Incorporating PFAS in Industrial Wastewater Discharge Permits to Minimize Risk or Extent of Future CERCLA Liability
PFAS are being detected in drinking water systems across the United States. Moreover, evolving regulatory developments already require or soon will
require that public water systems sample for and remediate these chemicals (see, e.g., here). When public water systems find PFAS, which is a
significant possibility, public water systems are likely to look to upstream industrial facilities to recoup their remediation costs. And, once PFOA and PFOS becomes CERCLA hazardous substances (likely Summer 2023), public water systems will have a federal cause of action to do so: CERCLA cost recovery.
Among other potential defendants, public water systems may target upstream industrial facilities that have PFOA or PFOS in their wastewater discharges. Indeed, recent U.S. EPA guidance explains that the Clean Water Act’s National Pollutant Discharge Elimination System (NPDES) program, which regulates wastewater discharges, “interfaces with many pathways by which [PFAS] travel and are released into the environment, and ultimately impact water quality and the health of people and ecosystems.”
Industry categories known or suspected to discharge PFAS include: organic chemicals, plastics & synthetic fibers (OCPSF); metal finishing; electroplating; electric and electronic components; landfills; pulp, paper & paperboard; leather tanning & finishing; plastics molding & forming; textile mills; paint formulating; and airports. Of course, this is not an exhaustive list.
While U.S. EPA’s Office of Water is working to revise Effluent Limitation Guidelines and develop water quality criteria to support technology-based and water quality-based effluent limits for PFAS in NPDES permits, there are currently no enforceable limits at the federal level. As an interim measure, recent U.S. EPA guidance describes steps that NPDES permit writers can implement under existing authorities to reduce PFAS discharges, including incorporating monitoring requirements, best management practices, and site-specific limits developed on a best professional judgment basis into permits.
An important question will be whether upstream industrial facilities that have PFAS in their wastewater discharges will be able to rely on the federally permitted release exemption as an affirmative defense to CERCLA liability. This exemption provides that parties are not liable under CERCLA for federally permitted releases. See 42 U.S.C. § 9607(j). The exemption also extends to state permitted releases under federally approved programs. Blankenship v. Consolidation Coal Co., 850 F.3d 630, 638 (4th Cir. 2017).
In the NPDES context, the exemption most notably covers “discharges in compliance with a permit.” See 42 U.S.C. § 9601(10)(A). The limited case law on this issue sheds light on two points. First, the exemption can only cover what a NPDES permit can regulate – the discharge of pollutants into navigable waters from a point source. Second, the exemption does not apply with respect to releases that (1) were not expressly permitted, (2) exceeded the limitations of the permit, or (3) occurred at a time when there was no permit.
In 1995, U.S. EPA offered some guidance as to its interpretation of the scope of this exemption. Specifically, the Agency stated that the exemption would apply if: (1) the source, nature, and amount of the potential release had been identified and made part of the public record during the permitting process, and (2) the permit contains a condition requiring that the treatment system be capable of eliminating or abating the potential release.
Going back further in time, in a 1988 proposed rule that never took effect, U.S. EPA explained that the exemption covers discharges that are in compliance with a permit limit that specifically addresses the discharge in question. To qualify, the permit must either address the discharge directly through specific effluent limitations or through the use of indicator pollutants. In the case of the latter, the administrative record prepared during permit development must identify specifically the discharge of the pollutant as one of those pollutants the indicator is intended to represent.
Industrial facilities that have PFOA or PFOS in their wastewater discharges should evaluate whether their permits have any provisions that address these chemicals. Assuming they do not, which is the most likely scenario at this early stage, it is unlikely that the federally permitted release exemption will apply. However, if there are provisions that address these chemicals, or if the applicable permitting agency seeks to add such provisions through original permit issuance, modification, or renewal, businesses should consider the extent to which this will influence whether the federally permitted release exemption may apply.
Specifically, when negotiating permit conditions, businesses should keep in mind that U.S. EPA guidance suggests that for the exemption to apply, the source, nature, and amount of the potential PFOA or PFOS release must be identified and made part of the public record during the permitting process, and the resulting permit must contain a condition requiring that the treatment system be capable of eliminating or abating the potential release.
Considering this guidance, it is unlikely that the incorporation of mere monitoring requirements and/or best management practices that do not eliminate or abate the potential release of PFOA or PFOS will be sufficient for a discharger to rely on the federally permitted release exemption. However, the incorporation of site-specific limits developed on a best professional judgment basis likely will.
Indeed, it may be in the best interest of businesses to advocate for provisions in their permits that address PFOA and PFOS to minimize their risk or extent of future CERCLA liability. An important consideration will be the cost of eliminating or abating the potential release of PFOA or PFOS now versus the likelihood and associated cost of being sued for CERCLA cost recovery and ultimately having to pay the costs associated with remediating the unpermitted discharges of PFOA or PFOS later.
We will continue to provide timely updates on U.S. EPA’s ongoing efforts to regulate PFAS under the various environmental statutes at the Corporate Environmental Lawyer.
By Daniel L. Robertson, Associate Attorney
On May 4, 2023, the Department of Justice (DOJ) announced a first-of-its-kind Title VI environmental justice interim resolution agreement with the Alabama Department of Public Health (ADPH). The resolution follows an investigation DOJ and the Department of Health and Human Services (DHHS) initiated in November 2021 into whether ADPH violated Title VI of the Civil Rights Act and Section 1557 of the Affordable Care Act. Both laws prohibit discrimination against individuals in programs receiving federal funding.
