Response to Monsanto’s rebuttal of Seralini study (1)

Monday, 24 September 2012 09:52
http://www.gmwatch.org/index.php?option=com_content&view=article&id=14226:response-to-monsantos-rebuttal-of-seralini-study-1

NOTE: Monsanto has rushed out a rebuttal (summary below, item 2) of Prof Seralini’s lifetime rat feeding study on its commercialised GM maize NK603. The study found that the GM maize caused massive tumours, premature death, and organ damage in the rats. Similar effects were seen from feeding some groups of rats tiny amounts of Roundup, the herbicide that the maize is grown with, well below the permitted levels for food, feed, and drinking water.

Below (item 1), we address one of Monsanto’s arguments, the first bullet point in the summary in item 2, “Research protocol does not meet OECD standards”.
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1. GMWatch response to Monsanto’s rebuttal of Seralini’s study on GM NK603 maize and Roundup (part 1)

MONSANTO: This study does not meet minimum acceptable standards for this type of scientific research. Research protocol does not meet OECD standards… Despite author’s reference to OECD Testing Guidelines, the study design does not meet OECD standard for number of animals in a chronic study design (50 per group), GLP status of laboratory and analytical facilities is not clear. Doses selected for GMO and Roundup are not based on standard approaches for dose setting.

GMW: We’re happy to be able to alert GMW readers to what has become the commonest dodge employed by industry and regulators to fend off the inconvenient findings of independent science on risky products. In this dodge, industry and regulators claim that the study wasn’t done according to the protocols set by the Organisation for Economic Cooperation and Development (OECD) and that it wasn’t, or may not have been, conducted according to Good Laboratory Practice (GLP) rules. They conclude that they can ignore the findings of the study and the risky product can stay on the market.

What are OECD protocols and GLP rules?

OECD protocols were designed by industry and government representatives with the aim of creating an internationally harmonised system of tests that industry would do on its products in support of regulatory approval. The OECD protocols mean that industry only has to do one set of tests to gain approval in any OECD member country.

While the OECD protocols make things easier and cheaper for industry, they have been criticised by independent scientists for being outdated, inflexible, and insensitive — in other words, they are likely to miss important toxic effects. They were never claimed to represent the best science; they were a compromise that industry could afford and regulators could accept. Independent scientists have no interest in following OECD protocols because they are not necessarily the best tool to detect effects.

GLP is a set of laboratory management rules brought in by regulators in the 1970s and 1980s to combat widespread and serious industry fraud in the testing of chemicals for regulatory purposes (two high-profile cases of which involved Monsanto and glyphosate). GLP dictates how scientists commissioned to do testing for industry must carry out, record, and archive their experiments. While history shows that GLP doesn’t prevent fraud, it leaves a paper trail so that if fraud does later come to light, investigators are more likely to be able to identify the perpetrator.

Again, independent scientists usually do not follow GLP rules because it’s expensive in terms of labour hours and because they view them as irrelevant. Independent science has always had its own quality control system in the form of the peer-reviewed publication system, which subjects a study to the critical review of peers, the journal editor, and, after publication, fellow scientists who can repeat the experiment and test its findings.

OECD protocols and GLP rules are not, and were never meant to be, a hallmark of good science. Yet industry and regulators misuse these two standards to dismiss studies done by independent researchers, which generally do not conform to OECD protocols or follow GLP rules. Thus OECD protocols and GLP rules have become a shield for industry to protect it from the findings of independent scientists.

Thus we’ve ended up in a situation where there are, for example, hundreds of independent studies showing harm from low doses of the food packaging chemical bisphenol A, and some limited industry studies that claim to show safety. Yet industry and regulators cling to the industry studies on the purported grounds that they are more “relevant to human risk assessment” (OECD-conformant) and “reliable” (GLP).

In fact, there are no good scientific reasons why industry studies should be considered more relevant or reliable than independent studies, and many reasons why they are less so. But if regulators were to abandon arbitrary definitions of relevance and reliability, they would have little alternative but to ban many chemicals, pesticides, and GMOs.

