On September 29, 2022, The World Health Organization (WHO) published its draft guidance on perfluorooctanoic acid (“PFOA”) and perfluorooctane sulfonate (“PFOS”) in drinking water, which are the most widely studied of the per- and polyfluoroalkyl substances (PFAS). PFAS are a vast group of man-made chemicals found in many consumer products due to their desirable chemical properties. PFAS, however, resist degradation and, in some cases, have migrated into soil and groundwater, which created concern regarding its environmental and human health impact. As a result, a number of government agencies, including the US Environmental Protection Agency (“EPA”) and a number of state governments, have issued recommendations and/or imposed maximum limits on PFAS in drinking water.

In 2016, the EPA issued Lifetime Health Advisories (“LHA”) for PFOA and PFOS of 70 parts per trillion (“ppt”) in drinking water. Since that time, a number of states have issued more stringent maximum contaminant levels for PFAS, including PFOA and PFOS. For instance, California has set notification levels as low as 5.1 ppt for PFOA and 6.5 ppt for PFOS. In addition, earlier this year EPA issued new LHAs for PFOA and PFOS that reduced the recommended levels to 0.004 ppt for PFOA and 0.02 ppt for PFOs. Those levels are 17,500 times and 3,500 times, respectively, lower than EPA’s prior LHAs, and levels that are essentially zero, as current techniques are unable to detect PFAS at those levels. While EPA asserted that its revised LHAs are based on emerging science, a number of groups have criticized EPA’s actions and called into question the scientific basis for its new LHAs. In fact, the American Chemistry Council (“ACC”) recently filed suit against EPA seeking to challenge the new LHAs for PFAS, noting that “EPA’s revised [LHAs] for PFOA and PFOS reflect a failure of the Agency to follow its accepted practice for ensuring the scientific integrity of its process.” The WHO’s draft guidance lends support to those, including the ACC and National Academy of Sciences, who have criticized EPA’s LHAs. Based on its review of the current scientific and medical studies, the WHO recommends a limit of 100 ppt for PFOA and PFOS in drinking water, a limit that is 25,000 times higher than that which the EPA recommends. In addition, Health Canada recently issued its guidance for PFOA and PFAs in drinking water. It recommends limits of 200 ppt for PFOA and 600 ppt for PFOS, further calling into question EPA’s LHAs.

While the WHO’s guidance is significantly at odds with that of the EPA’s, many are stating that this difference underscores the amount of uncertainty with regard to the impact of PFAS on human health. In issuing its recommendation, the EPA found its recommended limit to be at a “level of drinking water contamination below which adverse health effects are not expected to occur,” while WHO concluded that “uncertainties in identifying the key endpoint applicable to human health following exposure to PFOS and/or PFOA are too significant to derive a Health Based Guidance Value (HBGV) with confidence.” However, WHO determined that “due to the potential adverse health effects reported in both humans and animals following higher level exposure to PFOS and/or PFOA” a guidance value for PFOA and PFOS in drinking water was warranted. It is important to keep in mind that WHO is a global entity that considers in its guidance countries around the world, some of which may not have the technological capabilities to remediate PFAS in drinking. Additionally, WHO’s draft guidance is only a background document, which is open for public comment until November 11, 2022, and can potentially change.

EPA plans to issue binding maximum contaminant levels for PFOA and PFOS (and possibly other PFAS chemicals) either later this year or early in 2023. While its LHA’s suggest that EPA is targeting MCLs approaching zero, it will be interesting to see whether the ACC’s legal challenge and WHO’s new draft guidance alters EPA’s decision-making. Those regulatory decisions will have a tremendous impact on the economy, as MCLs approaching zero could force most, if not all, water providers to remediate PFAS, who may then look to litigation to recover those costs. As such, it is important for water suppliers and other stakeholders to closely monitor the ACC’s legal challenge and EPA’s MCL regulatory actions in order to adequately prepare to meet future regulatory requirements and the potential exorbitant costs that may be associated with compliance, as well as to stay abreast of potential opportunities to challenge any such regulatory action.

