Study linking GM maize to cancer must be taken seriously by regulators

Trial suggesting a GM maize strain causes cancer has attracted a torrent of abuse, but it cannot be swept under the carpet Professor Gilles-Eric Séralini, professor of molecular biology at Caen University in France, knows how to inflame the GM industry and its friends.

For seven years he and his team have questioned the safety standards applied to varieties of GM maize and tried to re-analyse industry-funded studies presented to governments.The GM industry has traditionally reacted furiously and personally. Séralini has been widely insulted and smeared and last year, in some desperation, he sued Marc Fellous, president of the French Association of Plant Biotechnology, for defamation, and won (although he was only awarded a nominal €1 in damages). But last week, Seralini brought the whole scientific and corporate establishment crashing down on his head. In a peer-reviewed US journal, Food and Chemical Toxicology, he reported the results of a €3.2m study. Fed a diet of Monsanto’s Roundup-tolerant GM maize NK603 for two years, or exposed to Roundup over the same period, rats developed higher levels of cancers and died earlier than controls. Séralini suggested that the results could be explained by the endocrine-disrupting effects of Roundup, and overexpression of the transgene in the GMO.

This was scientific dynamite. It was the first time that maize containing these specific genes had been tested on rats over two years – nearly their full lifespan – as opposed to the 90-day trials demanded by regulators. Around a dozen long-term studies of different GM crops havefailed to find similar effects. Séralini’s study also looked at the toxicity of the Roundup herbicide when fed directly to rats.If the study stood up, then the consistent arguments of the industry that its GM maize is safe might be fatally undermined, with immense political, financial and social consequences. But barely had the paper surfaced than it was attracting heavyweight academic criticism.

Commentators variously claimed the study to be “biased”, “poorly performed”, “bogus”, “fraudulent”, “sub-standard”, “sloppy agenda-based science”, “inadequate” and “unsatisfactory”. Séralini was said to have “sought harm” for the rats, the experiment was dismissed as “inhumane” and the research group was called “partisan”. France was voted as “the most anti-science country in anti-science Europe” and vociferous GM supporters such as Mark Lynas urged people to sign a petition demanding full disclosure of the data (only a few hundred have).Meanwhile, GM opponents were said to be the “climate skeptics of the left”, Séralini and his scientists were labelled “crafty activists” and “anti-science” and the group that funded the study was accused of “polluting science communication” by asking for an embargo on the paper.Séralini and the other authors of the study responded that they were surprised at the “violence” of their critics.

But it was a triumph for the scientific and corporate establishment which has used similar tactics to crush other scientists like Arpad Pusztai of the Rowett Institute in Scotland, who was sacked after his research suggested GM potatoes damaged the stomach lining and immune system of rats, and David Quist and Ignacio Chapela, who studied the flow of genes from illegally planted GM maize to Mexican wild maize. But now that the dust is settling, let’s look at some of the criticisms and Seralini’s responses.

“This is not an innocent scientific publication. The study was designed to produce exactly what was observed,” said Dr Bruce Chassy, professor emeritus of food science at the University of Illinois, who has worked as a consultant for GM companies and has been a member of the US Food and Drug Administration’s Food Advisory Council which is fully behind GM.

“This study appears to be without scientific merit,” said Martina Newell-McGloughlin, director of the International Biotechnology Program at the University of California/Davis, which has close links to Monsanto and other GM companies.”Although this paper has been published in a peer–reviewed journal with an [Impact Factor] of about 3, there are anomalies throughout the paper that normally should have been corrected or resolved through the peer-review process,” said Maurice Moloney, InsChief Executive of Rothamsted Research.

“The control group is inadequate to make any deduction,” said Anthony Trewavas, prominent champion of GM food and a former member of the governing council of Britain’s leading plant biotech research organisation, the John Innes Centre.”We have to ask whether a diet with this level of maize is normal for rats. Another control with an alternative diet should have been included,” said Dr Wendy Harwood, senior scientist at the John Innes Centre.

