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Moderated conference on GMOs in the pipeline, hosted by the FAO Biotechnology Forum in 2012

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Tue, 27 Nov 2012 18:26:30 +0100
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This is Aruna Rodrigues again. As a new-comer to this conference and with just days to go for the deadline to post replies on this subject, I am responding collectively to all those who have posted their responses on Bt brinjal – I will be posting a couple more on different aspects of the independent scientific appraisal of the Mahyco-Monsanto bio-safety dossier. The importance of the appraisal of Bt brinjal is that with the government-imposed moratorium on it, the regulators were morally bound in the public interest, to stop open release of GMOs in field trials until they had satisfactorily addressed safety issues and the open conflict of interest that exists. Indeed, the Parliamentary Standing Committee on GM crops in its report published in August, came to the conclusion that for the present all open field trials in “any garb” must cease forthwith. Most of the documents quoted in this message form part of the Jairam Ramesh Report, available on the website of the India’s Ministry of Environment and Forests (MoEF). Subsequently, the Supreme Court nominated Technical Expert Committee, in the first of its two-stage report has arrived at the same conclusion. Many conditions need to be addressed, and until then, open field trials must stop. 



This message deals with the genetic construct and the molecular characterisation of Bt brinjal, which is the starting point of any appraisal of a GMO event. The following comments rely essentially on Prof Jack Heinemann’s assessment of the raw data of the ‘dossier’ both for the Supreme Court and the Minister’s review process. It demonstrates minimal regulatory oversight of a self-assessed biosafety-dossier by the developers and serious cover-up by Mahyco-Monsanto. Some of the more important findings are provided here as examples of these serious charges: 



a.  Chimeric Gene Construct of Bt Brinjal: Seralini was asked by the regulators to clarify why he called Bt Brinjal event EE1 a ‘chimeric gene’. In reply he pointed the regulators to page 33 of Monsanto’s Dossier! (Did they even read it, is the obvious question?). The construct is described as having 99.4% identity with Cry 1 Ac, which the Regulators described as a difference of only 1 amino acid. A very quick calculation by both Dr P Bhargava and Prof Antoniou revealed the accurate count of a difference of 7 amino acids at the claimed 99.4% identity. As Heinemann was to point out much later in 2012, the question of a difference of 1 amino acid was never on record. The difference of 7 is “consistent with the original description by Monsanto, 1997”. However, at “94% identity” (consistent with current GenBank comparison), there could be a difference of up to 70 different amino acids. “To conclude that a novel protein is likely to be of no safety concern because of even as few differences as 7 amino acids is not a research-based conclusion. Changes of single amino acids can significantly alter the characteristics of proteins (a fact that underpins the field of directed evolution”. The critical and fundamental characterisation of the event was not completed, usually because of assumption-based reasoning. “When such fundamental misunderstandings of the basic tools of the procedure were demonstrated by the developer, seemingly went unchallenged by the regulator, it was very difficult to accept assurances that the other procedures in the evaluation of Bt brinjal could be trusted”. (Heinemann, 2012) 

b. Several scientists including India’s leading entomologist Dr Keshav Kranthi have said that the Bt brinjal construct is old and outdated; it could well be termed ‘gene dumping’ (Andow). 

c. Monsanto states on pg 93 of its dossier that “it is unlikely that seed or other brinjal tissues would enter aquatic habitats”. This has been proved wrong. Bt corn residues and pollen were found to concentrate in streams and have a significant effect on aquatic organisms in the US Midwest. 

d. Methods and number of insertions: Mahyco has not eliminated the possibility that there is more than one insertion of recombinant DNA and that all insertions are free of vector “backbone” DNA. Such experiments are relatively inexpensive and the methods so common that they are taught in some high schools, so there should be absolutely no reason to fail on this first step of a safety assessment. “I HAVE NEVER SEEN LESS PROFESSIONALISM IN THE PRESENTATION AND QUALITY ASSURANCE OF MOLECULAR DATA THAN IN THIS STUDY” (Heinemann) 

- Novel RNA (Ribonucleic acid) and Proteins 

“MAHYCO HAS PROVIDED NO INFORMATION WHATSOEVER ON NOVEL RNAs”. This is a significant omission. According to (Codex, 2003) (p. 14, paragraph 32), “Information should be provided on any expressed substances in the recombinant-DNA plant; this should include: the gene product(s) (e.g. a protein or an un-translated RNA); the gene product(s)’ function…”. Moreover, since Mahyco uses the nos3′ terminator (The role of the terminator is to signal the end of a gene to prevent the production of transcripts from "downstream" DNA) in its construct it has an added obligation to look for novel RNAs. The nos3′ is NOT an efficient terminator in eukaryotes,(organisms of one or more cells each with a nucleus and other well-developed intracellular compartments. Eukaryotes include all organisms except bacteria, viruses, and certain (blue-green) algae which, by contrast, are prokaryotes), leading to read-through, longer mRNA molecules and potential fusion proteins. 



Aruna Rodrigues

Sunray Harvesters,

Bungalow 69

Mhow - 453441

M.P. India

e-mail: arunarod (at) gmail.com



[The reference to Codex (2003) is to the 'Guideline for the conduct of food safety assessment of foods derived from recombinant-DNA plants'. This text, as well as three others that represent the outcome of the Codex Alimentarius Commission's work on principles and guidelines for food safety assessment of foods derived from modern biotechnology, are available in a short publication entitled 'Foods derived from modern biotechnology' (2209, 2nd edition). The four texts are the Principles for the risk analysis of foods derived from modern biotechnology; Guideline for the conduct of food safety assessment of foods derived from recombinant-DNA plants; Guideline for the conduct of food safety assessment of foods produced using recombinant-DNA micro-organisms; and guideline for the conduct of food safety assessment of foods derived from recombinant-DNA animals. See http://www.fao.org/docrep/011/a1554e/a1554e00.htm (in English, French and Spanish) or contact codex (at) fao.org for more information...Moderator].



[To contribute to this conference, send your message to [log in to unmask] For further information on this FAO Biotechnology Forum, see http://www.fao.org/biotech/biotech-forum/]



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