D. Glass Associates, Inc.

Government and Regulatory Affairs
Renewable Fuels and Industrial Biotechnology

David J. Glass, Ph.D., Representative Projects and Experience

Recent Experience (2013- present)

Biofuels and Bio-based Chemicals. Dr. Glass has coordinated preparation of three MCANs filed with the U.S. EPA for biofuel production microorganisms and has also advised companies on a variety of regulatory issues relating to the uses of improved microorganisms or transgenic plants for biofuels or bio-based chemical production. He has also conducted assessments of specific industrial biotechnology markets and provided strategic regulatory plans for companies that have included advice for compliance with regulation of animal feed ingredients. These projects have included the following.

As Director of Regulatory Affairs at Joule Unlimited Technologies, Inc. (2011-2013)

Renewable Fuels Regulation. Coordinated presubmission meetings with EPA biotechnology staff; worked with company scientists, engineers and outside counsel to prepare a Microbial Commercial Activity Notice (MCAN) for a modified cyanobacteria strain for production of ethanol, which was submitted to EPA in July 2012; coordinated responses to EPA questions about MCAN; coordinated negotiation of a consent order for approval of limited activities under the MCAN. Prepared and submitted a new fuel pathway petition under the U.S. EPA Renewable Fuel Standard. Obtained a Medium Alcohol Fuel Producer Permit for a commercial bioethanol facility. Also responsible for other aspects of regulatory compliance relating to renewable fuel production and commercialization.

Prior Experience

National Renewable Energy Laboratory. Worked with NREL scientists, technology transfer staff and outside counsel to prepare an MCAN for a modified Zymomonas strain for production of ethanol, including coordination of a presubmission conference call with EPA staff (2011-12). The MCAN was submitted in April 2011, but EPA review has been deferred pending development of additional data requested by EPA.

Advanced ethanol and industrial biotechnology companies. In addition to the projects referenced above for a bio-based chemical company (2010) and an advanced ethanol company (2007-11), Dr. Glass advised a cellulosic ethanol company on the applicability of TSCA biotechnology regulations to the use of modified microbial strains for production of ethanol (2010), and for another company, he presented a seminar on TSCA biotechnology regulations as part of a half-day consulting visit (2010). 

Applied PhytoGenetics, Inc. Dr. Glass obtained USDA permits for the first U.S. commercial phytoremediation projects to use transgenic plants (2003-05). Two field tests were conducted under these permits, one in Danbury, Connecticut and one in northern Alabama. Dr. Glass also assisted another phytoremediation company obtain a permit for a transgenic field test.

Energy Biosystems, Inc. Dr. Glass advised the company on regulation of engineered organisms,  presented a seminar for company officials on U.S. biotechnology regulation, and assisted the company in meetings with EPA that led to a favorable EPA ruling on the adequacy under the TSCA biotech regulations for contained R&D use of the company’s proposed bioreactor for coal desulfurization (1995).

Envirogen, Inc., Dr. Glass advised the company on the applicability of federal and state regulations on their plans in the early 1990s to commercialize genetically modified microorganisms for biotreatment of trichloroethylene. Dr. Glass obtained a favorable ruling from EPA on the containment status on the company’s proposed biotreatment reactor for R&D use with engineered microorganisms (1992).

U.S. biotreatment company. Dr. Glass advised a U.S. company that was contemplating the use of engineered microorganisms for hazardous waste treatment on the impact of federal and state biotechnology regulations on their plans (1992-1993).

BioTechnica International, Inc. Dr. Glass obtained EPA approval under TSCA for field trials of engineered nitrogen fixing microorganisms, which were among the first outdoor tests of genetically modified microorganisms to take place in the U.S. (1988-90). These projects included liaison to the EPA and state regulatory agencies, government relations in Washington and state capitals, and community and public relations programs to ensure local support for the tests. Dr. Glass also won USDA approval for several transgenic plant tests, including the first field test of engineered corn (1989-90).

Prepared reports for several companies and a trade association summarizing and analyzing EPA's 1991 draft proposed rule, its 1994 proposed rule and 1997 final rule for the regulation of certain microbial products of biotechnology under the Toxic Substances Control Act. Thorough familiarity with the 1997 amendments to USDA's biotechnology regulations. Numerous presentations and publications on EPA biotechnology regulation under TSCA, USDA biotechnology regulation under the Plant Pest Act and other biotechnology regulatory topics.

This page was last updated August 25, 2015.

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