D. Glass Associates, Inc.
Renewable Fuels and Industrial Biotechnology
David J. Glass,
Ph.D., Representative Projects and Experience
with EPA’s biotechnology regulations under TSCA, dating back to the
Agency’s interim policy in the late 1980s. Coordinated the drafting of
Microbial Commercial Activity Notices (MCANs), assisted in the
preparation of a
Premanufacture Notice and a Low Volume Exemption modification.
companies in compliance with the Tier 1 exemption and R&D
the biotechnology rule. Facilitated agency interactions and advised
on the impact of the biotechnology regulations on their activities.
projects have included.
Animal Feed Ingredients
company. Advised company on
applicability of TSCA biotechnology regulations to the development
microorganisms for chemical production; coordinated preparation of
an MCAN for
the modified strains (follow-on to a project conducted in 2010).
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.
company. Advised company on
applicability of TSCA biotechnology regulations and assisted in 2017
of an MCAN for a modified microbial production strain.
company. Advised and assisted on
various matters relating to compliance with TSCA regulations,
for MCAN and PMN filings, coordinating meeting with EPA staff, and
compliance with Tier I exemption requirements.
ethanol company. Advised company on
various matters relating to TSCA biotechnology regulations. In
advice on the impact of TSCA regulations on the development of
microbial strains for ethanol production; coordinated presubmission
with EPA staff.
- European industrial biotechnology company. Advised on applicability of TSCA regulations, coordinated in-person
consultation with EPA staff.
research products company.
Advised company on applicability of TSCA regulations, facilitating
with EPA regarding status of company products under the rule.
novel microbial strains.
the applicability of its strains for the tiered exemptions under the
Advised companies on questions
relating to use of GMOs for fuel or chemical production under TSCA
and on other U.S. and international regulatory questions.
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
status for this product.
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
information on regulatory status of other products in multiple
renewable fuels company.
in planning for AAFCO submission and GRAS determination for a novel
aid in animal feed.
Advised companies on strategies and
planning to gain approvals for the use of inactivated microbial
biomass as an animal
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
renewable fuels company. Helped
company clarify interpretation of certain pathway definitions under
Renewable Fuel Standard.
industrial biotechnology company.
strategic background information on renewable fuels and
company. Provided strategic consultation
for regulatory compliance for proposed use of novel microorganisms
animal feed, and bio-based chemical applications, including
applicable regulations in a specific global region.
a novel biofuel feedstock.
a detailed market and regulatory analysis for a company
investigating the use
in animal feed of a novel energy crop species.
company. Assisted company identify
regulatory status, markets and potential partners for products that
industrial enzyme activity.
Advised on regulatory
status of enzyme products in North America.
Director of Regulatory Affairs at Joule Unlimited Technologies,
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.
- 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).
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
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).
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).
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
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).
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.
page was last updated October 9, 2017.
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