Classification Level: Unclassified

4.1

TASK

IMPLEMENTATION OF LABORATORY BIORISK MANAGEMENT CWA 15793

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

WP4

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

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 bioterrorism 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.

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WP4: EUROPEAN LABORATORY RESPONSE NETWORK (LRN) FOR ANIMAL BIOTERRORISM THREATS TASK 4.1: IMPLEMENTATION OF LABORATORY BIORISK MANAGEMENT CWA 15793

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 “Laboratory Biorisk Management CWA 15793:2011” (CWA 15793), a management system which is built around the principle of continual improvement 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

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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

WP4: EUROPEAN LABORATORY RESPONSE NETWORK (LRN) FOR ANIMAL BIOTERRORISM THREATS TASK 4.1: IMPLEMENTATION OF LABORATORY BIORISK MANAGEMENT CWA 15793

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) interinstitutional 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 Management 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.

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Contents Abstract 4 Bridging Statement

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Link to EU CBRN Action Plan

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Other relevant Actions

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Contribution towards overall objective of AniBioThreat

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Task leader

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Task partners

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Authors of this report

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Aim 8 Background 8 Methodology 10 Results and Discussion

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Conclusion 17 Future Outlook and Recommendations 18 Publications from Task 4.1

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Acknowledgements 20 References 21 Appendix 21

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 implementing 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 therefore 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.

WP4: EUROPEAN LABORATORY RESPONSE NETWORK (LRN) FOR ANIMAL BIOTERRORISM THREATS TASK 4.1: IMPLEMENTATION OF LABORATORY BIORISK MANAGEMENT CWA 15793

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 management. 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. Action B.16 (first bullet point) Member States together with the Commission 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) Member States together with the Commission 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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WP4: EUROPEAN LABORATORY RESPONSE NETWORK (LRN) FOR ANIMAL BIOTERRORISM THREATS TASK 4.1: IMPLEMENTATION OF LABORATORY BIORISK MANAGEMENT CWA 15793

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 management 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

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 enforcement 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).

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.

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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).

WP4: EUROPEAN LABORATORY RESPONSE NETWORK (LRN) FOR ANIMAL BIOTERRORISM THREATS TASK 4.1: IMPLEMENTATION OF LABORATORY BIORISK MANAGEMENT CWA 15793

Figure 2. Biorisk and the relationship between biosafety and laboratory biosecurity with some examples of operational topics.

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 governments 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-CheckAct 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.

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WP4: EUROPEAN LABORATORY RESPONSE NETWORK (LRN) FOR ANIMAL BIOTERRORISM THREATS TASK 4.1: IMPLEMENTATION OF LABORATORY BIORISK MANAGEMENT CWA 15793

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.

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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 roadmap 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

WP4: EUROPEAN LABORATORY RESPONSE NETWORK (LRN) FOR ANIMAL BIOTERRORISM THREATS TASK 4.1: IMPLEMENTATION OF LABORATORY BIORISK MANAGEMENT CWA 15793

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 interoperability 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 decisionmakers in the security and emergency management 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 implementation 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

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WP4: EUROPEAN LABORATORY RESPONSE NETWORK (LRN) FOR ANIMAL BIOTERRORISM THREATS TASK 4.1: IMPLEMENTATION OF LABORATORY BIORISK MANAGEMENT CWA 15793

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.

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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 implementation 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

WP4: EUROPEAN LABORATORY RESPONSE NETWORK (LRN) FOR ANIMAL BIOTERRORISM THREATS TASK 4.1: IMPLEMENTATION OF LABORATORY BIORISK MANAGEMENT CWA 15793

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 Immuno­prophylaxis (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 implementation 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 management 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.

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WP4: EUROPEAN LABORATORY RESPONSE NETWORK (LRN) FOR ANIMAL BIOTERRORISM THREATS TASK 4.1: IMPLEMENTATION OF LABORATORY BIORISK MANAGEMENT CWA 15793

Biorisk The LABorATory Biorisk MAnAgeMenT sTAndArd A Bridging Tool for Laboratory Biosafety and Biosecurity

Figure 4. Different kind of personal protective equipment (PPE) was demonstarted and some participants were also to try in practice.

