Fundamentals of Laboratory Biosecurity and Biosafety Risk Assessments
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1 Fundamentals of Laboratory Biosecurity and Biosafety Risk Assessments Conceptual Considerations ABSA 22 October 2008, Reno Dr. Morten Bremer Mærli, Ronald Barø, Alexander Flesjø Christiansen, Dr. Stephen McAdam
2 Intentional Unintentional Biorisk Biosecurity Biosafety Slide 2
3 Biosecurity is different Dealing with actors that will - Explore and exploit opportunities to reach their goals - Potentially try to circumvent risk mitigating measures Proactive risk mitigation ( us ) Proactive risk generation ( them ) Slide 3
4 Core Questions What are the Implications of this New Paradigm? Does it affect me and my organization? If so, how and why? Slide 4
5 Outline Biosecurity and Biosafety compared, standard risk assessment Conclusions Slide 5
6 Risk Assessment Risk assessment is the overall process of - risk identification, - risk analysis, and - risk evaluation Essential part of any risk management processes Slide 6
7 The Platform: ISO Risk Management Risk Management Communication & consultation Establishing context Risk Assessment Risk identification Risk analysis Risk evaluation Risk treatment Monitoring & review ISO 31000: Risk management Guidelines on principles and implementation of risk management (draft June 15, 2007) Slide 7
8 Risk assessment is always done towards one or more objectives In our setting: - Biosecurity - Biosafety Slide 8
9 Risk Identification Establishing context Risk assessment Communication & consultation Risk identification Risk analysis Monitoring & review Risk evaluation Risk treatment Slide 9
10 Risk Identification A process to find, list and characterize elements of risks (ISO 73) Include risks whether or not they are under the control of the organization Slide 10
11 Risk Identification: Conceptual Risk Traits and Triggers Biosecurity Risk Biosafety Risk Trigger Gain, or desire to harm or threaten Breakages, errors in operation, or system failures Trait Purposeful Accidental Initiator Man Man or nature Origin External, possibly with insider(s) Internal, possibly external Slide 11
12 Risk Identification: Conceptual Risk Characteristics Biosecurity Risk Biosafety Risk Targeted (time, scope, location) Yes No Tailored Yes No Damage-maximizing Possibly No Discriminatory Possibly No Opportunistic Often Never Slide 12
13 Risk Analysis Establishing context Risk assessment Communication & consultation Risk identification Risk analysis Monitoring & review Risk evaluation Risk treatment Slide 13
14 Risk Analysis Systematic use of information to identify sources and to estimate the risk (ISO 73) Information can include historical data, theoretical analysis, informed opinions, and the concern of stakeholders (ISO 73) Involves consideration of the causes and sources of risk, their consequences, and the likelihood that those consequences may occur. Risk analysis may be qualitative, semi-quantitative or quantitative, or a combination of these Slide 14
15 Biosafety Risk Estimation Slide 15
16 Biosecurity Risk Estimation Capability Motivation Opportunity Estimation of Consequence Estimation of Likelihood Estimation of security risk Slide 16
17 Risk Analysis: Risk Probabilities and Consequences Biosecurity Risk Biosafety Risk Probability Consequence Likelihood Optimized Frequency Often predicable, yet arbitrary Slide 17
18 Risk Combination of the probability of an event and its consequences (ISO 73) Risk = Probability x Consequences Risk (safety) = P ( frequency ) x C ( arbitrary ) Risk (security) = P (Intentions, capabilities) x C ( optimized ) Optimized does not necessary mean maximized Slide 18
19 Risk Evaluation Establishing context Risk assessment Communication & consultation Risk identification Risk analysis Monitoring & review Risk evaluation Risk treatment Slide 19
20 Risk Evaluation Determine the significance of the risk Assist in making decisions about treating or accepting risk Slide 20
21 Risk Evaluation: Information and Competence Biosecurity Risk Biosafety Risk Facility information Competence demands Interest to suppress Understanding of Assets, Threats, Asset-Threat relations Interest to share Understanding Assets Slide 21
22 Concerns and Competence Core Concern: Biosafety Core Competencies: - Pathogens and toxins - Work processes and procedures - Rules and regulations Biosafety Core Concern: Biosecurity Core Competencies: - Pathogens and toxins - Work processes and procedures threat Biosecurity - Rules and regulations - Potential perpetrators - Site Vulnerabilities - and their interplay.. asset vulnerability Slide 22
23 Risk Treatment Establishing context Risk assessment Communication & consultation Risk identification Risk analysis Monitoring & review Risk evaluation Risk treatment Slide 23
24 Risk Treatment Process of selection and measures to modify risks (ISO 73) Measures may include avoiding, optimizing, transferring or retaining risks Slide 24
25 Risk Treatment: Residual Risk Biosecurity Risk Biosafety Risk Residual risk Dynamic Static Proactive (and continued) risk generation Slide 25
26 Risk Treatment: Risk Perception We act on perceived risk rather than objective measures of risk Perceptions likely to grow particularly strong when Risk assessments more dependent upon assumptions, than a strong experience- and knowledge-base Strong (excessive) media attention Several factors increasing personal concerned are fulfilled.: Slide 26
27 Inclinations: Factors Increasing Concern Biosecurity more prone to personal preferences than biosafety!? Biosecurity Biosafety Uncontrollable Fatalities grouped in space and time Effects dreaded Unfamiliar Children at risk Identifiable victims Much media attention Involuntary Caused by human actions or failures Covello V.T., Sandman P.M. and Slovic P. (1988), Risk Communications, Risk Statistics and Risk Comparisons:A manual for plant managers. Washington DC: Chemical Manufactures Association. Legend: more pluses, potentially higher perceptional impact (possible values) Slide 27
28 Risk Treatment: Other Persistent Challenges Organizational factors - Risk management Resources, prioritizations - Limited funds highly likely - Low-probability/high consequences Synergies and conflicts - Signs, information,, - Learning Updated competence - moving target Slide 28
29 Conclusions Biosecurity more than an extension of strong Biosafety Intentional acts add important dimensions to Biosecurity risks Biosecurity scenarios entail different actors, triggers and origins Biosecurity risk assessments and responses differ accordingly, - Need for dedicated expertise, tools, and assessments Slide 29
30 Conclusions, resource-wise A definitive need to understand implications of biosecurity risk responses New demands on the organization, the management, and personnel - Competence: biosecurity risk assessment and risk management - Acceptance: new SOPs and measures beyond personal protection - Awareness: e.g. new considerations on role of perception - Alertness: new set of persistent risk treatment challenges Tools and methodology development Slide 30
31 Conclusions, finally Biosecurity and Biosafety assessments should be conducted separately, BUT Biosecurity and Biosafety governed under the same Biorisk Management System Slide 31
32 Slide 32
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