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Overview and Recommendations
A peer review panel meeting to evaluate the validation status of a
revised Up-and-Down Procedure (UDP) for acute oral toxicity was held in July
2000 (announced in the Federal Register 65 FR 35109, May 31, 2000),
and was followed by a teleconference in August 2001. The Panel endorsed revisions to further reduce the number of
animals needed to estimate a median lethal dose (LD50) necessary for hazard
classification and labeling of chemicals and products. In agreement with the peer review panel, the ICCVAM
recommended that the revised UDP test guideline should: (1) replace the Organisation for Economic Cooperation
and Development (OECD) UDP test guideline from 1998 and (2)
be used instead of the conventional LD50 test to determine the acute oral toxicity hazard of chemicals. ICCVAM
concluded that use of the revised UDP test guideline will reduce and refine animal use.
Results of the
peer review were used to prepare a revised OECD Test Guideline and
Guidance Document on Acute Toxicity that were adopted in December
2001. ICCVAM's recommendations to use the revised UDP in place
of the conventional LD50 test were transmitted to Federal
agencies on March 21, 2003. Agency responses were made available to the
public on March 10, 2004.
ICCVAM Test Method Recommendations on Acute Oral Toxicity
ICCVAM Test Method Recommendations:
Appendix A 
of Peer Review Evaluation Report
Complete Peer Review Evaluation Report
(NIH 02-4501 - November 2001)
Transmittal of ICCVAM Recommendations and Agency Responses
Transmittal Letter on Acute Systemic Toxicity
from Dr. Kenneth Olden to the Agency Heads (March 21, 2003)
Agency Responses:
- National Institute of Environmental Health Sciences (NIEHS)
Letter from Dr. Olden to the NIEHS Record (September 9, 2003)
- Agency for Toxic Substances and Disease Registry (ATSDR)
Response from Henry Falk, Assistant Administrator (August 25, 2003)
- Consumer Products Safety Commission (CPSC)
Response from Todd Stevenson, Office of the Secretary (September 9, 2003)
Commission Vote and Acceptance
(on CPSC website)
Briefing Package
(on CPSC website)
- Environmental Protection Agency (EPA)
Response from Joseph Merenda, Director, Office of Science Coordination and Policy (December 2, 2003)
- Food and Drug Administration (FDA)
Response from Mark McClellan, Commissioner of Food and Drugs (September 9, 2003)
- National Cancer Institute (NCI)
Response from Andrew von Eschenbach, Director (August 25, 2003)
- National Institutes of Health (NIH)
Response from Elias Zerhouni, Director (September 5, 2003) [PDF]
- National Institute for Occupational Safety and Health (NIOSH)
Response from John Howard, Director (September 30, 2003)
- National Library of Medicine (NLM)
Response from Donald Lindberg, Director (August 8, 2003)
- Occupational Safety and Health Administration (OSHA)
Response from John Henshaw, Office of the Assistant Secretary
- U.S. Department of Agriculture
Response from Bobby Acord, Administrator, Animal and Plant Health Inspection Service (September 22, 2003)
- U.S. Department of Defense
Response from Charles Holland, Deputy Undersecretary of Defense for Science and Technology
(September 30, 2003)
- U.S. Department of Energy
Response from Marvin Frazier, Director, Life Sciences Division (September 24, 2003)
- U.S. Department of the Interior
Response from Charles Groat, Director, U.S. Geological Survey (August 27, 2003)
- U.S. Department of Transportation
Response from Samuel Bonasso, Acting Director, Research and Special Programs Administration (May 7, 2003)
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