D. Glass Associates, Inc.

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

David J. Glass, Ph.D. Experience with Industrial Biotechnology Regulation

EPA TSCA Biotechnology Program

Extensive experience with EPA’s biotechnology regulations under TSCA, dating back to the Agency’s interim policy in the late 1980s. Coordinated the drafting of three submitted Microbial Commercial Activity Notices (MCANs) with others in preparation, assisted in the preparation of one Premanufacture Notice. Assisted companies in compliance with the Tier 1 exemption and R&D exemption under these regulations. Facilitated agency interactions and advised companies on the impact of the biotechnology regulations on their activities. Specific projects have included.

Bio-based chemical company. Advised company on applicability of TSCA biotechnology regulations to the development of modified microorganisms for chemical production; currently coordinating preparation of an MCAN for the modified strains (follow-on to a project conducted in 2010).

European developer of microbial strains for biofuel production. Advised and assisted in compliance with the TSCA regulations, including successful filing of an MCAN for novel strains.

Industrial biotechnology company. Advised and assisted on various matters relating to compliance with TSCA regulations, including planning for MCAN and PMN filings, coordinating meeting with EPA staff, and assisting in compliance with Tier I exemption requirements.

Advanced ethanol company. Advised company on various matters relating to TSCA biotechnology regulations. In 2007-11 provided advice on the impact of TSCA regulations on the development of modified microbial strains for ethanol production; coordinated presubmission meeting with EPA staff.

European industrial biotechnology company. Advised on applicability of TSCA regulations, coordinated in-person consultation with EPA staff.

Laboratory and research products company. Advised company on applicability of TSCA regulations, facilitating interactions with EPA regarding status of company products under the rule.

Start-up company developing novel enzymes. Advised on the regulatory status of proposed products, including creating a strategic plan for EPA regulatory compliance.

Developer of novel microbial strains. Confirmed the applicability of its strains for the tiered exemptions under the EPA TSCA biotechnology regulations.

Several companies. Advised companies on questions relating to use of GMOs for fuel or chemical production under TSCA regulations, and on other U.S. and international regulatory questions.

Regulation of New Animal Feed Ingredients

European developer of microbial strains for biofuel production. Submitted AAFCO Ingredient Definition request for use of the company’s novel strains in animal feed, also coordinating expert panel review of GRAS status for this product.

European industrial biotechnology company. Assisting in preparations for GRAS determination for novel microbial animal feed ingredient, including coordination of visit to FDA. Also provided information on regulatory status of other products in multiple industry sectors and geographies.

International bio-based chemical company. Helped determine FDA regulatory status of a biotechnology production process for an animal feed ingredient.

April 2016 David Glass Regulatory Experience Page 2

European renewable fuels company. Assisted in planning for AAFCO submission and GRAS determination for a novel processing aid in animal feed.

Several companies. Advised companies on strategies and planning to gain approvals for the use of inactivated microbial biomass as an animal feed ingredient.

Renewable Fuel Regulations

Joule Unlimited Technologies. Obtained EPA approvals for a new fuel pathway under the Renewable Fuel Standard and applications for EPA certification for sale of the fuel (see below).

European renewable fuels company. Helped company clarify interpretation of certain pathway definitions under the Renewable Fuel Standard.

European industrial biotechnology company. Provided strategic background information on renewable fuels and biotechnology regulations.

Other Regulatory Matters

Industrial biotechnology company. Provided strategic consultation for regulatory compliance for proposed use of novel microorganisms in food, animal feed, and bio-based chemical applications, including assessment of applicable regulations in a specific global region.

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

International biotechnology company. Assisted company identify regulatory status, markets and potential partners for products that enhance industrial enzyme activity.

Asian bioproducts company. Advised on regulatory status of enzyme products in North America.

At Joule Unlimited Technologies (in-house and as a retained consultant)

Coordinated presubmission meetings with EPA staff; worked with company scientists, engineers and outside counsel to prepare a Microbial Commercial Activity Notice (MCAN) for a modified cyanobacteria strain for production of ethanol; coordinated negotiation of a consent order for approval of limited activities under the MCAN. Coordinated preparation of a new pathway petition to EPA under the Renewable Fuel Standard, approved March 2016, achieved EPA registration for E10 and E15 ethanol, and obtained an Alcohol Fuel Production permit from the Alcohol Tax and Trade Bureau.

Earlier activities as an independent consultant

2010-2011. National Renewable Energy Laboratory. Worked with staff and outside counsel to prepare an MCAN for a modified microbial strain for ethanol production.

2010. Cellulosic ethanol company. Presented seminar on TSCA biotechnology regulations as part of half-day consulting visit.

2010. Cellulosic ethanol company. Advised company on applicability of TSCA biotechnology regulations to the use of modified microbial strains for production of ethanol.

2007-2010. Projects for the bio-based chemical company and advanced ethanol company described above.

David Glass has been involved with biotechnology regulation since the mid-1980s. For BioTechnica International in 1988-90 he obtained some of the earliest EPA approvals for outdoor field tests of live genetically modified agricultural microorganisms, and later advised agricultural and environmental biotechnology companies on the impact of government regulation on their planned uses of modified microorganisms. Information on Dr. Glass’s activities prior to 2007 can be found on the D. Glass Associates, Inc. website.