Strategies for Navigating Changing PFAS Regulations

Consumer products manufacturers are facing a maze of new state PFAS regulations across the U.S.

To date, 23 states have proposed or enacted over 75 regulations for per- and polyfluoroalkyl substances (PFAS) in consumer products. PFAS is a catchall term that includes over 10,000 different fluorine-based chemical compounds used in at least as many products. Product categories presently facing regulation include children's products, food packaging, cosmetics and personal care products, and cleaning products, as well as textiles, fabrics, carpets, rugs, and upholstery.

The regulations vary in their requirements from disclosure and product labeling, to bans on the intentional addition of PFAS, to thresholds for the unintentional addition of PFAS based on total organic fluorine. A comparison of state regulations reveals numerous difficulties and little convergence, including ambiguous language and inconsistencies in compliance timelines, testing standards, and penalties for noncompliance. Collectively, this has created a maze of PFAS regulations for manufacturers of consumer products to navigate.

For industry, the pace of PFAS legislation marks an unprecedented turning point in how chemicals are regulated.

Widespread persistence driving novel regulatory approaches

In the U.S., chemical regulations are usually enacted by one or more federal agencies following a systematic procedure that examines multiple aspects of a chemical compound's effects on humans and the environment. Generally, this kind of analysis and regulation has proceeded one compound at a time, addressing factors such as the degree of harm or hazard, unsafe exposure levels, and persistence in the environment.

PFAS are an extremely diverse group of chemistries, and correspondingly, they are widely used across many applications and industries for a variety of reasons. While some are long-lasting chemical compounds that break down very slowly over time, others are not. Despite this, several states are now proposing novel regulatory approaches that treat PFAS as a single class or set restrictions on total organic fluorine without regard for chemical structure or influence on health or environmental risk.

According to the Environmental Protection Agency, there are several critical gaps in our present understanding of PFAS, including how harmful they may be to people and the environment. To date, it has proposed maximum containment levels for six specific PFAS compounds in drinking water. However, because of the widespread use of PFAS and the persistence of some PFAS in the environment, consumer advocacy groups are driving more aggressively for regulations at the state level.

For industry, the pace of PFAS legislation marks an unprecedented turning point in how chemicals are regulated, particularly since the analytical methods needed to confidently identify PFAS in different product types are still evolving. It will be imperative for product manufacturers to monitor developments in this area, as the current approach to PFAS seems likely to signal a more pervasive shift in mindset about how many chemicals could be regulated in the future.

Unintended consequences of PFAS regulations

Given the uncertainty surrounding the impacts of PFAS, consumer advocacy groups have proposed banning all PFAS. However, their application and presence in a multitude of consumer products, combined with a lack of qualified substitutes, pose a serious dilemma: How does industry writ large quickly and safely address the components and products that may be impacted by new regulations?

Many of these proposed or newly enacted regulatory approaches to PFAS will place manufacturers in untenable positions.

For example, certain PFAS are used in the production of many medical products, including surgically implantable devices, heart patches, and catheters, as well as respirators and ventilators. If there's no qualified substitute for the specific PFAS compounds in these critical lifesaving medical devices, should these products be banned despite the rigorous biocompatibility and patient safety testing medical devices are already subject to? If so, what impacts to human health or even life could follow? In some cases, these consequences could pose greater risks than PFAS exposure.

Beyond medical applications, the indiscriminate reduction or elimination of PFAS in consumer products is expected to disrupt commerce and daily activities.

For example, PFAS are used in the semiconductors in electronic devices, including smartphones, laptops, computers, and more. Automobiles have multi-year development cycles and complex, multi-layer supply chains that involve hundreds of global vendors. There are numerous components throughout that supply chain where PFAS substances may be introduced — intentionally or unintentionally — such as fuel lines and hoses, seals and gaskets, green-house gas emission controls, and batteries used in electric vehicles.

Some of these components are critical to reducing the carbon footprint of vehicles, which means some PFAS regulations may be at odds with established environmental goals. Even if acceptable product substitutes were available today, it's unlikely automobile manufacturers could sustain proposed production timelines.

Many of these proposed or newly enacted regulatory approaches to PFAS will place manufacturers in untenable positions. They may feel obligated to challenge impracticable regulations in court, risk non-compliance as they search for alternatives to current production processes, or incur steep costs to comply immediately with the most stringent state requirements, if compliance is even feasible.

Taking practical steps to understand where and how PFAS may be included in your products now is the best way to prepare for the future.

Developing a PFAS regulatory compliance strategy

As a manufacturer, the first step to developing a PFAS compliance strategy is to clearly understand your present situation, starting with which specific consumer product regulations apply to your products, what new regulations may be upcoming, and most importantly, whether your consumer products contain PFAS. If they do, it is crucial to understand whether PFAS are being introduced into discrete components of your products, intentionally or unintentionally, and which PFAS may be present.

We help clients begin the process by seeking to understand:

1. What goes in (e.g., raw materials, recycled materials, manufacturing equipment, water used during processing, packaging, and containers)?
2. What goes out (e.g., the product itself, waste, and water streams)?
3. What chemical changes may be occurring (e.g., reactions, processing steps, temperature, pH)?

Analytical testing may be necessary to comply with PFAS requirements. However, developing and validating test methods for certain consumer products can take 3-6 months or longer and may not provide the desired detection limits. There are numerous technical challenges with isolating and accurately measuring the diverse range of PFAS, requiring targeted test methods for different products, compounds, or matrices.

For example, EPA method 537, first issued in 2009 and updated in 2020, measures 29 specific PFAS in drinking water. Many laboratories have developed proprietary "modified method 537" methodologies for specific consumer product groups and for an increasing number of PFAS compounds. Laboratories are also looking to adapt EPA's recently finalized method 1633, which measures 40 specific PFAS in environmental samples such as wastewater, surface water, groundwater, soil, biosolids, sediment, landfill leachate, and fish tissue. However, none of these methods have been independently validated and standardized for general applicability across industries and products.

Some laws intended to ban intentionally added PFAS and reduce unintentional PFAS are based on a measure of total organic fluorine. However, methods for measuring total organic fluorine in consumer products may not be readily available, and total organic fluorine may not reliably indicate the presence or concentrations of PFAS in consumer products. Obtaining reliable, accurate, and reproducible data on a particular PFAS-containing product requires expert understanding of PFAS applications and existing analytical approaches, as well as the intent and scope of PFAS regulations.

Preparing now for the regulatory landscape of the future

There are presently more questions than answers regarding state PFAS regulations. It is important for consumer products manufacturers to monitor evolving regulations and the specific impacts of new laws.

Faced with emerging state PFAS regulations, consumer products manufacturers can consider:

• Participating in the development of and comment periods for legislation and regulatory rulemaking processes that will affect their products
• Presenting scientific evidence and recommending alternatives if the proposal is not based on sound science or has infeasible implementation requirements
• Requesting an exception due to the essential nature of a specific product, if applicable

While we don't know the specifics of upcoming PFAS regulations, we do know they are coming — and imminently. Taking practical steps to understand where and how PFAS may be included in your products now is the best way to prepare for the future. Building and maintaining strong product stewardship programs that account for the entire lifecycle, including disposal and recycling, and developing alternatives and contingencies for targeted components and ingredients will position you to not only respond to PFAS regulations but maintain resiliency in the face of industry and regulatory uncertainty.