for the Bureau of Animal Industry

1. BBIOIORRISKISK MMANAGEMENTANAGEMENT
(Assessment, Mitigation & Performance)
Miguel Mártin N. Moreno II, MDMiguel Mártin N. Moreno II, MD
SLMC–RBD, Research Scientist
PhBBA, Founding Secretary

2. DefinitionsDefinitions
BiosafetyBiosafety
– containment principlescontainment principles,, technologiestechnologies andand
practicespractices implemented to preventimplemented to prevent
unintentional exposureunintentional exposure to pathogens andto pathogens and
toxins or theirtoxins or their unintentional releaseunintentional release
BiosecurityBiosecurity
– Institutional and personal securityInstitutional and personal security
measuresmeasures designeddesigned to prevent the loss,to prevent the loss,
theft, misuse, diversion or intentionaltheft, misuse, diversion or intentional
releaserelease of pathogens and toxinsof pathogens and toxins

3. Biosafety is to keep badBiosafety is to keep bad
bugs from peoplebugs from people
Biosecurity is to keep badBiosecurity is to keep bad
people from bugspeople from bugs

4. BRM is more than just……BRM is more than just……

5. BioriskBiorisk = risk associated with= risk associated with
biological materialsbiological materials
Safety componentSafety component Security componentSecurity component

6. Biosafety & BiosecurityBiosafety & Biosecurity

7. Biosafety & Biosecurity SynergyBiosafety & Biosecurity Synergy
Raising awareness of riskRaising awareness of risk
Implementation of graded levels of protectionImplementation of graded levels of protection
based on risk managementbased on risk management
Registration of biological agentsRegistration of biological agents
Redundancy of building installations toRedundancy of building installations to
ensure continuationensure continuation
Waste managementWaste management
Monitoring and AuditMonitoring and Audit
TrainingTraining
etcetc

8. Biorisk Management ModelBiorisk Management Model
3 Key Components3 Key Components
1.1. BioriskBiorisk AAssessmentssessment
2.2. BioriskBiorisk MMitigationitigation
3.3. BioriskBiorisk PPerformanceerformance
AMPAMP modelmodel

9. BIORISK MANAGEMENTBIORISK MANAGEMENT
Assessment,Assessment, Mitigation, PerformanceMitigation, Performance

10. Biorisk ManagementBiorisk Management
Assessment,Assessment, Mitigation, PerformanceMitigation, Performance
What is a hazard?
Hazard is a source that has
the potential for causing harm

11. Biorisk ManagementBiorisk Management
Assessment,Assessment, Mitigation, PerformanceMitigation, Performance
What is a risk?
Hazard only a risk in a
specific environment or situation
Is hazard = risk?

12. Biorisk ManagementBiorisk Management
Assessment,Assessment, Mitigation, PerformanceMitigation, Performance
What is a threat?
Threat is a human who can cause harm – intentionally or
unintentionally – to other people, animals, or the institution

13. Biorisk ManagementBiorisk Management
Assessment,Assessment, Mitigation, PerformanceMitigation, Performance
What is a risk?
Risk can be based on either
a hazard and/or a threat

14. Biorisk ManagementBiorisk Management
Assessment,Assessment, Mitigation, PerformanceMitigation, Performance
Risk is the combination of the likelihood1
and the consequence2
of an undesirable event related to a specific hazard or threat
1
probability of occurrence 2
severity of the event

15. Biorisk ManagementBiorisk Management
Assessment,Assessment, Mitigation, PerformanceMitigation, Performance
Where is the higher risk for an infection
of the personnel? Why?
1. Spill of 0.5ml cell culture with high
concentration of influenza A H1N1 on the floor
of a BSL2 laboratory?
2. Spill of 5ml Ebola Zaire virus culture over the
positive pressure suit of a personnel in a BSL4
laboratory?
Analyze these scenarios:

16. Biorisk ManagementBiorisk Management
Assessment,Assessment, Mitigation, PerformanceMitigation, Performance
Analyze this:

17. BIORISK MANAGEMENTBIORISK MANAGEMENT
Assessment,Assessment, Mitigation,Mitigation, PerformancePerformance

18. Biorisk ManagementBiorisk Management
Engineering controlsEngineering controls – equipment, materials or– equipment, materials or
any other aspect of work environment thatany other aspect of work environment that
reduce or prevent exposure to hazardsreduce or prevent exposure to hazards
Assessment,Assessment, Mitigation,Mitigation, PerformancePerformance

19. Biorisk ManagementBiorisk Management
Administrative controlsAdministrative controls – policies, standards,– policies, standards,
guidelines to control risksguidelines to control risks
Assessment,Assessment, Mitigation,Mitigation, PerformancePerformance

20. Biorisk ManagementBiorisk Management
Practices & ProceduresPractices & Procedures – processes, activities– processes, activities
that have been shown in practice to be effectivethat have been shown in practice to be effective
Assessment,Assessment, Mitigation,Mitigation, PerformancePerformance

21. Biorisk ManagementBiorisk Management
Personal Protective EquipmentPersonal Protective Equipment – devices worn– devices worn
by workers to protect themselves againstby workers to protect themselves against
hazardshazards
Assessment,Assessment, Mitigation,Mitigation, PerformancePerformance

22. Biorisk ManagementBiorisk Management
Assessment,Assessment, Mitigation,Mitigation, PerformancePerformance
Analyze this:

