Minutes of the 14th meeting of the ACNF_PGT held on 15th May 2024

These minutes are subject to confirmation by the Subcommittee. 

Members are required to declare any personal interest in matters under discussion; where Members have a particularly close association with any item, the Chair will limit their involvement in the discussion. In cases where an item is to be discussed in their absence, a Member may make a statement before leaving. 

Minutes of the 14th meeting of the Products of Genetic Technologies (PGT) Subcommittee of the Advisory Committee on Novel Foods and Processes, held on 15th May 2024, Online using Microsoft Teams.

Attendance

Committee Chair

Dr Andy Greenfield 

Committee Members

Professor George Bassel  

Professor Wendy Harwood  

Professor Huw D. Jones 

Professor Clare Mills 

Dr Ray Kemp 

Co-opted Member

Professor Alastair Macrae

FSA Observers

Mr Adekunle Adeoye - Regulated Services, Senior Policy Advisor  

Mrs Annabel Rice - Regulated Services, Senior Policy Manager  

Mrs Jessica Dewhurst - Regulated Services, Policy Advisor 

Observers (external) 

Ms Ivy Wellman - Defra, ACRE Secretariat 

Dr Richard Lloyd Mills - Defra, ACRE Secretariat 

Observers (devolved administrations) 

Mrs Aileen Livingstone - Food Standards Scotland 

Dr Karen Pearson - Food Standards Scotland

Sciences 

Mrs Siobhan Watt - Food Standards Scotland 

Mr Peter Madden - FSA, Wales 

Mr Xosé Álvarez - FSA, Wales 

Secretariat

Dr Rachael Oakenfull - Team Leader, Regulated Products Risk Assessment (GT); Technical Secretary ACNFP 

Ms Victoria Balch - Administrative Secretariat 

Mr Liam Blacklock - Science Secretariat 

Mr Matt Hall - Science Secretariat 

Dr Andrew Hartley - Science Secretariat 

Dr Karin Heurlier - Senior Secretariat 

Dr Annalisa Leone - Science Secretariat 

Ms Lucy Thursfield - Science Secretariat 

Dr Rhys Williams - Senior Secretariat 

1. Apologies and Announcements 

The Chair welcomed the Members, representatives from the FSA, observers from the devolved administrations, external observers, and the Secretariat team.  

Professors Pete Lund, Bruce Whitelaw, Paul Fraser and Hans Verhagen and Dr Elizabeth Lund sent their apologies and provided comments on items by correspondence ahead of the meeting. 

The Chair reminded Members of the need to declare any interests prior to the discussions on each item.  

Grants with Syngenta (Huw D. Jones) and with Bayer (Professor Wendy Harwood) are reported as Non-Personal Interests on Members’ profiles (ACNFP Website), in accordance with the ACNFP/PGT Code of Practice; they are not treated as conflicts of interest, and therefore these Members can take part in discussions of items relating to Syngenta or Bayer.  

2. Matters Arising ACNFP/PGT/13/MA 

• The Secretariat addressed the Members’ comments on the minutes for ACNFP PGT 12. 

• Minutes for ACNFP PGT 13 were shared for comments prior to this meeting and were reviewed for amendment and agreement under item PGT/13/Min. 

• The secretariat is working with FSA Policy on the best way to communicate the minimum data requirement for Genetically Modified Microorganisms (GMM) applications and the position on 90-day animal feeding toxicology studies. 

• Following discussions at PGT13, Committee Advice Documents (CADs) for RP1868 and RP1869 were reviewed in ACNFP165.  

3. FSA update 

Members were updated on the progress of drafting the technical guidance for the Precision Breeding framework since the discussion held in ACNFP166. Further feedback has been received from Members as well as from colleagues from Defra and FSA, and feedback is sought from the ACNFP expert in risk communication. 

Members were informed of the processes and timelines for publication, clearance and engagement that will follow the completion of the technical guidance. 

4. ACRE/Defra update 

Members were informed that recent discussions in ACRE meetings have focussed on applications for environmental release.  

Defra and FSA jointly notified WTO of the draft Precision Breeding (PB) regulations and are planning to lay the Statutory Instrument for the PB secondary legislation in July 2024, expecting it to come into force in 2025. Defra is currently working on guidance for applications for marketing authorisation of PBOs. 

5. Minutes of the ACNFP-PGT13

ACNFP/PGT/13/Min 

Minutes of the thirteenth Subcommittee meeting were reviewed; some changes were requested, and it was agreed these minutes would return in PGT 15th meeting for further review. 

6. Genetically modified Maize MON 87429 (RP1962) (Reserved Business)

ACNFP/PGT/14/01 

• Minutes to be released at a later date -   

7. Genetically modified MS11 and MS11 x RF3 canola (RP307)    (Reserved Business)

ACNFP/PGT/14/02 

• Minutes to be released at a later date

8. Genetically modified Canola NS-B5ØØ27-4 (RP1745) (Reserved Business)

ACNFP/PGT/14/03 

• Minutes to be released at a later date

9. Precision Breeding Discussion (Reserved Business)

ACNFP/PGT/14/04 

Following the discussion of the PB draft technical guidance produced by FSA at the 166th meeting of the ACNFP, the Secretariat identified outstanding technical questions requiring further clarification. 

The Subcommittee reviewed the outstanding questions and provided expert input as requested. The Secretariat confirmed that the feedback received would be considered in revising the draft, and Members would be contacted individually by correspondence where expert advice was needed to further refine the draft. 

The Subcommittee was also presented with hypothetical case studies drawn from examples found in the available peer reviewed literature. The case studies were designed to reflect a range of anticipated future applications. The Subcommittee was asked to test the suitability of the self-assessment process outlined in the technical guidance, and in particular in flowcharts illustrating the guidance, by assigning each case study to its appropriate tier using the draft guidance.   

The Subcommittee assessed four case studies covering different crops to test the draft guidance.  

Building on their collective expert knowledge, or by researching the scientific literature, the Subcommittee answered all the questions highlighted in the flowcharts provided as part of the guidance. This resulted in assigning all examples to Tier 1; Members commented that this was in accordance with their views on the safety of the examples examined, confirming that the self-assessment process worked well. Given the variety of examples assessed, Members expressed the view that it is likely that a wide range of future applications will be assessed as Tier 1. 

The Secretariat noted that:  

• The choice of the comparator used in determining the impact of the genetic change(s) on the PBO was critical for a correct self-assessment; 

• The addition of a flowchart for the “other safety concern” criterion may ensure this step of the triage was given relevant consideration; 

• The effect of processing on food and feed safety, intended use and conditions of use were areas where further expertise in addition to that represented in the Subcommittee may sometimes be needed to be able to reach conclusions; 

• There should be clear guidance on what steps applicants should take when they are uncertain of their answer(s) to questions highlighted in the guidance. 

The Secretariat confirmed these observations would be taken into account when further reviewing the draft guidance, including taking advice on the processing aspects and risk communication.  

Action –The Secretariat to review the feedback provided by The Committee and make amendments to the draft Technical Guidance before seeking final input by Chair.   

10. Item for information

Written policy updates on GM and PB were circulated ahead of the meeting 

11. Any other business

Members were informed of a change of date for the PGT16 in-person meeting now scheduled for the 8th October 2024 in London. 

Date of next meeting

The next ACNFP meeting is scheduled for 12th June 2024 (hybrid); the next ACNFP-PGT meeting is scheduled for 17th July 2024 (virtually).