FDA Regulation of Environmental Contaminants of Food

Regulation of environmental contaminants cannot be done by administrative licensure, but must, instead, be reactive. 21 United States Code Sec. 406 authorizes the agency to set tolerances for certain constituents. Sec. 409 applies to additives and some packaging. Since Sec. 409 includes the ''Delaney clause'' which forbids approval of additives found to cause cancer in humans or animals, it does not provide the opportunity for risk-benefit decision-making available in Sec. 406. The US Food and Drug Administration (FDA) has favored use of Sec. 406. While hearings are customary in the regulatory scheme, the FDA has not held a single hearing on a Sec. 406 tolerance. The agency announced in 1977 that it did not intend to rely on informal rulemaking procedures. Further, only 2 substances have been subjected to careful analysis permitting realistic assessment of FDA's performance in this area. Congress should amend the Act to identify the precise criteria the FDA should use, and authorize the FDA to take into account the capability of available analysis methods. Congress should identify the factors to be considered in a risk benefit analysis. An opportunity for oral presentation of arguments should be provided, and the FDA should be required to begin a more formal procedure within a specified period after announcement of an action level. The present procedures, or lack thereof, are too expensive in terms of fairness and explication.