This article focuses on one of many abrupt, and in some views, unlawful, EPA policy shifts frustrating lawyers and confusing the public. The EPA moved in 2021 from a “conditions of use” approach to evaluating chemical risk to a “whole chemical” approach. This seemingly modest change is a key reason why lawyers advising chemical stakeholders are struggling and why there may be a lot of TSCA litigation in the EPA’s future.

Chemicals are the foundational origin of just about everything we enjoy and cannot live without. The federal law that authorizes the U.S. Environmental Protection Agency (EPA) to regulate industrial chemical substances is the Toxic Substances Control Act (TSCA), an almost 47-year-old law significantly amended in 2016 by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg). Lautenberg’s passage was a bipartisan triumph marking the do-over of a law that many believed did not ensure chemical safety.

The past seven years are no cause for celebration, however, as the three different administrations that have occupied the White House since 2016 have made a mess of Lautenberg’s implementation. EPA’s recent move from a “conditions of use” approach in evaluating existing chemical risk to a “whole chemical” approach is one of many abrupt EPA policy shifts frustrating lawyers and confusing the public.  TSCA litigation is plainly in our future.

On Nov. 16, 2022, the U.S. Environmental Protection Agency (EPA) published a supplemental proposal modifying its 2021 proposed rule that would amend the 2018 Toxic Substances Control Act (TSCA) fees rule. The EPA’s assistant administrator warned us to be prepared for sticker shock. The proposed increases are significant. This article discusses what you need to know.

Given the passage of time since the Toxic Substances Control Act (TSCA) was enacted in 1976, the public’s growing awareness of the potential for exposure from chemicals in “articles,” or finished goods, during use, and greater focus on the implications of end-of-life product disposal, the U.S. Environmental Protection Agency’s (EPA) regulation of articles under TSCA has shifted significantly. Historically, EPA elected not to regulate articles for the most part. EPA’s more recent announcement of its intent to regulate chemicals in articles to a much greater extent has caught many off guard and reflects a significant shift in U.S. chemical regulation policy.

The U.S. Environmental Protection Agency held a webinar on August 17, on the “EPA PFAS Strategic Roadmap: Research Tools and Resources.” The webinar provided a brief overview of EPA’s PFAS Strategic Roadmap and ongoing efforts by EPA’s Office of Research and Development (ORD) to address key per- and polyfluoroalkyl substances (PFAS) research needs for environmental decision-making. 

The U.S. Environmental Protection Agency (EPA) has issued two new documents for recipients of Section 4 test orders under the Toxic Substances Control Act (TSCA). The good news is these documents offer relief to stakeholders who otherwise would be responsible for chemical testing costs for certain chemicals they produced or imported.

The U.S. Environmental Protection Agency (EPA) invited on July 6, 2022, small businesses to participate as Small Entity Representatives (SER) for a Small Business Advocacy Review (SBAR) panel. The EPA seeks self-nominations directly from entities that may be subject to the rule requirements; self-nominations were due July 20, 2022. The panel focuses on the agency’s proposed rule to collect data to inform each step of the Toxic Substances Control Act (TSCA) risk evaluation and risk management process. Participating in the SBAR, or at least tracking its activities and engaging as much as possible, is encouraged. The reasons for engagement are discussed in this article.

Since the US Supreme Court issued its blockbuster ruling in West Virginia v EPA, 597 US _ 2022 WL 2347278 (30 June 2022), many are asking whether the Court’s amplification of the 'major questions doctrine' (MQD) might be used to seek to limit the US EPA’s authority in implementing Congress’s 2016 amendments to TSCA, the Frank R Lautenberg Chemical Safety for the 21st Century Act (Lautenberg). Lynn L Bergeson, managing partner of the law firm Bergeson & Campbell, says there's little doubt that West Virginia v EPA will be used to seek to limit the agency's authority in implementing the 2016 amendments to the law. 

