Biosafety, Biosecurity

and Biorisk
Management
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 Overview of Biosafety and
Biosecurity
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 Biosafety vs. Biosecurity
BIOSAFETY
“The containment principles, technologies and practices that are
implemented to prevent unintentional exposure to pathogens
and toxins or their accidental release”

BIOSECURITY
“The protection, control and accountability for valuable biological
materials within laboratories in order for their unauthorized
access, loss, theft, misuse, diversion or intentional release.”
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(WHO, 2006)
 Laboratory Biosafety
• LABORATORY ACQUIRED INFECTION
• US Biological weapons 🡪 Franklin Roosevelt (1943)
• Camp Detrick (Ira L. Baldwin)
• Installation of biological research and development
• BIOSAFETY is important in handling biological weapon
development
• Newell A. Johnson
• Class III biosafety cabinets
• Laminar flow hood
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• American Biological Safety Association (ABSA) 🡪 1984

 Other Concepts and Contributors
in the Biosafety Practice
• Arnold Wedum
• Use of mechanical pipettors to prevent LAI
• Director of Industrial Health and Safety at US Army Biological Laboratories
• Worked with Morton Reitman on epidemiological studies
• Increasing mortality and morbidity of smallpox (1967)
• CDC-USA
• State Research of Virology and Biotechnology Vector (Russia)
• 1974-Classification of Etiological Agents on the Basis of Hazard
(CDC)
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• 1976-NIH Guidelines for Research Involving Recombinant DNA

molecules
 Organizations of Biosafety and
Biosecurity
• American Biological Safety Associations (ABSA)
• Asia-Pacific Biosafety Association (A-PBA)
• European Biological Safety Association (EBSA)
• Philippine Biosafety and Biosecurity Association (PhBBA)
• National Laboratory Biosafety and Biosecurity Action Plan Task Force
• DPO No. 2006-2500, September 15, 2006
• Biological Risk Association Philippines (BRAP)
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 Laboratory
Biosecurity
• Select Agent Regulations (1996)
• Monitor transfer of microorganisms from one location to another
• Anthrax attack 🡪 2001
• Revised Select Agent Regulations (2012)
• Biological Agents and Toxins Act (Singapore, 2005)
• Act on Prevention of Infectious Diseases (Japan, 2005)
• Amended by Infectious Disease Control Law
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 Guidelines
• Comite Europeen de Normalisation (CEN)
• CEN Workshop Agreement 15793 (biorisk management)
• Laboratory Biosafety Manual (WHO, 1983)
• Biosafety Levels, types of Biosafety cabinets, good microbiological
practice, disinfection and sterilization
• Packaging and transport regulations
• Cartagena Protocol on Biosafety (2003)
• Safe transfer, handling and use of living modified microorganisms
• EO 430 s 1990 (National Committee on Biosafety of the
Philippines)
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• EO 514 (National Biosafety Framework, March 17, 2006)

 Hazard, Threat and
Risk

• Hazard is an object that can cause harm

• Threat is a person who has an INTENT or ABILITY to cause

harm to other people, animal, or the institution

• Risk can be based on either a hazard and or a threat

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 Risk, Likelihood, and
Consequences
• Risk is the likelihood of an event/incident with a hazard that has
consequences

• Likelihood is the probability of an event occurring

• Consequences is the severity of an event

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 Classifications of Microorganisms
based on RISK GROUPS
• Risk Group 1
• Unlikely to cause human or animal disease
• Risk Group 2
• May or may not cause infection (moderate individual and community
risk)
• Medications and preventive measures are available
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 • Risk Group 3
• May cause serious diseases (high individual risk, moderate community risk)
• Medications and preventive measures are available
• Risk Group 4
• LIFE THREATENING, Contagious (high individual and community risk)
• Medications and preventive measures not available
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 Classification of Laboratories
Based on Biosafety Level
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 Biosafety Level 1
(BSL-1)

• ORGANISMS: Well characterized, do not cause disease

• GLP: Basic laboratory safety practice/standard microbiological
practice, safety equipment, facility design requires only basic
containment level
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 Biosafety Level 2
(BSL-2)
• ORGANISMS: Indigenous moderate risk agents
• GLP: Good microbiological techniques, sharps disposal,
biosafety manual (waste decontamination and medical
surveillance policies) + GLP in BSL 1
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Z
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 Biosafety Level 3
(BSL-3)

• ORGANISMS: Indigenous or exotic organisms with potential

respiratory transmission (aerosol)
• GLP: Primary and secondary barriers, ALL PROCEDURES should be
performed in a biosafety cabinet, personnel must be highly trained or
supervised by competent scientists in handling these
microorganisms, lab gowns must be decontaminated, all wastes
should be decontaminated
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 Biosafety Level 4
(BSL-4)
• ORGANISMS: Dangerous and exotic, life threatening, may be
aerosol transmitted and no vaccines or treatment available
• GLP: Highly trained staff with enough competency to handle
these microorganisms, positive pressure suit
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 BSC 3 and Positive Pressure
suits
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 Biorisk
Management
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 Biorisk and Biorisk
Management
• Biorisk
• Risk associated to biological toxins or infectious agent
• Source may be unintentional exposure, unauthorized
access, accidental release or loss, theft, misuse,
diversion or intentional unauthorized release of the
biohazards
• Biorisk Management
• Integration of biosafety and biosecurity to manage the risks
when working with biological toxins and infectious agents
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(CWA 15793 Laboratory Biorisk Management Standard)

 AMP Model for Biorisk
Management
ASSESSMENT

BIORISK
MANAGEMENT
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PERFORMANCE MITIGATION
 Assessment Mitigation Performance

• Risk, hazard • Elimination • Assurance

and threat • Control • Improvement
identification • Proper
• Likelihood and practices
consequence and
evaluation procedures
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 Risk
Assessment
• Identify hazards and risks, likelihood and consequence
• Steps:
• Define the situation
• Define the risks
• Characterize the risks
• Determine if risks are acceptable or not
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 Risk
Characterization
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 Mitigation
• Control measures to eliminate risks (Salerno, 2015)
Elimination
Substitution
Engineering Controls
Administrative Control
Use of Personal Protective Equipment
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 Performance
• Performance Evaluation
• Systematic process to achieve objectives and
goals
• GOAL: REDUCE OR ELIMINATE RISKS
• Performance Management
• Reevaluation on the effectiveness of mitigation
strategy
• RETAIN or CHANGE?
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 Procedures in Performance
Evaluation Identify the
key issues
of concern
Define
Evaluate and refine
indicators
Outcome
indicators and metrics

Define activities
Provide findings indicators and
from indicators metrics

Collect data and

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report indicator
results