ACRE Meetings

ACRE/07/M3

MINUTES OF THE 115th MEETING OF ACRE IN ROOM 401, NOBEL HOUSE, LONDON, THURSDAY 27TH SEPTEMBER 2007

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 Pretty
Mr J Orson
Professor M Bailey

Assessors:

Dr J Davey SASA
Mr N Cooke WAG
Ms V Collins WAG
Mr D Bevan WAG

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 Peters and Mr Cross.

1. Minutes of the 114th Meeting, May 3rd 2007

The minutes were agreed.

2. Matters Arising

2.1 Changes in the secretariat

Dr Kate Morley has left the secretariat to take up a new position in Defra. Her post will be filled in due course. Following Joe Pereira’s departure, Darryl Carter has joined the secretariat.

2.2 Ministerial changes

Phil Woolas MP now has the GM portfolio in Defra and has met with GM officials. There has been a change of government in Scotland. Northern Ireland is now devolved and has a coalition government and Wales also now has a coalition government. Defra’s new Ministers, as well as those of the Devolved Administrations, may wish to meet the ACRE chairman.

2.3 Weed-monitoring working group

There had been no further developments since the meeting in February. The chairman agreed to discuss with the secretariat options for taking this forward. The committee considered that any proposals needed to be feasible and robust, and that there were compelling scientific and policy reasons to reach conclusions on the issues the group was covering.

2.4 Notification for Part C consent from Bayer CropScience to market herbicide-tolerant oilseed rape, lines Ms8, Rf3 and Ms8xRf3 - ref C/BE/96/01

Belgium issued consent for GM oil seed rape MS8, Rf3 and Ms8XRf3 on 25 May.

2.5 Notification for Part C consent from Florigene Ltd to market carnation “Florigene Moonlite” - ref C/NL/04/02

The Netherlands issued consent for the GM carnation (Dianthus caryophyllus) ‘Moonlite’ on 11 July.

2.6 Notification for Part C consent from BASF Plant Science to market a GM potato modified for starch composition, line EH92-527-1 - ref C/SE/96/3501

The vote at Council in July delivered no qualified majority.

2.7 Application from Monsanto under Regulation (EC) No. 1829/2003 on genetically modified food and feed for authorisation of NK603 X MON810 maize - ref EFSA-GMO-NL-2005-26 - and from Pioneer Hi-Bred International Inc. and Mycogen Seeds for authorisation of 1507 X NK603 maize - ref EFSA-GMO-NL-2005-17.

Votes on the authorisation of these applications for GM maize hybrids were inconclusive at Standing Committee 8 June and these decisions were referred to the Council, which met on 26 September. No qualified majority was reached for 59122 GM maize (Herculex) or these 2 GM maize hybrids.

2.8 Austrian safeguard action for oilseed rape line GT73.

Austria renewed its safeguard action for oilseed rape line GT73, genetically modified for glyphosate herbicide tolerance (C/NL/98/11), in July. Austria has re-submitted the same evidence that was assessed by ACRE last year. ACRE remains of the opinion that no new evidence has been provided by the Austrians that would cause ACRE to doubt its previous risk assessment of this GM product. ACRE therefore continues to recommend that the safeguard action should not be supported on the basis of the data presented in the Austrian submission relating to the environmental risk assessment of this product.

2.9 Application by BASF for a Part B field trial of GM potatoes resistant to Phytophthora infestans-ref 06/R42/01.

The trial at the Cambridgeshire site went ahead though it was partially destroyed by protesters. The GM Inspectorate has inspected the site and has concluded that there were no risks to human health or the environment arising from this trial.

2.10 Progress on a GM medicine application

ACRE was updated on the progress of an application to market a GM medicinal product consisting of or containing a GMO, which it had previously assessed. 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.

