BASIC CONCEPTS ON LAB BIOSAFETY AND BIOSECURITY Flashcards
origins of biosafety is rooted in the?
US Biological Weapons Program (1943)
an inherent component of biological weapons development
Biosafety
early progenitors to the nearly ubiquitous engineered control
ventilated cabinet
are possible sources of Laboratory Acquired Infections (LAI)
pathogenic microorganisms
Laboratory biosafety and biosecurity traces its history in _____and _____
North America and Western Europe.
who ordered the US Biological Weapons Program
US President Franklin Roosevelt
the first scientific director of Camp Detrick.
Ira L. Baldwin
1969
President Richard Nixon terminated the US Biological Weapons program.
developed specific technical solutions such as Class III Safety Cabinets and Laminar flow hoods to address specific risks.
Newell A. Johnson (in year 1943)
establishing biological weapons program for defensive purposes
Camp Detrick (Fort Detrick) → Year 1943
In 1907 and 1908, _________described the use of _______ to prevent _______.
Arnold Wedum; Mechanical Pipettors; laboratory-acquired infections.
In 1909, a pharmaceutical company in __________ developed a ______ to prevent infection from mycobacterium tuberculosis.
Pennsylvania; ventilated cabinet
in this year, Mortality and morbidity increased due to small pox
1967
in this year, Wedum and Microbiologist Morton Reitman, analyzed multiple epidemiological studies of laboratory-based outbreaks
1966
in this year US President Richard Nixon terminated the US Biological Weapons Program
1969
introduced the concept of establishing ascending levels of containment associated with risks in handling groups of infectious microorganisms that present similar characteristics
“Classification of Etiological Agents on the Basis of Hazard”
CDC
Centers for Disease Control and Prevention in the US
in this year, CDC published “Classification of Etiological Agents o the Basis of Hazard”
1974
SRCVB VECTOR
State Research Center of Virology and Biotechnology VECTOR in Russia
in this year, the NIH of the United States published “NIH Guidelines for Research Involving Recombinant DNA Molecules”
1976
explained microbiological practices, equipment, and facility necessarily corresponding to four (4) ascending levels of physical containment
“NIH Guidelines for Research Involving Recombinant DNA Molecules”
NIH
National Institutes of Health
WHO’s third edition of Laboratory Biosafety Manual was published on what year
1983
who jointly published the Biosafety in Microbiological and Biomedical Laboratories in 1984
CDC and NIH
director of Industrial Health and Safety at the US Army Biological Research Laboratories
one of the pioneers of Biosafety that provided the foundation for evaluating the risk of handling infectious microorganism.
(1944)
Arnold Wedum
1996
US Government enacted the Select Agent Regulations to monitor the transfer of a select list of biological agents.
AMERITHRAX → “anthrax attacks”
2001
materials that pose the greatest risk of deliberate misuse, and the remaining select agents.
Tier 1 Agents
in this year, the Select Agent Regulations sought to address the creation of two tiers of select agents.
2012
in 2005, other countries implemented and prescribed biosecurity regulations for bioscience facilities. state the three
Biological Agents and Toxins Act (Singapore)
Act on Prevention of Infectious Diseases (South Korea)
Infectious Disease Control Law (Japan)
In this year, the Danish Parliament passed a law that gives the Minister of Health and Prevention the authority to regulate the:
1. possession
2. manufacture
3. use
4. storage
5. sale
6. purchase or other transfer
7. distribution, transport and disposal of listed biological agents.
2008
who published the CEN Workshop Agreement 15793 (CWA 15793) which focuses on Laboratory Biorisk Management.
Comité Européen de Normalisation (CEN)
CEN was developed among experts from 24 countries, state some of them
○ Argentina
○ Australia
○ Belgium
○ Canada
○ China
○ Denmark
○ Germany
○ Ghana
○ UK
○ US, etc.
when did CEN expired
2014
when was CEN updated
2011
Cartagena Protocol on Biosafety [Year]
2003
Ensure an “adequate level of protection in the field
of safe transfer, handling, and use of living modified organisms (LMOs) resulting from biotechnology.”
Cartagena Protocol on Biosafety
this was established under E.O. 430 series of 1990 and formed on the advocacy efforts of scientists
NATIONAL COMMITTEE ON BIOSAFETY OF THE PHILIPPINES
when did the Office of the President promulgated E.O. 514
establishing the National Biosafety Framework (NBF)
March 17, 2006
when the philippines signed Cartagena Protocol on Biosafety
May 24, 2000
“Set in place policies on the importance and release of plants and plant products derived from modern
biotechnology.”
