[Federal Register: June 29, 2007 (Volume 72, Number 125)]
[Notices]
[Page 35705-35708]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29jn07-55]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-0498; FRL-8137-2]
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 a set of issues pertaining to the potential for
atrazine to affect amphibian gonadal development.
DATES: The meeting will be held on October 9 - 12, 2007, from
approximately 8:30 a.m. to 5 p.m, eastern time.
Comments. The Agency encourages that written comments be submitted
by September 24, 2007 and requests for oral comments be submitted by
October 2, 2007. However, written comments and requests to make oral
comments may be submitted until the date of the meeting. Anyone
submitting written comments after September 24, 2007, should contact
the 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
16, 2007.
Special accommodations. For information on access or services for
individuals with disabilities, and to request accommodation of a
disability, please contact the Designated Federal Official (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 Crystal Dr., Arlington, VA 22202.
Comments. Submit your comments, identified by docket ID number EPA-
HQ-OPP-2007-0498, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments. Your use of
the Federal eRulemaking Portal to submit comments to EPA electronically
is EPA's preferred method for receiving 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-
2007-0498. If your comments contain any information that you consider
to be CBI
[[Page 35706]]
or otherwise protected, please contact the DFO listed under FOR FURTHER
INFORMATION CONTACT to obtain special instruction 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 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 web
site 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: Joseph E. Bailey, DFO, Office of
Science Coordination and Policy (7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave., N.W., Washington, DC 20460; 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-2007-0498 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 September
24, 2007, to provide 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 September 24, 2007, should contact the DFO listed under
FOR FURTHER INFORMATION CONTACT. There is no limit on the extent of
written comments for consideration by 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 October 2, 2007, 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
[[Page 35707]]
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: amphibian ecology/biology,
ecotoxicology, developmental toxicology, endocrine disruption,
statistics and risk assessment methodology. 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 16, 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 10 ad hoc scientists. FIFRA SAP members are
subject to the provisions of 5 CFR part 2634, Executive Branch
Financial Disclosure, as supplemented by the EPA in 5 CFR part 6401. In
anticipation of this requirement, prospective candidates for service on
the FIFRA SAP will be asked to submit confidential financial disclosure
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 web site 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 the Environmental Protection Agency (EPA), Office of
Prevention, Pesticides and Toxic Substances 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 the FQPA of 1996,
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 Panel. As a peer review
mechanism, the FIFRA SAP provides comments, evaluations and
recommendations to improve the effectiveness and quality of analyses
made by Agency scientists. Members of the FIFRA SAP are scientists who
have sufficient professional qualifications, including training and
experience, to provide expert advice and recommendation to the Agency.
B. Public Meeting
EPA conducted an extensive review of open literature and
registrant-submitted studies concerning the potential effects of
atrazine on amphibian gonadal development and concluded in 2003 that
there was sufficient information to hypothesize that atrazine exposure
can result in effects on amphibian gonadal development. EPA also
concluded that there was insufficient evidence to refute or confirm
that hypothesis because the collective studies failed to show that
atrazine produced consistent, reproducible effects across the range of
exposure concentrations and amphibian species tested in the studies.
EPA summarized the studies and its evaluation of the studies in a White
Paper and presented its analysis, conclusions and recommendations to
the SAP during the meeting held on June 17 - 20, 2003.
The SAP concurred with EPA's interpretation of the available data
and with EPA's recommendations to seek additional data. Additionally,
the SAP concurred with the study approach described in the White Paper
for addressing uncertainties identified in the available studies.
In response to the uncertainties identified in the White Paper and
based on the recommendations made by the SAP, EPA issued a Data Call-in
Notice (DCI) on November 12, 2004, to Syngenta Crop Protection, Inc.
and other atrazine registrants. The DCI required the registrant to
conduct amphibian studies to determine if exposure to atrazine can
affect amphibian gonadal development. Secondary objectives of these
studies were to provide information on the repeatability of previous
observations, develop a sound dose-response relationship, and determine
the developmental sensitivity of the amphibian species that are being
tested.
On October 9 -12, 2007, EPA will return to the SAP with a second
White Paper discussing the results of the registrant's amphibian
studies conducted in 2005 - 2006. In addition, EPA has continued to
review the open literature studies investigating whether
[[Page 35708]]
atrazine exposure affects amphibian gonadal development. For the SAP
meeting, EPA plans to include only those studies published in the open
scientific literature that tested atrazine alone and examined
atrazine's potential effects on amphibian gonadal development. Studies
on mixtures of pesticides that include atrazine as well as studies of
the potential for atrazine to cause adverse effects other than
amphibian gonadal development are not being considered for the SAP
meeting.
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-September. 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 web site or may be
obtained from the OPP Regulatory Public Docket at http://www.regulations.gov
.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: June 21, 2007.
Clifford J. Gabriel,
Director, Office of Science Coordination and Policy.
[FR Doc. E7-12571 Filed 6-28-07; 8:45 am]
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