Monsanto's "corrupt science" in GM assessment
Dr Brian John
In a new Report (1) written by Madeleine Love (Researcher for MADGE Australia Inc) and submitted to the elected politicians of Western Australia and South Australia, it has been revealed that "evidence" based on corrupt science has been accepted at face value by regulators across the globe prior to the issuing of consents for RR canola commercialization and feed and food use.
RR canola (oilseed rape) has consent for cultivation in Australia, United States, Japan and Canada:
It is allowed in Europe for processing and feed use, but not for cultivation. In its assessment of GT73, EFSA reported: "the GMO Panel has considered all the evidence provided and is of the opinion that GT73 oilseed rape is as safe as conventional oilseed rape and therefore the placing on the market of GT73 oilseed rape for processing and feed use is unlikely to have an adverse effect on human or animal health or, in the context of its proposed use, on the environment." (17 August 2004)
Love has now pointed out that the studies on which these consents were based were highly defective and probably fraudulent. Also, none of the studies were true health / safety studies. As is often the case with feeding studies contained within "approval dossiers", the emphasis is not on the health or physiology of the animals involved, but upon "nutritional equivalence" and '"performance" parameters such as animal weight, growth rates etc. Animal welfare and wellbeing figures hardly at all in the studies, and animal deaths, replacements and ailments are hardly ever recorded -- and yet the regulators (including EFSA) blithely accept that all is well, without asking any serious questions about the validity of the research which passes under their noses. Is that down to incompetence, negligence, or a deliberate policy of "don't look, don't see"?
To quote the author:
"there have been reports on four animal production studies using GM RR canola. Two were done by Monsanto (trout & chickens), one by collaborating bodies in Canada on lambs using GM and non-GM feed prepared and provided by Monsanto, and there is an abstract report of a similar study done in Canada on pigs. Where the Monsanto data was explicitly available we can read that the feeds were contaminated and differentially prepared at Monsanto's will. Monsanto failed to provide full information on deaths and removals from the studies. There is no information that can be learnt from the studies, except that farmers should not feed their animals on feed prepared by Monsanto! However, the material provides clear evidence on the lengths to which Monsanto has gone to prevent information about the feed value of their GM RR canola crop emerging, and their preparedness to use corrupt feed and practices, and to report on it."
The Trout feeding trials (2) (3)
"Information on the growing of the seed, and on the processing of the seed into meal for the feeding study is in a 440 page pdf document supplied by FSANZ. The manner in which the canola meal was produced for this trial was outrageous. It is not the place to detail this astonishing record here. In short, the different GM and non-GM varieties were grown side by side in plots at a number of sites in Canada. The feed used in the trials was grossly contaminated, so much so that the trials had to be repeated. The seed was reported to have been 'mixed'. Protocols had been specially changed for the processing of the seed into meal, leading to the toasting of meal at greater levels of heat "at the option of the Sponsor" (Monsanto)."
"Additionally, these GM plots were not sprayed with Roundup, which means that the seed used in the trout trials didn't contain Roundup residues. This may have given a further positive bias, and does not represent the nature of the material that would be fed to animals in Australia the point of the crop to farmers is that it can be sprayed with Roundup to eliminate weed competition."
"On another matter, 20% of the feed used in the trials was derived from soy. Was this GM soy, capable of masking the results? It was reported neither as GM nor non-GM. This is a common problem faced in reviewing animal trials."
"The published study went through the motions, carefully describing all the differences noted between the different feeding groups, and then in the discussion said 'However, because of a mixing error that occurred prior to the first study, samples of seed labeled GT200 and GT73 were essentially equivalent in composition'. That is, the results are meaningless."
"FSANZ relied 100% on this material for human health and safety assessment. There was no independent alternative we don't understand why a body charged with food safety didn't immediately reject the material. The OGTR relied on the material for safety for agricultural workers and for approval for use as an animal feed, despite the clear and documented lack of integrity of the company involved. Both FSANZ and the OGTR referred to this study as evidence. We haven't seen any evidence to say they read into the material any further than the abstract. Each body had the right to commission its own research, but chose not to."
The Chicken Study (4)
"Monsanto conducted this study. Monsanto prepared the canola meal for the GM variety and its (reportedly) non-GM counterpart. Based on their conduct in the trout trials Monsanto could've done anything in the growing of the seed or the preparation of the meal ...
