Genetically Manipulated Food News

17 February 1997

Table of Contents

Friends of the Earth Mailout
Belgian Media Attacks the Commission
Austria Bans Gentech Maize
Publication on Genetically Modified Maize

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The current Mailout of FRIENDS OF THE EARTH EUROPE contains many articles worth to read but regarding of the size (53 kbyte) I will provide you only with an excerpt. You can retrieve the whole MAILOUT with a message to gentech-request@tribe.ping.de and a subject line containing "archive get docu/foee297.txt".


FRIENDS OF THE EARTH EUROPE
BIOTECHNOLOGY PROGRAMME

Mailout Vol. 3 (1997), Issue 1, 31st January 1997. In this issue


THE CONTROVERSY CONTINUES OVER
CIBA S GENETICALLY MODIFIED MAIZE .....
FRANCE DELAYS INTRODUCTION .....

Although the Commission granted authorization, on 18th December 1996, for the placing on the market of Ciba Geigy s genetically modified maize, different factors have developed over recent weeks which are hampering the market release. Firstly, there was quite a significant delay in the Commission officially informing the French government that the market release had been approved. On 9th January, a Commission spokesman said that notification is imminent , indicating that imports of the genetech maize into the EU could then go ahead. However, it was only as recently as 27th January - more than five weeks after the decision was taken - that a Commission spokesman indicated that France had finally been officially notified, although he gave no explanation for the delay.

In the meantime, no sooner was the decision for authorization of market release taken by the Commission than the French government announced that it would not allow the import of genetech maize from the U.S. unless the product was labelled. This is quite paradoxical since France was the notifying Member State which originally requested authorization for the placing on the market, and which continued to support the proposal unwaveringly during its troubled passage through the Council and the Commission! (It was only due to France s positive vote at the meeting of the Environment Council in June 96 - all the other Ministers voted against with one abstention - that the decision was passed back to the Commission.)

At the end of December, however, the French Agriculture Minister, Philippe Vasseur, issued a statement saying that he would not authorize the release of genetech maize as long as the labelling issue had not been settled. Furthermore, French farmers will not be allowed to grow genetech maize until the Ministry clears it release on the French market, the statement said. The French demands for labelling were made in connection with remarks made by Environment Commissioner Ritt Bjerregaard, on the day that authorization was announced, that better labelling was desirable and that a proposal in this regard would be put forward under the review of Directive 220. France has indicated that if new EU labelling regulations are not forthcoming soon, it will draft its own labelling rules but, either way, this could be quite a lengthy process.

The outcome of the situation then is that until such time as France - the country which notified request for market release in the first place - has given the go-ahead on its home territory, the genetech maize remains, in effect, banned in all other EU Member States. Not unexpectedly, this has displeased U.S. exporters and there are noises from Washington warning of another transatlantic trade dispute. During January, it was reported that several shipments of genetech maize from the U.S. had already been impounded by French customs authorities.


THE BELGIAN MEDIA ATTACKS THE COMMISSION .....

In another interesting development, the Belgian paper Le Soir published a fierce attack on the Commission on Monday, 27th January -a front page article and nearly one full inner page. In particular, the articles are very critical of the way the European Commissioners reached their decision, and of the reports of the three scientific committees which were instrumental in the decision-making.

In this connection, at their daily news briefing with reporters on 29.01.97, a Commission spokesman acknowledged, in reference to the Le Soir articles, that not everybody is happy with the decision to authorize Ciba s maize and indicated that the reports of the three scientific committees were freely available on request from his office. Copies of the reports were duly provided to the FoEE Biotech Programme within the next 24 hours, which is interesting inasmuch as our previous request to the biotechnology unit of DG XI asking for copies of these reports has still not been answered.

