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EMD 545b Biosafety, Biosecurity, and the Evaluation of Biohazards

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1 EMD 545b Biosafety, Biosecurity, and the Evaluation of Biohazards
The relatively new course is entering its 5th year. Dr. Curtis Patton asked OEHS to prepare this course for EPH students to: Provide an awareness of the profession of Biological Safety w/in the discipline of Occupational Health and Safety; To demonstrate safe practices (to protect themselves and others) for those EPH students who may end up handling infectious agents in the laboratory or field as a vocation; and To provide those EPH students who will end up in a career in Public Health with the foundation of biological safety as public health officials who may have to respond to emergencies, participate in outbreak investigations or investigations of lab-acquired infections, and also to provide those who may manage organizations with employees at risk – so they know what their employees should be doing to protect themselves. Course Lecture #1

2 Lecture #1 Outline Course intro, objectives, syllabus review
Texts, handouts, microbiology assessment Student Interests (goals of course) Biosafety (then and now) Biohazards: here, there, everywhere Profession of Biosafety, resources Laboratory Acquired Infections The Course Handouts for the first class are: Syllabus for 2008 semester Course Overview Description handout Excerpts from the CDC BMBL 5th Edition Excerpts from the NIH rDNA Guidelines, April 2002 Show the course book – Biosafety: Principles and Practices, ASM Press, 4th Edition (available through the Yale Bookstore – can order a copy – may be able to get it cheaper on EBAY) SHOW STUDENTS A COPY OF THE BOOK – PASS AROUND FOR THEM TO LOOK AT. LET STUDENTS KNOW that all books for the course (course readings, etc.) will be on reserve at the EPH library in the basement of 47 College Street under course #545B – Biosafety, Biosecurity, and the Evaluation of Biohazards. All course materials, powerpoint lectures, course exercises and samples will be maintained online at the Classes Version 2 Website for Yale University under Course 545B Spring 2008 Semester (EPH) Classes Version 2 website is: This slide provides an overview of today’s lecture

3 Course Objectives Illustrate science and profession of biosafety
Examine the application of biosafety in various settings Provide a foundation in the principles of biohazard containment and control Here’s what we hope to do with today’s lecture We also have invited students who have taken the class in previous years to give you a brief overview of what they were able to gain from the class. Feel free to ask them any questions about their experiences, the workload, what they thought (etc.)

4 Course Syllabus Lectures Tours
1st half of course Tours Building HVAC system, cooling tower Biohazard containment facility Animal facility tour Guest speakers Bioaerosol or “project” sampling location Selected by student teams The course schedule is currently written down in an order on the syllabus and we try to follow this schedule. Lectures before the mid-semester break are fairly set in stone and don’t change. We’ve changed the subject matter of lectures in the latter ½ of the course to try and bring in lecture topics that may be of a burning interest for the students. The course is interactive with in-class exercises and group field projects. We will tour the following locations: Cooling Tower and see the biocide delivery systems to control Legionella A Yale School of Medicine Mechanical Room to see the components of a building HVAC system (Heating Ventilation and Air Conditioning System) – which comes in handy for indoor air quality evaluations. One of Yale’s biocontainment BSL3 laboratories (either an animal or cell culture suite) or a specialized facility like the LEPH Insectary. We also have had Guest Speakers, Previously we’ve invited in for lectures to the students representatives from: The Yale Animal Resources Center to review Animal Care and Use and Regulatory Services Functions on campus A Director from the New Haven Department of Public Health to talk about Food Sanitation in New Haven Yale Police Hazardous Materials Emergency Responders w/ Emergency Responders from the Office of Environmental Health & Safety Building Services and Operations staff (to show how building systems are maintained and how to verify that BSL3 high risk laboratories are working properly). The course also has a student directed “biosafety related” project that is done in small groups. Each group gets to select the project of their choice. It is generally related to a sampling project of some kind, surface swab, bulk samples, water sampling, or what most groups do for experience using the equipment, a bioaerosol sampling project to determine how contaminated a particular environment may be. Students have to come up with a hypothesis as to why a particular area may be more of a risk for mold/bacteria than other areas and develop a sampling plan and carry it out. The samples are sent to a lab or incubated at OEHS. Students analyze the results and write a report as a group. The Safety Office helps the students with the sampling project. In many cases, students are able to join in on “real life” situations examined by the Safety Office and take replicate samples for their own reports while working side by side with OEHS representatives.

