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July 2000 News
USDA Revises Policy 12
July 6, 2000
The USDA's Animal and Plant Health Inspection Service (APHIS) has revised Policy 12 of its Animal Care Policy Manual, placing greater emphasis on the consideration of alternatives to painful procedures and allowing researchers additional options in their search for possible alternatives.
The policy manual serves to clarify the intent of the Animal Welfare Act (AWA). Policy 12 provides guidance specifically on the AWA requirement that principal investigators consider alternatives to procedures that may cause more than momentary or slight pain or distress to the animals, and that they provide a written narrative of the methods and sources consulted in their search for alternatives.
Traditionally, this consideration of alternatives has meant performing a database search. The revised policy recognizes, however, that in some circumstances -- such as in highly specialized fields of study or cutting-edge research -- the databases a researcher might normally search may contain very little on possible alternatives. In these cases, then, conferences, colloquia, subject expert consultants, or other sources may provide relevant and up-to-date information regarding alternatives in lieu of, or in addition to, a database search.
When a database search is the primary means of meeting the AWA requirement, the accompanying narrative must, at a minimum, include: the names of the databases searched; the date the search was performed; the period covered by the search; and the key words and/or search strategy used.
In cases where conferences, expert consultants, or other sources are used, the written narrative still must provide the Institutional Animal Care and Use Committee (IACUC) with sufficient documentation -- such as the consultant's name and qualifications, the date and content of the consult, and so on -- to assess whether the investigator made a reasonable and good faith effort to determine the availability of alternative methods. If the search identifies a bona fide alternative method, the written narrative should justify why this alternative was not used.
For federally mandated animal testing, however -- such as testing product safety/efficacy/potency -- the written narrative need only cite the appropriate government agency's regulation and guidance documents, according to the revised policy.
A more subtle change in Policy 12 shifts the emphasis from the search for alternatives to the consideration of alternatives -- that is, simply performing the requisite search isn't enough; researchers should actively consider possible alternatives. This shift in emphasis includes the key point that investigators should consider alternatives during the planning phase of the proposal, so that appropriate alternative methods may be incorporated into the experimental design from the outset.
The revised version also discusses of the concept of alternatives in greater detail, defining each of the 3R's of replacement, reduction, and refinement. It points out, however, that potential alternatives must be consistent with the goals of the research or they are not, by definition, alternatives.
The new policy, issued June 21, 2000, replaces the original Policy 12 dated April 14, 1997. The revised version is available here.
The Animal Welfare Information Center (AWIC) is an information service of the National Agricultural Library specifically established to provide information about alternatives. AWIC offers expertise in formulation of the search strategy and selection of key words and databases, and more. For information on their services go here.
Altweb recently launched a new global search engine designed to help search for alternatives. It allows researchers to search several information sets simultaneously: the databases MEDLINE, TOXLINE, and AGRICOLA, as well as the entire contents of the Altweb site and a list of related internet sites that contain information on alternatives or animal welfare. You can access this search engine here.