What we need is a biosafety authority

What we need is a biosafety authority

The BRAI Bill fails to address concerns surrounding GM crops at a time when opposition to GM is growing

First Published: Sun, Aug 11 2013. 07 08 PM IST
When Bt cotton was introduced, the biosafety tests conducted before commercialization claimed that contamination is not a major issue. Photo: Mint
When Bt cotton was introduced, the biosafety tests conducted before commercialization claimed that contamination is not a major issue. Photo: Mint
Updated: Sun, Aug 11 2013. 07 08 PM IST
A draft law to create a Biotechnology Regulatory Authority of India (BRAI) has been tabled in Parliament. If approved, it will replace the existing Environment Protection Act (EPA), 1989 rules and BRAI will replace the genetic engineering appraisal committee (GEAC) as a regulatory body.
The BRAI Bill fails to address the concerns surrounding genetically modified (GM) crops in India at a time when opposition to GM is growing in the country. There are two key assumptions on which the Bill is based: one that modern biotechnologies (read GM) are essential for improving agriculture, and two, their safety can be easily ensured by following certain protocols and be regulated.
Let’s see how true the assumptions are.
Almost 17 years after the introduction of the first GM crop in the world, only four crops—soybean (47%), maize (32%), cotton (15%) and canola (5%)—account for 99% of GM crops under cultivation globally. Only five countries (the US, Brazil, Argentina, Canada and India) account for 90% of the total GM cropped area. The rest of the world seems to be improving agriculture even without GM.
In the past 17 years, there have been umpteen reports and research papers that highlight various biosafety problems of GM crops. In India, the first and only GM crop, Bt (Bacillus thuringiensis) cotton was introduced in 2001 with the promise that it will reduce farm distress by reducing expenses on pesticides. After 11 years, we still find that 68% of the farmers’ suicides are from four major cotton growing areas. The use of pesticides initially came down due to reduction in bollworm infestation but increased again because of rising sucking pest attacks. There have been several other problems such as skin allergies to agricultural workers during the stage when the bolls burst, and a fall in soil fertility due to the impact on soil microorganisms.
When Bt cotton was introduced, the biosafety tests conducted before commercialization claimed that contamination is not a major issue. But when the University of Agricultural Sciences, Dharwad, released its version of Bt cotton, it was found to be contaminated with Mahyco Monsanto’s proprietary trait and had to be withdrawn from the market. The contamination, in hindsight, was inevitable. Given that India is a centre of origin, and a major centre of diversity for important food crops such as rice and brinjal, such contamination risks cannot be simply wished away.
The parliamentary standing committee on GM foods and the technical expert committee appointed by the Supreme Court have both pointed out these problems and have suggested a ban on further field trials and commercialization of GM crops till an improved regulatory system is put in place.
Instead of addressing these issues, the BRAI Bill only dilutes the current regulatory system, overriding the role of state governments in decision-making, and bypassing citizens’ right to information by including a clause on confidentiality of commercial information. India being a signatory to the Nagoya—Kuala Lumpur supplementary protocol on liability and redress is mandated to establish a strong liability and redress mechanism. But the penal clauses for erring in this Bill are extremely weak.
The BRAI Bill in its current format will do more harm than good. We must conceive of an alternative regulatory regime around GM crops with the primary mandate of protecting our health and environment from the risks of modern biotechnology. Such a regime should be based on the precautionary principle and must lay down protocols for independent testing, post-marketing monitoring, and rigorous assessments of long-term health and environmental impact of all GM crops.
Ramanjaneyulu G. V. is an agricultural scientist working with Centre for Sustainable Agriculture. Comments are welcome at otherviews@livemint.com

Hematotoxicity of Bacillus thuringiensis as Spore-crystal Strains Cry1Aa, Cry1Ab, Cry1Ac or Cry2Aa in Swiss Albino Mice

The biosafety data submitted by Mahyco on bt cotton also carried similar results…the animal morbidity in AP, Maharashtra after feeding on bt cotton leaves also had similar symptoms….unfortunately indian scientific system never researched upon this.

