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Greenpeace critique of Monsanto’s Roundup Ready Oilseed 
Rape, GT731 
October 2004 
Introduction 
The dossier and subsequent information submitted by Monsanto contain many 
inadequacies, conflicting statements and unexplained differences between the GE 
(genetically engineered) OSR (oilseed rape), GT73 and the parental line. Original 
material has not been disclosed, contravening EU legislation. Despite the numerous 
irregularities in the dossier, many member States have been limited in their critical 
scrutiny and the EFSA (European Food Safety Authority) has given GT73 a positive 
opinion. 
Here, we document the irregularities of the feeding trials, the failings of EFSA’s 
evaluation, the lack of consideration for the environmental consequences of accidental 
releases, concerns regarding the secrecy of fundamental studies and question the ability 
of EU regulatory authorities to competently regulate GE foodstuffs in a manner that 
assures food and environmental safety. It is arranged in three parts: 1) The bad science 
of GT73 feeding trials, 2) Technical critique of EFSA’s opinion on GT73 and 3) Concerns 
about regulatory authorities’ handling of the application. Finally, we conclude that the 
application for the import and processing of GT73 should be rejected. 
The bad science of GT73 feeding trials 
Introduction 
To support their application for the import of Roundup Ready oilseed rape, GT73, 
Monsanto submitted 3 feeding trials on rats, 2 on trout and 2 on quails. However, all are 
flawed. 
Rat studies 
It is not clear from the dossier what experimental protocol was followed. Since standard 
protocols do exist, the protocol used should be stated. 
Rat study no. 1, (Naylor, 1994) 
This first study showed a 10% loss in bodyweight, but was rejected because the GE 
seed had got mixed up with another GE variety: “As a consequence of co-mingling of 
the seed, a second study was undertaken”. This raises the question of how, if Monsanto 
can’t even separate the seed adequately for it’s own feed trials, are GE and non-GE 
OSR expected to be kept separate at commercial scales? 
Rat Study no. 2 (Naylor, 1995) 
V.i.S.d.P Dr. Christoph Then, Greenpeace e.V., Große Elbstraße 39, 22767 Hamburg
In the second rat study, only processed GE OSR is used because the effects of 
unprocessed 
OSR according to Monsanto has “little practical relevance to commercial practices since 
unprocessed ground oilseed rape seed is not fed to animals”. 
Significant differences were found: “relative liver weights were increased approximately 
12-16% for males and females fed the 15 % (but not the 5%) GTOSR diet compared to 
parental line controls.” 
Substantially equivalent or not?: Monsanto first tried to explain the differences as a 
product of two factors: 1) increased glucosinolate levels in the GE OSR and 2) the 
processing of oilseed rape. 
Monsanto claim in the SNIF (3c) that “There are no specific differences when GT73 is 
compared to conventional oilseed rape except for its tolerance to glyphosate. GT73 has 
been shown to be substantially equivalent, with exception of the introduced trait…”. But, 
then Monsanto informs that the level of total glucosinolate in the GT73 OSR-meal was 
approximately 0.6 gm/kg, twice as high as in the parental Westar line. This is not 
consistent with Monsanto’s claim that herbicide tolerance is the only difference between 
GT73 and ist non-GM parental line. To use the differences in the glucosinolate levels as 
an explanation for differences in the feeding trials contradicts with the claim of 
substantial equivalence. 
Subsequently, Monsanto decides that glucosinolate levels are not the cause of the 
differences. In the additional information supplied on 18th November 1999, Monsanto 
decide “our hypothesis that differences in glucosinolate levels accounted for the 
observed differences in liver weight is not supportable based on the available data.” This 
implies that the differences seen were either due to the processing or the GE product 
itself. A further experiment using unprocessed OSR could determine the differences are 
due to processing or the GE product. Monsanto did not conduct this key study but 
instead conducted a 3rd rat study using wider controls. Nevertheless, without offering any 
justification, the EFSA in its opinion simply considers that the enlarged livers as “an 
incidental finding”2 
Rat study no. 3 (Naylor, 1996) 
After the original submission for marketing of GT73, Monsanto then conducted a third rat 
study! “The purpose of this study was to determine whether the liver and kidney weights 
of rats fed processed meal from the RU3 fall within the range of liver and kidney weights 
of rat fed processed meal from nine commercial varieties of canola from Canada and 
oilseed rape from Europe.” In other words, this third study was conducted with controls 
from as wide as range as possible, even from different continents. This third study 
seems, therefore, to be deliberately designed to mask any differences that occurred in 
the second rat study when GT73-fed rats were compared only to rats fed the parental 
line, Westar. Such a study design does not appear to follow any acceptable protocol. 
Predictably, no significant differences were observed. To go to this effort to refute the 
V.i.S.d.P Dr. Christoph Then, Greenpeace e.V., Große Elbstraße 39, 22767 Hamburg
findings of the previous study, but yet not perform a key experiment testing the 
hypothesis that differences are due to processing rather than the GE product itself is 
absurd. This does not give any reassurances regarding feed safety. 
Monsanto conclude: no more evidence necessary! 
In their additional information, 18th November 1999, Monsanto state: “While we do not 
have a scientific explanation for the observed differences in liver weight in the second 
rat feeding study, the fact that this finding was not observed in the first and third feeding 
studies suggest the finding is not reproducible and probably not biologically significant.” 
Monsanto further conclude: “While we do not have further information to understand the 
differences in weight gain in the first feeding studies, and the increased liver weight in 
the second rat feeding study, when the processing of canola meal is carefully controlled 
(as done in the third feeding study), we find no differences in weight gain, food 
composition, or organ weights (liver and kidney” between rats fed RR canola and the 
parental line and commercial lines. Thus, the earlier findings do not appear to be 
biologically meaningful and further evidence to support earlier hypotheses is no longer 
needed.” 
This conclusion is based wholly on the third study. The reason for the differences in the 
previous study has still not been examined. 
Trout feeding studies 
The first trout study also suffers from a co-mingling of seed and was repeated. In the 
second study3, significant differences were noted, but were considered positive 
attributes so of no concern! “The only significant differences detected in the second 
experiment were PR [protein retention] and whole body moisture, protein, and fat 
concentrations. In each case, fish fed GT73 exhibited improvements in the three 
variables as compared to fish fed Westar. Increased retention of dietary protein is a 
positive attribute of a feed, and the higher protein, lower fat concentrations should also 
be considered a positive attribute of the fish produced.” However, the long-term effects 
of these so-called “positive attributes” are not known. It’s quite possible that these could 
become adverse effects in the long term. These short-term feeding trials are so limited 
that any significant differences, even if they appear positive, should be investigated 
thoroughly. 
Quail studies 
Quail were selected because they may feed on OSR seeds left in the field after harvest. 
However, Quail were fed GE OSR for only 5 DAYS! This is a wholly unnaceptable 
timescale for testing of wholesomeness of GE OSR. Again, the seed was co-mingled 
and the experiment was repeated but again for only FIVE days. Despite the timescale, 
the second study did reveal that the “…quails in the GT73 group exhibited a slight 
reduction in body weight gain during the exposure period (day 0 – day 5). However, 
there was no reduction in body weight gain for the entire test duration (day 0 – day 8). 
