Module 6 Reviewer: Biosafety & Biosecurity

I. Definitions
• Biosafety:
o Idea: Protecting people and the environment from germs.
o Definition: "The containment principles, technologies, and practices that are implemented to
prevent unintentional exposure to pathogens and toxins, or their accidental release."
o Focus: Procedures, Practices, and Containment equipment to prevent accidental infection or
release.
• Biosecurity:
o Idea: Protecting germs from people.
o Definition: "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."
o Focus: Security protocols, access controls, and inventory systems to prevent intentional misuse
or theft.
In Summary: Biosafety focuses on accidents while Biosecurity focuses on intent.
II. History of Laboratory Biosafety
• 1900s - Early Precursors:
o Arnold Wedum: described the use of mechanical pipettors to prevent lab-acquired infections
(1907-1908).
o 1909: The first ventilated cabinet (a progenitor to the biosafety cabinet) was developed in
Pennsylvania to prevent M. tuberculosis infection.
• 1940s - Origins at Camp Detrick (Fort Detrick):
o The US biological weapons program in 1943, which was active during the Cold War is a major
catalyst.
o Ira L. Baldwin: First scientific director; established the scientific foundation.
o Newell A. Johnson: Designed early biosafety modifications and equipment for the facility.
o Arnold Wedum (Director of Industrial Health & Safety, 1944): Founding figure. His key
contributions were:
1. Systematic Risk Evaluation: Created the framework for assessing the dangers of
handling infectious microbes.
2. Formal Hazard Recognition: Defined biological hazards within lab workflows.
3. Development of Safeguards: Engineered the specific practices, equipment (like
mechanical pipettors), and facility controls needed for containment.
4. Epidemiological Analysis: With Morton Reitman, he analyzed lab-based outbreaks,
providing data-driven insights into how lab-acquired infections occur.
O Post World War II, it was designated as a permanent installation for biological research and
development
• 1966:
o Charles Baldwin created the universal biohazard symbol for labeling biological materials
carrying significant health risks.
o Arnold Wedum and Morton Reitman analyzed multiple epidemiological studies of laboratory-
based outbreaks.
• 1967: Due to an increased morbidity and mortality due to smallpox, WHO aggressively pursued the
eradication of the virus.
o TWO Remaining Locations of Smallpox:
• CDC in the US and State Research Center of Virology
• Biotechnology VECTOR in Russia
• 1969: The US biological weapons program was terminated by President Richard Nixon.
• 1970s - 1980s - Guidelines:
o 1974: CDC published "Classification of Etiological Agents on the Basis of Hazard."
o 1976: NIH published "NIH Guidelines for Research Involving Recombinant DNA Molecules,"
laying the foundation for biosafety codes of practice.
o 1983 & 1984: Publication of the WHO Laboratory Biosafety Manual (1983) and the NIH's
"Biosafety in Microbiological and Biomedical Laboratories (BMBL)"(1984) marked the formal
development of laboratory safety as a standard practice.

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 o 1984: Founding of the American Biological Safety Association (ABSA), signifying the recognition
of biosafety as a distinct scientific discipline.

• The Role of the Biosafety Officer:

o A designated professional who ensures that the proper equipment and facility controls are in
place based on the laboratory's specified biosafety level.
o Works with an institutional Biosafety Committee to foster a culture of continuous monitoring
and improvement.

