Points Covered by Various Speakers during Presentation to GEAC on 18th July, 2016 at Indira Paryavaran Bhavan, New Delhi
A team of civil society representatives associated with Alliance for Sustainable and Holistic Agriculture (ASHA) made presentations to the GEAC on 18.07.2016. The team was given two hours of uninterrupted time managed by themselves. The following were the team members:
- Ms Kavitha Kuruganti, representative of Alliance for Sustainable & Holistic Agriculture
- Mr Rajesh Krishnan, Co-Convenor, Coalition for a GM-Free India and organic farmer
- Dr Debal Deb, Ecologist
- Dr Sharad Pawar, Breeder and Fellow, NAAS
- Mr Kapil Shah, National Secretary, Organic Farming Association of India
- Mr Rampal Jat, President, KisanMahapanchayat
- Mr Yudhvir Singh, Convenor, Indian Coordination Committee of Farmers’ Movements
- Mr Ananthoo, Safe Food Alliance
The presentations began with Kavitha Kuruganti thanking GEAC for organizing this special meeting to hear them out and giving them two hours of time. She requested that the team not be classified as “NGOs” since it does not capture the fact that scientists, farmer unions and others are part of the team. She requested that full minutes of their presentations be made and put in the public domain, and that they receive a written response to all the points being raised, to which the Chairperson consented.
Kavitha Kuruganti clarified that their inputs were limited to mostly issues around agronomic evaluation and environmental safety assessment of DMH 11 and promised to come back with analysis on parental lines and health safety studies. A compilation of more than 60 studies, drawing from GM canola experience worldwide, on the adverse impacts of the crop has also been circulated to GEAC members.
Points from Rajesh Krishnan’s Presentation:
The presentation was mainly on dangers of HT crops, experiences from other countries, Indian situation with regard to HT crops and GM mustard’s herbicide tolerance trait.
- Bar gene inserted in both the parents and its offspring confers HerbicideTolerance to Glufosinate Ammonium (GA). Further, the double enhancer promoter used in the male parental line is a clear indication of the crop developer’s intent to create a Herbicide Tolerant crop. All the 3 GMOs being considered by the regulators are 100% Herbicide Tolerant (HT).
- Even though this is HT crop, biosafety dossier does not describe this as HT crop and only says herbicide need not be used – this is hiding of important information in risk assessment. This also meant that these GMOs have not been tested as HT crops should have been, resulting in incomplete testing and unreliable conclusions.
- HT crops are documented to have various adverse impacts, both on the environmental and health front. The potential health impacts include Carcinogenicity, Neurotoxicity, Endocrine disruption, teratogenic effects, reproductive health crisis etc. and a compilation of scientific studies on such crops is part of a book distributed to the GEAC by the team. Ecological impacts includes creation of “superweeds” which cannot be controlled by herbicides, impacts on soil biology, on beneficial insects and other farm flora and fauna.
- HT crops have other important implications especially in the Indian growing context – weeds are food, fodder and medicines especially for the poor in the country; further, manual de-weeding which forms a large employment source for rural women will get replaced, taking away employment opportunities from them and affecting their livelihoods. Use of HT GM crops also affects the ability to adopt multiple cropping which is an important practice to reduce riskiness in the age of climate change. This will also impact organic farming. Additionally, there are concerns about IPRs and patents on herbicides and the GM crops creating exclusive marketing and profiteering opportunities to a few MNCs.
- HT crops increase use of herbicides, and also chemical residues in consumer food. In countries like the USA, it has been seen as a leading cause of litigations between farmers, given the damage caused due to herbicide drift.
- Various executive, legislative and judicial committees have advised/recommended/warned clearly against the introduction of HT crops in Indian agriculture.
- The matter of HT crops and risk assessment regime are sub-judice and so, GEAC cannot approve commercial cultivation of HT mustard.
- There are ample scientific evidences of health and environmental toxicity of Glufosinate Ammonium (against which this HT mustard is designed). EU regulation restricts usage of this herbicide. A special handout about the adverse effects of glufosinate was circulated to all GEAC members.
- Scientific evidence exists of a strong relation between foraging of honey bees, honey production and Herbicide Tolerant crop. Mustard is an important crop for bee-keepers and honey bees all over North India. Any impact on honeybees will have an impact on mustard crop yields, other crop yields, biodiversity in general and on honey industry.
- Glufosinate Ammonium is not registered for use in mustard crop by CIBRC, although developer used this to produce seeds.
- Pesticide end usage is not monitored in India and illegal use of herbicide cannot be controlled. Farmers will certainly make use of the HT trait of this crop.
