New Animal Care Guide Leaves Details To Scientists' Discretion

Sidebars How to Get the Guide Committee to Revise the ILAR Guide REVISIONIST: Retired teacher Jo Ann Steggerda's presence on the panel was criticized. Most laboratory scientists, and even some animal-welfare advocates, are applauding the newly published seventh edition of the Guide for the Care and Use of Laboratory Animals. The new edition, the first update since 1985, was published by the National Research Council's Institute of Laboratory Animal Resources (ILAR). It places far greater reliance on scientific judgment in the housing and care of research animals, and moves away from mandating specific solutions. However, some animal-care experts remain uncertain about how to interpret a few of its provisions and are worried that compliance may increase their costs. The ILAR guide's requirements are binding on all research supported by Public Health Service agencies, such as the Centers for Disease Control and Prevention and the National Institutes of Health. Many other institutions and companies voluntarily follow its mandates. "I think it's greatly improved" over earlier editions, maintains John D. Young, a veterinarian and director of comparative medicine at the Cedars-Sinai Medical Center Research Institute in Los Angeles. Ticking off the virtues of the new guide, Young says, "It's fleshed out a lot more. There's a lot more information. There's a lot more in the way of citations. It greatly expands the suggested literature that [can] be consulted prior to making decisions. It's all-encompassing. It's very detailed, very thoughtful, and I don't find anything that I'm in conflict with." DISPLEASED: Martin Stephens of the Humane Society believes "much more can and should be done to help animals." Animal-protectionist groups, however, maintain that the guide's new focus on scientific judgment does not reflect their concerns. "Our view is that much more can and should be done to help animals in laboratories," argues Martin L. Stephens, vice president for animal research issues at the Humane Society of the United States, headquartered in Washington, D.C. "We're a long way from fully embracing the approach of the 'Three Rs': replacement, reduction, refinement [of animal use]. We're a long way from having adequate regulations. We're a long way from having an open system. We're a long way from eliminating questionable experiments." The most significant aspect of the ILAR guide may be its so-called performance approach: It sets goals for the care of animals and leaves most of the detailed methods of achieving those goals up to scientists and animal-care professionals on-site. The alternative to performance guidelines is usually referred to as the "engineering" approach: inflexible requirements for everything from cage size to the capacity of the ventilation system. "This 'performance' approach is desirable," reads the ILAR guide, "because many variables (such as the species and previous history of the animals, facilities, expertise of the people, and research goals) often make prescriptive ('engineering') approaches impractical and unwarranted." For example, the guide contains tables suggesting cage sizes for various species. However, it states that the space allocations may be increased or decreased to meet performance goals with the approval of a facility's Institutional Animal Care and Use Committee (IACUC). Under the Animal Welfare Act-first passed by Congress in 1966 and amended most recently in 1985-every institution that uses animals for research is required to maintain an IACUC. These performance goals direct IACUCs to recognize that a cage's volume is not the only thing that should be considered in assessing space adequacy. The ILAR guide encourages group housing of social animals, for instance, and advocates that raised resting surfaces be provided to cats. "Does [the animal] perform species-typic behavior in the cage?" asks Thomas L. Wolfle, ILAR's program director. "If it does, and it utilizes space in a way judged appropriate by people who know that species, then that's about as far as we can go in terms of cage space and design. HOW TO GET THE GUIDE The full text of the Guide For The Care And Use of Laboratory Animals is available on the Institute of Laboratory Animal Resources (ILAR) site on the World Wide Web (http://www2.nas.edu/ilarhome/). Individual hard copies can be obtained for free; call ILAR at (202) 334-2590. Multiple copies may be purchased from the National Academy Press; call (800) 624-6242. "The good thing about [the performance approach] is that it provides flexibility-options by which to achieve such things as the health of personnel working with laboratory animals and flexibility for achieving optimal cage sizes in parameters that are listed," he adds. "[It recognizes] that animal welfare is not a science. It's an art, and that art requires well-trained, compassionate people." But the performance approach is not without difficulties. "The bad part about it is that performance standards are harder to regulate," notes Wolfle. "It's hard to go into an institution and say, 'Yes, you are absolutely on target,' or 'No, you're not on target.' That is a judgment call: Are the animals in a state of well-being or aren't they?" Some groups have even more basic objections to the performance approach. "The move away from minimum standards has us concerned," counters the Humane Society's Stephens. "The goals that are specified in performance standards are ill-defined and amorphous, and therefore we feel that performance standards are little more than buzzwords that one pays lip service to. "In our view," he notes, "good facilities are going to try to do the right thing, and they shouldn't have any problem. The problem comes in largely when you have facilities that are operating in bad faith. They can easily use the phrase 'professional judgment' as a smoke screen to continue business as usual." COMMITTEE TO REVISE THE ILAR GUIDE J. Derrell Clark (chairman) Director Animal