Brm 1

TASK4.1IMPLEMENTATION
OF LABORATORY
BIORISK MANAGEMENT
CWA 15793
Classification Level: Unclassified
WP4With the financial support from the Prevention of and
Fight against Crime Programme of the European Union
European Commission – Directorate – General Home Affairs

TASK 4.1
IMPLEMENTATION OF LABORATORY BIORISK
MANAGEMENT CWA 15793
Task leader
SVA
Task partners
ANSES, CVI, RIVM, SMI (Associated partner), SVA
Authors of this report
Bo Sundqvist (SVA), Ulrika Allard Bengtsson (SVA), Johan Olsson (SMI),
Sandor Bereczky (SMI), Rickard Knutsson (SVA)
How to refer to this document
Sundqvist, B., Allard Bengtsson, U., Olsson, J., Bereczky, S., Knutsson, R. (2013),
Implementation of Laboratory Biorisk Management CWA 15793,
ISBN number 978-91-87147-11-1
ISBN number 978-91-87147-11-1 Layout To Be Frank Printed by Davidsons Tryckeri 2013

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WP4: EUROPEAN LABORATORY RESPONSE NETWORK (LRN) FOR ANIMAL BIOTERRORISM THREATS
TASK 4.1: IMPLEMENTATION OF LABORATORY BIORISK MANAGEMENT CWA 15793
The AniBioThreat project was in 2010 awarded a
grant by Directorate General Home Affairs under
the programme “Prevention of and Fight Against
Crime”. One issue stated in the call text in 2009
under this programme was animal bioterrorism
threats. The focus of AniBioThreat is therefore
based on threats to living animals, animal feed
and food of animal origin. As part of this, it is
foreseen that the project will enhance inter
national cooperation and promote networking for
bridging security with animal and public health.
The objectives are furthermore based upon
some of the identified actions in the EU Chemical,
Biological, Radiological and Nuclear (CBRN)
Action Plan (2009) (1), the recommendations
of the CBRN Task Force Report (2009) (2) and
especially the work that took place in the Bio
subgroup threats to animal, and food and feed
for animals (2008), and the Biosubgroup detection
and diagnosis (2008, June).
The project is divided into the following six
work packages (WPs); WP1 the establishment
of a network between law enforcement, forensic
institutes, first responders, intelligence, veterinary
institutes, public health agencies and universities,
WP2 threat assessment, WP3 early warning/
detection, WP4 European Laboratory Response
Network for animal bio-terrorism threats, WP5
detection and diagnostics and WP6 dissemination.
Specific objectives of the WPs
are as follows:
• To facilitate effective international cooperation,
improve training and establish a network
between law enforcement, forensic institutes,
first responders, intelligence agencies,
veterinary institutes, public health agencies
and universities (WP1).
• To improve monitoring and threat assessments
(WP2).
• To investigate early warning and rapid alert
for animal disease outbreaks caused by
criminal acts (WP3).
• To establish a European Laboratory Response
Network approach to counter animal bio-
terrorism threats (WP4).
• To enhance research and development of
detection methods of animal diseases, such as
anthrax, botulism and viral diseases caused
by criminal acts (WP5).
• To disseminate the outcome of the project
to relevant stakeholders through exercises,
workshops, publications, and academic
courses and to strengthen research through
existing EU projects (WP6).
The overall objective of AniBioThreat is to improve
the EU’s capacity to counter biological animal bioterrorism threats
in terms of awareness, prevention and contingency.

4
Capacity and Capability
The overall goal of the EU CBRN Action Plan is
an all-hazards approach to reduce the threat of
damage from CBRN incidents of accidental,
natural or intentional origin, including acts
of terrorism.
This deliverable has improved EU’s capacity
and capability to counter biological animal
bioterrorism threats in terms of awareness,
prevention and contingency in following areas:
Education and training capacity and capability
Research capability
Risk assessment capability
Cooperation/interoperability capability
Surveillance and rapid alert capability
Diagnostic and laboratory response
network capacity and capability
Forensic awareness capability
Contingency planning capability
Joint exercise capacity
Readiness assessment and
medical countermeasure capacity
Communication and information sharing capability
Strategic, tactical and operational
decision making capability
Abstract
Task 4.1 is dedicated to suggest an implementation
plan of the CEN workshop agreement “Labora-
tory Biorisk Management CWA 15793:2011”
(CWA 15793), a management system which is
built around the principle of continual improve-
ment through the Plan-Do-Check-Act (PCDA)
cycle. The CWA 15793 is an internationally
recognized document and by implementing
the CWA 15793 harmonisation and conformity
regarding biosafety and laboratory biosecurity
(biorisk) will be facilitated.
Laboratory Response Networks (LRN:s) are
established from a security perspective in several
countries such as the Netherlands, France and
Sweden and have a function as a preparedness
measure for a coordinated diagnostic response
capability in case of a bioterrorism incident or
other biocrimes. The EU project AniBioThreat has
identified the need of an integrated European
LRN to strengthen the preparedness against
animal bioterrorism. The CWA 15793 can facilitate
trust and credibility towards a future European
LRN. The implementation of CWA 15793 is an
assurance that the work performed at the
laboratories is managed in a structured way
with continuous improvements.
The five AniBioThreat partner institutes
consist of ANSES in France, CVI and RIVM in
the Netherlands and SVA and SMI (associated
partner) in Sweden. The five partners in Task 4.1
are national and/or international laboratory
reference institutes for public or animal health
and possess high containment laboratories and
animal facilities.
As a first step towards implementation of the
CWA 15793 the five partners gathered, discussed
and exchanged existing information concerning
biosafety/laboratory biosecurity (biorisk).
Biosafety/biosecurity officer meetings were
organized between the partners as well as a
study visit at the Institute of Virology and
Immunoprophylaxis (IVI), Switzerland with the
aim to discuss the roadmap for implementation
of the CWA 15793 and to get input from an
institute which already has implemented the
CWA 15793.
At the AniBioThreat first annual meeting a
biosafety mini-symposium was organised to
give an introduction on biosafety with e.g. risk
assessments criteria and risk group classification
of biological agents concerning human and animal

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pathogens. Personal protective equipment (PPE)
was also demonstrated in practice.
Furthermore, a Biorisk booklet, has been
produced at an early stage with the scope to raise
awareness, inform and educate about the message
of the CWA 15793, its connection to the EU CBRN
Action Plan and other important guidelines and
standards. The Biorisk booklet has also been
distributed at conferences like the EBSA, Nordic
Biosafety Network and other meetings.
To evaluate the current status of the biorisk
management system a “CWA 15793 Compliance
Checklist” was developed. The “Checklist”was
used to perform a gap analysis to establish the
current compliance status of biosafety and
laboratory biosecurity management to the CWA
15793 in the five partner institutes. Results of the
gap analysis demonstrated that the institutes
have a biorisk management programme in place,
however, several gaps were identified which need
to be addressed towards the full implementation
of the CWA 15793.
Biorisk management exercises have also been
identified as a useful tool to control compliance
status and thereby implementation of the CWA
15793. An exercise concerning an insider threat
and loss of a biological agent was performed at
SVA within the AniBioThreat project to evaluate
implementation of the contingency plans, and
also as an activity in the implementation process
of the CWA 15793. The outcome of the exercise
was perceived as very useful and improvements
to enhance biorisk preparedness were identified.
Based on the activities within the scope of the
AniBioThreat project, the following requirements
are suggested to promote implementation: (i),
support from the top management of the orga
nisations (ii) knowledge about the CWA 15793,
(iii) compliance audit checklist and gap analysis,
(iv) training and exercises, (v) networking
within LRN:s and other networks, (vi) inter-
institutional audits.
By implementing CWA 15793 at various institutes,
a well prepared LRN can be established which
would strengthen the European animal bio
terrorism response capabilities.
The activities of the Task 4.1 have been
important for the initiation and starting up the
implementation process of the CWA 15793 at the
five partner institutes. All participating partner
institutes have investigated the possibility to
implement the CWA 15793 and at least two
institutes (SVA and SMI) have taken the formal
decision to implement.
In view of the announcment that the CWA
15793 is due to expire in 2014, it is very important
to instantly react and make the CWA 15793 a
sustainable and internationally recognised
system/standard to manage biorisks in the
biorisk management community.
Deliverable according to
Grant Agreement
Implementation of Laboratory Biorisk Manage-
ment CWA 15793:2011 (recommendations).
Description of Deliverable
The deliverable consists of a report describing the
working process which have been undertaken in
Task 4.1 during the AniBioThreat project.
The main document contains the gap analysis
results and recommendations and tools to support
the implementation of the Laboratory Biorisk
Management CWA 15793:2011 (CWA 15793) (3).
A Biorisk booklet has been produced with the
pupose of raizing awareness and to inform and
educate about the message in the CWA 15793.

