Problems with GEAC’s decisions and recent field trial approvals
In the recent past GEAC has held four meetings at close intervals and approved numerous field trials. The Coalition for a GM-Free India has already put out two media statements explaining why these clearances are objectionable and these can be accessed here: http://indiagminfo.org/?p=749 and http://indiagminfo.org/?p=725. While some of the meetings have been held during the last 3 months of earlier UPA government’s tenure and one meeting after the new NDA government was formed, it is well within this government’s authority to stop all field trials.
Apart from the serious problems with regard to lack of policy consistency that also seems to be defying judicial and parliamentary processes at this point of time, and apart from the fact that field trials continue to pose huge risks given the nature of the technology and the state of regulatory affairs in the country, there are numerous problematic issues with many of these trials. For instance some violate GEAC’s own rules.
The Coalition has put together some relevant information on this and would like to highlight serious pitfalls pertaining to these approvals, from information gleaned from various sources including media reports.1 The details of these meetings ranging from 118, 119, 120 and 121 are not available in the public domain. That in itself is a problem, where GEAC has reversed the process of the last 10 years of making minutes available in the public domain. So, why does the regulatory body want to hide from the public now? And what does it want to hide?
This note seeks to explain issues at a level of detail that is illustrative of lack of science and policy driving the GEAC decisions.
What are the regulators trying to hide?
GEAC has inexplicably, without assigning any reasons, violating its own past decision to be transparent, stopped posting full minutes of its meetings online since Meeting 117. The agenda of the GEAC meetings are also not posted online. A brief note is posted online which gives no information about what field trials were approved, for which crops, which seasons, what locations, what are the events, and which applicants have been given approvals.2 The practice of posting full minutes of GEAC began with the 40th meeting way back in 2004. At that time, a decision was taken with a view to ensuring greater transparency.3
The lack of transparency leaves the public completely in the dark about field trial approvals and puts a question mark on the approval decisions and also about how public interest is being served by the regulator by keeping the public in the dark. Also the fundamental question arises about why this secrecy, if not to sneak in GMOs somehow or the other? How is this supposed to improve public confidence in the regulator or the regulators’ credibility of being a scientific, independent body?
The IGMORIS (the Indian GMO Research Information System) website is maintained by the Department of Biotechnology, under which RCGM (Review Committee on Genetic Manipulation) is housed. RCGM is mandated with issuing the letters for field trials for GM crops. All letters issued to proponents were made available on the IGMORIS website (albeit a little late). Now they have also put an end to transparency. The menu options in the IGMORIS website where the letters of permission could be viewed have been disabled and do not allow access to the public.
So now there is no way for the public to know what permissions have finally been granted, in which states, in which locations for which seasons, leaving room for unscientific decisions, illegal practices, unapproved trials and other undesirable practices.
The IGMORIS website is also the public repository for biosafety data, after a hard won battle initially in the CIC (Central Information Commission) and later in the Supreme Court, which had directed that all biosafety data should be made accessible and available to the public. The regulator has stopped posting biosafety data in the public domain, violating Supreme Court orders. Currently, on the IGMORIS website, under the section “Biosafety data of new Genes/Events of GM Crops”, some data is available for two cotton events and one maize event of Monsanto – MON89034* NK603.
This contains only published studies from abroad and biosafety studies done in the USA in early and mid 2000s. There are no reports of any biosafety studies done in India4, even though the crop has been approved for BRL-II field trials (considered the penultimate stage before commercial cultivation application).
In the recent spate of approvals, it appears that two other crops have been granted approval for the advanced BRL-II trials- GM mustard and Bt brinjal. Bejo Sheetal has been granted permission to carry out BRL-II field trials , but no biosafety data uploaded on IGMORIS. Centre for Genetic Manipulation of Crop Plants, (CGMCP) has been granted permission for BRL-II filed trials of their GM mustard, again no biosafety data available.
Open air deliberate releases of untested, unknown GMOs under various garbs of “field trials”
It is seen that under the title ‘field trials’, various kinds of open air releases of GMOs are allowed. ‘Seed production field trials’ for instance. Or IRM strategy field trials. Or feeding studies field trials. These, in addition to event selection, BRL I and BRL II field trials. It is not clear whether any consistent or scientific approach drives these.
