Since the inception of the Animal Welfare Act (AWA) of 1966, and through several revisions of the law, most laboratory rats, mice and birds have been excluded from regulatory oversight by the U.S. Department of Agriculture (USDA), the agency charged with administering the act.

The legal status of these animals--which comprise about 95 percent of nonhuman animals used in laboratory research--may soon change, however. Last fall, in an out-of-court settlement, the USDA agreed to consider amending its definition of "animal" to include rats, mice and birds in AWA regulations.

Funding for such rulemaking has been delayed at least until October. But the proposed change, coupled with a controversial proposal that the department also expand its definition of and reporting requirements for pain and distress in laboratory animals, has spurred heated debate within the scientific community.

"The bureaucracies that will be put in place, if this happens, will be incredibly expensive," says Mount Holyoke College psychologist Karen L. Hollis, PhD, a member of APA's Committee on Animal Research and Ethics (CARE).

Indeed, some believe that's just the result that anti-animal research groups that pressed for the rule change have been seeking: to disable animal research by making its cost prohibitively high--particularly at small institutions that have not previously had to support such extensive record-keeping for the few animals they use in research and teaching.

Petition and lawsuit

In January 1999, the Alternatives Research and Development Foundation (ARDF), an organization affiliated with the American Anti-Vivisection Society, and others petitioned the USDA to amend its rules to bring rats, mice and birds under the department's regulatory umbrella. They argued that the exclusion of rats, mice and birds from USDA regulations' definition of animal is "arbitrary and capricious" and that it discourages efforts to develop research models that do not involve using animals.

Soliciting public comment on the proposed rule change, the USDA noted that extending AWA coverage to rats, mice and birds would have a substantial financial impact on institutions and investigators. Further, the department suggested, such coverage would "significantly affect overall AWA enforcement." The USDA estimated that conducting annual inspections of research facilities that use rats, mice and birds would cost at least $3.5 million, about one-third of its Animal Care budget.

Soon, ARDF and others filed suit against the USDA, maintaining that the agency had stepped outside its legal rights by excluding rats, mice and birds from AWA oversight.

In October, USDA officials settled the case, concerned that if they lost in court, a judge could have compelled the department to write new rules immediately--and could have even dictated specific aspects of the regulations, such as what standards of care should apply and which facilities or activities should and should not be exempted.

"We wanted to avoid that and to preserve the normal notice and rulemaking process," says Ron DeHaven, DVM, deputy administrator of the USDA's Animal Care division.

Rulemaking won't begin anytime soon, however. In an 11th-hour development, U.S. Sen. Thad Cochran (RĀ­Miss.) introduced a rider to the USDA appropriations bill for fiscal year 2001, forbidding that federal funds be used for rulemaking concerning rats, mice and birds' inclusion under the AWA before Oct. 1, 2001. President Clinton signed the bill last October.

Unnecessary burden

Many researchers and scientific organizations, including APA, have argued that the vast majority of rats, mice and birds used in research already enjoy ample protection by other means. According to government estimates, at least 90 percent of these animals are protected through the National Institutes of Health and other federal funders; through universities' Institutional Animal Care and Use Committees (IACUCs); through scientific societies' ethical guidelines; and through voluntary accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC).

Establishing another level of oversight through the AWA, opponents of the change believe, would bury researchers and institutions in needless paperwork and threaten the research and teaching that depend on nonhuman animals.

At the Johns Hopkins University, for example, animal care administrators expect that if investigators are required to keep detailed breeding or surgical records of rats, mice or birds--as they are for other warm-blooded animals regulated by the USDA--the financial and paperwork burdens will be significant.

"The outcome of this process would be that money allocated for research would instead be used to pay for writing reports--reports that would show that the actual care of rats, mice and birds in research is fine," says Nancy Ator, PhD, a psychologist at the Johns Hopkins School of Medicine and APA's representative to AAALAC.

Many in the research community also fear that including rats, mice and birds under USDA regulations could also endanger other laboratory animals, such as nonhuman primates, by diverting federal funds from their protection.

Regulatory incentive

Proponents of the new regulations maintain that it's only logical to provide AWA protection to the species that account for the great majority of research using nonhuman animals.

