investigators and IACUCs to make this process of considering alternatives not only much easier but also considerably more effective. We are looking forward to that development.
Policy 11. Dr. DeHaven has provided an excellent description of the possible changes to Policy 11. Of course, the definitions are extremely important because they determine not only what is reported, and where and how it is reported, but they determine also when Policy 12 might apply and play a role in decisions.
I do want to emphasize, as did Dr. DeHaven, a fairly major problem with the current Column E definition in which animals are assigned to Column E based on whether anesthetics or analgesics were withheld because they would interfere with the aims of the study. A very literal, technical application of this definition does not include the more important issue of whether the animal actually experienced pain or distress. I believe this area is of common concern for most of the participants in this discussion.
Another issue is that the current definition does not take into account the availability of many methods to alleviate pain and distress that are not classified as analgesics or anesthetics. For example, if a disease state is the cause of a painful or distressful condition, the effective treatment of that condition could obviously alleviate it. Alternatively, if a behavioral approach were used to alleviate anxiety or distress through something like training, conditioning, social housing, or simply comforting by a trusted caretaker, these methods of pain and distress alleviation would not count because they are not anesthetics or analgesics. The same description applies to other classes of drugs such as anti-inflammatory agents or antihistamines; they do not count for the purpose of reporting. This issue should be addressed so that the full range of pain alleviation methods can be credited. Unfortunately, some of these problems are embedded in the language of the regulations and may require a rule making to correct. I believe this area requires attention along with the changing definition and reporting requirements.
Another favorite topic is that of rats, mice, and birds. Dr. DeHaven has already alluded to this topic. You probably ask what this has to do with pain and distress. The PHS policy already covers all vertebrates, so there should be little change in the day-to-day care of these animals as a result of USDA coverage, at least at PHS-supported institutions. Our main public comment to USDA on this issue is that we seek consistency with the existing PHS standards and the Guide for the Care and Use of Laboratory Animals (NRC 1996). However, if one factors in modified reporting requirements, Policy 12 requirements, and possible definition changes for pain and distress, the sheer numbers involved could increase the administrative load on institutions very significantly.