DOJ’s investigation found that ADPH’s enforcement of sanitation laws threatened residents of Lowndes County with criminal penalties and property loss for sanitation conditions they did not have the capacity to alleviate. Median household income in the county is just under $32,000, and 28.3% of county residents live below the poverty line. As of 2022, 80% of residents did not have reliable sewage systems. The process is complicated in part due to the clay soil in the area being incompatible with regular wastewater systems, causing them to often fail. Residents unable to afford specialized systems, estimated to cost between $6,000 and $30,000, have resorted to a system known as “straightpiping” whereby piping systems or ditches are constructed to draw wastewater away from the home. This often results in these wastes being exposed on the property and increasing related healthcare risks caused by exposure to raw sewage. DOJ’s investigation further found that ADPH engaged in a pattern of inaction and/or neglect concerning the health risks associated with raw sewage, and failed to take meaningful action to address the disproportionate burden and impact of these issues on Black residents of Lowndes County. Approximately 72.5% of county residents are Black.
Under the agreement, ADPH agreed to: suspend enforcing sanitation laws against residents who lack the means to purchase functioning septic systems; measure public health risks from raw sewage exposure of different populations; develop a public health awareness campaign regarding raw sewage exposure; create or supplement education materials for Lowndes County health care providers to provide more information on symptoms and illness related to raw sewage exposure; conduct a comprehensive assessment to determine the appropriate septic and wastewater management systems for Lowndes County homes; and create a plan to improve access to adequate sanitation systems. ADPH is also required to consistently engage community residents, government officials, subject matter experts and environmental justice advocates on each aspect of the agreement. DOJ and DHHS in turn have suspended their investigation as long as ADPH complies with the agreement.
One day following its announcement, DOJ released a statement marking the one year anniversary of the establishment of its Office of Environmental Justice, including a fact sheet of department accomplishments from the prior year. The Office’s actions include supporting the DOJ’s lawsuit to improve safe drinking water access in Jackson, Mississippi, training DOJ attorneys on environmental justice best practices, and developing community-outreach best practices for DOJ departments nationwide. DOJ also highlighted an ongoing investigation into potential discriminatory practices by the city of Houston in how it responds to illegal dumping.
Thursday’s move reinforces the federal government’s emphasis on advancing environmental justice initiatives, following President Biden’s recent Executive Order on Revitalizing Our Nation’s Commitment to Environmental Justice For All. As we discussed in a recent client alert, companies should evaluate and instill best practices to navigate this evolving landscape. We will continue to monitor environmental justice developments on the Corporate Environmental Lawyer.
On April 12, 2023, a federal district court judge in North Dakota issued a temporary injunction blocking implementation of the EPA and Army Corps of Engineers regulations redefining Waters of the United States (“WOTUS”) under the Clean Water Act (“CWA”) (the “2023 WOTUS Rule”). The injunction was issued in a challenge brought by 24 states, and will take effect in those states: Alabama, Alaska, Arkansas, Florida, Georgia, Indiana, Iowa, Kansas, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Utah, Virginia, West Virginia, and Wyoming.
The WOTUS definition is one of the most controversial and highly-litigated aspects of the CWA, if not all environmental law, because it has wide-ranging implications. The definition of “waters of the United States” is so important because it sets the jurisdictional limits of the CWA. Under the CWA, EPA and the Army Corps have the power to regulate, among other things, the discharge of pollutants to navigable waters from a point source (33 U.S.C. § 1362(12)) and the discharge of dredged or fill material into navigable waters (33 U.S.C. § 1344). “Navigable waters” are defined in the CWA as “the waters of the United States, including the territorial seas.” 33 U.S.C. §1362(7). “Waters of the United States” is not defined further under the CWA, so the agencies have been left to try to craft a definition.
The Army Corps and EPA first proposed a WOTUS definition in 1977 and it has faced revisions and legal challenges ever since. The WOTUS definition has faced Supreme Court review in three previous cases, and is currently pending review in a fourth Supreme Court case, Sackett v. U.S. Environmental Protection Agency, 19-35469, on appeal from the U. S. Court of Appeals for the Ninth Circuit.
Jenner & Block Wishes Bon Voyage to Gay Sigel as She Starts Her Next Adventure with the City of Chicago
As Gay Sigel walked through the doors at One IBM Plaza in Chicago, fresh out of law school and ready to launch her career as an attorney at Jenner & Block, she could not have envisioned the tremendous impact she would have on her clients, her colleagues, and her community over the next 39 years. Gay started her legal career as a general litigator, but Gay and Bob Graham were quick to realize how the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) was creating a new and exciting area of the law that was increasingly important for the firm’s clients: Environmental Law. Gay and Bob saw an opportunity to specialize in that area and founded Jenner & Block’s Environmental Health and Safety Practice. Gay has been an ever-present force in the EHS community ever since.
Over her 39-year career at Jenner & Block, Gay has worked on some of the most significant environmental cases in the country for clients ranging from global Fortune 50 corporations to environmental organizations to individuals. For more than a decade, she taught environmental law at Northwestern University, helping shape the next generation of environmental lawyers. She has worked on issues of global impact, like those affecting climate change, issues of local impact like those related to combined sewer overflows to the Chicago River, and issues of individual impact like those involving employee safety and health. No matter the subject, Gay has always been a tireless advocate for her clients. We often describe her as the Energizer Bunny of environmental lawyers: she is the hardest working attorney we have ever met.
