The Nickel Report

Within the first five months of 2024, the United States Environmental Protection Agency (EPA) finalized two rules under section 6(a) of the Toxic Substances Control Act (TSCA) that would impose extensive bans and restrictions on uses of chrysotile asbestos and methylene chloride. Aside from a 2019 EPA rule prohibiting the manufacturing (including importing), processing, and distributing in commerce of methylene chloride for consumer paint and coating removal, these are the first two broadly applicable risk management rules that EPA has promulgated since Congress amended TSCA in 2016 to manage unreasonable risks to human health or the environment through broad restrictions on existing chemicals.

Back in October of 2023, we provided a list of “Frequently Asked Questions” and answers regarding the US Environmental Protection Agency’s (EPA’s) final reporting rule for per- and polyfluoroalkyl substances (PFAS) under the Toxic Substances Control Act (TSCA). As of May 8, 2024, many companies are facing a one-year countdown to the deadline for submitting their reports to EPA. To help you prepare for this impending deadline, we are providing a second installment of “Frequently Asked Questions” and answers about EPA’s rule.

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.

On April 10, 2024, the U.S. Environmental Protection Agency (EPA) released a pre-publication copy of its final rule to establish limits on six per-and-polyfluoroalkyl substances (PFAS) in drinking water under the Safe Drinking Water Act (SDWA). The rule will be effective 60 days after publication in the Federal Register.

On February 21, 2024, the US Environmental Protection Agency (EPA) released its final rule adjusting the fees it collects under the Toxic Substances Control Act (TSCA). EPA is required under TSCA Section 26 to review and, if necessary, adjust the fees every three years to ensure that funds are sufficient to defray part of the costs of administering TSCA. While EPA has significantly increased TSCA fees for manufacturers, importers, and processors of chemicals, it has also finalized new, key exemptions from fee requirements. These new fees will be effective on April 22, 2024.

By March 1, 2024, all establishments that produce pesticides, devices, or active ingredients for pesticides must file their annual production reports for the 2023 reporting year pursuant to Section 7 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 7 U.S.C. § 136e(c)(1). Last year, EPA’s Office of Enforcement and Compliance Assurance reminded stakeholders that the agency is poised to take action against companies that violate FIFRA and noted that non-compliance with the requirements related to producing pesticides and devices by EPA-registered establishments is increasing.

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

In 2022 and 2023, the United States Environmental Protection Agency (EPA) proposed five risk management rules under Section 6(a) of the Toxic Substances Control Act (TSCA) imposing restrictions and bans on chemical uses. This is the first group of risk management rules that EPA has published since Congress amended TSCA in 2016, establishing EPA’s process to address “unreasonable risks” identified for certain uses of existing chemicals. These proposed rules provide a roadmap for EPA’s approach to chemical regulation under Section 6(a), establishing the precedent for future regulation.

Companies should anticipate more proposed bans, especially for consumer uses of a chemical, along with significantly lower chemical exposure limits compared to occupational exposure limits. Rigorous workplace requirements, including exposure monitoring, respiratory protection and additional personal protective equipment (PPE) requirements are also expected. And, the absence of industry data on a chemical’s use may lead to more stringent proposed regulation.

On October 11, 2023, the US Environmental Protection Agency (EPA) released its long-awaited final rule imposing detailed reporting requirements on entities that have manufactured or imported per- and polyfluoroalkyl substances (PFAS) for commercial purposes at any time since January 1, 2011. Notably, the reporting rule also applies to importers of articles containing PFAS, which could include many consumer, industrial, and commercial products, and requires reporting on PFAS as a component of a mixture. The rule does not have any exclusions for PFAS that are impurities, byproducts, used in commercial research and development (R&D), or only present in a mixture or article in trace amounts. And, unlike many state PFAS reporting laws, this reporting rule is not limited to only intentionally added PFAS.

