Federal Law

Universities and the institutions or organizations which carry out animal-based research or teaching fall under the "Animal Welfare Act" (Public Law 89-544, 1966 and subsequent amendments including Public Law 99-158, 1985). Complete copies of the Act, Amendments and Regulations are available at the USDA Website. In essence, the Act mandates unannounced inspections by officials of the U.S. Department of Agriculture to ensure compliance with regulations for humane care of animals used in research, their housing, and medical care including "the appropriate use of anesthetic, analgesic, or tranquilizing drugs, when such use would be proper in the opinion of the attending veterinarian at the research facility." The objective of the legislation is to "effectively minimize the pain and discomfort of the animals while under experimentation." Annual reports are required which Veterinary Resources prepares on behalf of our institutions.

All scientists at UM,B must comply with the Animal Welfare Act. The Act covers nonhuman primates, dogs, cats, rabbits, guinea pigs, hamsters, and aquatic mammals and any other warm-blooded animal used for biomedical research (except laboratory mice, rats and birds).

Enforcement of federal law is carried out by veterinary inspectors of the U.S. Department of Agriculture who make unannounced site visits. Reports filed by these inspectors are available to the public under the Freedom of Information Act.

Public Health Service - National Institutes of Health

The Office of Laboratory Animal Welfare (OLAW, formerly Office for Protection from Research Risks, Division of Animal Welfare) at the National Institutes of Health Public Health Service Policy on Humane Care and Use of Laboratory Animals was promulgated in 1985 and most recently revised in October, 2000. The complete policy with all updates can be found at http://www.grants.nih.gov/grants/olaw/olaw.htm. Several significant changes occurred in the 1996 revision of the 1979 policy.

a. The policy requires that each institution receiving PHS funds for research involving animals submit detailed information in an Animal Welfare Assurance letter regarding the institution's program for the care and use of animals.

b. Awardee institutions are required to identify an institutional official who is ultimately responsible for the institution's program for the care and use of animals, and a veterinarian qualified in laboratory animal medicine who will direct or supervise the program. Institutions are also required to designate clear lines of authority and responsibility for those involved in animal care and use in PHS-supported activities.

c. The policy defines the role and responsibilities of Institutional Animal Care and Use Committees (IACUC) and requires the involvement of such committees in all aspects of PHS-supported research at those institutions. The policy requires that Institutional Animal Care and Use Committees include an individual unaffiliated with the institution, a veterinarian who has program responsibilities and who has training or experience in laboratory animal science and medicine, a practicing scientist experienced in research involving animals, and a member whose concerns are in a nonscientific area.

d. The policy requires Institutional Animal Care and Use Committees to review and approve those sections of applications for PHS funds that relate to the care and use of animals before PHS funds may be awarded.

e. Institutions that are not accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) are required to conduct a self-assessment of the institution's program, based on the Guide for the Care and Use of Laboratory Animals, 1996. Significant deficiencies in the institution's program must be identified and the institution must adhere to an approved plan and schedule for correction of the deficiencies. Such institutions are assigned to category 2 on PHS grants and contracts.

NIH Principles for use of Animals

(Federal Register, May 20, 1985, Vol. 50, No. 97, Office of Science and Technology Policy.)

These principles were prepared by the Interagency Research Animal Committee. This Committee, established in 1983, serves as a focal point for federal agencies' discussions of issues involving all animal species needed for biomedical research and testing. The committee's principal concerns are the conservation, use, care, and welfare of research animals. Its responsibilities include information exchange, program coordination, and contributions to policy development.

Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training.

The development of knowledge necessary for the improvement of the health and well-being of humans, as well as other animals, requires in vivo experimentation with a wide variety of animal species. Whenever U.S. Government agencies develop requirements for testing, research, or training procedures involving the use of vertebrate animals, the following principles shall be considered; and whenever these agencies actually perform or sponsor such procedures, the responsible institutional official shall ensure that these principles are adhered to:

The transportation, care, and use of animals should be in accordance with the Animal Welfare Act (7 U.S.C. 2131 et seq.) and other applicable Federal laws, guidelines and policies.

Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society.

The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. Methods such as mathematical models, computer simulation, and in vivo biological systems should be considered.

Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals.

Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure or, if appropriate, during the procedure.

The living conditions of animals should be appropriate for their species and contribute to their health and comfort. Normally, the housing, feeding, and care of all animals used for biomedical purposes must be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied. In any case, veterinary care shall be provided as indicated.

Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their in-service training, including the proper and humane care and use of laboratory animals.