March 24, 2003
Dr. Bobby Accord
Administrator, APHIS/USDA
4700 River Rd.
Riverdale, MD 20737
Dear Dr. Accord:
I am writing on behalf of The Humane Society of the United States (HSUS) and our seven million members and constituents, in regards to the USDA proposal entitled "Animal Welfare: Definitions for and Reporting of Pain and Distress" (Federal Register, July 10, 2000). The proposal addresses two distinct issues, namely defining distress and revising the pain and distress categories, but we would like to specifically address the latter. We understand that the USDA will soon be making a decision on this issue.
According to the Federal Register notice itself (enclosed), "[a] different categorization system could produce data that more accurately depicts the nature of animal pain or distress and provide a better tool to measure efforts made to minimize animal pain and distress at research facilities." This statement clearly indicates that the USDA recognizes the importance of improving the categorization system. The HSUS firmly supports this effort. We strongly recommend that the USDA transform its current classification system into a graded scale of pain and distress that reflects levels of severity (sometime termed "invasiveness"). In our submitted comments on the issue, we proposed a system that essentially would replace the current three categories with three new categories, namely, minor, moderate, and severe. For continuity between the current and proposed systems, we proposed that the minor category be subdivided according to whether or not pain and/or distress relief was provided. If this continuity were deemed to be unnecessary, then the new proposal boils down to a simple system of minor, moderate, or severe. Any "gray" areas between minor and moderate, and between moderate and severe, could be minimized through USDA guidance and exemplars.
The proposed revision is straightforward and would not increase the workload of institutions, as some institutions have self-servingly argued. The revised system would finally permit the USDA to issue annual animal welfare enforcement reports that provide an accurate picture of what the research animals are experiencing, thus providing interested stakeholders with a more accurate picture of the true cost of research to the animals. Moreover, the revised system also would help identify those techniques that cause the most severe pain and distress, and thus allow interested stakeholders to focus much needed attention on how to alleviate these adverse effects. Moreover, the new system would allow international comparisons regarding animal use, given the prevalence of similarly graded severity scales overseas.
Severity scales similar to what we have proposed are already in use in several countries, including Canada, Finland, The Netherlands, New Zealand, Switzerland, and United Kingdom. The British Home Office, the Canadian Council on Animal Care, and the New Zealand Ministry of Agriculture and Forestry each submitted comments in support of adoption of a true severity scale in the U.S. Identifying international trends in the severe category would inevitably lead to a focus on how procedures in that category could be refined in order to decrease, and perhaps eventually eliminate, pain and distress on a worldwide basis. This would lead to a true focus on the Three Rs of replacement, reduction, and refinement, as USDA Policy #11 intends.
The current pain and distress classification has several shortcomings. The Federal Register notice published by USDA recognizes this and states as follows:
"For example, the current system does not include a means to report:
-
An assessment of the relative intensity or duration of pain or distress either observed in the animal or anticipated to be experienced by the animal;
-
An assessment of the anticipated or observed efficacy of the pain- or distress-relieving agent provided to animals undergoing a painful or distressful procedure;
-
A distinction between procedures causing animal pain and procedures causing animal distress;
-
Animals that were prevented from experiencing pain or distress by the appropriate and effective use of pain- or distress-relieving methods or procedures (e.g., well-anesthetized animals that undergo terminal surgery);
-
Animals that did not experience pain or distress due to the appropriate and effective use of pain- or distress-relieving methods or procedures other than anesthetic, analgesic, or tranquilizing agents;
-
Animals that experience unrelieved pain or distress for a reason other than that the use of anesthetic, analgesic, or tranquilizing drugs would have adversely affected the procedures, results, experiments, surgery, or tests; or
-
Animals that experience pain or distress without having been used in a procedure (e.g., illness in animals that have been genetically altered to develop disease)".
There are additional problems with the current system that were not captured in the Federal Register notice; for example, there is no category for procedures causing pain and distress that are partially but not fully alleviated by the administration of drugs.
Given the many problems with the current classification system, it is not surprising that widespread inconsistencies and underreporting of research animal pain and distress by U.S. institutions have been uncovered. The current statistics reported to the USDA and available to the public may not only be giving an erroneous picture of the current situation and recent trends, it may also provide a false sense of security for those who use and care for laboratory animals. If IACUCs and laboratory personnel continue to use a vague and ill-defined reporting system to claim few research animals are suffering, their level of attention to the recognition and alleviation of pain and distress will be diminished.
We recognize that some may argue that without a definition of distress, the current reporting system should not move forward. However, we see little connection between these issues. In addition to comments from the international community (mentioned above), there are various individuals and groups in the U.S. that support the adoption of a revised classification system that reflects levels of pain and distress; these include the Deputy Director of Extramural Research at National Institutes of Health, representatives of University of California, Davis; Binghamton University, Dow Corning, Alternatives Research and Development Foundation, and a number of animal protection organizations. In addition to these groups, virtually all observers agree at the very least that the current reporting system is deeply flawed.
In summary, we urge the USDA to promptly revise and simplify its categorization system so that it reflects the levels of pain and distress that animals experience. Thank you for your time and consideration.
Sincerely,
Martin L. Stephens, Ph.D.
Vice President, Animal Research Issues
