ILAR Journal Online, Volume 37(2) 1995: Laboratory Animal Care Policies and Regulations

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ILAR Journal V37(2) 1995
Laboratory Animal Care Policies and Regulations

United States
Thomas E. Hamm, Jr., Ralph B. Dell, and Richard C. Van Sluyters

Thomas E. Hamm, Jr., D.V.M., Ph.D., is a professor in the College of Veterinary Medicine and University Director of Laboratory Animal Resources at North Carolina State University. Ralph B. Dell, M.D., is IACUC chairman of Columbia University and professor of pediatrics at the College of Physicians and Surgeons, Columbia University, New York, New York. Richard C. Van Sluyters, O.D., Ph.D is a professor in the School of Optometry, and Chairman of the IACUC at the University of California, Berkeley.

OVERSIGHT

Oversight of animal care and use in the United States is provided mainly by two overlapping national laws: the Animal Welfare Act (7 USC 2131-2157) and the Health Research Extension Act (42 USC 289d), which was amended November 20, 1985 by Public Law 99-158 to cover, in addition to many other matters pertaining to animals, the care and use of animals in research.

The regulations that implement the Animal Welfare Act are published in the Code of Federal Regulations (9 CFR 1-3). These regulations are administered by the U.S. Department of Agriculture (USDA) and apply to both the care and any use of laboratory animals covered by the regulations regardless of funding source. Animals are defined as "any live or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or any other warm-blooded animal, which is being used, or is intended for use for research, teaching, testing, experimentation, or exhibition purposes, or as a pet" (9 CFR 1.1 ). Animals currently exempted from these regulations include, "...birds, rats of the genus Rattus and mice of the genus Mus bred for use in research, and horses not used for research purposes and other farm animals, such as, but not limited to livestock or poultry used or intended for use as food or fiber or livestock or poultry used or intended for use for improving animal nutrition, breeding, management, or production efficiency, or for improving the quality of food or fiber" (9 CFR 1.1).

The Health Research Extension Act is implemented by the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) (PHS, 1986). This policy is applicable to all activities conducted and supported by the Public Health Service (PHS) involving any live vertebrate animal used or intended for use in research, research training, experimentation, biological testing, or related purposes. The PHS Policy requires compliance with the Animal Welfare Act and requires institutions to use the Guide for the Care and Use of Laboratory Animals (Guide) (NRC, 1985) as a basis for developing and implementing an institutional program for activities involving animals.

The Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching (Consortium for Developing a Guide, 1988) has been developed for institutions that use agricultural animals in their programs. All states have their own laws governing the humane treatment of animals within their borders (NABR, 1991), but usage by research institutions is usually exempted. Twenty states have simple facility licensure requirements and a few have only very general regulations governing research usage of animals. In reality, nearly all states defer to federal law providing protection for research animals. There also may be local laws, and most institutions have in-house policies governing the use of animals. These are so varied that they cannot be adequately summarized here.

FUNDING

The offices that administer the national laws are currently funded by the national government. The AWA is under the auspices of USDA, while the PHS Policy is handled by the National Institutes of Health. The funding for the implementation of the national, state, and local laws usually comes from the regulated institution and grant funds awarded to individual investigators who use animals in their research.

ENFORCEMENT

The Animal Welfare Act is administered by the USDA's Animal and Plant Health Inspection Service (APHIS), Regulatory Enforcement and Animal Care Branch (REAC). REAC employs approximately 80 veterinary medical officers who conduct unannounced inspections at least once a year at institutions that use animals in research, education, and testing. These inspections involve only the species covered under the Animal Welfare Act. In addition, APHIS inspects dealers and vendors of regulated species. If deficiencies are found by the veterinary medical officer, they are noted on an inspection form, and the institution is given a time interval to correct the deficiencies. If the deficiencies are not corrected within the allotted time period, a warning may be issued. If severe deficiencies are found, or if deficiencies are not corrected, administrative legal proceedings may be initiated, which can result in fines and loss of registration to operate as a research facility.

