Per- and polyfluoroalkyl substances (“PFAS”) are everywhere these days. And not just in consumer products that we use every day or in drinking water and soils, but also in the news. This is because the science around PFAS tells us that these “forever chemicals” represent an emerging concern. The short-term and long-term risks are still being evaluated, but studies show that exposure at certain concentrations can be detrimental to human health and the environment. The evolution of laboratory techniques so they can routinely detect these compounds in the low parts per trillion has also changed the public’s and regulators’ understanding of how widespread such contamination now is, albeit at low concentrations.

As a result, public and regulatory attention to PFAS is at an all-time high. The Biden Administration has brought an increased focus to addressing these chemicals, while federal and state regulatory agencies are rapidly investigating and studying PFAS in order to provide up-to-date information regarding potential health effects, sampling and analysis, treatment techniques, and guidance on future changes to regulations and policies. The scientific and regulatory landscape is quickly shifting and will likely continue to do so over the next few years.

PFAS are a group of thousands of human-made (synthetic) compounds. The most notable are perfluorooctanoic acid (“PFOA”), perfluorooctanoic sulfonate (“PFOS”), hexafluoropropylene oxide dimer acid (“HFPO-DA” or “GenX”), perfluorobutane sulfonic acid (“PFBS”), and perfluorohexane sulfonic acid (“PFHxS”). These chemicals are commonly referred to as “forever chemicals” because the compounds are very stable, do not typically deteriorate in the environment, and may accumulate over many years in animals and the human body.

There are dozens of pathways to be exposed to PFAS, including in drinking water, workplace exposure, eating fish from waters containing PFAS, and using everyday consumer products (such as nonstick cookware, grease-resistant papers and containers, cleaning products, personal care products, paints, waxes, stain and water resistance treatments on clothing, carpets, etc.). These chemicals were first identified in the U.S. in the early 1940s and quickly became an everyday household item because of their resistance to grease, heat, oil and water, but their impact on human health and the environment has only started to be understood and addressed over the last few decades.

Regulation of PFAS Has Been Slow, But Broad and Sweeping Regulatory Changes are Coming Soon

Last year, in what is considered the most comprehensive PFAS legislation to date, the U.S. House of Representatives passed H.R. 2467 “PFAS Action Act of 2021.” The Act called for several significant regulatory actions by the United States Environmental Protection Agency (“U.S. EPA”) to address the prevalence and impact of PFAS. In July 2021, the Act was referred to the U.S. Senate, Committee on Environment and Public Works. As of today, the legislation has not made it out of the committee.

Shortly thereafter, U.S. EPA Administrator, Michael S. Regan, formed the U.S. EPA Council on PFAS and tasked the Council with creating the PFAS Strategic Roadmap (the “Roadmap”) to develop “an ambitious plan of action to further the science and research, to restrict these dangerous chemicals from getting into the environment, and to immediately move to remediate the problem in communities across the country.” The Roadmap incorporated many of the regulatory actions envisioned by H.R. 2467. The Roadmap outlined the following major steps that U.S. EPA would take over the next few years.

• Propose new standards under the Safe Drinking Water Act, 42 U.S.C. §300f et seq., for PFOA and PFOS in 2022, with final action on the standards in 2023.
• Publish toxicity assessments and health advisories for certain PFAS.
• Propose to designate PFOA and PFOS as “hazardous substances” under the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA”), 42 U.S.C. §9601 et seq., in 2022 and finalize in 2023 and propose designations of other PFAS compounds.
• Propose effluent limitations guidelines (“ELGs”) under the Clean Water Act, 33 U.S.C. § 1251 et seq., in 2023 and 2024 for PFAS in several industrial categories, including organic chemicals, plastics and synthetic fibers, metal finishing, and electroplating. U.S. EPA stated it has enough data to support these guidelines and will launch detailed studies in 2022 to collect data to support a potential rulemaking in other categories.
• Propose final recommended PFOA and PFOS ambient water quality criteria for aquatic life in 2022 and for human health by 2024.
• Finalize an information gathering rule for PFAS under Section 8 of the Toxic Substances Control Act requiring reporting of information such as use, production volume, disposal, exposure and hazards for PFAS manufactured or imported since 2011.

These are only a few of the major steps outlined in the Roadmap. Once finalized, these regulations and rules would trigger obligations across many impacted industries and the rest of the regulated world, including tracking, recording, and reporting releases that exceed a certain reportable quantity. Designation under CERCLA could also result in sites that had been previously remediated to reopen to address PFAS contamination and could increase the overall number of contaminated sites requiring remediation, thus leading to additional cost recovery and contribution claims. It has already delayed final completion of remedies at some older CERCLA National Priorities List (“NPL”) sites. Further, because of their unique chemical properties, PFAS are resistant to common remediation technologies used to address other pervasive contaminants. Therefore, remediation can often be more expensive and time consuming. It is important that impacted industries understand the PFAS risk at contaminated sites at which they are currently involved and have been involved.

