Antibiotic Genes Found In Aventis GM Rape Trials

336/02
15 August 2002

IMPURITIES FOUND IN AVENTIS GM RAPE SEED FARM SCALE EVALUATIONS

DEFRA and the Scottish Executive have been informed by the biotechnology company Aventis CropScience Ltd of some impurities in the Aventis GM oilseed rape seed used in the Farm Scale Evaluation crop trials.

All of the seed is resistant to the herbicide glufosinate ammonium, but up to 2.8% of the seed contains a slightly different modification with an additional gene that confers resistance to the antibiotics neomycin and kanamycin.

Scientific experts on the Advisory Committee on Releases to the Environment (ACRE) advise that this does not present any risk to human health as the antibiotic resistance gene occurs naturally in bacteria, and so the antibiotics have few medical uses.

ACRE are satisfied that in these circumstances, the presence of this different modification does not pose any additional risks to the environment. The crop will be harvested and destroyed, as in all previous farm scale evaluation trials.

However the release of the additional GM rape is not covered by the consent covering the farm scale evaluations. This is a potential breach of the regulations covering the release of GM crops. The GM Inspectorates for England and Scotland are investigating.

The additional GM material is not considered to have affected the biodiversity studies of the farm scale evaluations. DEFRA has asked the independent Scientific Steering Committee overseeing the studies, for advice and it will formally reply to Government in due course.

The seeds in question were sown as part of the Farm Scale Evaluations in England in 1999 at three sites, in 2000 at six sites and are currently being grown at 12 sites. The same seed is currently being grown at two sites in Scotland. The plants in this year's trials are due to be harvested and destroyed in the next few weeks. None of the GM plants or seeds in any year have entered the food or feed chain, in common with all crops grown in the Farm Scale Evaluation trials.

ACRE have advised the best course of action for those crops currently growing is for them to be harvested as normal over the next few weeks, using best farming practice to minimise seed shed. Harvested seed will be destroyed.

ACRE are critical of both Aventis, for a lapse in the quality control of their seeds, and the regulatory authorities for not detecting it. ACRE advise that the types of genetic modification involved are so similar that the presence of the additional transformation events does not in these circumstances pose any additional risks to human health or the environment.

DEFRA has requested additional assurances from Aventis concerning the purity of the oilseed rape seed to be sown this autumn in the farm scale evaluations. If necessary, additional testing of this seed will be carried out by the GM inspectorate prior to planting.

DEFRA Minister Elliot Morley, said:

"This issue demonstrates our need to be vigilant with quality control. The Government has asked for an investigation and if the conclusion shows that consent conditions have been breached a prosecution may result.

"The forthcoming public debate on GM issues will provide an opportunity to review current GM controls and regulations."

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Notes for editors

1. The letter from Aventis and ACRE's advice has been added to the Public Register and will very shortly be available online at http://www.defra.gov.uk/environment/acre/. ACRE'S advice can be found below at Editor's note 9.

2. The different modification found in up to 2.8% of the Aventis oilseed rape seed contains one additional gene. This gene confers resistance to the antibiotics neomycin and kanamycin. The gene allows the plants that carry it to survive in the presence of these antibiotics that normally kill plant cells. The gene concerned was derived originally from bacteria, and many bacteria contain the gene that is found in the transgenic plants. Because genes conferring kanamycin and neomycin resistance are already widespread in bacteria, these antibiotics have few medical uses. Genes can transfer from plants to bacteria, but they do so very infrequently, if at all. Because less than 3% of the seed contains the antibiotic resistance gene, the chances of bacteria taking up the gene from this source are very low. ACRE has advised that the antibiotic resistance carries no risk to the environment.

3. All of the lines concerned, including those that should not have been present at these sites, have been through a thorough risk assessment carried out by an independent committee of scientific experts, the Advisory Committee on Releases to the Environment (ACRE). ACRE has also reconsidered its risk assessments in the light of the new information concerning unauthorised GM presence. They have concluded that there is no risk to human health or the environment.