Early results show that using bioremediation to break down “forever chemicals” is working at an airport around Madison, Wisconsin. At the Dane County Regional Airport, scientists are introducing microbes into the groundwater to reduce the presence of PFAS in the water. Per- and polyfluoroalkyl substances (PFAS) are manmade chemicals that break down very slowly, if at all, in the natural environment. They have been used in food-packaging, cleaning products, paints, fire-fighting foams implemented at airports, and stain and water resistant fabrics, carpeting, and clothing. Studies have correlated adverse health effects to the presence of PFAS in groundwater and soil.

Bioremediation is the process of using living organisms such as fungi and plants and microorganisms such as bacteria to break down pollutants in the environment. Typically, when addressing groundwater remediation, microorganisms are introduced into the water source and provided nutrients. With the added nutrients, scientists are able to stimulate the growth rate of the bacteria and increase their metabolisms to eat the contaminant faster. The bacteria is able to either remove the contaminant completely or break it down into harmless inorganic constituents. One of the most prevalent uses of bioremediation is in the cleanup of oil spills, and was employed extensively for the Exxon Valdez and Deep Water Horizon spills.

Bioremediation is significantly cheaper than alternative methods of remediation such as incineration, solidification, oxidation or land filling. By relying on naturally occurring microorganisms, plants and fungi, the underlying remediation processes are both continuous and renewable. Recent successes with PFAS bioremediation in situ have resulted in cleaning up the environment without the need to move huge amounts of water or soil for treatment. Due to the natural metabolic action of bioremediation, it may take longer than other methods of remediation. However, data from the Dane County Regional Airport revealed a 97% reduction of PFAS in the first nine months.

At MG+M, we are leaders in the area of PFAS litigation and risk management. Our lawyers are trained in bioremediation and experienced at its implementation, boasting graduate level coursework in the field and having worked extensively with experts in bioremediation, including in the remediation of the largest oil spill in history. With our deep understanding of bioremediation opportunities and processes, our attorneys are better able to guide you through the challenges of PFAS risk, litigation, regulation and remediation.

Recently, a three-judge panel of the US Court of Appeals for the Sixth Circuit granted interlocutory review of an enormous class action that could significantly impact the future of PFAS litigation. The decision came as defendants in Hardwick v. 3M, currently before the US District Court for the Southern District of Ohio, appealed the district court’s decision certifying what may be the largest class of plaintiffs in history. The forthcoming ruling is of particular import because it has the potential to be a landmark ruling for class actions and considerably affect the future of PFAS litigation.

Filed in 2018, named plaintiff Kevin Hardwick, a former firefighter, alleges exposure to PFAS from his gear and the fire suppressant used in his line of work. At the time, plaintiff sought nationwide certification of a class consisting of “any individual residing within the United States… with 0.05 parts per trillion (ppt) or more of PFOA and at least 0.05 ppt or more of any other PFAS in their blood serum.” For context, many reports indicate the proposed class potentially consists of 95% of the US population.

Earlier this year, the Ohio district court limited class certification to all Ohio residents who have “0.05 parts per trillion (ppt) PFOA (C-8) and at least 0.05 ppt of any other PFAS in their blood serum.” The district court explained this was the most appropriate step because, while Ohio recognizes medical monitoring claims, a number of other states do not recognize such a claim.  That said, the court also stated it might expand the class to other states that also recognize these claims. Even reducing the class to only Ohio residents results in a certified class of at least 11 million people, making it the largest class action in history.

Interestingly, the lawsuit does not seek monetary damages. Rather, plaintiffs seek injunctive relief through the establishment of a science panel to study the adverse impact of PFAS on human health, as well as medical monitoring for its affected class members.

Given the potential for massive liability due to the size of this class certification and the relief sought, defendants appealed the court’s class certification. Defendant’s arguments focused on class standing, cohesiveness, and the relief sought.

