ACRE Meetings

ACRE/08/M1

MINUTES OF THE 117th MEETING OF ACRE AT NOBEL HOUSE, LONDON, THURSDAY 21ST FEBRUARY 2008

Attendance:

Members:

Professor C Pollock (Chairman)
Dr P Hirsch
Professor K Lindsey
Dr J Stoye
Professor J Bale
Professor J Dunwell
Dr R Hails
Professor M Rees
Professor J Pretty
Dr M Bonsall
Professor A Peters
Mr E Cross
Mr J Orson
Invited expert:
Dr S Pollitt MHRA (item 4)

Assessors:

Dr J Davey  SASA
Ms V Collins  WAG
Dr S Hugo  CSL
Ms A Hope  NE
Dr P Logan  HSE

Defra:

Dr A Gilliland (Secretary)
Dr L Ball
Dr S Popple
Mrs S Wort
Ms G Townsend
Mr D Sherlock

Apologies for absence were received from Professor M Bailey

1. Minutes of the 116th Meeting, 6th December 2007
ACRE/07/M4

The minutes were agreed subject to one revision.

2. Matters Arising

2.1 Secretariat’s move

The secretariat was due to move to the 8th floor in Millbank (connected to Nobel House) on 25th February and would provide new contact details as soon as possible.

2.2 Open meetings

A sub-group was to meet after the main meeting to discuss the format of ACRE open meetings. This has been postponed, but the sub-group will report back in due course.

3. Matters agreed by circulation

3.1 Research paper: toxins in transgene crop by-products may affect headwater stream ecosystems.

ACRE advice was agreed after full discussion both at the last meeting and by email circulation. Advice will be published in due course.

3.2 Application from Monsanto Europe S.A. to market MON 863 maize – ref. C/DE/02/9: EFSA statement on the use of nptII as a selective marker gene and EFSA GMO Panel review of the statistics applied to a rat feeding study with MON 863 maize.

ACRE advice has been agreed by circulation on this GMO and has been published. A response was sent to Dr John regarding his letter to ACRE, in line with the December minutes.

3.3 EFSA scientific opinion on application (EFSA-GMO-UK-2005-19) to import and process GA21 maize (glyphosate-tolerant) under Regulation EC/1829/2003.

ACRE generic advice was updated to reflect the inclusion of this GM maize to the advice and published on the web. There was no QM at Standing Committee in December.

3.4 Defra research report CPEC38 – quantitative approaches to the risk assessment of GM crops

This has been published on the web.

4. Application to market a human medicinal product consisting or containing a GMO under regulation EC/726/2004
ACRE/08/P1

ACRE was briefed on this application by Dr Liz Pollitt of the MHRA. This application had been submitted to the European Medicines Evaluation Agency in accordance with regulation EC/726/2004. Under this legislation information on the assessment of the application may only be made available as part of the European Public Assessment Report following the Commission decision at the end of this process.

5. Application for Part B Consent from University of Leeds to Release GM Solanum tuberosum with resistance to potato cyst nematodes. Ref: 07/ R31/ 01
ACRE/08/P4

ACRE discussed the application from Leeds University to conduct an experimental field release of potatoes genetically modified for resistance to potato cyst nematode (PCN). The applicant proposes to release six GM potato lines. All of these GMOs contain the selectable marker gene neomycin phosphotransferase (nptII). The potatoes (Solanum tuberosum cultivar Desiree) express (i) cysteine proteinase inhibitor (cystatin) from rice and/or (ii) a repellent of synthetic origin. Both are targeted against PCN. Expression of these PCN resistance genes in the modified potatoes will occur throughout plant growth and development. The location of gene expression in the plants will depend on the promoter and will occur either in the whole plant or in the root only. The primary objective of the proposed release is to determine the level of field resistance of the transformed potato lines to PCNs. A secondary objective is to establish if there are any effects on non-target nematodes from the potato lines expressing the repellent. The applicants plan to trial the potatoes at one location near Leeds, on a Leeds University-owned farm.

