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Biorisk An Engineering Safety Module Prepared by Valentin Malenkov Reviewed by Prof. Marc Aucoin Sponsored by: MINERVA (www.safetymanagementeducation.com/) and MITACS Chapter 1: Introduction to Biorisk Biorisk 2 Chapter 1: Introduction to Biorisk Module Outline Chapter 1: Introduction to Biorisk Chapter 2: Microorganisms, Pathogens, and Toxins Chapter 3: Regulation of Biohazardous Materials and Risk Management Systems Chapter 4: Risk Assessments, Risk Groups, and Containment Levels Chapter 5:Biohazardous Material Containment Biorisk 3 Chapter 1: Introduction to Biorisk Learning Objectives 1. Understand what is meant by biorisk 2. Be able to differentiate between biosafety and biosecurity 3. Gain a historical context on the development of today’s biosafety 4. Understand the international and Canadian environment in terms of biosafety standards and regulations Biorisk 4 Chapter 1: Introduction to Biorisk Defining Biosafety “Biosafety is a combination of containment principles, technologies and practices that, together, help prevent exposure to, or release of, infectious material or toxins that can cause harm to humans or animals” [Public Health Agency of Canada] • Guiding principals for preventing harm when handling biohazardous material • Protocols can be formal or informal • Nature of biohazard and activity determine standards/protocols required Biorisk 5 Chapter 1: Introduction to Biorisk Infection Control in Our Everyday Lives • Everyday infection control? – Hand-washing to avoid spread of germs • Hand washing, decontamination showers – Properly cooking meat to kill parasites • Heat sterilization (autoclaves) – Proper disposal of biodegradable waste to prevent pest infestations • Waste disposal and containment protocols – Coughing into a tissue or the crook of your arm to prevent the spread of colds (instead of your hand) • Best practises change with time Image [1] Biorisk 6 Chapter 1: Introduction to Biorisk Biosafety vs Biosecurity “Biosafety protects people of biohazards, biosecurity protects biohazards from people” [Public Health Agency of Canada] • Biosafety: Protects people and the environment from exposure to harmful biological materials – Maintaining containment – Preventing exposure – Emergency response protocols Biorisk 7 Chapter 1: Introduction to Biorisk Biosafety vs Biosecurity (cont’d) • Biosecurity: Prevents misappropriation and misuse of potentially harmful biological agents – Secure storage – Limited access – Inventory of stock • “Biosecurity” for animal infection control between populations/farms (requires context) – This definition not used for this module (unless specified) Biorisk 8 Chapter 1: Introduction to Biorisk Biosafety Background: The Biohazard Symbol Image [2] • Very distinct and well known symbol • Used internationally to indicate biohazard (threat to living organisms) • Developed at Dow Chemical Company in 1966 • "We wanted something that was memorable but meaningless, so we could educate people as to what it means.“ Charles Baldwin, Dow Engineer Biorisk 9 Chapter 1: Introduction to Biorisk Disease Shaping Human History • Impacted human history from the very beginning – Early human development • Low population until migration from Africa (~65,000-80,000 years ago) from zoonotic diseases?* [1,2] • Diseases migrated with humans and evolved alongside [3] – Shaped ongoing development • Major population culls world-wide through epidemics • Allowed easier colonization (up to 90% mortality among natives) [3] Zoonotic Diseases: Any disease capable of infecting more than one species Biorisk Chapter 1: Introduction to Biorisk Disease Shaping Human History (cont’d) 10 • Major epidemics in human history[3] – Black Plague (1347-1351) • Brought from China by caravan trade • Up to 1/3 of Europe's population killed – “Great dying” in the Americas (Starting in the1600’s) • Disease brought by Europeans • Local population vulnerable, up to 90% mortality – HIV/AIDS (1950-present)[4] • World-wide pandemic • 40 million infected world-side (2003) Image [3] Biorisk 11 Chapter 1: Introduction to Biorisk Poor Infection Control in Early History • Poor hygiene – Increases prevalence of pests and parasites – Increases chance of secondary transmission • Lack of knowledge and tools of modern medicine – Microorganisms as yet undiscovered – Antibiotics not discovered until 1933 Biorisk 12 Chapter 1: Introduction to Biorisk Early Infection Control • Quarantine of infected individuals* – Not always instituted – Ectoparasites and pests still transmit infection (ticks, fleas, rats) • Burial/cremation of infected bodies – Not intended as preventative measure – Measures abandoned in epidemics (manpower unavailable) *Can you think of modern