Feed consumption was comparable for all groups” (EFSA Journal (2004) 29, 1-19 (p14 
V.i.S.d.P Dr. Christoph Then, Greenpeace e.V., Große Elbstraße 39, 22767 Hamburg
4.2.3). Apparently, the GT73 quails suffered weight loss during the time they were fed 
GT73, and only recovered the weight loss in the subsequent three days when they were 
no longer fed GT73. Yet the findings are ignored. 
UK regulatory authorities are concerned with the feeding studies 
Two of the UK advisory committees on GE crops, ACRE (Advisory Committee on 
Releases to the Environment) and ACAF (Advisory Committee on Animal 
Feedingstuffs), issued advice in September 20034 that includes concerns over the 
feeding trials: 
“ACAF considered the animal feed studies provided in the dossier. No significant 
differences in growth were observed between rats fed GT73 or Westar parental variety 
oilseed rape (Naylor, M. W. 1995; MSL-14164). However, the relative liver weights for 
the rats fed 15% processed GT73 oilseed rape were found to be significantly higher than 
controls. This was attributed by the notifiers to higher glucosinolate concentration in the 
GM diets compared with the corresponding control diets. This adverse effect was not 
observed in a subsequent rat experiment (Naylor, M. W. 1996; MSL-14778), ACAF is 
not satisfied that the subsequent feeding study satisfactorily supports this hypothesis as 
the two studies are not equally comparative. Therefore ACAF remains of the view that 
the adverse response in rats to a diet containing 15% GT73 requires further 
explanation.” 
“ACRE and ACAF are not satisfied that the notifiers have supported the hypothesis that 
increased liver weight in rats fed GT73 compared with controls is attributed to higher 
glucosinolate content levels in the test material. A satisfactory explanation for this 
potentially adverse response observed in the rat feeding study is required.” 
Conclusion on GT73 feeding trials 
Monsanto is picking and choosing studies as it pleases. After the second rat study 
showed significant differences, the experiment was repeated with a wide range of 
canola. Why? 
From their conclusion of the rat studies, it is evident that Monsanto are simply trying to 
not perform additional experiments, or indeed determine the reason behind these 
significant differences. Instead the feeding trials have been repeated in such a way as to 
mask any real differences. These differences could turn out to be important because 
these feeding trails are very short. Significant differences could be indicative of longer-term 
problems. It is vital that the underlying reason for the significant differences should 
be satisfactorily determined. 
V.i.S.d.P Dr. Christoph Then, Greenpeace e.V., Große Elbstraße 39, 22767 Hamburg
2. Critique of EFSA’s opinion on GT73 
Introduction 
The GMO panel of the EFSA was set up to contribute to an improved risk assessment of 
GE crops in the EU. However, analysis of the GT73 assessment made by EFSA 
demonstrates that the EFSA has not contributed to a higher level of consumer and 
environmental protection from GE crops and foodstuffs. 
Molecular Data 
When describing the GE constructs in GT73, (Section 2.2.2) EFSA states “The 
sequencing of 3’ and 5’ flanking regions revealed that 40 base pairs (bp) of parental 
(Westar) DNA is absent from GT73, and that GT73 contains 22 bp of DNA adjacent to 
the 5’ insert/plant junction which is not present in Westar”. This means that there has 
been a small deletion of plant DNA in the GE plant and small extra fragment of DNA (it 
is not clear where this extra fragment originates from). The significance of these 
irregularities has not been examined in depth. EFSA should have initiated further 
studies, but instead it simply sates that there are no similarities between these 
sequences and known toxins and allergens. But these are not the only concerns from 
molecular irregularities. Are these fragments functional? What has been deleted from 
the plant, was a gene or regulatory sequence? These questions remain unanswered. 
Compositional analysis – pooled data and significant differences 
The EFSA detail (Section 3.2.2) the analysis performed “Kernels from oilseed rape 
(GT73, Westar and other commercial varieties) were obtained from field trials in Canada 
(1992 [7 sites], 1993 [5 sites]), 1997 [4-19 sites per variety]) and Europe (1994 [3 sites], 
1995 [3 sites]).” But, in the dossier and further information, these data are pooled from 
the different locations. This is exactly one of the major criticisms of poor quality data that 
was made prior to the initiation of the EFSA. Pooling of data can mask any variations 
present. Therefore, such data cannot be submitted in support of compositional 
sameness. 
Even though the data was pooled significant differences were noted: the level of 
linolenic acid was lower and, importantly, glucosinolate levels were higher in the GE 
oilseed rape. Why these levels are different has not been investigated further, the EFSA 
has simply accepted two possible explanations for the difference in glucosinolate levels 
from Monsanto as “reasonable explanations”. These explanations include variation 
within the original cultivar and variation induced by tissue cultivation. This is not 
scientifically rigorous, the EFSA should have rejected the GE crop at this point, or at 
least asked for further studies to determine exactly why these differences exist. It is 
certainly not in keeping with the philosophy of substantial equivalence as a starting 
point, i.e. where significances are noted they should be investigated. 
V.i.S.d.P Dr. Christoph Then, Greenpeace e.V., Große Elbstraße 39, 22767 Hamburg
The differences in glucosinolate levels could be important 
The glucosinolate levels are important because they are known antinutrients. As the 
EFSA states, the EC maximum allowable for this type of oilseed rape is 25 ìmol/g seeds 
(9 % moisture content). But Monsanto haven’t even given the concentration of 
glucosinolate in seeds, they have only estimated that they are below the threshold by 
converting this maximum into alkyl glucosinolates/g of defatted meal, which have been 
measured. However, no indication of moisture content is given and the estimates are 
just rough calculations. Much of the analysis on these glucosinolate levels is from 
samples pooled from different locations and most of the data are from GE oilseed rape 
that hasn’t even been sprayed with Roundup (the 6 herbicide that would be used with 
the GE oilseed rape). Analysing for glucosinolate levels in seeds is routine analysis – if 
would be easy for EFSA to ask for further studies on the glucosinolate levels but 
instead, they simply conclude “The glucosinolate levels reported are thus clearly below 
the maximum content set by the European Commission”. 
No environmental considerations of GT73 oilseed rape imports 
No reasons are given why EFSA and many Member States authorities do not consider 
the environmental implications of imports of oilseed rape, as environmental 
considerations are supposed to be part of their remit. Import of GT73 will result in feral 
GE oil seed rape populations. Most recently, a study conducted by the Japan Wildlife 
research Centre revealed that around the port of Kashima (and possibly also Kobe port) 
imported oil seed rape (GE and non-GE) is growing wild in 25 out of 48 checking points 
at locations within 5 km radius of the port.5 There was possible GE canola reseeding at 
17 out of the 23 confirmed locations. Thus, GE feral oilseed populations are likely to 
occur at sites of importation and distribution. 
