
Elizabeth Resek
Acting Director, Office of Science
Coordination and Policy.
[FR Doc. E8–13773 Filed 6–17–08; 8:45 a.m.]
BILLING CODE 6560–50–S
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ENVIRONMENTAL PROTECTION
AGENCY
[FRL–8581–6]
Science Advisory Board Staff Office;
Clean Air Scientific Advisory
Committee (CASAC); Notification of a
Public Advisory Committee Meeting
and Teleconference of the CASAC
Sulfur Oxides (SOx) Review Panel
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: The Environmental Protection
Agency (EPA) Science Advisory Board
(SAB) Staff Office announces a public
meeting and a teleconference of the
Clean Air Scientific Advisory
Committee’s (CASAC) Sulfur Oxides
(SOx) Review Panel (Panel) to conduct
a peer review of both EPA’s Integrated
Science Assessment for Sulfur Oxides—
Health Criteria (Second External Review
Draft) (EPA/600/R–08/047) as well as
EPA’s forthcoming document: Risk and
Exposure Assessment to Support the
Review of the SO2 Primary National
Ambient Air Quality Standards: First
Draft.
DATES: The meeting will be held on
Wednesday, July 30, 2008 from 8:30
a.m. to 5 p.m. and Thursday, July 31,
2008 from 8:30 a.m. to 2 p.m. (Eastern
time). The public teleconference will be
held on August 12, 2008 from 11 a.m.
to 1 p.m.
Location: The meeting will take place
at the Marriott at Research Triangle
Park, 4700 Guardian Drive, Durham, NC
27703, telephone (919) 941–6200.
FOR FURTHER INFORMATION CONTACT: Any
member of the public who wishes to
submit a written or brief oral statement
(5 minutes or less) or wants further
information concerning this meeting
must contact Dr. Holly Stallworth,
Designated Federal Officer (DFO), EPA
Science Advisory Board (1400F), U.S.
Environmental Protection Agency, 1200
Pennsylvania Avenue, NW.,
Washington, DC 20460; via telephone/
voice mail: (202) 343–9867; fax: (202)
233–0643; or e-mail at
Stallworth.holly@epa.gov. General
information concerning the CASAC or
the EPA Science Advisory Board can be
found on the SAB Web site at https://
www.epa.gov/sab.
SUPPLEMENTARY INFORMATION:
Background: The Clean Air Scientific
Advisory Committee (CASAC) was
established under section 109(d)(2) of
the Clean Air Act (CAA or ACT) (42
U.S.C. 7409) as an independent
scientific advisory committee. CASAC
provides advice, information and
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recommendations on the scientific and
technical aspects of air quality criteria
and national ambient air quality
standards (NAAQS) under section 109
of the Act. The CASAC is a federal
advisory committee chartered under the
Federal Advisory Committee Act
(FACA), as amended, 5 U.S.C., App. The
Panel will comply with the provisions
of FACA and all appropriate SAB Staff
Office procedural policies.
Under the Clean Air Act, EPA is
required to carry out a periodic review
and revision, as appropriate, of the air
quality criteria and the NAAQS for six
criteria air pollutants, which include
sulfur oxides. Primary standards set
limits to protect public health,
including the health of ‘‘sensitive’’
populations such as asthmatics,
children, and the elderly.
EPA is in the process of reviewing the
primary National Ambient Air Quality
Standards (NAAQS) for sulfur oxides.
As part of that process, EPA’s Office of
Research and Development (EPA–ORD)
issued the first draft of its Integrated
Science Assessment for Sulfur Oxides—
Health Criteria (EPA/600/R–07/108) in
September of 2007 and received
CASAC’s advice in a public meeting on
December 6–7, 2007 as well as in a letter
to the Administrator on January 9, 2008.
