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Testing Regulations and Guidelines
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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 ICCVAM website. These links are for the convenience of visitors to our site. 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]
  • Revisions to 49 CFR Parts 171-180 to maintain alignment with international standards: Final rule announced in Federal Register, January 29, 2011 [PDF - HTML]
U.S. EPA Regulations (on EPA Website)

FDA Redbook - Guidance for Industry and Other Stakeholders: Toxicological Principles for the Safety Assessment of Food Ingredients

Occupational Safety and Health Administration
Proposed rule on hazard communication: Federal Register, Sept. 30, 2009
View complete Proposed Rule [PDF - HTML]
(Note: PDF is a large document and may take a few moments to open.)

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 OECD iLibrary Website)
OECD Test Guidelines and Guidance Documents (available on 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) (third revised edition, 2009 — Available on UNECE website)

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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