9: BASIC CONCEPTS ON LABORATORY BIOSAFETY AND BIOSECURITY Flashcards
- “The containment principles, technologies, and practices that are implemented to prevent unintentional exposure to pathogens and toxins, or their accidental release.”
- protects people from bad germs
BIOSAFETY
- “The protection, control, and accountability for valuable biological materials within laboratories, in order to prevent their unauthorized access, loss, theft, misuse, diversion or intentional release”
- protects germs from bad people
BIOSECURITY
- is terrorism involving the intentional release or dissemination of biological agents.
BIOTERRORISM
environmental health engineer for Dow Chemical Company; 1966
- Charles Baldwin
- Used in labeling biological materials carrying significant health risks
o Striking – to draw immediate attention
o Unique and unambiguous
o Quickly recognizable and easily recalled
o Easily stenciled
o Symmetrical
o Acceptable to groups of varying ethnic backgrounds
BIOSAFETY SYMBOL
The host from which the microorganism originates. The carrier host might not show symptoms.
- Source
The organism in which the microorganism infect. The new host must be susceptible.
- Host
The type of microorganism that causes infection or hazardous condition.
- Agent
The means of transmission, mostly direct or indirect. Some routes of transmission include air, insect, direct contact and contaminated surfaces.
Transmission
- began in 1943
- US Biological Weapons Program
- ordered by President Franklin Roosevelt
Biosafety
first scientific director
- Ira L. Baldwin
designed modifications in the Camp
- Newell A. Johnson
- 1907-1908
- Described the use of mechanical pipettors to prevent laboratory acquired infections
- Recognized as the Pioneer of Biosafety
ARNOLD WEDUM
- A pharmaceutical company in Pennsylvania developed ventilated cabinet to prevent infection from M. tuberculosis
1909
- smallpox outbreak
- WHO aggressively pursued eradication of smallpox virus
- WHO Assembly consolidated the remaining virus stocks to:
o Center for Disease Control (CDC) - U.S.A.
o State Research Center of Virology and Biotechnology VECTOR (SRCVB VECTOR) – Russia
1967
- CDC Published the Classification of Etiological Agents on the Basis of Hazard
1974
- National Institutes of Health (NIH) published Guidelines for Research Involving Recombinant DNA Molecules
1976
- WHO released the first edition of Laboratory Biosafety Manual
1983
- CDC and NIH released the first edition of Biosafety in Microbiological and Biomedical Laboratories
- American Biological Safety Association (ABSA)
1984
- US government enacted the Select Agent Regulations
- Monitor transfer of select list of biological agents from one facility to another.
1996
- Amerithrax
- Revised Select Agent Regulations
- required specific security measures for any facility that used or stored one or more agents on the new, longer list of agents.
2001
- Revision of Select Agent Regulations
- Creation of two tiers of select agents
- Tier 1 agents pose greater risk of deliberate misuse.
2012
Provides international regulatory
framework to ensure “an adequate level
of protection in the field of safe transfer, handling, and use of living modified organisms (LMOs) resulting from modern biotechnology”.
- Cartagena Protocol on Biosafety (2003) – UN
- Laboratory Biosafety Manual, 1983
- Containment levels 1-4.
- Laboratory Biosafety Manual – WHO
- Updated in 2011 and expired in 2014.
- CEN Workshop Agreement 15793 - CEN Workshop Agreement 15793 (CWA 15793), February 2008.
- March 17, 2006
- Combination of policy, legal,
administrative, and technical
instruments developed to attain
objectives of CPB.
- National Biosafety Framework
Policies on importation and release of plants and plant products derived from modern biotechnology.
- DA AO No.8
- Policy guidelines on laboratory biosafety and biosecurity.
- Minimum standards and requirements
for clinical laboratories.
