TOPIC 1: BIOSAFETY RISK ASSESSMENT AND MANAGEMENT Goals and Objectives of a Biorisk

Management System:
HAZARD 1. To protect employees, the community and the environment
- an object or situation that has the potential to cause adverse from risks associated with biological agents handled in the
effects when an organism, system or (sub) population is laboratory.
exposed to it. (WHO, 2020) 2. The system provides a framework for
1. Assessing and controlling biological hazards and risks in
RISK the laboratory
- a combination of the likelihood of an incident and the severity 2. Continually improving the management of the biological
of the harm (consequences) if that incident were to occur risks
(WHO, 2020)
Laboratory safety is not an endpoint goal. Instead, laboratory safety is a
Likelihood - potential to be released constant culture that requires the commitment, dedication, and
Consequence - severity of the outcome continual improvement of its members to function.

INCIDENT A healthy and functioning culture of safety is one where monitoring and
- an occurrence that has the potential to, or results in, the reporting are valued, where issues are rapidly and openly addressed as
exposure of laboratory personnel to biological agnts and /or they are identified, and efficient systems are in place to prevent a safety
their release into the environment that may or may not lead to issue from becoming a safety incident.
actual harm. (WHO, 2020)
Risk Assessment
• What are the possible risks posed by working with the
biological agent?
• Are the facilities adequate?
• Are the laboratory personnel suitably trained to address the
risk?
• Are the facilities secure?

Risk Mitigation
o BIOSAFETY - protecting people from dangerous pathogens
• How can I reduce the level of risk?
o Engineering control: Reverse isolation - we isolate the patient
• How can I apply the pertinent "controls" to mitigate the risk
level?
• Should I apply more than one control?
• Should the application be concurrent?

Performance Evaluation
• Are the controls adequate?
• Has the risk of exposure been reduced?
• Have new risks emerged after the application of the controls?
• Have there been and reports of accidents or incidents?
• How can the biosafety level be improved upon?
• Continuous Quality Improvement (CQI)
BIOSECURITY - protecting pathogens from dangerous people
includes containment principles, technologies, and practices
implemented (SOPs) to prevent unintentional exposure or release of
pathogens

BIORISK MANAGEMENT
- it 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. (CEN
Workshop Agent (CWA) 15793:2008)
IN CONCLUSION
• Biological agents in themselves do not pose a risk to society It is important to note that risk can never be completely eliminated unless
• Processes involving biological agents pose a risk to laboratory the work is not performed at all. Therefore, determining if the initial and/or
users and to society (e.g. these processes may be critical to residual risks are acceptable, controllable or unacceptable is a vital part
the development of vaccines, therapeutic agents or diagnostic of the risk evaluation process.
procedures)
• Biorisk management focuses on mitigating the risk posed by RISK MITIGATION
biological agents by the application of pertinent controls. There are five (5) control measures used to mitigate risk. They are
• There is always a certain level of risk which is termed as organized by their relative effectiveness in reducing risks and are referred
“residual risk” to as the Hierarchy of Controls.

THREE COMPONENTS OF BRM

*Substitution of B.
1.
A – Assessment anthracis with B.
2.
M – Mitigation – Process of implementing thuringiensis (less
control to reduce or minimize the risks to dangerous experimental
acceptable level (ex. Wearing PPEs, surrogate)
undergo training
3. P – Performance Evaluation
*AMP Model illustrates the balanced role among the components of BRM
 1. Elimination/Substitution: Remove or replace hazardous C. Unidirectional Workflow: Implement a workflow that moves
materials when possible. from pre-PCR to post-PCR areas to minimize contamination
2. Engineering Controls: Use equipment like biosafety cabinets risks.
to contain hazards. D. Controlled Access Zones: Establish zones to separate
3. Administrative Controls: Establish standard operating laboratory spaces from office and public areas, enhancing
procedures and provide training to minimize risks. biosafety.
4. Personal Protective Equipment (PPE): Ensure the use of
Additional notes:
appropriate PPE, such as gloves, lab coats, and eye protection.
Pre-PCR – should have a minimal contamination
PERFORMANCE EVALUATION
General Decontamination Practices in the Molecular Biology
• One of the best ways to manage and reduce risk is to
Laboratory
evaluate data collected from control measures. These control
Effective decontamination is essential to prevent contamination and
measures include reports from unplanned events, incidents,
ensure accurate experimental results. Key practices include:
and effectiveness of risk mitigation strategies.
• You can take an active role to evaluate risks in your 1. Surface Decontamination: Clean work surfaces before and
laboratory by: after procedures using 70% ethanol or a 10% sodium
1. Reporting incidents and near misses to your supervisor, hypochlorite solution, followed by sterile water to remove
so these events can be tracked and investigated for residual disinfectant.
corrective actions 2. Equipment Decontamination: Regularly disinfect laboratory
2. Reviewing existing control measures for effectiveness equipment, such as pipettes and centrifuges, to prevent cross-
3. Continually assessing risks associated with your work contamination.
and your workplace and modifying the ways you reduce 3. Hand Hygiene: Wash hands thoroughly with soap and water
these risks before and after handling biological materials.
4. Use of UV Irradiation: Utilize UV lamps in closed working
areas, like biosafety cabinets, for decontamination by
irradiation.
Biosafety
- Biosafety is the application of safety precautions that reduce a
laboratorian’s risk of exposure to a potentially infectious
microbe and limit contamination of the work environment and,
ultimately, the community. (CDC)
Biosafety Levels
- are used to identify the protective measures needed in a
laboratory setting to protect workers, the environment, and
the public.

