December 01, 2000


 Lawsuit settlement draws ire of research community

Congress delays agreement to regulate research on rats, mice, birds

Posted Nov. 15, 2000 

Under the terms of a controversial out-of-court settlement with an animal rights group, the USDA has agreed to initiate rule making to expand federal animal care regulations to include birds and laboratory rats and mice.

Shortly after the settlement was reached Sept 25, some in the biomedical research community sharply criticized the department's decision, saying the regulations would cost millions of dollars to implement and potentially hinder research.

Johns Hopkins University and the National Association for Biomedical Research had petitioned to intervene in the settlement by naming themselves as defendants in the suit, but the US District Court of the District of Columbia dismissed the motions in October, and the settlement was allowed to stand.

But a last-minute amendment to the Agriculture Appropriations bill will delay the agreement from moving forward for at least a year. Mississippi Sen Thad Cochran introduced a provision that forbids the USDA from spending funds in the coming fiscal year on any rule-making process that changes the definition of "animal" in the Animal Welfare Act.

In March 1999, the Alternatives Research and Development Foundation, the scientific affiliate of the American Anti-Vivisection Society, sued the USDA to remove the exclusion of birds, rats, and mice from the definition of "animal" in the Animal Welfare Act. The foundation supports the development and use of alternatives to laboratory animals.

Birds and laboratory rats and mice are not included in the rules that direct the USDA to enforce regulations and set standards for veterinary care and animal husbandry. These standards include requirements for handling, housing, feeding, sanitation, ventilation, shelter from extreme weather, veterinary care, and separation of species when necessary.

Research facilities that use animals include hospitals, colleges and universities, diagnostic laboratories, and private firms in the pharmaceutical and biotechnology industries. These facilities must be licensed and comply with the Animal Welfare Act. They must issue annual reports on the number and species of regulated animals used in research, testing, and experimentation, and whether pain-relieving drugs were used. If not, then an explanation is required. The Institutional Animal Care and Use Committee oversees compliance and provides documentation to USDA-APHIS inspectors.

According to the National Association for Biomedical Research, about 1.2 million animals used annually for research are regulated under the law. These include such warm-blooded animals as nonhuman primates, dogs, cats, rabbits, guinea pigs, hamsters, and farm animals, when used for research. But an estimated 23 million rats and mice are also used for research each year.

Tina Nelson, American Anti-Vivisection Society executive director, said the settlement grants rats, mice, and birds the right to minimal standards of care and treatment in laboratories.

"This is a significant victory for animals," Nelson said. "The more than 90 percent of animals used in laboratories who currently have no legal protection could now be covered by federal law."

As part of the settlement, the USDA agreed to initiate and complete rule making on the regulation of birds, rats, and mice within a reasonable amount of time. The department will provide counsel for the American Anti-Vivisection Society with semi-annual status reports on procedural progress, and with a copy of the proposed rule and then final rule when it appears in the Federal Register.

The AAVS was "extremely outraged and disappointed" over Cochran's amendment to delay funding. "[The agreement] is not going to stop scientific research at all. It's just going to afford rats, mice, and birds the legal protection that they deserve," Nelson said.

NABR Executive Vice President Barbara Rich believes the year allows the research community time to consider the ramifications of the settlement. NABR supports public policy that promotes humane care and treatment of laboratory animals in research. The organization opposes the settlement on account of the logistical burden and associated costs it would create for biomedical research institutions. Rich doubts whether the USDA has the resources to inspect the hundreds of additional research facilities that would have to comply with the new regulations.

Many research institutions, such as the National Institutes of Health, already have in place guidelines regulating the use of research animals not covered by the Animal Welfare Act. NABR estimates that about 90 percent of all laboratory mice and rats are covered by one or more of these rules.

"We think the opportunity to take the year and carefully consider this change and the effect it might have is a very good thing," she said.

In a letter to those in the biomedical research community concerned about the decision, Agriculture Secretary Dan Glickman explained the reason for settling the suit was to avert a potential court order mandating immediate coverage of rats, mice, and birds, without an opportunity for public comment.

"Such a judgment might have required [the] USDA to immediately extend coverage under existing standards to rats, mice, and birds-with no opportunity for input of any kind from the research community and other interested parties," Glickman wrote.

USDA spokesperson Susan McAvoy said, "He felt this was the best that we could do for both parties."