[Federal Register Volume 75, Number 83 (Friday, April 30, 2010)]
[Notices]
[Pages 22779-22783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-10231]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2010-0383; FRL-8823-8]
FIFRA Scientific Advisory Panel; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: There will be a 3-day meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to
consider and review a set of scientific issues related to review of
SHEDs-Multimedia version 4, Peer consult on PBPK Modeling, and a SHEDS-
PBPK Permethrin study.
DATES: The meeting will be held on July 20-22, 2010, from 9 a.m. to
approximately 5:30 p.m.
Comments. The Agency encourages that written comments be submitted
by July 8, 2010 and requests for oral comments be submitted by July 15,
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 July 8, 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 May 14,
2010.
Webcasting. This meeting may be webcast. Please refer to the FIFRA
SAP's website, 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.
[[Page 22780]]
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-2010-0383, 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-
2010-0383. 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 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-2010-0383 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 8,
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 July 15, 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 July 15, 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
[[Page 22781]]
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.
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: pesticide exposure, general statistics, exposure modeling, dose
modeling, and risk assessment. 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 14, 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 12-15 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 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 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 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
The Food Quality Protection Act (FQPA) amended laws under which EPA
evaluates the safety of pesticide residues in food. Section
408(b)(2)(D)(v) and (vi) of the Federal Food, Drug, and Cosmetic Act
(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. Aggregate
assessments account for multiple sources and routes of exposure for a
single chemical. FQPA-mandated cumulative assessments combine exposures
and doses to two or more chemicals that share a common mechanism of
toxicity.
EPA's Office of Pesticide Programs (OPP) and Office of Research and
Development (ORD) have been conducting collaborative science to inform
the Agency's anticipated pyrethroid cumulative risk assessment (CRA).
This FIFRA 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. Through a coordinated multi-disciplinary
effort,
[[Page 22782]]
ORD and OPP scientists have developed new approaches for Commulative
Risk Assessment (CRA) which are incorporated into ORD's SHEDS-
Multimedia (Stochastic Human Exposure and Dose Simulation) computer
model and software. SHEDS-Multimedia (http://www.epa.gov/heasd/products/ sheds_multimedia/sheds_mm.html) is a physically-based,
probabilistic model that predicts for user-specified population cohorts
exposures incurred via eating contaminated foods or drinking water,
inhaling contaminated air, touching contaminated surface residues, and
ingesting residues from hand-to-mouth or object-to-mouth activities. It
can simulate aggregate or cumulative exposures over time via multiple
routes of exposure (dietary & non-dietary residential) for multiple
types of chemicals & scenarios. To do this, it combines information on
chemical usage, human activity data (e.g., from Consolidated Human
Activity Database (CHAD; www.epa.gov/chadnet1) 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 (e.g., built-in simple source-to-
concentration module, user-entered time series from other models or
field study measurements) for obtaining concentration inputs. SHEDS-
Multimedia also includes a simple built-in pharmacokinetic (PK) model.
In addition, SHEDS-Multimedia exposure outputs can be used as inputs to
more sophisticated physiologically-based pharmacokinetic (PBPK) models
which can, in turn, be used to model and estimate tissue burden and
urinary concentrations of chemicals through class-oriented approaches.
The combined exposure- and dose- modeled outputs will be compared
against real-world biomonitoring data, and will be integrated with
corresponding effects research.
An earlier version of the SHEDS-Multimedia model (version 3) was
originally presented to the SAP for review in August 2007 (http://www.epa.gov/scipoly/SAP/meetings/2007/081407_mtg.htm). In that
version, only the aggregate residential module of SHEDS-Multimedia was
operational, and then only for post-application exposures (i.e.,
pesticide applicators were not considered). In that 2007 meeting, the
SAP reviewed the aggregate residential (post-application only) version
of SHEDS-Multimedia (version 3), as well as conceptual plans for the
SHEDS dietary module and for the PBPK modeling.
This July 2010 SAP will focus on work conducted by ORD and OPP
scientists since 2007 on these models, and will consist of:
(i) A formal review of SHEDS-Multimedia version 4 which now
includes dietary as well as both applicator and post-application
residential exposures, and allows for cumulative as well as aggregate
assessments;
(ii) A peer consult on refinements to the PBPK models and how SHEDS
outputs are introduced into and used by PBPK models; and
(iii) Demonstration of the application of linked SHEDS-PBPK models
with a permethrin case study.
The methods and models reviewed by this SAP will provide new science
and data that will inform the CRA for pyrethroids and support future
cumulative risk assessments. The overall goal of this SAP is to review
these individual and linked state-of-the-science exposure and dose
assessment tools with a permethrin case study to support the Agency's
pyrethroid CRA.
The purpose of this review is to request input from the SAP on this
updated version of the models and related software. Specifically, the
FIFRA SAP Panel at this meeting will be asked to review:
(i) The dietary module of SHEDS-Multimedia version 4, including
algorithms, inputs, and results illustrated with a permethrin case
study;
(ii) The residential module of SHEDS-Multimedia version 4,
including algorithms, inputs, and results illustrated with a permethrin
case study;
(iii) The SHEDS-Multimedia version 4 aggregate (dietary and
residential modules combined) permethrin case study, including
algorithms, inputs, and results;
(iv) Update on PBPK modeling since the 2007 SAP, and approaches for
and results of linking SHEDS-Multimedia with PBPK models, illustrated
with a permethrin case study; and
(v) Plans for a mini-cumulative (2-3 chemicals) cumulative
pyrethroids assessment, including proposed methodologies using linked
SHEDS-Multimedia and PBPK models.
Review of the SHEDS-Multimedia model (both dietary and residential
modules) will include review of: The approaches, methodology, and
algorithms used in SHEDS; annotated SHEDS SAS code; the SHEDS Graphical
User Interface (GUI) and its ease of use; and technical and user
manuals. The Panel will be asked to focus on non- chemical-specific
default inputs at this SAP meeting. While a permethrin case study is
being presented for model illustration and evaluation purposes, the
Panel will not be asked to assess permethrin outputs.
Overall, the science and products being reviewed in this SAP
provide exposure and risk assessors within and outside the Agency with
an externally peer-reviewed physically-based, probabilistic human
exposure model for multimedia, multi-route/pathway chemicals. In
addition, the issues associated with refinements to PBPK models and how
SHEDS outputs are linked to and used by PBPK models will be discussed
both in general and by a demonstration of the application of linked
SHEDS-PBPK models to a permethrin case study. It is anticipated that
the review of this material by the SAP will assist ORD and OPP in both
producing a plan for applying these tools to inform any future
pyrethroids CRA and a generalizable approach that can be applied to
other chemicals in the future.
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 June. 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 website or may be
obtained from the OPP Regulatory Public Docket at http://www.regulations.gov.
List of Subjects
Environmental protection, Pesticides and pests.
[[Page 22783]]
Dated: April 27, 2010.
Frank Sanders,
Director, Office of Science Coordination and Policy.
[FR Doc. 2010-10231 Filed 4-29-10; 8:45 am]
BILLING CODE 6560-50-S