For more, see: Antoniou, M., M. Habib, et al. (2011). Roundup and birth defects: Is the public being kept in the dark?, Earth Open Source. http://bit.ly/IP2FWH (section 4)

How do OECD protocols apply to Seralini’s study?

Seralini based his study on the chronic toxicity part of OECD protocol no. 453. It states that for a carcinogenesis trial you need a minimum of 50 animals of each sex per test group but for a toxicity trial a minimum of 10 per sex suffices.

Monsanto’s earlier 90-day feeding study on NK603, submitted to the EU in support of its approval, had been re-analysed by Seralini’s team. They found it reveealed signs of liver and kidney toxicity:
de Vendomois, J. S., F. Roullier, et al. (2009). “A comparison of the effects of three GM corn varieties on mammalian health.” Int J Biol Sci 5(7): 706-726.

So for this new experiment, Seralini’s team chose a chronic toxicity protocol to see if the signs of liver and kidney toxicity escalated into something serious, which they clearly did.

We MUST remember that the study embarked on by Seralini’s team was NOT a carcinogenicity study but a chronic toxicity study. That is, they did not embark on a study to see if the GM maize or Roundup caused cancer. The rise in tumour incidence was unexpected and a surprise and thus not planned for.

So it is disingenuous to call this work a carcinogenicity study. The experimental design that Seralini used, compared with Monsanto’s 90-day study, was more extensive (longer; greater number of tests groups; greater range of parameters measured; diets better characterised including certainty that the control diet was non-GM, which Monsanto failed to provide data on in their 90-day feeding trial data; proper control diets as stipulated by EU GMO legislation instead of irrelevant control diets as used by Monsanto).

It is also worth remembering that Monsanto used 20 rats of each sex per group in its feeding trials but bizarrely, they only analysed 10, the same number as Seralini. So Monsanto does not have a leg to stand on on this point! We wonder why Monsanto only analysed 10 rats out of 20. Were these randomly chosen or were they selected because they were apparently healthy? Monsanto’s data, like most such industry feeding trial data on GMOs, is not published so we cannot check this.

Monsanto is responsible for the fact that Seralini’s group did not design their study as a carcinogenicity study. Monsanto either did not know that the GM maize could have carcinogenic effects because it had failed to test it, or it did know and hid the fact. So it would not occur to any independent scientist to test for this.

Given Seralini’s results, it is now up to Monsanto to pay for a full carcinogenicity study on the NK603 maize, which, however, must be carried out by independent scientists with no conflicts of interest.

As EFSA has repeatedly said, it is industry’s responsibility to prove that its products are safe. Clearly it has not done that. So NK603 must be withdrawn from the market until it has been proven safe.
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2. Monsanto Comments: Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize
Undated; released September 2012
Full document available at:
http://www.monsanto.com/products/Documents/ProductSafety/seralini-sept-2012-monsanto-comments.pdf
Summary reproduced below

Summary:
This study does not meet minimum acceptable standards for this type of scientific research, the findings are not supported by the data presented, and the conclusions are not relevant for the purpose of safety assessment.

Toxicologists and public health experts find fundamental problems with the study design. Critical information about how the research was conducted is absent, and the data presented do not support the author’s interpretations. Among the key shortcomings are:

*Research protocol does not meet OECD standards
*Source and quality of corn used is unclear.
*Critical details on diet preparation and dietary intake are absent.
*Complete lack of data pertaining to assertions of liver or kidney histopathology, liver function tests, and cytochrome activity.
*Lack of any statistical analysis for mortality or tumor incidence endpoints.
*Mortality rates and tumor incidence in all groups fall within historical norms for this strain of laboratory rats, which is known for a high incidence of tumors.
*Data presented are highly sporadic, using different methods for male and female animals, and are not sufficient to support conclusions drawn.
*There is a lack of dose-response relationship throughout the study.

There is no plausible mechanism for the results reported with genetically modified maize, and the results are inconsistent with an extensive body of experience and scientific study.

Extensive animal and in-vitro (test-tube) data has demonstrated that glyphosate does not cause cancer or tumors, nor is an endocrine disrupter. This study does not provide information which calls into question the extensive safety evaluations of glyphosate or Roundup herbicides.