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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EMD 545bBiosafety, Biosecurity,and the Evaluationof Biohazards

Course Lecture #1


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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


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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


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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


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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


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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, email, or online)

  • Previous coursework or experience in Micro or Molecular Biology?


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Students

  • Introductions

  • Student Interests

    • What do YOU hope to get out of the class?

  • Course Goals!!


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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


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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



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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)


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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


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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


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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???


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OEHSBiosafety

  • “We don’t make the jobs you do…..

  • We make the jobs you do safer.”


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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)


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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


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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


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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)


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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)


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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)


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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


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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)


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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)


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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.


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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


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    Sulkin & Pike

    1930 - 1978

    4,079 LAI’s

    168 fatalities

    Brucellosis

    Q-Fever

    Hepatitis

    Typhoid Fever

    Tularemia

    Tuberculosis

    Dermatomycosis

    VEE

    Harding & Byers

    1979 - 2001

    1,267 over LAI’s

    22 fatalities

    M. tuberculosis

    Q Fever

    Hantavirus

    Arboviruses

    Hepatitis B Virus

    Brucella

    Salmonella

    Shigella

    LAI’s (1930 - 2001) Harding & Byers


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    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?


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    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


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    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


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    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)


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    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)


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    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


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    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


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    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


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    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


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    Biosafety Profession

    • Also requires knowledge of:

      • immunology, molecular biology, epidemiology

      • microbiology, cell biology

      • animal care and use, cell culture techniques

      • immunizations, risk management

      • aerobiology


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    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!)


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