On September 8, the U.S. Environmental Protection Agency (EPA) and the U.S. Army Corps of Engineers (Corps) (together, the Agencies) published a final rule in the Federal Register to amend the Agencies’ January, 2023 “waters of the United States” (WOTUS) definition (Amended Rule). 88 Fed. Reg. 61,964 (Sep. 8, 2023).[i] According to the Agencies, these amendments conform that definition to the Supreme Court’s Sackett decision. 

EPA finalized a rule effective on August 7, 2023 concerning the treatment of confidential business information (CBI) claims made in Toxic Substances Control Act (TSCA) submissions. Companies who submit any information to EPA under TSCA and want their confidential information to be protected from public disclosure must comply with these new requirements for CBI claims. Failure to follow these procedural requirements can result in EPA’s denial of the confidentiality claims and the information being made public.

The US Environmental Protection Agency (“EPA”) recently finalized its long-anticipated National Enforcement and Compliance Initiatives (“NECIs”) for fiscal years 2024 through 2027, naming six “priority areas” on which EPA’s Office of Enforcement and Compliance Assurance (“OECA”) will focus its enforcement efforts and direct additional resources. In his first significant action since being confirmed by the Senate on July 20, 2023, OECA Assistant Administrator David Uhlmann issued a memorandum on August 17, 2023 to the EPA Regional Administrators, advising of the six NECIs. He stated that over the next four years EPA will “address the most significant public health and environmental challenges, protect vulnerable and overburdened communities, and promote greater compliance with our environmental laws.”

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 May 3, 2023, EPA released its proposed risk management rule under Section 6(a) of the Toxic Substances Control Act (TSCA) to impose restrictions on the manufacture, import, processing, distribution, and use of methylene chloride, a widely-used solvent in a variety of consumer and commercial applications. This is the first risk management rule proposed by EPA since it issued revised risk determinations last year based on its new “whole chemical approach” and policy for assuming that personal protective equipment (PPE) is not used by workers. It also reflects a substantial expansion of the regulatory prohibitions applicable to a chemical that was already subject to TSCA risk management restrictions, albeit more limited ones, under EPA’s prior framework for risk management actions.

EPA is proposing to prohibit the manufacture, processing, and distribution in commerce of methylene chloride for consumer use; prohibit most industrial and commercial uses of methylene chloride; require a workplace chemical protection program (WCPP) for certain identified conditions of use that are allowed to continue; and provide certain time-limited, critical use exemptions under Section 6(g) of TSCA for uses of methylene chloride that would otherwise significantly disrupt national security and critical infrastructure. Stakeholders have until July 3, 2023 to comment on the proposed rule.

On April 6, 2023, President Biden issued Executive Order 14094, Modernizing Regulatory Review. This Executive Order (EO) makes several important changes to the Office of Management and Budget’s (OMB) regulatory review process for federal agency regulations. The EO significantly affects which regulations qualify for interagency review, modifies the OMB gatekeeping function by which meetings are granted on proposed rules, and requires the Office of Information and Regulatory Affairs’ (OIRA) to amend policies underlying how the federal government conducts cost-benefit analysis. In addition, OIRA has released a suite of new draft guidance documents that serve to implement the EO that, if finalized, will impact the review process for regulations. These guidance documents are open for comment as described below.

On April 6, 2023, President Biden issued Executive Order 14094, Modernizing Regulatory Review. This Executive Order (EO) makes several important changes to the Office of Management and Budget’s (OMB) regulatory review process for federal agency regulations. The EO significantly affects which regulations qualify for interagency review, modifies the OMB gatekeeping function by which meetings are granted on proposed rules, and requires the Office of Information and Regulatory Affairs’ (OIRA) to amend policies underlying how the federal government conducts cost-benefit analysis. In addition, OIRA has released a suite of new draft guidance documents that serve to implement the EO that, if finalized, will impact the review process for regulations. These guidance documents are open for comment as described below.

President Biden issued his second veto late last week. The President’s second veto protects a U.S. EPA rule that went into effect on March 20, 2023. That rule redefines “waters of the United States” (WOTUS), and at a high conceptual level, returns the Agency’s interpretation of WOTUS to that of the Obama administration, an interpretation that was revoked and replaced by the Trump administration.

