Many investigators and state and local regulatory agencies 

 evaluate the significance of toxic contamination in fish and shellfish 

 relative to human health concerns simply by comparing tissue 

 concentrations of selected chemicals to Action Levels or tolerances 

 established by the Food and Drug Administration (FDA). ( An Action 

 Level is a restriction on chemical contamination. Foodstuffs with 

 concentrations of a chemical exceeding the Action Level are re- 

 quired by federal law to be confiscated and destroyed.) Action 

 Levels do not provide a sufficient basis for all local risk assess- 

 ments because they are available only for chemicals likely to be at 

 levels of concern to commercial fisheries on a national basis. They 

 do not, therefore, include some chemicals highly suspected of 

 causing cancer or other adverse effects that might be of concern 

 in some local areas due to higher-than-average local fish consump- 

 tion and high, localized contamination levels. 



Action Levels are national protective levels set by 



FDA. Tolerance levels indicate the ability of an 



organism to fend off an adverse effect. 



FDA is authorized to develop Action Levels or tolerances for 

 specific localities if it is in the national interest. Tolerances have 

 legal enforcement status, whereas Action Levels have less formal 

 regulatory limits. To date, however, all Action Levels and toler- 

 ances have been developed to be protective on a national basis, 

 rather than regionally or locally. 



The procedure for determining these national protective levels 

 involves assessing the health risks to the average national con- 

 sumer of a foodstuff. It presumes the consumer eats foods from a 

 typical "national market basket," and weighs the resulting average 

 national health risks against the likely national economic impacts 

 of setting particular levels as Action Levels or tolerances. There- 

 fore, FDA has stated that Action Levels and tolerances are not 

 intended to protect local consumers of fish and shellfish, like 

 sports-fishermen, who may eat more of a given fish than the 

 average national consumer. 



Risk Assessment 



Estimation, using best available scientific methods, 

 of the probable health risks of a given activity. 



Risk Management 



The use of regulatory tools to protect against levels 

 of risk deemed unacceptable based on risk assess- 

 ment and socioeconomic considerations. 



FDA has the lead responsibility for managing risks related to 

 consumption of foods distributed in interstate commerce. For some 

 chemicals in foods, EPA assists FDA in its risk management 

 responsibilities by helping conduct the technical risk assessments 

 that are the starting point of risk management. FDA then incor- 

 porates economic considerations and develops Action Levels and 



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