Semi Annual Program Reviews and Facility Inspection Betty Goldentyer, DVM Betty Goldentyer, DVM Eastern Regional Director USDA, APHIS, Animal Care
Animal Welfare Act §2143 (b) Research Facility Committee: establishment, membership, functions, etc. (3)The Committee shall inspect at least semi-annually all animal study areas and animal facilities and review…
Animal Welfare Act §2143 (A) Practices involving pain to animals, and (B) the condition of animals, to ensure compliance with the provisions of this chapter to minimize pain and distress to animals.
Animal Welfare Act Regulations §2.31 (C) IACUC Functions (1)Review at least once every six months, the research facilitys program for the humane care and use of animals Using AWAR as a basis for evaluation Using AWAR as a basis for evaluation
Animal Welfare Act Regulations §2.31 (C) (2) Inspect, at least once every six months, all of the research facilitys animal facilities including animal study areas…. (3) Prepare reports of its evaluations and submit the reports to the Institutional Official
Consider AWA directs us to review practices involving pain and minimize pain and distress AWA directs us to review practices involving pain and minimize pain and distress AWAR IACUC function #1 – review the program for humane care and use AWAR IACUC function #1 – review the program for humane care and use
Program Review Institutional policies, procedures and responsibilities Animal environment, housing and management Veterinary medical care Physical plant
Hot Topics Unannounced/Announced Unannounced/Announced Inspection of laboratories Inspection of laboratories Remote sites Remote sites Subcommittees Subcommittees Access and Biosecurity Access and Biosecurity
Announced ? Unannounced Its up to the IACUC Its up to the IACUC Unannounced can be helpful in a problem area Unannounced can be helpful in a problem area Can switch back and forth Can switch back and forth
Inspecting Individual Labs Study Area means any building, room, area, enclosure, or other containment outside of a core facility or centrally designated or managed area in which animals are housed for more than 12 hours. Study Area means any building, room, area, enclosure, or other containment outside of a core facility or centrally designated or managed area in which animals are housed for more than 12 hours.
It Depends The Institution is responsible for all the activities The Institution is responsible for all the activities USDA can inspect all the activity areas USDA can inspect all the activity areas
Some Options IACUC has authority to inspect IACUC has authority to inspect Can inspect Randomly or rotating Can inspect Randomly or rotating Can inspect based on activity Can inspect based on activity Pain category Pain category Species Species
Remote Sites Must be inspected Must be inspected Can use a subcommittee Can use a subcommittee Cant exclude any member Cant exclude any member Watch for conflict of interest Watch for conflict of interest
Using Subcommittees At least 2 members At least 2 members Cant exclude anyone Cant exclude anyone Can include consultants Can include consultants AALAC site visit works if 2 IACUC members present AALAC site visit works if 2 IACUC members present
Access and Biosafety Announced Inspections Announced Inspections Order of inspection Order of inspection Unaffiliated member access? Unaffiliated member access?
Hot Topics All Inspection related All Inspection related
Big Picture AWA - review practices involving pain and minimize pain and distress AWA - review practices involving pain and minimize pain and distress IACUC function #1 – review the program for humane care and use IACUC function #1 – review the program for humane care and use