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Beware Monsanto’s Soybeans Safety Assessment Flawed
Monsanto’s safety assessment application to the Japanese health ministry for Roundup Ready soybeans was “inadequate and
incomplete,” according to assistant professor MASAHARU KAWATA , of Nagoya University, Japan.
Monsanto maintains there is no difference between GM soybeans and conventional strains. But according to the Japanese
study, Monsanto’s safety tests misrepresent data and included testing proteins not derived from the GM plant;
insufficient feeding experiments; and intentional neglect of “inappropriate” data. Since the components of the GE
soybean that people are eating are still unknown, governments who have approved the GE soybean should review their
safety assessments.
Tested soybeans not exposed to herbicide
Commercial crops of Roundup Ready soybeans are usually sprayed with the herbicide Roundup (glyphosate). However, both
the genetically modified soybean strain and the parent strain that Monsanto used for feed tests were NO T sprayed with
Roundup herbicide during cultivation. Monsanto produced a minimal amount of soybeans grown with applications of Roundup,
but only enough to test for glyphosate residues. This testing checked for residual gl yphosate, a toxin that kills
plants by inhibiting a plant enzyme , in the harvested forage, hay and seed. But testing was not done on the effects on
other metabolic pathways which must also be taken into account when such artificial genes are inserted.
Several tons of soybeans used in the safety assessments were not produced with Roundup. No explanation is given for this
in the documents. For consumers, the test results obtained by using a sample grown differently from the GE- marketed
soybean are meaningless.
GE soybean amino acid sequence unknown
The protein Monsanto analysed was from E.coli, not from RoundUp ready soybeans! Testing assumed the protein expressed in
the bio-engineered soybean has the same amino acid sequence as the soil bacterium E coliform from wh ich the genetically
engineered gene was extracted. This can only be verified when the soybeanproduced protein is isolated and the amino acid
sequence is determined. Exchanging genes between bacteria and a higher organism can sometimes result in partial change
of amino acid and/or post-translational modification after expression. It was presumed Monsanto had determined the amino
acid sequence of the GE soybean but it had not.
Monsanto sequenced only 15 amino acids from the protein that was expressed in E. coliform. The rest of the sequence was
an assumption about the sequence of the bacterial DNA. They determined only 3.3% of the expected t otal of 455 amino
acids and the protein is not from soybeans. The test described in the documents is the only method to verify antigenic
equivalence of proteins. But antigenic similarity itself does not prove that the am ino acid sequences are the same. The
real sequence of the GE protein in the soybean that we are eating is still unknown.
Animal tests used wrong protein
Acute toxicity tests on rats were also carried out using the protein produced by E. coliform. Monsanto says in the
application that extracting large amounts of the GE protein from soybean is difficult. This is an unaccept able excuse
because there is a possibility that the inserted gene works differently in soybean than in the original bacterium.
Moreover, according to the application document, 0.238mg of GE protein is detected in one gram of genetically modified
soybean, which is enough to extract without difficulty.
This kind of problem could be resolved if all the amino acid sequence in GM soybeans had been sequenced and confirmed
equal as the bacterium. The experiment appears to have been conducted on the presumption that the other GE soybean
proteins are the same as the non-GM soybean as long as they are not toxic. If so, this is too easy an assumption and a
one-sided approach. The core of this problem is whether or not the soybean gene is affecte d by insertion of a foreign
gene. The series of experiments described are fundamentally invalid.
Minimal feeding tests
Animal feeding tests are important for safety assessment. Monsanto conducted these experiments on rats, cows, chickens,
catfish and quail. However, the scale of the experiments was very inadequate. For example, in rat exp eriments, raw and
toasted soybeans both genetically modified and non-modified were fed to only 10 rats in each group and the feeding
period was only 28 days. Toxicity across generations or chronic toxicity will not be mea sured by such limited
experiments.
Even with these far from satisfactory experiments, the data for body and organ weight of liver, kidney and testicles
show obvious differences in the male rats between groups fed wild strain soybean and those fed bio-engin eered soybean.
Raw soybean-fed groups showed no difference. But male groups fed toasted GE soybean, weighed 6.7% less than the group
fed the ordinary soybean and 13% less than the group fed the commercial feed-mix at the end of the tes t period 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 were far from satisfactory both in the samples and the statistical method used. The Nagoya University
group transcribed all raw data and redid the statistical analysis. The result again showed the apparent growth obstacle
for the body and kidney weight in the male rats group fed toasted GE soybean. There was no such difference in the female
rats group, possibly due to the amount of the feed intake. Where males took 25-30g /day, female rats took only 18-20g
(approx. 70% of male)/day. It is highly possible that female rats would also show significant growth difference if the
experiment was conducted on a much larger scale, with a longer feed ing period.
