Ruling On Lab Rodents Could Reduce Oversight Of All Animal Sites

Ruling On Lab Rodents Could Reduce Oversight Of All Animal Sites WASHINGTON--Animal rights activists are pleased about a federal judge's ruling last month that the United States Department of Agriculture acted in an "arbitrary and capricious" manner in excluding rats, mice, and birds from its interpretation of a federal law meant to protect research animals. But the judge's favorable decision in their suit could result in less-frequent inspections of research facilities housing these and other warm-blooded animals, says a government official responsible for enforcing the law. On January 8, in the U.S. District Court here, Judge Charles Richey ruled that the Agriculture Department had no valid reason to omit from inspection, called for under the 1971 amended version of the Animal Welfare Act, an estimated 15 to 20 million rodents and birds--representing 85 percent of all animals used in research labs across the country. The law requires USDA to register and inspect regularly any institution or company that uses, breeds, or cares for laboratory animals. He ordered department officials to review their decision--made in 1971 because the department wished to direct its limited resources toward the well-being of such higher-order animals as dogs, cats, and primates--as a first step in issuing regulations to cover rodents and birds. USDA currently oversees some 7,600 sites, including colleges, companies, and carriers of research animals, which it inspects an average of 1.5 times a year. In addition, institutions that receive federal money from the Public Health Service, which includes the National Institutes of Health, follow guidelines that stipulate the proper treatment of all research animals in their care. "All of our grantees have on file with our office an approved animal welfare assurance plan," says John Miller, director of NIH's division of animal welfare. "It covers everything from proper animal husbandry, through care during the experiment, to euthanasia, when appropriate, upon completion of the research." The suit was brought by the Washington, D.C.-based Animal Legal Defense Fund and the Humane Society of the U.S. in 1990 after alternative efforts to change the USDA regulations proved unsuccessful. "It closes a loophole in the USDA's interpretation of the act," says Martin Stephens, vice president for laboratory animals at the Humane Society. "We hope it marks the beginning of the department's efforts to protect species that it has ignored for two decades." USDA must first decide whether to appeal the ruling. If no appeal is filed, the agriculture department is expected to draw up regulations that are similar to guidelines in use by other federal agencies for the care and treatment of rodents and mice. It could also adapt existing language in the Animal Welfare Act written for "miscellaneous" animals. But a USDA official says that he fears the most lasting impact of Richey's decision could be a serious erosion of the department's current inspection schedule. Without more money, says Richard Crawford, director of the animal care staff at USDA's Animal and Plant Health Inspection Service (APHIS), the department may be able to visit each year only one-half or fewer of the facilities under its jurisdiction. "If it only doubles our work load," says Crawford, "there will be places that we just won't get to." APHIS has an annual budget of $9.6 million, which pays 65 veterinarians and another two dozen lay inspectors to conduct unannounced inspections across the country. Crawford and others estimate that the ruling could make the department responsible for several hundred more sites, mostly smaller academic institutions, startup biotech and pharmaceutical companies, and breeders that handle only rodents and birds. Neither the government nor the activists claim that there is widespread abuse of rodents by researchers. Every institution that receives money from the Public Health Service (PHS) must follow guidelines for the proper care and treatment of all of its experimental animals. And any institution found guilty of violating those guidelines runs the risk of having its funding withdrawn. But the activists say that Richey's ruling, once translated into regulation, will eliminate the possibility of legal abuse of rodents and mice. "The PHS guidelines don't have the same status and penalties under the law that will be the case under APHIS," says Stephens. "PHS takes an educational approach to compliance. Why, they don't even call them inspections; they conduct site visits instead." NIH's Miller agrees that his agency takes a different approach to the care of animals. He says that the 1,400 institutions under his jurisdiction rarely are subjected to surprise visits because that's not how NIH operates. "We did six technical site visits last year, picked at random when an institution's [five-year] assurance plan was up for renewal; but it's been at least a few years since we did a visit `for cause' [stemming from a tip that something was wrong at that institution]," he says. "Our approach is based largely on trust, and we believe that it is more effective [than USDA's] because it places the burden on the institution to make sure it does what it has promised to do." The true impact of Richey's ruling, say most observers, won't be known until USDA puts the new regulations into effect and APHIS officials know how much money they will have to carry out their additional duties. Both Stephens and Barbara Rich, vice president of the National Association for Biomedical Research, which lobbies on behalf of the research community, say that they plan to work for an increase in the agency's budget. An additional $3 million should do it, Stephens estimates. In the meanwhile, say animal activists, Richey's ruling represents a small, logical step forward. "It's absurd that USDA doesn't recognize rats, mice, and birds as animals," says Christine Stevens, president of the Animal Welfare Institute in Washington, D.C. "No other scientific nation makes that distinction."

Ruling On Lab Rodents Could Reduce Oversight Of All Animal Sites

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