ACRE Meetings

ACRE/07/M4

MINUTES OF THE 116th MEETING OF ACRE AT THE UNVERSITY OF ESSEX, COLCHESTER, THURSDAY 6TH DECEMBER 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 J Pretty
Dr M Bonsall
Professor M Bailey
Professor A Peters
Mr E Cross

Assessors:

Dr J Davey SASA
Mr M Williams WAG
Dr S Hugo CSL
Ms A Hope NE

Defra:

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

Apologies for absence were received from Mr J Orson. The chairman thanked Professor Pretty for organising this meeting. 

1. Minutes of the 115th Meeting, 27th September 2007

The minutes were agreed.  

2. Matters Arising

2.1 Changes in the Secretariat

Following Kate Morley’s departure, a position on the ACRE secretariat has been advertised in New Scientist and will be filled in due course.

2.2 ACRE appointment

The process of appointing a new member to ACRE was completed prior to this meeting. Members welcomed Dr Bonsall to the committee.

2.3 Applications from Pioneer Hi-Bred International Inc. and Mycogen Seeds Monsanto under Regulation (EC) No. 1829/2003 on genetically modified food and feed for authorisation of 1507 X NK603 maize (ref EFSA-GMO-NL-2005-17) and 59122 maize (ref EFSA-GMO-NL-2005-12), and from Monsanto for authorisation of NK603 X MON810 maize (ref EFSA-GMO-NL-2005-26).

Commission Decisions were published on 24 October for these maize products intended for feed and food use, and for import and processing, but not cultivation. All of the GMOs received positive safety assessments from EFSA and underwent the full authorisation procedure set out under EU legislation. As Member States failed to return a qualified majority decision for or against these authorisations in the Standing Committee on the Food Chain and Animal Health, and then in the Council, the dossiers were sent back to the Commission for decision. The authorisations are valid for 10 years, and any products produced from these GMOs will be subject to the EU labelling and traceability legislation.

2.4 Application by Monsanto under Part C of Directive 2001/18/EC to market NK603 x MON810 GM maize (C/GB/02/M3/3)

Monsanto has withdrawn its notification under Directive 2001/18/EC as it has received authorisation for import and processing under the Food and Feed Regulation EC/1829/2003 and does not require dual authorisation.

2.5 Austrian safeguard measures

At the Environment Council on 30 0ctober voting took place on two Commission proposals to repeal all the safeguard measures taken by Austria to prohibit the use and sale of GM maize MON 810 and T25. No qualified majority was reached and the decision was referred back to the European Commission for decision.

2.6 SACGM meeting, 7 February 2008.

The committee was notified that a small group of members may need to attend the next SACGM meeting where a trial for GM vaccine is likely to be on the agenda and will require joint discussion between the deliberate release and contained use advisory committees and competent authorities. 

3. Matters agreed by circulation

3.1 Application from Pioneer Hi-Bred International Inc. under Regulation (EC) No. 1829/2003 on genetically modified food and feed for authorisation of 59122 x 1507 X NK603 maize in the EU, including the use for cultivation of varieties (ref. EFSA-GMO-UK-2006-30)

Preliminary ACRE advice has been agreed by circulation on this application and comments have been sent to EFSA.

3.2 Application from Dow AgroSciences under Regulation (EC) No. 1829/2003 on genetically modified food and feed for authorisation to use 1507 x 59122 maize in the EU, including the use for cultivation of varieties (ref. EFSA-GMO- NL-2005-28).

Preliminary ACRE advice has been agreed by circulation on this application and comments have been sent to EFSA.

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

Preliminary advice was agreed by circulation and comments sent to the EMEA.

3.4 Opinion on an Application from Bayer CropScience under Regulation (EC) No. 1829/2003 on genetically modified food and feed for authorisation to import and process A2704-12 soybean (ref. EFSA-GMO-NL-2005-18).

Final ACRE advice has been agreed.

3.5 Defra research report CPEC9 - the insertion of cauliflower mosaic virus into host genomes during natural viral infections.

This report was published on the web in November. This was a highly technical report and no separate ACRE advice was required beyond what had been recorded in the minutes of the September meeting. 

