Risk and Regulation Redux:
Revisiting Regulatory
Frameworks in Light of New
Biotechnologies
Emily Marden
Sidley Austin LLP
University of British Columbia
Deepti Kulkarni
Sidley Austin LLP
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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U.S. Coordinated Framework for Biotechnology
Reflects Context of Period
• Asilomar Conference
• Early U.S. lead in biotechnology
• Risk-based versus precautionary
• Concerns about tinkering with life
Key Presumptions
• 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 Dates
• 1986
• 1992
• 2017
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Resulting Regulation: Coordinated Framework
USDA
FDA
EPA
Plant pests,
plants, seeds
Food and feed
Plant
Pesticides
Animal
biologics
Medical
products
Herbicides
GE Animals
Meat and
poultry
PPA, AHPA,
FMIA, PPIA,
EPIA, VSTA
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Cosmetics
FDCA, PHSA
Chemicals, new
microorganisms
FIFRA, TSCA,
FDCA
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Labeling
Trajectory is interesting because with focus on risk-based regulation,
labeling debates became focus of many
Moving
forward
2016-today
2001-2015
1990-2000
• Federal policy
established and
implemented
• Survives legal
challenge
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• Uptick in state
and local
initiatives
• Vermont law
survives
preliminary
legal challenge
• First GE animal
approved for
food use
• Federal GE
labeling law
passed
• Federal
regulations to
be
implemented
by USDA
• Full
implementation
of federal
regulations
• Impact on
consumers
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Persisting Questions
Relationship between
regulation, uncertainty and risk
Impacts on R&D, innovation,
food security
Value
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Social and
ethical issues
(e.g., ownership,
alteration of life,
transparency)
Regulatory
complexity
Consumer
understanding
Lack of
harmonization
Role of
government
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Novel Biotechnologies
• Gene editing, synthetic biology, genomics
• Enabling technologies with the potential for a large number of new end
products
Transgenesis/
recombinant
DNA
New
biotechnologies:
genomics, gene
editing, synthetic
biology
Conventional
methods:
mutagenesis,
polyploidy,
protoplast
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Challenge for Regulators
Durability of current regulatory frameworks
•
•
•
•
Scope of existing statutes
Availability of regulatory triggers
Ensuring any novel safety issues considered
Ensuring appropriate risk-benefit balance
Consideration of extra-regulatory issues
• Proprietary issues
• Social/consumer issues
• Ethical issues
Harmonization
• Different national and international frameworks
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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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Extra-Regulatory Issues
Harmonization
Moral and
Ethical Issues
Proprietary
Issues
Transparency
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Conclusions
Social/ethical
Commentary
Innovation
Path
Forward
Regulatory
Law
Stakeholder
Comment
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BACK UP
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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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US: FDA and EPA
FDA
• Draft Guidance: GE Animals
o Broad and process-based
o “Intentionally altered” as trigger
o Request for data to assess risk
• Request for Information: Plant-based Foods
o Consulting on whether there are safety issues to be
considered
EPA
o Intends to clarify its approach consistent with
Coordinated Framework
o TSCA model
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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).
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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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Challenges
Extraregulatory
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
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