40 CFR 799 - IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS

EPA is promulgating this final rule under section 4(a)(1)(B) of the Toxic Substances Control Act (TSCA) to require manufacturers, importers, and processors to conduct testing to obtain screening level data for health and environmental effects and chemical fate for 15 high production volume (HPV) chemical substances listed in this final rule. This test data is needed in order to help EPA to determine whether these 15 HPV chemical substances pose a risk to human health and/or environmental safety. Based on comments received by EPA on the proposed rule for this final rule, EPA has determined that only 15 of the 29 HPV chemical substances proposed for testing meet the criteria for testing at this time.

The Agency is proposing to amend the Toxic Substances Control Act (TSCA) section 5(a) Significant New Use Rule (SNUR), for certain polybrominated diphenylethers (PBDEs) by: Designating processing of six PBDEs, or any combination of these chemical substances resulting from a chemical reaction, as a significant new use; designating manufacturing, importing, and processing of a seventh PBDE, decabromodiphenyl ether (decaBDE) for any use which is not ongoing after December 31, 2013, as a significant new use; and making inapplicable the article exemption for SNURs for this action. A person who intends to import or process any of the seven PBDEs included in the proposed SNUR, as part of an article for a significant new use would be required to notify EPA at least 90 days in advance to ensure that the Agency has an opportunity to review and, if necessary, restrict or prohibit a new use before it begins. EPA is also proposing a test rule under TSCA that would require any person who manufactures or processes commercial pentabromodiphenyl ether (c-pentaBDE), commercial octabromodiphenyl ether (c-octaBDE), or commercial decaBDE (c-decaBDE), including in articles, for any use after December 31, 2013, to conduct testing on their effects on health and the environment. EPA is proposing to designate all discontinued uses of PBDEs as significant new uses. The test rule would be promulgated if EPA determines that there are persons who intend to manufacture, import, or process c-pentaBDE, c-octaBDE, or c-decaBDE, for any use, including in articles, after December 31, 2013.

EPA is revoking certain testing requirements for six chemical substances and all the testing requirements for four chemical substances. EPA is basing its decision to take this action on information received since publication of the first test rule for certain high production volume chemical substances (HPV1). HPV1 established testing requirements for those 10 chemical substances. On the effective date of this direct final rule, persons who export or intend to export the four chemical substances for which all the testing requirements are revoked are no longer subject to section 12(b) of the Toxic Substance Control Act (TSCA) export notification requirements triggered by HPV1.

Bisphenol A (BPA) (Chemical Abstracts Service Registry Number (CASRN) 80-05-7), a high production volume (HPV) chemical, is a reproductive, developmental, and systemic toxicant in animal studies and is weakly estrogenic. EPA is providing this ANPRM to request comment on requiring toxicity testing to determine the potential for BPA to cause adverse effects, including endocrine-related effects, in environmental organisms at low concentrations. EPA is also seeking comment on requiring environmental testing consisting of sampling and monitoring for BPA in surface water, ground water, drinking water, soil, sediment, sludge, and landfill leachate in the vicinity of expected BPA releases to determine whether environmental organisms may currently be exposed to concentrations of BPA in the environment that are at or above levels of concern for adverse effects, including endocrine-related effects. This ANPRM is directed only toward the environmental presence and environmental effects of BPA. EPA is working with the Department of Health and Human Services (HHS) on potential human health issues, but is not considering any additional testing specifically in regard to human health issues at this time.

EPA issued a final rule in the Federal Register issue of January 7, 2011, concerning testing of certain high production volume (HPV) chemical substances to obtain screening level data for health and environmental effects and chemical fate. This document is being issued to correct a typographical error concerning the required date of submission for letters of intent to test and exemption applications. The correct date by which EPA must receive a letter of intent to test or an exemption application from manufacturers (including importers) in Tier 1 is March 9, 2011.

EPA is promulgating a final rule under section 4(a)(1)(B) of the Toxic Substances Control Act (TSCA) to require manufacturers, importers, and processors of certain high production volume (HPV) chemical substances to conduct testing to obtain screening level data for health and environmental effects and chemical fate.