NOT-OD-22-114 - Request for Information (RFI) on Flexibilities for Conducting Semiannual Animal Program Review
NOT-OD-20-145 Request for Information (RFI) on Flexibilities for Conducting Semiannual Animal Facility Inspections
NOT-OD-19-028 Request for Information (RFI): Input on Draft Report from Working Group on Reducing Administrative Burden to Researchers for Animal Care and Use in Research
NOT-OD-22-048 Notice of Clarification of Reporting Requirements for Animal Welfare Act Regulated Institutions, "Guidance on Flexibilities for Conducting Semiannual Inspections of Animal Facilities"
This Notice provides Assured institutions with flexibilities that may reduce administrative burden when conducting semiannual animal facility inspections.
Background
The Office of Laboratory Animal Welfare (OLAW) oversees animal activities of Assured institutions by the authority of the Health Research Extension Act of 1985 (HREA) and the Public Health Service (PHS) Policy on the Humane Care and Use of Laboratory Animals (Policy). The HREA and PHS Policy require that Institutional Animal Care and Use Committees (IACUCs) review the care and treatment of animals in all animal study areas and facilities at least semiannually to evaluate compliance with applicable guidelines. The resulting semiannual report submitted to the Institutional Official (IO) must be signed by a majority of the IACUC members. The PHS Policy IV.B.3. and IV.F. require, among other things, the report to include the following:
- A description of the nature and extent of the institution’s adherence to the PHS Policy, Guide for the Care and Use of Laboratory Animals (Guide) , and Animal Welfare Regulations (AWRs)
- A description of, and reason for, each departure identified
- Deficiencies distinguished as minor or significant with a reasonable and specific plan and schedule for correcting each deficiency
- Any minority views
- Identification of facilities that are accredited by AAALAC International
The 21st Century Cures Act, Section 2034(d), directed the National Institutes if Health (NIH), United States Department of Agriculture (USDA), and Food and Drug Administration (FDA), to conduct a review of applicable regulations and policies for the care and use of laboratory animals and to make revisions, as appropriate, to reduce the administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals. In response to NOT-OD-19-028, the public identified semiannual inspections as an area to reduce administrative burden by reducing the inspections to occur annually rather than semiannually. In the report Reducing Administrative Burden for Researchers: Animal Care and Use in Research, the Working Group determined that the potential risks to animal welfare of less frequent IACUC inspections outweigh the burden on the IACUC and the principal investigator (PI; see page 60). Decreasing the frequency of IACUC inspections from semiannually to annually would require statutory changes to the laws and has a strong likelihood of negatively impacting animal welfare. Additionally, semiannual inspections have been identified as a critical component of post-approval monitoring of activities for many domestic assured institutions. Therefore, the required interval for inspections will continue to be semiannually.
Additional details and resources may be found at Semiannual Facility Inspections.
Flexibilities for Conducting Semiannual Inspections of Animal Facilities
The PHS Policy IV.B.2. requires that IACUCs inspect at least once every six months, all the institution’s animal facilities (including satellite facilities) using the Guide as a basis for evaluation. An Animal Facility as defined by the PHS Policy III.B. includes any and all buildings, rooms, areas, enclosures, or vehicles, including satellite facilities, used for animal confinement, transport, maintenance, breeding, or experiments inclusive of surgical manipulation. A Satellite Facility is any containment outside of a core facility or centrally designated or managed area in which animals are housed for more than 24 hours.
The AWRs also require that the IACUC inspect, at least once every six months, all the research facility’s animal facilities, including animal study areas, using the AWRs, 9 CFR Chapter 1, subchapter A Animal Welfare, Parts 1 4, as a basis for evaluation. AWRs 9 C.F.R. 1.1 defines Study Area as 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.
This Notice highlights flexibilities that are available to IACUCs when conducting semiannual inspections. These flexibilities may be used alone or in combination to meet institutional needs and circumstances, provided that animal welfare and the quality and rigor of the inspection are not compromised.
The USDA Animal and Plant Health Inspection Service has reviewed and concurs with the guidance provided in this Notice.
- The PHS Policy Footnote 8 and 9 C.F.R. 2.31(c) (3) of the AWRs allow IACUCs to determine the best means of evaluating the institution’s facilities. For areas housing non-Animal Welfare Act (AWA)-regulated species, the IACUC may use as few as one qualified individual or ad hoc consultant, who need not be an IACUC member or institutional employee, to conduct the facility inspections. Qualified individuals should have training and a working knowledge of the PHS Policy, Guide, and the AWRs to appropriately evaluate the facilities and identify deficiencies and animal welfare issues.
