emd 545b biosafety biosecurity and the evaluation of biohazards
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EMD 545b Biosafety, Biosecurity, and the Evaluation of Biohazards. Course Lecture #1. 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

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lecture 1 outline
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
course objectives
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
course syllabus
Course Syllabus
  • Lectures
    • 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
course syllabus5
Course Syllabus
  • Projects
    • 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
  • 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, email, or online)
  • Previous coursework or experience in Micro or Molecular Biology?
  • Introductions
  • Student Interests
    • What do YOU hope to get out of the class?
  • Course Goals!!
  • 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
  • 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
biohazard settings biosafety applications11
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)
biohazard settings biosafety applications12
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
biohazard settings biosafety applications13
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
biohazard settings biosafety applications14
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???
oehs biosafety
  • “We don’t make the jobs you do…..
  • We make the jobs you do safer.”
biosafety historical perspective seymour block
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)
biosafety historical perspective seymour block17
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). 1478-1553
  • Venice Magistry of Health- fumigated cargo and mail from ships, 1438
biosafety historical perspective seymour block18
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
biosafety historical perspective seymour block19
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)
biosafety historical perspective seymour block20
Biosafety: Historical Perspective (Seymour Block)
  • Joseph Lister- antiseptic use on open wounds (phenol), poured directly into wounds, lowered infection rate from 90 - 15%, (1860’s - 1880’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)
pertinent biosafety events
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
  • 1966-1968- development of Biohazard Symbol
  • 1969- Lassa Fever LAI’s at Yale
  • 1970- OSHA, EPA created (OSHA General Duty Clause)
pertinent biosafety events22
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)
  • 1980-1984 - CDC/NIH Biosafety handbook, WHO text
  • 1981- 1st HIV cases reported
pertinent biosafety events23
Pertinent Biosafety Events
  • 1986- EPA Medical Waste Requirements
  • 1988-1994- needles/syringes found on beaches on east coast, Medical Waste Tracking Act established
  • 1988-1992- resurgence of TB cases, MDR-TB observed
  • 1988-1991- OSHA Bloodborne Pathogens Standard
  • 1990- 1st Human Gene Transfer trial initiated (ADA)
  • 1993- Hantavirus outbreak, Southwest USA
  • 1994- Publication of Richard Preston’s, The Hot Zone
  • 1994- Sabia LAI, Yale
  • 1995 - Hendra virus, Australia/Avian flu, Hong Kong
  • 1996- Mad Cow Disease (BSE)
pertinent biosafety events25
Pertinent Biosafety Events
  • 1997- Influenza A Virus (H5N1) in poultry, Hong Kong
  • 1999- West Nile Virus, 1st time ever in U.S.
  • 1999- 1st 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
  • 2003 - SARS Virus
  • 2004 – Bird Flu (H5N1) concerns return
  • 2004 – SARS LAI’s, Tularemia LAI’s (BU)
pertinent biosafety events26
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.
laboratory acquired infections harding byers
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
lai s 1930 2001 harding byers
Sulkin & Pike

1930 - 1978

4,079 LAI’s

168 fatalities




Typhoid Fever





Harding & Byers

1979 - 2001

1,267 over LAI’s

22 fatalities

M. tuberculosis

Q Fever



Hepatitis B Virus




LAI’s (1930 - 2001) Harding & Byers
lai s 1930 2001 harding byers29
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 1930 - 1978, and from 1979 - 1999!
  • Name that percentage?
secondary infections lai s harding byers
Secondary Infections (LAI’s)(Harding & Byers)
  • The transfer of an occupationally acquired infection to another person outside of the work environment.
    • Uncommon (8 reported 1979 - 2001)
    • (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
laboratory acquired infection lai summaries
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
laboratory acquired infection lai summaries32
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)
laboratory acquired infection lai summaries33
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)
laboratory acquired infection lai summaries34
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
laboratory acquired infection lai summaries35
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
biosafety profession
Biosafety Profession
  • Resources:
    • American Biological Safety Association www.absa.org
    • Centers for Disease Control & Prevention www.cdc.gov
    • National Institutes of Health www.nih.gov
    • World Health Organization www.who.org
biosafety profession37
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
biosafety profession38
Biosafety Profession
  • Also requires knowledge of:
    • immunology, molecular biology, epidemiology
    • microbiology, cell biology
    • animal care and use, cell culture techniques
    • immunizations, risk management
    • aerobiology
biosafety profession39
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!)