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BiosafetySymposium_2014_RA
- 1. 2014 Biosafety Symposium Rx Risk: Assessing risks in a less prescriptive environment Canadian Biosafety Symposium Winnipeg, MB June 12, 2014 Liz Krivonosov, PEng, CIH, ROH Mireille Cartier, PhD KRMC Inc.
- 3. 2014 Biosafety Symposium Outline • CBSG requirements • Assessment overview • Biosafety program – Risk assessment components – Local risk • Case study – viral vectors
- 4. 2014 Biosafety Symposium RISK Evaluation • Anticipation • Evaluation – hazard • Assessment - probability • Control – Mitigation/Management Author: Carl Pritchard
- 5. 2014 Biosafety Symposium CBSG Standards – Risk Assessment
- 6. 2014 Biosafety Symposium Risk Assessment Requirements CBSG Standard • R4.1.4 – An overarching risk assessment to be conducted and documented to identify the hazards and appropriate mitigation strategies for the proposed activities involving infectious material and toxins
- 7. 2014 Biosafety Symposium Risk Assessment requirements CBSG Standard • R4.1.5 – A local risk assessment (LRA) to be conducted and documented to examine: • each activity • identify risks • develop safe work practices .
- 8. 2014 Biosafety Symposium Less prescriptive environment G4.3.8 - Although the agencies assign containment levels for pathogens, the CBSG is performance based, which allows personnel to use LRAs to determine the mitigation strategies for their activities as each situation is different.
- 10. 2014 Biosafety Symposium Risk Assessment Risk analysis must answer 3 questions 1. What can happen? – Hazard identification 2. What is the chance it will happen? – Occurrence likelihood 3. What are the consequences of the event? – Occurrence consequences
- 12. 2014 Biosafety Symposium HAZARD IDENTIFICATION RISK MANAGEMENT EXPOSURE ASSESSMENT RISK CHARACTERIZATION Will it be harmful? Potential in workplace How hazardous is agent & intended use? Procedures & facilities to minimize exposure Classic Risk Mitigation Model
- 13. 2014 Biosafety Symposium Overarching Risk Assessment to identify the most important issues
- 14. 2014 Biosafety Symposium Biosafety Program Overarching Risk Assessment Biosecurity RA Medical Surveillance RA Emergency Response Plan RA Communication Plan RA Local RA Local RA Local RA
- 15. 2014 Biosafety Symposium Overarching Risk Assessment Better to prevent or remove rather than mitigate
- 16. 2014 Biosafety Symposium Overarching Risk Assessment Should contain: – Plan of the facility – Focus on all biological laboratories – Description of the biological material used – Identification of personnel handling the material – Type of activities (diagnostics, research, animal work, etc.)
- 17. 2014 Biosafety Symposium Biosecurity Risk Assessment Biosecurity is implemented to prevent: • Theft • Intentional release of pathogens • Misuse
- 18. 2014 Biosafety Symposium Biosecurity Risk Assessment 2 complementary consequences should be considered: 1. Loss of Valuable Biological Material (VBM) material with a special value • scientific • historic (strain collections, reference strains, etc.) • economic (clinical material, vaccines, etc.) 2. Malicious use of the material to harm the population Henrietta Lacks
- 19. 2014 Biosafety Symposium Biosecurity Risk Assessment • Physical Security - Building Management • Personnel Security - Human Resources • Material Control and Availability -PI/BSO • Transport Security - Shipping/Receiving • Information Security – IT department • Program Management – H&S/BSO
- 20. 2014 Biosafety Symposium Medical Surveillance Risk Assessment Potential of the biological material to cause infection/disease to be assessed (PHAC PSDS, BMBLv5, etc.) • Consequences of infection • Known conditions in worker which could affect disease outcome • Pre-placement worker evaluation • Vaccine availability • Treatment availability – Post-exposure prophylaxis – Treatment of infection/disease • Medical surveillance of employees in the case of dangerous pathogens
- 21. 2014 Biosafety Symposium Emergency Response Assessment • Assessment of possible/probable scenarios (reg & after hours) – Exposures (cuts, and splashes), spills – Loss of power – ventilation, sample storage • Roles and responsibilities – internal and local emergency response
- 22. 2014 Biosafety Symposium Emergency Response Assessment TRAINING and EXERCISES • First responders, security, staff working with agents • Availability of equipment • reporting and investigation procedures
- 23. 2014 Biosafety Symposium Emergency Response Assessment EVACUATION ROUTES EMERGENCY ACCESS OVERIDE ENTRY
- 24. 2014 Biosafety Symposium Communication Assessment • Target Audience? – Notification of internal staff, regulators, medical staff, public • Training • Roles understood?
