BIOSAFETY,

BIOSECURITY AND
BIORISK MANAGEMENT

CLARENCE JANE ANDRA-GERVACIO, RMT, MLS (ASCPi)CM

 INTRODUCTION TO BIORISK
MANGEMENT

Hazards Everywhere !

• Chemical Hazards
• Biological Hazards
• Physical Hazards
• Safety Hazards
Biological Agent
• Any microbial entity , cellular or non
cellular, naturally occuring or
engineered, capable of replicationor of
transferring genetic material that may be
able to provoke infection, allergy,
toxicity and other adverse effects in
humans, animals, or plants
Example : Bacteria, fungi, virused, viroids,
endo and ectoparasites
 INTRODUCTION TO
BIORISK MANAGEMENT

Biological Material
• any medical comprised of , containing , or that may
contain biological agents and or their harmful
products, such as toxins and allergens
 INTRODUCTION TO
BIORISK MANAGEMENT

Biohazard

• Potential source of harm caused by

biological materials
INTRODUCTION TO
BIORISK MANAGEMENT

BIOSAFETY

BIOSECURITY
 INTRODUCTION TO
BIORISK MANAGEMENT

Laboratory Biosafety

• Containment principles, technologies and

practices implemented to prevent
unintentional/ accidental exposure to
pathogens and toxins or their
unintentional/accidental release
 INTRODUCTION TO
BIORISK MANAGEMENT

Laboratory Biosecurity

• Institutional and personal security measures

designed to prevent the loss, theft, ,misuse
diversion, or intentional release of
pathogens and toxins
INTRODUCTION TO
BIORISK MANAGEMENT

BIOSAFETY
Accidental / Unintentional

BIOSECURITY
Intentional/ Deliberate
INTRODUCTION TO
BIORISK MANAGEMENT

BIOSAFETY
Protecting people from bad bugs.

BIOSECURITY
Protecting bad bugs from bad people.
INTRODUCTION TO
BIORISK MANAGEMENT
 INTRODUCTION TO
BIORISK MANAGEMENT

Biosafety Biosecurity

• Engineering controls • Doors with locks

(ex. Biosafety • Password/PIN
• Access control • Card readers
cabinets, directional • Personel Management/
airflow, anterooms) • Biometric(ex
reliability
• Inventory of biological
fingerprints)
• Good laboratory work hazards • Cameras
practices( ex • Proper decomentation/ • Information
handwashing, spill disposal of waste security
clean up) materials • Fences
• Proper shipping • Bars on windows
• Personal Protective procedures • Magnetic switches
• Practices and on doors
Equipmenf (PPE)
Procedures • Alarms
 INTRODUCTION TO
BIORISK MANAGEMENT

Principles of Biosafety
1. Practice and procedures
- Standard practices
- Special practices and considerations
2. Safety equipment
3. Facility design and construction
4. Increasing levels of protection
 INTRODUCTION TO
BIORISK MANAGEMENT

Principle of Biosafety
1. Standard Microbiological Practices

• Most important concept/ strict adherence

• Aware of potential hazard
• Trained and Proficient in techniques
• Supervisors responsible for :
- Appropriate laboratory facilites
- Personnel and Training
• Special practices and precautions
-Occupational Health Programs
 INTRODUCTION TO
BIORISK MANAGEMENT

Principle of Biosafety
2. Safety Equipment

• Primary containment barrier

• Minimize exposure to hazard
- Prevent contact / contain aerosols
• Engineering controls/ equipment
• Personal protective equipment (PPE)
- gloves, gowns, respirator, faceshield, booties
• Biological safety cabinets
• Covered or ventilated animal cage systems
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BIORISK MANAGEMENT

Principle of Biosafety

3. Facility Design and Construction

• Secondary barrier / Engineering controls

• Contribute in worker protection
• Protects outside the laboratory
- Environment and neighborhood
• Ex. Building and lab design, ventilation, autoclaves, cage wash
facilities.
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BIORISK MANAGEMENT

Principle of Biosafety
4. Increasing Levels of Protection

Biosafety levels 1-4 (BSL)

• Increasing levels of employee and environmental protection
• Guidelines for working safely in research & clinical laboratory facilities

Animal Biosafety levels 1-4 ( ABSL) and Agricultural (BSL-3-Ag)

• Laboratory animal facilities
• Plant GMO facilities
• Animal models that support research
• Guidelines for working safely in animal research facilities
 INTRODUCTION TO
BIORISK MANAGEMENT