4. ACRE open meeting in 2008 ACRE/07/P26

The secretariat asked ACRE to discuss the holding of an open meeting next year. Previous ACRE open meetings have had a specific theme at which ACRE consulted on a particular issue such as the farm-scale evaluations. The committee discussed the idea of future open meetings and agreed to hold an open meeting next year. Although the confidentiality of some aspects of the work that ACRE is required to give advice on poses some practical difficulties for holding open meetings, the committee agreed that this should not prevent open meetings being held. ACRE discussed that the best way forward to advance their ideas would be to form a sub-group with a view to having its first meeting in February next year to begin more detailed planning.

ACTION: Secretariat to plan sub-group meeting for early next year.

5. Applications to release previously unlicensed mites into glasshouse and tunnel-grown crops ACRE/07/P27

This item was presented to ACRE by CSL.

i) Licensing function

Section 14 of the Wildlife and Countryside Act (WCA) 1981 prohibits the release ‘into the wild’ of animals that are non-native into Britain. Derogation may be provided by a licence granted under Section 16 of the WCA, dependent on the outcome of a risk assessment. Defra is responsible for carrying out this assessment in England and may seek advice from ACRE on the risks posed to human health and the environment by the release of these organisms.

Responsibility for the issuing of licences for the use of non-native organisms as biocontrol agents under the WCA has transferred within Defra from the GM Team to Plant Health Division. Plant Health Division has commissioned the Central Science Laboratory (CSL) to manage all aspects of this licensing function on behalf of Defra. Wildlife Species Conservation Division of Defra still has policy responsibility for non-native species issues. Six applications have been received since June 2006 (3 new licences and 3 renewals).

The licensing process remains unchanged; the previously established consultation group comprising a recognised expert in the field of biocontrol and conservation bodies in England is consulted on all applications. Devolved administrations in Scotland and Wales are also consulted. A dedicated email address and web area are being established to provide information for potential applicants and to improve accessibility and visibility of this area 1.

CSL envisages that advice will be sought from ACRE on new applications for licences where the consultation group do not reach consensus or raise areas of potential concern. Advice may also be sought on issues of a more generic nature where these are seen to be occurring repeatedly in applications received.

The committee requested to be kept informed of all licence applications received; CSL undertook to do this and to summarise key issues for each application, including whether the applications is for renewal or a new licence, the purpose, potential risks and/or negative impacts and potential benefits.

ii) Applications to release Amblyseius ovalis and Amblyseius montdorensis

Defra has received 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. Both applications were for large-scale trials to determine the efficacy of the organisms. Due to the similarity of the applications they were considered together. Both organisms are slightly more cold-tolerant that the previously licensed mite Amblyseius swirskii (A. montdorensis demonstrates slightly enhanced cold tolerance to A. ovalis), but data were presented for each mite to support claims that A. ovalis and A. montdorensis would not be capable of surviving winter in the UK climate. Both mites are polyphagous predators with broad reported host ranges, and both are reported to be relatively mobile when in contact with plant material. Both organisms offer potential benefits to extend the temperature range for biocontrol in glasshouses and to reduce pesticide use, in particular A. montdorensis provides an option for the biological control of whitefly and thrips in tomato crops, which the previously unlicensed A. swirskii does not.

The consultation group raised no objections to licences being granted for trials in glasshouse crops, however concerns were raised over the proposal to release the mites into polytunnels. Advice was sought from ACRE firstly to gain agreement as to whether these organisms were suitable for licensing for trials in glasshouses, and secondly, whether the scope of licences should also extend to tunnel-grown crops.

ACRE considered the data provided indicated that release into glasshouses for trials purposes would not present risks to the environment, and that there were tangible potential benefits of their use in these environments.

When considering release into polytunnels the committee considered there was insufficient evidence that the scale of the potential risks and consequences of release into a wider receiving environment had been assessed, or were understood. The committee raised questions as to the ability of populations of the organisms to evolve increased cold tolerance, given that five or six generations may establish outdoors, and whether, over time, this could lead to localised populations capable of over-wintering, for example in isolated warm spots or microclimates. Linked with this was a lack of data regarding the potential impact of large locally established populations of A. ovalis or A. montdorensis on the ecology of local native communities during the periods of short-term establishment, in particular in view of the polyphagous nature of the mites. Assurance as to the purity of organisms released was also considered to be of particular importance for releases into conditions of reduced containment.

