ISIS Report 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
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 . 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 . 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 . 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 . 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" . 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 . A sanitized version of the study was recently published in a scientific journal .
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 .
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 ."
One very disturbing aspect of the original Monsanto study  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 . 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.
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