PRINCIPLES OF MEDICAL LABORATORY SCIENCE 1

LECTURE 6: BASIC CONCEPTS ON LABORATORY BIOSAFETY AND BIOSECURITY

INSTRUCTOR:
MARK ERICSON B. BALADAD, RMT. – COLLEGE OF MEDICAL LABORATORY SCIENCE
1ST SEMESTER | A.Y 2022 - 2022
• In 1984, it was the formation of American
FUNDAMENTAL CONCEPTS OF Biological Safety Association (ABSA)
LABORATORY BIOSAFETY AND • Arnold Wedum described the use of
BIOSECURITY mechanical pipettors to prevent
laboratory-acquired infections in 1907 and
Biosafety
1908.
“The containment principles, technologies,
• Biological safety cabinet
and practices that are implemented to prevent
• In 1909, pharmaceutical company in
unintentional exposure to pathogens and toxins, or
Pennsylvania developed a ventilated cabinet
their accidental release.”
to prevent infection from Mycobacterium
Biosecurity tuberculosis.
• In 1967, height of increasing mortality and
“The protection, control and accountability for morbidity due to smallpox.
valuable biological materials within laboratories, in • World health Assembly consolidates the
order to prevent their unauthorized access, loss, remaining virus stocks into two locations:
theft, misuse, diversion, or intentional release”. o Center for Disease Control and
Prevention (CDC) in United States
Biosafety protects people from germs
while biosecurity protects germs from people. o State Research Center of Virology and
Biotechnology VECTOR (SRCVB
● In 1966, Charles Baldwin created the VECTOR) in Russia
biohazard symbol used in labeling biological
materials carrying significant risks. CDC Classification of Etiological
(1974) Agents on the Basis of Hazard
● Introduced the concept of
Center for
Disease establishing ascending levels
Control and of containment associated
Prevention with risks in handling groups
of infectious microorganisms
● that present similar
characteristics
BRIEF HISTORY OF LABORATORY BIOSAFETY NIH (1976) Guidelines for Research
• Laboratory biosafety and biosecurity traces its National involving DNA Molecules
Institute of ● Explained in detail the
history in North America and Western Europe.
Health microbiological practices,
• The origins of biosafety is rooted in the US equipment, and facility
biological weapons program which began in necessarily corresponding to
1943, as ordered by then US President four ascending levels of
Franklin Roosevelt and was active during physical containment
Cold War.
● In 1983, WHO first edition of Laboratory
• It was eventually terminated by US President
Biosafety Manuel
Richard Nixon in 1969.
● In 1984, the CDC and NIH’s jointly-published
• In 1943, Ira L. Baldwin became the first
first edition of the Biosafety in
scientific director of Camp Detrick (became
Microbiological and Biomedical
Fort Detrick) and was tasked with
Laboratories
establishing the biological weapons
● Arnold Wedum, director of Industrial Health
program for defensive purposes to enable
and Safety at the US Army Biological
the United States to respond if attacked by
Research Laboratories in 1944
such weapons.
● Recognized as one of the pioneers of
• Newell A. Johnson designed modifications biosafety that provided the foundation for
for biosafety at Camp Derrick. evaluating the risks of handling infectious
o He developed special technical microorganisms. And for recognizing biological
solutions such as Class III safety hazards and developing practices, equipment,
cabinets and laminar flow hoods to and facility safeguards for their control.
address specific risks. ● In 1966, Wedum and microbiologist Morton
Reitman, colleagues at Fort Detrick, analyzed

ABELAINE DAWARA
 PRINCIPLES OF MEDICAL LABORATORY SCIENCE 1
LECTURE 6: BASIC CONCEPTS ON LABORATORY BIOSAFETY AND BIOSECURITY
INSTRUCTOR:
MARK ERICSON B. BALADAD, RMT. – COLLEGE OF MEDICAL LABORATORY SCIENCE
1ST SEMESTER | A.Y 2022 - 2022
multiple epidemiological studies of 5. Biological Risk Association Philippines
laboratory-based outbreaks. (BRAP)