Open-ended approvals without season specificity or location specificity
GEAC has initiated a fairly recent practice of granting open-ended approvals with no time limit for field trials. GEAC till the recent past, approved field trials for specific seasons (with season and year specified in the approvals). Later, it started the practice of relaxing the norm to grant approvals which were valid for one year; then it began approvals valid for two years (any season) and now all field trials are approved with an open ended “for any appropriate season subject to NOC”. Similarly, even locations are kept open-ended, with the option of doing trials wherever an NOC is obtained. This is unscientific and does not build confidence about the intentions and practice of the regulators.
Specific problems with approvals in the last four meetings (118,119,120,121)
Across the last four meetings, it appears that numerous field trials at various stages have been approved and extensions have also been granted to cases where field trials could not be carried out in time (“revalidation”). In some cases, permission has been granted for adding more locations and changing locations.
It appears that 47 approvals have been granted. 72% (34 of the 47) of them are of Private sector and 62% (29 of 47) approved are of Multinational seed companies and their subsidiaries. Out of these, 15 belong to the extended Monsanto – Mahyco family of companies (Mahyco, Monsanto, Sungro Seeds, Devgen). Other multinationals include: BASF (2 applications cleared), Pioneer (9), Bayer (1), DuPont (1), Bejo Sheetal (1). Other private sector applications cleared are: Rasi Seeds (2), Metahelix (2), Ankur Seeds (1). In the public sector applications, Central Potato Research Institute (1 application), Centre for Genetic Manipulation of Crop Plants of Delhi University (3 applications), Sugarcane Research Institute (1 application), CICR (1 application), UAS-Dharwad (4 applications), CRIDA (1) and University of Calcutta (1) have been cleared. Additionally, one CGIAR institute, ICRISAT, got one application cleared.
Crops covered under these trials include: rice, wheat, maize, sorghum, cotton, brinjal, mustard, potato, sugarcane and chickpea.
A brief summary of some of the problems/concerns with the field trial approvals:
1. Approval of field trials of crops for which India is the centre of origin/diversity: Field trials have been approved for numerous lines of rice, brinjal, sugarcane, mustard, chickpea and Indian cotton species. 26 of the 47 applications cleared fall in this category. Let us not forget that China has not attempted a GM version of soybean even though GM soybean is the largest cultivated GM crop in the world, given that it is the Centre of Origin/Diversity of soybean.
2. 11 field trials approved are for HT crops (for which SC-TEC majority report has explicitly recommended a ban). These include HT rice, HT corn and HT cotton. Right from 2004 onwards, various bodies looking into the matter of GM in India have recommended against HT crops for India. While it is clear that policy directives are not used by the regulators on matters such as this, there is a complete lack of recognition of the problems being faced elsewhere with HT crops.
This is extremely worrying at a juncture where super weeds have become an insurmountable problem5 in the US (covering 60 million acres, this is more than double the area under Bt cotton in India)6 causing mayhem. It has led to the unprecedented rise in use of herbicides and cocktails of herbicides (threatening health and environment) and is leading to the development of GM crops incorporating older, more harmful herbicides.
There are numerous studies pointing out to adverse health impacts too including large environmental health crises unfolding in some South American countries.
3. 12 field trials are for Bt food crops. This, when the TEC majority report has explicitly asked for a ban on Bt genetic modification in food crops and when the Parliamentary Standing Committee’s report has recommended a re-appraisal of the safety of Bt cotton. Three are for Bt brinjal using the new Cry1Fa1 gene, and three are for rice. One Bt trial is for sugarcane and another for Bt chickpea.
Bt food crops for direct consumption is not being attempted almost anywhere else in the world and the TEC has pointed out that India need not become a guinea pig on this count.
4. Field trials have been approved potentially for 19 states (listed below) including the newly formed Telangana. Approvals pertain to the following states:
Haryana, Punjab, Bihar, Kerala, Maharashtra, Tamil Nadu, Karnataka, Andhra Pradesh, Rajasthan, Uttar Pradesh, Gujarat, Madhya Pradesh, West Bengal, Chhattisgarh, Jharkhand, Odisha, Delhi, Telangana, Himachal Pradesh
States that showed disinclination to approve field trials: Of this list, 12 states listed below have in the past refused to issue NOCs and/or have expressed that they will not allow field trials within the state.
