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[SANET-MG] petition for non-regulated status maize MON8801 (MON 863 by another name)
August 17, 2005
Prof. Joe Cummins
Petition for non-regulated status of maize MON 88017 Bt Cry 3Bb1 (MON
863 by another name)
Monsanto Corporation has submitted a petition to USDA/APHIS
non-regulated status of maize line MON 88017. That maize line is a
slightly altered version of MON863 maize (which has been granted
non-regulated status) along with a gene for glyphosate herbicide
tolerance. The docket containing the APHIS environmental assessment and
receiving public comment is designated APHIS-2005-0068 . The public
comment period ends September 11,2005(1). As will be shown below the
parent line MON863 has been found to threaten human and animal health
and the derived line 88017 does not appear to have been substantially
altered in that regard. I urge others to comment , using the docket
listed in reference 1, on the non-regulated designation of MON88017 maize.
MON 88017 was based on the non-regulated maize strain MON863 (YieldGard
rootworm) which was deregulated in 2002. MON88017 contains the Bacillus
thuringiensis (Bt) toxin Cry3Bb1 toxin gene along with the EPSPS gene
that confers tolerance to the herbicide glyphosate. The actual
construction included a sytnthetic approximation of the cp4 EOSPs gene
to which the chloroplast transit peptide CTP2 was fused. The gene was
driven by the rice actin promoter enhanced by a rice actin intron placed
upstream of the translation start codon, transcription was terminated
using the Agrobacterium NOS 3’ terminator. The synthetic approximation
of the Cry 3Bb1 gene was driven by a CaMV promoter with a duplicated
enhancer , the wt CAB leader sequence from a wheat chlorophyll a/b
binding protein, followed by a rice intron enhancer located just
upstream of the translation start codon, transcription was terminated
the terminator tahsp173 from wheat heat shock protein.(1). It was noted
that the Cry 3Bb1 of MON88017 differed from the Cry 3Bb1 gene in MON 863
by a single amino acid(1,2). Earlier the United States Food and Drug
Agency (FDA) noted that the Cry Bb1 toxin produced in MON 863 differed
from the original natural gene product produced in the bacterium seven
amino acids and by an additional amino acid in the second position from
the start of the toxin protein (3). Regulators and proponents seem to
assume that all amino acids in a protein are equivalent and that it is
acceptable to switch a few amino acids with out any notice, even though
that few is not consistent with genetic reality where it is clear that
single amino acid changes often lead to major mutations. Furthermore,
the Cry 3Bb1 toxin produced in bacteria in environmental and mammalian
safety testing as a surrogates for the toxin produced in maize because
pure bacterial toxin is cheaper to produce in pure form in bacterial
cultures (4). That kind of evaluation is too risky to provide valid data
for food and feed that effects millions of people.
The evaluation of the food and feed safety of MON 88017 was based
primarily on the previous evaluation of MON863. “results from acute oral
toxicity demonstrate that the Cry3Bb1 protein is not acutely toxic and
does not cause any adverse effects” (1). The study upon which the above
conclusion was based was deemed confidential but subsequrntly released
after a great deal of public pressure. The study was a thirteen week
feeding study with MON863 maize grain fed to rats which were then
sacrificed and thri organs and tissues studied (5) A sanitized version
of the study was recently published (6).
Dr. Arpad Pusztai was commissioned by the German government to evaluate
the Monsanto study. His report was deemed confidential but was released
after agreement was reached with all concerned parties (7). Lim Ching of
the Third World Network summarized Dr. Pusztai’s report “MON863 produces
a novel Bt toxin (Cry3Bb1) to protect it against corn rootworm. Despite
the many flaws in the experimental design and execution of Monsanto's
study, a number of unexplained and significant effects could be seen in
the rats fedwith MON863.
The differences and their potential implications are: increased basophil
count, which
may indicate allergic reaction; increases in the number of lymphocytes
and white
blood cells, which usually increase in the presence of infections,
cancer, various
toxins, and disease states; decreased reticulocyte count, which is
indicative of
anaemia; decreased kidney weight, which points to blood pressure
problems; and
elevation in blood sugar levels, which cannot be dismissed as biologically
insignificant, given the diabetes epidemic.
