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.

Every year, the federal government passes the National Defense Authorization Act, allocating the budget for the Department of Defense (DoD). In this year’s bill, the US House of Representatives voted to require the DoD to monitor and reduce potential contamination by per- and poly-fluoroalkyl substances (PFAS). PFAS are a group of man-made chemicals commonly used as surfactants in both industrial and consumer goods, and are known for their extreme biopersistence. The widespread use of PFAS over the course of the past fifty years has led to groundwater contamination of varying degrees throughout the United States, including groundwater contamination near military sites where PFAS-containing products are frequently used as fire suppressants. Individuals who are exposed to high levels of products that contain PFAS—such as members of the military who regularly work with PFAS-containing fire suppressants—are reported to have higher levels of PFAS in their blood. Specifically, the bill addresses regulation and reporting of PFAS by the military.

Under the new bill, the DoD must report on (1) PFAS destruction alternatives to incineration, (2) sources of PFAS contamination at military sites and (3) the progress made by the DoD to replace PFAS in firefighting foam for military applications. Currently, the only fire suppressants that meet military performance standards contain PFAS. The legislation further requires the DoD to test PFAS in drinking water in department run schools. Finally, the DoD must track health problems of service members and veterans, provide blood testing to exposed service members, and notify service members and their families about their exposure to PFAS and the potential health risks.

If passed, the Environmental Protection Agency will publish criteria for water quality and set discharge limits for industrial uses of PFAS. The military would then be required to follow state clean-up regulations for PFAS contamination.

While this legislation has passed the House, it must still pass the Senate and be signed into law by the White House. If these provisions remain in the final bill, the effects will be immediately felt throughout the nation. Notably, the EPA will regulate how much PFAS can enter the environment moving forward, and require the military to remediate and develop alternatives. Recent pronouncements by the EPA regarding what it would view as “acceptable” levels in drinking water—which are near zero—suggest that, if and when this legislation is passed, the government sector, private sector and the military will be engaged for years to come in extensive and costly remediation efforts nationwide.

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.

On June 15, 2022, the Environmental Protection Agency (EPA) released new health advisories for drinking water relating to four select classes of per- and polyflouroalkyl substances (PFOA or PFOS) —also referred to as PFAS chemicals. Dubbed “forever chemicals,” and found in such common consumer products as shampoo, food wrappers, and non-stick cookware, PFAS chemicals have gained nationwide attention in recent years both for their extreme bio-persistence and their ubiquity in consumer and personal care products.

In a drastic departure from the agency’s 2016 advisory health limit of 70 parts per trillion (ppt) for PFOA and PFOS, the EPA now recommends limits approaching zero (0.004 and 0.02 for PFOA and PFOS, respectively) based on what it claims to be new medical and scientific research. In addition, the EPA went even further and issued health advisories for “GenX” chemicals and perfluorobutane sulfonate (PFBS) (10 ppt and 2,000 ppt, respectively), two additional PFAS chemicals designed to replace PFOA and PFOS, due to growing concern that PFAS chemicals cause adverse health effects. While today’s guidance acts as little more than a recommendation to local leaders, the EPA reports that it is on track to propose mandatory standards in the fall of 2022. Should the recommended health advisory levels be adopted by the still-pending peer review of the Scientific Advisory Board and processed through the executive rulemaking process, the failure of local water authorities to meet these standards will result in financial penalties.

Maintaining PFAS levels below those suggested in the EPA’s recent guidance will be incredibly difficult, and perhaps impossible, for local water authorities. PFAS have earned their designation as forever chemicals due to their inability to naturally degrade over time. This environmental resistance and water solubility of PFAS, coupled with approximately 80+ years of prevalent use in consumer and industrial products, has resulted in their almost ubiquitous presence in global waterways. The burden to finance the testing, construction, maintenance and operation of PFAS removal systems will fall squarely on local water utilities, which must now prepare to develop systems that can meet levels that fall below even the EPA’s ability to detect. Overburdened and underfunded municipalities faced with this dilemma will almost certainly seek to recover these costs from the manufacturers, producers and suppliers of PFAS chemicals and PFAS-containing products.

The nationwide campaign against the production and use of perfluoroakyl and polyfluoroakyl-containing products continues in California, with the California assembly passing expansive legislation to ban the use of up to potentially 12,000 separate chemicals in cosmetics.

On May 26, 2022, the California State Assembly passed A.B. 2771. Introduced by assembly member Laura Friedman (D-Glendale), the bill seeks to amend the state’s health and safety code to include a complete ban of personal care products that contain intentionally added perfluoroalkyl and polyfluoroalkyl substances (PFAS). If, as expected, some version of the proposed amendment is approved by the senate and governor and enacted into law, the proposed amendment would make the express finding that “PFAS have been linked by scientific, peer-reviewed research to severe health problems, including breast cancer and other cancers, hormone disruption, kidney and liver damage, thyroid disease, developmental harm, and immune system disruption.” It would also make the express finding that “PFAS chemicals have been found in a wide variety of cosmetics and personal care products, including foundation, mascara, lipstick, and various eye and face products.” (Proposed Amendment to California Health and Safety Code Section 108981.)

Friedman, along with many consumer rights advocates, praises the bill as “a critical step towards reducing unnecessary exposure.” The proposed bill is highly problematic, however, from the standpoint of the personal care/cosmetics industry, which represents several billion dollars per year in revenue in California alone. First and foremost, A.B. 2771 drastically expands the existing prohibition against the addition of PFAS into cosmetics, seeking to exclude the use of any “fluorinated organic chemicals containing at least one fully fluorinated carbon atom.” While appearing to be fairly tailored to a single class of chemicals, the EPA’s CompTox Chemicals Dashboard: Master List of PFAS Substances currently reports a total of 12,034 chemicals that fall under A.B. 2771’s description. It is currently unknown how the state will go about enforcing the expansive ban and what PFAS, if any, will take priority in their exclusion. It is further unknown what the precise boundaries of the terminology “intentionally added” will be applied.

At this point, the only thing that can be predicted with certainty is that civil litigation is bound to follow the passage of A.B. 2711 in California—most likely in the form of consumer class actions. For, although A.B. 2711 itself does not provide for civil penalties for violations of the proposed act, California’s Unfair Competition Law (Business & Professions Code Section 17200) permits private citizens to seek an injunction and financial restitution against any business for alleged “unlawful” acts. This broad language, combined with the Unfair Competition Law’s four-year statute of limitations, means that certification of a class of consumers for the purchase of PFAS containing cosmetics could theoretically encompass millions of individual plaintiffs. Restitution on a class-wide basis would require disgorgement of four years of profits for a single company. It is therefore of critical importance for companies to remain up-to-date as these developments continue in order to ensure they can adapt early and often to the imminent changes to their markets.