Principles of Medical Technology Practice 1
Chapter 6
BRIEF HISTORY OF LABORATORY
BIOSAFETY
Individuals who handle and process
microbiological Specimen are vulnerable to
pathogenic microorganisms which are possible
sources of laboratory acquired infections (LAI).
Laboratory biosafety and biosecurity traces its
history in North America and Western Europe.
The origins of biosafety is rooted in the US
biological weapons program which began in
1943, as ordered by then US President Franklin
Roosevelt and was active during the Cold war.
It was eventually terminated by US President
Richard Nixon in 1969.
In 1943, Ira L. Baldwin became the first
scientific director of Camp Detrick (which
eventually became Fort Detrick), and was tasked
with establishing the biological weapons program
for defensive purposes to enable the US to
respond if attacked by such weapons.
After the Second World War, Camp Detrick was
designated a permanent installation for biological
research and development.
Biosafety was an inherent component of
biological weapons development.
Later on, 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 such as
Class III safety cabinets and laminar flow hoods to
address specific risks.
Consequent meetings eventually led to the
formation of the American Biological Safety
Association (ABSA) in 1984.
The association held annual meetings that soon
became the ABSA annual conferences (Salerno
et al., 2015).
Outside USA: Arnold Wedum
 described the use of mechanical pipettors
to prevent laboratory-acquired infections
in 1907 and 1908 (Kruse (1991), cited by
Salerno, 2015).
VENTILATED CABINETS
 early progenitors to the nearly ubiquitous
engineered control now known as the
biological safety cabinet, were also first
documented outside of the US biological
weapons program.
 In 1909, a pharmaceutical company in
Pennsylvania developed a ventilated
cabinet to prevent infection from
Mycobacterium tuberculosis.
At the height of increasing mortality and
morbidity due to smallpox in 1967, WHO
aggressively pursued the eradication of the
Virus (College of Physicians of Philadelphia
2014).
World Health Assembly consolidated the
remaining virus stocks into two locations: the
 Center for Disease Control and Prevention
(CDC) in the United States
 State Research Center of Virology and
Biotechnology VECTOR (SRCVB
VECTOR) in Russia.
In 1974, the CDC published the Classification
Of Etiological Agents on the Basis of Hazard,
that introduced the concept of establishing
ascending levels of containment associated with
risks in handling groups of infectious
microorganisms that present similar
characteristics.
TWO years later, the National Institutes Of
Health (NIH) of the United States published the
NIH Guidelines for Research Involving
Recombinant DNA Molecules.
 It explained in detail the microbiological
practices, equipment, and facility
necessarily corresponding to four
ascending levels of physical containment.
BIOSAFETY LEVELS ARE:
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o 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.
o concentrated in a combination of
engineered controls, administrative
controls, and practices,
o Emphasizing the equipment and
facility controls with little attention
given to risk assessment
o This progress in biosafety practice
continued until the emergence of a
community of “biosafety officers”
who adopted the administrative
role of ensuring that the proper
equipment and facility controls are
in place based on the specified
biosafety level of the laboratory.
Arnold Wedum
Anthrax attacks of 2001, also known as
Amerithrax
 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.
Revision of the Select Agent Regulations in
2012
 sought to address the creation of two tiers
of select agents and to make the
regulations more risk-based
TIER 1 AGENTS
 materials that pose the greatest risk of
deliberate misuse, and the remaining select
agents.
 additional security measures
 Other countries also relatively
implemented and prescribed biosecurity
regulations for

 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 bioscience facilities.
practices, equipment, and facility
safeguards for their control.
In 1966, Wedum and microbiologist
Morton Reitman, analyzed multiple
epidemiological studies of laboratory-
based outbreaks;

