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ACRE/08/M2
These minutes are subject to approval following formal adoption at the next ACRE meeting.
MINUTES OF THE 118th MEETING OF ACRE AT JESUS COLLEGE, OXFORD, THURSDAY 3rd JULY 2008
Attendance:
Members:
Professor C Pollock (Chairman)
Dr P Hirsch
Professor K Lindsey
Dr J Stoye
Professor J Dunwell
Dr R Hails
Professor J Pretty
Dr M Bonsall
Professor A Peters
Mr E Cross
Mr J Orson
Professor M Bailey
Assessors:
Dr J Davey SASA
Ms V Collins WAG
Dr S Hugo CSL
Ms A Hope NE
Dr K Hayter NE
Dr M Paton HSE
Prof H Platt NIEA
Defra:
Dr A Gilliland (Secretary)
Dr L Ball
Dr S Popple
Dr L Gilliam
Mr D Sherlock
Apologies for absence were received from Professor Rees and Professor Bale. The chairman thanked Dr Bonsall for hosting this meeting.
1. Minutes of the 117th Meeting, 21st February 2008 ACRE/08/M1
The minutes were agreed subject to two revisions.
2. Matters Arising / Secretariat Report
2.1 Secretariat staff changes
The secretary reported that Darryl Carter had left Defra and the ACRE Secretariat in March. The committee welcomed Dr Lucy Gilliam who had recently joined the ACRE secretariat from Rothamsted Research.
2.2 New assessors
The committee welcomed Dr Michael Paton as the new HSE assessor in place of Dr Paul Logan. Dr Paton is the new SACGM secretary and at future ACRE and SACGM meetings, there will be an update of both committees’ activities under this agenda item. ACRE also welcomed Professor Howard Platt, attending for the first time as assessor for Northern Ireland.
2.3 ACRE appointments
This was the last ACRE meeting for Dr Stoye who had decided to stand down at the end of his current term in August. The chairman thanked him for his contribution to the work of ACRE and wished him well for the future. An advertisement for a replacement would be issued shortly.
Professor Rees and Mr Cross have been reappointed until June 2009, by which time they will have served 10 years on the Committee. Professor Bale and Mr Orson have been reappointed for another 4 years which will take them up to 10 years service. The chairman thanked these members for the contributions they had made to date to the work of ACRE.
2.4 Application for Part B Consent from University of Leeds to release GM Solanum tuberosum with resistance to potato cyst nematodes. Ref: 07- R31- 01.
Defra issued consent for this trial based on the favourable advice from ACRE on 9 May. However, on 5 June, the GM potato trial was totally destroyed. The GM Inspectorate has confirmed that it did not identify any risks to human health or the environment resulting from destruction of the trial.
At the consent holder’s request, the chairman recently met the consent holder and informed him that it was not for ACRE to comment on the implementation of regulations for the operation of Part B releases in specific cases. However, the consent holder was free to follow up his concerns that the current regulations disadvantaged GM developments in agriculture. It was emphasised that it would be up to the regulators (Defra) to judge the force of the arguments put forward, rather than ACRE.
2.5 Public Engagement ACRE Sub-group
The sub-group met for the first time on May 1st and a further meeting was scheduled to follow the main ACRE meeting on 3 July (see item 12 for further details).
3. Matters agreed by circulation
3.1 Application for Part B Consent from University of Leeds to Release GM Solanum tuberosum with resistance to potato cyst nematodes. Ref: 07- R31- 01.
Additional information requested from the applicant was supplied to ACRE for assessment. ACRE considered the information and it did not identify any risks to human health or the environment from the very small scale trial to release PCN-resistant GM potatoes. The Committee agreed its advice by circulation and its advice was published on 9th May.
3.2 Application from Florigene Ltd for Part C Consent in the EU under Directive 2001/18/EC - EFSA Opinion on a notification to import, distribute and retail cut flowers of the genetically modified carnation ‘Florigene Moonaqua (123.8.12)’. Ref C/NL/06/01.
