In 1996, through the enactment of the Food Quality Protection Act (FQPA), the U.S. Congress directed EPA to screen pesticides for estrogenic activity in humans using validated assays or other scientifically relevant information (OSRI) and gave the Agency discretionary authority to screen for other endocrine effects. The Safe Drinking Water Act Amendments (SWDA) of 1996 authorized EPA to screen drinking water contaminants for similar activities.
To meet these requirements, the USEPA developed the Endocrine Disruptor Screening Program (EDSP) that uses a tiered approach for determining whether a substance may have an effect in humans that is similar to an effect produced by naturally occurring estrogen, androgen, or thyroid hormones. The core elements of the EDSP consist of; Setting priorities for chemicals to be screened and tested, Tier 1 Screening using 11 in vitro and in vivo (mammalian and non-mammalian) validated assays, Tier 2 Testing (assays still under review) designed to encompass critical life stages and processes over a broad range of doses administered by a relevant route of exposure, and Hazard Assessment using both Tier 1 Screening and Tier 2 Testing data along with OSRI to characterize hazard. OSRI can also be used to provide EPA with relevant data to determine the need for further screening (Tier 1) and/or testing (Tier 2). At this time, the first list of chemicals, identified and mandated by EPA, have been screened in Tier 1 assays and the data currently being evaluated by the agency. EPA has identified a second list of chemicals for Tier 1 screening with registrants currently anticipating the receipt of test orders.
ToxStrategies professionals have the scientific expertise to address endocrine disruption issues which include study design to address the role of endocrine disruption in the development of specific tumors, assay validation to assess endocrine disruption, and scientific oversight in which over 20 test substances were screened using Tier 1 assays. ToxStrategies professionals also have extensive industry and regulatory experience to assist clients with all aspects of EDSP which include:
- Point of contact for Consortia; implementation and oversight of program
- Identification and critical review of peer-reviewed and regulatory study data for preparation and submission of “Other Scientifically Relevant Information” (OSRI)
- Development of EDSP Tier I testing strategy
- Dose- and/or Concentration selection for Tier I assays (design of dose range finding studies)
- CRO assay placement and study monitoring; developing and tracking timelines
- Data Submission of EDSP Tier 1 study results to EPA
- Preparation of Weight-of-Evidence, using OSRI and Tier 1 data to determine need for Tier 2 Testing
- Design studies to address data gaps to determine need for Tier 2 Testing (Provide OSRI)
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