PRINCIPLES IN MLS PRACTICE 1
Title of the lesson: Basic Concepts on Laboratory Biosafety and Biosecurity
Lecturer/Professor: Ms. Arianne Rose A. Lim
Transcriber/s: John Carlo P. de Pedro
Basic Concepts on Laboratory
Biosafety and Biosecurity
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OUTLINE
Brief History of Laboratory Biosafety
Brief History of Laboratory Biosecurity
Local and International Guidelines on
Laboratory Biosafety and Biosecurity
Different Organizations in the Field of
Biosecurity
Fundamental Concepts of Laboratory
Biosafety and Biosecurity
Classifications of Microorganisms
According to Risk Groups
Categories of Laboratory Biosafety
According to Levels
BRIEF HISTORY OF LABORATORY
BIOSAFETY
 In 1967, Mortality and morbidity increased due to small
pox.
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 Laboratory biosafety and biosecurity traces its history in
North America and Western Europe.
 Individuals who handle and process microbiological
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specimen are vulnerable to pathogenic microorganisms
which are possible sources of Laboratory Acquired
Infections (LAI)
In 1943, the origins of Biosafety is rooted in the US
Biological Weapons program as ordered by the US
President Franklin Roosevelt and was active during the
Cold War.
 Ira L. Baldwin became the first scientific director
of Camp Detrick.
In 1969, President Richard Nixon terminated the US
Biological Weapons program.
Newell A. Johnson designed modifications for biosafety at
Camp Detrick. He engaged some of the leading scientists
about the nature of their work, and developed specific
technical solutions such as Class III Safety Cabinets and
Laminar flow hoods to address specific risks.
In 1984, American Biological Safety Association
(ABSA) was formed.
In 1907 and 1908, Arnold Wedum described the use of
Mechanical Pipettors to prevent laboratory-acquired
infections.
In 1909, a pharmaceutical company in Pennsylvania
developed a ventilated cabinet to prevent infection from
mycobacterium tuberculosis.
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Serious concerns about biosafety practices
worldwide were raised, contributing directly to the
decision of the World Health Assembly to
consolidate the remaining virus stocks into two
locations: the Center for disease Control and
Prevention (CDC) in the US and State
Research
Center
of
Virology
and
Biotechnology Vector (SRCVB VECTOR) in
Russia.
In 1974, CDC published the Classification of Etiological
Agents on the Basis of Hazard
In 1976, the National Institutes of Health (NIH) of the
United States published the NIH Guidelines for Research
Involving Recombinant DNA Molecules.
WHO’s first edition of Laboratory Biosafety Manual
(1983) and the CDC and NIH’s jointly-published first edition
of the Biosafety in Microbiological and Biomedical
Laboratories (1984), marked the development of the
practice of Laboratory Safety.
Biosafety officers adopted the administrative role of
ensuring the proper equipment and facility controls are in
place based on the specified biosafety level of the
laboratory.
Arnold Wedum, director of Industrial Health and Safety
at the US Army Biological Research Laboratories was
recognized as one of the pioneers of Biosafety that
provided the foundation for evaluating the risk of handling
infectious microorganism.
In 1966, Wedum and Microbiologist Morton Reitman,
analyzed multiple epidemiological studies of laboratorybased outbreaks..
BRIEF HISTORY OF LABORATORY
BIOSECURITY
 In 1996, the US Government enacted the Select Agent
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Regulations to monitor the transfer of a select list of
biological agents.
In 2001, after the terrorist attacks and the anthrax
attacks also known as Amerithrax, the US government
changed its perspective.
The revised Select Agent Regulations 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.
In 2012, the Select Agent Regulations sought to address
the creation of two tiers of select agents.
 Tier 1 Agents are materials that pose the
greatest risk of deliberate misuse, and the
remaining select agents.
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 Singapore’s Biological Agents and Toxins Acts is similar
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in scope with the US Regulations but with more severe
penalties for noncompliance.
In 2005, South Korea’s Act on prevention of Infectious
Diseases was amended to require institutions that work
with listed Highly Dangerous Pathogens to implement
laboratory biosafety and biosecurity.
In Japan, the Infectious Disease Control Law was
recently amended under Japan’s Ministry of Health, Labor
and Welfare. It also established four schedules of select
agents that are subject to different reporting and handling
requirements for possession, transport, and other activities.
In Canada, Canadian Containment Level (CL3) and CL4
facilities that work with risk group 3 or 4 are required to
undergo certification.
In 2008,The Danish Parliament 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 agents.
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DIFFERENT ORGANIZATIONS IN THE FIELD OF
BIOSAFETY
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LOCAL AND INTERNATIONAL GUIDELINES ON
LABORATORY BIOSAFETY AND BIOSECURITY
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In February 2008, the Comite Europeen de
Normalisation (CEN), a European Committee for
Stardardization published the CEN Workshop Agreement
15793 (CWA 15793) which focuses on Laboratory Biorisk
Management.
