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U.S. and international regulatory agencies require toxicological testing to protect
humans, animals, and the environment from hazards that may be posed by chemicals or products.
The links below lead to more information about U.S. Federal and international laws, regulations,
and guidelines relevant to regulatory toxicology testing.
Note: Some links on this page lead to pages outside the NICEATM-ICCVAM website. These links are for the
convenience of visitors to our site. NICEATM-ICCVAM is not responsible for
the availability or content of these external sites, nor do we endorse, warrant or guarantee the
products, services or information described or offered at these other sites.
General U.S. Federal Regulations and Rules
U.S. Consumer Product Safety Commission (CPSC) Regulations (on CPSC Website)
U.S. Code of Federal Regulations (CFR): 16 CFR Part 1500, Federal Hazardous Substances Act - Hazardous Substances and Articles: Administration and Enforcement
Section 1500.3: Definitions - includes definitions of "hazardous substance", "toxic", "corrosive", "irritant", etc.
[PDF]
U.S. Department of Transportation (DOT) Rules and Regulations (on DOT Website)
49 CFR Part 172 Appendix C, General Requirements for Shipments and Packagings
Subpart A: includes definitions of hazardous materials for transportation purposes, and hazard classes [PDF]
U.S. EPA Regulations (on EPA Website)
FDA Redbook - Guidance for Industry and Other Stakeholders: Toxicological Principles for the Safety
Assessment of Food Ingredients
Relevant U.S. Federal Laws: Available on the Government Printing Office Website
Public Law 104-170 - 1996 Food Quality Protection Act
Public Law 104-182 - 1996 Safe Drinking Water Amendments
International Guidances and Documents
Organisation for Economic Co-operation and Development (OECD) Guidelines for the Testing of Chemicals:
List of Health Effects Test Guidelines (on SourceOECD Website)
OECD Test Guidelines and Guidance Documents (available on NICEATM-ICCVAM website)
ICCVAM Comments on OECD Draft Test Guidelines and Guidance Documents
European Centre for the Validation of Alternative Methods:
ECVAM Scientific Advisory Committee statements on alternative methods issued at the 26th meeting of ECVAM (April 2007)
[PDF]
United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS)
(revised 2005) [PDF]
TSAR: Tracking System for Alternative Test Methods Review, Validation and
Approval in the Context of EU Regulations on Chemicals
Links to Method-Specific Guidelines, Regulations and Laws
ICCVAM Guidelines and Processes
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