Bihar, Kerala, Tamil Nadu, Karnataka, Rajasthan, Uttar Pradesh, Madhya Pradesh, West Bengal, Chhattisgarh, Jharkhand, Odisha, Himachal Pradesh
So the question arises about why field trials are being approved for these states, especially when the new government expressly states its respect for the federal setup of the nation. Is it the intention to arm twist these states repeatedly or to somehow sneak in GMOs?
5. Herbicide tolerant GM wheat (MON71800) of Monsanto, infamous for Oregon contamination incident in the US7,8 – which led to ban of imports of US wheat to Japan, Russia and the European Union – has been granted approval for pollen flow trials by the GEAC. For years now, GM wheat has been almost suspended even in North American countries.
Globally GM wheat is a rejected crop, with sustained and strong opposition, the world over, from farmers and consumers. The western world is not interested in genetically modifying its basic staple grain. This is probably among the less than 3-4 GM wheat trials going on anywhere in the world. At this juncture, the rationale of seeking and granting approval for GM wheat trials in India is suspect and worrying.
6. GEAC approvals for events withdrawn from the regulatory approval process in other countries: Two events, (one a Bt trait and the other a HT trait) withdrawn by Monsanto from the approval process in the European Union (MON89034* NK603, NK603)9 in 2103 and 2014 are sought to be introduced in India through these approvals. At the same time, DuPont/Pioneer has withdrawn two applications for GM maize of which one is for 1507* NK60310. Crops containing these events have been approved by GEAC across 6 field trials in India, including advanced BRL-II trials.
(MON89034 * NK603) is the withdrawn stacked event maize that has been approved for the advanced BRL-II trials and another cow feeding trial, in parallel. One of the trials of this HT Bt hybrid maize was implicated in unauthorised (illegal) planting of HT maize by Monsanto as per GEAC’s own monitoring team but GEAC has chosen to remain silent rather than answer pointed questions on this matter.
Herbicide tolerant maize of Monsanto – NK 603 – was withdrawn in 2014 by Monsanto, from the approval process in the European Union. GEAC has approved 3 stacked crop events with this event NK603 belonging to Monsanto for four field trials – (MON 89034 x NK603 HT Bt Maize, TC1507 X MON810 X NK603 Maize, TC1507 x NK603 Maize).
DuPont/Pioneer’s event 1507* NK603 (licensed from Monsanto) has been withdrawn by the company in 2014 and GEAC has approved it for “cow feeding” trials.
What is interesting about the withdrawal of these applications, particularly NK603, is that these withdrawals happened around the same time as Prof Seralini’s rat study (with NK603) has been republished11.
MANY GM RICE TRIALS APPROVED
7. The iron fortified rice of Kolkata University approved for field trials with 10 metres isolation distance (conflict of interest decision of GEAC12), has been granted extended validity. Dr Swapan Kumar Datta who was involved in the R&D related to this GMO and whose wife is involved in the project continues to be a member of the GEAC after its reconstitution on 13/3/2013 as an ‘expert member-institutional nominee’ of ICAR. Incidentally newer studies are showing how transgene flow is mediated by flower-visiting insects and this kind of transgene flow is much higher than previously assumed.
8. Rain of Bt rice: Event selection trials of Bayer, Metahelix, Pioneer and Devgen have been approved for event selection trials in two locations each.
In the past, it was a Bt rice of Mahyco that was implicated in a serious contamination issue in Jharkhand. To this day, no action has been taken on the company.
Devgen rice trials have been approved for trials in Punjab, a Basmati growing area. The approval violates GEAC norms laid down in meeting 73 on 10/01/2007 stating that Basmati growing states like Punjab, Haryana, and Uttarakhand in particular should not have rice field trials13.
9. Seven HT rice lines of Mahyco have been granted approval for BRL – 1 trials. Trials have been approved for any 10 locations across the country, whereas according to GEAC 104th meeting conducted on 15/11/2010, the norms, number of locations, area under trials is clearly specified14. The minutes clearly state that BRL-1 trials are to be held in 2-3 locations for 2 seasons.