Gay’s true passion is to make this world a better, more just place for others. So, throughout her career as an environmental, health, and safety lawyer, Gay has devoted her time, energy, and emotional resources to innumerable pro bono cases and charitable and advocacy organizations. Her pro bono work includes successfully protecting asylum applicants, defending criminal cases, asserting parental rights, and defending arts organizations in OSHA matters. Among her many civic endeavors, Gay was a founding member of the AIDS Legal Council of Chicago (n/k/a as the Legal Council for Health Justice); she was the Secretary and active member of the Board of Directors for the Chicago Foundation for Women; and she was on the Board of the New Israel Fund. Gay continues to promote justice wherever she sees injustice, including as an advocate for women’s rights, particularly for women’s reproductive rights.
In both her environmental, health, and safety practice as well as her pro bono and charitable work, Gay is a tremendous mentor to younger (and even older) attorneys. She is curious, committed, exacting, fearless, and demanding (though more of herself than of others). We all give Gay much credit for making us the lawyers we are today.
Gay is leaving Jenner & Block to embark on her next adventure. She is returning to public service as Assistant Corporation Counsel Supervisor with the City of Chicago's Department of Law where she will be focusing on environmental issues. The City and its residents will be well served as Gay will bring her vast experience and unparalleled energy to work tirelessly to protect the City and its environment. We will miss working with and learning from Gay on a daily basis, but we look forward to seeing the great things she will accomplish for the City of Chicago. We know we speak for the entire firm as we wish Gay bon voyage—we will miss you!
By Steven M. Siros, Co-Chair, Environmental and Workplace Health & Safety Law Practice
U.S. EPA issued its long anticipated interim updated drinking water health advisories for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) that replace previous U.S. EPA health advisories for these per- and polyfluoroalkyl substances (PFAS) that had been set at 70 parts per trillion (ppt). The updated advisory levels, which U.S. EPA claims are based on new science and consider lifetime exposure, evidence that U.S. EPA believes that adverse health effects may occur with concentrations of PFOA or PFOS in water that are about as close to zero as you can get. U.S. EPA notes that these interim health advisories will remain in place until EPA establishes a National Primary Drinking Water Regulation.
U.S. EPA has set a new health advisory level of 0.02 ppt for PFOS and 0.004 ppt for PFOA. These new levels are dramatically lower than U.S. EPA's previous 70 ppt level that applied to both PFOA and PFOS. U.S. EPA also set final advisories for hexafluoropropylene oxide dimer acid and its ammonium salts (also referred to as GenX) at 10 ppt and perfluorobutane sulfonic acid (PFBS) at 2,000 ppt.
Interestingly, U.S. EPA's health advisory levels for both PFOA and PFOS are set well below the current analytical detection limit of 4 ppt. Responding to questions as to how the regulated community is supposed to demonstrate compliance with these health advisory levels, U.S. EPA acknowledged it was a "complicated matter" and U.S. EPA's advice was for water providers to test for PFAS using the currently analytical methodology that can test to 4 ppt.
Environmental groups and the plaintiffs’ bar were quick to applaud the new health advisory levels, noting that any detectible levels of PFOA or PFOS represent unacceptable levels of these compounds in drinking water. The regulated community, on the other hand, blasted the new health advisory levels, claiming that the advisory levels ignored U.S. EPA’s commitment to embrace scientific integrity.
Regardless of which side of the fence that you find yourself, it is clear that U.S. EPA’s new PFAS health advisories will be relied upon by plaintiffs to file lawsuits in any instance where a detectible concentration of PFOA and/or PFOS is found in drinking water which in turn is likely to keep drinking water providers throughout the United States awake at night.
We will continue to provide updates on U.S. EPA’s efforts to regulate PFAS at the Corporate Environmental Lawyer blog.
By Steven M. Siros, Co-Chair, Environmental and Workplace Health & Safety Law Practice
On May 18, 2022, U.S. EPA updated its Regional Screening Level tables to include five new per- and polyfluoroalkyl substances (PFAS). The five new PFAS compounds added to the RSL tables are hexafluoropropylene oxide dimer acid and its ammonium salt (HFPO-DA – sometimes referred to as GenX chemicals), perfluorooctanesulfonic acid (PFOS), perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA), and perfluorohexanesulfonic acid (PFHxS). U.S. EPA added its first PFAS substance, PFBS or perfluorobutanesulfonic acid, to the RSL tables in 2014 and updated that listing in 2021 when U.S. EPA released its updated toxicity assessment for PFBS.
The RSLs are risk-based screening values for residential and industrial soils and tap water that U.S. EPA relies upon to help determine if remediation is necessary. Although U.S. EPA is quick to point out that the RSLs are not cleanup standards, regulators at both the state and federal levels rely on these RSLs to drive decision-making at contaminated sites. The regulators also rely on these RSLs notwithstanding that U.S. EPA has yet to officially designate any PFAS as a CERCLA hazardous substance or RCRA hazardous waste (although efforts are ongoing on both fronts--CERCLA hazardous substances / RCRA hazardous wastes).
U.S. EPA set the screening levels for PFOA, PFOS, PFNA, and PFHxS based on the Minimal Risk Levels from the Agency for Toxic Substances and Disease Registry’s toxicological profiles. The screening level for HFPO-DA was set based on a final, peer-reviewed toxicity value. For example, the screening level for PFOS is set at 38 parts per trillion for tap water and 1.6 parts per million for industrial soils and the screening level for PFOA is set at 60 parts per trillion for tap water and 2.5 parts per million for industrial soils
As we await further U.S. EPA action with respect to regulating PFAS under RCRA and CERCLA, it is interesting to note that U.S. EPA is currently engaged in a significant information gathering exercise related to historical PFAS use. Relying on its authority under CERCLA Section 104(e), U.S. EPA has recently issued scores of information requests seeking information regarding facilities’ past PFAS uses and practices. The use of these information requests is consistent with the statements in U.S. EPA’s 2021 PFAS Roadmap where U.S. EPA indicated that it intended to rely on its various enforcement tools to identify and address PFAS releases.
