The Guidelines for Neurotoxicity Risk Assessment continue the guidelines development process initiated in 1984. These Guidelines set forth principles and procedures to guide EPA scientists in evaluating environmental contaminants that may pose neurotoxic risks, and inform Agency decision makers and the public about these procedures. These Guidelines are the Agency's first statement on setting principles and procedures to guide EPA scientists in conducting neurotoxicity risk assessments. These Guidelines have been developed by a cross-Agency Technical Panel organized by the Risk Assessment Forum.
A link between human exposure to some chemical substances and neurotoxicity has been firmly established. The Guidelines emphasize that risk assessment will be conducted on a case-by-case basis. They stress that information will be fully presented in Agency risk assessment documents and that Agency scientists will identify the strengths and weaknesses of each assessment by describing uncertainties, assumptions, and limitations, as well as the scientific basis and rationale for each assessment. The Guidelines bridge gaps in risk assessment methodology and data by identifying these gaps and the importance of the missing information to the risk assessment process, encouraging research and analysis that will lead to new risk assessment methods and data. The Guidelines specifically note the special vulnerability of the nervous system of infants and children to environmentally relevant chemicals and provide guidance for the interpretation of data from developmental and reproductive studies involving assessment of nervous system structure and function.
The Guidelines help develop a sound scientific basis for neurotoxicity risk assessment and promote consistency in the Agency's assessment of nervous system effects. As in the case of earlier risk assessment guidelines, the principles articulated in these Guidelines will be incorporated into program-specific guidance and procedures. Risk assessment guidelines are not regulations and do not impose legally binding requirements on EPA, states, or the regulated community.