ACRE advice was updated to reflect its consideration of the EFSA opinion. The committee agreed that their previous favourable advice on this notification was still applicable.
3.3 EFSA Opinion on an application from Bayer CropScience (EFSA-GMO-UK-2004-04) to import LLRICE62 (glufosinate tolerant) under Regulation (EC) 1829/2003.
The EFSA opinion was circulated to ACRE. ACRE agreed to update its existing advice on applications for import and processing of GM crops that are unable to grow under UK conditions to include this application.
3.4 EFSA scientific opinion on an application from Bayer CropScience (EFSA-GMO-UK-2005-25) to import and process T45 oilseed rape (glyphosate-tolerant) under Regulation EC/1829/2003.
The EFSA opinion was circulated to ACRE. The production and sale of this GMO was discontinued in 2005, as such, the consent would authorise trace quantities in oilseed rape imports for processing into the EU. ACRE discussed the EFSA opinion and formulated and agreed advice. The advice will be published on the web prior to the vote in Standing Committee on 14 July.
3.5 Application from Monsanto to renew authorisation to cultivate MON810 maize in the EU – ref EFSA-GMO-RX-MON810.
ACRE agreed preliminary advice by circulation. Comments on the environmental risk assessment for this GMO were transmitted to EFSA.
3.6 Application to market under Regulation EC/726/2004 a human medicinal product consisting or containing a GMO.
Following the ACRE discussion of this application in February, comments were transmitted to the EMEA according to the required procedure.
4. Update on notifications for authorisation under the GM food and feed EU Regulation EC/1829/2003 ACRE/08/P9
Since the previous update to ACRE (in February 2008), five new applications that are relevant to ACRE (because they concern live GMOs) have been submitted under the GM food and feed regulation. Four applications were to import, process and use GMOs in the EU (reference numbers: EFSA/GMO/NL/2008/51; EFSA/GMO/NL/2008/52; EFSA/GMO/UK/2008/53 and EFSA/GMO/UK/2008/56). For more information, please refer to: http://www.efsa.europa.eu/EFSA/ScientificPanels/GMO/efsa_locale-1178620753812_GMOApplications.htm). ACRE considered the summary notification information formats (SNIFs) for these applications. ACRE concluded that it was familiar with the transgenes introduced into these GMOs and that it did not require further information before EFSA’s scientific opinions on these applications were published. The fifth new application (reference: EFSA/GMO/CZ/2008/54) is for the cultivation of MON 88017 maize in the EU. Once this application is validated by EFSA, ACRE will assess its environmental risk assessment and post-market monitoring plan.
In addition, the status of nine existing applications had changed since the previous ACRE meeting. Seven applications had been validated (EFSA/GMO/UK/2007/42; EFSA/GMO/UK/2007/43; EFSA/GMO/NL/2007/45; EFSA/GMO/UK/2007/47; EFSA/GMO/UK/2007/48; EFSA/GMO/UK/2007/49 and EFSA/GMO/NL/2007/46). The latter is an application to cultivate (import, process and use as food and feed) T25 maize in the EU. The UK is leading on the environmental risk assessment of this application. ACRE discussed a strategy for this assessment. In the first instance, this will involve a small working group that will assess the application for gaps and weaknesses. This will report back to / consult the whole committee. EFSA has published its overall opinion on an application to import and process (and use for food and feed purposes) T45 oilseed rape (EFSA/GMO/UK/2005/25). ACRE discussed the scientific component of this opinion and agreed advice via email. This advice will be published on ACRE’s website.
The member states leading on the environmental risk assessment of applications to cultivate NK603 maize (EFSA-GMO-NL-2005-22) and 59122 maize (EFSA-GMO-NL-2005-23) have published their respective reports. These will be taken into consideration by EFSA when it delivers its opinions on these applications. ACRE considered these assessment reports under separate agenda items (7 and 8 respectively). ACRE will provide its final advice once EFSA has issued its opinions and the dossiers are complete.
