On May 3, 2023, the U.S. Environmental Protection Agency (EPA) proposed under Section 6(a) of the Toxic Substances Control Act (TSCA) to prohibit most uses of methylene chloride. This column summarizes this important initiative.

The implementation of the game-changing 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act, amending the Toxic Substances Control Act (TSCA), is now a hotbed of legal dispute. Lawsuits challenging key aspects of the law’s implementation are piling up. While all are legally noteworthy, one citizen enforcement case in particular merits attention. As discussed below, two recent cases have raised novel issues pertinent to the scope of the U.S. Environmental Protection Agency’s (EPA) Significant New Use Rule (SNUR) authority under TSCA Section 5 and a more general challenge to the agency's right to pre-empt citizen actions if the government is 'diligently prosecuting' the act a citizen plaintiff wishes to restrain. The resolution of these cases and both issues will have important implications, making these cases worth watching.

A major task we face in achieving circularity is ensuring that policies remain nimble in addressing environmental and public health challenges. Our suite of laws and their regulatory implementation sometimes reflect an unhelpful resistance to circularity, expressed in policies that are indifferent or antithetical to an efficient transition to true resource economy.

In a somewhat unexpected move, Congress enacted the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) on December 29, 2022, as part of the Omnibus Appropriations Act. MoCRA significantly strengthens the U.S. Food and Drug Administration’s (FDA) authority over cosmetic products. Key provisions are summarized in this article.

On Feb. 14, 2023, the Maine Department of Environmental Protection (MDEP) announced a much-anticipated proposed rule intended to clarify the notification requirements and sales prohibitions for products and product components containing intentionally added perfluoroalkyl and polyfluoroalkyl substances (PFAS). This reporting requirement has generated attention given its broad scope and “first out of the gate” nature. This article contains a summary of the guidance.

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.

The Federal Trade Commission (FTC) is tinkering with the Guides for the Use of Environmental Marketing Claims (Green Guides). Given the growing appeal of “green claims” for a variety of products, it is fitting the FTC is refining and modernizing the Green Guides to help marketers avoid making environmental marketing claims that are unfair or deceptive under Section 5 of the FTC Act. Importantly, the FTC seeks to update the guides “based on increasing consumer interest in buying environmentally friendly products.”

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.

In August, the U.S. Occupational Safety and Health Administration (OSHA) announced it is considering revisiting the Process Safety Management (PSM) standard. This column summarizes why OSHA is thinking of amending the standard and what you can do to engage in the process.

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.

Cleanup costs under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) are about to get a lot more expensive. The U.S. Environmental Protection Agency (EPA) announced on September 6, 2022, that it will propose to designate perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), two of the most widely used per- and polyfluoroalkyl substances (PFAS), as hazardous substances under CERCLA. The rulemaking would also require entities immediately to report releases of PFOA and PFOS that meet or exceed the reportable quantity (RQ). This article discusses the proposal.

The scope of what diligence is due in any corporate transaction has evolved greatly over the past decade, particularly with respect to transactions involving chemical products. Once upon a time, transactional due diligence involving chemical products, whether ‘neat’ (pure) chemicals, formulations or end-use products, typically consisted of a phase I or phase II environmental site assessment (ESA) focusing on identifying contamination derivative of chemical releases into environmental media as effluent, emissions, fugitive releases or waste, as well as quantifying the potential for such releases to pose litigation risks or regulatory enforcement, or require costly remediation. Increasingly, parties to corporate transactions now continue to focus on these liabilities and on the compositional elements of chemical products themselves as potential sources of liability and commercial disruption. This article explains why the transition to chemical product due diligence has been slow and offers a few tips to help assess what diligence is due in corporate transactions involving chemical products.

