BASIC CONCEPTS ON LABORATORY aggressively pursued the eradication of the Virus

BIOSAFETY AND BIOSECURITY (College of Physicians of Philadelphia 2014).

 World Health Assembly consolidated the
BRIEF HISTORY OF LAB. BIOSAFETY remaining virus stocks into two locations: the
• Individuals who handle and process  Center for Disease Control and Prevention
(CDC) in the United States
microbiological Specimen are vulnerable to
 State Research Center of Virology and
pathogenic microorganisms which are possible Biotechnology VECTOR (SRCVB VECTOR)
sources of laboratory acquired infections (LAI). in Russia.
• Laboratory biosafety and biosecurity traces its  BIOSAFETY LEVELS ARE:
history in North America and Western Europe.  The technical means of mitigating the
• The origins of biosafety is rooted in the US risk of accidental infection from or
biological weapons program which began in release. of agents in the laboratory
1943, as ordered by then US President Franklin setting as well as the community and
Roosevelt and was active during the Cold war. environment it is situated in.
• It was eventually terminated by US President  concentrated in a combination of
engineered controls, administrative
Richard Nixon in 1969.
controls, and practices,
 After the Second World War, Camp Detrick  Emphasizing the equipment and facility
was designated a permanent installation for controls with little attention given to risk
biological research and development.
assessment
 Biosafety was an inherent component of  This progress in biosafety practice continued
biological weapons development. until the emergence of a community of
 Later on, Newell A. Johnson designed “biosafety officers” who adopted the
modifications for biosafety at Camp Detrick. administrative role of ensuring that the proper
 He engaged some of Camp Detrick’s equipment and facility controls are in place
leading scientists about the nature of
based on the specified biosafety level of the
their work and developed specific
laboratory.
technical solutions such as Class III
 Arnold Wedum
safety cabinets and laminar flow  director of Industrial Health and Safety
hoods to address specific risks.
at the US Army Biological Research
 Consequent meetings eventually led to the Laboratories in 1944.
formation of the American Biological Safety  recognized as one Of the pioneers of
Association (ABSA) in 1984. biosafety that provided the foundation
 The association held annual meetings for evaluating the risks of handling
that soon became the ABSA annual infectious microorganisms and for
conferences (Salerno et al., 2015).
recognizing biological hazards and
 Outside USA: Arnold Wedum developing practices, equipment, and
 described the use of mechanical pipettors to
facility safeguards for their control.
prevent laboratory-acquired infections in 1907  In 1966, Wedum and microbiologist Morton
and 1908 (Kruse (1991), cited by Salerno, 2015).
Reitman
 VENTILATED CABINETS  colleagues at Fort Detrick
 early progenitors to the nearly  analyzed multiple epidemiological
ubiquitous engineered control now
studies of laboratory-based outbreaks;
known as the biological safety cabinet,  1996, the US government
were also first documented outside of  enacted the Select Agent Regulations
the US biological weapons program.  to monitor the transfer of a select list of
 In 1909, a pharmaceutical company in biological agents from one facility to
Pennsylvania developed a ventilated cabinet to another.
prevent infection from Mycobacterium
 Anthrax attacks of 2001, also known as
tuberculosis. Amerithrax,
 At the height of increasing mortality and  revised Select Agent Regulations =
morbidity due to smallpox in 1967, WHO required Specific security measures for
Basic Concepts on Laboratory Biosafety and Biosecurity |Page 1 of 6
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DEPARTMENT OF MEDICAL TECHNOLOGY, FAR EASTERN UNIVERSITY - MANILA
 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
 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
bioscience facilities.
 Singapore’s Biological Agents and Toxins Act
 similar in scope with the US regulations
but with more severe penalties for
noncompliance (Republic of Singapore
2005).
 South Korea, the Act on Prevention of
Infectious Diseases in 2005
 amended to require institutions that
work with listed “highly dangerous
pathogens” to implement laboratory
biosafety and biosecurity requirements
to prevent the loss, theft, diversion,
release, or misuse of these agents.
 In Japan, the Infectious Disease Control Law
 recently amended under Japans Ministry
of Health, Labor, and Welfare.
 It also established four schedules of
select agents that are subject to different
reporting and handling requirement for
possession, transport and other activities
 Then in Canada, Canadian containment level
(CL) 3 and CL4 facilities
 Work with risk group 3 or 4
 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
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DEPARTMENT OF MEDICAL TECHNOLOGY, FAR EASTERN UNIVERSITY - MANILA
LOCAL AND INTERNATIONAL GUIDELINES
ON LAB BIOSAFETY & BIOSECURITY
 February 2008, Comité Européen de
Normalisation (CEN),
 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.
 developed among experts from 24 different
countries including Argentina, Australia,
Belgium, Canada, China, Denmark,
Germany, Ghana, UK, US, among others.
 updated in 2011 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
 Since it originated in the European
workshop agreement framework, confusion
among countries outside Europe arose
especially in the United States in terms of its
applicability.
 Nevertheless, the agreement was used until
it officially expired in 2014.
 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.
Prepared by: Mr. D.N.P. Sumulong, RMT
  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)
 2003
 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.
 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 Philippines (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)
 guidelines for its implementation,
strengthening the National Committee
on Biosafety of the Philippines
 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
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DEPARTMENT OF MEDICAL TECHNOLOGY, FAR EASTERN UNIVERSITY - MANILA
 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
 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:
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
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
Prepared by: Mr. D.N.P. Sumulong, RMT
 contribute to the development of the best FUNDAMENTAL CONCEPTS OF LABORATORY
biosafety practices. BIOSAFETY AND BIOSECURITY

