Basic Concepts on

Laboratory Biosafety
z
and Biosecurity

Jobhel Christy U. Abad, RMT

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Brief History of laboratory Biosafety

 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 United States to respond if
attacked by such weapons.
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Brief History of laboratory Biosafety

 After the Second World War, Camp Detrick was designated a

permanent installation for biological research and 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
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Brief History of laboratory Biosafety

 Outside the United States included Arnold Wedum who

described the use of mechanical pipettors to prevent laboratory-
acquired infections in 1907 and 1908.

 Moreover, ventilated cabinets, early progenitors to the nearly

ubiquitous engineered control now known as the biological
safety cabinet

 In 1909, a pharmaceutical company in Pennsylvania developed

a ventilated cabinet to prevent infection from Mycobacterium
tuberculosis.
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Brief History of laboratory Biosafety

 Increasing mortality and morbidity due to smallpox in 1967,WHO

aggressively pursued the eradication of the virus.

 World Health Assembly decided to consolidate the remaining

virus stocks into two locations: Center for Disease Control and
Prevention (CDC) in the United states and the State Research
Center of Virology and Biotechnology VECTOR (SRVCB
VECTOR) in Russia
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Brief History of laboratory Biosafety

 In 1974, the CDC published Classification of Etiological Agents on the Basis

of Hazard

 In 1976, 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.

 These guidelines laid the foundation for the introduction of a code of

biosafety practice. This code, along with 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 biosafety
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Brief History of laboratory Biosafety

 Biosafety levels 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.

 In 1966 Wedum and microbiologist Morton Reitman, colleagues

at Fort Detrick, analyzed multiple epidemiological studies of
laboratory-based outbreaks.
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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 facility to another.

 After the terrorist attacks and the anthrax attacks of 2001, also
known as Amerithrax, the US government changed its
perspective. The revised Select Agent Regulations 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.
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Brief History of Laboratory Biosecurity

 The revision of the Select Agent Regulations in 2012 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.

Other countries also relatively implemented and prescribed

biosecurity regulations:

 Singapore’s Biological Agents and Toxins Act is similar with

the US Regulations but with more severe penalties for
noncompliance.
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Brief History of Laboratory Biosecurity

 In South Korea, the Act on Prevention of Infectious Diseases

in 2005 was 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 was recently

amended. It also established four schedules of select agents
that are subject to different reporting and handling requirements
for possession, transport, and other activities.
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Brief History of Laboratory Biosecurity

 In Canada, Canadian containment level (CL) 3 and CL 4

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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Local and International Guidelines on
Laboratory Biosafety and Biosecurity
 In February 2008 the Comité Européen de Normalisation (CEN),
a European Committee for Standardization published the CEN
Workshop Agreement 15793 (CWA 15793) which focuses on
laboratory biorisk management.

 The CWA 15793 was developed among experts from 24

different countries including Argentina, Australia, Belgium,
Canada, China, Denmark, Germany, Ghana, UK, US, among
others. It was updated in 2011 and intended to maintain a biorisk
management system, the agreement was used until it officially
expired in 2014.
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Local and International Guidelines on
Laboratory Biosafety and Biosecurity

 WHO in 1983 published its 3rd edition of the Laboratory

Biosafety Manual. It includes information on to the different
levels of containment laboratories (Biosafety levels1-4), different
types of safety cabinets, good microbiological techniques, and
how to disinfect and sterilize equipment.

 In terms of biosecurity, it covers the packaging required by

international transport regulations and other types of safety
procedures for chemical, electrical, ionizing radiation, and fire
hazards.
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Local and International Guidelines on
Laboratory Biosafety and Biosecurity
 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
pharmaceutical purposes.
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Local and International Guidelines on
Laboratory Biosafety and Biosecurity
 The new National Committee on Biosafety of the Philippines
NCBP) established under E.0. 430 series of 1990 was formed
on the advocacy efforts of scientists. The mandate focuses on
the organizational structure for biosafety.

 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.
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Local and International Guidelines on
Laboratory Biosafety and Biosecurity

 The 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.

 The NBF can be 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.
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Local and International Guidelines on
Laboratory Biosafety and Biosecurity

 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.
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Different Organizations in the Field of
Biosafety
1. American Biological Safety Association (ABSA) a regional
professional society for biosafety and biosecurity founded in
1984. It promotes biosafety as a scientific to discipline and
provides guidance to its members on the regulatory regime
present in North America.

2. Asia- Pacific Biosafety Association (A-PBA) a group

founded in 2005 that acts as professional society for biosafety
professionals in the Asia-Pacific region. Its members are from
Singapore, Brunei, China, Indonesia, Malaysia, Thailand, the
Philippines, and Myanmar.
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Different Organizations in the Field of
Biosafety

3. European Biological Safety Association (EBSA) a non-profit

organization founded in June 1996, EBSA focuses on 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.
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Different Organizations in the Field of
Biosafety

5. Biological Risk Association Philippines (BRAP) 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.
z Biohazard warning
sign for laboratory
doors
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Fundamental Concepts of Laboratory
Biosafety and Biosecurity

 The WHO Laboratory Biosafety Manual (LBM) defines

BIOSAFETY as "the containment principles, technologies, and
practices that are implemented to prevent unintentional
exposure to pathogens and toxins, or their accidental release.“

 On the other hand BIOSECURITY "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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Fundamental Concepts of Laboratory
Biosafety and Biosecurity

 In 1966, Charles Baldwin, an

environmental health engineer working for
the Dow Chemical Company containment
systems products, created the biohazard
symbol used in labeling biological
materials carrying significant health risks.
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Classifications of Microorganisms
According to Risk Groups

 Risk group classification for humans and animals is based on

the agent's pathogenicity, mode of transmission, host range, and
the availability of preventative measures and effective treatment.
Through the classification, infective microorganisms are
classified as:

1. Risk group 1 - includes microorganisms that are unlikely to

cause human or animal disease. These microorganisms bring
about low individual and community risk.
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Classifications of Microorganisms
According to Risk Groups

 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. This risk group
bring about moderate individual risk and limited community risk.
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Classifications of Microorganisms
According to Risk Groups
 Risk group 3 - includes microorganisms that are known to cause
serious diseases to humans or animals and may present a
significant risk to laboratory workers. 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. They bring about high
individual risk, and limited to moderate community risk.

 Risk group 4- includes microorganisms that are known to

produce to life-threatening diseases to humans or animals. It
represents a significant risk to laboratory workers
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Categories laboratory Biosafety
According to Levels
 Biosafety Level 1 (BSI-1) 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
organism sunder the NIH Guidelines. 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.
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Categories laboratory Biosafety
According to Levels
 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. Examples of microorganisms that could be
handled under this level are Hepatitis B virus, HIV, salmonellae, and
Toxoplasma species. BSL-2 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. All procedures where infectious
aerosols or splashes may be created are conducted in biosafety cabinets or
other physical containment equipment.
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Categories laboratory Biosafety
According to Levels

 Biosafety Level 3 (BSL-3) puts emphasis on primary and

secondary barriers in 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. Examples
of microorganisms handled here are Mycobacterium
tuberculosis, St. louis Encephalitis virus and Coxiella.
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Categories laboratory Biosafety
According to Levels
 Biosafety Level 4 (BSI-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 aerosol
route, for which there are no available vaccines or treatment.
Specific practices, safety equipment, and appropriate facility
design and construction are required for instance when
manipulating viruses such as the Marburg Or the Crimean-
Congo hemorrhagic fever and any other agents known to pose a
high risk of exposure and infection to laboratory personnel,
community, and environment.
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Biorisk Management

Jobhel Christy U. Abad, RMT