Basic concepts on laboratory biosafety and biosecurity

History of laboratory biosafety

❖ Laboratory biosafety and biosecurity traces its history in North America
and Western Europe.
❖ Began in 1943, biosafety is rooted in the US biological weapons program,
and was ordered by president Franklin Roosevelt.
❖ President Richard Nixon eventually terminated it in 1969
❖ In 1943, Ira L. Baldwin - became the first scientific director of the Camp
Detrick(Fort Detrick).
❖ 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
❖ 1907 and 1908, Arnold Wedum – described the use of mechanical pipettors to
prevent laboratory –acquired infections.
- moreover, ventilated cabinets, early progenitors to the nearly ubiquitous
engineered control now known as the biological safety cabinet, were first
documented outside of the US biological weapons programs.
❖ in 1909, a pharmaceutical company in Pennsylvania developed a ventilated
cabinet to prevent infection from mycobacterium tuberculosis.
❖ Biosafety practices worldwide were raised during the height of increasing
mortality and morbidity due to small pox in 1967.
❖ In 1974, CDC published the Classification of Etiological Agents on the Basis of
Hazard, that introduced the concepts of establishing ascending levels of
containment associated with risk in handling of groups of infectious
microorganism that present similar characteristics.
❖ The National Institute of Health of US published the NIH Guidelines for Research
Involving Recombinant DNA Molecules, it explained in detail the microbiological
practices, equipment's, and facility necessarily corresponding to four ascending
levels of physical containment.
❖ 1983- WHO’s first edition of Laboratory Biosafety manual.
❖ 1984- NIH’s jointly-published first 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 risk to human health
❖ Biosafety Levels – are the technical means of mitigating the risk of accident
infection from or release of agents in the laboratory setting as well as the
community and environment it is situated in.
❖ Biosafety levels are concentrated in a combination of engineered controls,
administrative controls, and practices, the emphasis is clearly on the equipment
and facility controls, with little attention given to risk assessment.
❖ This progress in Biosafety practice continued until the emergence of a
community of “Biosafety Officers” who adopted the administrative role of
ensuring the proper equipment and facility controls are in place based on the
specified biosafety level of the laboratory.
❖ Arnold Wedum was recognized as one of the pioneers of biosafety that provided
the foundation for evaluating the risk of handling infectious microorganism and
for recognizing biological hazards and developing practices, equipment's, and
facility safeguards for their control.
❖ 1996 – US government enacted the Selected Agent Regulations to monitor the
transfer of a select list of biological agents from one facility to another.
❖ The revision of the Selected Agent Regulations in 2012 sought to address the
creation of two tiers of select agents.

⦿ HISTORY OF LABORATORY BIOSECURITY

❖ TIER 1 AGENTS
- are materials that pose the greatest risk of deliberate misuse, and the
remaining selected agents. This change was intended to make the regulations
more risk-based, mandating additional security measures for Tier 1 Agents.
❖ prescribed biosecurity regulations for bioscience facilities.
A. Singapore – Biological Agent and Toxic act, similar in scope with the US
regulations but with more severe penalties for non compliance.
B. South Korea – Act on Prevention of Infectious Disease, was amended to
require institutions that work with listed “highly dangerous pathogens” to
implement laboratory safety and biosecurity requirements to prevent the
loss, theft, diversion, release or misuse of these agents.
C. Japan – Infectious Disease Control Law, it established four schedules of select
agents that are subject to different reporting and handling requirements or
possession, transport, and other activities
D. Canada – Canadian containment level (CL) 3 and 4 facilities that work with risk
group 3 and 4 are required to undergo certification.
E. Danish – 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.

⦿ GUIDELINES ON LABORATORY BIOSAFETY AND BIOSECURITY

❖ WHO in 1983, published its 3rd edition of Laboratory Safety Manual. Its include
the different levels of containment laboratories (Biosafety 1-4), different biological
safety cabinets, good microbiological techniques, and how to disinfect and
sterilize equipment.
❖ in terms of Biosecurity, it covers the packing required by inter national transport
regulations and other types of safety procedure chemical, electrical, ionizing
radiation, and fire hazard.
❖ The 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 in the field of safe
transfer, handling, and use of living modified organisms (LMOs) resulting from
modern biotechnology”.
❖ The new National Committee on Biosafety of the Philippines (NCBP),
established under E.O. 430 series of 1990 was formed on the advocacy efforts of
the scientist.
❖ NCBP focuses on the organizational structure for biosafety:
o procedures for evaluation of proposal with biosafety concerns
o Procedures and guidelines in the introduction, movement, and filed release of
regulated materials,..
o Procedure on physico-chemical and biological containment.
❖ March 17, 2006, Office of the President promulgated E.O. 514 establishing the
National Biosafety Frame work.