D. Glass Associates, US

David Glass is a consultant specializing in industrial/environmental/agricultural biotechnology regulatory affairs, with over 30 years experience with government regulation of the commercial uses of modified microorganisms and plants and other products of biotechnology.
David has provided strategic advice to numerous environmental and industrial biotechnology companies regarding compliance with the regulations of EPA, FDA and other agencies. Specifically, he has advised biofuel and bio-based chemical companies on the applicability of the EPA TSCA regulations to the use of modified microorganisms in fuel or chemical manufacture, he has advised clients on regulatory requirements for several types of FDA-regulated products, including food and feed additives, cosmetics, color additives and dietary supplements (nutraceuticals), and he has assisted in the preparation of submissions for approval of three animal feed ingredients.

Day 3 – Session 6: Regulatory Challenges & Barriers to Solutions

Achieving Regulatory Approval for Microbial Inoculants or Soil Additives


Modern genetic technologies have led to increased interest in developing microbial products to improve plant growth or crop yield, including efforts to enhance nitrogen fixation or uptake of other nutrients, or to generally enhance the phytobiomes of important crop species. Those products utilizing genetically modified microorganisms may face regulatory barriers in many countries of the world; and in the U.S., those products not meeting the definition of pesticides might be regulated by the Environmental Protection Agency under its biotechnology regulations under the Toxic Substances Control Act (TSCA). Under these regulations, such products might require agency approval not only for commercial sale, but also prior to any outdoor field testing. Although projects involving the outdoor uses of modified microorganisms will trigger enhanced regulatory scrutiny, it is possible to obtain such approvals through proper planning. This presentation will review the regulations of the U.S. and other countries that would govern development of enhanced microbial inoculants and soil additives, it will discuss applicable precedents of successful approvals, and will present strategies for obtaining needed regulatory clearances for new inoculant or soil additive products.