Monsanto was dismissive: “This study does not meet minimum acceptable standards for this type of scientific research, the findings are not supported by the data presented, and the conclusions are not relevant for the purpose of safety assessment.”

Here are the criticisms in a nutshell and Séralini’s responses:

1. The French researchers were accused of using the Sprague Dawley rat strain which is said to be prone to developing cancers. In response Séralini and his team say these are the same rats as used by Monsanto in the 90-day trials which it used to get authorisation for its maize. This strain of rat has been used in most animal feeding trials to evaluate the safety of GM foods, and their results have long been used by the biotech industry to secure approval to market GM products.

2. The sample size of rats was said to be too small. Séralini responded that six is the OECD recommended protocol for GM food safety toxicology studies and he had based his study on the toxicity part of OECD protocol no. 453. This states that for a cancer trial you need a minimum of 50 animals of each sex per test group but for a toxicity trial a minimum of 10 per sex suffices. Monsanto used 20 rats of each sex per group in its feeding trials but only analysed 10, the same number as Séralini.

3. No data was given about the rats’ food intake. Seralini says the rats were allowed to eat as much food as they liked.

4. Séralini has not released the raw data from the trial. In response he says he won’t release it until the data underpinning Monsanto’s authorisation of NK603 in Europe is also made public.

5. His funding was provided by an anti-biotechnology organisation whose scientific board Séralini heads. But he counters that almost all GM research is funded by corporates or by pro-biotech institutions.

So where does that leave the public?

Despite the concerns over Séralini’s methodological flaws, it looks as though the study will not be swept under the carpet. It is the longest study done on this variety of maize and many argue that it must be taken seriously by regulators and governments. French health and safety authorities now plan to investigate NK603 and the study’s findings and the European Food Safety Agency has said it will assess the research. Séralini is now demanding that all the data be assessed by an independent international committee, arguing that experts involved in the authorisation of the maize should not be involved.Equally, the study reopens questions about the regulation of GM crops. There has long been concern that these foods have been evaluated poorly and that the companies have taken advantage of lax regulation. The GM industry, which keeps its own research secret, has resisted investigation or any change.In fact, there is one irony that a few scientists have pointed out but who have been drowned out in the furore. Séralini’s study was not so much about the dangers of GM technology, but the toxicity of the Roundup herbicide used on the crops. Here’s Ottoline Leyser, associate director of the Sainsbury Laboratory, University of Cambridge:

“Like most of the GM debate, this work has very little to do with GM. The authors of the paper do not suggest that the effects are caused by genetic modification. They describe effects of the roundup herbicide itself and effects that they attribute to the activity of the enzyme introduced into the roundup resistant maize. There is good evidence that introducing genes into crops using GM techniques results in fewer changes to the crops than introducing them using conventional breeding.”

Late lessons from early warnings: science, precaution, innovation

The European Environment Agency has come up with the part 2 of their path breaking report “Late lessons from early warnings: science, precaution, innovation”. ( 800 pages)  with a summary report of 48 pages . The part 1 of this report was released in 2001 to global acclaim. This report and case studies is peer reviewed . According to the EEA (http://www.eea.europa.eu/publications/late-lessons-2):
The 2013 Late lessons from early warnings report is the second of its type produced by the European Environment Agency (EEA) in collaboration with a broad range of external authors and peer reviewers. The case studies across both volumes of Late lessons from early warnings cover a diverse range of chemical and technological innovations, and highlight a number of systemic problems. The ‘Late Lessons Project’ illustrates how damaging and costly the misuse or neglect of the precautionary principle can be, using case studies and a synthesis of the lessons to be learned and applied to maximising innovations whilst minimising harms.
All versions of the report are available here: summary, full report,e-book, kindle form : http://www.eea.europa.eu/publications/late-lessons-2
 
