Animal welfare activists, smarting from a defeat in Congress, plan to campaign across the United States to convince state legislators that laboratory rats, mice, and birds used in biomedical research require greater protection than afforded by federal law. Most major US research organizations, however, maintain that the 15 to 20 million animals used in labs--about 95% in biomedical research--are adequately protected under existing public and private regulations. More federal oversight, they say, would only burden researchers with paperwork and expense while creating no real benefit for the animals.
The 2002 Omnibus Farm Bill, signed into law in May, included an amendment exempting "birds, rats of the genus Rattus, and mice of the genus Mus, bred for research" from the Animal Welfare Act. The AWA requires researchers to keep records by cage or by research protocol for most warm-blooded vertebrates, whereas records for cats, dogs, and nonhuman primates must be maintained for individual animals. Enforced by the US Department of Agriculture (USDA), the AWA regulations have teeth: Violators are punishable by fines of as much as $2,500 per violation per day.
RATS AT RISK Major research organizations have feared that scientists might be required to keep records on millions of caged lab animals to comply with AWA's bookkeeping requirements. The cost of this paperwork, reporting, and inspection could total $280 million annually, according to the American Physiological Society (APS). By excluding some of the most common lab animals from AWA, Congress handed biomedical research establishments a victory during their long and frequently contentious battle with animal welfare activists.1 In response, animal rights groups have carried their standards into the states. "We're confident we're going to be able to revisit the issue," says John McArdle, executive director of the Alternatives Research & Development Foundation (ARDF) in Eden Prairie, Minn.
The Arlington, Va.-based Working Group to Preserve the Animal Welfare Act aims to seek legislation in each state that will impose standards of care and reporting requirements. The proposed laws could require researchers to consider using alternative procedures to reduce animal suffering; the laws could also mandate state lab inspections. Planning is just getting underway, and specifics still need to be worked out, says Nancy Blaney, the group's coordinator.
Research proponents remain unfazed. "State legislatures don't want to spend a lot of time getting paperwork requirements on rats, mice, and birds," says Tony Mazzaschi, associate vice president of the Association of American Medical Colleges (AAMC) in Washington, DC. Even if such legislation passes, state governments lack resources and trained personnel to conduct inspections of laboratory animals, says Frankie Trull, president of the National Association for Biomedical Research in Washington, DC. "It's not just an issue of states preempting federal law. It's that the states just don't have the qualified people."
HELMS TO THE HELM The exclusionary amendment, authored by then Sen. Jesse Helms (R-NC), was endorsed by APS and most major biomedical research organizations, including AAMC and the Federation of American Societies for Experimental Biology (FASEB).
In addition to exempting rats, mice, and birds, the Farm Bill also instructed the National Academy of Sciences to conduct a study on research animals, which the Bush administration elected not to fund.
The Institute for Laboratory Animal Research (ILAR) produces and updates the Guide for the Care and Use of Laboratory Animals, the set of practices required by the National Institutes of Health and other federal granting agencies. Institutions receiving federal funds and using vertebrates in research-including rats, mice, and birds- submit an assurance agreement to the US Public Health Service, which states that they will abide by ILAR rules. Compliance is required for funding, but NIH does not make unannounced inspections.
In addition to the ILAR rules, nearly every major medical school and teaching hospital complies with the more stringent requirements of the private Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC). Taken together, these requirements create an "overarching framework [that] enables all the players to work toward the common goal of good animal care," says Joseph R. Haywood, professor of pharmacology at the University of Texas Health Sciences Center, San Antonio, and a former site inspector for AAALAC. "Contrary to the picture that the activists try to paint, the system is working."
In the United Kingdom, regulation of animal research is more restrictive than in the United States, with some government controls dating back to 1876. The current Animals (Scientific Procedures) Act requires licensing of research projects involving animals, even projects not using government funds. Regulation in Europe varies by country.
No matter what regulations they follow, US scientists who use transgenic mice in their research treat them with kid gloves, Mazzaschi says. "These are very, very valuable animals that are often worth hundreds, if not thousands, of dollars," he adds. "I don't think anyone could make a sustainable claim that these animals are not being treated humanely."
Ted Agres (firstname.lastname@example.org) is a freelance writer in Washington, DC.