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Synthetic Biology:
Unique Challenges for
Public Policy
Kelly Drinkwater
[email protected]
Research Group of Kenneth Oye, MIT
BioBuilder Workshop, July 25, 2013
What bio-ethical issues are
generally addressed in HS biology?
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Cloning

Genetically modified crops (moral, environmental)
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Genetic testing and privacy
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Human subjects ethics
...can we go farther?
Synthetic Biology's Challenge:
Regulation without stifling innovation
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Environmental safety
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Intellectual property rights
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Security / bio-terrorism
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iGEM
Following: Discuss how to integrate these into your
classrooms
Handout available & please email with questions!
SynthBio products pose new risks to
the environment
Algae raceway pond (Biofuels)
Algal bloom near Cornwall
Tarball from Deepwater
Horizon oil spill
...heard of these folks?
Who's regulating this thing?!
Not part of
my mandate!
Current environmental regulations
are a patchwork

EPA: "Toxic Substances or Pesticides"

USDA: "Plant Pests"
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FDA: "Food, drugs, or animal feed"

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Lab research is covered by NIH Guidelines, like all
recombinant DNA work
Medical applications are better regulated (FDA &
other countries' equivalents)
Current environmental regulations
are a patchwork

EPA: "Toxic Substances or Pesticides"

USDA: "Plant Pests"

FDA: "Food, drugs, or animal feed"

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Lab research is covered by NIH Guidelines, like all
recombinant DNA work
Theme:
Medical
applications are
better regulated
(FDA &
Not
regulating
genetic
information
other countries'as
equivalents)
information
What counts as an
environmental harm?



Changes to ecosystem services, such as:

Carbon/nitrogen cycling

Arability

Recreational value
Changes to species composition of an ecosystem
Not well defined, and partly a philosophical
question
What makes a synthetic bug
likely to cause harms?

Fitness / survival

Evolution / mutation / genetic instability

Horizontal gene transfer
Fitness: Will the bug outcompete
native species?
Assumption: Genetic modifications impose a
metabolic burden.
Modified organism will be less fit than the wild-type
and will not compete.
Reality: Some applications require a highly fit
organism!
Even if the organism may be less fit, the assumption
has not been rigorously tested.
Evolution / Instability: Will the bug
change out from under us?
Assumption: Mutations and evolution can be ignored
on the bench-top scale.
Reality: Mutations and evolution cannot be ignored
on the industrial scale. Will the organism change its
genotype or phenotype? Will mutations inactivate
any safety features?
Horizontal Gene Transfer:
Will inserted genes escape?
Assumption: HGT is rare, and nearly impossible
between organisms not closely related.
Reality: HGT is far more common than we thought
even 10-15 years ago, and occurs even across
kingdoms!
Archaea to Bacteria
Fungus to Animal
Bacteria to Animal
Fitness / Survival
Evolution / Instability
"Recruitment of genetic elements
to ensembles that cause harm"
Horizontal
Gene Transfer
Security, Bio-Warfare, Bio-Terror

Legacy laws: Select Agent List, Australia Group
Guidelines

Voluntary screening of DNA synthesis orders

Dual Use Research of Concern
Legacy rules outlaw organisms,
not information
United States Select
Agent List




Australia Group
Guidelines
"No organisms from this list of nasty pathogens..."
...or "genetic elements associated with the
pathogenicity of those organisms."
No clear guidance on what that means (and what
about dangerous sequences from other species?)
Organism-based rather than information-based
regulations
Screening: "The Guardian started it"
"The DNA sequence of smallpox, as
well as other potentially dangerous
pathogens such as poliovirus and 1918
flu are freely available in online public
databases. So to build a virus from
scratch, a terrorist would simply order
consecutive lengths of DNA along the
sequence and glue them together in the
correct order. This is beyond the skills
and equipment of the kitchen chemist,
but could be achieved by a wellfunded terrorist with access to a basic
lab and PhD-level personnel."
Voluntary screening by
DNA synthesis providers




"Clearly this should not
be possible!"
Lots of conferences
HHS issues screening
guidance
Companies voluntarily
screen customers and
orders; informationbased regulation!
(But now we have benchtop DNA
Dual Use Research of Concern
(DURC)

Research for peaceful purposes, which could also
be used for nefarious ends

Covers many fields: nuclear, cybersecurity, bio

Examples...
Spanish Flu and Mousepox
H5N1 (Avian) Flu:
Fouchier and Kawaoka
Controversy:
Safer to keep it secret?

Should the research be done at all? In many cases,
the peaceful justifications are weak.

If the research is done, should it be published?

Who decides?
Patents and IP:
The Anti-Commons Problem
Certainty
More IP
Protection
More Free Use
ANTI-COMMONS
Uncertainty
Why is Anti-Commons a problem
in synthetic biology?

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One product might use dozens or hundreds of parts,
all owned by different people
Some parts are free, some are proprietary, some are
uncertain
Many parts may be covered by over-broad
patents... but who wants to challenge?
Laws about gene patentability are in flux (many
genes of interest are not made free by Myriad
decision)
Work with iGEM Safety Committee


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Ensure participant safety
Model safety practices for
an international audience
Encourage students to
discuss broader implications
Instill a culture of
responsibility
Why is iGEM important to
policymakers?


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Massive diffusion of
technical skills; should
be managed
A chance to model
proactive, not reactive,
risk management
A test-bed for real
regulatory issues
To sum up...

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Synthetic biology presents interesting new
challenges and risks in many different areas
Regulators and others are actively working to
address those risks and attack uncertainties
Hopefully this will be interesting to your students!
Discussion: How can this be
integrated into the classroom?



Formats for discussion: Debate, Four Corners,
current events writing? Others?
How could this integrate with BioBuilder and with
existing course content?
How could this integrate across disciplines?
(Environmental Science, History, Civics /
Government?)