Basic Concepts on

Laboratory Biosafety
and Biosecurity
 Brief History of Laboratory Biosafety
 Traces its history in North America and Western Europe
 Its origin was ordered by US President Franklin Roosevelt and is rooted in the
US biological weapons program in 1943; active during the Cold War.
 Terminated by US President Richard Nixon in 1969

Former US President Former US President

Franklin D. Roosevelt Richard Milhous Nixon
(1882 – 1945) (1913 – 1994)

https://www.biography.com/us- https://en.wikipedia.org/wiki/Richard_Nixo
president/franklin-d-roosevelt n
Brief History of Laboratory Biosafety
 In 1943, the first scientific director of Camp Detrick (which eventually
became Fort Detrick), Ira L. Baldwin, was tasked to establish a biological
weapons program for defense purpose to enable the US to respond to if
attacked by biological weapons.
 Camp Detrick was designated a permanent installation for biological research
and development after the Second World War.

http://shipseducation.net/pesticid
es/baldwin.htm

https://en.wikipedia.org/wiki/United_States_Army_Biologi http://operationwhitecoatmovie.com/archive/usamriid/ind
cal_Warfare_Laboratories ex.html
Brief History of Laboratory Biosafety
 Newell A. Johnson designed modifications for biosafety at Camp Detrick. He
developed specific technical solutions such as Class III safety cabinets and
laminar flow hoods to address specific risks.
 In 1984, American Biological Safety Association (ABSA) was formed which held
annual meetings which became the ABSA annual conference.

http://www
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Brief History of Laboratory Biosafety
 Arnold Wedum, a contributor outside the US, described the use of mechanical
pipettors to prevent laboratory acquired infections.
 Other contributions outside of the US biological weapons program were the
ventilated cabinets, early progenitors of the biological safety cabinet.
 A pharmaceutical company in Pennsylvania developed a ventilated cabinet to
prevent infection form Mycobacterium tuberculosis in 1909.

https://cmr.asm.org/content/cmr/4/ https://cmr.asm.org/content/cmr/4/2/207.full.pdf
2/207.full.pdf
Brief History of Laboratory Biosafety
 Mortality and morbidity due to smallpox escalated in 1967.
 During this time, serious concerns about biosafety practice worldwide were
raised, which led to the decision of the World Health Assembly to consolidate
the remaining virus stocks into two locations:
 the Center for Disease Control and Prevention (CDC) in the US http://news.bbc.co.uk/2/hi/health/4638938.stm

 State Research Center of Virology and Bacteriology VECTOR (SRCBV VECTOR) in

Russia
 The concept of establishing ascending levels of containment associated with
risks in handling groups of microorganisms that present similar characteristics
was introduced by the CDC through the publication of Classification of
Etiological Agents on the Basis of Hazard. https://www.google.com/url?sa=i
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Brief History of Laboratory Biosafety
 The National Institutes of Health (NIH) of the US published the NIH Guidelines
for Research Involving Recombinant DNA molecules in 1976 which explained in
details the microbiological practices, equipment, and facility necessarily
corresponding to four ascending levels of physical containment.
 The development of the practice of laboratory safety was marked by the
introduction of a code of biosafety practice together 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).
 Biosafety officers 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.

https://www.oie.int/eng/BIOTHREAT2017/P
resentations/5.1_KOJIMA-presentation.pdf
Brief History of Laboratory Biosafety
 In 1944, Arnold Wedum, director of Industrial Health and Safety at the US
Army Biological Research Laboratories, was recognized as one of the pioneers
of biosafety that provided the foundation for evaluating the risk of handling
infectious microorganisms and for recognizing biological hazards and
developing practices, equipment, and facility safeguards for their control.
 In 1966, Wedum and a colleague, microbiologist Morton Reitman, analyzed
multiple epidemiological studies of laboratory-based outbreaks.
Brief History of Laboratory Biosecurity
 In 1996, the Select Agent Regulations was enacted by the US government to
monitor the transfer of a select list of biological agents from one facility to
another.
 Terrorist attacks and anthrax attacks, known as Amerithrax, escalated in the US in
2001 which made the US government change the perspective of the Select Agent
Regulations.
 The revised Select Agents regulations required specific security measures for any
facility in the US that use or stored one or more agents on the new, longer list of
agents.
 The revision of the Select Agent Regulations in 2012 sought to address the
creation of two tiers of select agents:
 Tier 1 agents – materials that pose the great risk of deliberate misuse
 And the remaining select agents https://www.bizarrepedia.com/anthrax/
Brief History of Laboratory Biosecurity
 Other countries relatively implemented and prescribed biosecurity regulations for
bioscience facilities:
 Singapore’s Biological Agents and Toxins Act is similar to the US regulations but with
more severe penalties for noncompliance.
 South Korea’s amended Act on Prevention of Infectious Diseases in 2005 required
institutions that work with the listed “highly dangerous pathogens” to implement
laboratory biosafety and biosecurity requirements.
 Japan’s Infectious Disease Control Law was recently amended under Japan’s Ministry of
Health, Labor and Welfare which established four schedules of select agents that are
subject to different reporting and handling requirements for possession, transport and
other activities.
 Canadian containment level (CL) 3 and CL 4 facilities that work with risk group 3 and 4
are required to undergo certification.
 The Danish Parliament passed a law in 2008 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.
Local and International Guidelines on
Laboratory Biosafety and Biosecurity
 The Comité Europeén de Normalisation (CEN), a European Committee
on Standardisation, published the CEN Workshop Agreement 15793 in
2009 which focuses on laboratory biorisk management.
 The CWA 15793 was 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 the CWA 15793 originated in the European workshop
agreement framework, confusion among countries outside Europe
arose especially in the US in terms of its applicability.
 CWA 15793 expired in 2014.
Local and International Guidelines on
Laboratory Biosafety and Biosecurity
 The WHO published its 3rd edition of Laboratory Biosafety Manual in 1983 to
address concerns on biosafety guidance for research and health laboratories,
issues on risk assessment and guidance to commission and certify
laboratories; which contains information on the following:
 Different levels of containment laboratories (Biosafety levels 1-4), biological safety
cabinets, good microbiological techniques, and how to disinfect and sterilized
equipment
 In terms of biosecurity, the 3rd edition of Laboratory Biosafety Manual covers
the packaging required by international transport regulations and other types
of safety procedures for chemical, electrical, ionizing radiation, and fire
hazards. https://www.amazon.com/dp/9241546506/re
f=rdr_ext_tmb

