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Risk Assessment

Risk Assessment. Objectives. Define risk assessment as it relates to biosafety Understand the risk assessment process and how to implement it Discuss risk factors in the risk assessment process Address exam topics 15, 16, 17, 18, 22, 23, 26, & 30. Risk .

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Risk Assessment

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  1. Risk Assessment

  2. Objectives • Define risk assessment as it relates to biosafety • Understand the risk assessment process and how to implement it • Discuss risk factors in the risk assessment process • Address exam topics 15, 16, 17, 18, 22, 23, 26, & 30.

  3. Risk • Risk implies the probability that harm, injury, or disease will occur – CDC/NIH BMBL

  4. Biological Risk Assessment • Risk assessment is a process used to identify the hazardous characteristics of a biological agent, the activities that can expose an individual, the likelihood of infection, and the consequences of an infection. – CDC/NIH BMBL 5th ed. • Subjective process • The key to biosafety

  5. Risk Assessment Methodologies • CDC/NIH Biosafety in Microbiological and Biomedical Laboratories, section II • NIH recombinant DNA guidelines, section II-A • WHO Laboratory Safety Manual, Part I 2. • Sandia National Laboratory Report - Biosafety Risk Assessment Methodology http://www.biosecurity.sandia.gov/BioRAM/Biosafety%20Risk%20Assessment%20Report.pdf

  6. Risk Assessment Goal • Assign appropriate practices and facility requirements to a protocol • Individual • Community • Environment

  7. Primary Considerations • Agent(s) • Procedures • Experience

  8. Risk Groups • Risk Group 1 • No or low individual and community risk • Unlikely to cause disease in healthy subject • Risk Group 2 • Moderate individual risk, low community risk • Can cause disease Lab exposures may result in infection, but effective treatment and preventative measures are likely available and risk of spread of infection is limited • Usually fecal/oral or inoculation hazard • Risk Group 3 • High individual risk, low community risk • Usually causes serious disease but does not easily spread. Effective treatment and preventative measures are likely available. • Usually airborne hazard • Risk Group 4 • High individual and community risk • Causes serious disease and can be readily transmitted. Effective treatment and preventative measures are not usually available • viral

  9. Risk Group Examples • RG 1 – Bacillus subtilis • RG 2 – Salmonella typhi • RG 3 – Coxiellaburnetii • RG 4 – Herpesvirussimiae

  10. Risk Group Resources • ABSA database • http://www.absa.org/riskgroups/index.html • NIH rDNA guidelines • http://oba.od.nih.gov/oba/rac/Guidelines/APPENDIX_B.htm • WHO • Others – Canada • http://www.phac-aspc.gc.ca/lab-bio/res/psds-ftss/index-eng.php

  11. Risk Group does not automatically equate to Biosafety Level

  12. Risk Group Exercise • Adeno-associated virus (AAV) • Adenovirus • Escherichia coli K-12 • Escherichia coli O157:H7 • Mycobacterium tuberculosis • Bacillus anthracis • Coccidiodesimmitis

  13. Other Agent Factors to Consider • Pathogenicity • Routes of exposure • Concentration / Infectious dose • Stability • Treatment options / vaccine availability

  14. Host Susceptibility • Assume “normal” host • Age • Sex • Vaccination status • Assess personnel performing work • Reproductive risks? • Remember animal and plant pathogens

  15. Procedural Considerations • Location of work • Scale • Aersolization potential • Use of sharps • Personal protective equipment • Containment equipment • Animal or plant models • Cell cultures • Genetic manipulation

  16. Recombinant DNA • Genes inserted • Antimicrobial resistance • Oncogenes • Toxins • Increase of virulence • Extension of host range • Stability in environment improvement • Human gene transfer

  17. Experience • Personnel proficiency • Previous experience • Technique • Training

  18. The Process • Who performs the risk assessment? • PI or lab director initially • Available tools • CDC - http://www.cdc.gov/biosafety/publications/BiologicalRiskAssessmentWorksheet.pdf • Sandia - http://biosecurity.sandia.gov/BioRAM/Biosafety%20Risk%20Assessment%20Report.pdf • IBC forms • Documentation • http://www.lbl.gov/ehs/biosafety/manual/html/3.0.shtml

  19. Biotoxins • Chemicals of biological origin • LD50 • NIH rDNA guidelines • Select Agent toxins • Examples • Botulism, Cholera, Diptheria

  20. Additional Considerations • Biosecurity • Field studies • Shipping • Effluent / Waste

  21. Risk Assessment Challenge • What facilities and practices would you require? • Analysis of clinical samples of TB • Antibiotic susceptibility testing of INDs for TB • Imaging study of Yellow fever vaccine strain • Diagnostic studies of CJD • Vaccine research on HIV

  22. Questions?

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