2.11 ACRE appointment

Members were informed that the interviews for the new ACRE appointment would be held on 28 September

3. Matters agreed by circulation

3.1 Notification for Part C consent from Florigene Ltd to market carnation “Florigene Moonaqua” - ref C/NL/06/01

Since the last meeting in May, two sets of ACRE advice have been agreed by circulation on this application.

3.2 General advice on notifications under EU Regulation 1829/203 to import live GMOs that have a limited potential to grow and flower outside of agricultural conditions in the UK.

This is the second category of general advice that ACRE has agreed and it covers imports of 59122 Bt/HT maize following publication of EFSA opinion. The advice is now published.

3.3 Application from Pioneer Hi-bred International Inc. and Mycogen Seeds under Regulation (EC) No. 1829/2003 for authorisation to use 59122 maize in the EU – ref EFSA-GMO-NL-2005-23

Preliminary advice was agreed by circulation.

3.4 Research report - new Bt toxins in the EU GMO application process: a review of published research into impacts on non-target insects and ecosystem services

This review of published research into impacts on non-target insects and ecosystem functions is now on the web.

3.5 Notification for Part C consent from BASF Plant Science to market a GM potato modified for starch composition, line EH92-527-1 - ref C/SE/96/3501

ACRE advice on GM starch potato (line EH92-527-1) was updated and placed on the on the web following the discussion of the EFSA opinion on the use of the nptII gene as a selective marker gene.

3.6 EMEA consultation on guidance for environmental aspects of gene therapy medicinal products.

ACRE was consulted on this by circulation and a response on behalf of Defra and ACRE was transmitted to the EMEA.

3.7 Consultation document on updating the code of practice for Scientific Advisory Committees.

The newly created Go- Science (formerly OSI) in the Department for Industry, Universities and Skills (DIUS, formerly DTI) issued a consultation document. The ACRE response was agreed after a workshop on the consultation questions and was been transmitted to DIUS.

4. Application to market a veterinary medicinal product consisting of or containing a GMO – review of environmental risk assessment under Regulation (EC) No. 726/2004 ACRE/07/P16

ACRE considered the environmental risk assessment aspects of a marketing application for a medicinal product containing or consisting of a GMO. 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. Update on notifications for authorization under the GM Food and Feed Regulation (EC) No. 1829/2003ACRE/07/P17

Since the previous update to ACRE (in May 2007), 6 new applications have been submitted under the GM Food and Feed Regulation; 5 applications are relevant to ACRE as they concern live GMOs (rather than derived products). 4 of these applications are for events that ACRE has not considered previously and as such. ACRE considered their Summary Application Information Formats (SNIFs) at this meeting. The SNIF for T25 maize (used in the FSE trials) was not discussed. ACRE will be asked to advise on the environmental risks associated with this GMO once the new application is validated and the entire dossier is available. EFSA does not make the full applications available until they have been validated.

ACRE considered the SNIFs for applications: EFSA-GMO-UK-2007-41, EFSA-GMO-UK-2007-42, EFSA-GMO-UK-2007-43, EFSA-GMO-NL-2007-45. Publicly available information on these applications is available at: http://www.efsa.europa.eu/en/science/gmo/gm_ff_applications.html

In addition, the status of 10 of the existing applications (which are relevant to ACRE) has changed since the last update. 9 of these applications have been validated by EFSA. These are: EFSA-GMO-NL-2007-15, EFSA-GMO-UK-2007-20, EFSA-GMO-UK-2007-21, EFSA-GMO-NL-2007-28, EFSA-GMO-UK-2007-30, EFSA-GMO-UK-2007-34, EFSA-GMO-NL-2007-36, EFSA-GMO-NL-2007-37 and EFSA-GMO-NL-2007-38. EFSA has issued a new Opinion on 1 application (EFSA-GMO-NL-2005-18).

ACRE requested the molecular data in application EFSA-GMO-NL-2007-45 once this becomes available. In particular, the committee was interested in the information provided by the applicant on the use of GM to silence a gene associated with the biosynthesis of oleic acid.

