Civil Society and Implementation of UNSCR 1540Vienna, 8-10 January 2013

Tim Trevan

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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European DIYbio Code

 

16 August 2012 8

US DIYbio Code

 

16 August 2012 9

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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TREVAN@ICLSCHARTER.COM4245 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

9 January 2013 24