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Item 1
David Schubert, Professor
Cellular Neurobiology Laboratory CNB-S
November 18 2009
Mr Jairam Ramesh
Hon'ble Minister of Environment and Forests Government of India
425 Paryavaran Bhavan CGO Complex, Lodhi Road New Delhi 110003, India
Dear Mr. Jayaram Ramesh:
My name is Dr. David Schubert. I have a PhD in immunology and am a professor at the Salk Institute for Biological Studies in San Diego, California. The Salk Institute is considered one of the best medical research institutes in the world. I am writing this text because of my concern about the introduction of brinjal genetically modified with bacterial Bt toxin into the food supply of India. There are several reasons that the introduction of this genetically engineered (GE) food plant should not be allowed. They include:
1)    The lack of need. Brinjal is not a crop threatened by an overwhelming insect infestation.
2)    Environmental risk. Brinjal is native to India and the GE genes will unquestionably contaminate the native population.
3)    Higher costs. The purchase of seeds on an annual basis as opposed to saving seed from year to year will increase costs at all levels of the food chain.
4)    Social and political dependence. Once a foreign company controls the seed market of any single food plant, seed for more GE plants will follow, and the company will have tremendous power over both the farmers, which constitute a major segment of the Indian population, as well as the political process. This has clearly happened in the United States (US), where Monsanto is a major financial supporter of both political parties, and therefore has political appointees who dictate both national and international agricultural policy.
5)    Finally, GE brinjal expressing Bt protein poses a serious health risk to those who consume it. This is the issue that I wish to address. First, however, I would like to debunk some myths that are used by the proponents of GE brinjal to claim that it is safe.
Bt cotton (I will use the term Bt throughout to mean a family of Cry 1 insecticidal endotoxins produced by the bacterium Bacillus thuringiensis) is grown in India, and it is claimed that there have been no serious human health problems due to its cultivation. This statement is irrelevant since cotton is not consumed by people, but as you must be aware there is very good evidence that the consumption of Bt cotton plants by farm animals leads to serious health problems and sometimes death. Bt maize is grown in the US and it is claimed that because there has been no documented Bt maize-associated disease, Bt brinjal is therefore safe to eat. This conclusion is invalid for several reasons.
First, only a small fraction of the Bt maize produced in the US is eaten directly. The vast majority in used as animal food and to make oil, high fructose syrup, and ethanol, none of which would contain the Bt protein. The maize containing the Bt protein that is consumed is largely in the form of highly processed corn chips and related snack foods that are not major components of the diet. In contrast, the Bt protein in brinjal will be directly consumed in massive quantities because the vegetable is a significant component of the Indian diet. In addition, it will be prepared in an infinite number of ways, leading to potential chemical changes in the protein causing unknown toxicology and immunogenicity. Cooking can readily change the structure and antigenicity of a protein. Did the feeding studies done with Bt brinjal include cooked product?
Second, it is logically false to claim that because there is no evidence of illness following the introduction of a GE product, therefore the product is safe to eat. In fact, perhaps my major concern with the introduction of any GE food is that even if it did cause an illness, it would not be detected because of the lack of epidemiological studies and the technical limitations for detecting such an illness. For example, to detect an epidemic of a disease, an incidence of at least two fold above the background rate of the disease is required. Therefore, if Bt brinjal were to cause a disease like Parkinson's, which has an incidence of about 20 new cases per year per 100,000 people, then in India 200,000 new cases per year would have to be diagnosed and tabulated in order to identify a significant increase, and there would still be no way to associate the disease directly with a Bt crop. In addition, many environmentally caused diseases take many decades of exposure to develop symptoms.
Clearly, once Bt brinjal is commercially released, there will be no way to monitor adverse health effects caused by the product. There are at least four mechanisms by which the introduction of the Bt toxin gene into the Brinjal genome can cause harm. These include (1) the random insertion of the Bt gene into the plant DNA and the resulting unintended consequences1, (2) alterations in crop metabolism by the Bt protein that results in new, equally unintended and potentially toxic products, (3) the direct toxicity of the Bt protein, and (4) an immune response elicited by the Bt protein. There are scientifically documented examples of all four toxic mechanisms for Bt crops.