4. The FSE trials will not be terminated. ACRE has concluded there is no risk to human health or the environment and that the most appropriate action if for those crops currently growing to be harvested as normal at a date that minimised seed shed. The crops will all be harvested within the next few weeks. If the crops were harvested now the process of cutting and collecting without the use of a harvester (as would be necessary if the crops were cut early) may in some cases result in more seed shed.

5. The Government is awaiting the formal advice of the scientific steering committee overseeing the ecological studies for an assessment of the impact on the studies. It is considered at this stage that the results are unlikely to affected as the studies are assessing the impact of the management of the GM crops on wildlife and this has not changed.

6. The purity of the GM seed used in the FSEs is the responsibility of the consent holder. The GM inspectorate carries out audits of all consent holders to establish that suitable quality control procedures are in place, and they visited Aventis on 14th November 2000 and 3rd April 2002. The inspectorate did not report concerns regarding the quality control procedures at Aventis on either occasion. In the light of this incident DEFRA are considering imposing more stringent requirements on consent holders concerning seed purity and are reviewing our inspection procedures. They will be strengthened as necessary. The GM Inspectorate has been asked to investigate the incident, and if they conclude that the consent conditions have been breached a prosecution may result.

7. At this stage it is not known how the how the two GM seed varieties came to be mixed. We will investigate this so that we can assess what action might need to be taken to prevent similar problems. Seed impurities can arise in three ways: through cross-pollination, through admixture (physically mixing of seed after harvest) or through 'volunteers' (seed spilt from one crop growing in a following crop).

8. We would expect this incident to feature in the public debate, which will start this autumn. The current GM control and regulatory regime is an issue for discussion.

9. Advisory Committee on Releases to the Environment Consideration of new information concerning the presence of unexpected transformation events in seed sown under consents 00/R14/8, 98/R19/18 and 00/R33/9 is set out below.

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Advice of the Advisory Committee on Releases to the Environment under Section 124 of the Environmental Protection Act 1990
13 August 2002

On 7 August ACRE were asked for advice on information in a letter from Aventis (dated 2 August) stating that oil seed rape seed used under consents 00/R14/8, 98/R19/18 and 00/R33/9 contained transformation events additional to those originally notified in these consents. The seed containing the additional transformation events was sown on 14 sites in spring 2002 as part of the Farm Scale Evaluations (FSE) of GM crops. In the past the same seed batch has been used in FSE sites in 1999 and 2000, and at small scale research trials at Scottish Agricultural College (SAC). A full list of sites where seed from this batch has been sown is given at Annex A.

The transformation events notified under consents 00/R14/8, 98/R19/18 and 00/R33/9 are Ms8 and Rf3, which contain:

The bar gene encoding phosphinothricin acetyltransferase which confers resistance to the herbicide glufosinate.
The barnase gene which confers male sterility.
The barstar gene which inhibits the action of the barnase gene, thus restoring fertility in the hybrid line .
The additional transformation events that have been identified are Ms1, Rf1 and Rf2. These transformation events contain the same genes as Ms8 and Rf3, and also contain the nptII gene which encodes neomycin phosphotransferase which confers resistance to the antibiotics neomycin and kanamycin.

Ms1, Rf1 and Rf2 have been released previously under Part B research. Ms1 and Rf1 have a Europe-wide marketing consent issued in the UK on 28 February 1996.

Via an e-mail discussion, ACRE were asked to reconsider our risk assessment for consents 00/R14/8, 98/R19/18 and 00/R33/9 in the light of the new information, and to consider whether the plants currently growing should be harvested early, and whether the post-harvest monitoring requirements of the consents should be altered.

ACRE's advice:

ACRE was disappointed to be informed that unexpected transformation events had been present in oil seed rape seed over a number of years without detection by either Aventis or the Regulatory Authorities. They noted that the material had now been rigorously tested and that the presence of genetically modified material was now fully characterised. In particular, tests have indicated the absence of genes encoding glyphosate tolerance.