BRIEF HISTORY OF LABORATORY

BIOSECURITY

In 1996, the US government enacted the

Select Agent Regulations to monitor the
transfer of a select list of biological agents
from one facility to another.
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 Then in Canada, Canadian containment
level (CL) 3 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.
 Around the world, biosecurity
implementation has become a purely
administrative activity based on a
government-developed checklist.
Local and International Guidelines on
laboratory Biosafety and Security
In February 2008, Comité Européen de
Normalisation (CEN), a European Committee for
Standardization published the CEN Workshop
Agreement 15793 (CWA 15793).
 focuses on laboratory biorisk management
 offers a mechanism where stakeholders
can develop consensus standards and
requirements in an open process.
 can be applied to international
stakeholders, however, they do not have
the force of regulation while conformity is
voluntary.
WHO in 1983 published its 3rd edition of the
Laboratory Biosafety Manual
To address concerns on biosafety guidance for
research and health laboratories, issues on risk
assessment and guidance to commission and
certify laboratories
 includes information on the different levels
of containment laboratories (Biosafety
levels 1-4),
 different types of biological Safety
cabinets,
 good microbiological techniques, and
 how to disinfect and sterilize equipment
 covers the packaging required by
international transport regulations
 other types of safety procedures for
chemical, electrical, ionizing radiation, and
fire hazards.
 emphasis on the continuous monitoring
and improvement directed by a biosafety
officer and the biosafety committee
 Unfortunately, there is no mechanism to
insure that the WHO biosafety guidance is
being adhered to, or that people working in
laboratories are sufficiently trained.
The Cartagena Protocol on Biosafety (CPB)
 Made effective in 2003 which applies to
the 168 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.”
 The regulations primarily tackle the safe
transfer, handling, and use of LMOs that
may have adverse effects on the
conservation of biological diversity except
those that are used for pharmaceuticals
purpose.
 It provides a framework for assessing the
risk of LMOs and is focused on ensuring
that LMOs do not negatively affect
biodiversity.
The new National Committee on Biosafety of
the Philippihes (NCBP) established under E.O.
430 series of 1990 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;
 procedures on physico-chemical and
biological containment
On March 17, 2006, the Office of the President
promulgated EO 514 establishing the National
Biosafety Framework (NBF)
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 It prescribes the guidelines for its
implementation, strengthening the
National Committee on Biosafety of the
Philippines.
 It 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.
 It is considered as an expansion of the
NCBP, which since 1987 has played an
important role in pioneering the
establishment and development of the
current biosafety system of the country and
was acknowledged as a model system for
developing countries.
The 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. It aid
in evaluating and monitoring processed food
derived from or containing GMO.
 Currently, DOH, in the midst of
technological advances, recognizes the
need to update the minimum standards and
technical requirements for clinical
laboratories. It requires clinical
laboratories to ensure policy guidelines on
laboratory biosafety and biosecurity (DOH
Administrative Order No. 2007-0027)
Different organizations in the field of biosafety:
1. AMERICAN BIOLOGICAL SAFETY
ASSOCIATION (ABSA)
 Founded in 1984
 Regional professional society for biosafety
and biosecurity
 Promotes biosafety as “scientific
discipline”
 Provides guidance to its members on the
regulatory regime present in North
America.
2. ASIA-PACIFIC BIOSAFETY
ASSOCIATION (A-PBA)
 Founded in 2005
 Acts as a professional society for biosafety
professionals in the Asia-Pacific region
 Its members are from Singapore, Brunei,
China, Indonesia, Malaysia, Thailand, the
Philippines and Myanmar
 Active members of the International
Biosafety Working Group are required to
directly contribute to the development of
the best biosafety practices.
3. EUROPEAN BIOLOGICAL SAFETY
ASSOCIATION (EBSA)
 Founded in June 1996
 Non-profit organization
 Aims to provide a forum for discussions
and debates on issues of concern and to
represent those working in the field of
biosafety.
 encouraging and communicating among its
members information and issues on
biosafety and biosecurity as well as
emerging legislation and standards.
4. PHILIPPINE BIOSAFETY AND
BIOSECURITY ASSOCIATION
(PhBBA)
 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
 Also included are members of the steering
committee and technical working group of
the National Laboratory Biosafety and
Biosecurity Action Plan Task Force as per
DPO No. 2006-2500 dated September 15,
2006
 A 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 the laboratory biosafety and
biosecurity.
5. BIOLOGICAL RISK ASSOCIATION
PHILIPPINES (BRAP)
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 Non-government and Non-profit  methodologies,
association that works to serve the  personnel expertise and responsibility,
emergent concerns of biological risk  control and accountability for research
management in various professional fields: materials including:
 Health  microorganisms and culture stocks,
 Agriculture  access control elements,
 Technology  material transfer documentation,
 It has launched numerous activities in  training, emergency planning and
cooperation and collaboration on a  program management among
national and international scale in the others.
promotion of biosafety, biosecurity, and
biorisk management as scientific Charles Baldwin (1996)
disciplines.  Environmental health engineer (Dow
 “Assess. Mitigate. Monitor.” Chemical Company containment systems
FUNDAMENTAL CONCEPTS OF products)
LABORATORY BIOSAFETY AND  Created the BIOHAZARD SYMBOL
BIOSECURITY used in labeling biological materials
carrying significant health risks.
WHO Biosafety and Laboratory Biosafety  He wanted something “Memorable but
Manual (LBM) defines BIOSAFETY as the meaningless” = so they can educate
“Containment principles, technologies and people about it.
practices that are implemented to prevent
unintentional exposure to pathogens and toxins, or WHO recommends an agent risk group
their accidental release” classification for laboratory use that describes
FOUR GENERAL RISK GROUPS based on
 focuses on laboratory procedures and principal characteristics and relative hazards
practices necessary to prevent exposure to posed by infectious toxins or agents.
and acquisition of infections
 “PROTECTS PEOPLE FROM Risk group classification for humans and animals
GERMS” is based on the agent’s:

