Industrial Biotechnology Regulation: Biofuels, Bio-Based Chemicals.

• 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 and other federal and state agencies.

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

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

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

• Assist in planning for, and compliance with, the U.S. Renewable Fuel Standard, including analysis of pathway applicability, preparation and filing of new fuel pathway petitions, planning for issuance of RINs, liaison to EPA.

• Obtain fuel pathway approvals under the California Low Carbon Fuel Standard, through the filing of Method 2A or 2B pathway petitions.

• Obtain EPA certification of motor vehicle fuels (e.g. alcohol, diesel) under 40 CFR Part 79; and approval for civilian and military aviation fuels.

• Compliance with renewable fuel standards and sustainability programs outside the U.S., including the EU Renewable Energy Directive.

• Obtain U.S. Treasury Department (TTB) permits for fuel alcohol production plants and other permits for biofuel plant construction and operation.

David J. Glass, Ph.D. has over 30 years experience in the biotechnology industry, including extensive experience with the regulation of industrial and agricultural uses of engineered organisms, and 20 years experience in technology licensing. Dr. Glass managed agricultural biotechnology regulatory affairs for BioTechnica International, after which he held several positions in academic technology transfer, while providing regulatory support for industrial, environmental, and agricultural biotechnology companies. Dr. Glass 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 other permits relating to biofuel production.