In February 2022, France and the United States announced their commitment to protect our shared environment for future generations against the harm resulting plastic pollution.Both nations stated their united recognition of the transboundary impacts of plastic pollution and the importance of mitigating plastic waste at its source. On March 2, 2022, as reported by the 5th UN Environment Assembly (UNAE-5.2) in Nairobi, both France and the United States, along with 173 other nations, adopted a Resolution to End Plastic Pollution with an international legally binding agreement by 2024, with discussions beginning in 2022. Significantly, the Resolution to End Plastic Pollution defines “plastic waste” to include “microplastic.” Building upon the historic collaboration between France and the United States regarding plastic waste and learning from the contrasts in their governmental structures and approaches to environmental regulation, this French and United States Comparative Law Analysis and Recommendations Regarding Plastic Waste is offered for use by policy makers in the upcoming negotiations regarding the global plastic waste treaty.

On May 6, 2022, the U.S. Environmental Protection Agency (EPA) proposed reporting and recordkeeping requirements for asbestos under Section 8(a) of the Toxic Substances Control Act (TSCA). Unsurprisingly, the proposed requirements are extensive and tough.  This article provides a summary.

Per- and polyfluoroalkyl substances (PFAS) are getting a lot of attention in the United States and globally. Their varied chemical properties make the categorization of “PFAS” into a single category chemically and scientifically questionable. Increasingly, the ability to make distinctions among this large chemical category is challenging, yet failure to do so could be unwise. This article provides information on PFAS, and offers a few suggestions to keep in mind when making business decisions.

The ubiquity of per- and polyfluoroalkyl substances (PFAS) and the manufacturing sector’s decades-long reliance on them to impart functionalities in a dizzying array of products put the investor between the proverbial rock and a hard place. PFAS varied chemical properties make the broad categorisation of ‘PFAS’ into a monolithic category of ‘forever chemicals’ chemically and scientifically questionable.

For better or worse, however, that is exactly what is happening today, and distinguishing between commercially promising and commercially risky PFAS chemicals is challenging. Yet, the ability to make this distinction could be the difference between a great investment and a commercially disastrous one. This article explores this difficult assessment, provides essential information on PFAS, and offers some suggestions to avoid making bad investment decisions.

The Biden Administration’s U.S. Environmental Protection Agency (EPA) is laser focused on achieving several “whole-of-government” priorities: addressing climate change, identifying and giving environmental justice greater consideration in decision-making, and following the science wherever it may lead. Knowing and respecting leadership in the Office of Chemical Safety and Pollution Prevention (OCSPP) tasked with achieving these laudable yet daunting objectives, there is no question the commitment is genuine. It is ironic, however, that EPA is applying the Toxic Substances Control Act (TSCA) in ways that are counterproductive to achieving these goals.

The Toxic Substances Control Act (TSCA) has long been considered the “poster child” of failure as a chemical control law when it comes to asbestos regulation. The U.S. Environmental Protection Agency (EPA) in its latest approach to regulating “legacy” uses may well invite heightened scrutiny. The EPA announced in December the availability of the Draft Scope of the Risk Evaluation for Asbestos, Part 2. In it, the agency will evaluate conditions of use of asbestos were excluded from Part 1 as legacy uses and associated disposals, and use conditions of asbestos in talc and talc-containing products. This article summarizes the EPA’s approach.

The environmental impacts of the digital economy are increasingly the focus of attention and concern. There is no question the demand for electricity, water and land have increased sharply in response to the growth in digital activity. Identifying, quantifying and mitigating environmental and ecological impacts are core to value creation, and investors must be mindful of how a company is positioned to create value while avoiding public rebuke for neglecting to account for the environmental impacts of greatly increased digital activity.

This article explores the digital economy, the growing set of metrics used to assess environmental sustainability in a digital economy, the tools companies are using to improve efficiency, lessen environmental impacts and increase supply chain transparency and traceability, and tips for investors in assessing a company’s environmental awareness of the impacts of greatly increased digital activity.

The U.S. Environmental Protection Agency (EPA) announced on October 21 that it intends to move further back the compliance dates related to articles containing phenol, isopropylated phosphate (3:1) (PIP (3:1)) to ensure supply chains for key consumer and commercial goods are not disrupted. The agency proposed extending the compliance date until October 31, 2024, along with the associated recordkeeping requirements for manufacturers, processors and distributors of PIP (3:1)-containing articles. This article discusses this important development.

