North America

Canada

There is no federal legislation pertaining to the use of animals in research, testing, or education in Canada. However, some provinces have established provincial laws, and there is a voluntary assessment program for the care and use of experimental animals. In addition, although there is no federal requirement to participate in the Canadian Council on Animal Care (CCAC) assessment program, some funding agencies require grantee institutions to comply with CCAC guidelines, and contractors performing work for the federal government are required to adhere to CCAC guidelines, as specified in the Public Works and Government Services Canada Standard Acquisition Clauses and Conditions Manual, Section 5, Subsection A, Clause A9015C: Experimental Animals. The CCAC, founded in 1968, places responsibility for humane animal care and use with the animal-care committee at each institution, which is granted specific authority and provided with terms of reference under which it operates (e.g., membership, authority, responsibilities, and functioning). The CCAC's mission is "to act in the interests of the people of Canada to ensure, through programs of education, assessment, and persuasion, that the use of animals, where necessary, for research, teaching, and testing employs optimal physical and psychological care according to acceptable scientific standards, and to promote an increased level of knowledge, awareness, and sensitivity to relevant ethical principles." Thus, the CCAC has two principal functions: the development of guidelines and policies to govern experimental animal care and use; and to monitor compliance with those guidelines and policies. The CCAC is an independent organization and receives funding from the Medical Research Council (MRC) and the Natural Sciences and Engineering Research Council (NSERC).

The CCAC establishes guidelines for its certified institutions to follow, currently contained in the two-volume Guide to the Care and Use of Experimental Animals. Adjunct guidelines address topics such as animal-use protocol review, transgenic animals, selecting appropriate endpoints, and developing an animal user-training program. The CCAC also has established several policies, the earliest of which addresses the ethics of animal research (1989). Other subjects covered by policies include review of scientific merit, social and behavioral requirements of experimental animals, acceptable immunological procedures, and categories of invasiveness.

On-site assessments using panels of experts from the animal care and use community and a representative nominated by the Canadian Federation of Humane Societies are conducted triennially. An institution is deemed to be in compliance if the CCAC report prepared by the assessment panel and approved by the assessment committee — a standing committee composed of at least four council members — contains only Regular, Minor, and/or Commendatory recommendations, and the institution submits an implementation report for any regular recommendations that are judged to be satisfactory. Institutions that have been found to be in Compliance or Conditional Compliance, will receive a CCAC Certificate of Good Animal Practice™.7 If the CCAC report contains major or serious recommendations whose corrections do not require verification by an on-site reassessment, but rather can be verified through documentation, and the institution provides to the CCAC an implementation report that is judged to be satisfactory, then compliance is maintained. Increasingly problematic status-determinations are conditional compliance, probation, and noncompliance. Recently, the MRC and NSERC revised the policy on compliance and noncompliance such that all funding agencies and government ministries and departments are notified of an institution's noncompliance with CCAC guidelines (2000).5 Sustained nonconformance with CCAC guidelines and policies can ultimately result in withdrawal of all animal-based research funding to the institution.

The United States

In the United States, oversight of animal care and use for research, testing, and teaching is achieved by numerous laws, regulations, policies, and guidelines from two principal governmental organizations — the United States Department of Agriculture (USDA) and the U.S. Public Health Service (PHS)*. Other guidance may be derived from scientific panels and endorsed by the government as required standards. Federal laws are annually compiled and categorized into their respective subjects (e.g., agriculture) and published as the United States Code (USC). The USC includes a discussion of the intent of Congress for establishing the law and any interpretations from the courts. Regulations are promulgated to enforce the corresponding law. Proposed regulations are published in the Federal Register for public comment. After the responsible agency reviews and addresses the public comments, the regulations are again published in the Federal Register in final format and then incorporated into the Code of Federal Regulations (e.g., 9 CFR).6,7 In general, laws address two specific areas: animal welfare and procurement, and animal importation and shipment.

U.S. Department of Agriculture

Federal laws for the humane treatment of animals have been in place since 1873, when Congress passed a law governing the treatment of livestock during shipment for export. The law was called the "28-Hour Law," after the maximum length of time animals could be transported before receiving food, water, and rest.8 This law was later repealed, and a new "28-Hour Law" was passed in 1906, which is still in effect today. However, the first federal law to protect non-farm animals was not passed until 1966 and was called the Laboratory Animal Welfare Act, administered by the Animal and Plant Health Inspection

* U.S. Congress, Office of Technology Assessment, 1986, Federal regulation of animal use, pp. 275-301, in Alternatives to Animal Use in Research, Testing, and Education, U.S. Government Printing Office: Washington, D.C.