Bridging Statement
One of the objectives of the AniBioThreat project
is to establish a European Laboratory Response
Network (LRN) approach to counter animal
bio-terrorism threats. A specific task in this part
is to inform and increase the awareness of the
concept biorisk and to inform and educate about
CWA 15793 and its connection to the EU CBRN
Action Plan. The primary target for this is the
participants in the AniBioThreat project, but also
other stakeholders involved in the biorisk field.
Another part of this task is to plan and initiate
implementation of the CWA 15793. By imple-
menting CWA 15793 in the national laboratory
response networks (NRL`s) such as the French, the
Dutch and the Swedish the harmonization for a
future European laboratory response network will
be facilitated and provide a bridging tool between
the involved disciplines for biorisk concepts.
Insider threats are one of the most challenging
threats in terms of bioterrorism. Increased
awareness as well as improved preparedness
regarding insider threat issues are needed for
organizations working with biological agents.
The CWA 15793 covers for example loss and theft
of biological agents (laboratory biosecurity) and
the implementation of the CWA 15793 is there-
fore a structured way to manage these threats.
In the AniBioThreat project, it is important to
learn from other institutes. Through study visits,
bridging between consortium members have
been established between human and veterinary
laboratories.
Contents
Abstract 4
Bridging Statement 6
Link to EU CBRN Action Plan 7
Other relevant Actions 7
Contribution towards
overall objective of AniBioThreat 7
Task leader 8
Task partners 8
Authors of this report 8
Aim 8
Background 8
Methodology 10
Results and Discussion 11
Conclusion 17
Future Outlook and
Recommendations 18
Publications from Task 4.1 20
Acknowledgements 20
References 21
Appendix 21

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Link to EU CBRN Action Plan
Action B.4 (second bullet point) (1)
The Commission together with the Member
States should take relevant steps so that:
• facilities possessing substances on the EU
list of high risk biological agents and toxins
consider as appropriate the implementation of
the CEN Workshop Agreement (CWA 15793),
WHO Laboratory Biosecurity Guidance or
their national equivalent standards – unless
equal or more stringent national regulations
have to be considered.
This action is linked with recommendations 117,
119 from the report of the CBRN Task Force (2).
Other relevant Actions
Action B.2
The Member States should establish:
• a registry of facilities possessing any of the
substances on the EU list of high risk biological
agents and toxins within each Member State
while allowing access to law enforcement,
taking security requirements into account;
• a process to verify whether security arrange
ments of facilities are adequate, including
diagnostic laboratories handling and possessing
any of the EU list of high risk biological
agents and toxins;
• a mechanism within facilities storing biological
agents and toxins on the EU list of high risk
biological agents and toxins to regularly
review the need of such biological agents and
toxins while keeping a good record of stored
materials.
Action B.14
• The Member States with the Commission
should encourage better cooperation among
relevant agencies in crisis and consequnce
management, response and recovery manage-
ment. A bio-specific checklist of requirements
for consequence management, response and
recovery should be developed and discussed
by the CBRN Advisory Group.
Action B.15 (first bullet point)
Member States together with the Commission
should identify and spread:
• good practice and well targeted training for
and education of individuals working with,
having access to and handling substances
on the EU list of high-risk biological agenst
and toxins.
should consider and, where appropiate, develop:
• together with relevant stakeholders, guide
lines at the EU level for minimum training
requirements for person working with, having
access to or handling, substances on the EU
list of high-risk biological agenst and toxins.
Action B.16 (second bullet point)
should consider and, where appropiate, develop:
• in conjuction with universities and professional
associations, minimum requirements for
academic training on bio-safety, potential
misuse of information and biological agents
and toxins and bio-ethics for undergraduate,
graduate and postgraduate students.

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Contribution towards
overall objective of AniBioThreat
The implementation of the CWA 15793 offers a
uniform structure and mutual understanding in
the collaboration between partners and labora
tories and staff will feel confident to work in the
biorisk management system. The implementation
process of the CWA 15793 will increase the
biorisk awareness and will help to identify and
make participants conscious of biological risks
and how to handle them.
The initiation process of implementing the CWA
15793 (gap analysis) is an important and valuable
experience with results about biorisk manage-
ment as well as being a bridging tool between
partners in the AniBioThreat project and by that
promote the establishment of an European LRN
for animal bioterrorism threats. The bridging
experience is notable since it covers both human
and veterinary laboratories and also extend into
the forensic and research laboratories.
Task leader
SVA
Task partners
ANSES, CVI, RIVM, SMI (Associated partner)
and SVA
Authors of this report
• Bo Sundqvist (SVA)
• Ulrika Allard Bengtsson (SVA)
• Johan Olsson (SMI)
• Sandor Bereczky (SMI)
• Rickard Knutsson (SVA)
Aim
To obtain recommendations for implementation
of Laboratory biorisk management CWA
15793:2011.
Background
The EU CBRN Action Plan has identified the need
for different kind of activities which increase the
awareness, understanding and conformity
regarding biosafety and laboratory biosecurity.
In that respect a robust response is considered
necessary to meet a covert and/or overt bio
terrorism incident and consequently diagnostic
network capabilities must be established.
Accordingly a diagnostic response strategy must
be able to handle both types of incidents that
requires a multidisciplinary network composed
of diagnostic capabilities both in law enforce-
ment agencies and public health organizations
such as environmental, agricultural, food,
veterinary and human medicine. All these
demands have resulted in the development of
Laboratory Response Networks (LRN) in several
countries, for instance in the USA, Canada,
Australia and South Korea. But also in the EU by
France, the National Network of Biotox-Piratox
laboratories, the Netherlands, National Network
of Laboratories for Terrorist Attacks (Landelijk
Laboratorium Netwerk terreur aanslagen,
LLN-ta) and Sweden, The Swedish Laboratory
Response Network (LRN) (Svenska Laboratorie
responsnätverket).
Figure 1. Examples of national LRN’s in the EU member
states, France: Biotox-Piratox, Sweden: Swedish Laboratory
Repsone Network (LRN) and Swedish Forum for Bio
prepardness Diagnostics (FBD), the Netherlands: Landelijk
Laboratorium Netwerk terreur aanslagen (LLN-ta).

9
The national LRNs needs to further improve
collaboration and intergration to improve the
effectiveness. But there is also an additional
need to further improve the collaboration and
harmonization between LRNs in the different
EU contries to improve at the EU-level the joint
capacity to couteract (animal) bioterrorism.
Another of the identified activities is the use
of a management system and performance
measurement tool and an integrated approach of
biosafety and laboratory biosecurity, collectively
referred as biorisk management (3).
People involved in the biorisk areas understand
and interpret terms and concepts in different
ways that will hamper and obstruct collaborative
work between groups of specialists. It is also an
obvious need for training and education of staff
and management engaged in laboratories
handling biological agents. And simultaneously,
there is also an increasing need to make govern-
ments and stakeholders aware of biorisk issues.
The CWA 15793 was initiated and adopted
because organizations, laboratories and others
involved in biosafety and laboratory biosecurity
activities worldwide identified the need for
harmonization and conformity regarding biosafety
recommendations and guidelines. The CWA
15793 represents a management system which
covers the administrative and operational
activities of a facility concerning biorisk and is
compatible with other quality management
systems and built around the Plan-Do-Check-
Act principle (PDCA cycle) (see Appendix 1).
The key components of the CWA 15793 are
biorisk assessment (identification of all possible
hazards/threats), mitigation measures (procedures
to effectively reduce risks) and performance
(check whether goals and standards are met).
Thus the knowledge and implementation of
the CWA 15793 offers a bridging tool for biorisk
concepts between the participants in the
AniBioThreat project. The implementation process
of the CWA 15793 will increase the awareness
concerning biorisk issues and the management
system approach with contineous improvements,
enables an organization to effectively identify,
monitor and control the biosafety and laboratory
biosecurity aspects of its activities.
Figure 2.
Biorisk and
the relationship
between
biosafety and
laboratory
biosecurity
with some
examples of
operational
topics.

10
Methodology
WP4 – Task 4.1 meetings
At the three WP 4 annual meetings – Task 4.1
actions needed to collect and compile existing
safety/biosecurity information per partner were
discussed and agreed upon. Compiled information
was distributed between the task members that
were used in the development of recommen
dations to facilitate the implementation of the
CWA 15793.
• Inventory of networks with knowledge of
CWA 15793.
Several biosafety networks were identified and some
of them were contacted for further information,
• Overview of legislation and rules in the
different EU countries (partners).
All partners reportred about legislation
concerning biosafety and biosecurity.
• Obtain consensus about terms and definitions
in CWA 15793.
Terms and definitions were discussed in Task 4.1
but also together with Task 1.1.
• Collect and “understand” the different
conditions per partner for implementation of
CWA 15793.
All partners presented their current situation
concerning biosafety and biosecurity programmes/
manuals.
• Compile and evaluate a compliance checklist
as tool to evaluate the compliance biorisk
status.
All partners used the compliance checklist to get
an overview and identify what parts were in place
and what parts were missing.
The Task 4.1 meetings have been very useful
and effective to make progress in the project. To
a large exent work can be performed in between
the meetings but it is however very important
and fruitful to meet and discuss in person to
facilitate networking and contact.
Biosafety /laboratory biosecurity (biorisk)
meetings
At five occasions joint meetings have been
arranged with biosafety/biosecurity (biorisk)
personnel from ANSES, CVI, RIVM, SVA, SMI.
The aim was to exchange information and
discuss the current status and implementation
strategies based on the CWA 15793 (3) and the
Guideline applied to the CWA 15793 (4). As a
practical tool to record and compare the results
the jointly developed “CWA 15793 Compliance
Checklist” in Excel was used.
Study visit
A biosafety/laboratory biosecurity officer meeting
was organized at the Institute of Virology and
Immunoprophylaxis (IVI), Mittelhäusern in
Switzerland. The aim was to discuss the road-
map for implementation of the CWA 15793 and
to get input from an institute which already has
implemented the CWA 15793. The study visit
involved participants from ANSES, CVI, RIVM,
SVA and IVI and consisted of biosafety officers,
quality assurance managers, technical personnel
and top management.
Biosafety mini-symposium
During the First Annual Meeting in Garderen,
the Netherlands, 13-15 April 2011, one of the days
was dedicated to a biosafety mini-symposium.
The aim of the day was to focus on biosafety in
the context of AniBioThreat and also to raise
awareness concerning biosafety/biosecurity
(biorisk) issues among the participants.
Exercise: Insider Threat
As part of SVA’s participation in the EU project
AniBioThreat, a pilot scenario exercise was
performed. In the CWA 15793 is listed a number
of emergency scenarios to exemplify different
biosafety and biosecurity issues. One of them is
related to the important and relevant “potential

