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A Word from OLAW and USDA

Lab Animal volume 52, page 52 (2023)Cite this article

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As mentioned by other Reviewers, the PHS Policy requires that proposals to use animals include a rationale for the approximate number of animals to be used and limit the number to what is necessary to obtain valid results1. It is the institution’s choice to document and monitor the number of animals acquired and used as works best for their program2. The documentation should include not only animals acquired or bred and then used in approved activities, but also animals produced and not used for the original purpose2. While increases in animal numbers are a significant change to an approved animal activity, with an existing policy in place an IACUC may administratively handle such changes and reduce burden3. In this case, the lack of clear communication with the researchers about the IACUC’s process has created an unnecessary complication and increased burden on those involved.

At issue in this scenario is confusion or uncertainty on the part of the Principal Investigator regarding this institution’s standard operating procedure (SOP) for reporting animal numbers, with focus on determining when an animal is deemed “used”. As noted by one Reviewer and in the Compliance Considerations, the AWA and regulations do not provide a definition of “used” in this context. To reiterate previously raised points regarding reporting of animal numbers used in research facilities, the AWA regulations only address this in two areas. First, proposals to conduct activities with animals (or make significant changes in an approved protocol) must provide an estimate of the number of animals and a rationale for the number and species used4. Second, the annual report must state the common names and numbers of animals used in each of the pain categories (i.e., columns C, D and E of the report)5. While it is entirely at the discretion of the institution and its IACUC how these numbers are tracked internally, having a system that facilitates accurate and consistent reporting under the AWA would seem advantageous.

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References

  1. 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).

  2. Public Health Service Policy on Humane Care and Use of Laboratory Animals – Frequently Asked Questions. Animal Use and Management, Question No. F.2. is the IACUC responsible for tracking animal usage? (US Department of Health and Human Services, Bethesda, MD, USA). https://olaw.nih.gov/faqs#/guidance/faqs?anchor=50359

  3. National Institutes of Health. Guidance on Significant Changes to Animal Activities. Notice NOT-OD-14-126 [online]. (National Institutes of Health, Bethesda, MD, August 2014). https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-126.html

  4. 9 CFR, Chapter 2, Subpart C – Research Facilities, § 2.31(e)(2).

  5. 9 CFR, Chapter 2, Subpart C – Research Facilities, § 2.36(b)(5-7).

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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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Correspondence to Patricia Brown or Betty Goldentyer.

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Brown, P., Goldentyer, B. A Word from OLAW and USDA. Lab Anim 52, 52 (2023). https://doi.org/10.1038/s41684-023-01127-y

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