LESSON 7: BIORISK

MANAGEMENT
POWERPOINT
BIOSAFETY

It refers to the containment principles, technologies, and practices that are

implemented to prevent unintentional exposure to pathogens and toxins, or their
accidental release.

BIOSECURITY

It refers to the protection, control, and accountability for valuable biological

materials within laboratories, in order to prevent their unauthorized access, loss,
theft, misuse, diversion, or intentional release.

BIORISK MANAGEMENT & THE AMP MODEL

Practices and procedures on biocontainment should be considered when
working with infectious agents and toxins in order to ensure biosafety &
biosecurity.

BIORISK

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 Risk associated to biological toxins or infectious agents

BIORISK MANAGEMENT

Integration of biosafety & biosecurity to manage risks when working with

biological toxins & infectious agents; a system or process to control safety and
security risks associated with the handling or storage and disposal of biological
agents and toxins in laboratories and facilities (CEN Workshop Agreement or
CWA)

BRM encompasses identification, understanding, & management aspects of a

system in interrelated processes.

THREE PRIMARY COMPONENTS:

Assessment

Mitigation

Performance

AMP model requires that control measures be based on a robust risk assessment
and continuous evaluation of their effectiveness & suitability.

RISK ASSESSMENT
Includes identification of hazards & characterization of risks possibly present in
the laboratory

HAZARD – anything with the potential to cause harm

RISK – possibility that something bad or unpleasant will happen

In order for a risk to occur, there must be a situation for the hazard to cause
harm.

1. Define the situation.

2. Define the risks.

3. Characterize the risks.

4. Determine if risks are acceptable or not.

MITIGATION PROCEDURES

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 Actions and control measures that are put into place to reduce or eliminate the
risks associated with biological agents and toxins

1. ELIMINATION – total decision not to work with a specific biological agent or

even not doing the intended work

2. SUBSTITUTION – replacement of the procedures or biological agent

3. ENGINEERING CONTROLS – physical changes in work stations,

equipment, etc.

4. ADMINISTRATIVE CONTROLS – policies, standards, & guidelines used to

control risks

5. PERSONAL PROTECTIVE EQUIPMENT(PPE)– protects workers against

chemicals, toxins, & pathogenic hazards

Not one of the mitigation controls or measures is completely effective at

controlling or reducing all risks.

PERFORMANCE EVALUATION

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 Performance evaluation is a systematic process intended to achieve
organizational objectives and goals.

Performance management is simply a reevaluation of the overall mitigation

strategy.

PDCA (Plan, Do, Check, Act)

LESSON 7

Biorisk Management and the AMP Model

In working with infectious agents and toxins in laboratories, one must

consider the practices and procedures on biocontainment to ensure
biosafety and biosecurity Proper management is necessary to carry out
total safety of laboratory workers and patients.

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 Biorisk is 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.

Biorisk Management is the integration of biosafety and biosecurity to

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

According to the CEN Workshop Agreement (CWA) 15793:2011, Biorisk

Management (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 laboratories and facilities. 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), and performance (P).

These components are collectively captured by what is called the AMP

model (World Health Organization, 2010). 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. Identified
risks can be either mitigated, avoided, limited, transferred to an outside
entity, or accepted.

Like a three-legged stool, a biorisk management 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.

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 Key Components of Biorisk Management

Risk Assessment
The 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.

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 an injury or loss) will happen. In order for a risk to
occur, there must be a situation for the hazard to cause harm (ISO/IEC
Guide 51:1999). 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 that occurrence.

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.

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 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 takes

into account the adequacy of any existing controls, and deciding
whether or not the biorisk is acceptable.

Mitigation Procedures
The second fundamental component of the biorisk management model is
mitigation. 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 (Salerno, 2015). There are five major areas of
control or measures that can be employed in mitigating the risks.

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 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. Definitely, 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 in order to reduce the
risks. For example, 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, such
as the Bacillus thuringiensis, an organism most commonly used in
biological pesticides worldwide.

The third control measure, setting of engineering controls, 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. 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 airlocks as laboratory entrances, or
separate buildings or modules to isolate the laboratory. systems to
decontaminate or remove agents from exhaust air, controlled access zones.

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 The fourth measure, the 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 biohazard or warning signages, markings, and
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).

The last mitigation control measure is the use of personal protective

equipment (PPE). These are 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 measure because it only protects the person who is
wearing it, and only when it is used correctly.

As emphasized by Salerno (2015), not one of the mitigation controls or

measures is completely effective at controlling or reducing all risks. The
effectivity of mitigating risks relies on the combination of all the different
measures and the proper utilization of each. It must be ensured that following
the measures would not be overdone because undoing particular measures are
definitely costly. 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. The model 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. These can be eliminated or replaced.

Performance management is simply a reevaluation of the overall

mitigation strategy. The diagram below shows the specific procedures in

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 conducting 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.

KEY POINTS

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.

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 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 rísk, risk related factors, and risk
perceptions among risk managers, risk communicators, the general public,
and other impacted parties.

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