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November 10, 2017

B&C, BCCM Publish Article On Microbial TSCA Compliance

Lauren M. Graham, Ph.D.

By Lauren M. Graham, Ph.D.

Industrial Biotechnology recently published a special issue to highlight the advances and challenges in algae-based products and applications.  The article, written by B&C® Consortia Management, L.L.C. (BCCM) affiliate Bergeson & Campbell, P.C. (B&C®) Managing Partner, Lynn L. Bergeson; B&C Senior Chemist, Richard E. Engler, Ph.D.; and BCCM Manager, Lauren M. Graham, Ph.D., examines the complex regulatory domain and discusses the significance and implications of the Toxic Substances Control Act (TSCA) for industrialized microorganisms, such as algae.  The article titled “TSCA Affects on Algae, Other Novel Biosources, and Bioprocesses” provides an overview of the fundamentals of TSCA, the U.S. Environmental Protection Agency’s (EPA) review of new substances, the impact that chemical identity has on EPA’s regulation of new substances, and available reporting exemptions.  In the article, the authors highlight the need for chemical product innovators “to understand how TSCA, significantly amended in 2016, applies to biomass starting material, including industrial microorganisms (such as algae); intermediates; and commercial products, and build TSCA compliance into business timelines and budgets.”  While the products of industrial microbes have the potential to reduce toxicity, greenhouse gas (GHG) emissions, and dependence on non-renewable resources, companies must comply with TSCA and the Federal Food, Drug, and Cosmetic Act (FFDCA) to ensure that such products successfully enter the market.