Compliance with the PHS Policy requires familiarity with each of these documents. This section describes each one and its relevance to the PHS Policy.

Guide for the Care and Use of Laboratory Animals

The Guide for the Care and Use of Laboratory Animals is a widely accepted primary reference on animal care and use. The seventh and latest edition of the Guide, published in 1996, was written under the auspices of the Institute for Laboratory Animal Research of the National Academy of Sciences.

The 1996 Guide demonstrates a shift toward performance standards which emphasize outcomes, as opposed to engineering standards which are prescriptive and may not allow sufficient flexibility or professional judgment to deal with unique circumstances. Recommendations in the Guide are based on published data, scientific principles, expert opinion, and experience with methods and practices that are consistent with high-quality, humane animal care and use. Extensive references found at the end of each chapter are key features of the Guide.

The Guide is intended to assist institutions in caring for and using animals in ways judged to be scientifically, technically, and humanely appropriate. Included in the Guide are descriptions of institutional responsibilities and professional standards. Institutional responsibilities include monitoring animal care and use, provisions for veterinary care, training for personnel, and the establishment of an appropriate occupational health and safety program. Professional standards encompass the animal environment, animal husbandry and management, veterinary care, and design and construction of animal facilities.

Familiarity with the standards and recommendations of the Guide is important because the PHS Policy mandates that institutions use the Guide as a basis for developing and implementing an animal care and use program.

United States Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training

The PHS Policy implements nine U.S. Government Principles that are the foundation for humane care and use of laboratory animals in this country. These principles were developed by the Interagency Research Animal Committee and adopted in 1985 by the Office of Science and Technology Policy. The principles are:

I. 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.*

II. 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.

III. 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 vitro biological systems should be considered.

IV. 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.

V. Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures should not be performed on unanesthetized animals paralyzed by chemical agents.

VI. 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.

VII. 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.

VIII. 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.

IX. Where exceptions are required in relation to the provisions of these Principles, the decisions should not rest with the investigators directly concerned but should be made, with due regard to Principle II, by an appropriate review group such as an institutional animal care and use committee. Such exceptions should not be made solely for the purposes of teaching or demonstration.

*For guidance throughout these Principles, the reader is referred to the Guide for the Care and Use of Laboratory Animals prepared by the Institute for Laboratory Animal Research, National Academy of Sciences.

Animal Welfare Regulations

The Animal Welfare Act (AWA), initially enacted in 1966 and amended in 1970, 1976, 1985, 1990, and 2002, is the principal Federal statute governing the sale, handling, transport and use of animals. The United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS)/Animal Care (AC) implements the AWA through the Animal Welfare Regulations found in the Code of Federal Regulations, Title 9, Chapter 1, Subchapter A, Parts 1, 2, and 3.

The AWA applies to all species of warm blooded vertebrate animals used for research, testing, or teaching, except farm animals used for agricultural research. The Farm Security and Rural Investment Act of 2002 amendments to the regulations that implement the AWA currently also exempt birds, rats of the genus Rattus, and mice of the genus Mus, bred for use in research.

The 1985 amendments to the AWA (Public Law 99-198, the Improved Standards for Laboratory Animals Act) were considered a watershed for laboratory animal welfare because for the first time the AWA clarified humane care, minimization of pain and distress, consideration of alternatives, institutional animal care and use committees, psychological well-being of primates, and exercise for dogs.

Compliance with the Animal Welfare Regulations, as applicable, is an absolute requirement of the PHS Policy.

Through a formal Memorandum of Understanding, USDA, FDA and NIH cooperate with one another to facilitate implementation of, and foster institutional compliance with, the Animal Welfare Regulations and the PHS Policy.

Report of the AVMA Panel on Euthanasia

The PHS Policy requires that euthanasia be conducted in a manner that is consistent with the professional guidance for relieving pain and suffering of animals found in the Report of the American Veterinary Medical Association (AVMA) Panel on Euthanasia (Report). This Report is updated from time to time; the most recent version is dated 2000.

The Report discusses only methods and agents supported by data from scientific studies. It emphasizes professional judgment, technical proficiency, and humane handling of the animals. Deviations from the Report are permitted by the PHS Policy only if the IACUC determines that they are justified for scientific reasons.

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