Since the Roadmap was published, several regulatory steps have been taken:

• Last month, in an open letter, U.S. EPA notified companies that manufacture, import, process, distribute, use, and dispose of High-Density Polyethylene (“HDPE”) containers and similar plastics that the presence of PFAS formed as a byproduct in these containers may be a violation of the Toxic Substances Control Act (“TSCA”), 15 U.S.C. §2601 et seq., and advised those companies regarding TSCA notification requirements. Because HDPE container use is widespread, this action may affect a large number of parties, including plastic recycling programs run by many state and local governments.
• U.S. EPA also removed certain PFAS from its Safer Chemical Ingredients List. The list is a “voluntary program that helps consumers, businesses, and purchasers find products containing ingredients that are safer for human health and the environment.”
• As discussed in our latest blog post, new standards have been approved by U.S. EPA suggesting that prospective purchasers of real property include an evaluation of PFAS in the Phase I Environmental Site Assessment if the substances are regulated by the state.
• According to its press release, U.S. EPA asked its Science Advisory Board to review recent scientific data and new analyses regarding the health effects of PFOA and PFOS. This was because the scientific documents “indicate that negative health effects may occur at much lower levels of exposure to PFOA and PFOS than previously understood and that PFOA is a likely carcinogen.”
• U.S. EPA announced important steps toward evaluating the existing data for certain PFAS and initiating proposed rulemaking under the Resource Conservation and Recovery Act (“RCRA”), 42 U.S.C. §6901 et seq., to list the chemicals as “hazardous constituents” subject to corrective action. Such a listing is also a precursor and required component to a hazardous waste listing under RCRA, subjecting the chemicals to additional regulation.
• U.S. EPA finalized the human health toxicity assessment for HFPO-DA or GenX and its Ammonium Salt to provide hazard identification, dose-response information, and derived toxicity values called oral reference doses for chronic and sub-chronic exposures.
• U.S. EPA recently requested in its proposed fiscal year 2023 budget an estimated $126 million to help implement its PFAS strategic roadmap.

Based on the current regulatory temperature, we expect more regulatory action in the next few months and years in line with the goals of the Biden Administration and the Roadmap.

States are Charging Ahead with Their Own Standards to Regulate the Impact of PFAS

Due to the timing (or lack thereof) of a federal regulatory response, states are leading the charge and promulgating their own standards to regulate the impact of PFAS. Most of the regulation has been in setting enforceable maximum contaminant levels (“MCLs”) in drinking water. There is no current federal MCL for any PFAS chemical, but U.S. EPA has established a non-enforceable health advisory level of 70 parts per trillion (ppt) for PFOA and PFOS combined. Many states have followed this guidance.

To date, Maryland, Virginia and the District of Columbia have not set specific MCLs for PFAS in drinking water, but all reportedly are monitoring the science and regulatory landscape. A handful of states have gone further, setting allowable concentration levels and ambient air limits. Until there is a comprehensive federal regulatory approach, we will continue to see a patchwork of state-by-state regulations and standards. For impacted industries, this could cause a challenge in regards to compliance.

PFAS Litigation is Not New, but it has been Gaining Steam the Last Few Years

Outside of the regulatory world, several litigation actions have been filed against manufacturers and distributers of PFAS. PFAS litigation is not new, but it has been gaining steam the last few years. In one such case filed in the U.S. District Court for the Southern District of Ohio, Kevin D. Hardwick v. 3M Company, et al., Case No. 2:18-cv-1185 (S.D. Ohio March 7, 2022), plaintiff alleged that PFAS manufacturers and distributers “knew for decades that these chemicals presented a serious risk of disease and harm, engaged in a systematic effort to conceal and deny the dangers of PFAS, misled regulators and the public, and made billions of dollars in profits while contaminating millions of people without their knowledge.” Plaintiff requested that the court certify a class consisting of all U.S. residents with a detectable level of PFAS in their blood and is seeking industry-funded medical monitoring to determine the health effects of numerous PFAS on humans.

Although the District Court Judge denied the larger class, the Judge certified a smaller class consisting of “individuals subject to the laws of Ohio, who have 0.05 parts per trillion (ppt) of PFOA (C-8) and at least 0.05 ppt of any other PFAS in their blood serum” and left open the possibility for the class to expand to residents of other states. This is a landmark decision that will allow the judicial system to continue evaluating the impact of PFAS on the health of the public, could drive new regulations, propel new PFAS science, and possibly guide future litigation.

On March 22, 2022, defendants appealed the ruling to the U.S. Court of Appeals for the 6th Circuit. Defendants argue that the class never should have been certified because the class does not comply with the requirements for injunctive-relief classes under Fed. R. Civ. P. 23(b)(2).

The 3M Company has already settled several claims regarding the company’s manufacturing and disposal of PFAS, including claims made by parties in New York, Alabama, and Minnesota. At $850 million, the largest ever settlement relating to PFAS contamination was in February 2018. The state of Minnesota settled its claims that the 3M Company had disposed of PFOA and PFOS in multiple landfills and unlined dumps which had damaged drinking water and natural resources in the Twin Cities metropolitan area. The company is also facing new lawsuits in California and North Carolina.

Conclusion

The PFAS regulatory, litigation, and insurance landscape is changing rapidly. Based on what we are seeing, we expect more regulatory action in the next few months and years in line with the goals of the Biden Administration and the Roadmap, more litigation claims being made against companies that manufacture, use, and dispose of PFAS, and more evolution in the insurance industry regarding how PFAS is taken into account. As we process and understand the changing landscape, we will write future blog posts to provide updates, and we welcome your feedback as we continue to develop this series. 

Opinions and conclusions in this post are solely those of the author unless otherwise indicated. The information contained in this blog is general in nature and is not offered and cannot be considered as legal advice for any particular situation. The author has provided the links referenced above for information purposes only and by doing so, does not adopt or incorporate the contents. Any federal tax advice provided in this communication is not intended or written by the author to be used, and cannot be used by the recipient, for the purpose of avoiding penalties which may be imposed on the recipient by the IRS. Please contact the author if you would like to receive written advice in a format which complies with IRS rules and may be relied upon to avoid penalties.

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