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Endocrine Disrupter Screening Program Test Orders (October 2009)

In August 1996 Congress passed the Food Quality Protection Act requiring that the U.S. Environmental Protection Agency (EPA) initiate the Endocrine Disruptor Screening Program (EDSP) to screen pesticides and other chemicals for their potential effects on the endocrine systems of humans and wildlife. In October 2009, EPA began issuing EDSP Test Orders to screen pesticides and other chemicals. Companies have 90 days to respond after receipt of the EDSP Test Orders for a given chemical; therefore, it is important for Test Order recipients to quickly determine and execute the approach that will be most appropriate for each Test Order.

The available options for responding to a test order include the following:

1. Generate Data: Individually generate new data for each test specified in the Order, which must also comply with the procedures prescribed in the Order.
All data must comply with the Good Laboratory Practice (GLP) rule and the tests must be conducted according to protocol requirements described
in the Order.

2. Submit or Cite Existing Data: Submit or cite an existing study in response to the Order. An Initial Response must include either the data or a reference
to the data for each test that is required, along with a rationale that explains how the study that is cited/submitted satisfies part or all of the Order.

3. Form a Task Force or Offer to Join a Task Force: Form a task force to share in the cost of producing the required data.

In responding to the test order, TSG would like to draw attention to the guidance provided by the Office of Management and Budget to the EPA on the subject of the use of existing data:

“EPA should promote and encourage test order recipients to submit Other Scientifically Relevant Information (OSRI) in lieu of performing all or some of the Tier I assays, and EPA should accept OSRI as sufficient to satisfy the test orders to the greatest extent possible."

Studies conducted for pesticide registration purposes, studies in the open scientific literature and other in vivo and in vitro studies may therefore be relevant in determining whether some of the endpoints associated with Tier I screening may be addressed by OSRI. EPA is preparing to review the responses and make decisions as to whether or not to require the entire Tier 1 battery for each chemical for which a test order has been issued by the EPA. The challenge for companies receiving the test order will be to marshal the available information that constitutes OSRI and to explain how this information addresses the endpoints in the Tier I battery, within the 90-day time limit after receipt of the Test Order.

TSG helped organize and co-sponsor the September 9-10, 2009 International Society of Regulatory Toxicology and Pharmacology (ISRTP) workshop entitled “The Endocrine Disruptor Screening Program: What Can Screening Results Tell Us About Potential Adverse Endocrine Effects?” Our team of Board-Certified toxicologists has extensive experience using available information to address human health concerns thereby avoiding unnecessary animal testing. If testing is necessary in response to the Test Order, TSG can assist in the placement of studies at laboratories qualified to undertake these studies. In addition, if it is in the interest of your company to form or join a Task Force to respond to the Test Order, the experienced regulatory consultants at TSG can assist with that as well.

For more information, please
Contact TSG.
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