Guidelines for Neurotoxicity Risk Assessment

policy and approved for publication. Mention of trade names or commercial products does not constitute endorsement or recommendation for use. SUMMARY: 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 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 (FR 60:52032-52056). 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. (2) 3½" high-density computer diskettes in WordPerfect format will be available from ORD regulatory agencies establish " inference guidelines " to promote consistency and technical quality in risk assessment, and to ensure that the risk assessment process is maintained as a scientific effort separate from risk management. A task force within EPA accepted that recommendation and requested that Agency scientists begin to develop such guidelines. In 1984, EPA scientists began work on risk assessment guidelines for carcinogenicity, mutagenicity, suspect developmental toxicants, chemical mixtures, and exposure assessment. Following extensive scientific and public review, these first five guidelines were issued on September 24, 1986 (51 FR 33992-34054). Since 1986, additional risk assessment guidelines have been proposed, revised, reproposed, and finalized. These guidelines continue the process initiated in 1984. As with other EPA guidelines (e.18011), EPA will revisit these guidelines as experience and scientific consensus evolve. These Guidelines set forth principles and procedures to guide EPA scientists in the conduct of Agency risk assessments and to inform Agency …