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biosafety and ethics

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  1. 1. Basic Biosafety Principles
  2. 2.  Principles and practices employed to protect laboratory personnel and the environment from exposure or infection while working with living organisms, biological materials, or agents.  Included are any materials that may be potentially infectious.  Includes recombinant DNA research What is Biosafety?
  3. 3.  The “agent” is the what creates risk  Risks to the worker or environment are often unknown  Determining “acceptable risk”? Agents and Risks
  4. 4.  There is always risk!  The risk must be identified  The risk is evaluated  The risk must be measured  Plan to minimize the risk Assessing Risk
  5. 5.  Assessment is conducted by a Biosafety Professional in partnership with and based on information provided by the Principal Investigator  The assessment is presented to the Institutional Biosafety Committee (IBC) for approval Who Determines Acceptable Risk?
  6. 6.  Understand the biology of the agent  Susceptibility and transmission within the host  Hazards associated with equipment and procedures  Goal:  Provide the highest practical protection and the lowest practical exposure Identifying Risk
  7. 7.  Worst case scenario -What might happen?  Likelihood of an event  Seriousness of the incident  Actions needed to resolve the problems Evaluating Risk Acceptability
  8. 8.  Since there is no such thing as “no risk”  “Safe” means risk has been judged acceptable  Judging risk is a subjective- humans make decisions  Measuring risk is objective- use available guidelines, data, and documentation  Keep records of how determinations were made due to subjective nature of the process What is Acceptable Risk?
  9. 9. Sunday, Sep. 20, 2009 Did the Plague Kill Illinois Scientist? By AP (AP / CHICAGO) — The University of Chicago Medical Center says the infection that killed a scientist may be connected to bacteria he researched that causes the plague. The university said Saturday that its researcher studied the genetics of harmful bacteria including Yersinia pestis, which causes the illness. He died Sept. 13. His name and age haven't been released The medical center says the bacteria he worked with was a weakened strain that isn't known to cause illness in healthy adults. The strain was approved by the Centers for Disease Control and Prevention for laboratory studies. An autopsy found no obvious cause of death but did find the presence of the bacteria. More tests are planned. No other illnesses have been reported.
  10. 10. Biosafety in Various Disciplines Biosafety is related to several fields  ECOLOGY: referring to imported life forms not indigenous to the region (Reggie the alligator)  AGRICULTURE: reducing the risk of alien viral or transgenic genes, or prions such as BSE/"MadCow“; reducing the risk of food bacterial contamination  MEDICINE: referring to organs or tissues from biological origin, or genetic therapy products, virus; levels of lab containment protocols BSL-1, 2, 3, 4 in rising order of danger  CHEMISTRY: i.e., nitrates in water, PCB levels affecting fertility  EXOBIOLOGY: i.e., NASA's policy for containing alien microbes that may exist on space samples - sometimes called "biosafety level 5"
  11. 11. Biosafety in Academic Research  Research Universities: Promoting safe laboratory practices, and procedures; proper use of containment equipment and facilities; provides advice on laboratory design and risk assesment of experiments involving infectious agents, rDNA in-vitro and in-vivo. Bottom Line: Risk & Containment
  12. 12. Biohazard Symbol  Charles Baldwin at National Cancer Institute at NIH.  Symbol to be “memorable but meaningless” so it could be learned.  Blaze orange – most visible under harsh conditions
  13. 13. Biosafety Issues  Laboratory Safety  Bloodborne pathogens (BBP)  Recombinant DNA (rDNA)  Biological waste disposal  Infectious substance and diagnostic specimen shipping
  14. 14. Biosafety Issues (con’t.)  Respiratory Protection  Bioterrorism and Select agents  Mold and indoor air quality  Occupational safety and health in the use of research animals  Biohazards used in animal models
  15. 15. Biohazardous Materials  Viruses  Bacteria  Fungi  Chlamydiae/Rickettsiae  Prions  Recombinant DNA
  16. 16. Biohazardous materials  Transgenic Plants, Animals and Insects