- Most patents on the Bar gene are owned by Bayer and GA’s only marketed brands in India are from Bayer. Bayer is about to buy up Monsanto as per reports. This leads to a monopolistic situation on the market.
- In 2002, Bayer’s/ProAgro’s GM mustard with the same bar-barnase-barstar technology was rejected by Indian regulators and the reasons that were applied then hold good to this GM mustard too, and this deserves to be rejected too.
- Despite all the above adverse evidence, this GM mustard was not tested as a HT crop. Comprehensive risk assessment protocols to test HT crop still do not exist in India.
Rajesh Krishnan urged the Committee to reject the application completely given that it is a HT crop which will have huge adverse impacts especially in a country like India.
Points from Dr. Debal Deb’s Presentation:
- Male Sterility trait (due to barnase gene) and Herbicide Tolerance trait (due to bar gene) will get transferred to farm saved seeds and neighboring mustard crop given that usual outcrossing rate is from 20 to 30%. This has implications for farm-saved seed of GM mustard hybrid grower as well as of neighboring non-GM farmer.
- Population genetics data is not complete as presented by the developer.
- Pollen flow study of GM mustard does not measure extent of crossing but has measured only distance of outcrossing. This is a serious lacuna in the objective and protocol of the study.
- Male Sterility trait is shown to break down at times, as per the GEAC’s own CCC team visits and as per the data presented by the crop developer. The developer’s report suppressed the incidence of male sterility breakdown in 7.43% of VarunaBn 3.6 trial in Ludhiana, and instead reported “No sterility breakdown observed”.
- It is important to assess the extent and conditions of such a breakdown, which was not done during GM mustard testing and obviously done with different protocols adopted by different centres under the name of “pollination behavior” testing. By such an assessment, it will become clearer as to what is the advantage of transgenic MS over Cytoplasmic MS.
- How much of the seed setting and yields observed in Varuna barnase are due to MS breakdown and how much due to outcrossing needs to be assessed to understand the efficacy of this technology being sought to be deployed by DU.
- Various testing methods and analysis employed to check ecological impact during BRL testing are unscientific/lack rigour, are incomplete and data reported is unreliable. Eg. No pollen flow study for parental lines, no statistical analysis for weediness, possible competitive advantage of GM lines with herbicide exposure is not studied, volunteer behavior in subsequent seasons not studied, pod shattering is not studied in quantitative manner, there is no explanation for variability in protein expression, impact on beneficial insects is incomplete as many insects like ants, gryllids, hoppers, spiders and butterflies are completely ignored even though they are known to be important parts of the mustard crop ecosystem.
- Further, methods used to collect data on aphids, beetles, larvae, honey bees, lacewing are unscientific and the data reported unreliable.
- Although recent publications depict several species of beneficial arthropods (ants, gryllids, hoppers, spiders and butterflies) to be common associated to the Indian mustard crop, biosafety study did not include any of these taxa.
- Honey bee foraging is not counted scientifically.
- Data seems to have been doctored as number of predators (coccinelids) is more than number of prey (aphids) per plant, which is against global ecological rule.
- Crossability studies are not done for parental lines and false claims are made in the report in this regard.
- The developer’s reports ignored authentic, internationally published data on (a) outcrossing of mustard (20% to 30%) with other Brassica oilseed species; (b) distance of mustard gene flow by bee pollination (exceeding 800 m), and give unsupported assumptions of “negligible outcrossing” and “bee pollination distance of <20 m”.
Dr Debal Deb ended his presentation by pointing out that he has given several relevant references that GEAC should go through, and concluded that based on the current set of environmental safety studies, it can be seen that the testing is inadequate, unscientific and analysis and conclusions incorrect and unreliable.
Points from Shri Rampal Jat’s presentation:
- Agriculture as per Indian Constitution is a State Subject and state governments have a key role to play in decision making with regard to decisions like that of approving GM mustard. Where are state governments involved here, he wanted to know.
- BJP’s 2014 Election Manifesto had promised clearly that GM crops will be brought in only after full scientific evaluation of their impacts on citizens and environment – however, the same is not being witnessed in this case.
- This subject is such that it requires great inter-ministerial coordination in addition to states. It is not clear that this is being studied by all ministries with equal seriousness.
- Full disclosure of all information is a must before any decision is taken. However, GEAC is working in a secretive fashion as of now. How can the public participate in such a case, even though the matter pertains to them?
- Technologies like GMOs have a direct bearing on seed sovereignty of farmers and farming community. The IPRs on such seeds are what big corporations find attractive about the technology as everyone can see. In such a case, what has GEAC done about assessing seed sovereignty implications, and why will it allow transgenics when they affect such sovereignty?
