Comprehensive Guide to Animal Biosafety Risk Assessment

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

20. 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 Case Study ExampleABSL-2 rDNA – Vaccinia Virus

21. 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 Case Study ExampleABSL-2 rDNA – Vaccinia Virus

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

23. 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 Case Study ExampleABSL-2 rDNA – Vaccinia Virus

24. 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 Case Study ExampleABSL-2 rDNA – Vaccinia Virus