5 Course Syllabus Projects Final Exam (major)
Risk assessment exercise (major) Regulatory Policy comparison (minor) Bioaerosol/env. micro sampling (major – team) Facility commissioning exercise (minor – team) Completed by group in class session Point/counterpoint challenge (major – team) Final Exam (major) Open book(s), open notes and handouts Other projects are a combination of self-directed and group activities. Each student has to write a risk assessment for an infectious agent in a work setting. Samples will be provided to guide the students in this process. The sampling project was discussed on the previous slide. The Point/Counterpoint challenge puts groups of students against each other to make the best argument for a particular containment option. For example, should we perform work with a certain pathogen (i.e. Rabies Virus) at BSL2 or BSL3? All students will get all the information they need to make these arguments during the class. Coming up with the best argument will be the challenge. Students will also “judge” the presentations and select the group with the “best” argument. There is a final exam – but is it “OPEN BOOK/OPEN NOTES/OPEN HANDOUT” and it is not a “memorization” exam – it is a fair assessment of your ability to apply what you’ve learned in class, and how to apply the lecture material to a few situations. Smaller class projects and homework assignments may also be used.

6 Texts Biosafety: Principles and Practices, 4th Ed.
CDC/NIH Biosafety in Microbiological and Biomedical Laboratories, 5th Ed. NIH Guidelines for Research Involving Recombinant DNA Molecules (April 2002) Handouts (hard copies, , or online) Previous coursework or experience in Micro or Molecular Biology? Here are the text books and reference guidelines that are used in the course. The 3 primary Texts are: Biosafety: Principles and Practices, 4th Edition from the American Society of Microbiology Press (ASM Press); The CDC/NIH Biosafety in Microbiological and Biomedical Laboratories, 5th Edition (available online – see syllabus for website); and NIH Guidelines for Research Involving Recombinant DNA Molecules, April 2002. Copies of sections from the CDC/NIH BMBL and NIH rDNA Guidelines will be provided to students, along with copies of the course lecture slides and other pertinent handouts that help reinforce key course topics. Although Microbiology and Molecular Biology are not prerequisites for the course, students without a background in these areas could benefit from some additional review of basic texts or online information to help them better understand the application of biosafety.

7 Students Introductions Student Interests Course Goals!!
What do YOU hope to get out of the class? Course Goals!! Allow the students to go around the class, introduce themselves, give information on their background experiences (education, prior work experience, prior research or clinical laboratory experience?) Ask students to outline what they HOPE to get out of the course? What specific fields within Public Health or the medical profession are the students interested in pursuing (if known) at this time? The course, especially later lectures, can be amended to fit in a lecture or two related to students interests and goals.

8 Biosafety The consistent application of safety measures to minimize or prevent exposure to the person handling the agent, lab and building occupants, the community and the environment. Key Safety Measures: good microbiological work practices safety and containment equipment facility design consideration General definition of biosafety. Concept of “confinement” and a focus on “containment” The 3 elements of Work Practices/Safety Equipment/Facility Design will be stressed in this course and in every Biosafety related regulation or guideline.

9 Biohazard Biohazard n (1967): a biological agent or condition (as an infectious organism or insecure laboratory conditions) that constitutes a hazard to man or his environment; also a hazard posed by such an agent or condition. Webster’s 9th New Collegiate Dictionary, Miriam- Webster Inc. Publishers, Springfield, MA USA, 1985 Classic definition of a biohazard from Webster’s Dictionary (old version). By highlighting the words “insecure laboratory procedures” as one component of what a biohazard is, the definition provides evidence for what epidemiologists who study Laboratory-Acquired Infections have identified: That 90% of LAI’s are related to a breakdown in good microbiological work practices.

10 Biohazard Settings/Biosafety Applications
Where? Ask the students where they think: Biohazards are; and Where Biosafety is used/needed List their findings on the board of flip chart

11 Biohazard Settings/Biosafety Applications
Research, including: human & animal pathogens, select agents (bioterrorism) toxins of biological origin rDNA research, Human Gene Transfer, plants, animals, large scale shipping, transport, import, export, permits training (BBP, TB, infection control, shipping, Biosafety, BSL-3, work practices, BSC’s) field work, work abroad (feral animal, insects, arthropods) Review the major settings where Biosafety exists to protect employees, others within their buildings, and those in the adjacent community (or beyond if communicable diseases are involved). Highlight the higher risk research applications in terms of individual risk (pathogens, toxins, and potentially infectious materials) and institutional risk (regulations, standards, and guidelines)

12 Biohazard Settings/Biosafety Applications
Clinical/Hospital Settings (helping sick people) micro labs, in- and out-patient facilities, infirmaries infection control, standard precautions, airborne precautions (TB, measles, varicella, flu) social workers, divinity and law school volunteers, students Biosafety’s relative INFECTION CONTROL predominates in the hospital/clinical setting. Infection Control is Biosafety in a different building, different population. However, the principals are very similar.

