THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE
Dear Friends and colleagues,
RE: New Analysis Casts Doubt on Safety of GE Maize NK603
We wish to bring to your attention a new report which questions the safety of Monsanto's GE maize NK603.
Approved for import for use in human food and animal feed in 2004 in Europe, it is currently being tested for cultivation in field trials in that continent.
Results of an analysis of Monsanto's test data, carried out by the French scientific research institute CRIIGEN, showed that rats that were fed the GE maize exhibited differences in their kidney, brain, heart and liver measurements, as well as significant weight differences compared to those fed with normal maize. Almost 70 statistically significant differences were observed and reported - 12 for hematology parameters, 18 for clinical chemistry parameters, nine for urine chemistry parameters, six for the organ weights (brain, heart, liver), 14 for body weights and body weight changes, and eight for food consumption. These could be warning signs of toxicity, but further tests still need to be done to confirm this.
This is the second such case involving GE maize produced by Monsanto. The first, known as MON863 which was subject of a peer-reviewed scientific study published in March 2007, also showed signs of toxicity of liver and kidney in rats fed with this maize over a period of three months. (see BIS 'Evaluation of MON863 raw data reveals toxicity to rats', dated 19 March 2007 -http://biosafety-info.net/bioart.php?bid=447).
This latest inquiry into the health impacts of GE food already approved in Europe and the lack of independent scrutiny on test data casts further doubt on the way these products are checked for safety by European authorities before being approved for sale and consumption.
Please find below the conclusions of the study (Item 1). The full analysis can be found at http://biosafety-info.net/article.php?aid=467
With best wishes,
Chee Yoke Heong
Third World Network
131 Jalan Macalister, 10400 Penang, Malaysia
Website: www.biosafety-info.net and www.twnside.org.sg
From 'Report on NK 603 GM maize produced by Monsanto company', June 2007
It can be concluded that no independent study of toxicity has been made other than the experiments directed and interpreted by the Monsanto company. In addition, the interpretations of data may be controversial. There was no open access to the organs from treated rats and slides of these organs.
The confidentiality of raw data material as claimed by Monsanto has no scientific or legal basis; all scientific data have to be published or made transparent as they are in market applications to the EU or its member states, as is done for public research if the GMO is meant to be used for food or feed in the EU. Also directive CEE/2001/18 indicates that risk assessment for health and the environment should be public for GMOs.
Whatever the results are, in such a controversial case the minimum expectation could be, as in public research, for the experiment to be repeated if no final conclusion can be drawn from the current data. CRIIGEN proposes to conduct new experiments - longer and on two generations of rats - and is asking for financial support for this project, which would be conducted applying OCDE standards.
The closest comparison to testing GMOs for safety that might be made is presented by pesticides, since this GMO has been genetically modified in order to tolerate a pesticide. European legislation on pesticides has for a long time been regulated by the directive CEE/91/414 and its successive amended versions. Where the toxicity study of pesticides in food and feed for humans and other mammals is concerned, this legislation lays down that three-month tests should be done for three species (generally rat, mouse and dog), and that pesticides are administered in food for one year to one species (generally a dog), and for two years to another (generally a rat, and approximately corresponding to its lifespan). There is no scientific reason for not carrying out experiments of this kind for the current GMOs. But these scientifically derived preconditions for testing GMOs before allowing them to go on the market might be seen as an ethical hurdle for market authorization if no adequate benefits can be expected from such products when compared to the disadvantages in making tests on animals.
The in vivo tests should be conducted as a final safeguard in testing unknown products that do not present negative in vitro effects. However, the use of specific in vitro tests should be encouraged by EU authorities before animal testings are performed; there is very large room for further improvements in GMO authorisation procedure.
In the case of NK 603 maize, it should be noted that the 90-day toxicology study appears to be the best published to date and the longest that has been performed with mammals. It shows significant effects in comparison to control laboratory animals, and in some instances even in comparison to the so- called very large "reference group". In all instances, it is recommended that:
1) The statistical analysis should be repeated by independent experts and the crude data put on a website for the scientific community.
2) The experiment should be repeated if the significant effects, as compared to the proper control group, are confirmed.