- DOH AO 2007-0027
- Member countries are North American countries
- Founded in 1984
American Biological Safety Association (ABSA)
- Member countries are Asia-Pacific Region countries: Singapore, Brunei, Indonesia, Malaysia, Thailand, Philippines, Myanmar, China
- Founded in 2005
Asia-Pacific Biosafety Association (A-PBA)
- Member countries are European countries
- Founded in June 1996
European Biological Safety Association (EBSA)
- Members are from: Health sector; Education sector; Executive, Legislative and Judiciary branches of the government
- Founded in 2008
Philippine Biosafety and Biosecurity
Association (PhBBA)
- Founded in 2015
- World Health Organization
Biological Risk Association Philippines (BRAP)
- pose a risk to national security, can be easily transmitted and disseminated, result in high mortality, have potential major public health impact, may cause public panic, or require special action for public health preparedness.
o Tularemia or “rabbit fever”
o Anthrax
o Smallpox
o Botulinum toxin
o Bubonic plague
o Viral hemorrhagic fevers
CATEGORY A
- are moderately easy to disseminate and have low mortality rates
o Brucellosis (Brucella species)
o Epsilon toxin of Clostridium perfringens
o Food safety threats (for example, Salmonella species, E coli O157:H7,
o Shigella, Staphylococcus aureus)
o Glanders (Burkholderia mallei)
o Melioidosis (Burkholderia pseudomallei)
o Psittacosis (Chlamydia psittaci)
o Q fever (Coxiella burnetii)
o Ricin toxin from Ricinus communis (castor beans)
o Abrin toxin from Abrus precatorius (Rosary peas)
o Staphylococcal enterotoxin B
o Typhus (Rickettsia prowazekii)
CATEGORY B
- are emerging pathogens that might be engineered for mass dissemination because of their availability, ease of production and dissemination, high mortality rate, or ability to cause a major health impact.
o Nipah virus
o Hantavirus
o SARS
o H1N1 (a strain of influenza)
o HIV/AIDS
CATEGORY C
- Classification of microorganisms based on principal characteristics and relative hazards
WHO Risk Groups
- Includes microorganisms that are unlikely to cause human or animal disease
- LOW individual and LOW community risk
RISK GROUP 1
- A pathogen that can cause human or animal disease but is unlikely to be a serious hazard
- Laboratory exposures may cause serious infection, but effective treatment and preventive measures are available and the risk of spread of infection is limited.
- Includes microorganisms cause human or animal disease but are unlikely to be a significant risk to laboratory workers and the community, livestock or the environment
- MODERATE individual risk and LIMITED community risk
RISK GROUP 2
- A pathogen that usually causes serious human or animal disease but does not ordinarily spread
- Effective treatment and preventive measures are available.
- Includes microorganisms that are known to cause serious diseases to humans or animals and may present significant risk to laboratory workers
- HIGH individual risk and LIMITED to MODERATE community risk
RISK GROUP 3
- A pathogen that usually causes serious human or animal disease and that can be readily transmitted from one individual
- Includes microorganisms that are known to produce life threatening diseases to humans and animals and present significant risk to laboratory workers
- Effective treatment and preventive measures are not usually available
- HIGH individual risk and HIGH community risk
RISK GROUP 4
- Primary means of containment, developed for working safely with infectious microorganism
Biosafety Cabinets
- Allows room air to pass into the cabinet and around the area and material within, sterilizing only the air to be exhausted
BSC Class 1
- Sterilizes air that flows over the infectious material, as well as air to be exhausted.
BSC Class 2
- Air coming into and going out of the cabinet is filter sterilized, and the infectious material within is handled with rubber gloves that are attached and sealed to the cabinet
BSC Class 3
- Level of the biocontainment precautions required to isolate dangerous biological agents in an enclosed facility.
- “Protecting People from Bad Bugs”
- Classification of laboratories based on protection provided to personnel, environment and community
Biosafety Levels
- Suitable for work involving viable microorganisms that are defined and with well-characterized strains known not to cause disease
- Basic level of containment
- Examples:
o Bacillus subtilis
o Naegleria gruberi
BIOSAFETY LEVEL 1
- Designed for laboratories that deal with indigenous moderate-risk agents present in the community
- All procedures are conducted in Biosafety Cabinets or Physical containment equipment
- Examples:
o Hepatitis B virus
o HIV
o Salmonella typhi
o Toxoplasma spp.
BIOSAFETY LEVEL 2
- Work with indigenous or exotic agents with a potential for respiratory transmission
- All procedures are required to be performed in the Biosafety Cabinet
- Examples:
o Mycobacterium tuberculosis
o St. Louis encephalitis virus
o Coxiella burnetti
BIOSAFETY LEVEL 3
- Required for work with dangerous and exotic agents that pose life-threatening diseases that may be transmitted via aerosol route
- Highest level of Containment
- Class III Biosafety Cabinet
- Examples:
o Marburg virus
o Crimean-Congo
o Hemorrhagic fever
BIOSAFETY LEVEL 4