Biosafety and

Biosecurity
Almay Minka R. Gamayon, RMT
Biosecurity or Biosafety?
Brief History of Laboratory
Biosafety
• North America and
Western Europe
• It was rooted in the US
Former US President Biological Weapons
Franklin D. Roosevelt Program (1943) ordered
(1882 – 1945) by US President Franklin
Roosevelt (Cold War).
• It was terminated by US
President Richard Nixon
(1969)

Former US President
Richard Milhous Nixon
(1913 – 1994)
 Brief History of Laboratory
Biosafety
• Ira L. Baldwin – first
scientific director of
Camp Detrick (Fort
Detrick)
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• Biological weapons
program
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• Camp Detrick –
permanent installation
for biological research
and development

https://en.wikipedia.org/wiki/United_States_Army_Biological_W
arfare_Laboratories
Brief History of Laboratory
Biosafety
• Newell A. Johnson
• Modification of biosafety at Camp Derrick
• Development of Class III safety cabinets and laminar
flow hoods
• American Biological Safety Association (ABSA)
1984
• Arnold Wedum
• Manual pipettors
• Biological Safety Cabinets were created
• 1909 – Pennsylvania, ventilated cabinet for
Mycobacterium tuberculosis
Brief History of Laboratory
Biosafety
• Smallpox (1967)
• Variola virus of the Orthopoxvirus family
• 3 out of 10 people died
• The World Health Organization aggressively pursued the
eradication of virus
• World Health Assembly
1. the Center for Disease Control and Prevention (CDC) in
the US
2. State Research Center of Virology and Biotechnology
Vector (SRCVB VECTOR) in Russia
Brief History of Laboratory
Biosafety
• Classification of Etiological Agents on the Basis of Hazard (1974)
• Published by the Centers for Disease and Control on 1974
• Concept of establishing ascending levels of containment associated with risks in handling groups of
infectious microorganisms

• NIH Guidelines for Research Involving Recombinant DNA Molecules (1976)

• Microbiological practices, equipment, and facility necessarily corresponding to four ascending levels of
physical containment.

• Laboratory Biosafety Manual (1983) by WHO and Biosafety in Microbiological and Biomedical
Laboratories (1984)

• Biosafety officers – Administrative role of ensuring that the proper equipment and facility controls
Brief History of Laboratory
Biosafety
Brief History of Laboratory
Biosecurity
• Select Agent Regulations
• These are established regulations by the US government to monitor the transfer of biological
agents from one facility to another.
• 2012
• 2 Tiers
• Tier 1 agents: materials that pose the great risk of deliberate misuse
• Other agents
• SINGAPORE: Biological Agents and Toxins Act
• SOUTH KOREA: Act on Prevention of Infectious Diseases
• JAPAN: Infectious Disease Control Law
• CANADA: undergoing certification for Containment Level 3 (CL3) and Containment Level 4 (CL4)
• DENMARK: Danish Parliament passed a law in 2008 that gives the Minister of Health and
Prevention authorization
Local and International Guidelines
on Laboratory Biosafety and
Biosecurity
• CEN Workshop Agreement 15793 (CWA 15793)
• Established on February 2008 by the European
Committee for Standardization
• It was developed from 24 different countries
(Argentina, Australia, Belgium, Canada, China,
Denmark, Germany, etc.)
• It was updated in 2011 to maintain the system among
diverse organizations and se out performance-based
requirements with the exclusion of the guidance for
implementing a national biosafety system.
• Despite of the limited applicability of the agreement,
they still continued to use it until it officially expired in
2014.
Local and International Guidelines
on Laboratory Biosafety and
Biosecurity
• World Health Organization (1983)
• Laboratory Biosafety Manual, 3rd
edition
• Concerns on biosafety guidance for
research and health laboratories
• Issues on risk assessment and guidance to
commission and certify laboratories
• The manual contains the following:
1. Levels of containment laboratories
(Biosafety levels 1-4)
2. Biological Safety Cabinets
3. Good microbiological techniques
4. How to disinfect and sterilize equipment
• The manual includes the packaging
required by international transport
regulations and other types of safety
procedures for chemical, electrical, ionizing
radiation, and fire hazards
Local and International Guidelines on
Laboratory Biosafety and Biosecurity
• Cartagena Protocol on
Biosafety (CPB)
• This manual provides an
international regulatory
framework that ensures
“an adequate level of
protection in the field of
safe transfer, handling,
and use of living modified
organisms (LMOs)
resulting from modern
biotechnology.
Local and International Guidelines on
Laboratory Biosafety and Biosecurity
• National Committee on Biosafety of the Philippines (NCBP)
• Executive Order 430 series of 1990
• Organizational structure for biosafety
• National Biosafety Framework (NBF)
• March 17, 2006, Executive Order 514
• Implementation, Strengthening the National Committee on
Biosafety of the Philippines
• Administrative Order Number 8
• Department of Agriculture issues A.O. 8 to provide rules in the
importation and release of plants and plant products derived from
modern biotechnology
• DOH Administrative Order No. 2007-0027
• Policy Guidelines on Laboratory Biosafety and Biosecurity
Different Organizations in the
Field of Biosafety
• American Biological Safety Association (ABSA)
• a regional professional society for biosafety and biosecurity
founded in 1984
• promotes biosafety as a 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
Different Organizations in the
Field of Biosafety
• European Biological Safety Association (EBSA)
• non-profit organization founded in June 1996
• aims to provide a forum for discussions and debates on issue of
concern and to present those working on the field of biosafety
• Philippine Biosafety and Biosecurity Association (PhBBA)
• created by a multi-disciplinary team with members coming from
the health an education sectors as well as individuals from the
executive, legislative and judicial branches of the government
• also include are members of the steering committee and technical
working groups of the National Laboratory Biosafety and
Biosecurity Action Plan Task Force established as per DPO No.
2006-2500 dated September 15, 2006
• its long term goal is to assist the DA and DOH in their efforts to
create a national policy and implement plan for laboratory
biosafety and biosecurity
Different Organizations in the
Field of Biosafety
• Biological Risk Association Philippines (BRAP)
• 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
• has launched multiple activities in cooperation and
collaboration with other associations, on the national and
international sale in the promotion of biosafety, biosecurity,
and biorisk management as scientific discipline.
• goes by the tagline, “assess, mitigate, monitor”
The Biological Hazard symbol
Fundamental Concepts of Laboratory
Biosafety and Biosecurity

