Biosafety Basics. Patrick Stockton, Director, Office of Biosafety Biosafety Community Liaison Committee June 26, 2017

Transcription

1 Biosafety Basics Patrick Stockton, Director, Office of Biosafety Biosafety Community Liaison Committee June 26, 2017

2 What is Biosafety? The discipline that addresses how to provide guidance and assistance to protect faculty, staff, students and the community from exposure to biohazardous materials that may be harmful humans, animals, plants or the environment

3 Risk There is always risk. Risk must be identified Risk is evaluated Process to minimize the risk Assessments: Done in partnership with and based on information provided by the Principal Investigator Goal: Provide the highest practical protection with the lowest exposure potential

4 Risk Assessment Routes of transmission Agent stability Infectious dose Concentration Treatment Experimental process Geographical region Experience and skill

5 What Are Risk Groups? Risk Groups: Categorization of the agent itself High-Risk Microbes Low-Risk Microbes

6 What Are Biosafety Levels (BSL)? BSLs consist of combinations of laboratory practices and techniques, safety equipment, laboratory facilities and risk group. High-Risk Microbes BSL-4 BSL-3 BSL-2 Dangerous and exotic, posing a high risk of aerosol-transmitted infections. Infections caused by these microbes are frequently fatal and without treatment or vaccines. Examples: Ebola, smallpox Microbes: Either indigenous or exotic can cause serious or potentially lethal disease through respiratory transmission. Examples: HIV, H1N1 Flu, Yersinia pestis (plague), Tuberculosis, SARS, rabies, West Nile Virus, rickets. Moderate potential hazard to personnel and the environment. Includes bacteria and viruses that cause only mild disease to humans, or are difficult to contract via aerosol in a lab setting. Examples: Most Chlamydiae, hepatitis A, B, C, influenza A, Lyme disease, Salmonella, mumps, and measles. Low-Risk Microbes BSL-1 Not known to consistently cause disease in healthy adult humans, and of minimal potential hazard to laboratory personnel and the environment. Examples: canine hepatitis, non-pathogenic Escherichia coli, and noninfectious bacteria

7 Biosafety and Containment Facility (secondary containment) Lab design HVAC configuration directional and single-pass air HEPA filtration additional safety measure Safety Equipment Equipment Controls (primary containment) - Biological Safety Cabinets - Fume Hoods - Centrifuge rotors/buckets w/gaskets Personal Protective Equipment - Respirators - Gloves - Eye protection - Lab coats and gowns Facility Design Safety Equipment Standard and Special Microbiological Practices Work Practices Microbiological Practices and Specialized Procedures Standard and Special Practices (aseptic technique)

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9 HEPA Filter High-Efficiency Particulate Air % efficient particle 0.3 µm

10 Biosafety Cabinets - BSC Personal protection from harmful agents inside the cabinet Environmental protection from contaminants contained within the cabinet Product protection to avoid contamination of the work, experiment or process

11 BSC Containment Class II, A2 Room Air HEPA-filtered Air Contaminated Air Positive Pressure Contaminated Air Negative Pressure

12 HEPA Housing Filtering of room air

13 Biosafety Basics BSL-1 Risk Group 1 Well-characterized agent NOT typically associated with human disease (healthy human adult) Low individual risk Low community risk NP e-coli, AAV, b. subtillis

14 BSL-1 A B Bench top PPE A B

15 Biosafety Basics BSL-2 Risk Group 2 Well-characterized agent Can cause disease (rarely serious) Low to moderate individual risk Low community risk Prophylaxis and treatments are available Exposure routes: Mucous membrane Ingestion Injection 4 Hepatitis, influenza A, Salmonella

16 BSL-2 B A A A B PPE BSC

17 Biosafety Basics BSL-3 Risk Group 3 Indigenous or exotic agents Associated with potentially serious or potentially lethal disease Moderate to high individual risk Moderate community risk Prophylaxis and treatments are available Exposure routes: Aerosol Mucous membrane Ingestion Injection 6 5 Mtb, HPAI, NDV

18 BSL-3 E D B A C A B C D PPE BSC PAPR Security E Envelope

19 Biosafety Basics BSL-3 AG Risk Group 3 High-consequence livestock pathogens Associated with potentially serious or potentially lethal disease Moderate to high individual risk High agricultural risk Prophylaxis and treatments may be available Exposure routes: Aerosol Mucous membrane Ingestion Injection 1 5

20 BSL-3 AG

21 BSL-3 AG E F C D A A B C PAPR APR Door Security B D E PPE Envelope F Box w/in a box

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23 Patrick Stockton Biosafety Officer/RO Manley Kiser Associate BSO/ARO Nancy Mead Biosafety Manager/ARO Anonymous Reporting Andrea Ferrero-Perez Biosafety Manager Chad Cheely Biosafety Professional