Whilst the application is for the import of GT73 grain for food/feed purposes only, seeds 
will escape into the EU environment, e.g. during processing and transport. As feral 
populations of oilseed rape are widespread in Europe, it is highly likely, that escaped 
seed will germinate, flower and potentially cross-pollinate with oilseed rape crops, feral 
populations or wild relatives in Europe. The assumption that populations of oilseed rape 
that result from losses during transport, storage and processing (the so called 
“volunteers”) “are easily displaced by other weeds” cannot be made, as the results of 
several studies have shown6. Pessel et al. (2001), Pessel and Lecomte (2002)7 Relict 
plants of oil seed rape persisted for at least 8 years after their last cultivation, most 
probably in the soil seed bank, that feral populations persisted also by local recruitment, 
and that the spatial distribution of feral populations is partially related to the transport 
traffic at harvest from the field to the silo. Eastham & Sweet (2002)8 reported feral rape 
populations existing for at least 10 years. Feral (non cultivated) populations of oil seed 
rape and GE oilseed rape volunteers have been found from trials in the UK9 producing 
populations for up to the three years (the entire length of the study). Control of feral 
V.i.S.d.P Dr. Christoph Then, Greenpeace e.V., Große Elbstraße 39, 22767 Hamburg
populations, e.g. with herbicides, could adversely affect biodiversity in hedgerows, 
roadside areas, railway banks which may also be a haven for wildlife. 
Also the proposition that oilseed rape (OSR) roadside populations are “often prevented 
from reaching maturity by mowing or by chemical treatment” is highly questionable. This 
most certainly would not apply to railway lines. Who is going to control these volunteer 
plants? And how? Control of feral populations, e.g. with herbicides, could adversely 
affect biodiversity in hedgerows, roadside areas, railway banks which may also be a 
haven for wildlife. 
There is the potential for gene transfer from GT73 to other Brassica species. For 
example, it has now been demonstrated that B. napus can hybridize and pass on the 
GE trait to B. rapa, a wild relative of B. napus occurring in Europe and which readily 
produces hybrids10. 
The costs associated with herbicide resistance in Brassica napus are probably 
negligible11. Even if the gene is neutral (as opposed to conferring a benefit), evolutionary 
theory predicts that the gene frequency will persist. It is a misconception that only 
beneficial genes will persist12. 
Such populations may also act as a reservoir of GE constructs for feral or planted 
conventional oilseed rape, which would compromise co-existence requirements. In 
addition, 7 there is the possibility of gene stacking, as has happened in Canada, where 
escapes have led to multiple herbicide resistance, leading to the increased use of other, 
less benign herbicides as reported by English Nature13. 
ACRE is also concerned with the possibility that spillages of oilseed rape could lead to 
feral populations of GE oilseed rape14: “ACRE still has concerns regarding seed spill 
and remains of the opinion that the post market monitoring plan should include active 
monitoring for spillage of GT73 seed during import, transportation and processing and 
include tests for the establishment of feral populations of GT73 oilseed rape. The plan 
should also include appropriate emergency plans should such populations be identified.” 
In summary, spillage of GE herbicide tolerant oilseed rape grain could result in feral 
populations, which could compromise cultivation of conventional oil seed rape. The 
persistence of oilseed rape seeds and feral populations is problematic for the control of 
any volunteers arising from a spillage, and raises the possibly of adverse effects on 
wildlife through herbicide applications on non cultivated land. There are clear issues of 
liability, which are not currently addressed. 
Conclusions on EFSA’s Opinion on GT73 
· Irregularities in the molecular characterisation have not been studied further. 
· Compositional analysis has been performed on samples pooled from different 
sites. 
V.i.S.d.P Dr. Christoph Then, Greenpeace e.V., Große Elbstraße 39, 22767 Hamburg
· Significant differences in composition have been found, but have not been 
investigated further. 
· There is no environmental consideration of oilseed rape imports, in particular 
no consideration of the fact that import of GT73 can result in feral GE oil seed 
rape populations 
V.i.S.d.P Dr. Christoph Then, Greenpeace e.V., Große Elbstraße 39, 22767 Hamburg
3. Concerns about regulatory authorities’ handling of the GT73 
application 
The three-tier risk assessment and public scrutiny of the application material set out in 
Directive 2001/18/EC is wholly dependent on the proper handling of the application by 
the country that received the notification, which in the case of GT73 is the Netherlands. 
However, the Dutch authorities have not met their obligations under the Directive, and 
this has severely hindered the entire subsequent risk assessment process. Also the 
subsequent “scrutiny” by Member States and by the EFSA deserves to be strongly 
criticised. Public scrutiny on the other hand has been largely impossible, due to large 
sections of the material illegally being kept secret. 
According to article 13.1 of the Directive, “The competent authority [in the Member State 
that receives the application] shall without delay examine whether the notification is in 
accordance with paragraph 2 and shall, if necessary, ask the notifier for additional 
information.” The exact requirements to the application material are set out in Annex II, 
Annex III and Annex IV of the Directive. 
Application material both incomplete and of unacceptable quality 
Despite this responsibility, the Dutch authorities accepted a clearly incomplete and not 
updated application for GT73. Although several Member States subsequently pointed 
out that the application was incomplete, the application process was still not suspended. 
The risk assessment cannot work as intended by Directive 2001/18/EC when incomplete 
applications are being considered. As highlighted by the example above (Compositional 
analysis – pooled data and significant differences) and by the highly questionable 
feeding trials, the application material received for GT73 was also of a generally poor 
quality. 
Material has illegally been kept secret preventing public scrutiny 
According to article 25.3 of Directive 2001/18/EC, “The competent authority shall, after 
consultation with the notifier, decide which information will be kept confidential and shall 
inform the notifier of its decisions”. Article 25.2 of the Directive clearly states that only 
information, “the disclosure of which might harm [the notifier’s] competitive position” can 
be treated as confidential and that “verifiable justification must be given in such cases”. 
However the Dutch authorities allowed a large part of the application to be kept 
confidential. This confidentiality is supposed to be applied only to material obtained 
through innovative research. However, much of the material in the GT73 application, 
that the Dutch authorities allowed to be stamped confidential, do not qualify for secrecy 
under Directive 2001/18/EC - no matter how unfavourable it is to the GMO. 
The vast confidential section of the GT73 application even includes basic animal 
wholesomeness studies (Naylor 1994, Naylor 1995, Naylor 1996), which show 
abnormalities in rats fed with GT73. Data from such feed trials involve absolutely no 
V.i.S.d.P Dr. Christoph Then, Greenpeace e.V., Große Elbstraße 39, 22767 Hamburg
material of interest to Monsanto’s competitors, and thus do not constitute a justifiable 
harm to the applicant’s competitive position. The material do therefore not qualify for 
confidentiality under article 25.2. Furthermore, feeding trials are part of the food safety 
assessment required by the Directive, which in turn is part of the environmental risk 
assessment detailed in Annex II. For the environmental risk assessment, and thus these 
feed trials, it is specifically stated in article 25.4 of Directive 2001/18/EC that this 
information “in no case may [...] be kept confidential”. The Dutch authorities have thus in 
clear breach of both articles 25.2 and 25.4 of the Directive impeded due public scrutiny 
of the application. To a large extent, other Member States have maintained this illegal 
secrecy. 
