Posted on December 09, 2022 by Lynn L. Bergeson
By Lynn L. Bergeson and Carla N. Hutton
On December 2, 2022, the U.S. Environmental Protection Agency (EPA) proposed significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for chemical substances that were the subject of premanufacture notices (PMN) and are also subject to Orders issued by EPA pursuant to TSCA. 87 Fed. Reg. 74072. The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required by that determination. Comments are due January 3, 2023.
According to EPA, during review of the PMNs submitted for the chemical substances that are the subject of the proposed SNURs, EPA concluded that regulation was warranted under TSCA Section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. Based on its findings, EPA negotiated TSCA Section 5(e) Orders requiring the use of “appropriate exposure controls” with the PMN submitters. EPA states that as a general matter, it “believes it is necessary to follow the TSCA Orders with a SNUR that identifies the absence of those protective measures as significant new uses to ensure that all manufacturers and processors -- not just the original submitter -- are held to the same standard.” The proposed SNURs also include significant new uses that EPA proposes to determine are not ongoing based either on information showing that the chemical is not on the TSCA Inventory or based on EPA’s review of Chemical Data Reporting (CDR) submissions under TSCA Section 8(a). EPA states that it “believes that these uses could significantly increase the magnitude and duration of exposure to humans and the environment to these chemical substances. Accordingly, EPA wants the opportunity to evaluate and manage risks, where appropriate, from activities associated with those uses, before manufacturing or processing for those uses were to begin.”
EPA states that the SNURs advance one of the “key actions” in the PFAS Strategic Roadmap where EPA stated it plans to revisit past regulatory decisions concerning per- and polyfluoroalkyl substances (PFAS) and address those that are insufficiently protective by imposing additional notification requirements. According to EPA, in this way, it “can ensure it has the opportunity to review PFAS before they are used in new ways that might present concerns.” More information on the PFAS Strategic Roadmap is available in our October 19, 2021, memorandum.