The implementation of the Toxic Substances Control Act (TSCA) provisions relating to regulating persistent, bioaccumulative and toxic (PBT) chemicals has been anything but smooth. On September 3, 2021, the Environmental Protection Agency (EPA) announced it intends to initiate new PBT rulemaking and anticipates proposing new rules for five PBT chemicals subject to final risk management rules under TSCA Section 6(h). Additionally, and happily, the agency extended the compliance dates for the prohibitions on processing and distribution and the associated recordkeeping requirements of one of these PBT chemicals, phenol, isopropylated phosphate (3:1) (PIP (3:1)). The action was imperative as EPA’s earlier-issued “No Action Assurance” (NAA) lapsed on September 4, 2021. This article provides key points related to this complicated area of TSCA regulation.

The U.S. Environmental Protection Agency (EPA) announced on June 10, 2021, three actions intended to protect communities from per- and polyfluoroalkyl substances (PFAS), as covered in July’s column “EPA Announces Blockbuster PFAS Actions.” This column focuses on one of them: an ambitious proposal intended to obtain comprehensive data on more than 1,000 PFAS manufactured in or imported into the United States. As discussed in this article, the proposal’s scope is enormous.

By any independent standard, the US electronics industry is huge – it was worth over $300bn in 2019 – and growing annually. Would it surprise you to know that as big, essential and powerful as it is, a single rule issued in January of this year by the US Environmental Protection Agency (EPA) nearly brought this sector to a halt? To this day, the rule is causing extraordinary disruption as electric and electronic device manufacturers, importers, processors, distributors and others scramble to adjust in its aftermath. This article tells the cautionary tale of PIP (3:1). This sad and largely avoidable tale crystalises the importance of understanding the long reach of the US industrial chemical control law, the Toxic Substances Control Act (TSCA) and its seemingly limitless potential for disrupting global supply chains.

When it comes to per- and polyfluoroalkyl substances (PFAS), the U.S. Environmental Protection Agency (EPA) is not messing around. The agency announced on June 10, 2021, three actions intended to protect communities from PFAS. This article summarizes the actions.

Just as the industrial chemical community was getting into a predictable, somewhat comfortable groove regarding commercializing new chemicals under the Toxic Substances Control Act (TSCA), the U.S. Environmental Protection Agency (EPA) decided to blow up the process. With it went any hope for business certainty in this highly volatile regulatory area.  While new administrations are entitled to shape policies to align with their agendas, the Biden Administration’s decision to rescind the new chemicals policies bodes badly for chemical innovation at the very time new, sustainable chemical innovations are most needed.  This article explains why the new chemicals policies portend major delays.

The U.S. Environmental Protection Agency (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) will be busy in 2021. Implementation of the 2016 amendments to the Toxic Substances Control Act (TSCA) will continue to dominate the Office of Pollution Prevention and Toxics (OPPT). In 2021, the EPA will need to complete outstanding risk evaluators of the 'first 10' chemicals and begin developing proposals for the section 6 risk management rules necessitated by the risk evaluations' conclusions. Given the tight statutory deadline for issuing proposed risk management rules, the complexity of the issues and the novelty of applying the new regulatory authorities, risk management decisions will likely present daunting challenges to the EPA as it sorts through the many legal and evolving policy issues at play. The EPA also now has four manufacture-requested risk evaluations that will parallel the 'next 20' chemicals for review. The change in administration makes the next four years especially 'unpredictable', not a word the business community welcomes.

June 22 of this year will mark the fifth anniversary since President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Popularly still known by the name of the 40-year-old statute it replaced, the new version of the Toxic Substances Control Act had a vision to follow in reforming a system for evaluating and regulating chemicals in commerce that everyone, from industry to green NGOs to government officials, agreed was weak and ineffective. The new TSCA, promising to fix a broken statute, received bipartisan support and was the first major environmental law in a quarter century.

If anyone on planet Earth thinks the Toxic Substances Control Act (TSCA), as amended, is not commercially consequential, think again. The implementation of the 2016 amendments by the U.S. Environmental Protection Agency (EPA) is triggering tremendous commercial disruption. The EPA’s March 8, 2021, announcement seeking comment on five final rules for persistent, bioaccumulative, and toxic (PBT) chemicals issued on January 6, 2021, and, importantly, granting a rare “No Action Assurance” regarding the PIP (3:1) rule, is demonstrable proof of TSCA’s enormous reach. The reasons behind this regulatory action are revealing and demonstrate why the PIP (3:1) experience is a cautionary tale.

