Bergeson & Campbell, P.C.,
Keywords: regulatory developments algae biomass
Summary:To ensure that algae biomass as a commercial feedstock is considered appropriately by federal regulators under the Toxic Substances Control Act (TSCA), the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) has initiated in 2015 the Biotechnology Algae Project. OPPT has legal oversight for the production and use of intergeneric microorganisms, including cyanobacteria, eukaryotic microalgae, and their products by application of genetic engineering approaches, including processes collectively referred to as biotechnology. EPA posted a document, US Environmental Protection Agency Biotechnology Algae Project, when it rolled out the project and notes in the document that OPPT is focusing its project around biotechnology algae applications. This presentation will address how the algae biomass community can best optimize the regulatory review process that is now underway so that OPPT develops a serviceable biotechnology algae regulatory strategy that fully reflects industry’s needs and commercial sensitivities. Industry’s continued participation in this project will help resolve critically important legal and regulatory issues for industry.