PMLS MT 101. - Basic Concepts of Laboratory Biosafety and Biosecurity (LESSON 6)

North America and West Europe

Modern biosafety practices originated here as a response to increasing concerns regarding laboratory-acquired infections (LAIs) and safe handling of hazardous microorganisms

Laboratory-Acquired Infections

Laboratory professionals who routinely handle clinical specimens and infectious agents face occupational risks that may result to this

Laboratory-Acquired Infections

Led to the establishment of biosafety standards, engineering controls, and regulatory guidelines

1943

When was the U.S. Biological Weapons program established?

U.S. Biological weapons program

what was established in 1943

World War 2

The modern concept of laboratory biosafety began during __________

President Franklin D. Roosevelt

authorized the modern concept of laboratory biosafety

Camp Detrick (Fort Detrick)

primary research facility for biological warfare studies

Ira L. Baldwin

first scientific director of camp detrick and played a major role in organizing biological research and laboratory safety practices

Newell A. Johnson

introduced engineering controls that significantly improved laboratory safety (ie. Class 3 biological safety cabinet, laminar airflow systems)

Class 3 biological safety cabinet, laminar airflow systems

What did Newell A. Johnson introduce

1966

research on laboratory acquired infections

Arnold G. Wedum and Morton Reitman

conducted epidemiological investigations on laboraory acquired infections

Arnold G. Wedum and Morton Reitman

Their work identified common routed of occupational exposure ad highlighted the need for the standardized laboratory safety practices and risk assessment

1967

Global Smallpox Containment

World Health Assembly (WHA)

following concerns over smallpox infections, they restricted the storage of variola virus to only two high-security reference labs

Centers fir Disease Control and Prevention (CD), United States;

VECTOR state research of virology and biotechnology, Russia

The only two reference laboratories for the storage of variola virus

1969

Termination of the US biological waste program

President Richard Nixon

This president officially ended the US biological waste program, renouncing the development and production of biological weapons and redirecting research toward peaceful public health and biomedical purposes

1974

Classification of Etiological Agents

Centers for Disease control and prevention

introduced a classification system for infectious microorganisms based on their degree of hard to a laboratory personnel and the community

Classification of Etiologic Agents

This framework evolved into the current Risk Group Classification System

1976

NIH Recombinant DNA guidelines

National Institutes of Health (NIH)

published the NIH guidelines for research involving recombinant DNA molecules

NIH guidelines for research involving recombinant DNA molecules

provided comprehensive safety recommendations for laboratories oerfrming genetic engineering and recomninant DNA research

1983

First WHO Laboratory Biosafety Manual

World Health Organization

Released the first edition of the Laboratory Biosafety Manual, establishing internationally recognized biosafety principles, containment practices, and laboratory safety recommendations

Centers for Disease Control and Prevention;

National institutes of Health

jointly published the first edition of the Biosafety in Microbiological and Biomedical Laboratories

Biosafety in Microbiological and Biomedical Laboratories

Made by CDC and NIH, one of the most widely recognized references for Laboratory biosafety practices

American Biological Safety Association

established to promote biosafety education, professional development, and the advancement of biosafety practices worldwide

1907-1908

Promotion of mechanical pipetting

Arnold G. Wedum

strongly advocated replacing mouth pipetting with mechanical pipetting devices, reducing LAIs caused by accidental ingestion or inhalation of infectionous materials

1909

Development of the Ventilated Safety Cabinet

Pharmaceutical Company in Pennsylvania, USA

developed one of the earliest ventilated laboratory cabinets designed to protect laboratory personnel from exposure of Mycobacterium Tuberculosis and other airborne pathogens

Ventilated Laboratory Cabinet by company in Pennsylvania USA

- laid the foundation for modern biological safety cabinets

- prevented spread of mycobacterium tuberculosis

biosafety officers

- develop and implement biosafety programs

- conduct risk assessments

- ensure compliance

- monitor safety practices and procedures

- verify

Arnold G Wedum

the pioneer of modern laboratory biosafety

Arnold G Wedum

research established scientific principles of biological risk assessment and emphasized the importance of engineering controls, safety practices, and proper containment

Laboraotry Biosecurity

A set of protective measures designed to prevent loss, theft, misuse, or intentional release of dangerous biological agents.

Works in conjunction with biosafety,

Biosafety

focuses on preventing accidental exposure to pathogens.

1996

Select Agent Regulations

Select Agent Regulation

Established to monitor and control the transfer of high-risk biological agents.

Post-9/11 and Anthrax Attacks (Amerithrax)

Terrorism heightened awareness of biological threats.

U.S. tightened biosecurity policies and introduced stricter lab security

2001

Post-9/11 and Anthrax Attacks (Amerithrax)

2012

Two-Tier Agent Classification

Tier 1 Agents

Highest risk for intentional misuse (e.g., anthrax)

Other Agents

Regulated, but lower threat level

Singapore

Biological Agents and Toxins Act

Similar to U.S. laws but with harsher penalties for violations

South Korea (2005)

Amended Infectious Disease Law

Laboratories handling dangerous pathogens must follow biosafety and biosecurity standards.

Japan

Revised Infectious Disease Control Law

Introduced 4 schedules of select agents with specific handling rules

Canada

Laboratories working with Risk Group 3 & 4 agents must be certified at CL3 or CL4 containment levels.

