BIOSAFETY AND BIOSECURITY
we could educate people as to what it means” Charles
BIOSAFETY – containment principles, technologies, and
practices implemented to prevent unintentional
exposure to pathogens and toxins, or their unintentional
release.
- All measures that prevent accidentally
exposure at biological agents and infections
and their released in environment.
BIOLOGICAL AGENT – any microorganism which may be
able to provoke any infections, allergy or toxicity in
humans, animals or plants.
BIOSECURITY – institutional and personal security
measures designed to prevent the loss, theft, misuse,
diversion, or intentional release of pathogens and toxins.
VBM – Valuable Biological Materials
*Biosafety protects people of biohazards, Biosecurity
protects biohazards from people*
BIOSAFETY – protects people and the environment from
exposure to harmful biological materials.
- Maintaining containment
- Preventing exposure
- Emergency response protocols
BIOSECURITY – prevents misappropriation and misuse of
potentially harmful biological agents.
- Secure storage
- Limited access
- Inventory of stocks
HAZARD/THREAT – the source of causative agent of a
particular risk.
LABORATORY SAFETY – “Keeping the people from bad
bugs”
LABORATORY SECURITY – “Keeping the bad bugs from
people”
BIOHAZARD SYMBOL – very distinct and well-known
symbol
- Used internationally to indicate
biohazard
- Developed at Dow Chemical Company
in 1966
“We wanted something memorable but meaningless, so
Baldwin, Dow Engineer
MAJOR EPIDEMICS IN HUMAN HISTORY
 BLACK PLAGUE (1347 – 1351) – brought from
China by caravan trade up to 1/3 of Europe’s
population killed
 “GREAT DYING” in the Americas (starting in the
1600s) - Disease brought by Europeans.
 HIV/AIDS (1950 – PRESENT) – world-wide
pandemic
- 40 million infected world-side (2003)
CLASSIFICATION OF HAZARD/THREAT
 Material – biological, chemical, radiological,
liquid nitrogen, flammable material, etc.
 Equipment – centrifuge, autoclave, biosafety
cabinet, etc
 People – immunocompromised worker, non-
competent staff, etc
 Environment – congested laboratory, etc
 Activity – procedures involving aerosol
generations, culture, sharp use, etc.
HAZARD is for biosafety, THREAT is for biosecurity
BIOSECURITY RISK – the risk of intentional removal
(theft) of a valuable biological material.
RISK – the potential that a chosen action will lead to an
undesirable outcome.
HAZARD – any source of potential adverse health effect,
harm or damage.
RISK - The likelihood that a person exposed to a hazard
will be harmed
EXPOSURE – the extent to which someone is subjected
to hazard.
HAZARD + EXPOSURE = RISK
LABORATORY ACQUIRED INFECTIONS
ROUTES OF LABORATORY EXPOSURES
 Ingestion
 Inoculation
 Contamination
 Inhalation

