Abstract
In 1996, the U.S. Congress passed the Food Quality Protection Act and amended the Safe Drinking Water Act (SDWA) requiring the U.S. Environmental Protection Agency (EPA) to implement a screening program to investigate the potential of pesticide chemicals and drinking water contaminants to adversely affect endocrine pathways. Consequently, the EPA launched the Endocrine Disruptor Screening Program (EDSP) to develop and validate estrogen, androgen, and thyroid (EAT) pathway screening assays and to produce standardized and harmonized test guidelines for regulatory application. In 2009, the EPA issued the first set of test orders for EDSP screening and a total of 50 pesticide actives and 2 inert ingredients have been evaluated using the battery of EDSP Tier 1 screening assays (i.e., five in vitro assays and six in vivo assays). To provide a framework for retrospective analysis of the data generated and to collect the insight of multiple stakeholders involved in the testing, more than 240 scientists from government, industry, academia, and non-profit organizations recently participated in a workshop titled "Lessons Learned, Challenges, and Opportunities: The U.S. Endocrine Disruptor Screening Program." The workshop focused on the science and experience to date and was organized into three focal sessions: (a) Performance of the EDSP Tier 1 Screening Assays for Estrogen, Androgen, and Thyroid Pathways; (b) Practical Applications of Tier 1 Data; and (c) Indications and Opportunities for Future Endocrine Testing. A number of key learnings and recommendations related to future EDSP evaluations emanated from the collective sessions.
Highlights
In response to public and scientific concern that various environmental chemicals may interfere with endocrine function in humans and wildlife, in 1996, the U.S Congress passed the Food Quality Protection Act (FQPA) and amended the Safe Drinking Water Act (SDWA) requiring the U.S Environmental Protection Agency (EPA) to implement a screening program to investigate the potential of pesticide chemicals and drinking water contaminants to adversely affect endocrine pathways
In 2009, the EPA issued the first set of test orders for Endocrine Disruptor Screening Program (EDSP) screening and a total of 50 pesticide actives and 2 inert ingredients have been evaluated using the battery of EDSP Tier 1 screening assays and the data submitted for review by EPA
In June 2013, EPA announced the second set of substances for EDSP Tier 1 screening, consisting of 41 pesticide active ingredients and 68 chemicals identified under the SDWA
Summary
In response to public and scientific concern that various environmental chemicals may interfere with endocrine function in humans and wildlife, in 1996, the U.S Congress passed the Food Quality Protection Act (FQPA) and amended the Safe Drinking Water Act (SDWA) requiring the U.S Environmental Protection Agency (EPA) to implement a screening program to investigate the potential of pesticide chemicals and drinking water contaminants to adversely affect endocrine pathways. The EPA launched the Endocrine Disruptor Screening Program (EDSP) and invested considerable time and effort over a number of years to develop and validate estrogen, androgen, and thyroid (EAT) pathway screening assays and to produce standardized and harmonized test guidelines for regulatory application. The workshop focused on the science and experience to date with the EDSP and identified opportunities to inform ongoing and future efforts to evaluate the endocrine disruption potential of chemicals. – The assessment and application of alternative test data (e.g., ToxCastTM, adverse outcome pathway data) could be useful in replacing Tier 1 screening assays provided that sufficient scientific validation of alternative approaches has been achieved for use in regulatory decision-making. – Collaboration, coordination, and communication among the regulatory community and stakeholders are vital to insuring future scientific relevance and success of the EDSP program for informing on endocrine potential and for protection of human health and the environment For the EDSP, and, over a longer-time period, replace Tier 1 screening (U.S EPA, 2011a). – A framework for a validation strategy that would provide the evidence required for acceptance of HTS assays and prediction models for regulatory applications should be developed and reviewed by multiple stakeholders and independent reviewers for subsequent implementation. – There are multiple centers of research that continue to advance thinking around potential for perturbation of endocrine pathways, including specific focal areas such as low-dose behavior, pathways of toxicity, and reverse toxicokinetics, all of which may inform Tier 1 screening data and beyond. – Explicit consideration of human and ecological exposure potential could be valuable in future prioritization and decision making efforts. – Current collaborations aimed at improvement of exposure assessment and reverse dosimetry screening with HTS data offer promise for developing a risk-based decision tool which could initially be used for priority setting and eventually for risk assessment purposes. – Collaboration, coordination, and communication among the regulatory community and stakeholders are vital to insuring future scientific relevance and success of the EDSP program for informing on endocrine potential and for protection of human health and the environment
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