The Biobased and Renewable Products Advocacy Group (BRAG) helps members develop and bring to market their innovative biobased and renewable chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.
Biofuels Digest Series On TSCA And The Bioeconomy
Biofuels Digest is running a "Thought Leadership" series of articles highlighting some of the ways the Toxic Substances Control Act (TSCA) applies to biobased products. The articles, written by Biobased and Renewable Products Advocacy Group (BRAG®) Senior Policy Advisor and former head of the U.S. Environmental Protection Agency's (EPA) Green Chemistry program, Richard E. Engler, Ph.D., cover key points throughout the manufacturing and commercialization process at which biobased companies need to be aware of TSCA requirements.
"The Toxic Substances Control Act and the Bioeconomy: Part 1, The Impact of Nomenclature on the Commercialization of Biobased Chemicals," published April 26, 2015, begins with some common misconceptions about TSCA:
When I meet people from bioeconomy companies, I ask them about their products' status under the Toxic Substances Control Act (TSCA). The most common answers I receive are: "TSCA doesn't apply because our product is not toxic," "TSCA doesn't apply because our product is naturally occurring," and "We are compliant with TSCA because we're making something that's already in commerce." This usually leads to a more in-depth discussion of how TSCA works and its idiosyncrasies with respect to biobased products. I do not ask this to be accusatory, rather I want to be sure that companies understand their obligations so that they do not run afoul of the law. TSCA penalties can add up quickly (maximum $37,500 per violation per day) and can threaten nascent companies if they are not diligent.
The article continues by detailing how the Chemical Abstracts Index name and identity of a substance is determined, how feedstock and production processes can affect identity, and the impact the name has on commercialization prospects since all chemicals in production must be listed on the TSCA Inventory.
"The Toxic Substances Control Act and the Bioeconomy: Part 2, Reportable Substances across the Manufacturing Process," published May 3, 2015, details when feedstocks, intermediates, and catalysts may be reportable under TSCA.
Importantly, in addition to final chemical products, TSCA also applies to the other chemicals used in the manufacturing process. Looking at the various stages of a typical manufacturing process allows us to examine how TSCA applies at each stage.
The article then discusses feedstocks, such as plants, sugars, and municipal wastes; isolated and non-isolated intermediates; and catalysts, such as metals, enzymes, and microoganisms; and how each of those is treated under TSCA.
The final article in the series will be published in Biofuels Digest on May 10, 2015, and we will feature excerpts in next week's BRAG Report.