Erratum: The Coalition’s calculation of Male Sterility breakdown in Varuna barnase line, as described in Point 5 (i) in the letter below to the Ministers and PM is incorrect, and we regret this mistake from our side. The Ludhiana trial data shows that out of 10 branches of male sterile Varuna barnase selfed, 176 pods were harvested with an average 3 seeds per pod, as opposed to 548 pods harvested with an average of 12 seeds per pod in the fertile branches of Varuna barnase selfed. 

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Today, a 7-member delegation consisting of scientists, representatives of farmer unions and consumer movements went in to make presentations to the Genetic Engineering Appraisal Committee (GEAC) with arguments and evidences that clearly show how the R&D and testing of transgenic mustard hybrid DMH-11 is a scientific fraud and why the GMO application needs to be rejected in toto immediately. However, despite being told that we will be 7 in number, and despite being told that we will need at least 2 hours for our presentations, GEAC began by telling us that only one person can come in front of the Committee and later, after we stood firm and all the 7 went in, being told that we will be given only 10 minutes. After 7-8 minutes of arguments back and forth, we were told that we will get 30 minutes. Given the number of issues that we had to bring to the notice of the Committee, and given the inadequacy of time being provided, we chose to walk out.

Find below the text of the letter sent to Minister for Environment, Forests & Climate Change and Minister for Science & Technology, with a copy to the Prime Minister in this context. We also share here presentations that were made by the Members of the Coalition, which are Annexures to the letter.

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June 20^TH 2016

To:

1. Shri Prakash Javadekar,

Minister for Environment, Forests & Climate Change,

Government of India.

2. Dr Harshvardhan,

Minister for Science & Technology,

Government of India.

Dear Sirs,

Re: 1. Demand immediate rejection of commercialization / “environmental release” application related to transgenic mustard hybrid DMH-11

2. Demand fixing of accountability on all regulators who have failed in their duty and responsibility related to biosafety assessment

3. Demand scrapping of GEAC and RCGM

4. Demand to stop funding of UDSC projects through taxpayer funds

This is to bring to your notice matters of great alarm and concern, as well as shame to the Indian scientific establishment itself, pertaining to transgenic mustard hybrid DMH-11’s development and so-called biosafety assessment. We draw your attention to the massive failures and rigged mechanisms adopted for the R&D and testing of DMH-11. The exaggerated benefit claims that don’t stand scientific scrutiny and the under-assessed and ignored risks of DMH-11 that reek of scientific irresponsibility, both of which have happened at taxpayers’ expense, are a shame to the nation, and this, without exploring safe and higher-yielding options that exist to increase mustard yield.

We write this letter to draw your attention to the concerns with regard to DMH-11 and its testing, and demand that if you truly believe in “scientific research” as is professed in media bytes and public statements, you not only reject the “environmental release” application totally and immediately, but also take action on all regulators who have failed in their regulatory mandate. It is time to scrap the GEAC and RCGM as the regulatory bodies that have been mandated to “protect environment, nature and health, in connection with application of gene technology” (EPA 1989 Rules). The story of DMH-11 transgenic hybrid mustard is as shameful as the story of Mahyco’s Bt brinjal which was rightly placed under indefinite moratorium by the earlier government recognising its responsibility towards science and responsiveness towards society. We hope at least now, the Government would take up a serious long-pending overhaul of the biosafety regime in the country.

The following are the important issues that break citizens’ faith in the integrity, rigour and dependability of GM regulators as well as the scientists applying as crop developers.

1. DMH-11 R&D AND TESTING HAVE BEEN RIGGED:

(a)  The GMO approved for R&D in 2003 is not the same as being assessed now! We have evidence from the project, which show that DMH-11 was a hybridization product of EH-2 barnase line X Varuna barstar line between 2003 and 2006. However, when DMH-11 re-appeared after a break of few years in 2010, for Biosafety Research Level (BRL) I testing, it had become a cross between Varuna barnase X EH-2 barstar line. This is scientifically unacceptable, that the same dossier is being maintained for different GMOs and events. From all materials available in the public domain, it appears that GEAC members have been kept in the dark about such a swapping of parents.

