Analysis of Jack Heinemann on the Bt Brinjal Biosafety

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Heinemann has previously provided evidence concerning the risk assessment and hazard identification of GM crops  and in particular the appraisal of Monsanto’s bio-safety dossier of Bt brinjal (molecular analyses) for the Supreme Court. He was also one of the independent academic scientists who responded to Shri Jairam Ramesh in his review process of Bt brinjal in 2009-2010. Heinemann’s credentials are well known. This document is his further analyses of the molecular characterisation of Bt brinjal and follows from a request that I (AR) made last year (ref. the Preamble).  It seemed appropriate  to undertake a deeper investigation of Bt brinjal Event EE 1 given the disquiet generated as a result of several separate appraisals of Monsanto’s  dossier by leading international scientific experts, which pointed to a shoddy environmental risk assessment; of studies claimed to have been done, but were not done or poorly done and significant health safety issues which raise concern. All  were comprehensively denied by the regulators and the EC II (Expert Committee II appointed by the apex regulator the GEAC to deal with various analyses of the Dossier and objection received to it). The clear need for long term testing for chronic toxicity (cancers and other problems) was also turned down, but which Shri Jairam Ramesh required when he imposed an indefinite moratorium on Bt brinjal pending independent scientific and long term studies. This is that further report of Prof H.

I am astounded at Heinemann’s findings and their serious implications.  At the outset, Heinemann says that a “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, (which) 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”. In other words if we may draw a very crude analogy, this stage of the risk assessment of a GMO (the molecular characterisation) is akin to the first steps of learning  to read as in CAT= cat and MAT= mat. There is also a curious divergence between the Monsanto reference work of 1997 and their Bt brinjal dossier. Did the regulators not bother to even check Monsanto 1997? Without going into undue detail (please see pages 6-9), I draw your attention to the following key points of Heinemann’s analyses along with my  comments.

  •  At this very first stage of the risk assessment and  testing of a GM crop,  (the molecular testing and characterisation) it is now apparent that there has been no regulatory oversight at all by either the RCGM nor the apex regulator the GEAC. The EC II report was as unreliable for safety oversight.

“The commercial trait in Bt brinjal is conferred by the Cry1Ac-like derived protein. This protein is not Cry1Ac isolated from natural plasmids of B. thuringiensis v. kurstaki, but a protein made from a series of in vitro modifications. —The GE “plasmid was the vector PVLEBK04, also called pMON10518 (Monsanto, 1997). Taken together, PV-LEBK04 has at least 10 different DNA elements that have been taken from different species, including soybeans, viruses, plasmids isolated from different species of bacteria, and many of which have also been extensively and separately subject to in vitro modification after being taken from their natural sources (see Table 2 of Monsanto, 1997)”.

  •  Chimeric or fusion gene: The Bt B gene is claimed as a fusion gene of Cry1Ac and Cry1Ab. Monsanto and the EC II report claimed that Bt B event EE1 was 99.4 % identical in amino acids to the natural Cry1Ac protein (p. 33 of Mahyco, 2008). There is no mention in the Dossier or the EC II report of  the multiple origins that form the fusion (see above). They further went on to say this corresponded to  only a difference in 1 amino acid. This is astonishing for other reasons than there can be no safety comfort derived from ‘only. However, Dr Bhargava very quickly corrected this fundamental error to say that on this basis, the difference was in fact 7 amino acids. Prof Michael Antoniou confirmed this as easily and as quickly. This is how basic such a calculation is to a molecular biologist. So what does this say of the GEAC, the apex regulator?  (The RCGM/DBT have become the official vending machine dispensing GM crops and are currently embarked openly, on aggressively pushing formal public-private partnership agreements to provide the  vehicle to promote GE crops, thereby, formalising corruption.

Heinemann says: ( EC II described the construct in Bt brinjal as composed of (the first) 466 amino acids from Cry1Ab and 712 amino acids from Cry1Ac (amino acids 1178 to 467). The regulator said in EC II: “This difference of 0.6% is attributed to the difference in presence of one amino acid at position 766 i.e. serine in place of leucine.”

However, as noted earlier, currently registered sequences for these proteins do not support that they were this similar. Moreover, a single amino acid difference in a sequence of 1178 amino acids would have been 0.1% rather than 0.6% as the scale of difference between the fusion and nature reported by the developer and accepted by EC IINeither the original Monsanto dossier nor the EC II numbers support the EC II conclusion that the fusion had a single amino acid difference from what is found in nature (JH).

“At 99.4% identity, there would be approximately 7 amino acid differences between the chimera fusion and natural Cry1Ac (consistent withoriginal description by Monsanto, 1997)”.

“However, when I construct the fusion using sequences published in Genbank, I find that the fusion is a maximum of 94% identical to Cry1Ac (GenBank: ABD37053.1) and only 95% identical to Cry1Ab (GenBank: ABV91087.1). Based on these matches, it is also not clear why the developers have historically called their fusion construct after cry1Ac rather than after cry1Ab, or more precisely, cry1Ac-like to accurately identify it as a product of modern biotechnology formed as a chimera of multiple origins. Thefirst 40% of the amino acids found in Cry1Ac2 were replaced with 466 amino acids from Cry1Ab, another insecticidal protein.