The PHS Policy is administered by the National Institutes of Health, Office for Protection from Research Risks (OPRR). No activity involving animals may be conducted or supported by the PHS until the institution conducting the activity has provided a written Assurance acceptable to the PHS, which complies with PHS Policy. If an institution restricts its Assurance to those portions of its animal care program supported by PHS funds, then PHS authority extends only to those areas. Most institutions assure the PHS that their total animal care program is being conducted in accordance with PHS Policy. In that case, all of the institution's animal care program is open to PHS scrutiny and policy requirements. OPRR investigates complaints against an institution, usually starting with a letter of inquiry. If deemed necessary OPRR will assemble a team, including outside consultants who are experts in laboratory animal medicine, and conduct an on-site review of the institutional Assurance. The purpose of the visit is to determine whether the institution is following the policies outlined in its Assurance and whether all aspects of the animal care and use program are in conformance with the Guide. If noncompliance is found, the Institutional Official is appraised of these deficiencies and given a date by which the deficiencies must be fixed. If the deficiencies are severe enough, OPRR can withdraw approval of the Assurance, thereby leading to the suspension of the expenditure of PHS funds for all research at that institution until such time as the deficiencies are corrected.

The American Association for Accreditation of Laboratory Animal Care (AAALAC) is a non-regulatory, not-for-profit organization founded in 1965 whose mission is to promote high standards of animal care, use, and well-being and enhance life sciences research and education through the accreditation process. Participation in the accreditation program is voluntary and at the initiative of individual animal programs. The Council on Accreditation evaluates animal programs by conducting site visits and reviewing annual reports. AAALAC relies on the Guide as its primary standard for evaluating laboratory animal care and use programs. In addition, AAALAC uses published references for supplemental information about procedures or techniques related to the care and use of laboratory animals. AAALAC accreditation demonstrates that a program has achieved a standard of excellence beyond the minimums required by law and conforms with the scientific community's accepted ethical practices. AAALAC is currently the only accrediting body recognized by the PHS for activities involving animals.

APPLICABILITY

The responsible party under each law is the institutional official, and it is this person to whom all correspondence is addressed. The institution makes the principle investigator the responsible individual with oversight by the attending veterinarian and the institutional animal care and use committee (IACUC). It is possible that infractions by a single investigator, if not corrected by the institution, could result in sanctions against the institution because it shows a failure to properly administer its animal care and use program.

The Animal Welfare Act and the PHS Policy provide standards for such items as construction of animal facilities, review and approval of proposed animal use, veterinary care, standards for occupational health, handling of hazardous agents, and training of animal care personnel and research staff.

ADMINISTRATIVE METHODS AND THEIR COSTS

PHS Policy and the Animal Welfare Act are administered in broadly similar ways and will be discussed together. Both make an institutional official responsible for the animal care and use program. An IACUC is required by both. The Animal Welfare Act requires a Chairman and at least two additional members.

The PHS Policy requires a minimum of five members including at least

"(1) one Doctor of Veterinary Medicine, with training or experience in laboratory animal science and medicine, who has direct or delegated program responsibility for activities involving animals at the institution; (2) one practicing scientist experienced in research involving animals; (3) one member whose primary concerns are in a nonscientific area (for example, ethicist, lawyer, member of the clergy); and (4) one individual who is not affiliated with the institution in any way other than as a member of the IACUC, and is not a member of the immediate family of a person who is affiliated with the institution (PHS, 1986, p. 5).
Many institutions have 10 or more members on the IACUC. The IACUC is charged with performing a semiannual review of the institution's animal care and use program and of the facilities where the animals are housed, using the Guide (NRC, 1985) and the standards of the Animal Welfare Act as a basis for evaluation. Reports of these two reviews are sent to the institutional official with recommendations for programmatic improvements if necessary and, if identified, deficiencies requiring timely corrective action. The IACUC is also charged with the task of reviewing all concerns expressed by anyone about the care and use of animals at the facility. The most time-consuming task for most IACUCs is the prior review of all protocols designed to use animals in research, education, or testing. Finally, the IACUC is authorized to suspend an activity that is not being conducted in accordance with the approved protocol. Suspension of an activity or disapproval of an animal use protocol by the IACUC cannot be overturned by the institution.

In reviewing protocols, the committee is to ensure that research projects will be conducted in accordance with USDA regulations and the PHS Policy unless acceptable justification for a departure is approved. Further, the IACUC must determine that the project conforms with the institution's Assurance and meets the following requirements as set forth in PHS Policy:

"a. Procedures will avoid or minimize discomfort, distress, and pain to the animals, consistent with sound research design, b. Procedures that may cause more than momentary or slight pain or distress to the animals will be performed with appropriate sedation, analgesia, or anesthesia, unless the procedure is justified for scientific reasons in writing by the investigator, c. Animals that would otherwise experience severe or chromic pain or distress that cannot be relieved will be painlessly sacrificed at the end of the procedure or, if appropriate, during the procedure, d. The living conditions will be appropriate for their species and contribute to their health and comfort. The housing, feeding, and nonmedical care of the animals will 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, e. Medical care for animals will be available and provided as necessary by a qualified veterinarian, f. Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures, g. Methods of euthanasia used will be consistent with the recommendations of the American Veterinary Medical Association (AVMA) Panel on Euthanasia (AVMA, 1993) unless a deviation is justified for scientific reasons" (PHS, 1986, pp. 7-8).
Annual reports are sent to the USDA and the PHS although the information requested by both is different.

