The following documents are part of the response sent by the Coalition for a GM-Free India to India's GM regulatory body - the Genetic Engineering Approval Committee (GEAC) - on the biosafety data and the proposal by Monsanto Mahyco for field trials & seed production of Bt brinjal (eggplant/aubergine).

The Coalition's response was endorsed by more than 250 leading organisations & eminent experts from various fields including farmers' organisations, organic farmers, agricultural scientists, microbiologists, medical professionals, and social scientists, amongst others.

The Coalition also communicated to the GEAC that it objected strongly to the fact that GEAC had stated in a press release on July 3rd that it WILL permit the trials, even while it was asking for feedback on the proposal to hold such trials. This, the Coalition said, was not just unacceptable but rendered the entire regulatory process farcical.

THE DOCUMENTS

Bt brinjal 1: Feedback on Bt Brinjal  (see below) 
Letter to the Chairperson of India's GM regulatory body

Bt brinjal 2: Signatories to the letter [1-120]

Bt brinjal 3: Signatories to the letter [121-270]

Bt brinjal 4: Annex 1
Letter to India's Minister for the Environment

Bt brinjal 5: More annexes
includes: a note by Dr Arpad Pusztai
a note from an Ayurveda expert (vaidya) 
comments on Monsanto Mahyco's claims
comments by Dr. Mae-Wan Ho and Prof. Joe Cummins

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Letter to the Chairperson of India's GM regulatory body

July 16, 2006

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

Dear Shri Parsheera

Sub: Feedback on Bt Brinjal biosafety & beyond

Sir, by now you would have received the initial feedback provided to the Minister for Environment & Forests with a copy marked to you, on June 15^th 2006, on the issue of Bt Brinjal and its very need. We are annexing that response to this letter for your ready reference [Annexure 1].

We would like to first record our serious objection to multi-locational limited field trials being conducted in various locations in the open environment, in farmers’ fieldswithout biosafety being cleared, without adequate monitoring and containment capabilities and very often, in violation of farmers’ rights. No liability has been fixed for biosafety violations pointed out earlier, giving a clear message that biosafety is not the regulators’ primary concern at all, though the GEAC has been created, constituted and allowed to function expressly for that.

The following is the collective feedback from the Coalition for GM-Free India which touches upon the earlier-made points even as it includes newer feedback on the biosafety testing protocols that have been adopted in the case of Bt Brinjal and the results of the tests.

1. We repeat that there is no need for Bt Brinjal to be introduced. This is not something that farmers have demanded and almost all major farmers’ organizations of the country have already rejected the proposal of entry of Bt Brinjal even if it is in the form of field trials and seed production, whether in the public sector or in the private sector. There is no crisis in the production of brinjal and it is absolutely false that the company’s data claims that there are upto 80 sprays of pesticides on brinjal crop. For the consumers, there is absolutely no benefit with Bt Brinjal but only a set of problems and dangers presented. All major consumer organizations of the country have already rejected the idea of Bt Brinjal. If despite the lack of need and demand, Bt Brinjal is permitted for field trials and seed production, what guarantee is GEAC is giving to us that this is indeed safe? What liability-fixing mechanisms exist to hold each individual member of GEAC accountable for these kinds of decisions taken?
   
2. There are other issues on which Brinjal farmers need intervention & support. Are the GEAC and concerned government ministries and departments giving any guarantee to farmers that they will procure the crop and stabilize prices with Minimum Support Price and guaranteed procurement to ensure a fair price to farmers? If not, what real benefits will accrue to farmers?
   
3. What guarantee are GEAC and the individual members who represent ministries that are mandated to protect consumer interests giving that consumer rights and choices will be upheld even after the entry of Bt Brinjal, if approved? Will labelling work for distinguishing between Bt and non-Bt Brinjal in our markets and haats? What choices are being left to consumers of the country who want to remain GM-free in their consumption and how will their fundamental right to safe food be upheld?
   
4. If Bt Brinjal is for reducing pesticide usage, then it has to be noted that Bt Brinjal has been compared with only conventionally-grown brinjal. This completely ignores the rich experience that exists within the Indian Council of Agricultural Research [ICAR] on Integrated Pest Management on brinjal, that too with non-chemical approaches. It also ignores the fact that there is vast experience with NPM and organic approaches which farmers have been successfully using for years now on a large scale. Does GEAC have data on such experience and does the Committee know how Bt Brinjal compares with such IPM/NPM/Organic experience?
   