13 Biohazard Settings/Biosafety Applications
Buildings/IAQ fungi, SBS, cooling towers, HVAC, floods, leaks, allergens Emergency Response police, fire, plant maintenance personnel, public health officials biohazard spills, exposures, incident review Environmental Issues mosquito control program, anthrax sampling (mailrooms) food sanitation Other clean air device monitoring (biosafety cabinets, other hoods) facility design, renovation, construction, and commissioning Mold, bacteria, dust mites, endotoxins, pollens, and other allergens are a huge problem among sensitive personnel and can create sensitivities in healthy individuals upon repeated exposure. The control of Bioaerosols is a huge field in buildings that have been built “tight” for energy saving purposes. Emergency Responders face known and unknown hazards and must use biosafety under difficult situations. In these cases it is best to work more conservatively. The anthrax letters of the Fall of 2001 and the introduction of West Nile Virus into the U.S. in 1999 led to new applications for biosafety professionals in attempting to control risk of pathogen dissemination in mailrooms and educating communities and grounds maintenance personnel on mosquito control actions. Very sophisticated “clean air devices” have been constructed to help researchers “CONFINE AEROSOLS AS CLOSE AS POSSIBLE TO THEIR POINT OF GENERATION.” – Karl Johnson/Arnold Wedum Quote. However, these devices must be tested and certified to ensure their proper use and the individuals who use them must be aware of the appropriate procedures. Lab design is also a critical field – ensuring that laboratories work as plan, testing and commissioning them to ensure that all features do what they were intended to are now becoming a big part of what biosafety professionals do. The control of biohazards/bioaerosols during construction and renovation projects is important in preventing unnecessary risk and exposure to immunocompromised personnel and those with allergies.

14 Biohazard Settings/Biosafety Applications
Cruise ships, airplanes, trains, buses, other crowded conditions Homeless shelters, prisons, schools Farms, agricultural settings (zoonotic agents) Hunting (gutting/dressing wildlife) Bioterrorism (local area response) Production of medical products, vaccines, drugs, biologics Outbreak investigations, war, refugee camps Other??? Every year, multiple foodborne outbreaks are identified each year. Noroviruses, Caliciviruses, E. coli 01577, Salmonella and Shigella are almost guaranteed to occur each year. The XDR/Multiple Drug Resistance TB Scare that occurred with one patient on series of long flights was thought to have potentially triggered an epidemic. Hobbies can create potential risk as hunter’s who catch and prepare their bounty can be exposed to ticks, other vectors, agents in the blood and tissues of the animals they catch. Field work may involve multiple biological hazards from bites or scratches from animals studies, to exposure to airborne particles generated from dried excretions or spores that have been dormant in soil that were unearthed by digging or erosion and have become airborne after it resting place has been disturbed.

15 OEHS Biosafety “We don’t make the jobs you do…..
We make the jobs you do safer.” This is a take-off on the old B-A-S-F Commercial and tag line. Biosafety Officers haven’t been in the research laboratories for some time. The jobs employees are performing, the experiments they conduct, the equipment they use and the types of materials they use are changing frequently. Biosafety has to not only keep pace with these changes, but also be able to critically evaluate what workers do, anticipate what situations may cause risk, recognize the exposure routes, recommend or implement control measures, and evaluate their effectiveness.

16 Biosafety: Historical Perspective (Seymour Block)
Homer (Odyssey XXII)- burned sulfur for fumigation, 800BC Hippocrates- involvement of fomes/fomites in disease process, 4th century BC Bible move campsites daily, care of wastes, strict dietary/cleanliness rules/regulations regarding lepers (ISOLATION) burn or boil clothing and equipment Aristotle - advised Alexander the Great (boil water, bury excreta) Seymour Block is one of the founding fathers and one of the most famous Environmental Microbiologists who have studied the field of Disinfection, Decontamination and Sterilization. He has edited perhaps the most significant volume of work on this topic, and has researched historical uses of disinfectants or Infection Control. One of the oldest references found was in Homer’s account of the use of sulfur to gas decontaminate a home after a relatively “bloody” bit of action contaminated the surroundings. One of the first “public health professionals,” Hippocrates – alerted others of the potential for sickness from contact with contaminated materials. The Bible contains references for infection control, waste control, decontamination and patient isolation. Would Alexander have been so “great” if Aristotle didn’t advise him to drink “sterilized” water and keep a clean bathroom?