Biosafety Levels

• Combination of laboratory practices and

procedures, safety equipment (primary barriers)
and laboratory facilities ( secondary barriers)
- Focus is on laboratory manipulation of the agents*

• Biosafety levels are also referred to as

Containment Levels
 INTRODUCTION TO
BIORISK MANAGEMENT
RISK BIOSAFETY LABORATORY LABORATORY SAFETY
SAFETY
GROUP LEVEL TYPE PRACTICES EQUIPMENT
1 Basic- Basic Teaching, GMT None: open bench work
Biosafety Research
Level 1

2 Basic- Primary health GMT, plus protective Open bench plus BSC
Biosafety sevices;diagnostic clothing, biohazard for potential aerosols
Level 2 services : research sign

3 Containment- Special Diagnostic As level 2 plus BSC and /or other

Biosafety services , research special clothing, primary devices for
Level 3 controlled access all activities

4 Maximum Dangerous pathogen As level 3 plus airlock entry Class III BSC, or positive
Containment units shower exit , special waste pressure suits in conjuction
Biosafety disposal with class II BSCs , double
Level 4 ended autoclave (through
the wall) filtered air
INTRODUCTION TO
BIORISK MANAGEMENT
 INTRODUCTION TO
BIORISK MANAGEMENT

BSL 2

• Agents of moderate hazard to personel or environment

• Basic lab, but restricted access, containment during
certain process (ex. Aerosols, large volumes , etc
• Autoclave and Biological Safety Cabinet desired
• Use good laboaratory practices, waste disposal and
aseptic techniques
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BIORISK MANAGEMENT

BSL 2+
• Used to describe laboratories where work with microorganisms is
conducted in a BSL-2 laboratory with biosafety practices and
procedures typically found at BSL-3
• The risk assesment process may determine that safety practices over
and above those required at BSL 2 are needed for a research project,
yet more complex BSL-3 laboratory facility is not necessary
• NOT a recognized containment level in biosafety guidance
documents
• Allows for research work with microorganisms including viral vectors to
take place in an environment where the safety practices are enhanced
over and above the practices required at BSL-2
• May not always be appropiate for pathogens that are infectious via
the inhalation route
 INTRODUCTION TO
BIORISK MANAGEMENT
Properties inherent to biological materials

• Importance of the disease or severity of the infection

• Infectivity ( virulence of the strain infective dose, mode of
transmision, natural route of infection)
• Host range of the micro-organism and spectrum of
specificity of target species;
• Potential of survival and dissemination in the community
• Availability and effective of prophylactic measures
 INTRODUCTION TO
BIORISK MANAGEMENT

Risk Groups

• Assignment of microorgarnisms into groups based on:

- Pathogenecity of the organism
- Mode of transmission and host range
- Local availability of effective preventative
measures
- Local availability of effective treatment
• Pathogen Safety Data Sheet (PSDS)
 INTRODUCTION TO
BIORISK MANAGEMENT
Classification of infective microorganisms by risk group
❑ Risk Group 1 ( no or low individual and community risk)
A microorganism that is unlikely to cause human and animal disease.
❑ Risk Group 2 ( moderate individual risk, low community risk)
A pathogen that can cause human or animal disease but its unlikely to be
serious infection, but effective treatment and preventive measures are
available and the risk of infection is limited
❑ Risk Group 3( high individual risk, low community risk)
A pathogen that usually causes serious human or animal disease but does
not ordinarily spread from one infected individual to another.
❑ Risk Group 4 ( high individual and community risk)
A pathogen that is 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
 INTRODUCTION TO
BIORISK MANAGEMENT

Risk groups are used in Risk Assessment

Biosafety levels are used in Risk Assessment

Risk group correlate but DO NOT

equate with Biosafety Levels !
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BIORISK MANAGEMENT

Laboratory Biosecurity

• Institutional and personal security measures

designed to prevent the loss, theft, ,misuse
diversion, or intentional release of
pathogens and toxins
 INTRODUCTION TO
BIORISK MANAGEMENT
Pillars of Biosecurity
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BIORISK MANAGEMENT

Physical Security ( 1 st pillar)

• Physical Security is the assurance of safety

from physical intrusion
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BIORISK MANAGEMENT
Graded Protection

• Different areas of a facility

will have different levels
of security based on risk.

