The Development of Science-based Guidelines for Laboratory Animal Care Proceedings of the November 2003 International Workshop (2004) / Chapter Skim
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Point/Counterpoint: The Cases For and Against Harmonization
Point/Counterpoint: The Cases For and Against Harmonization
Pages 199-224
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Point/Counterpoint: The Cases For and Against Harmonization
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We will discuss the cases for and against harmonization of laboratory animal guidelines and how we might approach balancing the need for accomplishing high-quality medical research while providing for optimal animal welfare. First, I would like to comment that I have been very impressed with this conference and the level of the discussions that have been taking place.
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This attendance truly reflects an international commitment to animal welfare. Clearly, harmonization has the potential to contribute to increased replicability and comparability of research and testing results based on the use of animals.
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Is it animal welfare? Is it laws, regulations, standards?
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Nevertheless, ICLAS opposes standardization because ICLAS is in constant liaison with countries and regions that have different cultures, traditions, religion, legislation, and regulations. A recent example of these differences has been evident during this workshop in discussions with Dr.
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When I say best animal welfare, I mean that which makes the animals feel good, not that which makes a regulator or an IACUC feel good. I believe we have established that there is not enough evidence for all of these things to be evidence based.
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Garnett, Office of Laboratory Animal Welfare (OLAW) , National Institutes of Health (NIH)
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DR. DELEEUW (Wim deLeeuw, Directorate of Inspection, Food & Consumer Safety Authority, Department for Veterinary Public Health, Animal Diseases, Animal Welfare & Feed, Den Haag, The Netherlands)
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Whether the laboratory is in Berlin or in Washington, I believe there is a common goal -- to define and provide for the needs of the laboratory animals. To that end, our common goal requires common, shared knowledge.
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In addition to the publications written by authors who represent the conventional scientific disciplines (e.g., behavioral sciences, laboratory animal sciences) and all of the different types of knowledge that are not necessarily published in the mainstream scientific journals, I believe we should also recognize the side of scientific information that is coming and needed.
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However, if everyone is using the same cage size and the same lack of enrichment, we are really studying the effects of those genes under a very small window of the total environment. It can also lead to false-negative findings, wherein one fails to detect true influences of either the biological manipulation in use or the genetic manipulation in use, because you looked in only one place, and the gene acts in many other places.
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Each country has its own legal requirements, culture, and attitudes, which extend beyond science, are sometimes political, and are sometimes personal. Actually, both the European countries and the United States are guiding the process independently by the ILAR Guide for the Care and Use of Laboratory Animals (Guide)
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If you accept my premise that there can be no mutually exclusive provisions in harmonized standards, then how can standards that contain different engineering standards (e.g., cage sizes) ever be harmonized?
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That example is the minimum freedom of movement that an animal should have. However, if we are able in the future to agree on basic principles, then the last step, harmonization of cage sizes, should not be a real problem.
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STOKES: Dr. Gauthier recommended a process that would allow input from all of the involved stakeholders -- the public, animal welfare groups, scientists, animal care specialists.
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Those of you who know me know that I am committed to animal welfare and to doing the right thing. As long as I have that responsibility in my organization, we will act accordingly.
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: Based on my previous laboratory animal experience, I believe that Dr. Miller has brought up a very good point
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So if, in fact, it is a good thing to harmonize processes, we will at least have many resources and examples. The good laboratory practices of OECD, with which many people agree, also relate to animal welfare.
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Many of you have mentioned that animal welfare groups should be part of the process, and I believe their inclusion gives the process a certain legitimacy, because the result are guidelines that are carried out within the walls of research institutions, where it is difficult for the public to know what is happening. However, if animal welfare representatives are involved at the front end, there will be more assurance that the guidelines themselves are at a decent level.
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DR. BLOM (Harry Blom, Utrecht University, The Netherlands, and Vice President of International Liaisons, Federation of European Laboratory Animal Associations (FELASA)
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As I mentioned earlier, I view AAALAC as performing de facto harmonization, or implementation. I authored an article in Lab Animal in the late 1990s titled "Harmonization: The Proof Is in the Practice." In retrospect, the title should have been "The Proof Is in the Performance." You can have all of the desired harmonized standards and all of the different desired standards, but these desires are meaningless unless you monitor implementation.
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DR. GAUTHIER: The Canadian Council on Animal Care operates a decentralized quality control peer-based system through the institutional animal care and use committee.
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Cathy Liss that the Animal Welfare Institute is providing some funding to work in this area. Since 1996, the American College of Laboratory Animal Medicine Foundation has provided small research grants to work at filling these gaps.
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highest priority, I described the need for funding to answer scientific questions to inform public policy in the animal welfare area. He was very interested and asked for examples.
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I hope that this initiative will be repeated. I urge all of you to attend the next FELASA meeting, to be held next year in Nantes, France, where the theme of the meeting will be internationalization and harmonization in laboratory animal care and use issues.
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