Background and Purpose
Both the Public Health Service (PHS) Policy and the Animal Welfare Act Regulations (AWAR) require that IACUC protocols specify, and include a rationale for, the approximate number of animals to be used . In addition, AAALAC International expects institutions to provide numbers for all vertebrate species at the time of annual report . These provisions implicitly require that institutions establish mechanisms to monitor and document the number of animals acquired or produced and used in approved activities in order to avoid use of animals in numbers that exceed the number estimated in the approved protocol. The choice of a specific mechanism to accomplish this goal is not federally mandated but must be found to be acceptable to regulatory and accrediting bodies.
The purpose of this policy is to explain the ARC requirements and procedures for tracking and reporting animals generated and used under approved protocols.
The source of all live vertebrate animals used for research, teaching, or testing activities must be identified in the approved ARC protocol.
DLAM will procure animals from commercial sources, whenever available, ensuring that animals are acquired from pre-qualified vendors, and will track animal numbers by species and protocol at the time of ordering.
Investigators that obtain animals for research purposes via alternative sources must notify DLAM prior to the arrival of the animals on campus and their numbers must be documented and reported directly to the ARC no less than annually, as described below.
- In-house breeding colonies:
a. Mammals (e.g., mice, rats) and birds: DLAM will identify and report all live young born or hatched in DLAM-managed vivaria and assure that these numbers are deducted from the appropriate breeding protocol. Investigators that directly manage their own breeding colonies in space that is not serviced by DLAM must track and report all newborn animals to the ARC through the ARC administrative office at least once/month using the New litters - Pup Counts form. ALL investigators must use the DLAM online transfer process to move animals from a breeding protocol to an experimental protocol.
b. Aquatics (e.g., zebrafish): Investigators are to perform a monthly census based on animals, rather than tanks, in order to maintain compliance with Fish and Wildlife regulations . One mechanism to perform the census is to take inventory of tanks by size, then estimate tank density for each size tank; each sized tank in the colony then is counted monthly and the estimated fish density per tank size multiplied by the number of tanks of that size to yield the census count for that month. The mechanism used to perform census will be documented in the lab SOP. Census data is to be available upon request.Also on a monthly basis, zebrafish users are to provide to the ARC a report of animals >3 days post fertilization used in the prior month.
Wild-caught animals and animals studied in the field:
On an annual basis, investigators are to tally and report to the ARC the number of wild-caught animals and those studied in the field for the period October 1 to September 30.
The annual report of wild-caught animals and those studied in the field will be initiated by the ARC administrative office and should be provided as follows for each species:
Category Total Pain Category B: Total number of animals bred, conditioned, or held, but not yet used for experimental purposes.
Examples: breeding, quarantine/acclimation prior to use
Pain Category C: Total number of animals used in experiments but subjected to no more than momentary pain/distress.
Examples: injections of non-toxic substances, peripheral blood collections not requiring anesthesia, euthanasia and harvesting of tissue only, observing natural behavior, behavioral testing without significant restraint or noxious stimuli.
Pain Category D: Total number of animals for which pain/distress is relieved by use of appropriate anesthetics, analgesics, tranquilizers or by euthanasia.
Examples: terminal surgery, survival surgery, retro-orbital blood collection, euthanasia of animals showing signs of more than slight or momentary pain and/or distress.
Pain Category E: Total number of animals for which pain/distress cannot be relieved by use of anesthetics, analgesics, or tranquilizers, as the use of these agents would interfere with the experimental design.
Examples: pain research, toxicity testing.
- Non-traditional commercial sources:
Investigators that obtain animals directly from non-traditional commercial sources (i.e., not through a DLAM procurement process such as an order or import) are to document and report to the ARC the number of animals received upon their arrival at the research facility. In addition, this information is to be tallied annually, using the pain categorizations described under item 2 above, for the period October 1 to September 30, and filed with the ARC through the ARC administrative office.
 AWAR 2.31,e,1; 2.31,e,2; PHS Policy IV,D,1,b; the Guide, p. 25
 AAALAC International Accreditation FAQ
 California Natural Resources Agency, Department of Fish and Wildlife: “Any person who applies for an Aquaculture or Fish permit shall also provide the actual number of animals specified by either the weight, volume or count” (page 14).
Approved 3/9/15; Revised 2/13/17, 1/28/19, 1/13/20