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.

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CWA 15793:2008

WP4 1

Figure 5. The Biorisk booklet “Biorisk, the laboratory biorisk management standard. A bridging tool for laboratory biosafety and biosecurity”.

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 decisionmakers in the security and emergency management 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

WP4: EUROPEAN LABORATORY RESPONSE NETWORK (LRN) FOR ANIMAL BIOTERRORISM THREATS TASK 4.1: IMPLEMENTATION OF LABORATORY BIORISK MANAGEMENT CWA 15793

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.

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).

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).

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.

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WP4: EUROPEAN LABORATORY RESPONSE NETWORK (LRN) FOR ANIMAL BIOTERRORISM THREATS TASK 4.1: IMPLEMENTATION OF LABORATORY BIORISK MANAGEMENT CWA 15793

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 management 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.

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

4.1 General requirements

4.1.1

Biorisk management system

4.2 Policy

4.1.2 4.2.1

Continual improvement Biorisk management policy

4.3 Planning

4.3.1

Planning for hazard identification, risk assessment and risk control

4.3.2 4.3.3 4.4 Implementation 4.4.1 and operation 4.4.2 4.4.3 4.4.4 4.4.5 4.5 Checking and corrective action

4.5.1 4.5.2 4.5.3 4.5.4

4.6 Review




16

4.5.5 4.6.1

Conformity and compliance Objectives, targets and programme Roles, responsibilities and authorities Personnel training, awareness and competence Consultation and communication Operational control Emergency response and contingency plans Performance measurement and analysis of data Records, document and data control Inventory monitoring and control Accident and incident investigation, non-conformity, corrective and preventive actions Inspection and audit Biorisk management review

Procedures or compliance are satisfactory Procedures or compliance are developing Procedures or compliance are challenging

2

3

4

5

6 7

8 9

10

WP4: EUROPEAN LABORATORY RESPONSE NETWORK (LRN) FOR ANIMAL BIOTERRORISM THREATS TASK 4.1: IMPLEMENTATION OF LABORATORY BIORISK MANAGEMENT CWA 15793

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 enforcement 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 contributed 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.

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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 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 management 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 harmonization for a future European laboratory response network (EU LRN) will be facilitated. Other options to continue and expand the implementation and learning process of implementing 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

18

and tools on the route towards an implementation of CWA 15793: • Advantage to have implemented the following 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.

WP4: EUROPEAN LABORATORY RESPONSE NETWORK (LRN) FOR ANIMAL BIOTERRORISM THREATS TASK 4.1: IMPLEMENTATION OF LABORATORY BIORISK MANAGEMENT CWA 15793

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 networks 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 collaboration between institutes within the biorisk mangement community to increase preparedness 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 development 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

19

WP4: EUROPEAN LABORATORY RESPONSE NETWORK (LRN) FOR ANIMAL BIOTERRORISM THREATS TASK 4.1: IMPLEMENTATION OF LABORATORY BIORISK MANAGEMENT CWA 15793

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 – DirectorateGeneral 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.

20

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/workshops/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-6fc0-437fb923-93951bb11d15

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

Biorisk The LABorATory Biorisk MAnAgeMenT sTAndArd A Bridging Tool for Laboratory Biosafety and Biosecurity

CWA 15793:2008

WP4 1

Task 4.1: Appendix 1

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

2

Task 4.1: Appendix 1

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

Task 4.1: Appendix 1

4

Task 4.1: Appendix 1

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.