GENERAL PRACTICES & BIOHAZARDS IN BSL-2 MOLBIO LAB

BSL-2 laboratories handle agents associated with human diseases that
pose moderate hazards.
In molecular biology, common risks include exposure to pathogenic
microorganisms, recombinant DNA, and potentially infectious
materials.
To mitigate these risks, the following general practices are
implemented:
1. Access Control: Limit access to authorized personnel; keep
doors closed during work to prevent public access.
2. Biohazard Signage: Post biohazard warning signs at laboratory
entrances and on equipment containing or contaminated by
potentially infectious materials. What are Biosafety Levels (BSLs)?
3. Hand Hygiene: Wash hands after handling biological The primary risks that determine levels of containment are:
materials, remove gloves, and before leaving the work area. ➢ Infectivity
4. Prohibition of Eating and Drinking: Do not eat, drink, or apply ➢ severity of disease
cosmetics in the work area to prevent contamination. ➢ transmissibility, and
5. Safe Sharps Handling: Use sharps only when no alternatives ➢ the nature of the work conducted.
exist; implement safety devices to minimize needlestick ➢ Origin of the microbe and the route of exposure
injuries.
Each biosafety level has its own specific containment controls that
6. Aerosol Minimization: Employ techniques that reduce aerosol
are required for the following:
generation during procedures like pipetting, centrifuging, and
• Laboratory practices
mixing.
• Safety equipment
Effective molecular biology workflows require distinct working areas • Facility construction
to prevent cross-contamination: CONTAINMENT
A. Pre-PCR (Clean Area): Dedicated to sample and reagent - The combination of physical design parameters and
preparation; maintaining a contamination-free environment is operational practices that protect personnel, the immediate
crucial. work environment and the community from exposure to
B. Post-PCR (Dirty Area): Designated for amplification and biological agents. The term “biocontainment” is also used in
analysis of PCR products; separation from the pre-PCR area is this context.
essential to prevent contamination.
 BIOLOGICAL SAFETY CABINET (BSCs)
BSCs, isolators and local exhaust ventilators are enclosed, ventilated
working spaces that can be used in laboratories as primary containment
devices.
THREE CLASSES OF BSC:
1. CLASS I BSC
2. CLASS II BSC
3. CLASS III BSC

BIOSAFETY LEVEL 4 (BSL-4)

CABINET LABORATORY: All work with infectious
agents or toxins is done in a Class III Biosafety
Cabinet.
 RISK GROUP 1
- A microorganism that is unlikely to cause human disease or
animal disease.
RISK GROUP 2
- A pathogen that can cause human or animal disease but is
unlikely to be a serious hazard to laboratory workers, the
community, livestock or the environment. Laboratory
exposures may cause serious infection, but effective treatment
and preventative measures are available and the risk of spread
of infection is limited.
RISK GROUP 3
- A pathogen that usually causes serious human or animal
disease but does not ordinarily spread from one infected
individual to another. Effective treatment and preventive
measures are available.
RISK GROUP 4
- A pathogen that usually causes serious human or animal
disease and that can be readily transmitted from one
individual to another, directly or indirectly. Effective
treatment and preventive measures are not usually available.

DONNING and DOFFING of PPE

• last line of defense and least effective method of control
against a hazard and
• does NOT take the place of engineering or administrative
controls
Donning - means to put on and use PPE properly to achieve the intended
protection and minimize the risk of exposure

Doffing - means removing PPE in a way that avoids self-contamination

• Gloves– protect hands and allow efficient removal of

organisms from hands
• Gowns and Aprons– protect skin and clothing
• Face masks– protect mucous membranes of mouth and nose
• Respirators- prevent inhalation of infectious material
• Goggles – protect eyes
• Face shields – mucous membranes of face, mouth, nose and
eyes

CLASSIFICATIONS OF MICROORGANISMS ACCORDING TO

RISK GROUP
 Donning and Doffing of Personal Protective Equipment

Donning Link:
[Link]

Doffing Link:
[Link]