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A Word from USDA and OLAW

Lab Animal volume 51, page 91 (2022)Cite this article

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In this scenario, after consultation with the veterinarian, a researcher extends the euthanasia endpoint of a group of deer mice, a species covered under the Animal Welfare Act (AWA)1, beyond the IACUC-approved humane endpoint of two centimeters of tumor growth. The justification was based on the need to continue data collection and not waste the animals unnecessarily.

The change in an endpoint of a study constitutes a significant change to an ongoing animal activity. Under the AWA regulations, a significant change requires Institutional Animal Care and Use Committee (IACUC) review and approval2. The Attending Veterinarian in this scenario did not have the individual authority to approve the tumor growth beyond what was written in the protocol as an endpoint. The Principal Investigator is required to submit the proposed significant change to the IACUC for review and approval before implementation. The submission should include the rationale for changing the endpoint, and address measures to minimize the pain and distress associated with the proposed change3. The incident is not reportable to the USDA; however it would be cited on the inspection report as a noncompliance with the regulatory requirement for IACUC approval of significant changes to an animal activity. Note: An institution may have additional approval processes besides the IACUC. The officials of these additional approval mechanisms do not have the authority to approve an animal activity or a significant change to an activity that has not been approved by the IACUC4.

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References

  1. Animal Welfare Regulations C.F.R. § 1.1 Definition of animal

  2. Animal Welfare Regulations 9 C.F.R. § 2.31 (d)(1)

  3. Animal Welfare Regulations 9 C.F.R. § 2.31 (e)(1-4)

  4. Animal Welfare Regulations 9 C.F.R. § 2.31 (d)(8)

  5. Institute for Laboratory Animal Research. Guide for the Care and Use of Laboratory Animals 8th edn. (National Academies Press, Washington DC, 2011). p. 114.

  6. Office of Laboratory Animal Welfare, National Institutes of Health. Notice Number: NOT-OD-14-126: Guidance on Significant Changes to Animal Activities, Available at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-126.html

  7. Public Health Service. PHS Policy on Humane Care and Use of Laboratory Animals. (U.S. Department of Health and Human Services, National Institutes of Health, Bethesda, MD, 2015). Available at: https://olaw.nih.gov/policies-laws/phs-policy.htm

  8. Office of Laboratory Animal Welfare, National Institutes of Health. Notice Number: NOT-OD-05-034: Guidance on Prompt Reporting to OLAW under the PHS Policy on Humane Care and Use of Laboratory Animals, Available at: https://grants.nih.gov/grants/guide/notice-files/not-od-05-034.html

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Authors and Affiliations

  1. Director, Office of Laboratory Animal Welfare, OER, OD, NIH, HHS, Bethesda, MD, USA

    Patricia Brown

  2. Deputy Administrator, Animal Care, APHIS, USDA, Riverdale, MD, USA

    Betty Goldentyer

Authors
  1. Patricia Brown
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  2. Betty Goldentyer
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Corresponding authors

Correspondence to Patricia Brown or Betty Goldentyer.

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Brown, P., Goldentyer, B. A Word from USDA and OLAW. Lab Anim 51, 91 (2022). https://doi.org/10.1038/s41684-022-00947-8

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