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Lexis Nexis Guide to the Toxic Substances Control Act
The Toxic Substances Control Act (TSCA) is the primary federal law authorizing the government to review most chemicals, other than those intended for foods, drugs, cosmetics, and pesticide applications, before they are introduced for commercial purposes. TSCA was significantly amended in 2016 when the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) was signed into law, modernizing the basic approach to chemical regulation (the first substantive change to TSCA in 40 years). This treatise addresses the modifications made by Lautenberg and corresponding EPA regulations implementing the Act’s reforms, and provides substantive guidance on how to adapt compliance programs to meet those requirements.
Publisher:
Matthew Bender
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The Toxic Substances Control Act (TSCA), enacted in 1976, provided the U.S. Environmental Protection Agency (EPA) with the first grant of broad authority to gather information on chemical hazards to assess risks across previously unregulated activities and industries and to use that information to regulate the manufacture, import, processing, use, distribution in commerce, and disposal of chemical substances other than foods, drugs, cosmetics, and pesticides. TSCA cuts across all business activities, from research through end of product life, and has a far broader scope than the media-specific environmental statutes passed in the same decade.
TSCA was overhauled in 2016 when the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) was signed into law, changing the basic approach of the law, including the premanufacture notification procedure, treatment of confidential business information, preemption of state laws, and the safety standard by which chemicals are evaluated. EPA is still in the process of issuing new rules and guidance documents to meet its obligations under Lautenberg.
Guide to the Toxic Substances Control Act (formerly known as The Toxic Substances Control Act: Reformed by the Lautenberg Act) is written for lawyers, regulatory affairs specialists, and commercial and business people who need to understand the details of the law and implement both old and new regulations. The 2024 edition, the first under the editorial direction of the TSCA team at Bergeson & Campbell, P.C., the premier law firm focusing on chemical law, regulation, science, and policy, includes detailed descriptions and practice pointers for each of the programs under TSCA.
The past year has been eventful, and this edition is chock-full of new text. EPA has completed more risk evaluations and moved into developing and implementing TSCA Section 6 risk management approaches. EPA has significantly expanded its regulation of per- and polyfluoroalkyl substances (PFAS). EPA issued the TSCA Section 8(a)(7) reporting rule, which is expected to provide EPA with information to assist the Agency in targeting its PFAS TSCA initiatives more specifically. Other Section 8 initiatives are under way. EPA issued a final TSCA Section 8(a) rule for asbestos reporting, has proposed a TSCA Section 8(d) rule to help chemical prioritization, and a TSCA Section 8(c) rule to assist with its risk evaluation efforts. EPA’s deployment of its Section 8 authorities is unprecedented.
Finally, revisions to the new chemical review process are front and center and discussed in detail in this edition. These changes reflect in part Agency efforts to address broad concern with the lengthy delays in processing chemical notifications and the sometimes overly conservative assumptions EPA reviewers apply, resulting in commercially challenging restrictions on new chemical production, distribution, and use. Other important TSCA changes the authors discuss are EPA’s initiatives narrowing opportunities to assert and maintain confidential business information claims, EPA’s revised approach to risk prioritization and evaluation, changes to the TSCA Section 4 testing program, new enforcement policies and practices, and much more.
The previous edition's ISBN is 9781663358691.
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Table of contents
CHAPTER 1 Introduction
CHAPTER 2 TSCA’s Scope
CHAPTER 3 Concepts of General Applicability
CHAPTER 4 The Inventory
CHAPTER 5 Premanufacture Notifications
CHAPTER 6 PMN Exclusions and Exemptions
CHAPTER 7 Microorganisms
CHAPTER 8 Reporting and Recordkeeping
CHAPTER 9 Exports and Imports
CHAPTER 10 Testing
CHAPTER 11 Prioritization, Risk Evaluation, Bans, and Restrictions
CHAPTER 12 Significant New Use Rules
CHAPTER 13 Penalties and Enforcement
CHAPTER 14 Acquisitions and Divestitures
CHAPTER 15 Resources
TABLE OF CASES
INDEX
