Introduction to Biological Risk Management

Introduction to Biological Risk

• Biorisk is the risk associated with biological materials and infectious diseases in a laboratory setting.
• Biorisk is equivalent to biosafety and biosecurity.
• Biosafety refers to applying appropriate knowledge, techniques and equipment to prevent exposure to hazards.
• Biosecurity encompasses procedures to protect individuals and populations from harmful biological/biochemical substances.
• Biorisk management effectively manages the risks of working with infectious agents and toxins in labs.
• This management involves assessment, mitigation and performance.
• Biological hazards encompass infectious agents, biological toxins, and genetically modified organisms (GMOs).
• The future use of nano-biotechnology constructs and synthetic biology constructs are also noted as biological hazards.

Laboratory Biosafety

• Laboratory biosafety focuses on principles, technologies, and practices designed to prevent unintentional exposures to infectious microorganisms, pathogens and toxins, or their unintentional release.
• The goal is to prevent harm to human, animal and the environment.

Laboratory Biosecurity

• This involves the protection, control and accountability of valuable biological materials to prevent unauthorized access, loss, theft, diversion or intentional release/misuse. It is to prevent man-made disasters.

Laws and Regulations

• Key Acts include OSHA Act 1994, PCID Act 1988, and Biosafety Act 2007.
• Other relevant laws and regulations include, Plant Pest Bill, Animal Act, Plant Quarantine Act, and quality act.

The Biosafety Act 2007

• The act fulfills Malaysia's obligations relating to the Cartagena Protocol on Biosafety.
• It governs genetically modified organisms (GMOs) and related activities.
• This act is enforced by the National Biosafety Board.

The Bioweapon and Toxin Act (2015)

• (Still in draft at time of writing)
• This act fulfills obligations related to the BWTC and the UN Security Council Resolution.
• The law defines "Biological Weapon" and "Biological Agent".
• It regulates high-risk select agents, activities involving Risk Group 3 and 4 organisms, and safety level 3 and 4 containment facilities.

International Standards & Guidelines

• WHO laboratory Biosafety Manual (3rd ed 2004)
• US NIH handbook on Biosafety in Microbiological and Biomedical Laboratories (5th ed 2009)
• CWA 15793: Laboratory Biorisk Management (defines minimum standards)

National Standards & Guidelines

• SIRIM Malaysian Standards MS 1042:3 (code of practice for safety)
• National Biosafety Board Guidelines for Contained Use Activity of Living Modified Organisms (LMOs) in progress.

Biorisk Management (BRM)

• Biorisk management (BRM) equals biosafety plus biosecurity.
• BRM systems manage and mitigate biological risks.
• Preventing harm is a primary goal of BRM.

AMP Model

• Biorisk management = Assessment, Mitigation, and Performance.
• This model is a key element for managing biorisk.

3 Key Components of Biorisk Management

• Risk Assessment: Identifying hazards, evaluating risks associated with biological agents/toxins, and determining risk acceptability
• Risk Mitigation: Actions and control measures employed to reduce or eliminate risk.
• Performance: Ensuring the biorisk management system works as intended and promoting continuous improvement.

Laboratory-Acquired Infections (LAIs)

• Laboratory acquired infections are infections specific to microbiology labs.
• A significant number of cases of microbiologists/scientists have died after contracting infections.
• 80% of LAIs are due to incorrect techniques.

Outbreaks

• Outbreaks are the localized occurrence of an incident or disease.
• The hierarchy of severity for infectious diseases is infection, outbreak, epidemic, pandemic.

Salmonella Outbreak

• A commercial strain of Salmonella Typhimurium caused illnesses in 35 states in 2010.
• The strain was identical to a commercially available strain used in teaching labs.
• There were cases of infection in individuals not connected with the labs.
• The pathogenic bacteria was likely transmitted in the belongings of lab workers.

Recent LAI Cases

• Recent laboratory acquired infection incidents include Malcolm Casadaban, vaccinia, brucella, SARS.

Other Topics

• E.coli, commensal bacteria (including lab strain E.coli K12) and strains relating to severe diarrhea, kidney failure and death.
• Shigella cases in Belgium.

Explore the critical aspects of biorisk, biosafety, and biosecurity in laboratory settings. This quiz delves into the methodologies for assessing and mitigating risks associated with infectious agents and biological hazards. Understand the key principles that underpin effective biorisk management.