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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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