Several battles are currently being fought in the US concerning USDA (United States Department of Agriculture) regulations for the care and use of animals in research, as embodied in the AWA (Animal Welfare Act). American immunologists have a huge stake in the ongoing animal welfare battles. Inattention to the debate could cripple biomedicine with over-regulation, time-consuming paperwork and increased costs, while providing little increased benefit to animals. Currently, groups with seemingly moderate agendas to improve the welfare of animals are waging many small battles that are slowly chipping away at the efficient pursuit of research. Although advocates of animal welfare are not at present calling for an immediate halt to the use of animals, the intent seems to be obstruction, with the ultimate goal of dismantling the enterprise through continuous legal challenge.
One of the battles concerns the lawsuit brought by the Alternatives Research and Development Foundation, affiliated with the American Anti-Vivisection Society, against the USDA, which oversees the welfare of animals in research and enforces federal regulations through inspections. The plaintiffs want rats, mice and birds, which account for 95% of the animals currently used for experimentation, included under the umbrella of the USDA's Animal Welfare Act, which regulates larger animals. The rationale for this omission is that other agencies have taken on the responsibility of monitoring the care of these animals. About 90% of them are covered under the Public Health Service Policy on Humane Care and Use of Laboratory Animals, which governs care of the animals supported by funds from the National Institutes of Health, the Centers for Disease Control and the Food and Drug Administration, among others. Noncompliance jeopardizes funding. The USDA does not have the manpower or budget to perform inspections of the over 2300 additional facilities that this would add to their purview. Despite advice to the contrary from many scientific organizations, the USDA has reached an out-of-court settlement and agreed to promulgate new rules to cover these small animals. Last-minute politicking in the US Congress, however, added wording to an appropriations bill that prevents the USDA from acting on the settlement for a year. Thus, researchers still have an opportunity to provide input on this issue.
If the changes were eventually incorporated into the AWA, Congress would have to appropriate additional funds. These would be needed to cover expansion of the USDA's staff to handle increased inspections and reporting and for the reimbursement of research institutions for their increased paperwork costs. Research would be delayed as time and resources were diverted from experiments to filing forms. Smaller universities and private companies that cannot support the costs associated with increased regulation have stated that their animal facilities would close. In addition, inspection of facilities that house larger animals could suffer, as USDA resources are overextended.
Another animal welfare proposal is currently under consideration. The Humane Society of the United States and others are encouraging the USDA to change the way pain and distress are classified in the current version of the AWA and to attempt to define the word “distress”. Any changes would become part of the AWA and be enforced through inspections and additional documentation. The Federation of American Societies for Experimental Biology (FASEB) and others are urging the USDA not to use the proposed definition for distress on grounds that it is alarmingly broad, with potential to be deliberately misconstrued. Although not in favor of any definition, the FASEB has offered an alternative that emphasizes the responsibility and judgment of the local institutional animal care and use committees (IACUCs), which comprise community representatives, researchers and veterinarians, to determine appropriate definitions based on accepted peer-reviewed standards. The IACUCs already ensure compliance with relevant regulations and quality care guidelines and are critical for sustaining an institute's animal experimentation privileges, granted by the Public Health Service or the USDA.
The suggestion to change the pain and distress classifications would greatly increase the time and money spent on compliance. The US classifications are less precise than those of some other countries, such as Switzerland. Were the US to adopt a system similar to that used elsewhere, paperwork would increase in complexity for researchers and IACUCs. However, there would be a greater incentive to reduce animal exposure to stressors, as records of large numbers of pained and distressed animals would be ready fodder for campaigns against the use of animals in research.
A good-faith effort to better the welfare of research animals should really focus on education. Every graduate student or medical fellow embarking on animal research should receive intensive instruction encompassing acceptable practice standards (including how to recognize, treat and prevent pain and distress) that is tailored to the animal and protocol. With modern instructional tools this would seem an achievable goal. In the long run, it is more education, not more regulation, that will provide the greatest improvements to the welfare of animals used in research.