Canada s Biosecurity Oversight Strengthening Biosecurity Risk Assessment

Transcription

1 UNCLASSIFIED Canada s Biosecurit Oversight Strengthening Biosecurit Risk Assessment ABSA 61 st Annual Biological Safet Conference October 16 th, 2018 Geneviève Lacroix Objectives Introduce the Public Health Agenc of Canada s Centre for Biosecurit Describe the Canadian Biosecurit Oversight Program Elements Introduce the Biosecurit Risk Assessment Methodolog 2 1

2 About the Public Health Agenc of Canada s Centre for biosecurit National authorit for biosafet and biosecurit of human pathogens and toxins WHO Collaboration Centre for Biosafet and Biosecurit Responsible for the administration and enforcement of the: Human Pathogens and Toxins Act (HPTA); Human Pathogens and Toxins Regulations (HPTR); and sections of the Health of Animals Act (HAA) and the Health of Animals Regulations (HAR). Purpose of the HPTA: to establish a safet and securit regime to protect the health and safet of the public against risks posed b human pathogens and toxins A risk-based licensing framework was designed to improve federal oversight of human pathogens and toxins in Canada Anone conducting controlled activities with human pathogens and toxins must obtain a valid Pathogen and Toxin Licence 3 Pillars of Biosecurit Oversight Biosecurit Risk Assessments Required for all licence holders Purpose is to identif and prioritize biosecurit risks, and to address those risks through the implementation of mitigation measures commensurate to the level of risk described in the Biosecurit Plan. Biosecurit Plan Required for all licence holders Purpose of a biosecurit plan is to prevent the loss, theft, misuse, diversion, or intentional release of biological assets and related facilit assets. The plan describes the measures implemented to address the biosecurit risks identified in the Biosecurit Risk Assessment. HPTA Securit Clearances Human Pathogen and Toxins Act (HPTA) Securit Clearance are required for all people who have access to a subset of high-risk biological agents (known as securit sensitive biological agents or SSBAs ). Purpose is to provide assurance that individuals who have access to SSBAs have been assessed to not pose a securit or diversion risk as a result of their access. 4 2

3 Conducting a Biosecurit Risk Assessment Guideline Overview This guideline describes best practices for conducting a biosecurit risk assessment in an organization where human or animal pathogens, toxins, or other regulated infectious material are handled or stored. It allows for the evaluation of appropriate mitigation measures identified via the risk assessment process. Who is this guide for Pathogen and Toxin Licence holders Biological Safet Officers Personnel in regulated facilities 5 Biosecurit Risk Assessment Steps Risk assessment methodolog involves the following five steps: 1. Develop an asset inventor 2. Assess biosecurit event e likelihood 3. Assess biosecurit event consequences 4. Analze 5. Determine risk tolerance The components within this guidelines are assessed using a scale of five values. Component (Quantitative) Component (Qualitative) Ver Low Low High Ver High 6 3

4 Preparation and Asset Inventor Preparation Gathering documentation Developing e an understanding d of the threat environment e Selecting the assessment team Schedule Asset Inventor Identifing assets Asset Asset Class Categor Prioritizing assets Asset Group Component SSBA Risk Group Tangible Biological Virus HIV No 3 Intangible Information Inventor Pathogen and Toxin Inventor Quantit 10 x 1ml tubes State Ease of Use Location Dual-Use Potential ti Frozen Difficult Freezer A No N/A N/A 1 Electronic N/A N/A N/A Priorit (3) High (4) People Emploee Scientist Professor N/A N/A 20 N/A N/A N/A Yes Ver High (5) 7 Likelihood Likelihood assessment involves: Identification of biosecurit event Identifing adversaries determining their motive, means and capabilit Identifing the targeted assets Determining the frequenc Time and location A value of one to five is assigned for adversar motive, means and capabilit, and biosecurit event frequenc in proximit and at a distance. The likelihood value is an average of the four elements, rounded to the nearest whole number. Scenario Biosecur it Event Categor Biosecur it Event Group Adversa r Class Adversa r Categor Adversa r Targeted Assets Adve rsar Motiv e Adve rsar Capa bilitie Likelihood Assessment s Freq uenc (Prox imit) Freq uenc (Dist ance) Likeli hood Intentional release of infected animal b animal rights group Deliberate Intentional release Outsider Activist Animal Rights Group Animal Ver High (5) Ver Low (1) Low (2) (3) (3) 8 4

5 Consequence Consequence assessment involves: Assessing the impact to public health, animal health and the organization Assessing vulnerabilities es and effectiveness ect e ess of mitigation measures es Pre-biosecurit event and post-biosecurit event A value of one to five is assigned for the impact to public health, animal health, the organization, and for the vulnerabilit of pre- and post-biosecurit event. The consequence value is the product of the impact value multiplied b the vulnerabilit value. Asset Impact Impact Mitigation Measure Vulnerabilit Animals High Public Health; High Animal Health; to organization High (4) Access Control Sstem Ver Low (1) Securit Guards Low (2) 9 Analze Risk Analzing risk involves: Risk calculation Creating the risk register Risk is calculated b multipling the likelihood value b the consequence value (i.e. impact and vulnerabilit). Risk The Range output of each risk 1 4calculation 5 18 will result in 19 a 34 value ranging 35 74from 1 to Risk Level Ver Low Low High Ver High ASSET Biosecurit Event LIKELIHOOD Adversar Likelihood CONSEQUENCE Impacts Impact Mitigation Measure Vulnerabilit RISK LEVEL Animals Release Outsider, Activist (3) High Public Health; High Animal Health; to Organization High (4) Access Control Sstem Ver Low (1) Securit Guards Low (2) Low (12) (24) 10 5

6 Risk Tolerance Risk tolerance involves: Determining the risk threshold Accepting risk Implementation of additional mitigation measures for unacceptable risks 11 Resources Available on the Public Health Agenc of Canada website Canadian Biosafet Guidelines Developing a Comprehensive Biosecurit Plan Conducting a Biosecurit Risk Assessment In consultation: Dual-Use in Life Science Research. E-learning Portal Free online training i and resources on laborator biosafet and biosecuritit Courses, videos, posters, interactive biocontainment tool Upcoming courses: Biosecurit Risk Assessment Insider and Outsider Threat 12 6

7 Thank ou Public Health Agenc of Canada Centre for Biosecurit