For areas housing AWA-regulated species, the IACUC may use subcommittees composed of at least two committee members and may also invite ad hoc consultants to assist in conducting the inspections. IACUC members involved in these inspections are not required to inspect together and may each inspect different parts of the facility.
As is always required by both the PHS Policy and AWRs, no IACUC member should be involuntarily excluded from the semiannual inspections, and the IACUC remains responsible for the evaluation and report to the IO.
- The USDA agrees with OLAW that the timing of facility inspections can include flexibility of within 30 calendar days of the six-month interval from the last inspection, provided there is no forward drift of the date from year to year. To avoid forward drift, the IACUC should consider scheduling facility inspections during the same calendar month from year to year. This 30-day flexibility allows extra time for IACUCs without changing the current or future dates of subsequent inspections.
- IACUCs may assign specific facility inspections to subcommittees, but biased evaluations should be avoided. For example, a committee member or qualified individual should not be the only person assigned to inspect areas for which that individual is responsible. This provides the checks and balances in the system of self-regulation and avoids biased evaluations that may arise when an individual is personally involved in the inspection. The PHS Policy and AWRs are silent on determining conflict of interest regarding semiannual facility inspections. Therefore, the IACUC has the discretion to determine which situations require additional inspectors, recusal, or other methods to minimize bias, based on the extent of the inspector’s involvement and the nature of the activity.
- OLAW and USDA allow IACUCs to perform inspections on a staggered schedule, where all facilities are inspected over time, provided each animal area is inspected at least every six months. The 30-day flexibility also applies to each area inspected on a staggered basis.
- IACUCs may choose whether the inspections are unannounced or if advanced notification is provided to relevant personnel. Announced visits may facilitate the inspection process by having key personnel available to answer any questions without compromising the rigor of the inspection process.
- IACUCs have discretion regarding oversight of areas other than animal facilities as defined by the PHS Policy, such as those used for routine weighing, dosing, immunization, or imaging, but should monitor these areas regularly to effectively oversee activities at the institution, as follows:
Areas housing non-AWA-regulated species that must be inspected at least semiannually include:
- All core, centrally designated or managed buildings, rooms, areas, enclosures, or vehicles, used for animal confinement, transport, maintenance, breeding, or experiments that include surgical manipulation.
- All areas outside of a core facility or centrally designated or managed area in which animals are housed for more than 24 hours or where surgical manipulations occur.
Areas housing AWA-regulated species that must be inspected semiannually include:
- All of the animal facilities, including animal study areas, provided however, animal areas containing free-living wild animals in their natural habitat need not be included in such inspection.
- Note: a 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.
- IACUCs may use videos, photographs, written descriptions, or other appropriate remote methods to inspect facilities housing non-AWA regulated species. These methods may be useful, for example, where no qualified individual has access to an inspection site (e.g., high containment and remote satellite facilities) or when one qualified individual provides a prerecorded or real-time virtual tour to IACUC members wishing to participate but who are unable to do so safely. However, for areas housing AWA-regulated species, only live feed is allowed for inspections using video. There is no requirement for IACUCs to retain these materials once the semiannual report has been submitted to the IO.
- IACUCs may use an AAALAC International site visit to meet the requirements for an IACUC semiannual inspection, provided it meets the requirements of the PHS Policy and AWRs. The subsequent facility inspection must be conducted no later than six months from when the AAALAC site visit occurred. This inspection has the same 30-day flexibility in timing. The IACUC must ensure that the following provisions of the PHS Policy and AWRs, as applicable, are met:
For institutions covered by the PHS Policy:
- The IACUC report to the IO must comply with PHS Policy IV.B.3., which requires that the report contain certain information regarding the institution's adherence to the Guide, including a plan and schedule for correcting each deficiency identified in the report.
- The report must be endorsed by the IACUC as an official IACUC report and submitted by the IACUC to the IO.
For institutions covered by AWRs, the report must comply with 2.31(c) of the AWRs, including:
- The assessment corresponds with the time the IACUC semiannual inspection was to be conducted
- At least two members of the IACUC assisted in conducting the inspection
- All members are informed of the program review to be conducted by the appointed subcommittee in sufficient time to request participation
- No IACUC member wishing to participate in any evaluation was excluded
- The report was signed by a majority of the IACUC members (individual digital signatures are acceptable)
- The program of humane care and use and facility inspection address all of the required areas
- Any identified departure from the AWA Regulations and Standards includes a description of and reason for the departure
- OLAW has developed a checklist to help IACUCs conduct the semiannual facility inspection. Institutions are not required to use this checklist, and it can be amended as necessary to reflect the institution’s program and needs. Inclusion of positive findings found during inspections is a useful practice to encourage continued improvements in the program. USDA concurs with the voluntary use of the checklist where applicable.
