USDA - APHIS - Animal Welfare

Policy #11: Painful and Distressful Procedures
Issue Date: March 25, 2011

References:
AWA Section 2143
9 CFR, Part 2, Sections 2.31(d)(1)(i,ii,iv), 2.31(e)(4), 2.33(b)(4), 2.36(b)(5,6,7)

History:
Replaces letters dated March 1, 1990; November 9, 1990; November 7, 1991; and May 8, 1992. Replaces policy dated April 14, 1997.

Justification:
Inspectors and the regulated community have requested guidance on procedures to avoid or minimize discomfort, distress and/or pain involving animals.

Policy:
A painful procedure is defined as “any procedure that would reasonably be expected to cause more than slight or momentary pain or distress in a human being to which that procedure is applied, that is, pain in excess of that caused by injections or other minor procedures”. The Institutional Animal Care and Use Committee (IACUC) is responsible for ensuring that investigators have avoided or minimized discomfort, distress and pain to the animals; appropriately considered alternatives to any procedures that may cause more than slight or momentary pain or distress; and consulted with the attending veterinarian in the planning of the procedures.

Examples of procedures that may cause more than momentary or slight pain include, but are not limited to, the following:

Surgery (survival or terminal): considered a painful procedure in which pain is alleviated by anesthesia. Survival surgery may also require the use of peri-operative analgesia.

Freund’s Complete Adjuvant: may cause a severe inflammatory reaction depending on the species and route of administration.

Ocular or Dermal Toxicity Testing: the dosing procedure itself is generally not painful but the reaction caused by the product being tested may cause pain.

Examples of procedures that may cause more than momentary or slight distress include, but are not limited to, the following:

Food and/or water deprivation or restriction beyond that necessary for normal presurgical preparation.
Noxious electrical shock or thermal stress that is not immediately escapable.
Paralysis or immobility in a conscious animal.
Forced exercise (e.g., swimming or treadmill protocols).
Infectious and inflammatory disease models.

Some procedures, including any of those in the lists above, may cause both pain and distress. Examples of procedures that may cause more than momentary or slight pain as well as distress would include studies involving extensive irradiation, inhalation toxicity studies or those involving tumor growth.

Animals exhibiting signs of pain, discomfort, or distress such as weight loss, decreased appetite, abnormal activity level, adverse reactions to touching inoculated areas, open sores/necrotic skin lesions, abscesses, lameness, conjunctivitis, corneal edema, and photophobia are expected to receive appropriate relief unless written scientific justification is provided in the animal activity proposal and approved by the IACUC.