even when tests are done, and pesticides are not always used according to directions;
thus, dangerous pesticide residues do make their way to the foods that people eat.^58Reasonable Certainty of No HarmThe Food Quality Protection Act of 1996 (FQPA) requires that tolerances be
‘‘safe,’’ defined as ‘‘a reasonable certainty that no harm will result from aggregate ex-
posure,’’ including all exposure through diet and other non-occupational exposures,
including drinking water, for which there is reliable information. It also distinguishes
between cancer and non-cancer effects, consistent with EPA practice. The law estab-
lishes a single, health-based standard for all pesticide residues in all types of food,
replacing the sometimes conflicting standards of the old law. There are no differences
in the standards applicable to tolerances set for raw and processed food. Additional
provisions ensure coordination with standards and actions under FIFRA for a more
consistent regulatory scheme.^59Risk AssessmentRisk assessment is a process used by the EPA to determine if pesticide residues on
food may prove harmful to human health. Toxicity and exposure are the two main
components in risk assessment. Toxicity indicates the capacity of a pesticide to cause
harm. Exposure describes how a pesticide will come in contact with the body and at
what quantity and duration. A person can be exposed by eating, breathing, or touch-
ing pesticides. A pesticide can be very toxic, but exposure is necessary for there to be
a health risk. The toxicity of a pesticide is usually determined by tests on laboratory
animals. Scientists expose the animals to high levels of a pesticide to determine what
health effects occur. The results of these studies give scientists the ability to determine
the relative toxicity of pesticides in various species of animals. Determining accurate
exposure to pesticides is a very difficult task. The exposure to a pesticide can be via
multiple routes and for varying durations. Certain assumptions are made about the
consumption of a food item under consideration. Often the exposure assessment is
on the high end of the data range to account for the possibility that someone might
consume a large quantity. In reality, people eat varying quantities of food and this
variability is not accounted for in traditional risk assessment.^60The Delaney ClauseThe Delaney Clause, named after Representative James J. Delaney, a New York
Democrat, is a provision that prohibits without exception the use of any food addi-
tives in processed food that may cause cancer in humans. Before the 1996 FQPA,
pesticides had been considered food additives and been subjected to the Delaney
Clause. Although a well-intentioned provision, there were significant problems in
applying the Delaney Clause to pesticide residues. If a pesticide that causes cancer in
humans or laboratory animals is concentrated in ready-to-eat processed food at a level
greater than the tolerance for the raw agricultural commodity, then the clause18 | Pesticides