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.

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.

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.