GENET archive


RISK ASSESSMENT & FEED: Indian Bt cotton demand rises by 30 per cent

                                  PART 1

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SOURCE: The Hindu, India



DATE:   06.07.2007

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HYDERABAD: Notwithstanding the controversies dogging it, Mahyco-Monsanto Biotech Limited is expecting 30 to 40 per cent growth in demand for its flagship Bt cotton (Bollgard I and II hybrids) this kharif.

Raj Ketkar, Joint Managing Director, MMBL told press persons here on Thursday that growth had been ”phenomenal” during the last five years across nine cotton growing states. The acreage under Bt cotton rose from 72,000 acres in the first year (2002) to 8.7 million acres in 2006.

About 2.2 million farmers have planted Bollgard and Bollgard II hybrids across the nine cotton growing states, ”showing increased acceptability”.


Sheep mortality

Referring to the sheep and goat mortality in Adilabad and Warangal, Mr. Ketkar and R. K. Sinha, Executive Director, All India Crop Biotechnology Association dismissed it as ”localised phenomenon”. In its ten years of global Bt cotton experience, there has not been a single instance of harm to an animal that grazed on Bt plant material.

They admitted that there has been no major field study after the commercial release of the Bt cotton. Nor was there a plausible explanation on cause of recurring deaths.

They explained that tests were conducted including evaluation of bio-safety data and feeding studies before the Bt cotton was released for commercial cultivation after approval from the Genetic Engineering Approval Committee.

Studies at the Centre for Animal Disease Research and Diagnosis, IVRI Rae Bareilly on goats and in laboratory rats fed with leftover Bt cotton indicated ”no untoward clinical effects”.

                                  PART 2

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SOURCE: Mutual PR, India

AUTHOR: Press Release


DATE:   05.07.2007

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New Delhi, July 5, 2007 ? In the recent past there have been a series of reports which have appeared in various sections of the media on the adverse effects of Bollgard (Bt) cotton on sheep/goat/cattle. The All India Crop Biotech Association (AICBA) would like to present some factual and scientific information with regards to these allegations.

This is with reference to the issue on the deaths of sheep/goats/cattle after eating Bt cotton crop waste in Andhra Pradesh:

- Genetic Engineering Approval Committee (GEAC), in its 77th meeting on May 19, 2007 gives clear indication that Bt cotton released for commercial cultivation has been approved after evaluation of biosafety data, which includes feeding studies. The 90?day animal feed studies conducted at the Industrial Toxicology Research Center, Lucknow, feeding studies conducted at GB Pant University of Agriculture, Pantnagar, on lactating Buffalo, on chicken at Avian Research Institute, Izatnagar, and fish at the Central Institute of fishery Education, Mumbai, all indicate no toxic effect. The fact is that in over ten years of global Bt cotton experience, there has not been so much as one instance of harm coming to an animal that has grazed on Bt plant material

- The GEAC however requested the Member Secretary to forward the report of the Directorate of Animal Husbandry, AP, to the members of the Scientific Investigation Committee constituted by the Ministry for their comments. The Committee desired that the views received from the experts may be placed before the GEAC in the next meeting

- GEAC reviewed the reports received from Joint Director, Centre for Animal Disease Research and Diagnosis, IVRI, Rae Bareilly, in its 78th meeting held on June 22, 2007. The report indicates that the limited studies conducted in the institute in goats and in laboratory rats fed with Bt cotton left over indicated no untoward clinical effects. The Toxicology laboratory of the Centre, showed absence of HCN, Nitrate/ Nitrite, Alkaloids and Glycosides in the samples analysed. Although the histopathological studies in laboratory rats are under process, based on the available facts, the Centre is of the view that there is a possibility of other diseases prevailing in the area during the occurrence of mortality.

- GEAC also reviewed some of the scientific reports published in international journals and views expressed by Punjab State Agriculture University, Ludhiana and Foundation for Biotechnology Awareness and Education and conclude that ”None of the reports or analysis concludes that Bt toxin is responsible for sheep mortality in Adilabad and Warangal in Andhra Pradesh”

- GEAC was also informed by the IVRI centre of its request to NGO, ANTHRA to provide suitable samples from animals (serum, blood, and tissues from dead cases) for differential diagnosis, which has not been received. GEAC has decided to forward the copy of the report of IVRI to the State Department of Agriculture and Directorate of Animal Husbandry, Govt. of Andhra Pradesh for necessary action

We would also like to draw your attention to the acute toxicity studies conducted in the USA:

- The acute oral toxicity study of Bt protein in mice conducted at the Agriculture Group/ Environmental Health laboratory, USA, concluded that there was no treatment related adverse finding in any of the groups administered B.t.k. HD?73 protein (Bt protein) by oral gavage at dosages up to 4200 mg/kg. The oral LD50 for B.t.k HD?73 (Bt protein) protein in mice is greater than 4200 mg/kg and the no?observed effect level is 4200 mg/kg. Further, mice gavage studies have shown that an intake of 4300 mg Cry1Ac / Kg body weight had no ill effect on the mice.