In formulating its advice ACRE noted that all of the transformation events concerned have been considered thoroughly on previous occasions, and have been deemed not to pose a risk to human health or the environment. The Committee further noted that both the current and past releases were subject to conditions that prevent entry of the genetically modified material into the food or feed chains, and that the additional events were present in no more than 2.8 % of the seed.

ACRE was content that its original risk assessment of Ms1 combined with Rf1, and of Rf2 alone continue to apply. ACRE considered potential interactions between the transformation events that had not been considered as part of the original risk assessments (for example, Ms8 with Rf1), and were content that these combinations did not pose any additional hazards not considered in the original risk assessments. Finally, ACRE considered the implications of the presence of the nptII gene encoding resistance to the antibiotics neomycin and kanamycin. This gene is not considered harmful since:

1. It will only be transferred from the GM plants to bacteria at very low rates, if at all,

2. Genes encoding resistance to these antibiotics (including the nptII gene itself) are widespread in naturally occurring bacterial populations, and,

3. The antibiotics concerned are of little clinical importance.

In addition, ACRE noted that the consent conditions on these releases are such that material containing the nptII gene will not enter the food or feed chains.

As a result of these considerations, ACRE concluded that the presence of the additional transformation events did not pose any additional risks to human health or the environment.

In the light of this conclusion and the imminent harvest of the trials, ACRE advised that the currently growing plants should be harvested on a date that would minimise seed shed, and that no changes to the conditions of the consents concerning post-harvest monitoring were required.

ACRE also recommends that Aventis give urgent attention to the robustness of their quality control procedures relating to seed purity and that they provide ACRE with a full molecular characterisation of the adventitious transformation events. Further, ACRE suggests that the GM Inspectorate should review their approaches to the analysis of the purity of seed material used in releases of GM plants.

ACRE also advises that there are no new plantings of GM winter oil seed rape in the coming autumn until firm assurances regarding the composition and provenance of the seed to be used have been provided, and, if necessary, appropriate testing carried out.

Annex A Locations where the seed batch containing Ms1, Rf1 and Rf2 has been sown:
Consent
Year
Grid Reference
Nearest village
County

98/R19/18
1999
SK 968 589
Boothby Graffoe
Lincolnshire

98/R19/18
1999
SU 157 919
Hannington
Wiltshire

98/R19/18
1999
SU 677 980
Shirburn
Oxfordshire

98/R19/18
2000
SK 959 592
Boothby Graffoe
Lincolnshire

98/R19/18
2000
SP 069 360
Laverton
Worcestershire

98/R19/18
2000
TA 265 382
East Newton
Hull

98/R19/18
2000
SP 241 486
Alderminster
Warkshire

98/R19/18
2000
NZ 137 115
Hutton Magna
Yorkshire

98/R19/18
2000
SO 675 313
Kempley
Gloucestershire

00/R14/8
2001
SAC

Aberdeenshire

00/R14/8
2002
SAC

Aberdeenshire

00/R33/9
2002
SK 600 712
Meden Vale
Nottinghamshire

00/R33/9
2002
TF 944 250
Horningtoft
Norfolk

00/R33/9
2002
TA 221 373
Aldborough
East Riding of Yorkshire

00/R33/9
2002
TM 102 875
Winfarthing
Norfolk

00/R33/9
2002
SJ 683 255
Hinstock
Shropshire

00/R33/9
2002
NZ 205 365
Oakenshaw
Durham

00/R33/9
2002
TF 216 976
Thorganby
Lincolnshire

00/R33/9
2002
TF 221 888
Ludford
Lincolnshire

00/R33/9
2002
SJ 399 262
Bagley
Shropshire

00/R33/9
2002
SE 820 490
Kilnwick Percy
East Riding of Yorkshire

00/R33/9
2002
ST 788 028
Hilton
Dorset

00/R33/9
2002
TA 065 596
Nafferton
East Riding of Yorkshire

98/R19/18
2002
NJ 746 301
Daviot
Aberdeenshire

98/R19/18
2002
NJ 772 280
Daviot
Aberdeenshire

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