Publications The Food Quality Protection Act of 1996

 

Elizabeth Andress, Ph.D.
Associate Professor and Extension Food Safety Specialist   eandress@uga.edu

Out Goes the Delaney Clause; It's Now Risk-Benefit Balancing

In July 1996, Congress passed the Food Quality Protection Act of 1996 (Public Law 104- 170) and the President signed the legislation on August 3. This Act amends the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA) in ways that change the regulation of pesticides in this country. These are the two major Acts that have governed the registration and use of pesticides in this country.

The Current Rules and Players

FIFRA: The FIFRA authorizes the Environmental Protection Agency (EPA) to determine whether a pesticide can be registered (approved) for use. For each chemical approved, the EPA sets a tolerance � the maximum residue level of the pesticide that will be legally permitted in or on a food, feed constituent or food component. In the setting of tolerances, the FIFRA allows the EPA to consider both risks and benefits from use of the pesticide.

FFDCA: Under Sections 408 and 409 of the FFDCA, the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) share responsibility for enforcing pesticide tolerances and therefore, for monitoring levels of pesticides in foods. Section 408 governs the setting of tolerances for pesticides in raw foods. Section 409 governs residues that concentrate in processed foods.

Enter the Delaney Clause and Processed Foods: Section 409 of the FFDCA contains the Delaney Clause, a 1958 food safety provision that prohibits an additive in processed food if it can be found to induce cancer in experimental animals. Pesticide residues in processed foods are considered as additives. This means that if any dose of a pesticide, regardless of how large, causes a tumor when fed to laboratory animals that no amount of the pesticide would be allowed in the food. (Any tumor is considered to be cancer for the purposes of the Delaney Clause.) There is no allowance for even a tiny bit of that additive or pesticide, regardless of how negligible or small the expected risk of cancer. And regardless of how small of an amount can be detected with sophisticated equipment and methods. For these reasons, the Delaney Clause has been known as a zero-risk standard � no risk at all is tolerated.

It's a Different Story for Raw Foods: The Delaney Clause, or Section 409 of the FFDCA, has therefore prohibited the government from issuing tolerances, or maximum residue limits, for processed foods if any links to cancer can be shown for a pesticide. Section 408 of the FFDCA governs pesticide residues in or on raw foods. However, different procedures for allowing pesticides are used under Section 408 (raw foods) compared to Section 409 (processed foods). The differences complicate the process of approving pesticides for use. The provisions in Section 408, like the FIFRA, allow for some consideration of risks and benefits to a pesticide's use and allow the government to determine levels of pesticide residues that would be legal to still have on raw foods, known as tolerances.

Under Section 408 of the FFDCA, Quantitative Risk Assessment is done by considering data from very rigorous research and related health studies, determining what would be considered acceptable daily intakes based on possible health hazards, making some assumptions about expected total dietary exposure, and applying some safety factors in calculating the estimated level of risk. Pesticide residues that do not exceed established tolerances are considered to be safe. Residues exceeding tolerances are considered illegal, but do not automatically mean the food is unsafe for consumption.

The New Game in Town

The Food Quality Protection Act of 1996 Sets One Standard: Amendments to the FFDCA made in Title IV of the 1996 Food Quality Protection Act (FQPA) now set one type of safety standard for both raw and processed foods. This legislation means that the Delaney Clause is repealed, and determination of safety for both raw and processed foods will use a procedure of quantitative risk assessment and weighing of risks and balances in deciding if a pesticide will be approved and a tolerance issued. Determination of safety for both raw and processed foods under the 1996 Food Quality Protection Act requires that there is "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."

There Are Even More Changes: Other amendments in the 1996 FQPA that impact food safety include:

• provisions that the Secretaries of HHS and Agriculture shall conduct surveys to document dietary exposures to pesticides among infants and children;
  
• requiring extra margins of safety for infants and children when approving pesticides;
  
• sets limits for allowing consideration of data on the actual percent of food treated with a pesticide when assessing chronic dietary risk;
  
• new right-to-know provisions for consumers, including
  
  • the publishing and wide distribution of consumer-friendly information regarding risks and benefits of pesticides in or on food,
    
  • a listing of actions taken that might present a higher risk than allowed and the foods on which the pesticides were used,
    
  • recommendations to consumers for reducing dietary exposure to pesticide residues in a manner consistent with maintaining a healthy diet;
    
• screening of chemicals for estrogenic effects (or other endocrine effects);
  
• authorized funding for increased monitoring of pesticide residues by FDA for the fiscal years 1997-1999.