The European BioSafety Association in a changing...
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The European BioSafety Association
in a changing world
Gijsbert van Willigen
EBSA President 2016 - 2017
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Biosafety and Biosecurity
• Biosafety describes the containment principles,
technologies and practices that are implemented to prevent
the unintentional exposure to biological agents and toxins,
or their accidental release
• Biosecurity describes the protection, control and
accountability for biological agents and toxins within
laboratories, in order to prevent their loss, theft, misuse,
diversion of, unauthorized access or intentional
unauthorized release
(adapted from WHO/CDS/EPR/2006.6 and CWA 15793:2011)
Biosafety is to keep bad bugs from people,
Biosecurity is to keep bad people from bugs
Milan, March 22, 2017
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Spectrum of biosafety and biosecurity
Biosafety Biosecurity
Threats for humans, animals and the economy
Milan, March 22, 2017
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Old fashioned biosafety
Milan, March 22, 2017 Slide 4
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Old fashioned biosafety
Slide 5Milan, March 22, 2017
Ignaz Semmelweis
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Old fashioned biosafety
Slide 6Milan, March 22, 2017
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Old fashioned biosafety
Slide 7Milan, March 22, 2017
Disease with clinical symptoms
Infection without clinical symptoms
(no evident disease; detectable in
lab tests
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Old fashioned biosafety
• 2009: Attenuated strain of Yersinia pestis
– 1 dead; aerosols (?)
• 2011: Bacillus cereus
– 1 researcher infected
• 2011: Salmonella typhimurium
– 32 infected during a microbiology course
– 41 secondary cases
• 2011: Vaccinia virus (cowpox virus)
– 1 infected; never worked with the virus
• 2011: Neisseria meningitidis
– Contaminated storage
Milan, March 22, 2017 Slide 8
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Old fashioned biosafety
Milan, March 22, 2017 Slide 9
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Old fashioned biosafety
• Protection from a known risk i.e. the pathogen
Milan, March 22, 2017 Slide 10
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Old fashioned biosafety
• Protection from a known risk i.e. the pathogen
Milan, March 22, 2017 Slide 11
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Old fashioned biosecurity
• Use natural occuring pathogens:
– Tularemia casualties were driven to the enemy driven resulting
in a epidemic (around 1400 BC)
– Catapulting plaque victims over the city wall (Caffa, Krim, 14th
century)
– Small pox blankets given to the native American population (16th
century)
– Salmonella typhi in water supplies (Egypt, 1948)
Milan, March 22, 2017 Slide 12
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Old fashioned biosecurity
• Use natural occuring pathogens:
– Salmonella in a salad bar in The Dalles, OR, USA (1984)
– Anthrax spraying in Tokyo, Japan (1993)
– Anthrax letters after the attacks of 9/11 (Amerithrax, 2001)
Milan, March 22, 2017 Slide 13
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Old fashioned biosecurity
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New biosafety threats:
Antimicrobial resistance
Slide 15
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New biosafety threats:
Globalization
Slide 16Milan, March 22, 2017
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New biosafety threats:
Globalization
Slide 17Milan, March 22, 2017
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New biosafety and biosecurity threats
• New techniques in biotechnology:
– Gene editing (Crispr/Cas)
– Genetically modified insects
– Gene silencing
– Synthetic biology
• Do we know the (safety and security) risks
connected with these techniques?
Milan, March 22, 2017 Slide 18
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New biosafety and biosecurity threats
• Potential risks of new techniques in biotechnology:
– Easy to use and cheap
– Techniques can be used for good an bad
– Risks of applying the technique are not well known, yet
– Risks of using products manufactured using these
techniques are not well known
Milan, March 22, 2017 Slide 19
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New biosafety and biosecurity threats
Milan, March 22, 2017 Slide 20
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New biosafety threat: New techniques
» Nanoparticles – Nanomedicine
» New vectors for gene therapy
» New plant breeding techniques:
» Reverse breeding
» Agro infiltration
» Gene editing
» GM insects released in the environment
Slide 21Milan, March 22, 2017
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New biosafety threats: a role for EBSA
Enhancing knowledge and understanding of
biological safety throughout Europe and the world
• establish and communicate best practices
• encourage dialogue on developing biosafety and biosecurity issues
• seek to influence and support emerging legislation and standards in the
areas of biological safety, biosecurity, biotechnology, transport and
associated activities
• act as a focal point for the consolidation of views
• represent the interests of its members in all areas relating to biosafety,
with the objective of ensuring the prevention of harm to man or the
environment from biological substances or materials.
