ISIS Prof. Joe Cummins and Dr. Mae-Wan Ho catch Monsanto.

[Guest guest]

25 Aug 2005 15:22:09 -0000

MON88017 Another MON863?

press-release

 

 

The Institute of Science in Society Science Society

Sustainability http://www.i-sis.org.uk

 

General Enquiries sam Website/Mailing List

press-release ISIS Director m.w.ho

========================================================

 

 

ISIS 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.

http://www.i-sis.org.uk/isisnews.php

 

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_safet

y/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/ManorBeast.php

 

11. Cummins J. Bt toxins in Genetically Modified Crops :

Regulation by Deceit Science in Society 2004 22,32

http://www.i-sis.org.uk/isisnews.php

 

 

 

========================================================

This article can be found on the I-SIS website at

http://www.i-sis.org.uk/

 

If you like this original article from the Institute of

Science in Society, and would like to continue receiving

articles of this calibre, please consider making a donation

or purchase on our website

 

http://www.i-sis.org.uk/donations.

 

ISIS is an independent, not-for-profit organisation

dedicated to providing critical public information on

cutting edge science, and to promoting social accountability

and ecological sustainability in science.

 

 

========================================================

CONTACT DETAILS

 

The Institute of Science in Society, PO Box 32097, London

NW1 OXR

 

telephone: [44 1994 231623] [44 20 8452 2729] [44 20

7272 5636]

 

General Enquiries sam Website/Mailing List

press-release ISIS Director m.w.ho

 

MATERIAL ON THIS SITE MAY NOT BE REPRODUCED IN ANY FORM

WITHOUT EXPLICIT PERMISSION.

FOR PERMISSION, PLEASE CONTACT enquiries