  17. 17. Transgenic Insects
  18. 18. Biohazardous Materials  Human and Primate Cells, Tissues, and Body Fluids  Brain Tissue from Demented Patients  Viral Vectors  Replication deficient viruses
  19. 19. Biosafety In Microbiological and Biomedical Laboratories “BMBL” (acronym) CDC/NIH Publication Safety “Guidelines” Regulations of Institution receives NIH funding Code of Practice and “Gold” Standard in Industry anl Gold Standard Clinical & Research Lab. Biosafety Concepts HHS Publication No. (CDC) 93-8395
  20. 20. The New BMBL  Early print edition….  Emphasis on “Risk & Containment”
  21. 21. The BMBL continues to be published by the CDC and the NIH 5th edition is now at the printers osfty/bmbl5/bmbl5toc.htm Biosafety Concepts The BMBL
  22. 22. Are the NIH Guidelines Optional?  “Guidelines” does not mean “optional”  They are a term and condition of NIH funding for recombinant DNA research. From Kathryn Harris, NIH, OBA
  23. 23. Biosafety Concepts from the BMBL Principles of Biosafety  Practice and Procedures  Standard Practices  Special Practices & Considerations  Safety Equipment  Facility Design and Construction  Increasing levels of protection
  24. 24. Principles of Biosafety Biosafety Levels 1-4 (BSL)  Increasing levels of employee and environmental protection  Guidelines for working safely in research & medical laboratory facilities Animal Biosafety Levels 1- 4 (ABSL)  Laboratory animal facilities  Animal models that support research  Guidelines for working safely in animal research facilities
  25. 25. Biosafety Concepts The BMBL (1) Standard Microbiological Practices  Most important concept / Strict adherence  Aware of potential hazard  Trained & proficient in techniques  Supervisors responsible for:  Appropriate Laboratory facilities  Personnel & Training  Special practices & precautions  Occupational Health Programs
  26. 26. Biosafety Issues The BMBL (2) Safety Equipment  Primary Containment Barrier  Minimize exposure to hazard  Prevent contact / Contain aerosols  Engineering controls/ equipment  Personal Protective Equipment (PPE)  Gloves, gowns, Respirator, Face shield, Booties  Biological Safety Cabinets  Covered or ventilated animal cage systems
  27. 27. Biosafety Concepts The BMBL (3) Facility Design and Construction  Secondary Barrier/ Engineering controls  Contributes to worker protection  Protects outside the laboratory  Environment & Neighborhood  Ex. Building & Lab design, Ventilation, Autoclaves, Cage wash facilities, etc.
  28. 28. Laboratory Design “Warehouse Type Lab”
  29. 29. Discussion  What are some of the negatives and positives of this open lab concept?
  30. 30. Biosafety Level-1 Concepts of Biosafety Biosafety Level-1 (BSL-1 or ABSL-1)  Well characterized agents  Agents not known to cause disease (in healthy human adults; now healthy immunocompetent adults)  Prophylactic treatment available  Open bench procedures  Animals in open cage system or open environment (outdoors)  Good laboratory practices
  31. 31. Risk Group 1 Agents  E.coli K-12  Transgenic Plants  Plasmids  Fungi  Mold  Yeast
  32. 32. BSL-1 Practices  Bench-top work allowed  Daily Decontamination  Manual pipetting  Required Handwashing  Red bag waste  Bio cabinet not required (unless creating aerosols)  2˚ containment
  33. 33. Risk Group 2 Agents  Human or Primate Cells  Herpes Simplex Virus  Replication Incompetent Attenuated Human Immunodeficiency Virus  Patient specimens
  34. 34. BSL-2 Practices Concepts of Biosafety Practices & Procedures  Agents associated w/ human disease  Treatment for disease available  Agent poses moderate hazard to personnel and environment  Direct contact or exposure  Percutaneous exposure  Scratch, Puncture, Needle stick  Mucus membrane exposure  Eyes, Mouth, open cut
  35. 35. BSL-2 Practices  Limited access to lab when work in progress  Daily decontamination  Mechanical pipetting  Labcoat, safety glasses and gloves required  Red bag & sharps containers required
  36. 36. BSL-2 Practices (con’t)  Biohaz. Sign posted at entrance to lab  Label all equipment (incubators, freezers, etc.)  TC room – negative air flow  Documented training  Baseline serology or pre- vaccination may be required
  37. 37. Risk Group 3 Agents  Human Immunodeficiency Virus  Mycobacterium tuberculosis  Coxiella burnetii