The committee concluded that the potential impact of the release of these organisms into open structures such as polytunnels could not be quantified on the basis of the evidence provided and that further data was required to provide assurance that the impact on the local environment of reduced containment releases has been assessed. The committee recognised the potential benefits of the availability of these biocontrol agents and considered it may be possible to obtain this data as part of a small-scale single site trial with a detailed post-release monitoring programme under a licence, and that Defra (CSL) should discuss this option with the applicant.

ACTION: CSL to discuss with the applicant the option of a small-scale single trial release of one of these organisms into polytunnels, and what form this might take.

iii) Output from the REBECA project (Regulation of Biocontrol Agents)

The committee was informed that the EU-funded REBECA project had recently been completed. The project was an “EU policy support action to review possible risks of biocontrol agents, compare regulation in the EU and the USA and to propose alternative, less bureaucratic and more efficient regulation procedures maintaining the same level of safety for human health and the environment but accelerating market access and lowering registration costs”. Part of the project was devoted to the assessment of protocols for macrobial invertebrate biocontrol agents, a key output of which was the development of an application form with associated guidelines, for submission to competent authorities for the import, shipment, rearing and release of invertebrate biological control agents in European countries. The documents are the product of a collaborative effort between researchers, industry and regulators. The information and data requested is clearly and logically described and meets the requirements currently outlined for the granting of licences under Section 16 of the WCA. Defra (CSL) proposed to adopt these forms and encourage all applicants to use this standard format to support harmonisation of the application process, and facilitate ease of assessment of applications by the consultation group and ACRE.

The committee considered this was a sensible proposal and welcomed measures aimed at unification and standardisation. The application form and guidance will be made available on the dedicated web area for this work at www.csl.gov.uk/nonnativebiocontrol. 

6. Update on notifications for authorisation under the GM food and feed EU Regulation EC/1829/2003 ACRE/07/P28

The Secretariat updated ACRE on applications submitted under the GM Food and Feed Regulation (1829/2003/EC). Since the last ACRE meeting in September 2007, there has been one new application (EFSA/GMO/NL/2007/47).This application was submitted by Pioneer and it is for the import and processing (and use as food and feed) of a GM soybean in which GM events 40-3-2 and 305423 have been stacked by conventional breeding. ACRE considered event 40-3-2 (which confers tolerance to glyphosate herbicides) at its meeting in December 2006 (ref: EFSA/GMO/NL/2005/24).This was in an application to cultivate as well as to import and use this GMO. There is an existing application to import and use 305423 soybean (ref: EFSA/GMO/NL/2007/45). The Secretariat provided ACRE with the Summary Notification Information Format (SNIF) for this application at its September 2007 meeting. More detailed information on the molecular characterisation of this event was discussed under agenda item 8 at this meeting.

In addition, the status of five existing applications has changed.EFSA has published its overall Opinion on an application to release GA21 maize for import and processing (and food and feed) purposes (EFSA/GMO/UK/2005/19). The scientific component of this opinion was discussed under agenda item 7 at this meeting. Four applications have been validated by EFSA. These are: EFSA/GMO/NL/2007/39, EFSA/GMO/UK/2007/4, EFSA/GMO/UK/2007/43, EFSA/GMO/NL/2007/45(for more detail, please refer to EFSA’s table of applications at: www.efsa.europa.eu/EFSA/ScientificPanels/GMO/efsa_locale-1178620753812_start-41_GMOApplications.htm)

7. EFSA scientific opinion on application (EFSA-GMO-UK-2005-19) to import and process GA21 maize (glyphosate-tolerant) under Regulation EC/1829/2003 ACRE/07/P29

EFSA has issued its scientific opinion on an application from Syngenta to import a glyphosate-tolerant maize into the EU. The scope of the application also includes food and feed use, which is not within ACRE’s remit. EFSA has concluded that it is ‘unlikely that GA21 maize will have any adverse effect on human health or on the environment in the context of its intended uses’. ACRE supported the content and quality of EFSA’s assessment of the environmental risks posed by this GMO and agreed with EFSA’s overall conclusion. ACRE considered that its advice on ‘applications to import and process GM crops that have limited potential to grow and flower outside of agricultural conditions in the UK’ applied to this application.

ACTION: ACRE generic advice to be updated to reflect the inclusion of this GM maize to the advice. 

