Environmental Litigation

In June 2022, the Environmental Protection Agency (EPA) released new lifetime health advisories (LHAs) for per-fluoroalkyl and poly-fluoroalkyl chemicals (PFAS). PFAS are a type of man-made chemicals found in many industrial and consumer products, soil and drinking water. According to the EPA, the new LHAs for PFAS in drinking water are “the level of drinking water contamination below which adverse health effects are not expected to occur.” The new LHAs for PFAS are 3,000 to 17,000 times lower than the previous 2016 levels, which now means that even the amount of PFAS found in rainwater is considered “unsafe.” While the LHAs are not binding regulations, they do provide guidance to federal, state and local governments in developing binding regulations, including those for future Maximum Contaminant Levels (MCLs).

The scientific basis for these drastic reductions in the LHAs has been called into question. In fact, the American Chemistry Council (ACC) recently filed suit against the 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.” Although the EPA acknowledges that drinking water standards for PFAS must be based on the best available science, ACC alleges that the EPA relied upon data, which was not peer-reviewed by the Agency’s Science Advisory Board when it published its new LHAs. Interestingly, the EPA even admits on its own website that there is not a full understanding of how to detect and measure PFAS in water, the extent of human PFAS exposure, the degree to which PFAS may adversely affect people, or how PFAS can be eliminated from drinking water supplies. Despite these unknowns, the EPA nonetheless promulgated LHAs which are so low and cannot be detected by current EPA methods, further calling into question the scientific validity of the Agency’s LHAs. In addition to the suit filed by ACC, there have been multiple lawsuits[1] which seek to overturn the LHAs on two grounds: there no definitive studies that demonstrate PFAS actually causes any adverse health effects in humans; and even those studies that suggest a link between PFAS exposure and human health problems are unable to determine a minimum level of exposure where such health effects, if any, are expected to occur.

Although the LHAs are unenforceable, they will likely serve as the foundation for future federal, state and local regulation of PFAS. While it is critical to protect human life, any effort to quantify maximum safe levels of exposure must be based on sound science, as any regulations will have a profound impact on the US economy and virtually every industry. For example, regulations that lower the MCLs or ban the use of PFAS[2] could derail President Biden’s plan to return semiconductor manufacturing to the US, as a large production of advanced semiconductors requires PFAS. Moreover, unnecessarily low regulatory levels or bans could harm renewable energy efforts and negatively impact the aerospace, automotive, building
Continue Reading The Chemical Industry Challenges the EPA’s New Lifetime Health Advisories for PFAS

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
Continue Reading Threat of Zero-Allowance Regulations Loom for Forever Chemicals

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

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.
Continue Reading US House Passes Legislation Requiring Extensive Reporting of PFAS by Department of Defense

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