What s cooking in the EFSA GMO Unit? Ad hoc meeting with GMO industry representatives Parma, Italy - 9 November 2017

Transcription

1 What s cooking in the EFSA GMO Unit? Ad hoc meeting with GMO industry representatives Parma, Italy - 9 November 2017

2 OUTLINE Key outputs since last meeting Ongoing GMO activities 2

3 SOME KEY DOCUMENTS PUBLISHED SINCE LAST MEETING 13 GMO Panel scientific opinions on GMO applications 8 New APs 5 Renewal APs 1 GMO Panel scientific opinion to supplement existing opinion on GM food and feed (i.e. EFSA-GMO-DE ) 5 GMO Panel scientific opinions on (1) annual 2015 PMEM report on maize MON 810, (2) new sequence information on soybean events , ; and carnation SHD ; maize DAS EFSA statement on the assessment of the potential integration of the DNA plasmid vaccine CLYNAV into the salmon genome 3

4 SOME KEY DOCUMENTS PUBLISHED SINCE LAST MEETING EFSA technical report Publication by Mesnage et al. (2016) "An integrated multi-omics analysis of the NK603 Rounduptolerant GM maize reveals metabolism disturbances caused by transformation process" Guidance documents Supplementary guidelines for the allergenicity assessment of GM plants Guidelines on possible derogation of existing requirements for applications of GM food and feed at low levels submitted under Regulation (EC) No 1829/2003 on GM food and feed Explanatory notes Update of the explanatory note on DNA sequence similarity searches in the context of the assessment of horizontal gene transfer from plants to microorganisms Explanatory note on literature searching conducted in the context of GMO applications for (renewed) market authorisation and annual PMEM reports on GMOs authorised in the EU market Report on the development and harmonisation of reliable sampling approaches for generation of data supporting GM plants risk assessment 4

5 REPORT ON SAMPLING STRATEGY 1. Analyse sampling needs for GM plants risk assessment 2. Screen sampling strategies (e.g. ISO, TOS, Codex Alimentarius) and evaluate their applicability to the generation of representative data 3. Based on the above, develop reliable and representative sampling methods for GM plants RA 5

6 REPORT ON SAMPLING STRATEGY Findings The report highlights deficiencies in reporting for currently available sampling protocols and highlights the need to eliminate bias-generating errors to secure sampling representativeness. It provides concrete suggestions to ensure that only representative sampling methods are used to provide the data necessary for GM plant risk assessment. The report indicates that some methodological/ scientific assumptions made regarding sampling operations are not always reported in submitted applications. 6

7 REPORT ON SAMPLING STRATEGY Outcome The report recommends applicants to provide information on sampling approaches in full, according with methods set out in the theory of sampling. The report highlights how new developments in the area of data collection could be applied for future assessments. It provides recommendations on how EFSA s RA might incorporate the most relevant and the latest knowledge on sampling. 7

8 REPORT ON SAMPLING STRATEGY What s next? EFSA might consider an ad hoc dialogue with industry to better understand how sampling is performed - with the aim of collecting and discussing background information on the sampling procedures. 8

9 EXPLANATORY NOTES IN PREPARATION Title Explanatory note on criteria for a suitable selection of forage material for the analysis of NEP levels and compositional data Objective This explanatory note provides a crop-specific definition of forage, supporting the appropriate selection of forage material, suitable for the analysis of NEP levels and composition of GM feed, as required by Regulation (EU) No 503/2013 Publication date Early

10 EXPLANATORY NOTES IN PREPARATION Title Objective Explanatory note on the quality parameters for the protein expression analysis in GM plants This technical note aims at providing clarity on the quality of protein expression datasets in order for the EFSA GMO Panel to reliably assess newly expressed protein levels in GM plants Publication date Early

11 EXTERNAL MANDATE ON OUR PLATE Title Technical note to applicants on, and checking of, the quality of the methodology, analysis and reporting covering full sequencing and insertion site analysis of GM event, and generational stability and integrity Deadline September 2018 Objectives 1/ To support and harmonise the GMOs RA 2/ To harmonise the data submission when DNA sequencing is used 3/ To start from JRC guidelines related to sequencing of the insert(s) and flanking regions and improve these where scientifically justified 4/ To define minimum requirements and recommendations for the sequencing of the insert(s) and flanking regions 5/ To reflect the scientific progress of the methodology used 6/ To cover junction read analysis and generational stability and integrity when addressed by Next Generation Sequencing 11

12 EXTERNAL MANDATE ON OUR PLATE Title Technical note to applicants on, and checking of, the quality of the methodology, analysis and reporting covering full sequencing and insertion site analysis of GM event, and generational stability and integrity State of play Ongoing set-up of an ad hoc Working Group (EC, JRC) Implementation From 1 st October 2018, EFSA will assess the quality of sequencing data (currently checked by DG JRC) 12

13 Scientific colloquium Save the date! Topic: The use of OMICS tools in the risk assessment When: April 2018 Where: Berlin, Germany Opening of registration and publication of the scientific programme foreseen for early

14 NEXT EFSA SCIENTIFIC CONFERENCE - SAVE THE DATE!!! EFSA Conference Science, Food & Society Parma 18-21/09/ participants HEADQUARTERS Fiere di Parma September

15 NEXT EFSA SCIENTIFIC CONFERENCE - SAVE THE DATE!!! Opening of registrations + call for poster abstracts: 3 rd week of January 2018 First announcement: 15

16 EFSA GMO Unit Thank you for your attention! 16