1. Risk and Regulation Redux: Revisiting Regulatory Frameworks in Light of New Biotechnologies
Emily Marden
Sidley Austin LLP
University of British Columbia
Deepti Kulkarni

2. Agenda Existing product- and process-based regulatory frameworks
Challenge for regulators posed by new technologies
Emerging regulatory responses and extra regulatory issues
Observations and expectations
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3. U.S. Coordinated Framework for Biotechnology
Asilomar Conference
Early U.S. lead in biotechnology
Risk-based versus precautionary
Concerns about tinkering with life
Reflects Context of Period
DNA technology on a spectrum with conventional breeding
Products are subject of regulation, not process
Existing statutes adequate to address risks
Regimes would be refined based on experience and scientific developments
Transparency important
Key Presumptions
1986
1992
2017
Key Dates
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4. Resulting Regulation: Coordinated Framework
USDA
Plant pests, plants, seeds
Animal biologics
Meat and poultry
FDA
Food and feed
Medical products
GE Animals
Cosmetics
EPA
Plant Pesticides
Herbicides
Chemicals, new microorganisms
PPA, AHPA, FMIA, PPIA, EPIA, VSTA
FDCA, PHSA
FIFRA, TSCA, FDCA
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5. Labeling
Trajectory is interesting because with focus on risk-based regulation, labeling debates became focus of many
Federal policy established and implemented
Survives legal challenge
Uptick in state and local initiatives
Vermont law survives preliminary legal challenge
First GE animal approved for food use
2016-today
Federal GE labeling law passed
Federal regulations to be implemented by USDA
Moving forward
Full implementation of federal regulations
Impact on consumers
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6. Relationship between regulation, uncertainty and risk
Persisting Questions
Relationship between regulation, uncertainty and risk
Impacts on R&D, innovation, food security
Value
Lack of harmonization
Regulatory complexity
Social and ethical issues (e.g., ownership, alteration of life, transparency)
Consumer understanding
Role of government
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7. Novel Biotechnologies
Gene editing, synthetic biology, genomics
Enabling technologies with the potential for a large number of new end products
Conventional methods: mutagenesis, polyploidy, protoplast
Transgenesis/ recombinant DNA
New biotechnologies: genomics, gene editing, synthetic biology
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8. Challenge for Regulators
Scope of existing statutes
Availability of regulatory triggers
Ensuring any novel safety issues considered
Ensuring appropriate risk-benefit balance
Durability of current regulatory frameworks
Proprietary issues
Social/consumer issues
Ethical issues
Consideration of extra-regulatory issues
Different national and international frameworks
Harmonization
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9. Regulatory Reframing
Modifying regulatory frameworks to address gene editing
Goal is to set forth regulatory criteria to apply to new technologies
e.g., USDA/APHIS proposed definition for “genetic engineering;” FDA/CVM proposed regulation of “intentionally altered genomic DNA” in animals
Excluding low-risk actions based on agency experience
Reflects regulatory experience with products and broader shifts in scientific understanding
e.g., USDA/APHIS proposed exclusions for GE organisms; shift to “analyze first system”
Narrowing regulatory scope to exclude modifications that could occur in nature
Reflects evolution in scientific and policy perspectives
Cements placement of biotechnology in spectrum of breeding techniques
e.g., “bioengineering” defined in National Bioengineering Food Disclosure Standard; USDA/APHIS proposed exclusion for GE organisms
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10. Extra-Regulatory Issues
Harmonization
Moral and Ethical Issues
Proprietary Issues
Transparency
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11. Social/ethical Commentary
Conclusions
Path Forward
Social/ethical Commentary
Regulatory Law
Stakeholder Comment
Innovation
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12. BACK UP
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13. US: USDA Proposed Rules
Refine definition of “genetically engineered” for purposes of regulations based to a greater degree on risk
Move to an “analyze first” regulatory system
Plant pest scope remains
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14. US: FDA and EPA FDA EPA Draft Guidance: GE Animals
Broad and process-based
“Intentionally altered” as trigger
Request for data to assess risk
Request for Information: Plant-based Foods
Consulting on whether there are safety issues to be considered
EPA
Intends to clarify its approach consistent with Coordinated Framework
TSCA model
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15. Regulatory Reframing on Genome
2016 National Bioengineered Food Disclosure Law
The term ‘bioengineering’ refers to a food that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques; and for which the modification could not otherwise be obtained through conventional breeding or found in nature.
USDA Revised Definition of “Genetically Engineered Organism”
Specifically, for purposes of the revised regulations, an organism would not be considered a GE organism if:
The genetic modification to the organism is solely a deletion of any size or a single base pair substitution which could otherwise be obtained through the use of chemical- or radiation-based mutagenesis.
The genetic modification to the organism is solely introducing only naturally occurring nucleic acid sequences from a sexually compatible relative that could otherwise cross with the recipient organism and produce viable progeny through traditional breeding (including, but not limited to, marker-assisted breeding, as well as tissue culture and protoplast, cell, or embryo fusion).
The organism is a “null segregant.”
(Proposed Rule, “Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms, Jan. 19, 2017).
Focus moves from the product as a whole to the genome with potential implications for extra-regulatory issues
FDA, Genome Editing in New Plant Varieties Used for Foods; Request for Comments, Jan. 19, 2017)
Recently, new technologies have emerged that are intended to alter the genomes of various organisms, including plants. FDA is aware that these technologies make it easier for plant developers to produce new plant varieties with targeted genetic modifications
EPA (TSCA) – Final Rule, “Microbial Products of Biotechnology,” CFR 725.3
Intergeneric: “microorganism is formed by the deliberate combination of genetic material originally isolated from organisms of different taxonomic genera.”
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16. Regulatory Reframing Represents a Significant Shift
Exception to this is for GE animals
This guidance addresses animals whose genomes have been intentionally altered using modern molecular technologies, which may include random or targeted DNA sequence changes including nucleotide insertions, substitutions, or deletions, or other technologies that introduce specific changes to the genome of the animal.
This guidance applies to the intentionally altered genomic DNA in both the founder animal in which the initial alteration event occurred and the entire subsequent lineage of animals that contains the genomic alteration.
Draft Guidance: Regulation of Intentionally Altered Genomic DNA in Animals, January 2017
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17. Challenges Extra-regulatory Issues Regulatory Frameworks
Agency mandates and resources mean certain issues are not addressed
Potential for persistent unresolved issues
May in turn affect acceptance
Can spur legislative changes
[Deepti + Emily]
Of course the issue is that there is no predictable pathway for considering these issues within the regulatory process.
Harmonization occurs at both an international and domestic level
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