Chapter 01: Introduction to Biological Risk PDF

CHAPTER 01 : Introduction to Biological Risk 1 Objectives of this topic  To understand: biorisk, biosafety, biosecurity, biorisk management system  Use the AMP model as a simple model for managing biorisk ‘BIORISK’  The risk associated with biolo...

CHAPTER 01 : Introduction to Biological Risk 1 Objectives of this topic  To understand: biorisk, biosafety, biosecurity, biorisk management system  Use the AMP model as a simple model for managing biorisk ‘BIORISK’  The risk associated with biological materials in the laboratory Biorisk = biosafety and biosecurity 2  Biorisk : Risk associated with biological materials and infectious diseases.  Biosafety : Apply the right knowledge, techniques and equipment to prevent exposure and potential infectious and biohazards.  Biosecurity : Procedures/measures designed to protect the population against harmful biological/biochemical substances. 3 Biorisk Management : The effective management of risks posed by working with infectious agents and toxins in labs. 4 Biological hazards Very generally : Infectious agents/ microorganisms Biological toxins Genetically modified organisms (GMOs) Used in teaching and research labs and in the near future Nano-biotechnology constructs Synthetic biology constructs 5 Laboratory Biosafety:  containment principles, technologies, and practices  to prevent unintentional exposure to infectious microorganisms/ pathogens and toxins  or their unintentional release 6  Prevent unintentional harm to human, animal and environment 7 Laboratory Biosecurity  protection, control and accountability for valuable biological materials within laboratories  in order to prevent their unauthorized access, loss, theft, diversion or intentional release/ misuse 8 Prevent man-made disasters 9 Laws & Regulations PCID Act 1988 Importation of OSHA Act 1994 pathogenic Personnel safety microorganism Workspace safety Biosafety Act 2007 All activities with GMOs Bioweapon and Others Toxin Act 2012 Plant Pest Bill Dual use organism Animal Act Biocontainment Plant Quarantine Environment Transport/ IATA Quality Act 1997 Import/ Export Biohazard waste MAQIS.. Scheduled waste 10 11 The Biosafety Act 2007  + Biosafety Regulations (2010)  fulfills M’sia obligations to the Cartagena Protocol on Biosafety  regulates any activities with genetically modified organisms (GMO) and/ or products of GMOs  Enforced by the National Biosafety Board (NBB) under NRE 12 The Bioweapon and Toxin Act (2015)  (Still in draft)  Fulfills M’sia obligations to the BWTC and the UN Security Council Resolution 1540 (28/04/04)  Related to Law of Malaya, Act 708, Strategic Trade Act 2010. ◦ [“Biological Weapon” means any microbial or other biological agents or toxins whatever their origin or method of production, of types and in quantities that have no justification for prophylactic, protective or other peaceful purpose, and weapons, equipment or means of delivery designed to use biological agents or toxins for hostile purposes or in armed conflict] ◦ [“Biological agent” means any microbial, micro-organism, virus or infectious substance derived from them naturally or artificially, as well as their components and whatever their origin or method of production]  Regulates high-risk ‘select agents’  Regulates activities with Risk Group 3 and 4 organisms  Regulates Biosafety Level 3 and 4 containment facilities 13  International Standards & Guidelines  The WHO laboratory Biosafety Manual ◦ 3rd ed (2004)  The US NIH handbook on Biosafety in Microbiological and Biomedical Laboratories ◦ 5th ed (2009)  The CWA 15793: Laboratory Biorisk Management ◦ defines minimum laboratory management system standards 14  National Standards & Guidelines  SIRIM Malaysian Standards MS 1042: 3 Code of Practice for Safety in laboratories. Biocontainment and Biosafety Practices for Microbiology Laboratories ◦ (in progress)  The National Biosafety Board Guidelines for Contained Use Activity of Living Modified Organism (LMO) 15 Biorisk Management (BRM)  Biorisk = Biosafety + Biosecurity  System to manage/ mitigate biological risks  Prevent harm from happening Pandemic Epidemic Natural disaster Outbreak Biosecurity Biosafety Infection 16  =Prevalent over a whole country or the Pandemic world =Widespread occurrence of an Epidemic infectious diseases in community @ particular time. Outbreak =Sudden occurrence of something unwelcome Infection =Process of infecting 17 Objectives of Laboratory BRM i. Prevent laboratory-acquired infections (LAIs) ii. Prevent secondary infections in general population Transmission from a laboratory worker carrying agent to other individuals Direct transmission from agent release “escape” from laboratory environmental contamination iii. Prevent secondary transmission to animal population 18 Laboratory –acquired Infections (LAIs) Pandemic Epidemic Outbreak Infection 19 Laboratory–acquired Infections (LAIs)  something you only get in a microbiology lab  Many cases of famous microbiologists/ scientists died after being infected by the organism they are studying e.g. Ricketts LAI’s 1930 -2001  Total 5,346 cases  190 deaths  under-reporting likely Harding AL, Byers KB. Epidemiology of laboratory-associated infections. In: Fleming DO, Hunt DL, editors. Biological safety: principles and practices. 