UCSF Addresses Animal Welfare Act Allegations, Questions Timing

The University of California, San Francisco (UCSF) has denied nearly every charge in a United States Department of Agriculture Complaint served last month alleging violations of the Animal Welfare Act.

In a response filed yesterday (Oct. 20), UCSF cites inaccuracies and redundancies in, and disagreements with, most of the allegations, and contests the USDA assertion that the gravity of the violations is great.

The University questions the timing of the Complaint, which is a compilation of citations issued by a local USDA inspector during inspections at UCSF between May 2001 and February 2003—nearly two, to three-and-a-half-years, ago. All of the allegations were addressed by UCSF at the time and, where appropriate, remedial measures were implemented. Corrective actions were reported back to the USDA or verified by the USDA at its subsequent inspection. The USDA has so far failed to explain why it has issued an aggregate Complaint at this time.

The University notes that the number of allegations contained in the USDA Complaint is misleading. The local inspector reported 26 citations for the May 2001-Feb. 2003 period. However, the Complaint, issued from Washington, DC, was structured in such a way that most of the citations were restated multiple times, under different categories, raising the total number of allegations to 61.

For example, one citation involved ceiling condensation that purportedly allowed “contaminants to drip from the ceiling onto cleaned and sanitized animal enclosures.” This led to five allegations in the Complaint because the incident was applied to five different animal species.

Of the allegations related to animals, UCSF contends that only one allegation represented potential discomfort to an animal. Many of the alleged violations in the Complaint related to record-keeping or housekeeping. UCSF disagreed with many of these allegations.

Several of the allegations have been reported inaccurately by the press.  For example, accusations in the press that UCSF scientists operated on animals without the use of anesthesia were wrong. The Complaint itself also contains a number of damaging inaccuracies, including allegations from a date on which no inspection was performed at UCSF by the USDA, and the misreading of standard instructions in veterinary records on the part of the USDA inspector.

UCSF has prepared a detailed response to each of the allegations. Some of the more significant allegations include:

* First, the Complaint claims that one marmoset was subjected to forced breeding while still nursing previous offspring, with the implication that this practice led to the subsequent death of the animal. In reality, however, what the Complaint describes is standard reproductive behavior by marmosets in captivity, and a necropsy revealed that a gastrointestinal ailment common to marmosets was the likely cause of death.

* Second, there are citations for failure to use post-operative analgesics. In all cases, the analgesics were either withheld for clinical reasons or were administered as indicated. 

* Third, there are allegations that suitable postoperative observation of animals was not performed on a few occasions. UCSF denies all but one of these claims. In the single exception, UCSF veterinary staff determined that there had been a failure to perform postoperative observation in accordance with the approved protocol, and initiated corrective action immediately. The failure was subsequently documented by the USDA Inspector. UCSF terminated the research protocol of its own volition.

“UCSF takes seriously its responsibility to provide optimal care for animals involved in research, and works diligently to continually improve care,” says Eugene Washington, MD, UCSF executive vice chancellor. “The University adheres to the highest standards for care and responds promptly to any alleged violation of those standards.

“What’s perplexing about the Complaint,” he says, “is that it represents old citations, all of which were addressed at the time they were issued. Moreover, the University’s record during the last five years demonstrates a strong commitment to the humane and ethical handling of animals.” To illustrate this point, he notes:

* The University’s recent full accreditation by the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC). This voluntary accreditation is recognized as demanding the highest ethical standards for the care and study of animals. It is considered the gold standard both by advocates and critics of animal research, says Nigel Bunnett, PhD, chair of the UCSF Institutional Animal Care and Use Committee (IACUC), which oversees the UCSF animal-research program, and UCSF professor of surgery and physiology. AAALAC accreditation involves review of policies and procedures, documentation and record keeping, regulatory (e.g. USDA) inspection-report review and inspection of facilities and animals. It reflects full compliance with the Animal Welfare Act, U.S. Public Health Services Policy on Humane Care and Use of Laboratory Animals (National Institutes of Health), the requirements of the Guide for the Care and Use of Laboratory Animals (National Research Council, Institute of Laboratory Animal Resources) and a number of other voluntary standards.

* The doubling of the University’s veterinary staff and its investment in increased environmental-enrichment programs to improve the well being of its animals.

* Strong support for the UCSF Institutional Animal Care and Use Committee to exercise its authority in overseeing the training of staff and the monitoring and strict enforcement of the regulations of the animal-research program.

• The University’s investment of nearly $100 million to build and equip new facilities that improve the housing and care of its animals.

“Animal research is essential for continued advances in human health,” says Washington.  “In working with animals, UCSF is deeply committed to maintaining the highest standard of excellence in animal care.”

## UCSF’s Oversight of Animal Research

* The UCSF Institutional Animal Care and Use Committee ( IACUC), which oversees animal care and study, is composed of a dedicated team of UCSF faculty members, including an anesthesiologist, a surgeon, a cardiologist, scientists who study pain, stress and neurotrauma, UCSF veterinarians, a registered veterinary technician and two members of the public, one of whom is also a veterinarian.

* A scientist may not begin a study involving animals until the proposed research protocol has been reviewed and approved by the UCSF IACUC.

* The IACUC reviews the proposed research protocol to ensure that the use of animals is justified, that the animals will receive the highest standards of care and that personnel are properly trained to carry out the research.

* The IACUC also reviews the proposed research protocol to ensure that investigators have demonstrated that they have seriously considered the 3 Rs: Replacement of research animals with cultured cells or computer models, where appropriate; Refinement of experiments to minimize distress; Reduction in the number of animals used in the protocol. The team scrutinizes the details of the proposed study and often requires changes to ensure the 3Rs are fully implemented wherever possible.

* Compliance of humane standards is assessed daily, with a team of veterinarians and technicians randomly auditing laboratories. Twice a year the IACUC inspects every room where animals are studied; UCSF receives regular, unannounced visits by its USDA inspector. Several mechanisms are in place for reporting errors, including anonymously. When errors are found, individuals are retrained, and, if warranted, studies are suspended or terminated.

* Standards of surgical care are high. The monitoring equipment, sterile techniques used in the surgery areas, and anesthetics and painkillers for post-operative recovery resemble those used for people in the hospital.

## The Value of Animal Research

The academic medical research community considers animal research essential for gaining fundamental insights into the biological nature of living organisms. It is crucial for enabling scientists to make headway against such ailments as cancer, cardiovascular disease, diabetes, Alzheimer’s and Parkinson’s disease, inflammatory diseases and chronic pain.

UCSF is recognized as one of the major contributors to advances against disease in the last half century. Studies in chickens and rodents led to the discovery that cancer is caused by normal genes gone awry—and to the 1989 Nobel Prize in Physiology or Medicine. Studies in rodents led to the discovery that an infectious protein known as prion (PREE-on) causes “mad cow” disease and several other rare neurodegenerative diseases in animals and humans - and led to the 1997 Nobel Prize in Physiology or Medicine. This discovery has propelled research into the role of protein misprocessing in both rare and more common neurodegenerative diseases, such as Alzheimer’s disease and Parkinson’s disease.