In conclusion, results showed that the Bt spore-crystals   genetically modified to express individually Cry1Aa, Cry1Ab, Cry1Ac or Cry2A can cause some hematological risks to vertebrates, increasing their toxic effects with long-term exposure. Taking into account the increased risk of human and animal  exposures to significant levels of these toxins, especially through diet,our results suggest that further studies are required to clarify the mechanism involved in the hematotoxicity found in mice, and to establish the toxicological risks to non-target organisms,especially mammals, before concluding that these microbiological control agents are safe for mammals

GM food harms pigs: New Research by Judy Carman

A groundbreaking new study [1] shows that pigs were harmed by the consumption of feed containing genetically modified (GM) crops.

GM-fed females had on average a 25% heavier uterus than non-GM-fed females, a possible indicator of disease that requires further investigation. Also, the level of severe inflammation in stomachs was markedly higher in pigs fed on the GM diet. The research results were striking and statistically significant.

Find a clear summary of the study here

Find the full paper here

Lead researcher Dr Judy Carman, adjunct associate professor at Flinders University, Adelaide, Australia,[2] said: “Our findings are noteworthy for several reasons. First, we found these results in real on-farm conditions, not in a laboratory, but with the added benefit of strict scientific controls that are not normally present on farms.

Find all the background on this study and on Dr. Judy Carman here: www.gmojudycarman.org

“Second, we used pigs. Pigs with these health problems end up in our food supply. We eat them.

“Third, pigs have a similar digestive system to people, so we need to investigate if people are also getting digestive problems from eating GM crops.

“Fourth, we found these adverse effects when we fed the animals a mixture of crops containing three GM genes and the GM proteins that these genes produce. Yet no food regulator anywhere in the world requires a safety assessment for the possible toxic effects of mixtures. Regulators simply assume that they can’t happen.

“Our results provide clear evidence that regulators need to safety assess GM crops containing mixtures of GM genes, regardless of whether those genes occur in the one GM plant or in a mixture of GM plants eaten in the same meal, even if regulators have already assessed GM plants containing single GM genes in the mixture.”

The new study lends scientific credibility to anecdotal evidence from farmers and veterinarians, who have for some years reported reproductive and digestive problems in pigs fed on a diet containing GM soy and corn.[3]

Iowa-based farmer and crop and livestock advisor Howard Vlieger, one of the coordinators of the study, said: “For as long as GM crops have been in the feed supply, we have seen increasing digestive and reproductive problems in animals. Now it is scientifically documented.

“In my experience, farmers have found increased production costs and escalating antibiotic use when feeding GM crops. In some operations, the livestock death loss is high, and there are unexplained problems including spontaneous abortions, deformities of new-born animals, and an overall listlessness and lack of contentment in the animals.

“In some cases, animals eating GM crops are very aggressive. This is not surprising, given the scale of stomach irritation and inflammation now documented. I have seen no financial benefit to farmers who feed GM crops to their animals.”

Gill Rowlands, a farmer based in Pembrokeshire, Wales who is also a member of the campaign group GM-Free Cymru, said: “This is an animal welfare issue. Responsible farmers and consumers alike do not want animals to suffer. We call for the rapid phase-out of all GMOs from animal feed supplies.”

Claire Robinson of the campaign group GMWatch said: “Several UK supermarkets recently abandoned their GM-free animal feed policies, citing lack of availability of non-GM feed. We call on the public to visit the new citizens’ action website gmoaction.org, where they can quickly and easily send an email to the supermarkets asking them to ensure their suppliers secure certified GM-free animal feed. This will mean placing advance orders for GM-free soy from countries like Brazil.”

Study details

The research was conducted by collaborating investigators from two continents and published in the peer-reviewed Journal of Organic Systems. The feeding study lasted more than five months, the normal commercial lifespan for a pig, and was conducted in the US. The pigs were slaughtered at the usual slaughter age of over 5 months, after eating the diets for their entire commercial lifespan.

