SMLS – Department of Medical Laboratory Science

Principles of Medical Laboratory Science Practice 1

PRELIMS, 1st Semester, A.Y. 2023-2024
Handout for Chapter 6 – Biosafety, Biosecurity and Biorisk Management

HISTORY OF BIOSAFETY AND BIOSECURITY INTERNATIONAL GUIDELINES FOR BIOSAFETY AND

Biological weapons BIOSECURITY
 Biological weapons was used as early as medieval  February 2008 – Comite Europeen de Normalisation
times. (CEN) published the CEN Workshop Agreement
 During World War II, various pathogens that causes 15793 (CWA 15793) offered mechanism where
diseases such as plague, cholera, anthrax, glanders stakeholders can develop consensus standards and
were used to kill people. requirements.
 Cannot enforce biorisk management, meaning
Franklin Roosevelt conformity is voluntary.
 Ordered biosafety program in case of an attack.
Active from the start of World War II up to Cold War.  Laboratory Safety Manual – WHO’s 3rd edition of
 Ira L. Baldwin – first director of Camp Detrick. Laboratory Biosafety Manual includes different levels
Established biological weapons program for defensive of containment laboratories (Biosafety Level 1-4),
purposes. different types of biological safety cabinets, good
 Fort Detrick – biological research and development. microbiological techniques and how to disinfect and
Newell A. Johnson designed modification for sterilize equipments.
biosafety such as development of Biosafety Cabinet  Puts emphasis on continuous monitoring and
Class III and laminar flow, addressing specific improvement directed by biosafety officer
biological risks. and the committee.

American Biological Safety Association (ABSA)  Cartegena Protocol on Biosafety (CPB) – regulatory
 Founded in 1984. Promotes biosafety as a scientific framework to ensure “an adequate level of protection
discipline and serve the growing needs of biosafety in the field of safe transfer, handling and use of living
professionals throughout the world. modified organism resulting from modern
biotechnology.”
Center For Disease Control and Prevention (CDC)
 One of the two centers together with State Research BIOSECURITY IN PHILIPPINES
Center of Virology and Biotechnology VECTOR (Russia)  National Committee on Biosafety of the Philippines
to contain the remaining smallpox virus stocks. (NCBP 1990) – focuses on organization structure for
 Established ascending containment levels in handling biosafety:
pathological agents.  procedure for evaluation of proposals with
biosafety concerns;
National Institutes of Health (NIH)  Procedures and guidelines on the introduction,
 1976 – explained in detail the microbiological movement and field release of regulated
practices, equipment and facility necessarily materials; and
corresponding to four ascending levels of physical  Procedures on physicochemical and biological
containment. containment.
 Together with CDC, they publish the first edition of  National Biosafety Framework (NBF) – aligned with
Biosafety in Microbiological and Biomedical CPB. Expansion of NCBP,
Laboratories, marking the development of practice of  Department of Agriculture Administrative Order No. 8
laboratory biosafety. – set policies on importation and release of plants and
products derived from modern biotechnology
2001 Anthrax Attack  DOH Administrative Order No. 2007-0027 – requires
 Also known as “Amerithrax” – anonymous letters sent clinical laboratories to ensure policy guidelines on
to politicians and newspaper outlets containing spores laboratory biosafety and biosecurity.
of Bacillus anthracis, the causative agent of anthrax.
 5 people died with several others infected due to this DIFFERENT ORGANIZATIONS IN THE FIELD OF BIOSAFETY
terrorist attack. AND BIOSECURITY
 American Biological Safety Association – society that
BIOSECURITY LAWS promotes biosafety as a scientific discipline and
 Revised Select Agent Regulations (USA) provides guidance to its members on the regulatory
 Biological Agents and Toxins Act (Singapore) regime present in North America
 Act on Prevention of Infectious Diseases (South Korea)  Asia Pacific Biosafety Association
 Infectious Disease Control Law (Japan)  European Biological Safety Association
 Philippine Biosafety and Biosecurity Association –
multidisciplinary team with members coming from
 SMLS – Department of Medical Laboratory Science

Principles of Medical Laboratory Science Practice 1

PRELIMS, 1st Semester, A.Y. 2023-2024
Handout for Chapter 6 – Biosafety, Biosecurity and Biorisk Management

health and education sectors as well as from the  Characterize the risks – compare the
government. A long term goal of the association is to likelihood and consequence qualitatively or
assist DA and DOH in their efforts to create a national quantitatively.
policy and implement plan for laboratory biosafety  Determine if risks are acceptable or not –
and biosecurity. taking into account the availability of
 Biological Risk Association Philippines – non- controls whether a risk can be accepted
government and non-profit organization (with tagline (within the acceptable level), to be reduced
AMM – assess, mitigate, monitor) (reduce the probability of the risk by
improving the controls), to be transferred
BIOSAFETY (transfer the responsibility of the risk to a 3rd
 Aims to protect public health and environment from party) or to be avoided (eliminate the cause
accidental exposure to biological agents. of the risk).
 Containment principles, technologies and practices.
MITIGATION PROCEDURES
BIOSECURITY  Actions and controls that are put into place to reduce
 Deals with the prevention of misuse through theft, loss, or eliminate the risks associated with biological
diversion or intentional release of pathogens, toxins or agents.
any other biological material  Elimination involves total removal or avoidance to a
 Protection, control and accountability biological agent which poses the highest degree of
risk reduction.
BIORISK MANAGEMENT  Substitution – replacement of the procedures or
 Actions and controls integrated to manage threats and hazards to reduce the risk
hazards when working with biological toxins and  Engineering controls – includes physical changes in
infectious agents. work stations in order to isolate the workers from the
hazard – this includes biosafety cabinets, autoclaves,
BIOHAZARD SYMBOL ventilations, negative pressure rooms,
 Created by Charles Baldwin, used to label biological decontamination cubicles or air treatment systems.
materials carrying significant health risks.  Administrative controls – refers to the policies,
standards and guidelines used to control the risks.
BIORISK MANAGEMENT Implementation of laboratory safety guidelines
 System to control safety and security risks associated belongs to this type of controls.
with the handling or storage and disposal of  PPE – devices worn to protect against biohazards,
biological agents and toxins in the laboratory. chemical and toxic hazards.
 3 Components of biorisk management:
 Assessment PERFORMANCE EVALUATION
 Mitigation  Involves monitoring of the mitigation measures
 Performance effectiveness (effective, ineffective or unnecessary).
 Reevaluation of the overall mitigation strategy.
RISK ASSESSMENT Performance evaluation also provides direction for
 Identification of hazards (threats and weaknesses) top-management and decision makers to be able to
that may cause harm. come up with reasonable and justifiable biosafety
 Risk is the possibility that something bad may occur. guidelines. Performance evaluation should be
 Likelihood – the probability of the risk performed to be able to provide a clear manifestation
occurring
of implementing the fundamental concept of biosafety
 Consequence – the severity of the impact
the risk may cause and biosecurity in the laboratory.
 Example: A presence of needle in the laboratory is a
hazard. The risk it may pose is that if someone uses it,
there can be a damage that may occur.
 Identification
 Define the situation – identification of the
hazard and at-risk hosts.
 Define the risks – how hosts may be
exposed to hazards