An example of the first is the discovery of unintended alterations in the synthesis of nine known carcinogens caused by the GE modification of tobacco, a crop in the same plant family as brinjal2. An example of the second is the abnormally high levels of the fiber molecule lignin produced in Bt maize3. This trait was discovered because of dramatic changes in the stiffness of the corn stalk. Since multiple strains of Bt maize have this trait, it is most likely that increased lignin production is associated with the expression of the Bt protein itself, not due to mutations caused by the GE process itself (item one above)4. Importantly, the synthetic route to lignin in plants is shared with that of rotenone, a plant metabolite known to cause Parkinson's-like disease in animals. It is very likely that there are many other unintentional changes in Bt crops, and a few more have recently been documented5.
The toxicity and immunological hazards of the Bt protein are discussed in more detail below. It should be emphasized that the majority of this material has been published in peer-reviewed journals and reproduced in more than one laboratory, therefore ruling out the possibility of an individual investigator's bias.
Allergies are complex responses of the immune system to foreign substances and vary widely between individuals in an unpredictable manner. Bt toxins have long been used as insecticidal sprays on a variety of crops, but the spray is a less toxic form of the protein than that made by GE plants. The spray consists of spores of the Bt toxin that must be activated in the gut of the insect. In contrast, Bt toxin in brinjal is a highly activated form of the Bt protein that does not require modification in the insect gut to become toxic. It is therefore much more potent than that used is sprays. Despite this major difference in Bt form and activity, and even though the spray is not ingested by farm workers, there is solid evidence that the Bt proteins elicit a strong immune response in some workers after a few months exposure, and it is likely that many more workers are affected, but associate their allergic response with the spray and decide to work elsewhere6. Since Bt proteins have amino acid sequence homology with known allergens, allergic reactions in some individuals are not unexpected7,8. Most importantly, it should be emphasized that the concentration and amount of Bt toxin protein that people will eat in Bt brinjal will be thousands of times higher than the exposure levels of farm workers.
In support of the human data, when animals are exposed to Bt toxins, the toxin also acts as a potent immunogen, eliciting responses from both the blood and gut-based immune systems9-11. Based upon these data, the US Environmental Protection Agency (EPA) recommended extensive safety testing of Bt crops for this trait12, but due to the lack of required safety testing for GE food crops in the US, this was never done4. Although I am sure that you are aware of this fact, it should be restated that the US agencies that allowed the introduction of Bt food crops did not require any demonstration that the GE food was safe for human consumption.
Additional animal studies have shown that Bt toxins directly cause tissue damage. For example, Fares and El-Sayed demonstrated that feeding mice Bt potatoes caused the appearance of structurally abnormal cells in the gut13. Other studies reported histopathological changes in the kidney and liver of rats feed Bt corn14, and changes in urea and protein levels in the urine of rats fed Bt rice15. While there was no extreme pathology in any of these studies, they were all short term (up to 90 days) and done with healthy animals. The outcome may be quite different if the Bt protein is consumed by infirm, under nourished, aged, or very young individuals, for the body responds quite differently in individuals compromised by any of these conditions, and all groups will be eating Bt brinjal. As far as I know none of the safety testing of Bt brinjal has taken this fact into account.
Since a significant fraction of any population falls within one or more of these categories, it is difficult to believe that the regulatory authorities could overlook this problem. To emphasize this point, it has recently been shown that the immune response to feeding very young and very old mice Bt maize is different from that of the non-GE maize fed control groups. Most interestingly, the immune responses were also very different in the young and old age groups16. These very robust data clearly demonstrate how difficult it is to extrapolate negative data from short term feeding studies in healthy adult animals to real world situations. They also further emphasize the need for extreme caution before the irreversible introduction Bt brinjal into the food chain.