11
loss of biological agents and toxins through theft
or any other reason” (CWA 15793, section 4.4.5.1).
Core emergency scenarios have been developed
in collaboration with Task 1.1 (Task 1.1 Appendix 6).
Thus, one of the scenarios was developed into an
emergency exercise, “the insider”, in collaboration
with two other partners in AniBioThreat, the
Swedish Civil Contingencies Agency (MSB) and
the Swedish National Police Board (RPS), both
of whom took part in the exercise.
The purpose of the exercise was to analyze
the strengths and weaknesses of SVA’s security
and emergency management, and its role and
work processes in a crisis. Another purpose was
to discuss development measures in the short and
long term to identify strengths and weaknesses
in the safety and preparedness management
(contingency plans) and to evaluate the inter-
operability between SVA and the police during
crisis management. By identifying the strengths
and weaknesses, activities can be undertaken to
reduce the vulnerability.
The exercise involved all of the decision-
makers in the security and emergency manage-
ment organization at SVA, including the Deputy
Director-General, security manager, biological
agents and feed specialists, communications
manager, human resources manager, biosafety
officer, state epizootiologist, agency lawyer and
head of technical service.
Biorisk compliance gap analysis
Based on the CWA 15793 (3) and the CWA 16393
– Guidance document to the CWA 15793 (4), a
gap analysis was individually performed by the
five institutes. Criteria used were the availability
of supporting documents (SOPs, handbooks,
guidances) and the level of compliance to these
documents. The presence of a supporting
document and the level of compliance were
scored, depending on how many of the items
mentioned in the Guidance document were
covered in the institute’s procedures. The
consistency of the gap analysis was made as
a relative assessment without any attempt to
harmonize between the institutes.
The purpose of the gap analysis was to get
information of areas that were compliant and not
compliant to the CWA 15793 and by that be able
to continue the implementation process.
Results and Discussion
WP 4 – Task 4.1 meetings
The results from the Task 4.1 meetings, where
the purpose was to collect and compile existing
information concerning biosafety/laboratory
biosecurity (biorisk) among the partners, are
described below. This information was valuable
and the base from where further activities were
planned towards recommendations for imple-
mentation of the CWA 15793.
• Inventory of networks with knowledge of
CWA 15793.
Many biosafety networks know about the CWA
15793, but in conclusion the research or security
community knowledge about the CWA 15793 is
generally very limited. The networks which were
contacted had made their own compliance checklist
and we did not get information about any official,
general checklist.
• Overview of legislation and rules in the
different EU countries (partners).
The outcome from this study was that legislation
concerning biosafety and laboratory biosecurity
differs among the partner countries. Some partner
countries have both a biosafety and laboratory
biosecurity legislation, whereas some countries
have a biosafety legislation (working protection)
but lack a laboratory biosecurity legislation.
• Obtain consensus about terms and definions
in the CWA 15793 (Task 1.1).
Consensus concerning terms and definitions were
obtained. Terms and definitions are very important
in this project (see also Task 1.1) to facilitate work

12
across different disciplines in e g a bioterror event.
In Task 4.1 it was agreed that the definitions used
in the CWA 15793 will be the ones we will use.
• Collect and “understand” the different
conditions per partner for implementation of
CWA 15793.
The participating partners have different biosafety
and laboratory biosecurity systems in place which
means that implementation of the CWA 15793
will demand different amount of effort and
resources. The diversity among the participating
partner institutes is natural and have been a
valuable platform from where fruitful discussions
for the development of the project have taken place.
• Compile and evaluate a compliance checklist
as a tool to evaluate the current compliance
status.
The result of the evaluation is described in the gap
analysis below.
We identified that many biosafety networks are
involved and have knowledge about the CWA
15793, but that there was no general “CWA 15793
Compliance Checklist” available. Therefore
activities to develop a checklist started. We also
learned that the participating partner countries
had very different situations concerning e.g.
legislation covering biosafety and laboratory
biosecurity, but there is no hinder to implement
the CWA 15793 as a complement to existing
legislation. Terms and definitions are complicated
and different disciplines sometimes use different
definitions for the same word. It is most valuable
that concensus is reached concerning this to
achieve the bridging between safety, security
and research.
Biosafety/ laboratory biosecurity (biorisk)
meetings
ANSES, CVI, RIVM, SMI and SVA exchanged
information and discussed the current status about
the implementation process. The discussion was
based on the CWA 15793 and the Draft Guideline
applied to the CWA 15793 and as the practical
tool the Excel file “CWA 15793 Compliance
Checklist” was used to record the result.
Partners decided to review and use the “CWA
15793 Compliance Checklist” to check the current
status of the biorisk quality system with the goal
to make a priority plan for the implemention of
of the CWA 15793.
At RIVM the design of a BSL 3/4 laboratory
started in 2002. Today the facility building is
in place and in the final validation phase. The
new BSL4 biosafety manual design is initially
integrated into the BSL 4 biorisk/safety manual.
For instance the BSL 4 biosafety manual has been
reviewed against the CWA 15793 to check that all
parts of the CWA 15793 have been included.
Further work is in progress with SOPs, documents,
templates etc with the long term goal that the
Biosafety manual will be in full compliance with
CWA 15793. However the management part is
not yet involved at this early stage.
At ANSES the discussion about the imple-
mentation process was about the CWA 15793,
the Guideline applied to the CWA 15793 and as
a practical tool to record the results use the Excel
file “CWA 15793 Compliance Checklist”. Another
purpose was to meet the new project members
and biosafety officers at ANSES and introduce
them into the project AniBioThreat, the WP 4 and
Task 4.1.
In summary the thorough discussions of
the biosafety/ laboratory biosecurity (biorisk)
systems used by the involved laboratories were
very learning and valuable to understand the
current situation and plan for further activities
concerning the implementation of the CWA. The

13
exchange of ideas and networking from these
meetings are very valuable for the outcome of
the project.
Study visit
A biosafety/laboratory biosecurity meeting was
organized at the Institute of Virology and Immuno-
prophylaxis (IVI), Mittelhäusern in Switzerland.
The aim was to discuss the implementation
and use of CWA 15793 and get input from an
institute which already fully has implemented
the biorisk management.
Figure 3. Participants from the different institutes at the study
visit IVI, Switzerland, 2012
The study visit consisted of an introductory
presentation of the IVI, and a background
presentation of AniBioThreat and Task 4.1 project.
Further arrangements were focusing on the
considerations that were made prior to the
decision by IVI to implement the CWA 15793
and the following practical approach how the
implementation steps have been introduced into
the management quality system.
Finally, the participants discussed in general
the difficulties and advantages with implementing
the CWA 15793 and the result was summarized
in the following way:
• The most important step to start the imple-
mentation of the CWA 15793 is to get the
management involved. That could be more
or less difficult and it’s important to show
and discuss different ways to address the
management. To show the advantages when
implementing the standard to the manage-
ment is essential.
• A gap analysis is a good and effective way
to start the implementation work and it will
identify areas which are already in place, but
also what is missing.
• To prioritize the gaps found are also important,
so the administrative load is balanced
• The size of the facility is also a factor to bear in
mind. It’s in some ways easier to implement a
system in a smaller organization than in a big
and maybe one can consider to start the
implementation in one area, like the high
containment, and see how that turns out
before continue with other areas.
• In smaller organizations one person can have
several responsibilities regarding biorisk
management.
• To implement a management system is not
done overnight – must take time (approx 3
years if you start from scratch)
It was very valuable to be able to make a visit at
the IVI and discuss the implementation process.
All the above mentioned activities are important
to make an implementation process sucessful. It
is not enough with a great engagement from the
biosafety people but the management must also
be involved. Both to provide resources and get
understanding in the organisation.
Biosafety Mini-symposium
The mini-symposium gave an introduction on
biosafety with risk assessments criteria and
risk group classification of biological agents
concerning human and animal pathogens.

14
Personal protective equipment (PPE) was also
demonstrated in practice.
Another topic that was discussed was how to
act during an outbreak. What kind of PPE is
needed, how to take samples in the field etc. The
role of the Biosafety Officer in such event was
also discussed. The outcome of the discussions
was that it is important with preparedness/
contingency plans which are trained through
exercises, and also networks which can be
contacted in an outbreak situation (natural or
deliberate).
The Biorisk booklet, an additional deliverable
from Task 4.1, was also launched during the
biosafety mini symposium (Task 4.1 Appendix 1).
The scope of the booklet is to raise awareness,
inform and educate about the message of the
CWA 15793, its connection to the EU CBRN
Action Plan and other important guidelines and
standards.
The primary target audience for the Biosafety
mini-symposium was the participants in the
AniBioThreat project, but the Biorisk booklet
could be of value also for other stakeholders. The
goal of the mini-symposium and accompanying
booklet was to show the importance of the CWA
15793 and to provide a bridging tool between the
participants from different disciplines.
The take home message from this event was that
it is very important to have this kind of training
sessions to raise awereness and give time for
discussions to enhance the knowledge among
the different praticipating disciplines. The
practical training part with the PPE was also
very valuable to get an understanding of the
function, and to provide the required protection.
Exercise: Insider Threat
The AniBioThreat project has developed a
number of preparedness scenarios. One of these
scenarios resulted in an insider exercise with the
overall objective to test the top management and
contingency plans for insider threat. In this
exercise the top management of SVA was involved
to handle an insider threat and a presumptive
loss of a biological agent.
The exercise involved all of the decision-
makers in the security and emergency manage-
ment organization at SVA, including the Deputy
Director-General, security manager, biological
agents and feed specialists, communications
manager, human resources manager, biosafety
officer, state epizootiologist, agency lawyer and
head of technical service.
The results from the “insider exercise” showed
unambiguously that the participants thought the
Figure 4. Different kind of personal protective equipment
(PPE) was demonstarted and some participants were also
to try in practice.
Figure 5. The Biorisk
booklet “Biorisk, the
laboratory biorisk
management
standard. A bridging
tool for laboratory
biosafety and
biosecurity”.
1
Biorisk
WP4CWA 15793:2008
The LABorATory Biorisk MAnAgeMenT sTAndArd
A Bridging Tool for Laboratory Biosafety and Biosecurity

15
exercise was relevantly structured and well
executed, and the overall objectives had been
achieved (Task 4.1 Appendix 2).
Additionally, as one of the important parts
of the CWA 15793, “Emergency scenarios”,
where identification of biorisk areas, response/
contigency plans and exercises are essential, this
exercise fulfilled a very valuable purpose and
was therefore also a part of the implementation
process of the CWA 15793 at SVA (5).
The results and conclusions of the exercise
clearly showed that:
• It was necessary and valuable to involve top
management in this kind of exercise,
• Joint training between SVA and the police
increased knowledge and understanding of
each other’s competence and way of working,
In total it can be concluded the results of the
exercise contribute to the improvement of and
revision of the contingency plans at SVA and also
a step further towards the implementation of the
CWA 15793.
Implementation decision making
In the decision process to implement CWA 15793
it was considered important that the entire
management board has been informed in order
to support and understand the biorisk concept.
Thus at different occasions the management
team at SVA was introduced to the CWA 15793
and ongoing work in Task 4.1.
On the 20th of May at the SVA Management
Board meeting a decision was made to implement
the Laboratory Biorisk Management CWA 15793.
The decision on implementation has been
facilitated and prepared by the activities that have
been performed within the AniBioThreat project
and more specifically by Task 4.1 dedicated to
the implementation of CWA 15793 by partner
institutes. The implementation will facilitate the
harmonization and conformity regarding bio
safety and laboratory biosecurity (biorisk) and
for an increased security culture.
The implementation will be organized by
Quality Manager Jerker Plobeck, Biosafety Officer
Ulrika Allard Bengtsson (standing, see figure 8) and
Deputy Director General Staffan Ros (sitting).
Figure 6. Security and emergency management at SVA
involved in insider threat exercise.
Figure 7. Director General Jens Mattsson signing the CWA
15793 implementation decision.

