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1 Laboratory Animals and Public Perspective REGULATORY ISSUES In recent years, virtually every aspect of biomedical research has been increasingly subjected to public scrutiny. A major concern is the justifica- tion of public funding. In addition, heightened public awareness and pres- sure have resulted in increased oversight in such areas as the health and safety of workers, the state of the environment, and the welfare of animals used in research, teaching, and testing. Design and review of protocols involving the use of animals should include consideration of applicable regulations and public accountability in each of those areas. Two federal laws govern the use of animals. The Health Research Extension Act (PL 99-158), passed in 1985, amended Title 42, Section 289d, of the U.S. Code and gave the force of law to the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS, 1996; hereafter called PHS Policy). PHS Policy applies to all activities conducted or funded by the Public Health Service (PHS) that involve any live vertebrate animal used or intended for use in research, training, or testing. It requires compliance with the Animal Welfare Regulations (AWRs), and it specifies minimal components of an institution's animal care and use program, oversight responsibilities, and reporting requirements. Programs for animal care and use must be based on the Guide for the Care and Use of Laboratory Animals (NRC, 1996 et seq.), hereafter called the Guide; any departure from its recommendations must be documented and justified. PHS

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2 RODENTS: LABORATORY ANIMAL MANAGEMENT Policy stresses institutional self-regulation and gives responsibility for oversight to an institutional animal care and use committee (IACUC). The Office for Protection from Research Risks (OPRR) is responsible for the general ad- ministration and coordination of PHS Policy. OPRR responsibilities in- clude reviewing and approving (or disapproving) institutional assurances, communicating with institutions concerning implementation of PHS Policy, investigating allegations of noncompliance by PHS-funded institutions, re- viewing and approving (or disapproving) waivers to PHS Policy, and mak- ing site visits to selected institutions. Title 7, Sections 2131 et seq., of the U.S. Code, popularly called the Animal Welfare Act and most recently amended in 1985 by PL 99-198, was originally written in 1966 to protect pets. Its focus has since shifted to protecting laboratory animals. In addition to requiring that the U.S. Depart- ment of Agriculture (USDA) establish minimal standards for animal hus- bandry, care, treatment, and transportation, the act now includes provisions to reduce animal use by eliminating unnecessary duplication and mandates consideration of alternatives to procedures that are likely to cause pain or distress in live animals. The amended act applies to most warm-blooded animals used or intended for use in research, teaching, or testing in the United States. Like PHS Policy, it emphasizes institutional self-regulation and gives oversight responsibility to an IACUC. Regulatory Enforcement and Animal Care (REAC), a part of the USDA Animal and Plant Health Inspection Service, administers and enforces the regulations (9 CFR 1-3) and carries out inspections of facilities to determine compliance. Labora- tory mice (genus Mus) and rats (genus Rattus), which make up more than 90 percent of the animals used in research, are not covered by the AWRs and are not subject to REAC inspection. However, there is a movement to include them; the decision on this issue is likely to be made in federal court. Other regulations, policies, and guidelines address animal-care issues, although they are not specifically directed at animal research. They include the Good Laboratory Practice rules promulgated by the Food and Drug Administration (21 CFR 58) and the Environmental Protection Agency (40 CFR 160 and 40 CFR 792), which provide standards for the care and hous- ing of test animals, and Biosafety in Microbiological and Biomedical Labo- ratories (Richmond and McKinney, 1993), which provides guidelines for containment of animals and animal wastes during and resulting from animal experimentation with pathogens. For reviews and discussions of the various regulations and guidelines, refer to Education and Training in the Care and Use of Laboratory Ani- mals: A Guide for Developing Institutional Programs, Part III, Chapter 1 (NRC, 19911; Use of Laboratory Animals in Biomedical and Behavorial Research, Chapter 5 (NRC, 19881; The Biomedical Investigator's Hand- book for Researchers Using Animal Models, Chapter 6 (Foundation for Bio

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LABORATORY ANIMALS AND PUBLIC PERSPECTIVE 3 medical Research, 1987~; and The Institutional Animal Care and Use Com- mittee Guidebook (IA C UC Guidebook) (ARENA/OPRR, 1992~. In addition to the regulations noted above, animal experimentation with hazardous agents is subject to regulations that govern handling, use, and disposal of hazardous agents, such as radioisotopes and toxic chemicals. Likewise, protection of workers from a variety of potential workplace haz- ards is mandated by occupational safety and health agencies at the federal level and, in many cases, at the state level. It is the responsibility of each investigator using animals to know and comply with relevant regulations, guidelines, and policies (federal, state, local, and institutional). ETHICAL CONSIDERATIONS The laws, regulations, policies, and guidelines discussed above estab- lish common standards for the humane care and use of laboratory animals. Recent revisions have refined earlier standards and improved the well-being of laboratory animals. Nevertheless, it is the obligation of every investiga- tor who uses animals to ensure that the highest principles of humane care and use are applied. These principles are summarized in the U.S. govern- ment "Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training" (published in NRC, 1996, pp. 116-118, and PHS, 1996, p. 1), which was prepared by the Interagency Research Animal Committee, a group whose main concerns are the conservation, use, care. ~nr1 w~.lf~r~ of research animals. The orincioles address such issues as _ ~ _, _ _ the value of the proposed work; selection of appropriate models; minimiza- tion of pain and distress; use of sedation, analgesia, or anesthesia when painful procedures are necessary; euthanasia of animals that might suffer severe or chronic pain or distress; provision of appropriate housing and veterinary care; training of personnel; and IACUC oversight of exceptions to the principles. The principles emphasize the role of the IACUC in deter- mining the appropriateness and value of proposed work in which animals are likely to be subjected to unalleviated pain or discomfort. Some kinds of research should be especially carefully reviewed and periodically re-evalu 1 "L ated by IACUCs' including studies that involve unalleviated pain or distress (such as those in which death is the end point) and studies that involve food or water deprivation. Some people and groups question the value of using animals in bio- medical research and suggest that the knowledge gained is not sufficiently anolicable to human disease to justify the pain, distress, and loss of life suffered by laboratory animals. However, Nicoll and Russell (1991) point out that animal research has contributed in an important way to 74 percent of 386 major biomedical advances made from 1901 to 1975 and that 71 percent of the 82 Nobel prizes for physiology or medicine awarded from