CWA 15793 can be applied to international stakeholders;
however, they do not have the force of regulation while
conformity is voluntary.
 Developed among experts from 24 different
countries including Argentina, Australia,
Belgium, Canada, China, Denmark, Germany,
Ghana, UK, US among others.
In 2011, CWA 15793 was 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.
In 2014, the agreement was used until it was officially
expired.
In 1983, WHO published its 3rd Edition of the Laboratory
Biosafety Manual.
In 2003, Cartagena Protocol on Biosafety made effective
which applies to the 168 Member-countries that 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 (LMO)
resulting from modern biotechnology
The National Committee on Biosafety of the Philippines
(NCBP) established under E.O 430 series of 1990 was
formed on the advocacy efforts of scientists.
On March 17, 2006, the Office of the President
promulgated E.O 514 establishing the National Biosafety
Framework (NBF) which prescribes the guidelines for its
implementation, strengthening the National Committee on
Biosafety of the Philippines.
NBF is a combination of policy, legal, administrative, and
technical instruments developed to attain the objective of
the Cartagena Protocol on Biosafety which the
Philippines signed on May 24, 2000.
In 1987, NBF considered as an expansion of the NCBP
which played an important role in pioneering the
establishment and development of the current biosafety
system of the country.
Department of Agriculture (DA) also issued
Administrative Order No. 8 to set in place policies on the
importation and release of plants and plant products
derived from modern biotechnology.
The Department of Health (DOH), together with NCBP,
formulated guidelines in the assessment of the impacts on
health posed by modern Biotechnology and its
applications.
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American Biological Safety Association (ABSA)
 Promotes biosafety as scientific discipline and
provides guidance to its members on the
regulatory regime present in North America
Asia Pacific Biosafety Association (A-PBA)
 Founded in 2005
 Acts as a professional society for biosafety
professionals in the Asia-Pacific Region. Active
members of the International Biosafety Working
Group are required to directly contribute to the
development of the best biosafety practices.
European Biological Safety Association (EBSA)
 Founded on June 1996
 Aims to provide a forum for discussions and
debates on issues of concern and to represent
those working in the field of Biosafety.
Philippine Biosafety and Biosecurity Association
(PhBBA)
 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.
Biological Risk Association Philippines (BRAP)
 A non-government 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.
FUNDAMENTAL CONCEPTS OF LABORATORY
BIOSAFETY AND BIOSECURITY
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Biosafety defines as the containment principles,
technologies and practices that are implemented to
prevent unintentional exposure to pathogens and toxins, or
their accidental release.
Biosecurity refers to 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.
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By simple definition, Biosafety protects people from
germs while Biosecurity protects germs from people.
In 1966, Charles Baldwin worked for the Dow Chemical
Company containment systems products, created the
biohazard symbol used in labeling biological hazards
Biosafety and Biosecurity share common perspectives in
terms of risk assessment and management methodologies,
personnel expertise, responsibility and control and program
management among others.
aerosol route, for which there no available vaccines or
treatment.
 Marburg and Crimean-Congo
Hemorrhagic Fever
CLASSIFICATIONS OF MICROORGANISMS
ACCORDING TO RISK GROUPS
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Risk Group 1 – Includes microorganisms that are unlikely
to cause human or animal disease.
 Low individual and Community Risk
Risk Group 2 – 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.
 Moderate individual risk, and limited to
moderate community risk
Risk Group 3 – Include microorganisms that are known to
cause serious diseases to humans or animals and may
present a significant risk to laboratory workers.
 High individual risk, and limited to
moderate community risk
Risk Group 4 – Includes microorganisms that are known
to produce life-threatening diseases to humans or animals.
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High Individual and community risk
CATEGORIES OF LABORATORY BIOSAFETY
ACCORDING TO LEVELS
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Biosafety Level 1 (BSL – 1) – Is suitable for work
involving viable microorganisms that are defined and with
well-characterized strains known not to cause disease in
humans.
 Bacillus subtilis, Naegleria gruberi, and
Infectious canine hepatitis virus
Biosafety Level 2 (BSL - 2) – 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.
 Hepatitis B Virus, HIV, Salmonellae,
Taxoplasma species
Biosafety Level 3 (BSL – 3) – Puts emphasis on primary
and secondary barriers in the protection of the personnel,
the community and the environment from infectious aerosol
exposure.
 Mycorium tuberculosis, St. Louis
Encephalitis Virus and Coxiella.
Biosafety Level 4 (BSL – 4) – Is required for work with
dangerous and exotic agents that pose high individual risks
of life-threatening diseases that may be transmitted via the
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