ACRE was asked to comment on the information provided by the applicant to assess the impact of this release on the environment.  ACRE noted that the applicant had field-trialled GM potatoes expressing cystatin genes in England under a previous authorisation. These GMOs are well-characterised and there were no harmful effects associated with their previous release. ACRE focussed its discussion on the synthetic gene and its product, a PCN repellent. ACRE discussed whether there were any risks specific to the insertion of DNA that encodes a peptide that does not occur naturally. ACRE advised that the same principles apply (and the same sort of molecular characterisation data are required) whether the DNA is derived ‘synthetically’ or cloned from an organism. For example, ACRE considered that inherently, there is no reason to expect that horizontal gene transfer of ‘synthetic DNA’ to soil microbes is more likely in this case  than in others where genes are natural ones. In its guidance on molecular data requirements, ACRE states that applicants should consider all genetic elements that could have been inserted into the GMO. ACRE noted that the applicant did not demonstrate that vector backbone DNA was absent from the GM potatoes or alternatively, carry out a risk assessment on the possibility that this DNA was present.

ACRE did not consider that the applicant had provided sufficient information on the specificity of the synthetic peptide. The applicant discussed the impact of the peptide on PCN but did not address the potential for it to affect other soil organisms. The Committee did not consider it likely that the peptide would have adverse consequences for soil biodiversity more generally, given that the peptide is exuded in very small amounts by the GM plants, it is not stable and does not exert a toxic effect on PCN. However, since there were no data provided to demonstrate its specificity to PCN and that it is not toxic to other organisms in the soil, ACRE felt there was too much uncertainty to draw this conclusion and asked for further information. ACRE considered that the inclusion of a further step e.g. a glasshouse study in the progression from laboratory experiments to field release might have been more appropriate in this case.

ACRE was asked to discuss scientific issues raised in the public representations that had been received by the date of the meeting. Many of these concerned the safety of the synthetic gene and its peptide product.

ACRE was asked to consider whether the conditions proposed by the applicant for growing the GM potatoes are suitable to manage any risks/ hazards associated with the field trial e.g. by preventing GM potato tubers from entering the food chain. These include the implementation of a separation distance between the GM field trial and non-GM potatoes, the management of land surrounding the trial site and post-release treatment and monitoring of the site. Some of these were raised as issues in some public representations. Should it receive satisfactory additional information on the specificity and safety of the synthetic peptide, ACRE anticipated that it would advise that similar limitations and conditions would apply as those imposed on BASF’s GM potato trial (details can be found at: www.defra.gov.uk/environment/gm/regulation/pdf/06-r42-01.pdf).

The public consultation on this application ends on 3 March. Further advice on any scientific issues raised in public representations will be sought by circulation and advice will be finalised after this date.

Action: Secretariat to draft advice for agreement by circulation.

6. Application by E Nema GmbH to release the entomopathogenic nematode Heterorhabditis bacteriophora as a biocontrol agent in England
ACRE/08/P6

Defra (CSL) has received an application to release a strain of the entomopathogenic nematode Heterorhabditis bacteriophora under Section 16 of the Wildlife and Countryside Act 1981 (WCA), for the biological control of black vine weevil larvae (Otiorhynchus sulcatus) in nurseries and chafer grubs (Phyllopertha horticola, Hoplia philanthus, Melolontha melolontha) on golf courses and sport fields. The established Consultation Group for non-native biocontrol applications (comprising nature conservation bodies in England and the devolved administrations, and a recognised biocontrol expert) had been consulted but consensus was not reached on whether a licence should be issued, consequently further advice was sought from ACRE.

Entomopathogenic nematodes (EPN) are obligate parasites with limited host range and mobility and are particularly susceptible to desiccation, predation and attack by fungi and the risks associated with them are generally considered low. H. bacteriophora is associated with the symbiotic bacteria Photorhabdus luminescens, which is not considered to be hazardous to human health.

Although a recently published paper cited the first findings of H. bacteriophora in Wales, Defra (CSL) had been advised that this nematode is not currently considered native or established in Britain. Furthermore, the applicant proposed to release a strain of H. bacteriophora hybridised from German and USA strains, which was said to be comparable to naturally occurring European strains. Releases of the nematode would be outdoors and potentially large scale, and the applicant did not plan to undertake any monitoring. The applicant stated the nematode could be expected to over-winter in Britain. The applicant argued that the nematode was not a generalist predator, although this point was contested by assessors; the applicant also cited references that point to a lack of evidence of significant adverse impacts of H. bacteriophora on non-target species, and a low potential for persistence in the receiving environment.Natural England, the Joint Nature Conservation Council and the devolved administrations had expressed concerns regarding the potential impact of this EPN on non-target organisms. Published research on the extent and impact of EPNs on non-target organisms under field conditions is limited and these studies have not been undertaken specifically for H. bacteriophora, or strain EN01. ACRE members noted that while there appeared to be very little evidence that H. bacteriophora can cause harm, the application did not discuss specifically which non-target species might be affected by the release of this nematode in Britain in the particular locations into which it would be released. The Committee discussed whether populations of this nematode could be sustained in the long-term in the absence of the host and considered the likelihood of this to be low based on information provided about the life-cycle of the nematode, although the dauer stage does provide some opportunity for persistence. It was noted that H. bacteriophora has been used extensively as a biocontrol agent outdoors since 1984 in the USA and other EU countries and there is no evidence that it has caused any negative environmental impacts in other northern European countries. ACRE members also recognised that this biocontrol agent would provide an alternative to the use of pesticides on sports turfs, which was considered to represent a significant benefit.