5

Task 4.1: Appendix 1

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, prevention 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. Furthermore, 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 harmonized among the users and may harm and

obstruct collaborative work between groups of specialists, laboratories, authorities, networks and other stakeholders. Bridging tools in AniBioThreat 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

Bridging seCUriTy, sAFeTy And reseArCh ement agencies forc en

s OP •S

SECURITY

SAFETY ies nc ge

Se

ti e s

Re ni

ch

ve

ar

rsi

se

cu

lt u

re • Pu

blication is es

ti sen

al

•U

a

RESEARCH

6

imal and Public • An He alt h

e • Classified info ltur rm cu ati y t on ri u c

e

aw •L

lture • Quality Ass y cu fet ura a S nc

Figure 2. Overview of different disciplines and cultures in AniBioThreat.

Task 4.1: Appendix 1

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

Foto: Polisen

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.

7

Task 4.1: Appendix 1

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

Task 4.1: Appendix 1

Biorisk – A neW ConCePT

Biorisk LABORATORY BIOSAFETY • Good Laboratory Practice

SHARED TOPICS

LABORATORY BIOSECURITY

• Access restriction

• Information security

• Compliance

• Access control

• Personal Protective Equipment (PPE)

• Emergency routines

• Transfer security • Physical security

• Biosafety cabinets

• Incident reporting and planning

• Personal security • Ventilation control • Inventory control • Waste handling • Revision • Standard Operating Procedures (SOPs) • Training and education • Transport of biological agents and toxins

Figure 3. The relationship between laboratory biosafety and biosecurity with some examples of operational topics.

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 laboratory biosafety and laboratory biosecurity 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.).

9

Task 4.1: Appendix 1

ThoUghTs FroM AniBioThre

Do you think the Laboratory Biorisk Management Standard will be use

Birgitta Rasmusson, Research Director, the Swedish National Laboratory of Forensic Science (SKL):

Johan Olsson, Deputy Veterinary Officer, National Veterinary Institute (SVA).

“ 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.”

“ 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.”

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.

10

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 communication and efficiency between the countries. The aim is to share a common vision on biosafety and biosecurity.”

Task 4.1: Appendix 1

AniBioThreAT PArTiCiPAnTs

ndard will be useful as a bridging tool for security, safety and research?

Per­Åke Mårtensson, Senior Adviser, Swedish Civil Contingencies Agency (MSB).

Oskar Karlsson, PhD­student, Swedish University of Agricultural Sciences (SLU).

“ 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.”

“ As the threats of zoonotic diseases are global, a common system for biorisk management could prove critical for increased 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 increased 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 biosecurity 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.”

11

Task 4.1: Appendix 1

LABorATory Biorisk MAnAgeMenT sTAndArd (CWA 15793:2008) The work which resulted in the CEN Workshop Agreement 15793 “Laboratory biorisk management 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 biosecurity 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 EUs CBRN Action Plan

Biological Weapon Convention, BWS

LBMS Minimum standard FMDV Figure 4. The LBMS is available as a free download at the CEN workshop 31 website. www cen.eu/CEN/sectors/technicalcommitteesworkshops/ workshops/Pages/ws31.aspx

12

Task 4.1: Appendix 1

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 management 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 mechanisms (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.

13

Task 4.1: Appendix 1

ACTiViTies in AniBioThreAT AniBioThreat project activities are organized in six work packages and each contains three tasks. Work PACkAge

TAsk

WP1 Network and training (horizontal)

Task 1.1 Terms, definitions and conceptual modelling

Task 1.2 Survey

Task 1.3 Training First responders

WP2 Threat assessment (vertical)

Task 2.1 Threat recognition

Task 2.2 Transaction analysis

Task 2.3 Operational framework and vaccine preparedness

WP3 Early warning (vertical)

Task 3.1 Surveillance systems

Task 3.2 Risk management/ Decision making

Task 3.3 Incident communication

WP4 European Laboratory Response Network (LRN) for animal bio-terrorism threats (vertical)

Task 4.1 Implementation of Laboratory Biorisk Management Standard, CWA 15793:2008

Task 4.2 Scenario-based modeling in the detection field

Task 4.3 Forensic response plan and improved forensic sampling and DNA analysis

WP5 Detection and diagnostics (vertical)

Task 5.1 Anthrax

Task 5.2 Botulism

Task 5.3 Virus detection

WP6 Dissemination (horizontal)

Task 6.1 Academic courses and workshops

Task 6.2 Research needs

Task 6.3 Exercise

Task 4.1 Implementation of Laboratory biorisk management standard (in yellow) and other interacting tasks (in light yellow).

