Session 1
Current Status: Identifying the Issues



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The Development of Science-Based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop Session 1 Current Status: Identifying the Issues

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The Development of Science-Based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop AAALAC International Perspective John G. Miller The Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International is a not-for-profit corporation established in 1965 as the American Association for Accreditation of Laboratory Animal Care. From its inception, AAALAC has had sound science as a principal focus. A 1964 report of AAALAC’s predecessor, the Animal Care Panel, included the following statements: “As part of the scientific community, the Animal Care Panel has been working to define the conditions of animal care which promote sound and proper animal experimentation. … The Animal Care Panel cannot and will not proceed with this program [accreditation] without the consent and support of the scientific community.” AAALAC’s current mission statement continues this emphasis on science, stating that the organization’s purpose is to “enhance the quality of research, teaching and testing by promoting humane, responsible animal care and use.” It is most appropriate that ILAR host this meeting, because the animal care and use standard most widely known in the global laboratory animal science community is ILAR’s Guide for the Care and Use of Laboratory Animals (Guide). AAALAC is proud to have developed the first edition of the Guide, under a 1962 contract from the National Institutes of Health (NIH). Serving as the principal standard used by both AAALAC and the US Public Health Service (PHS) in evaluating animal care and use, each of the seven editions of the Guide has been developed by scientists, with its guidance based on “published data, scientific principles, expert opinion

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The Development of Science-Based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop and experience with methods and practices that have proved to be consistent with high-quality, humane animal care and use.” This hierarchy of scientific support for its recommendations, from peer-reviewed data to experiential evidence, has been a hallmark of the Guide and has undoubtedly contributed to its widespread acceptance by the laboratory animal and more general scientific communities. Its utility as an international standard is demonstrated by the fact that the English version has been translated into nine additional languages. As noted above, the Guide is the principal standard used by both AAALAC and the PHS, with both applying its provisions to all vertebrate animals. When one considers the number of animals being used at academic and other institutions that receive support from the NIH and other PHS agencies, and the fact that all major US pharmaceutical companies and commercial suppliers of animals are accredited by AAALAC, it is reasonable to estimate that 90% or more of the research animals in the United States are cared for and used in programs that apply the standards of the Guide. This percentage is likely higher for laboratory mice and rats, and refutes the claims of those who state that because the US Department of Agriculture’s (USDA’s) Animal and Plant Health Inspection Service does not “regulate” mice and rats, these species are not “protected” in the United States. For nearly the first 15+ years of its existence, AAALAC accredited animal care and use programs only in the United States. Its first accredited program outside the United States was just across the border in Canada, but in 1986 Europe was included with the addition of a program in the United Kingdom. In 1996, the AAALAC Board of Trustees approved a new Strategic Plan that called for significantly increased emphasis on accreditation of programs internationally. Following the directions of that plan has led to remarkable success, with accredited programs currently in 18 countries on five continents. A new AAALAC service, begun in 1997 and called the Program Status Evaluation, has taken AAALAC representatives to additional countries, where institutions are striving to understand the accreditation process and bring their programs up to the AAALAC Standard. Through this international growth, AAALAC has had the opportunity to observe and evaluate programs from the Netherlands to the Philippines, and from Indiana to India. This experience has placed all of us involved with AAALAC, including the Executive Office staff, Council on Accreditation, and ad hoc consultants, in the position of de facto harmonization of different animal care and use standards into the referenced AAALAC Standard above. AAALAC employs a variety of existing standards and related guidance in its assessment of animal care and use programs. As already mentioned, the Guide is our principal standard, and we apply its provisions

