OVERVIEW - STATUS OF SCIENCE AND TECHNOLOGY ADVANCES IN AGRICULTURE BIOTECHNOLOGY Jaipur, 9-10 October 2014 Peter Kearns, PhD OECD New Plant Breeding Techniques – Working Group on Harmonization of Regulatory Oversight in Biotechnology (WG) – Emerging issues in harmonization – Discussion of new products and techniques used to produce them • • • • New traits – abiotic stress tolerance and industrial New breeding techniques Transportability of data Consensus documents might result WG Activities: NPBTs • To gathering information on NPBT and country experience • Workshop • Questionnaire circulated to gather country information – Six questions – 21 responses Purpose Information gathering Understand the products developed using NPBT Understand the techniques Share practical experiences with ERA of products developed using NPBT • Identify any new safety issues associated with products and/or with techniques themselves. • Identify any differences in approaches to ERA between countries • • • • • Use for Working Group discussion of potential next steps. New Plant Breeding Techniques (NPBTs)* • • • • • • • Agro-infiltration Cisgenesis/intragenesis Grafting on GM rootstock Oligonucleotide directed mutagenesis (ODM) Reverse breeding Site-directed nucleases (e.g. zinc finger nucleases) RNA-dependent DNA methylation *Lusser et al. (2012), “Deployment of New Biotechnologies in Plant Breeding”, Nature Biotechnology, 30, pp. 231-239. Questionnaire Responses • • • • • • • • • • • Argentina Austria Australia Bangladesh Belgium Canada Czech Republic Finland Germany Ireland Japan • • • • • • • • • • Mexico Netherlands Norway South Africa Switzerland Turkey United Kingdom United States European Commission Business Industry Advisory Committee Workshop Participation • 130 registered participants • OECD Member Countries – Enhanced engagement countries – Other observer countries – International organizations Workshop Issues • Overview of Techniques – Maria Lusser • Overview of research and products and views of ERA – Academic or public perspective – Corporate • Country Experience and perspective – Argentina, Australia, Japan, Netherlands, South Africa, United States, European Commission – Selected from questionnaire responses Results • Objective was to obtain more insight on ER/SA of NPBTs – More understanding on the type of plants in development with NPBT. – Sharing perspectives/experiences on ER/SA of products developed by NPBT. – Obtain input for the programme of the Workshop. • Responses and output – 21 responses submitted. – Summary of responses to the questionnaire: being prepared for publication What is considered NPBT Question I: Does your country consider NPBT? Which techniques does your country consider as NPBT? • Most countries indicate considering NPBT Cisgenesis/Intragenesis Grafting on GM rootstock • Techniques mentioned by Lusser, 2012 Oligonucleotide Directed Mutagenesis (ODM) • Other techniques mentioned (among others): • Accelerated breeding • RNAi • CRISPr/Cas Reverse Breeding Site Directed Nucleases (SDN) - Zinc Finger Nucleases (ZFN) - TAL like effectors (TALENs) - Mega Nucleases (MNs) RNA dependent DNA methylation Agroinfiltration Products developed Question II: Is your country seeing any plants developed by NPBT in the private or public sector? • Most mentioned techniques: • • • Cisgenesis/Intragenesis ODM SDN applications Potato with blight resistance by cisgenesis • Most mentioned crops: • • • Apple Potato Maize Apple with scab resistance by cisgenesis • Most mentioned traits: • • Fungal resistance Herbicide tolerance • Most developments are still in research phase. Herbicide tolerance oilseed rape developed by ODM Experiences with ERA Question III: Does your country have any practical experience in performing an ER/SA on plants developed from NPBT? • Most countries do not have practical experience • Scientific committees investigate potential new issues and formulate recommendations. Examples: Switzerland, Germany, Austria • A few countries indicated they have practical experience • They indicate that no new issues are identified Examples: the Netherlands, Ireland, Belgium, Australia • Many countries refer to EFSA opinions • EFSA opinion on Zinc Finger Nuclease-3/ SDN-3 applications • EFSA opinion on Cisgenesis/Intragenesis Other Question IV: Have the public or private sector provided their perspective regarding ER/SA of plant developed by NPBT? • Some countries refer to position papers of plant breeding associations. • Some countries mention the request from industry for legal/regulatory clarity on the need of a ER/SA. • Science-based ER/SA in a product-based approach rather than a process trigger. Question V: Are there other questions on NPBT that you consider important for your country? • What will be the regulatory/legal status of the NPBT? • How to anticipate on new techniques in the future? • Are there sufficient detection possibilities available? • Animals developed by new gene techniques? Four Categories of NPBTs Category I: Specific mutation(s) to a targeted site(s) in the genome Oligonucleotide Directed Mutagenesis (ODM) Applies small mutations to a specific site in the genome. Site Directed Nucleases (SDNs) - Zinc Finger Nucleases (ZFNs) - Mega Nucleases (MNs) - TAL Effector Nucleases (TALENs) Targets a specific site in the genome for small mutations or the insertion of a stretch of DNA. 14 Four Categories of NPBTs Category II: End-product free of transgenes RNA-dependent DNA methylation (RdDM) Reverse breeding Accelerated Breeding Applies epigenetic changes in the genome: the expression of specific genes can be changed without affecting the genomic sequence. Involves an intermediate step were foreign genetic material is present to supress meiosis. No foreign genetic material is present in the end product. In an intermediate step a transgenic approach is used to shorten the juvenile phase of a tree, hence speeding up the breeding process. No foreign genetic material is present in the end product. 15 Four Categories of NPBTs Category III: Genetic material derived from sexual compatible relatives Cisgenesis Intragenesis Introducing genetic material from sexual compatible relatives. 16 Four Categories of NPBTs Category IV: Targeting specific tissues of a plant Grafting on GM rootstock Agro-infiltration - Agro-infiltrations sensu stricto - Agro infection - Floral Dip Introduces transgenes only in the rootstock of a tree: the scion grafted on the rootstock remains free of transgenic DNA. Introduces transgenes transiently in a targeted tissue of the plant. 17 NPBTs: Some regulatory examples Rapid Trait Development System (RDTS™) is a SDN by Cibus; a herbicide Canola variety has been approved in Canada; USDA-APHIS, indicated they resemble plants developed through classical mutagenesis. British advisory body ACRE considered Cibus’ Canola plants products of classical mutagenesis. EXZACT™ Precision Technology by Dow Agrosciences; relies on zinc fingers; maize varieties have been with decreased levels of the anti-nutrient phytase; USDAAPHIS indicated that plants that contain targeted deletions applied by the cells native repair mechanisms are not considered to be regulated articles since they contain no transgenic sequences. Cisgenesis apple (from Wageningen) regarded by USDA-APHIS as a regulated article as it involved the use of Agrobacterium. 18 OECD’s Work on Biosafety Peter Kearns, Takahiko Nikaido, Bertrand Dagallier, Mika Hosokawa OECD’s Biosafety Team http://www.oecd.org/biotrack 19