The Coming Restrictions on Forever Chemicals

PFAS chemicals have lately come under scrutiny for their persistence in the environment and their potential harmful effects. There are currently two regulatory bodies addressing PFAS usage and production: the Environmental Protection Agency (EPA) in the US, and the European Chemicals Agency (ECHA) in the EU. Both agencies aim to regulate PFAS production, but their approaches differ significantly.

Opinions vary greatly on the regulatory pace, with some finding EPA moving too slow and others perceiving ECHA as moving too fast. EPA is currently requesting documentation for all manufactured PFAS compounds to understand their scope and prevalence. ECHA initially opted for a broad ban on the manufacturing of PFAS applications, but ECHA has since recognized the potential impact on industries, so their regulators have become receptive to feedback.

PFAS are used extensively in products such as Teflon due to their enhanced water-resistant properties or aqueous film forming foam. Since the beginning of the 21^st Century, they have been studied for their impact and toxicity to human and mammalian life. They are commonly referred to as "forever chemicals" because they do not break down through natural processes.

We caught up with Sonia Schwantes, director of products and innovation at NewAge Industries, to find out about the effects PFAS restrictions.

What do Per- and polyfluoroalkyl substance (PFAS) constitute and why are they important?

Sonia Schwantes: PFAS chemicals constitute a broad group of substances that are extensively used across various industries. Due to their persistence in the environment, they have earned the nickname “forever chemicals.” They’re important to note because of their potential impact on the environment, as well as the broad spectrum of industries and functionalities they’re used in and for.

What is that status of the European Chemicals Agency (ECHA) ban on the manufacturing of PFAS?

Sonia Schwantes: ECHA initially opted for a broad ban on the manufacturing of PFAS applications but has been receptive to feedback and is engaged in a collaborative process to ensure the final regulations are more nuanced. As of now we are waiting for deliberations and updates on the ECHA website.

Explain the importance of getting a balance in the regulatory pace of materials.

Sonia Schwantes: Given the widespread use of PFAS, industries, like medical devices and biopharmaceuticals, are concerned about potential disruptions. A ban could potentially lead to a scramble for replacements that require time to research, test and re-validate – if a replacement is even possible. This begins a cycle of resource constraints and disruptions in critical supply chains.

Striking the right balance between environmental protection and potential economic and healthcare consequences isn’t straightforward. This is because not all PFAS uses pose the same environmental risk.

How can companies manage the patchwork of state laws on PFAS materials?

Sonia Schwantes: Companies should educate themselves on state regulations on an ongoing basis so they don’t miss any changes.

Tell us about the organizations Biophorum and BPSA and how to advocate for further awareness and responsible solutions.

Sonia Schwantes: BPSA or Bio-Process Systems Alliance is an industry-led international association dedicated to the encouragement and adoption of single use technologies specifically in production of biopharmaceuticals and vaccines. Their website has an array of resources related to testing, quality control, industry news and much more. They also have a great article on the subject of ECHA’s proposed restriction on PFAS.

Biophorum similarly, is a collaborative geared towards making a difference in the world of biopharma. They work to connect, collaborate, and make improvements to systems that ultimately mean patients can receive benefits earlier. They have a three-part article on PFAS restrictions here

To advocate for awareness and responsible solutions, one must first ensure that they are educated. Resources within websites such as BPSA, Biophorum, and ECHA can be a great place to start but don’t stop there. Stay connected and plugged in so you’re ready when an opportunity to advocate further presents itself.