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Highlights of the Food Quality Protection Act of 1996
Federal Food, Drug and Cosmetic Act Provisions (FFDCA)
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.
- 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 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 ten-fold safety factor to take into account potential pre- and post-natal toxicity and completeness of data with respect to infants and children, unless on the basis of reliable data a different factor will be safe.
- 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.
Antimicrobial Pesticides: Establishes new requirements to expedite the review and registration of antimicrobial pesticides. Ends regulatory overlap in jurisdiction over liquid chemical sterilants.