5. Brinjal has great socio-cultural significance in the country. There are communities where a wedding feast is not complete without a special brinjal preparation. Does the GEAC or the company have adequate information/data on such aspects and what the impact of Bt Brinjal would be on such socio-cultural dimensions?
   
6. Brinjal is also used in Ayurveda for its medicinal properties [we are attaching a note from a Ayurveda Vaidya on this issue as Annexure 2]. Does GEAC or the company have data on this and about what Bt Brinjal’s impacts on the efficacy of such medicines would be?
   
7. Coming to the “biosafety tests” that have been conducted on Bt Brinjal it is repeated again through this letter that no independent studies have been taken up to test the biosafety of Bt Brinjal. The entire regulatory mechanism is relying on the developers of the product to come back to the regulators and actually report that something is indeed wrong with the process or product! This is of course impossible to happen and the past history with biotech corporations shows that companies like Monsanto have willfully suppressed information evolved through own investigations on harmful effects of GM crops. There is completely unacceptable conflict of interest in this matter and GEAC should therefore not take any decisions based on this set of studies and findings.
   
8. Initially, GEAC put up only the presentation made by M/s Mahyco and only later, after much protest from civil society groups was other information put up. However, we find that even now, while protocols that have been approved by DBT have been put up, no numbers in terms of findings are not available for the majority of tests conducted. Without looking at numbers, no intelligent feedback is possible.

Most of what is given below looks at shortcomings in the protocol and where possible, compares the findings with findings from other studies elsewhere. We would like to record our protest strongly here that opening the records and documents for only those people who can come all the way to Delhi for looking at the full biosafety data, precludes others from giving their expert opinions and feedback - it is only making this entire process of obtaining feedback a farcical one.

1. It is obvious from all the tests that they were done in great haste, to appease the regulatory requirements rather than to genuinely test for any potential adverse impacts, especially in the medium and long term. Very important tests including the effect of Bt toxin combined with pesticides [combination effect] was not taken up anywhere whereas this would be the reality of cultivation practices even with GM technology! In addition, there is of course the whole area of “unintended consequences” where the regulators and others do not even know the right questions to ask!
   
2. Data from elsewhere shows that there are serious health hazards connected with the genes used in making Bt Brinjal. The Cry toxins from Bt are known to be allergens and immunogens. The antibiotic-resistant marker genes [aad and nptII genes] bring their own serious concerns with regard to the safety of the product. The nptII gene confers resistance to antibiotics like kanamycin and neomycin. The aad gene confers resistance to streptomycin and spectinomycin. Further, the aad gene is under the control of a bacterial promoter. Both genes and DNA can theoretically get transferred into bacteria and cause antibiotic resistance. In a country which depends on antibiotics like streptomycin in its healthcare, this could be a dangerous development.
   
3. 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. The cauliflower mosaic virus (CaMV) 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.
   
