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

Minutes of the Second Public Meeting of the Scientific Advisory Committee on Genetic Modification (Contained Use) held on Thursday, 1st February 2007 - launch of the SACGM Compendium of Guidance

Chair

Prof Janet Bainbridge

Members

Dr Gary Burns
Dr John Carr
Dr Martin Carrier
Dr Peter Coyle
Prof Martin Gore
Dr Penny Hirsch
Dr Keith Howard
Mr Bob Osborne
Dr Brian Robertson
Dr Peter Searle
Dr Michael Skinner
Prof Ernie Gould

Secretariat

Mrs Diane Fox-Purday
Dr Jon Gawn
Dr Paul Logan
Mrs Diane Tsavalos

Departmental Assessors

Dr Androulla Gilliland (DEFRA)
Mr Paul Manser (DEFRA)
Ms Sarah Senior (HSE)
Dr Maggie Lacey (HSENI)

Speakers

Mr Geoffrey Podger HSE Chief Executive
Mr Patrick McDonald HSE Chief Scientist
Mrs Lorraine Medcalf HSE

Apologies

Dr Philip Minor

The meeting was opened by the Chair Professor Janet Bainbridge, who called on Geoffrey Podger, the Chief Executive of HSE, to give the opening remarks. Geoffrey welcomed attendees, before going on to talk about the importance of both good quality independent scientific advice, and of openness. He informed the meeting that he had previously been the Chief executive of the Food Standards Agency (FSA) from its inception in 2000, before becoming Chief Executive of the European Food Safety Authority (EFSA). This experience had shown him the importance of gaining the publics confidence and trust in the regulatory system. He went on to emphasise the importance of good guidance in a rapidly developing area of technology, such as biotechnology, which is an important part of the new economy. Geoffrey then thanked all the members of the committee for the hard work and dedication in developing the guidance, and providing HSE and the Competent Authority with high quality advice.

Patrick McDonald, HSE Chief Scientist then gave a short presentation on "What Government wants from Scientific Advisory Committees". He outlined the importance that Government places on obtaining the best advice available.

The Chair then gave a short introduction to SACGM, outlining the committees terms of reference and key issues covered during year, with a forward look to next years work plan.

This was followed by a presentation by the committee secretary Dr Paul Logan, who outlined the background to the Contained Use Regulations, highlighting the scope and breadth of the legislation, as well as difficulties and current developments.

Mrs Lorraine Medcalf, HSE GM Notification Manager then gave a short presentation on the notification system, before the Chair formally moved to launch the Compendium. This consisted of a series of talks by members of the SACGM working groups that had developed the guidance.

Dr Jonathan Gawn outlined the task involved, explaining the rationale behind the redrafting process. He was followed by Professor Martin Gore, Chair of the clinical trials working group. Martin explained how the clinical use of GM microorganisms was developing rapidly, in areas such as gene therapy and the development of novel vaccines.

Dr Brian Robertson, Chair of the Risk Assessment Working Group then went on to describe the approach taken to developing the guidance. He went on to look at future developments in the technology, and explain how guidance aimed to cover such developments.

Dr Michael Skinner, Chair of the Virus Working Group, then went on to inform the meeting of the rapid technological developments in the field of virology, and explain how these were impacting on research and development.

This was followed by Dr Penny Hirsch, Chair of the Containment & Control Working Group, who outlined the changing face of biotechnology, and the need for novel approaches to containment, for example, in relation to biopharming. 

Dr John Carr, Chair of the Plant Working Group then gave the final presentation, outlining the new approach being taken to risk assessment and containment of GM plants and GM plant pathogens. He went on to look at developments in the field, and highlight the challenges these presented.

Question and Answer Session

Question 1 – MRC Laboratory of Molecular Biology, Cambridge. Asked the committee about the use of formaldehyde for fumigation of high containment research facilities. He explained that he was currently involved in the development of a new facility in Cambridge, and was concerned that there may be a ban on the use of formaldehyde, as this would have major implications for the new facility.

In reply, the delegate was informed that formaldehyde might be classified as a carcinogen, although the matter was still under discussion in the EU. He was informed that HSE would keep the community up-to-date with any developments, and would provide advice on its continued use, or on the availability and safety of alternative approaches.

Question 2 – Crusade Laboratories Ltd. Asked the committee about the status under GM legislation of selectively replicating viruses.  He explained that his organisation used a virus that had been labelled as being GM, although it was a deletion mutant, and contained no transgenic material.

The delegate was informed that the legal advice was that the virus was deemed to be a GM product on the basis that it had been created using GM techniques. He was informed that this was an issue that the committee would be looking at during future meetings.  Furthermore, HSE was seeking advice from the European Commission, and was aware that there were divergent approaches taken by various EU member states. (This issue has been included on the agenda of the 11th SACGM meeting)

Question 3 – University of Aberdeen asked about the exemption of safe organisms from the scope of the contained use regulations, and whether this was an area that the committee would be looking at in the future. 

The delegate was informed that there is a provision in the European Directive and in the UK regulations, to exempt safe organisms, if they meet certain criteria. However, the European process is complex, particularly in comparison with the approach taken in the USA and in Australia. The SACGM would be looking at this matter and trying to establish a mechanism to move the process forward.

Question 4 – University of Sheffield asked whether or compliance with the guidance in the compendium would mean users had complied with the regulations.

In response, the delegate was informed that the guidance was not intended to be a legal text but rather to assist users in the process of risk assessment and approaches to containment. However, it was added that if users followed procedures outlined in the document, it was likely that they would have carried out suitable and sufficient risk assessments. In such circumstances, it was likely that they would comply with the requirements of the regulations.

There were no more questions, and the Chair closed the meeting, and invited attendees to a sandwich lunch.