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Are substantial equivalence & safety studies for GM soy fraudulent?

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Over 10 years ago the Pacific Ecologist reported that a Japanese research team uncovered serious discrepancies in safety reports submitted by Monsanto to the Japanese Health and Welfare Ministry. The Safety Assessment Application Documents were submitted in order to obtain a safety certificate necessary for the import of genetically modified (GM) soy to Japan. Based on these reports, submitted by JAPAN- MONSANTO, their herbicide-tolerant soybean was approved as food by the Japanese Ministry of Health and Welfare and as animal feed by the Ministry of Agriculture in 1996. The research team reported their findings to Japan's Agriculture and Fisheries Ministry but received no response.

The Japanese team, led by molecular biologist Masaharu Kawata, University of Nagoya, began with 40 people taking notes by hand over a period of 10 days. This was necessary because the documents, kept at the Food Safety Association, were only available for five hours per day three days per week. Photographing and photocopying were not allowed. The application submitted by Monsanto for Roundup Ready (RR) soybeans consisted of 10 volumes, which piled up to 1 meter high, with much of it in English.

Findings:

SUBSTANTIAL EQUIVALENCE

Dr. Kawata claims that Monsanto deliberately misinterpreted and disregarded data in their quest to prove their RR soybean is “substantially equivalent” to conventionally grown soybeans.

“We found a highly intended misinterpretation ignoring obvious data difference between A5403 [conventional] and 40-3-2 [GM] hybrid in the documents.” Analysis of raw soybeans showed no differences, but the toasted soybeans showed a marked difference. After processing at 108℃ for 30 minutes, the concentration of protein and potassium were not changed but the concentration of urease and lectin were significantly higher in the GM soybeans. Urease (an enzyme) and lectin (a protein) are considered harmful, physiologically active substances. Urease enzymes aid in the conversion of urea to ammonia and carbonic acid, which can cause kidney stones and liver problems. Lectin binds to carbohydrates and can cause intestinal problems. These physiologically active substances remained active even after heat treatment in the GM soybean, though those of the conventional soybean were easily denatured and inactivated.

Monsanto decided that the GM soybeans were merely insufficiently heated. They returned the sample to Texas A & M and ordered re-toasting at 220℃ for 25 minutes. “However re-toasting further widened the difference in the activity between the two [soybean] strains. ... [A] Scientist would usually conclude in such case that there is substantial difference between the two.” But instead Monsanto toasted the GM soybean sample two more times until they got the result they wanted: all proteins were denatured and inactivated. No protein can withstand repeated heat treatment and remain active. With this result, Monsanto concluded that genetically modified and non-modified soybeans are “substantially equivalent” and they finally had the lab tests to “prove” it.

“Monsanto based their argument on their presumption 'they can't be different' and their need 'there shouldn't be difference.' ... The English data volume did not show analysis data of third and fourth heat treatment, but the Japanese summary volume, as if there were data, has a graph showing after loss of activity and described that 'data from insufficient heat treatment is not adopted' and 'No substantial difference observed.' If you review only Japanese summary volume and not look into English data volume, you would be ushered to the conclusion of 'Safe'.”

FOREIGN PROTEINS EXPRESSED IN GM SOY UNKNOWN

Exchanging genes between bacteria and plants can sometimes result in the expression of unexpected or undesired proteins. The only way to determine if this has happened is to isolate the proteins and determine the amino acid sequence. The extra proteins that are expressed in the glyphosate-tolerant soybean as a result of the addition of bacteria and virus genes is known as the CP4EPSPS amino acid sequence. Kawata states, “Before inspection we presumed that [the] amino acid sequence of [the GM] soybean CP4EPSPS was determined. However, to my surprise, it was not.” Monsanto determined only 15 amino acids from the N-terminal of the protein, which is expressed in E-coli. They then assumed the rest of the sequence was the same as the known nucleotide sequence of the bacterial DNA, but “only 3.3% of expected total of 455 amino acids was decided, and the protein is not of soybean! ELISA test described in the documents is the only method [used] to verify antigenic equivalence of proteins. But antigenic similarity itself does not prove the amino acid sequences are the same. The true face of CP4EPSPS protein in the soybean that we are taking is still unknown.”