In its Order, the Sixth Circuit addressed several issues it found concerning regarding the district court’s decision. Addressing Article III standing, the Sixth Circuit found that the presence of PFAS in a plaintiff’s blood could potentially qualify as an injury-in-fact, due in part to Ohio’s recognition of medical monitoring claims after exposure to toxic substances and plaintiff analogizing the claim to battery. However, the court felt the relief sought—a science panel and medical monitoring—presented issues with regard to redressability as it would not do anything to address the presence of PFAS in plaintiff’s blood, nor prevent more from entering it. Further, the court also found plaintiff’s lack of evidentiary proof of a causal connection between his alleged injuries and the conduct of the defendants presented issues in terms of traceability.

Next, the court noted its concerns with the class certification, finding the fact that class members were likely exposed to PFAS “in different ways, in different amounts, and at different times” to be at odds with the commonality requirement for class certification and principles of class cohesiveness.

Lastly, the court addressed tertiary issues it found to be particularly important in its decision to review the district court’s class certification. The Sixth Circuit stated that a class certification of this magnitude creates a “reverse death knell” scenario “where the certification decision threatens such massive liability that it induces defendants to settle rather than defend the action on its merits.” Additionally, the court also felt it important to mention that, as stated in its ruling, the district court was considering expanding the class, which “underscores the need for a second look.” In sum, the Sixth Circuit found that defendants’ arguments presented “unsettled and important questions,” and granted their appeal for interlocutory review.

Nonetheless, the Sixth Circuit cautioned that resolution of whether the class may go forward presently awaits the merit panel’s review. Specifically, the court stated “[W]e hold merely that when a district court certifies one of the largest class actions in history, predicated on a questionable theory of standing and a refusal to apply a cohesion requirement endorsed by seven courts of appeals, to authorize pursuit of an ill-defined remedy that sits uneasily with traditional constraints on the equity power and threatens massive liability, such a decision warrants further review.”

If this class certification is approved, it could open the flood gates to the filing of similar cases in other jurisdictions, with more defendants added to the litigation. The impact would be massive, not only on manufacturers of PFAS, but also the downstream companies that manufactured, sold, and/or used products that contained PFAS, that may be pursued in later litigation for their alleged contribution to environmental PFAS exposure. Hence, considering the expansive impact this anticipated class certification ruling may have, we recommend that all companies that may have manufactured, sold, and/or used a product that contained PFAS closely monitor this case and other similar matters to assess potential liability.

In recent years, state and federal agencies have either passed or proposed increasingly stringent regulations regarding the use of per-fluoroalkyl and poly-fluoroalkyl substances (PFAS) in consumer products. Not surprisingly, the state of California has been at the forefront of these efforts. California’s place at the forefront of PFAS regulation continues, as the California legislature recently passed three new bills—AB 2771, AB 1817, and AB 2247—seeking to eliminate the use of PFAS in textiles and cosmetics.

AB 2771 would prohibit the manufacture, sale or marketing of any cosmetic product that contains intentionally added PFAS. AB 1817 would prohibit the manufacturing, distribution or marketing of any new textile article—including clothing—that contains regulated PFAS. AB 1817 also requires a manufacturer of textiles to provide customers or suppliers a certificate of compliance stating that the product does not contain regulated PFAS. Lastly, AB 2247 would require any manufacturer of PFAS or a product containing intentionally added PFAS to register the PFAS or the product containing intentionally added PFAS into a publicly accessible data collection interface. Violations of the reporting requirement would be subject to civil penalties and other enforcement provisions.

Governor Newsom is expected to sign the bills into law no later than September 30, 2022. If passed, these bills will go into effect January 1, 2025, with the exception of AB 2247, which would go into effect July 1, 2026.

However, even if these bills are passed, it is yet to be seen whether these bills will withstand judicial scrutiny given they are, arguably, at odds with federal law. The US Federal Drug and Food Administration—the federal agency charged with regulating the food, drug, and cosmetics industry—has not banned PFAS from any of the products under its purview. In fact, the FDA has specifically approved some types of PFAS for use in certain food contact applications, reflecting a governmental determination that there is a reasonable certainty that no harm will come from their use in the applications for which they have been approved. As such, it is expected that manufacturers of these products may challenge the enforcement of these statutes.