Lack of critical scrutiny by the authorities 
Although greatly hindered by the illegal secrecy, Greenpeace has, from other sources, 
obtained basic information about the questionable feed trials conducted with GT73. 
These feed trials illustrate very well that the authorities’ scrutiny of the application has 
been far from satisfactory. Many member states did not even react when presented with 
material of an unacceptable poor scientific standard. Greenpeace can fully understand 
why Monsanto designed and conducted the feeding trials as they did, and can fully 
understand why Monsanto would argue that the negative effects revealed in the feeding 
trials should simply be ignored. It is, however, totally incomprehensible why many 
regulatory authorities, including EFSA, have decided to accept this material. Having 
revealed significant changes also in the second feeding trial, Monsanto conducts a third 
trial clearly designed to mask rather than to further investigate the significant differences 
revealed in the earlier trials. The fact that many Member States and the EFSA, despite 
this, are ready to approve GT73 illustrates clearly - as did MON863 application– that the 
risk assessment performed according to Directive 2001/18/EC fails to address even the 
most obvious risks. 
Conclusion on the regulatory authorities’ handling of the GT73 
application 
Directive 2001/18/EC is based on the precautionary principle. Article 4 regarding 
the General obligations reads: “Member States shall, in accordance with the 
precautionary principle, ensure that all appropriate measures are taken to avoid 
adverse effects on human health and the environment which might arise from the 
deliberate release or the placing on the market of GMOs”. This obligation cannot 
be met when: 
· Incomplete material of an unacceptable quality has been accepted as a basis 
for the assessment. 
· Secrecy has illegally been applied to large parts of the application material, 
thus hindering public scrutiny. 
· Many competent authorities (including the EFSA) have chosen to simply 
disregard data showing potential adverse effects, which as a minimum should 
have been investigated further. 
V.i.S.d.P Dr. Christoph Then, Greenpeace e.V., Große Elbstraße 39, 22767 Hamburg
· The environmental risk assessment has not addressed the obvious risk that 
the marketing approval will result in feral GE oil seed rape populations. 
V.i.S.d.P Dr. Christoph Then, Greenpeace e.V., Große Elbstraße 39, 22767 Hamburg
4. Overall Conclusion 
Significant differences have been found in the feeding trials. These should have been 
thoroughly investigated. Instead, various factors have been offered as hypotheses and 
the experiment was repeated with a range of controls to mask any significant 
differences. In their opinion on GT73, EFSA do not require further analysis but accept 
Monsanto’s hypotheses. This is not adequately rigorous. The environmental 
consequences of accidental or unintentional releases of GT73 seeds during the import, 
transport or processing, have never been properly assessed. The authorities handling of 
the application could be improved on immensely, and should be if the public is to have 
trust in the regulators. The withholding of fundamental studies is contrary to an open and 
transparent regulation of GE foodstuffs and the Commission and Member States should 
take action to ensure the transparency of the evaluation process. For GT73, there are 
many irregularities and causes for concern. The application for the import and 
processing of GT73 should be rejected. 
Greenpeace International 
October 2004 
1 EFSA (2004) Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission 
related to the Notification (Reference C/NL/98/11) for the placing on the market of glyphosate-tolerant oilseed rape 
event GT73, for import and processing, under Part C of Directive 2001/18/EC from Monsanto, The EFSA Journal 
(2004) 29, 1-19. 
2 Ibid 
3 Brown, P.B., Wilson, K.A., Jonker, Y. & Nickson, T.E. (2003) Glyphosate tolerant canola meal 
is equivalent to the parental line in diets fed to rainbow trout. Journal of Agricultural and Food 
Chemistry, 51, 4268-4272. 
4 ACRE (2004) Advice on a notification for marketing of herbicide tolerant GM oilseed rape 
http://www.defra.gov.uk/environment/acre/advice/pdf/acre_advice36.pdf 
5 Bio Journal (August 2004) http://www5d.biglobe.ne.jp/~cbic/english/2004/journal0408.html 
6 Pascher K, Macalka-Kampfer S & Reiner H (2000) Vegetationsökologische und genetische 
Grundlagen für die Risikobeurteilung von Freisetzungen von transgenem Raps und Vorschläge 
für ein Monitoring. Bundesministerium f. soziale Sicherheit und Generationen, 
Forschungsberichte 7/2000. Dolezel M, Pascher K, Just G& Reiner H (2002) Abschätzungen 
von Umweltauswirkungen exemplarisch ausgewählter gentechnisch veränderter. Pflanzen auf 
unterschiedliche Standorte in Österreich als Resultat möglicher Freisetzungen. Im Auftrag des 
Bundesministeriums für Soziale Sicherheit und Generationen, Sektion IX. Forschungsbericht 
11/02 pp180 + Anhänge und Bildtafeln. 7 Pessel F, Lecomte J, Emeriau V, Krouti M, Messean A 
& Gouyon P (2001) Persistence of oilseed rape (Brassica napus L.) outside of cultivated fields. 
Theoretical and Applied Genetics 102: 841-846. Pessel, F.D. & Lecomte, J. (2002) Vers une 
compréhension de la dynamique des populations de colza "échappées" des cultures à l'échelle 
d'une région agricole (Towards an understanding of the dynamics of rape populations that have 
"escaped" from large-scale cultivation in an agricultural region), Oleagineux, Corps Gras, Lipides 
, 7: 324-328. 
V.i.S.d.P Dr. Christoph Then, Greenpeace e.V., Große Elbstraße 39, 22767 Hamburg
8 Eastham, K. & Sweet, J. (2002) Genetically modified organisms (GMOs): the significance of 
gene flow through pollen transfer. Expert’s Corner Series, European Environment Agency, 
Copenhagen. 
9 Norris, C.E., Simpson, E.C., Sweet, J.B. & Thomas, J.E. (1999) Monitoring weediness and 
persistence of genetically modified oilseed rape (Brassica napus) in the UK. In: Lutman, P.J.W. 
(ed.) Gene flow and Agriculture: Relevance for Transgenic Crops. BCPC Symposium 
Proceedings no. 72, pp. 255-260. 
10 DEFRA (2002) Monitoring large scale releases of genetically modified crops (EPG 1/5/84) 
incorporating report on project EPG 1/5/30: monitoring releases of genetically modified crop 
plants. Available at: http://www.defra.gov.uk/environment/gm/research/epg-1-5-84.htm Halfhill, 
M.D., Millwood, R.J., Raymer, P.L. Stewart, C.N. (2002) Bt-transgenic oilseed rape hybridization 
with its weedy relative, Brassica rapa. Environmental Biosafety Research, 1, 19–28. 
11 Snow, A.A., Andersen, B. & Jorgensen, R.B. (1999) Costs of transgenic herbicide resistance 
introgressed from Brassica napus into weedy B. rapa. Molecular Ecology 8, 605-615. 
