To									June 14, 2006

Shri Bir Singh Parsheera
Chairperson-Genetic Engineering Approval Committee [GEAC]
Ministry for Environment & Forests
Paryavaran Bhawan
CGO Complex, Lodhi Road
New Delhi 110003

Dear Sir

Sub: FEEDBACK ON Bt BRINJAL – BIOSAFETY AND BEYOND
	
We would like to begin by stating that while we welcome the fact that GEAC has offered, for the first time more than a decade after GM crop research began in India, to put up data related to findings from biosafety tests on Bt Brinjal, the entire process run was completely unacceptable. The data that was put up, as presentations by M/S Mahyco to the GEAC, is completely inadequate for any intelligent and scientific feedback to be provided. This also showed the world how GEAC takes its decisions. It is clear that a body that should ask basic, scientific questions related to health and environmental implications in addition to socio-economic implications for our farmers, has decided to function as a mere ‘bureaucratic approval’ body and runs its processes only on such company-produced meaningless presentations. This is a shame to this country, which is a signatory to international conventions like the Cartagena Biosafety Protocol that enshrine the concept of biosafety when it comes to GMOs. To make this farcical process worse, GEAC’s own press release put out through the PIB [Press Information Bureau] on May 25th, 2006 says that the company’s biosafety findings would be put up under the sub-heading “GEAC Clearance Shortly” on the MoEF’s website. Does that mean that the GEAC has already decided on the clearance shortly?

We provide our feedback on Bt Brinjal hereunder. Below, we bring up biosafety issues as well as more fundamental issues beyond biosafety, not in any particular order of importance. Much of this feedback should also serve as a feedback on the serious shortcomings of our biosafety regime in general and why there is a need to invoke the precautionary principle on GM crops.

1.	There is no justifiable reason whatsoever for experimenting on and introducing Bt Brinjal [and GM crops in general]: The GEAC or the DBT [Department of Biotechnology] has no good reason and justification to promote a GM Brinjal in this country. Pest management on Brinjal is being successfully practiced by numerous IPM, NPM and organic farmers with non-chemical, non-GE approaches with very satisfactory results all over the country. Within the ICAR establishment, numerous research projects, including on farmers’ fields, show that there are very good, inexpensive and absolutely safe results following non-chemical IPM methods in particular and IPM methods in general. Given such vast experience, why is there no political will to put the control over the technology in farmers’ hands? We are attaching to this letter a collection of such experiences which should provide a way forward for our thinking. We are once again reiterating that for the pest management paradigm to shift in this country, what is needed is political will and not GE-like solutions. We all know that pesticide use in fact has very little to do with pest/disease incidence any more and it has suited the pesticide industry and the regulators/agriculture scientists very well to encourage such a situation so far. To get out of this, we don’t need a technology-fix but an alternative paradigm of pest management which empowers the farmers to understand their farm ecology and depend on local resources and sustainable practices for pest management. 

2.	The science is imprecise: It is well known that GE is based on imprecise science and is an unpredictable technology as there is little control on where the new genetic construct will lodge within one or more of the target cell chromosomes. It is also well known that tests are not conducted to assess the results from the variety of genes that are inserted along with the desired gene [the markers, promoters, terminators etc. etc.]. Scientists do not understand the mechanisms of GE-induced changes in gene expression in sufficient detail. They do not know what to look for and these things are termed ‘unintended effects’. It is for this reason that on a whole range of issues, a great deal of research is required before any outcomes can be predicted in a reasonably assured manner. Unlike in other countries, in a country like India where a majority of our livelihoods depend on agriculture, any irrevocable or irreversible change to our agriculture needs to be reasonably sure that the benefits being projected are drawn from sound, long term scientific testing and that risk assessment parameters are broad-based. Elsewhere, risk assessment of GMOs also asks a very pertinent question – “is it [introduction of a GMO] socially and ethically justifiable?”. We are annexing a paper on such risk assessment so that GEAC might at least now pick up the appropriate framework for risk assessment given that millions of farmers in this country would be affected by your decisions.

3.	The Bt gene is a known toxin that impacts human health and livestock health adversely: Introduction or creation of a new or known allergen or toxin is a potential consequence of genetic manipulation, as experience worldwide shows. 

