EC decision on gene editing and other new biotechnologies; what does it mean for researchers and plant breeders?

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1 EC decision on gene editing and other new biotechnologies; what does it mean for researchers and plant breeders? Huw Jones PhD, FRSB Professor of Translational Genomics for Plant Breeding Institute of Biological, Environmental & Rural Sciences Aberystwyth University SY23 3EE Member of EFSA GMO Panel since 2009 Honorary Professor, School of Bioscience, Nottingham University Honorary Scientist, Rothamsted Research Monogram NIAB Cambridge April 2016

2 Initially, the Commission s opinion was due by the end of 2015, but the procedure was postponed. The Commission intends to complete the legal analysis on new breeding techniques by the first quarter of 2016, an EU spokesperson told EurActiv

3 A spokesperson from the EC said we are currently working on a legal analysis to give guidance on how to interpret the definition of GMOs in relation to organisms produced by new plant breeding techniques, The EC added that both the outcome and the timeline cannot be pre-empted for the time being. The ball has been kicked into the long grass

4 Lack of certainty in EU has serious implications for: Research, Innovation in breeding/healthcare and Trade I urge the commission to stimulate democratic innovation in plant breeding by excluding simple genome editing from current GMO regulation

5 Genome editing: Suite of technologies for targeted changes to genomes Site-directed nucleases such as ZFN, Talens or Crispr Cas-9 can be programmed to make indel mutations in any target sequence. A. A Zinc-Finger finger nuclease (ZFN) Oligo-nucleotide Directed Mutagenesis B TALEN B. Talens C CRISPR Cas-9 C. CRISPR CAS-9 Jones HD (2016) Biotechnology of Major Cereals, CABI HD Jones (2015) Nature Plants 1: 14011

6 Lots of research activity and publications Bortesi & Fischer (2015) The CRISPR/Cas9 system for plant genome editing and beyond. Biotechnology Advances 33 (2015) 41 52

7 Also coverage in main-stream news media University of California, Berkeley Professor of Chemistry Jennifer A. Doudna and Ulmea University Professor and Microbologist Emmanuelle Charpentier (R) speak onstage during the Breakthrough Prize Awards Ceremony Deoxyribonucleic acid (DNA) strands from a double helix model on display at the Science Museum April 23, 2003 in London Getty

8 Both for human applications..

9

10 And crop science / plant breeding

11 What s the problem in the EU? EU GMO regulations (EC 2001/18) defines a GMO as any novel organism made using recombinant DNA technology It is unclear whether crops modified using these genome editing technologies will be regulated as GMOs. This uncertainty is already hampering applied research, innovation and commercial plant breeding. The EC has been considering this question since 2007 and recent feedback from commission does not indicate and early resolution. My view: There are some applications of these techniques (ie. where no recombinant DNA remains in the commercialised plant and where the 'edit' is indistinguishable from a natural mutation) that should NOT to be regulated as a GMO.

12 Genome editing is not one thing Type 0 no change to DNA sequence Deactivated CAS-9 / altered epigenetic marks / transcriptional control Type 1 Site-directed mutagen; double-stranded breaks DNA repair via NHEJ; allele excision Type 2 SDN plus repair template (also ODM) Intentional small edits to native DNA via HR Type 3 Insert new gene into safe harbour Targeted GMO via HR (but allele replacement could be placed on other end of spectrum) < Naturalness / Interventionist / Detectable < Conventional breeding accessing variation in gene pool 1 only Conventional GMOs via random insertion of foreign DNA

13 SDN in type I mode GMO or not? Inserted recombinant DNA GMO in EU Conventional GM Host genome GMO in EU Mutation breeding (excl. from GMO regs) Host genome Inserted recombinant DNA removed by segregation = null segregant Gene editing via SDN GMO in EU? Only newly generated INDEL remains Targeted edit indistinguishable to unlinked from gene natural in host genome mutation

14 Global regulatory oversight of genome editing USDA have ruled that at least three products generated using genome editing are NOT Regulated products (a lowphytate maize, a HT canola and a mildew-resistant wheat). Canada use trait-based regulation but calls in all GMOs anyway Argentina and Japan have given guidance that on a case-bycase basis Type I & 2 genome editing would not be regulated as a GMO EC seems to have kicked the decision into the long grass!

15 Revision of the US Coordinated Framework for Regulation of Biotechnology

16 A ruling by New Zealand's Environmental Protection Authority that would have allowed new GM products developed by "genome editing" techniques to escape GMO regulation has been quashed in the High Court. This is an important precedentsetting case, won by the New Zealand Sustainability Council

17 Argentinian approach to assessing new biotechnologies Whelan & Lema (2015), Regulatory framework for gene editing and other new breeding techniques (NBTs) in Argentina. GM Crops & Food, 6:

18 Gene Repair OligoNucleotide (GRON) technology FOR IMMEDIATE RELEASE Cibus Global Announces Approval of First Commercial Product SU Canola in Canada San Diego (March 18, 2014) Cibus Global, a cutting-edge precision gene editing firm, announced today that its first commercial product Sulfonylurea Tolerant Canola has received Plant Novel Trait approval by the Canadian Food Inspection Agency. About Cibus Global Cibus Global is a leading precision gene editing company with a unique, patented technology for naturally modifying cell functions. Its technology enables access to global multibilliondollar markets in agriculture, specialty chemicals, and human health. It offers a disruptive alternative to transgenic (GM or GMO) approaches. Our core purpose is to lead the transition to sustainable agricultural and industrial products and improved human health by safely harnessing Nature s own genetic diversity.

19 A wheat variety rendered mildew-resistant through the targeted gene knockout via genome editing can be commercialized without clearing USDA regulatory hurdles for biotech crops. U.S. Wheat Associates said Ultimately, the marketplace will determine whether varieties developed with this new gene editing technology will be accepted. Developed by Calyxt, a subsidiary Cellectis,

20 Other relevant issues DuPont (via Caribou) have major interest in CC IP & will soon announce new crop varieties using gene editing. But they do not want to repeat mistakes but by early GMO commercialisation - licencing will be easy Jen Doudna, Emm Charpentier & Feng Zhang will soon win a Nobel prize. Major impact on public opinion.

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