P2. MLS 037 SAS 7

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 (CWA 15793 Laboratory Biorisk

Management Standard)

Three components of Biorisk Management

• Assessment

• Mitigation

• Performance

AMP Model

Like a three- legged stool, a

biorisk management fails if

one of the components, or

legs, is overlooked or is not

addressed

Risk Assessment

includes the identification of hazards and

characterization of risks that are possible present in

the laboratory

Hazard

refers to anything in the environment that has the

potential to cause harm

Risk

- 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.

Mitigation Procedures

- are actions and control measures that are put into

place to reduce or eliminate the risks associated

with biological agents and toxins (Salerno, 2015)

Elimination

the most difficult & 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

Substitution

- 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.

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 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

Administrative Contact

- refers to the policies, standards, and guidelines used to

control risks

- Examples: Proficiency and competency training for

laboratory staff, displaying of biohazard or warning

signages, markings, and labels, controlling visitor and

worker access, and documenting written standard

operating procedures

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

- is considered the least effective measure because it only

protects the person who is wearing it, and only when it is

used correctly

Performance Evaluation

- the last pillar of the biorisk management model which

involves a systematic process intended to achieve

organizational objectives and goals.

- ensures that the implemented mitigation measures are

indeed reducing or eliminating risks

 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.

AMP Model

illustrates the balanced role among the components

of BRM.

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.

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.

mitigation procedures

to be employed depend on the

result of a robust risk assessment. It is recommended not to overdo or

underdo the measures.