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The Development of Science-Based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop and principles worldwide. However, the Guide is intentionally written in general terms to allow flexibility in its application. Taken together with the Guide’s emphasis on performance as a measure of successful application, situations naturally occur in which professional judgments regarding appropriate implementation may differ. To assist AAALAC evaluators in these situations and to provide guidance to prospective and current accredited units, we have developed a list of publications and other documents we term our “Reference Resources.” The full list is available at http://www.aaalac.org/resources.htm, and includes references from Europe and Canada, in addition to US resources. They provide more specificity than the Guide in a wide variety of areas, and in many cases provide examples of appropriate outcomes that are useful when applying the Guide’s performance standards. The Reference Resources provide guidance in areas such as euthanasia methods (Report of the AVMA Panel on Euthanasia; Euthanasia of Experimental Animals (EC DGXI)); training (FELASA recommendations on the education and training of persons working with laboratory animals: Categories A and C); humane endpoints (Guidance document on the recognition, assessment, and use of clinical signs as humane endpoints for experimental animals used in safety evaluation (OECD)); and many more. The Guide and AAALAC’s Reference Resources share a very important common characteristic—both are science based. The process for adding references to our list requires that the Council on Accreditation vote approval before such addition. The key factor in the Council’s consideration of a prospective reference is scientific documentation of its validity and value to an animal care and use program. This factor has led on occasion to the Council’s disapproval of proposed resources in which, although originally science based, the supporting data are outdated. Similarly, existing references that have become outdated or have been super-ceded by newer science-based publications are removed and/or replaced. Evaluating an entire animal care and use program requires more than the application of the provisions and principles of the Guide and Reference Resources. A review of the process by which AAALAC assesses and accredits programs in the United States and internationally also helps demonstrate the mechanisms by which the wide variety of local standards, guidance, and policies are harmonized through the accreditation process to result in a common AAALAC Standard. In the United States and internationally, the legal and regulatory requirements applicable to the unit being evaluated constitute the baseline for accreditation. No program can receive AAALAC accreditation if it is in violation of the law. Thus, in the United States, all provisions of the Animal Welfare Act Regulations must be met for species covered by the USDA, and for units receiving PHS support, all elements of their Assur-

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The Development of Science-Based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop ance of Compliance with the NIH Office of Laboratory Animal Welfare must also be met. Program elements are then evaluated based on the provisions of the Guide; and when necessary and appropriate, specific Reference Resources are used to evaluate performance outcomes in areas in which the Guide is nonspecific or institutionally approved deviations from its recommendations have been employed. Critically important is that all principles of the Guide must be met. Finally, the expert professional judgment of the AAALAC Council on Accreditation is applied through a peer-review process, and a final accreditation status is granted. Internationally the process is practically identical. Again, no program can become AAALAC accredited if it is in violation of local legal and regulatory requirements. Use of individuals as ad hoc consultants who are familiar with these local requirements facilitates uniform and appropriate interpretation and application to the unit. Once these local baseline requirements are shown to have been met, the Guide becomes the next standard to be applied. It is important to note that when local requirements are more stringent than Guide recommendations, the former must be met to achieve accreditation. In some instances, the Guide includes provisions not addressed in national or supranational animal welfare legislation or regulations, for example, in the area of occupational health and safety. In such cases, two options are available. (1) Other local requirements may exist outside the animal welfare area, as is the case with occupational health and safety requirements in the European Union (Council Directive on the Introduction of Measures to Encourage Improvement in the Safety and Health of Workers at Work (Directive 89/391/EEC). (2) In the absence of alternative local standards, the Guide standards are used as the basis for evaluating program elements in these areas. As AAALAC has grown internationally, we have conducted assessments in countries without national regulatory standards or other requirements for animal care and use. In these instances—just as in the United States—the Guide and Reference Resources serve as the basis for our evaluation. Finally, the application of expert professional judgment through the peer review process by the Council on Accreditation determines a program’s final accreditation status. The key to maintaining consistency and uniformity of the AAALAC Standard across diverse international settings and standards is that all principles of the Guide must be met. Notwithstanding the broad array of standards and guidance available in the area of animal care and use, circumstances occasionally arise for which there is no applicable published standard. In addition, professional judgments may differ regarding the acceptability of practices or procedures not specifically addressed in existing standards. In these circumstances, AAALAC again looks to science for solutions. In fact, the process used by AAALAC follows that used by ILAR in developing the