When Bt Cotton was introduced in India, the same set of tests that are now being applied for Bt Brinjal have apparently been run by the company involved and everything was proclaimed to be safe. However, the human health effects of Bt Cotton in India are being reported from all cotton-growing states. Most farmers and farm workers are experiencing allergies of different kinds. Further, a recent scientific investigation made a clear correlation between the exposure to Bt Cotton and these adverse health effects [copy of the report attached]. There were also reports on mortality of sheep after grazing on Bt Cotton recently [copy of the Fact Finding Team’s preliminary investigation report attached]. While there have been no systematic investigations done in other places, there are informal reports however that livestock is being adversely impacted upon grazing on Bt Cotton fields from other places too. 

While this is the case with cotton, the consequences with a food crop, that too a vegetable crop which will be consumed quite directly, are unimaginable. Never before in the world has the Bt toxin been introduced into a vegetable crop, where the toxin would be consumed in large quantities and without much processing. We are annexing several scientific papers which point out that Cry1Ac gene, the Bt gene being used in Bt Brinjal, has many established adverse health impacts. These published, peer reviewed papers by scientists demonstrate that recombinant Cry1Ac protoxin is a powerful immunogen (able to produce an immune response), and when fed to mice, induced antibody responses similar to those obtained with the cholera toxin. Research shows that Cry1Ac actively binds to the inner surface of the mouse small intestine. This contests the often-heard argument that Cry proteins don’t affect mammals since they supposedly do not have receptors that bind the truncated toxin in the gut!

The entire infamous episode of Starlink contamination raises the question of whether other Bt toxins that were supposedly screened might nevertheless be allergens. Scientists accept that without a better understanding of food allergenicity, this question cannot be adequately answered.

There are serious limitations to current allergy testing procedures for GMO proteins. For example, recent results in Australia revealed that a protein previously consumed safely in beans had become immunogenic (similar to allergic reaction) when engineered into GMO peas.  The immunogenicity of the GMO peas would not have been detected by currently used tests.  Therefore, new allergy tests, and careful, long-term tests, are needed to assure the safety of Bt brinjal.  Other possible risk issues, such as possible unintended harmful changes in the Bt brinjal plants, can also only be addressed by careful long-term and other testing.

There are some nutritional and toxicological studies carried out on ingested plant GM DNA which provide information on the potential nature of the hazards of GM foods/feeds. These include: wasteful growth of gut tissues and bacterial proliferation, development of intestinal tumours, depression of the body’s immune system, interference with the normal development of vital organs of the body (liver, kidneys, sexual organs, etc.) and reproduction. The seriousness of these effects cannot be overemphasized because the harm will be the most pronounced in the young, the old and in people with intestinal disorders.

Both of the two human clinical studies carried out and published till date provide strong evidence of Horizontal Gene Transfer from food to humans. These studies showed that fragments of GM DNA were incorporated into the bacteria resident in the gut of human volunteers. Significant amounts of transgenic DNA is found to survive most commercial processing or in the gut of mammals, as per studies in various places. 

4.	The other genes introduced are toxic too: In creating Bt Brinjal, NptII gene has been used as a selectable marker. NptII codes for kanamycin resistance and globally, there are serious concerns with antibiotic resistance marker genes for obvious reasons – when there is horizontal gene transfer to gut or soil bacteria, this could spread antibiotic resistance widely. Gene flow, especially to pathogenic organisms, related to antibiotic resistance has been established in past studies. This will imply that disease treatment would be more and more difficult. 

Similarly, use of the CaMV 35 S [cauliflower mosaic virus] promoter, used in creating Bt Brinjal is a matter of concern. Published research shows that the 35S promoter can initiate transcriptional activity in human cells, despite the promoter being a plant-specific one. A scientific paper attached throws further light on this. 

The cauliflower mosaic virus (CaMV), the viral promoter used in Bt Brinjal has similarities with the human hepatitis B virus. As all genomes of living species contain dormant viruses, there is a potential for the CaMV promoter to reactivate them raising concerns related to cancers.

One of the major omissions in present day GM risk analysis is that no attempt has so far been made to investigate the obvious link between GM food and intestinal tumour development. As Dr Arpad Puzstai points out, “full reproductive experiments are required in which the reproductive performance of both male and female rats fed on GM- versus non-GM diets should be monitored for several generations because any problems with reproduction could have disastrous consequences for the environment”.

