Summary Abstract of UW-Madison/USDA Settlement Agreement
The United States Department of Agriculture (USDA), which enforces the Animal Welfare Act (AWA), completed its investigation of animal care at the University of Wisconsin–Madison. The investigation reviewed alleged violations of the AWA from 2007 to 2013. Seven citations were issued, all arising from routine USDA inspections of the UW–Madison animal program. Only two violations directly affected animal welfare, and one of the animals recovered fully. Other violations included the presence of expired drugs, housing and facilities issues such as peeling paint, a broken light fixture clip, bent metal flashing on a barn, a slippery animal room floor; and insufficient internal communication of animal health issues to veterinarians.
For the violations, USDA assessed UW–Madison a fine of $35,286, roughly half the amount that USDA guidelines allow. We do not know the basis for the fine because USDA does not attribute monetary amounts to specific citations, nor does it divulge its specific formula for calculating a fine. However, one factor that relates to larger fines is size of the institution. We believe the corrective actions made by UW–Madison in response to these events and the fact that most of the citable events did not directly affect animal welfare resulted in a relatively small fine, despite the fact that UW–Madison is one of the largest research universities in the country. It is further worth noting that the total number of violations is small given the large size of the UW–Madison animal program. We have chosen to accept USDA’s settlement agreement, which closes the investigation.
For more information, contact Eric Sandgren, director of the Research Animal Resources Center, at 608-890-0795.
Background regarding the USDA investigation process
In Fall 2010, the USDA initiated an investigation of citations given to UW–Madison since 2007. The process differs from the more common USDA inspections of animal programs and requires clarification.
USDA veterinarians “inspect” an animal program like UW–Madison’s several times a year. During these routine inspections, the USDA veterinary medical officer may issue a citation for things deemed non-compliant with the Animal Welfare Act. One of the regular functions of the USDA’s enforcement branch is to investigate accumulated citations at institutions across the country. The investigations are performed by federal investigators, not veterinarians.
Most of the USDA investigation of UW–Madison was conducted through on-site interviews from October 2010 through January 2011 with follow-up requests for more information. A final activity in summer 2013 investigated citations issued since 2010, after which the USDA and UW–Madison entered into a settlement agreement to resolve the investigation.
Descriptions of the seven citations and UW–Madison actions to address them
1. 9 C.F.R. § 2.33(b)(3) on or before May 29, 2009
Incident: A USDA review of laboratory records revealed that a dog experienced clinical complications following surgery and was euthanized according to the experimental protocol. Although the researcher was a doctor of veterinary medicine and provided appropriate clinical care to the animal, the researcher did not report the event to the research animal attending veterinarian on campus. The Animal Welfare Act mandates that researchers report adverse events to the attending veterinarian of the animal program, so UW–Madison was cited for failure “to communicate problems of animal health to the attending veterinarian in a timely and accurate manner.”
All of the clinical signs described in the USDA citation were known complications of the work under study (organ transplantation surgery), and the complications were anticipated in the animal care and use protocol. The communication omission had no effect on animal welfare; the animal was treated according to interventions prescribed in the protocol.
UW-Madison Response: In response to the citation, the university worked to reinforce for veterinarian researchers their responsibility to communicate observations to attending veterinarians. Within one week of the citation, the chair of the school’s animal care and use committee (ACUC) and the attending veterinarian met with the researcher and laboratory personnel to emphasize the importance of keeping the attending veterinarian apprised of the condition of all animals used in research. In addition, mandatory school-wide training was held approximately a month later for all principal investigators with the same message. The attending veterinarian and/or IACUC chair now continue to convey this message yearly at either departmental meetings or an all-faculty meeting. This responsibility is also now routinely communicated to all UW–Madison investigators during mandatory training.
2. 9 C.F.R. § 2.33(b)(3) on or before December 3, 2009.
Incident: A USDA inspector observed in a housing facility that a gerbil that had undergone no experimental procedures was obviously ill. Prior to this, information on the animal’s condition had not been reported to the attending veterinarian. The animal subsequently was euthanized. UW–Madison was cited for failure “to conduct adequate daily observations of all animals to assess their health and well-being, and to communicate problems to the attending veterinarian in a timely and accurate manner.”
UW-Madison Response: The ACUC chair and attending veterinarian met with the researcher and staff to emphasize and educate regarding the importance of reporting adverse events. A school-wide meeting was held for all investigators to ensure that everyone using animal models was aware of their responsibilities to adequately report adverse events.
3. 9 C.F.R. § 3.125(a) December 9, 2009
Incidents: During an inspection, USDA officials identified two issues in housing facilities and cited UW–Madison for failure “to maintain facilities in good repair.” No injuries to animals were observed or reported as a result of these two issues:
- Protruding metal flashing was observed on one corner of a holding barn where cows are housed.
- A pig was observed having difficulty standing on a housing pen surface composed of narrow slats.
UW-Madison Response: The broken metal flashing is believed to have been caused by a tractor making a sharp turn around the corner of the barn. It was repaired immediately and all facilities are now monitored for similar damage. The pig pen flooring is a standard commercial product used widely in hog production environments. However, in response to the inspector’s report, the flooring was improved with the addition of rubber mats, and other modifications were made, including housing animals in different rooms.