  • Furthermore, the developer reports that a leucine residue at position 766 has been replaced by a serine residue in planta. What appear to be small differences can be physiologically and immunogenically important. The change from leucine to serine at position 766 is of interest to the biosafety investigator because only the latter can be O-linked glycosylated by the addition of N-acetylgalactosamine through a side chain hydroxyl group (Mitra et al., 2006). “O-linked glycosylation has a profound effect on the antigenic properties of peptides—-“
  •  The implications of this are that the fundamental affinity-based tools used by developers to list and characterise all forms of the protein produced in the plant (e.g., western blots) may be compromised if they were not trained on the glycosylated forms that the plant may produce. All subsequent studies that are based on isolated proteins (e.g., digestibility, toxicity, and cooking studies) may then be invalid because they only have available to them a subset of the relevant protein isoforms that may be in the plant.
  • ·         At 94% identity (consistent with current GenBank comparison), there could be 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) —–. One of the characteristics that can be changed is immunogenicity. For example, several groups reported significant decreases of IgE binding to a major peanut allergen after mutating single nucleotides. Even more surprising, in some cases even a synonymous (i.e., differences in the nucleotide sequence of a gene that do not alter the resulting amino acid sequence) coding change can alter the characteristics of a transcript or protein, or levels of expression A single nucleotide polymorphism that results in a synonymous change can change the substrate specificity of the resulting protein, potentially by affecting its folding patterns during translation.  Furthermore, sequence identical proteins with differing tertiary structures can turn benign proteins into toxins –or agents that cause pathogenesis as demonstrated for the Prp proteins causing Creutzfeld-Jacob disease and mad cow disease

These are startling findings. They mean that Monsanto’s dossier is fundamentally flawed at its starting point. This is to put in politely. Without overstating the case, the more correct description is, fraudulent. There also appears to have been a deliberate cover-up of differences with their original doc of Monsanto 1997 and their Bt brinjal dossier. However, fraudulent dossiers are nothing new for Monsanto. There have been similar cases with other products in the EU and New Zealand. This kind of behaviour is to be expected from a company that has been formally indicted for bribes and cover-up, hounding farmers into bankruptcy, false advertising both in France where they had to retract and more recently in Vidharba for paid advertising and lies. Monsanto has also been indicted for some of the worst crimes against humanity. This is part of the formal record.

But what of our regulators and in particular the GEAC?  The charges against Monsanto in India for illegal field trials, illegal plantings, are serious enough to have pushed even the GEAC into the action of serving a show-cause notice, seemingly impotent. The recent case of the supposedly Desi BN cotton gene that has a Monsanto gene discovered in it, merely underscores the case that we have no regulation of any value that serves to protect India, her farmers and the public interest. As seriously, it  betrays either a significant lack of competence or a conflict of interest so deep that there is a great facilitation to promote GM crops and Monsanto especially, mortgaging the public interest. This means  that we have had 15 years of unsafe field trials and accelerating in the last 2-3 years to encompass numerous Bt genes in virtually all our food crops and including the failed technology in herbicide resistant crops. These greatly risk our bio-safety and indigenous seed stock  because of irreversible contamination, which is the main reason why untested open field trials are not acceptable.

Finally, the performance of Bt cotton is being hyped in order to prepare the way for other Bt crops. But without reliable statistics and a PMM(post market monitoring) of Bt cotton which should have been instituted by a conscionable regulator years ago, there is no evidence for the claims being made by Monsanto and the government regulator and other public institutions. Dr Kranthi ‘s  analyses of the performance of Bt cotton shows the onset of ‘resistance’ and the experience of other countries where insect resistance to Cry proteins is proven (ref the recent US EPA report on Bt corn 863) underscores the fact that this was a predicted outcome.

The worm in Bt brinjal

http://www.business-standard.com/india/news/sreelatha-menonworm-in-bt-brinjal/468903/

Sreelatha Menon: The worm in Bt brinjal
A new study questions safety assessments of Bt brinjal, asks for an independent regulator
Sreelatha Menon / New Delhi Mar 25, 2012, 00:00 IST

