Phenotypic characterisation provides important information about novel crops that helps their developers to make technical and commercial decisions. Phenotypic characterisation comprises two activities. Product characterisation checks that the novel crop has the qualities of a viable product-the intended traits have been introduced and work as expected, and no unintended changes have been made that will adversely affect the performance of the final product. Risk assessment evaluates whether the intended and unintended changes are likely to harm human health or the environment. Product characterisation follows the principles of problem formulation, namely that the characteristics required in the final product are defined and criteria to decide whether the novel crop will have these properties are set. The hypothesis that the novel crop meets the criteria are tested during product development. If the hypothesis is corroborated, development continues, and if the hypothesis is falsified, the product is redesigned or its development is halted. Risk assessment should follow the same principles. Criteria that indicate the crop poses unacceptable risk should be set, and the hypothesis that the crop does not possess those properties should be tested. However, risk assessment, particularly when considering unintended changes introduced by new plant breeding methods such as gene editing, often ignores these principles. Instead, phenotypic characterisation seeks to catalogue all unintended changes by profiling methods and then proceeds to work out whether any of the changes are important. This paper argues that profiling is an inefficient and ineffective method of phenotypic characterisation for risk assessment. It discusses reasons why profiling is favoured and corrects some misconceptions about problem formulation.

中文翻译：

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新农作物发展的问题表述和表型表征。

表型表征提供了有关新型农作物的重要信息，可帮助其开发人员做出技术和商业决策。表型表征包括两个活动。产品特性检查表明新作物具有可行产品的品质-已引入预期的性状并按预期工作，并且未进行会意外影响最终产品性能的意外更改。风险评估评估有意和无意的变化是否可能损害人类健康或环境。产品表征遵循问题制定的原则，即定义最终产品所需的特性，并设定决定新型作物是否具有这些特性的标准。在产品开发过程中检验了新型作物符合标准的假设。如果该假设得到证实，则开发会继续进行；如果该假设被伪造，则将重新设计产品或中止其开发。风险评估应遵循相同的原则。应该设定表明农作物构成不可接受风险的标准，并且应该检验农作物不具有这些特性的假设。但是，风险评估，尤其是在考虑新的植物育种方法（例如基因编辑）引入的意外变化时，往往会忽略这些原则。而是，表型表征试图通过概要分析方法对所有意外更改进行分类，然后继续确定任何更改是否重要。本文认为，概要分析是一种用于风险评估的表型表征的无效方法。它讨论了为什么支持概要分析的原因，并纠正了有关问题制定的一些误解。