The Food Quality Protection Act of 1996 (FQPA) was hailed as a welcome solution by many that had worked for years to remove the so-called "Delaney Clause" from pesticide laws. Although application of the Delaney Clause had the potential to remove many existing pesticides from use on a few crops, the changes in interpretation of the Delaney Clause by the Environmental Protection Agency (EPA) immediately preceding the passage of the Food Quality Protection Act, had greatly lessened the potential impact of the Delaney Clause. In addition to the removal of the Delaney Clause, the FQPA included incentives for the registration of specific pesticides on minor crops and the establishment of minor use programs at the US Department of Agriculture (USDA) and at the EPA. The term minor use now applies to all crops with less than 300,000 acres or for pesticides whose sales do not provide sufficient economic incentive for registration.

Since August 2, 1996, the Office of Pesticide Programs (OPP) at the EPA has redirected its efforts to address the FQPA provisions. All pesticides will now be forced to meet the new health based standard of "a reasonable certainty of no harm." The law also authorizes the EPA to focus registration efforts on safer and reduced risk pesticides as well as on how their efforts affect Integrated Pest Management (IPM) programs. Another provision of the FQPA requires the publication of information on foods containing pesticides registered for use but which do not meet the provisions "of a reasonable certainty of no harm."

In order to implement FQPA, the EPA has held a number of public meetings at which producers, registrants and consumer representatives provided input on the direction and content of the implementing regulations. These meetings generally resulted in intense discussions and provided interested parties the opportunity to give EPA a reality check on how FQPA implementation will affect the US food supply. Many of the provisions of the act will be clarified over the next three years. One important area of risk assessment yet to be implemented is endocrine disrupter screening and testing. Although there is little agreement on the final outcome of this discussion, this decision may have even more impact than the cancer risk assessments of the old law under the Delaney Clause.

Discussion Topics

Four areas of current discussion should be highlighted:

1. The FQPA is focused on protecting the health of infants and children. The law requires that an additional safety factor of 10x be applied where appropriate. For foods that are more common in the diets of infants and children such as apple juice, raisins or peaches, this factor can be the barrier to a pesticide being able to meet the safety standard.

2. Risk will also be judged based on aggregate exposure, which means that the chance of exposure to a pesticide through drinking water or home use must be factored into the equation. For some existing pesticides, this factor alone puts the risk above the allowable standard.

3. The third special issue, "cumulative exposure," is one that potentially affects many groups of pesticides. Cumulative exposure risk is based on the assumption that the consumption of food treated with a number of different pesticides with a similar mechanism of action is like consuming food treated with larger amounts of a single pesticide, and the residues of all the materials must be added to truly judge risk. EPA was recently given a scientific review on whether the cumulative exposure process should be used for organophospates (OP) pesticides. The conclusion--that there is no evidence that allows the OP's to be separated by different mechanisms of action--leads to a dire prediction that I will discuss in detail later.

4. Any pesticides authorized under FQPA Section 18 emergency registrations will be required to have tolerances in place. This requirement has prompted EPA to suggest that extensive reviews are required for each Section 18 now that time limited tolerances are being set. The Section 18 process will continue to be a very important option for crops such as tree fruits. However, the proposed FQPA project a rapid increase in Section 18 requests so that growers will have alternatives to the pesticides that are expected to be canceled. If EPA continues to use its existing nil tolerance assessment process on Section 18s, resources that should be used in the registration of new materials will be unavailable.

Tolerance

Tolerances issued must meet the reasonable certainty of no harm standard, taking into account all of the above four factors. Since the scientists are not in agreement with one another on some of these issues, we will continue to see the EPA use very conservative assumptions assessing total risk. These conservative assumptions will lead to use pattern restrictions or outright cancellation of many pesticides, commonly used on minor crops. The tolerance assessment process requires that all existing tolerances will be reassessed over the next ten years. The schedule is being described as a worst first list. This is indeed a dubious honor for those pesticides published for immediate review.

The tolerance reassessment schedule indicates that organophosphate, carbamate and carcinogens will be included in the first set (due for completion by August 1999). The first pesticides in this initial round of reassessments will include eight organophosphate pesticides that have tolerances on apples, pears and cherries as well as other tree crops. These are Guthion, Lorsban, Diazinon, Dimethoate, Malathion, Supracide, Penncap-M and Imidan. Since the first reviews are being done before cumulative effect and endocrine effect evaluations are included, pesticides may be reviewed more than once during the first three years.

Chemicals

The schedule for post harvest chemicals used on tree fruits is not quite as aggressive as that for the OP insecticides, but review times include some early probable tolerance assessments. The chemicals scheduled for pre-1999 include Captan, Diphenylamine (DPA), o-phenylphenol (SOPP) and Thiabendazole (TBZ). Ethoxyquin (Deccoquin) is scheduled for review by 2002. The biological active ingredients Biosave and Aspire are scheduled to be reviewed by 2005. Although EPA is mandated to meet this schedule, most observers believe the 1999 deadline will not be met, for all of the carcinogens including SOPP and Captan or for DPA and TBZ. Since these postharvest pesticides are usually the only control tools available for a disease or for scald control, loss of even one of the chemicals could leave the industry with no control tool. The potential for management gap for these disorders is very high. The USDA is conducting a survey on the use of post harvest tools for apples. This study is expected to highlight the necessity of keeping these chemicals registered and available.

The EPA has set priorities for new registrations in the following descending order: methyl bromide replacements, reduced risk pesticides, USDA-EPA vulnerable crops, minor uses, non minor use priorities and trade irritants. Each registrant is asked to rank its top five new registrations. Although this process occurs every six months, the backlog at the EPA means that the pipeline is clogged and very few new registrations are being completed.

Growers

The major need of the grower community is to have effective, economic crop protection tools in place to meet the pest challenges. The implementation of FQPA has introduced a great deal of uncertainty into whether this need can be met. At this stage, it can be said that there is a pest management gap that is looming in the future for many minor crops. After this dire prediction, it is logical to ask what is being done to avoid possible train wrecks.

Many growers have united to work on this issue through the Minor Crop Farmer Alliance (MCFA). The MCFA is working with the National Food Processors Association, the American Crop Protection Association, major crop commodity organizations and others under an umbrella working group. This group is coordinating their individual and joint efforts on FQPA implementation. Committees have been formed using the expertise of group. Results from these committees include the writing of a Section 18 tolerance process that would minimize the level of EPA resources required while maintaining full FQPA safety standards and progress toward the use of commodity and processor use and residue data in risk assessments. The NHC is currently working closely with the U.S. Apple Association and other industry groups to identify current OP use patterns and identify current uses where alternatives do not exist in a short term analysis or further, where there are alternatives, what the limitations might be. This information is being provided to the EPA Office of Pesticides Programs to aid in their risk assessment.

Conclusion

The bottom line is that much work remains to be done. The timetable published on tolerance reassessment appears to be unachievable. Cooperation between the EPA, growers and registrants has improved immensely, but the crystal ball still looks very gray and ominous. Each commodity needs to protect its interests by working with others who are committed to improve the implementation process under FQPA. Those commodities that do not add their support to joint efforts may wake up some day in the future without pest management tools to adequately protect their crops and livelihood.