D. Glass Associates, Inc. Regulatory Support for Renewable Fuels and Industrial Biotechnology D. Glass Associates, Inc. (DGA) can assist companies developing renewable fuels, bio-based chemicals, or pursuing other industrial biotechnology applications, by cost-effectively carrying out a broad range of regulatory affairs or government relations activities in support of company efforts.

Certification and Sustainability of Renewable Fuels. •  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.

•  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.

124 Bird Street Phone 617-653-9945 Needham, MA 02492 Fax 781-449-8045 www.dglassassociates.com dglass@dglassassociates.com

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 TSCA Experimental Release Applications (TERAs), Microbial Commercial Activity Notices (MCANs) and chemical Premanufacture Notices (PMNs) with the EPA, liaison to EPA and other federal and state agencies.

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

•  Analysis and compliance with foreign biotechnology regulations including EU biotechnology directives and the Cartagena Biosafety Protocol.

•  Preparing and submitting dossiers to support GRAS status or AAFCO New Ingredient Definitions for microbial biomass for use in animal feed.

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 25 years experience in technology licensing. Dr. Glass managed agricultural biotechnology regulatory affairs for BioTechnica International, then held several positions in academic technology transfer, while providing regulatory affairs support for industrial, environmental, and agricultural biotechnology companies. Dr. Glass has also directed regulatory affairs for Joule Unlimited Technologies, a leading U.S. renewable fuels company.

Monitor government and legislative activity relating to biofuels and bio-based chemicals, including international public policy matters.

•  Provide periodic reports to company management, or assist in government relations efforts in support of company initiatives.

Additional expertise and experience in strategic patent management, technology licensing, and negotiation of academic/industry agreements. •  Help manage patent portfolios, or assist with contract negotiations.

BioTechnica field test with modified nitrogen-fixing Rhizobia.

D. Glass Associates, Inc.

David J. Glass Regulatory Experience

Envirogen TCE biotreatment bioreactor.

Applied PhytoGenetics 2003 phytoremediation field test, Danbury, Connecticut.

David J. Glass, Ph.D. D. Glass Associates, Inc. 124 Bird Street Needham, MA 02492 Phone (617) 653-9945 Fax (781) 449-8045 dglass@dglassassociates.com www.dglassassociates.com

Please contact David Glass to discuss how D. Glass Associates can help your company.

Please visit or follow our blogs: “Advanced Biotechnology for Biofuels” and “Biofuel Policy Watch”

BioTechnica International, Inc. Obtained EPA approval for field trials of engineered nitrogen fixing microorganisms, among the first outdoor tests of genetically modified microorganisms to take place in the U.S. (1988-90); also obtained early USDA approvals for several transgenic plant tests (1989-90).

National Renewable Energy Laboratory. Worked with NREL staff and outside counsel to prepare an MCAN for a modified microbial strain for production of ethanol, including coordination of a presubmission conference call with EPA staff (2010-2011).

Applied PhytoGenetics, Inc. Obtained USDA permits for the first U.S. commercial phytoremediation projects using transgenic plants (2003-05).

Energy Biosystems, Inc.; Envirogen, Inc., Obtained favorable EPA rulings on the adequacy under the TSCA biotech regulations for contained R&D use of novel biotreatment reactors (1992, 1995).

Joule Unlimited Technologies. Obtained approval for a new fuel pathway petition under the U.S. EPA Renewable Fuel Standard, successfully obtained EPA registration for E10 and E15 ethanol, and obtained an Alcohol Producer Permit for a commercial bioethanol facility. Coordinated preparation of an MCAN for a modified cyanobacteria strain for production of ethanol and coordinated negotiation of a consent order for approval of activities under the MCAN (2011-2016).

Dr. Glass has coordinated preparation of six MCANs for biofuel or chemical production microorganisms. He has advised companies on the impact of biotechnology rules on the uses of improved microorganisms and plants for biofuels and chemical production, and has advised U.S. and international companies on market and regulatory matters affecting fuel, chemical, food and feed products. Representative projects (2013-16) include:

•  U.S. industrial biotechnology companies. Advising several companies on compliance with TSCA regulations for fuel or chemical R&D and manufacture; actively working with companies coordinating filings of MCANs for modified microorganisms and PMNs for novel chemicals.

•  European industrial biotechnology companies. Advising and representing two European companies on several aspects of U.S. regulatory compliance, including representation before EPA and FDA. Successfully filed one MCAN and submitted an AAFCO request for a new microbial animal feed ingredient definition.

•  European renewable fuels company. Advised company on specific questions under the U.S. Renewable Fuel Standard, and the requirements for regulatory approval for processing aids in animal feed. Assisted the company with several anticipated U.S. regulatory approvals.

•  Developer of a novel biofuel feedstock. Prepared a detailed market and regulatory analysis for a company investigating the use in animal feed of a novel energy crop species.

•  Advised other advanced ethanol companies, bio-based chemical companies, and research products companies on various matters relating to EPA TSCA compliance, U.S. RFS compliance, animal feed regulation, or other matters.