information and on assessment of the level of the contaminant found 

 locally and on local fish consumption patterns. 



It should also be understood that FFDCA permits the consideration 

 of factors other than health and safety in the setting of nationally 

 apphcable levels. Action levels are predicated not only on safety but 

 also on factors such as the economic impact likely to be experienced 

 by affected members of the food industry in complying with the estab- 

 lished levels. Therefore, particular risk management decisions made 

 by the federal agencies in managing interstate commerce may not be 

 in accord with, or take into consideration, the priorities of a particular 

 state. 



In several recent revocation actions of tolerances for cancelled pes- 

 ticides (i.e., DDT, aldrin/dieldrin, and chlordahe), a number of com- 

 menters raised concern about the EPA's decision not to recommend 

 lower action levels for such pesticide residues in fish. The Agency 

 concluded in its final rules revoking these tolerances that additional 

 data were needed before the Agency could make its final recommen- 

 dation on the fish action levels. It was recognized by the Agency that 

 some population groups may be at higher risk because of the frequency 

 and amount offish consumed locally. However, setting an enforcement 

 limit for this situation, while also satisfying the criteria for setting an 

 appropriate national Umit, is not usually possible. This is because 

 action levels announced and enforced by FDA apply to fish in inter- 

 state commerce, and it would be very difficult, if not impossible, for 

 FDA to enforce and defend in court differing regional limits. 



States need to understand clearly the way federal action levels are 

 developed if they are to adapt them to their local conditions or to 

 extract from them the critical scientific information which is applicable 

 generally and which would help to ensure a basic consistency in all state 

 decisions. All of this makes it important that, when action levels are 

 set, there be a clear distinction made between the risk assessment 

 components and any risk management components, e.g. economic 

 issues, and that there be a full explanation of any assumptions used in 

 deriving the final levels. 



As noted above, EPA takes enforcement and permit actions to protect 

 against human exposure to toxic substances from specific emission 

 sources and hazardous waste sites which can cause localized, intrastate 

 impacts on public health and the environment. Analyses to support 

 these regulatory actions include consideration of all exposure path- 

 ways, including fish consumption. When EPA (sometimes assisted by 

 ATSDR) is the lead agency (in lieu of a state) for making site-specific 

 decisions based on estimates of fish consumption risks (e.g., under 

 CERCLA, TSCA Section 6(e), PCB Spill Cleanup Policy, etc.), the 

 Agency also (1) advises the public of its findings and their relevance to 

 EPA's regulatory actions to control specific sources, (2) notifies state 

 and federal agencies of identified problems, and (3) recommends that 

 states take action under their police powers to protect public health. 



The assessment of risks associated with the consumption of con- 

 taminated fish involves questions of toxicity; e.g.: 



Risk Assessment Issues 



