Government and Regulatory Affairs
Regulation of Genetically Modified Organisms

It has long been felt that the powerful techniques of modern molecular biology will enable the creation of improved microbial strains, engineered for superior agricultural traits, enhanced biodegradative performance, or improvements for other environmental purposes. Genetically engineered plants, already commonly used in agriculture, might also have utility for improvements in phytoremediation. In addition, advanced biotechnology techniques are being used to develop exciting new approaches to biofuel production, including cellulosic ethanol and biodiesel fuels.

However, a variety of economic, market and regulatory pressures have limited the commercial impact of genetically modified microorganisms (GMMs) in environmental and some industrial applications. In reality, however,U.S. Environmental Protection Agency regulation of GMMs has eased considerably since the controversial days of the mid 1980s, to the point where regulatory issues should no longer present an obstacle to the commercial use of a GMM which met a specific technical or market need. Similarly, the possible use of transgenic plants in phytoremediation or biofuel production is now quite feasible under the biotechnology rules of the U.S. Department of Agriculture.

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Services Offered

D. Glass Associates, Inc. (DGA) offers a variety of regulatory consulting services, both for companies investigating or contemplating the use of engineered organisms in an agricultural, industrial or environmental application, and firms actively planning or implementing such uses. These services are described below, or click here for a downloadable PDF document.

Project Planning

To assist long-range planning and decision-making, companies who are investigating or beginning to plan for the use of genetically modified microorganisms (GMMs), algae or transgenic plants in agricultural, industrial or environmental applications need a clear understanding of the unique regulatory process that has evolved for biotechnology. D. Glass Associates can inform and advise companies about regulatory and policy changes that have made it easier to field test modified microbes and plants, and about existing regulations for bioreactor or field use of engineered organisms. D. Glass Associates can:

• Present a half-day seminar for key company decision-makers, describing federal and state biotechnology regulations and their impact on environmental biotechnology applications.
• Prepare an in-depth written report on the effect of federal and state biotechnology regulation,on specific company projects.
• Provide ongoing consultation and monitor developments on issues of concern to the company.

Project Implementation

For companies closer to the market, who are beginning to seek government approvals for field testing, pilot-scale or commercial use of GMMs, algae or transgenic plants, or who are actively planning that process, D. Glass Associates can assist in the following ways:

• Prepare a written implementation plan for a specific company project, analyzing likely regulatory needs and providing a timetable for approval.
• Assist in applying for and obtaining federal and state approvals to conduct GMM or transgenic plant field tests or for commercial use of engineered organisms in biotreatment, food or agricultural uses.
• Design and help conduct community relations programs in support of field testing or commercialization activities.

Please click here for more information on these services and our qualifications.

Qualifications

David Glass has over 25 years experience with the commercial uses of microorganisms and plants in the environment. He spent nine years at BioTechnica International, where he obtained approvals for some of the earliest U.S. field tests of genetically engineered agricultural microorganisms, and was a leading agbiotech industry spokesperson for much of the 1980s. As a consultant, he has advised several companies on the impact of EPA regulation on their plans for commercialize genetically modified microorganims for environmental applications. More recently, on behalf of Applied PhytoGenetics, Inc., Dr. Glass led the effort to obtain four USDA release permits and three extensions for field tests of transgenic plants for the phytoremediation of mercury, and Dr. Glass has advised leading biofuels companies on the impact of biotechnology regulations on their activities.

Follow our new blog Advanced Biotechnology for Biofuels