ACTION: Secretariat to circulate requested information when it becomes available.

6. Application from Pioneer Hi-Bred International Inc. for authorisation to use 59122 x 1507 X NK603 maize in the EU, including the use for cultivation of varieties - ref EFSA-GMO-UK-2006-30 ACRE/07/P18

Pioneer Hi-bred International has submitted an application under the EU GM Food and Feed Regulation to import and cultivate 59122 x 1507 x NK603 maize. This maize contains Cry 34Ab1, Cry35Ab1, Cry1F, epsps and pat genes and is resistant to coleopteran and lepidopteran insect pests and tolerant to glufosinate and glyphosate herbicides.

The application is currently at an early stage in the regulatory process. ACRE will consider the application again once it is in complete form and after EFSA has issued its scientific opinion. ACRE was asked to identify any concerns that could be highlighted to the competent authority leading on the evaluation of the environmental risk assessment (ERA) under Directive 2001/18/EC and to EFSA prior to the publication of its opinion.

ACRE is familiar with each of these events having considered applications for GMOs where these events are present singly or in stacked combinations.

ACRE noted that the insect-resistant traits associated with this GMO are not relevant to the UK at present (because the pests they are targeted against do not cause economic damage to maize crops here). However, the herbicide tolerance traits associated with this maize event may be attractive to UK farmers.

ACRE was satisfied with the information provided on the molecular characterisation of this maize (which it has assessed previously) and concentrated its efforts on the environmental risk assessment. ACRE agreed with the applicant’s assessment of the risks associated with gene transfer, persistence and invasiveness.

In considering the toxicity of this GM maize to target organisms, ACRE re-iterated (see discussion of 59122 maize for cultivation at ACRE’s meeting in May 2007) its requirement for further information on the synergistic action of the Cry34Ab1 and Cry35Ab1 proteins and the potential for interaction with other Cry toxins. ACRE considered that there was uncertainty about whether the spectrum of activity could be affected.

ACRE considered the potential effects on species that are not intended targets of the GMO. The committee re-visited its discussion on the potential for 59122 maize to adversely affect non-target Coleoptera in field margins. At its May (2007) meeting, ACRE concluded that laboratory studies on non-target coleopteran species were well-designed. However, ACRE considered that chrysomelid beetles should be included as these are likely to be present in crop margins and hedgerows. At this meeting, ACRE discussed potential exposure in more detail.

ACRE noted that the applicant does not provide evidence to support its conclusion that ‘the occurrence of any possible immediate and/or delayed, direct and indirect environmental impacts arising from cultivation, management or harvesting techniques is not expected’. ACRE considered that the applicant should provide an environmental risk assessment with respect to the potential impact of weed management practices involving the use of glufosinate and/or glyphosate herbicides. ACRE considered that the applicant should submit and discuss herbicide regime strategies that would not adversely affect farmland biodiversity as compared with current strategies used in association with non-GM crops. These discussions should highlight uncertainties that can be tested through post-market monitoring under commercial conditions.

The post-market monitoring plan provided for this application was discussed briefly and ACRE believes that it is inadequate in its current form. Further information is required on the environmental risk assessment of this product and changes to the ERA are likely to result in an altered post-market monitoring plan. ACRE will wait until a complete application has been received before assessing the post market monitoring plan in detail.

ACTION: Secretariat to draft and circulate preliminary advice for agreement.

7. Application from Dow Agro Sciences for authorization to use 1507 x 59122 maize in the EU, including the use for cultivation of varieties – ref EFSA-GMO-NL-2005-28ACRE/07/P19

Dow AgroSciences has submitted an application under the EU’s Food and Feed Regulation to import and cultivate 1507 x 59122 maize. This maize contains Cry 34Ab1, Cry35Ab1, Cry1F and pat genes and is resistant to coleopteran and lepidopteran insect pests and tolerant to glufosinate herbicides.

