1. Risk Assessment in Animal Biosafety ► Risk Assessment Factors  Pathogen/agent  Animal Model (species)  Procedures ► Proposed manipulations ► Assigned safe work practices

2. Risk Assessment in Animal Biosafety ► Risk Assessment Factors  Personnel  Protective Equipment ► Personal Protective Equipment/Clothing ► Engineering Controls/Safety Devices  Place/Facility for proposed research

3. Risk Assessment in Animal Biosafety ► Species ► Natural infections ► Unpredictable - physical hazards  Bites/scratches/splashes ► Permissive species ► Immune system of animal ► Shedding (urine, feces, sputum) ► Data? Transmission between cage mates? Between cages within room?

4. Risk Assessment Process ► Prior to initiation of work ► Principal Investigator submits written risk assessment  Written proposal  Registration Form ► Submitted to the IBC/IACUC/Biosafety Office

5. Committee Risk Assessment ► Questions/clarification ► Has PI started w/ Risk Group? Worked towards Biosafety Level?  Verify that PI has identified: ► Risks involved ► Routes of exposure (nature/ lab settings) ► Signs/symptoms of infection ► Potential for shedding from animals ► At risk personnel (those contraindicated from work) ► Any special medical surveillance requirements  Serum banking, immunizations, screening/evaluation

6. Committee Risk Assessment ► Questions/clarification  Verify that PI has Selected the Appropriate: ► BSL ► Work Practices ► PPE ► Containment Equipment  To maximize protection of staff  Does Facility meet requirements for BSL selected?

7. Risk Assessment – Proposed Procedures ► Manipulations planned with the animal  Blood collection  Tissue harvesting/necropsy  Aerosols, splash risk  Sharps  Genetic manipulation

8. Working Safely with Sharps

9. Risk Assessment - Personnel ► Immune status of host  Altered competency – suppression (disease, therapy)  Experience/Training WITH: ► Agent ► Animals ► Procedures ► Equipment ► Facility  Safety Record/Attitude

10. Risk Assessment ► Ensure that the PI’s group is involved in development of the SOP!  Take ownership

11. Risk Assessment – Equipment ► Cages/housing  Open  Static, MI (Filtration Efficiency)  Ventilated Cage Racks w/ HEPA filters ► PPE  Coat, gown, jump suits, full clothes change/shower  Masks, face protection, Respirators

12. Handling Microisolator Cages

13. Risk Assessment – Facility ► Conformity w/  ABSL-1, ABSL-2, and ABSL-3 Facilities ► Compliance with pertinent:  Guidelines  Regulations  Standards ► Enhanced Facilities

14. Risk Assessment - Process ► Professional Judgment Required ► Expertise  IACUC ► Animal model, animal care and use, animal regulations  IBC/BSO ► Agent, exposure routes, med. Surveillance, facility design, equipment use/certification  Principal Investigator ► Disease under study, scientific aim, lab techniques

15. Risk Assessment - Process ► After review of Risk Assessment Factors: ► Select most appropriate BSL  PPE  Work Practices  Engineering Controls  Facility Controls ► SOP’s prepared and approved ► Clearance for each researcher/animal handler ► Written Emergency Response Plans

16. Risk Assessment Process ► When you don’t have all the answers?  Be Cautious/Conservative  RA is evolving/dynamic process  Change as info comes in ► Communicate RA and RM decisions to all involved

17. LCMV – Risk Assessment Example ► National Risk Group Classification  RG3 – neurotropic strains, RG2 – non- neurotropic strains ► Previous LAI via airborne route ► Shedding from animal (urine) ► Clone 13 (persistent shedding) ► Environmental stability (survives for weeks in animal waste)

18. LCMV – Risk Assessment Example ► Use of sharps  Inoculations, bleeds, necropsies ► Transport of tissues, infected cells, virus ► Protective Clothing  Gowns, 2 pair of gloves, booties, face protection, Respiratory Protection ► Protective Equipment  Microisolator cages, biosafety cabinets ► Place – ABSL-3 facility

19. Case Study Example ABSL-2 rDNA Protocol – Vaccinia Virus ► Location A ► Registration(s)  IACUC  IBC ► Location B ► Registration(s)  IACUC  IBC  ARC Haz. Agent Form  EHS RTUIA-Animals  State Human Pathogen registration

20. Case Study Example ABSL-2 rDNA – Vaccinia Virus ► Location A ► Review of Training  IACUC Orientation  Animal Handling ► Location B ► Review of Training  IACUC Orientation  Animal Handling  EHS Classes ► Biosafety, BBP, Chem  Researcher Experience Form

21. Case Study Example ABSL-2 rDNA – Vaccinia Virus ► Location A ► Specific SOP created  none ► Location B ► Specific SOP created  Entry, exit, supplies  Protective clothing  Biosafety cabinet use  Safe sharps (devices/use)  Decontamination  Emergency response

22. Case Study Example ABSL-2 rDNA – Vaccinia Virus ► Location A ► Additional Requirements  Medical Surveillance ► Health history form ► Location B ► Additional Requirements  Medical Surveillance ► Health history form ► Vaccinia immunization consult ► Employee Health review

23. Case Study Example ABSL-2 rDNA – Vaccinia Virus ► Location A ► Training/Inspection  Facility orientation ► Location B ► Training/Inspection  Facility orientation  State DPH Inspection  ARC/EHS/VC start-up meeting w/ researcher  Researcher work practice observation

24. Case Study Example ABSL-2 rDNA – Vaccinia Virus ► Location A ► Implementation  Vaccinia needlestick  No incident report  Vaccinia LAI and bacterial sepsis  Hospitalization  Report to State DPH  Report to NIH OBA (significant incident/illness) ► Location B ► Implementation  No incidents to date