新型转基因生物 下一代基因工程：市场上有哪些？以及正在研发中的有哪些？德国联邦自然保护局（BfN）.pdf

1、www.bfn.dereimax16 New GMOs/NGTs:What is on markets and in development pipelines?Dr.Samson Simon,Dr.Finja Bohle Federal Agency for Nature Conservation(BfN),Germany Non-GMO Summit 8.10.2024Outline2 Introduction to genetic engineering,Transgenesis and New Genomic Techniques(NGT)The development pipelin

2、e and the market situation for NGT plants Environmental Risk Assessment of NGT plants in relation to the EU regulatory situation3Biotechnology is undergoing profound transitions due to Genome Editing tools anddigitalisation,artificial intelligence andautomatization.Genomes of organisms can now be sh

3、aped,redesigned and even shuffled to a revolutionary new extend,no matter if foreign genes are introduced or notOn the other hand,knowledge about the effects of these genetic changes in the organisms and the ecosystem is limited.Transition in BiotechnologyCategorisation of Genetically Modified Plant

4、s using New Genomic Techniques(NGT)The COM proposal for regulating plants modified with NGTsCategoryMolecular equivalence criteriaTransgenic GM-plants Conventional procedure or NGT TransgenesisDirective 2001/18NGT 2 Generated with NGT More than 20 modifications Type of modifications like NGT-1NGT 1(

5、no risk assessment)Generated with NGT Max.20 modifications:20 bp insertion/substitutionDeletions(unlimited)Cisgenesis(breeders gene pool“)Inversion of any sizeSources/ReferencesGelinsky 2024 A(continuous)study commissioned by the Swiss Federal Office of the Environment(FOEN)on NGT applications in th

6、e development pipelineUSA Regulatory status of NGT plants by the Animal and Plant Health Inspection Service(APHIS),which is an agency of the United States Department of Agriculture(USDA)Bohle et al.2024 a BfN publication analyzing the impact of the COM proposal on the NGT plant development pipeline