17 Biosafety: Historical Perspective (Seymour Block)
Susruta (Hindu physician)- cleaning/fumigation of OR before and after operations, 500 AD Great plagues- burn victims clothes, burned bodies on 10 foot poles, unique PPE worn by physicians (perfume in beak), full body coverage, Middle Ages Girolamo Fracastoro- referred to “seeds” or “germs” of disease. Identified 3 sources of contagion (contact, fomites, air) Venice Magistry of Health- fumigated cargo and mail from ships, 1438 One of the founding principles of Biosafety today is to “disinfect surfaces or equipment Before and After use.” Susruta had this idea 1500 years ago and we haven’t changed from this wonderful advice. A lot of interesting applications of protective measures and devices were established during the time of the Black Plague (Yersinia pestis). The reference to the “10 foot” pole is actually an example of an engineering control to create space/distance between a dead body and those carrying it. Infection Control practitioners still utilize a 3 ft rule to prevent the droplet spread of infectious disease agents today. Germs are defined as the “seeds” of disease about 500 years ago. The Venetian “Public Health Department” held ships carrying mail and other items out at a sea a safe distance away from port until they could gas decontaminate items before they were brought to land. Those organizations that protect the U.S. from agricultural and ecological damage (the United States Department of Agriculture, Animal Plant Health Inspection Service, and Plant Protection and Quarantine) use similar measures to quarantine/inspect materials before they are brought into the country.

18 Biosafety: Historical Perspective (Seymour Block)
Leeuwenhoek- studied effect of chemicals on “little animals” under microscope, 1676 Cotton Mather- 1st in America to vaccinate against smallpox (with smallpox, Jenner used Cowpox), 1720 James Lind- hygiene as sea (disinfection, filtration of water, cleaning and ventilation of sick bay, special clothes for physicians), 1757 Nicholas Appert- Canning method for food preservation, 1810 John Pringle- sanitary trench disposal of waste in warfare Our first microscope identified the animolecules (little animals) – bigger germs in active motion. Smallpox vaccinations (from China, to England, to the U.S.) Patient isolation in the Navy – Ventilation reference is important as we didn’t really remember this for until the 1950’s for true control of biohazards. It took us 200 years to catch on to what was being done on ships to prevent sick sailors from spreading their diseases to the healthy ones. Food safety took a big turn with the invention of using heat to inactivate germs before sealing the food in and other germs out. More waste disposal references to try to keep human resources in good shape to fight.

19 Biosafety: Historical Perspective (Seymour Block)
Oliver Wendell Holmes (1843), Ignaz Semmelweis (1847) Identified spread of puerperal fever to patients from medical staff. Introduced hand washing to thwart spread. Agostino Bassi (lawyer)- suggested use of germicides, patient isolation, and decontamination of clothes and excreta (1835) Louis Pasteur- Flame sterilization of surgical tools, heat sterilization of bandages before use on wounds, risk assessment enters forefront with his quote “Chance favors the prepared mind.” (1880’s) The two biggest names in Infection Control (Holmes and Semmelweiss) offer dualing accounts of the use of hand washing to prevent nosocomial infections from physicans to patients in surgery. Healthcare workers honor this finding today by washing their hands routinely before and after each patient contact. More references, from a lawyer at that, to use disinfectants, isolate patients and decontaminate reusable clothing and also wastes. Treatment of biomedical waste today is a huge industry and all hospitals have either an in house service or contract out the cleaning and decontamination of reusable protective clothing, linens and other fabric items used in healthcare. Pasteur introduces the concept of Risk Assessment, by promoting the idea of “thinking ahead” and researching potential outcomes.

20 Biosafety: Historical Perspective (Seymour Block)
Joseph Lister- antiseptic use on open wounds (phenol), poured directly into wounds, lowered infection rate from %, (1860’s ’s) Robert Koch- sterile technique, pure culture, use of solid media, tested over 70 disinfectants, (1881) Dakin- 0.5% hypochlorite used to disinfect wounds in WWI WWII-1st war with less deaths from disease than from battle wounds (disinfectants in common use) The man whose name is the basis for one of the largest household disinfectants of all time (Listerine – kills millions of germs on contact). Although phenol is not longer the principal ingredient of listerine, it was very effective in lowering surgical wound infections in the late 1800’s when poured all over the wound. Our first wide scale “tester” of disinfectants had to develop a method to ensure that there were not any confounding factors or contaminants in the cultures. Dakin’s solution (dilute bleach in water) was invented for wound disinfection. The WWII statistic is incredible but weapons were also getting better!

