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Semi Annual Program Reviews and Facility Inspection. Betty Goldentyer, DVM Eastern Regional Director USDA, APHIS, Animal Care. Animal Welfare Act §2143. (b) Research Facility Committee: establishment, membership, functions, etc.
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Semi Annual Program Reviews and Facility Inspection 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 facility’s program for the humane care and use of animals • 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 facility’s 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 • 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 • Inspection of laboratories • Remote sites • Subcommittees • Access and Biosecurity
Announced ? Unannounced • It’s up to the IACUC • Unannounced can be helpful in a problem area • 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.
It Depends • The Institution is responsible for all the activities • USDA can inspect all the activity areas
Some Options • IACUC has authority to inspect • Can inspect Randomly or rotating • Can inspect based on activity • Pain category • Species
Remote Sites • Must be inspected • Can use a subcommittee • Can’t exclude any member • Watch for conflict of interest
Using Subcommittees • At least 2 members • Can’t exclude anyone • Can include consultants • AALAC site visit works if 2 IACUC members present
Access and Biosafety • Announced Inspections • Order of inspection • Unaffiliated member access?
Hot Topics • All Inspection related
Big Picture • AWA - review practices involving pain and minimize pain and distress • IACUC function #1 – review the program for humane care and use