168 newly-weaned pigs in a commercial piggery were fed either a typical diet incorporating GM soy and corn, or else (in the control group) an equivalent non-GM diet. The pigs were reared under identical housing and feeding conditions. They were slaughtered over 5 months later, at the usual slaughter age, after eating the diets for their entire commercial lifespan. They were then autopsied by qualified veterinarians who worked “blind” – they were not informed which pigs were fed on the GM diet and which were from the control group.

The GMO feed mix was a commonly used mix. The GM and non-GM diets contained the same amount of soy and corn, except that the GM diet contained a mixture of three GM genes and their protein products, while the control (non-GM) diet had equivalent non-GM ingredients. Of the three GM proteins in the GM diet, one made a crop resistant to being sprayed with the herbicide Roundup, while two were insecticides.


Claire Robinson, GMWatch, UK: claire@gmwatch.org To phone within UK: 0752 753 6923. To phone outside UK: +44 752 753 6923

Dr Judy Carman, Adelaide, Australia

Email: judycarman@ozemail.com.au

Mr Howard Vlieger, Maurice, Iowa

Email: studentofthesoil@mtcnet.net

Changes in Actinomycetes community structure under the influence of Bt transgenic brinjal crop in a tropical agroecosystem

Amit Kishore SinghMajor Singh and Suresh Kumar Dubey

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BMC Microbiology 2013, 13:122 doi:10.1186/1471-2180-13-122

Published: 29 May 2013

Abstract (provisional)


The global area under brinjal cultivation is expected to be 1.85 million hectare with total fruit production about 32 million metric tons (MTs). Brinjal cultivars are susceptible to a variety of stresses that significantly limit productivity. The most important biotic stress is caused by the Brinjal Fruit and shoot Borer (FSB) forcing farmers to deploy high doses of insecticides; a matter of serious health concern. Therefore, to control the adverse effect of insecticides on the environment including the soil, transgenic technology has emerged as the effective alternative. However, the reports, regarding the nature of interaction of transgenic crops with the native microbial community are inconsistent. The effect of a Bt transgenic brinjal expressing the bio-insecticidal protein (Cry1Ac) on the rhizospheric community of actinomycetes has been assessed and compared with its non-transgenic counterpart.


Significant variation in the organic carbon observed between the crops (non-Bt and Bt brinjal) may be due to changes in root exudates quality and composition mediated by genetic attributes of Bt transgenic brinjal. Real time quantitative PCR indicated significant differences in the actinomycetes- specific 16S rRNA gene copy numbers between the non-Bt (5.62-27.86) x 1011 g-1 dws and Bt brinjal planted soil (5.62-24.04) x 1011 g-1 dws. Phylogenetic analysis indicated 14 and 11, actinomycetes related groups in soil with non-Bt and Bt brinjal crop, respectively. Micrococaceaea and Nocardiodaceae were the dominant groups in pre-vegetation, branching, flowering, maturation and post-harvest stage. However, Promicromonosporaceae, Streptosporangiaceae, Mycobacteriaceae, Geodermatophilaceae, Frankiaceae, Kineosporaceae, Actisymmetaceae and Streptomycetaceae were exclusively detected in a few stages in non-Bt brinjal rhizosphere soil while Nakamurellaceae, Corynebactericeae, Thermomonosporaceae and Pseudonocardiaceae in Bt brinjal counterpart.


Field trails envisage that cultivation of Bt transgenic brinjal had negative effect on organic carbon which might be attributed to genetic modifications in the plant. Changes in the organic carbon also affect the actinomycetes population size and diversity associated with rhizospheric soils of both the crops. Further long-term study is required by taking account the natural cultivar apart from the Bt brinjal and its near-isogenic non-Bt brinjal with particular reference to the effects induced by the Bt transgenic brinjal across different plant growth stages.

