Making sense of PFAS, their regulatory landscape, and litigation risks

There is little debate that "PFAS are everywhere."[1] Nor is it debatable that PFAS, a term used to encompass per- and polyfluoroalkyl substances, are a primary focus of regulatory action and are an increasingly common cause of liability. Nonetheless, almost nobody outside of a small scientific community knows much about PFAS, let alone how they will impact consumers and industry.

We set out to understand and share key information on testing and regulatory actions at a basic level. Although we are not scientists, we have science backgrounds and significant experience counseling food, agriculture, and chemical industry clients in the areas of litigation risk and regulatory compliance relating to chemicals and environmental issues.

We begin with a short history of PFAS testing, courtesy of a fantastic webinar on testing put on by the Bureau Veritas that is free. See PFAS Testing (bvna.com). According to its website, Bureau Veritas is a French company that operates worldwide and specializes in testing and certification services and is accredited for PFAS testing.

A Brief History of PFAS and Testing

PFAS refers to a group of thousands of synthetic chemicals used in a large number of consumer and industrial products.

PFAS testing began with the discovery of PFOA and PFOS, types of PFAS, in human blood.[2] Following that discovery, scientists began to discover that other substances and precursor compounds also transformed into PFOS and PFOA compounds.

As testing continued, toxicologists started to raise alarms that PFAS are toxic to animals, and manufacturers began to replace early chemicals with newer compounds, sometimes referred to as Gen X. Manufacturers claim that the newer compounds are less toxic, but science is beginning to demonstrate that they do exert a toxic effect and, in some cases, can be more toxic because of their chemical qualities.

Generally, the newer compounds have higher solubility. Because they are more soluble in water, they will move more readily and are likely to have an increased risk of toxicity. Thus, while it may be true that replacement compounds are less toxic, they are also more mobile so may present a greater overall risk profile.

What makes PFAS especially problematic for human health and the environment is that they do not biodegrade easily and tend to accumulate in the environment as they move down river streams and through the air. They are accumulated and absorbed throughout the food chain and, as a result, are found in a large proportion of our food sources.

Testing for PFAS Dark Matter

PFAS are composed of 5,000 or more compounds, most of which are unknown and uncharacterized. A typical PFAS analysis can only report on between twenty and fifty PFAS compounds, meaning that the overwhelming majority of PFAS compounds cannot be specifically detected. These unknown and undetected PFAS are referred to as "Dark Matter" – they are out there but not measured. Dark Matter, however, can break down or transform into PFAS that are measurable. Notably, just because they cannot be studied does not mean that they cannot contribute to toxicity. Indeed, they do.

• Testing at the individual PFAS compound level

The early days of PFAS testing was solely looking at individual PFAS compounds (using LC/MS/MS for science nerds). This method is still the best practice for measuring individual PFAS at very low levels. As noted above, there are only about 50 compounds that are tested at commercial laboratories. This method is primarily used for regulatory compliance.

• Testing for individual PFAS plus indicators of total PFAS

Another form of PFAS testing is the Total Oxidizable Precursors (TOPs) Assay. This tests for individual PFAS plus it provides a glimpse into the 5,000+ other compounds. The test first finds the individual PFAS (using the LC/MS/MS method), but then it oxidizes the precursors to the individual PFAS compounds (essentially creating and measuring additional individual PFAS).

This method is accurate for concentrations of individual PFAS plus indications of presence of "Dark Matter" PFAS. This method still misses some PFAS because not all PFAS break down to detectible compounds, and so it does not necessarily provide a total PFAS result.

• Scientists can now measure total PFAS

An emerging testing technique for total PFAS is Total Organic Fluorine (TOF). This method provides a more comprehensive picture of PFAS in a sample by using organic fluorine as a proxy for PFAS. It is not selective (meaning it doesn't identify individual PFAS) but can provide an accurate picture of the total known and unknown PFAS.

PFAS Use in Food Products and Recent FDA Action

Now that we have identified the relevant testing available, let's take a look at the history of PFAS use in food.[3] In the 1960s, the U.S. Food and Drug Administration (FDA) authorized specific PFAS for use in some food contact materials.

Fast forward to today and you will find specific PFAS approved for use in the following four categories:

(1) Non-stick cookware;

(2) Gaskets, O-Rings, and other parts used in food processing equipment;

(3) Processing aids for manufacturing food contact polymers to reduce build-up on manufacturing equipment; and

(4) Paper/paperboard food packaging for use as grease-proofing agents in fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags to prevent oil and grease from foods from leaking through the packaging.

Beyond approving PFAS for use in food packaging, the FDA has taken the follow regulatory actions with respect to PFAS:

• The FDA tests for PFAS but, notably, it states that it only tests for 30 types of PFAS. This is, of course, only a drop in the PFAS bucket.

• To address some of the broad safety concerns associated with PFAS, the FDA has negotiated the voluntary market phase-outs of certain short-chain PFAS (second gen), to be completed by December 2023.