Does it matter if the gene introduced in Bt brinjal varies from the natural brinjal by 70 amino acids rather than by one? What if the regulators in the country fail to detect this and rubber stamp a genetically-engineered vegetable on the basis of the premise submitted by the company that produced it — Mahyco in this case? The after-effects of the altered variety would consequently escape the attention of the regulators and the consumers would brave the brunt. A study conducted by an international research institute and commissioned by activist Aruna Rodrigues has said Bt brinjal was approved by the regulators on the basis of a wrong premise. The regulator Genetic Engineering Approval Committee (GEAC) of the Ministry of Environment was misled or chose to be so, says Rodrigues. Fortunately, for consumers and to the chagrin of the UPA government, the then Environment Minister Jairam Ramesh chose to put a moratorium on Bt brinjal till such time as research proved its safety for consumer. Now to the study that calls for a review of the regulation mechanism of biologically-engineered food produce in India: Dr Jack A Heinemann, professor of genetics and molecular biology, Centre for Integrated Research in Biosafety, University of Canterbury in New Zealand, did a molecular analysis of the Bt gene in response to a request by Rodrigues to look at the evaluation conducted by the GEAC. Rodrigues is the chief petitioner in a PIL on GM crops in the Supreme Court filed in 2005. Bt Brinjal has been developed with a pesticidal crystal protein Cry1Ac to give resistance against lepidopteron insects, in particular the brinjal fruit and shoot borer. The problem comes in the mismatch between the claims of the developer and the failure of the regulators to verify them. Cry1Ac protein is not derived from nature but made from a series of in vitro modifications. The first 40 per cent of the amino acids found in Cry1Ac2 were replaced with 466 amino acids from Cry1Ab, another insecticidal protein. The developer has claimed that the fusion construct is 99.4 per cent identical in amino acid order to the natural Cry1Ac protein. However, when Heinemann constructed the fusion, he found that it was maximum of 94 per cent identical to Cry1Ac and only 95 per cent identical to Cry1Ab. Based on these matches, it is also not clear why the developer has historically called their fusion construct after Cy1Ac rather than Cry1Ab, wonders the scientist. At 99.4 per cent identity, he says there would be approximately seven amino acid differences between the fusion and the natural Cry1Ac as described by Monsanto. At 94 per cent identity there could be up to 70 different amino acids, he says. According to him, changes of a single amino acid can significantly alter the characteristics of proteins. And one of them is immunogenicity. Says Rodrigues: It exposes the lapses on the part of our regulators. We don’t have any Bt expert in this country and the study underlines the need for independent studies before clearing a GM crop. In a letter to Jairam Ramesh recently, she cites the study and blames what she calls regulatory lapses “to the huge conflict of interest that exists and, therefore, the alarming degree of ‘interest’ there is to push for GM crops in Indian agriculture and Monsanto in particular”. Gyanendra Shukla, director, Monsanto, says the study will be looked into while Mahyco officials have chosen not to comment. Meanwhile, what the study underlines is something larger than Bt brinjal. It is about the need to have an independent regulator guided only by scientific evidence and not by anything else, as Heinemann says.

Bt brinjal has no history of safe use

http://www.downtoearth.org.in/content/bt-brinjal-has-no-history-safe-use

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Author(s): Latha Jishnu
Issue: Mar 19, 2012

Jack A. Heinemann, professor of molecular biology and genetics at the University of Canterbury, New Zealand, has expertise in genetic engineering, bacterial genetics and biosafety. As director of the University’s Centre for Integrated Research in Biosafety (INBI) since 2001, has contributed in no small measure to a better understanding and management of emerging biotechnologies.

INBI, says the academic, has special responsibility for developing tools that improve safety assessments of genetically modified organisms. These tools are aimed at helping government regulators and scientists with other specialities to access the best available and latest research and apply it to hazard identification. In an interview to Latha Jishnu, Heinemann explains why he was taken aback by the way Mahyco’s Bt brinjal data was assessed by the GEAC, the regulator, and its experts committees.

Jack A. HeinemannJack A. HeinemannWhat, according to you, are the most serious of the shortcomings/misrepresentations in the developer’s data? 

I can’t answer this question for all dossiers. At best I could answer it only for those I’ve seen. If you mean the Bt brinjal data, I don’t know where to begin. I think the most disappointing aspect of that dossier was that every experiment I personally reviewed seemed to have some significant flaw, or was only half finished, leaving effectively nothing to support the conclusions of safety. It had the semblance of authority, but lacked the substance.

Were you taken aback by the findings of your evaluation? Did you expect better monitoring by the Indian regulator and the expert bodies appointed by it given the agriculture profile of the country where farming is essentially a livelihoods issue rather than a commercial proposition?

Yes, I expected more attentiveness to the details, and for the regulator to exercise a greater distance from the data. At the very least, I would have expected the regulator to ask for clarification and data wherever the claims being made were based on assumption and reasoning rather than data.

You say that “the developer reports that a leucine residue at position 766 has been replaced by a serine residue in planta”. What does this mean and what are the consequences?

This means that the gene used in the plant is different from the gene in nature. It is different in several ways and this is just one of those ways. While this one particular amino acid change might sound insignificant, serine is very different from leucine. For example, plant cells often link arrays of sugar molecules to serine residues and these arrays can be structurally variable, affecting many different properties. In particular, the kinds of properties we would be concerned with are those that might affect the immune response of people or wildlife. These structural changes can also interfere with detection of the product after it enters the food chain. Lack of traceability reduces consumer choice and makes it more difficult to recall a product if it is later found to be unsafe.