21 Pertinent Biosafety Events
1918- Flu pandemic 1928- Discovery of antibiotics 1930’s - present - Biowarfare research continues (Japan’s Unit 731, many other examples before and after) 1930’s- U.S. Malaria Control Division (later CDC&P) 1940’s- Invention of Electron Microscope Can now see viruses! 1950’s -present- Viral Hemorrhagic Fever outbreaks 1967- Marburg virus outbreak in lab development of Biohazard Symbol 1969- Lassa Fever LAI’s at Yale 1970- OSHA, EPA created (OSHA General Duty Clause) There have been many influential moments in history with some relation to biosafety or infection control: 40 – 100 million lost their lives to the Flu in last century’s largest biological outbreak. Antibiotics gives many a “break” from infection control, believing this to be the magic bullet. Germs again used as weapons against enemies in war and in field trials. Discovered by the U.S. and Allies in WWI, the Japan Unit #731 was spared death in exchange for teaching the U.S. how to “harness biological agents in warfare” The CDC was originally set up for Malaria control. Once this was solved, they looked for other diseases to fight. The discovery of the Electron Microscope ended the slumber generated by the discovery of antibiotics. Viruses that were identified through filtration could now be seen. Devastating outbreaks of horrific diseases begin to pop up in South America and other tropical regions (or at least are described in these areas) as developed nations move further into underdeveloped areas of the globe. Huge outbreak of infections in Germany from cells from a monkey in a laboratory that were contaminated with the Marburg Virus. 31 infections and also spread of the agent in a hospital ward kills 6. The design of isolation rooms with negative air ventilation at a new German “isolation” ward stems from this event. Finally, a Biohazard Symbol that should stand the test of time is developed during a two year research period. The Lassa Fever Infections at Yale University were a seminal event in Biological Safety. So many issues were identified that could possibly have prevented the spread of infection and many of the controls were known at the time. This infection occurred in the LEPH research building in A Reader’s Digest Book entitled “Fever” was written about the infections and is in the EPH Library. Two were infected, one died (who was not aware that he was infected) and the other was saved through the infusion of convalescent serum from a patient that survived the disease. Both were infected via the airborne route of exposure from animals that were shedding the pathogen in their urine. The urine would dry in the bedding which would now contain dried virus, which would be made airborne when the mice would kick up their bedding. Surgical masks, which are not tight fitting, could not block an airborne infection. OSHA’s General Duty Clause requires Employers to provide a workplace free from recognized hazards in 1970.

22 Pertinent Biosafety Events
1974- Classification of Etiologic Agents on Basis of Hazard (Biosafety Levels 1 - 4) 1976- NIH rDNA Guidelines 1976- Ebola outbreak 1978- Smallpox LAI, England 1979- Laboratory Safety Monograph (NIH) 1979- Anthrax release from military research lab, Sverdlosk, Russia (>60 deaths) CDC/NIH Biosafety handbook, WHO text st HIV cases reported One of the responses to Yale’s Lassa Fever Virus infections (and infections at other institutions) is to create a risk based “Classification of Pathogens” on the basis of hazard. 4 Risk Levels are selected from Level 1 (safety, lowest risk) to Level 4 (most dangerous, Highest possible Risk). Lassa Fever is placed in the bucket of Level 4. Also Criteria for what these laboratories should “look” like and what features they should possess are developed. Yale’s facilities at the time of the infections were not even close to what would be required. New technology of recombining DNA lead investigators to hold their own conference (Asilomar 1975) calling for self-regulation of rDNA experiments. The NIH steps in and in 1976 issues the first set of rDNA Guidelines years later, these guidelines are still being used today. Biosafety Officers being named or hired at Universities who receive funding from the NIH for Research in order to comply with the Guidelines. Smallpox infection of researcher outside of the containment laboratory is a result of performing Risk Group 4 work in a lab designed more for Risk Group 3 agents. The pathogen escaped the facility and traveled about 200 feet to get to the unsuspecting dark room technician. Lack of alarms, insufficient secondary controls allowed an airflow reversal to carry pathogens that were created by discarding used waste items outside of the biosafety cabinet (which created aerosols – which were carried via the air down the hall into the animal Smallpox room and then across an access panel into a plenum and then into the dark room where it was inhaled by the technician. Victim’s mother is also infected with Smallpox while caring for daughter. Lab Safety Monograph – first freely available comprehensive biosafety manual. Anthrax deaths/infections (60/600) due to airborne spread of anthrax spores generated during the production of biological warfare agents through a window that was missing its HEPA Filter (High Efficiency Particulate Air). CDC/NIH work together to create the U.S.A’s first Biosafety Manual outside of the rDNA field. HIV hits the U.S. in 1981 and a spike in the need for Biosafety Professionals is seen.

