THE OFFICE OF RESEARCH

NEWS AND DOCUMENTS

• UCSF Denies Animal Welfare Act Allegations
• UCSF Denies Animal Welfare Act Allegations, Questions Timing
• Preface

UCSF Denies Animal Welfare Act Allegations

The following letter was sent October 21, 2004 to the UCSF campus community from A. Eugene Washington, MD, Executive Vice Chancellor.

"Animal Care and Research"

To the UCSF Community:

Four weeks ago Chancellor Bishop and I wrote to you about a Complaint from the US Department of Agriculture (USDA) regarding animal care and research at UCSF. With strong support from across our UCSF community, we have completed an intensive investigation of the USDA allegations and have used this inquiry as an opportunity to scrutinize even more closely our Institutional Animal Care and Use Program. Today I write to share with you our response to the USDA, which was submitted yesterday.

A succinct Preface to the Response, the complete Response document, campus press release, and the full text of the Complaint can be viewed.

In particular, I encourage you to read the Preface statement, which summarizes key points emphasized in the official document.

Our analysis leads me to conclude that UCSF has an excellent animal care program. The recent accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care is just one symbol of the high standard of animal care provided.

UCSF's achievements in animal care are, in large measure, due to our remarkably compassionate, dedicated, and effective faculty and staff. To you -- the UCSF Institutional Animal Care and Use Committee (IACUC), the research community, the Laboratory Animal Resource Center staff, and others -- I express my deep gratitude for your leadership and unwavering commitment to ensuring that research animals are treated humanely.

Sincerely,

A. Eugene Washington, MD
Executive Vice Chancellor

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UCSF Denies Animal Welfare Act Allegations, Questions Timing

News Release. Corinna Kaarlela, News Director
Source: Jennifer O'Brien, jobrien@pubaff.ucsf.edu , 415-476-2557
Date: Oct. 21, 2004

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.

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PREFACE

On September 14, 2004, the University of California, San Francisco (UCSF) received a Complaint from the United States Department of Agriculture (USDA) alleging violations of a Federal statute governing the care of research animals.

The USDA Complaint is a compilation of allegations made against UCSF during the period of May 2001 and February 2003. All of the allegations were addressed by UCSF at the time they were first received and, where appropriate, remedial measures were implemented. The USDA has so far failed to explain why it has now issued an aggregate Complaint..

UCSF has reviewed the Complaint in detail and has prepared a response to each of the allegations, which follows this Preface. The University is denying the vast majority of the allegations and vigorously contests the USDA assertion that the gravity of the alleged violations is great. Moreover, UCSF contends that only one allegation represented potential discomfort to an animal.

The total number of allegations contained in the USDA Complaint is misleading. In truth, many of the allegations derive from the same episodes, giving a false impression of frequency. For example, allegations of failing to monitor the condition of two lambs following surgery appear in eight different paragraphs. All of these allegations arise from a single episode involving two lambs, and all are denied by the University on the strength of the record.

Similarly, five separate citations for condensation on the ceiling of a single cage washing room were issued on the same day because the inspector argued that five species of animals were possibly affected. Other redundancies occur throughout the Complaint. To put these events in context, it should be noted that the total number of animals named specifically in allegations is 12 over the course of approximately 2 years [22 months] and among a cumulative census of over 10,300 animals covered by the USDA regulation.

Several of the allegations have been reported inaccurately by the press, reflecting unjustly on the staff and faculty at UCSF. For example, accusations in the press that UCSF scientists operated on animals without the use of anesthesia are patently 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 misreading of standard instructions in veterinary records.

The UCSF response is of necessity a legal document and requires some patience in reading. So it is worth summarizing here in plain language the response to some of the more substantial allegations. First, the Complaint claims that one marmoset was subjected to forced breeding while still nursing previous offspring, with the clear 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 postoperative 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 some 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 post operative observation in accordance with the approved protocol, and initiated corrective action immediately. The failure was subsequently documented by the USDA inspector. UCSF terminated the protocol of its own volition.

UCSF adheres fully to Federal requirements for approval and oversight of animal research. The campus has invested mightily in the care of laboratory animals, doubling its veterinary staff over the past four years and constructing a new state-of-the-art facility that will open early in 2005. The quality of animal care at UCSF received a strong endorsement recently when it was accredited by the Association for Assessment and Accreditation of Laboratory Animal Care, an independent agency whose approval is considered the gold standard by advocates and critics of animal research alike.

UCSF knows that the public has vested a trust in us and we take that trust very seriously. We know that we have a duty to provide laboratory animals with the most humane treatment possible. We believe that careful inspection of the document that follows will affirm our commitment to that duty and correct the wrongful misapprehensions engendered by the USDA Complaint.