EUROPEAN BIOLOGICAL SAFETY • BIOSAFETY

ASSOCIATION (EBSA) o Containment principles, technologies and
 Founded in June 1996 practices that are implemented to prevent
 Non-profit organization unintentional exposure to pathogens and
 Aims to provide a forum for discussions and toxins, or their accidental release.
debates on issues of concern and to represent
o focuses on laboratory procedures and
those working in the field of biosafety.
practices necessary to prevent exposure to
 encouraging and communicating among its
members information and issues on biosafety and acquisition of infections
and biosecurity as well as emerging legislation o “PROTECTS PEOPLE FROM GERMS”
and standards. • BIOSECURITY
o The protection, control and accountability
Philippine Biosafety and Biosecurity Association for valuable biological materials within
 PhBBA laboratories in order to prevent their
 Created by a multi-disciplinary team with unauthorized access, loss, theft, misuse,
members coming from the health and education diversion, or intentional release
sectors as well as individuals from the executive, o maintenance of secure procedures and
legislative, and judicial branches of the practices in handling biological materials
government
and sensitive information
 Also included are members of the steering
committee and technical working group of the o “PROTECTS GERMS FROM PEOPLE.”
National Laboratory Biosafety and Biosecurity • BIOSAFETY AND BIOSECURITY SHARE
Action Plan Task Force as per DPO No. 2006- COMMON PERSPECTIVES
2500 dated September 15, 2006 o in terms of risk assessment and
 A long-term goal = assist the DA and DOH in management,
their efforts to create a national policy and o methodologies,
implement plan for the laboratory biosafety and o personnel expertise and responsibility,
biosecurity. o control and accountability for research
materials including:
Biological Risk Association Philippines (BRAP) ▪ microorganisms and culture stocks,
 Non-government ▪ access control elements,
 Non-profit
▪ material transfer documentation,
 Serve the emergent concerns of biological risk
management in various professional fields: ▪ training, emergency planning and
 Health ▪ program management among others.
 Agriculture • Charles Baldwin (1996)
 Technology o Environmental health engineer (Dow
 Launched numerous activities in cooperation Chemical Company containment systems
and collaboration on a national and international products)
scale in the promotion of biosafety, biosecurity, o Created the BIOHAZARD SYMBOL used
and biorisk management as scientific disciplines. in labeling biological materials carrying
 “Asses. Mitigate. Monitor.” significant health risks.

