The Nickel Report

On April 19, 2024, the US Environmental Protection Agency (EPA) released a pre-publication copy of its much-anticipated final rule adding two per- and polyfluoroalkyl substances (PFAS) to the list of “hazardous substances” under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund). The rule will be effective 60 days after publication in the Federal Register.

EPA’s plans to investigate – and eventually establish limits on and liability for – PFAS in wastewater discharges and biosolids crossed a significant milestone on January 31, 2024, with the completion of two new analytical methods to detect these ubiquitous contaminants. The most significant of the two is Method 1633, which provides a standardized quantitative method for laboratories to detect 40 different PFAS compounds, at very low levels, in wastewater, surface water, groundwater, soil, biosolids, sediment, landfill leachate, and fish tissue. Method 1621 is a low-cost screening method for the presence of fluorine-containing organic compounds, which could lead to use of the more sensitive Method 1633 to further characterize any PFAS in the sample. EPA’s public statements provide no timeline for seeking approval of these methods for PFAS monitoring of wastewater discharges as part of 40 C.F.R. Part 136, but a Method Update Rule is likely to be proposed before the end of the year.

EPA has big plans for the PFAS data that these two new methods will generate.

On February 1, 2024, EPA released two proposed rules under the Resource Conservation and Recovery Act (RCRA) that will advance EPA’s PFAS Strategic Roadmap. These two actions would subject certain PFAS—and potentially other emerging contaminants—to RCRA corrective action and may also be a precursor to EPA listing certain PFAS as hazardous waste under RCRA. Once published in the Federal Register, comments on the Definition Rule will be due in 30 days, and comments on the PFAS Hazardous Constituent Rule will be due in 60 days.

In December 2023, federal agencies released their “Fall 2023” Regulatory Agendas that provide an outlook for numerous upcoming regulatory actions on chemicals that could have significant implications for the regulated community. Hunton Andrews Kurth LLP’s chemical regulatory team has provided analyses of these upcoming regulatory actions:

• EPA’s Recent Release of its “Fall 2023” Regulatory Agenda: Upcoming PFAS-Related Actions
• EPA’s Recent Release of its “Fall 2023” Regulatory Agenda: Upcoming Toxic Substances Control Act (TSCA) Actions

On October 17, 2023, the California Attorney General (AG) Rob Bonta released an enforcement advisory letter to manufacturers, distributors, and sellers of food packaging and cookware detailing how he intends to enforce AB 1200, a law which: 1) bans the sale of regulated per- and polyfluoroalkyl substances (PFAS) in food packaging in California, and 2) requires disclosure and labeling of chemicals on a “designated list,” including PFAS, that are present in the food contact surface or the handle of cookware products sold in California. Because the individual laws do not provide specific enforcement mechanisms, this announcement is the first time the AG’s office has articulated the authorities it plans to use to enforce these laws. The enforcement advisory letter provides a clear warning to the regulated community, from manufacturers to importers to distributors and retailers, that California will be enforcing its PFAS laws. Similar advisories could be issued in the future for California’s other laws restricting PFAS in juvenile products, textiles, and cosmetics.

As states across the country develop laws addressing per- and polyfluoroalkyl substances (PFAS), a patchwork of requirements has begun to emerge, creating challenges for those who manufacture, distribute, and sell products around the country. In 2023, over 200 bills were introduced addressing PFAS, including restrictions for PFAS in products. This trend is expected to continue.

In June 2023, federal agencies released their “Spring 2023” Regulatory Agendas that provide an outlook for numerous upcoming regulatory actions on chemicals which could have significant implications for the regulated community. Hunton Andrews Kurth LLP’s regulatory team have provided analyses of these upcoming regulatory actions:

• EPA’s Spring 2023 Unified Regulatory Agenda—Upcoming PFAS-Related Actions
• EPA’s Spring 2023 Regulatory Agenda—Upcoming TSCA Actions

In May 2023, Minnesota’s Governor Walz signed into law HF 2310, which bans the sale of certain products containing “intentionally added” per- and- polyfluoroalkyl substances (PFAS) in 2025 and then all products in 2032, and also establishes reporting requirements for products containing PFAS starting in 2026. Following Maine’s lead, Minnesota has now become the second state in the country to pass a broad ban on PFAS-containing products sold in the state. While reporting requirements apply to product manufacturers, the bans on sale, offer for sale, or distribution in the state apply to “persons,” including retailers. Companies who manufacture products for sale (and who sell) products in the state of Minnesota will need to prepare to assess the presence of PFAS in their supply chains in order to comply with these new requirements.