The application is currently at an early stage in the regulatory process. ACRE will consider the application again once it is in complete form and after EFSA has issued its scientific opinion. ACRE was asked to identify any concerns that could be highlighted to the competent authority leading on the evaluation of the environmental risk assessment (ERA) under Directive 2001/18/EC and to EFSA prior to the publication of its opinion.

ACRE is familiar with each of these events having considered applications for GMOs where these events are present singly or in stacked combinations. Having considered 59122 x 1507 x NK603 maize under the previous agenda item, ACRE concentrated on the difference between these applications.

Whereas the application for 59122 x 1507 x NK603 maize does not address the potential for weed management regimes to adversely affect farmland biodiversity, the application for 59122 x 1507 does. It cites the results of the UK’s farm-scale evaluations (FSEs). However, ACRE considered that it should acknowledge and discuss the probability that management practices other than those used in the FSEs will be used (for GM and non-GM maize). These discussions should highlight uncertainties that can be tested through post-market monitoring under commercial conditions.

ACTION: Secretariat to draft and circulate preliminary advice for agreement.

8. Molecular data requested by ACRE on GM food and feed applications ACRE/07/P20

During the update of GM food and feed applications at ACRE’s last meeting (May 2007), the Committee requested to see the molecular characterisation of events that were generated through the Cre-lox recombination system or by Agrobacterium mediated transformation of cereals. Consequently, the secretariat provided ACRE with molecular information submitted in applications EFSA-GMO-NL-2006-31 and EFSA-GMO-NL-2007-37. In the former, the Cre-lox system was used to excise the nptII marker gene from the commercial product (i.e. LY038 maize, which accumulates free lysine in its grain). In the latter, Agrobacterium-mediated gene transfer was used to modify MON89034 maize (which is resistant to certain insect pests).

ACRE noted that these applications are to import GM maize (their scope does not include cultivation) and consequently, environmental exposure will be minimal. However, ACRE considers it important to maintain an awareness of ‘state of the art’ in current applications. ACRE was content with the quality and presentation of the information provided in the applications.

9. EFSA Opinion on an application (EFSA-GMO-NL-2005-18) from Bayer Crop Science to import A2704-12 soybean (fluorinate tolerant) under Regulation (EC) no. 1829/2003ACRE/07/P21

ACRE considered EFSA’s opinion on an application from Bayer CropScience to import a GM herbicide-tolerant (glufosinate ammonium) soybean into the EU. As ACRE is responsible for assessing environmental risks and not food and feed safety, it restricted its consideration to sections 2 (molecular characterisation) and section 5 (environmental risk assessment and monitoring). ACRE noted that extraneous DNA (associated with the vector in which the DNA elements of interest were put together and copied) had been transferred to the GM soybean, including non-functional fragments of the bla gene (which confers resistance to the antibiotic ampicillin). Whilst ACRE concluded that this additional DNA did not increase the potential for the GMO to cause harm to the environment, it noted that the inclusion of extraneous DNA in transformation events does not conform to current best practice. ACRE referred to its guidance on best practice in GM crop design. ACRE agreed that its advice on GM crops that would have minimal environmental exposure, applied in this case. There is strong evidence that feral soybean will not persist in the UK if live seed is spilled during import.

Action: Secretariat to draft and circulate preliminary advice for agreement and publication

10. MON 863 maize from Monsanto Europe S.A. - 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/07/P22

EFSA statement on the use of nptII as a selective marker gene.

MON 863 is an approved 2001/18 GM maize product on the market in the EU. Consent was issued by Germany in February 2006. At its last meeting in May, ACRE considered and agreed with a statement made by EFSA on the use of the nptII gene as a selective marker in GM plants . The GM sub-group of the Advisory Committee on Animal Feedingstuffs (ACAF) was also consulted on this issue in relation to the safety of MON 863 as it is an approved product for import and use as animal feed and contains the nptII gene. The ACAF GM sub-group are in agreement with EFSA and the advice of the sub-group is that it remains content that the safety of MON863 is unchanged. ACRE has considered the advice of the ACAF GM sub-group and concludes that its previous assessment of the safety of MON 863 remains unchanged, i.e., that this GM maize does not pose a risk to human health and the environment and that marketing of this product for importation and processing in the UK will be no different from that of other maize imported for processing and animal feed purposes.

