Animal Welfare Act and USDA
The following are excerpts of the Animal Welfare Act and USDA regulations and policy that describe the legal expectations for the consideration of alternatives to animals and for the conduct of an alternatives search (excerpted from the Animal Welfare Information Center at the National Agricultural Library).
The Animal Welfare Act emphasizes minimizing pain and distress, but does not mention how alternatives consideration should be documented. It states in Section 13(a)(3)(B): “that the principal investigator consider alternatives to any procedure likely to produce pain or distress in an experimental animal;”
The Animal Welfare Act Regulations (9CFR, Part 2, Sec. 2.31 (d)(1)(ii)) indicate how consideration of alternatives should be accomplished: “
[The] IACUC shall determine that… The principal investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animals, and has provided a written narrative description of the methods and sources…”
The Federal Register (Vol. 54, No. 168, Thursday, August 31, 1989) gives the USDA rationale for making the alternatives consideration a written requirement and suggests a series of databases that can be searched to document whether or not alternatives are available:
“The principal investigator must provide a written narrative of the sources, such as biological abstracts, MEDLINE, the Current Research Information Service (CRIS), and the Animal Welfare Information Center that is operated by the National Agricultural Library. We believe that in fulfilling this requirement Committee members will discuss these efforts with the principal investigator in reviewing the proposed activity. We also believe that considerations of alternatives will be discussed during Committee meetings where proposed activities are presented for approval, and made part of the meeting minutes…”
The legislation indicates that the investigator must provide written narrative which demonstrates to the IACUC that alternatives, useful or not, were at least considered in the experimental design. The literature search is suggested as the best way to demonstrate this.
Policy #12 of the APHIS/AC Policy Manual clarifies the regulatory expectations for an alternatives search: “The minimal written narrative should include: the databases searched or other sources consulted, the date of the search and the years covered by the search, and the key words and/or search strategy used by the Principal Investigator when considering alternatives or descriptions of other methods and sources used to determine that no alternatives were available to the painful or distressful procedure. The narrative should be such that the IACUC can readily assess whether the search topics were appropriate and whether the search was sufficiently thorough.
“Reduction, replacement, and refinement (the three R’s) must be addressed, not just animal replacement.”