Laws and Regulations: Food

Tolerance Limits for Pesticide Residues

The responsibility for ensuring that pesticide residues in foods are not present above the limits is shared by three major government agencies.¹'¹ The Environment Protection Agency (EPA) determines the safety of pesticide products and sets tolerance levels for pesticides. The Food and Drug Administration (FDA) enforces the tolerances in all foods except meat and poultry products. The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) regulates commercially processed egg, meat, and poultry products including combination products (e.g., stew, pizza). In addition, any products containing 2% or more poultry or poultry products, or 3% or more red meat or red meat products are also under jurisdiction of the FSIS. The pesticides of concern usually include insecticides, fungicides, herbicides, and other agricultural chemicals. Table 1 illustrates examples of tolerance levels for pesticide residues in several food categories.^12,3! These tolerance levels are extremely low, usually below parts per million, but do not represent permissible levels of contamination where it is avoidable. In addition, blending of a food (or feed) containing a substance in excess of an action level or tolerance with another food (or feed) is not permitted, and the final product from blending is unlawful, regardless of the level of the contaminant.

Regulatory Inspection and Enforcement

The FDA monitors the levels of pesticide residues in processed foods. For imported products, the FDA checks a sample of the food at entry into the United States and can stop shipments at the entry. If illegal residues are found in domestic samples, FDA can take regulatory actions, such as seizure or injunction.

The U.S. Department of Agriculture also monitors pesticide residues in food.¹⁴¹ The Department was charged in 1991 with implementing a program to collect data on pesticide residues on various food commodities. The program has become a critical component of the Food Quality Protection Act of 1996 and currently is known as the Pesticide Data Program. The data on pesticides in selected commodities are used by the EPA to support its dietary risk assessment process and pesticide registration and by the FDA to refine sampling for enforcement of tolerances.

If a product is in violation of the tolerance limits, it is adulterated under the food law. The product may be destroyed or recalled from the market by the manufacturer or shipper. The recall may be initiated voluntarily by the manufacturer (or shipper) or at the request of the regulatory agency. The responsible agency also may seize the product on orders obtained from the Federal courts and may prosecute persons or firms responsible for the violation.

Tolerance Limits for Insect Fragments

Many food materials may contain natural but unwanted debris that cause no health hazards for humans. These debris may include insects, insect fragments, and rodent hairs and are considered unavoidable defects in foods with the current agricultural practices. In fact, the use of chemical substances to control insects, rodent, and other contaminants has little, if any, impact on natural and unavoidable defects in foods. The FDA contends that the use of pesticides does not effectively reduce the presence of these food defects. This has led the regulatory agencies to establish maximum levels of natural or unavoidable defects allowable in foods for human use. The FDA currently lists over 100 products from fruits to fish,^[s| and Table 2 shows only several examples. If no defect action level exists for a product, the FDA evaluates and decides on a case-by-case basis using criteria of reported findings such as length of hairs and size of insect fragments.

The FDA sets these action levels under the premise that it is economically impractical to grow, harvest, or process raw products that are totally free of nonhazardous, naturally occurring, unavoidable defects. It is incorrect, however, to assume that because the FDA has an established defect action level for a food, the manufacturer needs only keep defects just below that level. The defect levels do not represent averages of the defects that occur in any of the products. The levels represent limits at which FDA will regard the food product as adulterated and, therefore, subject to enforcement action. Like pesticide residues, blending of food with a defect at or above the current defect action level with

TABLE 1 Examples of Tolerance Limits for Pesticide Residues in Human Food

Source: FDA^|2> and USDA.™ ^a Dichlorodiphenyltrichloroethane.

another lot of the same or another food is not permitted. That practice renders the final food unlawful regardless of the defect level of the finished food.

