Risk Assessment in Animal Biosafety

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 PIs 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
• SOPs prepared and approved
• Clearance for each researcher/animal handler
• Written Emergency Response Plans

16
Risk Assessment Process

• When you dont 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 ExampleABSL-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 ExampleABSL-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 ExampleABSL-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 ExampleABSL-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 ExampleABSL-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 ExampleABSL-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