Again, I quote from the report: “What appear to be small differences can be physiologically and immunogenically important. The change from leucine to serine at position 766 is of interest to the biosafety investigator because only the latter can be O-linked glycosylated by the addition of N-acetylgalactosamine through a side chain hydroxyl group (Mitra et al., 2006).”  How serious are the implications?

We don’t know. No one can say without proper testing. That is the purpose of pre-market risk assessment, to identify molecular changes which might cause adverse effects. Once they are identified, then they can be evaluated through testing. Since developers keep complete control of these products, it would not even be possible for independent scientists such as those in INBI to even attempt testing. Only the regulator can insist on that testing.

You say: “Taken together, PV-LEBK04 has at least 10 different DNA elements that have been taken from different species, including soybeans, viruses, plasmids isolated from different species of bacteria, and many of which have also been extensively and separately subject to in vitro modification after being taken from their natural sources.” What does this mean for a consumer?

What it means is that in many different ways the Bt brinjal has no history of safe use. It is exceedingly unlikely that this diverse combination of genetic elements has come together in nature much less in plants that potentially could be the source of a significant amount of food someone eats. Thus, by international consensus and agreement, the Bt brinjal should benefit from credible safety testing.

Does this poor regulation stem from lack of expertise with the monitoring bodies? For instance, this inability to understand the finer points of a vector/plasmid map. In a case of research fraud in Bt cotton, scientists of public research laboratories passed off a genome sequence as their original DNA construct. The vector map went unchallenged.

This is not something I can answer. The question should be directed at the regulator. But I would ask both the senior managers of the regulatory authority and the minister what pressures are being placed on the regulator and whether these pressures are consistent with expectation that the regulator serves the broader public interest and is precautionary.

Is there a readiness on the part of regulators, specially in the US and Europe, to accept the developer’s data unquestioningly?

In my opinion, some regulators I have worked with seem to be less critical of the data from industry than I experience when I try to publish a scientific paper which has almost no impact on public health or the environment. This strikes me as strange. Not that the standard of review shouldn’t be high for academic research. What is strange is that it does not appear to be as high on a regular and uniform basis for research used by regulators. Most importantly, the requirement that the work and materials be available for independent replication of the results is blocked by proprietary secrecy. Really sound science can be, and is, regularly replicated by other scientists with no strings attached.

Other independent scientists have also pointed out huge shortcomings in the developer’s data and in the evaluation by the ECs. Yet, our regulators have done little to rectify the position. How can INBI help in such a situation?

INBI’s founding mission is to assist civil society and the public to find answers to questions raised by biotechnology. We particularly work with those who have limited or no access to research grants or private funding, essentially those who would be asked to live with any adverse consequences of a biotechnology but not receive the financial benefits. With our limited resources, this is how we try to help. We have no power of compulsion. We can only make the case to the public or to the political decision-makers who, if they agree, can then change policy or legislation to effect better review.

Has INBI been instrumental in strengthening biosafety regulation elsewhere? 

INBI’s work on a variety of corn called LY038 was used by many governments around the world. In the end, the product was pulled from pre-commercial development because some of these governments insisted that the developer answer some of the outstanding safety questions we raised. See  Europe balks at GE corn in NZ and Authority ignored corn risk – expert

INBI has participated in the development of international biosafety guidance documents under the Cartagena Protocol on Biosafety and made submissions to Codex Alimentarius. We have directly worked with training of officials, such as in Solomon Islands. With our partners Third World Network and GenOK-Centre for Biosafety in Norway, we conduct biosafety courses for regulators, civil society leaders, scientists, industry, journalists and decision-makers from developing countries. Through this activity we reach 50 people a year. INBI was also the major partner in production of the Biosafety Assessment Tool, a free to the public risk assessment mentoring website – The Biosafety Assessment Tool

Would you agree with the perception that the large majority of scientists are determined to gloss over the biosafety aspects of transgenic crops because they believe it is the magic bullet for all the problems of agriculture?

I could not possibly say what other scientists think. However, I find convincing the sociological research that shows that independent science is under threat from a network of public-private funding systems and the entrepreneurial aspirations of public universities and government departments. All too often these aspirations also lead to contractual obligations between public institutions and the companies, creating conflicts of interest. I review and discuss this research in my book, Hope not Hype: The Future of Agriculture Guided by the International Assessment on Agricultural Knowledge, Science and Technology for Development. It can be downloaded free at http://bch.cbd.int/database/record.shtml?documentid=100891

How does INBI manage to provide such a service without charging any fees? 

We work weekends and evenings!  All those working in INBI do so because we believe in the mission. We are public researchers working in a good public university and allied with other like-minded researchers in similar situations. While this work does not pay the bills, it does build our own competence and helps to focus us on the science that is important. The work has attracted some of the best students I’ve ever had, because they want to make a difference, not just make money. We benefit too. Not directly, but because we think it makes our other work better. So far, our employers agree!

GEAC, experts slip on basics?

