

[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