Resources College of Veterinary Medicine University of Georgia Dennis F. Kohn Professor of Clinical Comparative Pathology and Director, Institute of Comparative Medicine College of Physicians & Surgeons Columbia University Ransom L. Baldwin Professor and Sesnon Chair Department of Animal Science University of California, Davis J. Wesley Robb Professor Emeritus, School of Religion Professor Emeritus, School of Medicine University of Southern California Kathryn Bayne Associate Director for Accreditation American Association for Accreditation of Laboratory Animal Care Rockville, Md. Orville A. Smith Professor Physiology & Biophysics Core Staff Regional Primate Research Center University of Washington Marilyn Brown Director Animal Care & Use Program Dartmouth College Jo Ann D. Steggerda Champaign, Ill. Gerald F. Gebhart Professor Department of Pharmacology College of Medicine University of Iowa John G. Vandenbergh Professor Department of Zoology North Carolina State University Janet C. Gonder Director Comparative Medicine Baxter Healthcare Corp. Round Lake, Ill. William J. White Director Professional Services Charles River Laboratories Wilmington, Mass. Judith K. Gwathmey Associate Professor Cardiovascular Diseases and Muscle Research Laboratories Harvard Medical School Sarah Williams-Blangero Assistant Scientist Department of Genetics Southwest Foundation for Biomedical Research San Antonio, Texas Michale E. Keeling Professor of Veterinary Medicine Department of Veterinary Sciences University of Texas M.D. Anderson Cancer Center Houston John L. VandeBerg (ex officio) Scientific Director Southwest Foundation for Biomedical Research San Antonio, Texas "There are [minimum standards set], and these are called the Animal Welfare Regulations," Wolfle responds. Those rules are a result of the Animal Welfare Act, administered by the U.S. Department of Agriculture. "We think the guide exceeds the regulations in most areas. "In a way, Dr. Stephens is right," concedes Wolfle. He notes that some institutions that don't have a wealth of expertise may have more trouble with the guide's performance approach. "The guide spends some time talking about that and tries to use language to be helpful to the small institutions. But the bottom line is, if you don't have the expertise for a particular species, perhaps you shouldn't be using that species or you ought to call in the expertise from the outside." Focusing on engineering details of a facility, however, does not guarantee humane animal treatment, contends Wolfle. "I think performance standards provide an opportunity by which we can address the welfare, the environment, the behavioral needs of animals," he says. "I am an absolutely strong believer that animals can be well cared for in less-than-optimal facilities if the people are well-trained and compassionate. A sparkling facility itself means nothing without the proper people. And so what we're doing is putting the emphasis on the people end, so that they will . . . ensure the quality of life of the animals they're responsible for." Some scientists are worried, however, that the ILAR guide's specific recommendations may force some facilities to incur additional costs. "The recommendation for social animals to be group-housed is probably going to cause concern for some institutions, who, for example, use smaller dogs such as beagles," notes Young of Cedars-Sinai. "Some institutions may be left with the dilemma as to what to do about the fact that they have perhaps 100 stainless-steel cages for small dogs. Should they now rip all those out, sell the stainless steel for scrap, and put in runs for group housing?" Another concern is the guide's strong recommendation that rodents be housed in solid-bottom cages with soft bedding rather than in wire-bottom cages. Many facilities prefer wire-bottom cages, since they're easier to keep clean: Waste materials fall through the wire mesh onto collector trays. But the guide quotes studies suggesting that, given a choice, rodents prefer flat-bottom cages, and furthermore, rodents housed in wire-bottom cages often suffer from foot lesions. Although all rodents at Cedars-Sinai are housed in solid-bottom cages, Young notes that other institutions may not be so lucky. "Stainless steel lasts forever. It doesn't have to be replaced very often. There are a lot of rodents being housed in wire-bottom cages, and I think a lot of facilities are going to have to think seriously about abandoning those cages unless there's a scientific reason, and I can't think of many. They may have to incur great expense." A LONG-RANGE VIEW: Michael Hayre of Rockefeller University's Laboratory Animal Research Center notes that some of the guide's requirements that seem expensive may end up saving money for research labs over time. But Michael D. Hayre, a veterinarian and director of the Laboratory Animal Research Center in New York's Rockefeller University, points out, "Sometimes what may at first appear to be an expensive or time-consuming requirement may in the long term actually save money. When we improve the health of animals, we've seen that we're getting better research data, more reliable research data, [and] we have greater credibility with the American public on these issues. If you no longer have rodents with foot problems, you have a better research model right there. And you save costs in veterinary care." More important, he notes, "the transcending aspect of this is, it's more humane." Another area of concern for physiologist Richard Tallman, an associate professor at the Ohio State University (OSU) School of Allied Medical Professions in Columbus and chairman of OSU's IACUC, is how to interpret and implement the guide's new training requirements. The sentence that is causing Tallman some puzzlement reads, "Investigators, technical personnel, trainees, and visiting investigators who perform animal anesthesia, surgery, or other experimental manipulations must be qualified through training or experience to accomplish these tasks in a humane and scientifically acceptable manner." Although OSU's IACUC has long provided general training in animal care to all personnel who come in contact with animals, Tallman believes this sentence may mean that he will have to provide specific training in the actual experimental procedures in use in each individual laboratory. "We're still debating what this means and how it will play out," Tallman says. For now, he plans to rely on each principal investigator's attesting in writing that workers in his or her lab have been properly trained. Robert A. Whitney, former deputy surgeon general of the United States and currently president of the board of trustees of the Greenbelt, Md.