8. Molecular data requested by ACRE on GM food and feed applications ACRE/07/P30

During the update of GM food and feed applications at the last ACRE meeting (September 2007), ACRE requested to see the molecular characterisation information provided in application EFSA/GMO/NL/07/45. The application (submitted by Pioneer) is for the import and processing (and use as food and feed) of 305423 soybean. This GMO contains a fragment of an omega -6- desaturase gene 1(fad2-1) and an optimised version of the acetolactate synthase (als) gene. Both were derived from soybean. The inserted fad2-1 gene fragment suppresses transcription of endogenous omega -6- desaturase, which results in a soybean phenotype with increased oleic acid. The modified als gene confers tolerance to ALS-inhibiting herbicides. ACRE emphasised that this application is to import GM soybean (its scope does not include cultivation) and consequently, environmental exposure in the UK will be minimal (even if material is spilled accidentally during transportation). However, ACRE considers it important to maintain an awareness of ‘state of the art’ in current applications.

ACRE considered that the information provided in the application was of a high quality. The GMO was generated through particle bombardment (of two separate DNA fragments) and resulted in one insertion locus that comprised a number of intact and truncated copies of the functional elements. ACRE considered that this was not unusual for GM events generated via biolistic bombardment and concluded that this event had been well-characterised. It noted that this particular GM line/event would have been selected for over several generations from numerous other lines based on its favourable and stable phenotype.

ACRE assessed the characterisation of gene silencing that occurred in this GMO as a result of insertion of the fad2-1 gene fragment. The application describes the levels of transcription of three endogenous fad genes (with different levels of homology to the inserted fragment) and of a trypsin inhibitor gene that has the same promoter as that used to drive expression of the inserted fad2-1 gene fragment. ACRE considered the stability of the genotype of 305423 soybean. It noted that the applicant had identified one progeny plant where recombination between repeats of the fad2-1 promoter appeared to have occurred. ACRE considered the implications of genetic and phenotypic instability in this GMO. The Committee considered that if the GMO reverted to wildtype i.e. had levels of oleic acid in its seeds that were comparable to its non-GM counterpart, this would not pose an increased risk to human health or the environment. ACRE considered that this would not necessarily be the case, if silencing failed in GMOs with GM traits resulting from the silencing of regulatory genes. For this reason, a case by case assessment of each individual GMO is required.

9. Research paper: toxins in transgene crop byproducts may affect headwater stream ecosystems ACRE/07/P31

ACRE considered that the question posed by Rosi-Marshall et al., (2007) 2 in their research paper is valid in that it sets out to determine whether GM maize material containing Cry1Ab protein presents a hazard to caddisflies living in water-systems that receive debris from these plants.

The research comprises two parts. The first looks at the quantity of maize material that could enter, be transported and deposited in headwater streams and rivers that are adjacent to maize fields. Twelve water-courses in the agricultural mid-west of the USA were studied. ACRE noted that the study conditions do not represent the situation in northern European countries where maize is grown in rotation and on a smaller scale. The concentrations of functional Cry1Ab protein present in these systems were not measured in this study.

The second part of this research deals with laboratory feeding studies using two types of caddisflies and material from GM maize plants containing the Cry1Ab gene. ACRE concluded that these experiments were poorly designed, lacked any useful connection with the first part of the study and omitted necessary detail. In particular, ACRE considered that:

• The paper does not identify the source of the maize pollen or leaf material used in the feeding studies (e.g. the GM event or the varieties of GM and non-GM maize, which would give an indication of Cry1Ab protein content). Therefore, any differences in mortality or growth rate found in these feeding studies cannot be unequivocally attributed to the presence of Cry1Ab protein rather than to other unconnected compositional factors.
• The paper does not report the concentration of Cry1Ab protein present in the pollen or leaf material fed to the caddisflies, and therefore any effects on mortality or growth rate cannot be related to the dose of Cry1Ab protein.
• No differences in the growth rates or mortality of caddisflies fed GM and non-GM pollen were detected when the researchers used the ambient concentrations of pollen measured in this study. The researchers only reported an increase in average mortality when two to three times the observed maximum input rate of GM pollen was fed to the caddisflies.

Therefore, ACRE concluded that the susceptibility of the two species of caddisflies to Cry1Ab protein at levels likely to be experienced in the field has not been demonstrated.

