Animal Research: III. Law and Policy
III. LAW AND POLICY
This entry describes the laws and policies of the United States governing the care and use of animals in research, education, and testing; the history of these policies and laws since 1966; the issues addressed by these laws; and the lawsuits that have followed publication of regulations implementing these laws. Two federal laws govern the use of animals: the Health Research Extension Act of 1985 and the Animal Welfare Act, as amended. While all states have laws governing the care of animals, research usage is often exempted. Twenty states have simple facility licensure, and a few have only very general regulations governing research usage of animals. In reality, nearly all states defer to federal law in this area. A National Institutes of Health (NIH) document, Public Health Service Policy on Humane Care and Use of Laboratory Animals, which was revised in 2002, implements the Health Research Extension Act for all activities involving animals conducted or supported by the Public Health Service (PHS),while regulations implementing the Animal Welfare Act are in the Code of Federal Regulations, Title 9, Chapter 1, Subchapter A, Parts 1, 2, and 3 (known as animal welfare regulations). The PHS includes twelve health agencies within the U.S. Department of Health and Human Services (DHHS).
History of Public Health Service Policy
Regulations have been promulgated by the PHS since 1935, originally through one of its constituents, the National Institutes of Health (Whitney). NIH guidelines have provided direction and recommendations for caring for and using laboratory animals at NIH. Subsequently, a committee of laboratory scientists assembled by the Institute of Laboratory Animal Resources of the National Research Council (NRC) wrote the Guide for the Care and Use of Laboratory Animals (NRC guide). First published in 1963 and updated many times since, this work has become the standard guide in the field. The first policy based upon the 1963 NRC guide came from NIH in 1971. The PHS published its first policy on animal care in 1973, with revisions in 1973, 1979, 1986, 1996, and 2002. Each successive revision increased the specificity and level of responsibility of animal-care committees in the supervision of animal use.
At the outset of NIH policymaking in animal care and use in 1971, all institutions and organizations using warm-blooded animals for the purpose of research or other projects supported by NIH were required to give assurances that facilities for animals met "acceptable standards for the care, use, and treatment of such animals." This assurance could be met either by gaining accreditation through a professional laboratory-accrediting body (such as the Association for Assessment and Accreditation of Laboratory Animal Care International [AAALAC]) or by establishing a committee to evaluate the care and housing of animals used for NIH-sponsored activities. Institutions were also obligated to follow pertinent sections of the animal welfare regulations. In 1973, the NIH policy was replaced by the first of the PHS policies. Like the NIH policy preceding it, the first PHS policy required institutions either to be fully accredited or to have a standing institutional committee with a minimum of three members, including a veterinarian for those institutions using a "significant" number of animals. These committees were required to conduct periodic facility inspections, with the review of applications and proposals involving the use of animals considered optional.
The 1979 revision to the PHS policy required all institutions using animals, regardless of numbers used and accreditation status, to have a standing committee whose responsibility was oversight of the institution's animal-care program. In addition to the establishment of a committee of at least five members, including one veterinarian, the institution was obligated to establish a mechanism to review its facilities for warm-blooded animals for adherence to the principles contained in the NRC guide. The PHS policy recommended that AAALAC accreditation was the best means of satisfying this obligation, although periodic committee review of facilities and animals' care would suffice. Absent from the 1979 PHS policy was the requirement for review of individual proposals or projects, although review was encouraged. In 1986, however, the PHS policy was revised again, this time requiring the animal-care committees of institutions to take responsibility for specific organizational and supervisory duties in an effort to strengthen the system of institutional assurance.
History of Animal Welfare Regulations
A 1966 Life magazine feature titled "Concentration Camps for Dogs," along with other works published around this time, dramatized poor care and treatment of animals by some dealers who sold animals for biomedical research. This disclosure and the ensuing public outcry resulted in the introduction of twenty-nine bills in the U.S. Congress relating to the regulation of animal research. The bill that eventually became law was the Laboratory Animal Welfare Act of 1966 (LAWA; in 1970, after passage of the first amendments, the name was shortened to the Animal Welfare Act, or AWA). This act was limited to regulation of the sale and transportation of animals by dealers and the holding of animals by certain research facilities. Although the bill was passed, it was a compromise between far-reaching legislation and none at all; it did not apply to actual research usage of animals. The regulations implementing the LAWA specified that the housing facility provide shelter and protection from temperature extremes, that food and water be provided at least daily, and that cages be of a certain size and cleaned daily. These regulations also specified cage sizes and frequency of feeding and watering during transportation. Passage of amendments in 1970, 1976, 1985, and 1990 and of a law calling for the PHS policy extended federal regulations into areas covering the appropriate use and humane treatment of laboratory animals. The 1966 law regulated dogs, cats, hamsters, guinea pigs, rabbits and nonhuman primates. The 1970 amendment broadened it to include all warm-blooded animals, but regulations excluded birds, rats, and mice.