12 Ellstrand, N.C. (2001) When transgenes wander, should we worry? Plant Physiology, 125, 
1543-1545. Ellstrand, N.C., Prentice, H.C. & Hancock, J.F. (1999) Gene flow and introgression 
from domesticated plants into their wild relatives. Annual Review of Ecology and Systematics, 
30, 539-563. 
13 Orson, J. (2002) Gene stacking in herbicide tolerant oilseed rape: lessons from the Northern 
American experience. English Nature Research Reports no. 443, Peterborough, UK. Available 
at http://www.englishnature. org.uk/pubs/publication/PDF/enrr443.pdf 
14 ACRE (2004) Advice on a notification for marketing of herbicide tolerant GM oilseed rape 
http://www.defra.gov.uk/environment/acre/advice/pdf/acre_advice36.pdf 
V.i.S.d.P Dr. Christoph Then, Greenpeace e.V., Große Elbstraße 39, 22767 Hamburg

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Greenpeace Critique of Monsanto’s Roundup Ready Oilseed

  • 1. Greenpeace critique of Monsanto’s Roundup Ready Oilseed Rape, GT731 October 2004 Introduction The dossier and subsequent information submitted by Monsanto contain many inadequacies, conflicting statements and unexplained differences between the GE (genetically engineered) OSR (oilseed rape), GT73 and the parental line. Original material has not been disclosed, contravening EU legislation. Despite the numerous irregularities in the dossier, many member States have been limited in their critical scrutiny and the EFSA (European Food Safety Authority) has given GT73 a positive opinion. Here, we document the irregularities of the feeding trials, the failings of EFSA’s evaluation, the lack of consideration for the environmental consequences of accidental releases, concerns regarding the secrecy of fundamental studies and question the ability of EU regulatory authorities to competently regulate GE foodstuffs in a manner that assures food and environmental safety. It is arranged in three parts: 1) The bad science of GT73 feeding trials, 2) Technical critique of EFSA’s opinion on GT73 and 3) Concerns about regulatory authorities’ handling of the application. Finally, we conclude that the application for the import and processing of GT73 should be rejected. The bad science of GT73 feeding trials Introduction To support their application for the import of Roundup Ready oilseed rape, GT73, Monsanto submitted 3 feeding trials on rats, 2 on trout and 2 on quails. However, all are flawed. Rat studies It is not clear from the dossier what experimental protocol was followed. Since standard protocols do exist, the protocol used should be stated. Rat study no. 1, (Naylor, 1994) This first study showed a 10% loss in bodyweight, but was rejected because the GE seed had got mixed up with another GE variety: “As a consequence of co-mingling of the seed, a second study was undertaken”. This raises the question of how, if Monsanto can’t even separate the seed adequately for it’s own feed trials, are GE and non-GE OSR expected to be kept separate at commercial scales? Rat Study no. 2 (Naylor, 1995) V.i.S.d.P Dr. Christoph Then, Greenpeace e.V., Große Elbstraße 39, 22767 Hamburg
  • 2. In the second rat study, only processed GE OSR is used because the effects of unprocessed OSR according to Monsanto has “little practical relevance to commercial practices since unprocessed ground oilseed rape seed is not fed to animals”. Significant differences were found: “relative liver weights were increased approximately 12-16% for males and females fed the 15 % (but not the 5%) GTOSR diet compared to parental line controls.” Substantially equivalent or not?: Monsanto first tried to explain the differences as a product of two factors: 1) increased glucosinolate levels in the GE OSR and 2) the processing of oilseed rape. Monsanto claim in the SNIF (3c) that “There are no specific differences when GT73 is compared to conventional oilseed rape except for its tolerance to glyphosate. GT73 has been shown to be substantially equivalent, with exception of the introduced trait…”. But, then Monsanto informs that the level of total glucosinolate in the GT73 OSR-meal was approximately 0.6 gm/kg, twice as high as in the parental Westar line. This is not consistent with Monsanto’s claim that herbicide tolerance is the only difference between GT73 and ist non-GM parental line. To use the differences in the glucosinolate levels as an explanation for differences in the feeding trials contradicts with the claim of substantial equivalence. Subsequently, Monsanto decides that glucosinolate levels are not the cause of the differences. In the additional information supplied on 18th November 1999, Monsanto decide “our hypothesis that differences in glucosinolate levels accounted for the observed differences in liver weight is not supportable based on the available data.” This implies that the differences seen were either due to the processing or the GE product itself. A further experiment using unprocessed OSR could determine the differences are due to processing or the GE product. Monsanto did not conduct this key study but instead conducted a 3rd rat study using wider controls. Nevertheless, without offering any justification, the EFSA in its opinion simply considers that the enlarged livers as “an incidental finding”2 Rat study no. 3 (Naylor, 1996) After the original submission for marketing of GT73, Monsanto then conducted a third rat study! “The purpose of this study was to determine whether the liver and kidney weights of rats fed processed meal from the RU3 fall within the range of liver and kidney weights of rat fed processed meal from nine commercial varieties of canola from Canada and oilseed rape from Europe.” In other words, this third study was conducted with controls from as wide as range as possible, even from different continents. This third study seems, therefore, to be deliberately designed to mask any differences that occurred in the second rat study when GT73-fed rats were compared only to rats fed the parental line, Westar. Such a study design does not appear to follow any acceptable protocol. Predictably, no significant differences were observed. To go to this effort to refute the V.i.S.d.P Dr. Christoph Then, Greenpeace e.V., Große Elbstraße 39, 22767 Hamburg
  • 3. findings of the previous study, but yet not perform a key experiment testing the hypothesis that differences are due to processing rather than the GE product itself is absurd. This does not give any reassurances regarding feed safety. Monsanto conclude: no more evidence necessary! In their additional information, 18th November 1999, Monsanto state: “While we do not have a scientific explanation for the observed differences in liver weight in the second rat feeding study, the fact that this finding was not observed in the first and third feeding studies suggest the finding is not reproducible and probably not biologically significant.” Monsanto further conclude: “While we do not have further information to understand the differences in weight gain in the first feeding studies, and the increased liver weight in the second rat feeding study, when the processing of canola meal is carefully controlled (as done in the third feeding study), we find no differences in weight gain, food composition, or organ weights (liver and kidney” between rats fed RR canola and the parental line and commercial lines. Thus, the earlier findings do not appear to be biologically meaningful and further evidence to support earlier hypotheses is no longer needed.” This conclusion is based wholly on the third study. The reason for the differences in the previous study has still not been examined. Trout feeding studies The first trout study also suffers from a co-mingling of seed and was repeated. In the second study3, significant differences were noted, but were considered positive attributes so of no concern! “The only significant differences detected in the second experiment were PR [protein retention] and whole body moisture, protein, and fat concentrations. In each case, fish fed GT73 exhibited improvements in the three variables as compared to fish fed Westar. Increased retention of dietary protein is a positive attribute of a feed, and the higher protein, lower fat concentrations should also be considered a positive attribute of the fish produced.” However, the long-term effects of these so-called “positive attributes” are not known. It’s quite possible that these could become adverse effects in the long term. These short-term feeding trials are so limited that any significant differences, even if they appear positive, should be investigated thoroughly. Quail studies Quail were selected because they may feed on OSR seeds left in the field after harvest. However, Quail were fed GE OSR for only 5 DAYS! This is a wholly unnaceptable timescale for testing of wholesomeness of GE OSR. Again, the seed was co-mingled and the experiment was repeated but again for only FIVE days. Despite the timescale, the second study did reveal that the “…quails in the GT73 group exhibited a slight reduction in body weight gain during the exposure period (day 0 – day 5). However, there was no reduction in body weight gain for the entire test duration (day 0 – day 8). Feed consumption was comparable for all groups” (EFSA Journal (2004) 29, 1-19 (p14 V.i.S.d.P Dr. Christoph Then, Greenpeace e.V., Große Elbstraße 39, 22767 Hamburg
