Government and Regulatory Affairs
Environmental and Industrial Biotechnology

Representative Projects

While at BioTechnica International in the mid to late 1980s, David Glass obtained federal and state approvals for five of the earliest field tests of genetically engineered microorganisms in the United States. These were projects to field test recombinant strains of the nitrogen-fixing bacteria rhizobia, and these controversial projects included liaison to the EPA and state regulatory agencies, government relations in Washington and state capitals, andcommunity and public relations programs to ensure local support for the tests. These tests were among the first to be regulated by EPA under the Toxic Substances Control Act (TSCA). Dr. Glass also obtained approvals for field tests of transgenic plants, and was active in federal and state policy discussions regarding "environmental release" issues.

On behalf of Applied PhytoGenetics, Inc., Dr. Glass led the effort to obtain four USDA release permits (Nos. 03-044-01r, 03-058-01r, 03-099-01r, 04-058-01r), three extensions of these permits, and related movement permits, for field tests of transgenic plants for the phytoremediation of mercury. Two field tests were conducted under these permits, one in Danbury, Connecticut and one in northern Alabama. Dr. Glass has also assisted another phytoremediation company obtain a permit for a transgenic field test.

Currently assisting a start-up company that is developing transgenic plants for biofuels plan for USDA APHIS notifications and applications for its upcoming field tests. Also assisting an industrial biotechnology company plan for and manage the impact of EPA biotechnology regulations on its use of genetically modified microorganisms for production of cellulosic ethanol.  

Advised Envirogen, Inc. on the applicability of federal and state regulations on their plans in the early 1990s to commercialize genetically modified microorganisms for biotreatment of trichloroethylene. Assisted Envirogen obtain EPA's first formal ruling that the use of a biotreatment reactor with genetically engineered microbes would qualify for reduced regulation as a "contained system" under the agency's TSCA biotechnology program.

Advised a U.S. environmental biotechnology company on the regulation of engineered organisms: presented a seminar for company officials on U.S. biotechnology regulation, assisted the company in meetings with the EPA that led to a favorable ruling on the containment status of the company's pilot plant under the TSCA program, and provided advice and information that was critical in ensuring a commercial partner that regulatory matters were not an obstacle to the project.

Counseled a U.S. biotreatment company contemplating use of engineered organisms on the impact of federal and state biotechnology regulations on their plans.

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.

Served on biotechnology regulatory advisory committees in two midwestern states (Wisconsin, 1987-88; Minnesota, 1989-90), and provided a U.S. biotechnology company with an analysis of the proposed biotechnology regulations in Minnesota in 1991.

Conducted research for a midwestern analytical services firm on the status of underground storage tank regulation and reimbursement funds in several northeastern states that were the company's targets for expansion.