GM Free Cymru

GMO SAFETY STUDIES ARE FUNDAMENTALLY FLAWED; EU CONSENTS MUST BE REVOKED IMMEDIATELY

Dr Bernard Url
Executive Director
European Food Safety Authority
Via Carlo Magno 1A
43126 Parma, ITALY

Bernhard.Url@efsa.europa.eu
Sue Davies <sue.davies@which.co.uk>
Vytenis.Andriukaitis@ec.europa.eu
Carlos.Moedas@ec.europa.eu

17 June 2015

Dear Dr Url,

GMO SAFETY STUDIES ARE FUNDAMENTALLY FLAWED; EU CONSENTS MUST BE REVOKED IMMEDIATELY

I am writing to you to formally draw your attention to two significant developments from recent days.

1. It has been revealed from correspondence with animal feed manufacturer Purina that the chow routinely used in laboratory animal feeding safety / toxicology experiments with a view to GMO approvals is NOT tested for GMO or glyphosate contamination prior to packaging and delivery (1). The company has never claimed that the product which has been used in hundreds of feeding experiments is free of contamination, and yet it is always assumed to be "clean" by laboratory researchers, journal editors and peer reviewers, and (as far as we can see) by the EFSA GMO Panel as well. We are not aware of a single industry-sponsored toxicology / safety study in which the proprietary control group diet has been analysed and certified as GMO-free and glyphosate-free. The following laboratory results have been obtained by Dr Samsel:

High Performance Liquid Chromatography (HPLC) Analysis of Glyphosate:

PURINA RAT CHOW 5002 (.65ppm Glyphosate contamination)
Analyte Result Units Note
Glyphosate 0.65 mg/Kg MDL: 0.05 mg/Kg (ppm)
AMPA 0.35

PURINA CHOW 5K75 (.57ppm Glyphosate contamination)
Analyte Result Units Note
Glyphosate 0.57 mg/Kg MDL: 0.05 mg/Kg (ppm)
AMPA 0.27

PURINA CHOW 5LG3 (.37ppm Glyphosate contamination)
Analyte Result Units Note
Glyphosate 0.37 mg/Kg MDL: 0.05 mg/Kg (ppm)
AMPA 0.10

As you will be aware, the presence of contaminants -- even in quite small amounts -- in control group diets renders toxicology experiments completely worthless, since in the presence of experimental "noise" the real effects of consuming GMOs or glyphosate by the animals in the test group will be difficult if not impossible to pick up. False conclusions will be drawn, and the possibility has to be considered that scientific fraud has taken place where virtually no difference is detected in the health of both control and test groups. As you will also be aware, Monsanto has been accused of scientific fraud many times before, and the use of contaminated control group feed is one of the easiest ways of manipulating results so as to demonstrate a "no harm" conclusion.

2. Coincidentally, today (17 June) Prof Seralini and his group have announced the results of their latest research (2) demonstrating that there is serious and worldwide contamination of the laboratory rodent feed frequently used in experiments leading to the authorization of chemicals, GMOs, pesticides and drugs. In their experiments the research team analyzed the dried feed of laboratory animals using standard methods and with the help of accredited laboratories. These animal feeds, sourced from five continents, are generally considered balanced and hygienic. The study investigated 13 samples of commonly used laboratory rat feeds for traces of 262 pesticides, 4 heavy metals, 17 dioxins and furans, 18 PCBs and 22 GMOs. The results were overwhelming. All the feeds contained significant concentrations of several of these products, at levels likely to cause serious diseases and disrupt the hormonal and nervous system of the animals. This hides the effects of the products tested. For example, residues of glyphosate / Roundup were detected in 9 of the 13 diets. Eleven of the 13 diets contained GMOs that are grown with large amounts of Roundup. The conclusion is inescapable: the bulk of studies purporting to show that GMOs are safe, and which have used proprietary chows without testing for contamination, are worthless if not fraudulent, and cannot now be trusted in the context of EC safety assessments and the approvals process. Also, as pointed out by the research team, "It therefore appears that the long-term consumption of contaminated feed interferes with good experimental practice and that the cause of diseases and disorders found in laboratory rats has been too quickly attributed to the genetic characteristics of the species used." They are referring to the Sprague-Dawley rats commonly used in industry and independent studies.