16
Biorisk compliance gap analysis
The combined results of the gap analysis from
the five institutes (ANSES, CVI, RIVM, SMI, SVA)
demonstrated that the participating institutes
already have well developed biorisk manage-
ment programmes in place: more than three
quarters of the procedures were in place and the
majority of these procedures are in compliance
with the CWA 15793 (5). The results of the five
institutes were combined and the accumulated
result is shown in Table 1. The individual results
obtained at institutional level showed that none
of these institutes had a significant different level
of compliance. The gap analysis gave a rough
estimation of the current situation; further
analysis will be needed to get more detailed
information.
The exercises (eg Insider exercise) are also
a very important tool to verify the implemen
tation of plans, routines and instructions and
should be used regularly in different scenarios
as a measurement of compliance. Another
conclusion of the results is that for implemen
tation of the CWA 15793 full support of the top
management is needed as well as resources for
operation and maintenance.
Procedures or compliance are satisfactory
Procedures or compliance are developing
Procedures or compliance are challenging
Table 1. CWA 15793 gap analysis at five national reference laboratories involved in public and veterinary health in
France, the Netherlands and Sweden. The results are shown accumulated by the institutes: ANSES, CVI, RIVM, SMI
and SVA (BSL 1– 4 laboratories and animal facilities). Modified from reference 5.
Item Description Compliance status per sub-item
1 2 3 4 5 6 7 8 9 10
4.1 General
requirements
4.1.1 Biorisk management system
4.1.2 Continual improvement
4.2 Policy 4.2.1 Biorisk management policy
4.3 Planning 4.3.1 Planning for hazard identification,
risk assessment and risk control
4.3.2 Conformity and compliance
4.3.3 Objectives, targets and programme
4.4 Implementation
and operation
4.4.1 Roles, responsibilities and authorities
4.4.2 Personnel training, awareness and
competence
4.4.3 Consultation and communication
4.4.4 Operational control
4.4.5 Emergency response and contingency
plans
4.5 Checking and
corrective action
4.5.1 Performance measurement and
analysis of data
4.5.2 Records, document and data control
4.5.3 Inventory monitoring and control
4.5.4 Accident and incident investigation,
non-conformity, corrective and
preventive actions
4.5.5 Inspection and audit
4.6 Review 4.6.1 Biorisk management review

17
International dissimination symposium
and meetings
Poster at EBSA meeting 2012
The EU-project AniBioThreat – Implementation
of the Laboratory Biorisk Management Standard
(CWA 15793) as a bridging tool for law enforce-
ment agencies, animal and public health agencies
and universities (Task 4.1 Appendix 4).
Poster at EBSA meeting 2013
Harmonizing European Laboratory Response
Networks by implementing the CWA 15793
Laboratory biorisk management: use of a gap
analysis and an insider exercise as tools
(Task 4.1 Appendix 5).
CoVetLab meeting 2013
Presentation of the AniBioThreat and specifically
the Task 4.1 project at the CoVetLab (Collaboration
Veterinary Laboratory) annual meeting in
Copenhagen, 2013. The purpose was to make
the top managements of the institutes aware of
the ongoing work in Task 4.1 to implement the
CWA 15793 and the benefits for the participants
(Task 4.1 Appendix 6).
Conclusion
The results from the work in Task 4.1 has contri-
buted to the fulfillment of the several actions, in
first hand to Action B.4 (second bullet point) but
also the Action B.2 and B.15:
Action B.4
• Compliance checklist
• Gap analysis
• Biorisk booklet
• Recommendations
• SVA formal decision to implement
CWA 15793
• Publication accepted as part of AniBioThreat
Supplement Issue
Action B.2
• Action B.2 is mostly covered in the CWA
15793 since it has the section of laboratory
security (access control) and inventory of
agents, which has to be managed,
• Gap analysis showed that improvements in
this field can be made.
Action B.15
• Action B.15 concerning training of personnel
handling high risk biological agents and
toxins are also covered in the CWA 15793
where training is an essential part,
• Biosafety Mini-symposium,
• Biorisk booklet.
The activities of the AniBioThreat project and
Task 4.1 have been important for the initiation
and start up the implementation process of the
CWA 15793 at the five partner institutes.
Without the EU resources the start of the
implementation process and the spread of the
awareness and knowledge would have been
delayed. All participating partner institutes have
investigated the possibility to implement the
CWA 15793 and at least two institutes (SVA and
SMI) have taken the formal decision to implement,
which is a very good outcome of this project.
The Biorisk booklet was an important tool to
spread information regarding the CWA 15793 at
an early stage of the project. Since many of the
participants in the AniBioThreat project were
from disciplines other than the biological field it
was a good opportunity to raise awareness,
inform and educate about biorisks and how they
can be managed. The Biorisk booklet has also
been distributed at conferences like the European
Biosafety Association, Nordic Biosafety Network
and other meetings.

18
The development of the “CWA 15793 Compliance
Checklist” and performance of the gap analysis
has been a learning process and the conclusion
so far is that the gap analysis is a good igniter for
the CWA 15793 implementation process and a
very useful tool to get information about what
is in place and where improvements have to
be made. Performing the gap analysis is also a
valuable tool since it raise awareness about the
CWA and the biorisk issues all the participating
institutes have to deal with in their daily work.
Laboratories meeting the requirements for
the FMDV or the BSL 4 standards are already
compliant with most of the requirements of the
CWA 15793, but not necessarily other laboratories
like human, veterinary and forensic, working with
different biological agents. In these laboratories it
depends on laws in each country and working
according to the CWA 15793 is a significant
support and assistance to implement a manage-
ment system to better control laboratory biorisks.
By implementing the CWA 15793 in the
national response laboratories such as in France,
the Netherland and Sweden, there will be a
uniform structure and understanding regarding
work with biorisk issues and by that the harmo-
nization for a future European laboratory
response network (EU LRN) will be facilitated.
Other options to continue and expand the
implementation and learning process of imple-
menting the CWA 15793 could be the collaboration
in other networks e.g. Collaborating Veterinary
Laboratories (CoVetLab: www.covetlab.org),
biosafety organisations like the Nordic Biosafety
network (http://www.smittskyddsinstitutet.se/
nordic-biosafety-network), European Biosafety
Association (EBSA: http://www.ebsaweb.eu),
American Biosafety Association (ABSA: www.
absa.org) and International Veterinary Biosafety
Workgroup (IVBW: www.ivbw.camp9.org).
In summary we conclude that the following
recommendations can provide valuable guidance
and tools on the route towards an implementation
of CWA 15793:
• Advantage to have implemented the follo-
wing management standards:
– ISO 9001 (Quality)
– ISO 14001 (Enviromental)
– ISO 18001 (Occupational Health and Safety)
• Engagement, support and resources from
top management,
• Raising awareness and knowledge about the
CWA 15793 – All employees involved in the
work with biological agents should be
informed and involved in the implementation
process,
• Development and use of a compliance
checklist,
• Performance of gap analysis,
• Draft and use of emergency scenario booklet,
• Regularly performed training and exercises,
• Use of existing networks (like LRN and
others), where the implementation
process has started,
• Inter-agency audits between institutes and
external audits,
• Promotion and support from policy makers.
Future Outlook and Recommendations
The following recommendations are linked to
the Action B.4 (second point).
CWA 15793 as a sustainable international
standard/system to manage biorisk
Work with infectious agents around the world
is a growing market and the need to increase the
awareness, understanding and conformity
regarding biosafety and laboratory biosecurity has
been identified. The CWA 15793 is an important
international document that helps this growing
market to manage biorisks by an effective biorisk
management system and has been the harmo
nizing tool for laboratories around the world.

19
When it was announced that in September 2014
the CWA 15793 is due to expire and be withdrawn
by CEN, a current initiative started to transform
the CWA 15793 into an appropriate ISO-deliverable
or other internationally recognizable standard
(6, 7, 8).
EU has a great responsibility to take part in
this process and make the CWA 15793 (3) and its
associated guidance document, CWA 15693 (4),
a sustainable and internationally recognised
system/standard to manage biorisks in the
biorisk management community.
Biorisk management collaboration EU LRN’s
Biorisk management collaboration between
member states networks (LRN’s) for bioterror
incidents is very important. Implementation of
the CWA 15793 can facilitate trust and credibility
by aiding integration, exchange of personnel,
enabling sending and receiving samples and
ensuring liability towards a future European
LRN (EU LRN). Implementation of the CWA
15793 is a first step towards a more harmonized
management concerning biological agents. Other
areas which also can increase the collaboration
between LRN’s in Europe is harmonization
regarding transportation of biological samples and
collaboration concerning training and exercises.
Inter-agency audits
Inter-agency audits can be a valuable tool to
facilitate the implementation of CWA 15793 and
also an assurance that work performed at the
laboratories is performed in a structured way
with continuous improvements (according to
the PDCA cycle).
The use of existing networks is essential in the
implementation process and both LRN and other
networks within the biorisk community can be
very useful as discussion and learning partners.
As an example, networks can be a valuable
source performing inter-agency audits as an
external audit with experts from different
institutes.
This could also be an opportunity to exchange
knowledge and experience and a tool to continue
the important networking between institutes
and other stakeholders. Inter-agency audits is
an activity which has been planned but not yet
activated, and should be a prioritized activity in
existing networks.
More guidance and directions to promote net-
works how to implement the CWA 15793 at:
EU level – between member states
• Together with the international biosafety
associations promote the process towards a
sustainable and internationally recognized
biorisk management standard,
• Facilitate activities by funding that increase
harmonization concerning transportation of
biological samples/agents and toxins,
• Support by funding networking and collabo-
ration between institutes within the biorisk
mangement community to increase prepared-
ness against different biological threats/
events, by encouraging common training
and excercises.
Member state level – nationally between sectors
in animal and public health and law enforcement
• Participate in the work towards the develop-
ment of the CWA 15793 to an internationally
recognized biorisk management standard and
encourage inter-agency audits,
• Prioritize work towards harmonization
concerning transportation of biological
samples / agents and toxins,
• Encourage collaboration between states
and institutes concerning joint training
and exercises, to enhance the capability
of managing a biological threat/event

