(The Hindu): The Minister’s decision comes after a month of public consultations in seven cities, which were attended by approximately 8,000 people. They were organised after widespread protests against the Genetic Engineering Approval Committee’s (GEAC) recommendation of approval of Bt brinjal in October 2009.
Mr. Ramesh attributed the decision to several factors: lack of clear consensus among the scientific community; opposition from 10 State governments, especially from the major brinjal-producing States; questions raised about the safety and testing process; lack of an independent biotechnology regulatory authority; negative public sentiment and fears among consumers and lack of a global precedent.
“My decision is both responsible to science and responsive to society,” he said adding he did not come under pressure from any quarter in arriving at the decision.
This has come under much criticism, see edit in Indian Express, 'By playing to the gallery, Ramesh has not only withheld from the farmer an option that could increase productivity and drastically cut pesticide use. He has also undermined the institutional mechanism that has sustained this country’s cautious introduction of GM seeds like cotton and that is in the process of clearing other food crops like rice, okra and tomato.'
Clearly there is no consensus on this issue. An article in the Indian Journal of Medical Ethics raised another point, that is usually not mentioned in the public discussion:
The gene transfer in Bt brinjal involves two antibiotic resistance marker genes for resistance to Kanamycin and Streptomycin. These are important drugs among the very few that we have in our armamentarium against tuberculosis. Mahyco states that these genes need a bacterial promoter for their expression, which would not be present in Bt brinjal. However there is a possibility that these genes can spread to other pathogenic bacteria by horizontal gene transfer and become active
The testing requirements for GM crops are more lax than those for drugs. Drug trials are conducted in five stages, with the first stage, known as pre-clinical studies, involving only animals. Safety and efficacy issues in humans are addressed in the remaining phases. Government guidelines for research in transgenic seeds or plants only require toxicity (with testing periods of 14 to 90 days) and allergenicity tests (with testing periods of 14-37 days).
It is surprising that regulations for a product meant predominantly for human consumption do not insist on human trials. Though the guidelines state that information related to toxicity and allergenicity to both humans and animals must be generated by the developer, Mahyco's toxicology studies have been performed only on animals and are therefore equivalent only to the pre-clinical studies that are prescribed for drug trials. Save a test that demonstrates that the toxin is undetectable within one minute of cooking, there are no other tests that demonstrate the safety of Bt brinjal for human consumption. It must be noted that Bt tomatoes and Bt cabbage (currently under development) would often be eaten raw. It is estimated that a kilogramme of Bt brinjal would contain 5-47 mg of the toxin, 100 times the minimum inhibitory concentration (MIC95) for the pest larvae .
The safety assessments done so far cannot exclude the possibility that humans may develop resistance to antibiotics, allergies or biochemical abnormalities due to the toxin. A number of reputed scientists have expressed concerns about GM foods. Jeffrey M Smith's Genetic Roulette(23) has a long, fully referenced list of the health risks of genetically engineered foods.
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