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 3: Approaches to Current Guidelines--US and Europe
Session 3: Approaches to Current Guidelines--US and Europe
Pages 91-130
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From page 91... ...
Session 3 Approaches to Current Guidelines-United States and Europe
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The charge to the 1996 Guide committee was to develop a guidance document for laboratory animal care and use -- not to develop regulations. COMMITTEE FOR REVISION OF THE GUIDE The writing of the 1996 Guide spanned five committee meetings and involved seven major drafts with numerous minor drafts developed over a 2-year period.
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From page 94... ...
Given the lack of data on which to base detailed guidance in many aspects of animal care and use, the performancebased approach used in the Guide encouraged the development of data that could be used to improve animal care and use. The committee began the process by a careful review of the existing guidance and regulations.
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From page 95... ...
Overall, however, if there was little evidence available, the committee avoided the temptation to make assumptions and to extend conclusions beyond available data. Of concern to the committee was that any guidance had to fit practically and logically into existing animal care programs and had to be of sufficient impact/importance to suggest action.
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PRACTICAL ISSUES IN THE DEVELOPMENT OF GUIDANCE FOR HOUSING STANDARDS One of the most difficult sections to construct in the Guide was the animal environment section, which included housing needs of laboratory animals. Although it was intuitive that the housing environment of laboratory animals somehow affects their performance and well-being, there was not a great deal of information available to provide very specific recommendations.
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From page 97... ...
Environmental adaptation in both wild and laboratory animals suggests that consistency in environment may not be "normal" or perhaps even desirable. To demonstrate effects caused by temperature or relative humidity, it may be necessary to have a complex/ unique set of conditions present unless extreme and clearly unacceptable conditions are utilized.
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From page 98... ...
In 1969, a density-based set of recommendations using six weight categories was developed in all likelihood from a survey of common practices coupled with limited unpublished data. Although this guidance was modified slightly in ensuing years, principally by adjusting weight ranges and providing for very large animals, the body weight/space relationship remains almost linear, which is suspicious.
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From page 99... ...
It is also essential that there be consideration of confounding variables and confirmation of findings under field conditions. There should be some ranking of physiologic/metabolic and behavioral significance because simply describing that a condition exists and is statistically significant may not be adequate justification for providing for all eventualities in animal housing.
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Moreover, there has been an increased public interest in and awareness of animal usage in experimentation and a regard for their welfare. The author as a representative of a nongovernmental organization (NGO; see below)
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This realization led to the decision to include all of the following groups within the remit of the revision. The full list of species now includes rodents and rabbits; dogs, cats, and ferrets; nonhuman primates; birds; farm animals (sheep, goats, cattle, horses, (mini)
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From page 102... ...
In some cases, this cycle has been repeated several times, often with each stage reversing or revising issues discussed at the previous meeting. It should be noted that during the protracted process, there has been a war of attrition between interest groups, the outcome of which has been an eventual meeting of minds in consensus and the adoption of standards that are reasonable and accepted.
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· Scientific proof · Experience · Good/best practice Define good/best practice. · The European guidelines deal with these issues.
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The Chairman indicated that the revised Council of Europe Convention represented minimal guidelines rather than regulations. He also indicated that justifications for not following the guidelines could be presented.
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2. The treatment and conditions for laboratory animals should be evaluated regularly as new information becomes available.
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106 SCIENCE-BASED GUIDELINES FOR LABORATORY ANIMAL CARE 7. Because companies maintain research facilities in different countries, there is a need for harmonization, even in the absence of agreement.
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male and female mice. The indices we studied were survival, aggressive behavior or injuries, body weight, food and water consumption, cage microenvironment (in-cage ammonia and CO2 levels, temperature, and relative humidity)
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From page 108... ...
The incidence of alopecia among B6 female mice used in this study was relatively low, varying from 0 to 6% per treatment group, and was unrelated to cage type or housing density. Microenvironment in Cages Housing C57BL/6J Male Mice.
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From page 109... ...
There was no significant difference in male or female mean urinary testosterone output between the baseline and 8-week samples. Unlike the results for males in 51.7 in2 duplex or 67.6 in2 shoebox cages, urinary testosterone levels increased for males between baseline and 8 weeks, although not significantly.
