BIOSECURITY AND BIOSAFETY Flashcards
“the containment principles, technologies, and practices that are implemented to prevent unintentional
exposure to pathogens and toxins, or their accidental release”
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
an environmental health engineer working for the Dow chemical Company containment systems product, created the biohazard symbol used in labelling biological materials
1966 Charles Baldwin
where history of laboratory biosafety and biosecurity began
NORTH AMERICA AND WESTERN EUROPE
Origins of biosafety is rooted in the US biological weapons program , as ordered by then US President
Franklin Roosevelt and was active during the Cold War
1943
Who and when the biological weapon program terminated
1969 US President Richard Nixon
became the first scientific director of Camp Detrick (Fort Detrick)
1943 Ira L. Baldwin
Camp Detrick was designated a permanent installation for biological research and development.
After World War 2
designed modifications for biosafety at Camp Detrick.He engaged some of Camp Detrick’s leading scientists about the nature of their work, and developed specific technical solutions.
Newell A. Johnson
designed modifications for biosafety at Camp Detrick.He engaged some of Camp Detrick’s leading scientists about the nature of their work, and developed specific technical solutions.
Newell A. Johnson
formation of the American Biological Safety Association (ABSA)
1984
described the use of mechanical pipettors to prevent laboratory acquired infections in 1907 and 1908.
Arnold Wedum
first documented outside of the US biological weapons program
VENTILATED CABINETS (EARLY PROGENITORS TO BIOSAFETY CABINET)
a ventilated cabinet to prevent infection from M. tuberculosis was developed by a pharmaceutical
company in Pennsylvania
1909
increased morbidity and mortality due to smallpox → WHO aggressively pursued the eradication of the
virus
1967
TWO LOCATIONS OF THE REMAINING VIRUS STOCKS
CDC in the US and State Research Center of Virology and Biotechnology VECTOR in Russia
CDC published the Classification of Etiological Agents on the Basis of Hazard
1974
➢ NIH of the US published the NIH Guidelines for Research Involving Recombinant DNA Molecules
➢ These guidelines laid the foundation for the introduction of a code of biosafety practice.
1976
marked the development of the practice of laboratory safety.
WHO’S LABORATORY BIOSAFETY MANUAL (1983) AND CDC & NIH’S BIOSAFETY IN MICROBIOLOGICAL AND BIOMEDICAL LABORATORIES (1984)
are the technical means of mitigating the risk of accidental infection from or release of agents in the
laboratory setting as well as the community and environment it is situated in.
Biosafety Levels
ensures that the proper equipment and facility controls are in place based on the specified biosafety level of the laboratory.
Biosafety Officers
Director of Industrial Health and Safety at the US Army Biological Research Laboratories in 1944
Recognized as one of the pioneers of biosafety that provided the foundation for evaluating the risks of handling infectious microorganisms and for recognizing biological hazards and developing practices, equipment, and facility safeguards for their cont
Arnold Wedum
Wedum and microbiologist Morton Reitman, colleagues at Fort Detrick, analyzed multiple
epidemiological studies of laboratorybased outbreaks
1966
US government enacted the Select Agent Regulations
1966
Terrorist attack and anthrax attacks (Amerithrax) happened
2001
then required specific security measures for any facility in the United States that used or stored one or more agents on the new, longer list of agents.
THE REVISED SELECT AGENT REGULATIONS
revision of the Select Agent Regulations
2012
materials that pose the greatest risk of deliberate misuse and the remaining select agent
Tier 1 Agents
More severe penalties for noncompliance
SINGAPORE – BIOLOGICAL AGENTS AND TOXINS ACT
Require institutions working with “highly dangerous pathogens” to implement lab biosafety and
biosecurity Brief History of Laboratory Biosecurity
SOUTH KOREA ACT ON PREVENTION OF INFECTIOUS DISEASES IN 2005
Canadian containment level (CL) 3 and CL4 facilities required to undergo certification
Canada
Infectious Disease Control Law
Japan
When did they passed a law that gives the Minister of Health and Prevention the authority to regulate the possession, manufacture, use, storage, sale, purchase or other transfer, distribution, transport, and disposal of listed biological ag
Danish Parliament 2008
- Published by the Comité Européen de Normalisation in ?
- Focuses on laboratory biorisk management
- Offers a mechanism where stakeholders can develop consensus standards and requirements in an open
process
CEN WORKSHOP AGREEMENT 15793 (CWA 15793)
February 2008
- Published by the Comité Européen de Normalisation in ?
- Focuses on laboratory biorisk management
- Offers a mechanism where stakeholders can develop consensus standards and requirements in an open
process
CEN WORKSHOP AGREEMENT 15793 (CWA 15793)
February 2008
When did CEN updated and intended to maintain a biorisk management system among diverse organizations and set out performance-based requirements with the exclusion of guidance for implementing a national biosafety system
2011
The agreement (CEN) was used until it officially expired in
2014
Published by WHO in - to address concerns on biosafety guidance for research and health
laboratories, issues on risk assessment and guidance to commission and certify laboratories
3RD EDITION OF THE LABORATORY BIOSAFETY MANUAL 1983
Puts emphasis on the continuous monitoring and improvement directed by a biosafety officer and the
biosafety committee. Unfortunately. There is no mechanism to ensure that the WHO biosafety guidance is being adhered to, or that people working in laboratories are sufficiently trained
EDITION OF THE LABORATORY BIOSAFETY MANUAL
Made effective in - which applies to the - member countries provides an 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
2003
168 members
CARTAGENA PROTOCOL ON BIOSAFETY (CPB)
Established under E.O. 430 series of 1990 was formed on the advocacy efforts of scientists.
