At question is what constitutes ‘material alteration’ of behavior and whether the IACUC is the one empowered to make that determination. USDA APHIS has repeatedly declined to define the operative terms ‘invasive’, ‘harm’, and ‘material alteration’, except by example, and have instead relied upon the IACUC to consider each situation and arrive at a decision. Comments from the final rule for the Field Studies definition1 provide important insights regarding this question and the intent of the regulations. USDA APHIS noted (pg 6312) statements from two commenters that “…any study has the potential to harm or materially alter the behavior of animals under study; therefore no study could be classified as a field study.” Similarly, in responding to a comment on implantation of radiotransmitters on pg 6313, USDA APHIS responded that implantation by “…perforation or incision in a manner that could cause more than short-lived pain or distress may materially alter the behavior of the animal for more than a short period of time.” In addition to the foregoing comments, the USDA APHIS Animal Care Inspection Guide2 states that “[a]nimals euthanized, killed, or trapped, and collected, such as for study or museum samples, from their natural habitat via humane euthanasia” are not to be included on the USDA annual report. Finally, the recent Wild Animals Tech Note3 makes clear that death by methods that meet the regulatory definition of euthanasia are not considered “harm”. These responses by USDA APHIS to the final rule along with language in the Inspection Guide and the Tech note make clear that the intent was not to exclude all activities with free-ranging animals, but only those that meet some undefined level of material alteration of behavior.
In the case of undefined terms, the IACUC is the body charged with considering activities and making a determination as to whether they meet the regulatory definition. Additional wording in the final rule (pg 6313) states that “[m]embers of the IACUC are required to have the experience and expertise to assess the research institution’s animal programs, facilities, and procedures, including review of all proposed and ongoing research.” The examples for material alteration of behavior provided in the Tech Note depict activities likely to alter normal patterns for long periods of time or to impact survival or reproduction of individuals (fitness in evolutionary terms). Capture, particularly in traps, can result in some animals becoming trap wary and thus more difficult to capture a second time, but capture can also result in animals becoming more prone to capture for the food reward used as bait. In neither of these cases are animals behaving in an unnatural way; they are simply responding to input, including stressors in their environment, and altering behavior as they would if the stressors were native predators or situations encountered in the course of daily activities. In other words, stress and distress are distinct, with only distress likely to cause a material alteration of behavior. Similarly, activities that do not disrupt the animal’s ability to express normal species-specific behaviors and responses and that do not impact survival or reproduction should not be considered material alteration of behavior. These considerations aside, because the extent of impact is likely to vary among species, environments, and seasons, determination of whether specific activities meet the threshold of material alteration of behavior is the province of the IACUC and should be considered during protocol review.
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