[Federal Register: December 5, 2003 (Volume 68, Number 234)]
[Notices]
[Page 68038-68039]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05de03-59]
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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models and draft guidance for the application of these models to the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 The Splus[reg] model programs and draft
guidance document to be reviewed were developed for the EPA's National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: ShapardL@orau.gov 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: gift.jeff@epa.gov.
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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