Document ID: EPA-HQ-OPP-2007-1088-0001
Agency: epa
Document Type: Notice
Title: FIFRA Scientific Advisory Panel; Notice of Public Meeting
Posted Date: 2007-11-20T05:00Z

[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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