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Unauthorised material in GM crop trials
15/08/2002
Monitoring of Scottish GM crop trial sites has detected unauthorised GM material at the Scottish Agricultural College in Aberdeenshire, the Executive announced today.
Experts from the Advisory Committee on Releases to the Environment (ACRE) have confirmed that the impurities in oil seed rape, in seed supplied by Aventis CropScience Ltd, pose no threat to human health or the environment.
However, its presence still represents a breach of the stringent regulations which control the growing of GM crops and Ministers have asked the GM Inspectorate to investigate this matter and consider further enforcement action.
The same material has been found in 12 fields in England where similar action is being taken. It is understood that the unintentional contamination arose at some point in the seed production process as a result of intermixing of seed supplies.
In all cases the crops, which are being grown as part of controlled farm-scale evaluation programme, will shortly be harvested and destroyed.
Scottish and UK Ministers will be seeking guarantees that any plantings which are permitted this autumn will only take place after test results have been provided to the satisfaction of the regulatory authorities.
To this end Aventis will have to substantially overhaul its seed production systems.
The initial discovery of the impurities was made following a routine audit of the Scottish Agricultural College by inspectors appointed under the Environmental Protection Act.
Inspectors from the Scottish Agricultural Science Agency (SASA) carry out this function on behalf of Scottish Ministers. As part of their duties, the Inspectors sought verification that a GM oilseed rape variety which had been planted at the College's Aberdeenshire site was indeed the product for which a consent had been granted.
Although laboratory test results were inconclusive the research plots were destroyed before the crop could flower.
Around 2.8 per cent of the planted seeds are of a variety which is tolerant to the herbicide glufosinate ammonium but of a slightly different genetic structure from the variety which has approval for release. It is believed the presence of this material does not affect the results which have been collected as part of the trial programme but have sought the advice of the Scientific Steering Committee which oversees the trials.
After inquiries by the Inspectorate Aventis CropScience Ltd confirmed on August 7 that a batch of seed had contained unauthorised GM elements.
Seed derived from that batch had been used to plant several farm-scale evaluation sites in previous years and had been used for the planting of 14 sites this spring.
On receipt of the information from Aventis, the Executive and UK Government immediately consulted the regulatory advisory body, ACRE, to assess the extent of the risk involved. It has advised that the risks posed are no different to those posed by the GM crop for which consent has already been granted.
The conditions which apply to that consent have ensured that the crops are being routinely monitored, have separation distances in place and will destroyed after harvest. They will not enter the human or animal feed chain.
Ministers have asked the Executive's GM Inspectorate at SASA to investigate this matter and consider appropriate enforcement action. Their immediate concern is to ensure that any plantings which are permitted this autumn will only take place after seed test results have been provided to the satisfaction of the regulatory authorities.
The system of post hoc assurance which has operated up until now will not be acceptable for releases of Aventis products until the company has substantially overhauled their seed production systems to the satisfaction of the Inspectors.
Text of letter from Aventis dated 2 August 2002
PART VI ENVIRONMENTAL PROTECTION ACT 1990 AND THE GENETICALLY MODIFIED (DELIBERATE RELEASE) REGULATIONS 1992 AS AMENDED 1995 AND 1997 APPLICATION FOR CONSENT REFS: 00/R14/8, 98/R19/18 AND 00/R33/9 - NEW ANALYSIS OF SEED
Following the discovery of unexpected transgenic events in seed used in a small-scale agronomy trial at SAC, Aberdeenshire we have carried out further tests as set out below.
As a consequence of this we wish to notify you of the presence, at very low levels, of three additional events : Ms1, Rf1 and Rf2 in genetically modified herbicide tolerant spring oilseed rape seed sown under consent application reference numbers 00/R14/8 (held by SAC, Aberdeen) and 98/R19/18 and 00/R33/9 (held by ourselves).
As with the events Ms8 and Rf3 referred to in the above consents these additional events also confer herbicide tolerance to glufosinate ammonium and hybrid system components (see below) and have undergone a full risk assessment according to part C of Directive 90/220.
Although we cannot verify the source of this admixture it appears that it was present in some of the seed of the hybrid line PH96S452 which was sent to the UK, from Belgium, in seed batches in 1999, 2000 and 2002.
None of the produce from the seed batches grown in the UK will, or has, entered the food or feed chain, in accordance with the conditions of our part B consents, and has been grown to SCIMAC guidelines, to which these trials are subject.
Given the management of these trials, the fate of the produce and that these events are earlier versions of exactly the same trait, hence similar to Ms8 and Rf3, we don't believe there is any change to the conclusion of the risk assessment for the above consents nor any impact upon the scientific validity of the trials conducted using this seed.
We trust therefore that you agree with our view that the existing controls remain valid and appropriate for those trials currently being grown.
1. Identifying the presence of Ms1, Rf1 and Rf2
On June 21st 2002 we received an E-mail from the Scottish Agricultural College (SAC) in Aberdeen informing us that a batch of genetically modified herbicide tolerant spring oilseed rape seed contained an unknown event.
This was confirmed by another E-mail on July 3rd with information from the Inspectorate body SASA that after further analysis of seed samples, the event was different to that covered by the SAC consent (00/R14/8) and also not Ms1Rf1. It had been expected that any admixture was Ms1Rf1 as seed containing this event had previously been handled on the site.
A sample of 250gm was sent to the Bayer Cropscience laboratory's in Belgium for testing in July 2002. The analysis gave similar, although not identical, results to those obtained from the SASA and CSL laboratories which was confirmed to SAC in writing on 18th July (see enclosed).