Basic Concepts on Laboratory Biosafety and Biosecurity |Page 4 of 6

Prepared by: Mr. D.N.P. Sumulong, RMT
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DEPARTMENT OF MEDICAL TECHNOLOGY, FAR EASTERN UNIVERSITY - MANILA
 CLASSIFICATIONS OF MICROORGANISMS o It represents a significant risk to laboratory
ACCORDING TO RISK GROUPS workers
• WHO recommends an agent risk group classification o may be readily transmissible from one
for laboratory use that describes FOUR GENERAL individual to another
RISK GROUPS based on principal characteristics o effective treatment and preventive measures
and relative hazards posed by infectious toxins or are not usually available
agents.
• Risk group classification for humans and animals is CATEGORIES OF LABORATORY BIOSAFETY
based on the agent’s: ACCORDING TO LEVELS
1. pathogenicity,
2. mode of transmission,  CDC categorized laboratories into four biosafety
3. host range levels
4. availability of preventative measures  Biosafety level designations are based on:
5. Effective treatment  composite of the design features,
• Risk group 1 (No or Low individual and  construction,
 Containment facilities,
community risk)
 equipment,
o includes microorganisms that are unlikely to  practices, and
cause human or animal disease  operational procedures required for
o low individual and community risk working with agents from the various
• Risk group 2 (Moderate Individual Risk, Low risk groups
community Risk)  They are designated in ascending order, by
o includes microorganisms that are unlikely to degree of protection provided to the personnel,
be a significant risk to laboratory workers the environment, and the community
and the community, livestock, or the
environment Biosafety Level 1 (BSL-l)
o Laboratory exposure may cause infection,  suitable for work involving viable
microorganisms that are defined and with well-
however, effective treatment and preventive
characterized strains known not to cause disease
measures are available
in humans.
o While the risk of spread is limited, this risk  Bacillus subtilis, Naegleria gruberi, infectious
group bring about moderate individual risk canine hepatitis Virus, and exempt organisms
and limited community risk under the NIH Guidelines
• Risk group 3 (high individual risk, low  most appropriate among undergraduate and
community risk) secondary educational training and teaching
o includes microorganisms that are known to laboratories that require basic laboratory safety
cause serious diseases to humans or animals practices, safety equipment, and facility design
and may present a significant risk to that requires basic level of containment
laboratory workers.
o could present a limited to moderate risk if Biosafety Level 2 (BSL-2)
 for laboratories that deal with indigenous
these microorganisms spread in the
moderate-risk agents present in the community
community or the environment
 observes practices, equipment, and facility
o there are usually effective preventive design that are applicable to clinical, diagnostic,
measures or treatment available and teaching laboratories consequently
o high individual risk and limited to moderate observing good microbiological techniques
community risk  appropriate when work is done with human
• Risk group 4 (high individual and community blood, body fluids, tissues, or primary human
risk) cell lines where there is uncertain presence of
o microorganisms that are known to produce infectious agents
Iife-threatening diseases to humans or  Hand washing sinks and waste decontamination
animals. facilities must be available and access to the
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DEPARTMENT OF MEDICAL TECHNOLOGY, FAR EASTERN UNIVERSITY - MANILA
 laboratory must be restricted when work is being
conducted.
 All procedures where infectious aerosols or
splashes may be created are conducted in
biosafety cabinets or other physical containment
equipment.
 Examples
 Hepatitis B virus, HIV, salmonellae, and
Toxoplasma species.
 Laboratory staff must have specific and thorough
training in handling extremely hazardous infectious
agents.
 The laboratory is controlled by the laboratory
supervisor in accordance with institutional Policies.
 Marburg or the Crimean-Congo hemorrhagic fever

Biosafety Level 3 (BSL-3)

 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
 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
 Examples = MTB, St. Louis encephalitis virus,
Coxiella

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
 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 Class III biosafety cabinet
or in a full-body air-supplied positive-pressure
personnel suit.
 generally a separate building or completely isolated
zone with specialized ventilation requirements and
waste management systems
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