Tachibana Kaoruko, Kass George E N, Ono Atsushi, Yamada Takashi, Tong Weida, Doerge Daniel R, Yamazoe Yasushi
Department of Environmental Medicine, Kochi Medical School, Kohasu, Oko-cho, Nankoku-shi, Kochi 783-8505, Japan.
Food Safety Commission of Japan, Cabinet Office, Government of Japan, Akasaka Park Bldg, 22F, 5-2-20 Akasaka, Minatoku, Tokyo 107-6122, Japan.
Food Saf (Tokyo). 2019 Nov 22;7(4):83-89. doi: 10.14252/foodsafetyfscj.2018017. eCollection 2019 Dec.
This is a summary report of FSCJ (Food Safety Commission of Japan) workshop entitled "Future Challenges and Opportunities in Developing Methodologies for Improved Human Risk Assessments, which held in November 2018. Scientific advancements have facilitated the development of new methods for chemical risk assessments with the expansion of toxicological databases. They are promising tools to overcome challenges, such as situations of data insufficiency, estimation of internal exposure and prediction of hazard, and enable us to improve our human health risk assessment in food safety. In this review, current understandings on developments in chemical risk assessments, especially focusing on Threshold of Toxicological Concern (TTC) approach, non-testing and approaches (e.g. read-across), and physiologically based pharmacokinetics (PBPK) modeling are discussed as possible promising tools. It also discusses future challenges and opportunities regarding social environment buildings in which all stakeholders including scientific experts, risk managers and consumers are able to accept these new risk assessment technologies. International collaboration would increase and enhance the efficiency in forming innovative ideas and in translating them into regulatory practices. It would strengthen technical capacity of experts who contribute to regulatory decisions and also promote acceptance of new methodologies among stakeholders. Cross-sectional collaboration such as making good use of human data of pharmaceutical drugs will facilitate a development of fresh tools for food safety domains. Once a new methodology is recognized in risk assessment agencies as implementable, it needs to be acknowledged and accepted by wider range of different stakeholders. Such stakeholders include scientific experts who conduct risk assessment for the risk assessment agencies, food industries and consumers. Transparency in the risk assessment work performed by regulatory agencies should strengthen their credibility and promote the acceptance of risk assessment including the new methodologies used in it. At the same time, efforts should be continued by regulatory agencies to further communicate with consumers about the concept of risk-based assessment as well as the concept of uncertainty.
这是日本食品安全委员会（FSCJ）于2018年11月举办的题为“改进人类风险评估方法的未来挑战与机遇”研讨会的总结报告。随着毒理学数据库的扩展，科学进步推动了化学风险评估新方法的发展。它们是应对数据不足、内暴露估计和危害预测等挑战的有前景的工具，使我们能够改进食品安全领域的人类健康风险评估。在本综述中，将讨论化学风险评估发展方面的当前认识，特别是关注毒理学关注阈值（TTC）方法、非测试方法（如类推法）和基于生理的药代动力学（PBPK）建模等可能有前景的工具。还将讨论社会环境建设方面的未来挑战与机遇，在这样的环境中，包括科学专家、风险管理者和消费者在内的所有利益相关者都能够接受这些新的风险评估技术。国际合作将增加并提高形成创新想法并将其转化为监管实践的效率。这将加强为监管决策做出贡献的专家的技术能力，并促进利益相关者对新方法的接受。跨领域合作，如充分利用药品的人体数据，将有助于开发食品安全领域的新工具。一旦一种新方法在风险评估机构中被认为可实施，就需要得到更广泛不同利益相关者的认可和接受。这些利益相关者包括为风险评估机构进行风险评估的科学专家、食品行业和消费者。监管机构进行的风险评估工作的透明度应增强其可信度，并促进包括其中使用的新方法在内的风险评估的接受。与此同时，监管机构应继续努力，就基于风险的评估概念以及不确定性概念与消费者进行进一步沟通。
