Guidelines for Neurotoxicity Risk Assessment

The U.S. Environmental Protection Agency (EPA) is today publishing in final form a document entitled Guidelines for Neurotoxicity Risk Assessment (hereafter ``Guidelines''). These Guidelines were developed as part of an interoffice guidelines development program by a Technical Panel of the Risk Assessment Forum. The Panel was composed of scientists from throughout the Agency, and selected drafts were peer-reviewed internally and by experts from universities, environmental groups, industry, and other governmental agencies. The Guidelines are based, in part, on recommendations derived from various scientific meetings and workshops on neurotoxicology, from public comments, and from recommendations of the Science Advisory Board. An earlier draft underwent external peer review in a workshop held on June 2-3, 1992, and received internal review by the Risk Assessment Forum. The Risk Assessment Subcommittee of the Committee on the Environment and Natural Resources of Office of Science and Technology Policy reviewed the proposed Guidelines during a meeting held on August 15, 1995. The Guidelines were revised and proposed for public comment on October 4, 1995 (60 FR 52032-52056). The proposed Guidelines were reviewed by the Science Advisory Board on July 18, 1996. EPA appreciates the efforts of all participants in the process, and has tried to address their recommendations in these Guidelines. This notice describes the scientific basis for concern about exposure to agents that cause neurotoxicity, outlines the general process for assessing potential risk to humans because of environmental contaminants, and addresses Science Advisory Board and public comments on the 1995 Proposed Guidelines for Neurotoxicity Risk Assessment (60 FR:52032-52056). These Guidelines are intended to guide Agency evaluation of agents that are suspected to cause neurotoxicity, in line with the policies and procedures established in the statutes administered by the Agency.