WHO Biosafety and Laboratory Biosafety  pathogenicity,

Manual (LBM) defines BIOSECURITY as the  mode of transmission,
protection, control and accountability for valuable  host range
biological materials within laboratories in order to  availability of preventative measures
prevent their unauthorized access, loss, theft,  Effective treatment
misuse, diversion, or intentional release.
 maintenance of secure procedures and
practices in handling biological materials
and sensitive information
 “PROTECTS GERMS FROM
PEOPLE.”
Classifications of Microorganisms According to
Risk Groups:
BIOSAFETY AND BIOSECURITY SHARE 1. Risk group 1 (No or Low individual
COMMON PERSPECTIVES and community risk)
 in terms of risk assessment and  Includes microorganisms that are unlikely
management, to cause human or animal disease.
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 low individual and community risk
2. Risk group 2 (Moderate Individual
Risk, Low community Risk)
 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
3. Risk group 3 (high individual risk, low
community risk)
 includes microorganisms that are known to
cause serious diseases to humans or
animals and may present a significant risk
to laboratory workers.
 could present a limited to moderate risk if
these microorganisms spread in the
community or the environment
 there are usually effective preventive
measures or treatment available
 high individual risk and limited to
moderate community risk
4. Risk group 4 (high individual and
community risk)
 microorganisms that are known to produce
Iife-threatening diseases to humans or
animals.
 It represents a significant risk to laboratory
workers
 may be readily transmissible from one
individual to another
 effective treatment and preventive
measures are not usually available
Categories of laboratory biosafety according to
levels:
CDC categorized laboratories into four biosafety
levels:
Biosafety level designations are based on:
o composite of the design features,
o construction,
o containment facilities,
o equipment,
o practices, and
o operational procedures required for
working with agents from the various risk
groups
They are designated in ascending order, by degree
of protection provided to the personnel, the
environment, and the community.
1. Biosafety Level 1 (BSL-l)
 It is suitable for work involving viable
microorganisms that are defined and with
well-characterized strains known not to
cause disease in humans.
 Examples of microorganisms being
handled in this level are Bacillus subtilis,
Naegleria gruberi, infectious canine
hepatitis Virus, and exempt organisms
under the NIH Guidelines.
 It 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
2. Biosafety Level 2 (BSL-2)
 It is 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
Examples: Hepatitis B virus, HIV,
salmonellae, and Toxoplasma species.
 It is appropriate when work is done with
human blood, body fluids, tissues, or
primary human cell lines where there is
uncertain presence of infectious agents.
 Hand washing sinks and waste
decontamination facilities must be
available and access to the laboratory must
be restricted when work is being
conducted.
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All procedures where infectious aerosols Class III biosafety cabinet or in a full-body
or splashes may be created are conducted air-supplied positive-pressure personnel
in biosafety cabinets or other physical suit.
containment equipment.  generally a separate building or completely
isolated zone with specialized ventilation
3. Biosafety Level 3 (BSL-3) requirements and waste management
 emphasis on primary and secondary systems
barriers in the protection of the personnel,  Laboratory staff must have specific and
the community, and the environment from thorough training in handling extremely
infectious aerosol exposure. hazardous infectious agents.
 Work With indigenous or exotic agents  The laboratory is controlled by the
with a potential for respiratory laboratory supervisor in accordance with
transmission, and that may cause serious institutional Policies.
and potentially lethal infection are being
conducted here
Examples = MTB, St. Louis encephalitis
virus, Coxiella
 Performed in a BSC or other equipment
like a gas-tight aerosol generation chamber
Secondary barriers
 Highly required
 controlled access to the laboratory and
ventilation requirements to minimize the
release of infectious aerosols from the
laboratory while special engineering and
design features are being considered.
 Personnel must be supervised by scientists
competent in handling infectious agents
and associated procedures

4. Biosafety Level 4 (BSL-4)

 dangerous and exotic agents that pose high
individual risks of life-threatening diseases
that may be transmitted via the aerosol
route.
 no available vaccines or treatment
 Specific practices, Safety equipment, and
appropriate facility design and
construction are required
 Marburg or the Crimean-Congo
hemorrhagic fever
 agents known to pose a high risk of
exposure and infection to laboratory
personnel, community, and environment.
 The laboratory worker’s complete isolation
from aerosolized infectious materials is
accomplished primarily by working in a