There was presumably a difference in detection levels achievable since both the CSL and SASA laboratories could not detect any presence of Ms1 or Rf1. We identified that 2.8 per cent of the seeds contained sequences nptII and pNos. Of that, 93 per cent was Rf2, 6 per cent was Rf1 and 1 per cent was Ms1. Hence, the seed sample contained:
2.60 per cent : Rf2
0.17 per cent : Rf1
0.03 per cent : Ms1
1.1 The source and additional use of the seed batches
In addition to analysing the sample from SAC we also used our audit trail to trace other seed batches from the same original seed lot. The seed was multiplied as Basic seed in Belgium in 1997 to produce the hybrid variety, PH96S452. The parent seed was produced in Canada. A sample from the remaining batch, still held in Belgium, has since been analysed to compare with the sample from SAC. The results were almost identical: 92 per cent was Rf2, 7 per cent was Rf1 and 1 per cent Ms1. Hence the seed sample contained:
2.58 per cent : Rf2
0.20 per cent : Rf1
0.03 per cent : Ms1
Four different batches of this seed were sent to the UK for trials purposes:
Date/Batch/Quantity (kg)
- March 1999/1/50
- March 1999/2/75
- March 2000/3/450
- March 2002/4/600
The 6kg seed sample delivered to SAC in May 2000 was taken from batch 3 and planted in their trial in 2001 and 2002. The remaining seed from that batch and batches 1, 2 and 4 have been grown on farm scale evaluation sites:
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/NJ 907 214/Udny (SAC)/Aberdeenshire
- 00/R14/8:2002/NJ 907 214/Udny (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/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/Yorkshire
- 00/R33/9:2002/SY 788 028/Hilton/Dorset
- 00/R33/9:2002/TA 065 596/Nafferton/Yorkshire
- 98/R19/18:2002/NJ 746 301/Daviot/Aberdeenshire
- 98/R19/18:2002/NJ 772 280/Daviot/Aberdeenshire
Any seed left-over from these plantings has been disposed of, by deep landfill, and not carried over from one year to the next.
2. Similarity of the events Ms1, Ms8, Rf1, Rf2, and Rf3
Our hybrids are obtained by crosses between a female inbred line containing the event Ms8, with a male inbred line containing event Rf3. Ms8 and Rf3 are the up-to-date elite events developed in the framework of the projectsnamed "SeedLink" and "Liberty Link". Male sterile (Ms) lines, that do not produce pollen, and male lines containing a gene restoring the male fertility (Rf) produce hybrids which are also tolerant to the herbicide, glufosinate ammonium.
The first Ms and Rf events created were named Ms1, Rf1 and Rf2. From a combination of lines containing those events, several commercial hybrid varieties have been developed in different parts of the world, amongst which Canada is the most important.
These three events, Ms1, Rf1 and Rf2, contain the gene conferring the resistance to the antibiotic, kanamycin, (the construct containing the pNos and the nptII sequences). However, Aventis has subsequently developed transformations using just the bar gene (conferring the tolerance to the herbicide glufosinate ammonium) as the unique marker gene. Therefore the events Ms8 and Rf3 were created, without the kanamycin resistance marker gene, but still conferring herbicide tolerance to glufosinate ammonium.
Hence the only difference between hybrids containing Ms1, Rf1 or Rf2 and hybrids containing Ms8 and Rf3 is that the latter do not contain the kanamycin resistance cassette.
Lines containing Ms1 and Rf1 have been grown in the UK under both part B and part C consents, and Rf2 under a part B consent, during the previous 5 to 8 years. Indeed all have undergone a full risk assessment according to part C of Directive 90/220 which has led to decisions of placing on the market into the EU, no. COM 97/392/EC and COM 97/393/EC on June 6th 1997.
2.1 Future action by Aventis Cropscience
We believe that since this was not a deliberate release of Ms1, Rf1, or Rf2, that they are similar to those events covered by the consent and that both the risk assessment and scientific validity of the trials are unaffected, it is not necessary to take any additional action regarding the trials currently being grown. Hence (subject to hearing from you to the contrary) we propose continuing with the Farm Scale Evaluations while following the conditions of the consent to ensure that no produce enters the food or feed chain and with the usual monitoring of the sites the following season.
In addition, we will of course continue to follow the SCIMAC guidelines including adhering to the separation distances defined.
In addition any remaining seed from the batches of spring oilseed rape variety PH96S452, that may contain admixture from these events, will be destroyed. We believe this has already been done at SAC. We have committed to providing a different seed batch for next season which will be subjected to a more rigorous test system that we propose to put in place.
This future testing of seed batches, in addition to confirming the presence of Ms8 and Rf3, will also include analysis to ensure the absence of other events like Ms1, Rf1 and Rf2, subject to certain detection limits. This has already been actioned for next season so that test results will be available prior to planting the crop of winter oilseed rape within the Farm Scale Evaluation programme 2002/3.
I hope that this provides sufficient information to explain the situation and trust that you agree with our assessment. We look forward to your response and in particular confirmation of the actions as detailed above.
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
Advice of the ACRE
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 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 discover 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:
- It will only be transferred from the GM plants to bacteria at very low rates, if at all
- Genes encoding resistance to these antibiotics (including the nptII gene itself) are widespread in naturally occurring bacterial populations
- 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/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/Yorkshire
- 00/R33/9:2002/SY 788 028/Hilton/Dorset
- 00/R33/9:2002/TA 065 596/Nafferton/Yorkshire
- 98/R19/18:2002/NJ 746 301/Daviot/Aberdeenshire
- 98/R19/18:2002/NJ 772 280/Daviot/Aberdeenshire