LABORATORY ACQUIRED INFECTIONS – are infections,
either symptomatic or asymptomatic, that are acquired
through laboratory or laboratory-related activities, as a
result of working with infectious agents.
- Continue to occur despite control
practices and measures.
- Get worse and worse every year
Top 4 Lab Accidents resulting in LAI’s
 Spills and splashes
 Needle stick injuries
 Sharp objects lacerations
 Animal scratch/bite
Causes of Laboratory Exposures
 20% - caused by equipment failure
 80% - caused by human factors
o Not performing proper handwashing
o Eating in the lab work area
o Wrong/inadequate PPE
o Non-compliance to policies
Positive Outcomes for Reporting LAI’s
 Improvement of facility, training, SOP’s
 Collective organizational commitment
 Allocation of sufficient budget
Negative Outcomes for reporting LAI’s
 Social stigma associated with reporting
 Punishment/loss of job/end of career
 Loss of reputation
 More paper works
PRINCIPLES OF BIOSAFETY
 Practice and Procedures
o Standard microbiological practices
 Aware of potential hazard
 Trained and proficient in
techniques
 Supervisors responsible for:
 Appropriate laboratory
facilities
 Personnel and training
 Special practices and
precautions
 Occupational health
programs
o Special procedures and considerations
 Safety equipment
o Primary containment barrier
o Minimize exposure to hazard
 Prevent contact/contain
aerosols
 Engineering controls/equipment
 Personal Protective Equipment (PPE)
 Biological safety cabinets
 Covered or ventilated animal cage
system
 Facility design and construction
o Secondary barrier/engineering controls
o Contributes to worker protection
o Protects the outside of the laboratory
o E.g. building and lab design, ventilation,
autoclaves, cage facilities.
 Increasing levels of protection
o Biosafety Levels 1 -4 (BSL)
 Increasing levels of employee
and environmental protection
 Guidelines for working safety in
research and clinical laboratory
facilities
o Agricultural Biosafety Level 1 -4 (ABSL)
 Laboratory animal facilities
 Plant, GMO facilities
 Animal models that support
research
 Guidelines for working safely in
animal research facilities
PRINCIPLE OF BIOSECURITY
 Biosecurity Challenges
 Biological materials
o No devices to detect pathogens being
removed from a facility
o Easy to hide small vials, culture tubes
o Present in clinical labs. research labs,
private labs, gov’t labs
o Present in many locations wthin the lab
 By nature, are accessible to public
 Changing workforce
8 PILLARS OF BIOSECURITY
1. Material Control & Accountability – assurance
that there is an awareness of what exists on the
laboratory, where it is, and who is responsible
for it.
 Ensure the complete and timely
knowledge of:
o What materials exist
o Where the materials are
o Who is accountable for them?
 All materials should have an
accountable person who is ultimately
responsible for the material
2. Physical Security – is the assurance if safety from
physical intrusion
 3 Principles of Physical Security
o Detection
o Delay
o Response
 Graded Protection
o Property Protection Areas (Low
Risk Assets)
 Grounds
 Public access offices
 Warehouses
o Limited Areas (Moderate Risk
Assets)
 Laboratories
 Sensitive
administration office
 Hallways surrounding
Exclusion Areas
o Exclusion Areas (High Risk
Assets)
 High containment lab
 Computer network hubs
3. Personnel Security (Personal Reliability
Program) – evolved from Personnel
Management which is the assurance that the
people that are given access to sensitive
biological materials are reliable, honest and
trustworthy
 Objective of PRP
Understand that human factors can
significantly impact the success of bio
risk management
o To reduce the risk of theft and
fraud
o To reduce the risk of scientific
misconduct
o To support the procedural and
administrative access control
requirements
 Personnel Training – Security
Awareness
Promoting security awareness in
employees is one the most important
ways breaches in security can be
recognized.
Lab workers should be aware of who
should be and should not be on their
work areas
4. Information Security - is the assurance that
sensitive and valuable information stored in a
laboratory is protected from theft or diversion.
*Document control and computer security is
necessary to reduce risks in a facility
o Label information as restricted
o Limit distribution
o Restrict methods of communication
o Implement network and desktop
security
or 5. Transport Security – is the assurance that the
same rigorous processes that protect biological
materials on the laboratory follow those
materials when they are transported outside the
lab areas.
 Aims to reduce the risk of illicit
acquisition of high-risk biological agents
o Relies on chain of custody
principles and end-user
agreements
High risk agents are routinely
shipped worldwide for diagnostic
and research activities
 A local, national, and
international concern
 There is a need to
develop a common
standard
 2. Keep an eye on sample storage areas
a. Internal Transport and assign security responsibilities to each
- Movement of materials to and from other
restricted areas within a facility 3. Keep sensitive information safe
- May involve personnel from labs, 4. Provide suggestions for improving
shipping areas, disposal areas security
- In order to move materials safely and 5. Take training more seriously
securely
 Pre-approval process
b. External Transport
- Movement of materials from one
facility to another
- May involve commercial carriers
- Occur within a wide range of
international and state regulations
and standards

6. Organizational Management – is general

awareness that there is strong laboratory
leadership. The general administration, the
laboratory administration and the Biosafety
Officer must work to:
 Allocate responsibility and authority
among staff and lab managers
 Demonstrate good laboratory practices
and a commitment to responsible life
science research
 Establish a culture of responsibility
 Provide oversight to the entire Lab
biosafety program

7. Response and Resiliency - is general awareness

of the proper security counteraction and how to
spring-back into operations when one or more of
the biosafety elements and/or biosecurity pillar
collapse or breakdown respectively.

Response is bets achieved with collaboration

with gov’t and law enforcements

8. Security Awareness – is general awareness of

the proper security measures in your laboratory,
where the risks are, and what should be done.

If the people in your facility are aware of the

true biosecurity risks they face, they will be
more likely to:
1. Report if someone strange is walking
around