For comparison, Monsanto also brought in six additional commercially produced canola meals. The Monsanto data we obtained through the OGTR reported that all of these lines were GM contaminated for the Monsanto GM genes being trialled!! Monsanto wrote that it was to be expected because GM canola had been grown in Canada for a few years and naturally there’d be contamination. For all we know these commercial feeds may have been full strength Bayer GM Liberty Link canola, stacked by contamination with Monsanto genes Monsanto didn’t report testing for this. So we’re not really comparing GM vs non-GM feed, but Monsanto prepared feed versus commercially prepared feed. The trial is useless."
"The profound initial difference between the non-GM counterpart and the commercially produced meals can be read in the online published study. It appears that the non-GM and GM seed or meals had been considerably overcooked, as for the trout study. Moisture levels were very low, probably explaining higher apparent protein and fat levels in the GM and non-GM counterpart varieties prepared by Monsanto.
The different preparation may be able to account for the dramatic difference in deaths between the chickens fed the commercial meal and the chickens fed the Monsanto prepared meals. The study acknowledged:
"The differences in mortality between commercial reference diets and test and nontransgenic control diets may be attributable to differences in processing at the 2 facilities." Monsanto reported in their data that the deaths were "slightly higher than expected". In fact, female chickens reared on Monsanto prepared feed died at 3x the rate of females fed on commercial feed, and male chickens died at twice the rate. As a result of the very high number of deaths, the breast weight per pen and the breast weight/feed intake was significantly lower for the Monsanto processed feeds, but these results were not presented in the study they had to be deduced from the other data, accounting also for gender differences and concomitant body size in the death rates."
"The results presented by Monsanto were expressed in terms of the chickens that actually survived and appeared healthy at slaughter time they did not account for the lost production as a result of the very high number of deaths. This is not a fair presentation for farmers concerned at economic levels. There were deaths, and there were animals killed due to their unhealthy condition. Animals were also described as having been ‘removed’.
"We also don’t know how this trial may have been rigged to produce the results it did. In the data provided to the OGTR, Monsanto failed to report the details of 83 of the chickens removed from the study!!! They could take out skinny chickens, or fat chickens, and alter results".
"As a study on the effect of genetically engineered feed it can’t be viewed with any credibility. The difference between the Monsanto produced non-GM feed and the commercially produced non-GM feeds indicates strongly that something was wrong, and that whatever produced this effect may have overridden any GM effects that may have otherwise been observed. Furthermore, the animals were fed very large amounts of both corn and soy without mention of whether these were GM varieties, containing the same GM genes as the GM RR canola."
The Lamb / Sheep Study (5)
"There was no information to indicate whether the commercial canola meals were full strength Bayer GM canola meals, for example. Contamination is to be expected.
Again, the lambs fed on the Monsanto-prepared meal had significantly disadvantageous results. The clearest result is that the carcass yield grades were significantly reduced for these groups.
This study did not look at any variables that could be related to human health..... This was a food production study. It was not a human health safety study."
The pig study (6)
"A full-text version of this study does not appear to have been written up as a study for peer review, but the authors of the study came from one of the Agriculture and Agri-Food Canada research centres and the University of Alberta, Edmonton Canada.
MADGE has asked the authors for full study detail but has received nothing. We are only able to report from an abstract. The same feed groups applied as for the lamb study, and we expect that the feed provided by Monsanto was identical to that provided for the lambs, and that the commercial feeds were GM contaminated. No data was given for moisture content or protein and fat levels.
As for the chicken and lamb studies there were significant differences between the pigs fed on the commercially prepared canola meals, and those fed on the Monsanto-prepared meals.
"Average daily gains, daily feed intakes, and feed conversion efficiencies were similar when feeding the PAR and RRC diets, but some differences from the COM diets were notes (P>= 0.05)." The abstract didn't report the direction of difference. As for the lamb study there were differences in the carcass and meat quality evaluations, but didn't say what they were.
This was another food production study.
Five other studies using GM RR Canola (7)
"The studies were conducted in series, with the general intent being to identify the true fate of GM DNA in animals, and to determine whether it would be taken up by body tissues or by bacteria (and other microflora) in the digestive tract.
The series did not make any findings that the GM DNA had been taken up by digestive microflora, but the final study found that GM DNA was present in digestive tissues in sheep and pigs, and in the liver and kidney of pigs."
There was a heavy Monsanto involvement in these studies, and the implications of the findings have been widely discussed, for example by Werner Mueller:
and Jack Heinemann:
Report on animals exposed to GM ingredients in animal feed
Heinemann concluded: "The cumulative strength of the positive detections reviewed above leave me no reasonable uncertainty that GM plant material can transfer to animals exposed to GM feed in their diets or environment, and that there can be a residual difference in animals or animal-products as a result of exposure to GM feed."
