Commercial strategies using the advanced techniques of biotechnology for the production of biofuels or chemicals may be affected by biotechnology regulations that exist in the United States and elsewhere in the world. Biofuel or bio-based chemical companies need to be prepared for the impact these regulations may have on the testing and commercial use of engineered microorganisms, algae, or transgenic plants being developed for fuel or chemical applications. 

Genetic engineering of microorganisms to create improved catalysts (i.e. enzymes or the microorganisms themselves) for the conversion of biomass to ethanol, other fuels, or chemicals might be subject to regulation by the Environmental Protection Agency (EPA) under regulations promulgated in 1997 under the Toxic Substances Control Act. These regulations could cover microbes or microbially-produced novel enzymes intended for use in biofuel or chemical production, and would require notifications and certain data submission to EPA prior to commercial use.

D. Glass Associates, Inc. can assist companies and academic investigators learn about or comply with regulations governing the use of engineered microorganisms, algae 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 microbial production of fuels or chemicals, 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), Tier I exemption notifications and biotechnology bona fide requests with the EPA, liaison to EPA.

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

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

• Preparing and submitting GRAS notification petitions to U.S. FDA or AAFCO animal feed ingredient applications (e.g. for food use of dried distillers grains or other spent biomass).

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, algae 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 commercial applications that are ready to seek 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, Tier I exemption notifications, permit applications or other government submissions.