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 Toxic Substances Control Act (TSCA) offers tremendous unrealized potential to promote the development of more sustainable industrial chemicals. Despite the fact that Congress significantly amended TSCA in 2016 specifically to diminish the human health and environmental footprint of industrial chemicals, the U.S. Environmental Protection Agency (EPA) is interpreting the revised law in ways that ironically discourage the commercialization of new chemicals and reinforce a “new chemical bias” that undermines the commercialization of greener, more sustainable industrial chemicals. This article explores the EPA policies and practices that blunt the commercialization of promising, more sustainable industrial chemicals and offers recommendations to optimize TSCA to achieve greener chemicals.

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. 

On November 15, 2021, President Biden signed into law the Infrastructure Investment and Jobs Act (IIJA), reinstating the Superfund excise tax on certain chemical substances under Sections 4661 and 4671 of the Internal Revenue Code (Tax Code). Effective July 1, 2022, the tax many were glad to see expire is back; the first deposit of the tax is due on July 29, 2022. This article discusses the tax and the challenges it poses.

By any standard, federal enforcement of environmental laws in the US has been uneven, to say the least. The prevailing perception is that democrats are ‘greener’ than are republicans when it comes to environmental enforcement. The data is quite scattered, however, and it would seem no party has cornered the environmental protection market. The Trump administration may be the exception that proves the rule.

Most would agree civil and criminal enforcement case numbers were significantly below those of other administrations, all by design. A raft of other actions taken by the Trump administration crystallised that environmental enforcement was definitely not top of mind. Priorities today are decidedly different, and investors need to know the implications of the Biden administration’s commitment to the twin goals of environmental protection and environmental justice. This article explores these topics.

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.

On April 5, 2022, the California Office of Environmental Health Hazard Assessment (OEHHA) issued a notice recommending additional revisions to its proposal to modify Proposition 65 (Prop 65) Article 6 “clear and reasonable warnings” regulations for “short-form” warnings (Notice). OEHHA first proposed to change the short-form warning requirements on January 8, 2021. This column explains the significance of this development.

The Chemicals Strategy for Sustainability, adopted by the European Commission in October 2020, calls on the Commission to ensure that Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures (CLP Regulation) is the central legislation for hazard classification and allows the Commission to initiate harmonised classifications. This article examines the effect of possible CLP amendments.

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.

On November 15, 2021, President Biden signed into law the Infrastructure Investment and Jobs Act (H.R. 3684). The House passed the bill on November 5, 2021, by a vote of 228 to 206, and the Senate passed the bill on August 10, 2021, by a vote of 69 to 30. The bill provides a $1.2-trillion infusion of cash into the economy and contains many provisions important to the chemical processing sector. Highlighted below are some of the provisions in the 1,039-page bill that readers may find interesting.

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.

On July 13, 2021, Maine became the first state to enact Extended Producer Responsibility (EPR) legislation for packaging. On August 6, 2021, Oregon followed, enacting a similar EPR law applicable to packaging. Other states are poised to pass similar legislation. This article discusses the concept of EPR and summarizes the state legislation.

On 13 July 2021, Maine became the first state in the US to enact extended producer responsibility (EPR) legislation for packaging. Quickly thereafter, on 6 August, Oregon became the second state to enact a similar EPR law applicable to packaging. Other states are poised to enact similar legislation, following trends more mature in the European Union (EU) and elsewhere around the world.

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.

Food safety comes in many forms. Years ago, Congress passed the Food Quality Protection Act, amending the nation’s pesticide law to ensure a safer, more reliable, food supply. Consumer groups have urged Congress for years to modernize the nation’s food chemical law, the Federal Food, Drug, and Cosmetic Act (FFDCA), to address often-stated concerns with chemicals in food. Thus far, those concerns remain largely unaddressed by any legislative effort. Things may be changing. On July 26, 2021, Representative Jan Schakowsky (D-IL), chair of the House Energy and Commerce Subcommittee on Consumer Protection and Commerce, introduced the Food Chemical Reassessment Act of 2021 (H.R. 4694), which would require the U.S. Food and Drug Administration (FDA) to study and reassess chemicals used in food. This article summarizes the measure, and speculates on its likelihood of passage.

