standard for setting tolerances. The standards set must assure ‘‘a reasonable certainty
of no harm’’ to children’s health, a new and more protective requirement. Pre-FQPA
pesticide regulation did not include answering basic questions such as:
- Could the pesticide affect a child’s behavior, learning, or memory?
- Does it affect the developing nervous system, especially since many pesticides
work by short-circuiting the nervous system, and if so, how? - What is the impact of multiple pesticide exposures, as occurs daily in real life?
- What is the pesticide’s effect on the immune system?
- Does the pesticide disrupt hormone systems?^11
The Food Quality Protection Act of 1996
The statute removed the Delaney Clause and revised the approach to how risk
assessments are conducted, including a specific mechanism to consider risks to chil-
dren. The law requires an explicit determination that tolerances are safe for children,
includes an additional safety factor of up to tenfold to account for uncertainty in
data, and requires consideration of children’s special sensitivity and exposure to
pesticides.
These amendments fundamentally changed the way the EPA regulates pesticides,
based on a new standard of ‘‘reasonable certainty of no harm’’ that must be applied
to all pesticides used on foods. For more than two decades there were efforts to
update and resolve inconsistencies in the two major pesticide statutes, but consensus
on necessary reforms remained elusive. The FQPA represented a major breakthrough,
amending both major pesticide laws to establish a more consistent, protective regula-
tory scheme grounded in sound science. It mandates a single, health-based standard
for all pesticides in all foods; provides special protections for infants and children;
expedites approval of safer pesticides; creates incentives for the development and
maintenance of effective crop protection tools for American farmers; and requires
periodic reevaluation of pesticide registrations and tolerances to ensure that the scien-
tific data supporting pesticide registrations will remain current in the future.
Revising Tolerance-Setting Criteria for Pesticide Residues in Food
A key issue in the 104th Congress was whether to revise the so-called zero-risk
standard of the Delaney Clause (FFDCA, Section 409), which prohibits the addition
of potentially cancer-causing substances to foods. The application of the Delaney
Clause to pesticide residues was criticized for being unscientific and for creating a
confusing and inconsistent set of standards for safety, depending on whether a pesti-
cide was on raw or processed food and whether it was a carcinogen or not. Critics
of pesticide regulation under Delaney maintained that it was unscientific because
very low pesticide residues pose no significant risk to health. Technology is now
Pesticides in Food | 71