Applicability of this Guidance 



Manual 



Section 408 of the Federal Food, Drug and Cosmetic Act authorizes 

 EPA to establish tolerances (maximum permissible concentrations) or 

 action levels for pesticides in raw agricultural commodities, including 

 fish and shellfish. FDA is responsible for setting action levels and 

 tolerances for concentrations of other chemicals in fish, shellfish, or 

 other foods. FDA also has responsibiUty for enforcing the guidelines 

 developed by both EPA and FDA, which may involve removal of 

 adulterated foods (i.e., foods contaminated in excess of an action level 

 or tolerance) from interstate commerce. An action level is the mini- 

 mum concentration of chemical in food that may be cause for FDA to 

 take enforcement action. An action level is promulgated when a 

 tolerance or exemption authorizing the presence of a substance in food 

 has not been established or has been revoked. Action levels are estab- 

 lished and revised according to criteria in the Code of Federal Regula- 

 tions (21 CFR 109 and 509). An action level is revoked when a formal 

 tolerance for the same substance is established. In developing action 

 levels and tolerances, FDA and EPA take into account both the 

 magnitude of the health risks to consumers and the economic impacts 

 of banning food from a particular source. FDA and EPA set hmits on 

 chemical contaminants in fisheries products to achieve an optimal 

 balance of health protection and minimization of economic impacts on 

 food-producing and harvesting industries (e.g., commercial fisheries 

 and fish marketers). 



All action levels and tolerances to date have been developed to provide 

 national protection rather than on a regional or local basis. These 

 national standards protect the average consumer of a food product, 

 assuming the consumer eats foods from a typical "national market 

 basket" (U.S. FDA 1984). Action levels and tolerances are not in- 

 tended to protect certain local subpopulations, such as individuals 

 whose consumption of fish and shellfish from a given water body may 

 exceed the national average (Appendix A). 



EPA and FDA recognized the need to coordinate their activities and 

 guidance in assessing health risks from contaminated fish and shellfish. 

 The Standing Committee on Fish Contamination has been formed to 

 resolve potential differences in risk assessment calculations for specific 

 chemicals or specific exposure situations (Appendix A). The 

 EPA/FDA policy statement in Appendix A provides further discussion 

 of the evolving coordination between EPA, FDA, other federal agen- 

 cies, and the states. The EPA/FDA policy statement also describes 

 procedures whereby states can obtain further information or assistance 

 pertaining to risk management in specific local situations. 



EPA's nonregulatory technical guidance, including this manual and the 

 1986 final guidelines for risk assessment (U.S. EPA 1986a-e), is avail- 

 able to state and local governments responsible for fisheries manage- 

 ment, environmental protection, and public health. This manual is 

 intended for use as a handbook by those state and local agencies that 

 are responsible for assessing potential risks from local fish or shellfish 

 consumption. For example, it maybe useful in assessing risks to highly 

 exposed regional populations (e.g., certain fishermen or families who 

 may eat unusually large amounts of fish). This manual does not provide 

 guidance on policy issues that are beyond the scope of the technical 