Denmark (2008)

New law gave the Minister of Health authority to regulate:

Possession, transport, use, and disposal of dangerous biological agents.

February 2008

When did the European committee for standardization (CEN) release CEN workshop agreement 15793 (CWA 15793)

European committee for standardization (CEN)

WHo released the CEN workshop agreement 15793 (CWA 15793)

CEN workshop agreement 15793 (CWA 15793)

focuses on laboratory biorisk management

CEN workshop agreement 15793 (CWA 15793)

applicable internationally, not legally binding, voluntary

Argentina, Australia, Belgium, Canada, China, Denmark, Germany, Ghana, the UK, and the US

Enumerate the countries that agreed with the development of CWA 15793

2011

CWA 15793 was revised to promote a performance-based biorisk management system across organizations, excluding guidance for national biosafety frameworks.

1983

World Health Organization (WHO) published the 3rd edition of the Laboratory Biosafety Manual, advancing global biosafety standards.

2003

Cartagena Protocol on Biosafety came into effect, establishing an international framework among 168 member countries to ensure the safe handling and use of Living Modified Organisms (LMOs) from biotechnology.

National Committee on Biosafety of the Philippines (NCBP)

established under Executive Order No. 430 (1990), following strong advocacy by local scientists.

Executive Order No. 430 (1990)

National Committee on Biosafety of the Philippines (NCBP) is established under

March 17, 2006

Executive Order No. 514 was issued to implement the National Biosafety Framework (NBF), strengthening the role of the NCBP.

Executive Order No. 514 ; National Biosafety Framework (NBF)

On March 17, 2006, ___________ was issued to implement the ____________, strengthening the role of the NCBP.

National Biosafety Framework (NBF)

combines policy, legal, administrative, and technical tools aligned with the goals of the Cartagena Protocol

May 24, 2000

Philippines became a signatory of Cartagena Protocol on

National Biosafety Framework (NBF)

seen as an expansion of the NCBP and played a pioneering role in shaping the current national biosafety system.

Department of Agriculture ; Administrative Order No. 8

______________ issued ___________ to regulate the importation and release of biotech-derived plants and plant products.

Department of Health and NCPB

developed health risk assessment guidelines for modern biotechnology and its applications.

American Biological Safety Association (ABSA)

Promotes biosafety as a scientific field and guides members on biosafety regulations in the region.

Asia-Pacific Biosafety Association (A-PBA)

Serves as a professional network for biosafety practitioners; members help develop best practices.

2005

Asia-Pacific Biosafety Association (A-PBA) was established on

European Biological Safety Association (EBSA)

Provides a forum for discussion on biosafety issues and represents professionals in the field.

1996

European Biological Safety Association (EBSA) was established on

Philippine Biosafety and Biosecurity Association (PhBBA)

Supports DA and DOH in creating and implementing national biosafety and biosecurity policies.

Biological Risk Association...

A non-government group addressing biological risk management in health, agriculture, and tech sectors.

Biosafety

refers to the use of containment strategies, technologies, and procedures aimed at preventing accidental exposure to harmful pathogens or their unintended release into the environment.

Biosecurity

involves the safeguarding, monitoring, and responsible handling of valuable biological agents within laboratory settings to prevent unauthorized access, misuse, loss, theft, or intentional release.

1966

Charles Baldwin, while working at Dow Chemical Company, designed the now-universal biohazard symbol, which is used to mark materials that pose biological risks.

Charles Baldwin

This person made the universal biohazard symbol in 1966

Risk Group 1, Risk Group 2, Risk Group 3, Risk Group 4

Enumerate the classification of Microorganisms by Risk Groups

Risk Group 1

Microorganisms posing minimal or no risk to human or animal health, with low risk to individuals and the community.

Risk Group 2

Microorganisms posing limited risk to laboratory personnel, the community, animals, or the environment. Lab exposure may cause infection, but effective treatment and preventive options are available. Moderate risk to individuals and low to moderate risk to the community.

Risk Group 3

Microorganisms that cause serious illness in humans or animals, posing high risk to laboratory workers and individuals, with limited to moderate community risk.

Risk Group 4

Microorganisms that cause severe or fatal diseases in humans or animals, posing high risk to individuals and the community.

Biosafety Level 1

Work with well-defined, non-pathogenic microorganisms not known to cause disease in healthy humans. Examples: Bacillus subtilis, Naegleria gruberi, and infectious canine hepatitis virus.

Biosafety Level 2 (BSL-2)

Designed for handling moderate-risk, indigenous microorganisms using proper lab practices, safety equipment, and facility design in clinical, diagnostic, and educational settings. Examples: Hepatitis B virus, HIV, Salmonella species, and Toxoplasma species.

Biosafety Level 3 (BSL-3)

Uses primary and secondary containment to protect laboratory personnel, the public, and the environment from aerosol-transmitted infectious agents. Examples: Mycobacterium tuberculosis, St. Louis encephalitis virus, and Coxiella burnetii.

Biosafety Level 4 (BSL-4)

Reserved for high-risk, exotic pathogens that cause severe or fatal diseases, often transmitted through aerosols and lacking effective treatments or vaccines. Examples: Marburg virus and Crimean-Congo hemorrhagic fever virus.