  • 4. 4.2.3). Apparently, the GT73 quails suffered weight loss during the time they were fed GT73, and only recovered the weight loss in the subsequent three days when they were no longer fed GT73. Yet the findings are ignored. UK regulatory authorities are concerned with the feeding studies Two of the UK advisory committees on GE crops, ACRE (Advisory Committee on Releases to the Environment) and ACAF (Advisory Committee on Animal Feedingstuffs), issued advice in September 20034 that includes concerns over the feeding trials: “ACAF considered the animal feed studies provided in the dossier. No significant differences in growth were observed between rats fed GT73 or Westar parental variety oilseed rape (Naylor, M. W. 1995; MSL-14164). However, the relative liver weights for the rats fed 15% processed GT73 oilseed rape were found to be significantly higher than controls. This was attributed by the notifiers to higher glucosinolate concentration in the GM diets compared with the corresponding control diets. This adverse effect was not observed in a subsequent rat experiment (Naylor, M. W. 1996; MSL-14778), ACAF is not satisfied that the subsequent feeding study satisfactorily supports this hypothesis as the two studies are not equally comparative. Therefore ACAF remains of the view that the adverse response in rats to a diet containing 15% GT73 requires further explanation.” “ACRE and ACAF are not satisfied that the notifiers have supported the hypothesis that increased liver weight in rats fed GT73 compared with controls is attributed to higher glucosinolate content levels in the test material. A satisfactory explanation for this potentially adverse response observed in the rat feeding study is required.” Conclusion on GT73 feeding trials Monsanto is picking and choosing studies as it pleases. After the second rat study showed significant differences, the experiment was repeated with a wide range of canola. Why? From their conclusion of the rat studies, it is evident that Monsanto are simply trying to not perform additional experiments, or indeed determine the reason behind these significant differences. Instead the feeding trials have been repeated in such a way as to mask any real differences. These differences could turn out to be important because these feeding trails are very short. Significant differences could be indicative of longer-term problems. It is vital that the underlying reason for the significant differences should be satisfactorily determined. V.i.S.d.P Dr. Christoph Then, Greenpeace e.V., Große Elbstraße 39, 22767 Hamburg
  • 5. 2. Critique of EFSA’s opinion on GT73 Introduction The GMO panel of the EFSA was set up to contribute to an improved risk assessment of GE crops in the EU. However, analysis of the GT73 assessment made by EFSA demonstrates that the EFSA has not contributed to a higher level of consumer and environmental protection from GE crops and foodstuffs. Molecular Data When describing the GE constructs in GT73, (Section 2.2.2) EFSA states “The sequencing of 3’ and 5’ flanking regions revealed that 40 base pairs (bp) of parental (Westar) DNA is absent from GT73, and that GT73 contains 22 bp of DNA adjacent to the 5’ insert/plant junction which is not present in Westar”. This means that there has been a small deletion of plant DNA in the GE plant and small extra fragment of DNA (it is not clear where this extra fragment originates from). The significance of these irregularities has not been examined in depth. EFSA should have initiated further studies, but instead it simply sates that there are no similarities between these sequences and known toxins and allergens. But these are not the only concerns from molecular irregularities. Are these fragments functional? What has been deleted from the plant, was a gene or regulatory sequence? These questions remain unanswered. Compositional analysis – pooled data and significant differences The EFSA detail (Section 3.2.2) the analysis performed “Kernels from oilseed rape (GT73, Westar and other commercial varieties) were obtained from field trials in Canada (1992 [7 sites], 1993 [5 sites]), 1997 [4-19 sites per variety]) and Europe (1994 [3 sites], 1995 [3 sites]).” But, in the dossier and further information, these data are pooled from the different locations. This is exactly one of the major criticisms of poor quality data that was made prior to the initiation of the EFSA. Pooling of data can mask any variations present. Therefore, such data cannot be submitted in support of compositional sameness. Even though the data was pooled significant differences were noted: the level of linolenic acid was lower and, importantly, glucosinolate levels were higher in the GE oilseed rape. Why these levels are different has not been investigated further, the EFSA has simply accepted two possible explanations for the difference in glucosinolate levels from Monsanto as “reasonable explanations”. These explanations include variation within the original cultivar and variation induced by tissue cultivation. This is not scientifically rigorous, the EFSA should have rejected the GE crop at this point, or at least asked for further studies to determine exactly why these differences exist. It is certainly not in keeping with the philosophy of substantial equivalence as a starting point, i.e. where significances are noted they should be investigated. V.i.S.d.P Dr. Christoph Then, Greenpeace e.V., Große Elbstraße 39, 22767 Hamburg
  • 6. The differences in glucosinolate levels could be important The glucosinolate levels are important because they are known antinutrients. As the EFSA states, the EC maximum allowable for this type of oilseed rape is 25 ìmol/g seeds (9 % moisture content). But Monsanto haven’t even given the concentration of glucosinolate in seeds, they have only estimated that they are below the threshold by converting this maximum into alkyl glucosinolates/g of defatted meal, which have been measured. However, no indication of moisture content is given and the estimates are just rough calculations. Much of the analysis on these glucosinolate levels is from samples pooled from different locations and most of the data are from GE oilseed rape that hasn’t even been sprayed with Roundup (the 6 herbicide that would be used with the GE oilseed rape). Analysing for glucosinolate levels in seeds is routine analysis – if would be easy for EFSA to ask for further studies on the glucosinolate levels but instead, they simply conclude “The glucosinolate levels reported are thus clearly below the maximum content set by the European Commission”. No environmental considerations of GT73 oilseed rape imports No reasons are given why EFSA and many Member States authorities do not consider the environmental implications of imports of oilseed rape, as environmental considerations are supposed to be part of their remit. Import of GT73 will result in feral GE oil seed rape populations. Most recently, a study conducted by the Japan Wildlife research