The European BioSafety Association

in a changing world

Gijsbert van Willigen

EBSA President 2016 - 2017

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

Spectrum of biosafety and biosecurity

Biosafety Biosecurity

Threats for humans, animals and the economy

Milan, March 22, 2017

Old fashioned biosafety

Milan, March 22, 2017 Slide 4

Old fashioned biosafety

Slide 5Milan, March 22, 2017

Ignaz Semmelweis

Old fashioned biosafety

Slide 6Milan, March 22, 2017

Old fashioned biosafety

Slide 7Milan, March 22, 2017

Disease with clinical symptoms

Infection without clinical symptoms

(no evident disease; detectable in

lab tests

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

Old fashioned biosafety

Milan, March 22, 2017 Slide 9

Old fashioned biosafety

• Protection from a known risk i.e. the pathogen

Milan, March 22, 2017 Slide 10

Old fashioned biosafety

• Protection from a known risk i.e. the pathogen

Milan, March 22, 2017 Slide 11

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

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

Old fashioned biosecurity

New biosafety threats:

Antimicrobial resistance

Slide 15

New biosafety threats:

Globalization

Slide 16Milan, March 22, 2017

New biosafety threats:

Globalization

Slide 17Milan, March 22, 2017

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

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

New biosafety and biosecurity threats

Milan, March 22, 2017 Slide 20

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

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

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

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

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

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

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

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

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

EBSA Partners organizations

Slide 30Milan, March 22, 2017

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]

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

20th EBSA Annual Conference 2017Madrid, Spain April 25-28, 2017

21th EBSA Annual Conference 2018Copenhagen, Denmark April 17-20, 2018

EBSA: More informationwww.ebsaweb.eu

Slide 35