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 5 th 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%20Re port.pdf http://www.biosecurity.sandia.gov/BioRAM/ Biosafety%20Risk%20Assessment%20Re port.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 – Coxiella burnetii  RG 4 – Herpesvirus simiae

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

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/BiologicalRisk AssessmentWorksheet.pdf http://www.cdc.gov/biosafety/publications/BiologicalRisk AssessmentWorksheet.pdf Sandia - http://biosecurity.sandia.gov/BioRAM/Biosafety%20Risk %20Assessment%20Report.pdf http://biosecurity.sandia.gov/BioRAM/Biosafety%20Risk %20Assessment%20Report.pdf IBC forms  Documentation  http://www.lbl.gov/ehs/biosafety/manual/html/3.0.s html http://www.lbl.gov/ehs/biosafety/manual/html/3.0.s html

19. Biotoxins  Chemicals of biological origin  LD 50  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?