Food Quality Protection Act

C. DiFonzo
difonzo@msu.edu
Department of Entomology
Michigan State University
East Lansing, MI 48824

This document is reproduced with the permission of author C. D. Difonzo and Michigan State University. Presented here is Dr. Difonzo's summary statement on the 1996 Food Quality Protection Act from a Michigan State WWW publication ENT 812: Pesticide Policy and Michigan Specialty Crops Food Quality Protection Act.

graphic of a cornocopia and the text "Food Quality Protection Act (FQPA), enacted August 1996"

Background

The Food Quality Protection Act (FQPA) was passed unanimously by Congress in July 1997, and signed into law in August. The Act amends two other pieces of legislation. These are 1) the Federal Food, Drug, and Cosmetic Act (FFDCA), which covers food safety and tolerances for pesticides in food and 2) the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which sets guidelines for pesticide registration, classification (general versus restricted), and use, as well as applicator certification.

Several factors contributed to the passage of FQPA. One of these was the Delaney Clause, a law passed in 1960 that stipulated a zero tolerance for potential carcinogens in processed food. The Delaney Clause attempted to address the possible link between some pesticides and human cancer. However, the law soon produced problems. It did not hold raw foods to the same standard as processed foods - hence, the Delaney Paradox - a pesticide that could legally not be found in any amount in processed foods under Delaney could be used on the raw commodity. Another problem was that detection of pesticides improved greatly over the years, making a zero tolerance standard difficult to meet.

Another factor that contributed to the passage of FQPA was a 1993 National Academy of Science that examined pesticides in the diets of infants and children. The study pointed out that children are not small versions of adults. They instead are growing and developing, and therefore have different physiology than adults. The study speculated that some pesticides may have a greater impact on growing, developing children than on adults, so it concluded that food tolerances for pesticides should be lowered to account for the potential differences in sensitivity of children. Finally, in 1996, "Our Stolen Future" was published. This book dealt with endocrine disrupters, compounds which mimic or block hormones. It chronicled human health problems linked to endocrine disruption, as well as alleged developmental and reproductive effects on wild and domestic animals. It also listed actions that could be taken to protect humans from endocrine disrupting compounds; some of these suggestions were apparently incorporated into FQPA.

Changes to FIFRA

The FQPA makes several changes to FIFRA. Some of the more important changes are highlighted below.

Reregistration of pesticides: The EPA began reregistering pesticides in 1988. That reregistration process will now continue so that each pesticide will be reviewed approximately every 15 years to examine new health, safety, or efficacy data.

Reduced risk pesticides: The EPA is developing a category of reduced risk pesticides. Pesticides which fall into the category, such as Bt products, will be reviewed at a faster pace.

Antimicrobial pesticides: A new division at EPA was developed to handle registration of antimicrobial pesticides, which should streamline the process.

Minor use definition: The old definition of a minor use was a use on a crop grown on less than 300,000 acres. That definition is now expanded to include a use that is not supported by the registrant, but which i. is the only effective alternative, ii. is safer than other alternatives, or iii. is important in an IPM program. Under this new definition, even major crops like corn or soybean could support minor uses if the previously listed criteria are met.

Minor use incentives: FQPA contains incentives for registrants to develop and maintain minor use registrations. These include developing a separate minor use program in EPA, speeding minor use registrations, giving registrants extended exclusive rights for data to support an original registration, and providing funds for minor use development programs.

Changes to FFDCA

The changes to the Food, Drug, and Cosmetic Act are more significant than the changes to FIFRA. The overall impact will be to fundamentally change the way tolerances for pesticide residues in food are determined.

Delaney is Dead: The FQPA repeals the Delaney "zero tolerance" Clause for pesticides. Instead, the Delaney Clause is replaced with a single health based standard for raw and processed foods. The standard requires that tolerances assure with "reasonable certainly that no harm will result from aggregate exposure".

Infants and children: Up to a ten-fold safety factor can be added to tolerances to protect infants and children. This is in addition to the current 100-fold safety factor which is already used to account for the use of animals (versus humans) in laboratory testing, and the variability in potential adult response to pesticide exposure. Although the safety factor is geared towards pesticides used on food crops, non-food pesticides used in areas that could impact children must also provide additional data on potential effects on, and safety for, children. This would include, for example, pesticides used in swimming pools or applied for mosquito control.

