The United States Environmental Protection Agency (EPA) finalized two rules regarding per- and polyfluoroalkyl Substances (PFAS) entering into 2024 as part of the Toxic Substance Control Act (TSCA). The rulings are for helping the EPA determine the quantities and use of PFAS in the United States.
The first rule is for industries to engage the EPA in consultation before using one of the 329 inactive PFAS substances on the list. The second rule adds seven new PFAS chemicals to the database. The use of a PFAS substance listed in the database must be reported to the EPA.
Significant New Use Rule (SNUR) mandatory for inactive PFAS substances
According to JDSUPRA, "Following several extensions to its statutory deadline, the US Environmental Protection Agency (EPA) released its final Toxic Substances Control Act (TSCA) Reporting and Recordkeeping Requirements for Per- and Polyfluoroalkyl Substances (PFAS) on September 28, 2023. While the final rules largely track the draft rules released in June 2021, they include changes to address concerns raised during the comment period about the rule’s potential breadth and associated compliance burdens and a slightly expanded definition of what PFAS are covered by the new rule."
The EPA states that "[a]n inactive designation means that a chemical substance has not been manufactured (including imported) or processed in the United States since June 21, 2006."
EPA defines how this may affect your business
There are three areas of impact to manufacturers regarding PFAS in 2024: application, notification, and exemptions.
“The chemical substances for which EPA is finalizing a SNUR are the 329 PFAS that are both currently designated as inactive on the TSCA Inventory and that are not subject to an existing SNUR.” (pg. 1824);
Entities must notify EPA at least 90 days before commencing any manufacture, importation, or processing of any identified PFAS substances. (pg. 1823);
“EPA has determined as significant new uses: manufacture (including import) or processing of inactive PFAS for any use except:
Importing or processing of inactive PFAS-containing articles; and/or
Manufacture (including import) or processing of inactive PFAS:
As byproducts not used for commercial purposes;
In small quantities solely for research and development;
For test marketing purposes;
For use as a non-isolated intermediate; or
Solely for export from the United States.” (pg. 1825)
The two rulings are expected to be published March 11, 2024 and become effective sixty days later.
As with all compliance regulations, understanding what constitutes due diligence to the regulation is important. All companies must meet compliance obligations in order to continue manufacturing and selling product in the United States. Companies must have documentation that validates material content, supplier declarations, data collection practices, and systems for managing and controlling compliance.
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