EPA Publishes Final Second List Of Chemicals And Substances For Tier 1 Screening and Draft Paper on Endocrine Disruptors

EPA Publishes Final EDSP Policies And Procedures And Final Second List Of Chemicals And Substances For Tier 1 Screening: On June 14, 2013, EPA published a Federal Register notice describing its final policies and procedures for requiring Tier 1 screening under the Endocrine Disruptor Screening Program (EDSP) of chemicals for which EPA may issue EDSP test orders pursuant to Section 1457 of the Safe Drinking Water Act (SDWA) and Section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA). 78 Fed. Reg. 35909. FFDCA Section 408(p) directed EPA to develop a chemical screening program using appropriate validated test systems and other scientifically relevant information (OSRI) to determine whether certain chemicals may have hormonal effects. These final policies and procedures supplement the EDSP policies and procedures that were published in the Federal Register on April 15, 2009. According to EPA, the 2009 policies and procedures were originally developed for screening pesticide chemicals and relied, in part, on a regulatory context that is specific to pesticide chemicals. EPA states that “the presumptions applicable in that context are not necessarily applicable to this larger universe of chemicals,” which include chemicals used in pharmaceuticals and personal-care products, among others. In a separate Federal Register notice, also published June 14, 2013, EPA announced the final second list of 109 chemicals identified for Tier 1 screening under the EDSP. 78 Fed. Reg. 35922. The EDSP consists of a two-tiered approach to screen and test chemicals for potential endocrine disrupting effects. EPA states that the purpose of Tier 1 screening is to identify substances having the potential to interact with the endocrine system. Substances that have the potential to interact with estrogen, androgen or thyroid systems may proceed to Tier 2, which is designed to identify any adverse endocrine-related effects caused by the substance, and establish a quantitative relationship between the dose and that endocrine effect. EPA notes that the second list “should not be construed as a list of known or likely endocrine disruptors.” More information regarding the EDSP is available online.

EPA Releases Draft Paper On Endocrine Disruptors: On June 19, 2013, EPA posted a draft paper on endocrine disruptors. The paper, State of the Science Evaluation: Nonmonotonic Dose Responses as They Apply to Estrogen, Androgen, and Thyroid Pathways and EPA Testing and Assessment Procedures, concludes that EPA’s current testing strategy is unlikely to miss problems that chemicals believed to pose endocrine disruptor issues would present to people or the environment. Information about EPA’s draft science paper on nonmonotonic dose responses along with links to the paper and related documents are available online.