4. 9 C.F.R. § 3.75(a) July 14, 2010
Incidents: During an inspection, USDA officials identified two issues in housing facilities for nonhuman primates and cited UW–Madison for failure “to maintain housing facilities for nonhuman primates in good repair.” No injuries to animals were observed or reported as a result of these two issues:
- Peeling paint was observed above occupied animal enclosures in several rooms.
- A light fixture in a room had water inside the cover; the fixture was ajar because of a broken clip.
UW-Madison Response: Regarding peeling paint, animal housing rooms are sanitized routinely with water and chemicals, and few paint applications withstand this regimen. Repainting is thus a standard component of housing maintenance. To address chronic issues of peeling paint in the facility, certain rooms have been resurfaced with fiberglass-reinforced plastic panels.
The light fixture with the broken clip was one of 159 fixtures with 975 clips of different types in animal rooms at the facility. Water accumulation resulted from a recent room cleaning in which walls and ceiling are spray-washed. After the citation, an immediate change was made by the facility manager to ensure sufficient monitoring of the state of all light fixtures. More specific language focusing on checking fixtures was added to training instructions, and an entry for each light cover and clip was added to the mandatory daily room check performed by animal care staff. Further, the facility proactively replaced light fixtures in many of the animal rooms.
5. 9 C.F.R. § 2.33(b)(2) July 14, 2010
Incident: During an inspection, UW–Madison was cited for failure “to maintain a program of adequate veterinary care” because USDA observed expired or improperly labeled medications in some campus laboratories. No harm to animal well-being has been linked to this observation.
UW-Madison Response: UW-Madison continues to address the challenging issue of expired medications. Note that a citation is given if expired drugs are simply present in the laboratory (there is no requirement of proof they were used). Many discoveries of expired drugs arise because an investigator has simply not used them and their expiration has gone unnoticed. Thus, UW–Madison implemented a color-coded identification system to assist investigators in efforts to monitor expiration dates. UW–Madison’s animal care and use committees routinely look for expired medications during semiannual inspections.
6. 9 C.F.R. § 2.38(f)(1) on or about April 5, 2012
Incident: UW–Madison was cited for failure “to handle an animal as carefully as possible in a manner that did not cause trauma, physical harm, or unnecessary discomfort.” A cat sustained a thermal injury from equipment put in place to maintain body temperature during anesthesia. The injury was appropriately managed by staff veterinarians, and the animal recovered fully.
This incident was discovered by USDA during a routine inspection of UW–Madison records. The injury was sustained through the use of a commercially available chemical hand warmer commonly used by humans. The warmer was positioned on top of a heated IV bag that was placed next to an animal to keep it warm while under anesthesia. This arrangement/approach was used to maintain normal body temperatures because experimental conditions precluded the use of conventional heat sources such as warm-water blankets or heating pads. The procedure itself was noninvasive and painless. The anesthetic was used solely for chemical restraint because microphone recordings obtained from the animal’s ear required that it not move its head. During the procedure, the hand warmer slipped off the bag and came into contact with the animal. Veterinary staff members were monitoring the animal’s temperature throughout the procedure and made immediate adjustments based on temperature values at the time (this was noted in the USDA inspection report). Thus, the temperature change due to direct contact was noticed quickly and the hand warmer was promptly removed; the thermal injury that was caused by the hand warmer was not evident at the time of the event, but was detected during post-procedure monitoring and subsequently treated successfully.
UW-Madison Response: We regret that this animal was injured during an experimental procedure.The injury was appropriately managed by staff veterinarians, and the animal recovered fully. Program personnel altered their procedures to prevent a recurrence. Corrective measures were in place months prior to the USDA inspection and were acknowledged in the USDA inspection report. Additionally, UW–Madison self-reported the incident to federal authorities months before the USDA inspection. We also posted the report on the UW–Madison website at http://animalresearch.wisc.edu/regulatory-actions/regulatory-action-thermal-injury/.
7. 9 C.F.R. § 2.32(c)(3) on or about April 10, 2012
Incident: A review of records by USDA inspectors led them to cite UW–Madison for “inadequate training and instruction to its personnel.” During preparation for an emergency surgical procedure to treat a female rhesus monkey experiencing severe labor complications with possible pre-eclampsia, a technician left a pop-off valve in a closed position. Pop-off valves regulate the flow of gas and oxygen through anesthesia machines and are frequently closed to allow the anesthetist to mechanically breathe for an animal that is severely compromised. Sustained closure of the pop-off valve could lead to lung damage, but in this case, the valve was closed for only several seconds before it was discovered and opened. While the animal succumbed prior to the initiation of the surgical procedure, detailed histological evidence indicates the briefly closed pop-off valve was not a factor in the animal’s death. UW–Madison was cited for inadequate retraining because “the only action taken by the attending veterinarian was to speak to the employee about the incident.” USDA did not acknowledge additional retraining because it was not documented in the technician’s personnel file.
UW-Madison Response: Immediately after receiving the citation, the unit in which the event took place implemented a new retraining policy. After any incident where regulations or established unit operating procedures or policies are not followed, the unit’s training coordinator immediately schedules a retraining session with the person(s) involved. During the retraining session, the coordinator reviews the incident, retrains the individual(s) using pertinent laws, regulations, guidelines, and operating procedures, and documents the retraining on an approved form. Additionally, in response to the training citation, the entire unit underwent thorough anesthesia refresher training.