On March 29, 2023, the US Environmental Protection Agency (EPA) published in the Federal Register its long-awaited proposed rule to restrict certain per- and polyfluoroalkyl substances (PFAS) in drinking water under the Safe Drinking Water Act (SDWA). This action is part of EPA’s whole-of-agency approach in its PFAS Strategic Roadmap and is expected to directly affect 66,000 public water systems across the country. Comments on the proposal are due on May 30, 2023. EPA will also hold a public hearing on May 4, 2023 to receive stakeholder input on this important rulemaking.

The Maine Department of Environmental Protection (DEP) recently released a long anticipated proposed rule that would implement the procedures for Maine’s 2021 law[1] requiring manufacturers to submit notifications to DEP for products and product components containing intentionally added per- and polyfluoroalkyl substances (PFAS) sold in the state. Stakeholders will have until May 19, 2023, to provide comments on the proposal.

While Maine’s notification requirements went into effect on January 1, 2023, the proposed rule provides critical details on the applicability and procedures for notifications. Many manufacturers who received extensions from the January 1, 2023 notification deadline will be interested in reviewing the details of this proposal. The proposed rule provides important clarifications about the notification requirements, including:

In January 2023, federal agencies released their “Fall 2022” Regulatory Agendas that provide roadmaps for upcoming and long-term regulatory actions on chemicals that could have significant implications for the regulated community. These agendas make clear that the Biden Administration continues to prioritize regulatory actions to address per- and polyfluoroalkyl substances (PFAS) across multiple agencies. And the US Environmental Protection Agency (EPA) also continues to implement numerous regulatory initiatives to assess and mitigate chemical risks under the strengthened Toxic Substances Control Act (TSCA).

Hunton’s chemical regulatory team has provided analyses of these upcoming regulatory actions:

• EPA’s “Fall 2022” Regulatory Agenda – Upcoming PFAS-Related Actions
• EPA’s “Fall 2022” Regulatory Agenda – Upcoming Toxic Substances Control Act (TSCA) Actions

On January 12, 2023, the US Environmental Protection Agency (“EPA”) published its proposed National Enforcement and Compliance Initiatives ("NECIs”), soliciting public comment on the Agency’s potential Initiatives for fiscal years 2024 through 2027. These NECIs will guide EPA’s Office of Enforcement and Compliance Assurance (“OECA”) in its enforcement efforts over the next four years by focusing resources on “serious and widespread environmental problems where federal enforcement can make a difference.” Unsurprisingly, the identified NECIs build off EPA’s FY2022 Enforcement Results (on which we recently reported) and reflect OECA’s overarching goal: “to protect human health and the environment by holding polluters accountable and compelling regulated entities to return to compliance.”

On August 26, 2022, the US Environmental Protection Agency (EPA) released a pre-publication copy of its much-anticipated proposed rule adding perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) to the list of “hazardous substances” under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund). EPA asserts that this regulatory escalation of PFOA and PFOS will facilitate faster cleanup of contaminated sites and reduce exposures to these “forever chemicals.” If finalized, these hazardous substances designations will have significant and immediate impacts on many industries, from creating new reporting obligations to increased compliance, enforcement, and litigation risks related to site cleanup. EPA’s efforts involving PFOA and PFOS fall within the broader, whole-of-agency approach to addressing PFAS first announced in its PFAS Strategic Roadmap and represent its first ever exercise of its authority under CERCLA section 102(a) to designate a hazardous substance.

On June 15, 2022, the United States Environmental Protection Agency (EPA) released drinking water health advisories [1] for certain per- and polyfluoroalkyl substances (PFAS), resulting in the establishment of:

1. Near zero updated interim advisory levels for Perfluorooctanoic acid (PFOA) and Perfluorooctane sulfonic acid (PFOS) that are not only orders of magnitude below previously established levels, but that are also below detectable levels and, notably, were issued in advance of completion of peer review by EPA’s Science Advisory Board (SAB); and
2. Newly issued final advisories at low levels for GenX and PFBS chemicals that have been used as replacement chemicals for PFOA and PFOS.