This matter has been hotly contested in the federal courts. Indeed, the U.S. Supreme Court is poised to issue a ruling within the next several weeks on Sackett v. EPA, a decision which could substantially revise and narrow the Agency’s definition of “waters of the United States.” The Court’s decision here could send the Biden administration’s revised definition of WOTUS back to EPA for changes needed in-line with the Court’s decision, if and when issued.

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.

In late February 2023, EPA released for public comment its Draft Proposed Principles of Cumulative Risk Assessment under the Toxic Substances Control Act (“Draft Principles”), which proposes a set of principles for evaluating cumulative risks for chemicals undergoing risk evaluation under the Toxic Substances Control Act (“TSCA”). In conjunction with the Draft Principles, EPA also released its “Draft Proposed Approach for Cumulative Risk Assessment of High-Priority Phthalates and a Manufacturer Requested Phthalate Under the Toxic Substances Control Act,” (“Draft Proposed Phthalates Cumulative Risk Approach”), an approach for applying these Draft Principles to the evaluation of cumulative risks posed by certain phthalates undergoing TSCA risk evaluations. EPA referred to these documents as the “first steps” towards the Agency conducting cumulative risk assessments under TSCA.

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

A Question Every Retailer Must Be Prepared to Answer

Per- and polyfluoroalkyl substances (PFAS) have taken center stage. The Biden administration’s regulatory agenda plans numerous revisions to environmental regulations to address this broad class of pervasive substances. While the US Environmental Protection Agency grapples with implementing these initiatives, states are aggressively forging ahead with their own plans. Laws targeting PFAS in various products have taken effect and will continue to take effect in many states, representing a striking expansion from typical state regulations addressing environmental PFAS contamination from firefighting foam and other sources.

On December 22, 2022, EPA’s Integrated Risk Information System (IRIS) Program released its ORD Staff Handbook for Developing IRIS Assessments (IRIS Handbook). EPA began working on the approaches in the IRIS Handbook after a 2011 National Research Council report recommended several improvements to the overall IRIS assessment process. In 2020, EPA released a draft IRIS Handbook for public comment and commissioned a peer review by the National Research Council.

Established in 1985 to ensure Agency-wide consistent toxicity evaluations, IRIS assessments provide chemical toxicity values for noncancer and cancer human health effects resulting from chronic exposure to chemicals. These values are often utilized in EPA regulations under the Clean Air Act (CAA), the Safe Drinking Water Act (SDWA), and the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). While chemical risk evaluations conducted under the Toxic Substances Control Act (TSCA) require more information and analysis than that provided by an IRIS assessment, IRIS assessments will likely continue to be used to inform TSCA risk evaluations. State agencies and international bodies also rely on IRIS assessments.

Yesterday, the US Environmental Protection Agency (EPA) and the US Army Corps of Engineers (Corps) (together, the Agencies) published a final rule revising the definition of “waters of the United States” (WOTUS) subject to federal regulation and permitting requirements under the Clean Water Act (CWA).  This rule is the latest attempt by the Agencies to craft a durable rule defining WOTUS.  The new rule, which largely mirrors the 2021 proposal, asserts a broader geographic scope of federal jurisdiction than the 2020 Navigable Waters Protection Rule (NWPR).  In particular, the Agencies adopt the broadest possible interpretation of the Supreme Court’s decision in Rapanos (through incorporation of both the plurality’s “relatively permanent” test and Justice Kennedy’s “significant nexus” test).  The final rule would, for the first time, codify aspects of the Agencies’ 2008 Rapanos Guidance and would rely on the significant nexus test’s case-by-case approach for evaluating jurisdiction for tributaries, wetlands, and other waters.  The Agencies released the final rule while the Supreme Court considers the scope of CWA authority over a major category of WOTUS, “adjacent wetlands,” in Sackett v. EPA, and the Supreme Court could hand down a decision in the coming months that could require changes to the rule.