Centre revealed that around the port of Kashima (and possibly also Kobe port) imported oil seed rape (GE and non-GE) is growing wild in 25 out of 48 checking points at locations within 5 km radius of the port.5 There was possible GE canola reseeding at 17 out of the 23 confirmed locations. Thus, GE feral oilseed populations are likely to occur at sites of importation and distribution. Whilst the application is for the import of GT73 grain for food/feed purposes only, seeds will escape into the EU environment, e.g. during processing and transport. As feral populations of oilseed rape are widespread in Europe, it is highly likely, that escaped seed will germinate, flower and potentially cross-pollinate with oilseed rape crops, feral populations or wild relatives in Europe. The assumption that populations of oilseed rape that result from losses during transport, storage and processing (the so called “volunteers”) “are easily displaced by other weeds” cannot be made, as the results of several studies have shown6. Pessel et al. (2001), Pessel and Lecomte (2002)7 Relict plants of oil seed rape persisted for at least 8 years after their last cultivation, most probably in the soil seed bank, that feral populations persisted also by local recruitment, and that the spatial distribution of feral populations is partially related to the transport traffic at harvest from the field to the silo. Eastham & Sweet (2002)8 reported feral rape populations existing for at least 10 years. Feral (non cultivated) populations of oil seed rape and GE oilseed rape volunteers have been found from trials in the UK9 producing populations for up to the three years (the entire length of the study). Control of feral V.i.S.d.P Dr. Christoph Then, Greenpeace e.V., Große Elbstraße 39, 22767 Hamburg
  • 7. populations, e.g. with herbicides, could adversely affect biodiversity in hedgerows, roadside areas, railway banks which may also be a haven for wildlife. Also the proposition that oilseed rape (OSR) roadside populations are “often prevented from reaching maturity by mowing or by chemical treatment” is highly questionable. This most certainly would not apply to railway lines. Who is going to control these volunteer plants? And how? Control of feral populations, e.g. with herbicides, could adversely affect biodiversity in hedgerows, roadside areas, railway banks which may also be a haven for wildlife. There is the potential for gene transfer from GT73 to other Brassica species. For example, it has now been demonstrated that B. napus can hybridize and pass on the GE trait to B. rapa, a wild relative of B. napus occurring in Europe and which readily produces hybrids10. The costs associated with herbicide resistance in Brassica napus are probably negligible11. Even if the gene is neutral (as opposed to conferring a benefit), evolutionary theory predicts that the gene frequency will persist. It is a misconception that only beneficial genes will persist12. Such populations may also act as a reservoir of GE constructs for feral or planted conventional oilseed rape, which would compromise co-existence requirements. In addition, 7 there is the possibility of gene stacking, as has happened in Canada, where escapes have led to multiple herbicide resistance, leading to the increased use of other, less benign herbicides as reported by English Nature13. ACRE is also concerned with the possibility that spillages of oilseed rape could lead to feral populations of GE oilseed rape14: “ACRE still has concerns regarding seed spill and remains of the opinion that the post market monitoring plan should include active monitoring for spillage of GT73 seed during import, transportation and processing and include tests for the establishment of feral populations of GT73 oilseed rape. The plan should also include appropriate emergency plans should such populations be identified.” In summary, spillage of GE herbicide tolerant oilseed rape grain could result in feral populations, which could compromise cultivation of conventional oil seed rape. The persistence of oilseed rape seeds and feral populations is problematic for the control of any volunteers arising from a spillage, and raises the possibly of adverse effects on wildlife through herbicide applications on non cultivated land. There are clear issues of liability, which are not currently addressed. Conclusions on EFSA’s Opinion on GT73 · Irregularities in the molecular characterisation have not been studied further. · Compositional analysis has been performed on samples pooled from different sites. V.i.S.d.P Dr. Christoph Then, Greenpeace e.V., Große Elbstraße 39, 22767 Hamburg
  • 8. · Significant differences in composition have been found, but have not been investigated further. · There is no environmental consideration of oilseed rape imports, in particular no consideration of the fact that import of GT73 can result in feral GE oil seed rape populations V.i.S.d.P Dr. Christoph Then, Greenpeace e.V., Große Elbstraße 39, 22767 Hamburg
  • 9. 3. Concerns about regulatory authorities’ handling of the GT73 application The three-tier risk assessment and public scrutiny of the application material set out in Directive 2001/18/EC is wholly dependent on the proper handling of the application by the country that received the notification, which in the case of GT73 is the Netherlands. However, the Dutch authorities have not met their obligations under the Directive, and this has severely hindered the entire subsequent risk assessment process. Also the subsequent “scrutiny” by Member States and by the EFSA deserves to be strongly criticised. Public scrutiny on the other hand has been largely impossible, due to large sections of the material illegally being kept secret. According to article 13.1 of the Directive, “The competent authority [in the Member State that receives the application] shall without delay examine whether the notification is in accordance with paragraph 2 and shall, if necessary, ask the notifier for additional information.” The exact requirements to the application material are set out in Annex II, Annex III and Annex IV of the Directive. Application material both incomplete and of unacceptable quality Despite this responsibility, the Dutch authorities accepted a clearly incomplete and not updated application for GT73. Although several Member States subsequently pointed out that the application was incomplete, the application process was still not suspended. The risk assessment cannot work as intended by Directive 2001/18/EC when incomplete applications are being considered. As highlighted by the example above (Compositional analysis – pooled data and significant differences) and by the highly questionable feeding trials, the application material received for GT73 was also of a generally poor quality. Material has illegally been kept secret preventing public scrutiny According to article 25.3 of Directive 2001/18/EC, “The competent authority shall, after consultation with the notifier, decide which information will be kept confidential and shall inform the notifier of its decisions”. Article 25.2 of the Directive clearly states that only information, “the disclosure of which might harm [the notifier’s] competitive position” can be treated as confidential and that “verifiable justification must be given in such cases”. However the Dutch authorities allowed a large part of the application to be kept confidential. This confidentiality is supposed to be applied only to material obtained through innovative research. However, much of the material in the GT73 application, that the Dutch authorities allowed to be stamped confidential, do not qualify for secrecy under Directive 2001/18/EC - no matter how unfavourable it is to the GMO. The vast confidential section of the GT73 application even includes basic animal wholesomeness studies (Naylor 1994, Naylor 1995, Naylor 1996), which show abnormalities in rats fed with GT73. Data from such feed trials involve absolutely no V.i.S.d.P Dr. Christoph Then, Greenpeace e.V., Große Elbstraße 39, 22767 Hamburg
