FIFRA Scientific Advisory Panel; Notice of Public Meeting
[Federal Register: November 20, 2007 (Volume 72, Number 223)]
[Notices]
[Page 65336-65339]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20no07-63]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-1088; FRL-8339-7]
FIFRA Scientific Advisory Panel; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: There will be a 4-day meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to
consider and review the Scientific Issues Associated with the Agency's
Proposed Action under FIFRA 6(b) Notice of Intent to Cancel Carbofuran.
DATES: The meeting will be held on February 5-8, 2008, from
approximately 8:30 a.m. to 5 p.m., Eastern Standard Time.
Comments. The Agency encourages that written comments be submitted
by January 22, 2008 and requests for oral comments be submitted by
January 29, 2008. Written comments and requests to make oral comments
are accepted until the date of the meeting, but anyone submitting
written comments after January 22, 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
December 3, 2007.
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 Environmental Protection Agency
Conference Center, Lobby Level, One Potomac Yard (South Bldg.), 2777
Crystal Dr., Arlington, VA 22202.
Comments. Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-1088, 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-
2007-1088. 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
[[Page 65337]]
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 an ad hoc member
of the FIFRA SAP, requests for special seating accommodations, or
requests to present oral comments to the DFO listed under FOR FURTHER
INFORMATION CONTACT.
FOR FURTHER INFORMATION CONTACT: Sharlene R. Matten, DFO, Office of
Science Coordination and Policy (7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001;
telephone number: (202) 564-0130; fax number: (202) 564-8382; e-mail
addresses: matten.sharlene@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-2007-1088 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 January
22, 2008, to provide FIFRA SAP the time necessary to consider and
review the written comments. Written comments are accepted until the
date of the meeting, anyone submitting written comments after January
22, 2008 should contact the DFO listed under FOR FURTHER INFORMATION
CONTACT. Anyone submitting written comments of 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 FIFRA SAP submit their
request to the DFO listed under FOR FURTHER INFORMATION CONTACT no
later than January 29, 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 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: Wildlife epidemiology with avian incident
familiarity, avian agro-ecology, wildlife toxicology, environmental
chemistry and drinking water exposure to chemicals, deterministic and
probabilistic ecological risk assessment of chemicals (including
terrestrial risk assessment),
[[Page 65338]]
human toxicology with experience in pesticides causing
acetylcholinesterase inhibition, human toxicology with experience with
N-methyl carbamates (these pesticides pose specific challenges in the
laboratory), dermal toxicology with particular experience with using
animal toxicology data to extrapolate human risk, statistics and/or BMD
modeling, and human health risk assessment and approaches to hazard
assessment of chemicals. 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 3, 2007. The Agency will consider all
nominations of prospective candidates for this meeting that are
received on or before this date. However, final selection of ad hoc
members for this meeting is a discretionary function of the Agency.
The selection of scientists to serve on the FIFRA SAP is based on
the function of the panel and the expertise needed to address the
Agency's charge to the panel. No interested scientists shall be
ineligible to serve by reason of their membership on any other advisory
committee to a Federal department or agency or their employment by a
Federal department or agency except the EPA. Other factors considered
during the selection process include availability of the potential
panel member to fully participate in the panel's reviews, absence of
any conflicts of interest or appearance of lack of impartiality,
independence with respect to the matters under review, and lack of
bias. 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 12 to 15 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 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
In August, 2006, EPA published its Interim Reregistration
Eligibility Decision (IRED) document announcing EPA's intention to
cancel all uses of carbofuran due to ecological and occupational risks
of concern, as well as dietary risks from residues on food crops and in
contaminated drinking water. The IRED summarized the Agency's revised
human health and ecological risk assessments of carbofuran based on
available data, public comments, and other information received in
response to the preliminary risk assessments. In developing its
decision, the Agency used risk assessment methodologies that have been
previously vetted by the Scientific Advisory Panel (SAP). Since the
issuance of the IRED, the registrant has submitted for Agency review a
number of studies addressing ecological and human dietary risk as well
as other informational documents. EPA has reviewed all submitted data
and documents, as well as additional data developed at the EPA Office
of Research and Development. New data include comparative
cholinesterase data in juvenile and adult rats, dermal toxicity in
adult rats, brain acetylcholinesterase inhibition and recovery in
birds, the effect of food-matrix on carbofuran toxicity in birds, and
the effects of carbofuran on feeding behavior in birds. While these
submissions have resulted in certain refinements to EPA's assessment,
EPA continues to believe that all uses of carbofuran should be canceled
for the reasons identified above. Therefore, pursuant to section 25(d)
of FIFRA, EPA will be submitting for SAP review the action proposed in
a draft FIFRA 6(b) Notice of Intent to Cancel carbofuran registrations.
Accordingly, EPA is requesting the SAP panel members to review the
underlying scientific assessments, and to render an opinion on the
questions posed by the Agency, relating to the impact on health and the
environment of the actions proposed.
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
[[Page 65339]]
members for this meeting), and the meeting agenda will be available by
mid-January 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: November 13, 2007.
Elizabeth Resek,
Acting Director, Office of Science Coordination and Policy.
[FR Doc. E7-22612 Filed 11-19-07; 8:45 am]
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