• Concentric rings of
increasing security
spanning outside to
inside the facility
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BIORISK MANAGEMENT
Principle of Physical Security

• Detection

• Delay

• Response

• Access Control
 INTRODUCTION TO
BIORISK MANAGEMENT
Personnel Management (2nd pillar)

• The assurance that the people that are given access

to sensitive biological materials should have access.
• Understand that human factors can significantly
impact the success of biorisk management.
- to reduce the risk of thief and fraud
- to reduce the risk of scientific misconduct
• To support the procedural and administrative access
control requirements.
 INTRODUCTION TO
BIORISK MANAGEMENT
Material Control & Accountability (3rd pillar)

• assurance that there is an awareness of what exists in

the laboratory, where it is , and who is responsible for it.
• Ensure the complete and timely knowledge of:
- What material exist
-Where the materials are
- Who is accountable for them
• Objective is NOT to detect whether something is missing.
This could be impossible. The objective is to create an
environment that discourages theft and misuse by
establishing oversight
 INTRODUCTION TO
BIORISK MANAGEMENT
Transport Security (4th pillar)

• assurance that the same rigorous processes that protect

biological materials in the laboratory follow those materials
when they are transported outside laboratory areas.
Aims to reduce the risk of illicit acquisition of high
risk biological agents.
Relies on chain of custody principles and end user
agreements
• High risk agents are routinely shipped worldwide for
diagnostic and research activities
INTRODUCTION TO
BIORISK MANAGEMENT
 INTRODUCTION TO
BIORISK MANAGEMENT
Chain of Custody

• Aims to protect sample by documenting..

- All individuals who have control of sample
- Secure receipt of material at appropriate location
• Chain of custody documentation includes…
- description of material being moved
- contact information for a responsible person
- Time/ date signatures of every person who assumes
control
 INTRODUCTION TO
BIORISK MANAGEMENT
Information Security (5th pillar)

• assurance that the sensitive and valuable information stored in a laboratory

is protected from theft or diversion
• Protect information that is too sensitive for public distribution.
-Label information as restricted
- Limit distribution
- Restrict methods of communication
- Implementation network and desktop security
• Biosecurity-related sensitive information
- Security of dangerous pathogen and toxins
* Risk assessments
* Security system design
- Access authorizations
 INTRODUCTION TO
BIORISK MANAGEMENT
Information Security (5th pillar)

Communication Security
• Mail , email or fax security is required (spear phishing)
• Limited discussions in open areas
• Information should only be reproduced when needed and each copy
must be controlled as original
Network security
• Firewalls Licence and updated soft ware
• User authetication Restricted software
• Virus protection Remote and wireless access controls
• Layered network access
• Desktop security
 INTRODUCTION TO
BIORISK MANAGEMENT
Emergency/incident Response Plan
(6thth pillar)

• After an incident or calamity adequate measures must be taken to

limit the damage and to restore operations as soon as possible.

• In response plans , the measures that need to be taken are described

for each type of calamity.
 INTRODUCTION TO
BIORISK MANAGEMENT
Emerging biotechnology
(7th pillar)

• Monitoring and assesing the scientific , ethical, and social implications

of certain biotechnologies and as warranted, monitoring the
development and the integration of those technologies into scientific
and clinical practice
-Gene editing
- Human gene transfer
- recombinant technologies
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BIORISK MANAGEMENT
Dual-use research of concern
(l8th pillar)

DUR vs DURC

• Dual use research DUR- legitimate research that yields information

and technologies that could be misused for malevolent purposes
NOTE: Most life sciences research conceivably could be considered
DUR in that it has some potential to generate information that could be
eventually misused.
• Goal is to identify the subset that has highest potential for generating
information that could be readily misused = DUR of concern (DURC)
Biorisk

• effect of uncertainty expresses by the

combination of the consequences of an
event (including changes in circumtances)
and associated with likelyhood or
occurrence, where the bilogical material is
the source of harm
CONSEQUENCE + LIKELIHOOD = BIORISK
( Harm caused by biological material)

BIOSAFETY + BIOSECURITY = BIORISK

• CONSEQUENCE
LEVEL DESCRIPTOR CONSEQUENCES- DESCRIPTION

1 INSIGNIFICANT NO INURIES, LOW FINANCIAL LOSS

2 MINOR FIRST AID TREATMENT ON SITE

RELEASE IMMEDIATELY CONTAINED
3 MODERATE MEDICAL TREATMENT REQUIRED , ON
SITE RELEASE CONTAINED WITH
OUTSIDE ASSISTANCE , HIGH
FINANCIAL LOSS
4 MAJOR EXTENSIVE INJURIES, LOSS OF
PRODUCTION CAPABILITY, OFF SITE
RELEASE WITH NO DETRIMENTAL
RELEASE, MAJOR FINANCIAL LOSS
5 CATASTROPIC DEATH, TOXIC RELEASE OFFSITE
DETRIMENTAL EFFECT, HUFE FINACIAL
LOSS
• Biorisk Management