4. Pollen Flow studies: The pollen flow studies with regard to Bt Brinjal were done in two locations during 2002.
   
   1. It is not clear how the pollen flow studies have been taken up in the same year that the backcrossing programme began!!
   2. The one year study taken up is grossly inadequate to understand the potential contamination of and transfer to other species from Bt Brinjal and such studies require at least 5 years in different locations to understand the potential impacts.
   3. The Mahyco presentation itself talks about brinjal being cross-pollinated to an extent as high as 48% and ‘is often classified as a cross-pollinated crop’. Other references are available which record a similar level of outcrossing. Outcrossing primarily takes place with the help of insects.
   4. The pollen flow studies done in the case of Bt Brinjal do not assess the distance traveled by the transgene though the objective states so. The counting of spiny seedlings from the non-spiny Pusa Kranti brinjal variety’s progeny also does not indicate outcrossing percentage of the transgene. It only measures the outcrossing of other traits and not the transgenic trait, which is of utmost concern.
   5. Pollen travel distance was concluded as 20 meters and outcrossing percentrage as 1.5% to 2.7% based on this protocol with serious shortcomings. These results are highly undependable, both because the protocol is faulty and because the results are inconsistent with known information on such outcrossing. This outcrossing will obviously be a combined result of several factors, including the fact that insect load and activity itself might be low in a given situation [like the company’s campus]. This insect activity could also vary across kharif and rabi seasons. Therefore, what comes out of the limited testing by Mahyco in its campuses cannot obviously be generalized to all brinjal-growing situations in the country.
   6. In the protocol adopted here [concentric rings of Pusa Kranthi non-spiny hybrid around the Bt Brinjal plot], the movement of pollen gets effected drastically by the pollen load / density, micro-climate, physical hindrances etc. created by the crop (Pusa Kranti) taken around in concentric rings. As we all know, this is one of the factors always considered in modifying / reducing the isolation distances in seed production programs. This pollen load and density will also be affected by the size of the Bt Brinjal block in the middle. It is not clear from the data provided by the company how big the transgenic brinjal plot was in the middle.
   7. The study only looks at the potential transfer from one cultivated variety to another. It does not look at a whole set of issues related to potential transfer to wild and other related varieties and the subsequent impact on the eco-systems that are present for each of these varieties.
   8. We also note that there is no data or study of pollen viability which is also an important factor to consider, talking about outcrossing and insect pollination.
   9. Does GEAC or the company have data on all the related species to brinjal, wild and otherwise and where these exist? Do they have data on the eco-systems of such areas? Have they done any tests to understand the potential impacts of Bt Brinjal on such varieties and their eco-systems?
   10. The pollen flow studies should actively look at exceptional pollination events, since India is a centre of origin for brinjal.
   11. There is no data on other methods of propagation including seed spillage etc. The weediness tests [and test for volunteers] are completely inadequate and even one volunteer is a potential source of cross-pollination later on.
   12. The company-adopted protocol is obviously faulty, inapplicable to real growing conditions and has not obviously tested for transfer to wild varieties and the possibility of Bt Brinjal conferring an advantage to them.
       
5. Agronomic trials: It is not clear how the agronomic trials were conducted in Kharif 2004 and Kharif 2005 by the company. For each hybrid, multi-locational trials were conducted for only one year, in two locations only, based on which fruit damage and average fruit damage is being reported to be dramatically different between the Bt and non-Bt brinjal plots. The agronomic trials conducted by ICAR was for two years for the first set of five hybrids and for one year for another 3 Bt Brinjal hybrids. However, data from the first year of trials is not available in public domain and no intelligent feedback can be provided without information on the protocols used and the complete set of data generated.
   
   1. What was the protocol adopted for the company’s trials? Did it compare the Bt Brinjal with other alternatives like IPM, NPM, organic etc.?
   2. Who oversaw the data generated by the company, for each location and what were their monitoring findings?
   3. The agronomic performance overseen through the ICAR trials has misleading data and conclusions. This is unreliable since the data has not been statistically analysed. Even the data presented by Mahyco from its own limited field trials in farmers’ fields shows a 7-fold variability in yields per hectare, across hybrids and a 2.5-fold variability within a hybrid. This skews the averages quite a bit.
   4. These trials did not compare Bt Brinjal with other alternatives including non-chemical IPM, IPM, NPM and organic.
   5. There were at least three centres [of ICAR trials] which did not report back their results. The reasons have to be looked into.
   6. There is no data available on the economics of Bt Brinjal cultivation, though marketable yields are being reported. 
   7. There is no data available on the reduction in pesticide use, the main grounds on which Bt Brinjal is being brought in. Informal reports from at least one Centre of the ICAR-supervised trials indicate that pesticide use on the trial plot was really high.
   8. All ICAR trials are paid up trials, no independent assessment was made. There is a serious and objectionable conflict of interest in this.
   9. Our own investigations reveal that many of the scientists involved in such trials are also not adequately trained on biosafety issues and testing protocols.
      
6. Soil impact studies: There are several serious shortcomings with the protocol adopted for the soil analyses related to Bt Brinjal cultivation.

v      The soil impact studies have not been conducted to capture cumulative effects over several years of Bt Brinjal cultivation and have only analysed impacts for one season each

v      To estimate the impact of Bt toxin on soil microorganisms involves isolation and enumeration of micro-biota and study of biochemical characteristics for utilization of certain chemicals (or) compounds (or) production of metabolites by their physiological characteristics. Enzyme studies and finally the molecular behaviour of the genes responsible for particular characteristics have to be understood for changes.

