BIORISK MANAGEMENT

LECTURE
Biorisk Management and the AMP model - like a three-legged stool, a biorisk management
fails if one of the components, or legs, is
Biorisk overlooked or is not addressed.
- risk associated with biological toxins or - focuses on all components with equal attention
infectious agents.

- source of risk may be unintentional exposure to

unauthorized access, accidental release or loss,
theft, misuse, diversion, or intentional
unauthorized release of biohazards

Biorisk Management (BRM)

- the integration of biosafety and biosecurity to

manage risks when working with biological
toxins and infectious agents (CWA 15793
Laboratory Biorisk Management Standard)

- "a system or process to control safety and

security risk associated with the handling or
storage and disposal of biological agents and
toxins in laboratories and facilities.” (CEN
Workshop Agreement (CWA) 15793:2011)
- encompasses the identification, understanding,
and management aspects of a system in
interrelated processes
Divided into 3 primary components:
Assessment (A)
Key Components of Biorisk Management
Risk Assessment
- The initial step in implementing a biorisk
management (includes the identification of
hazards present in the laboratory)
Hazard
- refers to anything in the environment that has
the potential to cause harm

Mitigation (M) Risk

Performance (P) - generally defined as the possibility that

AMP model
- requires that control measures be based on a
robust risk assessment, and a continuous
evaluation of effectiveness and suitability of the
control measures.
- identified risks can be either: mitigated,
avoided, limited, transferred to an outside entity,
or accepted
something bad or unpleasant (such as an injury
or loss) will happen. (Ex. a sharp needle is a
hazard, but if no one is using it, the needle will
not pose any risks.) In performing risk
assessment, a structured and repeatable process
is followed. It consists of the following steps:
1. Define the situation - the risk assessment
team must identify the hazards and risks of the
biological agents to be handled. Next, at-risk
hosts, who could be humans or animals inside
and outside the laboratory, must be identified.
The work activities and laboratory environment
including location, procedures, and equipment
should also be defined.
2. Define the risks - defining the risks must
include a review of how individuals inside and
outside the laboratory may be exposed to the
hazards. It could either be through droplets,
inhalation, ingestion, or inoculation in case a
biological agent has been identified as the
hazard.
3. Characterize the risks - to characterize the
overall biosafety risks, the risk assessment team
needs to compare the likelihood and the
consequences of infection —either qualitatively
or quantitatively.
4. Determine if risks are acceptable or not - this
process of evaluating the biorisk arising from a
biohazard considers the adequacy of any existing
controls, and deciding whether or not the biorisk
is acceptable.
Mitigation Procedures
Mitigation
- second fundamental component of the biorisk
management model
Biorisk Mitigation Measures
- actions and control measures that are put into
place to reduce or eliminate the risks associated
with biological agents and toxins
Five (5) major areas of control or measures in
mitigating the risks:
Hierarchy of Controls
- describes the order of effectiveness (from most
effective to least effective) of mitigation
measures and implies that this order should be
considered when selecting and implementing
controls to reduce risks.
Elimination - most difficult and most effective
control measure, involves the total decision not
to work with a specific biological agent or even
not doing the intended work. Elimination
provides the highest degree of risk reduction.
Substitution - the second control measure, is the
replacement of the procedures or biological
agent with a similar entity to reduce the risks.
(Ex. a laboratory conducting research with the
pathogen Bacillus anthracis, responsible for
causing the acute fatal disease anthrax, could
potentially substitute a less dangerous
experimental surrogate)
Setting of engineering controls - includes
physical changes in workstations, equipment,
production facilities, or any other relevant aspect
of the work environment that can reduce or
prevent exposure to hazards. Examples are
installation of biosafety cabinets, safety
equipment (centrifuge with cover, autoclave, and
machines with indicators), facility design
enabling proper airflow, ventilation system to
ensure directional airflow, and air treatment
systems to decontaminate or remove agents
from exhaust air, controlled access zones,
airlocks as laboratory entrances, or separate
buildings or modules to isolate the laboratory.
Setting of administrative controls - refers to the
policies, standards, and guidelines used to
control risks. Proficiency and competency
training for laboratory staff is considered an
administrative control. The displaying of The diagram below shows the specific procedures in
biohazard or warning signages, markings, and conducting performance evaluation.
labels, controlling visitor and worker access, and
documenting written standard operating
procedures are some examples. Practices and
procedures of administrative controls comprise
minimizing splashes, sprays, and aerosols to
avoid laboratory-acquired infections or following
standard operating procedures (SOPs).

Use of Personal Protective Equipment (PPE) -

Devices worn by workers to protect them against
chemicals, toxins, and pathogenic hazards in the
laboratory. Gloves, gowns, and respirators are all
examples of PPE. PPE is considered the least
effective Moser because it only protects the
person who is wearing it, and only when it is used
correctly.
Note: not one of the mitigation controls or
measures is completely effective at controlling or
reducing all risks. (Salerno, 2015)
Performance Evaluation
Performance Evaluation
The result of a robust risk assessment must be
properly recorded, documented, and
communicated to all stakeholders of the
organization. Only through this final process that
findings could be decided upon, given
appropriate action, to be able to provide and
establish a clear manifestation of implementing
the fundamental concept of biosafety and
biosecurity in the laboratory

- last pilar of the biorisk management model

involves a systematic process intended to
achieve organizational objectives and goals.

- ensures that the implemented mitigation

measures are indeed reducing or eliminating
risks. It also helps to highlight biorisk strategies
that are not working effectively and measures
that are ineffective or unnecessary.

Performance Management

- simply a reevaluation of the overall mitigation

strategy.
KEY POINTS the general public, and other
impacted parties.
• Biorisk Management (BRM) is an
integral part in the implementation
of the concept of biosafety and
biosecurity in a laboratory. It involves
the process of assessment,
mitigation, and performance
evaluation.
• The AMP model illustrates the
balanced role among the
components of BRM.
• A robust risk assessment is the heart
of BRM. It ensures safety and security
of the people working in the
laboratory as well as all the
stakeholders in an organization.
• The different mitigation procedures
to be employed depend on the result
of a robust risk assessment. It is
recommended not to overdo or
underdo the measures.
• Performance evaluation is not a
linear process, rather, it is a
continuous process to monitor the
implementation of existing biosafety
procedures and practices. It provides
direction for decision-makers to be
able to come up with reasonable and
justifiable biosafety guidelines.
• Most importantly, communicating
BRM among the members of the
organization, especially to the top
management paves the way for
interactive transmission and
exchange of information and
opinions throughout the analysis
process about risk, risk-related
factors, and risk perceptions among
risk managers, risk communicators,