EPA Begins Asking for Data on Chemicals’ Endocrine Effects

This week, the U.S. Environmental Protection Agency began sending out test orders under its Endocrine Disruptor Screening Program (EDSP). EPA is asking chemical manufacturers to screen certain chemicals to determine whether they are endocrine disruptors – a term used to categorize any compound capable of causing certain reproductive and developmental abnormalities.

The first round of test orders covers seven pesticide chemicals, the names of which I would surely misspell if I attempted to recite them. You can find the list and more information here. The orders are being sent to all registrants for the pesticides in question. The first round of test orders were sent to 19 different firms, according to EPA’s website.

As expected, the test orders are loaded with references to Other Scientifically Relevant Information (OSRI) – existing studies that could limit or eliminate the need for industry to test their chemicals. Although that term appears in the law authorizing the EDSP, its prominence is a result of pressure from the White House Office of Management and Budget (OMB).

OMB added scads of language to EPA’s initial drafts that appears to encourage industry to submit OSRI. OMB’s edits have caused quite a stir in the public health crowd who say most currently available studies were not conducted with the goal of determining a chemical's effect on the endocrine system and did not study low-dose exposure. Endocrine disruptors are thought to disrupt hormone functions even at very low levels.

At this time, it is difficult to gauge the impact of OMB’s edits: if industry submits existing studies in tandem with fresh data generated through the EPA-developed testing protocols, no big deal; but if industry is able to submit studies in lieu of new testing, EPA may not get the data it needs to make critical decisions that protect the public from harmful substances. That back and forth, which could occur for multiple chemicals, will in part shape the EDSP and determine its effectiveness.

Ultimately, the decision rests with EPA. If the agency doesn’t believe OSRI submitted by industry is sufficient to determine the endocrine disrupting effects of these chemicals, it must push back and demand new data. If industry refuses, EPA has the authority to ban manufacturers from selling certain chemicals until they oblige.

The good news is that EPA appears ready to hold test order recipients to a tight schedule. Recipients have 90 days to tell EPA how they plan to find or generate the data. For those manufacturers submitting OSRI in lieu of new data, EPA writes, “You should be aware that if the Agency determines that the study is not acceptable, the Agency will require you to comply with this Order, normally without an extension of the required due date for submission of the data.” A progress report is due within one year, and the final responses are due within two years.

For more on the program and OMB’s role, see this article from the latest issue of The Watcher: “OMB Role in EPA Chemical Program Questioned.”

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