Author(s): Latha Jishnu
Issue: Mar 31, 2012

As the biotech industry takes heart from the prime minister’s remark, a fresh report shows India’s regulation and expertise on GM crops are sloppy

imageBangalore Declaration on GM crops is unveiled by FBAE president Shantu Shantaram (second from left) and secretary C Kameswara Rao (second from right)

BUOYED by the prime minister’s remark that NGOs were responsible for the moratorium on the release of GM or Bt brinjal, the biotech industry is stepping up its campaign to get it lifted along with “all constraints in the research and development work of biotech crops”. It is also asking the government to ensure that the regulator, Genetic Engineering Approval Committee (GEAC), carries out its mandated functions without hindrance till such time as the Biotechnology Regulatory Authority of India (BRAI) becomes operational.

In what it calls the Bangalore Declaration, top industry lobby groups, the Association of Biotech Led Enterprises-Agriculture Group (ABLE-Ag) and the Foundation for Biotechnology Awareness and Education (FBAE), also urged the passage of the BRAI bill without further delay. The so-called declaration was made after a series of industry-sponsored conferences held across the country to plug biotechnology as the tool for guaranteeing India’s food security. While this has triggered a predictable counter-campaign by the anti-GM crops movement, an unexpected embarrassment for the government and industry is a fresh report that has exposed more flaws in the data supplied by Mahyco, the developer of the Bt brinjal event EE-1, and the unquestioning acceptance of its claims by GEAC and the two expert committees (EC-I and EC-II) that advised it.

Jack A Heinemann
“To say that a novel protein is likely to be of no safety concern because of even as few differences as seven amino acids is not a research-based conclusion”
——Jack A Heinemann

The report by reputed geneticist and biosafety expert Jack A Heinemann has been submitted to the Minister of Environment and Forests (MoEF), Jayanthi Natarajan, under whose charge GEAC functions. Heinemann is professor of molecular biology and genetics at the University of Canterbury in New Zealand, and director of its Centre for Integrated Research in Biosafety (INBI).

His evaluation has vindicated once again the decision taken by Natarajan’s predecessor Jairam Ramesh in February 2010 to put on hold the commercial release of Mahyco’s Bt brinjal despite GEAC’s approval in 2009. Heinemann is the latest in a series of international scientists who have pointed out flaws in the Mahyco dossier on its EE-1 event (see ‘Holes in risk analysis of Bt brinjal’, Down To Earth (DTE), October 31, 2010). In his “cautious, precautionary principle-based approach” order, Ramesh had said the moratorium would stay “till such time independent scientific studies establish, to the satisfaction of both the public and professionals, the safety of the product from the point of view of its long-term impact on human health and environment”. Ramesh, now minister for rural development, had taken exception to Prime Minister Manmohan Singh’s implication in an interview given to Science (February 24, 2012) that the moratorium was the result of pressure from NGOs in the US and Scandinavian nations. In a rebuttal, Ramesh said his decision was determined by four factors: position of the states, lack of consensus among the scientific community, the fact that the tests were not completed and that there was no independent professional mechanism to instil confidence among people.

The Heinemann evaluation is scathing in its indictment of the developer, the regulators and the experts set by it. The most serious of the flaws, it points out, were the significant anomalies in the reporting of the constructs and in the characterisation of event EE-1. In addition, “it was apparent that critical and fundamental characterisation of the event was not completed, usually because of assumption-based reasoning [for example, the plasmid (or vector) does not transfer because the developer thought that it should not] that was often both faulty and also not confirmed by readily available science. When such fundamental misunderstandings of the basic tools of the procedure 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.” The GEAC comes in for particular censure because it “repeatedly failed to appreciate the significance of the plasmid map itself which clearly showed only a single T-DNA border sequence and ignored the reports from independent scientists who alerted EC II to this”.

The most alarming finding is that Mahyco’s Bt brinjal uses a binary plasmid vector PVLEBK04 that has at least 10 different DNA elements taken from different species, including soybeans, viruses, plasmids isolated from different species of bacteria, and many of which have also been extensively and separately subject to in-vitro modification after being taken from their natural sources. The commercial trait in Bt brinjal, according to Mahyco, is conferred by the Cry1Ac-like derived protein. However, Heinemann says the protein is not Cry1Ac isolated from natural plasmids of Bt but a protein made from a series of in-vitro modifications. The first 40 per cent of the amino acids found in Cry1Ac2 were replaced with 466 amino acids from Cry1Ab, another insecticidal protein.

Again, while the developer claimed that the fusion construct is 99.4 per cent identical in amino acid order to the natural Cry1Ac protein, the biosafety scientist finds the fusion is a maximum of 94 per cent identical to Cry1Ac and only 95 per cent identical to Cry1Ab. “What appear to be small differences can be physiologically and immunogenically important,” warns the report. Heinemann explains that at 94 per cent identity, there could be 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 seven amino acids is not a research-based conclusion” because changes of single amino acids can significantly alter the characteristics of proteins. The impact of poor initial characterisation includes: distrust of the detection method (which EC-II claimed without evidence was specific to Bt brinjal) because failure to properly confirm the number and structure of inserts undermines the design of the tools used to confirm transfer of the recombinant DNA through crosses; and invalidation of conclusions surrounding unintended changes.