23 Pertinent Biosafety Events
1986- EPA Medical Waste Requirements needles/syringes found on beaches on east coast, Medical Waste Tracking Act established resurgence of TB cases, MDR-TB observed OSHA Bloodborne Pathogens Standard st Human Gene Transfer trial initiated (ADA) 1993- Hantavirus outbreak, Southwest USA 1994- Publication of Richard Preston’s, The Hot Zone 1994- Sabia LAI, Yale Hendra virus, Australia/Avian flu, Hong Kong 1996- Mad Cow Disease (BSE) Medical Waste regulations, Rise in TB infections and the start of Human Gene Transfer research experiments en masse. OSHA issues a bloodborne pathogens standard in the wake of thousands of infections with Hepatitis B Virus. Another spike in the hiring of biosafety officers occurs again once the standard is issued. Hantavirus joins list of emerging infectious diseases. The “hot zone” scares the world with the big near miss in a non-human primate colony. Yale’s Sabia Virus infection is first big event to occur in world with infectious agents after the Hot Zone book as been read by many. This event at Yale received international notice as it marks how a Risk Group 4/BSL4 agent (Sabia was 1st classified as an unknown – after the infection, it was classified subsequently as a Risk Group 4 agent. More emerging infectious diseases identified (Hendra, Nipah), and Mad Cow (Bovine Spongiform Encephalopathy) marks a cross over from infected sheep parts consumed by cows.

24 Yale’s Sabia Virus incident in August 1994
Yale’s Sabia Virus incident in August The News reporters cited that he has been cut by a tube – but this was actually an airborne infection from a leak in the centrifuge. The response to the incident was horrible. The researcher didn’t immediately evacuate the lab; He wore a surgical mask which is not a respirator; He cleaned the spill later and stayed in the lab for about 4 hours breathing in “contaminated air” during the early part of this time; He never reported the incident to anyone; He didn’t recognize the signs/symptoms of the infection later when he started getting sick 3 to 4 days later; He traveled to Boston to meet with fellow scientists in a small meeting; The initial thought was the he had a recurrence of Malaria and was given anti-parasitic compounds; After this drug treatment didn’t work, he got worse and went to the YNHH Emergency Room; They called in the Infectious Disease Experts to try to figure out where he may have traveled to get such a disease; Only after being asked about travel to Africa and South America did he recall that he was working with a new pathogen and had an accident in the laboratory; He didn’t realize the potential AIRBORNE route of transmission; The only “new” quarantine area at YNHH was the very new Maternity Ward – the expectant mothers were moved to the old Maternity ward and the infected individual was the only patient in the entire ward!!!! The State of CT, City of New Haven, and the CDC were notified to report of the public health risk; 175 individuals in the Building and in his travels were identified as “exposed” and had to be followed up for 3 months to check if they were infected; Thankfully, nobody was infected and this was not a communicable disease! 6 to 9 months later, Sabia Virus was classified as a Risk Group 4 Pathogen. As a result of this infection, the State of CT dusted off an old set of regulations that were not directed to research laboratories previously, but started the discussions that led the registration and inspection of each research laboratory in the State of CT that were working with infectious agents.

25 Pertinent Biosafety Events
1997- Influenza A Virus (H5N1) in poultry, Hong Kong 1999- West Nile Virus, 1st time ever in U.S. st HGT death, UPenn OTC Protocol 1999- Nipah Virus, Malaysia (high mortality rate) 2001- Anthrax letters shipped via US Mail 2002- HGT Trials suspended after 2nd case of leukemia caused by integration of “defective” retroviral vector in host chromosome SARS Virus 2004 – Bird Flu (H5N1) concerns return 2004 – SARS LAI’s, Tularemia LAI’s (BU) Pandemic Influenza, SARS, West Nile Virus, Bioterrorism, and Select Agents have painted the landscape. Biosafety Officers experience another growth spurt in terms of extended work.

26 Pertinent Biosafety Events
2004 – TB Infections, Washington State (associated w/ Madison Aerosol Chamber). 2004 – Occular Vaccinia, Pennsylvania (route of exposure unknown). 2005 – Vaccinia infection from needlestick, Connecticut (animal research experiment) 2006 – Brucella infections – Texas A&M (associated w/ Madison Aerosol Chamber). 3 additional seroconversions to C. burnetii identified. 2007 – Significant non-compliance w/ Select Agent Regulations identified at Texas A&M (SA Research shut down). 2007 – U.S. Federal hearings on oversight of BSL3 and BSL4 laboratories. Madison Chambers designed to infect 100+ animals saves time, but spreads aerosols. Upgraded designs place all aspects of the Madison chamber that could present a risk inside a glove box for “real” primary containment. Multiple Vaccinia virus infections noted – Vaccinia is used as a surrogate for Smallpox and in immunology studies – however, break downs in work practices are found in both cases. The U.S. Government is in the process of trying to identify if more federal oversight is needed for BSL3 and BSL4 research.

27 Laboratory Acquired Infections (Harding & Byers)
Infections acquired through lab or lab related activities (symptomatic or asymptomatic) LAI’s came with golden age of Microbiology Typhoid 1885 Brucellosis 1887 Tetanus 1893 Lab acquired infections came hand in hand with conducting research with these agents. As soon as researchers began handling/performing research with these agents they became infected.

