Risk management and biosafety Introduction

Risk management and biosafety Introduction

• 1.
  INTRODUCTION TO BIOSAFETY& RISK MANAGEMENT Lecture 1 MLT- 5th
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  Introduction  Risk, ingeneral, is defined as a function of the likelihood an adverse event involving a specific hazard and/or threat will occur, and its consequences.  Biorisk is the chance that something dangerous could happen when working with biological materials—either by accident or on purpose.  It can harm to Human, animals, plants, or the environment.
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  Characterization of Biorisk 1.Based on Source of Risk  Accidental Risks (Biosafety-related): Accidental exposure (e.g., lab worker infected by a pathogen). Accidental release (e.g., pathogen escaping into the environment). Equipment failure, spills, or improper waste disposal.  Deliberate Risks (Biosecurity-related): Theft or diversion of pathogens/toxins. Misuse of biological materials for harmful purposes (bioterrorism, biowarfare). Insider threats (misuse by lab personnel).
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   Biosafety risks– risks from accidental exposure or release of harmful biological agents. Example: A lab worker accidentally pricks their finger with a needle containing Hepatitis B virus  Biosecurity risks – risks from the intentional misuse of biological materials, knowledge, or technology. Example: Intentional contamination of a water supply with Vibrio cholera.
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  Cont……… 2. Based onNature of Agent  Pathogenic organisms: bacteria, viruses, fungi, parasites.  Toxins: botulinum toxin, ricin, etc.  Genetically modified organisms (GMOs): with unintended harmful effects.
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  Cont…….  3. Basedon Consequences  Human health risks: infections, epidemics, pandemics.  Animal health risks: zoonotic transmission, livestock diseases.  Plant/agricultural risks: crop damage, food security threats.  Environmental risks: ecological imbalance, biodiversity loss.  Socio-economic risks: healthcare burden, trade restrictions, public fear.
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  Cont…….  4. Basedon Risk Level (Laboratory Classification – BSL 1–4)  Low risk: Agents not known to cause disease in healthy humans (e.g., non-pathogenic E. coli).  Moderate risk: Agents that cause mild disease but are rarely serious (e.g., Salmonella).  High risk: Serious or lethal diseases, but preventive or therapeutic measures exist (e.g., HIV, Hepatitis B).  Extreme risk: Dangerous and exotic agents with no treatment or vaccine (e.g., Ebola, Marburg virus).
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  How to Determineif Risks are Acceptable  Compare with Criteria/Standards  Use national or international biosafety guidelines World Health Organization , Centre for disease control and prevention, National Institute of Health Sciences.  Check if the risk falls within permissible levels (e.g., exposure limits, biosafety levels).  Balance Likelihood vs. Consequences  High likelihood + severe consequences → unacceptable  Low likelihood + minor consequences → may be acceptable  Consider Control Measures in Place  If engineering controls (biosafety cabinets, air filters), administrative controls (SOPs, training), and PPE are sufficient, the risk may be acceptable.  If not, more mitigation is required.
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  Cont…….  Use aRisk Matrix  Plot probability (rare → frequent) against severity (minor → catastrophic).  Risks in the red zone = unacceptable  Risks in the yellow zone = tolerable with controls  Risks in the green zone = acceptable
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  Biosafety Risk Assessment