Program Description
This program will address the federal regulations at issue in chemical commercialization, from R&D to commercial sales. For example, laboratory synthesis of chemicals is regulated under the Toxic Substances Control Act, if synthesis is conducted with the goal of eventually commercializing the substance produced. If you are engaged in chemical synthesis, you need to know when your activities are covered by federal regulations.
The Federal Food, Drug, and Cosmetics Act (FFDCA) regulates chemicals in foods and food contact products (e.g., packaging), as well as drugs and cosmetics. The Food and Drug Administration (FDA) has issue hundreds of pages of regulations that govern food contact substances alone. The Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) are implemented by EPA regulations, also hundreds of pages in length. While chemical substances that are regulated under FFDCA and FIFRA are usually excluded from TSCA’s jurisdiction, a substance can be regulated under all three statutes. Join us to learn what the basic regulatory frameworks of these statutes.
The presenters have worked with many companies to bring products to market and to defend them in federal enforcement actions for failure to fully comply with the regulations at issue.
Presenter Bios
Irene Hantman is an attorney with Verdant Law. Her practice focuses on the domestic regulation of chemicals and has written extensively on these issues. Ms. Hantman advises clients on the practical implications of final and proposed state and federal legislation and regulations. Her practice also includes enforcement defense.
Mark Duvall is a principal with Beveridge & Diamond. He co-chairs the firm’s TSCA and OSHA practices and chairs the firm’s FDA practice. His long experience includes work in-house with two chemical companies and substantial involvement with the legislative process that led to enactment of TSCA amendments in 2016.
This will be a virtual meeting via Zoom. There is no charge to attend but registration is required.
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