Date: 15 September 2004

Friends of the Earth Europe
Coalition against BAYER-dangers (Germany)
Gene Campaign (India)

Letter to the 25 EU Member States

Reject Bayer's application to import genetically modified rice into the EU

Friends of the Earth, Gene Campaign and Coalition against BAYER-dangers are writing to express their concerns about the application for a part C (marketing) approval under the GMOs Deliberate Release Directive 2001/18 for Bayer's glufosinate tolerant genetically modified rice LLrice62.

We remind the Commission and member states that European food law calls for a "high level of protection of human life and health and the protection of consumers' interests...taking into account, where appropriate, the protection of animal health and welfare, plant health and the environment." (1) Furthermore Member States must, 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."(2)

As pointed out by the applicant, rice "is the staple food for more than one-half of the world's population" and many EU citizens consume rice as a staple food. The Cartagena Protocol On Biosafety to the Convention On Biological Diversity notes that there are "limited capabilities of many countries, particularly developing countries, to cope with the nature and scale of known and potential risks associated with living modified organisms". The decisions by the European Union with respect to this GM rice will therefore be extremely influential in countries with limited resources to undertake their own regulatory review. Africa, for example, is one of the largest importers of rice, particularly sub Saharan African countries (3).

Although Bayer's application is only for the import and processing of genetically modified (GM) rice into the European Union, there could be also major environmental and health implication outside the borders of the Community, since this is were the rice -if approved- would have to be grown.

In particular Gene Campaign, Friends of the Earth Europe and Coalition against BAYER-dangers are concerned about the potential adverse impacts of Bayer's application in the centres of origin, notably in the developing countries where a regulatory framework on GMOs is often very weak or even non-existing.

Gene Campaign stresses that India is one of the centres of origin and diversity for rice and has substantial concerns about the possibility of genetic pollution of native rice germplasms. The importance of protecting this as a world resource cannot be over stated; rice gets its resistance to two of Asia's four main rice diseases from a single sample of rice that came from central India4. While Bayer dismisses the possibility of significant gene flow from its rice under cultivated conditions recent research from China, designed to replicate the occurrence of wild rice in the field, found transgene escape to wild rice (Oryza rufipogon Griff.) occurring at the rate of 1.21 and 2.19 % in the field (5). A recent study modelling commercial production of glufosinate tolerant rice in Latin America predicted that the development of herbicide resistant weedy rice populations would occur within 3 to 8 years (6). After the example of GM corn detected in Mexico, the global community should be fully aware that genetic contamination is possible even when the GM crop in question is not being cultivated in the country.

Gene Campaign fears that opening the EU market for GM rice would be a lure for rice producing nations to cultivate GM rice for the export market. It would be relatively easy to sell this proposal in the domestic context, because of the potential for export earnings, but this would overlook the very critical threat of genetic contamination in rice diversity areas.

Gene Campaign, which is asking for a moratorium on the cultivation of GM crops in their centres of origin and diversity, is alarmed that India could be tempted to produce GM rice for the EU market. It is particularly ironic that India and other centres of diversity for rice could end up jeopardising their principal food source for producing rice for the west.

This means that the EU has a moral obligation to undertake the most thorough and exhaustive analysis of the safety of this new GM crop, in order to be sure that it is safe for consumption and the environment where it is grown.

Friends of the Earth, Coalition against BAYER-dangers and Gene Campaign do not consider that a sufficiently rigorous assessment has been undertaken. It appears to us that a thorough investigation of the following issues is required in order to establish that adverse changes to the rice have not occurred as a result of genetic modification:

Furthermore, the environmental risk assessment and monitoring plan do not give sufficient consideration to the possibility of the escape of this GM organism through accidental spillage of grains in southern Europe, where rice could grow and contaminate non GM crops. Nor is there a realistic consideration of the potential for gene dispersal and consequent environmental impacts in the areas where the GM rice will be grown.

1. Integration of inserted gene sequence into a coding sequence of a 'novel gene'

Bayer's notification details how the inserted gene sequence is integrated into 'a coding region of a novel gene' (Annex 5, p25). Sequence alignment of the 5' prime flanking sequence against rice genome databases identified 18 homologous gene sequences to the one disrupted on several different chromosomes. Despite having no knowledge of the function of the disrupted gene they conclude ''These data allow to assume that disruption of the gene that occurred in Oryza sativa elite event LLRICE62 most likely does not influence the activity of the genome'. The only data to support this appears to be the claim that "in all our field production and grain quality testing experience, the plant has not suffered" (Notification section D2). However, loss of expression of one copy of a gene may affect the overall genetic function, and there does not appear to have been any attempt to investigate potential silencing of homologous genes. Subtle alterations may not be detected in the kinds of gross measures of agronomic performance, reproductive and vegetative fitness undertaken by Bayer.