WP1: NETWORK – HORIZONTAL

WP2:

WP3:

WP4:

WP5:

THREAT ASSESSMENT

EARLY WARNING

RESPONSE NETWORKS

DETECTION AND DIAGNOSIS

VERTICAL

VERTICAL

VERTICAL

VERTICAL

WP6: DISSEMINATION – HORIZONTAL Figure 5. Overview of work packages (WPs) in AniBioThreat.

14

Task 4.1: Appendix 1

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 laboratory biosafety and laboratory biosecurity 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)

15

Task 4.1: Appendix 1

16

Task 4.1: Appendix 1

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 stakeholders 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

ACT

DO

ACT TO MAKE NEEDED CHANGES TO THE MANAGEMENT SYSTEM

WORKSHOP MINISYMPOSIUM

CHECK

AUDIT CHECKLIST 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).

17

Task 4.1: Appendix 1

reFerenCes 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 Action B.4 (second bullet point) 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. Action B.15 (first bullet point) 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. Action B.16 (first bullet point) The Member States together with the Commission should 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.

18

Action B.16 (second bullet point) 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 The Member States together with the Commission should 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 www 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) www 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) www who.int/csr/resources/publications/biosafety/ WHO_CDS_EPR_2006_6.pdf

Task 4.1: Appendix 1

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!

19

Task 4.1: Appendix 1

www.anibiothreat.com

20

With 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: Appendix 2

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.

Task 4.1: Appendix 3

Laboratory Biorisk Management CWA 15793 -Compliance Checklist Structure 4.1

4.1.1

Items

The organization shall establish, document, implement and maintain a biorisk management system in accordance with the requirements of this Laboratory biorisk management standard.

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.

Policy Biorisk management policy

4.2.1

4.3 4.3.1

4.3.1.1

4.3.1.2

Compliance status/ comments

Biorisk management system

4.1.2

4.2

Requirement

Supporting documents

Actions

Responsible

General requirements

##################################################### ##################################################### ##################################################### ##################################################### ###########################################

Planning Planning for hazard identification, risk assessment Planning andand The organization shall ensure that a risk assessment system is resources 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. Risk The organization shall ensure the approach to risk assessment is assessment defined with respect to its scope, nature and timing so that it is timing and proactive rather than reactive. scope Hazard The hazards associated with proposed work shall be identified identification and documented.

4.3.1.3

Risk assessment

The organization shall ensure that suitable methodologies for assessing and recording risks are identified, implemented and maintained.

4.3.1.4

Task 4.1 CWA15793_Complaince checklist format_29 June 2013

4.3.1.5

4.3.2

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.

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.

Task 4.1: Appendix 3 Task 4.1 CWA15793_Complaince checklist format_29 June 2013 4.3.3

Objectives, targets and programme Biorisk control The organization shall establish, implement and maintain objectives and documented biorisk control objectives and targets for an effective targets control of biorisk at relevant functions and levels in the organization.

4.3.3.1

Monitoring controls 4.3.3.2

4.4

4.4.1

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.

Implementatio n and operation Roles, responsibilities and authorities Top management

4.4.1.1

Senior management 4.4.1.2

Biorisk management committee

4.4.1.3

Biorisk management advisor 4.4.1.4

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 verifymanager work associated with the control of biological agents A senior 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 onshall the performance ofto theactbiorisk A biorisk management committee be constituted 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. 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.

Task 4.1 CWA15793_Complaince checklist format_29 June 2013 Scientific management 4.4.1.5

4.4.1.6

Occupational health

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 equipment are available; The organization shall haveand access to appropriate occupational health expertise and establish an occupational health programme commensurate with the activities and risks of the facility.

