For many years, per- and polyfluoroalkyl substances (PFAS) have been ubiquitous in American commerce and industry. That ubiquitous use, and the fact that PFAS chemicals do not break down in the environment, has led to the presence of PFAS in groundwater to varying degrees throughout the country. As a result, the US Environmental Protection Agency (EPA) has turned its full attention to PFAS regulation. In fact, EPA issued a PFAS Strategic Roadmap that sets timelines by which EPA plans to take specific actions, as it states, “to safeguard public health, protect the environment, and hold polluters accountable.” Pursuant to the Roadmap, the EPA issued interim health advisories on June 15, 2022, in which they advised that the safe lifetime drinking level for PFAS chemicals are as low as .004 parts per trillion (ppt) for perfluorooctanoic acid (PFOA) and .02 ppt for perfluorooctane sulfonic acid (PFOS). To put that in context, one should understand that a level of .004 ppt equates to 1 drop out of 4.5 billion gallons of water., and that such miniscule levels are undetectable by current testing instruments, essentially making it zero.

According to the EPA, its interim health advisories are determined based on review of all available science by the EPA’s Science Advisory Board. It is unclear, however, on what the Science Advisory Board relied in reaching its conclusions concerning the level of exposure at which to set the advisory limit, as there is not only no current epidemiological studies that demonstrate that PFAS chemicals actually cause any adverse health consequences, there are certainly no scientific studies that support a level of exposure near zero.

The EPA’s interim health advisories are not regulations, and are not enforceable. They do, however, portend the maximum contaminant levels (MCLs) that the EPA is considering and may eventually enact for drinking water. The EPA is scheduled to issue its proposed regulatory level in fall 2022—only months away—and the rule is expected to go into effect in 2023.

In setting the MCLs, the EPA attempts get the MCL as close to the health advisory limit as feasible. Unlike with health advisories, though, the EPA must prepare a health risk reduction and cost analysis (HRRCA), which takes into account the quantifiable and non-quantifiable benefits that will result from the proposed standard, as well as the increased costs that will result from the proposed drinking water standard. It does not, however, require EPA to consider the benefits in the use of PFAS, including improved safety, durability and fuel efficiency in applications such as cars, airplanes, buildings and electronics, not to mention firefighting where its use is still mandated.

Should the EPA enact drinking water standards near the current health advisory limits, it is likely that the vast majority, if not all, water systems in the United States will require costly remediation. The State of New York estimates that remediation of PFAS in the state’s drinking water to a level of 4 parts per trillion, a standard 1,000 time less strict than the amount proposed by the EPA’s health advisory, would cost $1.5 billion for start-up costs and $78 million annually. In addition, Orange County, California, (one of 58 counties in the State of California) estimates that bringing PFAS levels in the county down to the state’s 10 ppt (2,500 times higher than the health advisory) would cost $1 billion. Based on these estimates, the cost of remediation across the country is expected to be in the tens, if not hundreds, of billions of dollars. The federal government has, however, only made $1 billion available for states to remediate PFAS from their water systems. While additional funds will likely be available from state governments, those are not expected to cover the enormous costs associated with bringing all water systems into compliance, which could result in public water systems going offline, with the resulting loss of public drinking water. In response, a number of states, counties, cities and other providers of drinking water have brought suit against the manufacturers of PFAS chemicals and in some cases against manufacturers of a small number of products that contained PFAS in order to recover the costs associated with drinking water remediation and/or mitigation.

Manufacturers of products that currently contain or previously contained PFAS would be wise to stay in tune with the actions of the EPA as it proposes MCLs for various PFAS chemicals. As more and more public water suppliers and owners of private wells are faced with the exorbitant costs of remediating drinking water that will surely arise once the EPA sets its MCLs (and states follow suit), many will be forced to bring suit to recover those costs. Many of those litigants are likely to cast a wide net in search of entities, including those companies that included PFAS in its products, to help pay for that remediation.

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.