20
Institutional level
• Implement the CWA 15793 (or national
equivalent standards) and in that process
raise awareness and knowledge among all
employees involved in the work with
biological agents and toxins,
• Participate in networks working with biorisk
management issues like transportation of
samples, to increase harmonization and
facilitate inter-agency collaboration,
• Use networks within the biorisk community
to perform inter-agency audits as a tool to
implement the CWA 15793 and work with
continous improvements,
• Regularly perform training and exercises
internally and in networks
Acknowledgements
The framework of the EU-project AniBioThreat
(Grant agreement: HOME2009/ISEC/AG/191)
with support from the Prevention of and Fight
against Crime Programme of the European
Union European Commission – Directorate-
General Home Affairs. This publication reflects
the views only of the authors, and the European
Commission cannot be held responsible for any
use which may be made of the information
contained therein.
Many thanks to Kathrin Summermatter,
Deputy Director, BSO (IVI ) for hosting the highly
appreciated study visit at IVI, Switzerland.
Publications fRom Task 4.1
Peer reviewed
• Sundqvist, B., Allard Bengtsson, U., Wisselink, H.J., Peeters B.P.H., van Rotterdam, B., Kampert, E., Bereczky, S.,
Olsson, NGJ., Szekely Björndal, Å., Zini, S., Allix, S., Knutsson. R. Harmonization of European Laboratory Response
Networks by Implementing the Laboratory Biorisk Management CWA 15793: Use of a Gap Analysis and an “Insider”
Exercise as Tools. 2013 Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science.
Accepted for publication.
Booklet
• AniBioThreat “Biorisk, the laboratory biorisk management standard. A bridging tool for laboratory biosafety and
biosecurity”, SVA:s report series 17 ISSN 1654-7098. A booklet to raise awareness of the new concept biorisk and
the message of the new Laboratory Biorisk Management Standard; CWA 15793.
Book chapters
• Contribution to book “Bioterrorism”, ISBN 978-953-51-0205-2, edited by Stephen A. Morse – Chapter “Diagnostic
Bioterrorism Response Strategies” by Rickard Knutsson, National Veterinary Institute (SVA), Sweden. The permanent
web address can be reached by http://www.intechopen.com/articles/show/title/diagnostic-response-strategies.

References
1. EC 2009a. Communication from the commission to the
european parliament and the council 19 on strengthening
chemical, biological, radiological and nuclear security in
the 20 European Union – an EU CBRN Action Plan.
15505/1/09 REV 1 COR 2. 26 November 2009.
Available from: http://register.consilium.europa.eu/pdf/
en/09/st15/st15505-re01co02.en09.pdf.
2. CBRN Task Force Report. Report of the CBRN Task
Force. Available from: http://ebsaweb.eu/ebsa_media/
Downloads/Activities+_+Projects/Biosecurity+and+
Biopreparedness/CBRNupdate02_02_2009/
CBRN+TF+Report_20_01_2009.doc
3. Laboratory biorisk management 15793:2011
(September 2011). Available from: http://www.cen.eu/
CEN/sectors/technicalcommitteesworkshops/work-
shops/Pages/ws31.aspx
4. Laboratory biorisk management – Guidelines for the
implementation of CWA 15793:2008. Available from:
ftp://ftp.cen.eu/CEN/Sectors/List/ICT/Workshops/
CWA%2016393.pdf
5. Sundqvist, B., Allard Bengtsson, U., Wisselink, H.J.,
Peeters B.P.H., van Rotterdam, B., Kampert, E.,
Bereczky, S., Olsson, NGJ., Szekely Björndal, Å., Zini, S.,
Allix, S., Knutsson. R. Harmonization of European
Laboratory Response Networks by Implementing the
Laboratory Biorisk Management CWA 15793: Use of
a Gap Analysis and an “Insider” Exercise as Tools.
2013 Biosecurity and Bioterrorism: Biodefense Strategy,
Practice, and Science. Accepted for publication.
6. U.S. Department of Energy and Sandia National
Laboratories, Evolution of CEN Workshop Agreement
15793:2011: An Evaluation of Options. February 2013.
7. European Biosafety Association (EBSA), Available from:
http://www.ebsaweb.eu/cwa
8. International Federation of Biosafety Associations
(IFBA), Available from: http://www.internationalbiosafety.
org/IFBANews.aspx?MenuItemID=ba3e49ab-6fc0-437f-
b923-93951bb11d15

appendix
Appendix 1:
AniBioThreat “Biorisk, the laboratory biorisk
management standard. A bridging tool for
laboratory biosafety and biosecurity”, SVA:s
report series 17 ISSN 1654-7098. A booklet to
raise awareness of the new concept biorisk
and the message of the new Laboratory Biorisk
Management Standard; CWA 15793.
Appendix 2:
Report from Exercise ‘Insider’, SVA, Uppsala,
November 2011. Results are reported as
restricted (Annex X). The annex has been
classified in accordance with the Swedish law
“Public Access to Information and Secrecy Act
(SFS 2009:400)”: Chapter 15, § 1, Chapter 15, § 2,
and Chapter 18, § 13.
Appendix 3:
CWA 15793 Compliance Checklist
Appendix 4:
Poster presentation, EBSA Portugal, 2011
Appendix 5:
Poster presentation, EBSA Switzerland, 2013
Appendix 6:
Presentation AniBioThreat, Task 4.1
at CoVetLab meeting Denmark, 2013

Task 4.1: Appendix 1
1
Biorisk
WP4CWA 15793:2008
The LABorATory Biorisk MAnAgeMenT sTAndArd
A Bridging Tool for Laboratory Biosafety and Biosecurity

2
TiTLe
“Bio-preparedness measures
concerning prevention, detection
and response to animal
bioterrorism threats”
ACronyM
AniBioThreat
ToTAL CosT
€7.003.992,26
FinAnCes
With the financial support from
the Prevention of and Fight against Crime
Programme of the european Union.
european Commission –
directorate-general home Affairs.
grAnT AgreeMenT nr
hoMe/2009/iseC/Ag/191
sTArT dATe oF The ProjeCT
1 october 2010
dUrATion
3 years
CoordinATor
national Veterinary institute
sVA, sweden

ConTenTs
PUrPose 5
AniBioThreAT
Bridging seCUriTy,
sAFeTy And reseArCh 6
Biorisk MAnAgeMenT sysTeM 7
deFiniTions 8
Biorisk – A neW ConCePT 9
ThoUghTs FroM
AniBioThreAT PArTiCiPAnTs 10
LABorATory Biorisk MAnAgeMenT
sTAndArd (CWA 15793:2008) 12
ACTiViTies in AniBioThreAT 14
ConCLUding reMArks 17
reFerenCes 18
Publisher Rickard Knutsson National Veterinary Institute (SVA), Uppsala, Sweden
Editors Bo Sundqvist (SVA), Ulrika Allard Bengtsson (SVA)
Photos SVA
Page 7: With permission from RPS
Page 13: With permission from SKL
Production To Be Frank
Printed by Danagårds Grafiska
ISSN: SVA:s report series 17 ISSN 1654-7098

5
PUrPose
The purpose of this booklet is to raise awareness,
inform and educate about the message in
the Laboratory biorisk management standard
CWA 15793, its connection to the EU CBRN
Action Plan and other important documents.
In addition, this material will in a longer
perspective improve the bio-preparedness to
handle biological animal threats.
The primary target audience is the participants
in the AniBioThreat project, but the document
could also be of value for other stakeholders
involved in the biorisk field. One goal of the
booklet is to show the importance of the
Laboratory biorisk management standard as a
bridging tool for biorisk concepts between the
participants in the AniBioThreat project. The
biorisk booklet is an additional deliverable
from WP 4 and Task 4.1: Implementation of
the biorisk management standard.
Figure 1. Symbol for Biological Hazard.
Source: Swedish Work Environment Authority.

6
AniBioThreAT
Bridging seCUriTy, sAFeTy And reseArCh
The AniBioThreat project aims to improve the
EU’s capacity to counter biological animal
terrorism threats in terms of awareness, preven-
tion and contingency by building bridges across
boundaries dividing countries, competencies and
disciplines. See figure 2 below. The focus of the
project is based on threats to living animals,
animal feed and food of animal origin. Further-
more, the project aims to enhance international
cooperation and promote multidisciplinary
networking for bridging security measures
between animal health and public health.
Understanding and interpretation of terms and
concepts used in the biorisk area are not harmo-
nized among the users and may harm and
obstruct collaborative work between groups of
specialists, laboratories, authorities, networks
and other stakeholders. Bridging tools in Ani-
BioThreat is needed and therefore we need to:
• Build networks within the biorisk area
(security, safety, research)
• Share experiences from different scientific
disciplines such as veterinary medicines,
food safety, forensic sciences and
computing sciences
• Provide education material
• Use common terms and definitions in order
to improve communication between partners
• Build scenarios on experiences for training
and exercise applications
SECURITY
RESEARCH
SAFETY
Se
curityculture•Classifiedinformation
• Law
enforcement agencies
Safety culture • Quality Assuranc
e
•SOPs•AnimalandPublicHealth
a
gencies
Research
culture • Publication is essential • U
niversities
Bridging seCUriTy, sAFeTy And reseArCh
Figure 2. Overview of
different disciplines and
cultures in AniBioThreat.

