Mice, rats, birds are pawns in radical petition

By Norma Bennett Woolf

Introduction

About 90 percent of rats, mice, and birds used in biomedical research are protected by regulations of the US Public Health Service and the Association for Assessment and Accreditation of Laboratory Care International, but animal rights activists want to transfer responsibilities for these species to the US Department of Agriculture to safeguard their own interests in the development, sale, and promotion of research alternatives to animal use.

Rats and mice make up the bulk of animals used in biomedical research and most are "already being maintained in conditions that meet or exceed the AWA requirements," according to USDA. And the 10 percent not already covered by regulations are not necessarily suffering because of the gap.

However, the campaign to force the department to include these species in the Animal Welfare Act distorts the issue by accusing the agency of "illegally" defining "animal" to exclude those species and insinuating that the exclusion exempts the the animals from regulations for humane care.

USDA has declined to make the change in the past for several reasons, including:

• the PHS and AAALACI regulations afford the animals' protection at an equal or higher level than the AWA;
• the department lacks budget resources to license and inspect an additional 2324 research sites (1990 estimate - see below); and
• changes in regulatory agencies would place an undue burden on the businesses and facilities that are regulated.

Petitioners

The hub of the petitioners' case is that coverage under the AWA requires scientists to consider alternatives to the use of animals and that USDA failure to include these species has erected a barrier to the development, sale, and use of alternatives.

One petitioners is a nonprofit foundation affiliated with the American Anti-Vivisection Society, an organization well-known for its opposition to the use of animals in scientific research. All of the petitioners seem to be heavily vested in the development and promotion of non-animal alternatives. They do not claim that rats, mice, and birds are unprotected, only that the lack of USDA oversight detracts from their ambition to phase out animal testing in favor of alternative research methods. To this end, they accuse USDA of illegally excluding rats, mice, and birds from the definition of animals in the Animal Welfare Act and allege that USDA coverage of these species is necessary to benefit development of alternatives and foster teaching of humane animal care in colleges and universities.

"USDA's failure to regulate the use of birds, rats, and mice provides a disincentive for researchers to use alternatives and thus, harms and impedes petitioners ability to educate and encourage researchers and students to use non-animal alternatives," said Barbara Orlans, a senior research fellow at the Kennedy Institute of Ethics at Georgetown University.

In Vitro International, which produces alternatives to animal use in research, claims that the USDA failure to regulate rats, mice, and birds in research hinders the company's ability to market its processes because current regulations do not require that researchers use alternatives where possible. Company president Rich Ulmer said that the company's "interest in preventing inhumane treatment of these animals is impeded by USDA's failure to require researchers to consider alternatives before using birds, rats, and mice."

Alternatives Research and Development Foundation, the AAVS affiliate, promotes and develops alternatives to animal use in research and alleges that "these programs are frustrated and impeded by USDA's illegal definition. USDA has illegally defined animal by excluding birds, rats, and mice. Consequently, there is no statutory requirement for researchers to consider alternatives when experimenting on birds, rats, and mice."    

USDA

The section of the AWA that defines animals is the focus of the petition effort. It reads:

"The term 'animal' means any live or dead dog, cat, monkey (nonhuman primate mammal), 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; but such term excludes horses not used for research purposes and other farm animals, such as, but not limited to livestock or poultry used or intended for use for improving animal nutrition, breeding, management, or production efficiency, or for improving the quality of food or fiber. With respect to a dog, the term means all dogs including those used for hunting, security, or breeding purposes."

USDA contends that "such other warm-blooded animal as the Secretary may determine is being used" gives the department flexibility to include or exclude some animals and that a 1970 report from the House of Representatives supports the view that the Secretary has discretionary authority in this matter. The department further contends that implementation of the change would be cost prohibitive to the department and to the regulated entities. The budget for AWA enforcement has remained relatively steady at $9.2 million for the past seven years; additional responsibilities for rats, mice, and birds would require a substantial increase in a staff that has faced necessary reductions in light of budget constraints.