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 6 September, the US EPA released its proposed rule to add perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) to the list of hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), also known as Superfund.

If finalized, these hazardous substance designations could have a significant impact on many industries, from creating new reporting obligations to increased compliance, enforcement and litigation risks related to site cleanup.

Click here to read the full article, published in Chemical Watch.

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 July 28, 2022, the US Environmental Protection Agency (EPA)  published the 2021 Toxics Release Inventory (TRI) preliminary dataset that provides public access to data about chemical releases, waste management, and pollution prevention activities that took place in calendar year 2021 at more than 20,000 federal and industrial facilities across the country. The 2021 preliminary dataset, which for the second year includes reporting on per- and polyfluoroalkyl substances (PFAS) added to the TRI by the 2020 National Defense Authorization Act (NDAA), has not yet undergone the complete TRI data quality process. EPA plans to publish the quality-checked dataset in October 2022, at which time it will be the basis for the 2021 TRI National Analysis interpreting the information and examining trends that is expected to be published in early 2023. Companies should bear in mind that information collected under the TRI program can be used not only to inform regulatory action, but also as a basis for enforcement by EPA and citizen suits.

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.

In a wide-ranging interview on environmental justice (EJ) issues with Inside EPA, Hunton Andrews Kurth LLP partner Matt Leopold discussed the US Department of Justice (DOJ) and Environmental Protection Agency’s (EPA) new enforcement strategy.

On April 12, 2022, the United States Environmental Protection Agency (EPA) announced a sweeping proposed ban on ongoing uses of chrysotile asbestos, the only form of asbestos known to still be imported into the United States. EPA’s proposed ban is the first risk management rule issued under the Toxic Substances Control Act (TSCA) since the 2016 Lautenberg Act overhauled the statute to give EPA new powers to review and regulate existing chemicals.

Does your company manufacture, process, distribute, use, or dispose of fluorinated high-density polyethylene (HDPE) containers and similar plastics? If so, it may be time for supply chain and process reviews aimed at identifying and eliminating possible per- and polyfluoroalkyl substance (PFAS) contamination.

With the busy holiday shopping season underway, retailers should remain vigilant in their efforts to protect consumers and themselves from the risks of selling potentially unsafe, ineffective or misbranded products in violation of the U.S. Environmental Protection Agency (EPA’s) federal pesticide law, the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).  As concerns with the spread of COVID-19 and new variants increase over the winter months, consumers are likely to stock up disinfectant products and devices like air purifiers and air filters marketed to reduce the transmission of COVID-19 and other microorganisms.  These products are tightly regulated under FIFRA, and retailers can unwittingly become entangled in regulatory enforcement actions for selling and distributing products that do not comply with EPA’s regulations.  FIFRA extends legal liability not only to the makers of violative products, but also retailers who sell them to consumers, whether or not the retailer was necessarily aware of the violation. In addition to EPA, state agencies also enforce state regulatory requirements applicable to these products.

After over two weeks of conferencing, the 26th Conference of the Parties to the United Nations Framework on Climate Change (COP26) concluded with the finalization of the Glasgow Climate Pact (the “Glasgow Pact”) listing the accomplishments of the summit. The Glasgow Pact reaffirms the long-term global goals (including those in the Paris Agreement) to hold the increase in the global average temperature to “well below 2°C” above pre-industrial levels and to pursue efforts to limit temperature increase to 1.5°C above pre-industrial levels. It also states that limiting global warming to 1.5°C requires “rapid, deep, and sustained reductions in global greenhouse gas (GHG) emissions, including reducing global carbon dioxide emissions by 45 per cent by 2030 relative to the 2010 level and to net zero around mid-century, as well as deep reductions in other greenhouse gases.”

