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Food Quality Protection Act limits Delaney Clause

The FQPA action suggests there may be some momentum for eliminating the Delaney Clause as it applies to food and color additives in any food safety reform measure that may pass Congress this term or next.

After unanimous approval by the House and Senate, President Clinton signed the Food Quality Protection Act (FQPA) into law on Aug. 3, 1996. The FQPA amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) specifically as it applies to pesticides. But some of the FQPA's reform measures, including revisions to the so-called "Delaney Clause," institution of an endocrine screening program, and granting the Food and Drug Administration limited civil fining authority, may shed light on the direction Congress and the White House will go with respect to food reform generally.

First, the FQPA amends the FD&C Act by replacing the Delaney Clause, as it applies to pesticide residues, with a negligible risk standard. The Delaney Clause, in Section 409 of the FD&C Act, prohibits the issuance of food additive regulations, including tolerances for residues of pesticides on processed foods, if the additive has been found in tests to cause cancer in man or animals. The FQPA makes the Delaney Clause inapplicable to pesticide residues in processed foods by removing such residues from the Section 201(s) definition of a "food additive."

Although pesticide tolerances for raw agricultural commodities are not directly subject to the Delaney Clause, under the Environmental Protection Agency's coordination policy, the Agency will not approve or retain a tolerance for a carcinogenic pesticide on raw agricultural commodities if the pesticide also requires a food additive regulation for residues on processed foods (because it concentrates in the processed food). If no such regulation can be promulgated by FDA because of Delaney, the net effect is the banning of the pesticide.

Now, new and existing pesticide tolerances for residues on both raw agricultural commodities (RACs) and processed foods are governed by a "reasonable certainty of no harm" safety standard under Section 408 of the FD&C Act. Based on the legislative history of the bill, this standard will be met where a risk evaluation using EPA risk assessment techniques leads to the conclusion of no more than a one-in-a-million risk. However, an additional ten-fold safety factor will be applied to tolerances of pesticide chemical residues found in foods that constitute a high percentage of infants' and children's diets.

The complex safety standard for tolerances and exemptions from tolerances for pesticide residues would be a determination by EPA as follows: "that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information."

Since the FQPA only amends the Delaney Clause with regard to pesticide residues, the Clause continues to apply to other food and color additives (which have a separate Delaney provision). However, the FQPA action suggests there may be some momentum for eliminating the Delaney Clause as it applies to food and color additives in any food safety reform measure that may pass Congress this term or next.

Under the FQPA, EPA is also required to develop a screening program to evaluate the estrogenic effects of pesticides and could, at its option, evaluate nonpesticidal substances as well, if those substances have a "cumulative" (e.g., synergistic) effect with pesticides. Within two years of enactment of the legislation, EPA would have to develop a program using appropriate validated test systems "to determine whether certain substances may have an effect in humans similar to the effect produced by a naturally occurring estrogen, or other endocrine effect as the administrator may designate."

The registrant of the substance (if it is a pesticide), its manufacturer, or its importer would be ordered to test the substance's estrogenic effect and submit the data to EPA. If a substance is found to have an endocrine effect on humans, EPA must take appropriate action. including consideration under other provisions of the FD&C Act, as is necessary to protect public health. Four years after enactment of the FQPA, EPA must report to Congress on the findings of the screening program.

Finally, the FQPA provides FDA with authority to impose civil money penalties for certain pesticide-related violations of the FD&C Act. The penalties are limited to $50,000 per individual, $250,000 per entity, and a maximum of $500,000 for all violations in a single proceeding. The fines may not be used in conjunction with existing penalties such as seizure, injunctions, and criminal actions.

Malcolm D. MacArthur is legal counsel to the Flexible Packaging Association, other trade groups, and corporations. Contact him at 202/434-4100.

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