day examples where quarantines still fail? Image [4] Image [4] Biorisk 13 Chapter 1: Introduction to Biorisk Modern Era of Biosafety • Began with discovery of microorganisms (1675) – Antoine Van Leeuwenhoek and Robert Hooke – Home-made magnification devices • First link between organism and infection (1854) – John Snow, local physician – Outbreak of cholera from a particular well – Prompted waste/water treatment reform • Modern bio-warfare – More directed and efficient than earlier efforts Biorisk 14 Chapter 1: Introduction to Biorisk Benefits of Biowarfare • Threat of biowarfare lead to increased research* – Major research efforts during Cold War – USA and USSR conducting work with Anthrax (B. anthracis), Plague (Y. pestis), Tularemia (F. tularensis), etc… • Research facilities built to contain lethal pathogens – Biosafety protocols and infrastructure – High rate of lab-associated infections – Led to current biosafety standards *Do you know of any modern day examples of the benefits of biowarfare/military research? Biorisk Chapter 1: Introduction to Biorisk Failure of Early Biosafety: Stepnogorsk[5] 15 • Cold-war era bio-weapons manufacturing facility – Located near town, by other facilities – Produced of Anthrax (~300 tonnes annually) – Part of USSR’s Biopreparat • Clogged filter removed without proper reporting – Procedures in place but no redundancy – Start-up protocols didn’t include check Fermentors at Stepnogorsk (Image [6]) Biorisk 16 Chapter 1: Introduction to Biorisk Failure of Early Biosafety: Stepnogorsk (cont’d) • ~100 casualties with many more infected – Local authorities not notified immediately – Cover-up of cause lead to further spread • Want to read more? – Biohazard: The Chilling True Story of the Largest Covert Biological Weapons Program in the World Told from the Inside by the Man Who Ran It (Ken Alibek, Stephen Handelman) Biorisk 17 Chapter 1: Introduction to Biorisk Biosafety Today • Built on past experience and new research – Better understanding of microorganisms – Past incidents studied for root cause – Risk assessments conducted for new work • Continues evolving with biotechnology – Recombinants and genetic manipulation – Biological production – Changing face of biowarfare Image [7] Biorisk Chapter 1: Introduction to Biorisk Biosafety in Canada 18 • All industries involved in biotechnology are regulated – Medical research • Vaccine candidates • Genetic modification of pathogens – – – – Food and drug manufacture Academic and industrial research labs Livestock farming and research Associated industries • Transportation • Decontamination Biorisk Chapter 1: Introduction to Biorisk Biosafety in Canada 19 [email protected] Biosafety and Biosecurity for Pathogens and Toxins News Subscribe/unsubscribe To un/subscribe from the Biosafety/Biosecurity mailing list please visit – http://www.phac-aspc.gc.ca/lab-bio/consul/hpta-lapht/subscribe-eng.php. Biorisk Chapter 1: Introduction to Biorisk Globe-Spanning Biosafety[6] 20 • Positive climate in international Biosafety • Annual conferences hosted in many regions – European Union – American Center for Disease Control and Prevention – African Biological Safety Association – International Center for Infectious Diseases (Winnipeg, Canada) Biorisk 21 Chapter 1: Introduction to Biorisk Conventions on Biosafety • The Biological Weapons Convention (1975) – Disarmament treaty for biological weapons[7] • Supplements 1925 Geneva Protocol • Prohibits development, production, stockpiling – Cold-war era agreement – 173 members states (Dec 2014) • The Australia Group (1984)[8] – Informal agreement for control of sensitive exports • Prevents bio/chemical weapons spread/development – Response to Iran-Iraq war chemical weapon use – 41 current members not counting the EU Biorisk 22 Chapter 1: Introduction to Biorisk Conventions on Biosafety (cont’d) • Convention on Biological Diversity (1992) – Mandated rules for work with “living modified organisms” (LMOs) – Stated the need for Biosafety protocols but did not mandate them • Cartagena Protocol on Biosafety (2000) – Discussion on safe use of LMOs – Risks to biodiversity and human health Biorisk 23 Chapter 1: Introduction to Biorisk Globe-Spanning Biosafety • World Health Organization (WHO) – “In the 21st century, health is a shared responsibility, involving equitable access to essential care and collective defence against transnational threats” – Agency of United Nations – Publish recommendations and standards, not regulations • International Federation of Biosafety Associations (2001) – Discussion between biosafety professionals – 13 member organization, 9 observer (45 nations represented) – Link between WHO, American/European/AsianPacific Biosafety Associations (ABSA, EBSA, APBSA