In an interview to DTE, Heinemann says, “Every experiment I personally reviewed seemed to have some significant flaw, or was only half finished, effectively leaving nothing to support the conclusions of safety. It had the semblance of authority, but lacked the substance” (see ‘Bt brinjal has no history of safe use’, www.downtoearth.org.in).

Critically and most importantly, the developer used a plasmid that was designed to transfer in toto. This has also been stated clearly by Monsanto which provided the developer with the plasmid. Yet, Mahyco, which is part-owned by Monsanto, and the two expert committees advising GEAC repeatedly failed to appreciate the significance of the plasmid map itself which clearly showed only a single T-DNA border sequence, and ignored the reports from independent scientists who alerted EC-II to this.

Mahyco has yet to respond to questions on these issue sent by DTE.

The Heinemann report, which is a more comprehensive evaluation of findings submitted earlier to MoEF, was prepared following a request to INBI whose mission is to assist civil society to find answers to questions raised by biotechnology. The tools it develops are available for free public use, but are optimised for those countries such as India that have ratified the Cartagena Protocol on Biosafety. The developer claimed that there was a single insert into the brinjal genome and that it corresponded to just the Cry1Ac-like gene intended for insertion, but Heinemann claims there are several reasons this evidence is incapable of demonstrating the required proof. For one, the only probe used was described as just “Bt”. Worse, no information was provided about sensitivity of the probe.

The report comes in the wake of FBAE secretary C Kameswara Rao calling for the removal of “unjustified and arbitrary constraints that jeopardise the functioning and development of agribiotech research such as the requirement of permission of state governments for field testing of biotech crops approved by the regulator, and the threat of legal action against the use of indigenous germplasm to develop biotech crops for indigenous use. Other signatories include B Sesikeran, director of National Institute of Nutrition, who was a member of EC-II; Gurudev S Khush, World Food Prize laureate and adjunct professor, University of California; and Klaus Ammann, honorary professor for biodiversity at University of Bern.

ABLE-Ag’s contention that opposition to biotechnology is driven by vested interests rather than scientific analysis reflects the prime minister’s stance. It says India has “one of most stringent regulatory systems in the world”. But even as ABLE-Ag and FBAE were making a pitch for Bt brinjal, the states’ opposition to even field tests of GM in their backyard was mounting, with Rajasthan becoming the latest to join their ranks (see ‘Rajasthan bans GM trials’).

Jairam Ramesh defends controversial Bt Brinjal decision

New Delhi: Union Minister Jairam Ramesh on Saturday defended his decision to put a moratorium on Bt Brinjal and said that he has never been influenced by NGOs in taking decision on Genetically Modified (GM) foods, during his stint as Environment Minister.

Jairam Ramesh said no NGO influenced his decision to put a moratorium on Bt Brinjal, a statement that comes against the backdrop of PM raising questions about the role of foreign funded NGOs in blocking use of genetic engineering.

Speaking to CNN-IBN, Jairam said the wide-spread opposition to GM crops from several states and the lack of public-sector backed GM seeds guided his decision.

“On Bt Brinjal since I was directly involved I can confidently say no foreign NGOs influenced my view. The moratorium on Bt Brinjal was imposed on March 9, 2010. Almost two years have passed. I went though a seven month process of public consultation with scientists, NGOs, civil society organisations, farmer organisations in which 8000 people participated. I wrote to chief ministers. I wrote to 50 scientists across India and the world,” said.

“Green Peace a foreign funded NGO accused me of propagating the line of Monsanto during a public hearing in Bangalore. So on Bt Brinjal, since I was directly involved, I can confidently say no NGOs influenced my views,” Ramesh, said.

He said his position on Bt Brinjal was determined by the positions of state governments, the lack of consensus among the scientific community, the fact that the tests were not completed and there was no independent professional mechanism which will instill confidence in the public.

“I did not ban Bt Brinjal. I decided lets put moratorium. Lets fulfill all these four conditions and then revisit the whole issue,” he said.

His remarks came in response to a question about allegations that some NGOs based in Scandinavian countries funded the protests against Bt Brinjal. His remarks also came against the backdrop of Prime Minister’s comments that some NGOs based in the United States and Scandinavian countries were not “fully appreciative” of the development challenges India faces.

Ramesh said as Environment Minister he enforced the moratorium on Bt Brinjal on February nine, 2010 after going through a seven-month process of public consultation.

The Rural Development Minister said that there were four concerns on the Bt Brinjal. “There was no scientific consensus for the need for Bt Brinjal, scientists were divided. MS Swaminathan, the father of the green revolution had also raised questions. The full protocol of tests had not been completed. Unlike Bt Cotton, Bt Brinjal is something you eat every day. Safety and reliability tests had not been completed,” he said.

