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Terminator-style field trials in India, court told (9/11/2006)

1.Terminator-style field trials in India - GM Watch
2.'REPLY' TO DELHI UNIVERSITY'S APPLICATION FOR FIELD TRIALS OF GM MUSTARD - Aruna Rodrigues
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1.Terminator-style field trials in India

The Public Interest Litigation (PIL) brought before the Supreme Court in India by Aruna Rodrigues and her co-petitioners has already led to a temporary ban on new GM field trials in India, starting from the 22nd of September.

But on the 13th October, the Supreme Court in response to an application from Delhi University, agreed to make an exception. Based on the evidence before it, the Supreme Court agreed to allow Delhi University to conduct field trials of their newly developed GM Mustard, subject to the condition that they would take all precautions and that they would completely destroy the crop if the Court became convinced that GM Mustard had bio-safety hazards.

Aruna Rodrigues has now brought forward some startling new evidence that suggests that in making its application to the Supreme Court, Delhi University may have suppressed important scientific information, and that this "has consequently undermined and compromised a critical bio-safety order of the Court."

Rodrigues' Reply Affidavit - in response to Delhi University's application - has just been released, ahead of a hearing (the date for which is still to be set), and you can read below a detailed press release summarising its content.

The Reply Affidavit draws on the expert evidence of 3 leading international scientists. And it states unequivocally that the GM mustard in question contains a Barnase and Barstar system. To quote from the press release:

"THE BARNASE - BARSTAR SYSTEMS ARE COMMONLY USED AS GURTS WHICH INCLUDE TERMINATOR GENES WITH A CLEAR VIEW TO PROFITEERING"

Alarmingly, not only does the Barnase and Barstar system have the potential to operate as a GURT, restricting access to fertile pollen and so causing sterility in seeds (thus forcing farmers to purchase new seed for every planting), but it is also "leaky".

This means, "Some of the pollen produced by the fertile hybrid [of the GM plant] would be pollen that included only the gene for barnase and not the gene for barstar (a natural consequence of meiosis or cell division).

Therefore, other crop or wild plant recipients fertilised by that pollen will produce male sterile offspring with the possibility of significant environmental disruption."

In other words, the GM mustard is potentially a Terminator-style plant that can still spread its intended sterility to other related plants in the environment.

This is of particular significance because:

"Mustard seed oil or Brassica juncea (Bj) is open pollinating which means that it out-crosses pretty well. The species has wild weedy relatives that it can easily interbreed with all over the world."

Delhi University completely failed to mention wild mustards, quite appart from other relatives, in its application. "In some of these species contamination has occurred several kilometres from fields. The risk of transgenic contamination through mustard is particularly high and has surprised scientists who at one time stated that contamination of distant species like wild charlock in the UK was impossible. It happened contrary to their predictions."

And as if this undisclosed issue of both transgenic and Terminator-style contamination of the environment weren't bad enough, "Barnase, even if expressed at low levels, could prove toxic to a wide range of animals that interact with the plant, including not only humans, but also rodents and bees. It could also enter the human food chain in bee honey."

The Petitioners are therefore calling for no exception to be made in the case of GM mustard, ie a total ban on *all* GM field trials. They say, "There is no alternative to this, if the interest of our farming community is to be protected. There is no alternative to this if we are also to avoid the irreversible and hazardous contamination of India's environment and her food chain."

They also note "the clear bias of our own government and a thoroughly discredited regulator" and that, "We must win the war for an objective and precautionary approach to genetic engineering and its hugely grave impacts in perpetuity."
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2.'REPLY' TO DELHI UNIVERSITY'S IMPLEADMENT APPLICATION FOR FIELD TRIALS OF MUSTARD DMH-11
THE G OF I [Government of India] IS SUBJECTING INDIANS TO THE RISKIEST & FASTEST EXPERIMENT ANYWHERE WITH REGARD TO GM FOODS AND ANIMAL FEED
PRESS RELEASE

Note: The data provided to the SC [Supreme Court] in Petitioners' Reply Affidavit is based on the expert evidence of 3 leading international scientists, specialists in their own fields. They are: Dr. Doug Gurian-Sherman of the Centre for Food Safety in Washington, Prof. Jack Heinemann, Director, the Centre for Integrated Research in Bio-safety, University of Canterbury and Prof. Joe Cummins Prof. Emeritus of Genetics, University of Western Ontario, Canada, and the Institute of Science and Society, UK.

