The effort to unravel the Delaney paradox and modernize food safety law has been under way for over a decade. The 104th Congress moved unexpectedly and with remarkable speed in rewriting and passing H.R. 1627, the "Food Quality Protection Act of 1996." Prior versions of this bill were generally known as the Bliley food safety reform bill, named after the Chairman of the Committee on Commerce, Congressman Thomas Bliley. This legislation had gone through several drafts since the 102nd Congress and had more than 225 co-sponsors in the House. But no one expected the legislation to move forward in the last weeks of the 104th Congress, with an election, appropriation bills, welfare and health care reform competing for limited House and Senate floor time.

A bipartisan group of leaders of the Committee on Commerce, including Democratic Congressmen Henry Waxman and John Dingel, began in early July to explore whether they could reach agreement on unresolved issues that had proven so divisive over the last 10 plus years. The Administration was consulted but not heavily involved, nor were outside groups.

A surprise announcement was made Tuesday, July 16th scheduling both a subcommittee and full committee markup of the newly and substantially rewritten H.R. 1627 on Thursday July 18th. Even after the markup the 18th, relatively few people had seen the complex new bill. Because of the strong support of Commerce Committee leadership, both Republican and Democrat, the votes in subcommittee and committee were unanimous. On Friday the bill was distributed in D.C. and around the country and its scope and significance were recognized, at least by some. The Washington Post ran a favorable editorial on the bill Monday, July 22nd, entitled "Sound Compromise on Pesticides." House leaders scheduled a floor vote the next Tuesday, July 23rd.

On Tuesday, July 23rd the "Food Quality Protection Act of 1996" passed the House of Representatives 417-0. Members praised each other at press conferences for working together so courageously in resolving such a tough set of issues. The next day in the morning the Senate Committee on Agriculture, Nutrition, Family farms and Forestry passed the House bill with little discussion and without change on an 18-0 vote. About 7:30 p.m. that same evening the bill passed the Senate in about one minute on a unanimous voice vote. A committee staff member told me a few days later that the bill would have died in the Senate if it had been held over just one day, given rapidly mounting panic and opposition from some major players in the pesticide industry.

The basic provisions of the "Food Quality Protection Act of 1996" implement the major recommendations of two NRC/NAS reports. The Committee on Commerce "Legislative Summary" states: "The Substitute (compromise bill) contains additional requirements for tolerance setting which are directly responsive to the recommendations of the National Research Council's report on Pesticides in the Diets of Infants and Children." In other statements the Committee, members of Congress and the Administration also noted that the bill's basic provision calling for a uniform standard in setting all tolerances was in response to the basic recommendations in Regulating Pesticides in Food: The Delaney Paradox, released in 1987. Senator Lugar discussed the 1987 NRC/NAS report at length in a hearing on H.R. 1627 a few days before passage of the bill in the Senate.

Bill Description
The "Food Quality Protection Act of 1996" amends the Food Drug and Cosmetic Act (FDCA) and the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). The major FDCA provisions eliminate the distinction in federal law between raw agricultural and processed food tolerances and hence end the Delaney Paradox.

FDCA Reforms

The bill requires that EPA apply a new uniform standard in setting all tolerances in food. Section 408 of the FDCA is amended to read:

"The Administrator (of EPA) may establish or leave in effect a tolerance for a pesticide chemical residue in or on a food only if the Administrator (of EPA) determines that the tolerance is safe..As used in this section, the term `safe', with respect to a tolerance for a pesticide chemical residue, means that the Administrator has determined 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."

The bill sets forth two conditions under which EPA may set tolerances at a two-in-one million risk level instead of one-in-one million, but this exception applies only in the case of pesticides causing non-threshold effects (i.e. cancer, for example). The conditions are related to the benefits arising from continued use of a pesticide.

