Guide to the Toxic Substances Control Act
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The Toxic Substances Control Act (TSCA) is the primary vehicle for enabling the government to review most chemicals, other than foods, drugs, cosmetics and pesticides, before they are introduced into commerce. TSCA was overhauled in 2016 when the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) 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. The United States Environmental Protection Agency is still in the process of issuing new rules and guidances to meet its obligations under the Lautenberg Act.
Guide to the Toxic Substances Control Act (formerly known as "The Toxic Substances Control Act: Reformed by the Lautenberg Act") is written for lawyers and regulatory affairs specialists who need to understand the details of the law and implement both old and new regulations and guidances. The 2023 edition includes detailed descriptions and practice pointers for each of the programs under TSCA and TSCA reform. The past few years have brought major developments in confidential business information, user fees, mercury reporting, reporting prospective use or processing of inactive substances, alternatives to animal testing, and Department of Justice limits on the use of guidances. In addition, EPA is still in the process of issuing regulations to implement the 2016 reform of the law. The EPA is also evaluating existing chemicals and has begun the mandatory task of addressing unreasonable risks. Stakeholders have instituted legal challenges to these actions, with more inevitably to come. Coupled with regulatory relaxation during the prior administration and the promise of regulatory enhancements this administration, the Toxic Substances Control Act has been and continues to be an area of intense activity. All these developments and more are described in detail so that practitioners can navigate the new regulations and understand the areas of uncertainty. There is also in-depth coverage of state chemical regulation laws, and practical resources including model procedures for incorporating TSCA requirements into daily operations.
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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 Compliance Programs
CHAPTER 14 Penalties and Enforcement
CHAPTER 15 Acquisitions and Divestitures
CHAPTER 16 State Chemical Regulation
CHAPTER 17 Resources
TABLE OF CASES