SAMPLES USED IN TESTS ARE NOT THE SAME AS WHAT WE EAT

Having assumed the soy protein was the same as the E-coli, they used the E-coli protein in their acute toxicity test

“[The] CP4EPSPS protein used for acute toxicity test on rat also came from that produced by E-coli harboring CP4EPSPS plasmid.” Monsanto claimed that it is too difficult to extract the protein from the soybean and that using the protein from E-coli is equivalent. Monsanto does a lot of hand waving around the word equivalent. But according to Kawata, “This is unacceptable because there is a possibility that the inserted gene work differently in soybean than was in the original bacterium, and therefore the expression product may be different from that of soybean. Moreover, according to the application document, 0.238mg of CP4ESPS protein is detected in one gram of genetically modified 40-3-2 soybean, which is enough concentration to extract without problem. This again is the typical 'All for the conclusion' approach by Monsanto. This kind of problem could be resolved if all CP4ESPS amino acid sequence in soybean had been analyzed and confirmed equal as the bacterium. The experiment looks like conducted on the presumption that the other soybean proteins are the same as the non-GM soybean as long as the CP4EPSPS is not toxic. If so, this is too easy and one-sided approach. The core of this problem is whether the soybean gene gets affected from insertion of foreign gene or not. The series of experiments described is incoherent on the fundamentals.”

Similar slight-of-hand tactics were employed in toxicity tests for insect-resistant Bacillus thuringiensis (Bt) crops, where only the Bt toxin itself was used in the feed and NOT the Bt as expressed in the GM product. This is based on the following faulty logic: a) a potato (or soy) is not toxic; b) if it can be shown that the Bt toxin (or E-coli protein) is non-toxic; then c) the Bt potato (GM soy) is safe. But the genetically engineered Bt potato is neither a regular potato nor is it the Bt toxin, just like salt (sodium chloride) is neither sodium nor chlorine. In fact, Arpad Pusztai published results showing that a GM potato (containing an insecticidal lectin known to be harmless to mammals by itself) does cause harm, for which he lost his funding and thus his job.

Why not just use the Bt potato or the GM soy in the animal experiments? Are they deliberately hiding something? And what's up with the scientists over at the FDA & the EPA who reviewed these data?

Measured glyphosate levels higher than safety standard

Because the soybean is designed to withstand direct application of glyphosate (active ingredient in Roundup), the herbicide residues in the harvested bean will be higher than the conventionally grown soybean. “Monsanto studied in detail how will be the results by changing factors like spraying times, concentration of the active ingredient glyphosate, duration of harvest after spraying, and cultivation places. The data show clearly that the concentration of glyphosate and AMPA (a degraded substance of glyphosate) in forage and hay increase greatly by postemergence application of the herbicide compared to that of conventional preemergence application, although the residual concentration in the plant differed from place to place. The largest value of the combined glyphosate and AMPA was 40.187 ppm in forage which is higher than the US safety standard of 15 ppm in forage and hay in 1994 when FDA and USDA accepted the application documents. The maximum combined concentration of glyphosate and AMPA in soybean seed was 13.178 ppm, which is less than 20 ppm of the US standard at that time. ... cultivating Roundup ready soybean may sometimes violates the US safety standard. We found a surprising description in the document to dissolve the problem.”

“In final conclusion, Monsanto say that 'the maximum combined glyphosate and AMPA residue level of approximately 40 ppm in soybean forage resulting from these new uses exceeds the currently established tolerance of 15 ppm. Therefore, an increase in the combined glyphosate and AMPA tolerance for residues in soybean forage will be requested.' They know very well that adoption of herbicide tolerance crop needs higher safety standards. In effect, the US tolerance standard of combined glyphosate and AMPA in soybean forage was changed to 100 ppm after they approved the genetically engineered soybean.”

Samples used in animal tests had not been sprayed with Roundup

The very reason for Monsanto to genetically modify the soybean is for tolerance to Roundup. “But surprisingly enough, our inspection revealed that both the gene modified soybean 40-3-2 strain and conventional strain A5403 were NOT sprayed with Roundup herbicide in their cultivation.” All of the the soybean used in the safety experiments was not sprayed with Roundup. “The reason is not stated in the documents.”

Spraying glyphosate on the soy would have caused biochemical compositional changes which include changes in fatty acid composition among other things. “The data obtained with such samples may be therefore not valid to guarantee safety of soybean that human and animals take in the real life, not just because of the residue glyphosate is a toxin to kill plants by inhibiting plant enzyme EPSPS. Effects on other metabolic pathway must be taken into account particularly when such artificial genes are inserted. For consumers, the test results using different sample than marketed soybean may be meaningless.”

