January 23, 2022

Volume XII, Number 23

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January 21, 2022

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EPA Denies TSCA Section 21 Petition Regarding Chemical Mixtures in Cigarettes

On October 29, 2021, the U.S. Environmental Protection Agency (EPA) announced its response to a petition submitted under Section 21 of the Toxic Substances Control Act (TSCA) seeking a rule requiring cigarette manufacturers to eliminate the hazardous chemicals used and to develop new product designs that eliminate or reduce the cigarette butt disposal risks to the environment. 86 Fed. Reg. 59931. EPA states that TSCA Section 6(a) authorizes it to determine if a chemical substance or mixture in manufacturing, processing, distribution in commerce, use, disposal, or any combination of these activities presents an unreasonable risk of injury to health or the environment. If EPA determines that there is unreasonable risk to health or the environment, then EPA must, by rule, issue regulations to the extent necessary so that the chemical substance no longer presents such risk. EPA notes that TSCA Section 3(2)(B), which defines “chemical substance,” excludes “tobacco or any tobacco product,” however. Under Section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FFDCA), “tobacco product” means “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product.” EPA states that it finds that the petitioner has not met its burden as defined in TSCA Sections 6(a) and 21(b)(1) “because cigarettes are not a product that can be regulated under TSCA section 6(a).”

©2022 Bergeson & Campbell, P.C.National Law Review, Volume XI, Number 312
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About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy process allows her to develop client-focused strategies whether...

202-557-3801
Carla Hutto, Bergeson Campbell PC environmental law regulatory analyst,Toxic Substances Control Act law attorney
Regulatory Analyst

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client...

202-557-3809
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