Per- and polyfluoroalkyl substances (PFAS) have likely become a focus of your chemical compliance recently as global governments and jurisdictions seek to limit their use. In the United States (US) in particular, the Environmental Protection Agency (EPA) has released a PFAS Strategic Roadmap, a comprehensive strategy that outlines actions regarding PFAS in the US over the next three years.
Since the Toxic Substances Control Act (TSCA) also governs how chemicals are reported, the EPA has now proposed several TSCA amendments to align it with the PFAS Strategic Roadmap. If you produce or manufacture products with PFAS, this may change your chemical reporting processes.
Proposed TSCA Amendments
Align Federal Regulations on Chemical Notices With Existing Law
Under TSCA, manufacturers and processers must submit premanufacture notices (PMNs) for new chemical substances, significant new use notices (SNUNs) for significant new uses, and microbial commercial activity notices (MCANs) for microorganisms with commercial applications.
Prior to 2016, the EPA only made safety determinations for around 20% of new chemical submissions. Under the proposed TSCA amendments, the EPA will make determinations for 100% of new submissions.
There will be five possible safety determinations for the submitted notices, and the EPA must make their determination before the chemical can enter the market.
Eliminate Certain Exemptions for PFAS and PBTs
Under existing regulations, if a manufacturer of chemicals has low production quantities, low environmental releases, or low human exposures, they could be granted an exemption from a complete PMN safety review. This is done by submitting a low volume exemption (LVE) or low release and exposure exemption (LoREX) prior to the chemical being manufactured. If the exemption is granted, then the chemical would undergo a 30-day review instead of the more stringent 90-day review.
The new TSCA proposals would eliminate these exemptions for new PFAS. Already, PFAS were unlikely to qualify for these exemptions, but with the new proposed rule this practice would be codified.
The new TSCA amendments would also make persistent, bioaccumulative and toxic chemicals (PBTs) ineligible for these exemptions.
Develop Consistency in the EPA’s Review Process of New Chemical Submissions
For the EPA to implement their PFAS Strategic Roadmap, their chemical review process needs to be as efficient as possible. The new TSCA proposals include a new practice that would allow the EPA to declare submissions incomplete if enough information is not included so they can move on to other complete submissions.
This means they would no longer be accepting amended notices. Instead, they would restart the review period for incomplete submissions and manufacturers would need to resubmit complete information.
What’s Next?
These changes to TSCA are still in the proposal phase, so they are not being implemented yet. Once the proposals are published in the Federal Register, the EPA will be accepting public comments for 60 days at regulations.gov.
However, even though the changes have not been implemented yet, it is highly likely some version of them will. Therefore, you should begin analyzing your manufacturing processes now for PFAS, especially if you have been granted exemptions in the past.
Get PFAS Support From Tetra Tech
The world of EHS compliance is changing rapidly, especially when it comes to PFAS. Keeping up with these changes and making sure your products are ready to go on the market in the midst of new regulations can be time-consuming and frustrating. You want to be able to keep your manufacturing running smoothly without having to constantly reassess your chemicals and processes.
Tetra Tech can help you build a solid compliance program that takes into account the new compliance landscape. If you need help identifying the PFAS in your manufacturing processes or supply chain, understanding your reporting requirements, or seeking out alternative substances for your products, contact Tetra Tech experts at [email protected]. We can help you work toward a sustainable future in the face of regulatory changes with everything from compliance assessments to reporting management and more.