11.22.21 Last week, EPA transmitted four important documents to the EPA Science Advisory Board (SAB) for peer review that included updated health assessments for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS). This peer review, which will start on December 16, will inform EPA’s development of a Maximum Contaminant Level (MCL) Goal and a future, legally enforceable National Primary Drinking Water Regulation for PFOA and PFOS under the Safe Drinking Water Act. As noted in the PFAS Strategic Roadmap: EPA’s Commitments to Action 2021-2024, EPA intends to release a proposed drinking water regulation for PFOA and PFOS in fall 2022. These scientific documents will provide the underpinnings for that important regulation.

Building on the Biden Administration’s strategy to achieve net-zero greenhouse gas (GHG) emissions by 2050, and as world leaders begin gathering in Glasgow, Scotland, yesterday, the US Environmental Protection Agency (EPA) issued a proposal under the Clean Air Act to significantly expand regulation of methane from oil and gas operations in the United States. The proposal—issued in conjunction with measures proposed by at least five other cabinet-level agencies to address GHG emissions—is part of President Biden’s “whole of government” approach to addressing climate change and represents EPA’s most ambitious regulatory effort to date to curb oil and gas sector emissions. EPA estimates compliance costs of $12 billion (present value, 3% discount rate) for existing sources, which it indicates would be offset by an estimated $4.7 billion (present value) through the capture of natural gas pursuant to the fugitive emission requirements in the proposal.

 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.

On August 30th, EPA granted the 2007 Petition from the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) requesting that EPA revoke all chlorpyrifos tolerances. This followed the Ninth Circuit order earlier this year for EPA to: “(1) grant the 2007 Petition; (2) issue a final regulation within 60 days following issuance of the mandate that either (a) revokes all chlorpyrifos tolerances or (b) modifies chlorpyrifos tolerances and simultaneously certifies that, with the tolerances so modified, the EPA "has determined that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information," including for "infants and children"; and (3) modify or cancel related FIFRA registrations for food use in a timely fashion consistent with the requirements of 21 U.S.C. § 346a(a)(1).”

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 January, EPA obtained data that some mosquito control pesticides contained detectable levels of certain PFAS.  In a joint investigation with the State of Massachusetts, EPA found that fluorinated high-density polyethylene (HDPE) containers containing a mosquito control pesticide were leaching PFAS into the product. Now, EPA is testing different brands of fluorinated containers to determine whether they contain and/or leach PFAS and has asked the states with existing stocks of these pesticides to discontinue use as EPA evaluates the issue. Information on the EPA activities can be found here. EPA also began working with USDA and FDA to get a better understanding of the use of fluorinated polyethylene containers for pesticides and other products.

The White House announced on July 22, 2021, President Biden’s nomination of David Uhlmann to be the Assistant Administrator for Enforcement and Compliance Assurance (OECA) at the US Environmental Protection Agency (EPA). Uhlmann is currently the director of the Environmental Law and Policy Program at the University of Michigan Law School and was previously a federal prosecutor for 17 years, including as the Chief of the Environmental Crimes Section of the US Department of Justice. His nomination signals the White House’s clear intent to reinvigorate EPA’s enforcement program after what the EPA’s Inspector General found in its March 31, 2020 report to be years of declining case statistics across multiple administrations.

Last month, EPA announced a planned update of the Toxics Release Inventory (TRI) reporting program, incorporating several additions.  The updates would expand the TRI program by adding new chemicals, facilities, and tools to increase accessibility of data.  The goal, according to EPA’s statement, is “to advance Environmental Justice, improve transparency, and increase access to environmental information.”

The Biden Administration’s enforcement priorities began to take shape last week, as the US Environmental Protection Agency’s (EPA) enforcement arm issued a pair of memoranda encouraging the use of certain tools in civil enforcement and settlements and for prioritizing enforcement efforts in environmental justice communities. Lawrence E. Starfield, a senior career EPA official currently serving as Acting Assistant Administrator for EPA’s Office of Enforcement and Compliance Assurance (OECA), issued both memoranda. The memos demonstrate a concrete shift in EPA’s enforcement philosophy—doubling down on Next Generation or “NextGen” compliance tools and Supplemental Environmental Projects (SEPs), and focusing on environmental justice—under the new administration. The specific ways in which EPA enforcement staff will carry out these policies are not yet known and will develop over time, but it is important for regulated entities to be aware of, and prepared for, EPA’s use of NextGen compliance tools and focus on strengthening enforcement in environmental justice communities.