"The primary argument on the other side...is that 90 percent of these animals are already covered by the Public Health Service and by AAALAC," says Kenneth Shapiro, PhD, executive director of Psychologists for the Ethical Treatment of Animals. "That's true, but the 10 percent that aren't covered--which exist primarily in small, liberal-arts colleges and in commercial genetic-engineering institutions--are a significant number of animals. Because USDA is tracking none of these animals, we don't know what the trends are in their use. For those of us in the animal welfare community who are very concerned about reducing the numbers used, that's a problem."

Regulatory protection through the AWA would also motivate investigators to consider alternatives to using nonhuman animals in their research, argues John E. McArdle, PhD, ARDF's director.

Some in the research community believe that McArdle and others in the animal-rights community are disguising their motives, however.

"The regulation of rats, mice and birds, as with so many of the animal-rights groups' other initiatives, does not really have to do with a significant problem having to do with animal welfare," contends Ator. "This has to do with increasing the cost of research. Their goal--stated in so much of their literature--is that they want to see an end to research that uses animals, and increasing regulation is one way of making it harder to do research."

APA's Executive Director for Science Richard McCarty, PhD, argues that "there is no evidence that the well-being of rats, mice and birds involved with research would actually be affected by more regulation. First of all, the protection that is already afforded by federal, state, local, professional and institutional policies means that adding USDA regulations would be of marginal--if any--value. Even the numbers of animals reported would likely be misleading and useless for tracking trends in animal use, because institutions would adhere to varying criteria for counting animals."

In addition to formal incentives for the appropriate treatment of animals, McCarty says, "Contrary to the misperception perpetuated by anti-animal research groups, scientists care a great deal for the welfare of their lab animals. Both for moral reasons and because useful, publishable data can be collected only from animals that are treated humanely, we don't use more animals than are necessary to answer our research questions."

Even among researchers, there is division on the question of regulating rats, mice and birds through the USDA.

Scott Plous, PhD, a social psychologist at Wesleyan University, reported in the American Psychologist (Vol. 51, No. 11) in 1996 that most APA members indicated they favored including all commonly used research animals in federal regulations. More recent research, he adds, has indicated that the majority of university IACUC members also support the inclusion of rats, mice and birds under the AWA.

But Edward A. Wasserman, PhD, a comparative psychologist at the University of Iowa and former chair of APA's CARE committee, counters, "The opinions of the general membership of APA are largely uninformed by the regulatory statutes already in place for the care and use of animals in research. Most members are practitioners, and the vast majority of psychological scientists study human behavior. So this doesn't give you a very good window on scientific opinion on the subject."

Indeed, Wasserman adds, "I believe the vast majority of researchers who use rats, mice and birds wouldn't be at all enthusiastic about including them in this regulatory scheme because it undoubtedly is going to mean more red tape, more paperwork and less time to do one's work."

Preparing for an uncertain future

The appropriations rider delaying the rulemaking process may have taken the anti-animal research groups by surprise, but "this won't happen twice," ARDF's McArdle says. "We're ready for them now." In fact, the delay gives players on both sides of the issue time to gather their armies.

"There is opportunity for several things to happen" before next October, says the USDA's DeHaven. For example, he suggests, Congress could take legislative action to clarify the intent of the AWA, stipulating whether rats, mice and birds should be excluded from USDA protection.

Even if that doesn't occur, DeHaven adds, it's difficult to predict the shape that any new regulations might take. It's unlikely the rulemaking process would result in no change to the regulations, DeHaven acknowledges. He suggests that any new regulations would be phased in slowly, buffering the cost to the government and perhaps also to investigators. In addition, he speculates, it's possible that regulations would cover all laboratory rats, mice and birds, but that inspections would take place only when inappropriate animal treatment is suspected or at facilities not overseen by other institutions.

Complicating the decision process is another fractious issue: whether or not the USDA should amend its requirements for reporting pain and distress in laboratory animals. A public comment period on that question ended in November. DeHaven expects the USDA will reach a decision in late spring or early summer. The process for writing regulations to govern the care and use of rats, mice and birds is likely to take at least three years. The outcome of that decision, which could compel even more detailed reporting of how AWA-protected species are treated, is likely to influence how any regulations concerning rats, mice and birds are written.

"There are all kinds of possible outcomes," DeHaven concludes. For USDA regulators, he says, "When this process begins, it will be our job to carefully consider all of the comments and at the end of the day, do the right thing for the right reasons."