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On September 29, 2022, The World Health Organization (WHO) published its draft guidance on perfluorooctanoic acid (“PFOA”) and perfluorooctane sulfonate (“PFOS”) in drinking water, which are the most widely studied of the per- and polyfluoroalkyl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 The WHO’s draft guidance lends support to those, including the ACC and National Academy of Sciences, who have criticized EPA’s LHAs.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)
Continue Reading WHO’s Recent Guidance Underscores Uncertainty With Regard to PFAS

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.
Continue Reading Sixth Circuit Grants Interlocutory Review of Massive PFAS Class Certification

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.
Continue Reading California To Pass Three Bills Regulating Use of PFAS in Cosmetics and Clothing

The National Academy of Sciences—a private, non-profit organization—recently issued a report regarding committee findings on the human health effects from exposure to per-fluoroalkyl and poly-fluoroalkyl substances (PFAS). PFAS are a class of over 12,000 man-made chemicals, commonly used in consumer and industrial products as a surfactant.

PFAS are also known as “forever chemicals” due to their bio-persistence. Due to their chemical structure, PFAS resist degradation over time due to the strength of the bond between their carbon and fluorine atoms. Further, even when their chemical structure is broken, they will re-assemble as PFAS. Largely for this reason, there has been growing concern in the regulatory and scientific community regarding human exposure to PFAS through drinking water and use of consumer products.

The academy’s report focused on seven (7) of the most commonly produced PFAS. The committee found that there was sufficient evidence of an association between PFAS exposure and decreased antibody response in adults and children, dyslipidemia in adults and children, decreased infant and fetal growth, and increased risk of kidney cancer in adults. The committee found only limited or suggestive evidence of an association between PFAS exposure and the following health effects: increased risk of breast cancer in adults, liver enzyme alterations in adults and children, increased risk of pregnancy-induced hypertension, increased risk of testicular cancer in adults, thyroid disease and dysfunction in adults, and increased risk of ulcerative colitis in adults. The committee found insufficient evidence to support any association between PFAS exposure and respiratory conditions, neurological effects, and any cancers other than kidney, breast and testicular cancer.

The committee findings are notable for a few reasons. First, the committee’s finding of a “limited” or weak association between PFAS exposure and certain types of cancer—such as breast cancer, and testicular cancer—undermines the studies on which many current personal injury suits against PFAS manufacturers and suppliers are premised. Second, although the committee found there was “sufficient evidence” of an “association” between PFAS exposure and certain health conditions, it stopped short of stating there was any “causal effect” between PFAS exposure and any adverse health conditions. 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. Although PFAS has been widely (and heavily) used in the United States for decades, no scientific organization or study has yet established a “causal link” between PFAS and adverse health outcomes. Despite the absence of a medical consensus as to whether PFAS constitutes a health risk, the National Academy of Science’s report nonetheless recommends that those individuals with suspected high levels of PFAS in their blood due to occupational or environmental exposures undergo testing, which will in turn be used in support of ongoing class action litigation demanding medical monitoring for those with elevated levels of PFAS exposure.
Continue Reading The National Academy of Sciences Issues Report on PFAS Health Effects

California has just added per- and poly-fluoralkyl substances (PFAS) to the list of chemicals requiring consumer warnings under Proposition 65, meaning that state residents can soon expect to see the words “cancer” and “reproductive harm” on such common consumer products as shampoo, nail polish, cookware and fast food.

PFAS are a group of man-made chemicals that have been widely used for decades in consumer products such as fast food wrappers, clothing and carpets, as well as industrial products such as firefighting foam. Although there are no epidemiological studies showing a statistically significant link between exposure to PFAS and disease, in 2006 the Environmental Protection Agency (EPA) Science Advisory Board stated that the chemical is “likely to be carcinogenic to humans.” State regulations of PFAS in water and consumer products swiftly followed, with California in the forefront. In addition to proposed legislation to ban the use of PFAS in cosmetics, California is now requiring any business that sells PFAS-containing products to provide a warning with the product, or face penalties of $2,500 per “violation.”

The impact of this latest regulation cannot be understated—PFAS are found in a wide variety of consumer products, and California is the world’s fifth largest economy. California obviously holds substantial influence in setting the standards for manufacturers, sellers and producers of goods across the globe. As such, the practical impact of adding PFAS to the list of chemicals regulated under California law is that a significant percentage of any business engaged in national or interstate commerce will now be required to place warnings on common, every-day products. Even virtual market place forums such as Amazon may be subject to Prop 65 enforcement actions. In order to manage Prop 65 risks and liabilities, businesses are advised to periodically review regulatory changes to ensure they remain compliant with Prop 65 requirements. In addition to implementing a system to track regulatory changes, it is also prudent that businesses adopt contractual provisions aimed at reducing their liability for a potential Prop 65 enforcement action. As more PFAS are added to the list in the coming years, it is crucial that businesses take the necessary steps now to minimize their risks and liabilities.
Continue Reading California Adds PFAS to List of Chemicals Subject to Prop 65 Enforcement Actions