The above citations clearly show that the family of Bt proteins can act as allergens in animals and some individuals. Most importantly for the health of the Indian population, if the introduction of Bt brinjal is allowed, an enormous number of individuals are going to consume amounts of Bt toxin that are thousands of times higher than anytime previously in the short history of this GE technology. This population is extremely heterogeneous in genetic makeup, age, and also with respect to underlying health. It is the genetics and health status of the individual that determines his or her response to foreign proteins such as Bt toxin. Less healthy individuals are much more prone to negative immune reactions.
Since the ability of Bt toxin to cause an allergic response in some individuals is unambiguous, it is virtually certain that within the vast Indian population a large number of people eating Bt brinjal are going to be or will become allergic to this foreign protein; this number cannot be predicted and some of the immune responses will likely be severe, causing anaphylaxis and possibly fatalities. Since there will be no way of tracking these adverse reactions within the population, and since once Bt brinjal is commercially grown, its genetic presence within a major calorie source for the Indian population is irreversible, a simple decision has to be made. Is the negligible benefit of Bt brinjal worth the clear risk? My conclusion is that it is not worth the risk and that it would be a profound disservice to India if Bt brinjal were allowed to enter her food supply.
David Schubert, Ph.D. Professor
Salk Institute for Biological Studies LaJolla,CA 92037
1. Schubert D. 2002 A different perspective on GM food. Nat Biotechnol 20:969.
2. Mungur R, Glass AD, Goodenow DB, Lightfoot DA. 2005 Metabolite fingerprinting in transgenic Nicotiana tabacum altered by the Escherichia coli glutamate dehydrogenase gene. J Biomed Biotechnol 2005:198-214.
3.   Saxena D, Stotzky G. 2001 Bt corn has a higher lignin content than non-Bt corn. Amer J Botany 88:1704-6.
4.   Freese W, Schubert D. 2004 Safety testing of genetically engineered food. Biotechnology and Genetic Engineering Reviews 21:299-325.
5. Zolla L, Rinalducci S, Antonioli P, Righetti PG. 2008 Proteomics as a complementary tool for identifying unintended side effects occurring in transgenic maize seeds as a result of genetic modifications. J Proteome Res 7:1850-61.
6.   Bernstein IL, Bernstein JA, Miller M, Tierzieva S, Bernstein DI, Lummus Z, Selgrade MK, Doerfler DL, Seligy VL. 1999 Immune responses in farm workers after exposure to Bacillus thuringiensis pesticides. Environ Health Perspect 107:575-82.
7. Metcalfe DD, Astwood JD, Townsend R, Sampson HA, Taylor SL, Fuchs RL. 1996 Assessment of the allergenic potential of foods derived from genetically engineered crop plants. Crit Rev Food Sci Nutr36 Suppl:S165-86.
8. FAO-WHO. Evaluation of Allergenicity of genetically modified foods. Report of a Joint FAO/WHO expert consultation on allergenicity of foods derived from biotechnology. January 22-25, 2001. 2001.
9.   Vazquez RI, Moreno-Fierros L, Neri-Bazan L, De La Riva GA, Lopez-Revilla R. 1999 Bacillus thuringiensis Cry 1 Ac protoxin is a potent systemic and mucosal adjuvant. Scandianavian Journal of Immunology 49:578-584.
10. Vazquez-Padron RI, Moreno-Fierros L, Neri-Bazan L, de la Riva GA, Lopez-Revilla R. 1999 Intragastric and intraperitoneal administration of Cry 1 Ac protoxin from Bacillus thuringiensis induces systemic and mucosal antibody responses in mice. Life Sci 64:1897-912.
11. Vazquez-Padron RI, Moreno-Fierros L, Neri-Bazan L, Martinez-Gil AF, de-la-Riva GA, Lopez-Revilla R. 2000 Characterization of the mucosal and systemic immune response induced by Cry 1 Ac protein from Bacillus thuringiensis HD 73 in mice. Braz J Med Biol Res 33:147-55.
