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A new report from the Government Accountability Office examines animal use in federal research and, in particular, reporting and data sharing about animal use. The report points out, among other things, that APHIS’s instructions have not ensured consistent and complete reporting in three areas: research with birds, activities outside the United States, and field studies outside a typical laboratory. The GAO recommended that APHIS clarify its reporting instructions and fully describe the potential limitations of the animal use data it makes available to the public. USDA stated that APHIS will take steps to implement GAO’s recommendations, with the exception of clarifying reporting instructions for activities outside the United States. GAO continues to believe that APHIS needs to ensure complete reporting of such activities by federal facilities.
The GAO also recommended that APHIS (1) develop a timeline for defining birds that are not bred for research and that are thus covered under the Animal Welfare Act and (2) requiring that research facilities report to APHIS their use of birds covered by the Act.
In response, the APHIS Animal Care program committed to submitting a recommendation and timeline for defining birds subject to the Animal Welfare Act by 30 September 2018. Presumably, this would lead to a formal regulatory process and the opportunity for public comment.
In addition, the GAO recommended that APHIS should provide research facilities with clear examples of studies that are excluded from the definition of "field study" and are thus covered by the Animal Welfare Act and that should therefore be reported to APHIS, as well as examples of studies that meet the definition of "field study" and thus should not be reported.
This comes against the background of the 21st Century Cures Act which mandates the federal agencies such as APHIS and the National Institutes of Health to reduce the burden of animal welfare regulations, as well as the anti-regulatory stance of the current Administration.
Background on the inclusion of birds
Amajor change in policy took place in 2004 when the agency decided, as a result of litigation, that it would begin to regulate rats, mice, and birds used in research (the law exempted "purpose-bred rats, mice, and birds so the agency rule would have affected other birds bred in captivity but not for the purpose of research, wild birds brought into captivity, and wild birds studied in the field). The agency began the process of developing regulatory standards by way of an advanced notice of public rulemaking, asking the stakeholders and the public for input as to what and how to regulate. Nothing more was heard until December 2011, when the agency announced that the proposed regulation was on hold pending an assessment of the agency's resources for implementing the rule. Nothing more has been heard since then. For all practical purposes, this regulation would have had little impact on those studying wild birds because it was unlikely that the agency would have attempted to oversee such research. However, it would have impacted those studying wild birds in captivity.
The new, extreme anti-regulatory stance of the current Administration led the OC to surmise that this regulation was in permanent repose. In fact, the listing for this pending regulation had been dropped from the semi-annual unified regulatory agenda of all pending regulatory processes. Now, it seems to have come back to life.
Background on field studies
The Animal Welfare Act regulations exempt field studies, defined as those that do not involve invasive procedures, harm to the animal, or material alteration of behavior. No further definitions have been provided. Recently, APHIS Animal Care attempted to develop guidance without any input from wildlife biologists. After strenuous objections from the Ornithological Council that process was put on hold. The Ornithological Council developed a survey to determine how IACUCs were interpreting those criteria; as of now, we have not received a sufficient number of responses. The few we received suggest that IACUCs are actually overly inclusive and requiring reviews (and reporting) for methods that do not involve any of those three conditions.
Edited by Ellen Paul