Biological Risk Assessment introductions

Biological Risk assessment

1. Develop Controls & Make Risk Decision Assess Hazards Supervise & Evaluate Identify Hazards Implement Controls SAFER LABORATORY OPERATIONS Risk Management Process

2. AMP model Biorisk Management = A ssessment M itigation P erformance

3. Process of identifying hazards and evaluating the risks associated with biological agents and toxins Taking into account the adequacy of any existing controls Deciding whether or not the risk is acceptable Risk Assessment

4. Actions and control measures that are put into place to eliminate or reduce the risks associated with biological agents and toxins Risk Mitigation

5. Evaluating and ensuring that the implementation of entire biorisk management system is working the way it was designed Performance

6. Assessment Mitigation Performance identify acceptable? reduce eliminate working? Continuous improvement

7. Risk Assessment Identify hazard characteristics of known infectious or potentially infectious agent or material Identify activities that can result in a person’s exposure to an agent Estimate the likelihood that such exposure will cause harm Estimate the probable consequences of such an infection

8. A biological risk assessment allows a facility, laboratory or other operation to determine the relative level of risk its different activities pose and helps guide risk mitigation decisions so there are targeted to the most important risks A biological risk assessment is an analytical procedure designed to characterize biological risks in a facility, laboratory or unit within it, or other type of operation dealing with potential pathogens or toxins Risk Assessment

9. Biorisk management Biosafety risk assessment Biosecurity risk assessment Biorisk Management

10. A biosafety risk assessment should consider every aspect of operations, including materials, equipment, and activities conducted that involves infectious disease agents or toxins. A biosecurity risk assessment should consider every asset as well as every vulnerability in an institution and its component laboratories and units. Biorisk Management

11. Why perform a biological risk assessment? A biological risk assessment allows a facility, laboratory, or other operation to determine the relative level of risk its different activities pose, and helps guide risk mitigation decisions.

12. Under-estimation & Over-estimation Under-estimation of risk adverse consequences Over-estimation of risk extra cost and burden but no enhanced safety unnecessary burden leads to circumvention of required safeguards

13. Hazard vs Risk A hazard is a source that has a potential for causing harm

14. Hazard signs

15. What is Risk? Risk is the probability of an adverse event. A hazard is not a risk without a specific environment or situation. A hazard only becomes a risk in a specific environment or situation, i.e. when there is Likelihood of exposure consequence of an adverse effect Risk = (Likelihood x Consequence)

16. Hazards What is a hazard?

17. What are the hazards and risks of an underwater wedding?

18. Let’s add something else to the picture

19. What is a Hazard? Hazard is a source that has a potential for causing harm A hazard is not a risk without a specific environment or situation

20. Hazards and Risk Identification

21. Recognize agents Basic microorganism awareness: Bacteria, fungi, protozoa, virus, etc. Risk Group Lists Recombinant DNA Toxins Synthetic bio Nano tech

22. Material Safety Data Sheet

23. Pathogen Safety Data Sheet

24. Estimating agents risk • Number of past laboratory infections • Natural mortality rate • Human infectious dose • Efficacy of immunization and/or treatment (if either of these are available) • Extent to which infected animals transmit the disease • Stability of the agent

25. Elements that modify risks Hazard evaluation is the starting point of the risk assessment Does the environment or activity change the risk? Laboratory versus field studies Animal studies? Procedures Does the planned experiment have the the potential to generate aerosols? Equipment Needles (sharps) Centrifuges Homogenizers Pipettes

26. Elements that modify risks Agent concentration Suspension volume SOP clarity Environment Quality of materials People (experience, training, familiarity) Complexity of the procedure

27. Protocol based risk assessment Characteristics of Laboratory Procedures There are four principal routes of transmission Ocular invasion Inhalation Ingestion Skin penetration

28. Procedure based assessment Procedures leading to contamination of skin and mucous membranes Contaminated surfaces or equipment Spills or Splashes into mouth, eyes or nose Contaminated fingers into mouth, eyes, nose Spills or splashes onto intact or non-intact skin

29. Mouth pipetting Splashes into mouth Contaminated fingers into mouth Eating or drinking in the lab Procedures leading to ingestion of agent

30. Hazard Analysis List major procedure or process Break procedure down into individual components Determine hazard(s) associated with individual component Identify way to deal with each hazard (hazard mitigation)

31. Risk is a function of likelihood and consequences R = f (L, C) Likelihood Very High Consequences Very Low Low Moderate High

32. Consider the risk if you are… R = f (L, C) at the zoo, looking at an adult tiger which is well fed, has a mild temperament and in a secure enclosure Risk Assessment Likelihood Very High Consequences Very Low Low Moderate High

33. Consider the risk if you are… Risk Assessment Likelihood Very High Consequences Very Low Low Moderate High holding a tiger kitten with a playful temperament

34. 36 Consider the risk if you are… Risk Assessment at the zoo and looking at mellow tiger kitten, which is located behind a glass window. Likelihood Very High Consequences Very Low Low Moderate High

35. Risk Assessment Determine Inherent Risk – ie . the risk that exists without any controls Determine consequence Determine likelihood Enter into IR table using the numerical values

36. LEVEL DESCRIPTOR LIKELIHOOD – DESCRIPTION 1 Rare May occur only in exceptional circumstances 2 Unlikely Could occur at some time 3 Possible Might occur at some time 4 Likely Will probably occur in most circumstances 5 Almost Certain Is expected to occur in most circumstances Likelihood

37. LEVEL DESCRIPTOR CONSEQUENCE – DESCRIPTION 1 Insignificant No injuries, low financial loss 2 Minor First aid treatment, on site release immediately contained 3 Moderate Medical treatment required, on site release contained with outside assistance, high financial loss 4 Major Extensive injuries, loss of production capability, off site release with no detrimental effects, major financial loss 5 Catastrophic Death, toxic release off site with detrimental effect, huge financial loss Consequence

38. LIKELIHOOD CONSEQUENCES Insignificant (1) Minor (2) Moderate (3) Major (4) Catastrophic (5) (5) Almost Certain M M H H H (4) Likely M M M H H (3) Possible L M M H H (2) Unlikely L L M M H (1) Rare L L M M H Risk Matrix

39. Scenario 1 You have encountered with an aggressive and hungry tiger while trekking in the jungle.

40. Scenario 2 You have seen a well fed caged tiger in the National Zoo.

41. Scenario 3 You are bottle feeding a cute tiger cub.