The GM chapter is chapter 19 ( pages 490- 517 only 20 pages all of us must read it) which compares GM technology the top down approach and agro-ecological approaches as bottom up. It goes thru case studies of whether Ht crops are suitable for global south, gives figures of GM area, the problems with confusing ‘lack of evidence of harm” with “ëvidence of lack of harm”, strangle hold of corporations, the lack of public sector and wiping out indigenous seeds , skill and so on after debating the agro-ecological approaches   and concludes that
“The early warning, or perhaps late lesson, to be heeded here is that if one follows the top-down, usually technologically oriented, approaches to innovation,the desired outcomes for addressing food insecurity will not be achieved. Top-down approaches will most likely fail to deliver on the
large promises of food security and alleviation of poverty, mainly because these approaches contribute to a feedback cycle that concentrates resources, knowledge, and influence as witnessed in the seed and agrichemicals sector (Adi, 2006; De Schutter, 2009; Fernandez-Cornejo, 2006; Howard, 2009).Through this power, top‑down providers can artificially homogenise both the conception of the problem to be solved and the solutions — such as GM crop plants — they propose. All too often questioning the rationality of the approach gets lost in the background of the unquestioning discussion over the use of the approach (Pavone, 2011 and see discussion in Boxes 19.1 an 19.2). Perhaps greater reflection and social deliberation into why and for whom agricultural innovations should be produced is needed if we are truly going to follow more sustainable pathways in the production of food and fibre. In the path ahead, societies In the path ahead, societies will have to make more conscientious choices of how to define and shape innovation to produce solutions that are appropriate for meeting global challenges related to agriculture. Bottom-up approaches are proving capable of getting sustainable, participatory and locally adapted solutions into the hands of those that need them most (Altieri, 2011a; Emerging issues | Hungry for innovation: pathways from GM crops to agroecology 510 Late lessons from early warnings: science, precaution, innovation De Schutter, 2011), but are incapable of flourishing where invention is limited to what can be easily described by prevailing IP instruments. Change the directions, distribution and diversity of innovation, and you change the world.”
Devi

Possible consequences of the overlap between the CaMV 35S promoter regions in plant transformation vectors used and the viral gene VI in transgenic plants

Possible consequences of the overlap between the CaMV 35S promoter regions in plant transformation vectors used and the viral gene VI in transgenic plants Download

Multiple variants of the Cauliflower mosaic virus 35s promoter (p35s) are used to drive the expression of transgenes in genetically modified plants, for both research purposes and commercial applications. The genetic organization of the densely packed genome of this virus results in sequence overlap between p35s and viral gene VI, encoding the multifunctional p6 protein. The present paper investigates whether introduction of p35s variants by genetic transformation is likely to result in the expression of functional domains of the p6 protein and in potential impacts in transgenic plants. A bioinformatic analysis was performed to assess the safety for human and animal health of putative translation products of gene VI overlapping p35s. No relevant similarity was identified between the putative peptides and known allergens and toxins, using different databases. From a literature study it became clear that long variants of the p35s do contain an open reading frame, when expressed, might result in unintended phenotypic changes. A flowchart is proposed to evaluate possible unintended effects in plant transformants, based on the DNA sequence actually introduced and on the plant phenotype, taking into account the known effects of ectopically expressed p6 domains in model plants.

Regulators Discover a Hidden Viral Gene In Commercial GMO Crops

Synopsis: A scientific paper published in late 2012 shows that US and EU GMO regulators have for many years been inadvertently approving transgenic events containing an unsuspected viral gene. As a result, 54 different transgenic events commercialized internationally contain a substantial segment of the multifunctional Gene VI from Cauliflower Mosaic Virus (CaMV) within them. Among these are some of the most widely grown GMOs, including Roundup Ready Soybean (40-3-2) and MON810 Maize. The oversight occurred because regulators failed to appreciate that Gene VI overlaps the commonly used CaMV 35S gene regulatory sequence.