Task 4.1: Appendix 3 Task 4.1 CWA15793_Complaince checklist format_29 June 2013 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.

Security management

A security manager shall be designated with responsibilities determined in accordance with requirements set out in this standard. In laboratories where animals are maintained, an animal care

4.4.1.7

4.4.1.8

4.4.1.9

4.4.2

Animal handling

manager shall be designated with responsibilities determined in accordance with requirements set out in this standard.

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.

Recruitment

The organization shall ensure that qualifications, experience and aptitudes relating to biorisk are considered as part of the recruitment process.

Competence

The organization shall ensure that personnel conduct activities within the facility under close supervision until competency has been demonstrated.

4.4.2.1

4.4.2.2

4.4.2.3

Continuity and The organization shall ensure that adequate back-up and succession contingency measures are in place to address the need for planning continuity and succession planning.

Training

4.4.2.4

The organization shall ensure that requirements and procedures for biorisk-related training of personnel are identified, established and maintained.

Task 4.1: Appendix 3 Task 4.1 CWA15793_Complaince checklist format_29 June 2013

4.4.3

Consultation The organization shall ensure that relevant biorisk information relating to its activities is communicated to and from employees and communication 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.

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.

General safety

The organization shall ensure that a formal process is in place to identify and manage risk associated with general safety.

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.

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

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

4.4.4.1

4.4.4.2

4.4.4.3

4.4.4.4

4.4.4.5

4.4.4.5.1

Work practices, decontaminatio n and personnel protection Good The organization shall ensure that all personnel handling microbiological biological agents and toxins are competent in good technique microbiological techniques and that appropriate resources (including time and equipment) are available to ensure such practices can be adhered to effectively.

Task 4.1: Appendix 3 Task 4.1 CWA15793_Complaince checklist format_29 June 2013

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.

Waste Management

The organization shall establish and maintain an appropriate waste management policy for biological agents and toxins.

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.

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.

4.4.4.5.3

4.4.4.5.4

4.4.4.6

4.4.4.6.1

Vaccination of Based on risk, the need for vaccination shall be identified and personnel 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.

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.

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

4.4.4.7.1

Task 4.1: Appendix 3 Task 4.1 CWA15793_Complaince checklist format_29 June 2013 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.

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.

4.4.4.7.2

4.4.4.7.3

4.4.4.8

Infrastructure The organization shall ensure that facilities, equipment and and operational processes are designed and run in a safe and secure way with management respect to biorisk management. Planning, design and verification

4.4.4.8.1

4.4.4.8.2

4.4.4.8.3

4.4.4.8.4

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 Commissioning The organization shall ensure that there is a formal process for and initial commissioning of new facilities and the final decommissioni decommissioning of existing ones. ng Maintenance, The organization shall establish and maintain documented control, procedures to ensure equipment and elements of the physical calibration, plant that may impact on biorisk be identified, purchased, certification maintained, calibrated, certified or validated in a manner and validation consistent with the intent and requirements of the biorisk management programme. 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.

Task 4.1: Appendix 3 Task 4.1 CWA15793_Complaince checklist format_29 June 2013

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.

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. 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.

4.4.4.8.6

4.4.4.9

4.4.4.10

4.4.5

Transport of biological agents and toxins

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.

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. The organization shall ensure that all credible and foreseeable emergency scenarios that may impact the organization’s biorisks have been identified.

Emergency scenarios 4.4.5.1

Emergency plans

4.4.5.2

4.4.5.3

4.4.5.4

Emergency exercises and simulations

Contingency 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. 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. 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.

Task 4.1: Appendix 3 Task 4.1 CWA15793_Complaince checklist format_29 June 2013

4.5

Checking and corrective action

4.5.1

Performance measurement and analysis of data

4.5.2

The organization shall ensure that records, documents and data Records, document and are established, controlled and maintained to provide evidence of conformity to the requirements of this standard and that they data control remain legible, readily identifiable and retrievable.

