The Development of Science-based Guidelines for Laboratory Animal Care Proceedings of the November 2003 International Workshop (2004) / Chapter Skim
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Session 1: Current Status: Identifying the Issues
Session 1: Current Status: Identifying the Issues
Pages 15-62
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Session 1 Current Status: Identifying the Issues
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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)
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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.
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) ; training (FELASA recommendations on the education and training of persons working with laboratory animals: Categories A and C)
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(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)
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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 indepth, 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.
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22 SCIENCE-BASED GUIDELINES FOR LABORATORY ANIMAL CARE 5. Euthanasia in holding rooms; 6.
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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.
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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.
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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: (1)
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THE COUNCIL OF EUROPE AND THE PROTECTION OF LABORATORY ANIMALS As early as 1971, the parliamentary assembly recognized that to protect animals against abusive and unnecessary experimentations certain norms should be established at an international level, to enable states to regulate such experiments in an harmonious way in their domestic law. A first draft of the Convention was elaborated by the Ad Hoc Committee of Experts on the Protection of Animals, the CAHPA.
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International Council for Laboratory Animal Science (ICLAS) Institute for Laboratory Animal Research (ILAR)
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Pending this revision, a resolution was drafted presenting guidelines for the improvement of the accommodation and care of laboratory animals, which would complement the guidelines in Appendix A The guidelines in the resolution were mainly based on the conclusions and recommendations of the International Expert Workshop on laboratory animal welfare that was held in 1993 in Berlin.
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. The work that has been done at the Council of Europe in the area of laboratory animal welfare was based on a very fruitful cooperation between member states and observers of various organizations.
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In 1979, ICLA was renamed the International Council for Laboratory Animal Science (ICLAS) , because much new knowledge in biology and medicine requires planned experiments with organisms or their parts.
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Scientific/Union members represent national or regional laboratory animal science and other scientific associations. Associate members represent commercial and academic organizations that support the aims of ICLAS.
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STRATEGIC PLAN The ICLAS Governing Board has developed a Strategic Plan to guide the organization through the next several years. The Strategic Plan includes the mission statement of ICLAS: "The International Council for Laboratory Animal Science advances human and animal health by promoting the ethical care and use of animals in research worldwide." ICLAS strives to act as a worldwide resource for laboratory animal science knowledge; to be the acknowledged advocate for the advancement of laboratory animal science in developing countries and regions; and to serve as a premier source of laboratory animal science guidelines and standards, and as a general laboratory animal welfare information center.
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Other regional scientific meetings and courses are organized by laboratory animal science organizations in the various regions of the world under the auspices of six ICLAS Regional Committees for the following regions: Europe, Asia, Africa (French and English regions) , Oceania, and the Americas.
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ILAR International Workshop on Development of Science-based Guidelines for Laboratory Animal Care ICLAS is a cosponsor of this workshop convened to discuss the available knowledge that can affect current and pending guidelines for laboratory animal care, identify gaps in that knowledge to encourage future research endeavors, and discuss the scientific evidence that can be used to assess the benefits and costs of various regulatory approaches affecting facilities, research, and animal welfare. Meeting for Harmonization of Guidelines (FELASA 2004, France)
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ICLAS membership includes countries from every region of the world; and b. The impact of ICLAS programs to ensure diffusion of good science and good animal welfare practices is felt worldwide, through ICLAS Meetings, Regional Programs, the Communication Program, and other ICLAS Initiatives.
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many years ago. The PHS Act was amended in 1985 to include the PHS Policy on Humane Care and Use of Laboratory Animals, implemented by my office, the Office of Laboratory Animal Welfare (OLAW)
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The PHS Policy also requires that institutions receiving PHS support design their programs to conform with the Guide for the Care and Use of Laboratory Animals (the Guide)
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WHAT IS AN ANIMAL WELFARE ASSURANCE? The Assurance is a written document that provides the basis for a trust relationship between the institution and the government.
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These reports are to include the dates of semiannual evaluations, significant program or facility changes, change in accreditation status, and changes in IACUC membership; and they must allow for minority views to be expressed. Prompt self-reporting of problems is an essential part of our trust relationship.
