PMLS Biosafety and Biosecurity 1
Pre-Finals Prof Pangan
Definitions
LABORATORY BIOSAFETY
 Containment principles, tech and practices
implemented to prevent unintentional exposure
to pathogens.
 PROTECTING PEOPLE FROM DANGEROUS
PATHOGENS
LABORATORY BIOSECURITY
 Institutional and personal security measures
designed to prevent the loss, theft, misuse,
diversion, or intentional release of pathogens.
 PROTECTING PATHOGENS FROM
DANGEROUS PEOPLE
History of Biosafety
1943
 Origin of biosafety is rooted from US biological
weapons program ordered by President
Franklin Roosevelt
 Ira L. Baldwin became the first scientific
director of Camp Detrick.
 Scientists converge at Camp Detrick to develop
defenses
 The research program pioneered the laboratory
facility designs, equipment and procedures used
for infectious disease research
 Camp Detrick was named after a US ARMY
flight surgeon during WW1, Frederick Louis
Detrick
1949
 A unique laboratory in Camp Detrick was used
to test the dispersal of biological agents in
aerosol
1950
 Experimentation/study of the dispersal of
biological agents in aerosol becomes a concern
prompting the army surgeon general to appoint a
medical liaison officer in biological warfare
laboratories
1953
 Medical defense research against biological
weapons was conducted by the ARMY
chemical corps and the ARMY medical unit.
Batch 2025
1969
 The biological weapons program was then
terminated by President Richard Nixon
AFTER WW2
 Camp Detrick was designated as a permanent
installation for biological research and
development
 Biosafety was an inherent component of
biological weapons development
Milestones
1907-1908
 Arnold Wedum described the use of
mechanical pipettors to prevent laboratory
acquired infections; these mechanical pipettors
replaced mouth pipetting.
 Ventilated cabinets/Biological safety cabinets
were first documented outside the US biological
weapons program
1909
 Pharmaceutical company in Pennsylvania
developed a ventilated cabinet to prevent
mycobacterium tuberculosis.
1944
 Arnold Wedum is recognized as a pioneer of
biosafety, who provided the foundation for
evaluating risks of handling infectious
microorganisms and recognition of biological
hazards
1966
 Wedum and microbiologist Morton Reitman
analyzed multiple epidemiological studies of
laboratory-based outbreaks among
laboratory workers
1967
 Smallpox era, WHO pursued the eradication of
the virus
 Consolidation of remaining virus stocks into 2
locations: US Center for Disease control and
Prevention (CDC), and Russia State Research
Center of Virology and Biotechnology
(VECTOR)
 PMLS Biosafety and Biosecurity 1
Pre-Finals Prof Pangan
1974
 CDC published the Classification of Etiological
Agents on the Basis of Hazard, introduces the
concept of ascending levels of containment
1976
 US NIH published the NIH Guidelines for
Research involving Recombinant DNA
Molecules
1983
 WHO’s 1st edition of the LABORATORY
BIOSAFETY MANUAL
1984
 CDC & NIH’s jointly published 1st edition of the
BIOSAFETY IN MICROBIOLOGICAL
AND BIOMEDICAL LABORATORIES
 These documents established the model of
biosafety containment levels with certain agents
which increased the biosafety levels for
biological agents that pose risks to human
health.
 BIOSAFETY OFFICERS, the administrative
role that ensures proper equipment and facility
control.
 American Biological Safety Association
(ABSA) was found which aims to promote
biosafety as the scientific discipline and serve
the growing needs of biosafety professionals;
one of the first associations founded for
biological safety and security.
History of Biosecurity
1996
 US government enacted the Select Agent
Regulations to monitor the transfer of a select
list of biological agents from one facility to
another
2001
 Anthrax attack in US (Amerithrax); after this
attack, the US government changed its
perspective and caused the revision of the the
Select Agent Regulations; Bacillus anthracis
was used in the attack.
Batch 2025
 spores of Bacillus anthracis was mailed in some
of the senators, where inhalation=pulmonary
anthrax
 The revision required specific security
measures for any facility, and a longer list of
agents.
2012
 Revision of the Select Agent Regulations sought
to address the creation of 2 tiers of select
agents.
 Tier1-greatest risk of deliberate misuse
 Tier2-remaining select agents
 This change was intended to make the
regulations more risk-based, mandating
additional security measures for Tier 1 agents.
Biosecurity Regulations in
other countries
SINGAPORE (2005)
 Biological Agents and Toxins Act-similar
scope with the US regulation but with more
severe penalties
SOUTH KOREA (2005)
 Act on Prevention of Infectious Diseases-
require institutions that work with listed “highly
dangerous pathogens” to implement laboratory
biosafety and biosecurity requirements.
JAPAN
 Infectious Disease Control Law-it established
four schedules of select agents that are subject
to different reporting and handling
requirements
CANADA
 Canadian containment level CL 3 and CL4
that work with risk group 3 or 4 requires
certification.
DENMARK
 Passed a law that gives the Minister of
Health and Prevention the authority to
regulate listed biological agents
 PMLS Biosafety and Biosecurity 1
Pre-Finals Prof Pangan Batch 2025

Local and International

Guidelines
1983
 WHO published its 3rd edition of the
Laboratory Biosafety Manual; to address
concerns on biosafety guidance

2003
 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 use of living modified organisms (LMO),
which applies to 168 member-countries.

February 2008
 Comite European De Normalisation (CEN)- a
European committee for standardization
published the CEN Workshop Agreement
15793 (CWA 15793), which focuses on
laboratory biorisk management ; the
workshop offers mechanism where stakeholders
can develop consensus standards and
requirements in an open process
 CWA 15793 was developed among experts from
24 countries, and was later updated in 2011

1990
 National Committee on Biosafety of the
Philippines (NCBP)-established under E.O.
430 series of 1990; Focuses on the
organizational structure for biosafety

2006
 March 17,2006-E.O. 514 was promulgated
establishing the National Biosafety Framework
(NBF), which prescribes the guidelines for its
implementation and strengthening the National
Committee on Biosafety of the Philippines

2007
 DOH Administrative Order No. 2007-0027-
requires clinical laboratories to ensure policy
guidelines on laboratory biosafety and
biosecurity