The 1970 amendments broadened the U.S. Department of Agriculture's (USDA) administrative responsibility to cover animal care throughout an animal's stay in research facilities, including the period during which research was being conducted. The 1976 amendments brought transportation carriers under the purview of the act, leading to more stringent standards for shipment of animals. The 1985 version of the AWA invested the USDA with responsibility for issuing and enforcing regulations regarding humane care, handling, and treatment of animals. Animals covered under the AWA include warm-blooded animals—such as dogs, cats, monkeys, guinea pigs, hamsters, rabbits, marine mammals, and normally wild animals—being used for research, testing, experimentation, exhibition purposes, or as a pet. Excluded from coverage are birds, rats, mice, and horses and other farm animals intended for use as food or fiber, or for use in improving animal nutrition, breeding, or management. The 1990 changes to the act added college-student work with animals to the list of areas over which a research institution has oversight responsibility.
Public Health Service Policy
PHS policy requires that each awardee institution provide a written assurance setting forth how that institution will comply with regulations. This assurance then forms the basis for the care and use of animals in research, education, and testing at that institution and is the basis for judging the adequacy of the institution's compliance with the policy. PHS policy calls for the establishment of a program for animal care and use, using the NRC guide as a basis for developing the program. Also required is the creation of an institutional animal care and use committee (IACUC), appointed by the chief executive officer of the institution. This committee must have at least five members, including at least one veterinarian experienced in laboratory animal science, one scientist, one layperson, and one person unaffiliated with the institution. PHS policy then charges this committee with oversight responsibility for: semiannual review of the program of animal care and use; semiannual inspection of facilities; review of research protocols, or proposals for the use of animals; investigation of all concerns raised by anyone regarding the humane use of animals at the institution; recommendations for personnel training; and suspension of activities deemed improper.
An institution's program for the care and use of laboratory animals encompasses institutional policies, laboratory-animal husbandry procedures, and veterinary care practices. Institutional policies address such personnel provisions as veterinary qualifications, procedures for safely handling hazardous agents, occupational health and personal hygiene including appropriate clothing and practices, and the prohibition of smoking and eating in animal rooms; special considerations are also addressed through policies, such as those concerning prolonged physical restraint of animals and multiple surgeries on a single animal. Laboratory-animal husbandry procedures include housing systems (size of cages and provision for social interaction among animals where appropriate); temperature, humidity, ventilation, lighting control, and cage and room sanitation schedules; and methods of animal identification and of clinical record keeping. Veterinary care practices include preventive-medicine strategies; methods for detecting and treating diseases; giving investigators advice about appropriate anesthesia, analgesia, and surgical and postoperative care; and methods of euthanasia.
Facility inspection covers not only visiting the physical plant but also assessing the health of the animals and reviewing portions of the institutional program for animal care. The physical plant should be properly constructed to house the species being used and to permit sterile surgery to be performed, if necessary.
PHS policy sets forth several criteria to be followed by the IACUC in reviewing protocols. These criteria go beyond mere care and housing guidelines. The care and use of animals in proposed research must be consistent with the NRC guide, unless acceptable scientific justification is provided for any deviation. The investigator must explain the rationale for using animals at all in the proposed research as well as the appropriateness of the species to be used, the number of animals, and their proposed use. PHS policy stipulates requirements for the use of sedatives, analgesics, and anesthetics if the proposed procedure might cause more than slight pain or distress; it also requires prompt euthanasia at the end of (or, when appropriate, during) a procedure for "animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved" and imposes methods of euthanasia consistent with American Veterinary Medical Association (AVMA) guidelines. All personnel involved in the use of animals in research must be appropriately trained and qualified in the procedures to be employed in the experiment.
Each IACUC must have procedures for investigating concerns raised about the care and use of animals at the institution. In addition, the IACUC must ensure that the institution has a training program for both animal-care staff (people actually caring for the animals) and research staff; videotapes and training handbooks may be used to satisfy this requirement. The final charge—the power to suspend an improperly conducted activity—must come from an official of the institution such as the chief executive officer or the vice president. Without this official support, the IACUC cannot fulfill its duty to ensure compliance with PHS policy.
Several features of PHS policy are of special importance. While its legal force is restricted to awardee institutions, its scope includes all live vertebrates. It was the first U.S. law to call for a consideration of animal welfare during a procedure and to call for the establishment of a committee to review protocols for the appropriateness of design, the importance of knowledge sought (as set forth in the "U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training," published in both the PHS policy and the NRC guide), and the competency of personnel. Thus, through PHS policy, committees have been created to review the use of animals in research, much like the committees that review the participation of humans in research.