- For farmers, self reliance is very important – this is also in the context of farm economics. Transgenics do not facilitate such self reliance and actually make farmers dependent on external sources. This is not supportive of farm livelihoods.
- This also thus impinges on dignified living by farmers for whom dignity is a matter of great importance.
- Choices will be taken away from farmers and consumers, and this is not acceptable.
He concluded by calling for a widespread public debate on the subject and urged GEAC not to proceed until the entire nation engages in such a debate for a chosen period of time.
Points from Dr. Sharad Pawar’s Presentation:
Dr Sharad Pawar made a presentation on the violations seen in agreed-upon protocols with regard to agronomic evaluation of GM mustard.
- AICRP protocol for release of cultivar is not followed in terms of number of locations and years per zone, blinding of entries as well as 10% outperformance rule. Trial results of GM mustard not scrutinized in scientific fora of AICRP.
- Checks (National, Zonal, Hybrid and Latest Release) recommended by AICRP are not used in any BRL field trial.
- Decisions of GEAC and conditions of permission letters have been violated every year of BRL testing. It is clear that developer tested entries as per his own convenience, setting up convenient protocols.
- DRMR has only transmitted the results of trials and it is incorrect to say ICAR supervised or monitored the trials.
- During 2006-07 (Multi-location trials), for once, a non-transgenic hybrid was used as a comparator and rightly so. This non-transgenic hybrid outperformed DMH-11, but it was removed from the testing at BRL level. Why?
- Existing mustard hybrids and some varieties give almost same yield – so there is no yield advantage for farmers.
- DMH-11 has extremely low test weight, which should not be commercialized.
He concluded that given that the very basis on which the transgenic mustard cultivars are being considered for release by the regulators is Yield, and given that yield testing has no scientific and rigorous, well-accepted protocol accepted, there is no scientific basis to release GM mustard hybrid.
Points from Kapil Shah’s Presentation:
- GMOs tested in the GM mustard dossier have been changed mid-way. Where in the initial years, the testing was for F1 of EH-2 (barnase) X Varuna (barstar), in 2006-07, seeds produced by crossing Varuna (barnase) X EH-2 (barstar). Since then, it has been Varuna (barnase) and EH-2 barstar, which are different GMOs than tested in earlier years, or even what has been permitted. Even after swapping the name of F1 (DMH-11) was kept the same, and the same dossier was maintained. This is scientifically wrong and unacceptable.
- Biosafety summary report submitted to regulators by developer for seeking permission for commercialization of transgenic mustard is misleading and wrong data is given.
- While reporting to regulators, yield of DMH-11 is notched up by 7.5% than actually received (and reported by DRMR) by increasing the yield by 15.2% for BRL-1 (second year) and by using average of averages to show higher results.
- Biosafety Trials for testing environmental safety cannot be considered valid to check the yield advantage as the purpose, protocol and comparators will have to be different for both kinds of trials. For a GMO which is being considered explicitly for its yield increase claims, the testing has to be that of AICRP’s agronomic evaluation, with same rigour applied.
- Comparators used for BRL testing are generally low yielders than recommended or decided checks to the tune of 10 to 15% to help DMH-11 look better. There have been violations of the decisions taken in GEAC meetings and conditions laid down in permission letters.
- BRL trial results are unbelievable and unreliable as derived yield (through pod-seed-test weight calculation) does not match with actual yield reported.
- Regulators permitted BRL-2 testing based on BRL-1 report which is full of mistakes and wrong figures. They should not have allowed the testing to proceed to BRL II stage at all and we have been asking for data evaluation at each stage before proceeding to the next stage.
- Observations related to disease occurrence, insect pest infestation, and population of beneficial insects during BRL testing are not reliable as it largely records NIL, and shows a somewhat untenable situation in reality.
- Biomass Production data collected during BRL testing are unreliable, inconsistent and untenable.
He concluded by saying that those who stand by good science should not be approving GM mustard.
Main Points from Mr Yudhvir Singh’s Presentation:
Mr Yudhvir Singh pointed out that the crisis of oilseeds production is not that of technology, but of policy decisions that are adverse to farmers. He reminded everyone of the strides that the country made with regard to oilseeds production under the Technology Mission on Oilseeds in earlier decades. The current terms of trade with other countries are not conducive to farmers growing and benefiting from oilseeds production, he said. He said remunerative prices along with incentivisation of oilseeds cultivation would address production issues.