12. BT S. 2000 Bt plant-pesticides risk and benefit assessments. FIFRA Scientific Advisory Panel. SAP Report No. 2000-07.
13. Fares NH, El-Sayed AK. 1998 Fine structural changes in the ileum of mice fed on delta-endotoxin-treated potatoes and transgenic potatoes. Nat Toxins 6:219-33.
14. Kilic A, Akay MT. 2008 A three generation study with genetically modified Bt corn in rats: Biochemical and histopathological investigation. Food Chem Toxicol 46:1164-70.
15.   Schroder M, Poulsen M, Wilcks A, Kroghsbo S, Miller A, Frenzel T, Danier J, Rychlik M, Emami K, Gatehouse A, Shu Q, Engel KH, Altosaar I, Knudsen I. 2007 A 90-day safety study of genetically modified rice expressing Cry 1 Ab protein (Bacillus thuringiensis toxin) in Wistar rats. Food Chem Toxicol 45:339-49.
16. Finamore A, Roselli M, Britti S, Monastra G, Ambra R, Turrini A, Mengheri E. 2008 Intestinal and peripheral immune response to MON810 maize ingestion in weaning and old mice. J Agric Food Chem 56:11533-9.
Item 2
Genetically Modified Crops:
Independent Scientists Write to the Prime Minister of India With Reference to The PMO Letter of July 2009 to Dr A Ramadoss which is Scientifically untenable
Note: This sign-on letter is prompted by the communication, authored in July, 2009, by Mr Prithviraj Chauhan, written in his capacity at that time as Minister of State in the Prime Minister’s Office. This letter entitled “Concern on Introduction of Genetically Engineered Crops and Food” was an official response to a letter from Dr A Ramadoss, addressed to Prime Minister Dr Manmohan Singh (full letter attached), dated 2nd February 2009, when he held the portfolio as India’s Minister of Health.
In its opening paragraph it says: “the various issues raised in your letter have been examined carefully and by applying the best scientific evidence available today”. However, the signatories to this letter wish to respectfully bring to the attention of Prime Minister Dr Manmohan Singh, numerous factual and scientific errors within the Chauhan letter. From the content of this letter and its phraseology, it is apparent that much of it was excerpted directly from promotional materials of the agricultural biotechnology industry, in particular the International Service for the Acquisition of Agri-Biotech Applications (ISAAA), an organisation that at best can be described as pseudo-scientific, funded primarily by Monsanto and other biotechnology multinational companies and whose purpose is to promote and facilitate the commercial introduction of genetically modified (GM) crops in the developing world. Inaccurate information has led to erroneous policy on GM crops and Bt brinjal in particular. Therefore, in the context of the current debate on the introduction in India of its first major GM food crop, Bt brinjal, to be grown on a commercial scale, we strongly urge the Prime Minister to consider the factual and authoritative scientific content of this letter. 
We hope that this letter will help to bring the true facts of GM crops into the open to enable an informed discussion on their unique risks to food security, farming systems and bio-safety impacts which are ultimately irreversible. We urge the Prime Minister, for the sake of the safety of the Indian people, and the welfare of Indian farmers, to re-address the official position on GM crops. The global community needs India to lead in the matter of exemplary regulation of these crops.
We highlight some of the many major inaccuracies found in the Chauhan letter in italicized quotes, followed by our comments with numbers in parentheses indicating items in the list of supporting References.

i.           With the rapid progress in advanced biology, biotech crops have been developed with the help of genetic engineering tools to possess special characteristics that make them better. ----also known as Genetically Modified (GM) or Genetically Engineered (GE) crops. The most common traits deployed in biotech crops so far include insect resistance, herbicide tolerance, virus resistance and improved product quality.
This statement broadly oversteps the facts and is in fact erroneous.
  • More than 95% of all GM crops are engineered to either synthesise an insecticide (Bt toxin) or to tolerate a broad spectrum herbicide (e.g. Roundup, Liberty) or both.
  • Despite many years of research, no GM crop is currently “deployed” with“improved product quality” as is claimed.         