Misinterpretation, false conclusions, ignored data
The Japanese researchers found clearly intentional misinterpretation in the Monsanto assessment. This was caused through
ignoring the differences shown in the documents between the ordinary soybean and the GE hybrid. Obvi ous differences
appeared after toasting at actual feed processing condition (108 degrees celsius, 30min). While the concentration of
total protein and potassium was not changed, the concentration of trypsin-inhibitor, ure ase, and lectin were
significantly higher in the toasted GM soybean, compared to that of the normal soybean. These physiologically active
substances remained active even after heat treatment in the genetically modified so ybean. However, those in the
herbicide-sensitive normal bean were easily denatured and inactivated.
Monsanto took this result to mean “the modified soybeans are not toasted sufficiently in the experiment” and returned
and asked for re-treatment of the sample to Texas A & M laboratory who processed the beans. Monsanto or dered the temperature of re-toast at 220 degrees Celsius for 25min,
which is considerably higher than normal processing of 100 degrees Celsius, 10 minutes. However re-toasting further
widened the difference in the activit y between the two strains. Another genetically modified soybean inserted with a
bacterial gene, also showed high heat-resistant properties.
Scientists would usually conclude by these results that there is substantial difference between the two. But Monsanto
dared to challenge this common practice and concluded the second toasting was still not enough. In the end, they toasted
two more times and got the result they wanted, i.e. all proteins were denatured and inactivated. With this result, they
concluded that genetically modified and non-modified soybeans have equivalent prope rties.
No protein can withstand repeated heat treatment and stay active. This is common knowledge of protein chemistry.
Monsanto based their argument on their presumption that “they can't be different” and their need that “they shouldn't be
different.” Their translation of the experiment is based on “the conclusion is safe” attitude but it is not at all
scientific.
Monsanto asks governments to lower safety standards
Adopting the Roundup tolerant soybean would increase the herbicide concentration in the soybean plants and seeds,
because the herbicide is directly sprayed on the plant before harvest. Monsanto studied in detail the resu lts of
changing factors like spraying times, concentration of the active ingredient glyphosate, duration of harvest after
spraying and growing locations.
The data shows clearly that the concentration of glyphosate and AMPA (a degraded substance of glyphosate) in forage and
hay was increased greatly by post-emergence application of the herbicide compared to that of conventi onal pre-emergence
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 saf ety standard of 15 ppm in forage
and hay in 1994 when FDA and USDA accepted the application documents.
In the final conclusion, Monsanto says: “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 pp m. Therefore, an
increase in the combined glyphosate and AMPA tolerance for residues in soybean forage will be requested.”
The US tolerance standard of combined glyphosate and AMPA in soybean forage was increased to 100 ppm after they
approved the GM soybean. The Japanese government also revised the safety standard of combined glyphosate and AMPA in
soybean seed from 6ppm to 20ppm in April 2000 at the request of the US government. By legalising the increase, Japan
could import soybeans from the US without violating the law.
Conclusion
Monsanto patch-worked the results of experiments with analyses that are full of holes, and manipulated the results. They
even requested the revision and lowering of safety standards. The Nagoya University team discovered facts showing
inadequate and incomplete safety assessment in the application document by Monsanto. The process of genetic
recombination and the results of other animal experiments remained uninspected by the team.
In May 2000, Monsanto informed countries importing US soybeans that Roundup resistant soybeans had two extra gene
fragments in the genome. They were there when the US FDA gave the initial approval to the GE soybeans in 19 92. All the
GE soybeans supplied worldwide contain these gene fragments. Monsanto asserts that these fragmented genes do not create
unknown proteins.
But for such basic facts to come to light eight years after the approval is a clear indication of how incomplete is the
state of knowledge about the genetic recombination of crops.. It also demonstrates how dangerous it is for governments
to rely on a commercial company’s information for data and safety assessments. We question the wisdom of experts at the
Japanese Ministry of Health and Welfare who concluded that the genetically engine ered Roundup Ready soybean was safe,
based on such an inadequate and incomplete application.
Postscript: In a note to the editor early August 2003, Professor Kawata said the research on the Monsanto soybean
application was sent to Japan’s Agriculture and Fisheries Ministry two years ago. However there has been no response
from the authority about the flaws discovered in the application, and Professor Kawata still awaits a response from
Monsanto-Japan.
- Masaharu Kawata, Assistant Professor, School of Science, Nagoya University, Japan This article was written in May 2001
and has been slightly adapted for publication in Pacific Ecologist.