Animal Welfare Regulations

Animal welfare regulations (AWRs) pertaining to the care and use of laboratory animals were extensively modified and rewritten following the 1985 amendments of the Animal Welfare Act to include provisions for an IACUC, for protocol review, and for more social interaction among the same species and between animals and their caretakers. These regulations are similar to PHS policy provisions because the secretary of the USDA was directed to consult with the secretary of the DHHS concerning the writing of regulations. In the AWRs, an IACUC committee with only slight differences from PHS policy is required (e.g., three members instead of five as a minimum, including an unaffiliated member and a veterinarian). The duties of the committee are very similar to the duties specified by PHS policy; instructions for reviewing protocols, however, are more detailed than those included in PHS policy. The AWRs require the investigator to search for alternatives to any procedure that may cause more than slight pain or distress and to assure that the proposed activity does not unnecessarily duplicate previous work. Several aspects of a personnel-training program are specified. In contrast to PHS policy, which requires institutions to develop an animal care and use program based upon the NRC guide, the AWRs have an extensive set of standards specifying the humane handling, care, treatment, and transport of various species of animals. The standards section of the regulations detail facility and operating standards, animal health and husbandry standards, and transportation standards for each regulated species. In addition, detailed specifications are given for marking dogs, cats, and other animals for the purpose of identification. In most, but not all, cases, the standards of the AWRs are the same as those of the PHS policy and, thus, are similar to the guidelines given in the NRC guide.

The AWA calls for the USDA to issue regulations in several areas. These regulations, which have engendered considerable public debate as well as the filing of a lawsuit, require exercise of dogs and the provision of a physical environment adequate to promote the psychological well-being of nonhuman primates. After considerable debate, the final regulations combined performance-based standards (standards that specify the desired outcome and leave the details of achieving that outcome to the regulated party) with design or engineering standards (standards that specify in measurable and objective terms how a particular outcome is to be achieved). It is the choice of performance-based standards that is especially controversial because plaintiffs in a lawsuit (see "Lawsuits" section below) alleged that they allow too much latitude for compliance by the regulated parties. It is generally true, however, that humane care and use of animals can be achieved under a variety of circumstances, making it difficult to use detailed engineering standards or specifications. For example, the regulations call for dry floors for most mammals. This can be accomplished by mopping the floor until dry, by wet-vacuuming the floor, by sloping the floor and letting water run off before placing an animal on the surface, and so on. Thus, there are a number of ways of achieving the desired goal, and it is the outcome itself that is specified rather than the steps needed to reach it. Critics of performance standards state that the goal often is not well described, leaving too much discretion to the regulated parties.

Another controversial aspect of the AWRs is that the regulatory definition of animal excludes birds, rats, and mice that have been bred for use in research; hence, these animals are not protected under the AWRs. The exclusion is a major one because more than 85 percent of animals used in research, education, and testing are rats, mice, and birds. The reason for the exclusion is to limit the scope and cost of annual USDA inspections; there are barely enough inspectors to review facilities and procedures involving larger vertebrate animals, whose use is thought to require more sensitivity and therefore more intense scrutiny. Adding rats, mice, and birds to the mandatory inspection list would exceed the capacity of the USDA, both because of the increased numbers of animals to be inspected and because there would be an increase in the number of registered research facilities requiring inspection. (A number of institutions use only rats and/or mice and therefore are not subject to inspection.) Because PHS policy defines animal as any vertebrate (with no exclusions), rats, mice, and birds are covered by PHS policy. In institutions not covered by PHS policy (e.g., industry and colleges not receiving PHS funds), the use of rats and mice remains largely unregulated, a glaring oversight unique to the United States (Orlans, 2000).

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