david glass presentation at 2016 bio world congress

"Updating the Coordinated Framework: What does it mean for biofuels and bio-based chemicals?"

David J. Glass, Ph.D.D. Glass Associates, Inc.

BIO World CongressApril 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

Biotechnology Coordinated Framework

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.

Modernizing the Coordinated Framework


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.

Modernizing the Coordinated Framework


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.

EPA Oversight over Industrial Biotechnology


Plant Protection Act. Regulation of transgenic plants used as feedstocks. 7 CFR Part 340.

Plant Protection Act. regulation of importation, interstate movementof plant pests: 7 CFR Part 330, 340.

USDA Oversight over Industrial Biotechnology


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.

FDA Oversight over Industrial Biotechnology


Coordinated Framework:Current Applicability to Fuels, Chemicals

USDA EPA

FDA

• Genetically modified plant feedstocks• Use of plant pest microorganisms

• Use of GMO crops, fermentation byproducts, spent biomass in animal feed


• Use of GM microorganisms or algae to produce fuels, chemicals

Coordinated Framework:Fuels, Chemicals, Areas of Potential Overlap, Cooperation

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


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”.

Coordinated Framework Review: Actions to Date


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.

Coordinated Framework Review: Actions to Date and Anticipated


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.

Coordinated Framework Review: Summary of Public Comments


Source: R. Barbero, OSTP, March 9, 2016 presentation

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.

Coordinated Framework Review: Summary of Public Comments


Source: R. Barbero, OSTP, March 9, 2016 presentation

Coordinated Framework Review: Case Studies Presented March 9


• 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.

Coordinated Framework:Possible Revisions Affecting Fuels, Chemicals

USDA EPA

FDA


USDA• Substantial revision, possible

simplification to Part 340 regulations?

• Broader scope to address noxious weed risk?


USDA EPA

FDA


• Substantial revision, possible simplification to Part 340 regulations?


EPA• Revisions to TSCA regulations?• Clearer guidelines for algae, synbio?• Chemicals: Coordinate PMNs, MCANs?• Impact of TSCA Reform?


USDA EPA

FDA




• 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?


USDA EPA

FDA




• 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?

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.


Coordinated Framework:My “Wish List”

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.


Conclusions/Predictions

Thank you very much!

David J. Glass, Ph.D.D. Glass Associates, Inc.124 Bird StreetNeedham, MA 02492 USAPhone [email protected]


david glass presentation at 2016 bio world congress

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