Lab Biosafety and Biosecurity Overview

Study Notes

In 1967, mortality and morbidity increased due to smallpox, raising serious concerns about biosafety practices worldwide.
In 1974, the CDC published the Classification of Etiological Agents on the Basis of Hazard.
In 1976, the National Institutes of Health (NIH) published the NIH Guidelines for Research Involving Recombinant DNA Molecules.
In 1983, the World Health Organization (WHO) published the first edition of the Laboratory Biosafety Manual.
In 1984, the CDC and NIH jointly published the first edition of Biosafety in Microbiological and Biomedical Laboratories.

In 1996, the US Government enacted the Select Agent Regulations to monitor the transfer of a select list of biological agents.
In 2001, after the terrorist attacks and the anthrax attacks, the US government changed its perspective on biosecurity.
In 2012, the Select Agent Regulations sought to address the creation of two tiers of select agents.

In 2008, the Comite Europeen de Normalisation (CEN) published the CEN Workshop Agreement 15793 (CWA 15793) on Laboratory Biorisk Management.
The Cartagena Protocol on Biosafety (2003) applies to 168 Member-countries, providing an international regulatory framework to ensure safe transfer, handling, and use of living modified organisms (LMOs) resulting from modern biotechnology.
The National Committee on Biosafety of the Philippines (NCBP) was established under E.O 430 series of 1990, and the National Biosafety Framework (NBF) was established under E.O 514 in 2006.

American Biological Safety Association (ABSA) promotes biosafety as a scientific discipline and provides guidance to its members on the regulatory regime present in North America.
Asia Pacific Biosafety Association (A-PBA) acts as a professional society for biosafety professionals in the Asia-Pacific Region.
European Biological Safety Association (EBSA) aims to provide a forum for discussions and debates on issues of concern and to represent those working in the field of Biosafety.
Philippine Biosafety and Biosecurity Association (PhBBA) assists the Department of Agriculture (DA) and Department of Health (DOH) in their efforts to create a national policy and implement plan for laboratory biosafety and biosecurity.

Biosafety defines as the containment principles, technologies, and practices that are implemented to prevent unintentional exposure to pathogens and toxins, or their accidental release.
Biosecurity refers to 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.

Risk Group 1: microorganisms unlikely to cause human or animal disease.
Risk Group 2: microorganisms unlikely to be a significant risk to laboratory workers and the community, with effective treatment and preventive measures available.
Risk Group 3: microorganisms that are known to cause serious diseases to humans or animals, with a significant risk to laboratory workers.
Risk Group 4: microorganisms that are known to produce life-threatening diseases to humans or animals.

Biosafety Level 1 (BSL-1): suitable for work involving viable microorganisms that are defined and with well-characterized strains known not to cause disease in humans.
Biosafety Level 2 (BSL-2): designed for laboratories that deal with indigenous moderate-risk agents present in the community.
Biosafety Level 3 (BSL-3): emphasizes primary and secondary barriers in the protection of personnel, the community, and the environment from infectious aerosol exposure.
Biosafety Level 4 (BSL-4): required for work with dangerous and exotic agents that pose high individual risks of life-threatening diseases.