Government and Regulatory Affairs
Renewable Fuels and Industrial Biotechnology

David J. Glass, Ph.D., Representative Projects and Experience

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 seven Microbial Commercial Activity Notices (MCANs), assisted in the preparation of a Premanufacture Notice and a Low Volume Exemption modification. Assisted companies in compliance with the Tier 1 exemption and R&D exemption under the biotechnology rule. 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; coordinated 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.
• Bio-based chemical company. Advised company on applicability of TSCA biotechnology regulations and assisted in 2017 submission of an MCAN for a modified microbial production strain.
• 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.
• 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.

• 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 coordinated expert panel review of GRAS status for this product.
• Early-stage research company. Currently helping company prepare an Animal Food GRAS Notice for submission to the FDA.  
• European industrial biotechnology company. Assisted 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.
• 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.

• 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.

• 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.

 As Director of Regulatory Affairs at Joule Unlimited Technologies, Inc. (2011-2013)

• Renewable Fuels Regulation. Coordinated presubmission meetings with EPA biotechnology 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, which was submitted to EPA in July 2012; coordinated responses to EPA questions about MCAN; coordinated negotiation of a consent order for approval of limited activities under the MCAN. Prepared and submitted a new fuel pathway petition under the U.S. EPA Renewable Fuel Standard, approved March 2016. Obtained a Medium Alcohol Fuel Producer Permit for a commercial bioethanol facility. Also responsible for other aspects of regulatory compliance relating to renewable fuel production and commercialization.

 Prior Experience

• National Renewable Energy Laboratory. Worked with NREL scientists, technology transfer staff and outside counsel to prepare an MCAN for a modified Zymomonas strain for production of ethanol, including coordination of a presubmission conference call with EPA staff (2011-12). The MCAN was submitted in April 2011, but EPA review has been deferred pending development of additional data requested by EPA.
• Advanced ethanol and industrial biotechnology companies. In addition to the projects referenced above for a bio-based chemical company (2010) and an advanced ethanol company (2007-11), Dr. Glass advised a cellulosic ethanol company on the applicability of TSCA biotechnology regulations to the use of modified microbial strains for production of ethanol (2010), and for another company, he presented a seminar on TSCA biotechnology regulations as part of a half-day consulting visit (2010). 
• Applied PhytoGenetics, Inc. Dr. Glass obtained USDA permits for the first U.S. commercial phytoremediation projects to use transgenic plants (2003-05). Two field tests were conducted under these permits, one in Danbury, Connecticut and one in northern Alabama. Dr. Glass also assisted another phytoremediation company obtain a permit for a transgenic field test.
• Energy Biosystems, Inc. Dr. Glass advised the company on regulation of engineered organisms,  presented a seminar for company officials on U.S. biotechnology regulation, and assisted the company in meetings with EPA that led to a favorable EPA ruling on the adequacy under the TSCA biotech regulations for contained R&D use of the company’s proposed bioreactor for coal desulfurization (1995).
• Envirogen, Inc., Dr. Glass advised the company on the applicability of federal and state regulations on their plans in the early 1990s to commercialize genetically modified microorganisms for biotreatment of trichloroethylene. Dr. Glass obtained a favorable ruling from EPA on the containment status on the company’s proposed biotreatment reactor for R&D use with engineered microorganisms (1992).
• U.S. biotreatment company. Dr. Glass advised a U.S. company that was contemplating the use of engineered microorganisms for hazardous waste treatment on the impact of federal and state biotechnology regulations on their plans (1992-1993).
• BioTechnica International, Inc. Dr. Glass obtained EPA approval under TSCA for field trials of engineered nitrogen fixing microorganisms, which were among the first outdoor tests of genetically modified microorganisms to take place in the U.S. (1988-90). These projects included liaison to the EPA and state regulatory agencies, government relations in Washington and state capitals, and community and public relations programs to ensure local support for the tests. Dr. Glass also won USDA approval for several transgenic plant tests, including the first field test of engineered corn (1989-90).
• Prepared reports for several companies and a trade association summarizing and analyzing EPA's 1991 draft proposed rule, its 1994 proposed rule and 1997 final rule for the regulation of certain microbial products of biotechnology under the Toxic Substances Control Act. Thorough familiarity with the 1997 amendments to USDA's biotechnology regulations. Numerous presentations and publications on EPA biotechnology regulation under TSCA, USDA biotechnology regulation under the Plant Pest Act and other biotechnology regulatory topics.
  

This page was last updated October 9, 2017.