Practice, Information, Training, Advocacy
Slide 22Milan, March 22, 2017
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New biosafety threats: a role for EBSA
• EBSA = a non-profit organization, open to
anyone working in the field:
– Formed in 1996
– From students and senior professionals
– From diverse disciplines (healthcare, academia,
emergency response, pharmaceutical/ biotech
industry, regulatory affairs etc.)
• Represent the Biosafety community
Slide 23Milan, March 22, 2017
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EBSA Vision
Slide 24Milan, March 22, 2017
• EBSA establishes and communicates best biosafety and biosecurity
practices amongst its members and encourages dialogue and discussions
on developing issues.
• EBSA influences and supports emerging legislation and standards,
with the objective of ensuring the prevention of harm to man or the
environment from biological substances or materials.
• EBSA represents and defends the collective interests of its members
in all areas relating to biosafety and biosecurity.
Enhancing knowledge and understanding of
biological safety and security throughout Europe
and the world
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EBSA’s objectives
• EBSA Strategy 2021 (2017-2021):
Slide 25
• Risk assessment
• Sustainability of biological risk controls
• Evidence base of biological risk controls
• Human factors
Milan, March 22, 2017
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EBSA’s objectives
• EBSA Strategy 2021 (2017-2021):
• What does a biosafety professional need?
• What is the added value of EBSA at a local and
global level?
• How can EBSA strengthen its position?
Slide 26Milan, March 22, 2017
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Networking
In the past year…
Did you face a biosafety or biosecurity issue for
which you wanted additional advice?
Did you know who to go to?
Did you whish you had asked for information?
Slide 27Milan, March 22, 2017
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EBSA Network
Slide 28
Enhancing knowledge and understanding of
biological safety & security via a network of
Biosafety Professional
Practice Information
Training Advocacy
Milan, March 22, 2017
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EBSA membership 2016
Slide 29
Individual
Members9 Georgia
5 Turkey
5 Armenia
3 Israel
3 Jordan
3 Pakistan
2 Australia
2 Azerbaijan
2 China
2 Tunisia
1 Afganistan
1 Algeria
1 Hong Kong
1 India
1 Japan
1 Mexico
1 Sudan
1 USA
4
13
18
4
16
20
21
2
8
43
2
47
4
14
26
1
7
1
1
1
12
1
13
68
Milan, March 22, 2017
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EBSA Partners organizations
Slide 30Milan, March 22, 2017
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EBSA Network
Slide 31
UN
…
AfBSA
ECCO
EC
Natl
minist
EFB
ISBR
CENESCB
FEMS
FEBSOIE
IFBA
IndustryANBio
JBA
A-PBA
OSHA-
EUR
Europa
BIO
ABSA
NBNet
BBP
GeBSA
BTWCEliz.
Griffin
Fd
AMEX
Bio
SBNET
ECDC
IBP
BVF
BBNet
IPPC
CBRN
ISO
WHO
[BAG]
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Key EBSA Activities
• Laboratory Biorisk Management CWA 15793:2011 (ISO TC 212 WG5 ISO/AWI 35001)
• Promote evidence based Biosafety & Biosecurity practices
Practices
• Annual conference (with sponsored participants)
• Newsletters
• Website with member’s sectionInformation
• Pre-conferences courses
• BSP Curriculum and Certification/CWA 16335:2011
• Course certificationTraining
• EU Biosecurity and Bio-preparedness – CBRN Action Plan
• Information for BTWC negotiations, UNSCR 1540
• Enhancing representation
Advocacy
Slide 32Milan, March 22, 2017
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20th EBSA Annual Conference 2017Madrid, Spain April 25-28, 2017
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21th EBSA Annual Conference 2018Copenhagen, Denmark April 17-20, 2018
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EBSA: More informationwww.ebsaweb.eu
Slide 35