You will be aware that there has been widespread criticism from NGOs of the use of dubious materials in GMO animal feeding experiments, and also criticism of the widespread assumption (without proof) that control diets are clean and pure (3). In a recent Report from Testbiotech contamination of the control group feed used in the GRACE study of MON810 maize was demonstrated, in the context of heavy criticism of many study shortcomings (4). Last year Mesnage et al (5) pointed out that the chow used in a GMO canola feeding experiment by Delaney et al was almost certainly contaminated, making the whole study corrupt and invalidating the authors' conclusions relating to the safety of the variety studied. Many other criticisms have been directed at the use of inappropriate or irrelevant isolines in control group feeding (6) but somehow the purity of the chow which makes up the bulk of the feed consumed by both control and test groups has more often been assumed than demonstrated.

All "food safety" toxicology and nutritional animal tests carried out in the past which have used Purina and other proprietary feed for control group samples, and which have been assumed to be GMO- and glyphosate-free, should now be considered as flawed if not fraudulent. Similarly, approvals issued on the basis of such tests should immediately be revoked, and renewed only after long-term feeding and multiple-generation toxicology tests, conforming to Good Laboratory Practice, have been carried out with GMO feed samples and control feed samples which have been carefully and independently tested with high accuracy techniques.

This is a matter of great public concern, and it demands the immediate application of the Precautionary Principle. We look forward to an urgent EFSA consultation followed by an EC announcement that there will be an indefinite freeze on all new GMO approvals. We also look forward to receiving your assurances as to the other related actions you propose to take in order to safeguard the health of EU citizens.


Yours sincerely,

Dr Brian John
GM-Free Cymru

NOTES

1. BREAKING: Lab Chow Contaminated by Glyphosate, by Barbara H. Peterson and Jon Abrahamson, Farm Wars, 15 June 2015
http://farmwars.info/?p=14095

2. http://www.gmoseralini.org/contaminated-lab-feed-invalidates-commercialization-of-chemicals-and-gmos-new-study/

3. Catacora-Vargas G. (2014). Sustainability Assessment of Genetically Modified Herbicide Tolerant Crops. The Case of IntactaTM Roundup ReadyTM 2 Pro Soybean Farming in Brazil in light of the Norwegian Gene Technology Act. Biosafety Report 2014/02. Tromsø, GenØk–Centre for Biosafety. - See more at: http://genok.com/arkiv/4185/#sthash.7LGorw8m.dpuf
Bøhn,T.et al., 2014. Compositional differences in soybeans on the market: glyphosate accumulates in Roundup Ready GM soybeans. Food Chemistry, 153, pp.207-215.
http://genok.com/arkiv/4185/

4. Testbiotech report dated 7-11-2014: www.testbiotech.org/node/1107
Comments regarding the GRACE publication "Ninety-day oral toxicity studies on two genetically modified maize MON810 varieties in Wistar Han RCC rats (EU 7th Framework Programme project GRACE)“
Andreas Bauer-Panskus
Christoph Then
Date of publication: 11.2014

5. Mesnage R, Defarge N, Spiroux de Vendômois J, Séralini GE. 2014.
Letter to the Editor regarding Delaney et al., 2014: uncontrolled GMOs and their associated pesticides make the conclusions unreliable.
Food Chem Toxicol. 2014 Oct;72:322.
doi: 10.1016/j.fct.2014.07.003. Epub 2014 Jul 2.
http://www.ncbi.nlm.nih.gov/pubmed/24997312

6. http://earthopensource.org/gmomythsandtruths/sample-page/2-science-regulation/2-1-myth-gm-foods-strictly-tested-regulated-safety/
GMO Myths and Truths: an evidence-based examination of GMO claims
Dr John Fagan, Dr Michael Antoniou and Claire Robinson, Earth Open Source, 19 May 2014
2.1 Myth: GM foods are strictly tested and regulated for safety