REGULATION OF ANIMAL RESEARCH

UNITED STATES

While proper care of animals used in research has been an on going priority for the majority of the scientific community, there have been some instances of mistreatment of animals in research laboratories. As a consequence of these occurrences, as well as pressure from animal protection groups and the public, Congress enacted laws to regulate the care and use of laboratory animals. Currently there are several layers of oversight of animal research, which are outlined below.

ANIMAL WELFARE ACT

The first federal law regulating animal research was the Laboratory Animal Welfare Act passed by Congress in 1966. This law covered the transport, sale, and handling of animals and provided for licensing of animal dealers to prevent pet theft and their sale to research facilities. The original act covered dogs, cats, nonhuman primates, guinea pigs, hamsters, and rabbits. This act was passed with the help of the Animal Welfare Institute, an activist group led by Christine Stevens, which advocated more humane animal practices in laboratories. The passage of the Laboratory Animal Welfare Act was also fueled by public outrage over an exposé in Life magazine that graphically documented the practice of pet theft for sale to research facilities.

The Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) enforces this act by inspecting laboratories and monitoring compliance with the act. The act, now known as the Animal



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Science, Medicine, and Animals REGULATION OF ANIMAL RESEARCH UNITED STATES While proper care of animals used in research has been an on going priority for the majority of the scientific community, there have been some instances of mistreatment of animals in research laboratories. As a consequence of these occurrences, as well as pressure from animal protection groups and the public, Congress enacted laws to regulate the care and use of laboratory animals. Currently there are several layers of oversight of animal research, which are outlined below. ANIMAL WELFARE ACT The first federal law regulating animal research was the Laboratory Animal Welfare Act passed by Congress in 1966. This law covered the transport, sale, and handling of animals and provided for licensing of animal dealers to prevent pet theft and their sale to research facilities. The original act covered dogs, cats, nonhuman primates, guinea pigs, hamsters, and rabbits. This act was passed with the help of the Animal Welfare Institute, an activist group led by Christine Stevens, which advocated more humane animal practices in laboratories. The passage of the Laboratory Animal Welfare Act was also fueled by public outrage over an exposé in Life magazine that graphically documented the practice of pet theft for sale to research facilities. The Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) enforces this act by inspecting laboratories and monitoring compliance with the act. The act, now known as the Animal

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Science, Medicine, and Animals Welfare Act (AWA), has been amended four times (1970, 1976, 1985, and 1991), each time elevating the standard of animal care. The amendment of 1985 was the most extensive and had two very significant results. First, an Animal Welfare Information Center (www.nal.usda.gov/awic) was established to provide researchers with a database of alternatives to painful animal experiments. Second, each research facility in the United States using protected species must register with the USDA and establish an Institutional Animal Care and Use Committee (IACUC) to review all experimental protocols involving live, warm-blooded animals. Similar committees had already existed to monitor clinical trials. The 1985 amendment to the AWA now extended the same careful review to research on animals. A quirk of the AWA, however, is the fact that it does not cover the most common species of laboratory animals, namely rats, mice, and birds. In passing the AWA, Congress left the definition of “animal” (that is, which species would be protected by the AWA) to the discretion of the Secretary of Agriculture, who opted not to include these species, primarily because the USDA has not had the resources to inspect all of these facilities. Despite numerous efforts by the animal protection community to change the AWA to include rats, mice, and birds, an amendment was recently passed by Congress to permanently exclude rats, mice, and birds used in research from coverage by the Animal Welfare Act. It should be noted, however, that these species are protected under Public Health Service Policy, though this oversight applies only to those research facilities that receive federal funding. There are institutions, for example some private companies and small teaching colleges, which only use rats, mice, and birds that are not subject to the AWA or Public Health Service Policy.

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Science, Medicine, and Animals THE PUBLIC HEALTH SERVICE POLICY ON HUMANE CARE AND USE OF LABORATORY ANIMALS (PHS POLICY) Another federal standard that guides the care and use of laboratory animals is the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy). PHS Policy is based on the Health Research Extension Act passed by Congress in 1985. This law applies to any research facility that receives PHS funds, which includes most universities and colleges that perform animal research. Scientists must comply with guidelines set forth in the Guide for the Care and Use of Laboratory Animals (the Guide, see below). Each research facility must maintain an IACUC and report whether they have AAALAC International accreditation (see below). While PHS Policy applies only to PHS-funded research, it is broader than the Animal Welfare Act in that all vertebrate animals (including fish and reptiles) are covered. INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC) An IACUC is established at each institution to review all proposed animal experiments. Each animal protocol must include: (1) a justification for using animals, the number of animals to be used, and the species chosen, (2) the procedures or drugs to be used to eliminate or minimize pain and discomfort, (3) a description of the methods and sources used to search for alternatives to painful procedures, and (4) a description of the search used to ensure that the experiment does not unnecessarily duplicate previous research. An IACUC typically has at least five members, one of whom must be a Doctor of Veterinary Medicine responsible for animal care at the institution. The committee must also include at least one scientist experienced in animal research, a professional whose primary concerns are not scientific (for example, an ethicist, clergyperson, or lawyer) and a member who is not affiliated with the institution in any

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Science, Medicine, and Animals way and who is meant to represent the interests of the community at large. The IACUC also inspects animal facilities twice a year to ensure that the institution is in compliance with federal regulatory policy. The Applied Research Ethics National Association (ARENA), in collaboration with the Office for Laboratory Animal Welfare at NIH, publishes guidelines to help institutions organize and support IACUCs and to help IACUCs provide effective oversight of the welfare of animals at their institution. ARENA’s sister organization, Public Responsibility in Medicine and Research (PRIM&R), holds yearly meetings for IACUC members and regularly holds training programs for new IACUC members. STATE AND LOCAL REGULATION Individual states may regulate the care and use of animals for research even further. Massachusetts, for example, has its own laws governing the care of research animals, and the Massachusetts Department of Public Health licenses and inspects animal research facilities that house dogs or cats. Many municipalities also have laws and regulations that establish more local control over animal research occurring in their jurisdiction. ASSOCIATION FOR ASSESSMENT AND ACCREDITATION OF LABORATORY ANIMAL CARE INTERNATIONAL (AAALAC INTERNATIONAL) The Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International) is a nonprofit organization founded in 1965 to promote uniform standards of animal care in U.S. laboratories. AAALAC International monitors animal care within the United States and accredits research institutions on a voluntary basis by evaluating laboratories every 3 years to ensure scientists comply with the guidelines set forth in the Guide. AAALAC International is also now accrediting research and testing programs throughout the world.