The cost of the administration of the committee (usually one and sometimes two or more staff) is usually borne by the administration using institutional funds, although in some organizations these administrative costs are collected through charges levied by the animal care facility. IACUC members usually serve without any additional compensation. Their salary is a cost that is provided by the individual's department.

STRENGTHS AND WEAKNESSES

One of the greatest strengths of the present system is that many of its rules and regulations are based on performance, as opposed to rigidly delineated "engineering" standards. Performance standards rely on the professional judgement of the institution's veterinary staff and IACUC to devise a suitable means for achieving specified goals, while engineering standards mandate detailed specifications that must be met. A weakness of the present system is that the two major sets of national regulations are not entirely uniform. For example, they differ in the species of animals covered. The Animal Welfare Act covers some species only when they are used in certain types of experiments and exempts the same species when they are used for other types of experiments. The requirements for cage sizes are also not consistent between the regulations. These and other differences have resulted in confusion when non-experts attempt to evaluate the extent of institutional compliance with regulations. An additional weakness is that the law requiring regulations was enacted without adequate provision for its fiscal impact on the research and instructional activities being regulated.

THE FUTURE

One possibility in the future is that new attempts will be made to mandate detailed engineering standards that are expensive to implement and will thwart efforts to employ local professional judgement. It would also erode a strength of the current regulations, which is that the regulations are goal-oriented (leaving much of the details of implementation up to the good judgement of professionals), rather than process-oriented regulations. Such efforts would divert funds from research and teaching with no substantial benefit and possibly causing great harm to animal welfare. Another likely possibility is that the current trend toward increased cooperation between regulating agencies will continue, with the result that a more uniform set of regulations will emerge over time.

The USDA has never had adequate funding to perform the inspections required by the regulations. That is a principal reason why they focus their inspections on species that were of concern when the regulations were enacted. Further decreases in the USDA budget, which at this time seem certain, will greatly decrease its ability to perform the required inspections. USDA will probably consider implementing user fees to pay for inspections in the future. Since funding for research is also decreasing from almost all sources, such fees would be difficult for most institutions to pay. Currently most facilities are inspected twice yearly by their IACUC, at least once a year by the USDA, and approximately one-third are accredited by AAALAC, which conducts on-site inspections at 3-year intervals. This is a very redundant inspection system that could be coordinated to reduce the number of inspections. Perhaps USDA could review IACUC and AAALAC reports and discontinue inspecting those facilities that are in compliance.

Currently some investigators are discontinuing animal-based research because it has become too expensive and, in some cases, too controversial. Undoubtedly in the future some institutions will begin to stop the use of animals for the same reasons. This will result in a diminished ability to make advances in biomedicine in this country.

REFERENCES

American Veterinary Medical Association (AVMA). 1993. Report of the AVMA Panel on Euthanasia. J. Am. Vet. Med. Assoc. 202:229-249.

Consortium for Developing a Guide for the Care and Use of Agricultural Animals in Research and Teaching. 1988. Guide for the Care and Use of Agricultural Animals in Research and Teaching. (Available at a cost of $5.00 each froth Association Headquarters, 309 West Clark Street, Champaign, IL 61820, Tel: 1-217-356-3182.)

National Association for Biomedical Research (NABR). 1991. State Laws Concerning the Use of Animals in Research. (Available from NABR, 818 Connecticut Avenue, Suite 303, Washington, D.C., 20006. Tel: 1-202-857-0540; Fax: 1-202-659-1902.)

National Research Council (NRC). 1985. Guide for the Care and Use of Laboratory Animals. Washington, D.C.: U.S. Department of Health and Human Services. NIH Pub. No. 86-23. (Available from Office for Protection from Research Risks National Institutes of Health, 6100 Executive Boulevard. MSC 7507, Rockville, MD 20892-7507. Tel: 301-496-7163)

Public Health Service (PHS). 1986. Public Health Service Policy on Humane Care and Use of Laboratory Animals. Washington, D.C.: U.S. Department of Health and Human Services. (Available from Office for Protection from Research Risks National Institutes of Health, 6100 Executive Boulevard, MSC 7507, Rockville, MD 20892-7507. Tel: 301-496-7163)