Micronutrient deficiencies such as iron (Fe), zinc (Zn), and vitamin A, constitute a severe global public health phenomenon. Over half of preschool children and two-thirds of nonpregnant women of reproductive age worldwide have micronutrient deficiencies. Biofortification is a cost-effective strategy that comprises a meaningful and sustainable means of addressing this issue by delivering micronutrients through staple foods to populations with limited access to diverse diets and other nutritional interventions. Here, we report on the proof-of-concept and early development stage of a collection of biofortified rice events with a high density of Fe and Zn in polished grains that have been pursued further to advance development for product release. In total, eight constructs were developed specifically expressing dicot ferritins and the rice nicotianamine synthase 2 (OsNAS2) gene under different combinations of promoters. A large-scale transformation of these constructs to Bangladesh and Philippines commercial indica cultivars and subsequent molecular screening and confined field evaluations resulted in the identification of a pool of ten events with Fe and Zn concentrations in polished grains of up to 11 μg g−1 and up to 37 μg g−1, respectively. The latter has the potential to reduce the prevalence of inadequate Zn intake for women of childbearing age in Bangladesh and in the Philippines by 30% and 50%, respectively, compared to the current prevalence. To our knowledge, this is the first potential biotechnology public-sector product that adopts the product cycle phase-gated approach, routinely applied in the private sector.

Dietary iron (Fe) deficiency affects 14% of the world population with significant health impacts. Biofortification is the process of increasing the density of vitamins and minerals in a crop, through conventional breeding, biotechnology approaches, or agronomic practices. This process has recently been shown to successfully alleviate micronutrient deficiency for populations with limited access to diverse diets in several countries (https://www.harvestplus.org/). The Fe breeding target in the HarvestPlus program was set based on average rice consumption to fulfil 30% of the Estimated Average Requirement of Fe in women and children. In this review, we present the reported transgenic approaches to increase grain Fe. Insertion of a single or multiple genes encoding iron storage protein, metal transporter, or enzyme involved in the biosynthesis of metal chelator in the rice genome was shown to be a viable approach to significantly increase grain-Fe density. The most successful approach to reach the Fe breeding target was by overexpression of multiple genes. Despite this success, a significant effort of 8–10 years needs to be dedicated from the proof of concept to varietal release. This includes large-scale plant transformation, event selection, collection of data for premarket safety assurance, securing biosafety permits for consumption and propagation, and collection of data for variety registration.

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