On July 27, the U.S. Environmental Protection Agency (EPA), published the final Significant New Use Rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS)* chemical substances under the Toxic Substances Control Act (TSCA), first proposed in January 2015.
The final SNUR requires persons to notify EPA at least 90 days before the start of manufacturing (including import), or processing of these chemicals for any use designated as a significant new use. This includes the import of a subset of LCPFAC chemicals as part of a surface coating on items, such as the PFOA utilized in Teflon in cookware. Upon notification, EPA will evaluate the proposed usage and make a determination on that notice. This is not the first SNUR published for PFAS compounds, but includes an expanded list that may affect your operations and regulatory responsibility.
The significant new use determination considers the following:
- The projected volume of manufacturing and processing of a chemical substance,
- The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance,
- The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance,
- The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.
Changes from the 2015 Proposal and Supplemental SNUR
The final SNUR does not include safe harbor provisions from earlier drafts of the proposed rule that would exempt importers from enforcement actions if they could demonstrate ongoing use prior to the effective date of the rule. The earlier supplemented SNUR proposed in March also included a “de minimis” provision that would have established de minimis thresholds for determining “reasonable potential for exposure.” Ongoing uses cannot be subject to the SNUR.
Reasoning for Further Regulatory Action
As we have discussed previously, these substances have been found in the blood of the general human population and wildlife, are widespread due to their unique chemical composition multiple pathways for exposure and have adverse effects in humans and the environment when present in certain concentrations. Due to greater attention, shifting attitudes, and federal and state efforts to regulate the chemicals, EPA expects their presence in the population to decline over time.
Who does the SNUR apply to?
If you manufacture (including import), process or commercially distribute chemical substances in the class of LCPFAC and perfluoroalkyl sulfonate chemical substances, you may be a potentially affected entity. These entities may include: chemical manufacturing and petroleum refineries; carpet and rug mills; manufacturers of computer and other electronic products, appliance, and components; manufactures of surgical and medical instruments; stores and retailers; and more.
For more information, please read the final rule, which goes into effect September 25, 2020. Businesses that are impacted by this rule should evaluate their operations, what activities may be subject to the rule, and the potential steps needed for achieving compliance.
*EPA recognizes that the acronym PFAS is now used for “perfluoroalkyl and polyfluoroalkyl substances” and will use the acronym accordingly.
If you want to learn more, sign up to watch our webinar on PFAS remediation and regulation.