Nevertheless, there were differences noted in the animals in the studies. Kawata reanalyzed Monsanto's submitted data and found statistically significant differences. For the rat study there were no differences found in the groups fed raw soybean meal. But males in the group fed the toasted GM soybean had 6.7% less body weight than the group fed toasted conventional soybean and 13% less than the group fed a commercial feed mix at the end of 28 days. “Though this difference is described as statistically significant in the data sheet, the conclusion ignores these results and states that 'no statistical significance is observed.'”

“The experiments are far from satisfactory in its sample size and the statistic method used. Our group transcribed all raw data and redid statistical analysis using Turkey multiple method. The result again showed the apparent growth obstacle for the body and kidney weight in male rats group fed with toasted [GM] 40-3-2 soybean. I wondered why there is no such difference in female rats group. The answer to this question seemed to be the amount of the feed intake where male took 25-30g/day, female rats took only 18-20g (approx. 70% of male)/day. It is highly possible that female rats also showed significant growth difference if experiment is conducted in much larger scale and with longer feeding period.”

To summarize:

  1. Monsanto knew that the toasted GM soybean contained extra, unhealthy enzymes and proteins so they subjected the samples to higher heat multiple times until the problem went away and then submitted those test results to prove substantial equivalence.

  2. Monsanto did not bother to determine the entire amino acid sequence in the modified soybean but only the first 15 amino acids. They then made the assumption that the remaining amino acids would be the same as the CP4EPSPS sequence in the bacteria. We still don't know what the actual expression is in the transgenic soybean.

  3. Based on their assumption in (2), they then used the CP4EPSPS protein from E-coli in their acute toxicity tests for GM soy.

  4. Monsanto knew that the glyphosate residues in forage were higher than allowed so they simply asked the EPA to raise the allowed limit. And the EPA did.

  5. Monsanto knew that there are substantial glyphosate residues in the GM soy and that the glyphosate could cause compositional changes in the soy, yet they submitted samples for animal testing that were never sprayed with glyphosate.

  6. Their safety studies still showed statistically significant differences yet they reported that the differences were not significant.

Monsanto has deliberately manipulated the samples in (1) & (5) and falsified their report in (6). In scientific circles, (1) (5) & (6) would be known as fraud. The methods employed in (2) & (3) are, at best, extremely sloppy. Number 4 just shows how the US government accommodates the biotech industry.

Because Monsanto has invoked patent rights on their GM products, it is illegal for anyone to perform tests on GM crops without prior permission. A 2009 Scientific American article states, “agritech companies such as Monsanto, Pioneer and Syngenta ... have explicitly forbidden the use of the seeds for any independent research. Under the threat of litigation, scientists cannot test a seed to explore the different conditions under which it thrives or fails. They cannot compare seeds from one company against those from another company. And perhaps most important, they cannot examine whether the genetically modified crops lead to unintended environmental side effects. ... as a result of restricted access, no truly independent research can be legally conducted on many critical questions regarding the technology. ... when scientists are prevented from examining the raw ingredients in our nation’s food supply or from testing the plant material that covers a large portion of the country’s agricultural land, the restrictions on free inquiry become dangerous.” The industry controls virtually every aspect of genetic engineering.

Monsanto provided the soybean samples to the Chinese Nutrition and Food Safety Research Institute for a 90-day feeding test required to obtain the safety certificate necessary for importing GM soy into China. “The samples were soybean cake, brown-yellow color, circular-disk shape.” The Chinese institute “did not test for chemical residues or glyphosate residues and they did not even carry out PCR tests on the external transgenic gene of the soybean cake samples provided by the Monsanto Beijing Office. Because the level of residues of glyphosate and its metabolites on the soybean samples are not specified, their contribution to the reported findings cannot be assessed!”

“Although the test found some anomalies, they were reported as being 'within range of historical control data of this laboratory, thus such deviation has no biological significance.' This is a pretext invented by Monsanto, which lacks [both] scientific [and legal] definition.”

Have all of the toxicology tests for the safety of GM soybeans been conducted in this manner? Has Monsanto provided all of the samples? Have any of them been tested? Is this same procedure used for other GM products?

Toxicology studies using Bt toxins alone, instead of Bt corn or potato, or E-coli proteins alone instead of GM soy protein would be like eating hops to determine the effects of beer. Safety studies on RR soybeans using samples subjected to high heat and never sprayed with Roundup would be like removing the percussion cap from a bullet, testing the bullet for safety and declaring all bullets are the same and therefore safe. Just don't put them in a gun. Is it any wonder that the results of Monsanto's safety studies differ from so many other published studies? GMOs are perfectly safe. Just don't eat them.

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