National Toxicology Program

[Federal Register: January 14, 1998 (Volume 63, Number 9]
[Notices]
[Page 2255 - 2256]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

National Toxicology Program; Board of Scientific Counselors' Meeting

Pursuant to Public Law 92-463, notice is hereby given of a meeting of the National Toxicology Program (NTP) Board of Scientific Counselors, U.S. Public Health Service, in the Conference Center, Building 101, South Campus, National Institute of Environmental Health Sciences (NIEHS), 111 Alexander Drive, Research Triangle Park, North Carolina, on February 5 and 6, 1998.

Agenda
The meeting will be open to the public from 8:45 a.m. to 4:00 p.m. on February 5, and from 8:45 a.m. to adjournment on February 6, with attendance limited only by space available. The primary agenda topic on February 5 will be a comprehensive evaluation of the strategies for use of transgenic mouse models in bioassays for carcinogenesis. Included will be an introduction, history and rationale for using transgenic animals to identify carcinogens, sharing of results from three mouse models -- p53^def, Tg.AC, and rasH2 --, NTP strategies for evaluating models, utility of transgenic model results for risk assessment, and regulatory agency perspectives. There are four issues that the Board will be asked to advise the NTP on, being: (1) Is the NTP approach to evaluation and validation of transgenic models for use in cancer bioassays sufficient and appropriate?; (2) How can existing models be best utilized? What are their limitations?; (3) What new models are needed, i.e., should the NTP seek to develop organ-specific tumor models; and (4) Are the scientific needs of regulatory agencies being adequately addressed? Background materials pertaining to the evaluation of transgenic models will be available on request from the Executive Secretary after January 12, 1998.

Among several agenda topics on February 6 will be a discussion of and opportunity for public comment on chemicals nominated for NTP studies that were reviewed by the NTP Interagency Committee for Chemical Evaluation and Coordination on August 15, 1997, and December 11, 1997. The Committee recommended nine chemicals and four mixtures for toxicological studies, recommended four chemicals be deferred for additional information, and recommended six chemicals not be studied. The chemicals/classes with CAS Nos. in parentheses are -- Recommended for Study: (1) 2-Acetylpyridine (1122-62-9); (2) Asphalt Fumes (8052-42-4); (3) 2-Chloropyridine (109-09-1); (4) Comfrey (72698-57-8) with Symphytine (22571-95-5); (5) Glycoluril (496-46-8); (6) Goldenseal (--) containing Berberine (2086-83-1) and Hydrastine (118-08-1; (7) Luminol (o--Aminophthalic Hydrazide) (521-31-3); (8) 4-Methoxy-N-methyl-1,8-naphthalimide (3271-05-4); (9) Myristicin (607-91-0); (10) 7-(2H-Naphthol[1,2-d] triazol-2-yl)-3-phenylcoumarin; (11) Orthanilic Acid (88-21-1); (12) Phenothiazine (92-84-2); and (13) Saw Palmetto containing b-Sitosterol (83-46-5). The chemicals for which No Study is Recommended are: (1) trans- 1,4-Dichloro-2-butene; (2) Dicyclopentadiene (77-73-6); (3) C.I. Direct Black 80 (8003-69-8); (4) Ethyl Cyanoacrylate (7085-85-0); (5) Isoamyl Acetate; and (6) 2,4,6-Tribromophenol. Chemicals Deferred for Additional Information are: (1) 3-Amino-5-mercapto-1,2,4-triazole (16691-43-3); (2) Diethylamine (109-89-7); (3) Isopropylamine (75-31-0); and (4) Triethylamine (121-44-8).

Also, on February 6 will be reports of recent meetings of the Report on Carcinogens and Technical Reports Review Subcommittees. The Board will review concept proposals on (1) genetic susceptibility of the pregastrulation embryo to environmental exposures, (2) molecular detection of aneuploidy in rodent germ cells, and (3) pathology support for the National Toxicology Program.

Public Input Encouraged
In order to facilitate planning for the meeting, persons wanting to make a formal presentation during the public comment period must notify the Executive Secretary, Dr. Larry G. Hart, P.O. Box 12233, Research Triangle Park, NC 27709 (telephone 919/541-3971; FAX 919/541-0295; or e-mail at hart@niehs.nih.gov) by no later than February 2, 1997, and, if possible, provide a written copy in advance of the meeting. Written statements should supplement and may expand on the oral presentation, or may be submitted in lieu of an oral presentation, and should be received by February 2 so copies can be made for distribution to Subcommittee members, staff, and the public. Oral presentations should be limited to no more than five minutes.

The Executive Secretary will furnish agenda and a roster of Board members and ad hoc expert reviewers prior to the meeting. Summary minutes subsequent to the meeting will be available upon request.

Dated: January 7, 1998

__________________________
Samuel H. Wilson, M.D.
Deputy Director
National Toxicology Program

[Billing Code 4140-01-P]