  • To date there are only four major commercialised GM crops (soya, maize/corn, cotton, canola/oilseed rape) most of which (soya, corn, canola) are used primarily as animal feed. All were commercialised in the late 90’s. Since then, no other commercially viable GM crop application has made it to market, especially due to farmers not accepting other GM crops (such as wheat, potatoes, and rice) for negative economic reasons (lack of buyers, loss of export markets).
  • GM crops have not been widely accepted around the world. 95% of all GM food crops are grown in only 5 countries: the US, Canada, Australia, Argentina, and Brazil. If you include fibre crops (cotton) India and China would be included. Only one GM crop is approved for cultivation within the European Union, MON810 corn, which has been banned by several member states invoking documented health and especially environmental risks.
  • Only two minor food crops have been released in the USA (squash, papaya) and one in Mexico (squash), which are engineered in an attempt to make them virus resistant. The outcome has been a mixed blessing; GM squash is resistant to some viruses but renders it more susceptible to attack by beetles (1).
ii.         “It is expected that development of crops with tolerance to drought and salinity, improved nitrogen use efficiency, enhanced yield, quality and nutritional properties coupled with existing traits will be technically feasible in the near future and be a real value addition in India. From a technological perspective, what is feasible tomorrow is even more promising but scientists and Indian Industry need a predicable regulatory and social environment. At the national level, it will make agriculture more efficient and competitive to meet the challenges of hunger, poverty, malnutrition and food security in tomorrow’s world (Global Knowledge Centre on Crop Biotechnology, 2008)”
These “promises” taken verbatim from ISAAA industry promotional material do not match either scientific fact or reality.
  • “tolerance to drought and salinity, improved nitrogen use efficiency, enhanced yield, quality and nutritional properties” are hypothetical claims which have been made by industry for 15 years. Despite vast sums invested in research they have failed to deliver on these promises. The listed traits are genetically complex. The basic problem is that GM as employed in agriculture is conceptually flawed, crude, imprecise and poorly controlled technology (2-4), that is incapable of generating plants that contain the required multiple, co-ordinately regulated genes that work in an integrated way to respond to environmental challenges.
  • Contrastingly, crop varieties already exist that are tolerant to drought or salinity, or have improved nitrogen use efficiency either naturally or specifically bred by conventional methods, and augmented in some cases by modern non-GM biotechnology gene mapping (“marker assisted selection”; MAS). For example a novel upland rice variety, Birsa Vikas Dhan 111 (PY 84), has recently been released in Jharkhand bred using backcrossing augmented with MAS with selection for multiple traits for improved root growth and performance under drought conditions (5). These methods are sustainable and safer approaches to crop improvement, less expensive and give significantly higher returns on investment. A fundamental redirection is required in agricultural investment in these areas.
  • GM has failed to produce crops with improved nitrogen use efficiency whereas conventional breeding and improved farming methods have made significant improvements in this area (6)
iii.       “The most compelling case for biotechnology and more specifically biotech crops, is their capability to contribute to increasing crop productivity, conserving biodiversity, reducing the environmental footprint of agriculture, mitigating climate change and reducing greenhouse gases, increasing stability of productivity and production, the improvement of economic, health and social benefits, the cost-effective production of renewable resource-based biofuels and thus provide significant and important multiple and mutual benefits to producers, consumers and global society.”
These claims again are a reiteration of industry promotional material and have no basis in science or the empirical evidence relating to the performance of GM crops.
  • ProductivityGM has not increased yield potential. Yields from GM crops to date have been no better and in the case of GM soya have been consistently lower. A 2009 report reviewing more than 20 academic studies clearly shows that the cultivation of GM herbicide-tolerant soybeans has not increased yields. Insect-resistant corn, meanwhile, has at best only improved yields marginally. This report found that increase in yields for both crops over the last 13 years was due to traditional breeding or improvements in agricultural practices (7).
