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In safe hands? Universities and companies in the United States could face $164 million in extra costs if campaigners succeed in extending to laboratory birds and rodents the legal protection already given to larger animals. Credit: CORBIS / STEVE CHENN

Lawyers for the US Department of Agriculture (USDA) have been given until tomorrow (16 July) to respond to a lawsuit filed in March by an animal rights group, the Alternatives Research and Development Foundation (ARDF).

The lawsuit, filed in US District Court in Washington, is the strongest challenge yet to the government's contention that some 23 million rats, mice and birds being used in research should not receive protection under the 1966 Animal Welfare Act.

If the USDA loses the lawsuit, the result would be annual, unannounced inspections at laboratories not now under the law's auspices, ranging from small liberal arts colleges whose animal use is confined to mice in psychology departments to labs at biotechnology start-up companies. Universities would be faced with a major increase in paperwork and other compliance requirements.

The lawsuit aims to require the department to extend the protection offered by the act. This explicitly covers dogs, cats, non-human primates, guinea pigs, hamsters and rabbits used in research. But it also applies to any “such other warm-blooded animal as the Secretary [of Agriculture] may determine” is being used in research and other activities.

Arguing that this clause gives the USDA discretion on whether to include other animals, the department excluded birds, and rats and mice, whose numbers are exploding in research and which make up some 95 per cent of US research animals. But animal rights activists contend that the law is meant to apply to all warm-blooded animals.

The government has been sued before to include rats, mice and birds under the act. In 1992, a federal judge agreed with the Humane Society of the United States and the Animal Legal Defense Fund that the animals should be covered. The judge called the USDA's argument “strained and unlikely”. But two years later, an appeals court reversed the decision, saying the plaintiffs had not demonstrated that they had the legal standing to sue.

This time, says John McArdle, the ARDF director, the plaintiffs are optimistic that they have demonstrated legal standing, which requires showing direct harm to a plaintiff. McArdle says the ARDF, which is based in Eden Prairie, Minnesota, is harmed by the way the USDA has interpreted the law because the group's purpose is to develop and promote the use of non-animal research methods.

The issue is generating considerable heat. During a public comment period that closed in May, the USDA received almost 40,000 comments on a petition submitted last year by the ARDF and others asking it to add rats, mice and birds to the act's protection.

If the lawsuit prevails, paperwork and inspections would increase significantly at most major research universities, which are already covered by the law because of their use of other animals. At the University of Michigan, for example, the change would mean inspections of 51,000 rats and mice, in addition to the 6,000 animals currently examined in an annual five-day visit by the USDA.

Equally important to animal activists, however, is that researchers who use rats and mice would have to demonstrate that they have considered alternative ways of conducting their research. The law requires investigators to demonstrate that they have looked for alternatives, both to painful procedures and to the use of animals altogether. They also have to show that the work does not unnecessarily duplicate previous work. “A lab animal does not have to be the method of choice,” says McArdle. “We want to require [researchers] under penalty of law” to consider alternatives.

Research advocacy groups, led by the National Association for Biomedical Research (NABR), argue that extending the law's coverage would cripple the branch of the USDA that is responsible for enforcing the law. With a $9.2 million budget and 65 inspectors — down from 88 six years ago — already covering 10,400 sites, the enforcers are stretched past breaking point, they say.

“Fundamentally we don't object to the addition of these species, but we don't want the whole programme compromised,” says Barbara Rich, NABR's executive vice-president. “I don't see how it wouldn't be.”

But critics argue that the USDA's finances are not the issue. “Justice demands that we treat equal situations equally unless there is a morally significant difference between them,” says Barbara Orlans, a senior research fellow at the Kennedy Institute for Ethics at Georgetown University in Washington, and one of the petitioners. McArdle says the USDA is “using a lack of money as a defence for not doing what they are legally required to do”.

Based on a survey of its members, the NABR concluded that an extra $84 million in administrative costs would be incurred at institutions already covered by the act. It estimates that, for companies and institutions not now covered, registration and compliance would cost at least $80 million. The USDA estimated in 1990 that the number of research institutions it regulates would almost double if rats, mice and birds were covered.

The department declines to comment because the issue is under litigation. But the USDA has previously argued that such a change “would have serious consequences for the protection of other species” covered by the law because it would dilute enforcement efforts. It noted that Congress has never moved to include the rodents under the act, although it has amended it several times. “The vast majority of rats, mice and birds used in biomedical research are already afforded certain protections,” it added.

This refers to the fact that researchers who receive Public Health Service funding agree to follow a policy on the humane use and care of laboratory animals that includes all vertebrates. But this policy does not require inspections, nor does it have the force of law.

Animal care administrators say that the requirements of excellent science, and the health service code, mean that rats, mice and birds are already treated as well as if they received protection under the act. “As far as the care of the animals [goes] it wouldn't make one whit of difference,” says Daniel Ringler, director of the unit for laboratory animal medicine at the University of Michigan.

But a survey last month in Lab Animal turned up surprising results from members of Institutional Animal Care and Use Committees, the panels of veterinarians, researchers and other faculty members responsible for ensuring that their institutions comply with animal welfare rules. Of 491 committee members surveyed, 73 per cent said that rats and mice should be covered by the act. The same proportion was true for the 287 animal researchers in this group.