Recommendations and Agency Responses

On February 28, 2008, ICCVAM forwarded recommendations on the use of in vitro test methods for estimating starting doses for acute oral systemic toxicity tests. ICCVAM recommended that the in vitro basal cytotoxicity test methods tested in the joint ICCVAM/ECVAM validation study should be considered before using animals for acute oral toxicity testing, and that the methods should be used where determined appropriate. Data from the test methods should be used in a weight-of-evidence approach for determining starting doses for in vivo studies. Using these in vitro methods where appropriate is expected to reduce the number of animals required for each toxicity test. ICCVAM concluded that the in vitro test methods are not sufficiently accurate to replace animals for regulatory hazard classification purposes.

ICCVAM's recommendations are provided in the report, ICCVAM Test Method Evaluation Report: In Vitro Cytotoxicity Test Methods for Estimating Starting Doses for Acute Oral Systemic Toxicity Tests (NIH Publication No. 07-4519).

A Federal Register notice announced availability of the ICCVAM Test Method Evaluation Report and final Background Review Document, and transmittal of ICCVAM test method recommendations to Federal agencies (Vol. 73, No. 58, pp. 15757-15758, March 25, 2008).

The recommendations were communicated to Federal agencies in letters from Dr. Samuel H. Wilson, Acting Director, NIEHS, to each agency head. Links to these letters can be found below. Responses from the agency heads will be posted as they are received.

• Agency for Toxic Substances and Disease Registry (ASTDR)
  
  • Letter from Dr. Wilson to Julie L. Gerberding, M.D., M.P.H., Administrator, ASTDR [PDF]


• Consumer Products Safety Commission (CPSC)
  
  • Letter from Dr. Wilson to Nancy A. Nord, Ph.D., Acting Chairwoman, CPSC [PDF]


• Environmental Protection Agency (EPA)
  
  • Letter from Dr. Wilson to Stephen L. Johnson, Administrator, EPA [PDF]


• Food and Drug Administration (FDA)
  
  • Letter from Dr. Wilson to Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs, FDA [PDF]


• National Cancer Institute (NCI)
  
  • Letter from Dr. Wilson to John E. Niederhuber, M.D., Director, NCI [PDF]


• National Institutes of Health (NIH)
  
  • Letter from Dr. Wilson to Elias A. Zerhouni, M.D., Director, NIH [PDF]


• National Institute for Occupational Safety and Health (NIOSH)
  
  • Letter from Dr. Wilson to John Howard, M.D., M.P.H., J.D., LL.M., Director, NIOSH [PDF]


• National Library of Medicine (NLM)
  
  • Letter from Dr. Wilson to Donald A.B. Lindberg, M.D., Director, NLM [PDF]


• Occupational Safety and Health Administration (OSHA)
  
  • Letter from Dr. Wilson to Edwin G. Foulke, Jr., Assistant Secretary, OSHA [PDF]


• U.S. Department of Agriculture
  
  • Letter from Dr. Wilson to Mike Johanns, Secretary of Agriculture [PDF]
  • Response from Kevin Shea on behalf of Cindy J. Smith, Administrator (received April 10, 2008) [PDF]


• U.S. Department of Defense
  
  • Letter from Dr. Wilson to Robert M. Gates, Ph.D., Secretary of Defense [PDF]


• U.S. Department of Energy
  
  • Letter from Dr. Wilson to Samuel W. Bodman, Secretary of Energy [PDF]


• U.S. Department of the Interior
  
  • Letter from Dr. Wilson to Dirk Kempthorne, Secretary of the Interior [PDF]


• U.S. Department of Transportation
  
  • Letter from Dr. Wilson to Mary E. Peters, Secretary of Transportation [PDF]