Prof Janet Bainbridge
Dr Gary Burns
Professor Martin Gore
Professor Ernest Gould
Dr Penny Hirsch
Dr Keith Howard
Professor David Lewis
Dr Philip Minor
Mr Robert Osborne
Dr Brian Robertson
Dr Peter Searle
Dr Michael Skinner
Professor Mary Collins
Professor Paul Freemont
Dr Michael Paton
Mrs Diane Tsavalos
Dr Louise Ball
Dr Francesca Culver
Dr Androulla Gilliland
Dr John Carr
Dr Martin Carrier
Dr Peter Coyle
Dr Margaret Lacey
1 The Chair welcomed everyone to the 14th meeting and extended a welcome to the guest speakers: Professor Mary Collins from University College London (agenda items 3 and 4) and Professor Paul Freemont from Imperial College, London (agenda item 8).
2 The minutes were accepted as a true and accurate recording of proceedings of the 13th meeting.
3 The Secretariat informed the committee that the actions from the previous meeting had been completed.
4 One Member enquired about the ongoing issue of ‘exemption of safe organisms’ from the GMO(CU) regulations and how this could be taken forward. The Secretariat explained that as yet, no genetically modified microorganisms (GMMs) had achieved exemption from the regulations and that the European Commission (EC) were reluctant to change their guidelines in this area until Member States had used the procedure to populate Annex II Part B of the Directive. For the Committee to pursue the matter, one suggested approach, to assist duty holders, would be to provide a UK focused interpretation of the EC guidance. However, this would have limited benefit as the EC process would still have to be met in order for the GMM to be put on the annex as an exempt organism. Alternatively, the Committee could develop an example of a safe organism to put forward to the EC, thereby meeting the EC requirement to test out the process and identify where the process could be improved and simplified. It was agreed that the Secretariat would canvas views on the approach of other like-minded Members States.
5 As part of the 2008 work plan, the Committee will consider the safety and containment of reverse genetics produced seasonal influenza vaccine strains. It may be that such constructs also fall into the category of safe organisms and therefore may be a useful example to test the exemption procedures.
Action: Secretariat to add topic to the work plan for 2008; canvas opinion from other Member States with a view to making joint representation to the EC for simplified procedures; and confirm the most up to date guidelines.
6 Members were informed of related GM issues discussed recently at other scientific advisory committees, namely, the Advisory Committee for Releases into the Environment (ACRE); the Gene Therapy Advisory Committee (GTAC) and ACDP. Of note were the proposal for a topic-based joint ACRE/SACGM public meeting; proposed changes to the definition of gene therapy and the remit of GTAC; and progress with the formulation of a set of common containment measures for human and animal pathogens through ACDP.
7 Secretariat provided feedback from the recent meeting of the EC Competent Authorities for contained use, where discussion focused on: a working group looking at new and novel technologies and their application to the contained use and deliberate release directives; and the results of a pan-European clinical trials questionnaire. Of note was the suggestion of adopting a harmonised approach, across Member States, to clinical trials involving GMMs. Consequently, representatives from Defra, Department of Health, Medicines Healthcare Regulatory Agency, HSE and the Chair of GTAC are to meet in July to consider a UK position.
8 Members were informed of and provided with a copy of the Innovations, Universities, Science and Skills Select Committee report on Biosecurity in UK research laboratories (published June 2008). A cross government response to the recommendations is being prepared and will be published later in the year.
9 The Secretariat reminded members of the SACGM response to the ‘Griffin Review’, which is a strategic review of capacity and capability of UK high containment facilities. Members felt that the review would benefit from gathering financial data on capital and on-going running costs for the maintenance and operation of different high containment facilities (e.g. laboratories, in vivo facilities, large scale production) to underpin the review’s conclusions. Several members offered to provide details of running costs for CL3 and CL4 facilities.
