Abstract

The regulation of plant breeding is gaining increasing scrutiny, particularly as it pertains to the regulation of gene editing and other new breeding technologies. Genome editing is used worldwide in both public and private plant breeding laboratories and there is considerable uncertainty about the ability of regulatory agencies to match the rapid scientific pace being set. This research focuses on Canada, where advances in plant breeding technology are constrained by the boundaries of the regulatory system established in the early 1990's. This research presents the results of a survey of 93 public and private plant breeders and their views on the existing Canadian regulatory framework regarding conventional breeding and genome editing techniques for plants with novel traits (PNTs). The results contribute to the ongoing debate regarding how, or whether, to regulate products of genome-edited plant breeding, beyond the existing agronomic and safety requirements. Plant breeders identify the level of Canadian crop research competitiveness and quantify the impacts of novelty within Canada's regulatory system for PNTs. One significant finding is that PNT regulations in Canada have created an innovation barrier in terms of applying genome editing technologies to the development of new varieties, particularly in public sector research.

Highlights

  • Regulatory uncertainty is one of, if not the, leading determinant for global research and development (R&D) investment

  • The regulatory uncertainty that exists within the European Union (EU) regarding the approval of genetically modified (GM) crops has resulted in multinational companies relocating much of their agricultural R&D activities to jurisdictions more conducive to the commercialization of these crop technologies (Smyth, 2019)

  • The high percentage of not responding leads us to question whether they are indifferent, or not willing to state how regulations have influenced their research. This survey of Canadian public and private plant breeders reveals there is cause for some concern regarding plants with novel traits (PNTs) regulations acting as a barrier to innovation

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Summary

Introduction

Regulatory uncertainty is one of, if not the, leading determinant for global research and development (R&D) investment. The regulatory uncertainty that exists within the European Union (EU) regarding the approval of genetically modified (GM) crops has resulted in multinational companies relocating much of their agricultural R&D activities to jurisdictions more conducive to the commercialization of these crop technologies (Smyth, 2019). It has never been more important for countries to have efficient regulatory systems, given the importance of regulatory competitiveness and attracting global R&D investment. Regulatory barriers carry significant costs, both fiscal and time to market. Smyth et al (2014) identify that regulatory barriers of 6 years reduce the return on investment to zero for private sector investors, while 2-year delays reduce the public sector returns to zero

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