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October 2000 News

Rats! Foiled Again

October 20, 2000

Rats, mice, and birds will have to wait at least another year to be considered "animals" under U.S. Department of Agriculture (USDA) regulations. Although the USDA recently agreed to an out-of-court settlement with the group seeking to change the regulatory status of these animals, Congress quickly voted to block implementation of this agreement for fiscal year 2001.

After nearly two years in court, the petition that sought the inclusion of rats, mice, and birds under the Animal Welfare Act (AWA) was close to success, but the U.S. biomedical community used its political clout to seek a last-minute roadblock to the process. Even as an agreement was being reached between the federal government and the petitioners, many pro-research groups and one major university launched a counterattack, claiming that "millions of dollars" and the future of critical research was at stake.

The AWA is the primary law that protects animals used for research in the United States. It first passed in 1966 and has been revised several times since then. A 1970 amendment defines the term "animal" as "any live or dead dog, cat, monkey (nonhuman primate), guinea pig, hamster, rabbit, or such other warm-blooded animal, as the Secretary may determine is being used, or is intended for use, for research, testing, experimentation, or exhibition purposes, or as a pet." USDA regulations, however, specifically exclude "Birds, rats of the genus Rattus, and mice of the genus Mus bred for use in research" in their definition. Wild-caught mice or rats are covered by the AWA, as are other such rodents as hamsters and guinea pigs. But the rats and mice that constitute an estimated 95% of all animals used in the laboratory are not.

In 1998 the Alternatives Research and Development Foundation (ARDF) brought suit against the USDA, arguing that this exclusion is arbitrary and capricious--based on economic concerns rather than on scientific or ethical considerations. The suit asks the USDA to amend its definition of "animals" to include rats, mice, and birds, thereby granting them protection under the AWA.

ARDF, a nonprofit organization affiliated with the American Anti-Vivisectionist Society, works to develop and promote the use of alternative, non-animal methods in research, testing, and education.

The proposed change would affect millions of animals. The National Association for Biomedical Research (NABR) estimates that 23 million lab rats and mice were used in 1998. No one knows the exact numbers, however. Research institutions must report annually to the USDA on the animals covered by the AWA--but there is no such accounting of rats, mice, and birds.

The AWA also spells out certain requirements for the humane care and treatment of animals. But again, rats, mice, and birds are excluded. They are excluded as well from the AWA requirement that researchers must search for alternatives to procedures that may be painful or distressful to the animals. This is what the ARDF suit seeks to rectify.

The suit argues that "Explicit provisions of the AWA require research facilities to undertake steps in the direction of using alternatives to animals when an animal experiment causes pain or distress… Because USDA has defined birds, rats, and mice as non-animals, there is no statutory or regulatory requirement that anyone consider alternatives to the use of these creatures."

Many research groups, such as NABR, the American Association of Medical Colleges (AAMC), and the Federation of American Societies of Experimental Biology, strongly oppose the proposed inclusion of rats, mice, and birds, contending that regulation of these animals would result in a substantial increase in cost and paperwork. Furthermore, they argue, rats, mice, and birds already are sufficiently protected by Public Health Service animal-care standards.

These care standards, however, are required only of researchers who receive federal funding. They do not apply non-research universities or to private biotechnology companies, where the development of transgenic mouse strains may lead to dramatic increases in the number of mice used in research.

Amid rumors that the USDA would settle out of court, NABR and the Johns Hopkins University--recipient of more federal research dollars than any other university – petitioned to be included in the suit to represent the interests of the research community.

Other members of the research community support the amended definition, however. A position statement by the American Association for Laboratory Animal Science, while expressing some concerns about the implementation of the process, holds that "The political and economic rational that led to the exclusion in the AWA of the vast majority of animals used in research is ethically indefensible." Lab Animal Magazine last year surveyed 491 members of the animal care and use committees that oversee the use of animals under the AWA--nearly two-thirds of whom are themselves animal researchers--and found that 73% felt the AWA should cover rats, mice, and birds.

Alan Goldberg, professor of toxicology at Johns Hopkins and director of the Johns Hopkins Center for Alternatives to Animal Testing, suggests that the issue is not whether we should count rats, mice, and birds but rather what can we do about the pain and distress they may suffer as research subjects. "If the issue is pain and distress," Goldberg says, "there should be ways for the animal protection community and the animal research establishment to work together to minimize and/or eliminate pain and distress in research protocols, where possible, and to document our success and failure in doing so."

ARDF and the USDA announced their settlement on Oct. 3. This agreement stipulates that the USDA will initiate and complete, in a reasonable time, a rulemaking on the regulation of rats, mice, and birds under the Animal Welfare Act. The settlement between the parties did not require court approval to go into effect, U.S. District Court Judge Ellen S. Huvelle declared, because the agreement was voluntary between the two parties. The judge dismissed all pending motions, including the petitions by Johns Hopkins and NABR to join the case.

"I’m expecting a quantum leap in the development and use of alternatives as a result of this decision," said John McArdle, director of ARDF, the primary plaintiff in the suit.

Many in the research community, however, were disappointed with the decision. "This settlement opens the door to an increased regulatory and paperwork burden on the scientists and their institutions that use rats, mice, and birds to conduct vital biomedical research," said a statement by the AAMC.

McArdle disagrees. "If you're maintaining good standards of husbandry for animals and keeping good records you’ll see little impact," he said.

USDA secretary Dan Glickman, in a letter to the research community regarding the settlement, noted that the "USDA entered into this settlement agreement with ARDF first and foremost in order to preclude the potential for an adverse judgment by the U.S. District Court that might have dictated the nature and timeframe for coverage of rats, mice, and birds." He emphasized that the rulemaking process will allow ample opportunity for public comments on proposed changes.

The settlement didn't settle the issue, however. Congress intervened. A last-minute amendment to the agricultural appropriations bill effectively postponed for one year any action by the USDA on this matter. Prompted by NABR, the University of Mississippi asked Senate Appropriations Committee Chairman Thad Cochran (R-Miss.) to introduce the rider to the bill, which subsequently passed both houses of Congress. The added language prohibits the USDA from spending any money "to issue a notice of proposed rulemaking, to promulgate a proposed rule, or to otherwise change or modify the definition of 'animal' in existing regulations pursuant to the Animal Welfare Act."

President Bill Clinton is expected to sign the agricultural bill into law.

"We are appalled at the lengths to which some biomedical trade associations will go to avoid their legal and moral responsibilities to the welfare of lab animals," McArdle said.

The effort to include rats, mice, and birds under the AWA will continue, however. "We've waited 30 years for these animals to have protection; I suppose we can wait one more," said McArdle. "It's unfortunate the animals have to wait."


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