The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.

Hungry for innovation: pathways from GM crops to agroecology

#GMCrops #Biosafety #AgroEcology

Late lessons from early warnings: science, precaution, innovation

David  A.   Quist,   Jack  A.   Heinemann,  Anne   I.   Myhr,   Iulie  Aslaksen   and   Silvio   Funtowicz

Hungry for innovation: pathways from GM crops to agroecology Emerging issues | Hungry for innovation: pathways from GM crops to agroecology download

Innovation’s potential to deliver food security and solve other agriculture-related problems is high on the agenda of virtually all nations. This chapter looks at two different examples of food and agricultural innovation: genetically modified (GM) crops and agroecological methods, which illustrate how different innovation strategies affect future agricultural and social options.

GM crops are well suited to high-input monoculture agricultural systems that are highly productive but largely unsustainable in their reliance on external, non-renewable inputs. Intellectual property rights granted for GM crops often close down, rather than open up further innovation potential, and stifle investment into a broader diversity of innovations allowing a greater distribution of their benefits.
Science-based agroecological methods are participatory in nature and designed to fit within the dynamics underpinning the multifunctional role of agriculture in producing food, enhancing biodiversity and ecoystem services, and providing security to communities. They are better suited to agricultural systems that aim to deliver sustainable food security than high external input approaches. They do, however, require a broader range of incentives and supportive frameworks to succeed. Both approaches raise the issue of the governance of innovation within agriculture and more generally within societies.
The chapter explores the consequences of a ‘top-down transfer of technology’ approach in addressing the needs of poor farmers. Here innovation is often framed in terms of economic growth in a competitive global economy, a focus that may conflict with efforts to reduce or reverse environmental damage caused by existing models of agriculture, or even deter investment into socially responsible innovation.
Another option explored is a ‘bottom-up’ approach, using and building upon resources already available: local people, their knowledge, needs, aspirations and indigenous natural resources. The bottom-up approach may also involve the public as a key actor in decisions about the design of food systems, particularly as it relates to food quality, health, and social and environmental sustainability.
Options are presented for how best to answer consumer calls for food quality, sustainability and social equity in a wide sense, while responding to health and environmental concerns and securing livelihoods in local small-scale agriculture. If we fail to address the governance of innovation in food, fibre and fuel production now, then current indications are that we will design agriculture to fail.

Though Bt Brinjal banned, Bt Cotton still reaches Indian mouths

Though Bt Brinjal banned, Bt Cotton still reaches Indian mouths

 DNA | Feb 13, 2013, 05:47AM IST


Ahmedabad: The debate over genetically-modified (GM) crops has taken a nasty turn across the globe because a veteran anti-GM activist, Mark Lynas, has switched sides and is now campaigning in favour of the technology.
Indian consumers do not directly consume GM food as the government has not allowed such crops after Bt Brinjal debacle. But as Bt Cotton is present in the country, consumers are passively eating GM food through milk of an animal fed cottonseed meals and food cooked in cottonseed oil. Bt Cotton is not totally pesticide or insecticide-free. All mammals are indirectly vulnerable due to the pesticides used in cotton farming, say scientists.

The debate has gone public in the European Union as the European Commission’s Agriculture and Rural Development is conducting a survey. Noting that genetically-modified organisms (GMOs) are considered incompatible with organic farming, the survey asks participants whether they specifically buy organic products because they are “GMO-free”. It also asks whether consumers would put up with higher prices if it meant the accidental, low-level presence of GMOs in organic products was clearly labelled.

It should also be noted that though the direct use of Bt food is not allowed in the country, consumers are already exposed to their ill-effects indirectly because of the use of Bt cottonseed as edible oil. Of the total cottonseed production, 90% goes into expeller for production of cottonseed edible oil. What is left after the expeller process — the residue — goes as cottonseed meal which is a widely used as feed for animals.