The problems encountered in the study of ‘growth factor-like’ effects on young rats, was attributed most likely, to the CaMv (cawliflower mosaic virus) viral promoter, a promoter put into Bt Brinjal too. Evidence suggests that the CaMv 35S promoter might be especially unstable and prone to horizontal gene transfer and recombination with all the attendant hazards: gene mutation, cancer, re-activation of dormant viruses and generation of new viruses.

Hazards from GM crops released into the environment may spread more readily through HGT because GM constructs are specifically designed to cross the interspecies barrier.

5.	Pending liability issues with regard to biosafety violations that need to be addressed first: Right from the first GM crop trials, there have been many reports from the civil society and the media which pointed out to serious GM regulatory failures in India. This failure was evident both from the company’s side [one doing GM research] and from the side of the regulators like the DBT and the GEAC.

Such failure of enforcement inevitably led to contamination of the supply chain from most field trials even before biosafety [within its limited framework in India] tests were completed. In the case of Bt Brinjal too, investigations of a field trial in Kurnool district of Andhra Pradesh pointed out to the fact that the farmer was allowed to sell the Bt Brinjal in the local market [report attached].  Even though this was brought to the notice of the regulators, no action towards fixing liability for such serious violations was initiated. 

One of the issues that emerged from investigating the Bt Brinjal trial in Kurnool was the observation by the farmer and his relatives that Bt Brinjal needed to be sold only in the mornings when its color was attractive and that it would change color as the day passed! Farmers’ observations about such issues are very sharp and this needs serious and deeper investigation. This was later corroborated by the field assistant employed by Mahyco, in a telephonic conversation. 

6.	Past history with corporate research shows suppression of important information: Monsanto, which is supplying the technology to Mahyco and others in the case of Bt Brinjal, is known from past experience to suppress facts that are unfavourable to the company and its potential markets. A secret study on Bt Maize showed significant harm caused to rats fed on the variety called MON 863. The study shows kidney abnormalities and unusually high levels of white blood cells. What is shocking was that the company then went ahead to conclude that these findings were irrelevant and should not be attributed to Bt Maize even though the rats fed on non-Bt Maize showed no such signs!  Given such dubious history, how are the regulators relying on data produced only by the company? There is a serious and objectionable conflict of interest in the fact that majority of the tests were undertaken by the company promoting Bt Brinjal [pollen flow studies, Cry1Ac protein expression, baseline susceptibility, protein estimation in cooked fruits, soil analysis, substantial equivalence studies etc. etc.]. Out of the various tests conducted, only four were conducted by public sector institutions. Where are independent studies to verify the claims of the company?  

7.	The tests done here are not adequate – Are we even asking the right questions? A Public Interest Litigation [PIL] on the lack of rigorous biosafety testing for GMOs in India points out that the current biosafety regime is woefully inadequate in India. A copy of the PIL petition is attached in the form of a booklet for ready reference. Often, we do not even have the right questions to ask when testing for safety of GMOs. As pointed out earlier, elsewhere, biosafety regime is inclusive of such pertinent questions as “is this socially and ethically justifiable?”. This requires the testing to be done against other known safer alternatives including ecological/sustainable agriculture practices. However, this was not done in the case of Bt Brinjal. Another paper by Dr Pushpa Bhargava way back in 2002 outlines what the biosafety regime should constitute. Going by the set of studies that the company has been asked to do by the regulators, it is obvious that feedback has not been picked up and lessons not learnt.

8.	The agronomic data unreliable and manipulated: Going through the Annual Report of Indian Institute of Vegetable Research on ICAR-supervised Bt Brinjal multi-locational trials in 2005-06, it is clear that the data presented is manipulated and unreliable. It is not clear why at least 3 out of the 11 Centres for trials did not report back. The data was not statistically analysed and wrong conclusions were drawn based on skewed averages. It is not clear how some centres could obtain such unbelievably high yields while most of the centres were below average. Is this going to be the situation in real life too for farmers? There is no data at all on pesticide use obtained through the trials though Bt Brinjal is developed ostensibly to reduce the use of pesticides. It is also clear that there were no trials taken up to compare with safer, cheaper, farmer-controlled alternatives like organic brinjal cultivation or NPM or IPM approaches. There was not even a comparison against IPM experience from all over the ICAR establishment from more than 10 years’ of work.