We will continue to provide timely updates on PFAS-related issues at the Corporate Environmental Lawyer blog.
By Steven M. Siros, Co-Chair, Environmental and Workplace Health & Safety Law Practice
On the 60th anniversary of the publication of Rachel Carlson’s groundbreaking book “Silent Spring”, the world continues to struggle to manage the human health and environmental risks associated with newly discovered emerging contaminants. Silent Spring focused on the challenges associated with managing the risks associated with pesticides (and more specifically DDT), and even today, many of the largest personal injury verdicts are associated with alleged exposure to pesticides.
Over the many years since Silent Spring, numerous contaminants have moved through the emerging contaminant life cycle, including asbestos, dioxins, PCBs, MTBE, BPA, 1,4-dioxane, and most recently, per- and polyfluoroalkyl substances (PFAS) (although PFAS seems stuck in the middle of the life cycle).
The life cycle journey of emerging contaminants has been influenced significantly by our improved ability to understand the potential impacts of these emerging contaminants on human health and the environment. As new contaminants are identified, resources are devoted to better understanding the potential environmental and health risks associated with these contaminants and regulations generally evolve to mitigate identified risks. In response to increased regulatory pressure, industry’s use of chemicals evolves and the risks are mitigated. Of course, industry’s use of these chemicals also evolves and is influenced by lawsuits when the regulations and/or the enforcement of the regulations lags.
In addition to improved understanding of the risks posed by some of these emerging contaminants, the fact that we are able to measure smaller and smaller quantities of these contaminants also impacts the life-cycle journey of these emerging contaminants. When I started practicing environmental law in the dark ages, contaminants in soil and groundwater were measured in parts per thousand. As science evolved to detect lower and lower levels, regulatory levels moved from parts per million to parts per billion, and then parts per trillion, and PCBs are now regulated in parts per quadrillion. As detection levels drop, the number of new emerging contaminants will increase and the life-cycle journey for each of these contaminants begins.
A lot can be said for the progress that has been made since the summer of 1962. Although some will argue it should still be faster, the time from discovery of the contaminant to identification of risks and regulation of these identified risks has greatly improved since the 1960s. This is due in part to the fact society has a much lower tolerance for risks posed by emerging contaminants and is much quicker to demand a response from the regulators now than was the case in the 1960s when environmental laws in the United States were in their infancy. A reformed TSCA is better situated to address both environmental and health and safety impacts of chemicals (both newly manufactured chemicals and new chemical uses). U.S. EPA, working in collaboration with manufacturers, implemented a global stewardship program to eliminate the manufacture and import of long-chain PFAS compounds. In October 2021, U.S. EPA announced its PFAS Strategic Roadmap intended to implement a whole-of-agency approach to addressing PFAS.
As our understanding of risks evolves and our detection levels drop, it is inevitable that we will continue to identify new emerging contaminants that need to be regulated. However, I think Rachel Carlson would be proud of the progress we have made and continue to make to ensure that the world is a safer place for everyone.
By Gabrielle Sigel, Co-Chair, Environmental and Workplace Health and Safety Law Practice
On this 52nd anniversary of Earth Day, I am not writing yet another, typically not very funny, riff on one of Shakespeare’s most famous lines. Instead, I am inspired by one of the most popular of our blogs, written in 2017 by our talented former partner, E. Lynn Grayson, “Imagine a Day Without Water.” To start our Earth Week series of daily blogs by our firm’s EHS department, I offer words of hope and gratitude for the vast amount of work that has been done to improve and protect the environment – work done by lawyers, scientists, policy makers, and members of the public, to name a few.
Imagine what lawyers and scientists faced in 1970, the year of the first Earth Day. There was oppressive soot and polluted air throughout urban and industrial areas in the United States. The Cuyahoga River was so blighted it had caught fire. Although there was a new federal Environmental Protection Agency and two new environmental statutes – the National Environmental Policy Act and the Clean Air Act, one of the most highly complex and technical statutes ever written – both needed an entire regulatory structure to be created in order to be operationalized and enforced. This foundational work had to be done when there was not even an accepted method for determining, much less regulating, environmental and public health risk. Then two years later, in 1972, a comprehensively overhauled Clean Water Act was enacted, followed within the next decade by TSCA, RCRA, and CERCLA, to address the consequences of past waste and chemical use, and to control their future more prudently. Other laws were also passed in that time period, including the Safe Drinking Water Act and the Endangered Species Act.
Although Earth Day was created in the U.S. – the idea of Senator Gaylord Nelson (WI-D) and supported by Representative Pete McCloskey (CA-R) (both lawyers) and grass roots organizers – environmental consciousness also was growing worldwide. The 1972 Stockholm Declaration, from the first UN Conference of the Human Environment, recognized the importance of environmental protection amid the challenge of economic disparities. That work, including of the United Nations Environment Programme, led to the 1992 “Earth Summit” issuing the Rio Declaration on Environment and Development, which adopted a focus on sustainable development and the precautionary approach to protecting the environment in the face of scientific uncertainty, and creating the United Nations Framework Convention on Climate Change, which itself led to the 1997 Kyoto Protocol and the 2015 Paris Agreement, as well as other global efforts focusing on climate change and resource conservation.
