ideas we are considering and on which we would like you to comment is a proposed definition of distress. We will suggest various pain and distress categorization schemes. We would certainly like your comments on anything we include in that Federal Register notice, but at the same time, please do not feel limited in giving us your comments regarding an example we might publish.
In the interim, we indeed will pursue a change to Policy 11. Because any rulemaking effort we might undertake is at best a 3-year process, I think we owe it to you and to our inspectors to establish a working definition of distress if we are going to require the same kind of considerations with distressful procedures as we have in the past with painful ones. Such an interim policy could be changed through a regulatory effort to become a much more enforceable definition or one that would carry more weight than a policy. Of course, one of the benefits of the definition or anything we put into policy is that it is much easier to change.
MS. LISS (Cathy Liss, Animal Welfare Institute): I have a question regarding remarks made by Dr. Harkness, who I believe has left. He mentioned a protocol that was put before an IACUC that called for two major operative procedures for cats. I wondered how that situation was resolved.
First, my hat is off to the IACUC for having done the right thing in admonishing the researcher about having two major procedures. Apparently they discussed it extensively and resolved it to prevent a recurrence. Second, Dr. Harkness mentioned that NIH had provided funding in the meantime, so, I am wondering where it went from there.
DR. GARNETT (Nelson Garnett, Office of Laboratory Animal Welfare, NIH): That description shocked me as much as everyone else. Under NIH grants review policy, it is actually not allowed for the study section even to review the application without evidence of protocol review. That situation may very well be the subject of an investigation.
DR. NEWCOMER (Christian Newcomer, University of North Carolina): At the University of North Carolina, we have a large number of hemophilic dogs and pigs. We currently do not record these animals in Category E although, of course, we do think that when they have bleeding episodes (which are frequent in those animals), they do experience distress despite the fact that they are given analgesics in response to visibly painful conditions, joint bleeds, and so forth. If you do revise Policy 11 with an acceptable definition of distress, it is very likely that these animals would clearly fit that definition of distress, and there still would be no place to record those animals on the annual report other than in Category C and/or E depending on their particular situation. This then is an example of where, despite what you do for the animal, you recognize that the animal has distress when you have finished administering therapies. It appears that there is no appropriate place to include that information in the form. Furthermore, it appears that it would require only a brief explanation because bleeding is intrinsic to their disease. I am interested to hear how you think that kind of event would be properly recorded in the future and in the present.