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.

However, a variety of economic, market and regulatory pressures have limited the impact of genetically modified microorganisms (GMMs) in commercial use to date, particularly in bioremediation. 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, recentregulatory relaxation by the U.S. Department of Agriculture should facilitate future use of transgenic plants in phytoremediation.

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 or environmental application, and firms actively planning or implementing such uses.

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) or transgenic plants in agricultural 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 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.

Qualifications

David Glass has over 20 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.