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From page 110... ...
The incidence of alopecia among B6 female mice ranged from 0 to 6% in the 8-week study and was not associated with a particular cage type or housing density. The incidence of alopecia in the 4-week study was density dependent, with five of six cages containing affected female mice at the highest density.
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From page 111... ...
Male urinary testosterone levels either remained relatively constant or decreased slightly over 8 weeks in the primary study. For female B6 mice housed in any of the three cage types, urinary testosterone levels increased over the course of the 8-week study.
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From page 112... ...
For this reason, it is necessary to re-evaluate the current guidelines in the context of what is known about this social species. Animal care should not be dictated by the anthropomorphic perceptions of animal caretakers and regulatory chttp://www.osha.gov/dts/sltc/methods/inorganic/id188/id188.html dhttp://www.cdc.gov/niosh/pel88/7664-41.html
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The role of the Guide is to ensure that laboratory animals are well treated and housed in a species-appropriate manner. This housing density study and others reported in the literature have included only a few inbred mouse strains.
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2002) : The exact numeric values for minimum cage sizes and heights as well as for maximum stocking densities can never be scientifically evaluated and "proved." Working out minimum requirements with respect to animal welfare and to supposed well-being of laboratory animals is a political question.
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In the absence of proof, we provide what common sense tells us is good animal welfare. Environmental enrichment is one of the major ways of trying to improve the welfare of laboratory animals in our care.
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It should be noted, however, that any necessary major changes in building constructions have until 2007 to be in place. NEEDS OF RATS AND MICE At the end of 1999, in an effort to identify and establish the most important needs of mice, rats, guinea pigs, rabbits, and dogs in their natural habitat, Novo Nordisk A/S and the Danish Animal Welfare Society invited internationally recognized animal welfare experts to participate in several workshops.
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. DISCUSSION Economy is sometimes used as an argument against larger cage sizes for experimental animals, and various calculations are used to support the argument.
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Beyond ensuring the conditions we believe greatly improve the welfare of the animals, the new system appears much more pleasant and inviting and should therefore contribute to a broader acceptance of experimental animal use by the public. It will be necessary for laboratory animal care guidelines to deal with minimum requirements.
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Jegstrup, and L Lidfors into new housing systems for laboratory animals.
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) , and in the United States (according to the Guide for the Care and Use of Laboratory Animals [NRC 1996]
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Participants seemed to agree that science-driven cage size recommendations are needed, and that ever-larger cage size mandates without supportable science are not justified. Focusing on cage size, rather than on behavior, forces the use of engineering, rather than on performance, standards.
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Many participants felt that changes should be made with due caution and based upon scientific evidence, professional judgment, and widely accepted "Best Practice." To avoid reinventing the wheel, and to help harmonize international standards, it is advisable to refer to existing standards (e.g., NRC 1996, CoE 2001, and other nations' codes of practice)
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1996. Guide for the Care and Use of Laboratory Animals.
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Participants affirmed small-group efficiency in contrast to the inertia of larger groups. They also opined that competent authorities should agree in advance to abide by the recommendations of the expert groups unless they vary radically from socially accepted norms.
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· The scientific and animal care communities need to convince competent authorities to be supportive of the need to gain more scientific data on factors such as cage sizes. They also need to convince society that such studies are worth the initial investment, because it may be perceived that funds are being redirected from health-related research.
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Additional indicators may come from indirect observations. For example, in instances in which guidance is less than adequate, interinstitutional variation in the implementations of guidelines due to professional judgment may indicate areas where additional guidelines are necessary to promote consistency in welfare and care.
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From page 127... ...
1996. Guide for the Care and Use of Laboratory Animals.
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From page 128... ...
GROUP HOUSING Both the Council of Europe (CoE 1986) and the Guide for the Care and Use of Laboratory Animals (the Guide)
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Without a raised floor space, the floor area for one rabbit should be 5600 cm2 and 6700 cm2 for two rabbits. Existing standards and guidelines for rabbit caging size also base minimum cage size on weight, including (1)
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