Presentation describing the status of the ongoing efforts to update and modernize the Federal Government's Coordinated Framework for Biotechnology Regulation.

1. David J. Glass, Ph.D.
D. Glass Associates, Inc.
BIO World Congress
April 19, 2016

2. In place since 1986 with only minor revisions
Environmental Protection Agency
 Microbial pesticides, plant pesticides
 Industrial uses of new microorganisms
U.S. Department of Agriculture
 Transgenic plants
 Potential plant pests
 Plant-produced industrial products
Food and Drug Administration
 Pharmaceuticals, biologics
 Diagnostics, medical devices
 Foods, food additives
 Animal feed, feed additives
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3.  July 2, 2015: White House OSTP
asks agencies to review policies
under the Framework.
 Goals: modernize the Federal
regulatory system for the
products of biotechnology and to
establish mechanisms for
periodic updates of that system.
 Objectives: to ensure public
confidence in the regulatory
system and to prevent
unnecessary barriers to future
innovation and competitiveness.
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4. One-Year Objectives:
 Develop updated Coordinated
Framework to clarify agency roles
and responsibilities.
 Formulate long-term strategy for
regulatory system to assess risks
of future products, while supporting
innovation, protecting health and
the environment, promoting public
confidence in the regulatory
process, increasing transparency.
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 Commission external, independent analysis of the future
landscape of biotechnology products (National Academy of
Sciences).

5.  Toxic Substances Control Act. MCAN reporting
for use of certain modified microorganisms for
fuel, chemical production. 40 CFR Part 725.
 Toxic Substances Control Act. TERAs for
proposed uses of certain modified
microorganisms in the open environment.
40 CFR Part 725.
 Toxic Substances Control Act. PMN
reporting for chemicals, mixtures
produced by microorganisms.
40 CFR Part 720.
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6.  Plant Protection Act. Regulation of
transgenic plants used as feedstocks.
7 CFR Part 340.
 Plant Protection Act. regulation of
importation, interstate movement
of plant pests:
7 CFR Part 330, 340.
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7.  Food, Drug and Cosmetic Act: oversight
over animal feed ingredients.
◦ Feed Additive Petitions
◦ Review of GRAS self-certifications
◦ Coordination with AAFCO Ingredient Definitions
 Food, Drug and Cosmetic Act:
◦ Voluntary consultation on GMO
plants for use in food, feed.
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8. USDA EPA
FDA
• Genetically modified plant feedstocks
• Use of plant pest microorganisms
• Use of GMO crops, fermentation byproducts,
spent biomass in animal feed
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• Use of GM microorganisms or
algae to produce fuels, chemicals

9. Use of plant pest microorganisms
in fuel or chemical production
Use of GM algae in fuel
or chemical production
Use of spent biomass
in animal feed
FDA consultation
on food use of GM
plants
USDA EPA
FDA
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10.  July 2, 2015: OSTP memo.
 July 2015: Interagency Working Group formed.
 September 30, 2015: EPA public meeting on
algae, synthetic biology.
 November 30, 2015: OSTP public meeting in
Silver Spring, MD., including public comment
period.
 January 2016: National Academy of Sciences
undertakes study of “Future Biotechnology
Products”.
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11.  March 2016: NAS appoints Committee, sets up
website for biotech study: www.nas.edu/biotech.
 March 9, 2016: OSTP public meeting in Dallas,
TX, presenting product-specific case studies.
 March 30, 2016: OSTP public meeting in Davis,
CA, with case studies and breakout discussions.
 April 21, 2016: Public comment period on USDA
regulations closes.
 Spring/Summer 2016: publication expected of
proposed update to Coordinated Framework, to
solicit public comment.
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12.  Some favored the use of risk-based, science-
based regulation, with uniform regulation
across products; while others recommended
regulating based on process, for mandatory
premarket review.
 Establish balance between the level of
regulation and the degree of risk, including
expanding exemptions
and fast-tracking
product reviews.
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Source: R. Barbero, OSTP,
March 9, 2016 presentation

13.  Difficulties for small companies and
academics to navigate the system.
 Need for more support for risk assessment
research.
 Recommended harmonization with
international guidelines and regulatory
partners.
 Suggested early
publication of safety data.
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Source: R. Barbero, OSTP,
March 9, 2016 presentation

14. D. Glass Associates, Inc.
• EPA: Regulate under
TSCA (TERA, MCAN).
• USDA: Permit needed
only if there are plant pest
sequences (e.g. CaMV
promoter).
• FDA: Consultation
suggested if algae
biomass intended for
animal (fish) food use.

15. USDA EPA
FDA
D. Glass Associates, Inc.
USDA
• Substantial revision, possible
simplification to Part 340
regulations?
• Broader scope to address
noxious weed risk?

16. USDA EPA
FDA
D. Glass Associates, Inc.
• Substantial revision, possible
simplification to Part 340
regulations?
• Broader scope to address noxious
weed risk?
EPA
• Revisions to TSCA regulations?
• Clearer guidelines for algae, synbio?
• Chemicals: Coordinate PMNs, MCANs?
• Impact of TSCA Reform?

17. USDA EPA
FDA
D. Glass Associates, Inc.
• Substantial revision, possible
simplification to Part 340
regulations?
• Broader scope to address noxious
weed risk?
• Revisions to TSCA regulations?
• Clearer guidelines for algae, synbio?
• Chemicals: Coordinate PMNs, MCANs?
• Impact of TSCA Reform?
FDA
• No real changes to Framework.
• Final rule for GRAS notification program?
• Integration with AAFCO process?

18. USDA EPA
FDA
D. Glass Associates, Inc.
• Substantial revision, possible
simplification to Part 340
regulations?
• Broader scope to address noxious
weed risk?
• Revisions to TSCA regulations?
• Clearer guidelines for algae, synbio?
• Chemicals: Coordinate PMNs, MCANs?
• Impact of TSCA Reform?
• No real changes to Framework.
• Final rule for GRAS notification program?
• Integration with AAFCO process?
• Clarify coverage of synthetic
biology?
• Clarify status of CRISPR, other
new techniques?
• Greater interagency
communication, coordination,
and/or central regulatory
clearinghouse?
• Risk that public comments
could lead to stricter
regulations, particularly
regarding GMO plants?

19.  Feed ingredients: Streamline FDA/AAFCO
procedures for feed use of GM
microorganisms, add staff to CVM.
 Bio-Based Chemicals: Coordinate MCANs and
PMNs; Clarify nomenclature issues for bio-
based mixtures.
 USDA Regulations: Strengthen statutory
authority, but exempt most research field
tests.
 New technologies: Clarify regulatory status of
synthetic biology, gene-editing, etc.
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20.  Most significant changes may affect uses of
synthetic biology, gene-editing techniques.
 USDA regulations could substantially change,
but impact on fuel, chemical feedstocks may
be minimal.
 Chances that major changes could be
implemented before change of
Administration?
 Other public policy issues (e.g. RFS) more
likely to affect industrial biotechnology.
D. Glass Associates, Inc.

21. Thank you very much!
David J. Glass, Ph.D.
D. Glass Associates, Inc.
124 Bird Street
Needham, MA 02492 USA
Phone 617-653-9945
dglass@dglassassociates.com
www.dglassassociates.com
D. Glass Associates, Inc.