Action: Secretariat to feed the Committee’s views to the ‘Griffin review’
10 The Secretariat informed the committee of several administrative matters. Following recommendations in the code of practice for scientific advisory committees, it is the intention to draft a code of practice tailored to SACGM. This will be circulated for comment at the next meeting. The Secretariat also informed the committee that it intends to recruit new members to restore SACGM to full cadre.
11 Secretariat explained that HSE’s science and technology strategy includes commissioning research that will improve understanding of health and safety risks and their control. HSE has commissioned a number of research projects related to biological agents (e.g. efficacy of respiratory protection against influenza bioaerosols; alternative fumigation methods for laboratories; suit decontamination). Of particular relevance is research into the safety of retroviruses being undertaken at University College London. Professor Mary Collins provided an overview of her laboratory’s research including the development of a rapid in vitro assay to measure rates of insertional mutagenesis for different retroviral/ lentiviral vectors. More specifically, the research has been able to identify at least two mechanisms of mutagenesis; and is assessing the contribution by different elements of the viral vectors (e.g. long terminal repeat; WPRE). The research initially funded for 1 year, has been extended for a further three years.
12 On behalf of the committee, the Chair thanked Professor Collins and recognised the invaluable contribution this research will make in providing evidence upon which classification of activities involving these viral vectors can be based. Members were asked to forward any recommendations for further applications of this work and other research topics, particularly in the area of GMO contained use, to the Secretariat.
Action: Members to forward suggestions for research topics to the Secretariat
13 The Secretariat outlined the on-going work stream looking at the most appropriate classification of activities involving retroviral/lentiviral vectors. The SACGM virus working group met on the 27th June: to assess the inherent hazards associated with these vectors; consider the range of uses to which they are being put; and to draft a revised version of section 2.11 of the SACGM Compendium of Guidance. Whilst the main conclusion from the working group was that commercial, self-inactivated, split plasmid vector systems presented a low hazard, the residual risk of insertional mutagenesis is relevant particularly where the vector expresses an amphotropic envelope. The working group discriminated between activities that involved, or did not involve, the use of sharps as their use was seen to significantly increase the potential for worker exposure. Consequently, the revised guidance bases classification, to a large degree, on whether control measures are required to minimise exposure to contaminated sharps.
14 The committee were invited to comment on the amended version of section 2.11, which was deemed to be a significant improvement, both in terms of clarifying the hazards associated with the viral vectors and in advising on classification of this type of work. However, Members agreed that further work is needed to ensure that routes of worker exposure, other than sharps, are also assessed. In particular, in the healthcare sector, it was reported that as much as 10% of seroconversions following exposure to blood borne virus contaminated materials resulted via the mucosal route. Secretariat agreed to review this information. Similarly some distinction in terms of risk was recommended for work with low titre/small volume work as opposed to high titre/large volume activities.
15 Members agreed that percutaneous injury should remain the focus of the guidance, but that duty holder should also be made aware of additional routes of exposure that may affect classification of the work. The Secretariat proposed to review and incorporate the comments of the committee and circulate an amended version of section 2.11 by email for the committee’s further comment and subsequent ratification. It is intended to revise the electronic version of the Compendium and to circulate the revised section to duty holders by emailed newsletter.
Action: Secretariat to amend guidance in light of SACGM comments, circulate for further comment and Committee ratification.
16 The Secretariat reported on progress with the implementation of the recommendations from the ‘Callaghan Review’ following the release of foot & mouth disease virus from Pirbright in 2007. Currently defra retain authorisation and licensing responsibility for work with specified animal pathogens; and (as of April 2008) HSE have acquired inspection and enforcement responsibilities in this area. Ultimately a new single regulatory framework will be introduced in 2010 that encompasses the contained use of human and animal pathogens. It is intended that this framework will be based on the GMO(CU) regulations, which will also be incorporated into the single set of regulations. The legal mechanism for achieving this involves the use of a legal reform order to amend the Health and Safety at Work etc Act 1974, to encompass environmental responsibilities and under which the new regulations can then be made.
