Topic: Definition of the term "field study" under the Animal Welfare Act Regulations
Background
OC's comments16 September 1998 (.pdf file)
Final rule 09 February 2000
Final update 17 January 2005

Background:  On 31 July 1998, the Animal and Plant Health Inspection Service published a notice (.pdf file) in the Federal Register proposing to clarify the definition of the term "field study"  under the Animal Welfare Act (AWA) regulations.  AWA regulations do not apply to field studies.  The proposed change would define field study such that a study that involves harm to animals, invasive procedures, or material alteration in behavior would not be considered a field study (and, therefore, would be subject to the AWA regulations and would require Institutional Animal Care and Use Committee approval).

Final rule announced 09 February 2000:  On Wednesday, 9 February 2000, USDA announced the final rule. The final rule simply replaced the word AND with the word OR. That is the only change made by USDA.

Click here (.pdf file) to read the full notice.

We are pleased to note that USDA responded to OC's comments as follows:

1. USDA had proposed to incorporate the words "potential to" harm or materially alter the behavior in the amended definition. OC objected, saying that virtually all field observation could have that effect at least on a temporary basis. USDA agreed not to include that term in the final definition.

2. OC also stated that the terms "invasive" "harm" and "materially alter the behavior" should be defined. Although USDA chose not to incorporate definitions in the final rule, it is considering the development of a policy statement that would provide examples of what APHIS consider invasive or noninvasive.

Final update 17 January 2005: The Ornithological Council receives reports that Institutional Animal Care and Use Committees (IACUCs) are requiring protocols for field work that clearly falls within the definition of the term field study, and that should therefore be exempt. The most obvious case of exempt field work is purely observational study. Merely observing birds should not trigger the protocol requirement. The Ornithological Council has raised this issue to the USDA and the National Institutes of Health, Office of Laboratory Animal Welfare, which implement the Animal Welfare Act and the Public Health Service Act, respectively. These government officials, and university officials with whom we have discussed this problem, respond by saying that universities are free to exceed the requirements of the Animal Welfare Act regulations. It appears that the primary reason for their desire to oversee all field work, exempt or not, is more out of a need or desire to oversee the safety and health aspects of such work, rather than the impact on animals. These universities are using their IACUCs to fulfill the institution's occupational health and safety and risk management functions, despite the fact that IACUC members are not trained in occupational health and safety and risk management.

The Ornithological Council urges ornithologists who are asked to submit protocols for field studies that should be exempt under the legal definition - and particularly those that are purely observational in nature - to report these instances to the Ornithological Council by contacting Ellen Paul at ellen.paul<at>verizon.net.

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