Compliance costs for regulatory approval of c4 rice

Abstract

So far, most new biotech crops have been developed by transforming one or two genes with preferred traits. Compliance costs for regulatory approval of this type of crop vary among countries and according to whether the new biotech crop is a food or non-food crop. However, whether a new biotech crop with multiple transformed genes would cost significantly more and take much more time to be approved is unknown. This paper estimates the compliance costs for the regulatory approval of C4 rice, a new GM rice plant required several gene transformations, assuming it would be realized simultaneously in the 13 Asian countries in 2035. We found it to be $18.8 million (undiscounted), around 16.3% of the total research and development (R&D) costs. We also estimated the present value of R&D costs for C4 rice in 2017 prices to be approximately $106 million. These estimated R&D costs could be useful to quantity the net welfare benefits from the introduction of C4 rice. In addition, donors could use this result as a guideline to fund additional investment required to develop C4 rice.