The Challenges of PFAS
Group of Synthetic Chemicals Complicates Product Stewards’ Efforts to Plan Ahead
A class of synthetic chemicals known as per- and polyfluoroalkyl substances (PFAS) has made headlines in recent years, turning their nickname “forever chemicals,” which refers to PFAS’ long-term residency in humans and the environment, into a household name. The widespread production and use of PFAS in consumer products and across industries is noteworthy due to the substances’ persistence in the environment and their potential to cause adverse health effects. Regulators around the globe are working with increasing speed to address PFAS. This increased attention from the public and regulatory bodies alike has drawn to the forefront an issue that product stewards have been tackling for years: how can they help companies manage regulatory requirements and risks related to PFAS?
The Synergist spoke with two product stewards in July to explore how professionals in this field are dealing with the challenges presented by PFAS. These experts currently work at 3E, a company that helps clients manage global regulatory compliance and product stewardship risk: Tara Jacola is senior director of regulatory consulting, and Miriam Schoepel, PhD, is 3E’s senior chemical regulatory compliance consultant for Europe.
Defining PFAS One of the biggest challenges of working with PFAS is that there is no universal definition for the group of chemicals, Schoepel says. For example, the European Chemicals Agency (ECHA) currently defines PFAS as “substances that contain at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I atom attached to it),” whereas EPA’s working definition of PFAS, as described in the agency’s National PFAS Testing Strategy, “identifies chemicals with at least two adjacent carbon atoms, where one carbon is fully fluorinated and the other is at least partially fluorinated.” These definitions disagree mainly on whether PFAS must contain only one fully fluorinated carbon atom or one fully and one partially fluorinated one. Schoepel, who has also worked with ECHA and the European Commission on the topic of PFAS, notes that many refrigerants and pharmaceuticals could fall under ECHA’s definition, which refers to substances that contain at least one fully fluorinated carbon atom.
“This is making our work really challenging because we have to adapt our mind and our thinking around these kinds of definitions,” Schoepel says.
Top Concerns When it comes to PFAS, product stewards’ main concerns include ensuring that products are safe for their intended use and don’t pose an unreasonable risk to downstream users or the environment. And with PFAS, many issues have to do with products’ end of life and their environmental impacts, including discharges from manufacturing. Accounting for PFAS or lack thereof is an essential part of product stewardship, and product stewards should understand whether and where PFAS are present in their organizations’ raw materials, products, and waste. This knowledge allows product stewards to help communicate about PFAS in products with customers in their companies’ supply chains.
This is easier said than done. As Schoepel explains, there is no universally agreed-upon list of substances that product stewards or companies can rely on when it comes to communicating about PFAS along the supply chain or confirming compliance. Some chemical understanding can help product stewards when there is uncertainty about whether a substance is a PFAS—particularly when a substance does not have a CAS number assigned to it. EPA hosts a “master list of PFAS substances” of interest to researchers and regulators but stresses that “[t]here is no precisely clear definition of what constitutes a PFAS substance.” According to Schoepel, ECHA has said it will never publish a regulatory binding list containing all PFAS with respective CAS identifiers; instead, the agency plans to use a generic group entry that ECHA states should describe the scope clearly (PDF).
Managing Regulatory Compliance Jurisdictions around the globe are taking action on PFAS, and changes in requirements are coming at all levels—even some states in the U.S. are banning PFAS in food packaging, cosmetics, and other products. This makes keeping up with regulations a lot of work for product stewards.
In the U.S., recent actions by EPA to address PFAS include updating its Toxics Release Inventory (TRI) chemical list to require reporting on five PFAS and issuing Toxic Substances Control Act (TSCA) test orders to require companies to conduct and submit testing on PFAS, which is part of the agency’s recently developed national PFAS testing strategy. Significant new use rules, or SNURs, and consent orders under TSCA are an additional area to watch, Jacola notes. In the European Union, ECHA proposed an EU-wide restriction on the use of all PFAS in firefighting foams earlier this year. And five European countries—the Netherlands, Germany, Denmark, Sweden, and Norway—are developing an EU-wide restriction proposal that would cover all PFAS in a broad range of uses.
In Jacola’s view, the U.S. is moving toward the “no data, no market” approach to chemicals espoused in REACH, the EU’s Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals. EPA’s national testing strategy for PFAS will require manufacturers to provide the agency with toxicity data and information on categories of PFAS chemicals. And now that certain PFAS are listed on EPA’s TRI, companies have to track and report their releases. But regulatory certainty is lacking, making it difficult for product stewards to predict what requirements will be in the coming years.
Companies that must adhere to European regulations are likewise struggling with rapidly changing requirements. Schoepel explains that European regulations try to protect against “regrettable substitution,” which is when a substance is replaced by another believed to be better or less hazardous but which proves to present an equal or worse hazard. Driven by this concern, European regulators have tried regulating PFAS one by one and by using a grouping approach. Now the EU is moving toward a universal PFAS restriction. According to ECHA, the European Commission is committed to phasing out all PFAS, “allowing their use only where they are proven to be irreplaceable and essential to society.” Schoepel says that the planned universal restriction combined with the proposed concept of essential use is making companies that do business in the EU uncertain about forward actions.
“As a product steward, your main initiative is to be able to inform your business of regulatory hurdles ahead and help plan forward actions,” Jacola adds. “This sense of ambiguity is a little unnerving. [Product stewards] don’t know what to communicate to their businesses due to the varying differences in definitions across the world.”
Business And Reputational Risk At a time when companies’ scores and rankings in environment, social, and governance (ESG) and sustainability are high priorities, business leaders are acutely aware of the emotionally charged conversations about PFAS happening on social media and elsewhere. For example, Schoepel says, following “PFAS” in the media brings up articles like “how to find makeup that doesn’t contain cancer-linked ‘forever chemicals.’” This type of language can drive companies’ concerns about potential reputational risks associated with their products.
Another way that PFAS can affect a company’s bottom line has to do with insurance. Schoepel has heard that some companies have been approached by their insurance providers to check whether they have PFAS in their portfolios because the chemicals could present an insurance risk.
“I think you could have all the greatest goals in the world and if you have PFAS in your chemical portfolio, it’s bringing you down,” Jacola adds. “We see the data, and it’s quite stark. And now it’s really in front of investors.”
The impact of PFAS on the environment presents further potential liability. For example, a recent EPA proposal seeks to designate two PFAS, perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act, commonly known as the Superfund law. If finalized, the plan could make the liability associated with PFAS contamination a bigger risk for businesses.
An Uncertain Future Moving forward, product stewards will be key in helping companies assess substitutes or replacements for PFAS. On the industry side, particularly in the U.S., Jacola sees companies looking to eliminate PFAS from their portfolios.
Product stewards will need tools to be able to monitor rapidly changing PFAS regulations and assess the compliance status of their product portfolios, Schoepel asserts. They will also have a role in creating organizational strategies around PFAS. She stresses the importance of including marketing staff, lawyers, and management in the development of PFAS strategies.
“This is not a topic which can be navigated from just one department,” she says.
KAY BECHTOLD is managing editor of The Synergist.
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