Articles

We heard a loud, collective sigh of relief when the U.S. Environmental Protection Agency (EPA) unexpectedly published a direct final rule on Sept. 5, delaying the Toxic Substances Control Act (TSCA) perfluoroalkyl and polyfluoroalkyl substances (PFAS) reporting deadline by an additional eight months.  The rule delayed the deadline from May 8, 2025, to January 11, 2026. For any company reporting exclusively as an article importer and is also considered a small manufacturer, the...

Canada recently joined a growing list of countries requiring the reporting of certain information on the manufacture, import and use of specific per- and polyfluoroalkyl substances (PFAS). On July 27, 2024, Canada’s Minister of the Environment published a Canada Gazette notice announcing a mandatory survey to obtain information on 312 listed PFAS. Canada’s “Guidance manual for responding to the: Notice with respect to certain per- and polyfluoroalkyl substances (PFAS)” states that...

Corporate entities are feeling the heat per-and poly fluoroalkyl substances (PFAS) are generating. PFAS manufacturers are being sued in record numbers in the US based on novel legal theories involving personal injury tort claims, product liability, environmental damage and fraud among other things. Heightened legal activity in other jurisdictions, including the UK and the European Union (EU), is expected. Manufacturers of products containing PFAS, and their downstream users, are also becoming...

On July 10, 2024, the U.S. Environmental Protection Agency (EPA) published a compliance guide for its final methylene chloride risk management rule issued under the Toxic Substances Control Act (TSCA). The final rule is complicated, and the compliance guide is a useful document for stakeholders to consider reading. ...

On June 14, 2024, the U.S. Environmental Protection Agency (EPA) issued proposed restrictions under Section 6(a) of the Toxic Substances Control Act (TSCA) to protect workers and consumers from exposure to N-methylpyrrolidone (NMP) (89 Fed. Reg. 51134). To address the unreasonable risks the EPA identified, the agency proposes a combination of worker and consumer protections. Given NMP’s ubiquitous applications, this is an important TSCA proposal....

The standard of judicial review for most critical TSCA determinations under section 19 is “substantial evidence in the record taken as a whole”. This is a tough standard, considerably more rigorous than the Administrative Procedure Act (APA) standard under section 706, where agency action will be set aside if it is “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” The recent Loper...

On 28 March, the Environmental Protection Agency (EPA) issued its long-awaited first final risk management rule under the Toxic Substances Control Acta (TSCA), banning the import and eventual use of chrysotile asbestos. This is the only form of asbestos known to be used in the US. You may be thinking now that because your company does not import or use asbestos, this does not affect you. You should care about it because the EPA’s approach...

The U.S. Food and Drug Administration (FDA), the primary federal agency committed to safe exposure to chemicals in the food supply, has recently stepped up efforts to ensure food safety, especially in the post-market assessment area. Stakeholders in commercial chemical operations and product lines involving chemicals used for or found in the food supply should be prepared for increased inspections and enforcement in this area. Chemicals in Food The Federal Food, Drug, and Cosmetic Act...

The US Environmental Protection Agency (EPA) recently issued final risk management rules under the Toxic Substances Control Act (TSCA) banning certain uses of two chemicals: chrysotile asbestos and methylene chloride. The identity of these two chemicals is less important than the process by which the EPA concluded that the banned uses of these chemicals pose unreasonable risks to human health and the environment, and the nature and intrusiveness of the workplace and other restrictions the...

A federal district court recently issued an Order to enjoin enforcement of California’s Proposition 65 warnings related to titanium dioxide in cosmetics and personal care products. This is the third case successfully challenging Prop 65 warnings on First Amendment grounds, with previous cases involving glyphosate and acrylamide, as discussed in our FIFRA blog. These are important cases with implications for companies facing Prop 65 warnings for other substances where the underlying...

The U.S. Environmental Protection Agency (EPA) issued on May 8, 2024, a final rule under the Toxic Substances Control Act (TSCA) to address the unreasonable risk of injury to health presented by methylene chloride under its conditions of use (COU). To no one’s surprise, the EPA banned most uses of the chemical. However, surprisingly, the EPA also adopted a de minimis threshold to account for impurities and the unintended presence of methylene chloride. The final...

A critical element of the U.S. Environmental Protection Agency’s (EPA) Draft National Strategy to Prevent Plastic Pollution (Strategy) is to “improve post-use materials management.”  The Strategy identifies potential voluntary actions EPA believes can be implemented to prevent plastic waste. Plastics recycling, both mechanical and “advanced,” is core to achieving improved post-use plastics materials management. Post-use plastics management, in turn, is core to achieving...

This past March, the U.S. Environmental Protection Agency (EPA) issued its first final risk management rule under the Toxic Substances Control Act (TSCA) to address the unreasonable risk of chrysotile asbestos to human health under certain conditions of use (COUs). Even if asbestos isn’t in your supply chain, don’t hit the brakes on reading further. All TSCA stakeholders need to understand this rule because it is a template for how the agency will address risk...