Notwithstanding the potential conflict between California and federal law, companies involved in the manufacture and sale of PFAS-containing cosmetics and textiles—including clothes and carpeting materials—should actively research alternatives to PFAS in their products right now. Businesses simply cannot assume that California’s new laws will be unenforceable, particularly with the EPA’s stated intent to further regulate PFAS. Should businesses fail to prepare, they could risk losing product sales in California, the world’s fifth largest economy.

On August 26, 2022, the US Environmental Protection Agency (EPA) announced proposed rulemaking to designate two types of per- and poly-fluoroalkyl substances (PFAS) as “hazardous chemicals” under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA).

PFAS are a class of man-made chemicals widely used as surfactants in industrial and consumer products, including but not limited to: firefighting foam, cosmetics, clothing, cookware, and carpeting. They are known for their bio-persistence, and, unlike most other chemicals, do not “break down” in the human body when consumed. The EPA’s proposal specifically applies to perfluorooctanoic acid (PFOA), and perfluorooctanessulfonic acid (PFOS), two of the most commonly used types of PFAS.

In the news release announcing the proposed rulemaking, the EPA states that its proposal “is based on significant evidence that PFOA and PFOS may present a substantial danger to human health or welfare or the environment.” The EPA goes on to claim: “PFOA and PFOS can accumulate and persist in the human body for long periods of time and evidence from laboratory and human epidemiology studies indicates that exposure to PFOA and/or PFOS may lead to cancer, reproductive, developmental, cardiovascular, liver, and immunological effects.”

While the language used by the EPA and other regulators strongly suggests to the public there is a medical consensus that PFAS exposure causes cancer and other adverse health effects, this is not the case. Despite the fact that PFAS have been widely and heavily used for decades in the United States, no epidemiological study to date has found a “causal effect”—versus an “association”—between PFAS exposure and cancer. A “causal effect,” in contrast to an “association,” is demonstrated where exposure to a particular substance shows a statistically significant increase in the number of certain health outcomes, such as cancer, as compared to what would be expected in a non-exposed population.

The EPA’s proposed designation of PFOA and PFOS as “hazardous substances” under CERCLA, if passed, is significant for a number of reasons. Companies who continue to manufacture and sell products containing PFOA or PFOS will be required to monitor and report releases of the chemical to the government, and will be regulated by the Department of Transportation under the Hazardous Materials Transportation Act.

Perhaps most significantly, designating both PFOA and PFOS as “hazardous” chemicals under CERCLA will lead to potentially limitless liability for some of the country’s biggest industries, including aviation, plastics, and oil. Under CERCLA, the Federal Government may order any party found responsible for contaminating land with a “hazardous” substance to pay for the costs of clean-up. The Federal government can—and more often than not does—cast a very wide net in assigning liability for the costs of remediating and/or removing hazardous substances from a designated site. For example, businesses or individuals may be apportioned liability under CERCLA simply for purchasing land known to be a source of prior contamination, for exercising “substantial control” over activities at the facility where the contamination occurred, or for transporting the hazardous substances. (Kaiser Aluminum & Chemical Corp. v. Catellus Development Corp. (976 F.2d 1338 (9th Circ. 1992; US. v. Bestfoods, 524 U.S. 51 (1998)). CERCLA penalties may also be applied retroactively, meaning that those contributing to the use of PFAS at a designated site can be held responsible for all or a portion of the clean-up costs even if the contamination occurred prior to PFAS being listed as a hazardous substance, or even prior to the passage of CERCLA itself. (US v. Monsanto, 858 F.2d 160 (4th Cir. 1988).

It is important to note that the EPA’s proposed designation will not become effective immediately. The proposed rulemaking is subject to the delays of public notice and comments requirements of the Administrative Procedure Act. Finally, given the lack of medical consensus as to whether PFOA and PFOS cause disease, versus the high cost of remediation, it is almost certain that the proposed rulemaking will be challenged in court by one or more members of the affected industries.