“There is no doubt that use of pesticide has gone down after the use of transgenic variety but it is not completely free from pesticides. The number of sprays used to grow cotton has come down but it has not stopped attacks by sucking pests,” says Dr KR Kranthi of Central Institute of Cotton Research (CICR).

Before the introduction of Bt Cotton, the fibre crop was susceptible to 162 varieties of pests and insects. In 1995, 54% of the total consumption of pesticide in the country was in cotton farming. The ratio had come down to 44% in 2001. After the introduction of two varieties of Bt Cotton seeds, the use of pesticide has further come down to 21%.

“Bt cotton does not need pesticides to protect the plant from bollworms pests. Bollworms were the key pests damaging 80% of the cotton losses in the country. Bt variety has an inbuilt mechanism to protect the plant from these pests. However, the problem of sucking pests is still there,” says agriculture scientist, Dr TL Dholaria.

According to various research studies, the total number of pesticide spray required for cotton has declined from 15 to 9 per crop season earlier.

“The number of spray needed has declined. It has also resulted in lowering the cost of farming. However, no one can claim that cotton farming has become completely pesticide free as farmers must continue to spray pesticide to control sucking pests,” said Dr Kranthi.

If one looks at the value chain of cotton farming, cotton seed is used for production of edible oil as well as cattle feed. Cottonseed is most widely used in cattle feed. These animals produce milk meant for human consumption. Consumption of cottonseed edible oil has also increased in the country.

“We all use milk and edible oil which may have some pesticides in it. As of now, we do not know the effects of this indirect consumption. However, we are also exposed to the consumption of hazardous chemicals used in manufacture of pesticides,” said Dr Dholaria.

“Insecticide costs as a proportion of total costs declined perceptibly in the post-Bt Cotton period, from 8.30% in 1996 to about 5.86% in 2008,” a study by Bhartiya Krishak Samaj and Council for Social Development concludes.


GM crops: Promises outweigh perils?

President of Bharatiya Kisan Sangh in Gujarat, Maganbhai Patel, ardently opposes cultivation of genetically modified (GM) crops in India. But on his farm in Modasa (Sabarkantha), Maganbhai harvests castor, groundnut, potatoes and well, BT Cotton, too. In a long comment on why GM crops need to be avoided at all costs, he said that after a decade of BT Cotton in Gujarat, multiple reports reveal per hectare yield is falling and fertilizer costs increasing.

However, when asked why he cultivates Bt Cotton, he says: “My dear, I don’t have an option. In
Gujarat, it is difficult to get any good quality non-Bt cotton seeds.”

Approximately 97% of seven million bales of cotton produced in Gujarat are from the genetically-modified seed. This cash crop has virtually swept Gujarat’s countryside in the last decade. Going by the increase in per hectare yield of cotton and, therefore, of huge profits, Gujarat farmers with an entrepreneurial bent of mind are now keen to experiment with more GM crops. But as anyone who has even a slim understanding of the issue will agree, this is fraught with dangers.

For the uninitiated, the Union ministry of environment and forest refused to allow the harvesting of GM crops in India after an elaborate public hearing process across the country three years ago. On Saturday, the country ‘celebrated’ three years of moratorium on Bt Brinjal.

The subject has always provoked contentious debates. In recent times, GM crops have been debated as much globally as in India, following a turnaround by the European anti-GM activist, Mark Lynas, who has ‘unconditionally’ withdrawn his crusade against the controversial technology.

Besides, field trials have been stopped in the country for now following concerns about the technology raised by the Supreme Court-appointed technical experts committee. And that perhaps explains the urgency to this debate right now.

A ‘National Seminar on GM crops and Food Security – Issues and Prospects’ has been organized on February 14-15 at Gujarat Vidyapith in Ahmedabad. Further, the theme of National Science Day on February 28 this year is ‘GM Crops and Food Security – Issues and Prospects’.

