Atla-Alternatives To Laboratory Animals最新文献

In 2020, the EU Commission's Joint Research Centre published the EURL ECVAM Recommendation on Non-Animal-Derived Antibodies. In advance of the publication of this EURL ECVAM Recommendation, Landsforeningen Forsøgsdyrenes Værn arranged for an expert presentation on non-animal-derived antibodies to the Animal Experimentation Council, which is the body responsible for the review and approval of projects involving animals in Denmark. The main concerns of Council Members following the presentation were the widespread unfamiliarity with phage display methodology in Denmark, and how it would be possible to adapt licensing decisions. Before deciding how to approach the implementation of the Recommendation, the animal experimentation authority Dyreforsøgstilsynet, of which the Animal Experimentation Council and its secretariat are part, probed the wider scientific community and requested an opinion from the National Committee on Laboratory Animals and Alternatives. Wider scientific opinion in Denmark spanned those who were, to a certain extent, positive toward the non-animal methodology and those who were sceptical. Consequently, the approach chosen by the Danish authority is to encourage and monitor the uptake of non-animal methods, while allowing time for adjustment. Change has been slow, but the seeds of change are sown.

Research involving the use of animals follows the Three Rs principles of replacement, reduction and refinement. Based on the principle of replacement, UK and EU legislation requires that technologies or alternative approaches directly replacing or avoiding the use of animals in experiments must be used wherever scientifically possible. However, replacement is often not thoroughly considered, and failures in the existing system of checks and balances are widespread. Existing guidance and advice on searching for and identifying alternative approaches and replacement techniques is confusing and misleading, and this contributes to the lack of knowledge and confidence in addressing replacement and the structural and procedural barriers around it. In this paper, we propose simple improvements to existing processes and a basic practical checklist, to help researchers identify and assess scientifically satisfactory replacement approaches. This tool will also support members of funding review panels, Animal Welfare and Ethical Review Bodies (AWERBs), Animal Welfare Bodies (AWBs), Animal Ethics Committees, and those editing and reviewing scientific journals in their scrutiny of applications, applicants and publications - particularly with regard to the use of alternative approaches and how these potential approaches were explored.

Agrochemical active ingredients are among the most toxicologically evaluated chemical substances, and genetically modified (GM) crops must be evaluated for safety and nutritional adequacy. Traditionally, these evaluations are conducted in vivo. There are concerted efforts in the agrochemical sector to reduce animal testing, but there is also an emphasis on updating test guidelines and fulfilling new data package requirements, which can both result in increased animal testing. The purpose of this project was to generate benchmarks for the numbers of vertebrate animals used in: a) evaluating agrochemical pesticidal active ingredients for human health hazards; and b) assessing GM crops for safety and nutritional adequacy, based on guideline studies for data package requirements. To achieve this, guideline studies employing vertebrates, as required by regulatory bodies for developing global data packages for new active ingredients and for GM crops, were listed. These listed guideline studies were reviewed, in terms of the study details and the required animal-use, which was determined based on best testing practices. For historical animal-use benchmarking, Corteva's six most recent agrochemical pesticidal active ingredients and four most recent GM crop events were evaluated. Across the six most recently developed active ingredients, an average of approximately 10,000 mammals were used for the testing of each (range: 5500-19,000); across the four most recently developed GM crops, the average number of vertebrates similarly used for each was approximately 1200 (range: 1000-1500). Though regulatory testing requirements are likely to change with time, as new technologies become available, this project has established a theoretical minimum requirement to help drive aspirational animal reduction goals, identified regulatory challenges associated with the reduction of animal-use, and helped to refine Corteva's vertebrate animal-use tracking approaches.

The use of adverse effect data from animals as the gold standard in regulatory toxicology has a long tradition dating back to the 1960s. It has also been increasingly criticised, based on both scientific and animal welfare concerns, and yet, animal studies remain the gold standard in most areas of toxicology to this very day. In the 1980s, when the first generation of non-animal methods were evaluated as alternatives to animal testing, it was logical to compare the 'new' data obtained with historical animal data. This worked reasonably well for simple endpoints, such as skin and eye irritation, but became problematic for the more complex systemic endpoints, since in these cases, the in vivo effects are not directly comparable to those observed in in vitro systems. While the need to redefine the gold standard is not new, there is still no consensus on how to do so. We propose a consistent principle that avoids the need for animal reference data, while also ensuring an equivalent or better level of protection. We argue that the gold standard can be redefined, or rather bypassed, by focusing on risk management outcomes rather than the outputs of animal methods. This allows us to more efficiently protect human health and the environment, ensuring the safe use of chemicals while also identifying less hazardous chemicals for use as substitutes. We describe how this might work out for two main contexts of use: classification and labelling, and risk assessment. This has implications for the implementation of the EU Commission Roadmap toward the phasing out of animal testing in chemical safety assessments.