“While the NGOs had a point of view, my position on Bt Brinjal was determined by opposition from state governments, lack of consensus among the scientific community, the fact that the tests had not been concluded, and there had been no independent professional regulatory mechanism, which could instil confidence in the public. That food crop which is going to be ingested are going to be safe for consumption. I did not ban Bt Brinjal. I said let’s fulfill these four conditions and then revisit the issue,” he added.

No NGO Pressure in Moratorium on Bt Brinjal: Jairam

http://news.outlookindia.com/items.aspx?artid=752933
No NGO Pressure in Moratorium on Bt Brinjal: Jairam

Union Minister Jairam Ramesh today said no NGO influenced his decision to put a moratorium on Bt Brinjal, a statement that comes against the backdrop of Prime Minister Manmohan Singh raising questions about the role of foreign funded NGOs in blocking use of genetic engineering.
“Green Peace a foreign funded NGO accused me of propagating the line of Monsanto during a public hearing in Bangalore. So on Bt Brinjal, since I was directly involved, I can confidently say no NGOs influenced my views,” Ramesh, who is on a three-day Kerala visit, told reporters here.

He said his position on Bt Brinjal was determined by the positions of state governments, the lack of consensus among the scientific community, the fact that the tests were not completed and there was no independent professional mechanism which will instill confidence in the public.

“I did not ban Bt Brinjal. I decided lets put moratorium. Lets fulfil all these four conditions and then revisit the whole issue,” he said.

His remarks came in response to a question about allegations that some NGOs based in Scandinavian countries funded the protests against Bt Brinjal.

His remarks also came against the backdrop of Prime Minister’s comments that some NGOs based in the United States and Scandinavian countries were not “fully appreciative” of the development challenges India faces.

Ramesh said as Environment Minister he enforced the moratorium on Bt Brinjal on February nine, 2010 after going through a seven-month process of public consultation.

Ramesh said consultations were held with scientists, NGOs, civil society organisations and farmer organisations in which around 8,000 people participated.

“I wrote to all Chief Ministers, I wrote to 50 scientists across the world. Firstly, states opposed Bt Brinjal. Secondly, there was no scientific consensus on the need for Bt Brinjal why Bt brinjal and in fact Father of Green Revolution M S Swaminathan himself had raised questions on where we were going,” he said.

He said Chief Ministers like Nitish Kumar (Bihar), Naveen Patnaik (Odisha), Narendra Modi (Gujarat), Shivraj Singh Chauhan (Madhya Pradesh) and B S Yedddyrupaa (Karnataka) have then raised questions about Bt Brinjal.

“I cannot ignore states. Ultimately in agriculture, we have to take states along with us,” he said.

“No state was with us on Bbt brinjal. Modi who is a great champion of Bt Cotton was not with us on Bt Brinjal. That is a very important distinction. But cotton does not have a same time of safety risk on humans as Bt Brinjal,” he said.

Monsanto let off the hook on Bt Brinjal Monsanto let off the hook on Bt Brinjal

http://www.tehelka.com/story_main51.asp?filename=Ne250212Monsanto.asp

CURRENT AFFAIRS
KARNATAKA

Despite violating the Biodiversity Act, American seed major escapes legal action, reports Imran Khan

Farmers protest against Monsanto in Bengaluru
Bad genes Farmers protest against Monsanto in Bengaluru

AFTER GUNNING for American seed major Monsanto and its Indian subsidiary Mahyco for violating the Biological Diversity Act in the Bt Brinjal case, the Karnataka State Bio-diversity Board has decided not to prosecute the violators.

The decision was taken on 20 January while reviewing the complaint of Bengaluru based Environment Support Group (ESG) against Monsanto, Mahyco and the University of Agricultural Sciences (UAS), Dharwad, accusing them of violating norms by illegally accessing six varieties of brinjal endemic to India and genetically modifying it, resulting in Bt Brinjal.

In a letter dated 15 February 2010 addressed to the KSBB and the National Biodiversity Authority (NBA), ESG had alleged that Monsanto, Mahyco and UAS used six local varieties of brinjal for developing Bt Brinjal without the approval of the board or the local biodiversity committees as required by law.

ESG said that the development of Bt Brinjal was undertaken on the basis of an MOU signed between Mahyco along with Sathguru (a front company of USAID and Cornell University) and UAS based on their deal of 2 April 2005. A similar deal was signed with Tamil Nadu Agricultural University, Coimbatore, and Indian Institute of Vegetable Research, Lucknow.

The KSBB wrote a letter to the NBA on 10 March 2010 seeking its legal opinion. On 11 August 2011, the NBA acknowledged that the complaint merits a legal case.

On 28 September, Minister of State for Environment and Forests Jayanthi Natarajan said in the Lok Sabha: “The NBA has recommended legal action against the alleged violators for accessing and using local brinjal varieties without prior approval of the competent authority.”

However, in a U-turn, the KSBB resolved: “It is for the NBA to take necessary action against the institutions/companies regarding alleged violations of provisions under the Biodiversity Act.”