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The Development of Science-Based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop Guide, that is, we look for published data in the area in question. When no relevant reports are located, scientific principles and expert opinion form the basis for resolution, with the final decision often informed by Council members’ experience with proven methods or practices. An example of this process involves the use of alcohol as a disinfectant. The Guide states that “alcohol is neither a sterilant nor a high-level disinfectant,” yet it is used extensively for these purposes in rodent survival surgery. To answer questions about the suitability of such use, the Council formed a subcommittee to research and address this issue. Based on the information in six refereed scientific journal articles, two additional references, and the Manual of Clinical Microbiology, the Council determined that alcohol was acceptable as a skin disinfectant, but under certain circumstances may not be adequate to sterilize or disinfect surgical instruments. These determinations were published in the AAALAC newsletter, Connection, and became part of the AAALAC Standard. Thus, the AAALAC Standard is not a static document. In fact, it is not based on a single document at all, but rather a compilation of many existing standards, guidelines, and policies that encompass all aspects of an animal care and use program. The majority of these are science based, a fact that not only gives credence to those, like the AAALAC Council on Accreditation, who interpret and apply them in an accreditation program, but also leads to the greater likelihood of acceptance and implementation by the scientists subject to their provisions. The AAALAC Standard is, therefore, an evolutionary product that is developing as internationally recognized standards are interpreted through the collective professional judgment of animal care and use experts and applied through an in-depth, multilayered, scientific peer-review process. Before providing a list of areas in which I believe more science would be useful, I will comment on the modification of existing standards. It is my strong belief that when existing long-standing guidelines or requirements appear to be meeting the welfare needs of animals, any significant changes should meet three requirements: (1) the change must be of clear benefit to the animals; (2) it should not interfere unnecessarily with the research; and (3) it should be science based. Finally, the following list comprises areas that I believe could benefit from additional scientific study and data. I provide them only as topics for consideration, with the hope that this workshop will serve as a venue for discussion. Enclosure dimensions; Wire-bottom cages; Environmental enrichment; Decapitation/cervical dislocation;

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The Development of Science-Based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop Euthanasia in holding rooms; Species separation; Sanitation requirements; and Ventilation requirements.

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The Development of Science-Based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop The Council of Europe: What Is It? Wim deLeeuw Shortly after the end of World War II, several movements and activities were born that were dedicated to European unification. As an overall result, the Council of Europe was founded as an international political institution in 1949. It is designed only with international cooperation in mind. The general aims of the Council of Europe are to: Protect human rights, democracy, and the rule of law in all member states; Promote awareness and encourage Europe’s cultural identity and diversity; Seek solutions to (social) problems facing European society; Consolidate democratic stability in Europe; Promote social cohesion and social rights; and Promote and develop a European cultural identity with emphasis on education. The actual areas of concern are human rights, health, education, culture, youth, sport, the environment, local democracy, heritage, legal cooperation, bioethics, animal welfare, and regional planning. Today, the Council of Europe has 45 member states, including about 800 million people. The Council of Europe must be distinguished from the European Union, which was set up in 1957 as the European Economic Community. First, it is not a supranational institution like the European Community. It

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The Development of Science-Based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop does not have legislative power. Its member states are cooperating on a voluntary basis. The Council of Europe cannot impose any rule on its member states. Second, unlike the European Union, the Council of Europe is not an economic organization. The geographical confines of the Council of Europe are larger than the membership of the EU. The EU has 15 member states: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden, and the United Kingdom. All of these countries are also member states of the Council of Europe. Next to these member states, however, the Council of Europe also includes 30 other European countries: Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, the Czech Republic, Estonia, Georgia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Malta, Moldova, Norway, Poland, Romania, the Russian Federation, San Marino, Serbia and Montenegro, Slovenia, Slovakia, Switzerland, the former Yugoslav Republic of Macedonia, Turkey, and Ukraine. THE COUNCIL OF EUROPE: HOW DOES IT WORK? The headquarters of the Council of Europe, Le Palais de l’Europe, is situated in Strasbourg, France. The Committee of Ministers is the decision-making body of the Council of Europe. It is composed of the Ministers of Foreign Affairs of the member states. This body officially adopts Conventions, Resolutions, Agreements, and Recommendations. The Committee of Ministers also ensures that the conventions and agreements are implemented. In addition, there are two other institutions: (1) The Parliamentary Assembly is the organization’s deliberative body, the members of which are appointed by national parliaments. (2) The Congress of Local and Regional Authorities of Europe is a consultative body that represents local and regional authorities. Governments, national parliaments, and local and regional authorities are thus represented separately at the Council of Europe level. The main tools of the Council of Europe to achieve its objectives are the following legal instruments: Recommendations—often referred to as “soft law.” There is no legal obligation to follow or implement these recommendations; and Conventions or treaties concluded between states. The member states are not legally obliged to sign a Convention, although they may be expected to do so since under the Council of Europe’s Statute, they have undertaken to “collaborate sincerely and effectively in the realization of the aim of the Council.” Nonetheless, there are different ways a member can deal with a Convention. It may choose to ignore the Convention as