What order is this and who ordered it
Administrative Order No. 8; Department of Agriculture
Formulated guidelines in the assessment of the impacts on health posed by modern biotechnology and its applications
DEPARTMENT OF HEALTH (DOH); together with National Committee on Biosafety of the Philippines (NCBP)
an order which requires clinical laboratories to ensure policy
guidelines on laboratory biosafety and biosecurity
DOH Administrative Order No. 2007-0027
State different organizations in the field of biosafety
American Biological Safety Association (ABSA)
Asia-Pacific Biosafety Association (A-PBA)
European Biological Safety Association (EBSA)
Philippine Biosafety and Biosecurity Association (PhBBA)
Biological Risk Association Philippines (BRAP)
Promotes biosafety as a scientific discipline and provides guidance to its members on the regulatory regime present in North America
American Biological Safety Association (ABSA)
when was American Biological Safety Association (ABSA) founded
Founded on 1984
Acts as professional society for biosafety professionals
in the Asia-Pacific region
Asia-Pacific Biosafety Association (A-PBA)
state the members of Asia-Pacific Biosafety Association (A-PBA)
○ Singapore
○ Brunei
○ China
○ Indonesia
○ Malaysia
○ Thailand
○ Philippines
○ Myanmar
Asia-Pacific Biosafety Association (A-PBA) was founded on
2005
A non-profit organization that aims to provide a forum for discussions and debates on issues of concern
European Biological Safety Association (EBSA)
Focuses on encouraging and communicating among its
members information and issues on biosafety and biosecurity as well as emerging legislation and standards.
European Biological Safety Association (EBSA)
European Biological Safety Association (EBSA) was founded on
1996
The long term goal of the association is to assist the DA and DOH in their efforts to create a national policy and implement plan for laboratory biosafety and biosecurity.
Philippine Biosafety and Biosecurity Association (PhBBA)
- included are members of the steering committee and
technical working groups of the National Laboratory Biosafety and Biosecurity Action Plan Task Force established as per DPO No. 2006-2500 dated September 15, 2006
Non-governmental and nonprofit association that works to serve the emergent concerns of biological risk management in various professional fields such as in the health, agriculture, and technology sectors
throughout the country.
Biological Risk Association Philippines (BRAP)
what is the tagline of Biological Risk Association Philippines (BRAP)
“assess, mitigate, monitor.”
Containment principles, technologies, and practices that are implemented to prevent unintentional exposure to pathogens and toxins, or their accidental releases.
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.
Biosecurity
differentiate between biosafety and biosecurity
Biosafety protects people from germs
Biosecurity protects germs from people.
where is biosafety practiced frequently [what type of institutions]
among institutions that handle and process microbiological specimen
An environmental health engineer for Dow Chemical Company Containment Systems Products, created the
biohazard symbol used in labeling biological hazards
Charles Baldwin
when did Charles Baldwin created the
biohazard symbol used in labeling biological hazards
1966
Low individual and Community Risk
Risk Group 1
Moderate individual risk, and limited to moderate community risk
Risk Group 2
High individual risk, and limited to moderate community risk
Risk Group 3
High Individual and community risk
Risk Group 4
this level of biosafety is suitable for work involving viable microorganisms that are defined and with well-characterized strains known not to cause disease in humans.
Biosafety Level 1 (BSL – 1)
basically designed for laboratories that deal with indigenous moderate-risk agents present in the community.
Biosafety Level 2 (BSL – 2)
Puts emphasis on primary and secondary barriers in the protection of the personnel, the community and the environment from infectious aerosol exposure.
Biosafety Level 3 (BSL – 3)
Is required for work with dangerous and exotic agents that pose high individual risks of life-threatening diseases that may be transmitted via the aerosol route, for which there no available vaccines or treatment
Biosafety Level 4 (BSL – 4)
risk group classification is based on
agent’s pathogenicity
mode of transmission
host range
availability of preventative measures
effective treatment
biosafety level designations are based on
- composite of the design features
- construction
- containment facilities
- equipment
- practices
- operational procedures
can cause disease, upon exposure (ex. salmonella; hepa b)
Risk Group 2
can cause disease, has available cure
Risk Group 3
causes diseases, no medication/treatment
Risk Group 4
