Standard Evaluation Procedures (SEPs) and Data Entry Spreadsheet Templates (DESTs) for EDSP Tier 1 Assays
EPA's Office of Chemical Safety and Pollution Prevention (OCSPP) has developed a set of Standard Evaluation Procedures (SEPs) which 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. The objective of the SEPs is to assist EPA reviewers and support comprehensive and consistent evaluations of major scientific topics; the SEPs also provide interpretive scientific and policy guidance where appropriate. The SEPs 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 set of eleven SEPs were developed by OCSPP for the EDSP Tier 1 battery to provide guidance to the Agency scientists who will be reviewing the data submitted for the Tier 1 assay battery. Each SEP will be used in conjunction with the appropriate EDSP Series 890 Test Guideline. While the SEPs were developed to explain specifically the principles of scientific evaluation of a Tier 1 assay within OCSPP, they 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. The DER will also 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.
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 The Agency submitted a separate draft guidance document of the Weight-of-Evidence (WoE) for public review and comment as described in a Federal Register Notice issued November 4, 2010 (75 FR 67963).
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 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.
Finally, 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.
You will need the free Microsoft Excel Viewer to view the DEST files file on this page.
You will also need the free Adobe Reader to view the SEP files on this page. See EPA's PDF page to learn more. If you need help accessing these PDF documents, please contact William Wooge at 202-564-8476 or firstname.lastname@example.org for assistance
Series 890 - Endocrine Disruptor Screening Program Test Guidelines
|Guideline Number||Assay||Standard Evaluation Procedures (SEPs)||Data Entry Spreadsheet Templates (DESTs)|
|890.1100||Amphibian Metamorphosis||September 2011 Version (PDF) (54 pp, 682K)||October 2011 Version (XLS)|
|890.1150||Androgen Receptor Binding (Rat Prostate)||October 2011 Version (PDF) (14 pp, 122K)||September 2011 Version (XLS)|
|890.1200||Aromatase (Human Recombinant)||August 2011 Version (PDF) (13 pp, 178K)||September 2011 Version (XLS)|
|890.1250||Estrogen Receptor Binding||October 2011 Version (PDF) (15 pp, 147K)||September 2011 Version (XLS)|
|890.1300||Estrogen Receptor Transcriptional Activation (Human Cell Line HeLa-9903)||September 2011 Version (PDF) (13 pp, 177K)||September 2011 Version (XLS)|
|890.1350||Fish Short-Term Reproduction||October 2011 Version (PDF) (22 pp, 248K)||September 2011 Version (XLS)|
|890.1400||Hershberger (Rat)||October 2011 Version (PDF) (19 pp, 244K)||September 2011 Version (XLS)|
|890.1450||Female Pubertal (Rat)||August 2011 Version (PDF) (21 pp, 200K)||September 2011 Version (XLS)|
|890.1500||Male Pubertal (Rat)||August 2011 Version (PDF) (21 pp, 211K)||September 2011 Version (XLS)|
|890.1550||Steroidogenesis (Human Cell Line – H295R)||August 2011 Version (PDF) (13 pp, 153K)||September 2011 Version (XLS)|
|890.1600||Uterotrophic (Rat)||September 2011 Version (PDF) (22 pp, 237K)||September 2011 Version (XLS)|