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4 RODENTS: LABORATORYANIMAL MANAGEMENT 1901 to 1982 were given for research that depended on studies with ani- mals. The regular occurrence of new infectious diseases of humans and animals-such as Legionnaire's disease, AIDS, Lyme disease, and canine parvovirus disease and the existence of diseases that kill hundreds of thousands of people and animals a year such as cancer, cardiovascular disease, and stroke make research in living systems imperative if we wish to continue to make medical progress. Most of the public are rightly concerned with the elimination of unnec- essary animal suffering and the protection of pets, and it is an obligation of scientists to educate the press, the legislature, and the public about the efforts made by the scientific community to minimize animal pain and suf- fering, the extensive review to which animal research is subjected, and the great benefits we and our pets derive from animal research. These benefits include the development of antiviral vaccines (e.g., vaccines against polio- virus, canine parvovirus, and feline leukemia virus), advances in tissue trans- plantation (e.g., of kidneys, corneas, skin, heart, liver, and bone marrow), and the development of new treatments for cardiovascular disease (e.g., open-heart surgery, valve replacement, and artery replacement). The educa- tional process should stress that scientists and most of the public agree that the use of animals in research is necessary, that animals should be cared for and used as humanely as possible, and that unnecessary suffering should be prevented. Results of such educational efforts are beginning to appear in the form of state and federal legislation to protect animal-research facilities and laboratories from vandalism. The educational process should continue, and all scientists should be committed to it. Useful discussions of the ethical issues related to animal research can be found in Use of Laboratory Animals in Biomedical and Behavioral Re- search (NRC, 1988~; The Biomedical Investigator's Handbook for Researchers Using Animal Models (Foundation for Biomedical Research, 19871; Mozart, Alexander the Great, and the Animal Rights/Liberation Philosophy (Nicoll and Russell, 1991~; and Education and Training in the Care and Use of Laboratory Animals: A Guide for Developing Institutional Programs, Part III, Chapter 2 (NRC, 19911. REFERENCES ARENA/OPRR (Applied Research Ethics National Association and Office for Protection Strom Research Risks). 1992. Institutional Animal Care and Use Committee Guidebook. NIH Pub. No. 92-3415. Washington, D.C.: U.S. Department of Health and Human Services. Available from either ARENA, 132 Boylston Street, Boston, MA 02116 or U.S. Govern- ment Printing Office, Washington, DC 20402 (refer to stock no. 017-040-00520-2). Foundation for Biomedical Research. 1987. The Biomedical Investigator's Handbook for Researchers Using Animal Models. Washington, D.C.: Foundation for Biomedical Re- search. 86 pp.

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LABORATORY ANIMALS AND PUBLIC PERSPECTIVE Nicoll, C. S., and S. M. Russell. 1991. Mozart, Alexander the Great, and the animal rights/ liberation philosophy. FASEB J. 5:2888-2892. NRC (National Research Council), Institute of Laboratory Animal Resources Committee to Revise the Guide for the Care and Use of Laboratory Animals. 1996. Guide for the Care and Use of Laboratory Animals, 7th edition. Washington, D.C.: National Academy Press. NRC (National Research Council), Commission on Life Sciences and Institute of Medicine, Committee on the Use of Laboratory Animals in Biomedical and Behavioral Research. 1988. Use of Laboratory Animals in Biomedical and Behavioral Research. Washington, D.C.: National Academy Press. 102 pp. NRC (National Research Council), Institute of Laboratory Animal Resources, Committee on Educational Programs in Laboratory Animal Science. 1991. Education and Training in the Care and Use of Laboratory Animals: A Guide for Developing Institutional Pro- grams. Washington, D.C.: National Academy Press. 139 pp. PHS (Public Health Service). 1996. Public Health Service Policy on Humane Care and Use of Laboratory Animals. Washington, D.C.: U.S. Departmentof Health and Human Services. 16 pp. Available from the Office for Protection from Research Risks, National Institutes of Health, 6100 Executive Boulevard, MSC 7507, Suite 3B01, Rockville, MD 20892- 7507. Richmond, J. Y., and R. W. McKinney, eds. 1993. Biosafety in Microbiological and Biomedi- cal Laboratories, 3rd ed. HHS Pub. No. (CDC) 93-8395. Washington, D.C.: U.S. Department of Health and Human Services. Available from Superintendent of Docu- ments, U.S. Government Printing Office, Washington, DC 20402.