The decision was commercially motivated

In it s report on the minutes of Commissioner s meeting of 18th December, -- from which it is clear that some Commissioners such as Bangemann, Brittan and Flynn strongly supported market release (Brittan quote: it will facilitate relations with the United States unquote, Flynn stressing the importance of biotechnology to the economic and employment sector, and Bangemann and Brittan seemingly unwilling to push for labelling due to fears of conflict with the WTO) -- Le Soir prints the text of a footnote which Commissioner Emma Bonino (Consumer Affairs, Fisheries, and Humanitarian Affairs) requested be annexed to the minutes. It reads as follows (translation from the French): While taking account of the findings of the three scientific committees which aimed to exclude the dangers to human health based on the information currently available, I regret that the College (of Commissioners) has taken a decision which is so sensitive to public opinion under the pressure and the urgency linked to the problem of the importation of significant stocks of maize from the United States. I think that deeper reflection could have been undertaken to ensure full consideration of the concerns of consumers and their desire for transparency. In particular, I would have liked the Commission to clearly request the Member States, by way of a recommendation, to carry out necessary monitoring on the mid- and long-term effects of genetically modified maize while ensuring, to the extent possible, adequate information for the consumer .

Concerning the reports of the three scientific committees (see separate article in this Mailout), the Le Soir article is scathing. The author says that these reports make stupefying reading and that they are extremely vague and brief, using phrases such as almost negligible risks for animal health, improbable in connection with allergies, remote with regard to transfer of antibiotic resistance. Le Soir also publishes an internal note emanating from the Commissioners Chefs de Cabinet in the days before the decision was taken: The maize originating from across the Atlantic is now being stocked in EU ports. This will put very heavy pressure on the Union which is requested to take a decision as soon as possible, for fear of facing actions for damage and interest. (GL with thanks to Andre Riche of Le Soir )


AUSTRIA BANS GENETECH MAIZE

After the Commission announced in December that it would grant market approval to Ciba Geigy s hotly disputed transgenic corn, the Austrian government immediately stated that Austria will use Article 16 of the Directive 90/220/EEC to stop the sale and use of this maize on Austria s territory. Neither the Austrian Health Ministry and the Environment Ministry are convinced about the safety of the product - even if three Scientific Committees of the Commission say otherwise.

Using the famous Article 16 means, in effect, that the market approval of the maize will once again have to be examined by the 15 member states (and not only the Commission s totally undemocratic and untransparent committees). The Competent Authorities of all Member States will, within 3 months, have to come to a conclusion whether they let Austria go ahead with its national prohibition or not. In the first case, the maize will not be allowed onto Austria s market. However, if the Competent Authorities (of the so-called Article 21 Committee ) vote against Austria, then the maize will also be allowed to be sold in Austria.

In order to come to a decision, the Committee has to vote by a qualified majority. Since already in April last year, when the maize was first on their agenda, the experts could not agree to let it pass, the chances are high that the experts will let Austria its own way and ban the maize. Denmark, Sweden and Luxembourg have already said that they might consider joining ranks with Austria. In addition, some other, larger countries, such as the UK may also remain should firm in their criticism of the corn. Should the Article 21 Committee find no conclusion (as was the situation last April), the whole dossier will have to go to back to the Council once again.

In short: the story of the maize is not over yet ......

(Thomas Schweiger, Global 2000)


SCIENTIFIC COMMITTEES PUBLISH THEIR REPORTS ON GENETICALLY MODIFIED MAIZE

On March 16, 1995 the Commission received a notification by the company Ciba-Geigy concerning the placing on the market of genetically modified maize, forwarded by the French Competent Authorities. On April 11, 1996 the Regulatory Committee foreseen by Article 21 of the deliberate release Directive 90/220/EEC failed to deliver an opinion on the measures proposed by the Commission. As reported in Mailout Vol. 2 N 4, the Environment Ministers rejected on 25th June a proposal to authorize the placing on the market of Ciba Geigy s genetically modified maize and instead asked the European Commission to reconsider the file. Only one country - France - supported the Commission s proposal, while 13 Member States were opposed, with Germany abstaining.

On 26th July the Commission issued a press release indicating that the scientific basis of the proposal to market this genetically modified maize would be further assessed by three scientific committees established at Community level. The three committees involved were the: Scientific Committee for Food (SCF), Scientific Committee for Animal Nutrition (SCAN), Scientific Committee for Pesticides.

