Capalbo Deise M F, Macdonald Phil, Fernandes Patricia Machado Bueno, Rubinstein Clara, Vicién Carmen
Embrapa Environment and International Life Sciences Institute, São Paulo, Brazil.
Canadian Food Inspection Agency, Ottawa, ON, Canada.
Front Bioeng Biotechnol. 2020 Jan 28;7:463. doi: 10.3389/fbioe.2019.00463. eCollection 2019.
Problem formulation is the formal opening stage of a risk assessment that determines its purpose and scope and hence guides the gathering of information data. The concepts of familiarity and history of safe use are an integral part of problem formulation. These concepts do not replace the case-by-case approach and are not taken as safety standards but are valuable components of the process that shape the generation of plausible, testable risk hypotheses. The International Life Sciences Institutes in Brazil and Argentina have facilitated numerous discussions on the scientific principles for risk assessment of transgenic crops in the Latin American region in the past 5-6 years. The session held at ISBR 15th elaborated on the familiarity concept and derived tools and their role in the evolution of risk evaluation criteria. Examples of how different countries in the Americas interpret and apply these conceptual tools show that familiarity is a valuable concept, although terms are very often confused and vaguely defined. Formalizing these terms with clear definitions and scope of application in guidelines and regulatory documents would reduce ambiguity, enhance predictability, and add transparency to the evaluation processes.
问题设定是风险评估的正式起始阶段，它确定风险评估的目的和范围，从而指导信息数据的收集。熟悉程度和安全使用历史的概念是问题设定不可或缺的一部分。这些概念并非取代逐案处理方法，也不作为安全标准，但它们是塑造合理、可检验风险假设生成过程的重要组成部分。在过去五六年里，巴西和阿根廷的国际生命科学研究所推动了拉丁美洲地区转基因作物风险评估科学原则的多次讨论。在国际生物风险研究学会第15届会议上举行的会议详细阐述了熟悉程度概念及其衍生工具，以及它们在风险评估标准演变中的作用。美洲不同国家对这些概念工具的解释和应用示例表明，熟悉程度是一个有价值的概念，尽管这些术语常常被混淆且定义模糊。在指南和监管文件中用清晰的定义和适用范围对这些术语进行规范，将减少模糊性，增强可预测性，并提高评估过程的透明度。