28 LAI’s (1930 - 2001) Harding & Byers
Sulkin & Pike 4,079 LAI’s 168 fatalities Brucellosis Q-Fever Hepatitis Typhoid Fever Tularemia Tuberculosis Dermatomycosis VEE Harding & Byers 1,267 over LAI’s 22 fatalities M. tuberculosis Q Fever Hantavirus Arboviruses Hepatitis B Virus Brucella Salmonella Shigella The study of LAI’s spanned many decades and at least 5 separate studies made up this pool of data. Only 20% of those infected could identify the specific route of exposure in these studies.

29 LAI’s 1930 - 2001 (Harding & Byers)
Total: 5, 346 LAI’s 190 deaths underreporting likely many more sub-clinical infections? Percentage that knew route of exposure similar from , and from ! Name that percentage? One “interactive” exercise to utilize here is a very simple STAND/SIT exercise that is used in various trainings to demonstrate statistical points. In advance of the lecture, place a sticker (colored dot, happy face, frown face, etc.) on the back of ONE OUT OF EVERY FIVE of your handouts. When this slide is shown – Ask the class to stand up Tell them that they represent the individuals who have been infected in the laboratory or by laboratory research since 1930. Tell them that Epidemiologists and Microbiologists have been analyzing data on Laboratory Acquired Infections, notably Drs. Sulkin and Pike, who started this work in the 1940’s/1950’s through to the 1970’s. Others have also continued this effort (Lynn Harding, Karen Byers, Drs. Dan Liberman and Emmett Barkley, and many others). One fact analyzed by these professionals was the percentage of individuals who could identify the route of exposure, or who knew how they got infected. Let the class know that this number has not changed very much over time and has been very difficult to determine in recent studies. Now ask the class to GUESS THE PERCENTAGE OF INFECTED RESEARCHERS WHO KNEW THE ROUTE OF EXPOSURE ASSOCIATED WITH THEIR INFECTION? Solicit the guesses from the group. Ask the class to flip over the handout that should have colored stickers on the backside. Ask those with the stickers to “sit down.” Those individuals represent the 20% who knew their specific route of exposure. Those who remain standing (the 80%) had no idea how they were infected. Then ask those standing to guess the most likely route of exposure for their infections. After input from the group, inform them that it is widely accepted that the AEROSOL Route of exposure was most likely implicated in these infections. Dr. Emmett Barkley (and others) analyzed many of these events and there were a variety of key findings that will be reviewed in this course, but among them were: virtually every laboratory procedure has the potential to generate aerosols; smaller aerosols, around 5 microns and smaller not only are more likely to penetrate the lower lung but have a very low terminal settling velocity or Vts – which tends to keep them in the air longer or float until they eventually hit the ground which could be hours later in some cases; some of those infected never stepped foot in a laboratory, but were exposed and infected from aerosols carried via the air through HVAC systems or just were not properly confined by primary or secondary containment measures; many of those creating the aerosols were not doing a good enough job here as many labs were not using appropriate primary containment devices such as Biological Safety Cabinets; those who were using biological safety cabinets were not using them appropriately. Again – much of this information will be covered in the remainder of the course. A few other AEROSOL studies to share are: the epidemiologist in San Francisco who tracked cases of Q-Fever, caused by Coxiella burnetii, in a swath 7 miles long by 1.5 miles wide in the late 1930’s downwind from a sheep processing site (abbatoir). Aerosols emanating from the process carried the zoonotic disease agent that far downwind and led to the infections of citizens newspaper report of prisoners in California, many immunosuppressed, who were infected with Cocciodies immitis (Valley Fever) after construction of a new prison adjacent to the current location unearthed spores of the agent which were carried via the air into the old prison yard and infected the inmates. The 1970’s Anthrax (Bacillus anthracis) outbreak in the former Soviet Union (Sverdlosk) after spores were accidentally released from a bioweapons manufacturing facility resulted in over 60 deaths and over 600 infections, some up to 2 miles+ away from the release point.

30 Secondary Infections (LAI’s) (Harding & Byers)
The transfer of an occupationally acquired infection to another person outside of the work environment. Uncommon (8 reported ) (2) Brucella- sexual transmission (2) Salmonella- microbiologist prepared dinner for family (one death) (1) Leptospira interrogans- through breast milk (2) Bordetella pertussis- to family members (1) B-Virus – spouse of injured animal care worker One of the worst possible outcomes of a LAI is the infection of those who are not present in the lab and who don’t work with the hazardous agent. The microbiologist who infected his wife and child was not himself infected and sheddding, but brought Salmonella typhimurium home with him on his hands or some other article of clothing.

