[Federal Register Volume 68, Number 234 (Friday, December 5, 2003)]
[Notices]
[Pages 68038-68039]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-30269]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-7595-2]


Peer-Review Workshop on Time-Dependent Models and Technical 
Guidance Document Developed for Benchmark Dose Analysis of 
Neurobehavioral Toxicity Screening Data

AGENCY: Environmental Protection Agency.

ACTION: Notice of a peer-review workshop and public meeting.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) announces an 
expert peer-review workshop to review two time-dependent dose-response 
models and draft guidance for the application of these models to the 
assessment of data generated under EPA neurotoxicity screening test 
guidelines (63 FR 26926, May 14, 1998). Oak Ridge Institute for Science 
and Education (ORISE), an EPA contractor, will organize, convene, and 
conduct the peer-review workshop.
    The workshop will focus on application of the new statistical and 
dose-response methods represented by these models to neurotoxicity 
data, but applications of these methods to other toxicological data 
will also be discussed. The Splus[reg] model programs and draft 
guidance document to be reviewed were developed for the EPA's National 
Center for Environmental Assessment (NCEA) and National Health and 
Environmental Effects Laboratory (NHEERL) by the University of South 
Florida. They are both available for download from the workshop's 
registration Web site, http://www.orau.gov/modelreview.
    Though the primary purpose of the workshop is to receive comments 
and suggestions from the peer-review panel members, members of the 
public are invited to attend the workshop as observers and will be 
allowed to present brief verbal and/or written comments at the end of 
the workshop. NCEA and NHEERL will consider comments received at the 
workshop in preparing the software and a revised guidance document for 
later release to the public.

DATES: The peer-review workshop will be held on Monday December 15, 
2003 from 8:30 a.m. to 5 p.m.

ADDRESSES: The peer-review workshop will be held in Classroom C-112 of 
the U.S. Environmental Protection Agency, 109 T.W. Alexander Drive, 
Research Triangle Park, North Carolina 27709. Logistics and 
registration for the workshop are being arranged by ORISE, P.O. Box 
117, Oak Ridge, TN 37831-0117. To attend the workshop, register by 
December 10, 2003, by going to the Web site at http://www.orau.gov/modelreview. Space is limited, and reservations will be accepted on a 
first-come, first-serve basis.

FOR FURTHER INFORMATION CONTACT: The EPA's contractor, Leslie Shaphard 
of ORISE, should be contacted at telephone: (865) 241-5784 or e-mail: 
[email protected] for details pertaining to the workshop, registration,

[[Page 68039]]

and logistics. For technical information contact: Jeff Gift, U.S. EPA, 
NCEA-RTP, B243-01, Research Triangle Park, NC 27711; telephone: 919-
541-4828; facsimile: 919-541-0245; or e-mail: [email protected].

SUPPLEMENTARY INFORMATION: The U.S. Environmental Protection Agency has 
supported the use of the benchmark dose (BMD) approach over the NOAEL/
LOAEL approach for deriving reference doses for use in the risk 
assessment process. The software that is currently available at the EPA 
BMDS Web site (http://www.epa.gov/ncea/bmds.htm) does not allow for the 
modeling of data that are longitudinal in nature (e.g., sequential 
measurements of effects). With this in mind, the EPA has supported the 
development of this time-dependent modeling software and guidance for a 
particular application, the derivation of benchmark dose (BMD) and its 
lower confidence limit (BMDL) for data generated from the battery of 
neurotoxicity screening tests under guidance developed by EPA NHEERL.
    Copies of the draft technical guidance document and the software 
will be available to the public at the registration Web site. 
Interested parties are invited to assist the EPA in further developing 
and refining this document at this peer-review workshop.

    Dated: December 1, 2003.
Peter W. Preuss,
Director, National Center for Environmental Assessment.
[FR Doc. 03-30269 Filed 12-4-03; 8:45 am]
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