On the matter of GM crops and their claims to solve several problems confronting us, he took the example of Bt cotton to point out that the claims have been laid bare for their false nature by now – pesticide use has gone up and bollworm has developed resistance and this vindicates the predictions made by many opponents of GM crops. He said that cotton seed has now landed itself into a deep crisis, while farmers have been incurring losses from secondary pest attacks in different states. Monsanto had benefited the most in the past 15 years of Bt cotton expansion in the country. Further, animals that have grazed on Bt cotton crop have started showing adverse impacts, with milk yield coming down and reproductive health affected. This is the experience of many farmers in North India. He said that even animals seem to know what is safe and what is unsafe, and given a choice he has seen that livestock do not prefer eating Bt cotton.
While that is the case with Bt cotton, to dabble in GM with a crop which is a very important crop for farmers in North India – Mustard – is unneeded and dangerous, he said. He pointed out that GEAC, in the name of listening to farmer representatives, is conveniently calling industry-backed persons, and passing them off as farmer leaders, as has happened in the June 20th 2016 meeting. He said that the regulators should know which are real farmer movements and which are not, and not get misled by people passing themselves as farmers’ representatives. He informed GEAC that a large number of farmer unions are against GMOs in general and this GM mustard in particular, and that the regulators should know that farmers’ unions reject this GMO.
Points from Ananthoo’s Presentation:
- Increase in production does not guarantee better financial returns to farmers.
- In the regulatory system, it is clear that there is no system to weigh benefits v/s risk. There is no need analysis being taken up. Regulators just entertain any application irrespective of need established.
- When it comes higher yield claims, other presenters have already presented the real picture with yields – how such results have been rigged and how data is showing inconsistencies and lack of reliability.
- When it comes to the second claim based on which the application has been put in by Delhi University, that of reducing India’s edible oil import bill through higher yields and production, it is apparent that oil import situation is affected by numerous variables at play. Releasing a high yielder cannot be directly and simplistically equated with reduction in Oil Import. Official data clearly proves that release of high yielders including hybrids did not improve yield or production in any linear fashion, nor did it reduce oil import bill.
- Mustard contributes just 24% of oilseed production and forms only 14% of oil consumption in India. So, claim on oil import reduction is not justifiable. Developer is fooling the nation. And regulators are not assessing the benefit claims being made.
- There are indeed alternatives that can increase oilseed production as well as mustard production in the country. These include non-GM technologies, policy support and institutional innovations. These have to be invested upon to bring real benefit to farmers.
- There is also the issue of Indian per capita edible oil consumption overshooting the recommended dosage. Therefore, to deal with the issue of oil demand, it cannot just be a supply side management – the government should also take interest in reducing per capita oil consumption for the benefit of health of the people. For poor households, to boost their oil consumption to the recommended dietary levels, healthy edible oil can be supplied through PDS.
- How will the rights of farmers and consumers who wish to remain GM–free be upheld? Organic farmers as well as non-GM farmers will certainly find their crop contaminated. What about their rights?
- Labeling is non-existent. What about unpackaged foods – how will consumer choices be protected towards safe food, right to know what is in their food and their right to informed choices?
- It is clear that impact on honey production, quality and exports has not been assessed as part of the risk assessment of GM mustard.
- Release of GM mustard will make huge negative impact on organic farming, which is not assessed. This is important given that governments are now promoting organic farming in a big way, and organic regulation prohibits transgenic content.
- Impact on Ayurveda has not been assessed even though mustard is used extensively in Ayurveda.
- Impact on cold pressed oil cake is not assessed, given the fact that it will contain residues of transgenes and herbicide.
- There are no liability, redressal, compensation and remediation mechanisms in place, and in the absence of such a regime, no GMO should be released.
- Safer Alternatives DO exist: System of Mustard intensification (SMI) and non-seed based technology yields much higher than present claim of yield increase. Why not to focus on them on priority?
- Role of GEAC is to appraise, not approve.
Ananthoo concluded by saying that consumers reject GM foods strongly. Further, he promised to come back to GEAC with analysis related to health threats from this GM mustard after data pertaining to health safety assessment is put out in the public domain.
Points from Kavitha Kuruganti’s Presentation:
Due to paucity of time, Kavitha Kuruganti could not run her PPT presentation and requested members to go through it later. Her presentation was a summary of the main issues raised by the team members who presented their objections to GEAC that day.
- In toto, three GMOs are described in one dossier, which is unacceptable, given that testing of these GMOs rigorously and separately has not been carried out, and all the three were clubbed conveniently into some tests that were carried out, while some tests were not done on the parental GMOs at all.
- The current GM hybrid named DMH-11 and its parental lines went to BRL testing straightaway without any prior testing.