Responsibility of Food Manufacturers

Food manufacturers are required to follow the standard manufacturing procedures under a federal regulation, known as good manufacturing practice (GMP), during food production.¹⁶¹ The GMP guidelines imply that all food materials used must not exceed the tolerance limits set for pesticide residues or any other poisonous or deleterious substances. The GMP also calls for the same regulatory requirement for natural or unavoidable defects in all food materials. The food materials susceptible to contamination may be tested for compliance or relied on a supplier’s guarantee or certification that they are in compliance. In addition, the GMP regulation stipulates that food manufacturers and distributors must utilize at all times quality control operations that reduce natural or unavoidable defects to the lowest level feasible with the current technology.

Potential Consumer Benefits

Through conducting a monitoring program, the federal government agencies work together to improve consumer protection. The EPA will continue to review scientific data on all pesticide products, while the FDA and U.S. Department of Agriculture will closely monitor levels of pesticide residues in all foods including both domestic and imported products. The U.S. Department of Agriculture’s data for 1998 suggest that violation of the pesticide tolerance limits was very low in all raw products including fruit and vege, wheat, and milk samples. In 1993, the FDA reported that no pesticide residues were found in infant formulas, and no residues over EPA tolerances or FDA action levels were found in any of the foods that were prepared as consumers normally would prepare them at home.¹⁷¹

Acknowledgments

Contribution No. 00-231-B, Kansas Agricultural Experiment Station, Manhattan, Kansas 66506, U.S.A.

TABLE 2 Examples of Tolerance Limits for Natural or Unavoidable Defects in Foods

Source: FDA.^(S|

References

• 1. FDA. FDA’s Food and Cosmetic Regulatory Responsibilities; U.S. Food and Drug Administration: Washington, DC, 1998; 1-5, http://vm.cfsan.fda.gov/~dms/regresp.html (accessed June 2000).
• 2. FDA. Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed; U.S. Food and Drug Administration: Washington, DC, 1998; 1-17, http://vm.cfsan.fda.gov/~lrd/fdaact. html (accessed June 2000).
• 3. USDA. Domestic Residue Book (Appendix I); U.S. Department of Agriculture, Food Safety and Inspection Service: Washington, DC, 1998; 1-30, http://www.fsis.usda.gov:80/OPHS/redbookl/ appndxl.htm (accessed June 2000).
• 4. USDA. Pesticide Data Program Annual Summary—Calendar Year of 1998; U.S. Department of Agriculture, Agricultural Marketing Service: Washington, DC, 2000; 1-19.
• 5. FDA. The Food Defect Action Levels—Levels of Natural or Unavoidable Defects in Foods that Present No Health Hazards for Humans. In FDA/CFSAN Food Defect Action Level Handbook; U.S. Food and Drug Administration: Washington, DC, 1998; 1-36, http://vm.cfsan.fda.gov/~dms/ dalbook.html (accessed June 2000).
• 6. CFR. Current good manufacturing practice in Manufacturing, Packing, or Holding Human Food. In Code of Federal Regulations, Title 21, Part 110; U.S. Government Printing Office: Washington, DC, 1999; 206-215.
• 7. FDA. FDA Reports on Pesticides in Foods; U.S. Food and Drug Administration: Washington, DC, 1993; 1-5, http://vm.cfsan.fda.gov/~lrd/pesticid.html (accessed June 2000).

Laws and Regulations: Pesticides

Introduction

Why Regulate Pesticides?

Chemical or biological pesticides have target specific toxicity that controls or eradicates pests falling under different groups. These products, though developed for specific usage, could have adverse effects on living beings and the environment and unchecked use can cause havoc. Regulating pesticides, therefore, would assure reasonable safety in use of these toxic substances and ensure that risks from pesticides to humans and their environment are minimized and are consistent with the benefits achieved by their use in terms of reduced losses.

Regulating pesticides at the international and national level should consider social costs in line with social benefits. Pesticides impose costs on society, such as health risks and environmental degradation, which are not borne by the user. The available policy remedies include bans on individual or classes of chemicals that prohibit the introduction of hazardous compounds into the environment, and economic instruments such as taxes, registration fees, and import duties that work to redistribute and adjust the social costs occurring for pesticide use and also provide the government with revenues that can be used to cover health costs and environmental clean-up activities.