Critics: Industry gets away with miserable GMO trials
Ingeniøren (the Engineer) – Denmark, 5 Nov 2012
English translation for GMWatch by volunteer translator
There are stricter requirements for research demonstrating that GM plants are harmful than for the tests on which approvals are based. This is the opinion of several international pressure groups, and they are supported by a member of the Danish Ethical Council.
Tougher and completely different standards are demanded of scientists to prove that GM crops constitute a considerable risk to human health than are requested of the industry to show that GMOs are safe to eat.
That is the critical message from a range of international pressure groups. Recently, the German organisation Testbiotech published a report that is strongly critical of the European Food Safety Authority (EFSA).
EFSA delivers the final assessments on which the approval of GM crops for human consumption is based.
According to the German organisation, which aims to put a critical focus on GM crops, EFSA is "in deep water" in its criticisms of a French study on rats.
According to the scientist who performed the study, Professor Gilles-Eric Séralini from the University of Caen, the rats that ate GM corn developed tumours more quickly, and the tumours were larger. The same picture appeared if the animals drank water polluted with concentrations of Roundup approved for drinking water.
EFSA strongly challenged the conclusions, and at the same time listed a number of criticisms of the French professor. EFSA pointed out that the number of rats in the test were too few – ten of each sex – in each test group, which according to EFSA was insufficient to determine if the fluctuations were significant or random. Furthermore, the strain of the rat used in the tests, Sprague-Dawley, is known for its tendency to develop tumours, if it has unlimited access to food.
On top of that, EFSA said there were several other problems with the scientific paper, including lack of information on the exact composition of the feed.
The problem with the arguments of EFSA, according to the strong criticism published by green NGOs, is that the tests on the basis of which EFSA has approved the introduction of certain GMO products into Europe are based on poorly designed research.
Testbiotech concluded in its report: "Several times EFSA has unquestioningly accepted the results of trials which are not conducted in accord with the scientific standards that EFSA now invokes to criticise the French tests. But unlike Séralini’s study, the previous studies concluded that there were no health effects from eating GM plants." This inconsistency indicates that EFSA cherry-picks the most convenient scientific standards to suit its argument.
The criticism of "double standards" in scientific experimentation is not only expressed by green NGOs.
According to a Danish senior scientist, Rikke Bagger Jørgensen, EFSA must correct its attitude. Rikke Bagger Jørgensen is employed at DTU Risø [Danish Technical University at Risø near the City of Roskilde] and is a member of the Danish Ethical Council. She performs risk assessments on GM crops, including on gene flow, and sees several ethical problems with research in relation to GM technology.
Rikke Bagger Jørgensen said: "Only one standard must be applied in the assessment of this type of scientific research. It does not make sense that EFSA is criticising one party, but not the other, for the same mistakes."
The Danish scientist points to an article in the scientific journal Food and Chemical Toxicology, which also published the article about the French rat study. The article was an assessment of 24 long-term GMO feeding studies. Of these several were included in different agencies' evaluations of industry requests for authorisations of GM crops.
The overall conclusion is that none of them show any risk from eating GMO products. However, the authors – most of them are from France – sharply criticise the scientific methods used in a wide range of articles. As an example, only 6 out of the 24 studies used the recommended number of test animals. The majority violated the OECD guidelines just as much as EFSA accuses the latest French rat tests of doing.
The same applies to another criticism: the non-GM control feed. Only 7 out of the 24 studies that considered GMOs safe to consume mentioned that the isogenic control lines were used. It means that the crops are the same apart from the genetic modification – another important criticism of Professor Séralini’s tests. [GMW: In fact Seralini did use the non-GM isogenic control line, so it's difficult to know what this means.]
"The use of isogenic strains is absolutely basic. Otherwise it’s like comparing apples with pears," according to Rikke Bagger Jørgensen.
The results of Monsanto's research must be made public
Rikke Bagger Jørgensen has obtained right of access to documents relating to the previous test (from a Freedom of Information request), which gave Monsanto approval of the GM corn (maize) NK603, the same GMO that Séralini tested. She is surprised that Monsanto's results are not immediately made public.
Rikke Bagger Jørgensen emphasizes: "We must know how much of the corn has been consumed by the rats. We can't see that in the French trial, and it is not revealed by Monsanto."
She finds it remarkable that both EFSA and in Denmark the DTU and The Food Institute immediately rejected the French results. She said: "A lot of people consider EFSA an oracle, but that is not always so. You may find strong opinions in these cases and all parties have an interest one way or another. That's why we need impartial research, assessed by the same standards. We don't want to listen to results if the research is not conducted properly."
However, she is certainly aware that the funding of proper tests may be a problem. It may, for example, require at least ten times as many rats than the 200 used in Séralini’s trial, if OECD's guidelines are to be met. According to international media the budget for the research was about 24 million Danish Krone.
The Danish scientist is not convinced that it is necessary to include that many rats in the test, and this point was also disputed by some statistics experts after Séralini published his paper. Her comments are: "I have been involved in developing guidelines, and I don’t think that they are always particularly well thought out. However, if a proper test requires 50 rats, in that case Séralini’s test is of course trashed. It is necessary that scientific standards are properly considered and established. Otherwise researchers may get away with something as basic as not using the correct control."
ANSES, the French equivalent to the Danish Environmental Protection Agency and Food Standards Agency, has previously criticized the EU for its over-lax approvals process for GMOs.