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FIFRA Scientific Advisory Panel; Notice of Public Meeting
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: May 16, 2007 (Volume 72, Number 94)]
[Notices]
[Page 27559-27563]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16my07-70]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-0388; FRL-8131-2]
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
review a set of issues being considered by the Agency pertaining to two
separate topics. On August 14-15, 2007, the Panel will consider a
Review of EPA/ORD/NERL's SHEDS-Multimedia Model, aggregate version 3.
On August 16-17, 2007, the Panel will review Assessing Approaches for
the Development of PBPK Models of Pyrethroid Pesticides.
DATES: The meeting will be held on August 14-17, 2007, from 8:30 a.m.
to 5 p.m, eastern standard time (est.)
Comments. The Agency encourages that written comments be submitted
by July 31, 2007 and requests for oral comments be submitted by August
7, 2007. However, written comments and requests to make oral comments
may be submitted until the date of the meeting. 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 May
29, 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-2007-0388, 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.
[[Page 27560]]
Instructions. Direct your comments to docket ID number EPA-HQ-OPP-
2007-0388. 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 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: Steve M. Knott, DFO, Office of
Science Coordination and Policy (7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone
number: (202) 564-0103; fax number: (202) 564-8382; e-mail addresses:
knott.steven@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-2007-0388 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 July 31,
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. 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 August 7, 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 process for developing a
pool of
[[Page 27561]]
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: Dietary and residential exposure modeling, probabilistic
exposure assessment, statistics, risk assessment with experience
understanding the data needed for risk assessment purposes, how to
interpret the data, and issues concerning intra-species and inter-
species extrapolation, pharmacokinetics with experience in the
development and application of PBPK models, and metabolism with
experience in the use of in vitro approaches for species extrapolation.
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 May 29, 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 for each topic. 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 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
The FQPA amended laws under which EPA evaluates the safety of
pesticide residues in food. Section 408(b)(2)(D)(v) and (vi) of the
FFDCA as amended by FQPA, specifies that when determining the safety of
a pesticide chemical, EPA shall consider aggregate exposure (i.e.,
total dietary (food and water), residential, and other non-
occupational) and available information concerning the cumulative
effects to human health that may result from exposure to other
substances that have a common mechanism of toxicity.
Pyrethroid pesticides are currently undergoing evaluation to
determine if a cumulative risk assessment is warranted for this class
of chemicals. As part of this evaluation, EPA will utilize the SHEDS
probabilistic model to estimate cumulative exposure to pyrethroid
pesticides; also, EPA is developing physiologically-based pharmacokinetic
(PBPK) models to aid in quantitatively assessing exposure dose response
relationships for individual pyrethroids and mixtures.
The FIFRA SAP will meet to review the following scientific issues:
1. Review of EPA/ORD/NERL's SHEDS-Multimedia Model, aggregate
version 3: The purpose of this review is to request input from the SAP
on EPA/ORD/NERL's Stochastic Human Exposure and Dose Simulation for
Multimedia, Multipathway Pollutants (SHEDS-Multimedia), aggregate
version 3. SHEDS-Multimedia version 3 is a state-of-science computer
model for simulating human exposures to multimedia, multipathway
environmental pollutants including pesticides. It is a physically-
based, probabilistic model that predicts, for user-specified population
cohorts, exposures incurred via eating contaminated foods or drinking water,
[[Page 27562]]
inhaling contaminated air, touching contaminated surface residues, and
ingesting residues from hand- to-mouth or object- to-mouth activities.
To do this, it combines information on chemical usage, human activity
data (e.g., from Consolidated Human Activity Database (CHAD) time/
activity diary surveys and videography studies), environmental residues
and concentrations, and exposure factors to generate time series of
exposure for simulated individuals. One-stage or two-stage Monte Carlo
simulation is used to produce distributions of exposure for various
population cohorts (e.g., age/gender groups) that reflect the
variability and/or uncertainty in the input parameters. While the core
of SHEDS-Multimedia is the concentration-to-exposure module, there are
various options (built-in source-to-concentration module; user-entered
time series from other models or field study measurements) for
obtaining concentration inputs, and SHEDS-Multimedia exposure outputs
can be used as inputs to PBPK models.
