D. Glass Associates, Inc.

Government and Regulatory Affairs
Industrial Biotechnology Regulation: Biofuels and Bio-Based Chemicals

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.

Industrial biotechnology
transgenic fuel feedstock Projects involving the genetic engineering of plants and trees to improve the feedstocks used in biomass conversion may be subject to regulation by the U.S. Department of Agriculture (USDA), under rules that were first instituted in 1987. Although these regulations have been progressively relaxed over the years, permits may be needed to grow transgenic energy crops for field testing or commercial use.

Services Offered

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.


David J. Glass, Ph.D. has over 30 years experience in the biotechnology industry, including extensive experience with the regulation of industrial biotechnology, and recent experience managing regulatory affairs for a major U.S. renewable fuels company. 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. Dr. Glass has advised several leading biofuels companies on the impact of biotechnology regulations on their activities, and has coordinated the preparation of three Microbial Commercial Activity Notifications (MCANs) for recombinant microorganisms for biofuel production, along with other submissions to EPA. He has also coordinated the preparation and filing with the U.S. EPA of a new pathway petition under the Renewable Fuels Standard, and has successfully obtained a Medium Alcohol Fuel Producer permit from the U.S. Alcohol and Tobacco Tax and Trade Bureau. Dr. Glass has extensively published and presented on numerous topics in biotechnology regulatory affairs.

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