There were also elevated levels of kidney inflammation, liver necrosis,
and other
observed changes. Dr. Pusztai says, "It is almost impossible to imagine
that major
lesions in important organs (kidneys, liver, etc) or changes in blood
parameters
(lymphocytes, granulocytes, glucose, etc.) that occurred in GM Maize-fed
rats, is
incidental and due to simple biological variability".
Monsanto also submitted a "follow-up study" in response to the concerns
raised over
MON863 by the French expert body that evaluates GMOs, the Commission du
Genie Biomoleculaire (CGB). Dr. Pusztai criticizes this "follow-up study" as
inadmissible.
This is because Monsanto defended changes in kidney weights by comparing
results
from the test animals with rats used in a completely different study,
conducted in a
different laboratory, using MON 863 hybrids with other GM maize samples.
In the
"follow-up study", the results of the original MON 863-study was quoted
(but not
actually re-done) for comparison. Dr. Pusztai asserts that this
inter-experimental
comparison is entirely inappropriate for nutritional evaluation and
should be
disregarded (8).”
One very disturbing aspect of the Monsanto study was the numerous
statistically significant differences between control and treated
animals. These significant results were minimized by comparing the
values with values in unrelated studies. Industrial toxicologists use
that questionable procedure to minimize significant impacts of the
products that they wish to have approved by regulators. The meaning of
statistical significance has been altered full fill the desires of
industrial public relations.
The Institute of Science in Society has reported numerous disturbing
features of the regulation of Bt Cry toxins in general and Cry 3Bb1 in
particular (9,10). It is certainly time to insure that the GM crops
given non-regulated status be adequacy tested before they are made
available commercially. MON88017 maize must be subject to a full animal
feeding study before it is released. The commercialization of yet
another maize strain known to be injurious to mammals seems to be adding
insult to injury. The information deemed “confidential Business
Information” was deleted from the petition for MON88017, such deletions
should be restored and scrutinized by all those evaluating the proposal.
References
1. Sidhu,R. and Brown,S. Petition for the determination of
non-regulated status for MON88017 Corn 2004 pp1-277
http://www.aphis.usda.gov/brs/not_reg.html
2. USDA/APHIS Decisions on Monsanto Petition 04-125-01P seeking a
determination of non-regulated status for Bt cry3Bb1 insect
reistance corn line MON 88017 2004 pp 1-41
http://www.aphis.usda.gov/brs/not_reg.html
3. US Food and Drug Administration Biotechnology Consultation Note.
To the File BNF No. 000075 2001 pp1-4
http://www.cfsan.fda.gov/~rdb/bnfm075.html
<http://www.cfsan.fda.gov/%7Erdb/bnfm075.html>
4. Cummins,J. Regulatory sham on Bt-crops Science in Society 2004,21,30
5. Burns,J. 13-Week Dietary Subchronic Comparison Study with MON 863
corn in rats preceded by a 1-week baseline food consumption with
PMI Certified Rodent Diet #5002 2002
http://www.monsanto.com/monsanto/content/sci_tech/prod_safety/fullratstudy.pdf
6. Hammond B, Lemen J, Dudek R, Ward D, Jiang C, Nemeth M and Burns
J. Results of a 90-day safety assurance study with rats fed grain
from corn rootworm-protected corn. Food Chem Toxicol. 2005 Aug 3
in press
7. Pusztai,A. Evaluation of and Final Report on the summary report of
the "13-Week Dietary Subchronic Comparison Study with MON 863 in
Rats Preceded by a 1-Week Baseline Food Consumption Determination
with PMI Certified Diet #5002(Report MSL-18175/Covance Study No.
6103-293)". http://www.twnside.org.sg/title2/service219.htm
8. Ching,L. Third World Network Biosafety Information Service
Evaluation of Monsanto’s Feeding Study on MON863 2005
http://www.twnside.org.sg/title2/service219.htm
9. Ho,MW and Cummins,J. GM food and feed not fir for man or beast
ISIS Report 2004 http://www.i-sis.org.uk <http://www.i-sis.org.uk/>
10. Cummins,J. Bt toxins in Genetically Modified Crops : Regulation by
Deceit Science in Society 2004 22,32
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