3/24/2020

Biosafety Training
Module 2: Risk Assessment
University Safety & Assurances
Biological Safety Program

What, Who, When, Why

“Risk assessment is a process used to identify the hazardous characteristics of a

known infectious or potentially infectious agent or material, the activities that can
result in a person’s exposure to an agent, the likelihood that such exposure will
cause a LAI, and the probable consequences of such an infection.”- BMBL, 5th
Edition
• What does a risk assessment identify?
• Who does the risk assessments?
• When should the risk assessments be conducted?
• Why should risk assessments be done at regular intervals?

University of Wisconsin-Milwaukee Biosafety Program 2

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Biorisk Management

Information Prioritization of Risk mitigation Implementation Review and

gathering, risk and controls • Biosafety Protocol evaluate, adjust
identification of • Probability • Elimination/ Approval as needed
hazards • Consequence Substitution • Biosafety Manual • Daily checks
• Agent • Engineering • SOPs • Group meetings
Controls • Annual review
• Host Environment
• Administrative • Biosafety Lab Visits
• Environment Controls
• Protocol Renewals
• PPE

University of Wisconsin-Milwaukee Biosafety Program 3

Information Gathering- Biosafety

Protocol, Lab Visits, Daily Checks

Environment Biological Agent Host

Lab design, organization, Characteristics Lab personnel

cleanliness
Health status
Routes of transmission
Lab techniques
Training and education
Epidemiology- LAIs
Language barriers
Engineering controls
Inactivation methods
PPE use
Location Risk Group Stress level

University of Wisconsin-Milwaukee Biosafety Program 4

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Routes of Transmission
• Direct contact- person to person
• Indirect contact- inanimate objects (fomites)
• Inhalation
• Ingestion
• Percutaneous

BIOLOGICAL AGENTS CAN HAVE MORE THAN ONE ROUTE

OF TRANSMISSION!

Biological Agent: Infectious Dose

Number of microorganisms required to initiate infection

Biological Agent Infectious Dose

Escherichia coli 108 CFU
E.coli O157:H7 10 CFU
Salmonella spp. 100-1000 CFU
Measles virus 1 virus

(CFU= colony forming unit)

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Biological Agent Risk Group

Classification
Risk Group NIH Risk Group Description
Classification

Risk Group 1 Agents that are not associated with disease in healthy adult humans (low individual risk,
(RG1) low community risk)

Risk Group 2 Agents that are associated with human disease which is rarely serious and for which
(RG2) preventive or therapeutic interventions are often available (moderate individual risk, low
community risk)

Risk Group 3 Agents that are associated with serious or lethal human disease for which preventive or
(RG3) therapeutic interventions may be available (high individual risk but low community risk)

Risk Group 4 Agents that are likely to cause serious or lethal human disease for which preventive or
(RG4) therapeutic interventions are not usually available (high individual risk and high
community risk)

University of Wisconsin-Milwaukee Biosafety Program 7

Prioritization of Risk
• Probability: what’s the likelihood something could happen?

• Consequence: what is the consequence if something goes

wrong?
Probability RG1 RG2 RG3 RG4
of Accident
Negligible Very low Low Low Medium
Low Very low Low Medium High
Medium Low Medium High Very high
High Low Medium High Very high
From: Biological Safety Principles and Practices, 5th Edition

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Elimination/ Mitigation
• Can you eliminate the risks?

• Determine if the risk is an acceptable risk.

• If the risk is an acceptable risk, that’s when you turn to

mitigation of risks:
• Substitution- safer agent? Alternative (safer) procedures?
• Engineering controls- Biosafety cabinets, modern centrifuges
• Administrative controls- training, education, monitoring, SOPs
• PPE- not just there, but use it regularly and follow an SOP

Implementation
• How do you implement the plans and procedures?
• If you’re a PI: regular meetings with your personnel, being the example,
clear accessibility and communication of procedures and expectations.
• Maintain approved biosafety protocols, current lab inspection files, SOPs, and lab
manuals in an easily accessible location and make sure you routinely review and
update materials as necessary and needed.
• Other lab personnel: Work with PI to understand how to use
equipment, understand the risks associated with your work, make sure
you’re adequately trained and educated in the work you will be
conducting

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Review and Evaluate

• Regularly re-assess experiments you’re conducting. Talk about
concerns, or if you have unexpected results.
• Communicate issues, accidents, and spills. If these happen,
review your materials and revise to reduce likelihood of incident
occurring again.
• Review your materials with the biosafety program and discuss
any concerns/ questions you may have.
• Have questions? Contact the Biosafety Program at uwm-
biosafety@uwm.edu.

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Module 2

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