To help achieve the ambitious goals of the European Green Deal, the European Commission adopted the chemicals strategy for sustainability in October 2020. The strategy suggests that the Commission can address pressing human health and environmental concerns by reinforcing Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures – one of the EU’s cornerstones for regulating chemicals.

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.

Emerging tools enabled by nanotechnology, synthetic biology, and other innovative technologies are today increasingly supplementing the ploughs and tractors so emblematic of the agricultural community of the past. These precision farming tools are ensuring a sustainable food supply otherwise threatened by climate change and population growth, among other global challenges, while diminishing worldwide greenhouse gas emissions. Genetically modified E coli is being used to produce synthetically-derived pheromones, substances beneficially used in agricultural applications to attract, capture, and eliminate harmful pests. Agricultural stakeholders use nanopesticides and nanofertilisers in drought-stricken regions, minimising the need for more conventional and environmentally consequential agricultural chemicals. GPS-based auto-steering systems for tractors augment human labour, freeing up effort better spent on other tasks. These technologies enable global agricultural professionals to address the climate change imperatives which threaten an increasingly fragile global food supply.

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) announced on April 29, 2021, that it will be “taking important steps under the Toxics Release Inventory (TRI) to advance environmental justice, improve transparency, and increase access to environmental information.” The EPA plans to expand the scope of TRI reporting requirements to cover additional chemicals and facilities, including those not currently reporting ethylene oxide (EtO) releases. The agency also announced enhancements to its TRI reporting tools, but this article will focus on the chemical expansion effort and why it is significant.

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.

In early April, a Florida pond that sits atop phosphogypsum tailings sprung a leak. State authorities scrambled to keep the pond from collapsing and flooding the surrounding area with millions of gallons of contaminated water. This situation likely wasn’t top of mind on February 8, 2021, when a group of environmental protection advocates prepared and submitted to the U.S. Environmental Protection Agency (EPA) a petition under Section 21 of the Toxic Substances Control Act (TSCA). The petition seeks to reverse the EPA’s 1991 “Bevill” regulatory determination excluding phosphogypsum and process wastewater from phosphoric acid production (process wastewater) from hazardous waste regulation under Subtitle C of the Resource Conservation and Recovery Act (RCRA). The timing of the Florida near-catastrophe could not be more ironic.

Two developments in the European Union in 2020 involving chemical regulations will almost certainly impact U.S. chemical stakeholders, according to Lynn L. Bergeson, managing partner of Bergeson & Campbell P.C. One initiative restricts certain chemicals in order to comply with the European Green Deal, while the other amends chemical disclosure requirements, she explains.

On April 16, 2021, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) posted two preliminary opinions for comment: Opinion on Gold (nano), Colloidal Gold (nano), Gold Thioethylamino Hyaluronic Acid (nano) and Acetyl heptapeptide-9 Colloidal gold (nano) and Opinion on Platinum (nano), Colloidal Platinum (nano) and Acetyl tetrapeptide-17 Colloidal Platinum (nano).

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.

Lawyers counselling companies in the biotechnology, biopesticide and related crop protection and industrial biotechnology areas appreciate the critically important role federal agencies play in ensuring the success of start-up businesses.

Federal agencies, including the US Environmental Protection Agency (EPA) and the US Food and Drug Administration (FDA), among others, wield enormous power over businesses that require premarket product approval. While we product approval practitioners know this, it comes as a bit of a surprise when investors, poised to make multimillion-dollar investments in start-up businesses, neglect to focus on the regulatory integrity of the start-up. This lack of focus invites costly mistakes. This article explains why, and how to avoid making these mistakes.

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.

As a new administration arrives in Washington, D.C., few things are certain except that 2021 is sure to be an eventful year.

While underlying partisan jockeying and prospects for bipartisan cooperation will greatly affect what may happen in the more limited context of chemical regulation, the Biden administration has already laid out priorities on the environment that will surely influence the U.S. Environmental Protection Agency’s (EPA) positions on climate change, the role of science, and regulation in general.