7
Biorisk
MAnAgeMenT sysTeM
A management system is a framework of
processes and procedures used to ensure that
an organization can fulfil all tasks required to
achieve its objectives. A biorisk management
system approach enables an organization to
effectively identify, monitor and control the
laboratory biosafety and laboratory biosecurity.
An effective biorisk management system
should be built on biosafety/biosecurity policies
including the concept of continual improvement
through the cycle of planning, implementing,
reviewing and improving the processes and
actions that an organization undertakes to
meet these goals. This is known as the PDCA
(Plan-Do-Check-Act) principle:
• Plan: Planning, including identification of
hazard and risk and establishing goals
• Do: Implementing, including training and
operational issues
• Check: Checking, including monitoring and
corrective action
• Act: Reviewing, including process innovation
and acting to make needed changes to the
management system
In order to facilitate the integration of all such
management systems of an organization, the
Laboratory biorisk management standard
(CWA 15793:2008) is compatible with the
EN ISO 9001:2000 (Quality), EN ISO14001:2004
(Environmental) and OHSAS 18001:2007
(Occupational Health and Safety) management
systems standards.
Foto: Polisen

8
deFiniTions
Biorisk(adapted from WHO, 2006)
The probability or chance that a particular adverse event
(accidental infection or unauthorized access, loss theft,
misuse, diversion or intentional release), possibly
leading to harm, will occur.
Laboratory biosafety
(adapted from: WHO, 2004)
Laboratory 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.
Laboratory biosecurity
(adapted from: WHO, 2006)
Laboratory 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.
Biorisk management system
(adapted from OHSAS 18001:2007)
Part of an organization’s management system used to
develop and implement its biorisk policy and manage
its biorisks.
• NOTE 1) A management system is a set of interrelated
elements used to establish policy and objectives and
to achieve those objectives.
• NOTE 2) A management system includes organizational
structure, planning activities (including for example,
risk assessment and the setting of objectives),
responsibilities, practices, procedures, processes
and resources.
8

9
Biorisk – A neW ConCePT
Biorisk
The term biorisk, which is the combination of
laboratory biosafety and laboratory biosecurity
has been used in laboratory settings during the
last few years. One advantage of the term biorisk
is that the management of the risks concerning
could be handled in a common way and not
separately, which is natural because many topics
are shared. See figure 3 above. Through this project,
there is an opportunity to spread the knowledge
and understanding of the concept of “biorisk” to a
broader audience involved in the many disciplines
and professions that intersect in this area (such
as the police, first responders, researchers, etc.).
LABORATORY
BIOSAFETY
• Good Laboratory
Practice
• Personal Protective
Equipment (PPE)
• Biosafety cabinets
• Ventilation control
• Waste handling
SHARED TOPICS
• Access restriction
• Compliance
• Emergency routines
• Incident reporting and
planning
• Inventory control
• Revision
• Standard Operating
Procedures (SOPs)
• Training and education
• Transport of biological
agents and toxins
LABORATORY
BIOSECURITY
• Information security
• Access control
• Transfer security
• Physical security
• Personal security
Figure 3. The relationship between laboratory biosafety and biosecurity with some examples of operational topics.

10
ThoUghTs FroM AniBioThre
Do you think the Laboratory Biorisk Management Standard will be use
10
Birgitta Rasmusson, Research
Director, the Swedish National
Laboratory of Forensic Science (SKL):
“I think the standard will
constitute an important
framework in future
collaboration between first
responders, biothreat experts,
forensic scientists and high
security laboratories both in
response to a suspected crime
involving biological agents
or natural outbreaks with
high-risk micro-organisms.”
Johan Olsson, Deputy Veterinary
Officer, National Veterinary Institute
(SVA).
“It is my firm belief that the
standard will provide an
extended awareness and a
novel way of thinking in
areas, like my own, where
security threats are not
part of the daily topic of
conversation.”
Aurélie Tierno, Biosafety Officer,
French Agency for Food, Environ
mental and Occupational Health
and Safety (Anses).
“I am truly convinced that
the LBMS will enable best
practices in laboratories
within the biorisk area.
It will be a crucial tool since
it will facilitate communi-
cation and efficiency between
the countries. The aim is to
share a common vision on
biosafety and biosecurity.”
sUMMAry
Overall the LBMS can be seen as a bridging tool as follows:
the need for harmonization and conformity regarding laboratory
biosafety and biosecurity will facilitate credibility in order to
control risks associated with the handling, storage and disposal
of biological agents and toxins.

11
AniBioThreAT PArTiCiPAnTs
ndard will be useful as a bridging tool for security, safety and research?
11
PerÅke Mårtensson, Senior Adviser,
Swedish Civil Contingencies Agency
(MSB).
“YES, working on security
issues are based on credibility.
The LBMS will facilitate the
establishment of credibility
between different stakeholders
such as law enforcement
agencies and animal and
public health agencies.”
Oskar Karlsson, PhDstudent,
Swedish University of Agricultural
Sciences (SLU).
“As the threats of zoonotic
diseases are global, a common
system for biorisk management
could prove critical for in-
creased preparedness. As my
project mainly focuses on
unknown viruses, the need
for good procedures handling
the samples is of critical
importance for good research.
If we are to develop an in-
creased preparedness against
infectious diseases and
emerging zoonotic viruses,
speaking the same language
amongst all the research
institutes will be a first big
step. The gains for the research
community crossbreeding with
the security community should
be obvious when it comes to
the implementation of a
combined paradigm for bio-
security and biosafety, LBMS.
From a research standpoint, it
provides a framework for how
we work and how we present
that work (a quality assurance
for the research) and also
provides a common language
for bridging security and
research, something of great
importance to my project.”
Trine Hansen, PhDstudent, Technical
University of Denmark (DTU).
“From my point of view, the
standard will definitely help
in the bridging of research and
security since a common
understanding between the
partners is provided. A better
understanding of each other
and common guidelines will
give higher quality of the
research.”

12
LABorATory Biorisk MAnAgeMenT sTAndArd
(CWA 15793:2008)
The work which resulted in the CEN Workshop
Agreement 15793 “Laboratory biorisk manage-
ment standard” (LBMS) was initiated because
organisations, laboratories and others involved
in laboratory biosafety and laboratory biosecurity
activities realized the need for a harmonization
and conformity regarding biosafety and bio-
security recommendations and guidelines. Some
of the most important reasons why the work on
the LBMS was initiated were:
• Many reference documents available
(standards, guidelines, codes etc)
• Reference documents are often technical
and nation-/region-specific
• Need for harmonization
(speaking the same language)
• Need to provide assurance to the international
community concerning biorisk issues
• Need for a management system
• Need for a standard which could be audited
and certified by a third party
• Need for a standard that was consistent with
other international standards and was based
on the WHO laboratory biosafety manual
(3rd edition 2004) and the WHO Laboratory
biosecurity guidance (2006)
The result of this work was the LBMS, which was
released in February 2008 from the European
Committee for Standardization. At first, this
standard was intended for laboratory work
concerning laboratory biosafety and laboratory
biosecurity (biorisk), such as the minimum
standards for laboratories working with FMDV
(Foot and Mouth Disease Virus) in vitro/in vivo.
The LBMS has thereafter also been identified as a
very useful tool for other areas involved in
biorisk issues, for example the EU CBRN Action
Plan (see Definition section 9) and the Biological
Weapon Convention (BWC). See figure 4 below.
The reLATionshiP BeTWeen
The LBMs, eU’s CBrn ACTion PLAn,
BWC And The FMdV sTAndArd
Figure 4. The LBMS is available as a free download at the
CEN workshop 31 website.
cen.eu/CEN/sectors/technicalcommitteesworkshops/
workshops/Pages/ws31.aspx
LBMS
EUs CBRN
Action Plan
Biological Weapon
Convention, BWS
Minimum
standard FMDV
www

13
The scope of the LBMS is to set requirements
necessary to control risks associated with the
handling, storage and disposal of biological
agents and toxins in laboratories and facilities
in order to:
• Facilitate international exchange and
harmonization
• Improve performance through the adoption
of recognized good practice
• Promote training and learning
• Increase awareness and adoption of manage-
ment system approaches within the sector
• Enhance internal auditing experiences
and commit the organization, management
system and facilities for third party
certification
• Provide stakeholders with a standard to be
used as a benchmark in setting requirements
for facilities in the areas of laboratory
biosafety and biosecurity
“Implementing the requirements of the LBMS is
likely to further biosafety and biosecurity at
facilities using, handling or storing hazardous
biological materials and toxins. There is also
the opportunity for stakeholders to use the
Standard and associated monitoring mecha-
nisms (e.g. future certification schemes) to
ensure that good practices are being adopted
and effective controls maintained. In addition,
the Standard should help ensure that facilities
are well prepared to respond in the event that
biological agents were released.”
Quoted from the laboratory biorisk management
standard and its applicability under the BWC,
BWC/MSP/2008/MX/WP.34-21 August 2008
The EU CBRN Action Plan has also identified
the need for different kinds of activities which
increase the awareness, understanding and
conformity regarding biosafety and biosecurity
issues, such as implementing the LBMS. This
need is consistent with the work of the EU
project AniBioThreat.

14
ACTiViTies in AniBioThreAT
AniBioThreat project activities are organized in six work packages and each contains three tasks.
Work PACkAge TAsk
WP1 Task 1.1 Task 1.2 Task 1.3
Network and training (horizontal) Terms, definitions and Survey Training First responders
conceptual modelling
Threat assessment (vertical) Threat recognition Transaction analysis Operational framework
and vaccine preparedness
Early warning (vertical) Surveillance systems Risk management/ Incident communication
Decision making
European Laboratory Response Implementation of Scenario-based Forensic response
Network (LRN) for animal Laboratory Biorisk modeling in the plan and improved
bio-terrorism threats (vertical) Management Standard, detection field forensic sampling
CWA 15793:2008 and DNA analysis
Detection and diagnostics (vertical) Anthrax Botulism Virus detection
Dissemination (horizontal) Academic courses Research needs Exercise
and workshops
Task 4.1 Implementation of Laboratory biorisk management standard (in yellow) and other interacting tasks (in light yellow).
WP2:
THREAT
ASSESSMENT
VERTICAL
WP3:
EARLY WARNING
VERTICAL
WP4:
RESPONSE
NETWORKS
VERTICAL
WP5:
DETECTION AND
DIAGNOSIS
VERTICAL
WP1: NETWORK – HORIZONTAL
WP6: DISSEMINATION – HORIZONTAL
Figure 5. Overview of work packages (WPs) in AniBioThreat.