Preamble: On the 13.10.2006 the SC issued allowed Delhi University (DU) to conduct field trials of their newly developed Mustard DMH-11 variety subject to the condition that they will take all precautions and will completely destroy it if the Court is convinced that GM Mustard DMH-11 has bio-safety hazards. Petitioners' 'Reply Affidavit filed on the 6th November, 2006 provides specific data on the Barnase and Barstar (B&B) system and gene modification represented by Mustard DMH -11. The evidence clearly demonstrates that (a) there is no reason whatsoever for these field trials to be given an 'exceptional' status; that on the contrary, the utmost precaution must be exercised for this GMO specifically, on various dimensions of bio-safety and; (b) that the hazards associated with the process of genetic engineering are fully applicable to the B&B genes.

There is clear, unequivocal evidence that FIELDS TRIALS lead to extensive contamination of the environment and the food chain in India and worldwide.

The current rice incident with BayerCropSciences LL601 (which was sown between 1998 and 2001 in field trials in the US), and which has effected 40% of US exports of rice worth hundreds of millions of $s reinforces just how serious the repercussions of contamination can be for a country. If the US is struggling to get to grips with the situation in a massive damage control exercise which has thus far largely failed, India's chances in a similar situation don't bear thinking about, especially with a Regulator that has turned approver of this demonstrated hazardous technology.

The DU Impleadment: DU has suppressed important scientific information about

DMH-11 from the SC. It has consequently undermined and compromised a critical bio-safety order of the Court, for a stoppage of all new field trials. Such submissions as this one, clearly economical with the truth and the science involved in the Barnase-Barstar gene modification of oilseed mustard, seek to promote the developers' own GM constructs with an ultimate view to their commercialisation as the main objective, overriding safety concerns which on the other hand must be primary. It also highlights how strategic and highly politicised partnerships between the Government of India and the US, encompassing the GE issue, like the recently inked-in 'Indo-US Agricultural Initiative' seriously compromise and undermine sovereign issues and the national interest, through the institutional affiliations they establish and or actively encourage with biotech, giving Monsanto and such companies unprecedented a nd direct access to India‚s genetic resources; they therefore serve to force or seduce our agricultural and research institutions into a direct conflict of interest through working with such partnerships.

Mustard seed oil or Brassica juncea (Bj) is open pollinating which means that it out-crosses pretty well. The species has wild weedy relatives that it can easily interbreed with all over the world. The Impleadment Application for field trials mentions that there are no crops compatible with the GMO mustard "growing around it or even near it and hence any accidental contamination with another crop is ruled out"; but it completely fails to mention wild mustards. "If this reflects an oversight on the applicant's part, this could indicate a very important risk issue that has been overlooked. In addition to Bj, several other wild Brassica species exist that can interbreed with oilseed mustard --- these species may be insect or wind pollinated and could survive indefinitely in the wild"(D G-S). In some of these species contamination has occurred several kilometres from fields. The risk of transgenic contamination through mustard is particularly high and has surprised scientists who

at one

time stated that contamination of distant species like wild charlock in the UK was impossible. It happened contrary to their predictions.

The Applicant claims that DMH-11 is "identical to the Ms8/Rf variety, developed, tried and tested in Countries such as Europe, USA Canada and Australia" and has "been certified safe for release into the environment" in these countries, and that "they have also certified that DMH -11 or Ms8/Rf is safe for growing in fields and the oil is suited for human consumption."

This is incorrect and misleading. There is no equivalence between the two varieties, (i.e. DMH-11 is mustard and is not identical to MS8/RF3 which is rape also known as canola). Nor has there been any human health assessment for the Barnase and Barstar genes in mustard.

THE BARNASE - BARSTAR SYSTEMS ARE COMMONLY USED AS GURTS WHICH INCLUDE TERMINATOR GENES WITH A CLEAR VIEW TO PROFITEERING

The GM Mustard variety DMH-11 uses the Barnase ˆ Barstar system of gene modification. Barnase ˆ barstar are used in GURTs (genetic use restriction technologies), a term that incorporates ŒTerminator‚ crops. GURTs are the generic term for sterilisation technology and barnase and barstar are genes that are used in combination in this technology. Sterilisation technology is used to prevent'Œunauthorised' use of patented material through farmers, sharing, exchanging seed or 'sowing what they reap'.

