Biorisk Mitigation Strategies

Biorisk Management: the AMP

Model

Biorisk Management
Biorisk Management= =
Assessment + Mitigation
Assessment, Mitigation,+Performance
Performance

Slide 2
 Key Components of Biorisk
Management
• Biorisk Assessment
– identifying and evaluating the hazards
risks associated with biological agents
and toxins

Slide 3
 Why Risk Assessment?
Group Exercise:
In your groups, please spend 5 more minutes to
discuss the following questions:

1. Why is it important to conduct a Risk Assessment

prior to implementing mitigation controls?
2. What outcomes would you expect when mitigation is
based on a thorough risk assessment?
3. What would you expect if mitigation is implemented
without conducting a risk assessment?

Write down your answers in your student guide and

be prepared to report out to the class.
Slide 4
 Risk assessment
• There is a simple five step approach to risk
assessment which involves:
1) Identify the hazards
2) Decide who might be harmed and how
3) Evaluate the risks and decide on
precautions
4) Record your significant findings
5) Review your assessment and update if
necessary

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 Risk Assessment-type OF
Hazard
• Step 1: identifying hazards: Biological hazards:
this includes bacteria and micro organisms of the
type encountered when working with infected people
or animals
• Handling waste materials (particularly in hospitals)
or working in contaminated Environments.

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 Risk Assessment- Biological
Hazards

Handling waste materials working with animals

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 Risk Assessment…risk
Assessment
• Step 2: Deciding who might be harmed and
how this could happen
• This includes,
− Researchers, Staff
− Students
− Patients
− Technicians
− cleaners
− visitors,
− Owners
− maintenance workers, contractors, employees
− Researchers away travelling or at another
workplace
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 RISK ASSESSMENT
• Step 3: Evaluating the risks and
deciding whether the existing controls
are sufficient
• Make an action list of work that giving
priority to high risks and/or risks which could
affect most people. Consider:
• Can the hazard be removed altogether ?
• If not, how can the risks be controlled so
that harm is unlikely?
• How severe is the harm likely to be?
• How likely is it to happen?
9
 Mitigation of Potential Risks
• If you really feel that you cannot
completely eliminate a hazard, the next
step is to control the risks so that any
harm to the people involved with it is
less likely.

10
 Key Components of Biorisk
Management
• Biorisk Mitigation
– Actions and control measures that are put
into place to reduce or eliminate the risks
associated with biological agents and
toxins

Slide 11
 Mitigation Strategies/ Procedures
• Example:
• What scientific approaches or
methodologies, if any, could be used
to minimize the identified risk(s):
• Of theft of the viruses?
• Of accidental exposure or release
of the viruses or samples?
• Of the consequences of misuse
of research materials and
results?
• To experimental animals?
• Of scientific misconduct?
Manage

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 Biorisk Mitigation Scenario
Group Exercise:
In your groups, please spend 5 minutes to
read the scenario and identify at least four
different risk mitigation measures.
Hint: Remember that mitigation measures
should address safety and security.
Write down each mitigation measure on a
sticky-note and place them on your flip-
chart. Be ready to report your answers out to
the class.
Slide 13
 Icky Virus
• A new virus has recently been discovered and named icky virus.
Symptoms include a high fever, bleeding of the gums and other
mucous membranes. Infected individuals develop a high fever, rash
followed by pneumonia within two or three days of the first sign of
disease. Elderly and young seem to be particularly afflicted. While
the mortality appears to be less than 10%, several people have
died including one lab technician and a hospital worker who treated
infected individuals. How the virus is transmitted and the routes of
exposure are unknown at this time. Contact with wild animals is a
risk factor for contracting the virus.
• Your laboratory has been tasked to isolate and identify the virus
using various methods. You will also be screening patient samples
from exposed individuals and testing a variety of wild animal blood
and tissues for the presence of the virus.
• The lab manager has asked your committee to brainstorm a list of
as many mitigation controls that could be used to reduce the risk of
handling this virus without regard to cost, feasibility or practicality.
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 Mitigation Control Measures
There are five major categories of
measures for controlling biological
risks in the laboratory.