5. Consultation on updated EFSA guidance document for the risk assessment of genetically modified plants and derived food and feed. ACRE/08/P16
The EFSA GMO panel has updated its guidance document for the risk assessment of GM plants and derived food and feed (although the latter is not within ACRE’s remit). This was a late addition to the ACRE agenda and as such, ACRE was asked to supply detailed comments to the secretariat within a month of this meeting. ACRE indicated that it would comment on the section dealing with potential impacts on biogeochemical processes. In particular, it considered that the examples provided were misleading. ACRE re-iterated its stance on the environmental risk assessment of GM plants with stacked events and that it holds a different view to EFSA.
ACTION: ACRE members to supply detailed comments on the updated EFSA guidance document on the risk assessment of GM plants and derived food and feed, within a month of this meeting.
6. Consultation on draft EFSA opinion on the risk assessment of genetically modified plants for non-food or non-feed purposes. ACRE/08/P17
ACRE was asked to comment on the draft opinion from EFSA on the risk assessment of GM plants for non-food or non-feed purposes. This (draft) EFSA opinion is intended to complement EFSA’s guidance on the risk assessment of GM plants (see previous agenda item 5). The main objective of the opinion is to highlight differences in the issues associated with the risk assessment of GM plants developed for non-food/feed purposes compared with GM plants with traits that were taken into account when the guidance was drafted. ACRE was asked to discuss whether EFSA has identified all the key issues associated with the risk assessment of GMOs of this type and to advise on whether it agrees with EFSA’s conclusions and recommendations on the criteria for risk assessing these GMOs. This was a late addition to the agenda as EFSA released its draft opinion for consultation close to the July meeting. The deadline for commenting to EFSA is September, but before the next scheduled ACRE meeting, as such ACRE was asked to supply detailed comments to the secretariat within a month of this meeting.
ACTION: ACRE members to supply detailed comments on the draft EFA opinion on the risk assessment of GM plants for non-food or non-feed purposes, within a month of this meeting.
7. Application from Monsanto for authorisation to use NK603 maize in the EU, including the use for cultivation of varieties – ref EFSA-GMO-NL-2005-22. ACRE/08/P11
ACRE first considered this application (EFSA-GMO-NL-2005-22), submitted under the GM food and feed regulation, in July 2006. The application is to market herbicide tolerant (glyphosate) maize varieties containing the GM event NK603. The scope of the application is for the import, processing and use in food and feed as any other maize, including cultivation in the EU. At this early stage, ACRE concluded that the applicant (Monsanto) had presented insufficient information and analysis of the risks posed to farmland biodiversity by herbicide regimes associated with the cultivation of this GMO.
Since then, EFSA and the Spanish Competent authority (who are leading on the environmental risk assessment of this application) have requested further information from Monsanto to develop the dossier so that a thorough evaluation can be carried out. Monsanto has provided further information on potential interactions on non-target organisms, potential impacts of herbicide management regimes and on the general surveillance plan. ACRE considered this further information and discussed whether its previous conclusions were still valid.
In particular, ACRE focused on the risk assessment and post-market monitoring of impacts on farmland biodiversity associated with herbicide management regimes used in association with the crop. Monsanto identified a risk in its application but concluded that adverse effects resulting from the use of recommended weed management practices in association with NK603 maize will fall within the range of those resulting from ‘modern’ cultivation practices associated with non-GM crops. The company is not proposing to carry out case-specific monitoring to confirm this conclusion. However, it has included questions on herbicide use and weed pressure (before and after treatment) in its farmer questionnaire for NK603 maize (as part of the general surveillance plan). ACRE considered that uncertainty about what herbicide management strategies will be adopted in association with NK603 maize in different biogeographical regions in the EU over time and their impacts on farmland biodiversity (relative to practices used in association with non-GM counterparts) warrants case-specific monitoring. As maize is a low biodiversity crop, ACRE considered that monitoring, rather than further studies carried out prior to marketing, was its preferred approach. This will provide information on real farming situations throughout the cultivation area over time. This is in agreement with the conclusion of the Spanish CA.
