[Federal Register Volume 75, Number 235 (Wednesday, December 8, 2010)]
[Notices]
[Pages 76457-76460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-30630]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2010-0588; FRL-8854-5]
FIFRA Scientific Advisory Panel; Notice of Public Meeting
AGENCY: Environmental Protection Agency.
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 Chlorpyrifos Physiologically-Based
Pharmacokinetic/Pharmacodynamic (PBPK/PD) Modeling linked to the
Cumulative and Aggregate Risk Evaluation System (CARES).
DATES: The meeting will be held on February 15-18, 2011, from 9 a.m. to
approximately 5:30 p.m.
Comments. The Agency encourages that written comments be submitted
by January 31, 2011 and requests for oral comments be submitted by
February 8, 2011. 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 31, 2011 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 December
22, 2010.
Webcast. This meeting may be webcast. Please refer to the FIFRA
SAP's Web site, http://www.epa.gov/scipoly/SAP for information on how
to access the webcast. Please note that the webcast is a supplementary
public process provided only for convenience. If difficulties arise
resulting in webcasting outages, the meeting will continue as planned.
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-2010-0588, 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
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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-
2010-0588. 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 Web site 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 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: 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
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-2010-0588 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
31, 2011, 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 31, 2011, 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 February 8, 2011, 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, 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 open and
on a first-come basis.
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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, organophosphate pesticides, cholinesterase
inhibition, data-derived uncertainty factors (also referred to as
chemical-specific adjustment factors), pharmacodynamic modeling,
physiologically-based pharmacokinetic modeling, biomonitoring data,
statistical modeling, probabilistic techniques, and dietary exposure to
pesticides. 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 22, 2010. 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 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 10-15 ad hoc scientists.
FIFRA SAP members are subject to the provisions of 5 CFR part 2634,
Executive Branch Financial Disclosure, as supplemented by 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. 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 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 FIFRA SAP
FIFRA SAP serves as the primary scientific peer review mechanism of
EPA's Office of Chemical Safety and Pollution Prevention (OCSPP) 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 the
Food Quality Protection Act of 1996 (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
Chlorpyrifos (0,0-diethyl-0-3,5,6-trichloro-2-pyridyl
phosphorothioate) is a broad-spectrum, chlorinated organophosphate (OP)
insecticide. In 2000, nearly all residential uses were voluntarily
cancelled by Dow AgroSciences, but agricultural uses remain. The 2000
human health risk assessment was largely based on adult laboratory
animal data (rat or dog) for cholinesterase inhibition and the
application of default uncertainty factors to address inter- and intra-
species differences including susceptible populations. Currently, the
Agency is developing a new human health risk assessment expected to be
released in 2011. In 2008, the FIFRA Scientific Advisory Panel (SAP)
reviewed a draft science issue paper on the human health effects of
chlorpyrifos. Since that time, Dow AgroSciences has undergone a
research effort to improve the existing physiologically-based
pharmacokinetic/pharmacodynamic model (PBPK/PD) developed by Dr.
Charles Timchalk and co-workers at Pacific Northwest National
Laboratory. Dow AgroSciences has also developed a proposed approach for
merging this PBPK/PD model with CARES Cumulative and Aggregate Risk
Evaluation System, see http://www.ilsi.org/ResearchFoundation/Pages/CARES.aspx, a publically-available probabilistic exposure model. The
purpose of the February 2011 SAP meeting will be to review the PBPK/PD
model and to evaluate the proposed approach for linking this PBPK model
to the probabilistic exposure model.
The linking of the chlorpyrifos PBPK/PD model with a probabilistic
exposure model may provide opportunities to calculate distributions of
exposure to chlorpyrifos and its metabolites with cholinesterase
inhibition levels across the U.S. population. In addition, this
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approach may allow estimation of data-derived uncertainty factors that
consider use of toxicokinetic and toxicodynamic data to inform
quantitative extrapolations for interspecies differences and human
variability in dose response assessment. The topics to be covered in
the February 2011 SAP are consistent with EPA's Office of Pesticide
Programs continuing efforts to improve the scientific basis for risk
assessment by broadening the application of probabilistic exposure
techniques and PBPK models. The Agency has a conceptually similar
effort on-going to link PBPK models for pyrethroids with Stochastic
Human Exposure and Dose Simulator (SHEDS) exposure software, a
probabilistic exposure model developed by the EPA's Office of Research
and Development, which was reviewed by the SAP in July 2010. The
current effort by Dow AgroSciences is a research effort which may, if
sufficiently robust, inform future risk assessments; the February
meeting is a key milestone in this research. The Agency will solicit
feedback from the Panel on technical issues related to PBPK/PD model,
the proposed approach for merging the PBPK/PD model with CARES, and the
use of such merged models in risk assessment.
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
late January 2011. 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.
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: November 23, 2010.
Frank Sanders,
Director, Office of Science Coordination and Policy.
[FR Doc. 2010-30630 Filed 12-7-10; 8:45 am]
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