Thus, within a split-second on our earth’s timeline, humans were able to tangibly improve and focus attention on the environment, through laws, agreements, governmental and private commitments, and public support. I note these developments, which were stimulated by lawyers on all sides, not to naively suggest that the global climate change, water accessibility, toxic exposure, and other environmental challenges that we face today can easily be solved, nor do I suggest that only lawyers can provide the solution. Instead, let’s take hope from the fact that in fewer years than the average for human life expectancy, there have been significant environmental improvements in our air, land, and water, and our collective focus on preserving the planet has been ignited.
These past efforts have improved the environment – not perfectly, but demonstrably. The legal structure that helped make these improvements happen has worked – not perfectly, but demonstrably. Hopefully, we will continue to work on these issues, despite their seeming intractability, under a system of national laws and global agreements. The alternative is too painful to contemplate.
Closing on a personal note, our firm’s Environmental Law Practice lost one of the best environmental lawyers in the profession, when Stephen H. Armstrong passed away last week. Steve was one of the first in-house environmental counsel I had the opportunity to work with when I began my focus on environmental law in the 1980s. He demonstrated how to respect the science, embrace the legal challenges, fight hard for your client, and always act with integrity. Although I was a young woman in a relatively new field, he consistently valued my opinions, supported my professional development, and with his deep, melodious laugh and sparkle in his eye, made working together feel like we shared a mission. And a ”mission” it was for him; I have never met any lawyer who cared more or wrestled harder about their clients’ position, while always undergirded by a deep reverence for doing the right thing. Once he joined our firm more than a decade ago, he continued being a role model for all of us. Our firm’s Environmental Law Practice, and all those who worked with him, will miss having him as a devoted colleague, friend, and mentor. Our earth has been made better for his life on it.
“The first thing we do, let’s kill all the lawyers.” William Shakespeare, Henry VI, Part 2, Act Iv, Scene 2 (circa 1591).
By Steven M. Siros, Co-Chair, Environmental and Workplace Health & Safety Law Practice
On December 20, 2021, U.S. EPA finalized its Fifth Unregulated Contaminant Monitoring Rule (UCMR) that will require public water systems (PWS) to collect monitoring data for 29 per- and polyfluoroalkyl substances (PFAS) and lithium in drinking water. Every five years, the Safe Drinking Water Act (SDWA) requires U.S. EPA to publish a new list of unregulated contaminants that will be monitored by PWS. UCMR 5 focuses almost exclusively on PFAS and targets 29 of the more than 4,700 PFAS that have been identified to date.
Starting in 2023, all PWSs serving more than 10,000 customers are obligated to monitor for these UCMR 5 contaminants while smaller PWSs (those serving less than 10,000 customers) must monitor subject to availability of appropriations (U.S. EPA is responsible for all analytical costs associated with PWSs serving less than 10,000 customers) and laboratory capacity. In response to comments on the draft UCMR 5 expressing concern about the lack of laboratory capacity to support the PFAS monitoring, the final rule notes that U.S. EPA expects laboratory capacity to quickly grow to meet UCMR demand. The final rule identifies applicable U.S. EPA test methods for each of the 29 targeted PFAS compounds. However, some commenters were critical that the final rule did not identify a testing technique to determine “total PFAS” in drinking water. The final rule acknowledges this issue but notes that U.S. EPA “has not identified a complete, validated peer-reviewed aggregate PFAS method” at this time.
The data collected is expected to inform U.S. EPA as it evaluates whether to set a specific drinking water limit or treatment standard under the SDWA for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS). U.S. EPA has committed to establishing a national drinking water regulation for PFOA and PFOS by the fall of 2023 and it is likely that additional PFAS will be in the SDWA regulatory pipeline in the near future.
We will continue to track U.S. EPA regulatory agenda at the Corporate Environmental Lawyer blog.
Analysis of Recent and Forthcoming State Legislation on Toxic Chemicals in Cosmetics and Personal Care Products and Preemptive Effects of Existing Federal Legislation
By Matthew G. Lawson
According to a report released in February 2021 by the organization Safer States, at least 27 US states will consider proposed legislation to regulate toxic chemicals in 2021. While a large driver of the proposed state laws is growing public concern over drinking water contamination from “emerging contaminants,” including PFAS (per- and polyfluorinated alkyl substances) and 1,4-dioxane, a secondary focus has been to minimize the risk of adverse human health effects from exposure to these toxic chemicals in cosmetics and personal care products. Two states—New York and California—are spearheading these efforts through recently enacted laws to limit or prohibit certain toxic chemicals in cosmetics and personal care products that are set to take effect in 2022 and 2025, respectively. As other states consider their own bills to enact similar regulation of chemicals in cosmetics and personal care products, heightened attention will likely be paid to what extent the existing federal regulation of these products may preempt this new wave of state legislation.
- Federal Regulation of Chemicals in Cosmetics and Personal Care Products
At the federal level, chemicals used in cosmetics and other personal care products are primarily regulated by either the Toxic Substrates Control Act (TSCA) or the Federal Food, Drug, and Cosmetic Act (FD&C Act). While TSCA broadly applies to any “chemical substance,” certain chemicals or uses of chemicals are exempt from TSCA if they are regulated by other federal statutes. Such products include “cosmetics” regulated by the FD&C Act, which are defined as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance.” While the distinction between a cosmetic and personal care product may not always be apparent to the consumer, the difference is crucial with respect to federal oversight of the chemicals contained in the product.
