Plant breeding innovation: A global regulatory perspective

Abstract

Background and objectivesWhile there has been continued improvement and increasing accessibility of enabling biotechnological tools, their ultimate deployment and range of applications in support of plant breeding will largely depend on how the resulting products are regulated and the extent of premarket assessment required. The features of GMO regulatory systems throughout the world are reviewed, with a focus on recent developments aimed at clarifying their application to biotechnological tools used for targeted mutagenesis and transfer of genetic material between crossable species.FindingsTo date, regulatory clarity for biotechnological innovations in plant breeding is limited to a small number of countries; the few countries with product‐based regulatory systems are generally able to continue using exiting regulatory provisions, and others have provided timely solutions that can result in the exclusion of some types of plant products from the scope of GMO regulations. However, the majority of countries are yet to take decisions on the topic. Their challenge is to achieve proportionate risk regulation for products developed using recent biotechnological tools that can result in a range of products, from transgenic plants to plants that are indistinguishable from conventionally bred plants.ConclusionsThe challenges for providing clarity on the regulation of plant breeding innovations are strongly linked to the features of the existing GMO regulations. Countries that regulate product risks are better equipped to adapt to technological change; conversely, countries that use process‐based regulatory triggers face the challenge of continuously adjusting to technological development and will lag behind unless they can timely develop criteria for regulatory exclusions. As a consequence of these different approaches, adopters of plant breeding innovations are faced with an uncertain and complex global regulatory situation that is unlikely to be resolved in the near future.Significance and noveltyThis review of the global regulatory status of plant breeding innovations demonstrates that to date, few countries have provided regulatory clarity. However, regulatory clarity, including consistent and predictable legislation with clear scope, triggers, and technical criteria, is required to facilitate technology adoption. The current uncertain and complex global regulatory situation is stifling innovation and the realization of the full potential of these technologies.