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Science, Medicine, and Animals THE GUIDE FOR THE CARE AND USE OF LABORATORY ANIMALS (THE GUIDE) The Guide, published by the National Research Council and the Institute for Laboratory Animal Research, is not only the basis for AAALAC International accreditation (mentioned previously) but is also a central part of Public Health Service Policy on the humane care and use of laboratory animals. The Guide’s recommendations are enforceable based on the Health Research Extension Act passed by Congress in 1985. The Guide has been updated six times. Noncompliance with the policies of the Guide results in loss of AAALAC International accreditation and is viewed as a serious matter that jeopardizes an institution’s funding by the NIH. Table 1: Summary of Laboratory Animal Oversight Regulation/ Regulatory or Oversight Body Main Points Animal Welfare Act Protects all warm-blooded animals except rats, mice, and birds bred for research. This includes zoos, circuses, research labs, hospitals, businesses, federal agencies, dealers, breeders, etc. Each research institution that uses a covered species must have an IACUC review all animal experiment protocols. The USDA licenses research facilities and conducts annual, unannounced inspections. Violations are punished with fines, cease-and-desist orders, and license suspension or revocation. PHS Policy Protects all vertebrate animals (including fish, reptiles, rats, mice, and birds) used in research funded by the Public Health Service. Each research facility provides a written plan for complying with PHS Policy and the Guide.

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Science, Medicine, and Animals PHS Policy Each research institution that receives PHS funding must have the IACUC review all animal experimental protocols and inspect the facilities. No routine, unannounced inspections, but all allegations of misuse are investigated by NIH’s Office of Laboratory Animal Welfare. Violations or loss of AAALAC accreditation can result in loss of PHS funding. IACUC A committee, organized at every research facility subject to the AWA, PHS Policy, or AAALAC accreditation, which must review and approve or deny every proposed animal protocol. Each animal protocol must include: A justification for using animals, the number of animals to be used, and the species chosen The procedures or drugs to be used to eliminate or minimize pain and discomfort A description of the methods and sources used to search for alternative to painful procedures A description of the search used to ensure that the experiment does not unnecessarily duplicate previous research Members must include: a veterinarian, a professional not involved in research (ethicist, lawyer, etc.), and a community representative (clergy, teacher, etc.). IACUC members must inspect their research facility twice a year. AAALAC International Nonprofit organization that accredits research facilities for compliance with the Guide. Accreditation is on a voluntary basis only. Announced site visits are conducted every 3 years.

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Science, Medicine, and Animals EUROPEAN UNION Prior to 1986, legislation regulating the protection of animals used in research varied among nations comprising the European Union. In 1986, the Council of the European Communities issued Council Directive 86/609/EEC. The purpose of this directive was to eliminate the disparities in laboratory animal protection laws among member nations. The directive outlines principles such as reduction in the number of animals used in research; guidelines for the adequate care of animals; elimination of unnecessary pain, suffering, distress or lasting harm; and avoidance of unnecessary duplication of experiments. While the provisions of the directive are specific, it is left to each member nation to determine how these provisions will be enacted and enforced. The directive also provided that each nation must comply with the directive by 1989 and that every 3 years each member nation must submit a report on the number of animals used in research. UNITED KINGDOM The major piece of legislation that regulates the use of animals in research in the United Kingdom is the Animals (Scientific Procedures) Act 1986. This act (also known as ASPA) provides for the licensing of experimental and other scientific procedures carried out on any vertebrate animal that may cause pain, suffering, distress, or lasting harm. This act covers all scientific procedures on any vertebrate animal from a simple blood draw to major surgery. While this act was passed in 1986, it continues to be amended to keep pace with changing attitudes and knowledge regarding animal care and use. In 1998, it was amended to more closely conform to Council Directive 86/609/EEC.

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Science, Medicine, and Animals 3Rs—Principle of reducing the number of animals used in research, refining scientific procedures to minimize pain, and replacing animal experiments with in vitro models when possible. The ASPA regulates through licensing projects and individuals. Project licenses are issued to those responsible for directing research programs and personal licenses are issued to individuals performing specific scientific procedures such as giving an injection or taking a blood sample. These licenses are reviewed and/or renewed every 5 years. The Animals Inspectorate is responsible for assessing applications for licenses and for inspecting work in progress to ensure compliance with ASPA, and each project must undergo an in-house ethical review process that usually involves a committee much like an IACUC. The issuance of a project license is dependent on several factors including adherence to the 3Rs (see 3Rs section), justification of cost and benefit, and training and experience. When the justification of the project is considered, several issues are further examined, such as the number of animals used, the specific product or knowledge that will be gained, and the severity of the procedures involved. Personal licenses depend mostly on sponsorship, that is, having a recognized authority vouch for an applicant’s qualifications, training, experience, competence, and character. The personal license also dictates the individual’s level of supervision and outlines the specific guidelines on the use of anesthetics, drugs, animal husbandry, and so forth that must be followed.