New Plant Breeding Techniques - NPBTs. Assessment of potential risks associated with their application

Transcription

1 New Plant Breeding Techniques - NPBTs Assessment of potential risks associated with their application 1

2 Biosafety of NPBT-crops? Until recently Biosafety was not a focal issue of discussions about NPBT crops in Europe European discussions mostly focused on legal/regulatory status EFSA considered the environmental safety of certain NPBT applications, which are likely regulated as GM (e.g. Cisgenesis, Transgenics by Zinc-Finger-Nuclease Type3) Some studies of national institutions of several European countries (incl. Switzerland) addressed biosafety questions 2

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4 Biosafety of NPBT-crops? Biosafety is a relevant issue considering NPBT-crops under development for commercialisation: Herbicide-tolerant varieties of major crop species NPBT-crops for food & feed production with modified composition NPBT-crops with altered environmental fitness (disease resistance, tolerance to environmental stress) 4

5 NPBT-Examples Marker assisted selection New trait combinations no additional variability created Cisgenesis-Intragenesis GM-like smaller range of source genetic elements & scope of recombination Targeted mutagenesis (by Site-specific Nucleases, Oligo Directed Mutagenesis) Different types of mutations may be created at specific genomic target sites Transgrafting Chimeric individual plants (e.g. modified rootstock non modified scion) Techniques to support breeding (Accelerated breeding) Modifications only present in breeding intermediates, not in breeding product Different characteristics of NPBTs 5 are relevant for specific RA requirements!

6 Challenges for risk assessment NPBTs are typically used in combination during breeding programmes Combination of: different NPBTs GM methods - other biotechnological methods (e.g. cell culture) - conventional breeding steps All above breeding methods are associated with their own specific types of & probabilities for unintended effects Overall risk is determined by all (intended & unintended) adverse effects of all involved steps! 6

7 Challenges for risk assessment different breeding techniques same traits Conventional Breeding incl. Classical Random Mutagenesis GMTechnology NPBT- ODM Cibus RTDS Rapid Trait Dev. System Clearfield like Herbicide Tolerant-crops (ALS-inhibiting herbicides) Environmental effects due to changed agricultural management with complementary broadband herbicides ODM: Oligonucleotide-directed mutagenesis 7

8 Challenges for risk assessment different breeding techniques same traits Conventional Breeding incl. Classical Random Mutagenesis GMTechnology NPBT- ODM Cibus RTDS Rapid Trait Dev. System Clearfield like Herbicide Tolerant-crops (ALS-inhibiting herbicides) Environmental effects due to changed agricultural management with complementary broadband herbicides ODM: Oligonucleotide-directed mutagenesis 8

9 Approach to address biosafety issues as outlined by our study Consideration of individual techniques Identification of risk relevant issues related to the known characteristics of used technologies (for examples see our report) Consideration of appropriate criteria for assessment In relation to identified risk issues for specific NPBT-crops Consideration of existing biosafety frameworks Are general principles applicable for NPBT-crops? Consideration of open questions Wider issues concerning risk assessment of NPBTs? 9

10 Criteria for RA of NPBT-crops Information on a set of aspects is considered relevant for the framing of a risk assessment: 1.Modifications introduced into the crop genome (which modifications are present in crop and where?) 2.Presence of non-native plant sequences 3.Modification of gene expression (intentional / unintentional; specific / unspecific) 4.Knowledge and experience with the traits generated by application of NPBTs (specific effects of the different traits developed by NPBTs in the biological context of the crop plant) 10

11 Applicability of existing biosafety frameworks All considered biosafety frameworks present challenges European Legislation, Cartagena Protocol, US-, Canadian regulations General principles are appropriate for NPBT-crops Scientific assessment of effects & uncertainties according to the risk model (incomplete knowledge/familiarity) Case-by-case assessment Existing guidance provides a general framework for RA of NPBT-crops No major additional issues identified for NPBTs Comparable environmental risk assessment (ERA)-issues as for GMcrops need to be addressed for NPBT-crops 11

12 Conclusions Some NPBT-crops have a relevant potential for adverse effects Risk assessment for such applications is considered necessary NPBT-crops need to be assessed in a case specific way broad range of applications & range of potential effects Specific characteristics of NPBT-methods need to be considered Biosafety framework for GMOs provides guidance for NPBT-crops However an appropriate design of RA is required (comparative approach?) Relevant issues for the RA need to be addressed, incl. long-term & indirect environmental risks Crucial question: What constitutes an appropriate trigger for RA requirements in case of insufficient existing knowledge? Knowledge gaps concerning unintended effects & uncertainties 12

13 Many thanks for your attention! Helmut Gaugitsch Head of Unit Landuse & Biosafety Environment Agency Austria Umweltbundesamt T: +43-(0) / echniques_and_risks_associated_with_their_application The generous support by the Swiss Federal Ethics Committee on Non-Human Biotechnology (ECNH) for our study is kindly acknowledged! Umweltbundesamt EuroParl-Conference Greens/EFA