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The Elusive Quest for PFAS Clarity: Navigating the Regulatory Maze Amid Scientific Uncertainty

Published October 6, 2024
Published October 6, 2024
Ave Calvar via Unsplash

One of the most contentious topics in the regulatory arena is the issue of per- and polyfluoroalkyl substances (PFAS) and what brands and manufacturers can realistically do to minimize their presence in consumer products. The various complexities and challenges of testing products for PFAS have resulted in more questions than answers, but that hasn’t stopped some regulatory bodies from instituting sweeping laws in an attempt to safeguard human and environmental health. The Independent Beauty Association (IBA) dived deeper into the problem with PFAS regulations in a dedicated session as part of its fall symposium, a two-da,y event covering timely and topical technical, regulatory, and sustainability matters. Here’s what the experts had to say about the PFAS legislative and regulatory landscape, where the science stands, and the realities of testing for these "forever" chemicals.

What are PFAS?

According to Barae Jomaa, principal toxicologist and international regulatory lead at Colonial Chemical, all PFAS contain a chain of carbon atoms bonded to fluorine atoms. This creates a very strong bond, which is why PFAS are often called “forever chemicals.” However, these substances can create problems when they eventually end up in the environment.

The Debate Around Defining PFAS

Different regulatory bodies, including the OECD, US EPA, and EU, use various definitions of PFAS. These definitions differ in their scope and criteria. For example, the CompTox chemical dashboard says 12,039 chemicals meet its PFAS definition, whereas the Organization for Economic Co-operation and Development (OECD) believes that number is over 20,000. The OECD definition is very broad, including any substance with a carbon-fluorine bond. This has been criticized as being too broad and not based on data showing potential harm. The EU adopted the OECD definition but made some exclusions for degradable substances. The varying state-level definitions of PFAS, such as in Washington, Vermont, Maine, California, Delaware, and West Virginia, create compliance challenges for companies selling products nationally or globally.

While not all 10,000-20,000 chemicals are harmful to human health, Jomaa says that the persistence of PFAS could cause problems down the line, and that is why many agencies worldwide are instituting laws that ban or restrict some of the most harmful substances.

“We need to have more studies [and] a better understanding of these different substances,” says Jomaa. “We're talking about thousands of substances, so this is a very huge task. It has to be an effort involving everyone involved: governments, [various] industries, and perhaps even the NGOs working together to try to clarify what substances are relevant and which aren't."

Testing Challenges

If defining PFAS is the first major challenge in regulating this class of chemicals, testing for PFAS is the second—and arguably the most complicated. Michele Castro, the director of growth for the North American Laboratories at NSF International, spoke to the lack of consensus and clarity around PFAS testing and why it poses a significant regulatory challenge for companies trying to comply.

There are challenges with broad tests like total organic fluorine versus more specific liquid chromatography-mass spectrometry (LCMS) testing to identify individual PFAS compounds. NSF has a broad definition of PFAS and is working to develop guidelines and standards through an impartial, consensus-based process with stakeholders. The goal is to create something that makes sense for industry while also maintaining consumer health and safety, based on the available data and evidence. Castro highlighted issues like background contamination, the lack of consensus on appropriate testing methods, and the need to balance various global regulations. The NSF is working with the current available information, but Castro acknowledged the need for more refined and harmonized definitions and standards in the future.

“We need to have more studies [and] a better understanding of these different substances."
By Barae Jomaa, principal toxicologist + international regulatory lead, Colonial Chemical

To illustrate the issue of background contamination, Castro shared one personal story about a lab that she visited that was having a PFAS contamination issue that no one could get to the bottom of, so they asked her to come check out the lab and review their sampling and testing procedures.

“I went out to the site, and I'm watching the guy, and he's putting hand sanitizer on, gets the sample, and writes with the Sharpie. And I'm like, well, there it is. That's where it's coming from,” says Castro.

Rachel Gartner, counsel at McDermott Will & Emery, emphasized the importance of understanding what is actually being tested for and the limitations of current testing methods, because the testing results and data collected can be problematic if the scope of what is being tested is not well-defined. She also suggested that companies carefully consider the implications of PFAS testing data and how it could potentially be used against companies in legal proceedings.

“Qualifying with your supply chain and your formulation to back up the data that the laboratories are producing are probably your highest insurances that [PFAS] is not being picked up somewhere, along with protocol and practices in sampling,” says Castro.

Safety Concerns and Regulatory Actions

The focus on known harmful PFAS is pushing the various regulations, but the panelists agree that there is a lack of data on the broader class of PFAS.

“Most of it is driven by substances like PFOA and PFOS, which have been found to be toxic through production and carcinogenic,” says Jomaa. Both substances have been banned for a long time and have been the focus of regulations like the Stockholm Convention on Persistent Organic Pollutants.

However, the list of known harmful PFAS is still relatively small compared to the thousands of existing PFAS substances. Regulators are concerned that if a subset of PFAS are found to be harmful, the rest may also pose risks, even without data to support it. This "hazard-based" approach, rather than a "risk-based" approach focused on exposure, is driving broader PFAS restrictions and bans.

France will ban the addition of any PFAS to cosmetics starting in 2026, and the EU is proposing a similar broad ban. The concern is that these regulations are moving faster than the scientific understanding and data on the safety of the broader class of PFAS compounds. Jomaa stresses the need for more holistic research on the effects of human health, environmental impacts, and potential treatment methods for PFAS.

“I'm not sure that we'll ever get to the very clear, perfect picture [knowledge] on all substances before these sorts of regulations kick in,” he says. “I feel these regulations will kick in, and that will be where it stops. In this case, the regulations are a bit faster than what the science can develop."

The PFAS issue remains highly complex, lacking consensus around definitions, testing, safety, and compliance. Specifically, the challenge of ensuring PFAS-free products is a nearly impossible standard based on data showing that PFAS are omnipresent. Continued research, collaboration between stakeholders, and regulatory clarity will be critical to addressing these challenges going forward.

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