The government is confused, scientist are divided, the anti-GM lobby is gaining traction amid the chaos, and seed marketing companies are getting desperate.
The international media is abuzz with debates, and true enough, this has trickled down to Gujarat as well. In a way, Gujarat has been the laboratory of GM crops in India, with the apparent runaway success of Bt Cotton mentioned earlier. If the fears related to genetically-modified food have any basis, Gujarat will be among the first states to be severely affected.Over and above the proliferation of Bt Cotton in our food chain through cattle feed and cottonseed oil, reports of multiple field trials of GM Maize, Brinjal and unconfirmed reports on GM Rice have come in.
Anand Agriculture University conducted field trials of Maize in 2011-12 and Brinjal 2009-10. Activists claim more field trials could have taken place “clandestinely directly with the farmer.” Without scientific monitoring and regulation, open field trials pose the danger of contaminating the surrounding fields and damaging the local ecology.

There is a very vocal section of activists who doubt the technology and actively campaign against it. Three years ago, they tasted victory in the moratorium on Bt Brinjal and, along with it, other GM crops as well. Their argument is that the technology claims to address the problem of low productivity but raises serious concerns about the technology’s long-term impact on human health, sustainability, ecology and environment.

Director of Center for Environment Education Kartikeya Sarabhai rues the fact that in India the debate about GM food is going back to the basics of productivity after reaching a certain level of maturity during the Bt Brinjal consultation process. “It has come back to productivity but that is not the only concern. There is tremendous pressure to restart this debate and I would wish the debate includes bio-safety, environment and ecological vulnerability, long term cost-benefit analysis, farmers’ independence and dependence on multi-national companies for GM seeds,” he said. CEE was the central monitoring authority for organizing public hearings across the country led by the then MoEF, Jairam Ramesh.

A very proactive anti-GM crusader in Gujarat, Kapil Shah of Vadodara-based Jatan Trust, claims the whole argument that people will go hungry if GM crops do not come to the rescue of human kind, is extremely exaggerated.

“The problem basically is of wastage, storage and distribution of farm produce. Every day we hear cases of tons of food grains going waste because of hoarding by big corporate houses with the help of politicians. Food scarcity is an artificially created phenomenon. 85% of GM maize goes for industrial use. According to data in the public domain, 12% people in United States faced food insecurity before GM crops were introduced; after GM, 15% people face food insecurity,” he said.

Seed marketing companies and pro-GM crusaders like Lynas quote ‘science’ and ‘scientists’ to defend their position. However, Shah instantly picks a hole in this argument claiming,“We want to believe science, but a close scrutiny invariably reveals they have been compromised. We are open to science, but it fails to reassure us that it is an unbiased independent opinion,” he says.


Battle lines harden over GM crops


New Delhi, Feb. 8: The biotechnology industry and an environmental group have hardened battle lines over the future of genetically modified food crops in India on the third anniversary of the indefinite moratorium on GM brinjal imposed by former environment minister Jairam Ramesh.

The agricultural group of the Association of Biotechnology Led Enterprises (ABLE) today said it was “disappointed over the continued delay” on GM brinjal, and warned the government’s “indecisiveness” was making it difficult for the industry to continue investing in research.

The agricultural focus group of ABLE has urged the Union government to end the moratorium on GM brinjal to draw benefits from crop biotechnology.

Sections of scientists believe India will need to quickly adopt GM crops to boost production despite land shortages and climate and environmental stresses.

But an environmental group campaigning against GM crops said there was substantial evidence from several countries to suggest that the adoption of GM crops “has not meant greater improvements in food security”.

The group that calls itself the Coalition for a GM-free India said multiple factors influenced food security and figures from many countries suggested there was little correlation between GM crops and food security.

“Argentina is the third-largest grower of GM crops but has seen no significant difference in its hunger situation during its years of expanding GM crops,” said Sridhar Radhakrishnan, convenor of the coalition.

“While Brazil, the second-largest grower of GM crops, shows a decline in hunger, the pace of this decrease has decelerated during the years when area under GM crops expanded,” he added.

