[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