The US Environmental Protection Agency (EPA) intends to issue in the coming months as many as 150 Significant New Use Rules (SNURs) for individual per- and polyfluoroalkyl substances (PFAS) that were previously authorized for use in the US under the Toxic Substances Control Act (TSCA) new chemicals review program. Doing so is likely to confound companies that received those prior authorizations, as well as potentially countless businesses that might be actively processing or using those substances in the US.
Recent announcements of this effort by the senior leadership of the Office of Chemical Safety and Pollution Prevention may have gone unnoticed by potentially affected businesses because the remarks were made at a conference which is typically attended by chemical manufacturers, but perhaps not by the companies that acquire and use formulations and end use products that might contain PFAS. Moreover, because many significant new use rules pertain to chemical substances for which the specific chemical identities are claimed as confidential business information under TSCA, the proposed rules may be difficult to interpret if they are even noticed by such businesses, because the specific identity of the regulated chemical will not be listed in the proposed rule, and a “generic” descriptor will be used instead. The consequences of overlooking a proposed significant new use rule can have grave consequences to US businesses.
When a new chemical substance is domestically manufactured or imported to the US, the substance must first be reviewed by EPA in accordance with Section 5 of TSCA and authorized for production and use in the US. A business seeking such an authorization must submit a premanufacture notification (PMN) to EPA. When reviewing PMNs and authorizing new substances, EPA may limit or restrict the ways in which the substance may be produced or used in the US by issuing an administrative order under Section 5(e) of TSCA establishing agreed-upon terms with the PMN submitter limiting such activities. However, once such terms are established, the PMN submitter may commence production and use in the US. When this occurs, the chemical also is added to the US Inventory of chemical substances which are no longer considered to be “new.” Because administrative orders issued under Section 5(e) are only applicable to the business that submitted the original PMN, EPA has typically, but not always, used its authority to issue Significant New Use Rules to impose through regulation similar restrictions upon others who might enter the US market. Such SNURs ensure EPA must be provided notice of, and has the opportunity to restrict, new uses of the chemical substance which has been listed on the US Inventory.
Apparently, over the life of the new chemicals program under TSCA (which dates back more than 40 years), EPA has issued TSCA Section 5(e) administrative orders restricting the original manufacturer or importer of as many as 150 individual PFAS, but did not issue SNURs to more broadly limit use of the substances by others who might acquire formulations or products containing these PFAS or otherwise enter the US market for the PFAS. Belatedly, EPA leadership has decided to try to put the regulatory genie back in the bottle by issuing approximately 150 new SNURs to presumably impose the same (or maybe additional) restrictions negotiated with the original PMN submitters upon anyone else who has entered the market or who acquires and uses formulations containing the PFAS. EPA personnel estimate the proposed SNURs will be issued in several “batches” including clusters of individual chemical substances, rather than through a single rulemaking addressing 150 chemical substances at one time.
Using SNURs in this manner and doing so long after a PFAS has entered the US market may be challenging to EPA, and should be closely monitored by the regulated community. The actions may be challenging to EPA because Agency policy and its long-standing legal interpretation has been that EPA may not use a significant “new use” rule to restrict or limit a use that already is “ongoing” (meaning a use that was commenced before the SNUR has been proposed in the Federal Register). Moreover, no public statement has been made asserting that EPA has received new test data or other information which would justify issuing such SNURs at this time. Entities that have already commenced any proposed new uses can (and must) respond to EPA during the public notice and comment period when such PFAS SNURs are proposed to advise EPA when a particular use has already been commenced. Doing so can “defeat” the SNUR, meaning EPA must then elect to withdraw the proposal and use a different regulatory mechanism (such as its Section 6 rulemaking authority) to restrict such “ongoing” uses. Failing to comment will lead EPA to conclude such uses are not actively ongoing, clearing the way for EPA to issue a final SNUR.
This new PFAS regulatory initiative underscores why it will be imperative that members of the regulated community that acquire formulated products that may contain PFAS, and those entities that may have already entered the PFAS market in the US by importing or domestically manufacturing a PFAS which is listed on the TSCA Inventory, carefully monitor EPA's rulemaking activities under TSCA. The failure to recognize and properly interpret a proposed SNUR which might restrict the use of a substance, formulation, or product that may have been in use by a business in the US for many years could result in compliance issues later if EPA were to issue a final SNUR because an affected entity failed to spot an obscure SNUR rulemaking and to timely advise EPA in writing that a use in which the entity has been engaged in years is “ongoing.” Given the complexities of significant new use rulemakings and the prevalence of substances that are identified in such proposed rules only by generic chemical names, the next few months will be worrisome for regulated entities who import or make or use PFAS (and PFAS-containing formulations and products) in the US.
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