Background 



assessment guidance on certain technical issues of toxicity and ex- 

 posure given in the main text of this guidance manual and other 

 guidance available from EPA and FDA. Section IV outlines a 

 proposed Standing Committee established to facilitate information 

 exchange, to deal with issues as they arise among the various jurisdic- 

 tions, and to encourage greater consistency in assessments and ad- 

 visories on chemical residues in fish. 



The protection of human health through the regulation and control of 

 contaminated food stuffs is a joint federal and state responsibility. To 

 do this job effectively requires that each party understand and respect 

 the mandates and roles of the other. 



The federal regulatory role is shared by FDA and EPA. FDA has direct 

 enforcement responsibility over all contaminated food, including fish 

 and shellfish that are shipped in interstate commerce. With respect to 

 pesticides, as a part of its registration procedure, EPA is responsible 

 for establishing tolerances (maximum permissible levels) for residues 

 of pesticide chemicals that may be anticipated to appear in fish. 

 Further, EPA is responsible for recommending, upon request from 

 FDA, the appropriate action levels on pesticides which may become 

 contaminants in food and for which a tolerance does not exist. FDA, 

 by agreement with EPA, also enforces these action levels (Federal 

 Register (FR) Vol. 39, No. 236, 42745, December 6, 1974). 



Because of considerations involved in the establishment of federal 

 action levels, such levels may or may not be directly applicable to the 

 needs of the states when individual states attempt to evaluate the safety 

 of the local consumption of fish by sports fishermen or others. When 

 the states have sought federal advice from EPA or FDA offices for 

 more detailed information beyond the simple statement of the 

 tolerance or action level, that advice has not always been clear, consis- 

 tent, and in accord with joint EPA/FDA policy. 



The issue of consistency in decisionmaking has arisen more often in 

 recent years as interest has broadened at both the federal and state 

 level in the use of risk assessment as one tool in reaching decisions 

 related to the consumption of contaminated fish. This trend is likely to 

 continue. For example, the Agency for Toxic Substances and Disease 

 Registry (ATSDR) is making a number of site-specific decisions, 

 pursuant to provisions of Superfund legislation, which deal with the 

 possibility of pollutants in fish. Also, EPA regional offices are under- 

 taking fish consumption risk assessments on a site- and area-specific 

 basis in order to evaluate the human health impacts of site-specific 

 regulatory decisions to control contamination sources. Additionally, 

 more states are actively addressing the need to issue fish consumption 

 advisories for local sports fishermen. 



Therefore, it is important that federal agencies speak out as clearly as 

 possible regarding their respective roles and that they establish proce- 

 dures that will enable the states to obtain, in a timely manner, the 

 information and advice they need in order to make decisions that 

 impact on the health of their citizens. 