2. Lack of consideration of unanticipated changes

A key concern relating to GM foods is whether the genetic modification has led to unanticipated changes to the genetic functioning of the organism, its metabolism and hence its safety. Bayer consider the composition of the LLRICE62 by measuring levels of the basic constituents of rice - amino acid composition, protein content; micro-nutrient levels etc. However, nowhere in the dossier is there any assessment of whether there have been any unexpected changes and entirely new compounds produced as a result of the genetic modification process. This lack is of particular concern given the evidence presented of gene disruption through integration of the transgenes.

Codex agreed its guidelines on 'the conduct of food safety assessment of foods derived from recombinant-DNA plants' in July 2003, and these should now be followed internationally (7). The guidelines recognise the necessity for risk assessment of foods produced using genetic modification and require a "pre-market safety assessment of...both intended and unintended effects, identifying new or altered hazards and identifying changes relevant to human health". This is because, according to a WHO expert, "for plants generated by recombinant technology, unanticipated effects may additionally arise from the process of introducing foreign genes or as a result of the effects of environmental factors/genetic background" (8).

The lack of any data, such as mRNA analyses, looking for unanticipated changes is a serious shortcoming in the application.

Furthermore, guidance by the former Scientific Committees on the safety assessment of GM foods notes that it should "not only include studies on newly expressed proteins but also the consequences of any genetic modification (e.g. gene silencing or over-expression of an endogenous gene)." (9)

It goes on to state that "the safety assessment must consider the presence of proteins expressed as result of the genetic modification, the potential presence of other novel constituents and/or possible changes in the level of natural constituents beyond normal variation."

For LLrice62, compositional differences between the GM rice and a non GM counterpart were found for a number of factors measured. The UK authority's assessment report notes that: "For a number of nutrients (including some fatty acids, iron, vitamin B1 and Vitamin E) compositional analysis was not achieved at all sites and all comparisons".

"Fat, protein, ADF acid detergent fibre, NDF neutral detergent fibre, and ash were markedly lower in transgenic rice bran than non-transgenic rice bran, while total carbohydrates were higher. For fat and NDF, these exceeded the 20% bio equivalence range". These differences were not investigated further, but were dismissed because "consistent trends" were not identified. This is a judgement which appears to have been made in the applicant's interest, not the interest of the public.

There are also some questions raised in the feeding studies. Animal feeding trials were limited to a poultry feeding study which show no differences between GM and non-GM fed birds, but which the UK authorities noted was of "limited capacity" to identify adverse effects. It is unclear whether glufosinate treated rice was used in this study. This is essential because in glufosinate tolerant crops using the pat or bar gene, after glufosinate is applied a new metabolite is produced in the plant (10) and this could influence the nutritional value of the feed.

A second feeding study over 100 days using pigs found that the animals fed the GM rice treated with the herbicide glufosinate gained weight more than animals fed untreated GM rice or non GM rice. This effect does not appear to have been investigated further.

3. Inadequate examination of existing allergic potential.

Rice is known to cause allergic reactions and has also been found to cause protein induced enterocolitis syndrome in infants11, an uncommon but severe form of food hypersensitivity. Even the applicant notes that "Recent studies showed, that the rice protein fraction contains proteins with an allergenic potential".

The guidance by the former EU Scientific Committees on the safety assessment of GM foods states that:

"If the host of the introduced gene is known to be allergenic, any potential change in the allergenicity of the whole GM food/feed should be tested by comparison of the allergen repertoire with that of the conventional non-GM variety."

The allergenic proteins found in rice have been identified and characterised and are in the class of trypsin inhibitor proteins. According to Bayer's Nutritional Impact Asessment report, increases in these proteins were observed for LLrice62.

Trypsin inhibitors in the GM rice were substantially higher in the bran of the GM rice (2.27 (TIU/mg protein ) than in the conventional rice (1.36 (TIU/mg protein ) (12).

Although reactions to rice are rare, they can be extremely serious, particularly for affected infants, and so considering the wide influence of the EU's opinion and the fact that rice can be the major part of the diets of the less affluent, serious consideration must be given to this before approval is granted.

