The Food Quality Protection Act

Introduction

After years of legislative stalemate, legislation was finally approved in 1996. Many of the most important provisions of "The Food Quality Protection Act" (Public Law 104-170). This law establishes a comprehensive regulatory system for the food we eat.

The Food Quality Protection Act (FQPA) of 1996 amended the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food Drug, and Cosmetic Act (FFDCA). These amendments fundamentally changed the way EPA regulates pesticides. The requirements included a new safety standard-reasonable certainty of no harm-that must be applied to all pesticides used on foods.

Background

Pesticides are regulated under two federal statutes. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) regulates the registration and agricultural use of pesticides. The Federal Food, Drug, and Cosmetic Act (FFDCA) sets standards for levels of pesticide residues on food. Pesticide residues are the amount of pesticides left in a food after the crop has been harvested and processed. This regulatory scheme is administered by three agencies (the Environmental Protection Agency, the Food and Drug Administration, and the Department of Agriculture).

Prior to 1996, both public interest groups and industry were dissatisfied with the regulatory system. Environmental and public health groups called for reform because most standards were too weak to protect public health. Older, more dangerous pesticides were not being removed expeditiously, the public didn't have vital information about risks in the food, and enforcement mechanisms were inadequate.

For more than thirty years, federal law applied conflicting standards to regulate pesticides in foods. Pesticides that may have caused cancer in humans or animals were banned from many processed foods under the Delaney Clause, regardless of the level of risk they posed. On the other hand, these same pesticides and others that may have caused adverse health effects could be used on raw foods under more lenient standards.

For industry, the Delaney Clause had become an increasing concern. Although the EPA had never strictly enforced the Delaney Clause--and even at its broadest application the Delaney Clause would have applied only to a small percentage of food--industry considered strict enforcement to be a looming threat to current pesticide practices.

In July 1992, the threat became imminent when the United States Ninth Circuit Court of Appeals ruled that the EPA had violated the Delaney Clause by allowing carcinogenic pesticides in processed foods under a de minimis risk policy.

Although Congress had made sweeping changes to FIFRA in 1978 and more modest revisions in 1988, the FFDCA provisions proved politically more difficult to amend and no legislative progress was made in either the House or the Senate.

The 1958 law received renewed scrutiny when the National Academy of Sciences issued a report entitled "Pesticides in the Diets of Infants and Children." This 1993 report exposed the inadequacies of the law in protecting infants and children from the risks of exposures to pesticides on food and issued recommendations for reforming the regulatory system.

Highlights of the Food Quality Protection Act

The Safety Standard. H.R. 1627 repealed the Delaney Clause's application to food and instead established a single, health- based standard for all pesticide residues on food. These residues must now be found to be "safe" by the U.S. Environmental Protection Agency. "Safe" is defined as "a reasonable certainty of no harm" to consumers. This change provides certainty to industry and substantially strengthens the safety standard for the vast majority of foods.

Protection of Infants and Children. One of the major criticisms of pesticide law was that it ignored the special risks that pesticides pose to infants and children. As a result, H.R. 1627 requires EPA to make a specific finding that permissible pesticide residues on food are safe for infants and children. In assessing the safety of pesticide residues for infants and children, EPA must consider the factors recommended by the National Academy of Sciences in its 1993 report, "Pesticides in the Diets of Infants and Children."

Consideration of Benefits. Under carefully crafted circumstances, the new law allows EPA to leave on the market pesticides that are necessary to avoid a significant disruption in the production of an adequate, wholesome, and economical food supply, but do not meet the new safety standard. If use of these pesticides is safe for infants and children and does not pose a risk of adverse "threshold" health effects, such as adverse health effects from acute exposures, EPA may permit the use of the pesticides so long as the lifetime risk to consumers does not exceed twice the lifetime risk allowed under the new safety standard.

Consumer Right-to-Know. H.R. 1627 also requires EPA to publish annually and distribute to large retail grocers for public display a pamphlet that (1) describes the risks and benefits of pesticides and (2) recommends ways to reduce dietary exposure to pesticide residues while maintaining a healthy diet. If EPA uses its authority to leave on the market pesticides that do not meet the new safety standard, the pamphlet must identify the foods on which these pesticides are used and list reasonable substitutes for these foods.

