When Congress passed the Animal Welfare Act in 1966, it charged the U.S. Department of Agriculture with safeguarding domestic warm-blooded animals from neglect and abuse. The stated intention of the law was to protect any creatures raised to be pets, put on exhibition, or used in research.
Some 95 percent of the animals that fit that description, however, were soon excluded from the act. The exempted group comprises an estimated 23 million rats, mice, and birds.
In writing regulations to enforce the new law, USDA excluded these small animals from regulation. It noted that the agency lacked enough inspectors to deal with the huge number of such animals. The agency continued to justify this exemption over the years, stating that most of the affected animals reside at research institutions where other oversight programs ensure their protection.
By current estimates, two-thirds of the thousands of institutions using exempted species for biomedical research now follow strict animal-care rules for all their animals. The Public Health Service has enacted guidelines to protect animals used in research funded by the National Institutes of Health. Various independent bodies—most notably, the Association for Assessment and Accreditation of Laboratory Animal Care (AALAC)—developed other guidelines. Adherence to such rules has not only become an integral part of qualifying for and maintaining federal research funding, but it’s also a requirement for any research that will be submitted to the Food and Drug Administration or the Environmental Protection Agency in support of a potential product or plan.
Nevertheless, there remain perhaps 1,500 research centers not subject to oversight. These include small universities that use rodents primarily in psychology experiments, biotech firms running preliminary toxicology or drug-development experiments, and breeders of rodents and birds.
Those are the places that worry John E. McArdle, a scientist who once experimented with laboratory animals but now directs the Alternatives Research and Development Foundation (ARDF) in Eden Prairie, Minn. “These institutions have never had to register [with any public or private agency], so we don’t know who they are. And no one goes in to inspect them.”
McArdle’s 10-year-old group has brought suits against USDA over several years, arguing for extension of the act to rats, mice, and birds.
USDA quietly agreed to just that last month in an out-of-court settlement of one suit with ARDF and the American Anti-Vivisection Society of Jenkintown, Pa., the group from which the foundation arose. The new rules would establish standards for the care, feeding, and housing of animals that were formerly exempted.
“This is a significant victory for animals,” announced the society’s executive director, Tina Nelson, shortly after the agreement was penned. “The more than 90 percent of animals used in laboratories who currently have no legal protection could now be covered by federal law.”
She spoke too soon.
Infuriated biomedical researchers have won a reprieve. A temporary, 11th-hour addendum to the USDA appropriations bill will freeze for 1 year any spending to draft animal-care rules for rats, mice, and birds.
Over the next year, the research community will campaign to overturn the new Animal Welfare Act extension, says Estelle A. Fishbein, vice president and general counsel for Johns Hopkins University in Baltimore. Make no mistake, says Fishbein, “we’re going to fight this tooth and nail.”
The goal of ARDF and other groups that sued the USDA, she maintains, is to make animal research so expensive and cumbersome that scientists will eventually forego it. If these animal-rights groups are permitted to get their way, researchers will move their laboratories out of this country, Fishbein contends. “There will certainly be a brain drain—to Asia, where they don’t have these regulations,” she says.
Good housekeeping
Establishing good-housekeeping and reporting standards for rodents and birds doesn’t sound controversial. And in theory, it isn’t, says Anthony J. Mazzaschi of the American Association of Medical Colleges in Washington, D.C. In fact, he says, “our position has always been that we don’t philosophically oppose rats, mice, and birds being included [in the act].”
Yet the history of how USDA has applied the act to other creatures—including dogs, chimps, and hamsters—suggests the new rules “will drown us in paperwork,” he says.
Johns Hopkins, the largest recipient of NIH funding and a major center for research using animals, estimates that the additional record keeping alone would cost it millions of dollars annually.
The university may house tens of thousands of mice at any time, observes Richard J. Traystman, a scientist who studies strokes and who has chaired John Hopkins’ Animal Care and Use Committee for more than 20 years.
He expects that the new rules will require tabulating how many animals reside at each institution, as USDA rules now require for the animals already covered. Since rodents breed readily and frequently, the sum changes daily and would require laborious tallies. No current government or private animal-welfare program requires such an accounting for these rodents and birds, he notes.
Moreover, Traystman says, records would have to note how each animal is treated, as they do now for large animals.
One scientist told Fishbein that the new record keeping would likely require hiring another person for each of his 17 research programs. “He doesn’t have enough square feet in his laboratory to accommodate 17 pencil pushers,” Fishbein told Science News, “never mind finding the money for their salaries. And that’s just one of our scientists.”
Taking a toll
The toll that the scientists elaborate would be taken at institutions already under tight animal-care regulations, observes Barbara A. Rich, executive vice president of the National Association for Biomedical Research (NABR) in Washington, D.C. Last year, NABR surveyed its 350 members, which include universities, medical schools, hospitals, professional societies, and pharmaceutical companies. Its findings, Rich says, suggest that centers already adhering to good-laboratory practices could collectively rack up $80 million in additional administrative costs to comply with the act.
Institutions that would for the first time face unfamiliar record keeping and unannounced yearly inspections could be hit even harder by the regulatory change. Reporting costs at these institutions could total “a minimum of another $100 million,” Rich notes.
Traystman argues that because research-funding institutions aren’t likely to increase grant awards to cover the new costs, complying with the extended Animal Welfare Act will sharply cut the amount of work accomplished per grant.