III. History of Laboratory Biosecurity

While security was always a concern, specific regulations intensified after key events.
• 1996: U.S. Select Agent Regulations were enacted.
• 2001: The Anthrax Attacks (Amerithrax):
o Terrorist attacks using anthrax spores sent through the mail prompted a major revision and
expansion of biosecurity regulations.
o The Select Agent Regulations were strengthened, requiring specific security measures for
facilities handling dangerous agents and creating a longer list of controlled agents.
• 2012: The Select Agent Regulations were revised again, creating a "Tier 1" category for agents that pose
the greatest risk of deliberate misuse.
• International Legislation:
o Singapore: Biological Agents and Toxins Act.
o South Korea: Act on Prevention of Infectious Diseases (2005).
o Japan: Infectious Disease Control Law.
o Canada: Certification of Canadian containment level CL3 and CL4
o Denmark: Authorization for the Minister of Health and Prevention to regulate the possession,
manufacture, use, storage, sale, purchase or transport and disposal of listed biological agents.
IV. Local and International Guidelines
I. International Guidelines & Agreements
1. CEN Workshop Agreement 15793 (CWA 15793)
• Published By: Comité Européen de Normalisation (CEN) in February 2008.
• Focus: To provide a standardized framework for Laboratory Biorisk Management (LBM).
Combines biosafety and biosecurity under one management umbrella.
• Key Features:
o Established a mechanism for stakeholders to develop consensus standards through an
open process.
o It was updated in 2011 to set out performance-based requirements for maintaining a
biorisk management system.
o It did not provide guidance for implementing a national-level biosafety system.
• Current Status: Officially expired in 2014 and is no longer in active use.
o Foundation for the concept of integrated biorisk management.
2. WHO Laboratory Biosafety Manual (3rd Edition)
• Published By: World Health Organization (WHO) in 1983.
• Primary Purpose: To provide essential biosafety guidance for research and clinical health
laboratories worldwide. It addresses critical issues of risk assessment and provides standards to
commission and certify laboratories.
• Key Features:
o Emphasizes a culture of continuous monitoring and improvement.
o This process is directed by two key roles:
1. A designated Biosafety Officer.
2. An institutional Biosafety Committee.
• Important Note: The manual provides guidance, not enforcement. It is a non-binding set of
recommendations. It lacks a formal mechanism to ensure adherence to its guidelines or to
guarantee that laboratory personnel are adequately trained.
3. Cartagena Protocol on Biosafety (CPB)
• Effective Since: 2003.
• Scope: An international treaty with 173 member countries (as of the document).

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 • Primary Objective: To establish an international regulatory framework for ensuring the
safe transfer, handling, and use of Living Modified Organisms (LMOs) resulting from modern
biotechnology.
• Key Focus:
o Provides a framework for the risk assessment of LMOs.
o Aims to ensure that LMOs do not have negative effects on biological diversity and human
health.
II. Philippine National Guidelines & Frameworks
1. National Committee on Biosafety of the Philippines (NCBP)
• Established Under: Executive Order E.O. 430, series of 1990.
• Formation: Advocacy efforts of scientists.
• Core Mandate:
o Establishes the organizational structure for biosafety in the Philippines.
o Develops procedures for evaluating proposals with biosafety concerns.
o Provides guidelines for the introduction, movement, and field release of regulated
materials.
o Outlines procedures for physico-chemical and biological containment.
2. National Biosafety Framework (NBF)
• Established: March 17, 2006.
• Legal: Promulgated through E.O. 514 by the Office of the President.
• Function: Prescribes the guidelines for implementing the NCBP's mandate, thereby strengthening
it.
3. Administrative Order No. 8
• Issued By: The Department of Agriculture.
• Purpose: To set in place policies on the importation and release of plants and plant products
derived from modern biotechnology.
• Collaboration: The Department of Health (DOH), together with the NCBP, formulated guidelines
for assessing the impact on health posed by modern biotechnology and its applications.
V. Key Organizations in Biosafety
• American Biological Safety Association (ABSA): Founded in 1984; a professional society that promoted
biosafety as a scientific discipline.
• Asia-Pacific Biosafety Association (A-PBA): Founded in 2005; serves as a professional society for
biosafety professionals in the Asia-Pacific region.
• With members from:
• Singapore • Malaysia
• Brunei • Thailand
• China • Philippines
• Indonesia • Myanmar
• European Biological Safety Association (EBSA): A non-profit founded in 1996 to represent those in the
field of biosafety in Europe.
• Philippine Biosafety and Biosecurity Association (PhBBA): Distinct for its multi-sectoral and multi-
disciplinary composition, including representatives from health, education, and the executive, legislative,
and judicial branches of government. It includes members of the steering committee for the National
Laboratory Biosafety and Biosecurity Action Plan.
• Biological Risk Association Philippines (BRAP): A non-government organization focused on biological
risk management across health, agriculture, and technology. Its tagline is "assess, mitigate, monitor."

