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Scientists Expose Monsanto's Fraudulent Safety-Testing Data for GE Soybeans

The following documents how the systematic corruption of
governmental responsibility by GM developers and proponents
underlies the release of GM crops to environment:

http://www.cropchoice.com/leadstry.asp?recid=2215
Monsanto GM soybean safety assessment flawed, Japan researcher says

(Sunday, Nov. 16, 2003 -- CropChoice news) -- Pacific Ecologist:
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 NOT 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 glyphosate, 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 which the genetically engineered gene was
extracted. This can only be verified when the soybean-produced
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 total 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 amino 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 unacceptable 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 affected 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 experiments, 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 measured 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. Obvious 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, urease, 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
soybean. 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 ordered the temperature of re-toast at 220
degrees Celsius for 25 min., which is considerably higher than
normal processing of 100 degrees Celsius, 10 minutes. However
re-toasting further widened the difference in the activity 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 properties.

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 ppm. 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 1992. 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 engineered 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.

Source: http://www.scoop.co.nz/mason/stories/HL0311/S00113.htm#a


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