 On October 18, 2021, the US Environmental Protection Agency launched its PFAS Strategic Roadmap: EPA’s Commitments to Action 2021-2024 (“Roadmap”)[i] setting forth its “whole-of-agency” approach to address per- and polyfluoroalkyl substances (PFAS). The Roadmap sets forth timeframes for EPA actions to address PFAS across environmental media and under various statutory authorities including the Toxic Substances Control Act (TSCA), Resource Conservation and Recovery Act (RCRA), Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), Safe Drinking Water Act (SDWA), Clean Water Act (CWA) and Clean Air Act (CAA). As such, EPA’s implementation of the Roadmap, including key initiatives rolled out in the days following its release, will affect a broad spectrum of industry sectors and facilities throughout the PFAS lifecycle who may face new and expanded regulatory requirements and obligations.

In a dramatic announcement last week, EPA suggested that if companies import, manufacture, or process a finished good for commercial sale, and that product is not a pesticide, not a firearm, not a tobacco product, and not a food, food additive, drug, cosmetic, or device, they will need to know all chemicals contained in those products. We explain more about this below.

EPA has traditionally declined to extend most of its chemical regulations to finished goods, which are known as “articles” under the Toxic Substances Control Act (TSCA), on the grounds it would be enormously difficult for importers of complex consumer products to determine the chemical identity of each chemical substance in these products. Industry stakeholders have generally supported this approach and have long taken the position that supply chains are too complex to expect finished product manufacturers to be aware of all chemicals in those products.

8.18.2021 EPA Finalizes Hazard Assessments for Two Fuel Additives (ETBE and tert-Butanol):

On August 18^th, EPA finalized the long-awaited hazard assessments for both Ethyl Tertiary Butyl Ether (ETBE) and tert-Butyl Alcohol (tert-Butanol).  ETBE was previously added to gasoline to increase its octane levels. It is still registered with EPA for use as a fuel additive, but it is not used currently in the United States.  tert-Butanol is one of the primary metabolites of ETBE and has also been used as a fuel oxygenate. It is also used for other purposes including as a solvent and as a dehydrating agent.

In the face of accelerating EPA and state regulatory activity on per- and polyfluoroalkyl substances (“PFAS”)[i], Congress is pressing forward with measures that would address or impose limitations on these “forever chemicals.” More than thirty such legislative measures are currently pending in Congress covering a number of subjects related to PFAS including, but not limited to, those involving military uses, funding assistance, detection and research, product stewardship, site remediation, and regulatory mandates. Of these, the most comprehensive initiative ...

Care about Drinking Water Regulations?

7.22.2021 Request for Comment and Public Workshop for California Drinking Water Public Health Goals for PFOA and PFOS: The California Office of Environmental Health Hazard Assessment (OEHHA) released a draft document for public review describing proposed Public Health Goals (PHGs) for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) in drinking water. A PHG is the level of a drinking water contaminant at which adverse health effects are not expected to occur from a lifetime of exposure.  PHGs published by OEHHA are considered by the State Water Resources Control Board in setting drinking water regulatory standards (Maximum Contaminant Levels, or MCLs) for California. The proposed PHG of 0.007 parts per trillion (ppt) for PFOA is based on kidney cancer in humans and the proposed PHG of 1 ppt for PFOS is based on liver and pancreatic tumors in laboratory animals. The draft technical support document can be found here. Public comments are due September 28, 2021. Details about how to send comments and a public workshop that will be held on September 28, 2021 can be found here.

The EPA Office of Water has taken a major step towards further regulation of per- and polyfluoroalkyl substances (PFAS) under the Clean Water Act.  On March 17, it published an advance notice of a proposed rulemaking (ANPRM) that could lead to development of effluent limitations guidelines (ELGs), pretreatment standards, and new source performance standards for PFAS manufacturers, formulators, and possibly other industries now being studied by EPA.  86 Fed. Reg. at 14,560.  These industries include pulp and paper manufacturers, textile and carpet manufacturers, metal finishing companies, and commercial airports.  The ANPRM is open for public comment through May 17.

