The safety assessment of all foods derived from genetically engineered plants is based on the evaluation of these foods relative to their conventional counterparts that have a history of safe use. This concept has been described in international consensus documents, such as the Principles for the Risk Analysis of Foods Derived from Modern Biotechnology and the Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants published by the Codex Alimentarius Commission.
In conducting the safety assessment of food/feed derived from GR2E Golden Rice, a number of criteria have been addressed including:
- characterisation of the transferred genes and their origin, function, and stability in the rice genome;
- characterization and concentrations of newly expressed proteins in the whole food;
- comprehensive nutrient compositional analyses of grain, straw, and derived bran;
- evaluation of intended and unintended changes; and
- the potential for any newly expressed proteins to be either allergic or toxic in humans or animals.
The purpose of these evaluations was to determine whether the use of GR2E Golden Rice in food, feed, or for processing, would raise any new safety concerns relative to conventional rice. The studies were not intended to address questions related to the efficacy of GR2E Golden Rice in helping to address vitamin A deficiency in affected population sub-groups, which can only be adequately addressed following regulatory authorization.
No potential public health and safety concerns were identified in the assessment of GR2E Golden Rice. Collectively, the data support the conclusion that food and/or livestock animal feed derived from provitamin A biofortified GR2E rice is as safe as food or feed derived from conventional rice varieties.