Guidance for Determining USDA “Field Study” Exemption for Annual Reporting
Number: IACUC-GUID-006
Responsible Office: Office of Research and Creative Scholarship (ORCS)
Applies to: Principal Investigators Conducting Animal Research
1. Purpose
The purpose of this policy is to define and clarify the ؿ IACUC’s responsibilities and procedures for reviewing wildlife field studies in accordance with USDA Animal Welfare Act (AWA) regulations and recent USDA guidance.
2. Definitions
Field Study: Observation/data collection without an impact upon the animal
- Exempt from USDA Reporting
- Oversight provided by OLAW and UM IACUC
Field Research: Observation/data collection that requires capture, redirection, behavior modification, sedation, invasive procedures, materially altering animal etc.
- USDA Reporting
- Oversight provided by OLAW, USDA-AHPIS and UM IACUC
3. Policy
The USDA Animal Welfare Act (AWA) states that field studies are exempt from the USDA requirement for IACUC review (section 2.31.d.1). It defines a field study as “a study conducted on free-living wild animals in their natural habitat. However, this term excludes any study involving an invasive procedure, harms, or materially alters an animal's behavior under study” (section 1.1).
These terms—"invasive," "harm," and "materially alter"—are not explicitly defined in the AWA itself, and in the past, the USDA allows individual IACUCs to interpret and define these terms to determine whether a study qualifies as a field study and is thus exempt from reporting. Although the AWA definition of a Field Research Study has not been updated to define the terms invasive, harm or materially altered, the USDA has now issued guidance on their interpretation of these terms. This updated guidance provides the ؿ IACUC with a clear rationale for deciding whether a specific field study meets the USDA's criteria for exemption.
Additionally, the USDA, APHIS Animal Care Inspection Guide states that “animals 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 in the USDA annual report. The AWA defines euthanasia as the “humane destruction of an animal accomplished by a method that produces rapid unconsciousness and subsequent death without evidence of pain or distress, or a method that utilizes anesthesia produced by an agent that causes painless loss of consciousness and subsequent death.”
Both chemical agents and commercially available kill traps are considered methods of euthanasia. Therefore, the killing of animals in the field using these methods is not subject to annual reporting requirements to the USDA. Moreover, a rare accidental death during the use of live traps also does not disqualify a study from being classified as a field study. These nuances allow IACUCs to carefully evaluate and categorize field research in compliance with USDA guidelines.
4. UM IACUC Oversight of Field Studies and Research Conducted in the Wild
While Field Studies, as defined in the AWA, and foreign field research are exempt from USDA animal welfare regulations, AAALAC International makes no distinction between laboratory and field studies, and thus, requires all research and teaching conducted by AAALAC-accredited institutions in the field, regardless of the location, to have some degree of IACUC oversight based on risk assessment, harm/benefit analysis, and hazard identification. Furthermore, the Office of Laboratory Animal Welfare (OLAW) requires IACUC review and approval if the fieldwork alters or influences the activity of the study animal.
Accordingly, independent of the determination of whether a study qualifies for a USDA exemption as a Field Study, any study conducted in the wild, regardless of location, that requires the handling of a vertebrate animal or significantly disturbs their normal behavior must receive UM IACUC approval prior to being conducted. Determination of whether a study will significantly disturb normal behavior is decided on a case-by-case basis by the IACUC and Attending Veterinarian, who may seek guidance from subject experts within and outside UM. Thus, all fieldwork requires UM IACUC review and approval and the USDA definition of Field Study mainly influences which free-ranging mammals used in research and teaching need to be reported to the USDA.
5. USDA Definitions for Wildlife Field Studies Not Exempt from USDA Reporting (Wildlife Research):
- Invasive procedures: 1) Studies with major operative procedures; 2) Intra-cardiac blood collections; 3) Arterial/venous cut downs for catheter placement; and 4) Surgical implantation of devices
- Harm: Procedures in which animals may experience 1) Death; 2) Pain or distress; 3) Trauma; 4) Overheating or excessive cooling; 5) Behavioral stress; 6) Physical harm; or 7) Unnecessary discomfort from handling
- Materially altered behavior: Activities for research purposes that 1) Use hormones or pheromones to change mating or migration patterns, 2) Activities that cause repeated nest/den disturbance during breeding and rearing of young; or 3) Relocation of migratory animals beyond their natural migration routes
Determination of whether proposed fieldwork qualifies as a USDA Field Study is made on a case-by-case basis by the IACUC based on the above definitions. However, below are examples of procedures that would make the proposed work suitable for classification as a USDA field study.
6. Field Studies (exempt from USDA reporting) may include the following procedures:
- Live-trapping animals in traps that are designed not to injure the animal and allow for some free movement within the trap (e.g. Culvert traps, Sherman traps)
- Short-term handling of animals at the site of capture or a nearby field processing location
- Collection of external morphometric data
- Marking the external surface of the animal via hair clipping or visible marking techniques (e.g., Sharpie pen, picric acid on fur or feathers)
- Swabbing of the mouth, nostrils, or rectum
- Injection of sterile liquids or materials (e.g., transponder tags) that are not expected to materially alter an animal’s activity or behavior
- Ear punching or clipping in rodents
- Blood collection through a needle, hematocrit tube, or by way of a skin nick
- Attaching external bands, tags, or transponders to limbs, neck, feathers, or ears
- Sedation or anesthesia is used to immobilize an animal rather than to provide analgesia
- Euthanasia by inhalation, chemical injection, or commercially available kill trap
Studies Conducted in the Wild Outside the United States:
Field research, even if it includes invasive procedures, harm, or material alteration of behavior, that is conducted outside the United States is exempt from USDA reporting since it is not within the jurisdiction of the USDA.
7. References
- Animal Welfare Act, Regulations and Standards in the Code of Federal Regulations (C.F.R.). Title 9 C.F.R., Chapter 1, Subchapter A - Animal Welfare, Parts 1, 2, and 3.
8. Review and Approval and Version History
|
Version |
Date |
Description of Changes |
Approved By |
|---|---|---|---|
|
1.0 |
May 14, 2024 |
Initial policy creation |
IACUC Committee |
|
2.0 |
September 26, 2024 |
Updated procedures for compliance |
Hicks |