Risk Assessment in Animal Biosafety
► Risk
Assessment Factors
 Pathogen/agent
 Animal Model (species)
 Procedures
►Proposed
manipulations
►Assigned safe work practices
Risk Assessment in Animal Biosafety
► Risk
Assessment Factors
 Personnel
 Protective Equipment
►Personal
Protective Equipment/Clothing
►Engineering Controls/Safety Devices
 Place/Facility for proposed research
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?
Risk Assessment Process
► Prior
to initiation of work
► Principal Investigator submits written risk
assessment
 Written proposal
 Registration Form
► Submitted
Office
to the IBC/IACUC/Biosafety
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
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?
Risk Assessment – Proposed
Procedures
► Manipulations





planned with the animal
Blood collection
Tissue harvesting/necropsy
Aerosols, splash risk
Sharps
Genetic manipulation
Working Safely with Sharps
Risk Assessment - Personnel
► Immune
status of host
 Altered competency – suppression (disease,
therapy)
 Experience/Training WITH:
►Agent
►Animals
►Procedures
►Equipment
►Facility
 Safety Record/Attitude
Risk Assessment
► Ensure
that the PI’s group is involved in
development of the SOP!
 Take ownership
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
Handling Microisolator Cages
Risk Assessment – Facility
► Conformity
w/
 ABSL-1, ABSL-2, and ABSL-3 Facilities
► Compliance
with pertinent:
 Guidelines
 Regulations
 Standards
► Enhanced
Facilities
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
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
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
involved
RA and RM decisions to all
LCMV – Risk Assessment Example
►
National Risk Group Classification
 RG3 – neurotropic strains, RG2 – nonneurotropic strains
► Previous
LAI via airborne route
► Shedding from animal (urine)
► Clone 13 (persistent shedding)
► Environmental stability (survives for weeks
in animal waste)
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
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
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
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




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
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
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