among investigators, veterinarians, laboratory animal care staff, and IACUCs to oversee the welfare of animals. There is an extensive process in place that, when operating effectively, ensures appropriate animal care. Pain and distress are considered in depth during the development of experimental protocols including veterinary prereview, IACUC review, and peer review by funding agencies and often by institutions. After protocols are approved and the work begins, animals are monitored throughout the study by animal care staff, research staff, and laboratory animal veterinarians. Consideration and observation by professionals in the institution are clearly the most effective means of minimizing pain and distress. In addition, this process is overseen by the IACUC during the semiannual inspection, the NIH assurance statement, the USDA in their annual inspection, and AAALAC International during the accreditation process.

With these assurances in place, why do we need to categorize experimental procedures and submit the numbers of animals in the respective categories to the USDA? As Barbara Rich of NABR pointed out at the SCAW meeting last month, the Animal Welfare Act only requires “. . . information on procedures likely to produce pain or distress in any animal and assurances demonstrating that the principal investigator considered alternatives to those procedures. . . .” I submit that quantitative information concerning animals experiencing pain and distress is not required by the Animal Welfare Act. In addition, because it fails to enhance the care and well-being of the animals, this requirement constitutes regulatory burden for the institutions. In their annual reports, institutions should be required to provide only qualitative information concerning the kinds of interventions performed on animals.

The question, “Do we need to change the classifications of pain and distress?” should be, “Do we need a classification system of pain and distress at all?” The answers are yes and no. No, we do not need one because the law does not require one, and the process of counting and reporting numbers of animals in different categories does not benefit the animals. Yes, we need a simple classification system to provide guidance and increase awareness of the investigators, laboratory animal veterinarians, and IACUCs. Such a system should be used only in the development, review, and implementation of a protocol to ensure that animals at risk receive extra attention.

The assessment of levels of pain and distress will always depend on individual interpretation. As Dr. Gebhart and Dr. Bayne told us this morning, the assessment will always depend on who is looking at the animals. This activity will be further complicated by the possible projection of personal feelings during the observations, which make it very difficult to categorize an animal regardless of how many subcategories are available. An additional complicating factor in the process is individual animal variation. As we heard earlier this morning, some animals recover from procedures better than others. This variation may relate to the differences in the individual sensitivity to pain, activity of the immune system, adaptation to stressful situations, or other factors we do not yet



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