1. January 2006 Biosafety Compliance Judy Pointer UNM Biosafety Officer
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