Federal and State Distinctions 



authority of Sections 306, 402(a) and 406 of the FFDCA (FR Vol 39, 

 No. 236, 42743-42748, December 6, 1974). 



In practice, FDA's regulation of contaminants has proceeded more 

 often through the use of action levels, rather than through formal 

 tolerances. Existing action levels meet the same criteria as tolerances 

 except they are intended for interim periods and can be instituted and 

 changed more quickly than tolerances. 



With respect to pesticide residues in food, EPA has the lead in estab- 

 lishing tolerances and recommending action levels. Under FIFRA, any 

 pesticide used in the country must be registered for specific uses 

 through procedures established by EPA. In addition, if the pesticide is 

 registered for use in the production of food, it must also have a 

 tolerance granted under FFDCA, limiting the amount of pesticide 

 residue in food. These pesticide tolerances are set by EPA and are 

 issued under the FFDCA for both raw agricultural commodities and 

 processed foods. FDA is responsible for enforcing food tolerances. 

 The use of action levels by EPA takes place in a somewhat different 

 administrative context from that of FDA. EPA can recommend to 

 FDA action levels on pesticide residues on foods to replace the formal 

 FFDCA tolerances that are revoked along with cancellation of a 

 pesticide registration in those cases in which the persistence of the 

 pesticide in the environment makes some continuing residue in food 

 unavoidable. EPA's criteria for establishing action levels are similar to 

 FDA's, but they also consider crop groupings and Codex AHmen- 

 tarious Commission recommendations (FR Vol. 47, No. 139, 42957, 

 Sept 29, 1982). 



Since 1971, action levels have been the result of close consultation 

 between the two agencies. Because action levels are similar to toleran- 

 ces in basis and effect and since EPA, under a 1971 Memorandum of 

 Understanding between FDA and EPA was delegated responsibility 

 for setting tolerances for pesticide contamination, EPA is responsible 

 for recommending the appropriate level at which a pesticide action 

 level is to be set. FDA is responsible for enforcing the action levels for 

 pesticides. 



The authority of the FFDCA does not extend to fish that are not in 

 interstate commerce. Accordingly, tolerances and action levels are 

 typically established on a national basis when it is judged that a national 

 problem exists for a particular contaminant. Thus, the federal authority 

 is limited, and action levels are tailored to national needs and national 

 patterns of consumption. For example, consumption levels of fish on a 

 national per capita basis are generally considerably less than that 

 typical of sports fishermen, or of most lakeshore or coastal regions of 

 the U.S. Nonetheless, action levels or, more particularly, the toxicity 

 information [Reference Dose, (RfD) or Acceptable Daily Intake 

 (ADI)] that is considered in the setting of action levels may be useful 

 to the states in establishing controls or advisories on local fish con- 

 sumption that is outside the jurisdiction of the federal agencies. If a 

 potential local health threat exists, a state or locality may wish to issue 

 warnings or provide guidance on the quantity of contaminated fish 

 which may be safely consumed, based on the best available toxicity 