EFSA GMO Panel review of the statistics applied to a rat feeding study with MON 863 maize.

A statistical analysis of the results of the 90-day rat feeding study that had formed part of the application dossier for MON863 maize was published in March . Seralini et al. concluded that rats fed MON863 maize kernels showed a number of statistically significant differences, including some that were indicative of liver and/or kidney toxicity.

The European Commission sought advice from EFSA on this new analysis and EFSA's response was published in June 2007 . The EFSA GMO Panel considered the biological significance of all statistically significant differences in the test parameters and has advised that this publication does not raise any new issues that are toxicologically relevant. The GMO Panel has therefore confirmed its previous opinion that "MON863 maize would not have an adverse effect on human or animal health … in the context of its proposed use". EFSA has also published a detailed statistical assessment of the data from the rat feeding study, which is available via the Scientific Reports area of the EFSA website:

www.efsa.europa.eu/en/science/scientific_reports/statistical_analyses_MON863.html. As MON863 maize is authorised for animal feed use, the ACAF GM sub-group was consulted and it has advised that it agrees with the EFSA conclusion that the statistically significant differences seen in body weights at various times during the 90 day study were probably attributable to fluctuations in food intake and not indicative of an adverse response. ACAF agrees with EFSA that the differences seen in the various (bio)chemical parameters and organ weights measured and highlighted in the paper by Séralini et al. arose largely by chance and, as it had previously concluded, are without toxicological significance. ACRE has taken into consideration both the ACAF GM sub-group and EFSA advice and consequently sees no reason to revise its original opinion on the safety of MON 863 when imported, processed or used for animal feed purposes.

ACTION: Secretariat to update advice and circulate for agreement.

11. Defra research report CPEC9 - the insertion of cauliflower mosaic virus into host genomes during natural viral infections ACRE/07/P23

ACRE considered a Defra-funded research report “The insertion of cauliflower mosaic virus into host genomes during natural viral infections”. The 35S RNA promoter of cauliflower mosaic virus (CaMV) has been widely used to facilitate gene expression in GM plants. The potential ability of the CaMV 35S RNA promoter to act as a hotspot for homologous recombination with infectious CaMV that could lead to virus integration and /or promoter inactivation has been raised as an issue for consideration when assessing risks to human health and the environment. Defra commissioned this research project to investigate the likelihood and extent of integration of CaMV DNA sequences into host plant genomes during natural viral infections in non-transgenic plants and in plants genetically modified to express genes that are under the control of the CaMV 35S RNA promoter. The study also sought to investigate the consequences of introducing the complete CaMV genome into the plant genome, and to examine the effects of CaMV infection on expression transgenes containing the 35S sequence.

The results of the study showed that integration of CaMV sequences into the genome of a CaMV-infected non-transgenic plant may occur, but at an extremely low frequency. Integration was detected in only one sample from non-transgenic Arabidopsis thaliana, one of the experimental host species tested in the course of the project. The other species investigated were Brassica napus (a natural host), Nicotiana benthamiana (an experimental host) and N. tabacum (not a host species). Thus, only a single non-GM Arabidopsis plant sample showed putative integration of CaMV sequences. This yielded several clones that when sequenced showed possible integration into different sites of the A. thaliana genome. The use of different PCR primers indicated that only a small region of the CaMV genome had potentially integrated into the A. thaliana genome. ACRE agreed with the investigators that it was not possible to establish the exact amount of the inserted fragments or the frequency of integration due to detection in only a single sample out of hundreds examined. However, no full-length or functional CaMV sequences were found to be inserted in any samples tested. ACRE applies its knowledge that such recombination events cannot be ruled out and that they occur at extremely low frequencies , and as such, the consequences for human health and the environment are negligible.