As we previously reported, for the first time in over 25 years, the U.S. Environmental Protection Agency (EPA) has approved the formal transfer of Clean Water Act (CWA) section 404 permitting authority to a state.  On December 22, 2020, the State of Florida – only the third state to receive such approval – “assumed” 404 permitting authority from the U.S. Army Corps of Engineers (Corps) in certain waters of the United States (WOTUS).  Since that time, CWA section 404 permit applicants have faced a number of questions about the scope and process of assumed 404 permitting.  Five of the top questions are listed below, followed by their answers.

On January 26, 2021, a coalition of advocacy groups and prominent asbestos plaintiffs’ experts launched two challenges to “Part 1” of the asbestos risk evaluation recently released by the United States Environmental Protection Agency (EPA).  EPA concluded in Part 1 that 16 of the 32 “conditions of use” analyzed pose an “unreasonable risk” to human health, but advocacy groups have criticized EPA for only addressing risks associated with chrysotile asbestos and excluding review of other fiber types.  Now, those groups have teamed up on a pair of legal challenges that could force EPA to revisit its Part 1 asbestos risk evaluation, which could delay risk management regulations.

A flurry of asbestos-related activity in the last weeks of 2020 will require the United States Environmental Protection Agency (EPA) to devote significant regulatory attention to asbestos in 2021.  The incoming Biden Administration will need to address these Toxic Substances Control Act (TSCA) developments, and the scope of that response will determine whether regulatory implications extend beyond asbestos to other chemical substances.

On November 9, 2020, EPA’s Office of Research and Development (ORD) released its long-awaited draft handbook that details the office’s process for developing chemical hazard assessments for its Integrated Risk Information System (IRIS) Program. The ORD Staff Handbook for Developing IRIS Assessments (IRIS Handbook) gives useful insight into ORD’s process to develop its IRIS assessments, which provide important toxicological information that federal and state environmental agencies consider when making regulatory and cleanup decisions under multiple statutory programs. EPA will accept comments on the draft handbook and charge questions until March 1, 2021.

On November 24, 2020, the U.S. Environmental Protection Agency (EPA) issued a Prepublication Notice finalizing its proposed decisions to not impose Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) Section 108(b) financial assurance requirements on three industries (Industries):

• Electric Power Generation, Transmission and Distribution;
• Petroleum and Coal Products Manufacturing, and
• Chemical Manufacturing.

EPA’s final rules neither remove any existing requirements nor impose additional, new requirements.  The final rulemakings will not affect EPA’s authority to take CERCLA response or enforcement action with respect to any particular facility or industry, nor will they affect EPA’s authority under other environmental statutes that may be applicable to the facility.  The final rules also will not affect EPA’s existing practice of imposing financial assurance requirements in CERCLA settlements and orders, which already provide protection against bankruptcies and other financial calamities that may impact performing parties at Superfund sites. [1]

On October 27, 2020, in a succinct order, the United States Court of Appeals for the District of Columbia Circuit (“the Court” or “D.C. Circuit”) denied motions for stay and for summary vacatur filed by several environmental advocacy groups, including the Environmental Defense Fund and Sierra Club, as well as states and local governments, with leadership from the States of New York and California in litigation challenging EPA’s Oil and Natural Gas Sector:  Emission Standards for New, Reconstructed, and Modified Sources Review, 85 Fed. Reg. 57,018 (Sept. 14, 2020) (“Methane Repeal Rule,” or the “Rule”).  Order at 1, California, et al. v. Andrew Wheeler, et al., No. 20-1357 (D.C. Cir. Oct. 27, 2020).  In addition to an opposition filed by EPA, regulated industry trade groups, including the American Petroleum Institute (“API”), weighed in with the Court on EPA’s behalf to oppose the stay.