System or process to control safety

and security risk associated with the handling
or storage and disposal of biological agents
and toxins in laboratories and facilities
• Biorisk Management system

management system or part of a

management system used to establish biorisk
management policies, objectives and
processes to achive those objectives
- coordinated activities to direct and control
an organization with regard to biorisk
Biorisk Management

Provide the highest practical

protection and the lowest
practical exposure
Biorisk Management

• BIOSAFETY RISK
-The risk of accidental exposure to or release
of a biological hazard

• BIOSECURITY RISK
- The risk of intentional removal (theft) of a
valuable biological material.
Why do we need BRM?
• To conform to prudent biosafety / biosafety practices
• Expand the research community’s awareness of the
importance of biological safety in the conduct of
good science through effective communication
• To prevent employees and their families from
acquiring laboratory associated infectious diseases
• To prevent contamination of the environment and
promote environmental quality.
Why do we need BRM?
• To comply with all applicable national, international
and local guidelines and regulations for the use of
biohazards
• Prevent loss, theft or misuse of microorganisms,
biological materials, and research-related
information
• Protect the reputation mission of the institute
• Enhance emergency preparedness and response
 The goal of biorisk management
is to identify and reduce risks
before they evolve into
near misses and accidents
The AMP Model
AMP model
Three Vital Questions
Assessment

Process if identifying the hazards/threats and

evaluating the risk associated with biological agents and
toxins, taking into the account the adequacy of any existing
controls, and deciding whether or not the risk are acceptable.

Hazards?
Threats?
Risk?
Hazard and Threat

• Hazard- a source or situation with a potential for causing

harm

• Threat- The potential cause of an incident which may

result in harm
*for biosecurity, threat is used to refer to an individual or group
of people who have the motive, means , and opportunity to cause harm
• “Risk is a result of a HAZARD /THREAT
given the particular situation”
Mitigation

Action and control measures that are put into

place to reduce or eliminate the risk associated
with biological agents and toxins.
Mitigation Control Measures

There are five major categories of measures

for controlling risk in the laboratory.
1. Elimination or Substitution
2. Engineering Controls
3. Administrative Controls
4. Practices and Procedures
5. Personal Protective Equipment
Elimination and Subtitution

• Removing the hazard, not working with the agent or

replacing the hazards with something less dangerous
Engineering Controls

• Physical changes to work stations, equipment,

materials, production facilities or any other
relevant aspect of the work environment that
reduce or prevent exposure to hazards
Administrative Controls

• Policies, standards and guidelines

used to control risk.
Practices and Procedures

• Processes and activities that have

been shown in practice to effective in
reducing risk
Practices and Procedures

• Processes and activities that have

been shown in practice to effective in
reducing risk
Personal Protective Equipment
(PPE)

• Devices worn by the worker to protect

againts hazard in the laboratory.
 Advantage and
Disadvantages
CONTROL MEASURE ADVANTAGES DISADVANTAGES
Eliniation or Substitution Immediate reduction risk Not always available or
posible

Engineering Efficient, eliminates Cost , Complexity

hazard

Administrative Authority approach Indirect approach,

primarily addresses the
human factor.
Practices and Procedures SOP based Training and supervision
(standardized approach) requirements

PPE Ease of use , relative cost Does not eliminate

hazard.PPE fails
exposure happens,
Uncomfortable , limits
,ability only protects the
user
Performance Evaluation

• The implementation of the entire biorisk

management system including evaluating and
ensuring that the system is working the way it
was designed. Another aspect of performance is
the process of continually improving the system
 Key Points

• Risk in laboratory setting can be either be

accidental(Biosafety) or intentional
(biosecurity)
• The establishment of a biorisk management
system identifies these risk and eliminate or
reduce its probability of causing harm
 Summary
WE CANNOT
• Lock –up all bugs
• Control all technology
• Contain all the knowledge
• Isolate all laboratorians
WE CAN
build awareness and educate
seek to communicate build trust
apply leadership in the lab
create an impact in the culture of the lab