Biosafety Vs Biosecurity

Biosafety:
“The containment principles, Biosafety
technologies and practices that protects the
are implemented to control
conditions under which persons from
infectious agents can be safely the agents.
manipulated and to prevent
unintentional exposure to Biosecurity
pathogens and toxins”
protects the
Biosecurity: agents from the
“Containment principles and
practices which are
personsTo prevent:
 Personal
implemented to prevent  Laboratory
intentional misuse and release  Environmental
of pathogens” exposure

Biohazard:
Biological substances that
pose a threat to the health
of living organisms,
primarily that of humans. 
 Four Primary Controls of Biosafety
Engineering PPEs SOPs Leadership
Four Primary Controls of
Biosafety
Locks on Gloves Emergency Training
doors Evacuation

Engineering Directional Eye Waste Vaccination

Airflow Protection Disposal
Personal Protective
Interlocked Laboratory Spill Cleanup SOP
Equipments (PPEs) doors Coats compliance

Standard Operating Biosafety N95 Needle Stick Surveillance

Procedures (SOPs) Cabinets

Administrative Autoclave Booties Lab Decon SOP

Evaluation/Va
Leadership lidation

HEPA filters PAPR Medical Background

Emergencies checks
 We could spend millions of rupees on
engineering, thousands on personal
protective equipment, hundred of hours
writing SOPs,----
BUT,
One misbehavior can instantly negate all
of these controls
 Specimens for which there is limited information

1. Standard precautions (2) should always be followed, and barrier protections

applied (gloves, gowns, eye protection), whenever samples are obtained from
patients.
2. Basic containment – Biosafety Level 2 practices and procedures should be the
minimum requirement for handling specimens.
3. Transport of specimens should follow national and/or international rules and
regulations.

Some information may be available to assist in determining the risk of handling

these specimens:

1. Medical data on the patient.

2. Epidemiological data (morbidity and mortality data, suspected route of
transmission other outbreak investigation data).
3. Information on the geographical origin of the specimen.
Why biosafety practices?

To protect:
• Workers,
• Products,
• Co-workers,
• Environment,
• Students, and
• Visitors
6
Biohazard Risk Assessment: Involves You and
………
• Principal Investigator - initiates risk review
• Biosafety Officer - assists PI
• Institutional Biosafety Committee - assists PI, reviews/approve PI’s
protocol submission
• Facilities staff
• Assistance through
– published listings, guidelines
– other experts at host institution, local public health
– other institutions working with same agents
– Government entities
Biological risk Mitigation
Risk

Six major types of hazards

are:
Physical. Noise, vibration,
lighting, electrical, heat and
cold, nuisance dust,
fire/explosion, machine
grinding, working space.
Chemical. Gases, dusts, fumes,
vapours, liquids.
Ergonomic. ...
Radiation. ...
Psychological. ...
Biological
Biological Risk Mitigation
Lessons Learned in Biosafety
Risk Assessment
The Most Obvious Risk
 Risk Assessment Process
• To determine the level of containment to handle a biohazardous agent
– Subjective process
• Based on the following
– Virulence
– Pathogenicity
– Infectious dose
– Environmental stability
– Route of spread
– Communicability
– Operations
– Quantity
– Availability of vaccine or treatment
– Gene product effects
• Toxicity, physiological activity, and allergenicity
Host range
Geographic considerations (endemic ?)
• All IBC applications include a section describing this risk assessment
process
• The IBC gives final approval to the biosafety level of containment

14
Chain of Infection and Means of Protection

15
 Biological Agent:
• The number of microorganisms required to initiate
infection
Q fever 10 organisms by inhalation

E. coli 108 organisms by ingestion Environmental stability

Resistance to drying
Malaria 10 organisms by IV injection Relative resistance to certain disinfectants
Growth cycle: spores – vegetative stage
Poliovirus 1 2 pfu by ingestion

Reference: Wedum, A.G., Barkley, W.E., and Hellman, A.

