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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