In the 21st century, we take as given a continuous stream of new and better products. From electronics to building materials to transportation solutions, the flow of new and better products and applications seems unending. New chemical substances play a fundamental role in creating those products and making existing products better. If the pipeline of new chemicals were closed off, the flow of new products and applications would slow to a trickle and eventually dry up. Modern life as we know it would not exist without the continued invention, production and use of new chemicals.

The U.S. Environmental Protection Agency (EPA) announced on January 15, 2021, that it has issued test orders under Section 4 of the Toxic Substances Control Act (TSCA) to obtain additional data on nine of the next 20 chemicals undergoing risk evaluation. Many in the industrial chemical community expect the EPA to use its TSCA testing authority much more in the coming years. The January orders seem to confirm that expectation. This article discusses the significance of the action.

The Biden Administration has embraced environmental justice with unprecedented gusto.  In its July 2020 Plan to Secure Environmental Justice and Equitable Economic Opportunity (Plan), the Biden Administration sets out in broad terms how it intends to use an “All-of-Government” approach to “rooting out systemic racism in our laws, policies, institutions, and hearts.”

On January 11, 2021, the U.S. Environmental Protection Agency (EPA) proposed to amend the 2018 Toxic Substances Control Act (TSCA) fees rule. This column discusses the proposal and its improvements to the rule.

The Toxic Substances Control Act (TSCA) authorizes the U.S. Environmental Protection Agency (EPA) to collect fees from chemical manufacturers (including importers) to defray a portion of the costs associated with TSCA implementation efforts. The TSCA fees rule requires payment for eight categories of fee-triggering events under TSCA, including EPA-initiated risk evaluations under TSCA Section 6. The EPA must prepare a preliminary list of manufacturers subject to fee obligations for EPA-initiated Section 6 risk assessments, which it did (see, “Are You on the List?” and “EPA Tells Businesses to Pay Up”). Since then, who pays for what has led to significant controversy. 

The U.S. Environmental Protection Agency (EPA) published the final risk evaluation for carbon tetrachloride on November 4, 2020. The EPA found unreasonable risks to workers and occupational non-users (ONU) for 13 of the 15 conditions of CCl4 use, but no unreasonable risks to the environment. According to the EPA, there are no consumer uses of this chemical. Most agree the findings are not unexpected. This article explains the assessment and the results.

The Toxic Substances Control Act (TSCA) is not the arcane federal law it once was. Amended in 2016 in response to a demand so loud and persistent from nongovernmental organizations, consumers, and, eventually, the industrial chemical community that Congress could no longer ignore it, TSCA is now a force with which to be reckoned. While the U.S Environmental Protection Agency’s (EPA’s) implementation of the 2016 Lautenberg Act that amended TSCA invites criticism among stakeholders, there is no disagreement that today TSCA is a more consequential law, deserving of legal practitioners’ attention.

On August 26, 2020, the U.S. Environmental Protection Agency (EPA) released the much-anticipated interim final list of businesses subject to risk evaluation fees for the 20 chemicals designated as “high priority” under the Toxic Substances Control Act (TSCA). Making the interim final list available now gives businesses and other stakeholders an opportunity to review the list for accuracy. It also provides time for businesses to reach out to form consortia to share in fee payments. That is a fancy way of saying the race is on to try to get off the list or find others to share in the not-so-trivial cost of $1.35 million — the EPA’s fee for work on the risk evaluation.

Ordinarily, government fees command little interest in corporate finance and board-level business circles. Newly imposed fees to defray the US Environmental Protection Agency’s (EPA’s) risk evaluation of high-priority chemical substances under Section 6 of the Toxic Substances Control Act (TSCA) are extraordinary, however, and are commanding significant interest. This article explains why.

As the expression goes, it is that time of year again.  Section 8 of the Toxic Substances Control Act (TSCA) requires manufacturers, including importers, to provide the U.S. Environmental Protection Agency (EPA) with information on the production and use of chemicals in commerce at four-year intervals.  The last reporting cycle for the requirement, known as the Chemical Data Reporting (CDR) requirement, was in 2016, so TSCA stakeholders have been gearing up since then for the current quadrennial reporting obligation, which commenced on June 1, 2020.  This column provides an overview of what is new and different since 2016.