Biorisk
Management

Biosafety Biosecurity
Biosecurity or Biosafety?
Classifications of Microorganisms
According to Risk Groups
RG1 RG2 RG3 RG4
Agents that are likely to
Agents that are not Agents that are Agents that are
cause serious or lethal
associated with disease associated with human associated with serious
human disease for
in healthy adult humans. disease which is rarely or lethal human disease
which preventive or
This group includes a list serious and for which for which preventive or
therapeutic
of animal viral etiologic preventive or therapeutic therapeutic interventions
interventions are not
agents in common use. interventions are often may be available. These
usually available. These
These agents represent available. These agents agents represent a high
agents represent a high
no or little risk to an represent a moderate risk risk to an individual but a
risk to the individual
individual and no or little to an individual but a low low risk to the
and a high risk to the
risk to the community. risk to the community. community.
community.
Categories of Laboratory Biosafety
According to Levels
• Center for Disease and Control categorizes your
laboratories into four biosafety levels:
• Biosafety Level 1
• Biosafety Level 2
• Biosafety Level 3
• Biosafety Level 4
• Designation of levels are based on operational procedures
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
Categories of Laboratory Biosafety
According to Levels
Biosafety Level 1
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. 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 laboratories that require basic laboratory
safety practices, safety equipment, and facility design that requires basic
level of containment.
Categories of Laboratory Biosafety
According to Levels
Biosafety Level 2
It 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 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. Handwashing sinks and waste
decontamination facilities must be available and access to the laboraoty
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.
Categories of Laboratory Biosafety
According to Levels
Biosafety Level 3
It puts 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 and potentially
lethal infection are being conducted here. Examples of microorganisms
handled here are Mycobacterium tuberculosis, St. Louis Encephalitis
virus, and Coxiella. All laboratory activities are required to be performed
in a biosafety cabinet or other containment equipment like a gas-tight
aerosol generation chamber. Secondary barriers for this level are highly
required including 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 in a BSL-3
laboratory.
Categories of Laboratory Biosafety
According to Levels
Biosafety Level 4
It is required for work with dangerous and exotic agents that pose high
individual risks for life-threatening diseases that may be transmitted via
aerosol rout, 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. 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. A BSL-4 laboratory is generally
a separate building or completely isolated zone with specialized
ventilation requirements and waste management systems. 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.
Categories of Laboratory Biosafety
According to Levels
Thank you!