This approval is in clear violation of this. In addition Supreme Court appointed TEC has asked for moratorium on HT crops.
10. Rice field trials in Punjab: Metahelix and Devgen GM rice trials have been approved for Punjab, which is a Basmati growing area.
As pointed out earlier, some of these approvals are against GEAC’s own decision not to approve any trials in Basmati growing rice belt of India. Further, it to be noted that even this policy, adopted for the right reason of protecting India’s trade security, does not take into account that in several years, non-basmati rice exports are higher in value than even basmati rice exports and therefore, this is a policy that should rightly apply to the entire country. Morever, India is the Centre of Origin/Diversity for Rice.
Bt BRINJAL IN ITS NEW AVATAAR:
11. Bt brinjal in another garb: Permission has been granted to Bejo Sheetal for BRL-II trials of its cry1Fa1 Bt brinjal and for event selection trials by Rasi seeds of Bt brinjal with Cry1Fa1 gene construct.
The PSC has in its report (2012) has strongly indicted the toxicity and other tests done, the lack of proper evaluation of results for Bt brinjal with Cry1Ac and asked for a full review of the approval process as well. While nothing has been done on that front nor improvements or changes have been instituted, GEAC has started clearing another Bt brinjal, one of which is in BRL II stage!
In addition, this gene construct is from Dr. Ananda Kumar, who was the former Director of National Research Centre for Plant Biotechnology (NRCPB). He and the NRCPB are involved in the Bt Bikaneri Narma gene controversy; the role of NRCPB in claiming ownership for the gene which was obtained through an MTA was indicted in the Sopory Committee report set up by ICAR to look into the Bt Bikaneri Narma fiasco.15
12. Approval granted for BRL-II of GM mustard containing Bar, Barnase & Barstar genes developed by the Centre for Genetic Manipulation of Crop Plants, (CGMCP). Also two other trials approved in parallel for feed study of leaves and seeds.
The crop developer is arguing that feeding studies for toxicity and allerginicity are not required.
Dr Deepak Pental, director of CGMCP and the crop developer, had previously admitted in an interview to media that GM contamination is possible to the extent that every mustard variety grown in India will contain GM genes.16
13. SPT rice trials: This is a GM method to create maintainer lines of rice. The technology is new and twice GEAC members sought a presentation from the company to understand the technology.
This technology is owned by Pioneer. In India approvals are being sought for field trials by bothDuPont and Pioneer separately. It has patented this technology and received approval for SPT maize in the US.
It has not applied in the US for SPT rice, which means India could be the first country where SPT rice is being tried. According to GEAC meeting minutes (100, 103, 113) DuPont has received approval for Field Trials. Now Pioneer has also got approval for the same.
Interestingly an optical seed sorting system is being developed in the US which is to be validated using the seeds produced as a result of the trials being carried out in India. According to GEAC’s 103rd meeting minutes17, DuPont will export the seeds (from these SPT rice trials ) to the US to test the sorter. The current trials approved for Pioneer, the parent company will also have the same conditions.
Also the question is why DuPont and Pioneer are applying separately for these trials?
14. Jayadhar cotton to be Bt: So far, when risks to cotton biodiversity with the spread of Bt cotton were discussed in various fora, cotton scientists would always respond by saying that the desi varieties ((the herbaceum and arboreum species of cotton) are under no threat of contamination from Bt cotton since Bt cotton exists in the hirsutum cotton. There are reports of breeder and foundation seed with NARS institutions also contaminated. GEAC has now approved field trials of desi cotton varieties, which have become the last resort for organic cotton growers of the country. Contamination of all varieties is now inevitable.