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The Development of Science-Based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop being not relevant or not applicable to the national situation. By taking that position, a member is not obliged to comply with its provisions. A member can sign the Convention, thus recognizing the value and existence of the Convention. After having signed a Convention, a member is still not obliged to comply with the provisions of the Convention. However, once a state has signed and ratified (i.e., its Parliament has approved the instrument) and the Convention has become effective, the state will be morally and legally bound under international law to implement the Convention. Thus, the state has become a Party to that Convention and must ensure that the provisions will be respected on its territory. Most Council of Europe Conventions are not directly applicable within a member state; they are not “self-executing.” The most common way for a state to implement them is to enact appropriate national legislation or to adapt its existing domestic law to make it correspond to the rules in the Convention. In contrast to the European Union, practically spoken, there is little legal enforcement of Conventions, which probably leads to variability in compliance. Some Conventions are also open for adoption by nonmember states. The Conventions and recommendations are drafted by governmental experts responsible to the Committee of Ministers, thereby providing for the interaction of political interests with technical considerations. They only have a legal status after they are adopted by the Committee of Ministers. More than 350 nongovernmental organizations (NGOs) are granted a consultative status. Within the context of the Council of Europe, there are several consultation arrangements, which enable NGOs to participate in intergovernmental activities and encourage dialogue. These NGOs are a vital link to the public at large and to specific parts of society. THE COUNCIL OF EUROPE AND ANIMAL WELFARE The work of the Council of Europe on animal protection was started in the 1960s. Since then, the following five Conventions on the protection of animals have been drawn up: On animals during international transport (ETS 65, 1968), which establishes general conditions for the international transport of animals; On animals kept for farming purposes (ETS 87, 1976), which is a framework convention. More detailed recommendations on species are given in separate guidelines; On animals for slaughter (ETS 102, 1979); On vertebrate animals used for experimental and other scientific purposes (ETS 123, 1986); and On pet animals (ETS 125, 1987).

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The Development of Science-Based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop Japan In Japan, animal experimentation is also regulated by laws. The types of regulations in Japan (Figure 1, right) resemble the US system, which holds each institution responsible for self-regulation. However, the designation of an equivalent of the IACUC, registration, and legal inspections of laboratory animal facilities are not stipulated in the law. LEGAL SYSTEMS IN JAPAN The detailed legal system in Japan is described in Figure 2 from an historical viewpoint. The Law Concerning the Protection and Control of Animals enacted in 1973 was amended in 1999 and given the new title of the Law for the Humane Treatment and Management of Animals. This law protects all species of animals from cruelty (Investigative Committee 2001). The law emphasizes respect for life, companionship with animals, and well-being of animals. It specifies the responsibility of the owner of the animal, and calls for the alleviation of pain and distress as well as the humane death of animals used for scientific purposes. Based on the law, the Standards Relating to the Care and Management of Experimental FIGURE 2 Regulations related to animal experiments in Japan.

