EPA Posts Endocrine Disruptor Screening Program Management Plan

According to the USEPA:

EPA has posted the Endocrine Disruptor Screening Program (EDSP) Comprehensive Management Plan on its website. The purpose of the EPA's EDSP is to protect people, wildlife and our environment from chemicals that may affect endocrine systems by screening pesticides, chemicals and environmental contaminants for their potential effects on estrogen, androgen and thyroid hormone systems.  EPA's EDSP Comprehensive Management Plan provides strategic guidance for agency personnel and outlines the critical activities that are planned for this program over the next five years. The plan is intended as an internal planning document, but is being made available to the public in order to be as transparent as possible.

For more information, the plan is available at http://www.epa.gov/endo

House Republicans Disagree with Endocrine Society on Need for EDSP

This week the Endocrine Society issued a series of recommendations "that will strengthen the ability of the current screening programs to identify EDCs." And now comes word that House Republicans are circulating language for the pending fiscal year budget that tries to limit the scope of EPA's endocrine-disruptor screening program (EDSP).

The Republican language is couched as an effort to "avoid unnecessary chemicals testing." It also tries to limit budgetary spending in an effort to restrict EPA's ability to formulate and implement policies on hydraulic fracturing, mountaintop mining, and other environmental issues that EPA is mandated to oversee. 

It's unclear on what basis the House Republicans believe that endocrine testing is "unnecessary" given that the lead scientific organization in that field is recommending greater attention to the issue. Endocrine testing was mandated by the 1996 Food Quality Protection Act, and EPA is a decade behind development of the testing regime required by that law passed unanimously by Congress.

More information on EPA's Endocrine Disruptor Screening Program can be found here.

EPA Releases Work Plan to Improve Evaluation of Chemicals in Endocrine Disruptor Screening Program

From the USEPA regarding the Endocrine Disruptor Screening Program:

"EPA is releasing an overview summary of the Agency’s work plan to improve the scientific methods used to evaluate chemicals that may impact the endocrine system in people and animals.  This work plan relies on scientific advancements in computational modeling, molecular biology, toxicology, and advanced robotics.  By incorporating these scientific advancements into evaluating chemicals under the Endocrine Disruptor Screening Program (EDSP), EPA will prioritize and screen chemicals with greater speed, efficiency, and accuracy, while minimizing the use of laboratory animals.  

The work plan, referred to as EDSP21, follows recommendations made by the National Research Council (NRC) in a 2007 report on toxicity testing.  Since EPA is required to complete registration review of registered pesticides by October 2022, new tools are needed to more quickly and efficiently screen and assess these pesticides.  Development and validation of these new tools will be a multiyear process.  As these new tools become ready for use, the EDSP will transition to rely on computational toxicology methods and high throughput screens to more quickly and cost-effectively assess potential chemical toxicity while minimizing the use of conventional whole animal studies.  The workplan summary describes this transition.

By way of background, EPA is required to screen pesticides and other chemicals for their potential to cause effects similar to those produced by estrogen and other natural hormones."  

The work plan can be downloaded from the EPA web site here.

EPA Releases Work Plan to Improve Evaluation of Chemicals in Endocrine Disruptor Screening

From EPA:

"EPA is releasing an overview summary of the Agency’s work plan to improve the scientific methods used to evaluate chemicals that may impact the endocrine system in people and animals.  This work plan relies on scientific advancements in computational modeling, molecular biology, toxicology, and advanced robotics.  By incorporating these scientific advancements into evaluating chemicals under the Endocrine Disruptor Screening Program (EDSP), EPA will prioritize and screen chemicals with greater speed, efficiency, and accuracy, while minimizing the use of laboratory animals.  

The work plan, referred to as EDSP21, follows recommendations made by the National Research Council (NRC) in a 2007 report on toxicity testing.  Since EPA is required to complete registration review of registered pesticides by October 2022, new tools are needed to more quickly and efficiently screen and assess these pesticides.  Development and validation of these new tools will be a multiyear process.  As these new tools become ready for use, the EDSP will transition to rely on computational toxicology methods and high throughput screens to more quickly and cost-effectively assess potential chemical toxicity while minimizing the use of conventional whole animal studies.  The workplan summary describes this transition.

