HSE - Scientific Advisory Committee on Genetically Modified Organisms (SACGM)

Minutes of the Eleventh Meeting of the Scientific Advisory Committee on Genetic Modification held on Thursday, 28th June 2007, in the Rose Room at Rose Court, Southwark Bridge, London

Chair

Prof Janet Bainbridge

Members

Prof Martin Gore
Prof Ernest Gould
Dr Penny Hirsch
Prof David Lewis
Dr Philip Minor
Dr Brian Robertson
Dr Peter Searle
Dr Michael Skinner

Departmental Assessors

Dr Francesca Day (DEFRA)
MsGlenda Townsend (DEFRA)
Mr Colin Dunn (HSE)

Secretariat

Dr Paul Logan
Dr Jonathan Gawn
Mrs Lorraine Medcalf
Mrs Joyce Levy
Mrs Diane Fox-Purday

Apologies

Dr Gary Burns
Dr John Carr
Dr Martin Carrier
Dr Peter Coyle
Dr Androulla Gilliland
Dr Keith Howard
Dr Maggie Lacey
Mr Bob Osborne
Mrs Diane Tsavalos

Welcome and Introductions

1  The Chair welcomed everyone, particularly Mr Colin Dunn, of HSE Policy Branch and Mrs Joyce Levy, of HSE Biological Agents Unit.

2  The agenda will be reordered to accommodate the guest speaker presentation.

3  Dr Francesca Day has taken over one of the DEFRA Departmental Assessors and has replaced Dr Paul Manser.

Minutes of the 10th Meeting – SACGM/06/06/P1

4  The minutes were accepted as a true and accurate record of proceedings.

Matters Arising

5  None

Secretariat Report

6  There was a meeting held in Berlin, Germany. As part of their presidency, they held a meeting of the Bio-safety Committee’s across Europe covering GMOs. Prof Janet Bainbridge, Dr Paul Logan and Dr Gary Burns attended from SACGM. There were presentations on how different committees operate across Europe. There is no consistency in approach in implementing the directive.  The SACGM Compendium of Guidance is used widely across Europe and the work of the SACGM is highly received. The science base is there but the interpretation in parts is very different.

7  The Office of Science and Innovation are carrying out a consultation exercise. The have produced an update to the Code of Practice for Scientific Advisory Committees. The document was issued on 25th June and the response date is 16th September 2007. The document is looking at existing guidelines on how Scientific Advisory Committees operate. HSE will be formulating a response as an organisation but if members of the committee or the committee itself want to respond then it is fine to do.

8  Paul Logan had a meeting with a consortium looking to do clinical trials in the UK involving a live measles virus with HIV (three Genes). The project will come to the SACGM for discussion. There was some confusion as to whether it should be discussed by GTAC. Clarity is required on the issue and guidance as to how to proceed.

9  Schedule 5 – ACTSA. The legislation is finally published. Action: All comments to Paul A.S.A.P.

10  SACGM Committee Members – Three members have resigned, Prof David Baulcombe, Dr Sue Mayer and Prof Peter Williams.  David will not be replaced, as there is already a plant expert on the committee. There will be an advertisement on the SACGM Website to replace the NGO and Bacteriologist Roles.

11  The European Commission is holding a Competent Authorities meeting on 9th July 2007 in Brussels. Dr Logan will be attending this meeting representing the UK Competent Authority.

Status and Classification of Herpes Simplex Virus Strain 1716 – SACGM/06/07/P3

12  Two guest speakers came along to the meeting to ask for technical and scientific input from the committee so the Competent Authority could make a decision on the outcomes of the discussion.

13  They wanted the committee to consider a request to reclassify a modified Herpes Simplex Virus being used in gene therapy trials. The virus is a deletion mutant, and contains no transgenic material.

14  They sent in a letter setting out three separate issues, 1.)  The status of HSV 1716 and whether this is a GMO within the terms of the GMO directives and the national legislation that has implemented them in the UK; 2.)  The classification of HSV1716; and 3.)  Potential exemption certificate for HSV1716. These three issues will be discussed in their presentation.

15  The company spoke to the German authorities and they believe it is not a GMO as it counts as mutagenesis and therefore falls out of the scope of the GMO Regs. It is agreed that the work should be classed as Class 1 not Class 2. The Company asked that if it was agreed that it was Class 1 then could they apply for an exemption certificate for this work. The Regs allow for the Competent Authority to exempt all or part of the regs subject to condition and limit of time. The Competent Authority needs to consider this. 

16  One Member informed the Committee he has acted as a consultant for this company.

17  The company wrote to the HSE approximately 5 years ago with the same question and the answer then was that they had used GM Technology to produce the virus so it falls into the GMO Category. They also wrote to the EMEA and their response was that it was a GMO Product.

18  Dr Keith Howard and Dr Peter Coyle have given detailed comments to the committee, as they are unable to attend the meeting today. A copy of the presentation was given out to the committee. There was just one hospital used in the trials.

19  HSV1714 was not used because it was not suitable because the cells would not replicate. They screened to see if it would replicate in regenerating liver but it did not. HSV Virus replicates in Tumours, What about pregnant mice. There are screening processes and pregnancy tests are carried out before a trial.

20  In light of this work, we may see more and more exemption certificate requests.

21  This is a difficult situation and the science and legal aspects do not necessarily go hand in hand. The Committee need some broader European advice on this subject.

Redrafting the Guide to the Genetically Modified Organisms (Contained Use) Regulations 2000

22  The issue is to consider early drafts of the revised ‘Guide to the Genetically Modified Organisms (Contained Use) Regulations 2000’. This document is being updated to reflect changes in legislation and advances/developments in technology.

23  Members should note that HSE is not seeking any advice on the regulations, only on the accompanying guidance.

24  Discussion has to take place with the Competent Authority and their lawyers on how this is to progress and how it effects the ACRE Meeting in September. After these discussions, it can go out for general consultation.

Exemption of Safe Organisms from the Scope of the Genetically Modified Organisms (Contained Use) Regulations 2000

25  The issue is to consider the mechanisms for excluding safe organisms from the scope of the Contained Use Directive. Such exemptions are permitted if the organisms meet certain criteria outlined in European guidance.

26  We need to abide with the EU Directive and the law as it sets out a process, as it is legal. We can look at this in the UK and see how we can move it forward. We should be able to make this decision, as it is not changing how the safety is carried out in Laboratories. HSE as a Competent Authority have given a commitment to look at this. Are there guidelines we could use to help progress this or get advice from the European Commission.

27  Individual GMSC’s to be able to nominate an individual to make decisions on their Class 1 work.

28  The work can be exempt but it still has to go to the local GMSC for discussion before any work is done.

29  The UK contribution could be to make it a lot more user friendly.

30  The CA could draw up a dossier of organisms to discuss at the SACGM.

Compendium Update – Feedback

31  Some questions were received. They will be circulated and discussed at the next meeting.

32  A printed version of the Compendium will be published soon. It will only contain Section 1 – 3. Sections 4 – 6 will be published separately as annexes, which can be purchased separately.

Any Other Business

33  The date of the next meeting will be Thursday 4th October 2007.

Close

The Chair thanked everyone for their attendance and drew the meeting to a close.