17 A parallel work stream will involve the formulation of a common set of containment measures for human and animal pathogens, which is being undertaken by a working group under the auspices of ACDP. Dr Gary Burns and Dr Mike Skinner will participate on behalf of SACGM.
18 Members impressed upon the Secretariat the importance of ensuring that the single set of regulations encompassed all aspects of the GMO(CU) regulations and not only human and animal pathogens. One Member also asked whether the opportunity would be taken to cover plant pathogens within the new regulations. It was also questioned whether the new regulations would include the laboratory security aspects (schedule 5) of the Anti-Terrorism, Crime and Security Act (ATCSA). The Secretariat confirmed that all aspects of GMO(CU) would need to be included to ensure compliance with the EC directive but that the requirements of Schedule 5 of ATCSA would remain independent. The request to consider plant pathogens would be passed onto the defra/HSE project team for their deliberation.
Action: Secretariat to forward SACGM comments to HSE/defra project board and to keep members appraised of developments pertinent to SACGM.
19 This item was postponed until further data are available.
20 The Chair welcomed Professor Paul Freemont from Imperial College, London. Professor Freemont gave a presentation on the field of synthetic biology including the ethos underpinning the topic (in particular the application of engineering, chemistry and computing principles of reproducibility and predictability into biological systems); the range of activities currently underway and envisaged; and outlined the challenges presented by the field to scientists and regulators (including evolution/mutation; risk assessment principles). The Chair thanked Professor Freemont and invited questions from Members.
21 The Committee noted that progress in DNA synthesis & sequencing, both in terms of capability and cost, had opened up a new approach to biological systems of greater scale and impact compared to traditional molecular biology techniques. Whilst significant advances had been made in certain areas (e.g. creating a minimal genome; synthesis of artemisinin intermediate); other areas still face significant challenges (e.g. redesigning genetic code to produce orthologous protein synthesis system). The Committee recognised many similarities between synthetic biology and genetic engineering.
22 In considering the adequacy of the GMO(CU) legislation to accommodate aspects of synthetic biology, Members raised the question of whether the existing definition of genetic modification required amendment. The existing definition requires modification to an existing organism, whilst it could be envisaged that synthetic DNA could be transferred to a recipient cell lacking genetic material – possibly not considered an organism. Members were of the view, that it was difficult to envisage a situation, where the genetic material had not been based on an existing organism or component thereof. Secretariat indicated that this would be a discussion point for the EC working group on new technologies.
23 The Chair asked that the Secretariat be informed of Members views on the adequacy of the short section on synthetic biology in the compendium in light of Professor Freemont’s presentation; and whether Members felt additional scientific expertise would be necessary for future notifications in this field.
Action: Members to consider adequacy of short section on synthetic biology in the Compendium and send comments to Secretariat.
24 The Chair explained that in addition to being recommended good practice, the production of an annual report for SACGM was an opportunity to publicise the important work of the committee amongst the GM scientific community, chief scientific advisors and public; and raise awareness of how scientific advice is applied in the regulation of GM work in the UK. There is no set format for an annual report. Members offered a number of helpful suggestions on layout (e.g. annexing Members’ details) and content (e.g. inclusion of details of external experts who have contributed to SACGM). It is intended to publish the annual report in the autumn.
Action: Members to forward comments and suggestions to Secretariat by mid August, with a view to publishing a final version in the autumn.
25 Given the growing public interest in synthetic biology, the Secretariats of ACRE and SACGM have suggested that a joint open meeting might be appropriate to provide the opportunity for members of the public to understand the range of activities encompassed by synthetic biology and how the area is being regulated. The BBSRC have organised a meeting in September to discuss regulation of synthetic biology, which will include participation by SACGM members. It was agreed to await the outcome of that meeting before deciding on the timing for such an open meeting.
26 There being no other business, the Chair thanked everyone for their attendance and contributions and drew the meeting to a close
Thursday, 20 November 2008