  • Conserving biodiversity—In South America, GM soy has been instrumental in speeding destruction of the Amazon rainforest (8)
  • Reducing the environmental footprint of agriculture—GM crops have led to vast increases in pesticide use, not decreases and therefore reduction of agricultural pollution cannot be claimed (9).
  • Mitigating climate change—No-till agriculture using herbicide-tolerant GM seeds does not reduce greenhouse gas emissions. Contrastingly, the high soil carbon sequestration within organic matter inherently produced by agro-ecological farming methods markedly reduces greenhouse gas emissions (10).
  • Climate change brings sudden, extreme, and unpredictable changes in weather, which requires that a cropping system be flexible, resilient and as genetically diverse as possible. GM technology offers just the opposite.
  • Stability of productivity and production—is much lower with many of the GM crops commercialised today. Herbicide tolerant GM soya is far more sensitive to heat or drought stress than conventional soya (11,12).
  • Improvement of economic, health and social benefits—consistently, introduction of GM crops is linked to loss of markets and degradation of rural communities (13-17), and evidence continues to mount regarding the health hazards of GM crops (for example see refs 18-25).
  • Biofuels—Reports from the World Bank and the United Nations Food and Agriculture Organisation have identified the biofuels boom—not lack of GM foods—as the main cause of the current food crisis (26,27). 
  • The IAASTD report* concludes that GM crops do not increase yield, have little to offer global agriculture and food security and the challenges of poverty, hunger and climate change. Instead it recommends applying low-input agro-ecological farming practices, whose use in the developing world has produced dramatic increases in yields and food security (28). [*The single largest research exercise on global agriculture in history, which was conducted with funding from multiple UN agencies and the World Bank. This report, published as Agriculture at a Crossroads, was produced under the auspices of the International Assessment of Agricultural Knowledge, Science and Technology for Development (IAASTD). It involved around 400 scientists and twice that number of peer-reviewers. It underwent two rounds of open international peer-review and was ratified overwhelmingly at the intergovernmental plenary in April 2008, including by India.]
iv.       “The concerns conveyed by you that the technology may induce instability in genetic level and have adverse health impact is not supported by scientific evidence”.
This is a scientifically indefensible statement because:
  • GM transformation can produce novel biochemical processes that are unpredictable and for which there is no natural history to assume are safe (2-4).
  • The GM transformation process is highly mutagenic leading to disruptions to host plant genetic structure and function, which in turn leads to disturbances in the biochemistry of the plant. This can lead to novel toxin and allergen production as well as reduced/altered nutritional quality (2-4).
  • It is not a question of if there are disturbances to gene function and biochemistry but to what degree they will be present within any given GM plant. For example, the levels of more than 40 proteins are altered significantly in the commercialised GM MON810 corn compared to equivalent non-GM corn, which included production of a new allergenic protein (3).
  • Numerous animal feeding studies demonstrate negative health impacts of GM feed on kidney, liver, gut, blood cells, blood biochemistry and the immune system (for example see refs 18-25).
  • Of greatest concern is that studies show negative health effects with GM crops that have already been approved and which have been grown commercially for 10-13 years (18-25). This highlights the inadequacy of the original criteria and set of data on the basis of which marketing approval was and is still being granted. 
Note: MON810 has since been banned by many EU countries including France and Germany. 
v.         “Biotech or GM crops are approved for environmental clearance/commercial release by regulatory authorities after passing through various regulatory stages starting from IBSC-MEC, RCGM and GEAC. The three-tier system is in the hands of the best scientists, technologists, agricultural and environmental experts in the country.... The regulatory system is adequate, reliable, efficient and transparent.... These SOPs are consistent with best international practices”. 
This position oversteps the mark and is technically inaccurate as highlighted above and as further evidenced below:
  • India’s Regulators do not require independent bio-safety tests, but uncritically accept as evidence of safety, research conducted by the company who is applying for commercial clearance of the product. This raises serious questions regarding impartiality and conflicts of interest, which are clearly justified, based on published evidence of bias in the research conducted by industry that is contrary to accepted normal scientific conduct (29).