Non-cosmetic, personal care products are regulated under TSCA, as amended by the Frank R. Lautenberg Chemical Safety Act of the 21st Century, which requires the Environmental Protection Agency (EPA) to identify “high-priority chemicals” used in existing commerce and determine whether any current uses of the chemicals “present an unreasonable risk of injury to health or the environment.” Where an unreasonable risk is identified, the EPA has discretion to impose conditions on or outright ban the chemical use. Prior to introducing a new chemical or new use of an existing chemical into commerce, manufacturers are required to provide notice to the EPA so that the agency may assess whether the proposed chemical or use will pose an unreasonable risk. In contrast, chemicals used in cosmetic products are regulated by the Food and Drug Administration (FDA) pursuant to the FD&C Act and generally do not require registration or preapproval by the agency before being introduced into commerce. Moreover, the FDA does not have authority to require a recall where it identifies a potential health hazard in a cosmetic product. However, the FDA does have authority to regulate the labeling of cosmetic products and to outright ban specific ingredients from being used in cosmetics generally.
- State Regulation of Chemicals in Cosmetics and Other Personal Care Products—Newly Enacted Laws and Anticipated Future Legislation
While the regulation of chemicals in cosmetic and personal care products has historically been left to the purview of the EPA and the FDA, in recent years a growing number of states have expressed interest in directly regulating chemicals in cosmetic and personal care products sold within their jurisdictions. In 2019 and 2020, state regulation of these chemicals took a significant step forward as New York and California signed into law two bills regulating chemicals used in cosmetic and/or personal care products. A brief description of both state laws is provided below.
- New York: On December 9, 2019, Governor Cuomo signed into law New York Senate Bill 4389-B/A.6295-A, making New York the first and only state to set a maximum contaminant limit of 1,4-dioxane in consumer products. While there are no direct consumer uses of 1,4-dioxane, the compound may be present in cosmetics and personal care products as a byproduct of the manufacturing process (according to one 2007 Study, approximately 22% of cosmetic and other personal care products may contain 1,4-dioxane). New York’s legislation, which takes effect on December 31, 2022, prohibits the sale of personal care products containing more than 2 ppm of 1,4-dioxane and the sale of cosmetic products containing more than 10 ppm of 1,4-dioxane.
- California: On September 30, 2020, Governor Newsom signed into law the Toxic-Free Cosmetics Act, California Assembly Bill 2762, banning 24 chemicals, including mercury, formaldehyde, and certain types of PFAS, from being used in cosmetic, beauty, and personal care products sold in California. California’s legislation is set to take effect in 2025 and will mark the first state-level prohibition on the various chemicals in cosmetic products.
In addition to New York and California’s recently enacted legislation, there are at least five bills currently being considered by various states that would further regulate chemicals in cosmetic and/or personal care products sold within the respective jurisdictions. A brief summary of these state bills is provided below:
- Connecticut: SB 404—Prohibiting the sale or distribution of consumer products that contain PFAS (currently before the Joint Committee on Public Health).
- Maryland: HB 0643—Prohibiting the sale or distribution of cosmetic products that contain PFAS, mercury, and other chemicals in certain instances (currently passed in both chambers and before the Governor).
- New Jersey: A 189 / S 1843—Prohibiting the sale and distribution of nail salon products that contain dibutyl phthalates, toluene, or formaldehyde (currently before the Assembly Consumer Affairs Committee); A 1720—Prohibiting the sale of hand sanitizers and body cleaning products containing triclosan (currently before the Assembly Consumer Affairs Committee).
- New York: A 143 / S 3331—Creating a list of “chemicals of concerns” known to exist in personal care products, requiring manufacturers of such products to disclose any chemicals of concerns contained in their products and prohibiting the sale of personal care products containing chemicals of concerns after three years (currently referred to Environmental Conservation Committee).
- Federal Preemption of State Laws
As more states continue to adopt new legislation to regulate chemicals in cosmetic and personal care products, manufacturers and/or trade organizations will likely bring preemption challenges to these state regulations. In the context of cosmetic products, the FD&C Act prohibits state or local governments from enacting “any requirement for labeling or packaging of cosmetics that is different from or in addition to, or that is otherwise not identical with” the federal rules. Thus, state laws that do not directly regulate the labeling or packing of cosmetics products but instead regulate the contents of these products will likely not run afoul of the FD&C Act’s preemption clause.
In contrast, state legislation governing chemicals in personal care products may be at a higher risk of being preempted by TSCA. TSCA broadly prohibits the enforcement of any state chemical regulation of a particular substance once the EPA completes a risk evaluation for the substance and either: (1) determines that the chemical will not present an unreasonable risk; or (2) concludes that the chemical presents an unreasonable risk under the circumstances of use, and promulgates a rule that restricts manufacturing or use of the chemical to mitigate the identified risks. Notably, the scope of TSCA’s preemption extends only to chemical uses examined in the EPA’s risk evaluation—meaning that the EPA’s failure to examine the use of a chemical in personal care products would make state regulation fair game. In addition, even where a risk evaluation of a particular chemical has been completed, TSCA will not preempt state laws that (1) only impose reporting, monitoring, or information obligations; or (2) environmental laws that regulate air quality, water quality, or hazardous waste treatment or disposal.
