In response to the issues raised in this scenario, the Office of Laboratory Animal Welfare (OLAW) and the United States Department of Agriculture, Animal and Plant Health Inspection Service, Animal Care (USDA, APHIS, AC) offer the following clarification and guidance:

The Public Health Service Policy on Humane Care and Use of Laboratory Animals is applicable to live vertebrate animals used in research, research training and biological testing and clearly applies to amphibians bred and used for research1. The Policy does not explicitly require an institutional mechanism to track animal usage by investigators in IACUC-approved activities, but it does require proposals to specify and to include a rationale for the number of animals to be used and requires that number to be limited to the minimum necessary to obtain valid results. Accordingly, institutions need to appropriately monitor and document numbers of animals acquired (through breeding or other means) and used in approved activities. Monitoring should not exclude the disposition of animals that are inadvertently or necessarily produced in excess of the number needed or that do not meet criteria (e.g., sex) established for the specific study proposal2.

The mandate in US Government Principle III to use the minimum number of animals necessary to obtain valid results is synonymous with a requirement to reduce animal numbers, which is one of the 3Rs3,4. IACUCs, acting as agents of institutions, are expected to implement and routinely evaluate this aspect of the institutional animal care and use program to ensure compliance with the PHS Policy. When deviations from the approved number of animals occur, the IACUC should review the circumstances, take appropriate action to correct any noncompliance and report to OLAW and the funding agency as applicable.

The Animal Welfare Act5 defines an animal as “any live or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or any other warm-blooded animal, which is being used, or is intended for use for research, teaching, testing, experimentation, or exhibition purposes, or as a pet. This term excludes birds, rats of the genus Rattus, and mice of the genus Mus, bred for use in research; horses not used for research purposes; and other farm animals, such as, but not limited to, livestock or poultry used or intended for use as food or fiber, or livestock or poultry used or intended for use for improving animal nutrition, breeding, management, or production efficiency, or for improving the quality of food or fiber. With respect to a dog, the term means all dogs, including those used for hunting, security, or breeding purposes.”

Although the Xenopus frogs discussed in this scenario are not covered under the Animal Welfare Regulations5, the policies and procedures implemented by the IACUC must continue to ensure that proposals utilizing all covered species are in compliance with the Animal Welfare Regulations.

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