9.	India is a Center of Origin and diversity for Brinjal: Our pool of genetic reserves would inevitably be contaminated and this is extremely dangerous given that we are a Centre of Origin and diversity for Brinjal. We have grown Brinjal for the past 4000 years in this country and it is an extremely popular and widely consumed vegetable. Needless to say, horizontal gene transfer from Bt Brinjal into wild, related species of brinjal has serious implications for the very future of Brinjal research and cultivation in the country. The genetic diversity is important because some of the strains will be naturally resistant to lethal pathogens and pests that may destroy the crops in the future. Once lost, this lack of diversity can lead to the complete loss of the crop. If the gene confers an advantage to the wild plants, it will spread in those plants and cause possible harm.  This is a very different risk than for the crop itself, since most crops, unlike their wild relatives, cannot survive without cultivation.  The U.S. National Academies of Science, in a report in 2004, said that genes that control pests, like Bt genes, have a good chance of giving wild plants an advantage and thereby spreading in the environment.  Several published experiments with Bt in rapeseed and sunflower have provided preliminary data that Bt genes can indeed give some wild plants a competitive advantage.  If the gene spreads in wild relatives of brinjal, its escape into the environment will likely be permanent. The toxin produced by the gene may then kill insects that feed on the wild plants. These insects, in turn provide food for other organisms such as birds and mammals, which may then suffer harm.  For these reasons, it is important to determine the possible harmful effects of the Cry1Ac gene in sexually compatible wild relatives and their ecosystems.  

The Cartagena Protocol on Biosafety, the only international law to specifically regulate genetic engineering and GMOs (largely focused on transboundary movement, but whose scope also applies to the use of all GMOs), recognises the importance of centres of origin and diversity, and requires this to be taken into account during the risk assessment. How has this principle been applied in the case of Bt Brinjal in India?

10.	Potential environmental hazards with Bt Brinjal: Existing evidence on environmental hazards with GM crops is enough for a precautionary principle to be invoked regarding their regulation. For instance, it was found in studies that GM crops grown in the UK were not only harmful to beneficial insects like ladybirds but could also indirectly harm other and higher life forms, including mammals, domesticated or wild animals/birds and ultimately man, both in the short- and long-term. The three-year UK farm-scale trials were the largest study ever to evaluate some of the ecological effects of GM crops. 

The assessments about frequency and importance of Horizontal Gene Transfer are premature at present. It is accepted that it [HGT] could have an environmental impact even at a frequency that was approximately trillion times lower than what the current risk assessment literature assumes it to be. The current methods of environmental sampling to capture genes or traits in a recombinant manner are too insensitive for monitoring evolution by HGT. This has serious implications for our bio-diversity, especially given that we are the Centre of Origin for brinjal. With the inevitable contamination of the seed stock, which is certain to take place with GM crops, recovering the original genetic stock will be impossible.

In the case of pollen flow, it is well known that there is ample opportunity for cross pollination in the case of Brinjal. The rates of natural cross pollination may vary depending on genotype, location, insect activity etc. However, it has been reported that the extent of natural outcrossing is from 2 to 48% in the case of India. Further, it is not clear whether there is enough data on the wild and weedy plants that are either close relatives or have some degree of cross-compatibility with these brinjal varieties. No tests have been done to check for cross-pollination with such relatives. The pollen flow studies on Bt Brinjal in India have been done only in one year [2002, even as the backcrossing programme was on?], in two locations, with reported outcrossing put at 1.46% and 2.7% in these two locations. Such pollen flow studies cannot obviously rely on data from one season and two locations. Studies elsewhere have shown that the likelihood of outcrossing from genetically engineered crops is much higher than in non-engineered crops. For obvious reasons, the same care that is taken for maintaining seed production standards [of 200 metres], has to be applied for the worst case scenario with Bt Brinjal, as a very minimum requirement. In such a case, will Bt Brinjal farmers, who are mostly small and marginal farmers, be able to conform to such guidelines?

Further, farmers from various parts of the country are reporting a decline in their soil productivity after growing Bt Cotton. While the regulatory tests related to Bt toxin presence and persistence in the case of Bt Cotton showed that the half-life of Cry1Ac protein in plant tissue was calculated at 41 days [which could then persist in the soil as other studies from elsewhere show], it is not clear how in the case of Bt Brinjal it is non-detectable in soil samples tested. Worldwide, it is generally accepted that Bt toxin does alter the soil micro-biology and that more studies are needed to understand the impact of Bt toxin on soil ecology.

Have the regulators studied the impact of Bt Brinjal on ecologically sensitive areas like the Eastern and Western Ghats and considered how they would prevent the entry of Bt Brinjal into such ecologically sensitive areas?
 