1. Elimination or Substitution
2. Engineering Controls
3. Administrative Controls
4. Practices and Procedures
5. Personal Protective
Equipment

Slide 15
 Mitigation Control Measures
Elimination : Removing the hazard from
workplace, not working with the agent
Substitution: replacing the hazard with
something less dangerous or alternative
substitute

Slide 16
 Mitigation Control Measures
Engineering Controls: Physical changes to work
stations, equipment, materials, production facilities,
or any other relevant aspect of the work
environment that reduce or prevent exposure to
hazards
I. Primary barriers- contain the agent at source
− BSC & other ventilation equipment
− Animal isolation cages
I. Secondary barriers- provide protection to
personnel and environment in case of a
release from primary containment
− Facility architectural features
− Facility mechanical systems

Slide 17
 2. Engineering Controls
A. Lab design: the laboratories are designed
to provide biosafety levels that
corresponding to microorganisms in risk
groups 1-4.
− Diagnostic and health-care laboratories
(public health, clinical or hospital-based)
must all be designed for Biosafety Level 2
or above

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 Laboratory design and facilities
• Lab design: during designing of lab, special
attention should be paid to conditions that are
known to pose safety problems like:
1) Formation of aerosols
2) Work with large volumes and/or high
concentrations of microorganisms
3) Overcrowding and too much equipment
4) Infestation with rodents and arthropods
5) Unauthorized entrance
6) Workflow: use of specific samples and
reagents.
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 Design features
The design of laboratories should take into account many things,
including but not limited to:
1. Sufficient space for the safe work; cleaning and maintenance.
2. Walls, ceilings and floors should be smooth, easy to clean,
impermeable to liquids and resistant to the chemicals and
disinfectants. Non-slippery Floors.
3. Bench tops should be waterproof and resistant to
disinfectants, acids, alkalis, organic solvents and moderate
heat.
4. Illumination should be adequate for all activities.
5. Laboratory furniture should be sturdy and easy to clean.
6. Storage space must be adequate to hold supplies for
immediate use and thus prevent clutter on bench tops and in
walkways.
7. Additional long-term storage space, conveniently located
outside the laboratory working areas, should also be provided
8. Open spaces between and under benches, cabinets and
equipment should be accessible for cleaning.
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 Design features
9. Hand-washing basins, should be provided in each laboratory
room, preferably near the exit door.
10. Doors should have vision panels, appropriate fire ratings, and
preferably be self-closing.
11. Separate room storage of personal belongings and for eating
and rest.
12. Safety systems should cover fire, electrical emergencies,
emergency shower and eyewash facilities & emergency exit.
13. Mechanical ventilation systems that provide an inward flow of
air without recirculation.
14. Good quality water is essential.
15. Good electricity supply and emergency lighting to permit safe
exit, and a stand-by generator.
16. Physical security… doors, windows, restricted acess
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 Basic laboratory
Biosafety Level 1 (BSL1)

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 Basic laboratory
Biosafety Level 2 (BSL2)

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 Biosafety Level 3 laboratory
• Containment lab

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 Biosafety Level 4 laboratory
• The maximum containment laboratory

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 Air-lock entrance to the Hot zone A biohazard suit

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 Mitigation Control Measures
B. Doors, Locks and
Cameras

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 2. Engineering Controls
C. VENTILATION EQUIPMENT
1. Chemical Fume Hoods: are
used when chemical
reagents may produce a
hazardous fume.
• Protect the person through the
flow of air inside.
• Does not contain a HEPA
filter… dilution ventilation
• Air flow should be checked to
assure proper ventilation.

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 2. Engineering Controls
C. VENTILATION EQUIPMENT
2. Clean air benches (horizontal
laminar flow)
 Outward air flow is directed toward
the worker’s breathing (no personal
protection)
 Protect the product (sterile
environment)
 Used with nonhazardous materials
like culture media prep.