  • 10. material of interest to Monsanto’s competitors, and thus do not constitute a justifiable harm to the applicant’s competitive position. The material do therefore not qualify for confidentiality under article 25.2. Furthermore, feeding trials are part of the food safety assessment required by the Directive, which in turn is part of the environmental risk assessment detailed in Annex II. For the environmental risk assessment, and thus these feed trials, it is specifically stated in article 25.4 of Directive 2001/18/EC that this information “in no case may [...] be kept confidential”. The Dutch authorities have thus in clear breach of both articles 25.2 and 25.4 of the Directive impeded due public scrutiny of the application. To a large extent, other Member States have maintained this illegal secrecy. Lack of critical scrutiny by the authorities Although greatly hindered by the illegal secrecy, Greenpeace has, from other sources, obtained basic information about the questionable feed trials conducted with GT73. These feed trials illustrate very well that the authorities’ scrutiny of the application has been far from satisfactory. Many member states did not even react when presented with material of an unacceptable poor scientific standard. Greenpeace can fully understand why Monsanto designed and conducted the feeding trials as they did, and can fully understand why Monsanto would argue that the negative effects revealed in the feeding trials should simply be ignored. It is, however, totally incomprehensible why many regulatory authorities, including EFSA, have decided to accept this material. Having revealed significant changes also in the second feeding trial, Monsanto conducts a third trial clearly designed to mask rather than to further investigate the significant differences revealed in the earlier trials. The fact that many Member States and the EFSA, despite this, are ready to approve GT73 illustrates clearly - as did MON863 application– that the risk assessment performed according to Directive 2001/18/EC fails to address even the most obvious risks. Conclusion on the regulatory authorities’ handling of the GT73 application Directive 2001/18/EC is based on the precautionary principle. Article 4 regarding the General obligations reads: “Member States shall, in accordance with the precautionary principle, ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the deliberate release or the placing on the market of GMOs”. This obligation cannot be met when: · Incomplete material of an unacceptable quality has been accepted as a basis for the assessment. · Secrecy has illegally been applied to large parts of the application material, thus hindering public scrutiny. · Many competent authorities (including the EFSA) have chosen to simply disregard data showing potential adverse effects, which as a minimum should have been investigated further. V.i.S.d.P Dr. Christoph Then, Greenpeace e.V., Große Elbstraße 39, 22767 Hamburg
  • 11. · The environmental risk assessment has not addressed the obvious risk that the marketing approval will result in feral GE oil seed rape populations. V.i.S.d.P Dr. Christoph Then, Greenpeace e.V., Große Elbstraße 39, 22767 Hamburg
  • 12. 4. Overall Conclusion Significant differences have been found in the feeding trials. These should have been thoroughly investigated. Instead, various factors have been offered as hypotheses and the experiment was repeated with a range of controls to mask any significant differences. In their opinion on GT73, EFSA do not require further analysis but accept Monsanto’s hypotheses. This is not adequately rigorous. The environmental consequences of accidental or unintentional releases of GT73 seeds during the import, transport or processing, have never been properly assessed. The authorities handling of the application could be improved on immensely, and should be if the public is to have trust in the regulators. The withholding of fundamental studies is contrary to an open and transparent regulation of GE foodstuffs and the Commission and Member States should take action to ensure the transparency of the evaluation process. For GT73, there are many irregularities and causes for concern. The application for the import and processing of GT73 should be rejected. Greenpeace International October 2004 1 EFSA (2004) Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the Notification (Reference C/NL/98/11) for the placing on the market of glyphosate-tolerant oilseed rape event GT73, for import and processing, under Part C of Directive 2001/18/EC from Monsanto, The EFSA Journal (2004) 29, 1-19. 2 Ibid 3 Brown, P.B., Wilson, K.A., Jonker, Y. & Nickson, T.E. (2003) Glyphosate tolerant canola meal is equivalent to the parental line in diets fed to rainbow trout. Journal of Agricultural and Food Chemistry, 51, 4268-4272. 4 ACRE (2004) Advice on a notification for marketing of herbicide tolerant GM oilseed rape http://www.defra.gov.uk/environment/acre/advice/pdf/acre_advice36.pdf 5 Bio Journal (August 2004) http://www5d.biglobe.ne.jp/~cbic/english/2004/journal0408.html 6 Pascher K, Macalka-Kampfer S & Reiner H (2000) Vegetationsökologische und genetische Grundlagen für die Risikobeurteilung von Freisetzungen von transgenem Raps und Vorschläge für ein Monitoring. Bundesministerium f. soziale Sicherheit und Generationen, Forschungsberichte 7/2000. Dolezel M, Pascher K, Just G& Reiner H (2002) Abschätzungen von Umweltauswirkungen exemplarisch ausgewählter gentechnisch veränderter. Pflanzen auf unterschiedliche Standorte in Österreich als Resultat möglicher Freisetzungen. Im Auftrag des Bundesministeriums für Soziale Sicherheit und Generationen, Sektion IX. Forschungsbericht 11/02 pp180 + Anhänge und Bildtafeln. 7 Pessel F, Lecomte J, Emeriau V, Krouti M, Messean A & Gouyon P (2001) Persistence of oilseed rape (Brassica napus L.) outside of cultivated fields. Theoretical and Applied Genetics 102: 841-846. Pessel, F.D. & Lecomte, J. (2002) Vers une compréhension de la dynamique des populations de colza "échappées" des cultures à l'échelle d'une région agricole (Towards an understanding of the dynamics of rape populations that have "escaped" from large-scale cultivation in an agricultural region), Oleagineux, Corps Gras, Lipides , 7: 324-328. V.i.S.d.P Dr. Christoph Then, Greenpeace e.V., Große Elbstraße 39, 22767 Hamburg
  • 13. 8 Eastham, K. & Sweet, J. (2002) Genetically modified organisms (GMOs): the significance of gene flow through pollen transfer. Expert’s Corner Series, European Environment Agency, Copenhagen. 9 Norris, C.E., Simpson, E.C., Sweet, J.B. & Thomas, J.E. (1999) Monitoring weediness and persistence of genetically modified oilseed rape (Brassica napus) in the UK. In: Lutman, P.J.W. (ed.) Gene flow and Agriculture: Relevance for Transgenic Crops. BCPC Symposium Proceedings no. 72, pp. 255-260. 10 DEFRA (2002) Monitoring large scale releases of genetically modified crops (EPG 1/5/84) incorporating report on project EPG 1/5/30: monitoring releases of genetically modified crop plants. Available at: http://www.defra.gov.uk/environment/gm/research/epg-1-5-84.htm Halfhill, M.D., Millwood, R.J., Raymer, P.L. Stewart, C.N. (2002) Bt-transgenic oilseed rape hybridization with its weedy relative, Brassica rapa. Environmental Biosafety Research, 1, 19–28. 11 Snow, A.A., Andersen, B. & Jorgensen, R.B. (1999) Costs of transgenic herbicide resistance introgressed from Brassica napus into weedy B. rapa. Molecular Ecology 8, 605-615. 12 Ellstrand, N.C. (2001) When transgenes wander, should we worry? Plant Physiology, 125, 1543-1545. Ellstrand, N.C., Prentice, H.C. & Hancock, J.F. (1999) Gene flow and introgression from domesticated plants into their wild relatives. Annual Review of Ecology and Systematics, 30, 539-563. 13 Orson, J. (2002) Gene stacking in herbicide tolerant oilseed rape: lessons from the Northern American experience. English Nature Research Reports no. 443, Peterborough, UK. Available at http://www.englishnature. org.uk/pubs/publication/PDF/enrr443.pdf 14 ACRE (2004) Advice on a notification for marketing of herbicide tolerant GM oilseed rape http://www.defra.gov.uk/environment/acre/advice/pdf/acre_advice36.pdf V.i.S.d.P Dr. Christoph Then, Greenpeace e.V., Große Elbstraße 39, 22767 Hamburg