We should also consider a scenario where our predominant pest management strategy relies more and more on one gene – the Bt toxin gene, across crops for a range of pests. Such a monoculture of the gene across crops and varieties is bound to spell doom sooner or later.

11.	Economic & Trade implications: There are serious economic and trade implications if India opts for Bt Brinjal. Once again, the assessment of such implications should be against other choices like staying non-GM as well as promoting organic farming. Even a country like Germany had experienced the enormous employment opportunities provided by the organic approach. On the other hand, transgenic agriculture would sound a death knell for any attempts related to organic farming in India. Contamination is inevitable and co-existence impossible. This would have serious economic implications for the farmers here.

12.	Consumer choices and rights: Transgenic contamination (contamination of the natural environment by GMOs) by more than one method, including wind blown and by cross- pollination is an established fact, beyond dispute and there can be no co-existence between GM and non-GM crops. Segregation even at the physical level is impossible in India. What happens to consumer choices and rights in such a case? Where would be the consumer’s right to choose in the case of vegetables, even if we assume that segregation upto an extent is possible and labelling could be made mandatory? Indian vegetable purchases from supermarket shelves are minuscule and obviously, labelling is not going to be an answer here.

13.	Proprietary Rights of the company: Even as the ABSPII project was publicising through the media that the technology would be available to the Indian public sector and later to the farmers on a cost-to-cost basis, with Monsanto providing the technology and Cornell University/USAID facilitating the process, Mahyco has informed the GEAC in its presentation on May 22nd that it had applied to the Patent Authority for a patent for "this unique event". This of course will open the floodgates of Indian seed industry to patents, which needless to overemphasise will violate farmers' rights. It will also mean that this technology will not be for everyone, though it is being projected otherwise! The true colors of the corporations behind the development of Bt Brinjal have begun showing.

14.	Specific feedback to the company’s claims on its findings through Bt Brinjal tests and trials: 

It is utterly meaningless to comment on the company’s claims apparently based on their studies and trials with Bt Brinjal. This is because no protocols are described for the tests nor any numbers or tables presented. However, from whatever’s put up on the MoEF’s website,:

1	The tests related to allergenecity and toxicity prescribed as part of biosafety testing are obviously inadequate as the experience with Bt Cotton in India shows. Despite being cleared as safe, Bt Cotton is reported to be causing widespread allergies in cotton growing belts of the country. Therefore, the protocols for such tests need to be re-looked at to capture the real adverse potential and such revised and better protocols applied for Bt Brinjal testing, especially given that it is a food crop with the toxin consumed in large quantities with no or very little processing.
2	Feeding tests done on goats do not capture the potential hazards as goats are known to be hardy animals, compared to sheep for instance. The protocol used in the case of Bt Cotton was to feed goats with cotton seed and the results apparently showed that there is no difference between feeding the goats with Bt Cotton seed and non-Bt Cotton seed. There were no multi-generational feeding tests done. What was not clear however was what the exact research protocol was - how old was the cotton seed, for instance? It is now clear that the tests did not capture the reality of farmers grazing their animals on Bt Cotton plants and not seeds. They also do not in any way predict what could happen with sheep. In the case of Bt Brinjal, there was no change in the testing regime from the Bt Cotton testing regime, despite such valuable lessons emerging from the field and despite this being a vegetable!
3	It is not enough to understand the effect of the Bt gene alone while understanding the impacts on human health and environment. It is important to capture the effects of the other genes transferred too. For this, a set of tests have to be evolved and undertaken.
4	It is surprising that the company says that the Bt toxin rapidly degrades in the soil. Published literature shows that this is not the case. There are many studies that show that Bt toxin can persist in the soil and retain its insecticidal activity. It is in any case known that the half life period of Cry1Ac toxin in plant tissue in the case of Bt Cotton is around 41 days. In such a case, why are the studies done by the company showing that the protein presence was non-detectable? At what stage of the crop was the test done?
5	What is the implication of growing Bt Brinjal in terms of the next crop, given the potential impacts on soil?
6	It is also surprising that pollen flow studies were done for just one year in two locations. Other information from India on pollen flow in Brinjal has results that should make any regulator sit up and take a cautious approach. The protocols used for devising Minimum Standards for Seed Production and Certification should be used here, since they have the worst case scenario built into the framework.
7	Such pollen flow studies should begin by listing out the wild species and related [compatible] species available in India in various regions of brinjal cultivation and check the effect of Bt Brinjal growth on such species, in a controlled environment [and not in farmers’ fields]. Where is the data on associated biodiversity [like insects, birds, animals, microbes etc.] which depend on brinjal and its related crops [both wild, related and cultivated] and where are the impact studies on such associated biodiversity?
8	No detailed molecular characterization has been provided by the company. This is important, since we now know that developers cannot control where the transgene insert lands and that DNA rearrangements occur, with the potential to affect the spatial and temporal expression patterns of nearby genes.
9	Bt protoxins differ immunologically from the truncated proteins used for testing purposes. There is evidence that the toxic portion of Cry1A proteins can have a different 3-D conformation depending on whether it is part of the protoxin or in its free state. DNA structurally associated with the protoxin is released during the proteolysis process that generates the toxic fragment from the protoxin. If safety testing was performed on truncated versions of bacterial surrogate proteins rather than the full-length plant-produced Bt proteins that people are actually exposed to, such testing is absolutely inadequte. It has been found often that biosafety testing does not take into account such a difference and it is not clear how the tests were conducted here.
10	It is obvious that investigations have not been carried out to check whether the bacteria in the GM agro-ecosystems have 'picked up' DNA sequence fractions of kanamycin resistance reporter genes.
11	What do the "isolated instances of necropsy" findings in all treatments indicate and what is the company's explanation, in the case of Sub-Chronic Oral Toxicity studies in rats? How many such instances in Bt-treated rats and how many in non-Bt treated?
12	Where is the data on how the Bt Brinjal affects children?
13	Where is the data on the cultural diversity that exists with regard to the cooking of brinjal in this country?
14	Where is data on quantified protein expression related to pest incidence and the complete growing season of the crop? Given that the expression of the toxin is highest in the fruit, the consumed part, what implications does this have for particular hybrids?
15	Deeper investigations into what the farmers have observed during field trials of Bt Brinjal – of color change as the day passes – have to be taken up.
16	There is no data that shows that pesticide use does come down with Bt Brinjal – by how much? How does it compare with NPM and organic practices?

