Canadian regulatory aspects of gene editing technologies

Abstract

The development of gene editing techniques, capable of producing plants and animals with new and improved traits, is revolutionizing the world of plant and animal breeding and rapidly advancing to commercial reality. However, from a regulatory standpoint the Government of Canada views gene editing as another tool that will join current methods used to develop desirable traits in plants and animals. This is because Canada focusses on the potential risk resulting from the novelty of the trait, or plant or animal product entering the Canadian environment or market place, rather than the process or method by which it was created. The Canadian Food Inspection Agency is responsible for the regulation of the environmental release of plants with novel traits, and novel livestock feeds, while Health Canada is responsible for the regulation of novel foods. Environment and Climate Change Canada, in partnership with Health Canada, regulates modified animals for entry into the environment. In all cases, these novel products may be the result of conventional breeding, mutagenesis, recombinant DNA techniques or other methods of plant or animal breeding such as gene editing. This novelty approach allows the Canadian regulatory system to efficiently adjust to any new developments in the science of plant and animal breeding and allows for risk-appropriate regulatory decisions. This approach encourages innovation while maintaining science-based regulatory expertise. Canadian regulators work cooperatively with proponents to determine if their gene editing-derived product meets the definition of a novel product, and whether it would be subject to a pre-market assessment. Therefore, Canada’s existing regulatory system is well positioned to accommodate any new innovations or technologies in plant or animal breeding, including gene editing.

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References

  1. CFIA (2018a) Questions and answers: genetically engineered petunias. http://www.inspection.gc.ca/plants/plants-with-novel-traits/general-public/questions-and-answers/eng/1504228888140/1504229002939. Retrieved 26 Sept 2018

  2. CFIA (2018b) RG-1 regulatory guidance: feed registration procedures and labelling standards

  3. CFIA (2018c) Directive 94-08 (Dir 94-08). Assessment criteria for determining environmental safety of plants with novel traits

  4. Environment and Climate Change Canada and Health Canada (2018) Regulation of animate products of biotechnology. https://www.canada.ca/en/environment-climate-change/services/managing-pollution/evaluating-new-substances/biotechnology-living-organisms/guidance-documents.html. Retrieved 1 Oct 2018

  5. Health Canada (2018) http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._870/FullText.html#h-144. Accessed 1 Oct 2018

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Acknowledgements

The authors thank Cécile Girard, Heather Shearer and Jordan Bean for their thoughtful review of the original presentation from which this manuscript is based, and the manuscript itself.

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Correspondence to Christine Tibelius.

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Ellens, K.W., Levac, D., Pearson, C. et al. Canadian regulatory aspects of gene editing technologies. Transgenic Res 28, 165–168 (2019). https://doi.org/10.1007/s11248-019-00153-2

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Keywords

  • Canada
  • Regulation
  • Legislation
  • Biotechnology
  • Gene editing
  • Novelty
  • Product-based
  • Plants with novel traits
  • Modified animals
  • The Canadian regulatory system