8. Application from Pioneer HiBred International Inc and Mycogen Seeds for authorisation to use 59122 maize in the EU, including the use for cultivation of varieties – ref EFSA-GMO-NL-2005. ACRE/08/P12
ACRE first considered this application (EFSA-GMO-NL-2005-26) to cultivate, import and use 59122 maize in the EU at its meeting in May 2007. The application was submitted under the GM food and feed regulation by Pioneer Hi-bred International Inc. and Mycogen Seeds. 59122 maize is modified for insect resistance and herbicide tolerance. The latter trait was introduced into the GMO as a selectable marker in the transformation process. As the applicant had not excluded the possibility that farmers could take advantage of this trait in the commercial cultivation of 59122 maize, ACRE considered that an appropriate environmental risk assessment should be carried out. This assessment was not included in the original application and it has not been requested by the competent authority (CA) leading on the environmental risk assessment (The Netherlands) of this application. ACRE’s position on this issue has not altered.
In its original assessment of the application, ACRE concluded that further detail on the mechanism of toxic action of the Bt proteins, Cry34Ab1 and Cry35Ab1and their potential to interact with other Cry proteins was required. At this meeting, ACRE reviewed all the information provided by the applicant. ACRE considered that it would be relatively straight-forward to develop the research to identify membrane proteins that bind to these Cry proteins. However, ACRE concluded that the evidence submitted did indicate that relatively few membrane proteins interact with these Cry proteins, suggesting a molecular basis for selectivity. This specificity is supported by the results of toxicity studies on non-target organisms.
ACRE noted that more evidence had been submitted by the applicant to support its conclusions on the potential for these Cry proteins to affect non-target organisms. The applicant had provided a more detailed rationale for selecting the species tested in its studies, further analysis of existing studies and results from additional field trials carried out in the EU. ACRE agreed with the Netherlands CA’s conclusion that toxicity to ladybird beetles (Coleomegilla maculata) had not been assessed properly by the applicant. ACRE noted that first tier toxicity studies were carried out on species from the USA. Field studies that showed no adverse effect were conducted in the EU. ACRE considered that uncertainty resulting from a lack of relevant susceptibility data should be addressed by the applicant.
9. Second annual report on general surveillance for 1507 maize in the EU. ACRE/08/P13
ACRE noted that the type and detail of information provided in the second annual post-market monitoring (PMM) report for 1507 maize was consistent with that submitted for other GM maize events approved for import (but not cultivation) in the EU. ACRE considered that environmental exposure resulting from maize spilled during import and processing will be minimal (as it has limited potential to germinate and flower outside of agricultural conditions in the UK). As such, ACRE concluded that the information provided in the report was proportionate to the risk.
ACRE considered that importation of GM oilseed rape could result in greater environmental exposure compared with GM maize. This is because spilled seed could germinate and develop into plants that flower. ACRE concluded that it would be useful to talk to industry representatives to gain a better understanding of the practicalities of handling imports of commodity crops. This would include a discussion about the systems in place to minimise spillage of living material and the eradication of feral plants. No monitoring reports for GM oilseed rape have been submitted to date. This is because GM oilseed rape events authorised under Directive 2001/18/EC have not been imported into the EU for commercial purposes.
Action: ACRE secretariat to investigate holding a meeting between ACRE and industry representatives to discuss the practicalities of importing and processing live GMOs in the EU. In particular, to discuss the systems in place to minimise environmental exposure.
