Standard Evaluation Procedures (SEPs) and Data Entry Spreadsheet Templates (DESTs) for Endocrine Disruptor Screening Program (EDSP) Tier 1 Assays
- Developed by EPA's Office of Chemical Safety and Pollution Prevention (OCSPP)
- Provide guidance for the review and evaluation of environmental and human health effects data submitted in response to test orders for the 890 Guideline Series for the Endocrine Disruptor Screening Program (EDSP) Tier 1 battery.
- There is an individual SEP for each of the eleven 890 Guideline Series EDSP Tier 1 assays that comprise the battery.
- Assist EPA reviewers and support comprehensive and consistent evaluations of major scientific topics.
- Provide interpretive scientific and policy guidance where appropriate.
- Provide a venue for standardizing data organization and evaluation procedures with the goal of increasing the efficiency, thoroughness and consistency with which individual study evaluations are prepared and assist the scientists to reach clear, reasonable and concise conclusions that are scientifically robust.
The SEPs do not provide guidance for making the determination that a chemical which has been screened using the EDSP Tier 1 assays should move on to Tier 2 testing. The Agency submitted a separate draft guidance document of the Weight-of-Evidence (WoE) for public review and comment as described in a Federal Register Notice issued November 4, 2010 (75 FR 67963).
SEPs may also have utility to other offices in the Agency. Using the guidance within the relevant SEP, Agency reviewers will develop Data Evaluation Records (DERs) for each of the submitted assays. The DERs will:
- Reflect how well the assay conforms to the Series 890 EDSP Test Guidelines and document basic study information such as materials, methods, results, significant deviations from the study protocol or guideline recommendations as well as their potential impacts.
- Provide the registrant’s conclusions, the EPA reviewer’s conclusions and any other information about the performance of the study that affects interpretation of the data within the context of the EDSP.
OCSPP has also developed a set of Data Entry Spreadsheet Templates (DESTs) that test order recipients may choose to use as a method for reporting all raw data in electronic format for the 890 Guideline Series for the EDSP Tier 1 battery. There is a DEST for each of the eleven 890 Guideline Series EDSP Tier 1 assays that comprise the battery. EPA is encouraging test order recipients to use the DEST as a method for standardizing raw data reporting and to assist EPA reviewers in the comprehensive and consistent evaluations of the raw data.
The study profile templates (SPTs) describe the layout and scope of information that should be contained within a study profile and can serve as a guide for the preparation of study documents. Applicants may include additional information beyond that prescribed in a particular study profile; however, it should be done without affecting or changing the format and content of the template.
Sort alphabetically or by Guideline Number by using the column headings. Find an assay by using the search function, or use both features together.
The SEPs, DESTs, and other EDSP guidance documents will be open to periodic updating and revision to reflect advances in the science as it come available. The SEPs and DESTs provide general guidance and are not binding on either the Agency or any outside parties. The use of language such as "will," "is," "may," "can" or "should" in the SEPs or DESTs does not connote any requirement for either EPA or any outside parties. As such, EPA may depart from the guidance or revise these templates where circumstances warrant and without prior notice.