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The Development of Science-Based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop Animals were specified in 1980 (Figure 2, left). The Standards cover the care and management of laboratory animals, but not the use of animals (Investigative Committee 1980). The same year that the Standards were announced, the Science Council of Japan advised the Prime Minister to prepare administrative guidance for the use of animals for scientific purposes (Science Council of Japan 1981). In 1987, in accordance with the advice of the Science Council of Japan, the Ministry of Education notified universities and other institutions to establish voluntary guidelines on animal experimentation (Ministry of Education 1987) (Figure 2, right). As a result of the notification, universities and even private research institutes formulated their own principles, guidelines, manuals, and other materials in accordance with the laws and with administrative guidance. Similarly, the scientific associations concerned have compiled guidelines for individual research fields to encourage members to balance science and animal welfare (JALAS 1987). Thus, animal experiments in Japan are regulated by a combination of legal and scientific developments. CURRENT STATUS Current regulations regarding animal experimentation in Japan are summarized in Table 1. The three categories include the following: laws consisting of the law, the standards, and the guide; administrative guidance issued by the Head of Science and International Affairs Bureau through their bulletin, which includes the notification; and voluntary guidelines formulated by individual scientific associations. Laboratory animal scientists in Japan have observed all three categories of regulations equally without the force of law but with a moral sense. The law, the standards, and the guide in the first category consist of 31, 10, and 4 TABLE 1 List of Regulations Regarding Animal Experiments in Japan 1. LAWS Law for the Humane Treatment and Management of Animals (Ministry of the Environment) —Standards Relating to the Care and Management, etc. of Experimental Animals —Guide for the Disposal of Animals 2. ADMINISTRATIVE GUIDANCE Notification Concerning Animal Experimentation Conducted by Universities, etc. (Ministry of Education) 3. VOLUNTARY GUIDELINES More than 12 guidelines on animal experiments formulated by individual scientific associations

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The Development of Science-Based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop TABLE 2 Characteristics of Regulations on Animal Experiments in Japan • Laws specify the responsibility of the owner of the animal • Laws call for 3Rs emphasizing the alleviation of pain and distress as well as humane death of animals used for scientific purposes • Administrative guidance encourages the ethical use of animals • Self-regulation system similar to the US and Canada • Recommendation for designating IACUC • Exemption from legal registration/inspection articles, respectively. Each has an associated explanatory handbook with 302, 115, and 68 pages of texts, respectively. The handbook for the Standards was edited by seven laboratory animal scientists, one medical doctor, and one representative of the Japan Animal Welfare Society to reflect the opinions of animal advocates. In Table 2, the characteristics of Japanese regulations on animal experiments are listed. Our ethical principles, known as the 3Rs, are the same as in Western countries. The law emphasizes refinement that focuses on the alleviation of pain and distress as well as the humane death of animals. The law adopts the self-regulation system for animal experimentation, and the notification only recommends designation of an IACUC (Ministry of Education 1987). Nevertheless, according to survey results, almost all medical schools and pharmaceutical companies as well as about one-third of breeders have established IACUCs even though the law does not mandate it. Laboratory animal and livestock facilities are exempted from registration and legal inspection. Instead, the Japanese Association for Laboratory Animal Science voluntarily conducts surveys every 3 years on the number of animals used for scientific purposes (CLACU 2003). It is therefore evident that laboratory animal scientists in Japan recognize the importance of replacement of live animals with insentient materials and reduction in the number of animals involved. Although our regulations may appear somewhat lenient and ambiguous from the Western viewpoint (Nomura 1995) (a feeling that has sometimes annoyed Japanese scientists when collaborating with Western colleagues), the authors believe that certain religious implications may underlie animal experimentation ethics and the structure of regulations in individual countries, as described below. RELIGIOUS IMPLICATIONS A Thai venerable who graduated from medical school made a presentation about the philosophy of Karma in Buddhism at the 2003 annual