Sky is falling…not!
“I know they’re saying the sky is falling,” McArdle says, “but it’s not true.” About one-third of animal-research centers have AAALAC accreditation, signifying exemplary animal care. He predicts that such institutions “would have to make absolutely no changes.”
McArdle anticipates that even institutions lacking this accreditation but receiving NIH funding will need to fill out just a couple of extra forms.
Where big change could occur is at formerly unregulated institutions. The law would require that they identify themselves, prove that they employ good-laboratory practices, and open their doors to unannounced USDA inspections.
Where animal care proves subpar, McArdle says, USDA would have the power to shut down a research program. And that’s as it should be, he maintains, because poor care induces stress in animals, compromising the value of any studies performed with them.
Even including currently unregulated institutions, “we expect everyone would have to do no more than what those receiving NIH funding now do,” he concludes.
“I don’t think we can say that,” counters Susan McAvoy of USDA’s Animal Plant Health Inspection Service (APHIS), which enforces the Animal Welfare Act. If a year from now the act’s extension still stands, no one knows what the final rules will look like, especially since they may undergo substantial changes to accommodate suggestions during a public-comment period, she says.
There is, however, at least one thing that would clearly change. Unlike existing guidelines covering rats, mice, and birds, the Animal Welfare Act’s regulations would carry the weight of law.
Daunting cost
Mary J.C. Hendrix, president of the Federation of American Societies of Experimental Biology, sees yet another potentially daunting cost of including rats, mice, and birds under the act. The change would require far more USDA inspections.
In a Sept. 15 letter to Agriculture Secretary Dan Glickman, she questioned whether this would “strain [USDA’s] already understaffed and underfunded animal-welfare enforcement program.”
Last year, that program undertook 11,000 site visits to police the current act, notes Laura D. Sanchez, with APHIS in Riverdale, Md. Just 71 inspectors carried out the work.
USDA recently hired four more. But with the new responsibility for checking up on formerly exempted animals, the inspection duties of APHIS’ $10-million animal-care program could double, believe analysts on both sides of the animal-rights issue.
If there aren’t enough inspectors to go around, USDA may try to cope by preferentially scrutinizing the institutions with the most animals, says John G. Miller, executive director of AALAC, based in Rockville, Md.
However, most large institutions have AALAC accreditation, he notes, including “essentially all major U.S. breeders [of these species] for research, all pharmaceutical manufacturers, and the top NIH grant recipients.” This suggests that the institutions most likely to be overlooked may be small, currently unregulated ones, which warrant the closest scrutiny, he says.
USDA’s new responsibilities may even deflect its resources from enforcing the act as it applies to the larger animals. As such, Hendrix argues, giving USDA all of this extra work might ironically “jeopardize the welfare of research animals.”
McArdle concurs that these are reasonable concerns. That’s why “we agree that they [USDA] will need a lot more money,” McArdle says.
More changes
Even more changes for animal researchers may loom, Traystman worries. A few years ago, USDA responded to “animal rightists” and increased the required size of cages for monkeys by an inch or two in each dimension, he notes. With a single new cage costing $5,000 and virtually all cages in use rendered obsolete, the U.S. health-research community suddenly took a several-million-dollar hit, Traystman asserts. The costs would be far greater if a similar change in cages for rats or mice was suddenly to be required, he says.
“USDA regulations also require that you mitigate pain and distress every time you do a procedure,” Miller says. “If you don’t, you have to write a report explaining why. Will we have to do that for every rat and mouse?” he asks.
Moreover, the USDA forms seem to assume that drugs are the only means to relieve pain, says J.R. Haywood, a researcher at the University of Texas Health Science Center in San Antonio, who uses rats to study hypertension. Keeping an animal warm after surgery, replacing lost fluids, and other measures often work as well in limiting discomfort, he observes. Such alternatives may even be necessary for the success of an experiment, he notes, because pain drugs might interfere with some treatments being studied.
USDA is also considering whether to add new categories of pain and distress that must be reported for all animals covered under the Animal Welfare Act. The agency could decide to make labs document, at the time that a procedure is occurring, any pain and distress for each animal, Haywood worries. It might require watching and recording the complete response of each of dozens of rodents—even if the pain associated with surgery, for example, lasts only 1 hour.
Though it might be nice to know these things, Haywood says, “you have to ask, Why is USDA collecting these data? What will it do with them?” In the end, filing such reports won’t improve the animals’ care, he argues.
Regulatory changes
Haywood charges that such regulatory changes, often spurred by campaigns in the animal-rights community, “are clearly intended to throw a wrench into biomedical research.”
“Nonsense,” says McArdle. While he would prefer that researchers eliminate their unnecessary use of animals, he concedes that many vital questions can only be answered by experiments on animals.
That’s just the line McArdle uses for popular consumption, Traystman counters. “What he is really looking to do is to create new burdens for [biomedical] investigators.” His goal is to make things so difficult that scientists abandon animal research, Traystman contends.
Whatever the motives for getting rats, mice, and birds included in the act, they are now covered by the law. The 1-year funding freeze will just give the biomedical research community another year to swallow the idea that change is inevitable, McArdle insists. “They’re not going to stop us. The budgetary maneuver just delays things a bit,” he says.