But crop biotechnologists say there is ample evidence GM crops have benefited both farmers and nations. “(GM) cotton has completely transformed India’s cotton industry,” said Seetharama Nadoor, executive director of ABLE’s focus group on agriculture.

“(GM) cotton has been one of the most rapidly adopted crops in the country, a great example of the potential. If we are to become globally competitive in agriculture, predictable regulatory frameworks that support research and timely approvals are critical,” Nadoor said in a statement today.

Ramesh had on February 9, 2010, imposed an indefinite moratorium on the release of GM brinjal after examining documents submitted by sections of the industry as well as several scientists who had urged caution and sought more rigorous evaluation of GM food crops before their release.

But sections of the biotechnology industry have consistently argued the decision to impose the moratorium was “not based on science”.

In October last year, the Scientific Advisory Council to the Prime Minister had released a statement that seemed to question the moratorium imposed on GM brinjal.

The council had said India would need to adopt a “judicious blend” of traditional breeding and GM technology to combat land shortages, low productivity, drought and post-harvest losses.

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.”

Monsanto’s GM corn Biosafety data raises serious concerns: Report

Greenpeace India demands the Union Minister for Environment and Forest, Jayanthi Natarajan, under whom sits the GEAC, to stop all open releases of GM crops, including those for field trials

New Delhi: Jan 29, 2013: In a startling development an independent scientific analysis released by Greenpeace India exposed major flaws in the Genetically Modified (GM) corn biosafety assessment process by the regulatory bodies in India.  Greenpeace India had asked Testbiotech, an independent research agency,  to assess data presented by the US biotech giant, Monsanto, to the Indian authorities ‘for biosafety tests prior to commercial approval’ of its GM corn variety.

The stacked gene GM corn (MON89034xNK603 ) with bacterial genes for pest resistance and herbicide tolerance leads the GM crop approval pipeline and has been released into fields several times in the past 4 years in the name of field  trials .

The biosafety and field trials data of the said GM corn data was accessed by Greenpeace through RTI procedures from the Department of Biotechnology(DBT) and Genetic Engineering Appraisal Committee (GEAC), which is the nodal agency for all environmental releases of GMOs in India. The RTI exercise also saw the CPIO of DBT being reprimanded by the Appellate Authority for providing wrong information to the applicant.

“On one hand the GM regulatory system in our country tries to hide crucial public information like the biosafety data of GM crops and on the other hand allows open field trials of them, which can lead to contamination of our food and seed supply chain. These field trials have been permitted for the last 4 years without biosafety studies being completed” said Shivani Shah, Sustainable Agriculture campaigner, Greenpeace India. According to the response received from DBT, these trials were permitted based on biosafety data generated by Monsanto itself in its labs in USA.

The Testbiotech analysis highlights that even those assessments’ presented have been found to be incomplete and lacking in scientific rigor. Interestingly most of the data provided was for the parent lines with the single genes with almost no studies on the stacked gene corn for which was the application.

The review report concluded that based on the data presented by Monsanto, no decisions can be taken on the safety of the plants. Apart from missing data and inadequate investigations, there are in fact substantial indications for health and environmental risks.

This stacked gene variety of Monsanto’s corn had been in controversy earlier  in 2011 when Greenpeace had exposed grave violations of field trial rules by the company in its trials at Bijapur District in Karnataka.

In the light of increasing evidences of  failure of the GM regulatory system in India and the potential impacts of GM crops to our health, environment and socioeconomic realities   Greenpeace Indiademands the Union  minister for Environment and Forest, Jayanthi Natarajan, under whom sits the GEAC, to stop all open releases of GM crops, including those for field trials.

Notes to the Editor:-

  1. Link to the report- http://www.greenpeace.org/india/en/publications/Analysis-of-the-data-submitted-by-Monsanto-to-the-Indian-authorities-on-genetically-engineered-maize-MON89034-x-NK603/