03-30269. 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.

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Protection Agency (EPA) announces an expert peer-review workshop to review two time-dependent dose-response models and draft guidance for the application of these models to the assessment of data generated under EPA neurotoxicity screening test guidelines (63 FR 26926, May 14, 1998).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 The Splus® model programs and draft guidance document to be reviewed were developed for the EPA's National Center for Environmental Assessment (NCEA) and National Health and Environmental Effects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: [phone] or e-mail: [e-mail] for details pertaining to the workshop, registration, and logistics. For technical information contact: Jeff Gift, U.S. EPA, NCEA-RTP, B243-01, Research Triangle Park, NC 27711; telephone: [phone]; facsimile: 919-541-0245; or e-mail: [e-mail].

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.