The Toxic Substances Control Act (TSCA) has a brand problem. Long thought of as a quirky, obscure federal law with limited application to entities beyond chemical manufacturers, TSCA’s relevance to the business community today is vast and expanding. Our new book, Chemical Product Law and Supply Chain Stewardship: A Guide to New TSCA, explains TSCA’s metamorphosis from idiosyncratic and discrete to game-changing and extensive. The book is written for product stewards, chemical innovators, investors, insurers, manufacturers, importers, exporters, and businesspeople of all stripes to assist them with understanding fully the profound impact TSCA has today on commercial transactions. The linchpin of TSCA’s transformation is the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg), enacted in 2016, and the U.S. Environmental Protection Agency’s (EPA) implementation of Lautenberg. EPA’s expansive implementation of Lautenberg has made TSCA a remarkably influential element in all commercial transactions in new, unexpected, and transformative ways.

Based on our many years of specialized TSCA practice, we wrote this book to ensure that regardless of legal training, stakeholders in the business communities and beyond can understand at a practical level how TSCA’s expanding jurisdictional relevance applies to a growing number of what we refer to as “nontraditional” TSCA stakeholders. At 200 pages, our book is chock full of practical, hands-on information, complete with helpful checklists, a glossary, and various templates of business documents to help make the TSCA journey easier.

We provide an overview of “old” TSCA and contextualize “new” TSCA (post-Lautenberg). The review includes a brief synopsis of the European Union’s (EU) enactment of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, Europe’s equivalent of TSCA, and how its approach to chemical management differs from TSCA.

We explain how entities that are deemed “importers of record” of finished commercial goods are, under TSCA, de facto manufacturers of the chemicals, and how EPA has targeted certain chemicals for TSCA restriction, even in finished commercial goods. To many unfamiliar with TSCA, it is bewildering to learn that import of a finished good that contains a chemical component can result in the importer’s change of status under TSCA from that of an “importer” of a finished good (or article) to that of a “chemical manufacturer” of the chemical component embedded in the product and therefore responsible for TSCA compliance for the chemical components that their imported articles contain.

We explore the processes EPA employs to evaluate “new” chemical innovations that are newly commercialized and new uses of “existing” chemicals that have been in commercial use for decades. This is followed by an overview of EPA’s risk evaluation and risk management processes. A general understanding of the concept of “unreasonable risk” as defined by TSCA is essential to make informed business decisions. We explain these concepts through the lens of business transactions, avoiding the scientific and legal jargon that may not successfully convey to all TSCA’s application in commercial contexts.

An important and often overlooked area of the law is the role TSCA plays in the due diligence that accompanies business transactions like divestitures, acquisitions, and related commercial transactions. Despite the outsized importance TSCA compliance has in any transactions involving an entity in the manufacturing sector, TSCA is often either overlooked or given inadequate attention. We identify commonly overlooked areas of transactions in the TSCA realm and offer checklists and other tools to assist in the due diligence process.

We discuss the growing number of limitations on chemicals defined as per- and polyfluoroalkyl substances (PFAS). Our focus in this book is on the regulation of PFAS under TSCA, the limitations that EPA applies to PFAS, and business strategies that might be considered in supporting existing and commercializing new PFAS substances.

We conclude with a review of what EPA is authorized to do in cases of noncompliance. EPA’s authority under TSCA is considerable. Chemicals can be risky business, and when it comes to the realm of enforcement, EPA means business and takes its responsibilities seriously.