David J. Glass, Ph.D. is a consultant specializing in industrial biotechnology and renewable fuels regulatory affairs, with over 30 years experience with government regulation of the commercial uses of modified microorganisms and plants and other products of biotechnology.
Dr. Glass 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, including the preparation of ten MCANs as well as PMNs and other chemical notices, providing opinions on the applicability of the TSCA biotechnology rule and its tiered exemptions on planned company activities, and conducting or facilitating interaction with EPA staff on numerous TSCA-related issues. Dr. Glass has also 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.
Dr. Glass previously served as director of regulatory affairs for Joule Unlimited Technologies, for which he was responsible for the first MCAN submitted to EPA for a modified cyanobacteria strain as well as the submission of a new fuel pathway petition under the Renewable Fuel Standard. Earlier in his career, Dr. Glass directed intellectual property and regulatory affairs for BioTechnica International, where he obtained government approvals for some of the earliest U.S. field tests of genetically modified microorganisms and transgenic plants. Dr. Glass has also written and published market reports on bioremediation, phytoremediation and other industry sectors, and has performed market research for clients on a wide range of industry segments. In addition, he has over twenty-five years’ experience in academic technology transfer. Dr. Glass holds a B.S. in biological sciences from Cornell University and a Ph.D. in biochemical sciences from Princeton University.