  38. 38. Biosafety Level 3 Working in High Containment Biosafety Level-3 (BSL-3 or ABSL-3)  Indigenous or exotic agents  Aerosol transmission  Serious health effects  Treatment may or may not exist
  39. 39. BSL-3 Practices  Public access NOT permitted  Daily decontamination after spill and upon completion of experiment  Autoclave required and waste is disposed at the end of day  Required foot activated handwashing sink and controls  No sharps unless absolutely necessary
  40. 40. BSL-3 Practices (con’t)  Aerosol minimization procedures required  Wrap around disposable clothing is required. Specialized equipment may be required depending upon procedures  Biohaz. Signs and labels posted  Air flow from low hazard to high hazard “Pressure Mapping”
  41. 41. BSL-3 Practices (con’t)  Bench top work not permitted  Documented training and personnel competency certification (for BSL-3 procedures)  Baseline serology  Spills – report immediately and treat accordingly  Vaccinations/post exposure protocols and SOP’s, Biosafety Manual, Biosafety Officer
  42. 42. UCSD’s BSL-3
  43. 43. Biosafety Level-4 Working in High Containment Biosafety Level-4  Builds on BSL-3/ ABSL-3 practices  Maximum containment facilities  Pressurized Containment Suite  BSL-3 + Class III Biosafety Cabinet  Chemical decontamination showers  Liquid effluent collection / decontamination  No BSL-4 labs exist at UCSD
  44. 44. Biosafety Level 4  Lassa Fever Virus  Ebola Hemmorrhagic Fever Virus  Marburg Virus  Herpes B Virus
  45. 45. Biosafety Concepts Working in High Containment Biosafety Level-4 (BSL-4 or ABSL-4)  Dangerous/exotic agents  Life threatening disease  Aerosol transmission  Agents of unknown risk of transmission or health affects  No known treatment
  46. 46. Animal Biosafety Level-4 Working in High Containment
  47. 47. Bacterial: 76% from clinical labs 8% from research labs Exposure: 60% acquired from inhalation Other exposures include: digestion, sharps, splashes, direct and indirect contact Laboratory Acquired Infections (LAI)
  48. 48. Viral  16% from clinical labs  70% from research labs  32% from animal related activities Laboratory Acquired Infections (LAI)
  49. 49. General Good Lab Technique  Hygienic Practices  No Smoking, Eating, Applying cosmetics, lip balm, contacts  Wash hands after procedures  Decontaminate lab bench before and after work
  50. 50. General Operational Practices  Proper attire  Minimum – lab coat, safety glasses, gloves  Plan your work  Know in advance what you are working with  Read available resources (MSDS) ftss/index.html
  51. 51. Animal Containment Points CDC - 1957 CDC & UCSD - 2005 Courtesy of Paul Vinson, CDC
  52. 52. Discussion # 2  Based on what you know about Biosafety Levels, Practices and Operational Controls, what are some discussion issues for conducting Biohazard risk assessments?  How do you approach risks when addressing a particular organism?
  53. 53. Risk Assessment In-Vitro In-Vivo Human Clinical Trial
  54. 54. Addressing Risk Assessments  What is the organism?  Is it Wild-type, attenuated, irradiated, or chemically treated? Look at kill data or kill curves.  What is the max. concentration, volume, infectious dose?  What is the work space like?  Aerosolizing procedures? How do they contain their aerosols?
  55. 55. Risk Assessment, con’t  Are personnel trained? Do personnel understand the organism, infectious dose and symptoms?  What are their experimental procedures?  Will they be transporting the material? Shipping intra, inter- state or international?  Are they doing tissue culture?  Do they have adequate containment equipment? Tom Pugh
  56. 56. Risk Assessment, Con’t  Are they doing this work in-vivo? Have you consulted and discussed this with the Vets and IACUC to determine special needs and housing?  Waste issues addressed?  Pregnancy issues with the organisms?
  57. 57. Risk Assessment, con’t  Do they share their Tissue Culture room?  Do they have more than 1 Biosafety Cabinet?  Occupational Health informed and set up to receive patient or offer counseling?
  58. 58. Accidental Spills  Evacuate area, alert personnel and cordon off so that aerosols may settle  Don PPE; Cover with paper towels and apply bleach (1 part bleach : 9 parts water  Allow 15 – 20 min contact time  Wipe up working towards center  Use tongs if broken glass is involved Is Recombinant DNA involved?
  59. 59. First Aid Measures  Splash to Eye or Needlestick Injury  Rinse thoroughly for 15 minutes at the eyewash or sink