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The Development of Science-Based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop meeting of the American Association of Laboratory Animal Sciences. Researchers in Buddhist countries regard animals as existing on the same level as humans and generally treat animals based on the philosophy of Karma. Buddha rewards or punishes people based on their deeds (Karma). The logic of reincarnation is called samsara, the endless round of rebirth and redeath based on the impersonal judge of the Natural World, on which the destiny of humans depends. Researchers in historically Christian countries, by comparison, appear to handle laboratory animals from the standpoint of the Lord of Creation. Researchers in Western countries give the impression of conducting animal experiments based on phylogenic domination of the animal. Therefore, they often cite the expression “humane care and responsible use.” PERSPECTIVE OF ANIMAL EXPERIMENTS IN JAPAN In Japan, we seek to combine Buddhist and Christian assumptions and to reach a point where humans should take responsibility for laboratory animals so that they can accomplish good Karma while using the animals for scientific purposes. If animals are suffering from infectious diseases, for example, they will not be able to provide reliable experimental data as their good Karma. Thus, microbiological control of the animal environment should be the responsibility as well as good Karma for people engaged in animal experimentation. Investigators in Japan may achieve the 3Rs principle in practice without any strict regulations because of the fear of samsara. However, the need to collaborate with Western colleagues requires compromise with the Western system. For this reason, we have been discussing appropriate strategies. There is current disagreement over whether we should aim toward more stringent regulations, similar to European countries, or continue the current self-regulation system as in the United States and Canada. To ensure a convincing self-regulation system, we will need to clarify the responsibility of persons who engage in animal experiments, define the role of the IACUC, and implement animal welfare practices compatible with scientific needs, as shown in Figure 3. As mentioned above, none of these elements are strictly stipulated by the law but are regulated by administrative guidance and voluntary guidelines to encourage flexible animal research. It is now time for us to consider a certain mechanism to defend animal research as well as a validation system for self-regulation to reach a social consensus on the necessity of animal experimentation.

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The Development of Science-Based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop FIGURE 3 Reinforcement of the self-regulation system within animal research facilities in Japan. REFERENCES CLACU [Committee for Laboratory Animal Care and Use, Japanese Association for Laboratory Animal Science]. 2003. The number of live animals used in experiments in 2001 [text in Japanese, summary in English]. Exp Anim 52:143-158. Investigative Committee [Investigative Committee on the Law for the Humane Treatment and Management of Animals]. 2001. Explanatory Handbook on the Law [text in Japanese]. Tokyo: Seirin Shoin. Investigative Committee [Investigative Committee on the Standards Relating to the Care and Management of Experimental Animals]. 1980. Explanatory Handbook on the Standards [in Japanese]. Tokyo: Gyousei. JALAS [Japanese Association for Laboratory Animal Science]. 1987. Guidelines on Animal Experimentation [in Japanese]. Exp Anim 36:285-288. Ministry of Education [Ministry of Education, Science and Culture, Science and International Affairs Bureau]. 1987. Notification on Animal Experimentation in Universities [in Japanese]. Nomura, T. 1995. Laboratory animal care policies and regulations in Japan. ILAR J 37:60-61. Science Council of Japan. 1981. Recommendation for the establishment of animal experiment guideline [in Japanese]. Exp Anim 30:173-178.

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The Development of Science-Based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop Process for Change—Development and Implementation of Standards for Animal Care and Use in Canada Clément Gauthier The Canadian Council on Animal Care (CCAC) is the national organization that has set and overseen the implementation of standards for the care and use of animals in science since 1968. It is a peer review organization involving close to 2000 scientists, veterinarians, animal care technicians, students, community representatives, and representatives of the animal welfare movement through its programs of assessment, guidelines development, education, and training. The CCAC pioneered the institutional animal care committee (ACC) as the local keystone of its decentralized ethical review and oversight system. For a detailed description, consult the following documents of the CCAC in the order indicated: The Assessment Program of the CCAC, 2000; Terms of Reference for Animal Care Committees, 2000; CCAC Guidelines on Animal Use Protocol Review, 1997; and Categories of Invasiveness in Animal Experiments, 1991. All of these documents are available on the CCAC web site [http://www.ccac.ca]. ACCs are now part of most legislated and voluntary frameworks for the regulation/oversight of animals used for scientific purposes worldwide. Although compliance with CCAC standards is voluntary for government and industry, it is mandated through federal spending power for academic institutions. Over the past decade, provincial and federal governments have increasingly recognized the CCAC as a quasi-regulatory system. CCAC standards are now referenced in the regulations to provincial laws relating to the use of animals for scientific purposes (CCAC

