In response to the issues raised in this scenario, the United States Department of Agriculture, Animal and Plant Health Inspection Service, Animal Care (USDA/APHIS/AC), the Food and Drug Administration (FDA) and the Office of Laboratory Animal Welfare (OLAW) offer the following clarification and guidance:

The Animal Welfare Act and regulations (AWR) and the PHS Policy require research facilities to ensure that procedures involving animals will avoid or minimize discomfort, distress and pain to the animals1,2. Toxicological studies are considered research procedures that may cause more than slight or momentary pain or distress to the animals involved. As such, the principal investigator must consider alternatives (e.g., replacement with a species of a lower phylogenetic order or using alternative methods as suggested in FDA test guidance documents regarding the use of in vitro methods). The written narrative description of the methods and sources used to determine that alternatives were not available must be provided to the IACUC1. In non-clinical studies, FDA may provide guidance on the use of rodent and non-rodent species in toxicological evaluations. When determining the appropriateness of a non-rodent species, consideration should be given to selecting a species of the lowest phylogenetic order that will yield the most informative data.

The rationale for involving animals, and the rationale for the appropriateness of the species to be used, as required in each research protocol by the AWR and the PHS Policy, may be developed from the information gathered in the search for alternatives1,2. This detailed explanation enables the IACUC to ensure that animal pain and distress are minimized, unless otherwise scientifically justified. It is the IACUC's responsibility to review and confirm that a sound, objective and logical reason has been provided for each of these required elements prior to approving the use of animals for the research proposal3.

The USDA inspector has the authority and duty to enforce the Animal Welfare Act and the regulations. Any noncompliant item could result in an inspection report citation, with further action taken as warranted.

Return to Protocol Review