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

This scenario addresses several regulatory issues which are of concern to USDA, APHIS: regulatory requirements for the use of farm animals in biomedical research, personnel training and required reporting. The facility in the scenario does not fall under the jurisdiction of the US National Institutes of Health Office of Laboratory Animal Welfare because it does not possess an Assurance.

Activities that use farm animals in biomedical research are required to adhere to the same regulatory requirements under the Animal Welfare Act Regulations (AWARs) as activities that use traditional laboratory animals. This includes minimizing pain and distress1. Policy #17 in the Animal Care Policy Manual provides additional guidance regarding the regulation of farm animals used in biomedical research2. The AWARs also require IACUC approval for the proposed activity and proposed significant changes to that activity, along with the use of aseptic procedures during survival surgery2.

It is the research facility's responsibility to ensure that all those involved in animal care and treatment are qualified to carry out their duties. Such persons are to receive appropriate training and instruction2. This requirement includes consulting veterinarians.

The AWARs do not require research facilities to report violations of the animal research activity to APHIS; however, facilities may choose to self-report incidents before they are discovered by the inspector. Self-reporting establishes a sign of good faith, which may be taken into consideration in the event that a facility becomes involved in an enforcement action3. Voluntary reports may be subject to requests made in accordance with the Freedom of Information Act.

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