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 2. Engineering Controls
D. Biological safety cabinets (BSCs)
− it remove particles that may infect the person
working with the biologically infected specimen.
− These hoods contain a HEPA (high-efficiency
particulate air) filter
 Three types
− BSC class I, Class II and Class III
− designed to provide protection for
− Personnel ( directional flow of air into cabinet)
− Environment (HEPA filtered exhaust)
− Product (except Class I) ..laminar flow of HEPA
filtered air
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 Class I BSC
• Unfiltered room air pass
over the work area
• Exhaust air is HEPA
filtered and returning to
the room
• No product protection
• Suitable for working with
moderate to severe
potential hazard (Risk
Groups 2 and 3)

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 Class II BSC
Protection for
• Personnel
• Product
• Environment

• Suitable for
working with
moderate to severe
potential hazard

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 Class III BSC

• Suitable for working with severe, exotic and dangerous

potential hazards (MOs risk group 3 and 4)
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 Mitigation Control Measures
Administrative Controls: Policies, standards
and guidelines used to control risks (work
safely) e.g.

− reducing the time workers are exposed to hazards

(e.g. by job rotation).
− increasing safety signage
− prohibiting use of mobile phones
in hazardous areas.
− Supervision /support

Slide 34
 Mitigation Control Measures
Tasks
Administrative Controls
Responsibilities
• Policies and risk management plan Activities
• Records for accidents
Budget
• laboratory Signs
• Education and training

35
 Mitigation Control Measures
Practices and Procedures: Processes and
activities that have been shown in practice to be
effective in reducing risks

Slide 36
 Mitigation Control Measures
• Practices and Procedures:
It includes a wide range of practices and
procedures adopted globally or locally and
proven to be effective in preventing or reducing
risk
− Good laboratory practices (GLP)
− Decontamination
− Personal protection
− Waste management

37
38
 Mitigation Control Measures
• Personal Protective Equipment:
Devices worn by the worker to protect
against hazards in the laboratory
• The hazards addressed by PPE like
biohazards, and airborne particulate
matter.
• Personal protective equipment is
designed to protect many parts of the
body, i.e., eyes, head, face, hands,
feet, and ears.
Slide 39
 Mitigation Control Measures
• Personal Protective Equipment:

• The use of personal protective equipment is

the least preferred method of protection from
hazardous exposures.
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 Mitigation Control Measures
Group Exercise:

Considering these categories of mitigation

control measures:
Elimination or Engineering Administrative Practices and Personal
Substitution Controls Controls Procedures Protective
Equipment
(PPE)

Please spend 5 minutes to categorize your

mitigation measures from the previous activity.
Place your sticky-notes under each category.

Slide 41
 Advantages and Disadvantages
Control Measure Advantages Disadvantages
Elimination or
Substitution

Engineering

Administrative

Practices &
Procedures

PPE
 Advantages and Disadvantages
Control Measure Advantages Disadvantages
Elimination or
Immediate reduction of risk Not always available or possible
Substitution

Engineering Efficient, Cost,

eliminates hazard complexity

Administrative Authority approach Indirect approach, primarily

addresses the human factor
Practices & Training and supervision
SOP based (standardized
Procedures requirements
approach)

Does not eliminate hazard, PPE

PPE
Ease of use, relative cost fails exposure happens,
uncomfortable, limits ability,
only protects the user
 Mitigation Control Measures
Group Exercise:

Considering these categories of mitigation

control measures:
Most Least
1 2 3 4 5
Effective Effective

Please spend 5 minutes to prioritize the five

types of controls from the perspective of
effectiveness.

Slide 45
 Control methods at the top of the list are, in general, more
Slide 46 effective and protective than those at the down.
 Car Safety vs. Motorcycle Safety

Car safety is all

about engineering
systems

Motorcycle safety is all

about PPE

Slide 47
 Identifying Controls
Exercise
Please watch the following video of an
incident/emergency response scenario
Identify and write down as many different
mitigation measures as you can
Assign the mitigation measures to one of
the five categories of controls
Video Clip

Slide 48
 Final Review

For 10 minutes, let’s discuss what we

have learned about Biorisk Mitigation
Strategies.

What did we What does it Where do we go

learn? mean? from here?

Slide 49
 Key Messages
• Definition of Mitigation and role in the AMP model.
• Mitigation is most effective when based on a
thorough risk assessment.
• There are five generally recognized categories of
control measures; each with various advantages
and disadvantages.
• Elimination or substitution is the most effective
means of mitigating risk; generally followed by
engineering controls; administrative controls;
practices and procedure; and finally PPE.
• It takes a combination of mitigation measures; in
addition to the risk assessment, the effectiveness
of mitigation also must be judged on your ability to
implement them.
Page 50
Thank You!
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