The mandate focuses on the organizational structure for biosafety: procedures for evaluation of
proposals with biosafety concerns; procedures and guidelines on the introduction, movement, and field
release of regulated materials; and procedures on physico-chemical and biological containment
NATIONAL COMMITTEE ON BIOSAFETY OF THE PHILIPPINES (NCB)
Established on -, after the promulgation of E.O. - by the Office of the President
Prescribes the guidelines for its implementation, strengthening the National Committee on Biosafety of
the Philippines
March 17, 2006
E.O 514
NATIONAL BIOSAFETY FRAMEWORK (NBF)
Issued by the Department of Agriculture to set in place policies on the importation and release of plants and plant products derived from modern biotechnology.
DOH, together with NCBP, formulated guidelines in the assessment of the impact on health posed by
modern biotechnology and its applications.
ADMINISTRATIVE ORDER NO. 8
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)
A regional professional society for biosafety and biosecurity founded in -.
o It 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) 1984
Acts as a professional society for biosafety professionals in the Asia-Pacific region
Its members are from Singapore, Brunei, China, Indonesia, Malaysia, Thailand, Philippines, and
Myanmar
ASIA-PACIFIC BIOSAFETY ASSOCIATION (A-PBA) 2005
Aims to provide a forum for discussions and debates on issues of concern and to represent those working in the field of biosafety
EUROPEAN BIOLOGICAL SAFETY ASSOCIATION (EBSA) June 1996
Created by a multi-disciplinary team with members coming from the health and education
sectors as well as individuals from the executive, legislative, and judicial branches of the
government
PHILIPPINE BIOSAFETY AND BIOSECURITY ASSOCIATION (PHBBA)
Also 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
A non-government and non-profit 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)
TAGLINE OF BIOLOGICAL RISK ASSOCIATION PHILIPPINES (BRAP)
Assess, Mitigate, Monitor
includes microorganisms that are unlikely to cause human or animal disease. These microorganisms bring about low individual and community risk
RISK GROUP 1
includes microorganisms that are unlikely to be a significant risk to laboratory workers and the
community, livestock, or the environment. Laboratory exposure may cause infection, however, effective treatment and preventive measures are available while the risk of spread is limited. This risk group bring about moderate individual risk and limited community risk
RISK GROUP 2
includes microorganisms that are known to cause serious diseases to humans or animals and
may present a significant risk to laboratory workers.
o It could present a limited to moderate risk if these microorganisms spread in the community or
the environment, but there are usually effective preventive measures or treatment available.
o They bring about high individual risk, and limited to moderate community risk
RISK GROUP 3
includes microorganisms that are known to produce lifethreatening diseases to humans or
animals. It represents a significant risk to laboratory workers and may be readily transmissible from one
individual to another while effective treatment and preventive measures are not usually
available. In effect, they bring about high individual and community risk.
RISK GROUP 4
includes microorganisms that are known to produce lifethreatening diseases to humans or
animals. It represents a significant risk to laboratory workers and may be readily transmissible from one
individual to another while effective treatment and preventive measures are not usually
available. In effect, they bring about high individual and community risk.
RISK GROUP 4
is suitable for work involving viable microorganisms that are defined and with well- characterized strains known not to cause disease in humans. This level is the most appropriate among undergraduate and secondary educational training and teaching laboratories that require basic laboratory safety practices, safety equipment, and facility design that requires basic level of containment
BIOSAFETY LEVEL 1 (BSL-1)
Examples of microorganisms being handled in BSL-1
Bacillus subtilis, Naegleria gruberi,
infectious canine hepatitis virus, and exempt organisms under the NIH Guidelines
is basically designed for laboratories that deal with indigenous moderate-risk agents present in
the community. It observes practices, equipment, and facility design that are applicable to clinical, diagnostic, and teaching laboratories consequently observing good microbiological techniques.
BIOSAFETY LEVEL 2 (BSL-2)
Examples of microorganisms that could be handled under level 2
Hepatitis B virus, HIV, salmonellae, and Toxoplasma species.
appropriate when work is done with human blood, body fluids, tissues, or primary
human cell lines where there is uncertain presence of infectious agents.
BSL-2
Puts emphasis on primary and secondary barriers in the protection of the personnel, the
community, and the environment from infectious aerosol exposure. Work with indigenous or exotic agents with a potential for respiratory transmission, and that may cause serious and potentially lethal infection are being conducted here.
All laboratory activities are required to be performed in a biosafety cabinet or other
containment equipment like a gas-tight aerosol generation chamber.
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 are no
available vaccines or treatment.
The laboratory workers’ complete isolation from aerosolized infectious materials is
accomplished primarily by working in a Class III biosafety cabinet or in a full-body, air-supplied
positivepressure personnel suit.
Also a laboratory is generally a separate building or completely isolated zone with specialized
ventilation requirements and waste management systems.
BIOSAFETY LEVEL 4 (BSL-4)
BIOSAFETY LEVEL 3 EXAMPLES
Yersinia pestis (plague)
Mycobacterium tuberculosis
St louis encephalitis virus
Coxiella
SARS
Rabies virus
West Nile virus
Hantaviruses
BIOSAFETY LEVEL 4 EXAMPLES
Ebola virus
Small pox virus
