BIORISK MANAGEMENT

GINA M. ZAMORA, MSMT

BIORISK MANAGEMENT AND
THE AMP MODEL
 Biorisk – is the risk associated to biological toxins or infectious agents.
 Biorisk management – is the integration of biosafety and biosecurity
to manage risks when working with biological toxins and infectious
agents.
 According to the CEN Workshop Agreement (CWA) 15793:2011,
Biorisk Management (BRM) is “a system or process to control safety
or security risks associated with the handling or storage and
disposal of biological agents and toxins in laboratories and
facilities”.
BIORISK MANAGEMENT AND
THE AMP MODEL (Assessment, Mitigation,
Performance)
 BRM encompasses the identification, understanding and
management aspects of a system in interrelated processes. It is
divided into three primary components:
Assessment (A)
Mitigation (M)
Performance (P)
 This components are collectively captured by what is called the
AMP model (WHO, 2010).
 BIORISK MANAGEMENT AND
THE AMP MODEL

 The model requires that control measures be based on a robust risk

assessment, and a continuous evaluation of effectiveness and suitability of the
control measures.
 Like a three-legged stool, a biorisk system fails if one of the components or
legs, is overlooked or is not addressed.
 In contrast to other risk management models, which typically focus heavily on
mitigation measures, AMP focuses on all components with equal attention.
KEY COMPONENTS OF BIORISK
MANAGEMENT
RISK ASSESSMENT
• Initial step in implementing biorisk management
• Includes identification of hazards and characterization of
risks that are possibly present in the laboratory
• HAZARD refers to anything in the environment that has
the potential to cause harm while RISK is generally
defined as the possibility that something bad or unpleasant
(such as injury or loss) will happen.
KEY COMPONENTS OF BIORISK
MANAGEMENT
• In order for a risk to occur, there must be a situation for the
hazard to cause harm.
• For example, a sharp needle is a hazard, but if no one is
using it, the needle will not pose any risks.
• Risk is the likelihood that an adverse event involving a
specific hazard or threat will occur followed by the
consequences of the occurrence.
STEPS IN RISK ASSESSMENT

• 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 following:
 Hazards and risks of the biological agents
 At-risk hosts (humans or animals)
 Work activities and laboratory environment
(location, procedures, equipment)
STEPS IN RISK ASSESSMENT

2. Define the risks – include a review of how individuals

inside and outside the laboratory may be exposed to the
hazards.
 Inhalation
 Droplets
 Ingestion
 Inoculation
STEPS IN RISK ASSESSMENT

3. Characterize the risk – the risk assessment team

needs to compare the likelihood and the
consequences of infection – either qualitatively or
quantitatively

4. Determine if the risks are acceptable or not –

this process of evaluating the biorisk arising from a
biohazard takes into account the adequacy of any existing
controls, and deciding whether or not the biorisk is acceptable.
KEY COMPONENTS OF BIORISK
MANAGEMENT
MITIGATION PROCEDURES
• The second fundamental component of the biorisk
management model
• Biorisk mitigation measures are actions and control
measures that are put into place to reduce or eliminate the
risks associated with biological agents and toxins.
• There are five major areas of control or measures that can
be employed in mitigating the risks.
FIVE COMPONENTS OF MITIGATION
PROCEDURES
1. 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
 Provides the highest degree of risk reduction
FIVE COMPONENTS OF MITIGATION
PROCEDURES
2. Substitution
 Second control measure
 Replacement of procedures or biological agent with
a similar entity in order to reduce the risks
 For example: A lab conducting research with the
pathogen Bacillus anthracis is substituted by a less
dangerous experimental surrogate such as the Bacillus
thuringiensis
 FIVE COMPONENTS OF MITIGATION
PROCEDURES
3. ENGINEERING CONTROLS
 Includes physical changes in work stations, equipment,
production facilities, or any other relevant aspect of work
environment that can reduce or prevent exposure to hazards
 Examples are installation of biosafety cabinets, safety
equipment, facility design enabling proper airflow,
ventilation system, air treatment systems, controlled access
zones, airlocks, separate buildings or modules to isolate the
laboratory
FIVE COMPONENTS OF MITIGATION
PROCEDURES
4. ADMINISTRATIVE CONTROLS
 Policies, standards, and guidelines used to control risks
 Proficiency and competency training for laboratory
staff is considered an administrative control
 Examples are displaying of biohazard or warning
signages, markings, and labels, controlling visitor and
working access, and documenting written standard
operating procedures
FIVE COMPONENTS OF MITIGATION
PROCEDURES
5. PERSONAL PROTECTIVE EQUIPMENT (PPE)
 Last mitigation control measure
 These are devices worn by workers to protect them against
chemicals, toxins, and pathogenic hazards in the laboratory
 Examples are: Gloves, Gown, Respirators
 LEAST EFFECTIVE MEASURE because it only
protects the person wearing it, and only when it is used
correctly
FIVE COMPONENTS OF MITIGATION
PROCEDURES

• The concept or 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.
KEY COMPONENTS OF BIORISK
MANAGEMENT
PERFORMANCE EVALUATION
 The last pillar 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
KEY COMPONENTS OF BIORISK
MANAGEMENT

 Also helps to highlight biorisk strategies that are not

working effectively and measures that are ineffective or
unnecessary. These can be eliminated or replaced
 Performance management is simply a reevaluation of
the overall mitigation strategy.
PERFORMANCE EVALUATION
PROCEDURES
Identify the Key Issues
of Concern

Evaluate and Refine Define OUTCOME

Performance Indicators Indicators and Metrics

Provide Findings from Define ACTIVITIES

Performance Indicators Indicators and Metrics

Collect Data and

Report Indicator
Results