Authority and Jurisdiction of 

 EPA-FDA Over 

 Contaminants in Fish 



Much of the substance of this section is drawn from two preambles in 

 the Federal Register (FR Vol. 39, No. 236, 42743-42748, December 6, 

 1974 and FR Vol. 47, No. 139, 42956-42958, September 29, 1982). 



The Federal Food, Drug and Cosmetics Act (FFDCA) is the principal 

 authority for both EPA and FDA actions directly relating to the safety 

 of fish as a human food source. Only under this Act can federal action 

 be taken against contaminated fish moving in interstate commerce as 

 being unsafe or unfit for human consumption. ■ 



The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 

 gives the EPA authority to deny registrations or cancel existing 

 registrations for pesticide chemicals whose use would (or does) cause 

 fish contamination to the extent that the risks of use of the pesticides 

 exceed the benefits. FIFRA also provides EPA with authority to collect 

 data on currently registered pesticides which may be causing fish 

 contamination. The Toxic Substances Control Act (TSCA) can be used 

 by EPA to regulate chemical substances to prevent such chemicals 

 from becoming contaminants in fish or shellfish. EPA can also take 

 action under RCRA or Superfund to prevent contamination offish and 

 shellfish caused by the release or anticipated release of hazardous 

 substances. 



Under the Clean Water Act (CWA), EPA publishes water quality 

 criteria. The criteria, based upon the best scientific information avail- 

 able at the time and the Agency's published risk assessment procedures 

 (FR Vol. 45, 79318-79379, November 28, 1980), assist the states in 

 establishing water quality standards. A description of the EPA risk 

 assessment procedures associated with contaminated fish can be found 

 in the main text of this guidance manual. 



EPA and FDA share the federal responsibility for the regulation of 

 contaminants in foods that move in interstate commerce. Under the 

 FFDCA, FDA has the primary federal role for assuring the safety of 

 the food supply, including fish and shellfish. FDA is responsible for 

 establishing safe levels for poisonous or deleterious substances (other 

 than pesticide residues) that contaminate food [e.g., heavy metals, such 

 as lead and mercury, and organics, such as polychlorinated biphenyls 

 (PCBs)]. 



Under ideal conditions, FDA will attempt to establish a formal Section 

 406 tolerance limiting the extent of allowable contamination of a food. 

 However, when toxicological data are scanty or conflicting, when 

 additional data are being developed, or when other conditions are 

 rapidly changing, the promulgation of a Section 406 tolerance may be 

 inappropriate. Nevertheless, it may still be appropriate to take some 

 regulatory action or to control exposure to a contaminant. In such 

 circumstances, FDA may consider developing an action level under 



Statutes 



Activities 