The authors of the paper, working for the European Food Safety Authority, concluded that functions of Gene VI were potential sources of harmful consequences. They further concluded that, if expressed, the fragments of Gene VI are substantial enough for them to be functional (Podevin and du Jardin (2012) GM Crops and Food 3: 1-5). This discovery has multiple ramifications for biotechnology. Foremost, there is the immediate question of GMO safety and whether the 54 events should be recalled, but secondly, the failure implicates regulators and the industry in a circle of mutual incompetence and complacency.

The discovery will also strengthen the argument for GMO labeling: if regulators and industry cannnot protect the public then why should they not be allowed to protect themselves?

by Jonathan Latham and Allison Wilson

Published today (January 21st) in Independent Science News:

http://independentsciencenews.org/commentaries/regulators-discover-a-hidden-viral-gene-in-commercial-gmo-crops/

 

Indian scientists found guilty of marketing contaminated GM cotton seeds

Indian scientists found guilty of marketing contaminated GM cotton seeds Dinesh C Sharma | New Delhi, December 14, 2012 | 10:40 A farmer in a cotton farm. In what appears to be a case of serious scientific fraud and subsequent cover up, Indian scientists have been found guilty of commercialising contaminated genetically modified(GM) cotton seeds despite knowing about contamination for several years. The GM cotton variety in question- Bikaneri Nerma Bt or BN Bt- was developed by the Nagpur-based Central Institute for Cotton Research(CICR) of the Indian Council of Agriculture Research(ICAR). It was commercialised in 2009 and was touted as an alternative to GM cotton marketed by Mahyco. Two years back, Mahyco complained to ICAR that BN Bt, in fact, contained a gene developed by its partner Monsanto. Now, an expert panel which was asked to investigate the contamination has submitted its report. The report reveals how the contamination took place and scientists at various levels tried to cover it up. The five-member panel was headed by leading biotechnologist and JNU vice-chancellor S K Sopory. Not only has the panel confirmed contamination with Monsanto gene, it has hinted that the contamination may not be “accidental”. “Accidental contamination would be difficult to explain”, the report says citing several technical reasons. After Mahyco complained, the seeds were tested at two labs once again. Certain tests conducted in 2004 at the National Research Centre on Plant Biotechnology, New Delhi showed it was indeed BN Bt while different batch of the same material taken to and tested at CICR in 2005 showed extensive contamination. “Thus, assuming only accidental contamination can not explain what has happened”, the report notes. The Indian variety was originally developed at the University of Agricultural Sciences(UAS), Dharwad and then further work was carried out at CICR Nagpur. The report says the variety got contaminated at Dharwad itself, where Monsanto variety was also being field tested. The most shocking part of the episode is the fact that scientists knew about the contamination and yet they went ahead with regulatory approvals and comercialisation of seeds. “There were indications prior to commercial release in 2009 that BN Bt was contaminated. These were not formally brought to the attention of relevant authorities. Neither these indications were followed up appropriately by the scientist who observed them nor was any attention paid by others who came to know of them”, the report has concluded. “There seemed to extreme hurry to come up with public sector Bt cotton”, it adds. CICR director Dr Keshav Kranthi knew there was something wrong with seeds brought by his predecessor Dr B.M. Khadi from UAS in 2005 itself. He kept silent for four years, participated in all bio-safety and other ICAR meetings, distributed seeds to farmers and even published papers in scientific journals. At UAS, the panel said, Dr Khadi and Dr I S Katageri were lax in maintaining purity of seeds. “Dr Khadi should have been more careful, as he got the information from Dr Kranthi about the contamination in 2008”, the report said. On the role of Dr Kranti, it says: “Dr Kranthi conducted analysis which gave him enough reasons to suspect about contamination in 2005 and 2008. Although these were crucial observations, he did not give written reports to his seniors.” ICAR has been blamed for faulty planning and poor oversight of the project. Desi Bt cotton trail ICAR’s Bt cotton variety ‘Bikaneri Nerma’ was approved by regulators in 2008 Seeds were distributed to farmers in 2009 and the variety commercialised It was found in 2010 that variety’s performance was poor and it contained Monsanto’s GM cotton gene ICAR set up committee to find out if the scientists have really made a distinct Bt cotton variety and how it got contaminated The panel has found that while an independent variety different from that of Monsanto does exist in lab, but it got contaminated in 2004-2005 Though scientists noticed contamination in 2005, they went ahead with seed multiplication and commercialization

