Assistance in identifying appropriate endpoints and in ensuring humane euthanasia
*This checklist is not all-inclusive; rather it provides examples of the veterinarian’s responsibilities, which may vary with each proposal.
C.3. Other Protocol Review Considerations
C.3.a. Agricultural Research
Farm animals are used in a variety of research contexts, including:
studies of basic biological processes,
studies of pharmacokinetics and organ transplantation, and
studies of nutritional, breeding and management methods to increase the supply and quality of food and fiber.
Unlike typical laboratory animals, farm animals used for research and teaching may be housed in many different kinds of environments, ranging from traditional laboratory environments to enclosed or extensive farm settings. Because of these factors, as well as the regulatory complexity surrounding farm animal oversight, determining standards for the evaluation of research, teaching, and testing using farm animals is more complicated than for other laboratory animals.
Applicability of PHS Policy and the AWRs Farm animals used for improving animal nutrition, breeding, management, production efficiency, or the quality of food and fiber are specifically excluded from the definition of “animal” in the AWA. The PHSPolicy applies to vertebrates used in research, research training and biological testing, funded by the PHS. Some Assurances extend coverage of the PHS Policy to all animal activities at an institution. Hence, farm animals used in research, teaching or testing may be covered by the PHSPolicy and the AWRs. Farm animals used in agricultural research may not be covered by either.
OLAW advises institutions that uniform and consistent standards are an essential ingredient in a quality animal care and use program. Public perception of a potential double standard should also be considered.
Standards for Evaluation of Agricultural Animal Research and Teaching In 1988, a consortium of organizations and agencies developed guidelines for the care and use of farm animals, the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching (known as the Ag Guide). The Ag Guide, revised in 1999, was written to aid IACUCs in the evaluation of projects involving farm animal research or teaching “for which the scientific objectives are to improve understanding of the animal's use in production agriculture and that may require a simulated or actual production setting.” The Ag Guide is comprised of overview chapters covering institutional policies, veterinary care, husbandry, and physical plant, as well as specific species chapters for horses, cattle, poultry, and sheep and goats. Adoption of the Ag Guide by an institution is voluntary, although the USDA endorses itas a basis for animal care review of USDA competitive grant submissions and projects receiving experiment station funding.
This dual system of oversight for research and agricultural animals can pose challenges for IACUCs. In order to be relevant to commercial production, agricultural research must often be conducted under conditions similar to those found on commercial farms. However, there are practices that are common in commercial agriculture that would not ordinarily be permitted under the regulations governing research; for example, castrating young animals without anesthesia or closely confining animals in cages or stalls throughout the production cycle. But determining whether a particular protocol is agricultural or biomedical research, and which standards should be applied, is not always straightforward. For example, studies of basic biological processes in farm animals may benefit food and fiber production, but may also have human health implications. USDA Policy 26 provides some clarification, stating that farm animals used to manufacture and test biologicals for nonagricultural or nonproduction animals, or for humans, are considered research animals and thus are regulated under the AWA. But gray areas remain, and IACUCs need to consider animal welfare, protocol requirements, and research or teaching goals when setting standards.
Recently, there has been recognition that some melding of these different guidelines and standards may be necessary and appropriate. For example, the Guide, while intended to apply only to farm animals used for research purposes, recognizes that such animals may sometimes be housed in farm settings, and recommends the Ag Guide as a useful resource in such situations. And although USDA-APHIS decided to regulate farm animals used in research in 1991, they did not develop specific standards; instead, they adopted the Ag Guide and the Guide as guidance documents (Policy 29).
AAALAC also uses both the Guide and Ag Guide as reference documents for the accreditation of farm animal facilities and programs. Thus, the use of a performance-based approach is desirable.
Review of Protocols and Facilities Institutions employ a number of different approaches to reviewing activities involving animals used for agricultural research and teaching. Some have a single committee that reviews all protocols, while others have a subcommittee or even a separate committee that reviews agricultural animal research protocols. (As applicable, committees must comply with the membership and review procedures required by PHS Policy and the AWRs.) There are benefits and limitations associated with each of these approaches. However, what is most important is that the institution ensures uniform and high-quality oversight of all research, teaching, and testing activities involving animals, regardless of the species or the type of research being conducted.
For thorough oversight of agricultural animal care and use, it is particularly important that there be agricultural expertise on the IACUC. The Ag Guide suggests that the IACUC include, among other members:
a scientist from the institution with experience in agricultural research or teaching involving agricultural animals;
an animal, dairy or poultry scientist who has training and experience in the management of agricultural animals; and
a veterinarian who has training and experience in agricultural animal medicine and who is licensed or eligible to be licensed to practice veterinary medicine.
There are unusual aspects of agricultural research that deserve careful consideration by IACUCs. As mentioned previously, there are certain husbandry practices common on commercial farms that have the potential to cause pain or distress that would not ordinarily be permitted under the regulations governing research. The Ag Guide recommends that IACUCs review these procedures, as well as husbandry conditions that do not meet the standards outlined in the Ag Guide, even if they are considered normal practice. Another unusual aspect of agricultural research is that the animals may be killed and marketed for human food at the end of studies, which means that there are special considerations with respect to avoiding residues from therapeutics and other drugs.
The extent of oversight is another issue that IACUCs need to address. At institutions with agricultural colleges, there may be multiple lines of authority for animal facilities and animal ownership. In addition, animals may be housed at off-site facilities at some distance from the main unit. The IACUC needs to ensure that there is adequate oversight of all animals under approved protocols. Agricultural and veterinary extension faculty may also conduct research or teach using privately owned animals on private farms, and the IACUC should consider whether or not these activities need to be covered by protocols.
Finally, the facilities in which agricultural animals are housed are often older than typical laboratory animal facilities. Because many of these facilities are semi-enclosed or open, there may be problems with rodent control and some other aspects of maintenance. Recordkeeping in agricultural animal facilities may be less complete than that required in conventional lab animal facilities. The IACUC should be aware that there can and should be a high standard of animal care even in modest facilities. The development and implementation of standard operating procedures for these facilities can help to ensure a consistent standard of animal care.
Conclusion Although not always required by law, the monitoring of food and fiber animal research and teaching activities can significantly benefit an institution by improving the overall quality of the animal care program. Because agricultural research often has the improvement of food or fiber production as an endpoint, standards may differ from those for research animals. This does not mean, however, that different ethical standards should be used by an IACUC in considering the use and care of farm animals used for food and fiber research. Experimental goals and animal welfare should both be considered when evaluating the use and treatment of these animals.
Curtis, S.E. 1994. Commentary: Farm animal use in biomedical sciences—melding the guidelines. ILAR News 36:35-39.
FASS (Federation of Animal Science Societies). 1999. Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching. Savoy, IL: FASS.
Joyner, G. 1990. Agricultural animal care review. AWIC Newsletter, Volume 1.
Mench, J.A., S. J. Mayer, and L. Kruslisch. 1992. The Well-Being of Agricultural Animals in Biomedical and Agricultural Research. Bethesda, MD: Scientists Center for Animal Welfare.
Stricklin, W.R. and J.A. Mench. 1994. Oversight of the use of agricultural animals in university teaching and research. ILAR News 36:9-14.
Swanson, J.C. 1998. Oversight of farm animals in research. Lab Animal 27, 28-31.
Tillman, P. 1994. Integrating agricultural and biomedical research policies: conflicts and opportunities. ILAR News 36:29-35.
AAALAC International Position Statement on “Farm Animals”.