10. Application to release the non-native psyllid Aphalara itadori for the classical biocontrol of Japanese knotweed (Fallopia japonica var. Japonica). ACRE/08/P14
Defra (CSL) has received an application for a licence to release the non-native psyllid Aphalara itadori under Section 16 of the Wildlife and Countryside Act 1981 (WCA). The applicant wishes to release the psyllid for the classical biological control of Japanese knotweed (Fallopia japonica var. japonica), a non-native species in the UK which is restricted under the WCA. If approved, this would be the first classical biological control programme against a weed species in the UK. Section 14 of the WCA prohibits the release into the wild of any animal which is ‘of a kind not ordinarily resident in and is not a regular visitor to Great Britain in a wild state’. Derogation from Section 14 can be obtained through the issuing of a licence under Section 16 of the Act, dependent upon the outcome of an assessment of the risks and potential benefits of release of the organism. Defra is responsible for the issuing of these licences for England and asked ACRE for its advice on the risks posed to human health and the environment by this release.
ACRE members discussed the application and supporting evidence at length, together with the consultation group’s comments and the applicant’s response to these. The committee recognised the potential value of a biological control agent for Japanese knotweed, and the need to very carefully balance the potential risks versus the potential benefits were acknowledged. Having considered the application, ACRE concluded that insufficient information had been provided to enable the members to support licensing the release of Aphalara itadori at this stage. The committee’s comments fell into three key areas:
i) Behaviour of the psyllid outside of its native environment: ACRE recognised that excellent work had been done in demonstrating the limited host range of the psyllid, which provided confidence that it is essentially monophagous. Members were concerned, however, at the lack of information provided as to the likely impact of the psyllid if it were to be released. In particular, whether it could reach sufficiently high densities to have an effect on the Japanese knotweed populations, and what might be the indirect effects of these levels of the psyllid? The applicant had explored the issue of parasitoids in detail, so there was reasonable confidence that Aphalara itadori would not itself be predated, but the Committee asked what the range of generalist predators that feed on psyllids is, and would they broaden their host range? The likelihood that A. itadori would become a preferred host and thus affect the balance of the community ecology was also raised. ACRE recognised the difficulties of undertaking such studies and gaining meaningful results, however it believes that the applicant could go further in examining this aspect of the release, and pointed out that it is possible to do small scale studies in a contained environment. ACRE commented that organisms released outside of their native environment can adapt their behaviour, and questioned whether there was any evidence that evolutionary pressure would lead to a change in the habitat of the psyllid once released. ACRE would expect to be provided with some indication as to the tertiary and tri-trophic interactions that might be expected, the level of change, if any, in the receiving environment and therefore any indirect effects on the community into which the psyllid would be released. ACRE was of the opinion that there is not a strong argument for limited release to enable this information to be gathered, because the agro-ecology varies significantly from place to place where Japanese knotweed is found. ACRE also asked for whether it had been established that A. itadori does not currently exist anywhere in the UK on Japanese knotweed via accidental importation.
ii) Post release monitoring: the absence, at present, of any firm arrangements for post release monitoring was thought to be undesirable and needed to be addressed. The likelihood of an extreme event occurring may be rare, but it is important that this would be picked up quickly to enable mitigation measures to be taken. Post release monitoring is also important to provide information as to the efficacy of the psyllid and the speed of its movement away from the sites of release and any impact of the psyllid on native ecology. The committee was of the opinion that it is the responsibility of the applicant to have arrangements in place to enable these aspects to be studied. The committee was informed that funding under the EC Life+ programme might be forthcoming in the near future, and that this would provide financial support for monitoring.
iii) Options for control of Aphalara itadori post release: ACRE considered the absence of information on potential chemical control of A. itadori to represent an omission. The committee believed information should be provided on the susceptibility of the psyllid to chemicals currently in use in the UK and the potential for mitigation should this be necessary post-release. In particular, this should address statements about the resilience of eggs and high numbers of nymphs to pesticide applications. The committee was informed that the Environment Agency has been examining the toxicity of weed control chemicals (glyphosate is currently used) on the psyllid, and developing a management programme for spraying Japanese knotweed at the most appropriate time in the season to enable control of the plants without destroying the psyllid populations.