Finally, the SHEDS-Multimedia version 3 single chemical model can
address many useful aspects of aggregate and cumulative risk
assessment, related to population aggregate exposures for different
multimedia chemicals and the important contributing pathways and
factors. Such information will be useful in identifying populations and
exposure scenarios of greatest concern for this class of chemicals.
These populations and exposure scenarios will in turn be used to
determine the most relevant chemical/pyrethroid combinations for which
hazard/exposure factors information will need further development in
order to support a PBPK dose modeling approach. EPA plans to extend the
current single chemical aggregate version of SHEDS to a cumulative
version. The cumulative version of SHEDS will be used to estimate
exposure resulting from cumulative exposure to pyrethroid pesticides.
At this meeting, the FIFRA SAP panel will be asked to review the
following: The dietary module of SHEDS version 3; the residential
module of SHEDS version 3; and planned methodologies for extending
SHEDS-Multimedia version 3 (aggregate) to SHEDS-Multimedia version 4
(cumulative).
Review of the dietary module will include the methodology and model
evaluation. Review of the residential module will include the SAS code,
graphic user interface (GUI), technical manual, and user manual. Review
of the planned methodologies to extend the single chemical aggregate
version of SHEDS (version 3) to the cumulative version (version 4) will
include: Algorithms for multiple chemicals and co-occurrence; fugacity-
based module for residential concentration predictions; new
methodologies for enhanced longitudinal activity diary simulation;
Sobol methodology for enhanced sensitivity analyses; planned approach
for combining residential and dietary modules; and planned coding and
GUI changes for version 4. The panel members will not be asked to
review chemical-specific inputs or evaluate outputs at this SAP meeting.
This SAP review is part of the Agency's ongoing process to enhance
probabilistic exposure, dose, and risk assessments, and OPP's ongoing
efforts to consider available probabilistic exposure and dose models to
address FQPA. To assist the FIFRA SAP in their review, each FIFRA SAP
member will be provided technical reports describing the SHEDS-
Multimedia version 3 model, annotated SHEDS code, GUI, a user guide for
the GUI, a technical document describing planned methodologies for
extending version 3 to version 4, and several relevant journal articles
for reference.
2. Assessing Approaches for the Development of PBPK Models of
Pyrethroid Pesticides: The development of these models offers many
challenges, including:
a. As a class, pyrethroid pesticides have many structural
similarities such that a ``generic'' model structure, with chemical
specific adjustments as needed, can be developed. Chemical specific
parameters are anticipated to include partition coefficients, hepatic
clearance rates and others.
b. It is anticipated that the PBPK models will be used for cross-
species extrapolation of internal dose metrics for assessing the risk
of pyrethroid neurotoxicity. Based on the results of in vivo
experiments in rats, blood and brain concentrations of parent compound
correlate with pyrethroid toxicity as measured by motor activity;
either of these metrics could be a model output for use in a cumulative
risk assessment.
c. Pyrethroids may have one or more chiral centers resulting in
numerous stereoisomers. There is limited information on the toxicity
and pharmacokinetics of the different stereoisomers. EPA proposes to
evaluate three modeling assumptions in order to address the
uncertainties due to chiral chemistry of the pyrethroids.
d. Finally, there is limited human data to calibrate and evaluate
these models for extrapolation to humans. EPA proposes to develop the
human model through the use of computational and in vitro experimental
approaches using human tissue. To evaluate this approach, EPA plans to
develop equivalent rodent and human in vitro databases for metabolic
and physiological parameters for use in the PBPK models. The utility of
this approach will be assessed by comparing rodent model predictions to
in vivo data. It is likely that scaling factors will be used in order
to incorporate these in vitro parameters into the rodent model. When
calibrating the human data, the scaling factors used in the rodent
models will be used in the human models.
The purpose of this review is to request input from the SAP on:
i. The appropriateness of a generic PBPK model,
ii. Potential dose metrics that are relevant for a cumulative risk
assessment,
iii. The proposed approach for the incorporation of chiral
chemistry into model structure, and
iv. The proposed approach for developing these models with limited
human dosimetry data. Planned methodologies for linking exposure to
PBPK will also be discussed.
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 late July. 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.
[[Page 27563]]
Dated: May 10, 2007.
Clifford J. Gabriel,
Director, Office of Science Coordination and Policy.
[FR Doc. E7-9426 Filed 5-15-07; 8:45 am]
BILLING CODE 6560-50-S