Inventory monitoring and control 4.5.3

4.5.4

4.5.4.1

4.5.4.2

4.5.4.3

4.5.4.4

The organization shall ensure that appropriate data are determined, collected and analysed to assess the suitability and effectiveness of the biorisk management system and to evaluate where continual improvement of the system can be made.

The organization shall ensure that a review of the inventory is conducted at predetermined intervals based on risk and at a level and frequency whereby materials can be accounted for in an appropriate manner. The organization shall ensure that the measures are put in place to minimize the quantities of biological agents and toxins that make up the inventory.

Accident and incident investigation, nonconformity, corrective and preventive actions Accident / incident investigation

The organization shall establish and maintain documented procedures to define, record, analyse and learn from accidents and incidents involving biological agents and toxins.

Control of The organization shall ensure that situations that do not conform nonconformitie to the requirements of this standard are identified and controlled s to prevent undesirable consequences. Records of the nature of the non-conformity and any subsequent action taken shall be maintained. Corrective The organization shall ensure action is taken to eliminate the action causes of non-conformities with the requirements of this standard in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered. Preventive action

The organization shall ensure action is taken to identify and eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential nonconformities

Task 4.1 CWA15793_Complaince checklist format_29 June 2013

4.5.5

Inspection and The organization shall ensure that a programme of inspection and audit audit is conducted which is appropriate to the risk associated with the facility. Inspections and audits shall be conducted at planned intervals to determine if the biorisk management system conforms to the documented plans and to the requirements of this standard, and that it is effectively implemented and maintained. Management responsible for the area being inspected / audited shall ensure that any actions are taken without undue delay to eliminate detected non-conformities and their causes. Follow-up activities arising shall include the verification of the actions taken and the reporting of verification results.

4.6

Review

4.6.1

Biorisk management review

Top management shall review the organization’s biorisk management system at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. The review shall include assessing opportunities for improvement and the need for changes to the system, procedures, policies and objectives. Records from the management review shall be maintained.

Task 4.1: Appendix 4

The EU-project AniBioThreat – Implementation of the Laboratory Biorisk Management Standard (CWA 15793) as a bridging tool for law enforcement agencies, animal and public health agencies and universities Ulrika Allard Bengtsson1, Henk Wisselink2, Aurélie Tierno3, Charlotta Löfström4, Jenny Berglund5, Bo Sundqvist1 and Rickard Knutsson1 1

National Veterinary Institute (SVA), Sweden; Central Veterinary Institute (CVI), the Netherlands;

2

3

French Agency for Food, Environmental and Occupational Health and Safety, France; Technical

4

5

University of Denmark, (DTU Food), Denmark; National Police Board (RPS), Sweden

The AniBioThreat project with the title “Bio-preparedness measures concerning prevention, detection and response to animal bioterrorism threats” was in 2010 awarded a grant with a total budget of approximately € 7 million, by Directorate General Home Affairs under the programme “Prevention of and Fight Against Crime”. The three year project aims to improve the capacity of the European Union (EU) to counter biological animal bioterrorism threats in terms of awareness, prevention and contingency. The focus of the project will be 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 international cooperation and promote networking for bridging security with animal and public health. The objectives are based upon some of the identified actions in the EU Chemical, Biological, Radiological and Nuclear (CBRN) Action Plan, the recommendations of the CBRN Task Force Report (2009, January) and especially the work that took place in the Biosubgroup threats to animal, and food and feed for animals (2008, July), and the Biosubgroup detection and diagnosis (2008, June). The project is divided into the following six work packages; (i) The establishment of a network between law enforcement, forensic institutes, first responders, intelligence, veterinary institutes, public health agencies and universities (ii) Threat assessment, (iii) Early warning/detection, (iv) European Laboratory Response Network for animal bio-terrorism threats (v) Detection and diagnostics and (vi) Dissemination. The AniBioThreat consortium consists of 15 partners from 8 European countries and the project started 1st of October 2010. One objective is to promote networking for bridging biosafety, security and research and increase the biopreparedness knowledge and awareness concerning biological animal terrorism. In all the work packages biosafety and biosecurity (biorisk) is a fundamental issue and especially work package (iv), task 4.1, which includes the implementation of the laboratory biorisk management standard (CWA 15793). This task aims to spread knowledge about these issues to the different partners in the project as well as other stakeholders involved in the biorisk field. One challenge is to raise awareness, inform and educate about laboratory biosafety and biosecurity (biorisk) to law enforcement agencies, universities and animal and public health institutes.