  • GM food compositional analysis is superficial and the minimum required to establish “substantial equivalence”, a scientifically conceptually flawed parameter that is virtually meaningless with respect to determining health risk (30).
  • Experimental design used by the applicant is flawed, almost invariably containing irrelevant “control” non-GM comparator crop varieties, which serve to mask rather than to isolate and reveal the effect of the GM transformation process (20,24).
  • The biological testing required is not adequate to detect either acute or chronic toxic effects of GM foods. At best, only 90-day feeding studies are required by the government’s SOPs without an obligatory requirement for toxicological and histological evaluation. In order to assess medium and long-term (life-long) health impacts it is necessary to conduct lifetime and multigenerational feeding studies. Only these will reliably determine fertility and chronic health impacts, which is essential because it is the intension that people will be eating GM foods for their whole lifetime (24).
  • Experimental data is invariably not made publicly available for independent scientific scrutiny under the pretext of commercial confidentiality. This has required court action (both in Europe and India) in order to obtain the information needed to assess the quality of the research submitted by industry to be scrutinised by authoritative bio-safety experts. Such independent re-evaluation of submitted industry data has repeatedly found that this research and its interpretation thereof to be flawed, inadequate, biased and thus misleading (20,24,25).
  • All of the above points are directly relevant to the current safety dossier of Bt brinjal and imply that the Indian government’s current requirements for GM food safety assessment are inadequate and need to be augmented.
vi.       “Given that the discovery and use of Bt has completed hundred years in 2002 and Bt technology has a long history of safety, proven efficacy and benefits, Bt brinjal promises to be of great value to Indian farmers. It may be noted that those who stand to gain from wide use of pesticides, often provide misleading information for commercial interests. The GM food assessed and approved through rigorous science based regulatory process has been endorsed by Nobel laureates and leading global scientists”.
This statement ignores research showing: 
  • Bt toxin is a proven potent immunogen raising justifiable concerns that it can give rise to allergic reactions (31,32).
  • Animals fed diets containing Bt corn have shown signs of direct toxicity (20-25).
  •  Independent re-evaluation of Monsanto’s own research on their Bt corn crops shows negative health effects even in short-term (90-day) animal feeding studies (20,25).
  • The Mahyco-Monsanto dossier of the raw experimental data of animal feeding studies with Bt brinjal shows highly statistically significant negative signs of toxicity on the functioning of multiple organ systems such as liver, kidney, blood and pancreas in all animals tested (especially rats, rabbits and goats). It is very important to note that these adverse effects were observed after only at most, a 90-day feeding time, which raises serious concerns about the safety of consuming this product over an entire lifetime. Long-term (at least 2-year) animal feeding studies were not done and are stated as not required by the apex Regulator, contrary to the science, which requires these studies to detect chronic slow-onset toxicity and cancer.
  • There is therefore, no scientific justification for the safety claim of Bt brinjal by India’s regulators, which are based on an uncritical acceptance of the interpretation of the data submitted by Mahyco-Monsanto. This has been heavily criticised by eminent scientists of international standing. 
vi.       “Biotech crops are environmentally friendly and have contributed significantly to reducing the emission of greenhouse gases from agricultural practice”.
These claims again simply quote material from industry promotional material, which as noted above is not supported by data in published peer review scientific journals:
  • GM crops are designed to be used in conjunction with synthetic pesticides and fertilisers, which are manufactured from oil and natural gas.
  • GM crops do not reduce greenhouse gas emissions.
  • Recent data from the US Department of Agriculture has shown a vast increase in herbicide use since the introduction of GM crops tolerant to the application of these agrochemicals (9).
  • Therefore, the introduction of GM crops has exacerbated rather than reduced agriculture’s carbon footprint and is clearly unsustainable.
Alternative proven technologies that can reduce the amount of fossil fuel used in farming already exist. This includes methods for reducing fertiliser applications, selecting farm machinery appropriate for each task, managing soil for conservation, limiting irrigation and agro-ecological farming techniques.