15
The following are AniBioThreat activities that
will increase the knowledge and application
of the biorisk management concept:
ACTiViTies in TAsk 4.1:
• Develop and evaluate a compliance audit
checklist to support the implementation
stages of the LBMS (Task 4.1)
• Prepare and provide supporting documents
for other disciplines involved in biorisk areas
(Task 4.1)
• Educate, inform and raise awareness of
guidelines to relevant stakeholders, such as
scientific community, police, animal and
public health organizations (Task 4.1)
• Plan and initiate implementation of the LBMS
(Task 4.1)
• Develop certification or verification of
the biorisk management system by an
independent third party (Task 4.1)
ACTiViTies in diFFerenT TAsks ThAT hAVe A
Link To TAsk 4.1 And The Biorisk ConCePT:
• Develop scenarios (Task 1.1, Task 4.2)
• Participate in the training program of first
responders and contribute to the Bioterrorism
Incident & Response Guide for first responders
in the capacity to counter animal terrorism
threats (Task 1.3)
• Prevention of loss and theft of biological
agents (Task 2.2)
• Vaccine preparedness (Task 2.3)
• Control of animal experiences for the
development of clinical decision support
systems (Task 3.1)
• Communication plan for laboratory incidents
(Task 3.3)
• Biorisk in association to forensic work
(Task 4.3)
• Biorisk in detection and diagnostics, such as
anthrax (Task 5.1), botulism (Task 5.2) and
virus detection (Task 5.3)
• Contribute to the specific training on good
practices and minimum requirements on
biorisk issues (Task 6.1)
• Research needs (Task 6.2)
• Exercise (Task 6.3)

17
ConCLUding reMArks
The aim of this booklet is to inform and increase
awareness of the concept biorisk and LBMS.
In conclusion:
• The LBMS is an important bridging tool
for improving collaboration between law
enforcement agencies, animal and public
health agencies and universities
• Education and raising awareness of the LBMS
is crucial prior implementation
• Facilitate collaboration (e.g minisymposium) in
the field of biorisk between different stake-
holders will lead to continual improvements
• Audit checklist for identification of gaps
• Act to make necessary changes according to
indentified gaps
• For implementation the top management of
organizations must be committed to
the LBMS and allocate resources
• Collaboration is built on trust and security
forms a basis for obtaining credibility which
is promoted by LBMS
• Implementation of LBMS will contribute to
reach the overall objective of AniBioThreat
PLAN
EDUCATION
CHECK
AUDIT CHECKLIST
DO
WORKSHOP
MINISYMPOSIUM
ACT
ACT TO MAKE
NEEDED
CHANGES TO
THE MANAGEMENT
SYSTEM
Figure 6. Implementation of the LBMS can be performed according to the Plan-Do-Check-Act Principle. Education and
knowledge form the basis for successful implementation of the LBMS. After increased awareness audits and actions can
take place followed by continual improvements in a process cycle (The Deming cycle).

18
reFerenCes
18
The eUroPeAn CoMMission (eC)
The EU CBRN Action Plan
Council conclusions on strengthening chemical, biological,
radiological and nuclear (CBRN) security in the European
Union – an EU CBRN Action Plan.
On 24 June 2009 the Commission adopted its communication
on strengthening chemical, biological, radiological and nuclear
(CBRN) security in the European Union – an EU CBRN
Action Plan, which was based on the findings of a CBRN
Task Force established by the Commission in February 2008,
involving both public and private stakeholders, as well as on
the results of its closing seminar, held in Prague, Czech
Republic in January 2009.
The eU CBrn ACTion PLAn
reLATed To The CWA 15793
The Commission together with the Members States should
take relevant steps so that:
• facilities possessing substances on the EU list of high risk
biological agents and toxins consider as appropriate the
implementation of the CEN Workshop agreement (CWA)
15793 WHO Laboratory Biosecurity Guidance or their
national equivalent standards – unless equal or more
stringent national regulations have to be considered.
Action B.14
The Member States together with the Commission should
encourage better cooperation among relevant agencies in
crisis and consequence management, response and recovery
management. A bio-specific checklist of requirements for
consequence management, response and recovery should
be developed and discussed by the CBRN Advisory Group.
Member States together with the Commission should identify
and spread:
• good practices on well targeted training for and education
of individuals working with, having access to or handling
substances on the EU list of high-risk biological agents and
toxins.
consider and, where appropriate, develop:
• together with relevant stakeholders, guidelines at the
EU level for minimum training requirements for persons
working with, having access to or handling, substances
on the EU list of high-risk biological agents and toxins.
The Member States together with the Commission
should consider and, where appropriate, develop:
• in conjunction with universities and professional
associations, minimum requirements for academic
training on bio-safety, potential misuse of information
and biological agents and toxins and bio-ethics for
undergraduate, graduate and postgraduate students.
Goal 4: Contribute to the development of a high
security culture of staff – Action H 6
identify, develop and spread good practices in security
training and education in order to raise awareness of
appropriate protection procedures related to persons working
with/having access to or handling high-risk CBRN materials.
Consideration should also be given to developing EU
guidelines for minimum security training requirements for
persons working with, having access to, or handling such
materials, based on the national experience across the
EU 27. This could be done by way of a peer review process
through which experts from the Member States would visit
each other with a view to learning from their experience
and exchanging best practices in specific fields.
The eUroPeAn CoMMission For The ConTroL
oF FooT-And-MoUTh diseAse (eUFMd)
Minimum standards for laboratories working with FMDV
in vitro/in vivo
fao.org/ag/againfo/commissions/docs/genses38/
Appendix_10.pdf
WorLd heALTh orgAniZATion (Who)
WHO, 2004.
Laboratory Biosafety Manual, vol. 3rd WHO/CDC/
LYO/2004.11.World Health Organization, Geneva (2004)
who.int/csr/resources/publications/biosafety/
Biosafety7.pdf
WHO, 2006.
Biorisk management – laboratory biosecurity guidance.
WHO/CDC/EPR/2006.6 World Health Organisation,
Geneva (2006)
who.int/csr/resources/publications/biosafety/
WHO_CDS_EPR_2006_6.pdf
www
www
www

19
Bridging seCUriTy,
sAFeTy And reseArCh
The aim of the project AniBioThreat
is to improve the eU’s capacity to counter
biological animal bioterrorism threats
in terms of awareness, prevention and contingency.
The project will contribute to create
a safer and more secure world.
To succeed, we need to carry on a borderless dialogue.
AniBioThreat builds bridges across boundaries
dividing countries, competencies, and disciplines.
in our work, we strive to be Collaborative,
Learning, efficient, and Alert,
to be a robust organization.
keep it CLeAr!

20
With the financial support from the Prevention of and Fight against Crime Programme of the European Union
European Commission – Directorate – General Home Affairs
www.anibiothreat.com

Appendix 2:
Report from Exercise ‘Insider’, SVA, Uppsala,
November 2011. Results are reported as
restricted (Annex X). The annex has been
classified in accordance with the Swedish law
“Public Access to Information and Secrecy Act
(SFS 2009:400)”: Chapter 15, § 1, Chapter 15, § 2,
and Chapter 18, § 13.

Laboratory Biorisk Management CWA 15793 -Compliance Checklist
Structure Items Requirement Compliance status/ comments Supporting documents Actions Responsible
4.1
General
requirements
4.1.1
Biorisk
management
system
The organization shall establish, document, implement and
maintain a biorisk management system in accordance with the
requirements of this Laboratory biorisk management standard.
4.1.2
Continual
improvement
The organization shall continually improve the effectiveness of
the biorisk management system through the use of the policy,
objectives, self-audit programme, audit results, analysis of data,
risk assessment, corrective and preventive actions and the
management review.
4.2 Policy
4.2.1
Biorisk
management
policy
#####################################################
#####################################################
#####################################################
#####################################################
###########################################
4.3 Planning
4.3.1
Planning for
hazard
identification,
risk
assessment and
4.3.1.1
Planning and
resources
The organization shall ensure that a risk assessment system is
established, implemented and maintained in accordance with this
standard and that the performance of the risk management system
is reported to senior management for review and as a basis for
improvement.
4.3.1.2
Risk
assessment
timing and
scope
The organization shall ensure the approach to risk assessment is
defined with respect to its scope, nature and timing so that it is
proactive rather than reactive.
4.3.1.3
Hazard
identification
The hazards associated with proposed work shall be identified
and documented.
4.3.1.4
Risk
assessment
The organization shall ensure that suitable methodologies for
assessing and recording risks are identified, implemented and
maintained.
Task 4.1 CWA15793_Complaince checklist format_29 June 2013
4.3.1.5
Risk
management
The organization shall ensure suitable methodologies for the
allocation of actions resulting from risk assessments, including
time lines, responsible persons and associated reporting and
approval mechanisms are identified, implemented and maintained.
4.3.2
Conformity
and
compliance
The organization shall ensure that all relevant requirements are
identified and fulfilled within the biorisk management system.
Legal requirements include national / federal, regional / state,
provincial, city and local regulatory requirements with which the
organization shall comply.

4.3.3
Objectives,
targets and
programme
4.3.3.1
Biorisk control
objectives and
targets
The organization shall establish, implement and maintain
documented biorisk control objectives and targets for an effective
control of biorisk at relevant functions and levels in the
organization.
4.3.3.2
Monitoring
controls
Management shall establish the controls and put in place
documented procedures for monitoring the effectiveness of the
controls being applied to reduce or eliminate the hazards
identified in the risk assessment process.
4.4
Implementatio
n and
operation
4.4.1
Roles,
responsibilities
and authorities
4.4.1.1
Top
management
Top management shall take ultimate responsibility for the
organization’s biorisk management system.
Top management shall ensure that roles, responsibilities and
authorities related to biorisk management are defined,
documented and communicated to those who manage, perform
and verify work associated with the control of biological agents
4.4.1.2
Senior
management
A senior manager shall be designated with operational
responsibility for overseeing the system for management of
biorisk.
Functions of the system for the management of biorisk shall
include:
a) providing appropriate resources to ensure adequate provision of
personnel, facilities and other resources deemed necessary for the
safe and secure operation of the facility;
b) reporting to top management on the performance of the biorisk
4.4.1.3
Biorisk
management
committee
A biorisk management committee shall be constituted to act as an
independent review group for biorisk issues. Reporting to senior
management, the committee shall:
a) have documented terms of reference;
b) include a representative cross-section of expertise, appropriate
to the nature and scale of the activities undertaken;
c) ensure issues addressed are formally recorded, actions
allocated, tracked and closed out effectively;
d) be chaired by a senior individual;
e) meet at a defined and appropriate frequency, and when
otherwise required.
4.4.1.4
Biorisk
management
advisor
A competent individual(s) shall be designated to provide advice
and guidance on biorisk management issues. This individual shall
report directly to the responsible senior manager and have
delegated authority to stop work in the event that it is considered
necessary to do so. This role shall be independent of those
responsible for implementing the programme of work.
4.4.1.5
Scientific
management
An individual(s) with responsibility for the scientific programme
within the facility shall be designated with responsibilities
relevant to biorisk management.
Functions shall include:
a) ensuring that all work is conducted in accordance with
established policies and guidelines described in this standard;
b) supervising workers, including ensuring only competent and
authorized personnel can enter and work in the facility;
c) planning and conducting work activities, and ensuring adequate
staffing levels, time, space and equipment are available;
4.4.1.6
Occupational
health
The organization shall have access to appropriate occupational
health expertise and establish an occupational health programme
commensurate with the activities and risks of the facility.

