[Federal Register Volume 70, Number 198 (Friday, October 14, 2005)]
[Notices]
[Pages 60076-60077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-20600]


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ENVIRONMENTAL PROTECTION AGENCY

[E-Docket ID No. ORD-2005-0022; FRL-7983-9]


Notice of a Scientific Peer-Review Meeting to Review the Draft 
Document: Approaches for the Application of Physiologically-Based 
Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment 
(EPA/600/R-05/043A)

AGENCY: Environmental Protection Agency.

ACTION: Notice of external peer-review panel meeting.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing 
that Versar Inc., an EPA contractor for external scientific peer 
review, will convene a panel of experts and organize and conduct an 
independent external peer-review workshop to review the draft report, 
``Approaches for the Application of Physiologically-Based 
Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment'' 
(EPA/600/R-05/043A), which was prepared by the National Center for 
Environmental Assessment (NCEA) within EPA's Office of Research and 
Development. Versar, Inc. invites the public to register to attend this 
workshop as observers. In addition, Versar, Inc. invites the public to 
give oral and/or provide written comments at the workshop regarding the 
draft document under review. The draft document and EPA's peer-review 
charge are available primarily via the Internet on NCEA's home page 
under the Recent Additions and Publications menus at http://www.epa.gov/ncea. In preparing a final report, EPA will consider 
Versar, Inc.'s report of the comments and recommendations from the 
external peer-review workshop. In addition to the workshop announced 
today, EPA previously published a Federal Register notice (70 FR 43692) 
announcing a separate process for public comment on the draft document 
on July 28, 2005 and a second Federal Register notice (70 FR 48950) 
announcing a 45-day extension (closing October 14, 2005) of the public 
comment period.

DATES: Versar, Inc. will hold the peer-review workshop from November 
10, 2005, to November 11, 2005. On the first day, the meeting is 
scheduled to begin at 8:30 a.m. and end at 5 p.m., Eastern Daylight 
Time. The public may attend the peer-review workshop on November 10, 
2005, as observers. In addition, members of the public in attendance at 
the workshop will be allowed to make brief (no longer than five 
minutes) oral statements at the commencement of the meeting. The second 
day of the workshop is scheduled from 8:30 a.m. to 12:30 p.m., Eastern 
Daylight Time. This second day will be not be open to the public and is 
meant to provide time for the peer-reviewers to begin drafting their 
comments on the draft report.

ADDRESSES: The external peer-review panel meeting will be held at the 
Hyatt Arlington located at 1325 Wilson Boulevard, Arlington, VA, 22209. 
The EPA contractor, Versar, Inc., is organizing, convening, and 
conducting the peer-review panel meeting. To attend the meeting, 
register by November 4, by calling Ms. Amanda Jacob of Versar, Inc., 
6850 Versar Center, Springfield, VA, 22151, at 703-750-3000 ext. 260, 
or via e-mail at [email protected], or by sending a facsimile to 703-
642-6954. Interested parties may also register on-line at: http://epa.versar.com/pbpk. Space is limited, and reservations will be 
accepted on a first-come, first-served basis. At the time of your 
registration for the meeting, please indicate if you intend to make an 
oral statement during the public comment period on the first day of the 
meeting.

FOR FURTHER INFORMATION CONTACT: Questions regarding registration and 
logistics for the peer review meeting should be directed to Ms. Amanda 
Jacob, Versar, Inc., 6850 Versar Center, Springfield, VA, 22151; 
telephone: 703-750-3000 ext. 260; facsimile: 703-642-6954; e-mail: 
[email protected]. If you have questions about the document, please 
contact Technical Information Staff, NCEA, U.S. Environmental 
Protection Agency, Washington, DC 20460; telephone: 202-564-3261; 
facsimile: 202-565-0050; or e-mail: [email protected].

SUPPLEMENTARY INFORMATION: On July 28, 2005, EPA published a Federal 
Register notice (70 FR 43692) that announced a 30-day public comment 
period through August 29, 2005, for EPA's draft report, ``Approaches 
for the Application of Physiologically-Based Pharmacokinetic (PBPK) 
Models and Supporting Data in Risk Assessment'' (EPA/600/R-05/043A). 
EPA published a second notice in the Federal Register on August 22, 
2005 (70 FR 48950) that extended the public comment period for 45 days 
from August 29, until October 14, 2005. On July 28, 2005, the draft 
document was made publicly available on NCEA's Web site for review and 
comment. An electronic version of the public docket is available 
through EPA's electronic public docket and comment system, E-Docket. To 
view comments, go to http://www.epa.gov/edocket/, select ``search,'' 
then key in the docket identification number, ORD-2005-0022. In the 
July 28, 2005, notice, EPA also announced that a subsequent Federal 
Register notice would announce the date and location of a workshop for 
independent external peer review of this draft document. Today's notice 
provides information on that external peer-review workshop.
    The purpose of the draft document is to describe some approaches 
for the use of physiologically-based pharmacokinetic (PBPK) models in 
risk assessment. PBPK models represent an important class of dosimetry 
models that are useful for predicting internal dose at target organs 
for risk assessment applications. Dose-response relationships that 
appear unclear or confusing at the administered dose level can become 
more understandable when expressed on the basis of internal dose of the 
chemical. To predict internal dose level, PBPK models use 
pharmacokinetic data to construct mathematical representations of

[[Page 60077]]

biological processes associated with the absorption, distribution, 
metabolism, and elimination of compounds. With the appropriate data, 
these models can be used to extrapolate across species and exposure 
scenarios, and address various sources of uncertainty in risk 
assessments. This report addresses the following questions: (1) Why do 
risk assessors need PBPK models; (2) How can these models be used in 
risk assessments; and (3) What are the characteristics of acceptable 
PBPK models for use in risk assessment?

    Dated: October 6, 2005.
Peter Preuss,
Director, National Center for Environmental Assessment.
[FR Doc. 05-20600 Filed 10-13-05; 8:45 am]
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