National Toxicology Program

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In September 2010, ICCVAM made recommendations on alternative testing methods and strategies for assessing the ocular hazard potential of chemicals and products to U.S. Federal agencies. These recommendations, contained in ICCVAM Test Method Evaluation Reports, are summarized below.

• ICCVAM recommended that pain management procedures should always be used to avoid or minimize pain and distress when it is determined necessary to conduct the Draize rabbit eye test for regulatory safety assessments. These procedures include the routine use of topical anesthetics, systemic analgesics, and humane endpoints.
  Read the ICCVAM Test Method Evaluation Report: Recommendations for Routine Use of Topical Anesthetics, Systemic Analgesics, and Humane Endpoints to Avoid or Minimize Pain and Distress in Ocular Safety Testing


• ICCVAM recommended that the Cytosensor microphysiometer (CM) test method can be used as a screening test to identify some types of substances that may cause permanent or severe eye injuries. ICCVAM also recommended that the CM can be used to determine if a limited range of substances will not cause sufficient injury to require hazard labeling for eye irritation. ICCVAM evaluated four other in vitro test methods for their usefulness and limitations for identifying substances with the potential to cause reversible and nonsevere ocular injuries and substances that do not require ocular hazard labeling. ICCVAM concluded that the performance of these methods must be improved before they can be used in regulatory safety testing to classify such substances. The report includes ICCVAM recommendations for future studies that could potentially improve these test methods.
  Read the ICCVAM Test Method Evaluation Report: Current Validation Status of In Vitro Test Methods Proposed for Identifying Eye Injury Hazard Potential of Chemicals and Products


• ICCVAM recommended further studies to characterize the usefulness and limitations of a proposed in vitro testing strategy that uses three in vitro test methods to assess the eye irritation potential of antimicrobial cleaning products.
  Read the ICCVAM Test Method Evaluation Report: ICCVAM Test Method Evaluation Report: Current Validation Status of a Proposed In Vitro Testing Strategy for U.S. Environmental Protection Agency Ocular Hazard Classification and Labeling of Antimicrobial Cleaning Products


• ICCVAM recommended that a proposed low volume rabbit eye test should not used for regulatory testing due to performance issues when compared to the current standard rabbit eye test
  Read the ICCVAM Test Method Evaluation Report: Recommendation to Discontinue Use of the Low Volume Eye Test for Ocular Safety Testing

The ICCVAM recommendations were communicated to Federal agencies in letters from Dr. Linda Birnbaum, Director, NIEHS. These letters and responses received from Federal agencies are available below.

• National Institutes of Environmental Health Sciences (NIEHS)
  
  • Letter from Linda Birnbaum, Ph.D., DABT, ATS, Director, NIEHS, to the ICCVAM Committee (January 14, 2011) [PDF]


• Agency for Toxic Substances and Disease Registry (ATSDR)
  
  • Letter from Dr. Birnbaum to Thomas R. Frieden, M.D., M.P.H., Administrator, ATSDR [PDF]
  • Response from Dr. Frieden (received February 11, 2011) [PDF]


• Consumer Product Safety Commission (CPSC)
  
  • Letter from Dr. Birnbaum to Inez Moore Tenenbaum, Chairman, CPSC [PDF]
  • Response from Todd Stevenson, Office of the Secretary (received March 11, 2011) [PDF]


• Environmental Protection Agency (EPA)
  
  • Letter from Dr. Birnbaum to Lisa P. Jackson, Administrator, EPA [PDF]
  • Response from John Fowle, Ph.D., DABT, Office of Pesticide Programs (received February 28, 2011) [PDF]


• Food and Drug Administration (FDA)
  
  • Letter from Dr. Birnbaum to Margaret Hamburg, M.D., Commissioner [PDF]
  • Response from Jesse L. Goodman, M.D., M.P.H. , Chief Scientist and Deputy Commissioner for Science and Public Health (received March 2, 2011) [PDF]


• National Cancer Institute (NCI)
  
  • Letter from Dr. Birnbaum to Harold E. Varmus, M.D., Director, NCI [PDF]
  • Response from Dr. Varmus (received February 8, 2011) [PDF]


• National Institutes of Health (NIH)
  
  • Letter from Dr. Birnbaum to Francis S. Collins, M.D., Ph.D., Director, NIH [PDF]
  • Response from Dr. Collins (received November 29, 2010) [PDF]


• National Institute for Occupational Safety and Health (NIOSH)
  
  • Letter from Dr. Birnbaum to John Howard, M.D., Director, NIOSH [PDF]
  • Response from Dr. Howard (received December 16, 2010) [PDF]


• National Library of Medicine (NLM)
  
  • Letter from Dr. Birnbaum to Donald A.B. Lindberg, M.D., Director, NLM [PDF]
  • Response from Dr. Lindberg (received January 13, 2011) [PDF]


• Occupational Safety and Health Administration (OSHA)
  
  • Letter from Dr. Birnbaum to David Michaels, Ph.D., M.P.H., Assistant Secretary of Labor for Occupational Safety and Health, OSHA [PDF]
  • Response from Dr. Michaels (received November 29, 2010) [PDF]


• U.S. Department of Agriculture
  
  • Letter from Dr. Birnbaum to Tom Vilsack, Secretary of Agriculture [PDF]
  • Response from Jose Diez, Associate Deputy Administrator, Veterinary Services (received October 7, 2010) [PDF]


• U.S. Department of Defense
  
  • Letter from Dr. Birnbaum to Robert M. Gates, Ph.D., Secretary of Defense [PDF]
  • Response from David Honey, Director, Research Directorate (received December 15, 2010) [PDF]


• U.S. Department of Energy
  
  • Letter from Dr. Birnbaum to Steven Chu, Secretary of Energy [PDF]
  • Response from Dr. J. Michael Kuperberg, Office of Biological and Environmental Research (received February 28, 2011) [PDF]


• U.S. Department of the Interior
  
  • Letter from Dr. Birnbaum to Ken Salazar, Secretary of the Interior [PDF]
  • Response from David Russ, Regional Executive, Northeast Area, U.S. Geological Survey (received January 7, 2011) [PDF]


• U.S. Department of Transportation
  
  • Letter from Dr. Birnbaum to Ray LaHood, Secretary of Transportation [PDF]
  • Response from Cynthia Quarterman, Pipeline and Hazardous Materials Safety Administration (received January 24, 2012) [PDF]