Summary of projects carried out by David Glass, D. Glass Associates, Inc., to assist U.S. and international industrial biotechnology companies prepare for and comply with government regulation of their activities.

1. 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.

2. 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.