4.4.1.7
Facility
management
Facilities manager(s) shall be appointed with responsibilities
relevant to facilities and equipment determined in accordance
with requirements set out in this standard.
4.4.1.8
Security
management
A security manager shall be designated with responsibilities
determined in accordance with requirements set out in this
standard.
4.4.1.9
Animal
handling
In laboratories where animals are maintained, an animal care
manager shall be designated with responsibilities determined in
accordance with requirements set out in this standard.
4.4.2
Personnel
training,
awareness and
competence
The organization shall ensure that personnel that have
responsibilities and/or perform tasks that may impact biorisk
management in the workplace are competent to do so.
Competence levels shall be judged on appropriate education,
training and experience.
The organization shall define required competency levels and
shall maintain records verifying that staff members have attained
and demonstrated those levels of competency.
4.4.2.1
Recruitment The organization shall ensure that qualifications, experience and
aptitudes relating to biorisk are considered as part of the
recruitment process.
4.4.2.2
Competence The organization shall ensure that personnel conduct activities
within the facility under close supervision until competency has
been demonstrated.
4.4.2.3
Continuity and
succession
planning
The organization shall ensure that adequate back-up and
contingency measures are in place to address the need for
continuity and succession planning.
4.4.2.4
Training The organization shall ensure that requirements and procedures
for biorisk-related training of personnel are identified, established
and maintained.

4.4.3
Consultation
and
communication
The organization shall ensure that relevant biorisk information
relating to its activities is communicated to and from employees
and other relevant parties.
Employee involvement and consultation arrangements shall be
documented.
Personnel shall have access to adequate and up-to-date
information pertaining to the biorisks of the organization.
4.4.4
Operational
control
The organization shall identify those operations and activities that
are associated with possible biological risk and where control
measures shall be applied.
The organization shall plan these activities, including
maintenance, and ensure that they are carried out under specified
conditions.
4.4.4.1
General safety The organization shall ensure that a formal process is in place to
identify and manage risk associated with general safety.
4.4.4.2
Biological
agents and
toxin inventory
and information
The organization shall ensure that an accurate and up-to-date
biological agents and toxin inventory is established and
maintained.
It shall ensure that records relating to the inventory of biological
agents and toxins are current, complete and stored securely with
adequate backup provision.
It shall ensure that transfers of biological agents and toxins
between laboratories at the facility or into and out of the facility
are recorded and controlled in line with the level of the risk.
4.4.4.3
Work
programme,
planning and
capacity
The organization shall ensure that the programme of work for the
facility is defined, documented and reviewed.
The organization shall establish criteria for work that requires
prior approval.
It shall ensure there is sufficient resource capacity and capability
to manage workflow, whether planned or unplanned
4.4.4.4
Change
management
The organization shall ensure that all changes associated with the
design, operation and maintenance of the facility are subject to a
defined and documented change management process.
4.4.4.5
Work practices,
decontaminatio
n and personnel
protection
4.4.4.5.1
Good
microbiological
technique
The organization shall ensure that all personnel handling
biological agents and toxins are competent in good
microbiological techniques and that appropriate resources
(including time and equipment) are available to ensure such
practices can be adhered to effectively.

4.4.4.5.2
Inactivation of
biological
agents and
toxins
The organization shall establish and maintain procedures to
ensure that appropriate methods for disinfection and
decontamination are chosen and implemented effectively.
The organization shall ensure that all contaminated or potentially
contaminated waste items have been identified and documented
(including those that may result from an emergency), and that
effective procedures are put in place to devise effective
decontamination and other appropriate treatments.
4.4.4.5.3
Waste
Management
The organization shall establish and maintain an appropriate
waste management policy for biological agents and toxins.
4.4.4.5.4
Clothing and
Personal
Protective
Equipment
(PPE)
The organization shall ensure that PPE needs are identified and
suitable equipment is specified, made available, used and
maintained appropriately within the facility.
4.4.4.6
Worker health
programme
The organization shall ensure that risk to worker health, and that
of other personnel whose health could be directly impacted by
exposure to biological agents and toxins, is managed effectively
including prevention and protection measures.
The requirements of the health surveillance programme shall be
determined by a defined health hazard identification and risk
assessment process involving all relevant personnel.
4.4.4.6.1
Vaccination of
personnel
Based on risk, the need for vaccination shall be identified and
shall cover groups identified as being potentially exposed to
biological agents or toxins.
The organization shall ensure that a vaccination policy be defined
and implemented, and that access to laboratories or work is
controlled for individuals until they comply with the policy.
4.4.4.7
Behavioural
factors and
control of
workers
The organization shall establish and maintain a programme to
address risk associated with human behaviour, including the
management of how workers interact with the facility and its
equipment.
4.4.4.7.1
Personnel
reliability
The organization shall ensure that a personnel reliability policy is
defined and implemented, and that access to facilities or work is
controlled for individuals according to the policy.

4.4.4.7.2
Contractors,
visitors and
suppliers
The organization shall ensure that suppliers, contractors, visitors
and sub-contractors adhere to the requirements of established
management systems and do not compromise biorisk management
of the facility.
4.4.4.7.3
Exclusion The organization shall ensure that measures are set in place for
the removal and exclusion of personnel (both temporary and, if
appropriate, permanent) from the facility where deemed necessary
through risk assessment.
4.4.4.8
Infrastructure
and operational
management
The organization shall ensure that facilities, equipment and
processes are designed and run in a safe and secure way with
respect to biorisk management.
4.4.4.8.1
Planning,
design and
verification
The organization shall ensure that a formal planning, design and
redesign process is adopted for the facility, based upon an
assessment of risk associated with the materials to be used and
activities undertaken.
The design process shall identify and incorporate all relevant
legislative requirements, together with information from
recognized standards, guidelines, industry good practices and
facility-specific risk assessments.
The design process shall identify and consult all relevant parties
associated with the facility and its operation.
All design features, construction techniques, materials and
equipment selected shall be documented in line with the need to
provide sufficiently specific and detailed instruction and
4.4.4.8.2
Commissioning
and
decommissioni
ng
The organization shall ensure that there is a formal process for
initial commissioning of new facilities and the final
decommissioning of existing ones.
4.4.4.8.3
Maintenance,
control,
calibration,
certification
and validation
The organization shall establish and maintain documented
procedures to ensure equipment and elements of the physical
plant that may impact on biorisk be identified, purchased,
maintained, calibrated, certified or validated in a manner
consistent with the intent and requirements of the biorisk
management programme.
4.4.4.8.4
Physical
security
The organization shall ensure that the controls for the physical
security of cultures, specimens, samples and potentially
contaminated materials or waste determined as part of the risk
assessment process are implemented and maintained.

4.4.4.8.5
Information
security
The organization shall have a policy and procedure in place to
identify sensitive information; a review and approval process shall
be used to control access to such information.
4.4.4.8.6
Control of
supplies
The organization shall ensure that purchases (including services)
conform to specified requirements. Controls shall be applied
depending on potential impact on the biorisk involved.
The organization shall ensure suppliers are evaluated and selected
based on their ability to provide products / services that meet the
requirements of this standard. Criteria for selection, evaluation
and re-evaluation shall be established. Records of the results of
evaluations and any necessary actions arising from the evaluation
shall be maintained.
4.4.4.9
Transport of
biological
agents and
toxins
The organization shall ensure that procedures for the safe and
secure transport of cultures, specimens, samples and contaminated
and potentially contaminated materials are established and
maintained in accordance with legal requirements for the
transport of dangerous goods.
4.4.4.10
Personal
security
The organization shall have a policy in place to provide personal
security support services to staff members that include, where
appropriate, personal security awareness training.
4.4.5
Emergency
response and
contingency
plans
The organization shall establish and maintain plans and
procedures to identify the potential for incidents and emergency
situations involving biological agents, toxins and materials, to
prevent their occurrence, to respond to emergency situations and
to limit the likely illness or other damage that may be associated
with them.
Emergency planning shall cover all aspects of biorisk and include
general safety, security and medical issues.
4.4.5.1
Emergency
scenarios
The organization shall ensure that all credible and foreseeable
emergency scenarios that may impact the organization’s biorisks
have been identified.
4.4.5.2
Emergency
plans
The organization shall ensure that biorisks are taken into account
when preparing and implementing emergency plans.
The organization shall ensure a system is established to
effectively manage medical and/or environmental emergencies,
including, but not limited to, the identification of potentially
infected workers and provision of immediate medical care to
exposed, ill or injured workers.
The organization shall also ensure that control measures in place
can be demonstrated as being reasonable and proportionate to the
scale and nature of the emergency.
Emergency plans shall be effectively communicated to all
employees and relevant third parties, and tested, with the
intention that everyone is aware of their obligations.
4.4.5.3
Emergency
exercises and
simulations
The organization shall ensure that structured and realistic
emergency exercises and simulations, including security drills are
conducted at regular intervals, based on risk, to test the plans,
prepare personnel, and learn from any good practices or
deficiencies identified.
4.4.5.4
Contingency
plans
The organization shall ensure that in the event of an emergency,
adequate contingency measures shall be in place to ensure the
safety and security of continued operations.

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