Biosafety and biosecurity biosafety levels

1. Biosafety and Biosecurity

2. What is Biosafety?
“Laboratory biosafety” is the term used to
describe the containment principles,
technologies and practices that are
implemented to prevent unintentional
exposure
to pathogens and toxins, or their accidental
release.
Laboratory biosafety manual
Third edition
World Health Organization
Geneva, 2004

3. Principles of Biosafety
• Protection of laboratory worker
• Equipment to prevent exposures
• Containment laboratory design
• Safe practices
• Biosafety guidelines
• Fort Detrick contributions

4. WHO Risk Groups (RG) 1-4: Agents are
categorized based on their relative risk
Pathogenicity of the organism
Mode of transmission and host range
Availability of effective preventive
measures (e.g., vaccines)
Availability of effective treatment (e.g.,
antibiotics)
Other factors

5. WHO Risk Groups
• Risk Group 1 (no or low individual and community risk)
A microorganism that is unlikely to cause human or animal
disease.
• Risk Group 2 (moderate individual risk, low community risk)
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 preventive measures are available and the risk
of spread of infection is limited.
Laboratory biosafety manual
Third edition
World Health Organization
Geneva, 2004

6. WHO Risk Groups
• 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. Effective treatment and
preventive measures are available.
• Risk Group 4 (high individual and community risk)
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.
Laboratory biosafety manual
Third edition
World Health Organization
Geneva, 2004

7. Biosafety Level 1 (BSL 1):
well characterized agents not consistently known to cause disease in
healthy adult humans of minimal potential hazard to laboratory
personnel and the environment
Biosafety Level 2 (BSL 2):
agents of moderate potential hazard to personnel and the
environment
Biosafety Level 3 (BSL 3):
indigenous or exotic agents which may cause serious or potentially
lethal disease as a result of exposure by the inhalation route
(applicable to clinical, diagnostic, teaching, research or production
facilities)
Biosafety Level 4 (BSL 4):
dangerous and exotic agents which pose a high individual risk of
aerosol-transmitted laboratory infections and life-threatening disease

8. Biosafety Level vs. Risk Groups
Biosafety Level (BSL):
BSL and RG – NOT THE SAME
Consist of combinations of laboratory
practices and techniques, safety
equipment, and laboratory facilities

10. BSLs based on
• Biosafety level designations are based on a
composite of the design features, construction,
containment facilities, equipment, practices
and operational procedures required for
working with agents from the various risk
groups.
Laboratory biosafety manual
Third edition
World Health Organization
Geneva, 2004

17. Biosafety Hazards &
Risk Assessment

18. Biosafety Hazards
• Agent Hazards
• Procedure Hazards
• Technique Hazards
• Worker Susceptibility to Disease
• Risk Assessment

19. Agent Hazards
• Pathogenicity
• Virulence
• Infective dose
• Transmission
• Stability and host range
• Occurrence of natural
disease
• Probable causes of LAI
Biosafety Hazards

20. Procedure Hazards
• Agent concentration
• Suspension volume
• Droplets and aerosols
• Protocol complexity
• Use of animals
• Use of sharps
Biosafety Hazards

21. Hazardous Techniques
• Handling infectious agents
• Sterile techniques
• Biological safety cabinets use
• Other primary barriers
• Training and mentoring
• Emergency response procedures
• Attitude
Biosafety Hazards

22. Biosafety Hazards
Worker Susceptibility
to Disease
• Potential for exposure
• Individual susceptibility
• Availability of effective Vaccine
• Availability of effective
Treatments

23. Principles of Bio-safety
These basic principles apply to every laboratory handling
micro-organisms or toxins and will help ensure the work is
done safely:
• Risk assessments
• Training
• Access & entry into the containment lab
• Personal protective equipment (PPE)

24. Principles of Bio-safety
• Work practices
• Cleanliness and tidiness
• Decontamination
• Emergency response

25. Risk assessment types
• Overarching risk assessment – will identify the
hazards and appropriate mitigation
management strategies for proposed activities
involving infectious material or toxins.
• Local Risk Assessment (LRA) – will examine
each activity, identify risks, and develop safe
work practices

26. Risk assessment types
• Pathogen Risk Assessment – will determine the
pathogen risk group
• Containment Assessment – will determine the
containment requirement for the pathogen and
the work proposed.
Biosafety Manual – containing institutional biosafety policies,
programs and plans. It is based on an overarching risk assessment
and LRAs.
Standard Operating Procedures, or SOPs – specific to the nature of the
work.