Given all the above, we demand that:

1	Since the effects of this technology/modified organism are unknown and since these are potentially hazardous, the use of this technology and release of those organisms must wait until the hazards are properly understood and the effects known. This requires the precautionary approach to be followed.
2	Biosafety testing should include testing for medium and long term effects on the environment and human/animal health, in addition to asking questions on the justification of releasing the GMO into the open environment on social and ethical grounds. [we attach relevant papers on what such testing should be like, as enunciated by scientists like Dr Pushpa Bhargava and Dr Arpad Pusztai as well as how other countries like Norway do their risk assessment]. For this, the regulators as a beginning, should put together all the available data on safer alternatives, as any environment assessment should, like IPM, NPM, organic etc., and compare Bt Brinjal with such alternatives.  
3	Proper biosafety tests should be taken up by independent and scientifically competent bodies in a transparent manner. Such tests should be allowed to take appropriate time needed to understand the medium and long term effects instead of being hastened in the pursuit of ‘fast-track approvals’.
4	The results of such tests should be made public and data published in a manner that it can be closely examined by the scientific community. It shall also be presented to all primary stakeholders [farmers and consumers] in a manner that meaningful debates are possible, through for instance, mandatory public notice and public hearings etc.
5	Such reviews and debates should also look at issues beyond biosafety and delve into socio-cultural and political aspects related to GM agriculture, given that millions of our lives and livelihoods depend on agriculture here in India.
6	The GEAC, especially representatives from the Health Ministry, Environment Ministry and the Agriculture Ministry on the Committee, should take on board current scientific data [health and environmental] from elsewhere to understand the potential impact of GMOs and to ask the relevant questions in the Indian context. Based on such available data, they should lucidly justify why a precautionary principle cannot be invoked straightaway, instead of falling into the trap of the Department of Biotechnology which apparently has only one mandate of promoting GMOs.

In summary, we believe that it would be a very grave, irreversible mistake to allow the large scale testing and seed production of Bt Brinjal in India. One must be absolutely sure that it will do no harm before this step is taken, since the experience with Bt Cotton shows that it was during large scale trials that contamination was allowed to happen. Since that time, there has been no improvement in the regulatory apparatus in the country. This precaution is particularly necessary when there is absolutely no need for the GE product, as is the case with brinjal.

Sincerely,