The higher yields that DU claim are NOT the result of these particular transgenes but rather a direct result of hybridisation of normal crop genes.

This is why in the case of corn that has natural male sterile genes, hybrid corn can be made that has nothing to do with genetic engineering. The agronomic higher yield characteristics (of BMH-11) are not "attributed to genetic engineering, specifically to neither barnase nor barstar; - the parental varieties of DMH-11 which appear to possess the valuable agronomic qualities independently of the insertion or expression of either barnase or barstar could be planted and research on them could continue without interruption." However, what is clear is that the Respondents are actually ONLY asking the SC for permission to continue testing their B & B genetic modifications per se! The Respondents‚ approach is of course disguised and opaque and only apparent on unravelling the science. It is important to note that applications like MS8/

RF3 for

'consultations' with the US FDA are made with the intention of commercialisation in mind. Nor is it reassuring that MS8/RF3, the canola variety claimed by the DU to be identical with mustard DMH -11, owned by BayerCropSciences, the very same company that has been responsible for two of the greatest disasters in the history thus far, of GM contamination. The earlier StarLink episode which contaminated the commodity system in the US has now been eclipsed by the current incident of rice LL601.

The barnase-barstar mutations are GURTs for bio-containment as well as a tool for hybrid vigour but are 'leaky' in both applications: GURTs because of the inherent failure rate are not "validated as a containment strategy".

Nevertheless, the barnase construct has the potential to act as a GURT

"because the barnase pollen can restrict access to fertile pollen". In

this particular case, because the data in the IA is incomplete, it is not known whether this particular B & B mustard is intended to be used as a GURT, which forces the farmer to buy new seed for every planting, or as a tool for making hybrids (which has been claimed by DU) or both. Some of the pollen produced by the fertile hybrid would be pollen that included only the gene for barnase and not the gene for barstar (a natural consequence of meiosis or cell division). Therefore, other crop or wild plant recipients fertilised by that pollen will produce male sterile offspring with the possibility of significant environmental disruption.

Barnase is Toxic: The barnase male sterility system is a particular concern because of the "use of a potent toxin to eliminate pollen production in the transgenic crop. Barnase, even if expressed at low levels, could prove toxic to a wide range of animals that interact with the plant, including not only humans, but also rodents and bees. It could also enter the human food chain in bee honey.

The barnase-barstar complex in transgenic mustard is likely to produce a strong immunological response such as inflammation or it may even be an allergen. However, these aspects do not appear to have been studied. Those countries contemplating imitating approvals of the United States, Canada and EU, should take a careful second look because there is new information that the barnase destruction of the male sex organs may have a holistic impact on (the entire plant) by effecting mobile RNAi molecules that are transported through, to withhold approval until adequate research has been done. It is no wonder that the corporations object to the labelling of transgenic crops so that toxic impacts will not be recognized right away".(Prof. JC)

The conclusion of the Reply to the impleadment is well summed up as follows:

"If the Court has issued the Order dated 22/09/06 because of uncertainties about the safety of GM constructs including the use of toxins, such as barnase, then I can see no compelling reason in this Application for DMH -11 to be considered an exception"(Dr. JH)

The Petitioners' repeated request therefore to the SC to stop all field trials is fully validated by the evidence. There is no alternative to this, if the interest of our farming community is to be protected. There is no alternative to this if we are also to avoid the irreversible and hazardous contamination of India's environment and her food chain. FIELD TRIALS logically, must follow-on from a stringent and comprehensive bio-safety test protocol as called for in the PIL and subsequent submissions, with due regard to the processes and procedures of such a protocol. The submission has also stated that given the clear bias of our own government and a thoroughly discredited regulator, the appointment of an independent OMBUDSMAN with the mandate to protect India's bio-safety is critical. We must win the war for an objective and precautionary approach to genetic engineering and its hugely grave impacts in perpetuity. An independent and autonomous overseeing OMBUDSMAN is required to redress the balance and act as a vigilant and correcting force on a continuing basis, to change the face of Regulation in India.

Aruna Rodrigues
Petitioner No1
Mhow, M.P.
Dated 7th November, 2006

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