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Important Regulatory Notes

Question: What must be covered by the semi-annual IACUC self-assessment?

Answer: The semi-annual self assessment must include all VA facilities and investigator areas where laboratory animals are used in procedures or housed for more than 12 hours. It must also include all facilities and programs which house animals purchased with VA funds (see paragraph 3.c. in VHA Handbook 1200.7). If the animals are housed in a satellite/ affiliate facility, a formal arrangement may be made between the VA IACUC and the facility such that the VA IACUC may review that facility's semi-annual self-assessment as an IACUC business item instead of sending a VA IACUC team to inspect that facility and program.  If the VA IACUC does not set up this type of agreement, the facility and its animal care and use program must be evaluated as part of the VA IACUC semi-annual self-assessment report.  

Question: What is a significant deficiency?

Answer:  Nearly identical definitions of a significant deficiency are found in the USDA AWA Regulations and PHS Policy.  The two definitions are below:

1.  USDA Animal Welfare Act Regulations, 9 CFR Part 2, Subpart C, Section 2.31, par. (c)(3):  “A significant deficiency is one which, with reference to Subchapter A, and, in the judgment of the IACUC and the Institutional Official, is or may be a threat to the health or safety of the animals.”

2.Public Health Service Policy on Humane Care and Use of Laboratory Animals, IV. Implementation by Institutions, paragraph B.3:  “…A significant deficiency is one which, consistent with this Policy, and, in the judgment of the IACUC and the Institutional Official, is or may be a threat to the health or safety of the animals. If program or facility deficiencies are noted, the reports must contain a reasonable and specific plan and schedule for correcting each deficiency…"

Question: Does the IACUC have to report significant deficiencies?

Answer:  It depends.  If the plan to correct a significant deficiency is not completed according to the schedule set by the IACUC in Form 2 ( TABLE of PROGRAM and FACILITIES DEFICIENCIES) and approved by a majority of a quorum, the USDA AWA Regulations state that the failure to correct must be reported in writing within 15 business days by the IACUC, through the Institutional Official, to USDA and any Federal agency funding that activity (USDA AWA Regs, 9 CFR Part 2, Subpart C, Section 2.31, par (c)(3)).  PHS Policy does not have the same requirement to report a failure to adhere to the correction schedule for a significant deficiency, but PHS Policy does require that the following be reported by the IACUC through the IO to PHS, regardless of whether a corrective plan is completed according to schedule:

Form 1 (Checklist), Page 9

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