Animal Welfare Regulations
Animal welfare regulations (AWRs) pertaining to the care and use of laboratory animals were extensively modified and rewritten following the 1985 amendments of the Animal Welfare Act to include provisions for an IACUC, for protocol review, and for more social interaction among the same species and between animals and their caretakers. These regulations are similar to PHS policy provisions because the secretary of the USDA was directed to consult with the secretary of the DHHS concerning the writing of regulations. In the AWRs, an IACUC committee with only slight differences from PHS policy is required (e.g., three members instead of five as a minimum, including an unaffiliated member and a veterinarian). The duties of the committee are very similar to the duties specified by PHS policy; instructions for reviewing protocols, however, are more detailed than those included in PHS policy. The AWRs require the investigator to search for alternatives to any procedure that may cause more than slight pain or distress and to assure that the proposed activity does not unnecessarily duplicate previous work. Several aspects of a personnel-training program are specified. In contrast to PHS policy, which requires institutions to develop an animal care and use program based upon the NRC guide, the AWRs have an extensive set of standards specifying the humane handling, care, treatment, and transport of various species of animals. The standards section of the regulations detail facility and operating standards, animal health and husbandry standards, and transportation standards for each regulated species. In addition, detailed specifications are given for marking dogs, cats, and other animals for the purpose of identification. In most, but not all, cases, the standards of the AWRs are the same as those of the PHS policy and, thus, are similar to the guidelines given in the NRC guide.
The AWA calls for the USDA to issue regulations in several areas. These regulations, which have engendered considerable public debate as well as the filing of a lawsuit, require exercise of dogs and the provision of a physical environment adequate to promote the psychological wellbeing of nonhuman primates. After considerable debate, the final regulations combined performance-based standards (standards that specify the desired outcome and leave the details of achieving that outcome to the regulated party) with design or engineering standards (standards that specify in measurable and objective terms how a particular outcome is to be achieved). It is the choice of performance-based standards that is especially controversial because plaintiffs in a lawsuit (see "Lawsuits" section below) alleged that they allow too much latitude for compliance by the regulated parties. It is generally true, however, that humane care and use of animals can be achieved under a variety of circumstances, making it difficult to use detailed engineering standards or specifications. For example, the regulations call for dry floors for most mammals. This can be accomplished by mopping the floor until dry, by wet-vacuuming the floor, by sloping the floor and letting water run off before placing an animal on the surface, and so on. Thus, there are a number of ways of achieving the desired goal, and it is the outcome itself that is specified rather than the steps needed to reach it. Critics of performance standards state that the goal often is not well described, leaving too much discretion to the regulated parties.
Another controversial aspect of the AWRs is that the regulatory definition of animal excludes birds, rats, and mice that have been bred for use in research; hence, these animals are not protected under the AWRs. The exclusion is a major one because more than 85 percent of animals used in research, education, and testing are rats, mice, and birds. The reason for the exclusion is to limit the scope and cost of annual USDA inspections; there are barely enough inspectors to review facilities and procedures involving larger vertebrate animals, whose use is thought to require more sensitivity and therefore more intense scrutiny. Adding rats, mice, and birds to the mandatory inspection list would exceed the capacity of the USDA, both because of the increased numbers of animals to be inspected and because there would be an increase in the number of registered research facilities requiring inspection. (A number of institutions use only rats and/or mice and therefore are not subject to inspection.) Because PHS policy defines animal as any vertebrate (with no exclusions), rats, mice, and birds are covered by PHS policy. In institutions not covered by PHS policy (e.g., industry and colleges not receiving PHS funds), the use of rats and mice remains largely unregulated, a glaring oversight unique to the United States (Orlans, 2000).
Protocol Review: Consideration of Pain and Distress and Numbers of Animals Used
Because both PHS policy and the AWRs explicitly require minimization of pain and distress of animals during research, there have been examinations of the implications and possible effectiveness of the IACUC consideration of these issues during protocol review (Dresser; Brody). Both regulations attempt to incorporate cost–benefit considerations, utilitarian theory, and some elements of a modified rightsbased philosophy (Dresser). The success of PHS policy and the AWRs depends fundamentally upon the recognition that animals can experience pain and distress that can be alleviated (NRC, 1992). The USDA requires an annual report from all registered institutions that lists the numbers of animals used in research and testing, classified by the degree of pain and distress: (1) minimal, transient, or no pain or distress; (2) pain and distress relieved by anesthetics, analgesics, or tranquilizers; and (3) pain and distress not treated. A detailed statement on category 3 procedures is required, including scientific justification for withholding drugs. Another classification scheme, developed by the Scientists Center for Animal Welfare, lists six categories instead of three (Orlans, 1987). Many IACUCs use some classification scheme for pain and distress, reducing the number of animals used in research that fall into the higher categories of pain and distress by applying the "three Rs" (replacement, reduction, and refinement) of William M. S. Russell and Rex L. Burch, authors of a book first published in 1959 called The Principles of Humane Experimental Technique.
