1986 EPA Risk Assessment 

 Guidelines 



In September 1986, EPA published final guidelines for assessing health 

 risks related to environmental pollutants. The guidelines are in five 

 parts (U.S. EPA 1986a-e): 



• Carcinogen Risk Assessment 



• Exposure Assessment 



• Mutagenicity Risk Assessment 



• Health Assessment of Suspect Developmental Toxicants 



• Health Risk Assessment of Chemical Mixtures. 



These guidelines pertain to health risk assessment for all environmen- 

 tal exposures [e.g., air exposure; ingestion of water or environmentally 

 contaminated foods; and other direct human contact with con- 

 taminated soils, water, sediments, or other materials ( Federal Register 

 51 No. 185, p. 34049)]. The guidelines were developed through a 2-year 

 process that included contributions and review by the larger scientific 

 community; full Agency consideration of public comments in response 

 to proposed guidelines on November 23, 1984; and review and approval 

 by the EPA Science Advisory Board ( Federal Register 51 No. 185, p. 

 33992). 



While U.S. EPA's risk assessment guidelines (1986a-e) apply to all 

 exposure routes, they do not contain detailed information on applica- 

 tion of the basic principles for each exposure route. This guidance 

 manual provides such step-by-step assistance for assessing health risks 

 from exposure through consumption of chemically contaminated 

 aquatic organisms. The guidance is applicable to freshwater, brackish 

 water, and saltwater fish and shellfish. The risk assessment methods 

 recommended in this manual are consistent with the principles set 

 forth in U.S. EPA (1986a-e). 



As described in a recent policy statement by EPA's Risk Assessment 

 Council and FDA (see Appendix A), FDA, EPA, and the states have 

 somewhat differing roles in assessing and managing risks from fish 

 consumption. FDA has the lead responsibility for risk management of 

 foods in interstate commerce or other products of national importance 

 including fish and shellfish. For some chemicals in foods (specifically 

 pesticides), EPA assists FDA in performing the technical evaluations 

 that support risk management decisions. The federal government is not 

 directly responsible for managing risks to individuals who consume 

 unusually large amounts of foods not in interstate commerce or foods 

 harvested from locally contaminated areas (e.g., some recreational 

 fisheries). Environmental agencies and health departments at the state 

 and local levels have responsibility for protecting consumers of local 

 fisheries products. These agencies are responsible for issuing public 

 health advisories and regulations related to local fisheries. 



Regulatory Roles and 

 Coordination of Federal, State, 

 and Local Agencies 



