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Recommendations and Agency Responses
 Environmental Health Perspectives Article (September 2008):
"Ocular Safety Assays Accepted" [PDF]
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. 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, and to the responses received from the agency heads, can be found below. The ICCVAM recommendations
were accepted by the Federal agencies,
and in vitro test methods may now be used
instead of conventional tests for certain regulatory testing purposes.
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. Several future studies were also recommended by ICCVAM which have
subsequently been carried forward as ICCVAM-nominated activities.
- 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 (April 25, 2008) [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]
- Response from Mr. Foulke (received May 13, 2008) [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]
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