Task 4.1: Appendix 4

In the AniBioThreat project these objectives will be promoted by for instance dedicated workshops, questionnaires and construction of biorisk emergency scenarios.

Task 4.1: Appendix 5

Harmonizing European Laboratory Response Networks by implementing the CWA 15793: use of a gap analysis and an insider exercise as tools Laboratory Response Networks (LRN’s) are established from a security perspective in several countries as a preparedness measure for a coordinated diagnostic response capability in case of a bioterrorism incident or other biocrimes. In general, these LRN’s are organized on a national level. The EU project AniBioThreat has identified the need of an integrated European LRN to strengthen the preparedness against animal bioterrorism. One task of the AniBioThreat project is to suggest an implementation plan of the Laboratory biorisk management CWA 15793:2011 (CWA 15793), a management system which is built around the principle of continual improvement through the Plan-Do-Check-Act (PCDA) cycle. The CWA 15793 can facilitate trust and credibility towards a future European LRN. The implementation of CWA 15793 is an assurance that work done at the laboratories is performed in a structured way with continuous improvements. As a first step towards implementation of the CWA 15793, a gap analysis was performed to establish the current compliance status of biosafety and laboratory biosecurity management to the CWA 15793 in five AniBioThreat partner institutes in France (ANSES), The Netherlands (CVI and RIVM) and Sweden (SMI and SVA). All five partners are national and/or international laboratory reference institutes in the field of public or animal health and possess high containment laboratories and animal facilities. Results of the gap analysis demonstrated that the participating institutes already have a wide biorisk management program in place. However, several gaps were identified which need to be addressed towards the full implementation of the CWA 15793. Despite differences between the participating institutes concerning their compliance status these differences are not significant. 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. Gap analyses and exercises are important and useful activities to facilitate implementation of CWA 15793. In this sense the PDCA cycle will enforce a structured way to work with continual improvements concerning biorisk management activities. 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 organisations (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 the CWA 15793 at each institute, a well prepared LRN for bioterrorism threats within the livestock sector in Europe can be established.

Task 4.1: Appendix 5

Harmonizing European Laboratory Response Networks by implementing the CWA 15793 Laboratory biorisk management: use of a gap analysis and an insider exercise as tools Sundqvist, B.1*, Allard Bengtsson, U.1, Wisselink, H.J.2, Peeters B.P.H.2, van Rotterdam, B.3, Kampert, E.3, Bereczky, S.4, Olsson, J.4, Szekely Björndal, A.4, Zini, S. 5, Allix, S.5, Knutsson. R.1

National Veterinary Institute (SVA), Sweden; 2 Central Veterinary Institute (CVI), The Netherlands; National Institute of Public Health and Environment (RIVM), The Netherlands; 4 Swedish Institute for Communicable Disease Control (SMI), Sweden, 5 French Agency for Food, Environmental and Occupational Health & Safety, France 1

3 Dutch

Introduction

• Laboratory response networks (LRN:s) are established in some countries as a preparedness measure for a coordinated diagnostic response capability in case of an bioterrorism incident. The need of an integrated European LRN has been identified by the EU project AniBioThreat, • The implementation of the CWA 15793 is one tool to facilitate a European LRN, by following the same structure concerning work with biological agents and toxins, •A first step towards implementation of CWA 15793 was to perform a gap analysis on the current compliance status of biosafety and laboratory biosecurity management. This was carried out by five AniBioThreat partner institutes in France (ANSES), Sweden (SVA and SMI) and The Netherlands (CVI and RIVM), • Biorisk incident exercises has also been identified to be an important tool for implementation of the CWA 15793 and an exercise concerning an insider threat was performed at SVA, fig 2.