ACRE advised that as this research fails to characterise accurately a hazard associated with the cultivation of GM maize containing the Cry1Ab protein, it is not useful in itself and does not provide a viable justification for further research. Consequently, it does not alter ACRE’s existing view of notifications to grow maize that have been genetically modified to express Cry1Ab protein. However ACRE noted that, at present, pests targeted by the current generation of Bt crops are not a problem in the UK and as such, these GM crops are not useful in this country.

ACRE was aware that the researchers have conducted field studies to investigate the impact of Bt maize on caddisflies but that they have not found any detrimental effects. This information is published as conference abstracts 3 rather than peer-reviewed articles, and as such, ACRE did not discuss it further, apart from stating that it was not surprised that this was the case. In addition, ACRE observed that there is an interest in the input of material and by-products from Bt crops into aquatic systems. This includes research that will be reported on at meeting of the Entomological Society of America. ACRE will monitor the output of this research.

ACRE briefly discussed the implications of the new EU Water Framework Directive. It considered that non-target impacts of new agricultural products and systems, including the cultivation of Bt crops should be monitored effectively under this new legislation.

10. Items for information

10.1 Response to Brian John on ACRE position on MON863 statisticsACRE/07/INF11

Dr Brian John communicated to ACRE via the secretariat regarding the minutes of the September meeting at which ACRE was presented with and discussed the EFSA opinion on the re-evaluated statistics data for MON863 maize rat feeding studies. In addition, Dr John provided a document that the CRIIGEN group sent to EFSA for ACRE to consider.

MON 863 is an approved 2001/18 GM maize product on the market for use in food, as feed and for import and processing in the EU, consent was issued in February 2006. The GM sub-group of the Advisory Committee on Animal Feedingstuffs (ACAF) is a committee that reports to the Food Standards Agency and whose Members are appointed by ministers. ACAF was consulted independently in relation to the safety of MON 863 as an approved product for use as animal feed. It has provided scientific advice over several years on this product and has always concluded that it has no concerns for the safety of MON 863 for animal feed purposes. Independently, ACRE was asked to consider the same data and information that had been provided to ACAF, with a specific remit to consider environmental risks and not food and feed safety.

ACRE’s own independent assessment of the information concluded that the re-revaluated rat feeding data did not present new information that would require the Committee to change its previous advice on import and processing of MON 863 maize and that its opinion was in line with the conclusions of EFSA and ACAF. At this meeting, ACRE was asked to discuss the CRIIGEN letter to EFSA. ACRE noted that this letter is dated July 2007 and that there is no published response from EFSA. The latest statement from EFSA can be found at: www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178621165358.htm. ACRE considered the issues on MON 863 rat feeding studies again and also assessed the document from CRIIGEN to EFSA and discussed whether it would need to change its previous scientific opinion on the safety of MON863. ACRE concluded that there was no new evidence that required any changes to its previous advice. ACRE also discussed a draft response to be sent via the secretariat to Dr John.

ACTION: Secretariat to reply to Dr John.

10.2 Comments and letter to the editors of PNAS concerning the paper it published on ”Toxins in transgenic crop by-products may affect headwater stream ecosystems” ACRE/07/INF12

Members noted comments from a consortium of scientists when considering item ACRE/07/P31. These were published on the Public Research and Regulation Initiative website www.pubresreg.org.

10.3 New Part B application – cyst nematode resistant potatoes

The committee was informed that the University of Leeds was about to submit an application to carry out a research trial of GM potatoes resistant to cyst nematodes.

10.4 EFSA Advisory Forum meeting, 13 November

Professor Hails gave an oral report on her attendance and contribution to a meeting on 13 November in Brussels. This was an EFSA Advisory Forum meeting on GMO Risk Assessment in Europe and was also attended by the secretary and chairman of the ACNFP. The meeting provided an opportunity for competent authorities to discuss best practice and there was a general wish for more prescriptive EFSA guidance, though EFSA is resistant to providing anything very detailed. 

11. Any other business

None 

12. Date and time of next meeting

Thursday 21 February, 2008 in Nobel House, London. 

ACRE Secretariat
December 2007

The web page has been established at www.csl.gov.uk/nonnativebiocontrol; the email address has been requested through Defra.

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

www.benthos.org/database/allnabstracts.cfm/db/Columbia2007abstracts/id/370