VI. Classification of Microorganisms by Risk Group

This system categorizes agents based on their inherent pathogenicity and risk to the individual and
community.
• Risk Group 1 (RG1):
o Definition: Microorganisms that are unlikely to cause human or animal disease.
o Risk Level: Low individual and community risk.
o Examples: Bacillus subtilis, Naegleria gruberi, E. coli K-12, Saccharomyces cerevisiae.
• Risk Group 2 (RG2):
o Definition: Unlikely to be a significant risk; may cause infection but effective treatment and
preventive measures are available; risk of spread is limited.
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 o Risk Level: Moderate individual risk, limited community risk.
o Examples: Hepatitis B virus, HIV, Salmonella species, Toxoplasma.
• Risk Group 3 (RG3):
o Definition: Known to cause serious human or animal disease; presents a significant risk to
laboratory workers.
o Risk Level: High individual risk, limited to moderate community risk.
o Examples: Mycobacterium tuberculosis, Bacillus anthracis, Coxiella burnetii, St. Louis
encephalitis virus.
• Risk Group 4 (RG4):
o Definition: Known to produce life-threatening disease; readily transmissible; effective treatment
and preventive measures are not usually available.
o Risk Level: High individual and high community risk.
o Examples: Ebola virus, Marburg virus, Smallpox virus.

VII. Categorization of Laboratories by Biosafety Level (BSL)

BSLs define the minimum containment required for working with specific risk groups, combining lab
practices, safety equipment, and facility design.
• Biosafety Level 1 (BSL-1):
o Agents: RG1
o Most appropriate among undergraduate and secondary educational training and teaching
laboratories that require basic laboratory safety practices.
o Examples: Bacillus subtilis, Naegleria gruberi, non-pathogenic E. coli strains.
o Safety Equipment: Basic PPE
o Facilities: Basic laboratory bench and sink required.
• Biosafety Level 2 (BSL-2):
o Agents: RG2
o Appropriate when work is done with human blood, body fluids, tissues, or primary human
cell lines where there is uncertain presence of infectious agents.
o Examples: Hepatitis B virus, HIV, Salmonellae.
o Practices: BSL-1 plus limited access, biohazard warning signs, "sharps" precautions,
a biosafety manual defining waste decontamination and medical surveillance policies.
o Safety Equipment: Biosafety cabinets (BSCs); specific PPE (lab coats, gloves, face and eye
protection).
o Facilities: BSL-1 plus an autoclave available for waste decontamination.
• Biosafety Level 3 (BSL-3):
o Agents: RG3
o Primary and Secondary barriers in the protection
▪ All laboratory activities are required to be performed in a biosafety cabinet or other
containment equipment like a gas-tight aerosol generation chamber.
o Examples: Mycobacterium tuberculosis, Bacillus anthracis, Coxiella burnetii, SARS-CoV-1.
o Practices: BSL-2 plus controlled access, decontamination of all waste, decontamination of
laboratory clothing before laundering.
o Safety Equipment: BSCs or other physical containment devices used for ALL open
manipulations of agents; PPE includes protective lab clothing, gloves, and respiratory
protection as needed.
o Facilities: Physical separation from access corridors; self-closing, double-door
access; exhaust air not recirculated (negative airflow into lab); entry through airlock or
anteroom; handwashing sink near laboratory exit.
• Biosafety Level 4 (BSL-4):
o Agents: RG4
o For work with dangerous and exotic agents that pose high individual risks of life-threatening
diseases with no available vaccines or treatment.
o Examples: Ebola virus, Marburg virus, Smallpox virus.
o Practices: BSL-3 plus clothing change before entering, shower on exit, decontamination
of all materials on exit from the facility.
o Safety Equipment: All procedures conducted in a Class III BSC (a gas-tight
enclosure) OR using a full-body, air-supplied positive-pressure personnel suit.
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 o Facilities: A separate building or completely isolated zone; dedicated supply and exhaust,
vacuum, and decontamination systems; all other requirements outlined for maximum
containment.

This material was prepared with the assistance of AI for formatting and standardization. Kindly review your PPT and books for complete information.