Early insight into the full scope of TSCA’s preemption provisions will likely be provided by anticipated challenges to individual state’s regulation of 1,4-dioxane. As explained above, New York has already taken steps to regulate 1,4-dioxane in personal care products and other states may soon look to follow suit. However, on January 8, 2021, the EPA released its final risk evaluation for 1,4-dioxane under TSCA. See 86 Fed. Reg. 1495. The EPA’s initial risk evaluation identified a number of “use conditions” in which 1,4-dioxane posed an unreasonable risk to occupational workers, but did not consider “use conditions” involving 1,4-dioxane’s presence in consumer products. In response to protests from industry, EPA’s final risk evaluation included a supplemental analysis of eight use conditions for 1,4-dioxane as a byproduct in consumer goods, including use in hobby materials; automotive care products; cleaning and furniture care products; laundry and dishwashing products; paints and coatings; and spray polyurethane foam. No unreasonable risks for these consumer uses were identified. Because the EPA’s supplemental risk evaluation examined but did not find any unreasonable risks from 1,4-dioxane in consumer products, an argument could be made that states are preempted from enacting their own 1,4-dioxane limits in consumer products. However, because the EPA’s risk evaluation did not specifically exclude cosmetic or personal care products, individual states may be able to argue that the preemption scope is limited only to the specific uses of 1,4-dioxane that were specifically examined during EPA’s risk evaluation. The resolution of any challenges to New York and other states’ regulation of 1,4-dioxane in consumer products will likely provide key insights into the scope of TSCA’s preemption powers.
In a unanimous decision authored by Justice Thomas, the Supreme Court of the United States ruled in the case of Guam v. United States, No. 20-382, 593 U.S. __ (2021), that a party must resolve “CERCLA-specific liability” in order to trigger contribution rights under § 113(f)(3)(B) of the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA”).
The question before the Court was whether a settlement between Guam and the United States that resolved claims under the Clean Water Act could be the basis for a contribution claim under § 113(f)(3)(B) of CERCLA. In this case, Guam and the U.S. EPA had entered into a Consent Decree following a Clean Water Act lawsuit, settling the United States’ Clean Water Act claims against Guam and requiring Guam take actions to close and cover a dump site. Thirteen years later Guam sued the United States under CERCLA for cost recovery and contribution, claiming the United States’ earlier use of the dump site exposed it to liability. The district court, in a ruling affirmed by the court of appeals, ruled that Guam had a contribution claim at one point, based on its Clean Water Act Consent Decree because that Decree required remedial measures and provided a conditional release, which sufficiently resolved Guam’s liability for the dump site and triggered a CERCLA contribution claim under § 113(f)(3)(B). However, the Decree also triggered the three-year statute of limitations, which had expired, leaving Guam without any viable claims.
The Supreme Court reversed the lower courts, rejecting the notion that the Clean Water Act Consent Decree was sufficiently similar to a CERCLA settlement to trigger contribution liability. The Court focused on a textual analysis of the statute, which states in relevant part that:
A person who has resolved its liability to the United States or a State for some or all of a response action or for some or all of the costs of such action in an administrative or judicially approved settlement may seek contribution from any person who is not party to a [qualifying] settlement.
42 U.S.C. § 9613(f)(3)(B).
Of particular note to the Court was the reference in § 113(f)(3)(B) to “response action”, which is a term of art in CERCLA, and appears throughout the Act. The Court reasoned that this language “is best ‘understood only with reference’ to the CERCLA regime.” Guam, slip op. at 6, quoting United States v. Atlantic Research Corp., 551 U. S. 128, 135 (2007). Thus, according to the Court’s reasoning, to resolve liability for a “response action,” a party must engage in a CERCLA-specific settlement, not “settle an environmental liability that might have been actionable under CERCLA.” Id. at 7.
In conclusion, the Court held that “[t]he most natural reading of §113(f)(3)(B) is that a party may seek contribution under CERCLA only after settling a CERCLA-specific liability.” Id. at 9.
Like most major CERCLA decisions, the Court’s ruling answers one question but raises many more. We can expect future litigation on the precise bounds of how specific a settlement need be to qualify as “CERCLA-specific” under the Court’s holding. There will also likely be litigation regarding how this ruling may apply to other provision of CERCLA beyond §113(f )(3)(B). As always, the Corporate Environmental Lawyer Blog will be monitoring these important developments and reporting on what you need to know.
On Friday, April 30, 2021, the Biden Administration’s Environmental Protection Agency (EPA) announced significant steps the agency intends to take under the Toxics Release Inventory (TRI) Program to implement expanded reporting requirements for companies that store and utilize hazardous chemicals, including new obligations to report the storage, use and any releases of ethylene oxide, a commonly used industrial chemical and sterilant for medical equipment and supplies. The TRI Program, which was established under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA), serves as a resource for the public to learn about annual chemical releases, waste management, and pollution prevention activities reported by nearly 22,000 industrial and federal facilities. Under the TRI Program, U.S. facilities operating in various industry sectors must report annually the quantity of certain chemicals they release to the environment and/or manage through recycling, energy recovery and treatment. A “release” of a chemical in the context of the TRI Program means that the chemical is emitted to the air or water, or placed in some type of land disposal.
