The uses of modified organisms (plants and microorganisms) in the open environment are among the most regulated of biotechnology projects, even at research stages. Recent advances creating powerful new tools for genetic modification have led to renewed interest in the development of novel microbial strains to enhance crop yields and address other agricultural goals, and for the remediation or treatment of contaminated sites or hazardous wastestreams. Companies developing such new innovative technologies need to be prepared for the impact government regulations may have on the field testing and commercial use of engineered microorganisms, algae, or transgenic plants. 

Genetic engineering of microorganisms for environmental use might be subject to regulation by the Environmental Protection Agency (EPA) under regulations promulgated in 1997 under the Toxic Substances Control Act. These regulations cover microorganisms used for purposes not regulated by other federal agencies, and could potentially encompass applications of modified microorganisms for enhanced nitrogen fixation and other non-pesticidal agricultural uses, as well as uses of modified microbes in bioremediation. Such uses might require notifications and data submission to EPA prior to field testing or commercial use.

D. Glass Associates, Inc. can assist companies and academic investigators learn about or comply with regulations governing the use of engineered microorganisms and transgenic plants in the United States and elsewhere in the world, including the following:

• Assist in all matters of compliance with U.S. EPA biotechnology regulations affecting environmental or agricultural use of microorganisms, including analysis of impact of EPA TSCA biotechnology regulations, preparing and filing Microbial Commercial Activity Notices (MCANs), Premanufacture Notices (PMNs), TSCA Experimental Release Applications (TERAs), and other EPA submissions and commuinications.

• Assist in obtaining U.S. Department of Agriculture permits for use of transgenic plants.

• Compliance with foreign biotechnology regulations including EU biotechnology directives and compliance with foreign regulatory programs under the Cartagena Biosafety Protocol.

For any of these areas of regulation, DGA offers the following services:

• Project planning: For companies that are investigating or beginning to plan for the use of engineered microorganisms or transgenic plants, DGA can advise companies about the impact of biotechnology regulations on company plans. This can take the form of a one-time seminar for key company decision-makers, an in-depth written report, and/or ongoing consultation on regulatory developments.

• Project implementation: For companies closer to field testing or commercial applications requiring government approvals, DGA can assist in planning and carrying out the necessary activities. This could include preparation of written implementation plans for company projects, arranging presubmission meetings with regulatory agencies, and coordination of the preparation and filing of MCANs, PMNs, TERAs, permit applications or other government submissions.