CONDITIONS FOR FIELD TRIALS DO NOT COMPLY WITH SUPREME COURT ORDERS, AND ARE NOT FOOL-PROOF
According to GEAC, “all GM crops field trials are subject to stringent norms as international norms which include the following:
i. Maintaining a crop specific isolation distance from the periphery of the experimental site to other sexually compatible fields as prescribed under the Indian Minimum Seed Certification Standards.
ii. Biological barrier by planting border rows all around the experimental plot. The width of the border row would vary on a case to case basis.
iii. Maintaining a physical barrier around the experimental plot to keep away unauthorized persons.
iv. Submission of a validated event specific test protocol of 0.01% before undertaking the trials.
v. Designating a lead scientist who would be responsible for conducting the trial.
vi. Crop specific post-harvest restrictions include (a) burning of the border rows and left over plants and plant parts from the entire experimental plot; (b) the trials sites should not be used for planting the same plant species and (c) the site should be monitored for volunteers and rendered non-viable before flowering.
vii. NOC from the respective State Governments where the trials would be conducted
These conditions imposed for the trials are not fool-proof, on top of the fact that the controversial technology itself is an irreversible living technology prone to contamination in the open air.
For instance, the crop-specific isolation distance to be maintained for the trials, based on the prescriptions of the Indian Minimum Seed Certification Standards is no guarantee against contamination. The IMSCS guidelines are meant for maintaining a particular level of genetic purity of a seed line in seed production practices and is not meant to prevent contamination from GMOs – a bee or wind may not follow the guidelines and GM contamination is very much possible even in the so-called self pollinated crops like rice despite these isolation distances. The genetic purity requirement for most crops is pegged at around 97-98% – by adopting these standards, the regulatory system is already allowing for 2-3% contamination (in fact, the chances are higher), whereas the Supreme Court Orders in 2007 say that “the GEAC shall take sufficient precautions to see that these trials are not causing any contamination to the cultivation of neighboring fields”.
Biological and physical barriers have not prevented unintentional or intentional contamination from GM field trials in the past – this was testified by no less than the Agriculture-Ministry appointed Sopory Committee in its investigation of the Bt bikaneri cotton contamination scandal, that too in NARS (National Agricultural Research System consisting of hundreds of universities, institutes, directorates etc. related to agricultural research) campuses.
One of the conditions for permitting field trials is the submission of a validated event specific test protocol of 0.01% for contamination testing. This condition in practice is a joke since we have RTI replies from more than half a dozen institutes which have taken up field trials to show that no contamination testing actually takes place. However, SC Orders which laid down this condition say: “Prior to bringing out the GM material from the green casino online house for conduct of open field trials, the approved institution should submit a validated event specific test protocol at an LOD of at least 0.01% to detect and confirm that there has been no contamination”. Once again, the Orders are being defied in the sense that there is no confirmation that there has been no contamination.
So, it is not clear why such protocols are being submitted. The GEAC of course does not even have oversight capacities over the trials it has approved, leave alone taking up contamination testing!
There are also some crop-specific post-harvest restrictions including the destruction by burning of all border rows, left over plants and plant parts from the entire experimental plot. This, we are yet to see being followed anywhere. In fact, there is sound documentation on video footage of plots where GM maize cobs were left out in the open after a so-called ‘seed production trial’ was conducted by Monsanto in Bijapur in Karnataka. Apart from this, there is video footage of field trial farmers stating that they have indeed harvested GM food from the trial plots and consumed it as well as sold it in the open market. It is also stated that the site should be monitored for volunteer plants – however, there is documentation by Gene Campaign, confirmed by a German lab later on, that GM rice volunteer plants have been left in the trial plot by Mahyco in a field trial in Jharkhand. What has been observed so far is that GEAC has no monitoring capabilities over a trial in a given test season, to ensure that no violations are taking place, leave alone monitor the same plot in subsequent seasons.
NO LIABILITY REGIME EXISTS
One of the most important points to note is that there is no liability regime in place for field trials, to put accountability on the applicant and the regulator for the risks that these field trials pose.
The Minister’s statements on “we cannot stop science” ignores the reality that it was during Bt cotton field trials that this GM crop spread illegally in India after which the regulators were forced to approve the crop. It also ignores the fact that a Committee set up under the Ministry of Agriculture (Sopory Committee) confirmed that contamination happened during field trials of a public sector GMO. It also ignores the fact that GEAC does not take action even when violations are brought to its notice.
It was a comprehensive assessment of the state of regulatory affairs that made various bodies, including scientific bodies, recommend a stopping of all field trials.
The information provided here could be incomplete and may have minor inconsistencies, which may be excused.
The contamination and appearance of volunteer GM plants occurred 8 years after the last field trial and Monsanto said that it could not explain how the contamination happened.