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OLAW cosponsors an entire series of animal welfare educational activities throughout the year, with active participation from all of the other players, including the regulated community. The wealth of information is beyond the scope of this presentation, but I invite you to visit this website (http://grants.nih.gov/grants/ olaw/olaw.htm)
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contains the basic requirements for federal rulemaking. For most rulemaking, the APA requires the following: · Publication in the Federal Register of a proposed rule, including either the terms or substance of the proposed rule; · Opportunity for public participation in rulemaking through submission of written comments on the proposed rule; · Publication in the Federal Register of a final rule, with an explana 41
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. TYPES OF RULES Among the several types of rules are a proposed rule, a final rule, an interim rule, an advance notice of proposed rulemaking, and a direct final rule.
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Final Rule Most rulemaking in APHIS concludes with a final rule. This document must contain a preamble that includes the following, at a minimum: a response to the issues raised by the public comments; an analysis of the anticipated economic effects of the final rule; a statement concerning any information collection requirements contained in the rule; and an effective date for the rule.
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If APHIS chooses to proceed with rulemaking, APHIS must issue a proposed rule. To ensure that the public receives notice of whether a direct final rule will become effective as indicated, APHIS publishes a brief notice after the comment period closes, either affirming the effective date or, if APHIS receives adverse comments, withdrawing the direct final rule.
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Although APA contains the basic requirements for rulemaking, including publication in the Federal Register, other laws and executive orders also apply to rulemaking. Among the various types of rulemaking documents, the most typical is a proposed rule followed by a final rule.
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In contrast, the European Union (EU) is focused on economic and political union.
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, there are numerous opinions about contemporary best practice, but there is no means of demonstrating optimum provision. In an attempt to resolve this problem, the Council of Europe established a series of technical expert working groups that were supported by a Secretariat, a steering group including representatives of the parties to the Convention, and various observers, including the Institute for Laboratory Animal Research, the US Department of Agriculture, and the Canadian Council on Animal Care, and a separate drafting group.
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, forensic enquiries, or education and training. The Directive includes an "informative Annex" on standards of care and accommodation that the member states shall "pay regard to." Furthermore "animal welfare" is not a Commission competence strictly speaking, and the Directive permits member states to "adopt stricter measures." Work on reviewing and revising the Directive started recently.
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The role of the European Centre for the Validation of Alternative Methods and the Interagency Coordinating Committee on the Validation of Alternative Methods will also be considered. HARMONIZATION AND DIVERSITY Within Europe, there might be one Directive and one Convention to protect animals used for scientific purposes; but even within the EU, there are nevertheless 15 ways of doing it.
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INTERNATIONAL COMPARISON OF REGULATIONS ON ANIMAL EXPERIMENTATION Europe The year 1986 was important in terms of the following: (1) the Council of Europe concluded the convention for the protection of vertebrate animals used for experimental and other scientific purposes; (2)
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USDA, US Department of Agriculture; IRAC, Interagency Research Animal Committee; DHHS, Department of Health and Human Services; AWA, Animal Welfare Act; PHS, Public Health Service; HREA, Health Research Extension Act; AWR, Animal Welfare Regulations; UFAW, Universities Federation for Animal Welfare; APHIS, Animal and Plant Health Inspection Service; MOU, Memorandum of Understanding; NIH, National Institutes of Health; FDA, Food and Drug Administration; ILAR, Institute for Laboratory Animal Research; IACUC, institutional animal care and use committee. conducted.
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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 Law Concerning Protection and Control of Animals, 1973 Prime Minister 1 2 Standards Relating to the Advice of Science Council of Japan Care and Management of 3 to establish guidelines for the use Laboratory Animals, 1980 laboratory animals,1980 Guide for the Disposal of Animals, 1995 Ministries concerned Notification Concerning Animal Experimentation Conducted by Academia (Ministry of Education, 1987)
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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.
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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.
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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.
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Documentation and record keeping Peer review and validation 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 Labo ratory Animal Science]
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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)
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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)
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. ILAR [Institute for Laboratory Animal Research]
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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.
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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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