Problem formulation and phenotypic characterisation for the development of novel crops

Area of Science:

• Agricultural Science
• Biotechnology
• Genetics

Background:

• Phenotypic characterisation is vital for novel crop development, informing technical and commercial decisions.
• It involves product characterisation (verifying intended traits and absence of adverse unintended changes) and risk assessment (evaluating potential harm to health or environment).
• Current practices, especially with new plant breeding methods like gene editing, often deviate from established problem formulation principles in risk assessment.

Purpose of the Study:

• To critically evaluate the effectiveness of profiling methods in phenotypic characterisation for risk assessment of novel crops.
• To argue that profiling is an inefficient and ineffective approach for risk assessment.
• To clarify and correct misconceptions regarding problem formulation in the context of novel crop development and risk assessment.

Main Methods:

• The paper reviews the principles of problem formulation as applied to product characterisation and risk assessment.
• It contrasts these principles with current practices in phenotypic characterisation, particularly the use of profiling for unintended changes.
• The study analyzes the reasons behind the preference for profiling methods.

Main Results:

• Profiling methods, used to catalogue all unintended changes in novel crops, are demonstrated to be inefficient and ineffective for risk assessment.
• The current approach often bypasses the crucial step of setting clear criteria for acceptable risk.
• Misconceptions about problem formulation contribute to the reliance on inefficient profiling techniques.

Conclusions:

• Phenotypic characterisation for risk assessment should adhere to problem formulation principles, focusing on predefined criteria for unacceptable risk.
• Profiling is not an optimal strategy for identifying and evaluating significant unintended changes.
• A return to rigorous problem formulation is necessary for robust and efficient risk assessment in novel crop development, especially with advanced breeding technologies.