(b) In the regulatory pipeline, from what we are aware of, no GMO got into BRL trials straightaway by this kind of maintenance of single biosafety dossier, and condensed all testing into 3 seasons. We object to this unacceptable haste and shortcuts of regulatory processes which compromises scientific rigour.

(c)  The overall claim and basis on which this GMO is being considered for approval for commercial cultivation is that field trials showed overall average higher yield over “national check” Varuna by 28.4%, and if this GMO is commercialized, India’s edible oil import bill will come down. We prove with evidence (Annexure 1 and Annexure 2) that:

• DMH-11 was tested against low-performing varieties released many decades ago, whereas the extant robust scientific system has scientific guidelines laid down for varietal testing which requires hybrids to be tested against hybrids and latest high performing comparators – hundreds of public sector scientists put themselves through such assessment, whereas a transgenic variety has been allowed unscientific and unreliable standards;
• DMH-11 was tested in ways that are contrary to GEAC decisions and permission letters and the developers and regulators are both responsible for this expediency and lack of rigour;
• DMH-11 was tested in just 8 locations and only in 2 locations for 2 seasons, based on which claims of benefits are being made – in all other locations, trials were one-off, for one season each; in Zone III, trials were done only in one location that too at BRL I stage only. This is obviously inadequate to assess the real performance of a variety that is sought to be released for farmers’ use;
• The one year that DMH-11 was tested with another non-transgenic hybrid also included as a comparator, the other hybrid out-yielded DMH-11. Even DMH-11’s claimed yield advantage against other “unscientific” Checks was just 20.3% (it could be just 17%, as reported in Progress Report of NDDB-Delhi University Biotech Project for the period of March 2010 to February 2012, submitted to the Academic Advisory Committee under Point “2. Biosafety analysis of transgenic hybrid DMH-11”);
• Environmental safety testing, bypassing rigorous agronomic evaluation, cannot be considered as a valid basis for yield claims related to DMH-11, which is the main basis for the introduction of this GMO;
• We further show that the 28.4% higher yield is also miscalculated by presenting a value derived from average of averages!;
• We also show that results of field data as reported by DRMR has been presented with changed values when submitted to GEAC (increased by 15.3%), for BRL I 2^nd year data (2011-12) from 2 two locations where trials took place. These two manipulations (average of averages and changed values) together have notched up the so-called yield benefit of DMH-11 by around 7.5%, within the wrong protocols used;
• We also present analysis to show that there is significant inconsistency in Yields as derived from data recorded during the trial for each entry, of plant stand, average number of pods per plant, average number of seeds per pod and average weight of 1000 seeds AND the seed yield in kilos per hectare reported for each entry. There is also a clear inconsistency between biomass weight and yields. Either the data on these (“vegetative, reproductive and survival biology”) parameters has been collected wrongly through unscientific sampling or the yield data being reported has been incorrectly created to favour DMH-11 (incidentally, both sets of data are collected the same day, at the time of harvest!) – either way, the entire test should stand null and void.

We end this section by pointing out that any testing of DMH-11 so far for its yield advantage claim has been unreliable in its protocol as well as reporting of data. ICAR’s DRMR in an RTI response stated that DRMR has not conducted any trial and the data received by DU/NDDB staff was passed to DRMR for onward transmission to DUSC/GEAC (Annexure 3).

The expediency and haste in testing raise serious questions about the scientific competence or integrity of the crop developers. The fact that GEAC has allowed the GMO to proceed this far based on unscientific claims exposes bare the incompetence and unscientific bias of the regulators. GEAC’s and the Developer’s claims that national check was used is NOTHING BUT A LIE, and we challenge the regulators to show a single trial where a proper check approved for national and zonal level evaluation has been used for BRL testing based on which higher yields are being claimed.