The U.S. Environmental Protection Agency (EPA) continues to regulate “forever chemicals,” named such for their persistence and risk to the environment and health. On July 27, 2020, the EPA issued a long-awaited final rule amending significant new use rules (SNUR) issued earlier on such chemicals — one pertinent to certain perfluoroalkyl sulfonate chemical substances and the other on long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances. To some, the final rule reflects comments on the proposed rule issued five years ago; to others, the rule weakens to the public’s detriment a proposal the Obama Administration issued. This article discusses the rule and its implications.

The Frank R Lautenberg Chemical Safety for the 21st Century Act is four years old. While to some 22 June 2016 seems like yesterday, the past four years have been transformational. The US EPA has worked hard, been timely and done well in thoughtfully implementing the changes. 

Anniversaries tend to inspire reflection on the past, and this year was no exception. The Environmental Law Institute, Bergeson & Campbell and the George Washington University Milken Institute School of Public Health convened for an all-day seminar on TSCA reform, four years after the enactment of Lautenberg. Diverse stakeholders offered their perspectives on TSCA implementation and shared candid reviews on where we are as a TSCA community.

Rather than look back, this article looks forward to the next four years and speculates on some of the many challenging topics the EPA and other TSCA stakeholders are likely to address.

Download a PDF of this article here. 

Section 8 of the Toxic Substances Control Act (TSCA) compels manufacturers (including importers) to provide the U.S. Environmental Protection Agency (EPA) with information on the production and use of chemicals in commerce. The last Chemical Data Reporting (CDR) cycle was in 2016, so TSCA stakeholders have been gearing up for this quadrennial reporting obligation in 2020. This column provides an overview of changes since 2016.

Under the amended Toxic Substances Control Act (TSCA), the U.S. Environmental Protection Agency (EPA) has authority to collect fees from chemical manufacturers and importers to defray a portion of the EPA costs associated with risk evaluation efforts.  The fees are quite substantial and who pays them has been the subject of considerable debate and uncertainty.  This column addresses issues that have caused confusion and anxiety for industry stakeholders regarding the self-identification criteria, time lines, and procedures, and seeks to add much needed clarity to this chaotic issue.

Much attention now focuses on COVID-19 and subsequent supply chain disruptions; here, we tackle supply chain communications and ways to optimize them. The Toxic Substances Control Act (TSCA) requires such communications, as do evolving best business practices. Managing supply chain communications effectively, and strategically optimizing the commercial interactions and exchanges of information they elicit are essential business practices.

The EPA’s amendments to the Toxic Substances Control Act reporting requirements have increased the need for chemical stakeholders to manage actively supply chain communications. Lynn L. Bergeson, owner and managing partner of Bergeson & Campbell P.C., explores the upsides to be realized through these communications and the perils of failing to seize them. Download a PDF of this article here.

Is your company potentially liable for a share of the U.S. Environmental Protection Agency (EPA) $1,350,000 fee for developing a Toxic Substances Control Act (TSCA) risk evaluation? This is a hot topic these days, given EPA’s notice dated January 27, 2020, identifying the “preliminary lists” of manufacturers, including importers, of the 20 chemical substances that EPA has designated as “high-priority” substances for risk evaluation and for which fees will be charged. Stakeholders are required by March 27, 2020, to “self-identify” as manufacturers of a highpriority substance irrespective of whether they are included on the preliminary lists identified by EPA.  

PBT chemicals have long been recognised to behave differently in the environment and in biological systems from non-PBT substances. The US Congress acknowledged this when amending TSCA in 2016 by crafting special provisions under the Regulation’s Section 6(h) that were uniquely applicable to PBTs. Last July, the EPA proposed a rule that would implement the section, but this caused much controversy and led to comments from, among others, the retail, coatings and aerospace sectors and NGOs. It also raised several novel legal issues relating to TSCA’s interpretation.

Nevertheless, the EPA must issue a final rule within 18 months of the proposal, that is to say by December 2020. This article focuses on the novel issues that have arisen and the implications of their resolution on affected stakeholders.