Some observers feel that IACUC review does not adequately reduce the number of animals used in research or the pain and distress of these animals. In a 1989 article, Mimi Brody suggested new legislation that would implement two oversight levels—first, a local committee; second, a national committee—to review uses of animals with "high ethical cost." Gary L. Francione argued in a 1990 article that open IACUC meetings, publicly announced and attended by interested members of the community, would improve the quality of protocol review. The two-committee approach has the disadvantage of delaying approval of certain types of research and has the potential for becoming excessively bureaucratic. The open-meetings approach presumes that the general public could comprehend the scientific details of the described procedures and would be able to judge the ethical and social justifications for the proposed procedure.
Lawsuits Concerning the Animal Welfare Regulations
As mentioned earlier, the definition of animals in the AWRs excludes birds, rats, and mice specifically bred for use in research. After parts 1 and 2 of the AWRs became final in 1989, the Animal Legal Defense Fund (ALDF) and the Humane Society of the United States (HSUS) filed a rule-making petition with the USDA to amend the regulations to include rats, mice, and birds in the definition of animals. After the USDA denied the petition in 1990, the ALDF and the HSUS brought suit in federal court, seeking a declaratory judgment and an injunction preventing the USDA from excluding coverage of rats, mice, and birds. In 1992 the ALDF and the HSUS were granted summary judgment, and the USDA was ordered to reconsider its denial of plaintiffs' petition in light of the court's opinion holding the exclusion of rats, mice, and birds to be arbitrary and capricious (Animal Legal Defense Fund v. Madigan, 1992). The USDA appealed, and on May 20, 1994, the court of appeals vacated the district court's decision and directed the lower court to dismiss, holding that none of the petitioners had demonstrated both constitutional standing to sue and a statutory right to judicial review under the Administrative Procedure Act—leaving regulations, and presumably practice, to stand unchanged (Animal Legal Defense Fund v. Espy, 1994). In 1998, however, the Alternatives Research and Development Foundation filed a new suit to force the inclusion of rats, mice, and birds under AWA. The USDA settled the case (Alternatives Research and Development Foundation v. Glickman) in 2000, agreeing to inclusions. But the Farm Security and Rural Investment Act of 2002 blocked the settlement. This amendment permanently denied rats, mice, and birds legal protection under AWA.
The USDA regulations concerning requirements for exercise of dogs and for a physical environment adequate to promote the psychological well-being of nonhuman primates were published in February 1991. The ALDF and others sued, alleging that these regulations did not comply with the 1985 amendments of the AWA because they did not provide minimum standards for exercise of dogs and for adequate cage size and environmental enrichment for nonhuman primates as required by Congress. The district court granted plaintiffs' motion for summary judgment in February 1993 (Animal Legal Defense Fund v. Secretary of Agriculture, 1993). It was unclear at the time of this decision whether the federal government would appeal the decision, so the National Association for Biomedical Research (NABR) moved to intervene in the case to ensure an appeal. Although the NABR motion was originally denied, the denial was reversed by the court of appeals. The federal government subsequently decided to pursue an appeal, and the consolidated appeal was argued in May 1994. Two months later, the court of appeals vacated the district court's decision and directed the lower court to dismiss, concluding that the ALDF and the other appellees lacked standing to challenge USDA regulations (for the same reasons cited in the ALDF/HSUS case), again leaving policy unchanged.
Federal laws and policies regarding the use of animals in research, education, and testing have progressed rapidly from the first enunciation of principles for the care of laboratory animals in the early days of NIH and the first animal welfare laws passed in 1966. Early policy had limited effects on the use of animals because of the generally careful practice standards already in place as well as the lack of enforcement of the new policy. Several U.S. programs and institutions had their funding suspended in the early 1980s, with increased USDA inspections and subsequent violations at numerous institutions in the years that followed, all of which serve as a warning that all animal-care policies must be followed (Rozmiarek). The evolution of policies for animal care and use shows a trend toward increased responsibility for and supervision by IACUCs, with greater emphasis on the level of assurances institutions must give, on IACUC membership, on the process of protocol review, and on the committee's power in matters involving activities using animals. This has resulted in more scrutiny of the care and use of animals in scientific research. The regulations in effect are comprehensive and, if followed, result in excellent care for animals. The penalties for not adhering to the regulations are great enough to encourage compliance and will assure that the privilege of using animals in research is carried out in a humane and careful manner.
ralph dell (1995)
revised by jeffrey kahn
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