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

The issue relevant to the Animal Welfare Act (AWA) is whether IACUC oversight is required to use blood and tissues obtained from an agricultural study in a biomedical pilot project.

The definition of an “animal” under the AWA and its regulations determines whether IACUC oversight is required. An animal is defined as any live or dead animal (warm-blooded) used or intended to be used for research, teaching, testing, research, or experimentation1. An animal activity that meets any of these criteria requires IACUC oversight, unless other statutory and regulatory exclusions apply2. With respect to the term “animal,” the definition excludes livestock or poultry, used or intended for use as food or fiber; improving animal nutrition, breeding, management, or production efficiency; or for improving the quality of food or fiber1. An animal activity that meets any of these criteria does not require IACUC oversight under the AWA regulations3.

In this scenario, the animals on the milk quality study are not covered under the AWA regulations because the animals are livestock used for improving the quality of food (milk). For this reason, the sharing of tissue and blood obtained from this project with an investigator conducting biomedical research does not require IACUC oversight. However, IACUC oversight would be necessary if the animals on the milk quality study are subjected to additional collections or activities not otherwise required by the study and that are only performed to support the pilot biomedical project. Those additional activities would be covered under the AWA regulations and require IACUC review and approval2.

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