The resolution made Leo Saldanha of ESG furious. “There is little doubt that this controversial resolution was passed to unhook Monsanto and its collaborators from biopiracy charges,” says Saldanha. “It is tenable to draw such a conclusion as the current action agitates against the consistent position held by the KSBB that our complaint has merit and action must be initiated.”

In a U-turn, the KSBB resolved that it is for the NBA to take action against Monsanto

Saldanha claims that former state environment minister and KSBB chairman Krishna Palemar had earlier demonstrated his intent to prosecute the violators. However, in the 20 January meeting of the KSBB, he became party to passing a resolution that amounts to abdicating his responsibility. Interestingly, Palemar was one of the three ministers caught in the infamous porngate scandal.

But KSBB officials had a different story to tell. “We lack the staff and technical expertise to pursue the case,” says KSBB Member Secretary KS Sugara. “The Act is new and our officers are not well versed with it. We don’t have the powers to prosecute anybody, it can be done only through the wildlife wing.”

Meanwhile, Additional Chief Secretary Kaushik Mukherjee was more forthcoming in his support for Monsanto. “It has not violated any laws and there is no need to seek permission from the board, since it’s an issue concerning the Indian Council of Agricultural Research. It’s just a hue and cry raised by NGOs. While they are eager to point out genetic modification in food crops, they don’t utter a word when it comes to drugs that have GM molecules,” he says

NBA Chairman Balakrishna Pisupati refused to comment on this issue. So was the case with Monsanto. A letter addressed to Mahyco Chief Technological Officer Usha Barwale Zehr seeking her company’s comment went unanswered.

“This is an astonishing act of abandoning the KSBB’s obligatory functions of taking appropriate legal action against Monsanto and Mahyco and their collaborators for committing criminal acts of biopiracy,” says Saldanha.

Imran Khan is a Senior Correspondent with Tehelka.com. 
imran@tehelka.com

Parliament told that Mahyco/Monsanto will be prosecuted for biopiracy in Bt Brinjal case


Funding of NBA on BT. BRINJAL
National Biodiversity Authority (NBA) has received a complaint from M/s. Environment Support Group, an NGO on the alleged violation by M/s. Mahyco / M/s. Monsanto and their collaborators for accessing and using the local brinjal varieties for development of Bt Brinjal. NBA has decided to proceed as per law against the alleged violators on the basis of reports of the State Biodiversity Board for accessing and using the local brinjal varieties without prior approval of the competent authority.

This information was given by the Minister of State for Environment and Forests (Independent Charge) Shrimati Jayanthi Natarajan in a written reply to a question by Shri M.P. Achuthan And Shri D. Raja in Rajya Sabha today.

Mahyco defends action in Bt brinjal trials

BS Reporter / Chennai/ Bangalore August 17, 2011, 0:33 IST

Seed company, Mahyco has clarified it has not violated any provision of the Biological Diversity Act, 2002, in its research to develop Bt Brinjal.

Recently, the National Biodiversity Authority of India (NBA) had recommended legal action against Mahyco and Monsanto for violating the biodiversity protection law in promoting Bt Brinjal. “Mahyco has not indulged in any activity which would be a violation of the Biological Diversity Act, 2002,” a company statement said.

In a resolution at its meeting on June 20, the NBA had decided to initiate legal action against Mahyco/Monsanto and their collaborators for using the local brinjal varities in developing Bt brinjal without a prior approval of the competent authorities, the Environment Support Group (ESG) said in a statement here, quoting from the resolution released on Thursday last in New Delhi.

The NBA decision was based on a complaint filed by ESG with the Karnataka Biodiversity Board on February 15, 2011.

“The state board investigated the matter and informed NBA on May 28 that six local varieties for developing Bt Brinjal were accessed in the state by the two companies without prior approval,” the statement said.

The board also recommended legal action against the University of Agricultural Sciences at Dharwad in north Karnataka, Tamil Nadu Agricultural University in Coimbatore, and Sathguru Management Consultants Ltd, representing the consortium involving the United States Agency for International Development and US’ Cornell University for collaborating with the seed firms in violation of the Biological Diversity Act (section 4).

The Bangalore-based ESG accused the agencies of illegally accessing 10 varieties of brinjal in Karnataka and Tamil Nadu without the consent of the regulatory boards although it was mandatory to protect the loss of biodiversity from contamination when transgencis are involved.

In addition, the law mandates that when biodiversity is to be accessed in any manner for commercial, research and other uses, local communities who have protected local varieties and have been cultivating for generations must be consulted, and if they consent, benefits must accrue to them as per the internationally applicable ‘Access and Benefit Sharing Protocol’.

The environmental release of the first ever Genetically Modified Food (Bt Brinjal — eggplant) in India, promoted by Mahyco (an Indian subsidiary of US-based Monsanto), was stayed by a February 2011 moratorium decision on the product’s environmental and commercial release by the then Environment Minister Jairam Ramesh. This decision was the outcome of public opinion gathered in a series of nation-wide public consultations that he held and was also based on a variety of scientific evidence and legal analysis.