The study did not find any evidence of integration of the CaMV genome in the same four plant species expressing the GFP transgene driven by the CaMV 35S RNA promoter. Thus, despite there being several hundred contiguous nucleotides in common between the CaMV genome and the 35S RNA promoter, recombination was an extremely rare event that was below the sensitive level of detection set in this study. ACRE examined the data and was satisfied with the conclusion that the 35S RNA promoter does not act as a recombination hotspot between CaMV and the 35S RNA promoter in transgenic plants.

The investigation also sought to determine whether integration occurred in the germline of plants, this was done by collecting and germinating seeds from the CaMV infected GM and non-GM plants and examined in the same way as the parent plants for evidence of CaMV integration. Integration was not detected in any leaf samples from the progeny of infected plants. This result is consistent with evidence from previous studies of CaMV, that the virus does not invade the germline tissue and is not known to be seed transmissible and therefore not transferable to the next generation. The committee noted this observation and concluded that the absence of germline transmission of CaMV was very significant in reducing the overall risk of adverse effects.

ACRE considered the results of this project and advise that they do not alter or add to current understanding on DNA virus integration into the genome of transgenic and non-transgenic plants as it is acknowledged that this occurs at extremely low frequencies. The committee also noted that although there is some evidence to show that CaMV infection of 35S - containing GM plants affects transgene expression , it appears to be both plant-species and virus strain-specific and that no significant effects on transgene expression were observed in this study. In summary, ACRE considered that this study did not identify any implications for the assessment of risks to human health or the environment from natural CaMV infection of transgenic plants genetically modified to contain the CaMV 35S promoter.

Action: Secretariat to publish report.

12. Defra research report AR0317– assessing the environmental impact of crop production practice: beyond the GM crop farm-scale evaluationsACRE/07/P24

Defra commissioned this research to provide further statistical assessment of the farm-scale evaluation (FSEs) results and to develop a risk assessment framework and a cost-effective system to assess the risks posed by new and novel farming technologies and practices to farmland biodiversity.

The report is comprised of four sections. The first analyses the results of the FSEs to determine the minimum level of sampling that would have detected the treatment effects. The report concluded that the same number of sites would need to be studied but that fewer sampling points could be taken. Treatment effects would have been apparent had the FSEs been restricted to monitoring the soil seed bank. However, these results could not have been interpreted in terms of their impacts on higher trophic levels. ACRE considered the implications of these findings for future large scale studies of farmland biodiversity and for the environmental risk assessment of herbicide- tolerant GM crops.

ACRE did not believe that reducing the number of transects taken at each site would make a significant difference on the economic viability of carrying out such trials. The committee was surprised that the report did not reflect a greater difference in cost associated with seed bank monitoring compared with that associated with transect sampling. ACRE considered that reducing future experiments to seed bank studies would reduce significantly the scale of the enterprise but that this was not necessarily the only or best approach. The committee discussed the use of ‘broad and narrow’ studies such as rapid visual monitoring of weed presence compared to ‘narrower, deeper’ studies such as seed bank monitoring. ACRE noted that the project report relates to environmental impact, whereas the discussion of the results on this section does not acknowledge that the FSEs were limited to studying farmland biodiversity.

The second section of the report describes a risk assessment framework. ACRE considered that the same basic principles underpin the risk assessment of GMOs in accordance with Directive 2001/18/EC. However, ACRE noted that applicants generally do not consider risk mitigation in their overall assessment of the risks. This concept is part of the 2001/18/EC regulatory framework and it is part of the framework described in this report. ACRE considers that there are alternative approaches to framing the environmental assessment of novel farming technologies and practices but noted that this method had be used effectively to generate the model described in the following section.

The third section of the report describes a new model for predicting the impact of changes in agricultural practices on wildlife and describes five case studies.