On March 6, 2024, the U.S. Environmental Protection Agency (EPA) promulgated revised National Ambient Air Quality Standards (NAAQS) for particulate matter (PM). The final rule was signed on Feb. 7, 2024. New NAAQS standards are always controversial, and this one is no exception. ...

On Jan. 26, 2024, the U.S. Occupational Safety and Health Administration (OSHA) issued updated enforcement guidance regarding compliance with OSHA’s standard for the Process Safety Management of Highly Hazardous Chemicals (PSM standard). The new directive, CPL 02-01-065, provides much-needed updates to the guidance issued in 1994 and explains OSHA’s current thinking regarding compliance with the PSM standard. ...

The New Year is upon us, and 2024 is shaping up to be consequential on a global scale.  First, let’s look at U.S. policy and regulatory developments. In this election year, competing priorities will dominate U.S. Environmental Protection Agency (EPA) actions. The agency will seek to complete as many actions as possible while tempering its expectations to avoid any significant pre-election missteps. While there is no consensus on whether the Biden administration’s commitment to policy...

No discussion of energy issues would be complete without some mention of the utility of used plastic as a feedstock in the production of fuels, energy and building block chemicals. In spring 2023, the US Environmental Protection Agency (EPA) released its Draft National Strategy to Prevent Plastic Pollution (Strategy) to identify voluntary actions to prevent plastic waste. Plastics recycling, including both mechanical and ‘advanced’, is core to achieving improved post-use plastics materials...

It seems like yesterday when the U.S. Environmental Protection Agency (EPA) issued a final rule prohibiting isopropylated phosphate (3:1) (PIP (3:1)), and for many in the manufacturing sector, the world got a little bit crazier. The EPA vowed to revise the final rule and did so on Nov. 24, 2023. The EPA’s proposal would amend the regulations for decabromodiphenyl ether (decaBDE) and PIP (3:1), two of the five persistent, bioaccumulative and toxic (PBT) chemicals addressed in...

Ask just about anyone doing business in the US making or importing products that contain chemicals what they think about the US Environmental Protection Agency’s (EPA’s) new per- and polyfluoroalkyl substance (PFAS) reporting rule, and you will get a decidedly grumpy response. Granted, no businessperson welcomes any new chemical reporting obligation, but by any standard, the EPA’s 11 October 2023 final PFAS reporting rule is problematic and is inviting uniquely scathing criticism....

Unsurprisingly, the U.S. Environmental Protection Agency (EPA) proposed on Oct. 31, to ban all uses of trichloroethylene (TCE) after determining it presents an unreasonable risk of injury to human health under conditions of use pursuant to the Toxic Substances Control Act (TSCA). TCE is widely used in cleaning and furniture-care products, degreasers, brake cleaners and tire repair sealants. Alternatives are available for many uses. The proposed rule would ban TCE’s manufacture, processing...

On September 28, 2023, the U.S. Environmental Protection Agency (EPA) released its long-overdue final rule under Section 8(a)(7) of the Toxic Substances Control Act (TSCA). The rule requires reporting and recordkeeping requirements for per- and polyfluoroalkyl substances (PFAS). As discussed in this article, the final rule is not what many of us expected nor wanted....

Sustainable chemistry has become more central to business success than ever. Societal preferences and climate change implications are pressuring product manufacturers to develop, use and process sustainable chemicals. This trend is here to stay, and cultural, legal and regulatory drivers accelerating this trend are growing exponentially....

The U.S. Environmental Protection Agency (EPA) announced on June 29, 2023, a new regulatory framework for addressing new per- and polyfluoroalkyl substances (PFAS) and new uses of existing PFAS. The framework outlines the EPA’s planned approach when reviewing these chemicals to ensure that, before they are allowed to enter commerce, they meet the safety standard under Section 5 of the Toxic Substances Control Act (TSCA). This article explains the significance of this development....

On June 20, 2023, the U.S. Environmental Protection Agency (EPA) proposed significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 18 chemicals subject to premanufacture notices (PMNs). The rulemaking reflects a level of EPA discomfort with certain new chemicals derived from plastic waste. This article explains the significance of this proposal....

Few words inspire the panic that ‘polyfluoroalkyl substance (PFAS)’ does. Companies producing, processing, distributing and using (whether knowingly or not) these substances must be aware of expanding legal liability and take steps now to minimise risk. This article outlines key US per- and PFAS developments, the legal and commercial implications of these developments, and measures stakeholders should consider taking to limit liability....

On 20 April the US EPA announced a proposed rule under section 6(a) of the Toxic Substances Control Act (TSCA) that would prohibit most uses of methylene chloride and require a workplace chemical protection program (WCPP) for non-prohibited uses. This article will outline the key elements of the EPA’s proposal and discuss the likely impact on industry. This article also looks at what this portends for the agency’s future rulemaking activities on chemical substances...

Each year about this time, companies are focused on the deadline to submit Toxics Release Inventory (TRI) data to the U.S. Environmental Protection Agency (EPA). Companies well acquainted with this reporting ritual have established protocols to collect the data to enable timely reporting. With the July 1, 2023, deadline rapidly approaching, there are a few new reporting features of which to be aware. This column briefly summarizes important new elements....

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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....