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The Food Quality Protection Act Introduction For nearly twenty years until 1996, Congress debated how to reform our nation's pesticide laws. Rep. Waxman led the fight in the House for tougher regulations and, as Chairman of the Health and the Environment Subcommittee, sponsored reform legislation and chaired hearings on this issue throughout the 1980s and 1990s. 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) are the result of a remarkable compromise forged by Rep. Waxman, Commerce Committee Chairman Thomas Bliley, and Rep. John Dingell. That compromise has been called the "most important law you never heard of," and establishes a comprehensive regulatory system for the food we eat. 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. The 103rd Congress (1993-1994) After the National
Academy of Sciences released its report on infants and children,
Rep. Waxman sponsored legislation (H.R. 4091) that reflected the
Academy's recommendations. At President Clinton's request, Rep.
Waxman also introduced H.R. 4362, the "Pesticide Reform Act
of 1994." None of these bills were approved by the 103rd Congress. The 104th Congress (1995-1996) In May 1995
Rep. Bliley, Chairman of the Commerce Committee, introduced a revised
version of the legislation he had introduced in the previous Congress.
This legislation, H.R.
1627, gained more than 230 cosponsors but was strongly opposed
by a number of environmental and public health groups. Concerned about the effects H.R. 1627 would have on public health, Representative Waxman introduced H.R. 1771, the "Pesticide Safety and Right-to-Know Act of 1995," in June 1995. In particular, H.R. 1771 focused on the harmful estrogenic and reproductive effects of pesticides, protected infants and children from risk, and provided strong public right-to-know provisions. At a June 29, 1995 hearing of the Health and the Environment Subcommittee, Dr. Philip Landrigan, the Chairman of the National Academy of Science's Committee on Pesticides, testified that H.R. 1627 was inconsistent with the Academy's recommendations because it would "perpetuate the current inadequately controlled exposure of children to pesticides in their diets and . . . likely worsen our children's exposure to pesticides." The Chairman of the American Academy of Pediatrics' Committee on Environmental Health, Dr. Routt Reigart, also testified in opposition to H.R. 1627 because it did not adequately protect the health of children. Both witnesses endorsed H.R. 1771. In 1996, as the Commerce Committee neared formal consideration of H.R. 1627, Rep. Waxman urged that he, Chairman Bliley, and Rep. Dingell try to resolve their differences on pesticide reform. Discussions began on July 10. With unexpected and extraordinary speed, a comprehensive agreement was reached by July 14. On July 17, the Waxman-Bliley-Dingell agreement was substituted for the original H.R. 1627 and was unanimously approved by the Health and Environment Subcommittee and subsequently by the Commerce Committee. The revised H.R. 1627 was immediately endorsed by both public health/environmental groups and industry. H.R. 1627 passed the House on July 23, 1996 by a vote of 417-0. On July 24, the Senate passed H.R. 1627 by Unanimous Consent. President Clinton signed H.R. 1627 into law (Public Law 104-170) on August 3, 1996. 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. Supporters of
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