What price mice?

Abstract

BECAUSE THEY ARE DEDICATED TO THE ELIMINATION OF the use of all animals in medical experiments regardless of the human cost, animal protectionist groups have moved vigorously to seek the assistance of the federal courts. Inspired by their taste of success in other areas, these groups are now attempting to make the use of mice, rats, and birds in biomedical research prohibitively expensive and extremely burdensome. This raises the distinct possibility that such research is in danger of experiencing the strangulation by red tape that is threatening medical research in the United Kingdom. The latest effort by animal protectionist groups is remarkably shrewd. In 1998 a recently established group calling itself the Alternatives Research and Development Foundation (ARDF), functioning under the umbrella of the American Anti-Vivisectionist Society, filed a petition for rulemaking with the US Department of Agriculture (USDA) asking that the USDA cancel the longtime exemption of mice, rats, and birds from its animal care regulations. The USDA published the petition in the Federal Register asking for public comment, but also presented a lengthy discussion of the USDA’s own serious objections to the demands of the petitioners. Rather than await the USDA’s decision on its petition, the ARDF moved to force the issue by filing suit in federal court claiming that the secretary of agriculture had arbitrarily and capriciously excluded mice, rats, and birds from the definition of “animal” in the Animal Welfare Act. Joining the ARDF as plaintiffs were a company describing itself as a manufacturer of laboratory tests to replace animal testing and a Beaver College student who claimed she had standing to sue because she had suffered an “aesthetic injury” from observing laboratory rats who had allegedly received “inadequate housing, water, food, and veterinary care.” The separate attempts in August and September 2000 by the National Association for Biomedical Research (NABR) and Johns Hopkins University to become parties to the litigation were thwarted when, in a sudden reversal of position, the USDA joined with the plaintiffs to obtain stays of the court proceedings while they engaged in private settlement negotiations. This meant that the court would not rule on the intervention motions of the NABR and Johns Hopkins, and that the settlement negotiations could proceed behind closed doors with no representative of research institutions present. Other government agencies with important interests in the use of rodents in medical research were not consulted by the USDA or admitted to the settlement negotiations. These included the National Institutes of Health, which has allocated billions of taxpayer dollars for biomedical research; the Food and Drug Administration, which has an interest in the use of rodents in toxicity testing of new pharmaceuticals; the Centers for Disease Control and Prevention, which uses rodents and birds in epidemiological investigations; and the US Department of Defense, which must use rodents in tests to combat bioterrorism and biowarfare. The settlement negotiations culminated with a complete capitulation of the USDA to the demands of the plaintiffs. The worst fears of researchers were realized when the USDA agreed to grant the plaintiffs’ petition for rulemaking to amend the USDA regulation excluding birds, rats, and mice from coverage under the Animal Welfare Act. The filing by the parties on September 28, 2000, of a voluntary stipulation of dismissal without prejudice ended the litigation for now, and the government agreed to pay the plaintiffs $18000 in attorney fees. Not unexpectedly, research scientists are asking, “What goes on here?” Fortunately, not all is lost. The USDA chose to ignore the many entreaties expressed by biomedical organizations, university presidents, and scientists not to engage in an outof-court settlement. Congress, however, did react to the disastrous settlement by adding language to the fiscal year 2001 Agricultural Appropriations bill prohibiting the USDA from spending any part of its appropriations to change the regulatory definition of “animal” in the regulations promulgated under the Animal Welfare Act. President Clinton signed the bill into law on October 28, 2000. Since the legislative “fix” was inserted into an appropriations bill, it is in effect for only 1 year. The research community now must engage in a concerted effort to obtain a permanent solution from