2. DMH-11 TESTING ABSOLUTELY INADEQUATE AND INCOMPLETE:

We had already pointed out above how the yield related results were rigged. It is also clear that DMH-11 was never put through some important tests – chronic health safety testing for example. Or its impacts on Indian Systems of Medicine, given that mustard is used in Ayurveda quite extensively in various ways. Similarly, the impacts on honey production and the honey industry by rigorous assessment on impact on honeybees. Experts have been asking for proteomics, transcriptomics and metabolomics related studies which have not been prescribed by GEAC so far and have not been undertaken for DMH-11 either. Only one sub-chronic toxicity study has been taken up, and no animal feeding studies. No risk assessment in the context of cold pressed oils, which have found increasing demand and acceptance from consumers, has been taken up.

3. DMH-11 TEST PROTOCOLS ARE UNSCIENTIFIC AND EVEN LAUGHABLE:

As demonstrated amply in Annexure 4 pertaining to different studies, we prove that unscientific protocols without any rigour of safety/risk assessment were used in DMH-11 testing and it is also clear that the crop developers prescribed convenient protocols for themselves, rubberstamped by the regulators. We also have analysis to show that conclusions have been drawn wrongly, despite data from the studies showing otherwise. As in the case of Bt brinjal, we can conclude that with DMH-11 too, the lacunae in biosafety assessment can be summarized as: required tests not done; test protocols being unscientific; test results being analysed wrongly; conclusions being drawn contrary to results. In all of this, regulators continue working in an incompetent, apathetic, secretive and conflicted manner.

4.   VERY BASIS OF ADMITTING THIS GMO APPLICATION UNFOUNDED AND QUESTIONABLE:

Regulators in the field of transgenics are supposed to use standard risk assessment frameworks, which necessarily have to include a reaIistic assessment of the claimed benefits because decision-making is supposed to involve an assessment of benefits as well as risks, in addition to evaluation of all existing options for an intelligent decision. However, we find that in the case of DMH-11, the regulators have not even begun asking the crop developer basic questions around the claimed benefits (Annexure 5) – will heterosis in one variety increase yields to an extent that India’s oil imports will come down as is being claimed? What are the base conditions for the same and do they exist? Is that borne out with the real life experience of DMH-1 which is a non-transgenic hybrid with heterotic vigour that came from the same crop developers? Have regulators studied why farmers actively rejected DMH-1 and what impact did DMH-1 have on oil imports after its release n 2009-10?  Have other safer and established alternatives to increasing yields of oilseeds in general and mustard in particular been evaluated? Has any assessment been done of how DMH-11 fares in comparison to highly successful, large scale farmer-level experiences of System of Mustard Intensification, for example? Have experiences of other countries which have CMS-based rapeseed mustard hybrids doing quite well been documented and assessed? It is a matter of serious concern that GEAC allowed this application to move forward this long without such basic questions being asked.

5. DMH-11: SERIOUS CONCERNS WITH MALE STERILITY AND HERBICIDE TOLERANCE:

1. It is clear from the data presented in the reports of field trials and the Central Compliance Committee’s visits to field trials for monitoring that Male Sterility trait of Varuna barnase line is breaking down, leading to self pollination (could be as high as 24%, as per data from Ludhiana). This means the very basis for approval of DMH-11 is faulty, and the purported advantage of heterosis will not be available. There is no data on how much of the yields, pod formation and seed setting in Varuna barnase is due to such Male Sterility breakdown and how much due to cross pollination.
2. It is also clear that the Male Sterility trait will spread and increase in subsequent generations as well as in contaminated neighboring fields (intra-specific cross pollination is inevitable, given our smallholdings and will not be limited to the 20 mts distance projected by the biosafety dossier). This will most certainly have implications for the yields of mustard growers and does not augur well for the farm livelihoods of mustard farmers. We also argue that selection pressure does exist in favour of DMH-11, given the yield lure being promised and the use of herbicide tolerance trait/herbicide.
3. Herbicide tolerance trait will also spread further and farmers will indeed use herbicide Glufosinate (which is disallowed as per the Insecticides Act right now in mustard) on their mustard crop in future, even though the crop developers coyly keep saying that “herbicide usage is not recommended”. This is especially so at the time of harvest, even at the risk of losing around 33% of the crop stand, since it is in fact easier to harvest that way, and reduce labour usage. It is ridiculous to think that farmers won’t use herbicides because the “crop developer has not recommended”. Herbicide usage will have its own huge environmental and health implications for mustard growers and consumers. Such implications have not been assessed at all in the case of DMH-11. This is also a clear case of going against repeated recommendations of various committees against herbicide tolerant crops in India.
4. Cross pollination will be much higher than what is being projected – the protocol adopted for testing pollen flow does not assess the actual pollen flow through insect pollinators etc. In fact, the good seed setting observations in Varuna barnase is an indication of the cross pollination potential, as per the applicant himself.
5. There is also a significant amount of evidence in literature on the inter-specific crossability of Brassica juncea including in the Indian context, which points to a threat to the diversity that exists here. However, the biosafety dossier discounts this possibility.