-based Scientists Center for Animal Welfare (SCAW), maintains that the point of view of the animal-welfare community was well represented in the process of revising the ILAR guide. "There were a number of hearings across the country with input from the animal-protection part of the community," he says. "I thought they had a well-balanced committee. I think [the guide] is very good." One way ILAR tried to make sure the voice of the animal-welfare community was heard was to appoint a concerned member of the general public to the revision committee. Wolfle selected Jo Ann D. Steggerda, a retired high school English teacher from Champaign, Ill. "She was in a middle position . . . from my perception of the public's desires," explains Wolfle. "She was not an antivivisectionist. She serves on the University of Illinois [at Urbana-Champaign] animal care and use committee. She's very involved in her community. She's a member of the local humane society. And so she fit the criteria. We wanted to bring in the public's perception of animal use." But the Humane Society's Martin Stephens expresses dismay at Steggerda's appointment. "The animal-protection community in the United States is not familiar with the outside member that ILAR appointed to the committee," he says. "This was not very reassuring. The whole point for the insistence on an outside member was to have someone serve as a kind of a watchdog, someone whom we could trust. We had no basis to say one way or another whether Mrs. Steggerda acted in that capacity. However, there's some basis for concern, given that she has no history of involvement in the animal-protection community, and also given her glowing, unbridled assessment of the resulting document." "I was very aware of the negative reaction of my appointment to the committee," acknowledges Steggerda. "I am not a national name, and I have never pretended to be a leader in the animal-rights movement. That does not mean that I am not sympathetic to their concerns, nor does it mean that I am not equally sympathetic to the research community who wishes to use animals. I am that strange person who tries to walk the fence between the two communities and be equally fair to both sides." About the suggestion that she was insufficiently energetic in promoting the cause of animal welfare on the committee, Steggerda replies, "I have to laugh at that. This is something that I worked hard on. So am I proud of the guide? You bet. I'm extremely proud of it. I'm proud of the work that the committee did, and I'm proud of the result that the committee produced," she declares. "I think that the goal of every single person sitting on that committee . . . the first goal that guided every bit of the work done . . . was animal welfare. "Did I always get my own way in how I wanted something treated?" she asks. "Of course not. But it is a consensus document. If that slot had been filled by a known animal rightist, I'm not sure that the great body of the public, who are not declared animal rightists, would have been represented at all. I tried to represent all views." In particular, Steggerda points to the guide's greatly expanded bibliography as one of her signal accomplishments on the committee. "I was able [to include] the journals and newsletters of some animal-protection organizations plus some specific papers and books by some animal-protection leaders. There is even an entire bibliographic section on alternatives [to the use of laboratory animals], and that is new." But this doesn't satisfy Stephens, who also complains that the guide is binding only on researchers who receive funding from Public Health Service agencies. Wolfle believes that the guide will have a far broader reach than that. "First of all, all federal agencies use it, not just NIH. All pharmaceutical companies use it, and they receive for the most part little or no federal funding. And as far as we know, all biotech firms use it," he says, adding, "it is being translated into five languages. It will be used broadly in other countries." Spokespersons for biotech giants Amgen Inc. of Thousand Oaks, Calif., and Genentech Inc. of South San Francisco, Calif., confirm that their companies follow the ILAR Guide voluntarily. "We do conduct our research in accordance with the guide," notes Kathleen Rinehart, corporate communications manager for Genentech. "Genentech encourages the utilization and development of alternative methods of study design aimed at reducing the number of animal experiments needed. And when animal experiments are needed, we want to make sure they're done at the highest standards." "That document had to be written in a way to serve varying types of institutions, in varying settings, with varying amounts of money, and varying levels of trained personnel," Steggerda comments. "It has to cover every waterfront, and it has to do it for years and years. Because of that, it cannot be overly prescriptive, but it cannot shirk the responsibility, either. I think it's a great advance in the field." Robert Finn, a freelance science writer based in Long Beach, Calif., is online at finn@nasw.org.

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How to Get the Guide Committee to Revise the ILAR Guide

New Animal Care Guide Leaves Details To Scientists' Discretion

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