National Toxicology Program

FOR RELEASE 11/16/95

contact - Sandra Lange, NTP
(919) 541-0530
or Bill Grigg, NIEHS
(919) 541-2605

The National Toxicology Program/National Institute of Environmental Health Sciences is pleased to send you this information which might be of interest to your readers

Announcement

Fourteen federal agencies today join the National Institute of Environmental Health Sciences in releasing a draft report on the criteria for the development and acceptance of new toxicological test methods by government agencies. The report encourages the development and use of new and revised test methods, including those referred to as alternative methods, that will provide for improved protection of human health and the environment. Toxicological test methods are used to assess the safety or potential hazard of various products and materials used by the public, including pharmaceuticals, vaccines, cosmetics, personal care products and contaminants found in our food, air and water.

Scientists are developing test methods that incorporate new scientific and technological advances according to the draft report, which was drafted by the ad hoc Interagency Coordinating Committee on the Validation of Alternative Methods.

Testing methods are being developed that can be conducted in less time and with less expense. Many of these provide for improved animal welfare, reduce the number of animals required, or do not require the use of animals.

The agencies that prepared the report sought to make it applicable to all proposed toxicological testing methods for human health and ecological effects, including those determined to be alternative methods.

"By incorporating into new test methods the advances in our scientific understanding of mechanisms by which chemicals exert their toxicity, we can improve our ability to predict the adverse health effects of such substances," said William Stokes, Ph.D., of the NIEHS, and co-chair of the interagency committee that prepared the report and organized the workshop. "Once new tests are developed, acceptance of the validated test methods within the regulatory agencies themselves is key to moving forward in this effort, and the draft report reflects the committee members'* recognition that interagency cooperation and uniform principles are necessary. "In fact," Dr. Stokes continued, "to insure the use of new improved tests on a worldwide basis it is critical to achieve international harmonization, and the final report will also serve as a principal reference for international adoption through the Organization of Economic Co-operation and Development." To provide an open forum for comment and discussion on the report, the National Toxicology Program has scheduled a "Workshop on Validation and Regulatory Acceptance of Alternative Toxicological Test Methods" December 11-12, 1995, at the Crystal Gateway Marriott Hotel in Arlington, Virginia. Comments will be sought from invited panelists and workshop registrants. Breakout groups will develop recommendations in three areas: validation criteria; regulatory acceptance criteria and processes; and proposals for future directions/strategies for implementation. The meeting is open to the public.

A final report will be produced in subsequent days. To receive registration information for the workshop and/or a copy of the draft report, please contact the NTP Liaison Office, P.O. Box 12233, MD: A3-01, Research Triangle Park, NC 27709; telephone 919 541 0530; fax 919 541 0295. Written comments may be sent to: Dr. William Stokes, NIEHS, P.O. Box 12233, Research Triangle Park, NC 27709.

Attached: Draft Report
               Registration Packet

*Agencies participating in the development of the report and the organization of the workshop are:

Agency for Toxic Substances and Disease Registry (ATSDR)
Consumer Product Safety Commission (CPSC)
Department of Defense (DOD)
Department of Energy (DOE)
Department of the Interior (DOI)
Department of Transportation (DOT)
Environmental Protection Agency (EPA)
Food and Drug Administration (FDA)
National Cancer Institute (NCI)
National Institute for Occupational Safety and Health (NIOSH)
National Institute of Environmental Health Sciences (NIEHS)
National Institutes of Health (NIH)
National Library of Medicine (NLM)
Occupational Safety and Health Administration (OSHA)
U.S. Department of Agriculture (USDA)