23. Biorisk ManagementBiorisk Management
Assessment,Assessment, Mitigation,Mitigation, PerformancePerformance
ADVANTAGES DISADVANTAGES
Engineering
Controls
Efficient,
Eliminates hazards
Costs, Complexity
Administrative
controls
Authority approach Indirect approach,
addresses human
factor
Practices,
Procedures
SOP-based
(standardized)
Training and
supervision required
PPEs Ease of use,
relative cost
No elimination of
hazard, uncomfortable

24. BIORISK MANAGEMENTBIORISK MANAGEMENT
Assessment, Mitigation,Assessment, Mitigation, PerformancePerformance

25. Biorisk ManagementBiorisk Management
Is the way in which someone orIs the way in which someone or
something functionssomething functions
Is the result of all the efforts of anIs the result of all the efforts of an
organization or a facilityorganization or a facility
Assures that a system works, isAssures that a system works, is
sustainable and that the risk issustainable and that the risk is
acceptableacceptable
e.g. no LAIse.g. no LAIs
Assessment, Mitigation,Assessment, Mitigation, PerformancePerformance

26. Biorisk ManagementBiorisk Management
Is managed byIs managed by controlcontrol of procedures,of procedures,
processes, structures andprocesses, structures and
responsibilitiesresponsibilities
IsIs assuredassured by checking the systemby checking the system
though audits and inspectionsthough audits and inspections
IsIs improvedimproved by setting and achievingby setting and achieving
(new) goals based on internal and(new) goals based on internal and
external feedbackexternal feedback
Assessment, Mitigation,Assessment, Mitigation, PerformancePerformance

28. CWA 15793:2008CWA 15793:2008
Biorisk Management System StandardBiorisk Management System Standard

29. CWA 15793:2008CWA 15793:2008
Biorisk Management System StandardBiorisk Management System Standard
A framework that integrates best practices andA framework that integrates best practices and
proceduresprocedures
Ensures that an organization can effectivelyEnsures that an organization can effectively
achieve all of its objectivesachieve all of its objectives
Frequently built around theFrequently built around the PlanPlan,, DoDo,, CheckCheck,,
ActAct cyclecycle

30. CWA 15793:2008CWA 15793:2008
Biorisk Management System StandardBiorisk Management System Standard

31. CWA 15793:2008CWA 15793:2008
Biorisk Management System StandardBiorisk Management System Standard

32. CWA 15793:2008CWA 15793:2008
Biorisk Management System StandardBiorisk Management System Standard
Implementation of CWAImplementation of CWA (gap analysis)(gap analysis)
Appointment of a BSO or Biorisk MgrAppointment of a BSO or Biorisk Mgr
– Ensures that all requirements of theEnsures that all requirements of the
standards are identified and addressedstandards are identified and addressed
– Interacts with different sections involvedInteracts with different sections involved
– Manages tasks and timelinesManages tasks and timelines

33. CWA 15793:2008CWA 15793:2008
Biorisk Management System StandardBiorisk Management System Standard
Gap analysisGap analysis
– Existing documentationExisting documentation
– ResponsibilitiesResponsibilities
– Document ownerDocument owner
– Status of requirementStatus of requirement
– LocationLocation
– Review and approvalReview and approval

34. CWA 15793:2008CWA 15793:2008
Biorisk Management System StandardBiorisk Management System Standard
Audits: who should conduct them?Audits: who should conduct them?
– Regular inspections for legal complianceRegular inspections for legal compliance
– National AuthoritiesNational Authorities
– QA auditsQA audits
Internal audits –BSO or BRMgrInternal audits –BSO or BRMgr
Biorisk management audits byBiorisk management audits by
independent review teamindependent review team

35. CWA 15793:2008CWA 15793:2008
Biorisk Management System StandardBiorisk Management System Standard
IncidentIncident
– Small spill inside a laboratorySmall spill inside a laboratory
– Large spill inside a laboratory without anyLarge spill inside a laboratory without any
consequences for the environmentconsequences for the environment
AccidentAccident
– Laboratory acquired infectionsLaboratory acquired infections
– Spills – release of biological agentsSpills – release of biological agents
– Failure of biosafety measuresFailure of biosafety measures
– Inadvertent release with no knowledge of itInadvertent release with no knowledge of it

36. CWA 15793:2008CWA 15793:2008
Biorisk Management System StandardBiorisk Management System Standard
Do you have a reporting system in place?
Accident reportingAccident reporting
– Not a “blame” cultureNot a “blame” culture
– Reporting needs to be encouragesReporting needs to be encourages
• Same type of accident?Same type of accident?
• Same person involved?Same person involved?
 WHY?WHY?

37. CWA 15793:2008CWA 15793:2008
Biorisk Management System StandardBiorisk Management System Standard
ConclusionsConclusions
– Biorisk Mgt System toBiorisk Mgt System to managemanage biosafety &biosafety &
biosecurity risksbiosecurity risks
– IntegrationIntegration into existing mgt systemsinto existing mgt systems
– Responsibility for the Biorisk managementResponsibility for the Biorisk management
lies uponlies upon top managementtop management
How is this in your organization?

38. Hazard identification
Risk Assessment
Policy
Objectives
Procedures Programs
Monitoring
Audit
Corrective / Preventive
Action
Review
Plan
Do
Check
Act

39. AcknowledgementsAcknowledgements
Biorisk Management (A, M, P)Biorisk Management (A, M, P)
Robert Heckert, DVM, CBSP
David Bressler, CBSP
Cecelia Williams, PhD
Socorro Lupisan, MD
Cristopher dela Cruz, DVM
PhBBA
SLMC-QC-RBD