3) Other experiments with rats for one and two years, and with two other species of mammals, should be conducted in order to study potential adverse effects of the genetic modification, to know if these are linked to the Roundup residues present in the maize, the genetic modification itself or other unintended effects. GMOs should not be exempted from pesticide evaluation if they contain pesticides or specific pesticide metabolites. NK603 should obviously be tested for glyphosate residues and other adjuvant Roundup residues. Some of these have been shown to be toxic for human cells (Richard et al., 2005, Environ. Health Perspect. 113, 6, 716-720 & Benachour et al., 2007, Arch. Environ. Contam. Toxicol. 53, 126 133).
In the absence of such results, consent for maize to be released into the environment, for food, feed or cultures, may present a serious risk to human and animal health and releasing it should be forbidden.
One should also underline that there is today no legal obligation on companies concerning the exact basic number or length of studies they have to make on mammals eating GMOs. This lack of precision (e.g. the Entransfood project) makes matters difficult for state authorities and companies.
It also gives consumers reason to put in question the safety of GMO-derived products. Therefore a mandatory protocol for experimental testings as is used in pesticide testing (combined with a clearing procedure for ethical questions related for instance to animal experiments) could help to settle public and scientific controversies and provide more evidence about the quality and the safety of these products.
Monsanto maize approved for human consumption potentially toxic, warns new study
Greenpeace demands immediate withdrawal of suspect maize from the market, and review of regulatory system
14 June 2007
Brussels, Belgium - New research into the health impacts of genetically engineered (GE) food already approved in Europe casts further doubt on the way these products are checked for safety by EU authorities before being approved for sale and consumption.
The study, carried out by French scientific research institute CRIIGEN on the results of rat feeding trials using a GE maize made by biotech firm Monsanto, highlights 60 significant differences between the rats that were fed the GE maize and those fed normal maize (all for 90 days). The first group showed differences in their kidney, brain, heart and liver measurements, as well as significant weight differences. These could be warning signs of toxicity, but have not been further investigated.
"Greenpeace is deeply concerned that genetically engineered crops and foods are getting the EU green light for sale despite alarming health anomalies occurring in test animals over very short test periods. We will be faced with eating these foods for years," said Marco Contiero policy adviser on GMOs at Greenpeace European Unit.
The Monsanto maize, known as NK603 maize, has been engineered to tolerate Monsanto's own herbicide. Approved for import for use in human food and animal feed in 2004, it is currently being tested for cultivation in field trials in Europe.
The scientists at CRIIGEN analysed Monsanto's own test results, which had informed the EU food safety authority's decision to approve the maize for sale. CRIIGEN's report  suggests that a far more thorough investigation is necessary.
Neither Monsanto nor the scientific committees consulted on the feeding trials disputed the differences found in the test animals compared to the control group. However, they dismissed the results as "not of biological significance". The CRIIGEN study questions that conclusion.
"It is alarming that a company which produces a genetically-engineered crop not only gets to design and conduct the safety tests of its own product, but also to analyse the results. The lack of any independent scrutiny of test data suggests that Europe's risk assessment procedure is overlooking the threats and not assessing risks at all, just rubberstamping company dossiers," said Marco Contiero.
This is the second such case: another Monsanto maize, known as MON863, subject of a peer-reviewed scientific study published in March 2007, also showed signs of toxicity of liver and kidney in rats fed with this maize over a period of three months.
Professor Gilles-Eric Séralini of CRIIGEN, the University of Caen and the French state commission on biotechnology (Commission du Genie Biomoleculaire, CGB) said: "The statistical analysis should be repeated by independent experts and the crude data put on a website for the scientific community to be involved. Further testing should always be carried out if the analyses of the data do not result in a clear outcome."
Greenpeace is campaigning for the withdrawal from the market of NK603 maize, pending further investigation and a re-evaluation of Monsanto's trials, and for the suspension of all genetically engineered product and crop authorisations until the current EU risk assessment system is reviewed.
Further contact information for reporters to get video, photos or report details
Media Officer, Greenpeace European Unit
Telephone: +32 2 274 1903
Telephone: +32 2 274 1906