In last month’s column, we reported on the January 27, 2020, notice from the U.S. Environmental Protection Agency (EPA) identifying the preliminary lists of manufacturers, including importers, of the 20 chemical substances the EPA designated as high-priority for risk evaluation and for which fees will be charged. The notice created a firestorm of criticism over the lack of any exemptions from being considered potentially responsible for paying a share of the EPA’s $1,350,000 fee for conducting a risk evaluation of a high-priority chemical. This column updates the status of this fast-changing matter.

Is your company potentially liable for a share of the U.S. Environmental Protection Agency (EPA) $1,350,000 fee for developing a Toxic Substances Control Act (TSCA) risk evaluation?  It may well be.  This is a hot topic these days, given EPA’s Federal Register notice published on January 27, 2020, identifying the “preliminary lists” of manufacturers, including importers, of the 20 chemical substances that EPA has designated as “high-priority” substances for risk evaluation and for which fees will be charged.  Until March 27, 2020, stakeholders are required to “self-identify” as manufacturers of a high-priority substance irrespective of whether they are included on the preliminary lists identified by EPA (yes, you must submit a form to EPA even if your company name is already identified by EPA).  The preliminary lists are available in Docket EPA-HQ-OPPT-2019-0677 and on EPA’s website at http://www.epa.gov/TSCA-fees.  This article explains the notice and suggests way to respond to it.

The U.S. Environmental Protection Agency (EPA) published on January 27, 2020, a notice identifying the preliminary lists of manufacturers (including importers) of the 20 chemical substances that the EPA designated as high-priority substances for risk evaluation and for which fees will be charged (85 Fed. Reg. 4661). The list and the EPA’s interpretation of the fee rule caught many off guard. This column explains why.

On December 20, 2019, the U.S. Environmental Protection Agency (EPA) released an updated “Working Approach” document that builds upon its November 2017 version. The EPA states that the updated version, “TSCA New Chemical Determinations: A Working Approach for Making Determinations under TSCA Section 5,” explains its approach for making affirmative determinations on new chemical notices under the Toxic Substances Control Act (TSCA). This article highlights key changes in the document.

Among the changes when the Toxic Substances Control Act (TSCA) was amended by the Frank R. Lautenberg Chemical Safety Act for the 21st Century, also known as Lautenberg or ‘new TSCA’, none is more consequential than the requirement that the US Environmental Protection Agency (EPA) conduct risk evaluations for ‘high priority’ chemical substances. We are now three years into new TSCA and this is being done, amid spirited debate and, inevitably, litigation.

The citizen suit provisions of the Toxic Substances Control Act (TSCA) are turning out to be a potentially powerful tool for advocates dissatisfied with risk evaluations conducted under TSCA Section 6. What is unclear is whether anyone intended this result. This column discusses the new and somewhat surprising role TSCA Section 21 citizen petitions may play in defining chemical risks under TSCA. The issue involves an interesting TSCA Section 21 petition filed in 2016 that has been the subject of litigation ever since. How the lawsuit plays out will have significant implications for TSCA stakeholders.

New chemical innovation is not as celebrated as innovation in electronics, materials, software, or other sectors, but it is every bit as important. Many believe, as do we, that new chemical innovation is essential to achieving sustainable development. For this reason, a close look at the 2016 amendments to the Toxic Substances Control Act (TSCA) and the U.S. Environmental Protection Agency’s (EPA) implementation of them offers valuable insights into whether the new U.S. industrial chemical management law and EPA policy initiatives implementing it are aligned with this goal. This article discusses EPA’s implementation of the TSCA amendments as they relate to new chemical innovation and highlights EPA policy positions and institutional practices that EPA should reconsider to alignmore closely with the goal of more sustainable new chemical technologies.

In 2018, the global M&A market achieved a transaction volume of $4.1 trillion, the third highest year ever for M&A volumes. Divestitures, spin-offs and split-offs are essential to defining corporate identity, a key shareholder imperative. This brisk pace is expected to continue. Whatever the motivation, M&A activity demands razor-sharp due diligence. The premise of this article is that due diligence often underestimates or, worse, ignores the impact implementation of revisions to the Toxic Substances Control Act (TSCA), the US industrial chemical safety law, has on commercial transactions. Implementation of these revisions is now influencing key sectors of the economy, making it essential that TSCA chemical risk evaluations be routinely included in M&A due diligence protocols.