Coordinator of the Golden Rice Network, International Rice Research Institute, Los Banos, Philippines
Copyright: International Rice Research Institute, 2011
In the last assessment of the pipeline of GM rice projects and prospective products (Stein and Rodríguez-Cerezo. 2009 Technical Report EUR 23486 EN), it was anticipated that up to 15 GM traits could be commercialized by 2015, and that these would come almost exclusively from Asia and that many also would be developed by public national centers. This assessment took into account those events or traits in the commercial and regulatory pipeline (5 events, including LLRICE62, in the US only) and those proposed to be in the advanced R&D pipeline (14 traits).
Reassessing the progress since then: one of the commercial pipeline events, Bt63, has received a biosafety certificate from the Chinese regulatory authority, but has yet to complete the varietal approval process (the validity of the biosafety certificate is until Aug, 17, 2014); two other events in China, KMD1 and Xa21, are no longer under active development in the country, and the other event, B827, had only a short- lived release in Iran. Of those in the advanced R&D pipeline, Golden Rice1 has been replaced with Golden Rice2, and many of the biotic and abiotic stress traits listed in the report have not advanced greatly. An exception can be found in the multiyear and event selection trials for new lepidopteran resistance materials in China and India. As will be discussed below, a number of these events could still be released by 2015.
In both China and India, there has been emerging government scrutiny of the release of GM traits in food crops, and the reticence to approve the products may be highlighted by the unfortunate handling of the Bt eggplant product in India: unfounded claims of health concerns with the Bt protein - one of the world’s most studied proteins and present in millions of hectares of maize and cotton grown annually in Brazil, Argentina, South Africa, and North America - has led to a delay in the final release of the product, in spite of obtaining biosafety clearance from the then final authority, the Genetic Engineering Approval Committee. The situation in India is also complicated by the fact that the new Biotechnology Regulatory Act of India and the Seed Law have still not been enacted. However, in neither India nor China, the apparent reticence has not slowed the advanced development of GM rice products, with noticeable increases in their field testing in recent seasons.
Agricultural biotechnology is a strategic industry for China and for now all GM rice development is being driven by mostly public sector institutions, but some of which have licensing agreements with prominent seed companies. In a recent review, Chen et al. reported on 17 advanced insect resistant GM rice projects, some of which also are combination traits with drought tolerance and herbicide tolerance (Chen, Shelton, and Ye, Annu. Rev. Entomol. 2011. 56:81-101 [Suppl]). Some of these traits are being developed in hybrid parents and in prominent varieties, suggesting a faster development path than those being developed in experimental, non-current varieties. In addition, at least one of these traits was started from more a thousand independent transformation events – a prerequisite often for the selection of a successfully performing commercial and “regulatory-ready” event.
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In India, late stage regulatory trials of Bt rice have been conducted by Maharashtra Hybrid Seeds Company (Mahyco). These efforts are closely followed by multilocation trials of additional Bt rice events and other traits, and some of these included event selection trials by BASF, Bayer CropScience, Pioneer Hi- Bred, and others (source: http://moef.nic.in/divisions/csurv/geac/information.html).The Golden Rice trait incorporates novel carotenoid biosynthetic genes that are expressed exclusively in the rice endosperm and leads to the accumulation of beta carotene in this edible portion of the rice grain; beta carotene in the plant-form precursor to vitamin A. A Golden Rice2 (Paine et al., 2005 Nat Biotechnol. 23: 482-487) event has been chosen for the project. The project has also secured additional funding from the Bill & Melinda Gates Foundation (to complement funding from the Rockefeller Foundation and the US Agency for International Development). Helen Keller International has joined the project to determine if the product will help alleviate vitamin A deficiency and if yes, to design a program to deliver the product to those most in need. It is anticipated that the regulatory dossier could be delivered to the regulators in the Philippines by as early as 2013 (www.irri.org/goldenrice).
A number of the leading GM rice traits/products have been examined in ex ante studies, with the most prominent on the economic and other advantages of Bt rice in China. One of these, conducted by Jikun HUANG and collaborators, compared the expected performance of Bt rice, in multiyear and multilocation field trials, to those of Bt cotton, already a success in China, because the Bt rice product was expected to have similar changes in seed cost, yield, labor costs, and pesticide reductions. These studies had also modelled the effect of a subsequent potential loss of the small rice export market from China to probably sensitive markets (e.g. Japan, Republic of Korea). These analyses predicted a net internal gain for rice production from Bt rice, five years following market introduction, of a multiple of the billion $ gain for the country from the introduction of Bt cotton (Huang, Hu, Rozelle, and Pray, 2005 Science 308: 688-690; ibid, 2008 Econ Development and Cultural Change 241- 261). An added aspect of these studies was a self-reported reduction in pesticide poisonings by the farm families in the Bt rice trials versus non-participants; these studies are being repeated in another large scale trial and will include clinical measurements of pesticide exposure (personal communication).
The effect of Golden Rice (and other nutritionally improved GM rice traits) on health consequences in a number of countries has studied using an ex ante Disability Adjusted Life Years (DALYs) approach to estimate the reduction in morbidity and mortality as a result of the adoption of these traits (Stein, Sachdev, and Qaim, 2006 Nat. Biotechnol. 24: 1200-1201; De Steur et al., 2010, Nat. Biotechnol. 28: 554-556). These current studies estimate that the traits would have significant impacts on the reduction of the health consequences of vitamin A deficiency and at costs often lower than those of other approaches. For Golden Rice, the existing studies were completed before the determination of the bioavailability/bioconversion rate of the beta carotene to vitamin A (more than 25% of the beta carotene in Golden Rice is converted to vitamin A in adults: Tang et al. 2009. Amer. J Clinical Nutr. 89:1776-83; later studies will report on related studies in children) and thus used much more pessimistic estimates of the conversion rate; plans are underway to update these ex ante studies.
In a rather novel valuation exercise, and one that has merited a Harvard Business School Case Study, Arcadia Biosciences is collaborating with the Ningxia Hui Autonomous Region (Ningxia) of China to establish a carbon credit methodology applicable to rice through the adoption of the GM Nitrogen Use Efficient trait developed by the company in the crop (http://hbr.org/product/arcadia-biosciences-seeds-of-