Regulatory Guidelines

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• ICH Guidelines
  The tripartite harmonised ICH guideline was finalised in June 1993. These guidelines give guidance on tests for reproductive toxicity in order to better reflect human exposure to medicinal products and allow more specific identification of stages at risk. These files are posted on the Website of the International Federation of Pharmaceutical Manufacturers Associations.

• OECD Guidelines
  This OECD site lists the current OECD guidelines for the Testing of Chemicals. Current guideline texts are sold on CD ROM or via paper copies which can be ordered from this Website. Drafts of new or revised guidelines are available for downloading.

• California Proposition 65 Documents
  This site contains documents from the California EPA including the California List of Chemicals Known to the State to Cause Cancer or Reproductive Toxicity.

• U.S. EPA Guidelines for Reproductive Toxicity Risk Assessment

  or alternately:

• Pestlaw Review of the U.S. EPA Guidelines for Reproductive Toxicity Risk Assessment
  The Guidelines for Reproductive Toxicity Risk Assessment discuss the scientific basis for concern about exposure to agents that cause reproductive toxicity and describe the principles and procedures to be followed in conducting risk assessments for reproductive toxicity. They include the female (non-pregnant and pregnant) and male reproductive systems.

• U.S. EPA Food Quality Protection Act of 1996
  On August 3, 1996 the Food Quality Protection Act (FQPA) of 1996 became law. Among other things, this law is intended to make sure that sensitive subpopulations, especially infants and children, will not become ill from consuming pesticide-treated foods. The following links provide information on 1) the inclusion of an additional 10X safety factor for children (above and beyond the 10X factor traditionally assigned to intraspecies variation) in EPA risk assessments for agricultural chemicals, 2) the home page for the EPA's EDSTAC advisory committee which was charged with developing an endocrine disrupters screening and testing program, and 3) the home page for the parallel effort of the OECD to harmonize guidelines for testing chemicals for the potential to cause endocrine disruption.

  • Addressing FQPA Safety Factors Affecting Children ("10-Fold" Safety Factor) and Discussion of In Utero Exposure for Carcinogenicity Studies
  • EPA's Endocrine Disrupter Screening and Testing Advisory Committee
  • OECD Chemicals Programme Co-ordination of Endocrine Disrupters Assessment Activities
    
    
• U.S. National Toxicology Program (NTP) Testing Information and Study Results
  The NTP conducts reproductive and developmental studies of commercial materials suspected of posing a high risk of these effects to the general public. Summaries of the results from NTP studies can be found at this site.