1972. J Am Vet. Med Assoc. 161:11, 1557-1567.
The always changing risk
The Greatest Risk
Running into barriers
Risk Group and Biosafety Level Definitions
 European Economic Community (DIRECTIVE 93/88/EEC, Oct. 1993)

(1) Group 1 biological agent means one that is unlikely to cause human
disease

(2) Group 2 biological agent means one that can cause human disease
and might be a hazard to workers; it is unlikely to spread to the
community; there is usually effective prophylaxis or treatment available

(3) Group 3 biological agent means one that can cause severe human
disease and present a serious hazard to workers; it may present a risk of
spreading to the community, but there is usually effective prophylaxis or
treatment available

(4) Group 4 biological agent means one that causes severe human
disease and is a serious hazard to workers; it may present a high risk of
spreading to the community; there is usually no effective prophylaxis or
treatment available
 NIH Guidelines on Recombinant DNA (April 2002)
(1) Risk Group 1 (RG1) agents are not associated with disease in
healthy adult humans.

(2) Risk Group 2 (RG2) agents are associated with human disease
which is rarely serious and for which preventive or therapeutic
interventions are often available.

(3) Risk Group 3 (RG3) agents are associated with serious or lethal
human disease for which preventive or therapeutic interventions
may be available.

(4) Risk Group 4 (RG4) agents are likely to cause serious or lethal
human disease for which preventive or therapeutic interventions
are not usually available.
 Canadian Laboratory Biosafety Guidelines (2nd ed. 1996)
(1) Risk Group 1 (low individual and community risk) This group includes those
microorganisms, bacteria, fungi, viruses and parasites, which are unlikely to cause
disease in healthy workers or animals.

(2) Risk Group 2 (moderate individual risk, limited community risk) A pathogen that can
cause human or animal disease but under normal circumstances, is unlikely to be a
serious hazard to healthy laboratory workers, the community, livestock, or the
environment. Laboratory exposures rarely cause infection leading to serious disease;
effective treatment and preventive measures are available and the risk of spread is
limited.

(3) Risk Group 3 (high individual risk, low community risk) A pathogen that usually
causes serious human or animal disease, or which can result in serious economic
consequences but does not ordinarily spread by casual contact from one individual to
another, or that can be treated by antimicrobial or antiparasitic agents.

(4) Risk Group 4 (high individual risk, high community risk) A pathogen that usually
produces very serious human animal disease, often untreatable, and may be readily
transmitted from one individual to another, or from animal to human or vice-versa
directly or indirectly, or casual contact
 CDC/NIH Biosafety in Microbiological and Biomedical
Laboratories (4th Edition 1999)

(1) BIOSAFETY 1 is suitable for work involving well-characterized agents not known to
cause disease in healthy adult humans, and of minimal potential hazard to laboratory
personnel and the environment.

(2) BIOSAFETY LEVEL 2 is similar to Level 1 and is suitable for work involving agents of
moderate potential hazard to personnel and the environment.

(3) BIOSAFETY LEVEL 3 is applicable to clinical, diagnostic, teaching, research, or

production facilities in which work is done with indigenous or exotic agents which may
cause serious or potentially lethal disease as a result of exposure by the inhalation
route.

(4) BIOSAFETY LEVEL 4 is required for work with dangerous and exotic agents which
pose a high individual risk of aerosol-transmitted laboratory infections and life-
threatening disease.
 High Risk Groups
Some population groups are at considerably higher risk of contracting malaria, and
developing severe disease, than others.

These include:
• Pregnant women
• Infants
• Children under 5 years of age
• Patients with HIV/AIDS
• Non-immune migrants
• Mobile populations
• Travellers

National malaria control programmes need to take special measures to protect these
population groups from malaria infection, taking into consideration their specific
circumstances.
 NIH Guidelines – Section II
 Safety Considerations
 Risk assessments: (Appendix B)
RG 1 RG 2 RG 3 RG 4
Agents that are Agents that are Agents that are Agents that are
not associated associated with associated with likely to cause
with disease in human disease serious or lethal serious or lethal
healthy adult which is rarely human disease human disease
humans serious and for for which for which
which preventive preventive or preventive or
or therapeutic therapeutic therapeutic
interventions are interventions interventions are
often available may be available not usually
(high individual available (high
risk but low individual risk
community risk) and high
community risk)
 Risk Assessment Factors

Anthology of Biosafety IV, Issues in Public Health, Chapter 10. J.Y. Richmond, Ed. ABSA, 2001 page 152