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      Problem formulation and phenotypic characterisation for the development of novel crops.

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          Abstract

          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.

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          Author and article information

          Journal
          Transgenic research
          Springer Science and Business Media LLC
          1573-9368
          0962-8819
          August 2019
          : 28
          : Suppl 2
          Affiliations
          [1 ] Syngenta Crop Protection AG, Rosentalstrasse 67, 4002, Basel, Switzerland. alan.raybould@syngenta.com.
          Article
          10.1007/s11248-019-00147-0
          10.1007/s11248-019-00147-0
          31321696
          f217cbce-bdad-41ff-8f89-bf1db50c4624
          History

          Plant breeding,Risk assessment,Profiling,Product characterisation,Hypothesis testing,Decision-making

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