Regulatory Research Agencies


Last updated: December 6, 2007

The Agency for Toxic Substances and Disease Registry (ATSDR) was created pursuant to the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, commonly known as the “Superfund” Act, which established a congressional mandate to “remove or clean up abandoned and inactive hazardous waste sites and to provide federal assistance in toxic emergencies.” Based at the Centers for Disease Control and Prevention (CDC), ATSDR is the lead agency for implementing the health-related provisions of the Superfund Act.

ATSDR’s key responsibilities in the context of regulatory toxicology include health consultations concerning specific hazardous substances, establishment and maintenance of toxicological databases, applied research and information development in support of public health assessments, and the creation and maintenance of approximately 300 toxicological profiles for hazardous substances found at more than 1,200 Superfund priority sites, as well as federal sites belonging to the Department of Defense and Department of Energy. ATSDR is specifically authorized to assist the US Environmental Protection Agency (EPA) in “determining which substances should be regulated and the levels at which substances may pose a threat to human health.”


Animal Use Activities

One of ATSDR’s key goals is to “[d]etermine human health effects associated with exposure to Superfund-related priority hazardous substances.” This function is predominantly accomplished by means of comprehensive reviews of peer reviewed and other pertinent scientific literature, the results of which are summarized in ATSDR toxicological profiles. However, in the case of certain “priority hazardous substances” that are deemed to possess insufficient data for ATSDR regulatory purposes, the Agency has established a Substance-Specific Applied Research Program as a means to fill gaps in the toxicological database. Since ATSDR itself lacks the authority to compel corporations to generate new toxicological data, it must rely on other agencies to promulgate test rules (e.g., EPA, under the Toxic Substances Control Act) and/or avail itself of other federal processes for the nomination of chemicals for toxicological evaluation (e.g., through the National Toxicology Program Interagency Committee for Chemical Evaluation and Coordination). Both scenarios have the potential to trigger new animal testing.


Alternatives Policies & Actions

ATSDR’s current involvement in 3Rs activities appears to be limited to its membership in the US Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM).