Advisory Committee on Releases to the Environment
MINUTES OF THE 93rd MEETING OF ACRE IN ROOM 7A/B/C, ASHDOWN HOUSE, LONDON, THURSDAY 22 JANUARY 2004
 

Attendance:

Members:

Prof C Pollock - Chairman
Professor M Bailey
Mr E Cross
Prof J Dunwell
Dr S Hartley
Dr P Hirsch
Dr P Hulme
Prof K Lindsey
Mr J Orson
Prof J Pretty
Dr M Rees
Dr J Stoye

Assessors:

Dr J Kerr SASA
Dr S Hugo CSL
Dr P Logan HSE
Dr S Lawrie FSA

Defra:

Dr S Hill (Secretary)
Dr C Pitcher
Dr A Gilliland
Dr L Ball
Mr D Sherlock

Apologies for absence were received from Professor Bale

1. Staff changes

Claire Pitcher had been promoted to fill the post vacated by the departure of Adrian Butt to DTI and Androulla Gilliland had been appointed as a permanent member of the Secretariat.

2. Minutes

2.1 Minutes of the 92^nd Meeting, 6 November 2003 ACRE/03/M8
The minutes were approved with one amendment

2.2 Minutes of the special meeting 25 November 2003
The minutes were approved

2.3 Minutes of the special meeting 15 December 2003
The minutes were approved

3. Matters Arising

3.1 Update on consents issued and current status: notification for Part C consent from Bayer CropScience Ltd to market herbicide tolerant rice LLRice62 - ref C/GB/03/M5/3

The UK submitted a positive assessment report to the Commission on 7 January.

3.2 Advice on the Farm-scale Evaluations

The advice was published on the web on 13 January. The Chairman thanked Professor Pretty for chairing the Farm-scale Evaluation open meetings and the press conference, and thanked members and the Secretariat for an excellent job which had reflected well on ACRE's methods of working.

4. Matters agreed by circulation

None.

5. Applications to market or release GMOs under Directive 2001/18/EC

5.1 Notification for Part C consent from Monsanto Europe S.A. to release maize genetically modified for herbicide tolerance and insect resistance - ref C/GB/02/M3/3 ACRE/04/P1

ACRE discussed the marketing application for import and use of GM hybrid maize containing transformation events NK603 and MON810, which confer tolerance to the herbicide glyphosate and resistance to certain Lepidopteran pests. The application does not include cultivation in the EU. The Committee previously discussed this application at meetings in May and November 2002 and July 2003. The most recent requests for further information related to (i) additional molecular characterisation of the parental MON810 maize line, in particular an assessment of risks associated with the possible presence of multiple inserts and backbone sequence; (ii) further statistical analysis of compositional data of the parental line NK603; (iii) a consideration of the stability of inserts in the GM hybrid maize; (iv) a revised post-market monitoring plan containing a more proactive general surveillance monitoring plan and more frequent reporting of the results. The information was satisfactorily provided. ACRE was content with the applicant's responses and with the ACAF GM sub group advice on aspects concerning animal feed safety.

Following a general discussion of the interpretation of animal feeding studies, ACRE requested the Secretariat to obtain clarification from ACAF regarding uniformity in the design of feeding studies and any implications for comparison of data from different trials.

Action 1: Secretariat to request advice on animal feed trials from ACAF.

The Committee agreed in principle with the general surveillance plan provided by the applicant. However, ACRE recommended that provision of the detailed arrangements for general surveillance should be made a condition of any consent to import into the EU. The further details should include who will be requested to provide information, the type and frequency of requests and how the company will ensure participation in surveillance monitoring. The Committee also recommended that monitoring reports should be provided by the applicant on an annual basis.

The Committee discussed the practicalities of grain importation with regard to monitoring. The Secretariat clarified the requirement under Directive 2001/18/EC that the lead competent authority must be notified immediately if there is any evidence that a GMO is having an adverse effect on human health or the environment.

The Committee asked the Secretariat to draft advice concerning this application, for consideration by circulation.

Action 2: Secretariat to draft advice on the application to market NK603xMON810 maize for consideration by the Committee.

5.2 Notification for Part C consent from Pioneer Hi-bred International Inc. and Mycogen Seeds to market insect resistant and herbicide tolerant maize derived from event 1507 - ref C/NL/00/10 ACRE/04/P2

ACRE discussed the marketing application for GM maize containing transformation event 1507, which confers resistance to certain Lepidopteran pests and tolerance to the herbicide glufosinate ammonium. The application is for the import and use of 1507 maize, not for its cultivation. The Committee previously discussed the application at its September meeting and asked for clarification from the applicant about the specific detection protocol for 1507. This was provided and ACRE was content with the response but noted that whilst the DNA sequence targeted for detection was event-specific (because it included a rearranged fragment of insert DNA) it did not span the intersection between host and insert DNA.

ACRE was informed by the Secretariat that ACNFP had requested further information on the potential allergenicity of the CRY1F protein in 1507 maize and that the applicant's response had been forwarded to the ACNFP.

ACRE considered the further information requested by other Member States, in particular the updated proposal to monitor the safety of animal feed products containing 1507 maize. The Committee agreed in principle with the general surveillance plan provided by the applicant but considered the detail and timeframes suggested to be inadequate. ACRE advised that consent for release should be conditional on the applicant providing a more detailed plan for monitoring animal feed safety before this maize is imported into the EU. The Committee also recommended that monitoring reports should be provided by the applicant on an annual basis. The Secretariat has also circulated the further information provided by the applicant to ACAF and will inform ACRE of the Committee's response on aspects concerning animal feed safety in due course. The Committee asked the Secretariat to draft advice concerning this application, incorporating the view of ACAF, for agreement by circulation.

Action 3: Secretariat to draft advice on the application to market 1507 maize for consideration by the Committee.

5.3 Notification for Part C consent from Syngenta seeds SAS to market insect resistant and herbicide tolerant maize derived from event Bt11 - ref C/F/96/05/10 ACRE/04/P3

This notification for marketing authorisation, including cultivation, is for insect resistant and glufosinate ammonium tolerant maize, event Bt11. ACRE considered this notification at its meeting in September 2003 when the Committee made several requests for additional information. This has now been provided by the notifier along with responses to objections made by other Member States. The Committee agreed that Syngenta had provided satisfactory responses to the requests regarding molecular characterisation. The full sequence of the Bt11 insert and maize flanking DNA has been provided. The Committee was satisfied that the amp antibiotic resistance marker gene had not been transferred from the donor vector to the GM maize and that the insert had not disrupted any maize endogenous open reading frames. In addition the Committee was content that the event specific detection protocol was truly event specific. On the issue of animal feed safety the Committee was pleased that compositional analysis of freshly cut Bt11 maize plants had been provided, the data suggested that Bt11 maize was equivalent to non-GM maize. The Committee awaits further advice from ACAF on this issue.

Further information relating to the environmental risk assessment was considered. The Committee noted that the notifier does not intend to promote the use of glufosinate ammonium herbicide on this product. As the risk assessment does not consider management regimes associated with the herbicide tolerant trait ACRE proposes that in order to ensure that herbicide is not used inadvertently on Bt11 maize that a prohibition of the use of glufosinate ammonium herbicides be imposed as a condition of consent. ACRE considered that the risk assessment for the insect tolerance trait with respect to the UK had been adequately considered. ACRE is supportive of the view that Bt11 maize should not be grown in the UK as the pests to which Bt11 maize is resistant are not currently a problem in the UK.

ACRE considered the additional information provided regarding the post-market monitoring plan. Members noted that Syngenta were not proposing any further case specific monitoring and the Committee argues that such monitoring is required (for example to monitor for the effectiveness of non-GM refuges and to test any assumptions made in the environmental risk assessment). From an EU perspective the committee recommends that an improved case specific monitoring plan be proposed before any consent is issued. With respect to general surveillance the committee again supported the notion that as a condition of consent further detail as to the logistics and reporting requirements be provided prior to the first cultivation of Bt11 maize in the EU.

The Committee asked the Secretariat to draft advice, incorporating comments from ACAF, for consideration by circulation.

Action 4: Secretariat to draft advice on the application to market Bt11 maize for consideration by the Committee.

6. Consideration of reports from Belgium, Austria and Dr. Mae-Wan Ho regarding GMO risk assessment ACRE/04/P4

ACRE was asked to consider three reports pertaining to risk assessment. Two with respect to molecular characterisation of GMOs from the Belgian Biosafety Authority and Dr Mae-Wan Ho and the third related to food/feed safety evaluation from the Austrian Federal Environment Agency.

The reports on molecular characterisation both claimed that independent analysis of approved GMOs has identified discrepancies when compared with information provided in the original marketing dossiers and in particular identified rearrangements in the DNA inserts and the surrounding flanking DNA. ACRE considered that whilst the conclusions of the Belgian report may well be accurate the committee could not comment in detail without access to the primary data, including DNA sequence information. The Committee requested that the Secretariat contact the Belgian authorities for this information. The Committee considered that it was important that DNA sequence information was provided in electronic format, so that members could carry out their own analysis of the sequence information, should they wish to.

Action 5: Secretariat to request further data from the Belgian Biosafety Authority.

Members considered that, should the conclusions of the Belgian reports be justified and accepted, the detail would be treated as additional information available now due to recent improvements in methods for the analysis of transformation events. ACRE acknowledge that when DNA is inserted into host plant genomes it is often accompanied by DNA rearrangements, and rearrangements may also occur during the early stages of backcrossing primary transformants with parental lines. However, the Committee was not aware of any evidence that suggests that, after the stable incorporation of the inserted DNA, it is any more likely to undergo mutations or rearrangements that the surrounding genomic DNA. From the perspective of risk assessment the key factor is to establish whether any new open reading frames are generated by the insertion of foreign DNA and any associated rearrangements or mutations. If novel open reading frames are generated they should be subject to thorough investigation to assess whether they pose any potential hazard. ACRE strongly refutes the claim of Dr Ho that transgenic lines are unstable and hence illegal. In conclusion this information adds to the knowledge of these GM lines rather than disputes previous knowledge and should the conclusions of these reports be accepted the Committee will review the relevant risk assessments.

Regarding the report from Dr Mae-Wan Ho Transgenic lines proven unstable ACRE considered that some of the comments made regarding ACRE were inaccurate and unfair. In particular ACRE contested the statement made by Dr Mae-Wan Ho that ACRE has stated that event specific molecular characterisation of GM crops is not necessary. In its response to ISIS of September 2003 ¹ ACRE advised that 'event-specific characterisation of successive generations of T25 maize would offer no further information regarding the safety of T25 maize'. ACRE was not rejecting the need for event specific molecular characterisation of GM events but was only stating that once stable expression of transgenes had been demonstrated then event specific characterisation of further generations was not required.

ACRE considered reports recently published by an Austrian inter-university research consortium investigating toxicology and allergenicity of GM crops and food. The reports concluded that the current safety evaluation of GM products is inadequate and in particular rejected the substantial equivalence approach to risk assessment and called for full toxicological testing of the whole GM plant. Members considered that the proposals were suggesting that GM crops should be tested in a similar manner to pharmaceuticals. The Committee considered the present approach to the assessment of GM crops and food to be adequate. This conclusion was also confirmed by the GM Science Review Panel ². GM crops are much more thoroughly assessed than new crops produced without the use of GM technology. There is no evidence to suggest that there are particular risks associated with the production of new varieties through GM than other methods of plant breeding. As the focus of these reports is mainly food and feed safety issued ACRE requested that these reports be considered further by the Food Standards Agency.

Action 6: Secretariat to ask the FSA for advice concerning the reports from the Austrian Federal Environment Agency

7. Sub-group to examine wider issues raised by the Farm Scale Evaluations of GM Herbicide Tolerant-Crops ACRE/04/P5

During ACRE's consideration of the implications of the results of the Farm Scale Evaluations (FSEs) of herbicide-tolerant (HT) GM crops, the Committee identified a number of additional issues that we worthy of further consideration. The Committee resolved to establish a sub-group to consider these issues. ACRE considered that the following broad areas should be investigated by the new subgroup:

• What magnitude of impact constitutes an adverse effect?
• Should environmental benefits be taken into account during the assessment of the release of GMOs into the environment?
• To what extent are the relative impacts of different crops and crop management practices understood?

The Committee agreed that subgroup of 5 ACRE members should take this forward, recruiting additional expertise from outside the Committee as appropriate. It was agreed that the new group would report to the full Committee regularly with a standing item on the agenda. In the first instance the subgroup would propose draft terms of reference for its own work and prepare a scoping paper. The membership of the group would be agreed by circulation following the meeting.

8. Oilseed rape volunteers - implications for usage of sites where releases of GM oilseed rape were carried out during the Farm Scale Evaluations ACRE/04/P6

In the light of new research, the Committee was asked to consider the implications for usage of sites where releases of GM oilseed rape were carried out during the FSEs. This matter had been considered previously by the Committee at their meeting in July 2003. As before, the Committee stressed that the potential persistence of oilseed rape volunteers did not pose a risk to human health or the environment. The Committee considered the modelling work of Begg et al. While the Committee felt that this work was an important and useful contribution to the field, the predictions made by the model needed careful validation against experimental data. The Committee considered that until further experimental data was available it was not possible to assess the significance of the conclusions presented in the new work. ACRE was concerned that, whatever the outcome, the farmers whose co-operation had ensured the success of the FSEs should not be disadvantaged.

9. Committee procedures ACRE/04/P7

ACRE considered a number of issues concerned with the operation of the Committee.

Following the success of the public meetings held during the ACRE's consideration of the results of the FSEs the Committee discussed the possibility of holding further open meetings in the future. The Committee felt that it was not appropriate to open the routine meetings of ACRE to the public. This would create significant practical difficulties for the Committee, and would not significantly increase transparency as the Committee already publishes detailed minutes, and all the advice that it issues. However, the Committee felt that there was merit in pursuing further open meetings, using the 'Select Committee' style, on specific topics. Suitable potential topics were thought likely to be generated by the work of the sub-group on issues raised by the consideration of the FSEs. The Committee asked the secretariat to consider holding such an open meeting in September 2004.

Action 7: Secretariat to consider arrangements for an ACRE open meeting in September.

The Committee decided that it did not want to pursue electronic circulation of papers for discussion at ACRE meetings, and that the present style of covering papers produced by the Secretariat was acceptable.

The Committee also considered the ACRE web site. The Committee is happy with the format, content and structure of the web site. However, the Committee also felt that the web address (http://www.defra.gov.uk/environment/acre/) gave the impression that ACRE was a Government institution working within Defra. The Committee preferred a web address that emphasised the independence of ACRE, and made clear that the Committee not only advises Defra ministers, but also those in the Devolved Administrations. The Committee considered that the address http://www.acre-gm.org.uk would be suitable, and asked the Secretariat to arrange for the web site address to be changed as a matter of urgency.

Action 8: Secretariat to arrange for a change in the ACRE web site address.

10. Any other business

10.1 Invitation to Belfast

DOE Northern Ireland had offered to host an ACRE meeting in 2004 in Belfast. The Committee accepted the invitation in principle and would consider suitable timing.

10.2 Contained use committee

Members were informed that the reconstituted GM contained use committee had met for the first time on 21 January. This was UK competent authority committee, for which HSE provided the Secretariat. Members would be sent contact details.

11. Date and time of next meeting

10:30 am on Thursday 26 February 2004, Rm 7A/B/C, Ashdown House

ACRE Secretariat
January 2004

1 http://www.defra.gov.uk/environment/acre/advice/pdf/acre_advice34.pdf
2 http://www.gmsciencedebate.org.uk/