v      The physiological and molecular aspects were not studied in different treatments in these soil analysis tests. Similarly accumulation of toxin through the leaf litter was not taken up, as the soil samples were collected on pre-harvest days. The toxin persistence in the soil seems unestimated.

v      The study results did not reveal the following: what are the lethal levels of toxins to kill the test invertebrates? What are the actual toxin levels in the soil in the pre-harvest and post-harvest seasons of Bt and non-Bt crops? What are the changes in enzymatic and physiological behaviour in soil biota? What are the genetic modifications that took place affecting the functions of the microbes?

v      It is not clear what the plot sizes for the study of soil invertebrates are, when the company took up the study in the two years [while one was on the campus, the other was during limited field trials, we are made to understand]. The reliability of data from a study like this depends a lot on the plot sizes used because insects and other invertebrates can readily move in and out of small areas.  There is little chance of detecting any effects when the plots are small.

v      From other studies that looked at soil invertebrates, especially from Bt eggplant crop, it can only be concluded that the impact on non-target invertebrates is not well understood.

v      It is also apparent that no comparison has been made with plots which grew non-Bt Brinjal.

v      The method of using insect bio-assays for measuring toxin levels in soil samples is unreliable. How do we know that the baseline susceptibility of the larvae chosen is not low? Other methods have to be adopted that would measure the toxin level as well as persistence.

v      Finally, what tests have been conducted to assess the impacts of Bt Brinjal cultivation on the next crop its growth, disease incidence, yields etc., - for medium and long term impacts in a cumulative sense, due to alterations in soil conditions which cannot be captured over just one season?

1. Toxicity & allergenecity/irritation tests:

v      It is claimed that several toxicity, irritation and feeding tests have been taken up to prove the safety of Bt Brinjal. However, no feedback is possible on the tests since no data has been shared, other than the protocols being shared.

v      All that the studies cover are possible acute and sub-chronic [90 days] effects. These tests do not look at long term sub-lethal effects, multi-generational effects, reproductive health effects due to organ damage or effects on growth etc. etc. It is very important that GEAC do not take a decision on a food crop, that too a vegetable crop, without such long term studies.

v      The acute oral toxicity test of transgenic brinjal result summary on page 28 of the first document put up on the MoEF website says that the control group was gavaged with non-transgenic cotton seed and not non-Bt brinjal! This is either a typographical error or the fact that the company supplies “set result summary” for various crops, whether Bt Cotton or Bt Brinjal!

v      Similarly, feeding tests as in the case of the feeding tests on goats consisted of feeding the animals “with a concentrate of which 12.5% was test seed and the concentrate itself will be 10% of the total feed”, whereas Bt brinjal could be fed directly in large quantities [and not just “test seed”] to cattle/livestock especially when there is surplus production and when there is dumping at market yards due to excess production. The cow feeding tests for instance were done with “a total mixed diet where all diets will have the same inclusion level of test/control substance or part of the concentration mixture” with around 2 kgs of fresh transgenic brinjals. When there is dumping in market yards, the consumption could be much higher than this. What tests have been done keeping in mind the worst possible scenario in real life and keeping in mind long term impacts?

v      As has been pointed out earlier in the sheep mortality fact finding reports, feeding tests have not been done against sheep [but on goats which are known to be hardier animals] and against real life open grazing conditions. The real feeding conditions also include the fact that they are grazed in open fields, with different parts of the plant consumed, possibly in combination with some pesticide sprays. The other possibility, as in the case of Bt Cotton, there could be misunderstanding amongst farmers that no sprays are required for the transgenic crop and therefore, grazing on the crop is much more safer! 

v      In the Primary Skin Irritation test done on rabbits, it is not clear what the “test article” was. The animals seem to have been treated with the transgenic vegetable, with two checks of non-transgenic brinjal and untreated check. However, past investigations into the health problems with Bt Cotton have shown that the cotton fibre of the Bt Cotton plant could be inducing the allergic reactions. Similarly, a Filipino study on Bt Maize showed that the pollen could be the allergy-causing agent. How then does a study on the vegetable conclude that workers who work in the Bt Brinjal fields will not be affected  [especially given the fact that the reports from various states out that workers are having skin allergy problems while working in bt cotton fields]?

