semi annual program reviews and facility inspection betty goldentyer, dvm betty goldentyer, dvm...

Semi Annual Semi Annual Program Reviews Program Reviews

and Facility and Facility InspectionInspection

Betty Goldentyer, Betty Goldentyer, DVMDVM

EasternEastern Regional Regional DirectorDirector

USDA, APHIS, USDA, APHIS, Animal CareAnimal Care

Animal Welfare Act Animal Welfare Act §2143§2143

(b) Research Facility Committee: (b) Research Facility Committee: establishment, membership, establishment, membership, functions, etc.functions, etc.

(3)(3) The Committee shall The Committee shall inspect at least semi-annually inspect at least semi-annually all animal study areas and all animal study areas and animal facilities and review…animal facilities and review…

Animal Welfare Act Animal Welfare Act §2143§2143

(A) Practices involving pain to (A) Practices involving pain to animals, andanimals, and

(B) the condition of animals, to (B) the condition of animals, to ensure compliance with the ensure compliance with the provisions of this chapter to provisions of this chapter to minimize pain and distress to minimize pain and distress to animals.animals.

Animal Welfare Act Animal Welfare Act RegulationsRegulations§2.31 (C) §2.31 (C)

IACUC FunctionsIACUC Functions

(1)(1) Review at least once every six Review at least once every six months, the research facility’s months, the research facility’s program for the humane care and program for the humane care and use of animalsuse of animals

Using AWAR as a basis for evaluationUsing AWAR as a basis for evaluation

Animal Welfare Act Animal Welfare Act RegulationsRegulations

§2.31 (C)§2.31 (C)(2) Inspect, at least once every six (2) Inspect, at least once every six

months, all of the research facility’s months, all of the research facility’s animal facilities including animal animal facilities including animal study areas….study areas….

(3) Prepare reports of its evaluations (3) Prepare reports of its evaluations and submit the reports to the and submit the reports to the Institutional OfficialInstitutional Official

ConsiderConsider

AWA directs us to review practices AWA directs us to review practices involving pain and minimize pain involving pain and minimize pain and distressand distress

AWAR IACUC function #1 – review AWAR IACUC function #1 – review the program for humane care and the program for humane care and useuse

Program ReviewProgram Review

Institutional policies, procedures and Institutional policies, procedures and responsibilitiesresponsibilities

Animal environment, housing and Animal environment, housing and managementmanagement

Veterinary medical careVeterinary medical care

Physical plantPhysical plant

Hot TopicsHot Topics

Unannounced/AnnouncedUnannounced/Announced Inspection of laboratoriesInspection of laboratories Remote sitesRemote sites SubcommitteesSubcommittees Access and BiosecurityAccess and Biosecurity

Announced ? Announced ? UnannouncedUnannounced

It’s up to the IACUCIt’s up to the IACUC

Unannounced can be helpful in a Unannounced can be helpful in a problem areaproblem area

Can switch back and forthCan switch back and forth

Inspecting Individual Inspecting Individual LabsLabs

Study AreaStudy Area means any means any building, room, area, building, room, area, enclosure, or other enclosure, or other containment outside of a core containment outside of a core facility or centrally designated facility or centrally designated or managed area in which or managed area in which animals are housed for more animals are housed for more than 12 hours.than 12 hours.

It DependsIt Depends

The Institution is responsible for all The Institution is responsible for all the activitiesthe activities

USDA can inspect all the activity USDA can inspect all the activity areasareas

Some OptionsSome Options

IACUC has authority to inspectIACUC has authority to inspect Can inspect Randomly or rotatingCan inspect Randomly or rotating Can inspect based on activityCan inspect based on activity Pain categoryPain category SpeciesSpecies

Remote SitesRemote Sites

Must be inspectedMust be inspected Can use a subcommitteeCan use a subcommittee Can’t exclude any member Can’t exclude any member Watch for conflict of interestWatch for conflict of interest

Using SubcommitteesUsing Subcommittees

At least 2 membersAt least 2 members Can’t exclude anyoneCan’t exclude anyone Can include consultants Can include consultants AALAC site visit works if 2 IACUC AALAC site visit works if 2 IACUC

members presentmembers present

Access and BiosafetyAccess and Biosafety

Announced InspectionsAnnounced Inspections Order of inspectionOrder of inspection

Unaffiliated member access?Unaffiliated member access?

Hot TopicsHot Topics

All Inspection All Inspection relatedrelated

Big PictureBig Picture

AWA - review practices involving AWA - review practices involving pain and pain and minimize pain and minimize pain and distressdistress

IACUC function #1 – review the IACUC function #1 – review the program for humane care and program for humane care and useuse