IU research facilities issued citations after death of animals

Two IU research facilities in Indianapolis, IU School of Medicine and Methodist Research Institute, received multiple citations by the U.S. Department of Agriculture Animal and Plant Health Inspection Service from two recent inspections.

IU School of Medicine received  eight total non-compliances during the two inspections, March 7 and June 6. During the first inspection, the facility received four indirect citations. During the second, the facility received four indirect citations, three of which were repeat non-compliance. 

Methodist Research Institute at IU Health was given seven citations on March 1. Of the citations, one was a direct citation and the others were indirect. However, because of the one direct citation, a visit by the USDA inspector was required within 45 days of the initial inspection, and the inspector found zero non-compliances on April 9.

Direct non-compliance is something that has a direct impact on an animal’s welfare. Repeat non-compliance is something the USDA has already cited the facility for in one inspection report that wasn’t taken care of.

David Sacks, USDA spokesman for the APHIS, said the USDA is most concerned with the direct and repeat non-compliances. If a facility receives a direct citation, an inspector must return to the facility within 45 days, and if the facility receives a repeat, the inspector must return within 90 days.

“They are always going to be unannounced visits,” Sacks said. “So they are always surprise inspections. (Inspectors) really want to get a real clear picture of how (facilities) are treating their animals. The best way to do that is to not tell a facility. When we show up, whether it is Indiana University or Harvard or Ringling Brothers Circus, if we regulate your facility, we are basically going to knock on the door and
announce ourselves. They have to let us in.”

The USDA inspection report for IU School of Medicine from June 6 reports a pig death. The pig weighed 2.8 kilograms prior to the procedure, which is below the protocol of using pigs weighing between 3 and 5 kilograms. While the animal died early the morning following the procedure, the report states “a definitive cause of death was not established for this animal.”

“Animal research has and will continue to play a vital role in medical advances for human health and has resulted in many life-saving and life-extending treatments,” according to a statement released by the IU School of Medicine.

“The Indiana University School of Medicine is committed to providing humane care to the animals involved in research, and this commitment is a significant component of the school’s reputation for high quality and cutting-edge research. Any concerns expressed by the U.S. Department of Agriculture in their routine inspections are taken very seriously. We performed a thorough investigation and responded to their concerns. As a result, we are making specific changes and taking the appropriate actions so this does not happen again.”

Also, a dog that did not receive the proper pre-surgical routine died after going into ventricular fibrillation on the table, according to the USDA’s inspection of Methodist Research Institute at IU Health stated in the protocol.

The report states that “preliminary necropsy findings showed a stomach severely distended with food. Failure to provide appropriate pre-operative care to the animals in accordance with established veterinary medical and nursing practices will cause stress, physical harm and unnecessary discomfort.”

Sacks said the USDA typically inspects every facility once a year. However, it utilizes a risk-based scheduling system.

“If you are a facility that isn’t having any non-compliance items, then typically you are going to see us once a year,” he said. “The inspector in each area determines how often they are going to visit. If you are a facility having problems adhering to the regulations or had an incident that we need to closely monitor, the inspector can determine how often he or she will go out.”

When a facility receives a citation, this doesn’t necessarily mean the facility will receive a violation post-inspection, Sacks said.

“Something that gets cited on an inspection report doesn’t mean it is equal to a violation,” he said. “Violation is something that comes about after we conduct an investigation. That is something more serious. An investigator is going to write down anything they see that is serious or not so serious. Everything and all they see that is not in compliance with federal regulations.” 

Every university research facility needs its own oversight committee, which is a group of individuals chosen by the university to approve research conducted there, Sacks said.

“You don’t contact the USDA to see if you can do that research,” he said. “You contact the oversight committee and spell it out to them. The USDA inspector is not going to be looking over your shoulder when you conduct the research. We are just going to make sure you did what you said you were going to do with the University. We are also going to make sure your animals are being properly cared for.”

Animal rights groups, such as Stop Animal Exploitation Now, send complaints to the USDA daily, said Sacks, who receives about 600 complaints or inquiries a year.

“If we get a formal complaint, we are going to look into it,” he said. “We are going to send the inspector to the facility to look into the allegations contained in that complaint. It is within the rights of these animal groups to be watchdogs of the USDA, and I understand their role and understand what they do.”

SAEN co-founder Michael Budkie said he contacts the USDA to urge the levying of fines in cases of severe violation of the Animal Welfare Act. The USDA is instructed by Congress to enforce the Animal Welfare Act, which states that these facilities must humanely care for and treat their animals, Sacks said.

Budkie wrote two letters to the USDA regarding the citations the IU facilities received.
“Our goal is to urge the USDA to administer the largest fine allowable by law so that a meaningful penalty can be assessed against a laboratory for criminal activity,” he said. “In the instance of the two facilities connected to IU, animals were killed through negligence in both facilities. Therefore, they clearly deserve major penalties.”

Sacks said different scenarios involve different details, and the USDA will address them depending on each case.

“There are a lot of different ways we can find out what is going on,” he said. “For the most part, these facilities call on their own. There is that much interest in animal welfare. If an animal dies in your facility or something happens, that doesn’t mean we are going to penalize that facility. But certain things are going to cause us to look into certain things further.”

Sacks said he realizes there are varying viewpoints.

“If you have half the country mad at you and half the country happy at you, you are probably doing the right thing,” he said.

“That is at the heart of everything we do,” he said. “We want to make sure our inspections are thorough and make sure our penalty actions are appropriate and do what we can to make sure the animals are properly cared for.”