First, use of a pesticide that ".protects consumers from adverse effects on health that would pose a greater risk than the dietary risk from the residue." The example cited in the House Committee report refers to use of a pesticide to minimize risk of aflatoxin contamination in livestock feed. For most pesticides, the practical significance of this provision is limited. High- risk pesticides pose total "worst case" cancer risks on the order of 100 in one million, based on existing tolerances. If the benefits provision is invoked, EPA would still need, at a minimum, to adjust such a pesticide's tolerances down on average by 98 percent, instead of 99 percent - an indistinguishable difference given uncertainties inherent in the risk assessment state of the art.

The second benefits exception is: "Use of the pesticide chemical.is necessary to avoid significant disruption in domestic production of an adequate, wholesome, and economical food supply." Few if any pesticides are essential to the entire food supply. If this provision referred to individual crops, it would be triggered with some regularity, but as is, it will not be. Plus, this benefits provision does not apply to pesticides causing adverse effects for which a threshold can be established (a level below which there is a "reasonable certainty of no harm") and any tolerance set at the higher level because of a benefits finding sunsets in five years (but can be extended).

The subsection "( C ) EXPOSURE OF INFANTS AND CHILDREN. -" states that in setting tolerances the Administrator shall assess pesticide risks taking into account available information on:

".consumption patterns among infants and children.'

".the special susceptibility of infants and children.including neurological differences between infants and children and adults, and effects of in utero exposure to pesticide chemicals."

".the cumulative effects on infants and children of such residues and other substances that have a common mechanism of toxicity."

".in the case of threshold effects,.an additional tenfold margin of safety for the pesticide chemical residues and other sources of exposure shall be applied for infants and children to take into account potential pre- and post-natal toxicity and completeness of data.the Administrator may use a different margin of safety for the pesticide chemical residue only if, on the basis of reliable data, such margin will fully protect infants and children."

On the key issue to California agriculture -- and the state's consumers -- of whether the Administrator may adjust exposure estimates for the percent of crop acres treated, the bill allows such adjustments only in the case of evaluating chronic exposure and risk, and only then if EPA has accurate data on pesticide use and "finds that the exposure estimate does not understate exposure for any significant population group." The value of California's pesticide use reporting system just went up several-fold.

The bill includes a "CONSUMER RIGHT TO KNOW" provision that requires EPA to:

"publish in a format understandable to a lay person, and distribute to large retail grocers for public display (in a manner determined by the grocer), the following information, at a minimum:

" "(1) A discussion of the risks and benefits of pesticide chemical residues in or on food purchased by consumers."

" "(2) A listing of .pesticide chemical residues in or on food that present a yearly or lifetime risk .[twice the allowable level on account of the benefits provision described above]"

" "(3) Recommendations to consumers for reducing exposure to pesticide chemical residues in a manner consistent with maintaining a healthy diet, including a list of food that may reasonably substitute for food listed under paragraph (2)."

A "SCHEDULE FOR REVIEW" is set forth that requires EPA to review and adjust tolerances as needed to meet the bill's basic safety standards and requirements. The schedule calls for:

"(A) 33 percent of such tolerances and exemptions [from the requirement for a tolerance] are reviewed within 3 years of the date of enactment.(B) 66 percent.within 6 years. ( C ) 100 percent .within 10 years of the date of enactment."

The subsection "PRIORITIES" calls upon the Administrator to "give priority to the review of the tolerances or exemptions that appear to pose the greatest risk to public health."

This means that most of the major food use insecticides and fungicides important to California agriculture will be assessed and adjusted downward in the next three years. This places a premium on decisive action now to assure the state is ready to participate in tolerance triage. Much effort will be needed to identify, and when possible preserve, essential and safe uses of pesticides which are likely otherwise to be abandoned by registrants. Growers, processors, IPM experts and state regulators will need to work together in making the case, and backing it up with credible science and revised labels, that certain pesticides can and will be used in California consistent with the new public health standard in H.R. 1627. If that does not happen within the timetable set forth in the bill, such pesticide uses will probably fall by the wayside.