At its February meeting, ACRE reviewed a paper published in Science (Butler et al., 2006) in which this risk assessment model was applied to the impact of growing GM herbicide-tolerant sugar beet on farmland bird populations (please refer to minutes of the February meeting).

The authors of the report note that the model would benefit from a better estimate of exposure to the change and from taking benefits as well as risks into account.

ACRE considered that the researchers had taken a pragmatic approach and that the model could be used to predict changes in groups of organisms but was sceptical about its use in predicting changes to individual species. The committee was surprised that the researchers had used multiple, rather than single regression in the model. There is significant ‘noise’ (un-accounted variance) associated with the relationships coming out of the model and ACRE emphasised the importance of understanding its source. ACRE considered that the use of sensitivity analysis would be useful in determining where to concentrate future effort.

Section four of the report considers the relevance of existing monitoring schemes in monitoring the effects of novel agricultural technologies. The report concludes that these schemes are not adequate in themselves and suggests supplementation with a farmer questionnaire. ACRE noted that the conclusions about the limitations of current surveillance schemes are compatible with the findings of Hugo et al., (2006). However, ACRE did not consider that the questionnaire devised by the authors was appropriate to highlight any effects on the wider environment.

13. Defra research report CPEC38 – quantitative approaches to the risk assessment of GM cropsACRE/07/P25

ACRE considered a Defra-commissioned report investigating the potential value of quantitative approaches in the environmental risk assessment of GM crops. The committee felt that it was a useful and interesting report and took note of the recommendations it makes.

ACRE discussed in detail the pros and cons of quantitative approaches to the risk assessment of GM crops. In doing so, it noted the contrasting situation for medicines, for which the risk assessment framework was devised. Whilst ACRE is in favour of quantitative methods, it considered that they are not the most relevant or useful approach in many cases. In support of this view, ACRE noted the difficulty that the researchers had in identifying case studies for quantitative assessment in this report. ACRE discussed the characteristics of information submitted in GM crop applications that makes quantitative risk assessment difficult or less useful than a qualitative approach. The committee considered the use of scoring systems but concluded that the case for putting numbers to judgements was not proven. In particular, ACRE was not clear how the researchers had converted nested probabilities to scores in this report.

The committee considered that standardising experimental design could be useful for certain types of studies. However, in the main, it favoured the idea of setting compliance standards rather establishing protocols i.e. for power analysis.

ACRE considered that the precautionary approach advocated in this report is consistent with ACRE’s view.

Action: Secretariat to publish report.

14. Items for information

14.1 A meta-analysis of effects of Bt cotton and maize on non-target invertebrates ACRE/07/INF7

Members noted the paper by Marvier et al. in Science, vol 316.

14.2 EFSA guidance document on the risk assessment of GM plants containing stacked transformation events ACRE/07/INF8

Members noted the final version of this guidance. The committee had commented on the draft for consultation.

14.3 Biodiversity duty guidance ACRE/07/INF9

Members noted that Defra’s guidance had been published.

14.4 ACRE meeting dates for 2008 ACRE/O7/INF10

Noted

14.5 Oral report from the Slovenia meeting in May

Professor Dunwell gave a report of the meeting organised by the Slovenian deliberate release competent authority, where he had given a presentation on biocontainment of transgenic crops with special reference to GM trees and biofuels. There were presentations and discussions on the definition of GM and on new emerging technologies. The next meeting in this series will be in Berlin next year.

14.6 Oral report from the EFSA meeting in June

The chairman attended a meeting in Italy organised by the GMO panel of EFSA to look forward on GM regulatory issues, and gave a presentation on environmental risk-benefit analysis. The meeting was useful for increasing understanding of the issues but the general view was that there was no great political pressure for changes in the regulatory framework.

15. Any other business

None

16. Date and time of next meeting

Thursday 6 December at the University of Essex, Colchester, hosted by Professor Pretty.