Synthetic Biology:Unique Challenges for
Public Policy
Kelly Drinkwater
Research Group of Kenneth Oye, MIT
BioBuilder Workshop, July 25, 2013
What bio-ethical issues are generally addressed in HS biology?
Cloning Genetically modified crops (moral, environmental) Genetic testing and privacy Human subjects ethics
...can we go farther?
Synthetic Biology's Challenge:Regulation without stifling innovation
Environmental safety Security / bio-terrorism
Intellectual property rights 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
Current environmental regulations are a patchwork
EPA: "Toxic Substances or Pesticides" USDA: "Plant Pests" FDA: "Food, drugs, or animal feed"
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"
Lab research is covered by NIH Guidelines, like all recombinant DNA work
Medical applications are better regulated (FDA & other countries' equivalents)
Theme:Not regulating genetic information
as 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
"Recruitment of genetic elements to ensembles that cause harm"
Fitness / Survival Evolution / Instability
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 well-funded terrorist with access to a basic lab and PhD-level personnel."
"Clearly this should not be possible!"
Lots of conferences HHS issues screening
guidance Companies voluntarily
screen customers and orders; information-based regulation!
(But now we have bench-top DNA synthesizers...)
Voluntary screening by DNA synthesis providers
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...
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
More IP Protection More Free Use
Certainty
Uncertainty
ANTI-COMMONS
Why is Anti-Commons a problem in synthetic biology?
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
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?
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...
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?)