Carusi Annamaria
Interchange Research, London, E5 8JW, UK.
Wellcome Open Res. 2024 Sep 2;9:167. doi: 10.12688/wellcomeopenres.20581.2. eCollection 2024.
Regulating industrial chemicals in foodstuffs and consumer products is a major aspect of protecting populations against health risks. Non-animal testing methods are an essential part of the radical change to the framework for toxicity testing that is long overdue in global economies. This paper discusses reasons why the drive to reduce animal testing for chemical safety testing is so difficult to achieve, as perceived by those who are closely involved in chemicals regulations in different capacities. Progress is slow, despite the fact that the ethico-legal conditions for a move away from animal testing are largely in place, and despite scientific arguments for a radical change in the paradigm of toxicity testing, away from reliance on animal studies. I present empirical data drawn from two studies in a European Commission context promoting non-animal methods. The aim of the paper is modest. It is to foreground the voices of those who deal with the science and regulation of chemicals on a day-to-day basis, rather than to offer a theoretical framework for what I heard from them. I offer a synthesis of the main challenges faced by non-animal alternatives, as these are perceived by people in different stakeholder groups dealing with chemicals regulation. I show where there are pockets of agreement between different stakeholders, and where the main disagreements lie. In particular there is dispute and disagreement over what counts as validation of these alternative tests, and by implication of the traditional 'gold standard' of animal testing. Finally, I suggest that the shift to non-animal methods in chemicals regulation demonstrates the need for the concept of validation to be broadened from a purely techno-scientific definition, and be more explictly understood as a demand for trust and acceptance, with more attention given to the complex social, institutional and economic settings in which it operates.
对食品和消费品中的工业化学品进行监管是保护民众免受健康风险的一个主要方面。非动物测试方法是全球经济中早就应该进行的毒性测试框架彻底变革的重要组成部分。本文讨论了为何减少用于化学安全测试的动物实验的努力如此难以实现，这是那些以不同身份密切参与化学品监管的人士所感受到的。尽管事实上摆脱动物实验的伦理法律条件在很大程度上已经具备，而且尽管有科学论据支持毒性测试范式从依赖动物研究转向彻底变革，但进展依然缓慢。我展示了从欧盟委员会推动非动物方法的两项研究中得出的实证数据。本文的目标较为适度。它是为了突出那些日常处理化学品科学和监管事务的人士的声音，而不是为我从他们那里听到的内容提供一个理论框架。我综合了非动物替代方法面临的主要挑战，这些是处理化学品监管的不同利益相关者群体中的人们所感受到的。我指出了不同利益相关者之间达成一致的领域以及主要分歧所在。特别是在什么算作这些替代测试的验证以及隐含的动物测试传统“黄金标准”方面存在争议和分歧。最后，我认为在化学品监管中转向非动物方法表明需要将验证的概念从纯粹的技术科学定义中拓宽，并更明确地理解为对信任和接受的要求，同时更多地关注其运作所处的复杂社会、机构和经济环境。