3rd ed. Washington, DC: ASM Press; 2001:35-54 20 Recent cases of LAI  Malcolm Casadaban (2009) Assoc Prof of Molecular Genetics, Cell Biology and Microbiology at the University of Chicago (1). ◦ Casadaban died following an accidental laboratory exposure to an attenuated strain of Yersinia pestis, a bacterium that causes the plague  5 cases of vaccinia virus in research labs, 2005-2007, US needlesticks while injecting mice  2 cases of brucella in clinical labs, 2006, US subculturing on open bench  Singapore – SARS (2003) ◦ Post-graduate student, Environmental Health Institute 21 Outbreaks Pandemic Epidemic Outbreak 22 “Salmonella hits US teaching labs”  Since August 2010, a commercial strain of Salmonella typhimurium has caused 73 confirmed illnesses, including one death.  The illnesses are spread over 35 states. Pennsylvania is hardest hit, with six confirmed illnesses.(2)  the outbreak strain was genetically identical to a commercially available strain used in some of the labs(3)  some of those infected in the outbreak, such as young children, had never visited a lab but lived with someone who worked in a lab and did not get sick (4)  This suggests that the lab worker carried the pathogenic bacteria home on bags, clothes or other objects (5) 23  5 cases Shigella in lab workers and secondary transmission to community, 2005, Belgium lab worker infected by contact with cultures infected grand-daughter who infected father, mother, great-grandmother  9 cases SARS outbreak in China, 2004 ◦ National Institute of Virology, China CDC ◦ Incomplete inactivation of the SARS virus during disposal ◦ Lab worker – infects 9 family members, 1 death ◦ 3 other lab workers were tested seropositive 24 Epidemics/Pandemics Pandemic Epidemic 25 Our good friend – E.coli  Commensal bacteria – billions of them in our guts  Lab strain E.coli K12 – attenuated, safe  EPEC, EHEC, EIEC, EAEC, ETEC etc. – severe diarrhea  E.coli O157:H7 - kidney failure, death  Ecoli O104:H4 – 2011 Germany outbreak; 50 deaths  Know exactly what you are playing with  If in doubt, ASK. 26 80% of LAIs are due to incorrect techniques  Protect yourselves, and also those around you.  Learn the correct way to do things  The first responsibility of a teaching lab is to teach its students how to handle themselves safety in a microbiology lab.  The first responsibility of a lab manager is to ensure that all of the lab personnel – and any visitors to the lab – are aware of, and follow, all lab safety and bio- containment practices. 27 Biorisk management issues  Teaching labs ◦ Low risk – use low-risk organisms ◦ Implement and maintain Good Lab Practices & SOPs ◦ Basic biosafety training  Research Labs ◦ Variable risks – depends on work being done ◦ Each case is unique ◦ e.g. pathogens, clinical samples, cell cultures, animal samples, large culture volumes etc. etc. ◦ Training, GLP, lab design, PPE, SOP as appropriate 28 Biorisk management issues  GMOs ◦ subjected to Biosafety Act 2007 ◦ All GMO work will require registration with IBC ◦ And notification/ application to the NBB  Biosecurity select agents ◦ High risks – depends on work being done ◦ e.g. human pathogens, pathogens of economically important crops/ animals, toxins ◦ Registration with IBC and approval from BWT Act ◦ Specialised biocontainment facilities & training 29 Biorisk Management :The AMP Model Biorisk Management = Assessment, Mitigation, Performance 30 AMP MODEL 31 3 Key Components of Biorisk Management Risk Assessment ◦ Process of identifying the hazards and evaluating the risks associated with biological agents and toxins, taking into account the adequacy of any existing controls, and deciding whether or not the risks are acceptable 32 3 Key Components of Biorisk Management Risk Mitigation ◦ Actions and control measures that are put into place to reduce or eliminate the risks associated with biological agents and toxins 33 3 Key Components of Biorisk Management Performance ◦ The implementation of the entire biorisk management system, including evaluating and ensuring that the system is working the way it was designed. ◦ Continuous improvement 34