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The Development of Science-Based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop 2003; Russell and Burch 1959) and in the policies of relevant federal departments and agencies. The underlying ethical basis of all CCAC guidelines and policies requires adherence to the 3Rs (reduction, replacement, and refinement) of Russell and Burch (1959). Maximizing animal well-being and minimizing pain and distress are the ethical drivers for the development of refinement measures. Housing conditions and environmental controls must be refined with the primary objective of meeting the social and behavioral needs of animals and of maximizing animal well-being. To minimize pain and distress, investigators frequently adopt practices believed to improve animal welfare based on anecdotal evidence. Although there is no commonly understood definition for the term “best practice,” per se, there is agreement on its content criteria and consensus on the fact that it must be evaluated by peers. The peer-based approach underlying the CCAC guidelines development process and the use of evidence-based learning loops in the evolution of best practices to implement these guidelines are two essential pillars of international harmonization of standards for the care and use of animals in science. Compliance with CCAC standards is ensured at the local level through ACC peer-based review of protocols and mandatory site visits of facilities. National quality assurance is provided through CCAC’s external, peer-based assessment visits, which include the assessment of the functioning of the ACC. At the June 2001 first International Symposium on Regulatory Testing and Animal Welfare organized by the CCAC in collaboration with the International Council for Laboratory Animal Sciences, the Breakout Group on Best Practices for Animal Care Committees and Animal Use Oversight concluded that future progress requires encouraging diversity of frameworks as a source of continuous improvement, and the networking of ACCs to identify, encourage, and share best practices (ILAR 2002). The institutional ACC plays a central role as the third pillar of international harmonization, for the following reasons: It is representative of the scientific culture and moral values of home countries; It facilitates communications and empowers informed decision making at the local level; It is already integrated as an accountable keystone of most national oversight and regulatory systems worldwide; and It provides each country with enhanced ability to influence international harmonization of best practices for animal care and use in science.

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The Development of Science-Based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop REFERENCES CCAC [Canadian Council on Animal Care]. 2003. Legislation in Canada related to experimental animals. In: Experimental Animal User Training Core Topics Modules, Module 1: Guidelines, Legislation and Regulations. Electronic document (http://www.ccac.ca/english/educat/Module01E/module01-11.html). ILAR [Institute for Laboratory Animal Research]. 2002. Proceedings of the ICLAS/CCAC International Symposium held in Québec City, Canada, June 21-23, 2001. ILAR J 43:S1-S136. Available at http://dels.nas.edu/ilar/jour_online. Russell, W.M.S., and Burch, R. 1992 [1959]. Principles of Humane Experimental Technique. England: Universities Federation for Animal Welfare, Potters Bar, Herts, UK.

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The Development of Science-Based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop Building Credible Science from Quality, Animal-based Information Paul Gilman The research and development arm of the US Environmental Protection Agency (EPA) employs 1,950 employees at 13 laboratories and research facilities across the nation. Its $700 million budget for fiscal year 2003 included a $100 million extramural research grant program. The focus of those people, facilities, and programs is the generation of credible, relevant, and timely research results—and technical support—that inform EPA’s policies, decision making, and promulgation of regulations. Setting those regulations, making those policies, and accomplishing those decisions with sound science requires the Office of Research and Development (ORD) to fulfill the following responsibilities: Production of relevant, high-quality, cutting-edge research results in human health, ecology, pollution control, and prevention investigations and in economics and decision sciences; Characterization of scientific findings properly; and Use of appropriate tools and approaches for the performance of science in the decision process. High-priority areas for ORD include research in human health, particulate matter, drinking water, clean water, global change, endocrine disruptors, ecological risk, pollution prevention, and homeland security. Each of these important areas of investigation may include the use of animal models.

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The Development of Science-Based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop In its role as a leader in the environmental and human health protection research communities, ORD upholds three fundamental tenets in the use of animals in its research: Animals represent a limited resource and are precious research tools; Quality and validity of data collected from animals must be assured; and Resultant research must have the full confidence of and acceptance by the scientific, regulated, and decision-making communities, and the public. Understanding the specific needs for and value of animal use is balanced with associated responsibilities in conducting such research. ORD adheres to Stringent review to assure responsible use; Annual review and accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care; Close scrutiny of animal protocols; and Continuous attention to the refinement of methodologies that reduce the number of or eliminate the use of animals.

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