https://www.medbox.org/lab
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Local and International Guidelines on
Laboratory Biosafety and Biosecurity
 Made effective in 2003, the Cartagena Protocol on Biosafety (CPB) provides
an international regulatory framework to “ensure an adequate level of
protection in the field of safe transfer, handling, and the use of living
modified organisms (LMOs) resulting from modern biotechnology.”
 Established under Executive Order 430 series of 1990, the new National
Committee on Biosafety in the Philippines (NCBP) was formed on the advocacy
efforts of scientists.
 The mandate of NCBP focuses on the organizational structure for biosafety:
procedures for evaluation of proposals with biosafety concerns; procedures and https://bch.cbd.int/protocol/10thAnniversa
ry.shtml
guidelines for the introduction, movement and field release of regulated materials;
and procedures on physico-chemical biological continment.

http://www.ncbp.dost.gov.ph/component/content/archive
Local and International Guidelines on
Laboratory Biosafety and Biosecurity
 The Office of the President promulgated E.O. 514 on March 17, 2006, establishing
the National Biosafety Framework (NBF) which prescribes the guidelines for its
implementation, strengthening the NCBP.
 The NBF is a combination of policy, legal, administrative, and technical instruments
developed to attain the objective of the Cartagena Protocol on Biosafety which in the
Philippines signed on May 24, 2000.
 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.
 DOH Administrative Order No. 2007-0027 – requires clinical laboratories to ensure
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 http://www.newmaker.com/company-
on the regulatory regime present in North America 3940-American-Biological-Safety-
Association-(ABSA).html

 Asia-Pacific Biosafety Association (A-PBA)

 Founded in 2005; acts as a professional society for biosafety professionals in the
Asia-Pacific region
https://a-pba.org/
 active members of the International Biosafety Working Group are required to
directly contribute to the development of the best biosafety practices
 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
https://ebsaweb.eu/
Different Organizations in 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
https://www.psmls.org.ph/partners-
 its long term goal is to assist the DA and DOH in their efforts to create a national policy sponsors/philippine-biosafety-and-
biosecurity-association
and implement plan for laboratory biosafety and biosecurity
 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” https://bioriskassociationphilippines.org/1s
t-brap-annual-convention/
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 2006, the WHO referred to biosecurity as “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.”
 By simple definition, “biosafety protects people from germs” while
“biosecurity protects germs from people.”
Fundamental Concepts of Laboratory
Biosafety and Biosecurity
 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 in
1966.
 Biosafety focuses on laboratory procedures and practices necessary to prevent
exposure to and acquisition of infections.
 Biosecurity focuses on the maintenance of secure procedures and practices in
handling biological materials and sensitive information.
Classifications of Microorganisms
According to Risk Group
RG 1 RG 2 RG 3 RG 4
Agents that are not Agents that are Agents that are Agents that are
associated with associated with associated with likely to cause
disease in healthy human disease serious or lethal serious or lethal
adult humans. This which is rarely human disease for human disease for
group includes a list serious and for which preventive which preventive
of animal viral which preventive or therapeutic or therapeutic
etiologic agents in or therapeutic interventions may interventions are
common use. These interventions are be available. These not usually
agents represent no often available. agents represent a available. These
or little risk to an These agents high risk to an agents represent a
individual and no or represent a individual but a low high risk to the
little risk to the moderate risk to an risk to the individual and a high
community. individual but a low community. risk to the
risk to the community.
community.
Categories of Laboratory Biosafety
According to Levels
References

 Benitez, P. A., Dumaoal, O. S. R., Estrella, F. P., Mortel, F. A., Nava, M. R. G.,
(2019) Principles of Medical Laboratory Science 1. Philippines, Quezon City: C
& E Publishing, Inc.
 (December 2009) Biosafety in Microbiological and Biomedical Laboratories.
(5th Ed.) US Department of Health and Human Services, Public Health Service,
Centers for Disease Control and Prevention, National Institutes of Health.