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Pesticide News Story: New Standard Evaluation Procedures Provide Guidance for Review of EDSP Tier 1 Assays; Support Consistency, Efficiency and Transparency in the Review Process

For Release: August 12, 2011

EPA has developed and is issuing a set of Standard Evaluation Procedures providing guidance for the review and evaluation of environmental and human health effects data submitted in response to requests for data for the Endocrine Disruptor Screening Program Tier 1 battery of screening assays.

Individual SEPs will be available for each of the 11 Tier 1 assays in the EDSP Test Guideline Series 890. SEPs assist agency reviewers and support comprehensive and consistent evaluations of major scientific studies and topics. By providing a venue for standardizing data organization and evaluation procedures, SEPs increase the efficiency, thoroughness and consistency of study evaluations, and assist agency scientists in reaching clear, concise, reasonable and scientifically robust conclusions. The first two SEPs for EDSP Test Guideline Series 890 studies are available on EPA’s website at http://www.epa.gov/scipoly/oscpendo/pubs/toresources/seps.htm. Additional SEPs will be added as they become available later this year.

Using the guidance in the EDSP SEPs, EPA reviewers will develop Data Evaluation Records for each of the submitted assays. DERs reflect how well assays conform to the EDSP Test Guidelines. The DERs document basic study information such as materials, methods and results, and provide the registrant’s and EPA reviewer’s conclusions. DERs capture information about the performance of the study that affects interpretation of the data within the context of the EDSP. EPA has also developed and is issuing standardized formats or study profile templates for industry to use for studies submitted to the agency in response to the EDSP Tier 1 battery test orders. These study profile templates for submissions are available on EPA’s website at http://www.epa.gov/pesticides/regulating/studyprofile_templates/studyprofile_templatelist.htm.

EPA initiated EDSP Tier 1 screening for the first list of 67 chemicals by issuing orders from late October 2009 through February 2010 requiring the testing of chemicals using the 11 screening assays. The purpose of the screening assays is to determine the potential for a chemical to interact with estrogen, androgen and thyroid hormone systems. Based on the data from the Tier 1 assays, if a chemical is shown to interact with these hormone systems, additional Tier 2 testing may be required.

For further information on the EDSP, visit http://www.epa.gov/scipoly/oscpendo/index.htm.

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