6.   INFRINGEMENT OF RIGHTS OF CHOICE FOR FARMERS AND CONSUMERS:

It is clear that any “environmental release” of DMH-11 (as the GEAC terms commercial cultivation) will leave no choices for farmers or consumers. This will irreversibly contaminate existing non-GM seed stock. Such a contamination will affect all farmers, and will immediately affect the organic status of organic mustard growers. It will also impact all those organic farmers who use mustard seedcake as a soil amendment since organic regulation prohibits this too. The impact on honey producers will also be adverse. As far as consumers are concerned, they will also be left with no choices of knowing what they are consuming, given that no labeling regime is enforced in the country.

7. NO LIABILITY REGIME IN PLACE:

We have been demanding for a long time now that a proper liability regime has to be put into place for the risks and damages that are bound to arise from environmental release of GMOs and this is missing even now. Without having such a liability regime in place, how is GEAC even considering a commercial cultivation approval?

There are of course several other issues of concerns, including on the matter of IPRs: while GEAC has ascertained that patents are currently held outside for some genetic materials used, it is clear from the crop developer’s statements elsewhere that some patents are held in India too. In any case, nothing prevents the crop developer from claiming those patents in future, or even selling them off to other entities. It is clear from a reading of all existing materials that the government has not studied the implications of this from the perspective of farm livelihoods or even criminalization of farmers (the infamous ‘Percy Schmeiser’ case where ‘patent infringement’ was ‘found’ involved GM canola using the same technology as DMH-11).

8. CONFLICT OF INTEREST HAS DESTROYED PUBLIC FAITH IN REGULATION:

Conflict of interest, which is repeatedly compromising scientific rigour in this field in India, has its ugly role to play in the entire story related to DMH-11. This includes the facts:

–          that a scientist in the crop developer team, Dr Akshay Pradhan, who is involved in each stage of DMH-11 R&D and testing, is also a GEAC member;

–          that Dr Deepak Pental, one of the main applicants is the head of the Research Advisory Council of DRMR supposed to oversee the trials and got to set his own test protocols;

–          that DBT sits in meetings that decide to formulate a proposal, accepts the proposal, funds the project and also ostensibly assesses biosafety;

–          that the head of RCGM in MoST is on the board of an industry-funded body ILSI and also gets commissioned to do safety studies as the then head of NIN and gets into biosafety assessment later on.

–          That a PPP consortium with several private players called Biotech Consortium India Limited (BCIL) gets funded by taxpayers’ funds in the DMH-11 project to prepare a roadmap for biosafety assessment and to prepare the dossier.

Why should anyone trust this set of scientists who are conflicted as regulatory decision-makers, to do comprehensive and rigorous risk assessment, as though there is no other scientific talent in the country for such biosafety assessment?

9. REGULATORS FAIL THE NATION BADLY:

The scientists and other regulators sitting in RCGM and GEAC are an utter disappointment in their discharge of their duty. We believe that they are being brought under pressure to give clearances, even if some of them have some scientific rigour and integrity. Several decisions which have postponed rigorous testing by postponing risk assessment to “post-release monitoring” shows a pre-conceived mindset amongst the regulatory body that DMH-11 has to be approved, irrespective of scientific fraud or risk.

