Lanzoni Anna, Castoldi Anna F, Kass George En, Terron Andrea, De Seze Guilhem, Bal-Price Anna, Bois Frédéric Y, Delclos K Barry, Doerge Daniel R, Fritsche Ellen, Halldorsson Thorhallur, Kolossa-Gehring Marike, Hougaard Bennekou Susanne, Koning Frits, Lampen Alfonso, Leist Marcel, Mantus Ellen, Rousselle Christophe, Siegrist Michael, Steinberg Pablo, Tritscher Angelika, Van de Water Bob, Vineis Paolo, Walker Nigel, Wallace Heather, Whelan Maurice, Younes Maged
European Food Safety Authority IT.
European Commission Joint Research Centre Ispra IT.
EFSA J. 2019 Jul 8;17(Suppl 1):e170712. doi: 10.2903/j.efsa.2019.e170712. eCollection 2019 Jul.
The current/traditional human health risk assessment paradigm is challenged by recent scientific and technical advances, and ethical demands. The current approach is considered too resource intensive, is not always reliable, can raise issues of reproducibility, is mostly animal based and does not necessarily provide an understanding of the underlying mechanisms of toxicity. From an ethical and scientific viewpoint, a paradigm shift is required to deliver testing strategies that enable reliable, animal-free hazard and risk assessments, which are based on a mechanistic understanding of chemical toxicity and make use of exposure science and epidemiological data. This shift will require a new philosophy, new data, multidisciplinary expertise and more flexible regulations. Re-engineering of available data is also deemed necessary as data should be accessible, readable, interpretable and usable. Dedicated training to build the capacity in terms of expertise is necessary, together with practical resources allocated to education. The dialogue between risk assessors, risk managers, academia and stakeholders should be promoted further to understand scientific and societal needs. Genuine interest in taking risk assessment forward should drive the change and should be supported by flexible funding. This publication builds upon presentations made and discussions held during the break-out session 'Advancing risk assessment science - Human health' at EFSA's third Scientific Conference 'Science, Food and Society' (Parma, Italy, 18-21 September 2018).
当前/传统的人类健康风险评估范式受到了近期科技进步和伦理要求的挑战。当前的方法被认为资源消耗过大，并不总是可靠，可能会引发可重复性问题，大多基于动物实验，而且不一定能让人了解毒性的潜在机制。从伦理和科学的角度来看，需要进行范式转变，以提供能够进行可靠的、无动物的危害和风险评估的测试策略，这些评估基于对化学毒性的机理理解，并利用暴露科学和流行病学数据。这种转变将需要一种新的理念、新的数据、多学科专业知识以及更灵活的法规。对现有数据进行重新整理也被认为是必要的，因为数据应该是可获取、可读、可解释和可用的。需要进行专门培训以培养专业知识能力，同时要为教育分配实际资源。应进一步促进风险评估人员、风险管理人员、学术界和利益相关者之间的对话，以了解科学和社会需求。推动风险评估向前发展的真正兴趣应推动这一变革，并应得到灵活资金的支持。本出版物基于在欧洲食品安全局第三届科学会议“科学、食品与社会”（2018年9月18 - 21日，意大利帕尔马）的“推进风险评估科学——人类健康”分组会议期间所做的报告和讨论。
