EPA is seeking comments on draft guidance, developed to aid not only EPA personnel but also chemical and pesticide manufacturers, environmental organizations and other interested parties in understanding the criteria the agency uses to determine when manufacturers could be required to conduct extensive tests to detect a pesticide or chemical’s potential to disrupt the endocrine system.
The draft guidance was prepared under the agency’s Endocrine Disruptor Screening Program (EDSP), which was established by congressional mandate in the 1996 Food Quality Protection Act and Safe Drinking Water Amendments. The EDSP is a two-tiered paradigm. The first consists of relatively quick cellular and short-term whole animal tests to determine whether a pesticide or chemical could potentially affect the hormonal actions of estrogen, androgen or the thyroid hormones. If so, EPA can require the manufacturer to conduct Tier 2 screening, which consists of much longer and expensive multigenerational tests of rodents, birds, fish, and other species, designed to determine whether a pesticide or chemical causes harm by affecting hormones identified in Tier 1.
The draft guidance describes questions EPA staff should consider as they review data submitted under the EDSP, considerations they should take into account and information they should communicate when they decide a pesticide or chemical should proceed to Tier 2 testing. EPA will accept comments on the draft until January 3, 2011.