31 Laboratory Acquired Infection (LAI) Summaries
PA Vaccinia LAI ocular infection (2004) Route unknown Breach in aerosol containment/poor work practices Failure to consistently wear gloves Absence of face protection while working outside of primary containment Failure to confine all procedures to biosafety cabinet Inadequate decontamination of contaminated work surfaces Possible hand to eye to contact during experiments Lack of awareness of signs/symptoms of disease Recent LAI – break down in work practices. Again, insufficient awareness of signs and symptoms. The infected worker had no idea that her swollen eye was a Vaccinia infection.

32 Laboratory Acquired Infection (LAI) Summaries
Vaccinia infection from needlestick (2005) Inadequate oversight, training Insufficient risk assessment, poor SOP utilized Poor work practices Transport of needles by hand to sharps container outside of room Recap of contaminated needles by hand Poor exposure response (delay in skin washing) No report of exposure (State reportable infection!) Secondary bacterial infection (required hospitalization) Very poor work practices with sharps leads to exposure and infection with Vaccinia virus, and hospitalization due to sepsis (a result of not cleaning the wound promptly and sufficiently).

33 Laboratory Acquired Infection (LAI) Summaries
Texas A&M Brucella infection (2006) Use of Madison Aerosol chamber Insufficient Risk Assessment for Agent and Operation Poor training of staff on use of chamber No secondary containment of device or animals removed from device (aerosols from hair of animals) No recognition of signs/symptoms of Brucella infection Untrained, unregistered researcher 3 Additional Q-Fever Infections (asymptomatic) unreported No immediate report of Select Agent infections to CDC (10 month delay) A major research institution is shut down by the federal government because of significant regulatory and biosafety lapses, which lead to 4 infections (1 symptomatic, 3 asymptomatic). The Madison Aerosol Chamber is involved once again.

34 Laboratory Acquired Infection (LAI) Summaries
BU Tularemia infections (2004) 3 cases – not identified by institution Discovered by personal physicians or ER No recognition of signs/symptoms of disease Attenuated BSL2 (non Select Agent strain?) If rDNA – in violation of NIH Guidelines! Lowering containment from BSL3 to BSL2 must be authorized by NIH OBA Inadequate risk assessment performed Inadequate containment, PPE, work practices Some procedures conducted on open bench Three infections over 9 months and nobody from the laboratory could identify what was happening. Not good news for a University hoping to open the Northeast’s first BSL4 Containment Facility.

35 Laboratory Acquired Infection (LAI) Summaries
Monkey B-Virus Infection (fatal), Georgia, 1997 (Yerkes Regional Primate Center) Ocular exposure during transport of non-human primate Insufficient training identified No agent-specific training on hazards associated w/ NHP’s No emergency/exposure response training provided Insufficient personal protective equipment No face protection provided Inadequate barrier (open cage) used for transport One of the most tragic LAI’s in recent memory. Many potential years of life lost in the death of a young woman at a regional primate research facility. Lack of safety training, protective clothing, engineering controls, and no incident or emergency response protocol helped prolong the delay in identifying the disease and getting antiviral medications to the young researcher, which could have saved her life. Although the facial mucous membranes were always considered a true exposure risk of infection with Monkey B Virus, very few non-human primate handlers actually wear safety glasses, goggles or face shields. The day after the death was announced, 100% of non-human primate research handlers were donning face protection. This marked the very first case of B-Virus (Cercopithicene Herpes Virus-1)

36 Biosafety Profession Resources:
American Biological Safety Association Centers for Disease Control & Prevention National Institutes of Health World Health Organization Excellent references to book mark and explore. ABSA, is the premier resource for Biological Safety information.

37 Biosafety Profession Certified Biological Safety Professional (CBSP) - Exam Task List Disinfection, decontamination, sterilization Work practices and procedures Risk assessment/hazard identification Regulatory aspects, standards & guidelines Program Management Equipment Operation and Certification Facility Design The CBSP Exam tests the student’s practical knowledge of the areas listed above.

38 Biosafety Profession Also requires knowledge of:
immunology, molecular biology, epidemiology microbiology, cell biology animal care and use, cell culture techniques immunizations, risk management aerobiology The breadth and scope of knowledge that the Biosafety Officer should have in order to perform their trade.

39 Biosafety Profession Sources of information/training
ABSA Professional Development short courses offered at annual conference and spring seminar local chapters and affiliates of ABSA Duke University MPH and DRPH degrees NIH Biosafety Training Program (BSL3/BSL4) Occ. Health/Public Health/Env. Health programs throughout U.S. and world Short courses (Harvard SPH, Eagleson Institute, Canada, AIHA, ASM, APIC, NSC, CSHEMA, etc.) Mentors (other biosafety officers, laboratorians, biosafety committee members, university courses (learning is ongoing!) Very few formal education programs, but other places to check in from time to time. The Duke University program is starting to close down. Colorado State University is attempting to create an MS Degree with a specialization in Biological Safety. Nothing beats a good mentor however!

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