"We have seriously considered the issue of bringing laboratory rats, laboratory mice, and birds under AWA regulation. As a regulatory agency, we are required to consider the effects of the regulations we promulgate and enforce on affected entities. Extending AWA coverage to facilities that use birds, laboratory rats, or laboratory mice would affect numerous entities, including many small businesses. As stated above, many of these entities currently meet PHS and AAALAC requirements. If these entities come under APHIS regulation, they might not incur costs associated with coming into compliance with the AWA requirements. However, these entities would incur costs pertaining to licensing or registration, and we do not necessarily believe that these new expenses would translate into a higher standard of protection for the animals, which are already being maintained in conditions that meet or exceed the AWA requirements," the USDA reported in the Federal Register.

In 1990 USDA examined the potential for including rats, mice, and birds in the AWA and came up with the following information from that study and an informal survey of animal care managers.

There were 2410 regulated research facilities in the US in 1990. If rats and mice bred for use in research had been brought under AWA regulation that year, an estimated additional 2324 research sites would      have required inspection. Regulating research facilities, breeders, dealers, and exhibitors that handled birds in 1990 would have added an estimated 2302 facilities to the inspection workload. To maintain the level of AWA inspections conducted in 1990 and conduct inspections of facilities that deal with rats, mice, and birds, Animal Care would have needed an estimated additional 34 veterinarians and 16 animal health technicians.  

Alternatives

USDA has provided four options as potential results of the petition:

1. Regulate the care provided to all rats, mice, and birds being used for purposes covered by the AWA at all facilities, including those not currently being regulated by USDA. This option would greatly increase the Animal Care inspection workload and, therefore, would cause inspection activities for all currently regulated facilities - especially breeders, dealers, carriers, and zoos and circuses - to be dramatically curtailed. In addition, developing regulatory standards for the care of birds would be difficult, time-consuming, and expensive because the housing and husbandry needs of avian species vary greatly. All Animal Care inspectors would need additional training in the veterinary and husbandry care needs of birds. Entities not currently regulated by APHIS would need to absorb costs associated with AWA regulation.

2. Regulate the care provided to all rats, mice, and birds at research facilities only. This option would increase the number of research sites for Animal Care to inspect and, therefore, would seriously compromise inspection activities for other currently regulated facilities, such as breeders, dealers, carriers, and exhibitors. As with option one, entities not currently subject to regulation by APHIS would become subject to such regulation, and the additional costs to these entities would not necessarily result in greater protection for the animals.

3. Regulate the care provided to all rats and mice at research facilities only. Again, this option would increase the number of facilities Animal Care inspects. However, the number would be less than the numbers that would result from the adoption of options one or two. This increase in regulated facilities would also result in reduced inspection activities for currently regulated facilities. As with options one and two, research facilities not currently subject to regulation by APHIS would become subject to such regulation.

4. Maintain the status quo. Do not initiate regulation of facilities dealing with rats of the genus Rattus, mice of the genus Mus, and birds. Current AWA inspection activities would not be adversely affected, and no additional entities would need to bear the costs of APHIS regulation.    

Other considerations

USDA may seek legislative authority to charge user fees to recoup 30-40 percent of the AWA operating budget. The fees would be assessed on license applications and renewals and other AWA-related activities and would likely result in a reduction from the current appropriations. However, the authority would apply only to existing services, so the agency is asking for public comment on the appropriateness of user fees for enforcement of the AWA for the care of rats, birds, and mice.

USDA closed its Federal Register comments this way: "In summary, we believe that extending AWA protection to rats and mice bred for use in research and birds with current AWA enforcement resources would have serious consequences for the protection of other species covered by the AWA regulations. To conduct annual inspections of research facilities that use rats, mice, and birds, we would need to reduce by approximately one-third the number of inspections in other areas, such as breeders and dealers of dogs and cats, commercial carriers, large and small zoos, and circuses. We believe that such a reduction in inspection services would greatly compromise our efforts to ensure AWA compliance of all currently regulated facilities and adequate protection to all currently covered species."