[Federal Register Volume 74, Number 221 (Wednesday, November 18, 2009)]
[Notices]
[Pages 59533-59536]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-27671]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2009-0851; FRL-8800-1]
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 Draft Framework and Case Studies on Atrazine, Human
Incidents, and the Agricultural Health Study: Incorporation of
Epidemiology and Human Incident Data into Human Health Risk Assessment.
DATES: The meeting will be held on February 2 - 5, 2010, from
approximately 8:30 a.m. to 5 p.m.
Comments. The Agency encourages that written comments be submitted
by January 19, 2010 and requests for oral comments be submitted by
January 26, 2010. However, written comments and requests to make oral
comments may be submitted until the date of the meeting, but anyone
submitting written comments after January 19, 2010 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 FIFRA SAP for this meeting should be provided on or before November
30, 2009.
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, VA 22202.
Comments. Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2009-0851, 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 Facility '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-
2009-0851. 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 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 the docket index
available at http://www.regulations.gov. Although listed in the 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
[[Page 59534]]
materials are available either 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 ad hoc members
of 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: Myrta R. Christian, DFO, Office of
Science Coordination and Policy (7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001;
telephone number: (202) 564-8498; fax number: (202) 564-8382; e-mail
address: [email protected].
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-2009-0851 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
19, 2010, to provide FIFRA SAP the time necessary to consider and
review the written comments. Written comments are accepted until the
date of the meeting, but anyone submitting written comments after
January 19, 2010 should contact the DFO listed under FOR FURTHER
INFORMATION CONTACT. Anyone submitting written comments at the meeting
should bring 30 copies for distribution to 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 26, 2010, 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
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, 35mm 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 open and
on a first-come basis.
4. Request for nominations to serve as ad hoc members of FIFRA SAP
for this meeting. As part of a broader process for developing a pool of
candidates for each meeting, FIFRA SAP staff routinely solicits the
stakeholder community for nominations of prospective candidates for
service as ad hoc members of 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: Risk Assessment; Human Epidemiology (particularly occupational
and environmental epidemiology); Mode of Action Analysis (particularly
those with MOA framework experience); Human Relevance Framework;
Pharmacokinetics (particularly animal to human extrapolation); Exposure
Assessment of Pesticides (both residential & agricultural worker).
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 November 30, 2009.
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 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
[[Page 59535]]
to serve on 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 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 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 FIFRA SAP
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. FIFRA SAP is a Federal advisory committee established in
1975 under FIFRA that operates in accordance with requirements of the
Federal Advisory Committee Act. 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 SAP on an ad hoc basis to assist in reviews
conducted by the SAP. As a peer review mechanism, FIFRA SAP provides
comments, evaluations and recommendations to improve the effectiveness
and quality of analyses made by Agency scientists. Members of 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
Data from epidemiology studies and human incident reports contain
valuable information about human exposure and response to pesticides.
This information can contribute to a weight of evidence analysis in the
characterization of human health risks. Epidemiology and incident data
do, however, pose challenges with respect to characterizing human
health risks. EPA is convening a meeting of the FIFRA Scientific
Advisory Panel (SAP) to discuss science issues related to using
epidemiology and human incident data in human health risk assessment.
The Office of Pesticide Programs (OPP) will solicit comment on a draft
framework for implementing such data into human health risk assessment
in addition to several case studies that illustrate scientific issues
to be addressed at the SAP meeting. OPP's draft framework describes a
weight of the evidence evaluation that uses the best available science
on mode of action, exposure, pharmacokinetics, animal and human data
from both in vivo and in vitro studies in addition to models such as
physiologically-based pharmacokinetic models when available. Three case
studies to be evaluated by the SAP are intended to illustrate the draft
framework and to highlight key science challenges with incorporating
epidemiology or human incident data into a risk assessment. The Agency
will solicit comment on the weight of the evidence approach for
evaluating and integrating the exposure, laboratory animal, and human
information.
A case study on the evaluation of several epidemiology studies
concerning atrazine will be presented. These epidemiology studies are
either ecologic or retrospective cohort studies in design. OPP, in
collaboration with EPA's Office of Water and Office of Research and
Development (ORD), will solicit comment on the strengths and weaknesses
of these types of epidemiology studies in addition to advice on the
appropriate way to use such studies in the atrazine human health risk
assessment. This case study is also the first step in EPA's atrazine
science re-evaluation plan as described to the November 3, 2009 FIFRA
SAP previously (http://www.epa.gov/scipoly/sap/meetings/2009/110309meeting.html).
A case study is also included to illustrate an analysis of reported
human incident cases using diazinon; a pesticide that has historically
been used in residential settings.
Additionally, a case study concerning the collaborative work by
scientists from OPP, ORD, and the National Cancer Institute (NCI) and
the National Institute of Environmental Health Sciences (NIEHS) on the
Agricultural Health Study (AHS) will be presented to: Compare the
exposure algorithms used by OPP and the AHS, and; consider temporal
relationships for multi-chemical exposure in the AHS. The purpose of
on-going work to compare the OPP and AHS exposure algorithms is to
better understand differences and similarities in the two approaches to
estimating worker exposure. Evaluation of temporal relationships for
multi-chemical exposure in the AHS will involve information on the
timing of uses and combined uses of pesticides, with particular
emphasis on pesticides which share the same mode of action. The Agency
will solicit advice on types of evaluations conducted to date and those
being proposed with the third case study.
The FIFRA SAP's advice will provide the Agency with input on
approaches to integrate diverse types of experimental toxicology and
epidemiology data. The SAP input will be considered in characterizing
atrazine's human health risks which will be presented to the SAP in
September 2010.
C. FIFRA SAP Documents and Meeting Minutes
EPA's background paper, related supporting materials, charge/
questions to FIFRA SAP, FIFRA SAP composition (i.e., members and ad hoc
members for this meeting), and the meeting agenda will be available by
early January. 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
[[Page 59536]]
SAP homepage at http://www.epa.gov/scipoly/sap.
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 10, 2009.
Frank Sanders,
Director, Office of Science Coordination and Policy.
[FR Doc. E9-27671 Filed 11-17-09; 8:45 am]
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