USDA: progress toward in vitro tests and other trends

The Animal and Plant Health Inspection Service of the United States Department of Agriculture has demonstrated a commitment toward replacement, reduction and refinement of animal use in the development and control of biological products. This presentation describes some specific approaches with which APHIS has reduced the number of animals used in testing by replacing host or laboratory animal potency tests with validated in vitro tests, reduced the number of animals required for tests by allowing sequential use of animals for tests of immunologically distinct entities, and replaced host or laboratory animal challenge studies with serological tests. It also describes APHIS' plans to reduce pain and suffering of animals by allowing euthanasia when death from causes unrelated to the test is expected. Finally, it reports on refinements in extraneous agent testing, which began when host animal tests were replaced with an in vitro test method and continued when the in vitro test was replaced with a more sensitive status of these approaches is discussed in the context of APHIS' current regulatory framework.