• Why else will a sub-committee feel compelled to finish its job within 15 days, that too when the planting season was already underway?
• Why is it that the regulators don’t even ask for raw data?
• Why is it that the regulators have not raised basic objections with regard to DMH-11 that too before going in for large scale trials, even though large irregularities are apparent in its R&D?
• Why is it that regulators have ignored biosafety violations pointed out not just by civil society groups but by their own CCC teams during field trials?
• There are also those regulators who don’t attend meetings and we find that GEAC takes important decisions without even a decent quorum (with just 11-12 members out of 30+ members). Can a regulatory body like GEAC have decision-making with such sparse attendance and participation?
• How can a GM regulatory body function without representatives from India’s Health Ministry, when the health of all citizens is at stake? Similarly, where are the representatives of AYUSH Ministry?

As concerned citizens of this country, we are ashamed of such regulators who repeatedly fail to accomplish their job, whether it be the case of illegal introduction of Bt cotton, continued illegal cultivation of HT cotton, clearance to Bt brinjal without proper appraisal etc. GEAC is clearly compromising on its scientific mandate at the cost of environment, health of citizens and livelihood security of our farmers. The GM mustard biosafety dossier, the little that we were able to study, is a scientific fraud and the regulators have chosen to keep mum about it.

10. RTI DATA ON GM MUSTARD CONTINUES TO BE WITHHELD:

Given the massive set of issues with the DMH-11 biosafety dossier, it is not surprising that the Ministry of Environment, Forests & Climate Change wants to hide the biosafety data from public scrutiny, saying that it “will do everything that it is legally required to do”. The CIC orders of April 1^st 2016 have not been complied with so far. This is surprising given that the GEAC had conveniently proffered the minutes of its last meeting in a CIC hearing to show the Central Information Commissioner how keen it was to share information with the public! By now, if the regulators were serious, they could have shared all data publicly. By not doing so, they are putting a dent in their own credibility. Should concerned citizens have to resort to their own sleuthing to stumble upon the real story of DMH-11? This is unhealthy and unscientific. What we present here is based on limited access to information and we have reason to believe that other serious discrepancies might be unearthed if data is put out for public scrutiny.

It is time that all documents and correspondence from the beginning pertaining to this GMO are put out into the public domain.

WE DEMAND:

Given all the scientific and independent evidence provided above and in supporting annexures which shows lack of scientific basis, rigour, competence, integrity and responsibility in the case of R&D and testing of DMH-11, and given that extremely successful and safe alternatives exist to improve mustard yields, we once again reiterate our demands for the following:

• Reject DMH-11 application in toto and immediately;
• Fix liability on crop developers for false/incorrect evidence provided willfully to regulators;
• Fix liability on regulators who have failed in their duty and responsibility;
• Scrap GEAC and RCGM immediately;
• Stop the public funding to the UDSC mustard breeding project since it is a classic case of irresponsible misuse of public funds and is bringing shame to the entire scientific establishment of the country. This requires a CAG audit given that crores of rupees of public funds have been spent on this scientific fraud.

We also demand that all documents pertaining to DMH-11 R&D from its inception be put out into the public domain immediately.

Sincerely,

 

Kavitha Kuruganti                         Kapil Shah                                  Dr Debal Deb

Mob: 08880067772                      Mob: 09427054132                      Mob: 09432674377

 

 

Ananthoo                                   Dr Sharad Pawar                          Yudhvir Singh

Mob: 09444166779                      Mob: 09820518757                      Mob: 09899435968

 

 

Copy to: Shri Narendra Modi, Prime Minister, Government of India.

Annexure 1: Comments on UDSC Proposal for Commercial Release of Transgenic Hybrid DMH-11, by Dr Sharad E Pawar 

Annexure 2: Serious Objections to Biosafety Trials of DMH-11 with Special Reference to Agronomic Data, by Kapil Shah

Annexure 3: Directorate of Rapeseed Mustard Research (DRMR) reply to RTI application of Ms Aruna Rodrigues

Annexure 4: Environmental Risks of DMH-11 & Unscientific Biosafety Trials, by Dr Debal Deb

Annexure 5: DMH-11: Serious Concerns & Objections From a Consumer Perspective, by Ananthoo  

Summary of our Objections to DMH-11 environmental release.