The EPA's Endocrine Disruptor Screening Program

Killing millions of wild animals in the name of "environmental protection"—now there's a warped idea—but that's exactly what the U.S. Environmental Protection Agency (EPA) plans to do.

What is the EDSP?

The EDSP is a massive chemical-testing program intended to screen chemicals for effects on the body's natural hormones (known as "endocrine disruption"). The program resulted from a 1996 law requiring the EPA to "develop a screening program … to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect as the [agency] may designate." However, once in the hands of the EPA, this simple mandate quickly mutated into what threatens to become one of the largest animal testing exercises in U.S. history.

First, the EPA put together an advisory committee with representatives from environmental groups, industry, and all other interested parties … except the animal protection community. Then, on the advice of its committee, the EPA expanded the scope of its Endocrine Disruptor Screening Program to examine not only estrogen-like effects but also effects on androgen and thyroid hormones. Then the EPA took it even further by vastly expanding the program's scope to include toxicity testing on birds, fish, amphibians, and invertebrates. The wildlife toxicity tests alone could potentially quadruple the number of animals who are killed as a result of this massive program.

How does the program work?

To test the chemicals, EPA has devised a two-tiered screening program. Tier 1 screening assays (the Tier 1 Battery) consists of five in vitro and six in vivo assays and are intended to identify chemicals that have the potential to cause endocrine disruption. These identified chemicals would then trigger Tier 2 testing, which is designed to identify and establish dose-response relationships for any adverse endocrine-related effects. 

What are some criticisms of the program?

PETA and other stakeholders have raised many criticisms about the program, such as a failure to adequately validate many of the Tier 1 assays. Validation is a process in which a test method is evaluated to determine whether the information that it produces is reliable, reproducible, and relevant to humans. Not only is test-method validation a prerequisite for good science, in the case of the EDSP, it is also required by law. The law mandating it for the EDSP, the Food Quality Protection Act of 1996, states that only appropriate validated test systems can be used in the program. Interestingly, prior to the EDSP, only non-animal tests were required to undergo validation (the dozens of animal tests that have been used for decades were never validated). Other criticisms of the EDSP include the lack of selectivity of many of these assays, the high false-positive rates of three of the assays, and the fact that EPA has no method in place to interpret mixed results—in the likely case that a chemical tests both positive and negative for endocrine effects. Visit our Scientific Problems page for more information.

How has PETA responded to the program?

In an attempt to limit the damage brought on by would-be environmental and wildlife protection groups that favor increased animal testing, PETA filed a legal petition with the EPA, calling on the agency to limit the scope of its endocrine program to an assessment of effects in humans, as was specified by the 1996 law. The EPA and the animals to be used in this testing program would have been far better off if the EPA had begun with this legally mandated scope, if only to explore scientifically whether or not this program had regulatory merit. In addition, non-animal methods were then available for several of the tests that pertain to human health effects. Unfortunately, the lawsuit was unsuccessful because of a finding of lack of standing.

Despite our efforts and criticisms of the program from numerous stakeholders, the EPA issued requests for information on the first 67 chemicals (Phase I chemicals) in June, 2007. Click here to read PETA's comments to the EPA about the list. All chemicals on the list are either pesticides or HPV chemicals and have already undergone many animal tests from which we can glean endocrine potential without further testing. Pesticides, for example, are among the most highly data-rich substances in existence. For registration, pesticide active ingredients and final products are usually subject to dozens of separate animal tests, including reproductive and chronic/lifecycle studies in rodents, fish, and birds. These tests kill thousands of animals and include many of the same endpoints addressed in the presumptive EDSP Tier 2 tests. Similarly, the U.S. EPA's Chemical Challenge Program also provides for the collection of data which can be used in the assessment of potential reproductive effects.

In a May 2009 letter to the Office of Management and Budget (OMB), PETA and other stakeholders questioned the usefulness of the EDSP and alerted the OMB to the potential for waste of resources, including the loss of thousands of animals' lives. The letter and two subsequent meetings successfully convinced the OMB that the cost/benefit for the program was inadequate—that there was very little benefit for such an extraordinary cost. As a result, and in a move highly unusual for the OMB, the agency instructed the EPA to use existing data whenever available in lieu of performing some or all of the tests in the Tier 1 Battery, which would save tax-payer dollars and the lives of thousands of animals. For example, the EPA could use information from its own ToxCast^TM program, launched in 2007, which uses in information from in vitro assays and allows connections to be rapidly made between in vitro assay results and existing data on chemicals. Most of the Phase I chemicals have already been tested in ToxCast screens, and nearly half of these showed no evidence of endocrine activity.

The OMB also instructed the EPA to "ensure sufficient opportunity … for public comment and peer review … on whether a chemical must proceed to Tier II." Such a period of assessment and review is critical for allowing the EPA to review the cost/benefit of each assay within the Tier 1 Battery and to delete assays that provide no added value. The EPA should also use this period of assessment as an opportunity to incorporate new non-animal assays that have been developed since the 1992 decision to incorporate the current battery of assays. 

In response to the EPA call for data for Phase I of the EDSP, PETA has submitted detailed reviews of existing data for 14 Phase I chemicals. In addition, we have presented an integrated strategy that would more efficiently assess chemicals for endocrine disrupting potential, and we have applied this approach in detail to two of the Phase I chemicals.

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