  • Dr Michael Antoniou, King’s College London School of Medicine, UK
  • Dr Thomas Bøhn, GenOk - Center for Biosafety, Tromso, Norway
  • Prof Philip L. Bereano, University of Washington, USA
  • Prof Marcello Buiatti, University of Florence, Italy
  • Prof Lawrence Busch, Michigan State University, USA
  • Prof Joe Cummins, University of Western Ontario, Canada
  • Prof Jack A. Heinemann, University of Canterbury, New Zealand
  • Prof Angelika Hilbeck, Swiss Federal Institute of Technology, Zurich
  • Prof Malcolm Hooper, School of Sciences, University of Sunderland, UK
  • Prof Carlo Leifert, Newcastle University, UK
  • Prof E R Orskov OBE, Macaulay Institute and Aberdeen University, UK
  • Prof Gilles-Eric Seralini, University of Caen, France
  • Prof David Schubert, Salk Institute for Biological Sciences, California, USA
  • Dr Joël Spiroux de Vendômois, CRIIGEN, Paris, France
  • Prof Brian Wynne, Lancaster University, UK
  • Prof Louise Vandelac, University of Québec at Montreal, Canada
  • Dr Christian Vélot, University Paris-Sud, France
  1. Indirect costs of a nontarget pathogen mitigate the direct benefits of a virus-resistant transgene in wild Cucurbita. Sasu MA et al. Proc Natl Acad Sci U S A, 106: 19067-19071, 2009.
  2. Transformation-induced mutations in transgenic plants: Analysis and biosafety implications. Wilson A.K. et al. Biotechnol Genet Eng Rev., 23: 209-234, 2006.
  3. Proteomics as a Complementary Tool for Identifying Unintended Side Effects Occurring in Transgenic Maize Seeds As a Result of Genetic Modifications. Zolla L et al. J Prot Res, 7: 1850-1861, 2008.
  4. Unintended Compositional Changes in Transgenic Rice Seeds (Oryza sativa L.) Studied by Spectral and Chromatographic Analysis Coupled with Chemometrics Methods. Jiao Z et al. J Agri Food Chem., 58: 1746-1754, 2010.
  5. Novel upland rice variety bred using marker-assisted selection and client-oriented breeding released in Jharkhand, India. Katherine Steele, Monday, May 4, 2009.
  1. No sure fix - Prospects for Reducing Nitrogen Fertilizer Pollution through Genetic Engineering.
Doug Gurian-Sherman and Noel Gurwick, Union of Concerned Scientists, 2009.
  1. Failure to Yield: Evaluating the Performance of Genetically Engineered Crops. Doug Gurian-Sherman. Union of Concerned Scientists, April 2009,
  1. Eating Up the Amazon, Greenpeace International, 2006,
  1. Impacts of Genetically Engineered Crops on Pesticide Use: The First Thirteen Years, C. Benbrook, The Organic Center, Nov. 2009,
  1. Agricultural Practices and Carbon Sequestration. Margaret Mellon and Dr. Doug Gurian-Sherman, Union of Concerned Scientists, USA. Report, 1 October, 2009.
  2. Monsanto's modified soya beans are cracking up in the heat. Andy Coghlan, New Scientist, 20 November 1999.
  3. GM soy hit harder by Brazil's drought than conventional varieties. Mario Osava, English IPS News via NewsEdge Corporation, Rio De Janeiro, 4 April 2005.
  4. Report: Argentina: A Case Study on the Impact of Genetically Engineered Soya How producing RR soya is destroying the food security and sovereignty of Argentina,
  1. Argentina's bitter harvest. Branford S. New Scientist, 17 April 2004.
  2. Rust, resistance, run down soils, and rising costs - Problems facing soybean producers in Argentina. Benbrook C.M. AgBioTech InfoNet, Technical Paper No 8, Jan 2005.
  3. A Disaster in Search of Success: Bt Cotton in Global South. Film by Community Media Trust, Pastapur, and Deccan Development Society, Hyderabad, India, February 2007.
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