GM crops in India at various stages of regulatory field evaluations as of 2012

                                (8 traits; 17 crops; 32 institutions)

Traits

 

Crops, Year(s) of approval and Product developers*

(*see the names of the product developers below by looking at the nos. in parenthesis)

Insect resistance

 

Brinjal/Eggplant – 2006, 2007 to 2010 (4,9,14,21,23,28,30);

Cabbage – 2006, 2009  (12,14); Castor – 2006, 2011 (19);

Cauliflower – 2006, 2008 (12,14) ; Chickpea – 2009 (25);

Corn /Maize – 2006, 2010 (10,15); Cotton – 2008 to 2012 (3,5,7,8,11,16);

Okra – 2006,2007(9); Rice- 2006, 2007 to 2011 (3,6,9,11,21,28);

Sorghum – 2009,2011 (20); Sugarcane – 2010 (27);

Tomato – 2006,2010 (9,23)

Virus resistance

 

Groundnut – 2006, 2009-2010 (24); Papaya – 2010 (22);

Potato – 2006, 2009 (17); Tomato – 2006,2010 (21,22);

Watermelon – 2010 (22)

Herbicide tolerance Corn/Maize – 2012 (10); Cotton – 2010, 2012 (3, 9)
Herbicide tole. &

Insect resis. stacked

Corn/Maize – 2008 to 2011 (10,13,15) ;

Cotton – 2008-2009, 2011-2012 (3,9,10,13,15) ; Rice – 2010 (3)

Drought tolerance Chickpea – 2009 (24); Groundnut – 2009 to 2012 (24);

Mustard – 2010 (25); Rice – 2011 (32); Sorghum – 2010 (18)

Yield enhancement Rice – 2011 (2)
Delayed ripening Tomato – 2006,2008,2010 (1,21,25)
Male sterile, female inbred lines Mustard – 2010-2011 (31) ; Rice – 2010-2011 (6)
Compiled by: Manjunath,T.M. (2012); Data source: http://igmoris.nic.in/field_trials.asp(refer to this website for details on genes/events).


Product developers:
Private companies: 
1. Avesthagen Ltd., 2. BASF India Ltd., 3. Bayer Bioscience Pvt Ltd., 4. Bejo Sheetal Seeds, 5. Dow Agrosciences India Pvt Ltd., 6. E. I. Dupont India Pvt. Ltd., 7. J. K. Agri Genetics, 8. Krishidhan Seeds, 9. Maharashtra Hybrid Seed Co. Ltd. (MAHYCO), 10. Monsanto India Ltd., 11. Metahelix Life Sciences Pvt Ltd., 12. Nunhems India Pvt Ltd., 13. Pioneer Overseas Corporation, 14. Sungro Seeds Pvt Ltd., 15. Syngenta Biosciences Pvt Ltd.,
Public Institutions: 
16. Central Institute for Cotton Research, Nagpur; 17. Central Potato Research Institute, Shimla; 18. Central Research Institute for Dryland Agriculture, Hyderabad; 19. Directorate of Oil Seeds Research, Hyderabad;  20. Directorate of Sorghum Research, Hyderabad; 21. Indian Agricultural Research Institute, New Delhi;  22. Indian Institute of Horticultural Research, Bengaluru; 23. Indian Institute of Vegetable Research, Varanasi;  24. International Crops Research Institute for the Semi-Arid Tropics (ICRISAT), Hyderabad; 25. National Research Center for Plant Biotechnology, New Delhi; 26. Rubber Research Institute of India, Kottayam; 27. Sugarcane Breeding Institute, Coimbatore/Lucknow; 28. Tamil Nadu Agricultural University, Coimbatore; 29. University of Agricultural Sciences, Bangalore; 30. University of Agricultural Sciences, Dharwad; 31. University of Delhi – South Campus, New Delhi; 32. University of Calcutta, Kolkata, 