ACRE advised that, in principle, sufficient evidence had been provided to support issuing a licence, but this advice was dependent upon information being made available to ACRE on the likely host range of H. bacteriophora strain EN01 in the locations in which it is likely to be released (i.e. nurseries and sports turfs), and its anticipated persistence under these circumstances. It was accepted that this information would be collated from published reviews. The applicant should also be required to deposit a voucher specimen of H. bacteriophora strain EN01 in a recognised nematode taxonomic collection.

Action: CSL to request additional information from the applicant.

7. Applications to release mites into tunnel-grown crops: response to ACRE advice
ACRE/08/P8

7.1 Response to ACRE advice

At the ACRE meeting of 6th December 2007, the committee advised Defra (CSL) on applications to release the non-native predatory phytoseiid mites Amblyseius ovalis and Amblyseius montdorensis for the control of whitefly and thrips in glasshouse and tunnel-grown crops of horticultural vegetables, ornamentals and fruit crops, notably strawberries. ACRE members had advised that the potential impact of the release of these organisms into polytunnels could not be quantified on the basis of the evidence provided, and that further data were required to provide assurance that the impact on the local environment of reduced containment releases had been assessed. ACRE recognised the potential benefits of the availability of these biocontrol agents and thought it might be possible to obtain the necessary data under a licensed small-scale single site trial with a detailed post-release monitoring programme.

The applicant had subsequently provided an outline proposal for such a study. This did not directly address the potential impact of the mites on the receiving environment, but instead focused on determining whether the mites do move away from the place of release and, if so, how far do they move. The applicant’s aim was to demonstrate for both mite species that movement of the mite from the crop in which it is released is limited, and to extrapolate from this that the impact on the receiving environment will also be limited.

The committee thanked the applicant for considering their request for such a study and for submitting the outline research proposal. ACRE members’ views were, however, that the use of trap plants as described to study mite movement would not adequately address the concerns raised by ACRE and advised against issuing a licence to undertake this study.

Action: CSL to provide feedback to the applicant on its research proposal.

7.2 Meeting of the Consultation Group and industry stakeholders to discuss applications for licences to release non-native biocontrol agents under the Wildlife and Countryside Act 1980

Following discussion of the preceding cases, ACRE recommended it would be beneficial for members of the established Consultation Group, industry stakeholders and Defra (CSL) to meet to clarify essential requirements for data that should be routinely presented in application dossiers, and for Defra to clarify the terms of reference of the Consultation Group and ACRE in advising on these applications. Defra (CSL) agreed that such a meeting would be extremely useful and that preliminary discussions were already underway.

8. Update on notifications for authorisation under the GM food and feed EU Regulation EC/1829/2003
ACRE/08/P2

Since the previous update to ACRE (in December 2007), 3 new GM maize applications have been submitted under the GM Food and Feed Regulation. These are relevant to ACRE because they cover import and processing. They do not include cultivation. The GMOs are double stacks and contain different combinations of the following GM events: GA21, Bt11 and MIR604. The reference numbers of these applications are: EFSA/GMO/UK/2007/48, EFSA/GMO/UK/2007/49 and EFSA/GMO/UK/2007/50 (for more information, please refer to: http://www.efsa.europa.eu/EFSA/ScientificPanels/GMO/efsa_locale-1178620753812_GMOApplications.htm). ACRE is familiar with these GM events and did not request any further information before EFSA’s scientific opinions on these applications are published.

In addition, the status of three existing applications had changed since the previous ACRE meeting. EFSA has published its overall Opinion on an application to release LLRICE62 for import and processing (and food and feed use) (application reference: EFSA/GMO/UK/2004/04). ACRE discussed the scientific component of this Opinion under a separate agenda item. Please refer to: ACRE/08/P3.

