Great Eastern's animal welfare oversight processes were put to the test and appear to be working as intended. Although every animal care and use program should be designed to maximize animal well-being and minimize the likelihood of problems arising, it is inevitable that things will occasionally go wrong in a large and complex program. The key is to have a mechanism in place to identify and address problems as early and effectively as possible, to ensure that any compromise to animal welfare is minimized.

In this scenario, a well-trained and experienced study technician, in the course of providing appropriate postprocedural monitoring and care to an animal, promptly recognized a problem and took immediate action to address the situation with both the Principal Investigator (PI) and the veterinary staff. The PI in turn reported the situation fully to the IACUC. Responding appropriately to this report of a possible animal welfare concern, the IACUC conducted a thorough investigation. In the course of their evaluation, they reviewed not only the actions taken by the technician during conduct of the procedure, but also the technician's training record and historical performance data. As a result of their findings, they concluded that the incident, while unfortunate, did not constitute a failure to follow procedures or comply with the regulations, and agreed, with the concurrence of the AV, that no further action was necessary.

In situations such as this, it is entirely appropriate for the USDA VMO to take note of the incident in the facility records and to review documentation relevant to any subsequent actions taken, including the IACUC investigation. However, from the information provided, there do not seem to be any grounds for concluding that the technician's training was inadequate, and no one should construe the IACUC's decision to investigate such an incident as proof of wrongdoing. According to Section 2.31(c)(4) of the Animal Welfare Regulations, the IACUC has an obligation to review and investigate concerns involving the care and use of animals at the facility. If, after a careful review, they determine that the training was adequate and procedures were followed appropriately, they may rule that the incident was not the result of any wrongdoing by the staff.

Slight differences in anatomy or physiology, in an animal's response to known or unknown compounds, or in its response to a standard procedure can all lead to an animal's unintended and unpredictable responses. In this case, the historical record dictates that the technician was appropriately trained and had previously conducted the epidural procedure successfully and without incident. It is, therefore, reasonable to conclude that this incident was the result of one of the aforementioned anomalies and not due to any deficit in training or experience on the part of the technician. The IACUC might have opted to validate this conclusion by requesting supplemental postprocedural monitoring of the next few animals by the veterinary staff, but in light of the technician's history, his or her prompt recognition and self-reporting of the problem, and the AV's endorsement of his or her abilities, the IACUC was perhaps justified in not taking this course in response to an isolated incident.

Although there is nothing to be gained by creating an adversarial relationship with the USDA, it seems appropriate in this case to provide a written summary of the sequence of events, actions taken by the IACUC, and the resulting conclusions, respectfully requesting that the agency reconsider the citation. If nothing else, this will put the rebuttal on record, documenting the institution's commitment to appropriate oversight of animal care and use.