(1) Summary and Guide to animal feeding studies reporting to use products of Monsanto’s GM RR canola (line GT73). Prepared by Madeleine Love of MADGE Australia Inc for Katie Ford, GM Advisor to the Hon Tony Burke, Federal Minister for Agriculture, Forestry and Fisheries: 22 December 2009
(2) MSL No.:17538; Stanisiewski et al 2001; Monsanto Company, Product Safety Centre, Biotechnology Regulatory Sciences.
(3) Brown PB, Wilson KA, Jonker Y, Nickson TE. (2003) Glyphosate tolerant canola meal is equivalent to the parental line in diets fed to rainbow trout. J Agric Food Chem. 51:4268-72
MSL-13063; Evaluation of Glyphosate Tolerant Canola as a Feed for Rainbow Trout; Brown PB, Wilson KA, Nickson TE Evaluation of Glyphosate-tolerant Canola Lines from the 1992 Canadian Field Trials; Nickson TE et al, Monsanto; Attachment #3: Protocol #92-02-30-01 for Experiment #92-447-702 “Processing Roundup-Tolerant Canola (RTC) and Control Westar Seed from the 1992 Canadian Field Tests.”
(4) Taylor ML, Stanisiewski EP, Riordan SG, Nemeth MA, George B, Hartnell GF (2004) Comparison of broiler performance when fed diets containing roundup ready (Event RT73), nontransgenic control, or commerical canola meal (vol 83, pg 456, 2004). Poultry Science 83:1758
MSL No.:17538; Stanisiewski et al 2001; Monsanto Company, Product Safety Centre, Biotechnology Regulatory Sciences. Sponsor Summary of Report for Study #00-01-43-10; Comparison of Broiler Performance When Fed Diets Containing Roundup Ready (Event RT73), Parental or Commercial Canola Meal
(5) K. Stanford1, J. L. Aalhus2, M. E. R. Dugan2, G. L.Wallins1, R. Sharma3, and T. A. McAllister3; Effects of feeding transgenic canola on apparent digestibility, growth performance and carcass characteristics of lambs; Can. J. Anim. Sci. 2003 83: 299-305; http://pubs.nrc-cnrc.gc.ca/aic-journals/2003ab/cjas03/jun03/cjas02-056.html
(6) J. L. Aalhus*1, M. E. R. Dugan1, K. A. Lien2, I. L. Larsen1, F. Costello1, D. C. Rolland1, D. R. Best1, and R. D. Thacker1 Effects of feeding glyphosate-tolerant canola meal on swine growth, carcass composition and meat quality. ; J. Anim. Sci. 2003. 81:3267; http://jas.fass.org/cgi/content/full/81/12/3267
(7) Alexander TW, Sharma R, Okine EK, Dixon WT, Forster RJ, Stanford K, McAllister TA. Impact of feed processing and mixed ruminal culture on the fate of recombinant EPSP synthase and endogenous canola plant DNA. FEMS Microbiol Lett. 2002 Sep 10;214(2):263-9; http://www.ncbi.nlm.nih.gov/pubmed/12351241?ordinalpos=8&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum
Sharma R, Alexander TW, John SJ, Forster RJ, McAllister TA. Relative stability of transgene DNA fragments from GM rapeseed in mixed ruminal cultures. Br J Nutr. 2004 May;91(5):673-81. http://www.ncbi.nlm.nih.gov/pubmed/15137918?ordinalpos=7&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum
Alexander TW, Sharma R, Deng MY, Whetsell AJ, Jennings JC, Wang YX, Okine E, Damgaard D, McAllister TA (2004) Use of quantitative real-time and conventional PCR to assess the stability of the cp4 epsps transgene from Roundup Ready (R) canola in the intestinal, ruminal, and fecal contents of sheep. Journal of Biotechnology 112:255-266
Alexander TW, Reuter T, Okine E, Sharma R, McAllister TA. Conventional and real-time polymerase chain reaction assessment of the fate of transgenic DNA in sheep fed Roundup Ready rapeseed meal. Br J Nutr. 2006 Dec;96(6):997-1005. http://www.ncbi.nlm.nih.gov/pubmed/17181873?ordinalpos=4&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum
Sharma R, Damgaard D, Alexander TW, Dugan ME, Aalhus JL, Stanford K, McAllister TA. Detection of transgenic and endogenous plant DNA in digesta and tissues of sheep and pigs fed Roundup Ready canola meal. J Agric Food Chem. 2006 Mar 8;54(5):1699-709 http://pubs.acs.org/doi/abs/10.1021/jf052459o