NIEHS: Program in alternative test method research, development and validation

JJ Heindel¹, WS Stokes¹, C Portier¹

1. NIEHS, NICEATM, RTP, USA

The NIEHS has developed several programs to promote basic research and to translate these discoveries into alternative test methods by promoting their development, validation and acceptance by regulatory agencies. The NIEHS Division of Extramural Research and Training(DERT) supports investigator-initiated basic research that can lead to the development of alternative test methods as well as the actual development of alternative toxicity tests via its grants program. It also supports the development and prevalidation of alternative toxicity tests via its small business innovation research (SBIR) grants and contracts and its small business technology transfer(STTR) program that specifically stimulates coordination between university researchers and small businesses. The NTP works to develop more efficient mechanism-based testing strategies such as genetically engineered models and the implementation of microchip based gene expression technologies for use in improving in vivo assays and development of in vitro assays. It also supports workshops to promote the development of alternative toxicity tests. The NTP Interagency Center for the Evaluation of Alternative Test Methods (NICEATM), in coordination with the Interagency Coordinating Committee for the Validation of Alternative Test Methods (ICCVAM), coordinates and directs the independent validation studies necessary to evaluate the scientific validity of alternative test methods for their proposed regulatory application. ICCVAM then forwards the NICEATM validation recommendations to the appropriate federal agencies for consideration of acceptance and incorporation in test guidelines, regulations and policies. DERT,the NTP and NICEATM have resources available to both fund and promote their particular aspects of the NIEHS alternative test development and validation program.

Date: Monday, August 22, 2005, 15.00 - 17.00 h, Estrel Hall A

3.2 Workshop: Establishing the 3Rs Principle around the World