EFSA has validated an application to import and process (and use as food and feed) MON88913 cottonEFSA/GMO/UK/2007/41. ACRE advice will be drafted and agreed after EFSA has issued its scientific Opinion.

EFSA has validated Monsanto’s application to renew its authorisation to cultivate MON810 maize in the EU. ACRE considered the application under the following agenda item.

9. Application from Monsanto to renew authorisation to cultivate MON810 maize in the EU – ref EFSA-GMO-RX-MON810
ACRE/08/P7

EFSA has validated Monsanto’s application to renew its authorisation to cultivate, import and use MON810 maize in the EU. This GMO was first authorised in the EU in 1998 and cultivated from 2003. The format of this application conforms to EFSA guidance on submitting applications to renew existing GMO authorisations under the GM Food and Feed Regulation. ACRE commented on this guidance in 2006.

As Defra is required only to comment on the environmental risk assessment of applications submitted under the GM Food and Feed Regulation, ACRE focused on molecular characterisation data that related directly to environmental risks. The committee noted that the molecular information included in this application is the same as that provided in other recent applications submitted under the GM Food and Feed Regulations. These are applications to import (but not cultivate) maizes with stacked GM events. Since this GMO was authorised in 1998, Monsanto has provided more extensive data on DNA flanking the insertion site and up-dated its bioinformatic analyses.

As MON810 maize is insecticidal, an important component of its environmental risk assessment is the potential for the Cry1Ab protein it contains to target beneficial non-target organisms. ACRE noted that in the recent past, it has had detailed discussions about the potential non-target effects of GMOs producing the Cry1Ab protein. This was in association with an application under Directive 2001/18/EC to cultivate Bt11 maize and safeguard actions submitted by other EU Member States. ACRE felt that the data in this application could have been better presented and relied on the assessor’s familiarity with the subject area. In particular, data directly relevant to the EU should have been separated from that specific to other parts of the world. ACRE noted that the concentration of Cry1Ab protein in MON810 maize pollen is low. This is well documented in the literature but not described in the section on protein expression in the technical dossier. Data on Cry1Ab levels in MON810 maize vegetative tissue are presented in the application. ACRE noted that maize cultivation in the EU is different to that in the intensive maize cultivation areas of the US. As such, the accumulation of maize debris in nearby streams is not equivalent to that reported by Rosi-Marshall et al., 20071. This conclusion was supported by comments submitted by Natural England. ACRE considered that the low levels of Cry1Ab protein in MON810 maize pollen means that the risk assessment should focus on potential impacts in the field and field margins.

ACRE considered a report by Greenpeace2 (How much Bt toxin do genetically engineered MON810 maize plants actually produce?) that was included with this application. This concluded that variation in the expression of Cry1Ab protein in maize tissue invalidates the risk assessment. ACRE did not agree. It considered that variability in protein levels is expected and that this may have implications for crop management if the levels of Cry1Ab are low, but that this does not affect conclusions about toxicity to non-target organisms.

MON810 maize was authorised in 1998 under Directive 90/220/EEC, which preceded the current GM deliberate release directive (2001/18/EC). Under this legislation a post-market monitoring (PMM) plan was not required. However, PMM of resistance to the target pests was a condition of the authorisation decision. In addition, Monsanto has included the results of a farmer questionnaire (which it was not required to carry-out) in this application. ACRE assessed the questionnaire in detail because it is the focus of Monsanto’s general surveillance plans in its new application. ACRE considers that the most important factor in general surveillance is detecting an adverse effect rapidly so that it can be reversed as quickly as possible. For questionnaires, coverage is the most important factor with questions kept direct and simple. However, in this case, given the insecticidal properties of MON810 maize, ACRE felt that the question on non-targets was not specific enough and should ask farmers about changes in insects in and around MON810 maize fields.

The secretariat will draft preliminary advice that will provide the foundation for further discussion by ACRE once the application is complete and EFSA has issued its scientific opinion. This preliminary advice will form the basis of Defra’s response to EFSA’s consultation on the environmental risk assessment of this GMO.

Action: Secretariat to draft preliminary advice for agreement by circulation.