27. Emergency Response and Incident
Reporting
• Spills of infectious materials, including spills
inside and outside the lab, as well as spills in
the Biological Safety Cabinet
• Loss of containment of any kind
• Accidental exposures, including near misses
• Mechanical failure, including the BSC and air
handling
• Animal Escape
• Medical Emergency
Any lab incident should be reported to the laboratory
supervisor immediately

28. Additional Safety Considerations
• Waste Management
• Chemical Hygiene
• Electrical
• Fire
• Radiation

29. The Chain of Infection
Route of Transmission
Pathogenic Agent
Portal of Entry
Reservoir
Susceptible Host
Route of escape

30. Reservoir of pathogen
Portal of escape
Transmission
Route of entry/infectious dose
Susceptible host
Incubation period
Illness
X
X
X
X
Breaking The Chain of Infection

31. The Chain of Infection
Breaking the chain to manage the risk:
– Pathogen: substitute a non pathogen (an avirulent strain)
– Reservoir of pathogen: eliminate reservoir (kill malaria
insect vector)
– Portal of escape: prevent splashes, aerosols
treat cooling tower for algae (Legionella)

32. The Chain of Infection
– Transmission: sharps precautions
– Route of entry/infectious dose: block with PPE;
use in low concentration/volume
– Susceptible host: immunize, enhance immune
system

33. The Chain of Infection
Worker related factors:
• Assume the worker (host) is an immuno-
competent adult
• Evaluate worker training, expertise, and attitude
in the risk assessment

34. What is Biosecurity?
“Laboratory biosecurity” refers to
institutional and personal security measures
designed to prevent the loss, theft, misuse
(states and non states agents),
diversion or intentional (states and non states
agents) release of pathogens and toxins.
Laboratory biosafety manual
Third edition
World Health Organization
Geneva, 2004

35. Developing a Biosecurity Program
• Scientific directors,
• Principle investigators
• Biological safety officers
• Institutional biosafety committee
• Laboratory and maintenance staff
• Administrative support
• Information technology group
• Law enforcement agencies and in-house security
staff.

36. Biosafety in Pakistan

40. General Laboratory Safety Procedures
• Be familiar with the materials you are working with (e.g., chemical,
biological, radioactive). Follow written laboratory protocols and review the
MSDS (Material Safety Data Sheets) for chemicals. Consider the toxicity of
the materials and the health and safety hazards of each procedure (e.g.,
generation of aerosols). Take advantage of the knowledge and experience
of laboratory personnel and the safety equipment that is available.
• Know the location of safety equipment and emergency procedures in your
area.
• Always wear appropriate clothing (e.g., pants, shirts, shoes) in the
laboratory. Open sandals are prohibited; shorts and skirts are not
recommended.
• Do not work alone in the laboratory. When hazardous operations are
conducted, arrangements should be made to have another person present
in the lab.
• Keep the laboratory and work area clean and uncluttered.
• Work with all hazardous chemicals inside a fume hood.
• Never eat, smoke, drink, prepare food or apply cosmetics in the laboratory.
• Do not leave reactions unattended.
• Prohibit/challenge unauthorized individuals from entering the laboratory.

41. GMT: Good Microbiological Techniques
• using proper aseptic techniques;
• wearing appropriate personal protective equipment;
• minimizing the production of aerosols or working in a biological
safety cabinet when aerosol production is unavoidable;
• employing universal precautions with blood borne pathogens;
• routinely disinfecting work surfaces and equipment/supplies used
in the experiment;
• immediately cleaning spills according to laboratory protocols;
• restricting work with infectious material to one area of the
laboratory;
• properly disposing of waste;
• routinely washing hands following any experiment and after
removing gloves; and
• reporting all accidents/incidents and seeking medical attention if
necessary.
• Proper labelling of the biological materials