Center for Endocrine Screening and Testing
The American Chemistry Council’s (ACC) Center for Endocrine Screening and Testing represents a premier scientific, technical, and advocacy resource for the chemical industry on endocrine issues, particularly in the U.S. Environmental Protection Agency’s (EPA)
Endocrine Disruptor Screening Program (EDSP). Managed through the self-funded
Chemical Products and Technology Division (CPTD), the ACC Center demonstrates effective engagement in each phase of the EDSP through a comprehensive range of activities and services.
ACC’s scientists and regulatory experts have been involved in all aspects of the program’s development since its authorization in 1996. The ACC team’s expertise encompasses all of the technical, policy, and regulatory aspects of the EDSP. When EPA issued its first set of test orders during the first phase of the EDSP in 2009 and 2010, through the Center, experts provided timely and effective response to assist ACC’s panels and member companies.
The EDSP Tier 1 screening is an ambitious testing program that is being implemented under new policies and procedures, utilizing a suite of newly validated—and expensive—test methods. As EPA moves forward in expanding the EDSP beyond pesticide chemicals to substances present in sources of drinking water, many more chemical manufacturers and users may be affected. In anticipation of the second phase of testing, the Center is ideally suited to assist companies and consortia with effective management and response to EPA’s EDSP requirements.
The wide range of services provided by the Center includes the following:
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Consortium formation and management through CPTD
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Interaction on behalf of members with EPA
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Preparation of Requests for Proposal (RFP) and proposal solicitation from contract labs
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Scheduling of testing to optimize other scientifically relevant information (OSRI), assay known performance, and limitations of testing protocols
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Review OSRI to determine whether one or more EDSP Tier 1 screens can be omitted
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Interpretation of test data for individual assays and the overall EDSP Tier 1 battery, as well as submittal to EPA.
ACC’s staff at the Center has a thorough and highly valuable understanding of EPA’s EDSP program. As an internal consulting group, staff members are a resource to serve the chemical industry in meeting EDSP’s unique challenges and requirements. For example, EPA and related global initiatives often require company responses in order to continually modify or improve screening techniques. The ACC staff’s skills and knowledge can assist with this and many other issues through its diverse experience, including:
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Participating in International Society of Regulatory Toxicology and Pharmacology (ISRTP) workshops that gather together experts in the field—academics, industry scientists, and government regulatory staff—to analyze and discuss critical elements of the EDSP
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Collaborating in a comprehensive review, published in peer reviewed scientific literature, of each EDSP Tier 1 assay, detailing strengths, limitations, pitfalls encountered in analyzing results and providing useful recommendations in order to enhance the interpretation of results
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Collaborating on a model approach to conduct a weight of evidence evaluation of individual EDSP Tier 1 screening assays and the Tier 1 battery
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Forming a consortia to conduct EDSP Tier 1 screening
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Leading consortia activities, including responding to test orders, identifying testing laboratories, contracting and managing testing, interpreting results, and submitting results to the Agency
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Evaluating the use of QSAR or other rapid screening assays to replace portions of the current Tier I screening assays
These services, in addition to enhanced advocacy support and strategic planning, underpin a track record of effective response to a range of government initiatives on the endocrine issue, including the EDSP. The Center’s staff members also represent ACC in the Endocrine Policy Forum, and play a significant role in the coalition’s efforts to develop a formal weight-of-evidence framework. Consortia at the Center will be able to draw on this and other experience for the scientific, regulatory, and technical aspects of EPA’s EDSP. Our specialists’ expertise with both endocrine screening and testing and consortia management is unsurpassed as staff members at ACC’s Center for Endocrine Screening and Testing collectively have decades’ worth of invaluable experience.
For further information about the Center, please contact: David Fischer at
[email protected], or (202) 249-6717.