Risk Assessment

1. Risk Assessment January 2006 Biosafety Compliance Judy Pointer UNM Biosafety Officer

2. Definitions • Biohazard: the potential of a biological substance to cause injury, illness, damage, or loss. • Consider biohazard potency: examples • If you get it, it can kill you [SARS, TB, Ebola] • If you get it, it’s unlikely to be fatal [Bordetella Pertussis -Mumps] • If you get it, it is likely to have no effect at all [E. coli – K12 derivatives, fixed or killed microbes, non-pathogenic microbes] • If you release it to the environment it is possible to cause harm to the public, flora, or fauna • Risk: the chance or likelihood that an injury, illness, damage, or loss will occur.

3. Biohazard potency dependent on many factors • Ease & type of transmission • ingestion, contact, fomites, droplet, aerosol, percutaneous injury • existing natural barriers to transmission (physical or biological) • Degree of pathogenicity, toxicity, virulence • Range of cell & species trophism, communicability • Human to human, animal to human, insect vectors required, immune cells only, etc. • Infectious dose & quantity • Concentration per volume & total volume handled • Environmental stability • Existing community immunity, vaccination, existing available treatments, immune status (suppression, age, sex, illness, etc.) • Procedures employed • Unknowns

4. Consider all potential risks - perceived and/or actual and the potential ramifications • Physical human health harm • Harm to domestic animals [economic], wildlife, or environmental ecosystems [water, air, forests, etc.] • Harm to UNM reputation or law suites [bad publicity] • Don’t assume because the hazard exists naturally that the justice system will not hold UNM scientists accountable. • Harm to public’s perception of scientists • Harm to the nation’s domestic security • Harm to your personal reputation • Violations of prohibitive regulations (laws) resulting in civil or criminal penalties for yourself or your employer

5. Assumptions related to Risk Group and Biosafety Level ratings • Risk ratings are developed assuming no containment parameters exist and the person(s) potentially exposed are normal healthy adult(s). • BSL levels represent performance standards which should reduce the risk thru mitigation techniques to a level that is acceptable to allow the work to proceed. • Impossible to reduce a risk to zero & cost/benefit ratio of trying to do so may not be acceptable.

6. Proceed with Risk Assessment to determine Biosafety Level needed • Consider the worst case scenario – Murphy’s Law! • No protections in place; agent is released; what could be the consequences? This equals the highest risk from working with it. • Consider the physical barriers possible to keep the worst case scenario from happening • Barriers can be physical/engineered, administrative, or PPE • 1o barrier: to protect the persons in the lab • 2o barrier: to protect those outside the lab • When unacceptable risk exists mitigate it by adding on multiple barriers (fail-safe) at the 1o and/or 2o levels, Examples: • work inside a BSC and wear a respirator = two 1o barriers • maintain the lab at negative pressure with doors closed and HEPA filter the exhaust from the lab = two 2o barriers • Always ensure there is at least one 1o barrier when the agent can cause human harm. Example: working with common pathogenic bacteria in a BSC; cover hands/arms so exposed skin does not become contaminated and result in later fomite transmission. • Once barriers needed are decided, compare to existing Biosafety Levels and add on or delete barriers as appropriate to mitigate the risk to acceptable level.

7. Discussion • Survey – useful? • Opinions or questions