v      In the sub-chronic oral toxicity test on rats, it is reported that “There were isolated instances of necropsy findings such as reddening of lungs, dilated kidney pelvis, distended uterus and abscess in salivary gland. The gross pathological changes observed during necropsy were confirmed histologically. The abscess noted grossly in salivary gland was confirmed histologically. Lungs reddening noted at necropsy in four animals, was identified as acute congestion. The incidence of pathological lesions being extremely small, and not dose dependent, was not considered to be of toxicological significance”. These findings need more explanation and these could indeed be the ‘early warnings’ that a precautionary approach requires. The GEAC should ask independent research bodies to conduct the test, with longer periods to find out if this is a finding that requires serious attention.

v      Similar are findings related to haematology, clinical chemistry etc., in the case of goat feeding and rabbit feeding studies which can be understood better only if all findings in terms of tabulated numbers are presented.

v      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. The pea immunology text is very important because it formally proves that the assumptions underlying the 'event based' approval process are fundamentally wrong. In this test, the Australians also used a latest testing procedure and this paper is annexed to this letter [Annexure 3].

Here, we are also attaching a note on this subject by the world renowned toxicologist, Dr Arpad Puzstai about how the safety testing procedures should ideally be, for various tests [Annexure 4]. Annexure 5 is a note from noted scientists Dr Mae Wan-Ho and Prof Joe Cummins on the serious inadequacies and shortcomings in the biosafety protocols adopted in the case of Bt Brinjal, including the serious implications of not testing beyond a limiting dose.

16.   Food Cooking and Protein Estimation studies: The company claims that studies have been done on protein estimation in cooked transgenic brinjal and reports that the Bt protein was undetectable cooked fruits and that the Cry1Ac protein rapidly degrades upon cooking.

v      We would like to know if the company or the GEAC have data on how many different ways brinjal is consumed in different parts of the country, by different communities. What does this data say?

v      The claim that the protein was undetectable and that it degrades rapidly is questionable. While it cannot be detected in its soluble form, what has happened to its breakdown products is important. What are the effects of such products?

17.   On India being the Centre of Origin for Brinjal: We would like to bring to your notice thatno GM crop has ever been released in its country of origin so far anywhere in the world. The overwhelming concerns about a Centre of Origin relate to environmental, agricultural, socio-cultural and IPR issues which have to be given a serious consideration by the regulators. A separate paper is annexed for your ready reference on this subject [Annexure 6] and we reiterate that even the Cartagena Biosafety Protocol to which India is a signatory recommends that a more cautious approach to impact assessment should be made with regard to transgenic crops in their Centres of Origin.

18.   On the socio-economic impact assessments: There seems to be the presence of a Mahyco member of staff at all times during the interviews which completely invalidates any findings of this survey.

Where is research on consumer acceptance, consumer willingness to pay for non-GM premiums, on potential effects of markets on farmers etc.? Where is research on socio-economic impacts vis-à-vis successfully established ecological alternatives?

Where is research on the implications of IPRs on farmers’ rights, economics, control over the technology, legal implications and so on, in the socio-economic impact assessment?

19.   Rights of farmers and consumers who wish to be GM-free: What protection and guarantee is GEAC going to provide for farmers and consumers of this country who have a right to be GM-free and their Right to Safe Food?

Based on this feedback, we demand that the GEAC:

-          respond to our questions and feedback point by point with all the seriousness that each point deserves

-          show proof that monitoring and accountability mechanisms are in place and have improved by fixing liability for the violations witnessed so far

-          not give any permission for large scale trials and seed production or even limited field trials for any GM crop in India until fundamental questions about the decision-making processes related to agricultural technologies are answered and guarantees provided to protect farmers’ and consumers’ fundamental rights to choices, to safe food etc. and until all the above questions are satisfactorily answered through broad-based public debates that use innovative approaches to include the primary stakeholders in this matter [farmers and consumers of this country and not the company which ‘developed’ the transgenic brinjal and therefore is staking its ownership claims through patent applications].

READ ON

Bt brinjal 2: Signatories to the letter [1-120]

Bt brinjal 3: Signatories to the letter [121-270]

Bt brinjal 4: Annex 1
Letter to India's Minister for the Environment

Bt brinjal 5: More annexes
includes: a note by Dr Arpad Pusztai
a note from an Ayurveda expert (vaidya) 
comments on Monsanto Mahyco's claims
comments by Dr. Mae-Wan Ho and Prof. Joe Cummins