MOLBIO LEC 2: BIOSAFETY

Laboratory Hazard Categories

Chemical, biological, physical, and safety hazards.

DOH AO 2021-0037 Required Protocols

Laboratory biosafety protocols and laboratory biosecurity protocols.

WHO Coordination of Global Health Began

1948

Purpose of WHO Laboratory Biosafety Manual

Provides required rules and protocols for safe laboratory implementation.

Biological Agent

Microbiological entity (natural or engineered) capable of replication or gene transfer that can cause adverse effects.

Biological Agent vs Biological Material

Agent is the microorganism itself; material is any substance containing the agent or its products (e.g., toxins).

Biohazard

Potential source of harm caused by biological materials.

Biosafety vs Biosecurity

Biosafety prevents accidental exposure; biosecurity prevents intentional misuse or theft.

Biosafety Summary

Protecting people from bad bugs.

Biosecurity Summary

Protecting bad bugs from bad people.

Four Principles of Biosafety

Practices and procedures; safety equipment; facility design and construction; increasing levels of protection.

Safety Equipment Role in Biosafety

Primary containment barrier that minimizes exposure and contains aerosols.

Secondary Barrier for Engineering Controls

Facility design and construction.

Principle Covering BSL-1 to BSL-4

Increasing levels of protection.

Risk Group 1 (RG1)

Low individual and community risk; unlikely to cause disease.

Risk Group 2 (RG2)

Moderate individual risk and low community risk.

Low Community Risk in RG2

Effective treatment/prevention exists and spread is limited.

Risk Group 3 (RG3)

High individual risk but low community risk.

Risk Group 4 (RG4)

High individual and community risk; serious disease, easy spread, no effective treatment.

Risk Groups vs Biosafety Levels

Risk groups used in risk assessment; biosafety levels used in risk management.

Risk Groups Equal Biosafety Levels

False.

BSL-1 Standard Practices

Good Microbiological Techniques (GMT).

Additional Equipment in BSL-2 for Aerosols

Biosafety Cabinet (BSC).

BSL-3 Distinguishing Practices

Special clothing, controlled access, directional airflow.

Unique BSL-4 Facility Features

Airlock entry, shower exit, special waste systems, double-ended autoclaves.

Mandatory Equipment in BSL-3

Biosafety cabinets and other primary containment devices.

Laboratory Biosecurity

Institutional and personal security measures preventing loss, theft, misuse, diversion, or intentional release of agents.

Graded Protection Concept

Concentric layers of increasing security toward high-risk areas.

Biosecurity Pillar for Access Control

Personnel management.

Objective of Material Control

Discourage misuse through inventory oversight and accountability.

Specimen Transport System

Triple packaging system.

Triple Packaging Containers

Primary, secondary, and tertiary containers.

Absorbent/Cushioning Material Placement

Between primary and secondary containers.

Chain of Custody Purpose

Documents specimen handling and transfer to preserve integrity and accountability.

Information Security Protects

Sensitive laboratory data and information from theft or diversion.

Dual Use Research of Concern (DURC)

Legitimate research that could be misused for harmful purposes.

Biosecurity Pillar Monitoring Ethics

Emerging biotechnology oversight.

Practice Shared by Biosafety and Biosecurity

Personnel reliability or inventory control.

Fences and Window Bars

Biosecurity measure.

Biorisk Definition

Risk from biological materials based on likelihood and consequences of an event.

Biorisk Formula

Likelihood + Consequence = Biorisk.

Risk Matrix Score Formula

Frequency × Severity.

Likelihood Score 3

Occasional (about once per year).

Severity Score 5 (Catastrophic)

Patient death.

Risk Matrix Score 15-25

Extreme risk; activity must not proceed.

High Risk Action (Score 8-12)

Modify activity and implement remedial controls.

AMP Model

Assessment, Mitigation, Performance.

AMP Assessment Goal

Identify hazards and determine acceptable vs unacceptable risks.

AMP Mitigation Goal

Reduce risk severity through control strategies.

Mitigation Hierarchy (Most→Least Effective)

Elimination, substitution, engineering controls, administrative controls, work practices/procedures, PPE.

Elimination Strategy

Remove the hazard entirely.

Substitution Strategy

Replace hazard with a safer alternative.

Engineering Controls

Modify workplace or environment to reduce exposure.

Administrative Controls

Policies and procedures that manage human-hazard interaction.

AMP Performance Role

Ongoing monitoring and evaluation of control effectiveness.

Performance Subcomponents

Controls, assurance, improvement.

Emerging/Re-Emerging Diseases (2019)

Polio, measles, COVID-19.

Disease Linked to Ebola Reston (2015 Timeline)

MERS-CoV.

2009 Pandemic

Pandemic A(H1N1).

Desired Aerosol-Control Equipment in BSL-2

Biosafety cabinet and autoclave.

GMT Meaning

Good Microbiological Techniques.

Biometric Access Control

Uses physical traits (e.g., fingerprints) for identity verification.

AMP Category: Hazard ID & Likelihood Evaluation

Assessment.

AMP Category: Substitution & PPE

Mitigation.

AMP Category: Assurance & Improvement

Performance.

Likelihood Once Every Few Years

Score 2 (Remote).

Severity: Injury Requiring Medical Care

Score 3 (Serious).

Risk Matrix: Probable × Serious

Score 12.

Risk Score 5 Classification

Moderate risk.

Low Risk Action (Score 1-3)

No action needed unless risk escalates.

BSL-3 Access Requirement

Controlled access with directional airflow.

Purpose of DURC Identification

Identify research with highest misuse potential.

Biosecurity Pillar for Scientific Misconduct Risk

Personnel management.

Example of Biological Material

Used surgical mask from a COVID-19 patient.

Goal of Biorisk Management

Highest practical protection and lowest practical exposure.