The underlying principles for the USDA Animal Welfare Act and the Department of Health and Human Services Health Research Extension Act are remarkably similar, especially on the pain and distress issues. I discuss the specific elements of these documents below.
Principle IV. US Government Principle IV is a good example: “Proper use of animals including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative.” I believe that statement is the simplest way of describing the “Three Rs” and the concept of alternatives.
The principle continues with that familiar anthropomorphic statement, which provides the starting point for making the necessary pain and distress assessments before determining how to avoid or minimize them. According to the statement, unless the contrary is established, investigators should consider that procedures that cause pain and distress in human beings may cause pain or distress in animals. It proceeds to address sedation, euthanasia, and other important points.
Another PHS policy (also NIH grants policy) that is not often mentioned is the requirement for investigators to address five very specific animal-related points in the vertebrate animal section of the NIH grant application. Study sections are expected to evaluate this information along with other components of the application. Applications without this information are considered incomplete.
In the statement at D, the principal investigator is asked to describe “procedures designed to assure that discomfort and injury to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research....” These are just two of the dozens of references to pain and distress in the PHS policy and in the Guide for the Care and Use Of Laboratory Animals (NRC 1996). I mention them because they are not very different from the intended outcome of the USDA requirement to consider alternatives, that is, the infamous Policy 12.
Policy 12. Although far more prescriptive, the USDA language in Policy 12 calls for essentially the same assurances that are required in an NIH grant application. Dr. DeHaven and I have had this discussion, and I believe the revised Policy 12 reflects a more appropriate focus on what will be done to minimize pain and distress and what steps will be taken or were taken to learn about the availability of various alternative systems.
On this subject, some of you may be aware that our office is cosponsoring the production of an alternative search engine, working with the Johns Hopkins Center for Alternatives to Animal Testing and a number of other project team members. This search engine is now at the beta test stage, and we are very excited about its prospects. It is designed and intended to provide useful tools for