Products in pipeline:

Of the 17 crops listed in the table, only brinjal or eggplant (Solanum melongena) incorporated with the lepidopteron specific Btgene, cry1Ac, for controlling the Fruit-and-Shoot Borer, Leucinodus orbonalis,  has undergone all the biosafety and agronomic tests between 2000 and 2008 as originally prescribed by the regulatory committees. The Bt gene was introduced into brinjal hybrids by Mahyco and into local varieties by Tamil Nadu Agricultural University and University of Agricultural Sciences (Dharwad) and these were recommended by GEAC as safe and beneficial for commercial approval in 2009.  However, the then Minister of Environment & Forests, after the controversial public consultations and apparently under tremendous pressure from certain activist groups, announced a moratorium in February 2010, saying it has to undergo some more safety tests without specifying them. As of now, the moratorium is still in force. Thus, Bt-brinjal is foremost among the crops awaiting final approval. While Bt-rice and Bt-okra, both developed by Mahyco, have undergone Multi-Location Research Trials (MLRT), all other crops with various traits are in the first or second year of Biosafety Research Level-1(BRL-1). The biosafety data of approved genes/events as well as of new genes/events under regulatory evaluation are available at: http://igmoris.nic.in/major_developments.aspThese are the products in pipeline, but considering the prevailing regulatory uncertainty in the country, it is difficult to forecast when these will be approved.

Dr. T. M. Manjunath
Consultant in Agri-biotechnology & Integrated Pest Management
“SUMA”, #174, G – Block, 9th Cross,
Sahakaranagar
Bengaluru 560092,
India

Email: Manjunathtm (at) gmail.com

Supreme Court appointed Technical Expert Committee Report and GM field trials

As you know, today we had a Roundtable of farmer unions and scientists on GM crops and latest Supreme Court expert committee report at Hyderabad, organized by Rythu Swarajya Vedika. I am attaching the photograph, Telugu press release, the summary of the Tech committee recommendations and summary of Parliamentary Standing Committee report. Main details in English are below.
The key participants were: Vadde Sobhanadreeswara Rao (former Agriculture Minister), Dr. G.V. Ramanjaneyulu (CSA), Prof. Aldaz Janaiah (ANGRAU Agricultural University), Dr.A.Prasad Rao (AP Rytu Sangham CPM), Kirankumar Vissa (Rytu Swarajya Vedika), Ravula Venkaiah & Pasya Padma (AP Rytu Sangham CPI), Gade Diwakar (AIKMS), Dr. D. Narasimha Reddy (policy analyst), Dr.Chandrasekhar K (former Director, Extension, ANGRAU), Venugopal Reddy (Telangana Kisan Samiti).
All the participants were unanimous in supporting the recommendations of the Expert committee to impose a moratorium on field trials of GM crops. They urged the Supreme Court to accept the expert committee report, and informed that they are sending the requests in writing on behalf of respective farmer unions. They asserted that GM crops need strong regulation and testing and it is dangerous to conduct field trials before biosafety is established. They also demanded that the biosafety testing be made more meaningful with long-term and inter-generational tests, and independent testing instead of depending on company data.
They were also very vocal in condemning the false and misleading statements by the biotech industry lobby, and some so-called farmer organizations which are acting as agents of biotech industry that Indian farmers will be at a big loss if GM crops are delayed. They asserted that GM crops should not be pushed in a hurry, and they are not indispensable for food security or farmers’ welfare.