- Assuming a similar upper safe limit for goats, in order to have an intake of 4300 mg. of Cry1Ac/Kg of body wt., the goat should eat (assuming the goat weighs 15 kgs) 24,339 kg of leaf/50,300 kg of boll rind, which is not practically feasible.

Additionally, media reports mention that organophosphorus compounds, nitrates, and nitrites have been detected in the viscera of sheep. These compounds are in no way associated with Bt cotton.

The expanded use of Bt cotton by an ever increasing population of Indian farmers is overwhelming evidence that the very people who depend upon it for their livelihood feel it is both effective and safe. According to the ISAAA brief, Global status of commercialized biotech/GM crops: 2006, of the 6.3 million hectares of hybrid cotton in India planted in 2006 (70 per cent of all the cotton area in India), 60 per cent, or 3.8 million hectares, was insect protected Bt cotton. This is a remarkably high proportion and clearly demonstrates that farmers are confident of the performance and safety factors of Bt cotton.

Scientists around the globe have extensively studied the safety aspects of Bt proteins and have deemed them safe for animal consumption. Some of their findings are:

- Globally, microbial Bt products have been in use for over 40 years with exemplary safety record; In India these products have been in use since 1990 and were accorded priority registration on account of high level of safety

- Safety assessment of insect?protected cotton has been published;

- The Bt protein (Cry1Ac) is quickly digested in mammalian gastric fluid and provides a source of amino acids similar to dietary proteins currently fed to animals;

- Bt proteins are acutely toxic to target insects due to the reaction of the protein within the cells of the insect. This reaction is proven not to occur in mammals rendering it non?toxic if ingested;

- The US EPA requires, as part of registration process, that acutely high dosages of insect?control proteins be administered to laboratory rodents as a safety precaution. Absolutely no adverse effects have been observed in rodents dosed with Bt proteins introduced into commercialised plants. Additionally, no transgenic protein has been detected in the tissues of dairy cattle, growing calves, broiler chickens, or swine when fed biotechnology derived crops;

- Specific studies conducted in India all conclude no adverse effects when animals were fed Bt protein in Bt cotton

- Bt crops or their byproducts have been evaluated in feeding studies with animals. All studies have concluded that Bt crops are as safe as their non Bt counterparts.


Background of Bollgard cotton in India

After Maharashtra Hybrids Seeds Co Ltd (Mahyco) received regulatory approval in March 2002, Mahyco Monsanto Biotech (MMB)* sold 72,000 acres of the three approved Bollgard™ hybrids in the first year. In 2003, the second year of launch, the acreage under Bollgard™ cotton increased three?fold to 230,000 acres. In 2004, Rasi Seeds received approval for one hybrid and Bollgard™ sales rose to 1.3 million acres, a six?fold increase over the previous year. In 2005, Bollgard™ was planted across all nine cotton growing states with a million farmers planting it on 3.1 million acres. The year 2006 has witnessed a phenomenal increase in Bollgard™ acreages across the nine cotton growing states. About 2.2 million farmers have planted Bollgard™ and Bollgard™ II hybrids across 8.7 million acres in 2006.

* MMB is a 50:50 marketing JV between Mahyco and Monsanto Holdings Private Limited. MMB has co?licensing agreements with a number of Indian cotton seed companies to bring Bollgard™ to Indian farmers.

This statement is to clarify any misperceptions that may arise in the readers’ mind.


About All India Crop Biotechnology Association (AICBA):

The All India Crop Biotechnology Association (AICBA), an industry association of the major companies engaged in agricultural biotechnology in India, has been formed in 2003 to promote the benefits agri?biotechnology for modernizing Indian agriculture and enhancing the livelihood of Indian farmers. The association has been actively working with the stakeholders, including the regulators, farmers, scientists and media for advocating the cause of GM technology to ensure India’s food and nutritional security and to sustain Indian agriculture’s international competitiveness. It has been seen as a reliable partner in the growth of Indian agriculture, has, within a short span of its existence, worked with the government to establish the policy framework for rapid acceptance and growth of GM technology. The Association counts among its members, a total of 15 leading Indian seed companies engaged in agriculture biotechnology including most of the multinationals. Some of them are also technology provider. The Executive Committee of the Association is headed by Mr M Ramasami of Rasi Seeds as the President. Mr R K Sinha, IAS (Rtd), is the Executive Director, who represents the Association and is responsible for maintaining suitable dialogue with various regulatory agencies/ministries on various industry related issues.


For further information, please contact:

Indroneel Roy / Sanjeev K Mehra

Mutual PR

09811224689 / 09350516229



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