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EPA Finalizes Second List of Chemicals to be Screened under EDSP

In a series of three Federal Register notices last week, EPA outlined actions it is taking in its Endocrine Disruptor Screening Program (EDSP) to help determine the health risk of potential endocrine disrupting chemicals.  EPA published the final second list of chemicals to screen, opened a comment period on the Information Collection Rule (ICR) that allows EPA to request information from chemical manufacturers for chemicals to be screened, and released the final policies and procedures governing the screening process.  The EDSP, established under the Federal Food, Drug, and Cosmetic Act (FFDCA), requires EPA to develop a chemical screening program to determine whether certain substances may have hormonal effects.  The EDSP consists of a two-tiered approach to screen and test chemicals for potential endocrine disrupting effects.  Tier 1 screening is to identify substances that have the potential to interact with the endocrine system (specifically, the estrogen, androgen, or thyroid hormone systems) using a battery of assays. Substances shown to have the potential to interact with the endocrine system 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.  The EDSP results do not cause any chemicals to be directly regulated under the SDWA, but data from the screenings would support the evaluation of health effects in the SDWA regulation process.

The final second list includes 109 chemicals identified for Tier 1 screening under EDSP.  The second group of chemicals to be tested consists of chemicals that the FFDCA requires be screened, i.e., pesticide active ingredients and chemicals used as pesticide inert ingredients and other chemicals as referenced in Section 1457 of the 1996 amendments to the SDWA (“any other substance that may be found in sources of drinking water if the Administrator determines that a substantial population may be exposed to such substance”). EPA published the draft second list in a Federal Register notice in November 17, 2010.  When finalizing the second list, EPA removed 25 chemicals and substances from the draft second list based on two criteria:  the manufacturer, importer or registrant cannot be clearly identified or the chemicals are not likely to be biologically active or are incompatible with testing assays for various reasons.  The list of removed chemicals includes a number of pesticides that are regulated in drinking water even though they are no longer used in the US.  The final list includes many pesticides, two Perfluorinated Compounds, and three pharmaceuticals (erythromycin, nitroglycerin, and quinoline). The list also includes an array of other chemicals such as those used for industrial manufacturing processes, as plasticizers, or in the production of pharmaceutical, personal care products, and toxic substances. Because this list of chemicals was selected on the basis of exposure potential only, it should neither be construed as a list of known or likely endocrine disruptors nor characterized as such.  The final list contains a number of SDWA regulated compounds and many more that are on the Contaminant Candidate List.

For the full list of chemicals to be screened and explanation of why chemicals were retained or dropped, see the Register notice for the final second list. To review the policies and procedures governing the EDSP process, see the Register notice on Final Policies.  Finally, for information on the ICR that will allow EPA to request data on these chemicals, see the Register notice on the ICR.