By way of background, EPA is required to screen pesticides and other chemicals for their potential to cause effects similar to those produced by estrogen and other natural hormones."  
 

You can download and read a copy of the work plan on the Endocrine Disruptor page here.

EPA Seeks Public Comment on Industry Petition for Guidance on Endocrine Disruptor Chemicals

The USEPA on August 10, 2011 published a notice in the Federal Register "seeking public comment on a June 21, 2011 petition" from three major trade associations requesting the Agency "develop and publish guidance explaining the criteria by which EPA will make its decisions on data received in response to the test orders issued under the Endocrine Disruptor Screening Program" (EDSP).

Almost two years ago EPA initiated the EDSP Tier 1 screening for a list of 67 chemicals for the potential of being endocrine disruptors.  Orders for testing were issued in the months following, with manufacturers of the initial list of chemicals being required to conduct eleven Tier I screening assays.  The goal of the suite of assays is to "determine the potential for a chemical to interact with estrogen, androgen and thyroid hormone systems."  Chemicals that were identified as possible disruptors could be subject to a second tier of assays designed to further evaluate and quantify endocrine effects. Last month the Inspector General faulted EPA for not moving fast enough to identify endocrine disruptor chemicals, and this response is unlikely to speed up the process.

Herein lies the reason for the industry petition.  Despite efforts to develop higher level assays, the exact assays to be required and the criteria for selecting them remains uncertain.  Crop Life America (CropLife), the Consumer Specialty Products Association (CSPA), and the Responsible Industry for a Sound Environment (RISE) filed the petition in an effort to better understand how EPA will use the Tier 1 screening data.  Particularly, the trade associations want EPA to "fully analyze the Tier 1 screening data received in response to the list 1 test orders and revise the guidance to be developed to reflect what is learned by the analysis in order to ensure scientifically sound determinations and to protect the public health and the environment."  In other words, what exactly are you going to do with the data received, and can you at least figure out what it all means before jumping into requiring the suite of tests for hundreds of other chemicals.  And definitely don't even think about requiring Tier 2 tests before you know whether the Tier 1 tests provided any reliable information.

The Federal Register notice can be downloaded as a PDF here.

More information on EPA's Endocrine Disruptor Screening Program can be found on their web site.

Inspector General Faults USEPA for Inaction on Endocrine Disruptor Chemicals, Recommends Fixes

The Office of Inspector General (IG) at the USEPA has issued a report on EPA's Endocrine Disruptor Screening Progam (EDSP), and the results are not good.  Fourteen years after it was mandated in the Food Quality Protection Act (FQPA) and Safe Drinking Water Act (SDWA), "EPA's EDSP has not determined whether any chemical is a potential endocrine disruptor."  In fact, according to the IG report, "EDSP has not developed a management plan..., or established outcome performance measures to track program results."

In addition, EDSP has "missed milestones for assay validation and chemical selection established by the 2001...NRDC...settlement agreement."  What's more, even though the EDSP noted that it "was unaware of the complexities, resources, and time needed to validate assays until years after the 2001 settlement agreement was signed," it made only rudimentary adjustments to its milestone schedule.  To the IG, the lack of management plan by EPA and the EDSP severely restricts its ability to meet the requirements of the statute.  The IG notes that the EDSP "plans to develop a management plan" but "had not done so at the time of our review."

To correct these deficiencies, the Inspector General report makes the following recommendations:

• define and identify the universe of chemicals for screening and testing
• develop and publish a standardized methodology for prioritizing the universe of chemicals for screening and testing
• finalize specific Tier 1 and Tier 2 criteria to evaluate testing data
• develop performance measures
• develop a comprehensive management plan, and
• hold annual program reviews.

EPA responded to the IG's report but the IG felt the response was inadequate for some of the recommendations.  They consider the first three and last of the six recommendations "unresolved."

Clearly more effort on the part of EPA, and of Congress to provide funding to EPA so they can do what Congress has mandated, is necessary.

The Inspector General's report, 11-P-0215, can be downloaded as a PDF here.