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David Glass Presentation at 2016 BIO World Congress

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

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David J. Glass, Ph.D.
D. Glass Associates, Inc.
BIO World Congress
April 19, 2016
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
D. Glass Associates, Inc.
 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.
D. Glass Associates, Inc.
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.
D. Glass Associates, Inc.
 Commission external, independent analysis of the future
landscape of biotechnology products (National Academy of
Sciences).
 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.
D. Glass Associates, Inc.
 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.
D. Glass Associates, Inc.

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David Glass Presentation at 2016 BIO World Congress

  • 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 D. Glass Associates, Inc.
  • 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. D. Glass Associates, Inc.
  • 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. D. Glass Associates, Inc.  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. D. Glass Associates, Inc.
  • 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. D. Glass Associates, Inc.
  • 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. D. Glass Associates, Inc.
  • 8. USDA EPA FDA • Genetically modified plant feedstocks • Use of plant pest microorganisms • Use of GMO crops, fermentation byproducts, spent biomass in animal feed D. Glass Associates, Inc. • 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 D. Glass Associates, Inc.
  • 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”. D. Glass Associates, Inc.
  • 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. D. Glass Associates, Inc.
  • 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. D. Glass Associates, Inc. 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. D. Glass Associates, Inc. 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. D. Glass Associates, Inc.
  • 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.