All three were been requested to give their opinion on the scientific basis of the proposal, especially in respect to the assessment of the effects on human health and on the environment of the release of genetically modified maize (Zea mays L.) containing the Bt-endotoxine gene CRYIA(b) (mediating an insect tolerance), the glufosinate ammonium resistance gene bar (coding for the protein phosphinothricin acetyl transferase (PAT); mediating a herbicide tolerance) and the (non-expressed) TEM1 s-lactamase gene bla (mediating a tolerance to the antibiotic ampicillin).

At the meeting of the Environment Council in Luxembourg on 15th October, Commissioner Bjerregaard, informed Environment Ministers of the state of play and that the three committees had embarked on an in-depth examination of this dossier. The topic was back on the agenda again for the Environment Ministers during the Council meeting on Monday, 9th December. The Commission finally decided on 18th December in favour of placing on the market the genetically modified maize, based on the positive assessment of the three Committees, delivered on 9 and 13 December 1996. The arguments of the Committees can be summarised as follows (NB: the single text passages have been quoted directly from the reports):

Toxicity :
The CRYIA (b) toxin has a long history of use against insect larvae and has also been shown not to be harmful when ingested by higher animals. The native CRYIA (b) Protein has been tested for acute toxicity and no mortality has been reported to 5 g per kg body weight in mice. In the plant kernels itself, the protein is only expressed at a level of 5 ppb (parts per billion). The protein itself is rapidly degraded in vitro in simulated gastric fluid.

The native PAT protein has also been tested for acute toxicity in mice and no mortality has been reported to 5g per kg body weight in mice.

Allergenicity :
Allergic effects are not be expected because the sequence of the CRYIA (b) and of the PAT protein do not show homologies with known allergens. Moreover, the proteins appear to be readily degraded by simulated gastric fluid in vitro. (NB: The committees had to argue in this indirect way of proof because existing scientific methods are not able at the moment to exactly assess the allergic potential of a novel protein in advance.)

Concerns about the antibiotic :
There is no evidence that genes from plants have been ever transferred under natural conditions to bacteria. In a separate expert meeting, several questions relating to antibiotics were discussed and the committees concluded from the discussion that there are no serious concerns related to the use of antibiotics and that degeneration of DNA through processing of maize and the enzymatic decomposition of DNA in the gastrointestinal tract makes the residual amount of intact DNA which could contain a gene very small. Furthermore, the transfer rate is very small and even if a transfer would take place, it would have no detectable additional effect, as the bla gene mediating an ampicillin resistance is already widely spread in the human gastrointestinal tract. The used pUC TEM1 s-lactamase is, in addition, not capable to inactivate the newer generation of penicillins used in humane medicine. The TEM1 s-lactamase has a very narrow spectrum of resistance compared to variants of E.coli strains living in the human gut.

Nevertheless the SCF was conscious of the general question of the use of genes coding for antibiotic resistance and proposes to scrutinise the future needs and application of marker genes.

Although differences between the concentration of other components of toxicological or nutritional relevance in the GM plant and the parent plant were statistically significant in some instances, the measured levels were still within the published reference biological variation of maize. (NB: This quite broad definition of biological variation clearly shows that for the implementation of the Novel Food Regulation, this expression had to be defined more precisely. Otherwise, it could be possible that, for example, the discovery of a new variety of maize in the High Andes of Peru, with a extremely high or low level of a specific substance could be taken as a reference too.

The PAT gene is only used as a marker gene. The direct use of glufosinate-ammonium is not planned and has not so far been authorized under Directive 91/414/EEC for direct application.

SCF : Ciba s maize is substantially equivalent :

From a political point of view, the report of the SCF is of special interest because the SCF expressed the position, that the transgenic maize is substantially equivalent to the corresponding non-transgenic maize and that the composition of the transgenic maize is within the known biological variation . In case the maize would have been authorized under the Novel Food Regulation (NFR), this would have resulted in:

(a) a simplified notification procedure according to Art. 5 of the Regulation, and (b) no labelling, because according to Art 8(1)a, sentence 3 of the NFR, the novel food will be labelled only in case it is not identical to a conventional food. Identical, however, is defined as a food which can be differed by analytical methods from a conventional one, taking into account the natural biological variation .

It is, however, unclear why the SCF can argue that the composition is within the biological variation, when in the same report the Committee agreed on the fact that neither the CRYIA nor the PAT nor the lactamase gene is normally expressed in plants. (JK)


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