Results

• The combined results showed that about three-quarters of the procedures were in place and half of these procedures items were in compliance with the CWA 15793, • Generally procedures concerning biosafety and combined biosafety/laboratory biosecurity were in place, but areas like specific laboratory biosecurity issues, inventory monitoring and control, review and communication were partly missing, • Differences occurred between the participating institutes, both concerning existing procedures and compliance, but no significant differentiation, • The insider exercise showed that the emergency plans were partly implemented, but also a need for improvements concerning organizational and structural issues, •The exercise also demonstrated that involvement of the top management is essential.

Figure 2 Photo from the insider exercise at SVA

Figure 1 Implementation of the CWA 15793 will be performed according to the Plan-Do-Check-Act Principle

The CWA 15793 is a management system built around the principle of continual improvement through the Plan-Do-Check-Act (PDCA) cycle and is therefore compatible with other management systems, fig 1.

Conclusions

Based on the activities performed the following can be concluded to promote implementation of the CWA 15793; • Support of the top management • Knowledge of the CWA 15793 • Compliance audit checklist and gap analysis • Training and exercises • Inter-agency audits • Use existing networks like LRN and other

With 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: Appendix 5

The EU-project AniBioThreat – Implementation of the Laboratory Biorisk Management Standard (CWA 15793) (LBMS) as a bridging tool for law enforcement agencies, animal and public health agencies and universities Ulrika Allard Bengtsson1, Henk Wisselink2, Aurélie Tierno3, Charlotta Löfström4, Jenny Berglund5, Bo Sundqvist1 and Rickard Knutsson1

National Veterinary Institute (SVA), Sweden; 2 Central Veterinary Institute (CVI), the Netherlands; French Agency for Food, Environmental and Occupational Health and Safety, France; 4 Technical University of Denmark, (DTU Food), Denmark; 5 National Police Board (RPS), Sweden 1 3

Introduction

Results

preparedness measures concerning prevention, detection and response to animal bioterrorism threats” aims to improve the capacity of the European Union (EU) to counter biological animal bioterrorism threats in terms of awareness, prevention and contingency. • The focus of the project will be based on threats to living animals, animal feed and food of animal origin. • The AniBioThreat consortium consists of 15 partners from 8 European countries and from different disciplines such as veterinary institutes, juridical authorities, law enforcement, universities, research institutes other public officials. • The vision of the project is to bridge security, safety and research (see Figure 1). One of the tasks and deliverables is a partner implementation scheme guide of the LBMS.

In the AniBioThreat project we will use the LBMS to raise awereness among the partners about biorisk issues, use the same definitions to be able to talk the same language and by that build bridges to achieve the overall objective. Based on this the following acitivites will be used to implement the LBMS: • Prepare a booklet about biorisk and LBMS • Organize a biosafety minisymposium for veterinary institutes, police, forensic institutes and universities • Develop and evaluate a compliance audit checklist to support the implementation of the LBMS • Act to make needed changes to the management system

• The 3 year AniBioThreat project with the title “Bio-

-Why implement a LBMS in a non-laboratory environment?

Figure 2 Implementation of the LBMS can be performed according to the Plan-Do-Check-Act Principle Figure 1 Overview of different disciplines and cultures in AniBioThreat

The scope of the LBMS is to set requirements necessary to control risks associated with the handling, storage and disposal of biological agents in laboratories and facilities. This scope is not only bound to laboratories but can also be a scope for all disciplines involved in the biorisk field.

Conclusions

The LBMS is an important bridging tool between disciplines, independent laboratory background or not. 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 and audits actions can take place followed by continual improvements in a process cycle, "The Deming cycle”, (see Figure 2).

With 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: Appendix 6

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1

Task 4.1: Appendix 6

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 Chrime 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

www.anibiothreat.com

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!

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