U.S. Congress, Office of Technology Assessment, 1986, State regulation of animal use, pp. 305-331, in Alternatives to Animal Use in Research, Testing, and Education, U.S. Government Printing Office: Washington, D.C.

Service (APHIS), US DA. At the time, this law was primarily directed at dog and cat dealers, as it required that individuals or corporations that bought or sold dogs or cats for laboratory activities be licensed and adhere to certain minimum standards for the care of animals, and that users of cats or dogs for research register with the USDA and also meet minimum standards for animal care. For animal users, the law applied only to animals held prior to or after the laboratory activity. Interestingly, the New York Anticruelty Bill of 1866 addressed the use of animals in research and predated federal interest in this subject.9

The Laboratory Animal Welfare Act of 1966 was amended in 1970, 1976, 1985, and 1990 to broaden coverage of the law. Public Law 91-579, the Animal Welfare Act of 1970, increased the species of animals covered under the law to include all warm-blooded animals and increased the scope of applicability of the law to include the time animals were held in the facility. Specifically exempted were horses not used in research and agricultural animals used in food and fiber research, retail pet stores, state and county fairs, rodeos, purebred cat and dog shows, and agricultural exhibitions. Public Law 94-279, the Animal Welfare Act Amendments of 1976, included common commercial carriers, such as airlines, under the law, which subsequently led to the development of standards for shipping containers and conditions of shipment. Public Law 99-198, the Improved Standards for Laboratory Animals Act, added several new provisions to the law, including: minimization of animal pain and distress; consideration of alternatives to painful procedures; consultation with a doctor of veterinary medicine for any practice that could cause pain to animals; limitation on conducting more than one major survival surgery on an animal; establishment of an Institutional Animal Care and Use Committee (IACUC) to provide oversight of the animal care and use program and facilities; provision of specific training to personnel; provision of exercise to dogs; and a stipulation to promote the psychological well-being of nonhuman primates. The most recent amendment to the Animal Welfare Act, Public Law 101-624, Food, Agriculture, Conservation, and Trade Act of 1990, Section 2503, Protection of Pets, established a holding period for dogs and cats at shelters and other holding facilities prior to sale to dealers. The law also requires dealers to provide written certification to the recipient regarding the background of each animal.

Of increasing debate has been the exclusion of rats and mice from the Animal Welfare Act. The 1970 amendment to the Animal Welfare Act stated that an animal was defined as: "Any live or dead dog, cat, monkey (nonhuman primate animal), guinea pig, hamster, rabbit, or other such warm-blooded animal as the Secretary may determine is used, or is intended for use, for research, testing, experimentation, or exhibition purposes, or as a pet." In this way, the Secretary of the Department of Agriculture was given the authority to determine which animals would be covered by the Act. In 1977, the USDA promulgated regulations that specifically excluded rats, mice, and birds from the definition of "animal." To date, rats (Rattus rattus), mice (Mus sp.), and birds remain excluded from coverage of the Act.

Since the 1966 Act, Congress has vested the USDA with both promulgation and enforcement authority. The USDA is required to conduct unannounced annual inspections of research facilities, with follow-up inspections until any cited deficiency has been corrected. Exempt from this provision are federal research facilities. Research, intermediate handlers, and common carriers are required to register with the USDA, while animal dealers and exhibitors must be licensed. Research facilities and U.S. government agencies are required to purchase animals only from licensed sources, unless the source is exempted from obtaining a license. Failure to comply with regulatory requirements, despite formal notification of the violation and an opportunity to effect a correction, can result in fines levied on the facility, suspension of authority to operate, and even permanent revocation of the facility's license to operate. Penalties can be imposed on the facility such that some portion of the fine is mandated to be spent on the operation of the facility (e.g., physical plant repairs) to improve the program of animal care and use. Thus, the enforcement arm of the USDA's oversight responsibility is strong, and has been used over the years to improve animal welfare at dealers, exhibits, and research facilities.

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