DR. ANNA LOWIT: SENIOR SCIENTIST, HEALTH EFFECTS DIVISION,
PESTICIDE PROGRAM, ENVIRONMENTAL PROTECTION AGENCY
The Pesticide Program is a licensing program regulating pesticide products in the U.S., with the major role of reviewing the effects of pesticides on human and ecological health.
The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) requires the registration of new products, use of existing products, and review of older pesticides, and the ability to issue data call-ins. The risk-benefit balancing of the safety standard says that a pesticide will be registered if it will not cause “unreasonable adverse effects on the environment.” FIFRA also covers worker protection, certification, and training.
The Federal Food, Drug, and Cosmetic Act requires the EPA to establish limits for pesticides on domestic and imported food and food items for animals. The safety standard is not risk-benefit based and calls for a “reasonable certainty of no harm.”
In 1996, Congress passed the Food Quality Protection Act (FQPA) to maintain the
“reasonable certainty of no harm” safety standard and to require more sophisticated science to look at aggregate exposure and cumulative risk. FQPA also requires an additional 10x safety
factor for the protection of children.
Pesticides first registered before November 1, 1984 are required to undergo complete review for human health and environmental effects. The Reregistration Eligibility Decisions (REDs)
were completed in September 2008. The Pesticide Program is also beginning the process of
registration review of pesticides on a 15-year cycle.
FIFRA also requires that when a company discovers new effects of a pesticide or that a
pesticide causes effects at a lower dose than previously thought, they must report the
information to the EPA for an expedited review.
Risk assessments are developed with rigorous science. Pesticides are required to have
extensive toxicology and exposure data, primarily provided by industry.
The cancer risk assessment guidelines follow a paradigm of “data first, default second.” The EPA makes the best use of all available data from animal, human, in vitro, and predictive tools before assuming a linear relationship between dose and outcome when making
assessments.
The Pesticide Program has a transparent public process and convenes on a regular basis for scientific peer reviews on their approaches, guidance documents, models, and individual
chemical assessments.
Indianapolis, IN
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October 21, 2008