EPA–ORD has now updated and revised
its draft document, Integrated Science
Assessment for Sulfur Oxides—Health
Criteria (Second External Review Draft,
EPA/600/R–08/047). EPA’s Office of Air
and Radiation (EPA–OAR) released its
Sulfur Oxides Health Assessment Plan:
Scope and Methods for Exposure and
Risk Assessment in November 2007 and
received consultative advice from
CASAC in the public meeting of
December 6–7, 2007. EPA–OAR is
completing its draft document: Risk and
Exposure Assessment to Support the
Review of the SO2 Primary National
Ambient Air Quality Standards: First
Draft. The purpose of the July 30–31
meeting is for the CASAC Panel to
conduct a review of these two
documents. The purpose of the August
12, 2008 teleconference is for the
CASAC to finalize its draft advisory
report on the Agency’s Risk and
Exposure Assessment.
Technical Contact: Any questions
concerning EPA’s Integrated Science
Assessment for Sulfur Oxides—Health
Criteria (Second External Review Draft)
should be directed to Dr. Jee Young Kim
in EPA’s Office of Research and
Development at 919–541–4157 or
kim.jee-young@epa.gov. Any questions
concerning EPA’s Risk and Exposure
Assessment to Support the Review of the
SO2 Primary National Ambient Air
Quality Standards: First Draft should be
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]]>Agencies
[Federal Register Volume 73, Number 118 (Wednesday, June 18, 2008)]
[Notices]
[Pages 34736-34739]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-13773]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2008-0489; FRL-8369-1]
FIFRA Scientific Advisory Panel; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: There will be a 3-day meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to
consider and review an evaluation of the common mechanism of action of
pyrethroid pesticides.
DATES: The meeting will be held on September 9-11, 2008, from
approximately 8:30 a.m. to 5 p.m, eastern time.
Comments. The Agency encourages that written comments be submitted
by August 26, 2008 and requests for oral comments be submitted by
September 2, 2008. However, written comments and requests to make oral
comments may be submitted until the date of the meeting. Anyone
submitting written comments after August 26, 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 July
2, 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.
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Comments. Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2008-0489, 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'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-
2008-0489. 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 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
https://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 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: Joseph E. Bailey, DFO, Office of
Science Coordination and Policy (7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001;
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.
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-2008-0489 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 August
26, 2008, to provide the 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. Anyone submitting written
comments after August 26, 2008 should contact the DFO listed under FOR
FURTHER INFORMATION CONTACT. There is no limit on the extent of written
comments for consideration by 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
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FOR FURTHER INFORMATION CONTACT no later than September 2, 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 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: Pyrethroid pesticides; voltage-sensitive
sodium channels; mode of action analysis; motor activity and functional
observational battery; and dose Response modeling. 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 July 2, 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 10 ad hoc scientists.
The 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 (OPTS) 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
Pyrethroid pesticide usage has increased in the past decade in
agricultural and residential settings. The Office of Pesticide Programs
is in the early stages of evaluating the potential risks from increased
exposure to these pesticides. As part of this evaluation, OPP is
developing an analysis of the toxicity profiles of these pesticides and
is evaluating whether or not some or all of the pyrethroid pesticides
share a common mechanism of action (i.e., those pesticides that produce
a common toxic effect by a common mechanism of toxicity). The Agency
will be seeking the Scientific Advisory Panel's advice on a set of
scientific issues raised in a draft science policy document proposing
to establish a common mechanism group for the pyrethroid pesticides.
The proposed grouping may include two or more sub-groups. Establishing
a common mechanism group is the first stage toward
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developing a cumulative risk assessment as required under the Food
Quality Protection Act. Pending the outcome of this panel review, the
Agency may begin work on the cumulative risk assessment for those
pyrethroid pesticides that are determined to share a common mechanism.
The Agency will be seeking advice from the SAP on the following areas
related to the toxicity of the pyrethroid pesticides:
1. Interpretation of in vivo motor activity and functional
observational battery;
2. Interpretation of recent in vitro literature studies involving
sodium, calcium, and chloride channels;
3. Structural and functional similarities among these chemicals;
and
4. The variability of animal studies conducted by different routes
of administration and vehicles (e.g., dietary admix or corn oil vehicle
gavage).
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-August. 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: June 12, 2008.
Elizabeth Resek
Acting Director, Office of Science Coordination and Policy.
[FR Doc. E8-13773 Filed 6-17-08; 8:45 a.m.]
BILLING CODE 6560-50-S