10. EFSA Opinion on an application (EFSA-GMO-UK-2004-04) to import LLRICE62 (glufosinate tolerant) under Regulation (EC) 1829/2003 from Bayer CropScience
ACRE/08/P3

ACRE considered the quality, content and conclusions of EFSA’s scientific Opinion on application EFSA-Q-2004-145, which is for the import and use of LLRICE62 in the EU. ACRE is familiar with this GMO, having assessed an application for LLRICE62 under Directive 2001/18/EC. The application was transferred to the GM Food and Feed Regulation soon after it came into force. The UK competent authority led on the risk assessment of this GMO under Directive 2001/18/EC and this was underpinned by detailed advice from ACRE. ACRE reviewed its existing advice on GM crops that are not grown in the UK and agreed that it applied to this GMO.

Action: Secretariat to update existing advice on applications for import and processing of GM crops that are unable to grow under UK conditions to include this application.

11. ACRE 2007 Annual Report
ACRE/08/P5

Members considered the structure and content of the draft report and provided comments. They agreed to provide any further suggestions and any revisions to their career details and register of interests by 3rd March.

Action: Secretariat to amend the draft report in the light of comments and information provided by ACRE.

12. Items for information

12.1 Analysis of Marshall et al (2007): Toxins in transgenic crop by-products may affect headwater stream ecosystems
ACRE/08/INF1

Members noted letters which had appeared in PNAS in response to the Marshall et al paper

12.2 Annual reports on general surveillance for NK603 and MON863 maize in the EU.
ACRE/08/INF2

These reports were presented to ACRE for information. ACRE had seen previous post-market monitoring reports for NK603 and MON863 maize and these latest reports did not differ in structure and provided little new data.

12.3 Updated Code of Practice for Scientific Advisory Committees
ACRE/08/INF3

Members noted the published version of the updated Code and that many of their comments were reflected in it. The committee agreed in principle to operate as proposed in the event of urgent advice being required where it has not been possible to go through the normal channels. The proposal was that the chairman will act on behalf of the committee to ensure a timely response, with the committee being informed as soon as possible of the advice and being given an opportunity to comment on it. The chairman wished to discuss this further at the next ACRE meeting as the committee would need to consider that any individual speaking for it would have expertise limited to certain areas only. The chairman also wished to discuss the requirements for openness.

12.4 Application to market a veterinary medicinal product consisting of or containing a GMO under Regulation EC/726/2004 - assessment of the responses to the adopted list of questions
ACRE/08/INF4

ACRE was updated on a veterinary medical product case on which it had previously commented. This application had been submitted to the European Medicines Evaluation Agency in accordance with regulation EC/726/2004. Under this legislation information on the assessment of the application may only be made available as part of the European Public Assessment Report following the Commission decision at the end of this process.

12.5 Non-native biocontrol agents: licences currently issued
ACRE/08/INF5

CSL provided a list of licences in response to the request made by ACRE at its December meeting.

12.6. Oral report - meeting of the Royal Society’s Genetically Modified Crops Consultation Group.

Professor Dunwell reported on his attendance at this meeting. The Royal Society was considering revisiting the question of GM crops and formed an interim consultation group, with Professor Dunwell attending. The conclusions were that GMOs were not appropriate to revisit as an issue in isolation but should be considered as part of a general review of food security and sustainability. The proposal will need approval by the Royal Society council, which would take 6-9 months, and the audience will be national policy makers including Government, food suppliers and retailers.

If ACRE wished to co-sponsor a science-based review of new technologies, this would be a longer-term project and an internal sponsor in the Royal Society would be required. Other options to taking this forward with the Royal Society may need to be considered.

13. Any other business

13.1 Professor Sir Howard Dalton

Members expressed their regret following the recent death of Defra’s former Chief Scientist, Professor Sir Howard Dalton, and offered their condolences.

13.2 Cotton bollworm resistance to Bt in the USA

Mr Orson highlighted a recent report of increased cotton bollworm resistance to Bt. The Secretariat was aware of the paper published in the February edition of the Journal of Nature Biotechnology and agreed to circulate more information to the Committee.

14. Date and time of next meeting

Thursday 1st May 2008 in Nobel House

ACRE Secretariat
February 2008

1. E.J. Rosi-Marshall, J.L. Tank, T.V. Royer, M.R. Whiles, M. Evans-White, C. Chambers, N.A. Griffiths, J. Polkelsek and M.L. Stephen. Toxins in transgenic crop byproducts may affect headwater stream ecosystems. PNAS (2007)104 (41): 16204 – 16208.

2. Greenpeace report