Preemption. To promote national uniformity, states are preempted from setting their own safety standards when EPA has established a pesticide tolerance that meets the new safety standard. However, states are not preempted from establishing more stringent standards if EPA uses its authority to leave on the market pesticides that do not meet the new safety standard, nor are they preempted from enacting right-to-know laws, such as Prop. 65 in California. Under a petition process, states can receive permission to establish their own standards when justified by compelling local conditions.

Other Provisions. The new law requires EPA to review existing pesticide tolerances under the new safety standard over a phased 0-year schedule; directs EPA to consider international pesticide standards when setting U.S. standards; directs EPA to harmonize its actions under the FFDCA to the extent practicable with its actions under FIFRA; provides FDA with enforcement mechanisms other than seizure; and directs EPA to establish tolerances when granting emergency exemptions for pesticide application.

FROM THE EPA:

Highlights of the Food Quality Protection Act of 1996

Health-Based Safety Standard for Pesticide Residues in Food: The new law establishes a strong, health-based safety standard for pesticide residues in all foods. It uses "a reasonable certainty of no harm" as the general safety standard, the same approach used in the Administration's 1994 bill.

• A single, health-based standard eliminates longstanding problems posed by multiple standards for pesticides in raw and processed foods.

• Requires EPA to consider all non-occupational sources of exposure, including drinking water, and exposure to other pesticides with a common mechanism of toxicity when setting tolerances.

Special Provisions for Infants and Children: The new law incorporates language virtually identical to the Administration's 1994 bill to implement key recommendations of the National Academy of Sciences report, "Pesticides in the Diets of Infants and Children."

• Requires an explicit determination that tolerances are safe for children.

• Includes an additional safety factor of up to ten-fold, if necessary, to account for uncertainty in data relative to children.

• Requires consideration of children's special sensitivity and exposure to pesticide chemicals.

Limitations on Benefits Considerations: Unlike previous law, which contained an open-ended provision for the consideration of pesticide benefits when setting tolerances, the new law places specific limits on benefits considerations.

• Apply only to non-threshold effects of pesticides (e.g., carcinogenic effects); benefits cannot be taken into account for reproductive or other threshold effects.

• Further limited by three "backstops" on the level of risk that could be offset by benefits considerations. The first is a limit on the acceptable risk in any one year -- this limitation greatly reduces the risks. The second limitation is on the lifetime risk, which would allow EPA to remove tolerances after specific phase-out periods. The third limitation is that benefits could not be used to override the health-based standard for children.

Tolerance Reevaluation: Requires that all existing tolerances be reviewed within 10 years to make sure they meet the requirements of the new health-based safety standard.

Endocrine Disruptors: Incorporates provisions for endocrine testing, and also provides new authority to require that chemical manufacturers provide data on their products, including data on potential endocrine effects.

Enforcement: Includes enhanced enforcement of pesticide residue standards by allowing the Food and Drug Administration to impose civil penalties for tolerance violations.

Right to Know: Requires distribution of a brochure in grocery stores on the health effects of pesticides, how to avoid risks, and which foods have tolerances for pesticide residues based on benefits considerations. Specifically recognizes a state's right to require warnings or labeling of food that has been treated with pesticides, such as California's Proposition 65.

Uniformity of Tolerances: States may not set tolerance levels that differ from national levels unless the state petitions EPA for an exception, based on state-specific situations. National uniformity, however, would not apply to tolerances that included benefits considerations.

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

Pesticide Reregistration Program: Reauthorizes and increases (from $14M to $16M per year) user fees necessary to complete the review of older pesticides to ensure they meet current standards. Requires tolerances to be reassessed as part of the reregistration program.

Pesticide Registration Renewal: Requires EPA to periodically review pesticide registrations, with a goal of establishing a 15-year cycle, to ensure that all pesticides meet updated safety standards.

Registration of Safer Pesticides: Expedites review of safer pesticides to help them reach the market sooner and replace older and potentially more risky chemicals.

Minor Use Pesticides:

• Establishes minor use programs within EPA and USDA to foster coordination on minor use regulations and policy, and provides for a revolving grant fund to support development of data necessary to register minor use pesticides.

• Encourages minor use registrations through extentions for submitting pesticide residue data, extensions for exclusive use of data, flexibility to waive certain data requirements, and requiring EPA to expedite review of minor use applications. These incentives are coupled with safeguards to protect the environment.

Anti-Microbial Pesticides: Establishes new requirements to expedite the review and registration of anti-microbial pesticides. Ends regulatory overlap in jurisdiction over liquid chemical sterilants.