Recommendations and Agency Responses

On October 25, 2007, ICCVAM forwarded its first recommendations for the use of in vitro methods for ocular safety testing to Federal agencies. ICCVAM recommended that the four alternative test methods included in their evaluation should be considered before using animals for ocular safety testing, and that the methods should be used when determined appropriate.

Two of the methods, the Bovine Corneal Opacity and Permeability (BCOP) assay and the Isolated Chicken Eye (ICE) assay, are considered to have sufficient performance to substantiate their use for regulatory hazard classification testing of some types of substances. The two other methods, the Isolated Rabbit Eye (IRE) assay and the Hen’s Egg Test – Chorioallantoic Membrane (HET-CAM) assay, are not considered to currently have sufficient performance and/or sufficient data to substantiate their use for regulatory hazard classification purposes, but may have applicability for other uses. ICCVAM recommends that the test methods should be used in a tiered-testing strategy, where positive substances can be classified as ocular corrosives or severe irritants without the need for animal testing.

ICCVAM's recommendations are provided in the report, ICCVAM Test Method Evaluation Report: In Vitro Test Methods for Identifying Ocular Corrosives and Severe Irritants (NIH Publication No. 07-4517). The report includes ICCVAM’s general recommendations for all of the methods, and specific recommendations for each of the four test methods.

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]
  • Response from Dr. Gerberding (received April 7, 2008) [PDF]


• Consumer Products Safety Commission (CPSC)
  
  • Letter from Dr. Wilson to Nancy A. Nord, Ph.D., Acting Chairwoman, CPSC [PDF]
  • Response from Todd Stevenson on behalf of Chairwoman Nord (received February 14, 2008) [PDF]


• Environmental Protection Agency (EPA)
  
  • Letter from Dr. Wilson to Stephen L. Johnson, Administrator, EPA [PDF]
  • Response from Elizabeth Resek on behalf of Mr. Johnson (received April 25, 2008) [PDF]


• Food and Drug Administration (FDA)
  
  • Letter from Dr. Wilson to Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs, FDA [PDF]
  • Response from Dr. Norris Alderson on behalf of Dr. von Eschenbach (received April 24, 2008) [PDF]


• National Cancer Institute (NCI)
  
  • Letter from Dr. Wilson to John E. Niederhuber, M.D., Director, NCI [PDF]
  • Response from Dr. Niederhuber (received February 29, 2008) [PDF]


• National Institute of Environmental Health Sciences (NIEHS)
  
  • Letter from Dr. Wilson to NIEHS file [PDF]

• National Institutes of Health (NIH)
  
  • Letter from Dr. Wilson to Elias A. Zerhouni, M.D., Director, NIH [PDF]
  • Response from Dr. Zerhouni (received April 29, 2008) [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]
  • Response from Dr. Howard (received February 14, 2008) [PDF]


• National Library of Medicine (NLM)
  
  • Letter from Dr. Wilson to Donald A.B. Lindberg, M.D., Director, NLM [PDF]
  • Response from Dr. Lindberg (received April 7, 2008) [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]
  • Response from Robert Foster on behalf of Secretary Gates (received April 14, 2008) [PDF]


• U.S. Department of Energy
  
  • Letter from Dr. Wilson to Samuel W. Bodman, Secretary of Energy [PDF]
  • Response from Dr. Jerry Elwood on behalf of Secretary Bodman (received February 20, 2008) [PDF]


• U.S. Department of the Interior
  
  • Letter from Dr. Wilson to Dirk Kempthorne, Secretary of the Interior [PDF]
  • Response from Susan Haseltine on behalf of Secretary Kempthorne (received April 23, 2008) [PDF]


• U.S. Department of Transportation
  
  • Letter from Dr. Wilson to Mary E. Peters, Secretary of Transportation [PDF]
  • Response from Carl T. Johnson on behalf of Secretary Peters (received February 15, 2008) [PDF]