Toxicity & aggregate exposure: When setting a tolerance, the EPA now must consider aggregate exposure to compounds with a common mechanism of toxicity. Aggregate exposure includes not only dietary (food) sources of residues, but also exposure to non-food residues through water, gardens, lawns, golf courses, pets, homes, businesses, etc. Compounds with a common mechanism of toxicity would be such groups as OPs, pyrethroids, or Bts, and would also include pesticides with food and non-food uses. The "risk cup" is filled with the risk from aggregate exposure to pesticides with a common mechanisim of toxicity. When the risk cup is full, registrants must reduce risk prior to adding pesticides to the cup or eliminate uses.

Review of tolerances: All existing tolerances will be reviewed over the next 10 years - 33% within 3 years, 66% within 6 years, and 100% within 10 years. The first reviews will focus on the "Worst First":

1997: B2 ("probable human") carcinogens - pesticides which cause cancer in lab animals, but human evidence is lacking. Includes EBDC fungicides.

1998: Organophosphates (OPs) - pesticides which are toxic to humans due to their effect on acetylcholinesterase function. Includes such insecticides as Diazinon, Dursban, Guthion, Lorsban, Malathion, and Orthene.

1999: Carbamates - pesticides with a similar mode of action as OPs, but are often not as long-lasting in their effect. Includes Benlate, Furadan, and Sevin.

Endocrine disrupters: The endocrine system is a group of organs in the body, for example the thyroid, pituitary, thymus, ovaries, and testes, that secrete hormones directly into the blood stream. These hormones move to target cells in the body and influence development, reproduction, and metabolism. An endocrine disrupter is a compound that mimics or blocks a hormone, or disturbs its target. Endocrine disrupters therefore can disrupt normal body processes. Examples would include DDT, a pesticide which impacted bird reproduction, and thalidimide, a drug taken by pregnant women that caused birth defects. The EPA must test all pesticides (food or non-food use) and inert ingredients for endocrine disrupting effects. A blueprint for the screening program must be developed within two years, and the program itself must start within three years. No protocol is currently available for detecting and evaluating compounds as endocrine disrupters, but it is expected that the emphasis will be on estrogenic effects, and that the testing will use both cell culture and lab animals.

Consumer right-to-know: The EPA must develop a brochure that informs consumers about pesticide risks and benefits, plus ways to reduce exposure to pesticide residues in food (for example, by peeling and washing produce). The brochure is targeted for distribution in large retail grocery stores.

Impacts of FQPA

The impact of the FQPA on pesticide manufacturers, pesticide users, and consumers is still being debated. As the EPA interprets and implements this legislation, the picture will become clearer. However, some potential impacts can be discussed.

Loss of certain pesticide classes: The most serious potential impact is the loss of entire classes of compounds. The four most likely classes are:

  1. triazine herbicides due to concerns about groundwater contamination and endocrine disruption,
  2. organophosphates and/or
  3. carbamates due to toxicity concerns, and
  4. EBDC fungicides, which are targeted as B2 carcinogens.

However, loss of an entire class of compounds is unlikely due to the importance of some of the compounds in food production and human health. It is more likely that only certain problematic compounds from each class would be lost.

Reduction in section 18 exemptions: Section 18 exemptions, permission granted by the EPA in emergency situations to use a pesticide on a crop for which it is not registered, have been changed under FQPA. A time-limited tolerance geared towards protecting children is now required for the proposed section 18 pesticide on the crop of interest. This could slow the approval of some section 18s as registrants and states gather additional data to support the time limited tolerance, or disallow some section 18s if a tolerance cannot be reached.

Loss of minor uses: In order to meet the new standard of no harm resulting from aggregate exposure, registrants may choose to drop minor uses of a pesticide in favor of more profitable registrations. This is potentially troublesome in a state like Michigan, which economically depends on a healthy minor crops base.

Changes in labeling and usage: Rather than eliminate a use, a registrant could make changes in its product labeling or use to reduce human exposure and residues. These changes might include increasing the reentry or preharvest intervals, changing protective equipment requirements, reducing the use rate or number of sprays, or switching to a safer, lower AI formulation.

Lowering of tolerances: The net effect of FQPA is to push tolerances for pesticides residues in food even lower than present levels. This is due to accounting for alleged sensitivity children, plus the combined effects of considering aggregate exposure and pesticides with common mechanisms of action.