- Trial protocols have been rigged and fixed conveniently by developer himself. Why lesser standards for risky GMO compared to the AICRP system in which scores of non-GM scientists are putting themselves through?
- No scientific evidence that DMH-11 is out yielding existing best performing cultivars.
- DMH-11 testing woefully inadequate in various ways including several important tests not undertaken at all.
- Farmers will lose sovereignty and diversity with the approval of GM mustard. The issues related to IPRs are unclear as yet.
- Crops like GM mustard, if approved will lead to serious infringement on rights of choices of farmers and consumers.
- GM mustard development, testing and regulation is full of objectionable conflict of interest and that explains to an extent how the application proceeded this far in the first instance.
- Regulators have failed the nation badly as seen in the huge evidence of lack of scientific rigour or even accuracy in the way tests have been conducted. She asked GEAC to accept the responsibility for failure to discharge duty.
- DMH-11 is a story about promoting bad science.
- This is GURT, prohibited under PPV&FRA.
- Even if testing was done adequately and was not rigged with convenient protocols, this set of GMOs are not acceptable at all, given that they are all herbicide tolerant. That itself was grounds enough for GEAC to have never accepted the application in the first instance, she said.
- She pointed out that there is huge opposition to GMOs in our food systems nationwide, and that if GEAC proceeds with approving this application, there will be large resistance that the government has to encounter.
She ended her presentation urging GEAC to reject the application in toto and pointed out that GEAC should not have processed the application this far at all. She also asked for liability to be fixed on the crop developer for incorrect and false information provided, and that Delhi University be blacklisted in the regulatory system. She also demanded that GEAC share all information with regard to these 3 GMOs in the public domain.
The Chairperson of GEAC thanked the team members for their presentations. She said that agronomic evaluation is not the forte of GEAC and they are meant to take up biosafety assessment mainly. While many points raised like traditional seed diversity conservation and seed sovereignty are indeed important, GEAC may not be in a position to address all of these and the government has to look into these issues. Several inadequacies have been pointed out, and GEAC will look into the same, she said. She also pointed out that regulatory improvements are a constant and progressive process undertaken.
The Co-Chair, Dr Veluthambi said that use of strong language like ‘doctored’, ‘fudged’ etc., may be avoided. He assured that the GEAC is also keen on taking up only scientifically rigorous analysis and to ensure correctness of data. He pointed out that whether or not GM crops are needed at all is a different debate and that this meeting cannot go into that discussion. However, scientific experiments should be conducted and allowed to continue so that many questions may be subjected to such research and answers found.
Dr Pushpa Bhargava, the Supreme Court Appointee in GEAC said that he finds at least 4 reasons for the scrapping of the GM mustard project: (a) Given that the only reason for looking at this GMO is yield increase claims, and given that the evidence presented by the team shows that wrong comparators have been used, the yield increase claims are unjustified; (b) Swapping of GMOs being tested amounts to academic dishonesty and should not be permitted; (c) Use of a herbicide tolerant gene was unnecessary and it appears to have a hidden agenda – such crops should not be allowed into India; (d) There are no liability laws and a workable liability regime present in the country. He also urged GEAC to collectively look into the materials submitted by the ASHA team and said that there should be a point by point response given to them, and that the team should be taken up on the challenge that they threw of withdrawing incorrect statements if any.
Dr SK Apte thanked the team for their detailed presentations and was keen on knowing the team’s reasoning as to why parental lines should not be released.
Dr SS Banga pointed out that Male Sterility breakdown is not a major concern and that in every system of male sterility, this occurs. On agronomic evaluation, he said that may be the hybrid cannot be recommended, but the parental events can be, so that further research for better yielding hybrids can happen. He said that GM mustard if approved, will be one more choice in the market for farmers. He said that farmers are intelligent and will adopt or reject a product based on its efficacy – they rejected DMH-1 which is prone to shattering, he pointed out. We cannot overrule gene flow – however, its persistence depends on fitness advantage, he said.
Prof Luther Rangrezi said that given that groups which are opposed to GMOs fundamentally are making this presentation, the evidence presented should be seen from that perspective.
The meeting ended with Dr S R Rao sharing that a Sub-Committee has been constituted to look into the biosafety assessment. Further, a risk assessment unit consisting of more than 20 experts who are also receiving training from FDA is in place in DBT now. A Risk Assessment and Management Plan has been sought now and after an RARM document is created, and once a decision is taken, the decision document along with RARM will be put out in the public domain. He said that the GEAC is in no hurry to take a decision.
The Chairperson concluded the meeting thanking the ASHA team for their presentations and telling them that they can continue giving their inputs to the regulators and that the process of dialogue will continue.