Safety Assessment of Food and Feed Derived from GM Crops: Using Problem Formulation to Ensure “Fit for Purpose” Risk Assessments

Collection of Biosafety Reviews. 2013;8:72-101

Abstract:  All genetically modified (GM) crops intended for use in food and feed must be assessed for their safety to humans and animals. The data and methodology used to conduct these assessments has been developed over many years. International organisations like the Food and Agriculture Organization (FAO) of the United Nations, the World Health Organization (WHO) and the Organisation for Economic Cooperation and Development (OECD) have been facilitating the harmonisation of food and feed risk assessment methodologies. The Codex Alimentarius Commission, established by FAO and WHO in 1963, has developed harmonised international food standards, guidelines and codes of practice and promoted coordination of all food standards work undertaken by international governmental and nongovernmental organisations. The risk assessments undertaken to assess the safety of GM crops used in food and feed follow these standards. These risk assessments are conducted to support national regulatory authorities in making decisions on whether or not to approve the use of a GM crop in their country. Thus, the risk assessments must comply with every requirement outlined in the country’s regulatory framework and provide clearly laid out robust scientific information to facilitate this decision-making process. In other words, the risk assessment must be “fit for purpose”, clearly providing the necessary information. Using the problem formulation methodology in risk assessments provides a tool to ensure that the assessments are fit for purpose. Problem formulation takes into account national protection goals and key regulatory requirements and drives the compilation of information relevant for the assessment. Given the wealth of information on food and feed risk assessment methods and the existence of internationally-agreed consensus documents, the aim of this review is not to provide a comprehensive guide on how to conduct food and feed risk assessments. The aim is rather to demonstrate how problem formulation can be used in these assessments to ensure that they are fit for purpose and can indeed facilitate decision-making.

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