civil society and implementation of unscr 1540 vienna, 8-10 january 2013 tim trevan
TRANSCRIPT
Risk SpectrumNon-residual Risk is addressed pre-event by prevention,
mitigation, resilience & preparedness (& avoidance)
Residual Risk is addressed post-event by Emergency Response (detection, diagnosis, containment, treatment, recovery,
investigation)
Natural Accidental Intentional
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NaturallyOccurringPandemic
ReemergingInfectiousDiseases
UnintendedConsequences
of Research
LaboratoryAccidents
Lack ofAwareness
PolicyChoices
Negligence(Failure to
Follow SoPs)
Crime &Counterfeit
DrugsSabotage
AttackLeading to
Release
BiowarfareTerrorism State BW
Synthetic Biology and 1540
Varying views on what synthetic biology is.
Engineering approach to biology:• Design for purpose• Use of standard components
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What are the risks?• Security – misuse to design BW
– Combination of improved genomics, IT, automation of sequencing/synthesis and on-line services (including design tools), making design possible, easier and more accessible/distributed
• Safety – unintended consequences– Of research or of continued evolution of genetically
modified species released into the environment
• Safety – laboratory accidents/release
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Who is involved?• Gene Foundries (main clients academia and Big Pharma)
• Fabrication Centres• Oligo producers• Gene-design tool creators/Gene designers• Academia (6 Academies, iGem, FBI)
• Corporate R&D (eg biofuels)
• Citizen scientists
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ICLS Synthetic Biology Project
Objectives
• Global adherence of gene foundries to a version of the ‘Code’• Vertical expansion to include all involved in synthetic gene
commerce (suppliers, designers, manufacturers, clients)• Development of a code for all active players in synthetic
biology (ie all above plus academia, corporate R&D, citizen scientists)
• Creation of a global forum to discuss issues as they arise• Keep ahead of the curve in managing associated risks
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What has been done?• IASB and IGSC Codes of Conduct• US DHSS Guidelines• Common features:
– Check orders for gene sequences of concern– Check clients– Keep records– Links with law enforcement (FBI outreach initiative)
• DIYer Codes, iGem rules, SynBerc• ICLS Heidelberg Meeting/SynBio Project
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ICLS Heidelberg MeetingAddressing Global Security Meeting
• Perceived needs– Common customer (black and white list) and gene
sequence databases– International coordinating body and ‘seal of approval’ for
gene foundries– International law enforcement Points of Contact equivalent
to FBI programme– A code of conduct and a systems approach to biosafety
and biosecurity for all working in SynBio
16 August 2012 Synthetic Biology: Biosafety and Biosecurity Considerations
10
Heidelberg Outcomes:Don’ts
1. No to shared client data:– No white lists– Black lists the responsibility of governments
2. No to common gene sequence database– Not practicable/proprietary– Problems of gene sequence vs species
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Heidelberg Outcomes: Dos Part 1
1. Use Common language to explain to clients need for screening
2. Test ‘Seal of approval’, certifying guidelines-compliant
3. Address gene sequence vs species issue jointly
4. Keep a watching brief on pathways/new constructs
5. Consider client code of conduct
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Heidelberg Outcomes: Dos Part 2
6. Consider licenses for smaller research outfits/citizen scientists/small market clients
7. Seek global adherence to the gene foundry code
8. Create a global forum for discussion of SynBio issues
9. Seek a general code of conduct for all SynBio actors
10. Address environmental and biosafety issues
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Heidelberg Outcomes:Dos Part 3
11. Engage Interpol as global PoC on law enforcement issues
12. Engage BTWC National PoCs
13. Use the BTWC meetings to progress synbio issues
14. Address sales to legitimate entities in ‘pariah’ states
15. Address issues of transport of synbio products
16. Leverage existing synbio networks to work on broadening and globalisation issues
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Heidelberg Outcomes:Report
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• Printed copies available• Distributed by FBI at 6 Academies
Meeting in DC, June 2012• Special thanks to sponsors
• UK SPF• FBI• Sloan Foundation
• Thanks to partners• IASB• IGSC• Other participants
Next steps1. Engage Interpol
2. Engage the Six Academies
3. Engage more governments
4. Engage Citizen Scientists, Corporate R&D, Big Pharma
5. Meet Chinese gene foundries (Aug 2012, Shanghai)
6. ICLS/BGI co-host conference in Hong Kong, 7-8 March 2013– Engage/invite BRIC and emerging biotech countries– Broaden participation vertically and horizontally– Lay groundwork for biosafety and environmental engagement
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Relative Strengths of Government vs Civic Society
Government
• International aspects• Legislation and regulation• Surveillance• Interdiction/Prevention• Preparedness and Planning• Enforcement• Forensic assessments• Education
Civic Society
• Institutional Practice• Personal Practice• Culture/Self-policing• Cutting Edge Knowledge• Distributed Networks:
– Flexible and Responsive– Resilient– Innovative– Local and global - REACH
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Basic Home Truths 1
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• If you want things to happen, they need to add value locally, not make your interlocutor’s work harder
• To be sustainable, action plans have to address local priorities
• This means local priority setting and ownership, which is loss of control of the agenda for the outside ‘helpers’
Basic Home Truths 2
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• In most countries, there are no biosecurity specialists
• Biosafety and biosecurity is not even the second hat – way down the list
• Must be careful how we use good people – must not take them away from doing things which are more important
So …
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• If biosafety and biosecurity, and BWC implementation, are secondary priorities with other players then, in engaging these other players, we must address these issues as secondary objectives within a greater whole which addresses locally identified priorities.
Motivations
• Biosafety• Biosecurity• Certification• Career advancement• Compliance• Liability protection• Financial
• Status/image• Altruism• Personal connection
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Government and Civic SocietyWorking Together
Public Health, Agriculture, Food Safety,EnvironmentWater, Soil
Trade, Customs
EducationSci/Tech
TradeSecurityLaw Enf.
Gvt Regulatory Agencies, Customs,
Law Enforcement
Security ServicesNational Security
Import/ExportArmed Forces
Customs/Border
Occupational Safety,
Industry, Education,Certification
NaturallyOccurringPandemic
ReemergingInfectiousDiseases
UnintendedConsequences
of Research
LaboratoryAccidents
Lack ofAwareness
PolicyChoices
Negligence(Failure to
Follow SoPs)
Crime &Counterfeit
DrugsSabotage
AttackLeading to
Release
BiowarfareTerrorism State BW
Health Professionals & Societies,
farmers etc…
AcademiaSchools
NGOs Trade and professional associations
Outreach programmes,
First responders
Biosafety Associations,Professional
trainers
Thank you
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[email protected] Fairfax DriveArlington VA 22203
202-659-8058www.iclscharter.org
Towards A New Methodology?
Define risk
profile = conseque
nces to be
avoided
Establish triage criteria
and threshhol
ds
Identify causes
(categories, sub-
categories)
Identify events/ac
tions which
give rise to these
Identify all
potential counter-
measures
Filter options through
risk profile/bu
dget
Derive action plan
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