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The Replacement of Animal Tests

Robert D. Combes

Progress toward the acceptance and application of validated alternative test methods as replacements for animal tests, is being frustrated by the unsatisfactory procedures involved in approving new test guidelines and deleting existing ones

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2018-05-31T11:58:08+00:00 Tags: , |

The Seventh Amendment to the Cosmetics Directive: what does DG Enterprise want from ECVAM?

Regina Schumann

A short overview is given of the current situation regarding the draft seventh amendment to the EU cosmetics directive, Council Directive 76/768/EEC. Future perspectives are discussed.
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Human Research Tissue Banks: The ATRA Project for Establishing a Human Research Tissue Bank in Switzerland

Massimo Tettamanti, Sara Tralamazza, Marina Berati, Max Molteni and Natascia Gamba

A large number of experiments in biomedical research are carried out on tissues, but, even though the results should be applicable to humans, these tissues are mainly of animal origin. The difficulty encountered in obtaining human organs and tissues is an acknowledged problem: not enough human tissues are available to meet research needs. We are introducing the ATRA Project, with the purpose of supporting progress in biomedical research in Switzerland through the establishment of one or more human tissue banks, which will be able to find, treat, preserve and supply human material. Where similar projects have already been launched, concerns have been expressed that donation for research purposes might compete with donation for transplantation, but most organs and tissues are in any case non-transplantable. Surplus surgical tissue is considered “sanitary waste”, and must be treated according to specific regulations for collection, packaging, transport, treatment and disposal. A human tissue bank would not only abate the costs of treating sanitary waste, but would actually turn what is now considered waste into a resource which could be used to save human and animal lives.
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Comments on the Sub-group Reports of the EU Technical Expert Working Group on the Revision of Directive 86/609/EEC on the Protection of Animals Used for Experimental and Other Scientific Purposes

Robert Combes and Michael Balls

A critical analysis is presented of the reports produced by four Technical Expert Working Group Sub-groups (SGs) on Ethical Review, Cost–Benefit, Authorisation and Scope, which were published on the EC website (http://ec.europa.eu/environment/chemicals/lab_animals/ia_info_en.htm), as part of the European Commission (EC)’s review of EU Directive 86/609 EEC. This is in addition to our official response to the internet consultation questionnaire, submitted to the Commission on behalf of FRAME. Whilst the respective SG reports were extensive and detailed, we have identified several shortcomings, and in particular, a frequent lack of consensus among the SG members, resulting in a lack of clear guidance for the EC on what the revised Directive should contain, with reference to a number of crucial issues. Such indecisiveness could lead to wide discrepancies in the approaches of the EC, the European Parliament and the EU Member States concerning many issues of importance to animal welfare and the implementation of alternatives to animal experiments. These concerns range from logistical issues, such as requirements for named officers in authorised establishments, and the recording and publishing of statistics on animal use, to ethical and scientific problems, including the use of non-human primates, local ethical review, and education and training on the essential link between the Three Rs concept and best scientific practice. In each case, the basis for our concerns is explained, and suggestions for improvements to be incorporated into the revised Directive are made, in the hope that the harmonisation of approaches to laboratory animal experimentation and the use of alternative methods in the Member States can be maximised.
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Estimates for Worldwide Laboratory Animal Use in 2005

Katy Taylor, Nicky Gordon, Gill Langley and Wendy Higgins

Animal experimentation continues to generate public and political concern worldwide. Relatively few countries collate and publish animal use statistics, yet this is a first and essential step toward public accountability and an informed debate, as well as being important for effective policy-making and regulation. The implementation of the Three Rs (replacement, reduction and refinement of animal experiments) should be expected to result in a decline in animal use, but without regular, accurate statistics, this cannot be monitored. Recent estimates of worldwide annual laboratory animal use are imprecise and
unsubstantiated, ranging from 28–100 million. We collated data for 37 countries that publish national statistics, and standardised these against the definitions of ‘animals’, ‘purposes’ and ‘experiments’ used in European Union Directive 86/609/EEC. We developed and applied a statistical model, based on publication rates, for a further 142 countries. This yielded our most conservative estimate of global animal use: 58.3 million animals in 179 countries. However, this figure excludes several uses and forms of animals that are included in the statistics of some countries. With the data available, albeit for only a few countries, we also produced, by extrapolation, a more comprehensive global estimate that includes animals killed for the provision of tissues, animals used to maintain genetically-modified strains, and animals bred for laboratory use but killed as surplus to requirements. For a number of reasons that are explained, this more-comprehensive
figure of 115.3 million animals is still likely to be an underestimate.
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