Biorisk Management and the AMP Model MT101  ADDB SEP 2023

LEGEND:
BLUE – TOPIC
PINK – SUBTOPIC KEY COMPONENTS OF BIORISK
MANAGEMENT

BIORISK MANAGEMENT AND THE AMP RISK ASSESSMENT

MODEL
 Biorisk - the risk associated to biological
toxins or infectious agents.
 The source of risk may be
unintentional exposure to
unauthorized access, accidental
release or loss, theft, misuse,
diversion, or intentional
unauthorized release of
biohazards.
 The process of identifying hazards,
evaluating the risks associated with
biological agents/toxins.
 Initial step in implementing a biorisk
management process relies on risk
assessment which includes the
identification of hazards and
characterization of risks that are possibly
present in the laboratory.

 Biorisk Management - the integration of  Hazard refers to anything in the

biosafety and biosecurity to manage risks environment that has the potential to cause
when working with biological toxins and harm.
infectious agents (CWA 15793 Laboratory
Biorisk Management Standard).  Risk is generally defined as the possibility
that something bad or unpleasant will
 BRM encompasses the identification, happen, such as an injury or loss.
understanding, and management aspects of RISK HAZARD
a system in interrelated processes. It is Risk refers to a Hazard is defined as
divided into three key components: situation which is something that can
assessment (A), mitigation (M), and exposed to harm, cause harm, loss or
performance (P). These components are danger or loss. danger.
collectively captured by what is called the Potential of harm Potential source of
harm
AMP model (World Health Organization,
Probability Physical object,
2010).
situation or setting
 CEN Workshop Agreement (CWA) It can be expressed It cannot be
in degrees. expressed in
15793:2011, Biorisk Management
degrees.
(BRM) is a “system or process to control
safety and security risks associated with
the handling or storage and disposal of
biological agents and toxins in the
laboratories and facilities.”

 A biorisk management system fails if one

of the components is overlooked or is not
addressed.
In performing risk assessment, a structured and
repeatable process is followed:
1. Define the situation – the team must
identify the hazards and risks of the
biological agents to be handled. Next, at-
risk hosts (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 – 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 – the team needs
to compare the likelihood and the
consequences of infection—either
qualitatively or quantitatively.
4. Determine if risks are acceptable or not
– takes into account the adequacy of any
existing controls, and deciding whether or
not the biorisk is acceptable.
MITIGATION PROCEDURES
 Second fundamental component of the
biorisk management model.
 Biorsik mitigation measures are actions
and control measures that are put into
place to reduce or eliminate the risks
associated with biological agents and
toxins.
Hierarchy of controls of mitigation measures
 Elimination - the 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. It 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 in order to reduce the risks.
o Ex. Bacillus anthracis (a
pathogen responsible for
causing the acute fatal disease
anthrax), could substitute a less
dangerous experimental
surrogate such as Bacillus
thuringiensis.
 Engineering controls - the third control
measure which includes physical changes
in work stations, equipment, production
facilities, or any other relevant aspect of
the work environment that can reduce or
prevent exposure to hazards.
o Ex. Installation of biosafety
cabinets, safety equipment,
facility design, enabling proper
airflow, ventilation system to
ensure directional airflow, and
air treatment systems.
 Administrative controls - the fourth
measure that refers to the policies,
standards, and guidelines used to control
risks. Proficiency and competency training
for laboratory staff is considered an
administrative control.
 This practice or procedure minimizes
splashes, sprays, and aerosols to avoid
laboratory-acquired infections or following
standard operating procedures (SOPs).
 o Ex. Displaying of biohazard or END! ★
warning signages, markings,
and labels, controlling visitor
and worker access, and
documenting written standard
operating procedures.

 Personal protective equipment (PPE) -

the last mitigation control which are
devices worn by workers to protect them
against chemicals, toxins, and pathogenic
hazards in the laboratory.
o Considered the least effective
measure because it only
protects the person who is
wearing it, and only when it is
used correctly.
o Ex. Gloves, gowns, respirators.

 As emphasized by Salerno (2015), not one

of the mitigation controls or measures is
completely effective at controlling or
reducing all risks.

 The concept of a hierarchy of controls

describes the order of effectiveness (from
most effective to least effective) of
mitigation measures and implies that this
order should be taken into account when
selecting and implementing controls to
reduce risks.

PERFORMANCE EVALUATION

 The last pillar of the biorisk management

model is performance evaluation that
involves a systematic process intended to
achieve organizational objectives and
goals.

 Performance management is simply a

reevaluation of the overall mitigation
strategy.