- 25. 2014 Biosafety Symposium Communication Assessment • Regular updates • Changing conditions • Uncertainty • Timeliness
- 26. 2014 Biosafety Symposium Risk Communication – Dealing with Uncertainty Risk = Hazard + Outrage Dr. Peter Sandman Responding to Community Outrage: Strategies for Effective Risk Communication
- 27. 2014 Biosafety Symposium Local Risk Assessment LRAs are step-by-step risk assessments of specific experimental protocols leading to standard operating procedures
- 28. 2014 Biosafety Symposium LRA – General Information • Goal of the experiment • Responsible PI • List of personnel involved • Location
- 29. 2014 Biosafety Symposium LRA – Biological Material Detailed information about the biological material for thorough understanding of the consequences of exposure: • pathogenicity and infectivity • infectious dose • route of infection • mode of transmission
- 30. 2014 Biosafety Symposium LRA – Medical Assessment Specific for the organism and the experimental protocol. Medical Information: • General from the overall medical surveillance RA • Specific related to the protocol
- 31. 2014 Biosafety Symposium Step-by-step description of experimental protocol including various parameters and special precautions • manipulations • location of the work • risk potential: quantity, aerosol generation, open bench, etc. • special precautions LRA - Protocol
- 32. 2014 Biosafety Symposium LRA - Manipulations
- 33. 2014 Biosafety Symposium LRA – Location of Work
- 34. 2014 Biosafety Symposium LRA Risk potential: quantity, aerosol generation, etc.
- 35. 2014 Biosafety Symposium LRA – Special Precautions Adding or removing PPE Specific to the various experimental steps:
- 36. 2014 Biosafety Symposium LRA – Special Precautions Moving from one containment level to another Specific to the various experimental steps:
- 37. 2014 Biosafety Symposium LRA – Document 1 General information about the project, personnel and the biological material Local Risk Assessment General Information PI: John Tremblay Project: Studies with various Human Immunodeficiency Virus mutants Personnel: ________________________ Location: Smith building, labs 123, 167, 190 and 193 Biological Material: Various HIV mutants grown in different established cell lines Pathogen Safety Data Sheet for HIV is attached [Description of the different mutants] Medical Assessment: HIV is a bloodborne pathogen leading to lifelong immunodeficiency… No vaccines Post-exposure prophylactic treatment available: protocol to obtain treatment in case of exposure Personnel with specific medical conditions should consult their medical doctor for evaluation …
- 38. 2014 Biosafety Symposium LRA – Document 2 Detailed information about the protocol Various templates available on the web
- 39. 2014 Biosafety Symposium Viral Vector System Pseudotyped HIV – 4 mutant plasmids to encode the various HIV proteins required for the generation of pseudovirus – very low risk of Replication Competent Virus (RCV) – VSV G envelope – broad tropism – Transfer plasmid encoding luciferase protein for detection
- 40. 2014 Biosafety Symposium HIV viral vector – 3rd generation
- 41. 2014 Biosafety Symposium Issues to consider with viral vectors Use of viral vectors for the transfer of genetic material in human cells: • Potential for replication-competent viruses • Integration inactivation/activation of autologous genes • Change in tropism related to different envelope protein • Production of foreign proteins: – Toxic proteins – Oncogenes – Viral proteins • Seroconversion
- 42. 2014 Biosafety Symposium Conclusions Less prescriptive environment: • More flexibility in terms of work environment and procedures • More documentation to provide appropriate justification • Thinking through the entire procedure and potential risks • Written documentation available for consultation by all personnel
- 43. 2014 Biosafety Symposium Rx Risk: Assessing risks in a less prescriptive environment
- 44. 2014 Biosafety Symposium Liz Krivonosov, PEng, CIH, ROH President liz@krmc.ca Mireille Cartier, PhD Biosafety Specialist mireille@krmc.ca KRMC Inc. www.krmc.ca 2014 Biosafety Symposium Risk Assessment - Completed