Browse: Departments Dates Agencies
EPA ID: [EPA-HQ-OPP-2007-1088; FRL-8339-7]
SUBJECT CATEGORY: FIFRA Scientific Advisory Panel; Notice of Public Meeting
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.
DOCUMENT 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.
SUMMARY: FIFRA Scientific Advisory Panel,
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.
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 EPAHQOPP20071088 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 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: Wildlife epidemiology with avian incident
familiarity, avian agroecology, 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
Nmethyl 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://www.regulations.gov. II. Background
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 pesticiderelated 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.
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 foodmatrix 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.
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
midJanuary 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.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. E722612 Filed 111907; 8:45 am]
BILLING CODE 656050S
FOR FURTHER INFORMATION CONTACT Sharlene R. Matten, DFO, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 204600001; telephone number: (202) 5640130; fax number: (202) 5648382; email addresses: matten.sharlene@epa.gov.
14 CFR Part 39 40 CFR Part 52 14 CFR Part 71 33 CFR Part 165 50 CFR Part 679 47 CFR Part 73 26 CFR Part 1 40 CFR Part 180 33 CFR Part 117 50 CFR Part 17 44 CFR Part 67 50 CFR Part 648 14 CFR Part 97 33 CFR Part 100 40 CFR Part 63 50 CFR Part 622 44 CFR Part 65 50 CFR Part 660 26 CFR Part 301 39 CFR Part 111 40 CFR Part 300 6 CFR Part 5 40 CFR Part 271 47 CFR Part 64 40 CFR Parts 52 and 81 50 CFR Part 665 44 CFR Part 64 10 CFR Part 50 49 CFR Part 571 47 CFR Part 76