The antinutritional compound phytic acid is also found in rice bran, preventing absorption of minerals. Rice bran is the main by product of rice processing used in animal feeds and according to Bayer's Nutritional Impact Assessment report phytic acid content was also higher in the GM rice bran (5.14mg/100g) than the non GM rice bran (4.49mg/100g), although it is unclear what from the document what units these figures express.

So, the level of key anti-nutritional compounds is increased in the GM rice in comparison to its non GM counterpart. These findings were dismissed because the differences are not statistically significant, but considering the difficulties in sampling and resulting small sample sizes, which means that only extremely large differences would be statistically significant, as well as the fact that this is a staple food for many consumers both in and outside the EU, further investigation of these observed differences must be undertaken.

4. Shortcomings in the assessment of the potential for adverse impacts on the environment

The application concerns the importation of GM glufosinate tolerant rice (Oryza sativa) for use in food and feed and does not include cultivation. Rice is grown in 5 southern EU member states - Italy, Spain, Greece, Portugal and France. Although gene flow to crop rice or weedy red rice is possible in such areas (13,14,15), Bayer consider this risk to be 'theoretical', because LLRICE62 is not intended to be grown in Europe (Page 43 of notification). However, nowhere in the notification does Bayer provide data on:

If there was an accidental spillage of the GM rice in southern Europe, it may germinate and cross pollinate farmed rice or wild red rice. The introduction of herbicide tolerance genes into weedy rice could pose considerable problems for farmers in southern Europe. If non-GM rice were to be contaminated, farmers could suffer economic losses. About 0.89mt of rice are imported into Europe annually, and on such a scale the potential for rare events to occur must be given consideration.

Friends of the Earth, Gene Campaign and Coalition against BAYER-dangers consider that for all the above reasons, LLrice62 should not be granted approval for import and marketing in the EU, because there is insufficient evidence that it will not cause adverse effects to human health and the environment.

15 September 2004

Contact: Geert Ritsema
GMO Campaign Coordinator
Friends of the Earth Europe

1 Regulation No 178/2002 of the European Parliament and of the Council of 28 January 2002, laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety.
2 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms
3 USDA trade figures for rice show that while the EU imported 0.9 million tonnes in 2002/3, countries in sub Saharan Africa imported 6.2 million tonnes
4 World Resources Institute
5 Chen LJ et al. (2004) Gene flow from cultivated rice (Oryza sativa) to its weedy and wild relatives
Annals of Botany 93 (1): 67-73
6 Madsen KH, Valverde BE, Jensen JE (2002) Risk assessment of herbicide-resistant crops: A Latin American perspective using rice (Oryza sativa) as a model Weed 16 (1): 215-223
7 Guideline for the conduct of food safety assessment of foods derived from recombinant-DNA plants. CAC/GL 45-2003.
8 Haslberger, A. (2003) Codex guidelines for GM foods include the analysis of unintended effects. Nature Biotechnology 21: 739-741.
9 Guidance Document For The Risk Assessment Of Genetically Modified Plants And Derived Food And Feed 6-7 March 2003 Prepared for the Scientific Steering Committee by The Joint Working Group on Novel Foods and GMOs Composed of members of the Scientific Committees on Plants, Food and Animal Nutrition. Paragraph 4.4
10 OECD (2002) Series on harmonization of regulatory oversight in biotechnology, No 25. Module II: Phosphinothricin. ENV/JM/MONO(2002)14
11 Nowak-Wegrzyn A (2003) food protein-induced enterocolitis syndrome caused by solid food proteins Pediatrics 111(4) 829-835
12 Bayer. Report No NI 01 EUR 01 C011512 Nutritional Impact Assessment Report on
Glufosinate Tolerant Rice Transformant LLRICE62 Table 4.18.1
13 OECD (1999) Series on Harmonization of Regulatory Oversight in Biotechnology No.14. Consensus document on the biology of Oryza sativa (rice). ENV/JM/MONO(99)26
14 Messegeur, J. et al (2001) Field assessments of gene flow from transgenic to cultivated rice (Oryza sativa L.) using a herbicide resistance gene as tracer marker. Theoretical and Applied Genetics 103: 1151-1159.
15 Zhang, N., Linscombe, S. & Oard, J. (2003) Out-crossing frequency and genetic analysis of hybrids between transgenic glufosinate herbicide-resistant rice and the weed, red rice. Euphytica 130: 35-45.