BRIEF HISTORY OF LABORATORY CLASSIFICATIONS OF MICROORGANISMS

BIOSECURITY ACCORDING TO RISK GROUPS
● In 1996, the US government enacted the Risk Group 1
Select Agent Regulations to monitor the ● A microorganism that is unlikely to cause
transfer of a select list of biological agents human or animal disease.
from one facility to another. ● Risk Level: No or low individual and
● After the terrorist attacks and the anthrax community risk
attacks of 2001, also known as Amerithrax, the ● Biosafety Level: BSL-1
US government changed its perspective’.
● The revision of Select Agent Regulations in Risk Group 2
2012 sought to address the creation of two ● A pathogen that can cause human or animal
tiers of select agent. disease but is unlikely to be a serious hazard
● In Singapore, Biological Agents and Toxins to the environment. Laboratory exposure may
Act similar with the US regulations but with cause serious infection, but effective treatment
more severe penalties for noncompliance. and preventive measures are available
● In South Korea, the Act on Prevention of ● Risk Level: Moderate individual risk, low
Infectious Diseases in 2005 was amended to community risk
require institutions that work with listed “highly ● Biosafety Level: BSL-2
dangerous pathogens” to implement
laboratory biosafety and biosecurity Risk Group 3
requirements to prevent the loss, theft, ● A pathogen that usually causes serious human
diversion, release, or misuse of these agents or animal disease but does not ordinarily
● In Japan, the Infectious Disease Control spread from one infected individual to another.
Law was recently amended under Japan’s Effective treatment and preventive measures
Ministry of Health, Labor and Welfare. It also are available.
established four schedules of select agents ● Risk Level: High individual risk, low
that are subject to different reporting and community risk
handling requirements for possession, ● Biosafety Level: BSL-3
transport, and other activities.
Risk Group 4
● In Canada, Canadian containment level (CL) 3
● A pathogen that usually causes serious human
and CL4 facilities that work with risk group 3 or
or animal disease and that can be readily
4 are required to undergo certification.
transmitted from one individual to another.
● In 2008, the Danish Parliament passed a law
Effective treatment and preventive measures
that gives the Minister of Health and
are not usually available.
Prevention the authority to regulate the
● Risk Level: High individual and community
possession, manufacture, use, storage, sale,
risk
purchase or other transfer, distribution,
● Biosafety Level: BSL-4
transport, and disposal of listed biological
agents.
CATEGORIES OF LABORATORY BIOSAFETY ACCORDING
TO LEVELS
DIFFERENT ORGANIZATIONS IN THE FIELD OF
BIOSAFETY BSL-1
1. American Biological Safety Association ● Microbes not known to consistently cause
(ABSA) disease in immunocompetent adult humans of
2. Asia-Pacific Biosafety Association minimal potential hazard to laboratory
(A-PBA) personnel and the environment.
3. European Biological Safety Association ● Examples: skin bacteria and yeast
(EBSA)
BSL-2
4. Philippine Biosafety and Biosecurity
● Microbes pose moderate potential hazard to
Association (PhBBA)
personnel and the environment

ABELAINE DAWARA
 PRINCIPLES OF MEDICAL LABORATORY SCIENCE 1
LECTURE 6: BASIC CONCEPTS ON LABORATORY BIOSAFETY AND BIOSECURITY
INSTRUCTOR:
MARK ERICSON B. BALADAD, RMT. – COLLEGE OF MEDICAL LABORATORY SCIENCE
1ST SEMESTER | A.Y 2022 - 2022
● Examples: herpes simplex,
common cold viruses (RSV, rhinoviruses), and
salmonella

BSL-3
● Indigenous or exotic microbes that may cause
serious or potentially lethal disease via
inhalation.
● Examples: tuberculosis, SARS-CoV-2, highly
pathogenic avian influenza, plague (Yersinia
pestis)

BSL-4
● Exotic agents that pose a high risk of
aerosol-transmitted laboratory infections and
life-threatening disease that is frequently fatal,
for which there are no vaccines or treatments.
● Examples: Ebola virus and smallpox virus

KEY POINTS
• The formulation of biosafety guidelines and
practices is a breakthrough in the sciences.
Knowing both the history of biosafety and
biosecurity on a national and international
scale aids in enriching current trends in
biosafety and biosecurity practices.
• There are several organizations across
continents which advocate biosafety and
biosecurity.
• Laboratory biosafety and biosecurity are two
important concepts in laboratory practice. The
integration of principles into actual laboratory
practice especially in an academic institution
provides protection from pathogenic
microorganisms by way of unintentional or
intentional release into the environment.
• Microorganisms are classified into four
different Risk Groups namely, Risk group 1,
Risk Group 2, Risk Group 3 and Risk Group 4,
based on an agent’s pathogenicity, mode of
transmission, host range, and the availability
of preventative measures and effective
treatment.
• Laboratories are classified according to
biosafety levels, namely, Biosafety level 1,
Biosafety Level 2, Biosafety Level 4. Each
level is designed to work with organism in
each risk group.

ABELAINE DAWARA