Regulatory Challenges Presented by Genome Editing Industry Perspective. 29 Nov 2017 / Felicity Keiper

Transcription

1 Regulatory Challenges Presented by Genome Editing Industry Perspective 29 Nov 2017 / Felicity Keiper

2 Genome Editing in Plant Breeding Genome editing for targeted modifications/introductions of one or more genes Technology development Multiple rounds of crossing and selection to integrate the desired traits into elite breeding lines Variety development and selection + Trait discovery One or more trait(s) developed using gene editing crossing Selection for multiple traits Commercial seeds Elite lines Variety with new / improved traits Page 2

3 Why are we Concerned with Regulation? Globally there is limited clarity on the regulatory status of genome editing Page 3

4 Why are we Concerned with Regulation? Globally there is limited clarity on the regulatory status of genome editing Page 4

5 Why are we Concerned with Regulation? Globally there is limited clarity on the regulatory status of genome editing Page 5

6 Why are we Concerned with Regulation? Globally there is limited clarity on the regulatory status of genome editing Page 6

7 Why are we Concerned with Regulation? Example: Australian grain export countries (wheat, barley, maize, oats, canola, sorghum) * Regulated according to existing regulatory frameworks applicable to genetically modified organisms Page 7

8 Regulatory Status of Genome Editing Genome editing is used in plants for targeted genetic modification, resulting in different categories of plant products with different regulatory status Targeted editing of native DNA sequences SDN-1 SDN-2 ODM Genome Editing Targeted insertion of gene sequences SDN-3 SDN-3 Page 8

9 Regulatory Approaches to Genome Editing Product-based Am I Regulated Under 7 CFR part 340? Case-by-case determination of whether the product is a regulated article 2017 proposed revisions to 7 CFR part 340 withdrawn stakeholder consultation ongoing Regulated where it presents a plant pest or noxious weed risk: the plant itself is a pest, the development technique involved the use of plant pests, or the insertion of plant pest sequences Several genome edited crops determined to have non-regulated status (see Letters of Enquiry) Sulfonylurea-tolerant canola (ODM) Corn with reduced phytate production (ZFN/SDN-1) Rice with disease resistance (TALEN/SDN-1) Waxy corn with high amylopectin starch production (CRISPR/SDN-1) Non-browning white button mushrooms (CRISPR/SDN-1) Wheat with improved powdery mildew-resistance (TALEN/SDN-1) Drought and salt tolerant soybean (CRISPR/SDN-1) Alfalfa with improved nutritional content (TALEN/SDN-1) Page 9

10 Regulatory Approaches to Genome Editing Product-based No GMO regulatory framework Only true product-based system: case-by-case assessment of product irrespective of process Regulation triggered by expression of a novel trait irrespective of technology used to introduce it GM / genome edited plants are not automatically novel Novelty requires new traits, changed traits or new uses Product is regulated where the novel trait is (i) new to the Canadian environment (did not exist before 1996), and (ii) has the potential to affect the specific use and safety of the plant with respect to the environment and human health New techniques can be managed by the existing novel trait regulatory framework Sulfonylurea-tolerant canola (ODM) approved in 2013 (see Determination DD ) Page 10

11 Regulatory Approaches to Genome Editing Argentina First country with a process-based regulatory scheme to clarify the regulatory status of plants developed using genome editing methods Res 173/15 Products assessed on a case-by-case basis to determine if new combination of genetic material Data submitted to demonstrate absence of a joint and stable insertion into the plant genome of one or more genes or DNA sequences that are part of a defined genetic construct Includes an Early Consultation Procedure for hypothetical expected products in the early design stage System is functional: ODM & SDN-1 crops determined to have non-regulated status New combination of genetic material? 60 days No Yes Not regulated under Res 763/11 for activities with GMOs Regulated under Res 763/11 for activities with GMOs Page 11

12 Regulatory Approaches to Genome Editing Chile Method to establish on a case-by-case basis if the genome edited plant product is in/out of the scope of Resolution Nº 1523 of 2001 Decision within 20 working days Operational since Aug 2017 Brazil Draft Normative Resolution Anticipated to be generally aligned with Argentina and Chile Expected by end 2017 Australia Technical Review of the Gene Technology Regulations Commenced Oct 2016 Purpose to clarify application to genome editing Interim solution: SDN-1 excluded from regulatory scope Third review of the National Scheme for the Regulation of Gene Technology Commenced Jul 2017 Currently in Phase Two Consultations Review of how the Food Standards Code applies to food derived using new technologies Commenced Jun 2017 Scope: definitions of Standard Page 12

13 Industry View Principle Plant varieties developed through the latest breeding methods should not be differentially regulated if they are similar or indistinguishable from varieties that could have been produced through earlier breeding methods. Criteria not in the scope of GMO regulation where: It does not contain a novel combination of genetic material The final plant product solely contains the stable insertion of inherited genetic material from sexually compatible plant species Any form of mutagenesis is involved Page 13

14 Regulatory Status of Genome Editing Summary Globally there is limited clarity on the regulatory status of genome editing The few countries with product-based regulation have continued to apply existing regulatory provisions (e.g. US & Canada) Few countries with process-based regulations have implemented new rules providing exclusions (e.g. Argentina & Chile; to come Australia & Brazil) Majority of countries yet to decide challenged by reconciling product-based triggers with proportionate risk regulation Industry view: plant products of genome editing should not be regulated as GMOs when they could also be developed using conventional methods of plant breeding Because, regulation should be science-based and proportionate to the risk associated with the product Page 14

15 Thank you! Contact: Felicity Keiper