In the absence of the information listed above, ACRE members concluded that they could not advise on the potential risks versus the benefits posed to human health and the environment posed by this release. The Committee requested to be kept informed of the progress of this application.
11. Application to release the entomopathogenic nematode Heterorhabditis bacteriophora as a biocontrol agent in England: response to request for further information. ACRE/08/P15
At its meeting on 21 February ACRE advised Defra (CSL) on an application to release the entomopathogenic nematode Heterorhabditis bacteriophora strain EN01 under Section 16 of the Wildlife and Countryside Act 1981 (WCA). The organism would be released 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 Committee had advised that, in principle, sufficient evidence had been provided to support issuing a licence, but that this should be dependent on information being made available to ACRE, by the applicant, 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 requested information had been provided and reviewed by the Committee. ACRE thanked the applicant for the comprehensive response to their request. ACRE members confirmed that they were satisfied that release of Heterorhabditis bacteriophora strain EN01 could proceed under licence. The applicant will be required to deposit a voucher specimen of H. bacteriophora strain EN01 in a recognised nematode taxonomic collection.
12. Report from the Public Engagement ACRE Sub-group and discussion of action points ACRE/08/P10
Proposals for future ACRE meetings with the aim of public engagement were discussed by ACRE. The Public Engagement sub group met on 1 May to discuss its terms of reference, its work plan and initial proposals for public engagement. The minutes of the first meeting of the sub group are published (please see http://defra/environment/acre/about/pdf/public-engagementminutes080501.pdf). The sub group proposed four ideas for future public engagement meetings:
- To hold a future ACRE meeting as a meeting open to members of the public by pre-registration (later this year). The chairman of ACRE will present a short introduction to the membership and operation of ACRE. The agenda can cover non-confidential material and include items that the Committee discusses in meetings, such as issuing advice to government for the import of GMOs, recent GM research papers and projects, engagement with other Committees and other bodies at a European level. There will also be an opportunity for questions from the audience.
- ACRE to contribute to a future meeting (early 2009) that is already being organised, to be held by the Institute of Biology, the Centre for Ecology and Hydrology, and the British Ecological Society and that would cover the issues of rural land use. Currently, it is envisaged that the ACRE chairman would give a presentation and that other ACRE members would be involved in break out discussion sessions.
- To hold a future ACRE meeting or meetings with the aim of horizon scanning (possibly 2009/10) ACRE assesses the release of all GMOs, those that are intended for agricultural use, as well as for human and veterinary medical use. The choice of subject will be decided closer to the time of the meeting, but it is intended to be a discussion of the regulatory implications of releasing the products of any novel GM technology into the environment.
- To hold an ACRE meeting jointly with another scientific body to discuss scientific and regulatory issues for an emerging bio technology, for example synthetic biology.
The chair of the sub group outlined the above proposals to ACRE. ACRE agreed the approach, the proposed meeting ideas and to holding the first of these meetings later this year.
ACTION: Secretariat to begin detailed planning for the first of its public engagement meetings.
13. Items for information
13.1 Application to market a human medicinal product consisting of or containing a GMO under regulation EC/726/2004 – CHMP questions.
ACRE/08/INF6
ACRE noted the paper.
13.2 Bt crop effects on functional guilds of non-target arthropods: a meta-analysis. ACRE/08/INF7
ACRE noted this report.
13.3 ACRE research priorities. ACRE/08/INF8
ACRE discussed two emerging biotechnologies of potential future relevance to its remit, that of synthetic biology and self dispersive GMOs such as GM insects. Members had the opportunity to examine and discuss potential future regulatory challenges and research requirements relating to these technologies specifically focusing on the consequences of environmental release of such GMOs.
14. Any other business
None
15. Date and time of next meeting
25 September 2008 in London
ACRE Secretariat
July 2008
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