On June 11, 2020, the California Assembly passed the Toxic-Free Cosmetics Act, Assembly Bill (A.B.) 2762 [1], by a bipartisan vote of 54-0.  If enacted by the Senate, the law would be the first in the United States to ban twelve ingredients, including mercury and formaldehyde, from beauty and personal care products sold in California due to toxicity concerns.

California’s Proposition 65 (Prop 65), adopted in 1986 by state voters, has long been considered among the most far-reaching right-to-know and toxic chemical reduction statutes in the country. It now has competition from Washington State’s Pollution Prevention for Healthy People and Puget Sound Act (the “Act”), SSB 5135 (Chapter 292, 2019 Laws), signed into law on May 8, 2019, by former 2020 presidential candidate Governor Jay Inslee. Numerous commentators have called the Act, the nation’s “strongest” policy for regulating toxic chemicals in consumer products.

Congress is exploring regulatory action for PFAS as states begin to implement their own regulations for the chemicals. Hunton Andrews Kurth attorneys, Dan Grucza and Chuck Knauss outline approaches companies can take while operating in this changing legal landscape.

Despite the many benefits of PFAS, there continues to be a rise in regulatory action, legal implications and environmental, health and safety concerns related to the “forever chemicals.” Hunton Andrews Kurth attorneys Dan Grucza and Chuck Knauss give an inside look into the changing regulatory landscape of PFAS.

On Thursday, July 11, 2019, the House of Representatives approved amendments to the fiscal 2020 National Defense Authorization Act to address contamination from PFAS chemicals.

Per- and polyfluoroalkyl (PFAS) chemicals are colloquially known as “forever” chemicals due to their ability to build up and to persist over time. PFAS chemicals regulated under this bill have long been used to manufacture a wide range of products, like firefighting foam, cookware, stain repellents, apparel and food packaging and wrappers.

On March 15, 2019, the House Subcommittee on Environment and Climate Change held a hearing titled, “Protecting Americans at Risk of PFAS Contamination & Exposure.” The hearing examined approaches to eliminate or reduce environmental and health risks to workers and the public from per- and polyfluoroalkyl substances (PFAS).

EPA has shown a little love for states wanting action on per- and polyfluoroalkyl substances (PFAS). On February 14, 2019, EPA announced its PFAS Action Plan, calling it “the most comprehensive, cross- agency action plan for a chemical of concern ever undertaken by the Agency.” The Action Plan consists of 23 priority action items with the majority identified as short-term or generally taking place or expected to be completed in the next two years.

Because of their widespread environmental presence, persistence and bioaccumulation, the group of substances known as PFAS have been described as a “Perfect Storm” of liability. The number of plaintiff’s suits concerning PFAS have spiked in the last few years. Also, EPA faces increasing bipartisan calls from Congress to adopt new drinking water standards and cleanup levels. In the interim, states are filling the void. In October 2017, the New Jersey Department of Environmental Protection  announced a maximum contaminant level (MCL) of 14 parts per trillion for PFOA. Some NGO’s have called for levels as low as 1 part per trillion.

In May, EPA issued its 2016 Final Effluent Guidelines (ELG) Program Plan, which is EPA’s first screening step to selection of industries for possible revision or development of technology-based limits on wastewater discharges (i.e., effluent limitations guidelines and standards (ELGs)). 83 Fed. Reg. 19281 (May 2, 2018). EPA releases a new ELG plan every two years, and the process bears watching because it cuts across all industry types (there are 59 industries with final ELGs in place) and provides some perspective on EPA’s assessment of pollutants of concern and emerging technologies to address those pollutants.

As explained in an earlier post, PFAS (per- and polyfluoroalkyl substances) are highly fluorinated manmade compounds that are reported to have a variety of adverse health effects. PFAS are resistant to heat, water and oil. These properties have led to use of PFAS compounds in a wide-range of products designed to be waterproof, stain‑resistant or non‑stick, such as carpets, furniture, cookware, clothing and food packaging. They are also used in fire retardant foam at airfields and industrial processes involving flammable and combustible liquids. PFAS compounds are resistant to chemical breakdown. This property, combined with their extensive use, explain why PFAS compounds are being found in drinking water supplies throughout the country.