EPA is developing a fully electronic, Web-based submission system to handle the receipt of responses to future Endocrine Disruptor Screening Program test orders. On Tuesday, December 3, 2013, 1:00 to 4:00 pm EDT, EPA will conduct a Web-based walk through of the EDSP submission module currently under development and seeking input from potential industry users of the system. The focus of the session is on the functionality of the system, and that specific requirements for test orders will not be discussed during the demonstration.
EPA’s Science Advisory Panel met on July 30-August 2, 2013, to review “Weight-of-Evidence: Evaluating Results of EDSP Tier 1 Screening.” The SAP has released the minutes of this meeting. They criticized EPA’s Tier 1 Amphibian Metamorphosis Assay on several grounds, including the following:
“The concentrations of Chemical S achieved in the aquarium water in the AMA were below the targeted nominal concentrations, and there was large variability in the measured concentrations. For these reasons the Panel disagreed with the Agency’s conclusion that the exposure was reasonably quantified. Because of the low solubility and high variability in the measured concentrations of Chemical S, and a lack of information on how the measured concentrations of Chemical S compare to expected environmental exposures, the Panel concluded that the results do not enable reviewers to determine responses.”
A recent blog posting challenges the notion that some chemicals can cause endocrine effects that reduce human sperm counts. This posting is an article entitled My Sperm Is Fine—The Myth of Endocrine Disruption. The study it discusses shows no evidence of sperm decline after 16 years of sampling of the most relevant cohort of Danish males. The article suggests that researchers did not publish the study results because they do not support the researchers’ hypothesis of endocrine disruption.
This article explains that
The National Research Council’s Nonmonotonic Dose Response Committee will meet for the third time on December 9, 2013 – December 10, 2013, at the Keck Center, 500 5th Street, NW, Washington D.C. This NRC committee is reviewing EPA’s draft paper State of the Science on Nonmonotonic Dose Response. This meeting is closed in its entirety, but a closed session summary is supposed to be posted after the meeting. Endocrine disruption issues are prominent in this NRC review.
Click here for the NRC website for this project.
On June 25-28, 2013, EPA’s Science Advisory Panel reviewed and rejected EPA’s proposed EDSP Tier 2 tests. The SAP Minutes speak for themselves on this issue:
“The focus of this SAP meeting was on the validation status of the proposed EDSP Tier 2 ecotoxicity tests. The Panel supports the scientific rationale and purpose, representative species chosen, biological and toxicological relevance of the major endpoints selected and measured, and the validation process used by EPA for all four proposed Tier 2 ecotoxicity texts. However, the inter-laboratory variability indicates that all four Tier 2 ecotoxicity tests are not yet repeatable and transferable. In particular, there are flaws in the experimental design and statistical analysis, lack of clarity in the protocol and precision in conducting the assays, and a need for additional reference chemicals (generically referred to as positive controls).”
The U.S. Food and Drug Administration has published for comment its draft Guidance for Industry Endocrine Disruption Potential of Drugs: Nonclinical Evaluation. According to the FDA, “This draft guidance provides recommendations to sponsors of investigational new drug applications, new drug applications, and biologics license applications regulated by the Center for Drug Evaluation and Research (CDER) regarding nonclinical studies intended to identify the potential for a drug to disrupt the endocrine system. The guidance discusses factors that should be considered when determining the nature and extent of nonclinical studies necessary to characterize potential endocrine disruptor properties of drugs.” This FDA guidance on endocrine disruption testing does not mention EPA’s EDSP program. The FDA asks for comments on this draft guidance by November 19, 2013.
The NAS/NRC will hold its second meeting to review EPA’s draft paper State of the Science on Nonmonotonic Dose Response on September 30 to October 1, 2013, at the Keck Center, 500 5th Street, NW, Washington, D.C. This meeting will not be open to the public. A closed session summary will be posted on the NAS/NRC website after the meeting. The EDSP has been a frequent topic of comments so far in this review.
The CRE website was attacked with the result that had we not pulled down the website we would have risked loosing content.
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Two Science Advisory Panels have criticized EPA’s use of the Amphibian Metamorphosis Test as part of EPA’s Tier 1 EDSP screening battery. A May SAP recommended that EPA not use the AMA for any additional chemicals because its test results to date have too many problems and flaws. A July SAP has also identified many flaws in the AMA test. Click here to read SAP meeting transcript discussion of AMA at pages 368 to 373.
EPA’s Science Advisory Panel met on May 21-23, 2013, to review EPA’s Tier 1 EDSP tests. The SAP minutes for this meeting are now available online. They include the SAP’s recommendation at pages 39-44 that EPA not use the Amphibian Metamorphosis Assay to screen any additional chemicals until and unless EPA solves several problems with the AMA.
Click here to read SAP minutes.