TSCA Affects on Algae, Other Novel Biosources, and Bioprocesses

The Toxic Substances Control Act (TSCA) is the federal gap-filling chemical control law regulating chemical substances used in applications other than food, drugs, cosmetics, and pesticides, and other uses that are regulated by other federal authorities. Chemical product innovators need 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. Doing so will better assure uninterrupted business operations and consistent TSCA compliance. The products made by and from industrial microbes and algae have the potential to reduce toxicity, greenhouse gas (GHG) emissions, and dependence on non-renewable resources. These microorganisms can be used to manufacture a wide variety of products, including fuels and fuel additives, chemicals, materials, food, and feed. To ensure these products successfully enter the market, it is critical for companies that manufacture microorganism-based products to understand and comply with TSCA and the Federal Food, Drug, and Cosmetic Act (FFDCA). Since 1997, the U.S. Environmental Protection Agency (EPA) has considered intergeneric microorganisms to be new chemical substances regulated under TSCA.1 Microorganisms created from chemically synthesized genes can be considered intergeneric if the synthetic sequence is not identical to the genetic sequences found within the organism's genus.2