As we move further into 2024, the urgency around per- and polyfluoroalkyl substances (PFAS) is growing, and it has never been more critical for manufacturers to be proactive about reducing and eliminating them from production.

Dubbed "forever chemicals" for their persistence in the environment and the human body, PFAS are a central focus for regulators. The complex and growing network of mandates is in a state of change, poses a challenge for manufacturers trying to understand and stay ahead of risks.

The first step to compliance is understanding regulatory requirements as they develop.

On October 11, 2023, the U.S. Environmental Protection Agency published the final PFAS reporting rule under Section 8(a)(7) of the Toxic Substances Control Act (TSCA). This rule created reporting requirements for companies that have manufactured or imported PFAS since January 1, 2011. They have 18 months from the rule’s effective date to gather and submit data. The reporting portal will open on November 12, 2024, and reports are due by May 8, 2025.

Beyond federal rulemaking, most U.S. states either have or are developing their own regulations. These state-level requirements are complex, each carrying its own set of risks. SaferStates predicts that at least 35 states will introduce PFAS policies in 2024. Folllowing is a brief overview of some of the most notable state-level PFAS regulations.

• The Northeast Waste Management Officials Association. Encompassing eight Northeastern states, NEWMOA has proposed legislation to reduce PFAS contamination through reporting requirements and by gradually phasing out PFAS.
• Maine. In 2021, the state prohibited using intentionally added PFAS in all products, set to begin in 2030. They also created reporting obligations for products containing PFAS starting January 1, 2025.
• California. The state has enacted several regulations to disclose, control or restrict PFAS use. Several PFAS are also in the scope of Proposition 65 warning-label requirements.
• Minnesota. The state introduced reporting obligations for products containing PFAS effective January 1, 2026. Similarly, there is a phased-in restriction of specified PFAS product categories up to a total ban in 2032.
• New Jersey. The state has proposed registration and restrictions similar to those in Maine and Minnesota. However, this bill also introduces a $1,000 fee.
• Michigan. The state introduced PFAS product restrictions, including food packaging and fire-fighting foams. They also provide funding for PFAS cleanup and remediation.
• Colorado. The state has proposed regulations around PFAS similar to Maine and Minnesota. However, Colorado did not include a provision for exempting critical or unavoidable use.

In the European Union, the REACH Restricted Substances List and the Candidate List of Substances of Very High Concern (SVHCs) create additional layers of complexity for manufacturers. The Restricted Substances List already contains certain PFAS substances and subgroups, but there is a proposal to expand it to include all PFAS, potentially bringing over 10,000 substances into scope. Proactive compliance requires manufacturers to continually monitor this regulatory process, and engage with suppliers to ensure they have the necessary data on substances in parts and articles.

The Stockholm Convention on Persistent Organic Pollutants (POPs), implemented in the EU through the POPs Regulation, restricts or reduces the use of hazardous organic compounds, including several PFAS. To maintain compliance in 2024, manufacturers must survey their supply chains and, where necessary, evaluate alternative substances and redesign materials to eliminate PFAS.

Manufacturers face several challenges as a result of all these moving parts. Failure to work proactively toward monitoring and planning to meet these requirements can lead to severe consequences, including obsolescence risks, supply chain disruptions, lawsuits, brand damages and more. The stakes are undoubtedly high. Following are some common pitfalls to watch out for, as you meet compliance challenges head-on in 2024.

One common misstep, especially for companies in the medical device industry, is assuming that because they may have exemptions to specific PFAS requirements (such as TSCA reporting requirements), they are inoculated from PFAS-related risks. That couldn’t be further from the truth, and this idea can undermine a company’s ability to manage its risk proactively.

First, even though they may be primarily regulated by the Food and Drug Administration instead of the EPA, they may still have obligations. For example, if they imported parts with PFAS not considered medical devices when imported, those are still in scope. 

Second, product obsolescence is at the heart of many of the upcoming disruptions that will arise from PFAS. It’s unlikely that any manufacturers will be immune from the effects of supply chain disruption.

For instance, 3M’s decision to stop manufacturing PFAS by the end of 2025 will likely accelerate alternative assessments and the demand for PFAS-free parts. This will create substantial and costly product redesign, requalification and recertification challenges. It’s not a foregone conclusion that exemptions from PFAS phase-outs could be granted ,even if there are expectations that they will consider the strategic importance of a given product or the difficulty of adapting to the regulatory restriction.

Many manufacturers don’t realize PFAS may be present in the early stages of their supply chain, in the form of minimal amounts used as additives or processing aids during manufacturing (for example, mold release agents). These hidden risks stem from the fact that PFAS have become integral to specialized applications, and are typically not listed in bills of materials (BOMs). The phase-out of these products can lead to unexpected manufacturing disruptions and difficulties in vital aspects of the manufacturing process.

The Department of Homeland Security’s Report on Critical Per- and Polyfluoroalkyl Substance Uses highlights a worrying scenario in which industries are blindsided by the discontinuation of products critical to operations. This possibility also means manufacturers may need more time to develop and qualify alternatives. In short, the signs of potential obsolescence are not always found in BOMs, and companies need to prepare for the worst.

To mitigate PFAS risks, manufacturers should identify these substances in their supply chain by proactively engaging with suppliers. Understanding the intricacies of global regulations, recognizing common compliance pitfalls, and proactively managing PFAS risks are essential to ensuring compliance and safeguarding against PFAS impacts.

Neil Smith is a regulatory and sustainability expert for product sustainability with Assent.