• In mid-2022, the FDA tested 81 samples of mainly imported "clams, cod, crab, pollock, salmon, shrimp, tuna, and tilapia."

• • "Using the best available science, the FDA evaluated individually the PFAS detected that have toxicological reference values."

• • "The FDA determined that the estimated exposure to perfluorooctanoic acid (PFOA), a type of PFAS, from the samples of canned clams, which were from China, is likely a health concern."

• • "For the canned clam samples with the two highest levels of PFOA, there would be a potential health concern for consumers who eat more than approximately 10 ounces (oz) of these clams per month, except for young children, who should limit consumption to 2 oz per month."

• • Two companies recalled their products as a result of the testing.

• The FDA's testing was narrow in terms of the types of products tested as well as the number of PFAS tested for (those with toxicology referencevalues). In other words, FDA testing did not account for the 5,000+ PFAS Dark Matter compounds.

• The FDA notes that testing will continue and points to the EPA's recent efforts as proof that the government is taking action on PFAS.

It is important to note that companies that want to make voluntary label claims about PFAS on the products should carefully weigh the risks and benefits of doing so. As noted above, there are methods of testing total PFAS but those are not widely available. Therefore, it may not be reasonable to claim that a product is PFAS-free unless you can take advantage of total PFAS testing methods.

Companies (perhaps especially seafood companies) should also begin to consider whether they should take into account PFAS as part of their food safety plan and designate PFAS as a hazard that needs controlling.

What is the EPA Doing?

In October 2021, the Environmental Protection Agency (EPA) announced its PFAS Strategic Roadmap, laying out timelines by which the agency planned to take action to safeguard public health, protect the environment, and hold polluters accountable. EPA's actions are focused on the Clean Water Act, public drinking water systems, and regulations under the Resource Conservation and Recovery Act (RCRA) and the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA).

On the Clean Water Act front, EPA issued a memo to reduce discharges of PFAS from point sources as part of its National Pollutant Discharge Elimination System (NPDES) program. As the agency works to set effluent guidelines and issue water quality criteria, expect PFAS limits to start being included in those permits.

In March 2023, the EPA announced a proposed National Primary Drinking Water Regulation (NPDWR) for six PFAS, four of which were Gen X chemicals, known to occur widely in drinking water throughout the United States.[4] EPA anticipates finalizing the regulation by the end of 2023.[5] In parallel, EPA announced the availability of $2 billion from the Bipartisan Infrastructure Law to address emerging contaminants (including PFAS) in drinking water. The funding will be allocated to states and territories and available to communities as grants through EPA's Emerging Contaminants in Small or Disadvantaged Communities grant program.

Finally, EPA issued in April 2023 an Advance Notice of Proposed Rulemaking asking for public input regarding the designation of PFOA and PFOS as hazardous substances under CERCLA, which would likely result in more aggressive efforts from the agency to hold polluters accountable. EPA is also expected to propose two rules by the end of 2023 listing four PFAS substances as hazardous under RCRA.

Summary of Federal Efforts

Needless to say, there is at the moment little enforcement happening at the Federal level as the FDA and EPA are still in study-and-plan-mode. However, EPA's efforts to regulate certain PFAS in drinking water, through its NPDES program and under CERCLA and RCRA, could quickly result in aggressive enforcement and cleanup actions against polluters. The caveat is that FDA and EPA are both only addressing a tiny fraction of PFAS currently being used.

What Are States Doing?

In contrast, states are making PFAS regulatory waves.

States are attempting to fill in the federal regulatory gap by enacting broad, sweeping regulations (sometimes not well informed). Because these efforts may be less informed, they are more likely to have unintended consequences. For example, a state bill that bans PFAS altogether in consumer goods will have the consequence of banning all "Dark Matter" PFAS that are difficult to detect and, indeed, not detectable by many commercial laboratories. In that case, compliance may be impossible. Very few state laws have passed the implementation and challenge stage, so we will report on those as they arise. At this time state bans vary in their scope: some are enforceable against manufacturers only while others also focus on suppliers and retailers. The types of products covered include cookware, cosmetics, textiles, food packaging, firefighting foam, and other consumer products, illustrating how widespread PFAS use has become.

Litigants are also taking advantage of state tort laws to raise contamination claims against companies that manufacture or use PFAS. In recent months, there have been enormous settlements reported relating to PFAS contamination, including a $10.3 billion settlement against a single manufacturer.

Certainly, plaintiff's lawyers will not focus just on the 20-50 PFAS that are individually identifiable. They will no doubt perform the broader total PFAS testing which will significantly raise the toxicology profile of the contaminated site or product and, as a consequence, the cleanup costs and settlement value. Note, however, there are challenges with the total PFAS testing as it cannot now identify all individual PFAS (and, therefore, making causation difficult to establish).

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