A major component of EPA’s announcement is the agency’s intent to regulate ethylene oxide. The use and release of ethylene oxide by medical device sterilization companies have prompted a number of recent high-profile lawsuits alleging that releases of the chemical into the environment have caused increased cancer rates in communities adjacent to the facilities. EPA’s announcement notes that many existing sterilization facilities “are located near areas with Environmental Justice concerns,” and that individuals living adjacent to these facilities may be at a heightened risk from exposure to ethylene oxide. “Every person in the United States has a right to know about what chemicals are released into their communities,” EPA Administrator Michael S. Regan stated. “By requiring new and more data on chemical releases from facilities, EPA and its partners will be better equipped to protect the health of every individual, including people of color and low-income communities that are often located near these facilities but have been left out of the conversation for too long.” In the coming months, EPA will provide further details regarding the specific actions the agency intends to take to require sterilization facilities that use ethylene oxide to report under the TRI Program.
In addition to implementing new reporting requirements for companies utilizing ethylene oxide, EPA announced several other steps the agency plans to take that will increase reporting and public access to information under the TRI Program, including:
- Finalizing a longstanding proposed rule that will add natural gas processing facilities to the industry sectors covered under the TRI Program thereby increasing the publicly available information on chemical releases and other waste management activities of TRI-listed chemicals from this sector;
- Continuing to add new per- and polyfluoroalkyl substances (“PFAS”) to the list of chemicals that require reporting under the TRI Program, including the addition of perfluorobutane sulfonic acid (PFBS) following EPA’s toxicity assessment of the substance;
- Proposing a new rule to add high-priority substances under the Toxic Substances Control Act (TSCA) and chemicals included in the TSCA workplan to the list of chemicals that require reporting under the TRI Program; and
- Increasing public access to TRI data through improved search functionality and improved website interface.
EPA’s announcement marks the most recent step by the agency to implement the Biden Administration’s focus on environmental justice as a top priority of its environmental agenda. On the same day that EPA announced the agency’s updated TRI policy, EPA circulated a memorandum to all EPA-staff, indicating the additional actions the agency intends to take to fulfill its environmental justice commitment. These actions include: (1) increasing inspections of facilities that pose the most serious threats to overburdened communities; (2) focusing on implementing remedies that benefit communities, including through the incorporation of supplemental environmental projects; (3) increasing communications with overburdened communities to develop improved cleanup and non-compliance solutions; and (4) identifying locations where state regulators are not adequately protecting local communities and taking increased enforcement actions to “pick up the slack” if state regulators have not taken appropriate or timely actions.
The Corporate Environmental Blog will continue to follow developments on this issue in the coming months as EPA provides additional details on the specific actions it intends to take to expand the TRI Program.
By Steven M. Siros and Matthew G. Lawson
The North Carolina Department of Environmental Quality (DEQ) is continuing to investigate an unexplained source of per-fluorinated compounds (PFAS) contamination that may be associated with the deployment of a fire-fighting compound in response to a major gasoline release by the Colonial Pipeline system on August 14, 2020. The Colonial Pipeline, which spans 5,500 miles from Houston, Texas, to Linden, New Jersey, runs through a number of southern and mid-Atlantic states, including North Carolina. The active pipeline delivers an average of 100 million gallons of liquid petroleum products each day. On August 14, 2020, a leak in the pipeline resulted in the release of approximately 1.2 million gallons of gasoline into the environment near the town of Huntersville, North Carolina. The release was the largest onshore gasoline spill in the United States in over 20 years and in connection with Colonial Pipeline’s emergency response to that release, Colonial Pipeline sprayed a commonly used fire suppressant known as F-500 encapsulate on the contaminated land to minimize the risk that vapors from the release would ignite.
However, following Colonial Pipeline’s initial emergency response, new questions have emerged regarding PFAS that was detected at the release site. As part of the ongoing efforts to investigate the nature and extent of the gasoline release, DEQ directed Colonial Pipeline to collect samples from the F-500 encapsulate and test that encapsulate for various PFAS formations. The resulting test data found elevated levels—as high as 22,600 parts per trillion (“ppt”)—of at least three different PFAS compounds. Samples of a nearby surface water showed PFAS concentrations ranging from 1 ppt to 14.9 ppt.
The source of the PFAS is not readily apparent, however, because as verified by the Safety Data Sheet , F-500 is not known to contain PFAS compounds. In fact, F-500 acts differently than aqueous film forming foam (AFFF) to fight fires. AFFF is intended to separate oxygen from the fuel while F-500 works by removing the heat, neutralizing the fuel, and interrupting the free radical chain reaction. As such, it does not rely on fluorine compounds for effectiveness.
It is possible that the source of the PFAS identified by Colonial Pipeline was a result of residual AFFF residing in the storage tank or in the fire-fighting equipment that was used to dispense the F-500 encapsulating agent. The F-500 was transported to the site by the Pelham Alabama fire department and the fire-fighting equipment that sprayed the F-500 was supplied by the Hunterville Fire Department. However, notwithstanding that the equipment was supplied by the municipal fire departments and that the F-500 is not known to contain PFAS compounds, DEQ has still requested that Colonial Pipeline provide data demonstrating that there have been no PFAS impacts to soil or groundwater as a result of the emergency response.
This a cautionary tale for environmental health and safety professionals charged with maintaining emergency spill response materials, including fire suppressant products, for their respective organizations. Such professionals are faced with a unique challenge of ensuring that products maintained for spill containment or remediation purposes are not only fit for these purposes, but also that these products do not contain chemicals that pose a potential threat to human health or the environment. This challenge is particularly acute with PFAS, of which there are over 5,000 different formulations which can be found in a large variety of different consumer and industry products. Even if a decision is made to swap out one product that may historically contained PFAS with a new product that is purportedly PFAS-free, care should be taken to ensure that product distribution equipment is PFAS-free. Otherwise, one might find oneself in the unfortunate position of having to defend against claims relating to PFAS impacts in the environment.