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[SANET-MG] another version of a conroversial GM maize
http://www.i-sis.org.uk/mon.phpISIS Press Release 25/08/05
MON88017 Another MON863?
Prof. Joe Cummins and Dr. Mae-Wan Ho catch Monsanto trying to get a
different version of an already controversial GM maize variety deregulated
This article has been submitted to the US EPA on behalf of the
Independent Science Panel (identifier: APHIS-2005-0068-0008). Please add
your support by registering your opposition in the docket and referring
to this article and its identifier number.
Monsanto Corporation has submitted a petition to USDA/APHIS for
non-regulated status of a transgenic maize line MON 88017 that was made
with the same plasmid sequence as was used for event MON863. The
petition is put up for public comment ending September 11,2005 [1].
MON863 has raised serious concerns in Monsanto's own secret feeding
studies, which came to light during an application for market approval
in Europe. There is reason to treat MON88017 with suspicion until proven
otherwise.
MON88017 was derived by transforming the maize plant material with the
same Cry3Bb1 plasmid sequence as used in maize strain MON863 (YieldGard
rootworm), which was deregulated in 2002. In addition, MON88017 contains
the EPSPS gene that confers tolerance to the herbicide glyphosate. The
actual construction included a synthetic approximation of the cp4 EPSPs
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 Cry3Bb1 gene was driven by a cauliflower mosaic
virus (CaMV) 35S promoter with a duplicated enhancer, the wtCAB 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 by the terminator of tahsp173 from
wheat heat shock protein [2]. The Cry3Bb1 of MON88017 differed from the
Cry3Bb1 gene in MON 863 by a single amino acid [2, 3].
Earlier, the United States Food and Drug Agency (FDA) noted that the
Cry3Bb1 toxin produced in MON863 differed from the original natural gene
product produced in the bacterium by seven amino acids and by an
additional amino acid in the second position from the start of the toxin
protein [4]. Regulators and proponents seem to assume that it is
acceptable to switch a few amino acids without any consequence, even
though the genetic reality is that a single amino acid change is often
sufficient to produce lethal effects. Furthermore, the Cry3Bb1 toxin
used in many environmental and mammalian safety tests was a surrogate
produced in bacteria, and not the actual toxin produced in maize because
pure bacterial toxin is cheaper to produce in pure form in bacterial
cultures [5]. That kind of evaluation is too risky and misleading to
provide valid data for food and feed that affects millions of people.
The evaluation of the food and feed safety of MON 88017 was based
primarily on the previous evaluation of MON863. According to the
company, "results from acute oral toxicity demonstrate that the Cry3Bb1
protein is not acutely toxic and does not cause any adverse effects"
[2]. The study upon which the above conclusion was based was withheld
under the claim of confidential business information, but subsequently
released after a great deal of public pressure and a successful legal
challenge by Greenpeace Germany. The study was a thirteen-week feeding
trial with MON863 maize grain on rats that were then sacrificed to
examine the organs and tissues [6]. A sanitized version of the study was
recently published in a scientific journal [7].
Dr. Arpad Pusztai was commissioned by the German government to evaluate
the Monsanto study. His report was also deemed confidential, but was
released after agreement was reached with all concerned parties [8].
Pusztai's report stated, "..this imperfectly designed and executed study
revealed a huge list of significant differences between the various
biologically meaningful parameters of rats fed GM maize diets and the
proper controls.."
"..the study strongly indicates that feeding rats on diets containing
significant amounts of MON 863 corn can potentially be detrimental to
the health of these animals and may cause major lesions in important
organs (kidneys, liver, etc.), interfere with the function of their
immune system (lymphocyte, WBC, granulocyte counts) and change their
metabolism (glucose)…"
Pusztai summarized the differences between GM fed and control-fed rats,
and their potential implications: 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 changes. Pusztai added, "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 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). Pusztai criticized this
"follow-up study" as inadmissible. 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
MON863 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. As Pusztai asserts, this inter-experimental
comparison is entirely inappropriate for nutritional evaluation and
should be disregarded [9]."
One very disturbing aspect of the original Monsanto study [6] was the
numerous statistically significant differences between control and
treated animals, which were initially ignored; and then minimized by
comparing the values with values in unrelated studies [9]. The very
meaning of statistical significance has been altered for the purpose of
misleading the public in order to get its product approved that has
clear signs of being unsafe.
The Institute of Science in Society has reported numerous unsatisfactory
features of the regulation of Bt Cry toxins in general, and Cry3Bb1 in
particular [10, 11]. It is certainly time to ensure that the GM crops
given non-regulated status are fully and adequacy tested. MON88017 maize
must be subject to a full animal feeding study and environmental
assessment that should be made available for public scrutiny before it
is released. The commercialization of yet another version of a
transgenic maize strain already strongly suspected of being harmful to
mammals is adding insult to injury. The regulators have deleted
paragraphs deemed "Confidential Business Information" from Monsanto's
MON88017 petition. Such deletions should be restored and scrutinized by
all those evaluating the proposal, as this is a matter of public health.
References
1. The USDA/APHIS docket and location for public comments on
APHIS-2005-0068 can be contacted at the URL:
http://docket.epa.gov/edkfed/do/EDKStaffCollectionDetailView?objectId=0b0007d48094774f
2. 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
3. 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
4. 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
5. Cummins J. Regulatory sham on Bt-crops Science in Society 2004, 21,30.
6. 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
7. 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
8. Puszta 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
9. Lim LC. Third World Network Biosafety Information Service Evaluation
of Monsanto's Feeding Study on MON863 2005
http://www.twnside.org.sg/title2/service219.htm
10. Ho MW and Cummins J. GM food and feed not fit for man or beast ISIS
Report 2004 http://www.i-sis.org.uk
11. Cummins J. Bt toxins in Genetically Modified Crops : Regulation by
Deceit Science in Society 2004 22,32
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