Articles

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 Bright decision overturning Chevron has...

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 circularity....

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. ...

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 shifts in chemical management has elicited desirable results, reasonable people will agree it...

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...

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...

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....

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....

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....

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....

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....

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...

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...

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...

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 nations, adopted a...

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....

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...

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...

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....

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,...

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...

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...

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)....

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...

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...

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 February 25, 2021, the Organization for Economic Cooperation and Development (OECD) will hold a webinar on “Assessing the dispersion stability and dissolution (rate) of nanomaterials in the environment” to discuss the scope, content, and use of Test Guideline No. 318: Dispersion Stability of Nanomaterials in Simulated Environmental Media and its accompanying guidance document. ...

There has been remarkable consolidation in the analytical services sector in the US and elsewhere globally over the past few years. Make no mistake; the need for analytical and related testing services is growing significantly. Because of the legal and regulatory frameworks that demand such services, however, there is considerable need for attendant technical expertise to staff these laboratories, and the need for specialised expertise is also growing exponentially. This article summarises...

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...

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...

Partially hydrogenated oils (PHO), the products of incomplete catalytic hydrogenation of food oils, have been widely employed by the food industry for more than a century. Their exceptional stability and technologic characteristics made them the preferred choice for the production of several food products including margarines, bakery goods, and frying oils. Some of these highly prized characteristics were provided by the high content in trans fatty acids (TFA), defined as fatty acids with one...

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...

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,...

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...