respectively), and the International Veterinary Biosafety Working Group http://www.internationalbiosa fety.org (Image 8) Biorisk 24 Chapter 1: Introduction to Biorisk Regulatory Bodies in Canada • Public Health Agency of Canada (PHAC) – “To promote and protect the health of Canadians through leadership, partnership, innovation and action in public health.” – Regulations and permits for human pathogens and facilities working with them • Canadian Food Inspection Agency (CFIA) – “Dedicated to safeguarding food, animals and plants, which enhances the health and well-being of Canada's people, environment and economy.” – Regulations and permits for food production, packaging, and livestock and crop health • More detailed regulatory overview in Chapter 3 Biorisk Chapter 1: Introduction to Biorisk References [1] Bar-Yosef O. Belfer-Cohen A. (2001) From Africa to Eurasia — early dispersals. Quaternary International, vol 75, issue 1 [2] Smithsonian.com < http://www.smithsonianmag.com/history/the-great-human-migration-13561/?no-ist> [3] Grady, S., & Tabak, J. (2006). Biohazards: Humanity's Battle with Infectious Disease. New York: Infobase Publishing. [4] Centers for Disease Control and Prevention (2011) “HIV surveillance--United States” [5] Mauroni, A. (2003). Chemical and Biological Warfare. Santa Barbara: ABC Clio [6] Mackenzie R, Burhenne-Guilmin F, et al. (2003) An Explanatory Guide to the Cartagena Protocol on Biosafety. Gland, Switcherland: IUCN. [7] http://www.un.org/disarmament/WMD/Bio/ [8] http://www.australiagroup.net/en/origins.html Biorisk Chapter 1: Introduction to Biorisk Attribution for images used 26 1. 2. 3. 4. 5. 6. 7. “Man washing hands”, This work has been released into the public domain by its author, Bill Branson (Photographer). Original source: https://visualsonline.cancer.gov/retrieve.cfm?imageid=4393&dpi=300&fileformat=jpg Internationally recognized symbol. Original source: http://www.michigan.gov/documents/CIS_WSH_part476_54539_7.pdf “An illustration of an undertaker during the Bubonic plague”, This work is in the public domain in its country of origin and other countries and areas where the copyright term is the author's life plus 70 years or less. Original source: Transferred from en.wikibooks to Commons by Adrignola using Commons Helper “Nederlands: mummie van Usai, zoon van Nehket-26e dynastie, Museo Civico Archeologico, Bologna”, Author: Paul Hermans,. Permission is granted to copy, distribute and/or modify this document under the terms of the GNU Free Documentation License, Version 1.2 or any later version published by the Free Software Foundation; with no Invariant Sections, no Front-Cover Texts, and no Back-Cover Texts. A copy of the license is included in the section entitled GNU Free Documentation License. “Technicians set up an assay test for Ebola within the U.S. Army Medical Research Institute of Infectious Diseases' containment laboratory. Samples are handled in negative-pressure biological safety cabinet to provide additional layer of protection.” Author: Randal Schoepp, USAMRIID. This image is a work of a U.S. Army soldier or employee, taken or made as part of that person's official duties. As a work of the U.S. federal government, the image is in the public domain. Original source: https://www.dvidshub.net/image/1936263. “The cellar of 'Building 221' houses ten of these twenty thousand litre tanks to cultivate the anthrax.“. Author: Petra Wijnsema. Photograph used with the express permission of the author. “Cell culture”, Author: Umberto Salvagnin. This file is licensed under the Creative Commons Attribution 2.0 Generic license. Original source: https://www.flickr.com/photos/kaibara/3075268200/ Biorisk An Engineering Safety Module Prepared by Valentin Malenkov Reviewed by Prof. Marc Aucoin Sponsored by: MINERVA (www.safetymanagementeducation.com/) and MITACS Chapter 1: Quiz Biorisk 1. 2. 3. 4. 5. 6. Chapter 1: Introduction to Biorisk A disgruntled lab employee with access to the pathogen storage facilities attempts to acquire samples for their personal gain. Is this first and foremost an issue of Biosafety or Biosecurity? True or False: burial and cremation of bodies during epidemics was a major preventative measure used to reduce transmission of the disease before modern medicine. True or False: Biowarfare research prior to and during the Cold War could be said to have benefitted Biosafety and Biosecurity. Name three of the every-day infection control behaviours which were related to biosafety protocols in this chapter. Does the World Health Organization regulate work conducted with biohazardous material around the world? What are the two organizations responsible for the regulation of importation, transport, and use of human and animal pathogens in Canada?