In a letter to the Union Minister for Environment, Forest and Climate Change Bhupender Yadav, the civil society network Coalition for a GM-Free India has objected to the apex regulatory body Genetic Engineering Appraisal Committee (GEAC) “proceeding inexorably towards approval for commercial cultivation of hazardous, herbicide-tolerant GM mustard”, stating, the biosafety assessment of GM mustard has been ignored.
Seeking “urgent intervention” of the minister, the letter says, the process of review of GM mustard has not been “rigorous enough”, the GEAC “doesn't seem to be really serious about either assessing its safety or efficacy”, and “to this day, the full biosafety dossier of GM mustard has not been put out for independent scientific scrutiny.”
Signed by Kavitha Kuruganti, Kapil Shah, Sridhar Radhakrishnan and Rajesh Krishnan, the letter insists, “It is quite objectionable that the regulatory body prescribes some studies, which the applicant repeatedly refuses to conduct, and GEAC takes back its own recommendations, repeatedly.”
Text:
This is to express our serious objections to and concerns about the way the apex regulatory body Genetic Engineering Appraisal Committee has been functioning with regard to the appraisal process of GM crops it is entrusted with, and particularly GM food crops. The approval could result in the spread of unsafe, unneeded and unwanted GMOs in the country. This letter in particular is regarding herbicide tolerant GM mustard developed by Dr Deepak Pental & team of CGMCP.The processing of this application from the beginning is in fact a good reflection of the unreliable, unsystematic and unscientific approach of our regulator for gene technologies. In fact, it is aware citizens who pointed out that Dr Pental and team had even changed the GMO approved for R&D in between, while regulators were unaware of that development and continued to process the application even as the applicant never informed the regulatory body of this fundamental change.
It is worth noting that this GM mustard uses the pretext of creating hybrid technology in a plant like mustard but in effect is a herbicide tolerant crop. The entire biosafety assessment of GM mustard so far has not taken this fact into account. Also ignored in the regulatory tests is the fact that a deadly herbicide like glufosinate will be used along with this GMO (there is adequate evidence of adverse impacts of this herbicide on health and environment for this to have raised warning bells for our regulators; this includes emergence of ‘superweeds’). This showcases a very serious deficiency in our regulatory regime.
While that is the straightforward story on the serious lapse with regard to biosafety, on the other hand, even on a simple thing like assessment of efficacy, data clearly shows that the so-called hybrid technology of using genetic modification using the bar-barnase-barstar system has been ineffective. GM mustard developed by CGMCP has no yield advantage to provide to Indian farmers. We have also shown very clearly how the best yields in the world are from non-GM conventional breeding in the global mustard-rapeseed production scenario.
SERIOUS DEFICIENCIES IN THE SAFETY & EFFICACY ASSESSMENT SO FAR
Apart from very serious lapses on the very safety assessment protocols adopted for this GM mustard, not taking into account the most important fact that GM mustard is a herbicide-tolerant crop, the following issues are worth noting:- Study protocols were designed by the applicants in many studies as we pointed out earlier.
- A majority of the studies were done by the applicant. A study claimed to be done by the National Institute of Nutrition was actually outsourced.
- Appraisal of the dossier did not have the participation of persons with required expertise even for the limited number of parameters for which the GMO was assessed.
- No guidelines were in place for Environmental Risk Assessment when the GM mustard application was processed.
- Several tests that should have been taken up during the biosafety assessment phase were pushed by a sub-committee of GEAC (which actually was not a “sub-committee” of the regulatory body but included external people including known GM crop proponents) into post-release monitoring studies with a complete disregard for the fact that GMOs are living organisms with a technology that is irreversible and uncontrollable once released into the environment.
- The GEAC meeting minutes related to GM mustard show that there are inconclusive discussions and processes initiated within the regulatory body on whether HT crop applications should be considered for commercial cultivation at all, whether toxicity test conclusions being drawn are right, and whether GM mustard should undergo feeding trials or not. Regulators showed no consistency in following up on their own discussions and concerns expressed on these matters.
- A certain AFES document which was put out in the public domain (drafted by the DBT which is the main funder of GM mustard) lacked reliability that is demanded of regulators who are expected to protect citizens from the risks of gene technologies/modern biotechnology. While individual test reports have concluded something, AFES document concludes the opposite. In the past, we have shown with examples how data from weediness studies are inconclusive, how certain claims in the AFES document of some tests done are unfounded, how and why pollen flow study conclusions are unreliable and how agronomic evaluation is deceptive and doctored.
- Concealed data so far on the health safety front shows significant differences in compositional analyses between GM and non-GM counterparts. These were brushed aside and attributed to agro-climatic changes, which should not have been allowed in the first instance in any rigorous experiment. Based on falsely-established-equivalence, several other tests have not been carried out on GM mustard. Sub-chronic toxicity studies reveal statistically significant differences in biochemistry parameters, histo-pathological differences and bodyweight gains. However, these were brushed aside too.
- In spite of the fact that (i) GM mustard had not proven itself effective as compared to non-GM mustard varieties and hybrids released in India, (ii) despite lack of proof of concept of hybrid technology using genetic modification, (iii) despite studies indicating lack of safety, (iv) despite many studies that were not taken up, and without putting out the biosafety dossier in the public domain in clear violation of earlier Supreme Court orders at the time of public debate on Bt brinjal, GEAC chose to give its green signal to unsafe GM mustard, in its 133rd meeting on 11/05/2017. While doing so, GEAC claims to have placed some terms and conditions, and left the matter for “further approval by competent authority”.
- The Government of India subsequently recorded the following decision on the matter: "Subsequent to receipt of various representations from different stakeholders, matters related to environmental release of transgenic Mustard are kept pending for further review".
- Later, on 21/03/2018, GEAC in its 134th meeting discussed GM mustard approval again, as part of Agenda Item 4.1. The following was recorded with regard to GEAC’s deliberation in this meeting on GM mustard: “After detailed discussion and keeping in view that the application has been referred back to GEAC for re-examination, the committee agreed that the applicant may be advised to undertake field demonstration in an area of 5 acres at 2-3 different locations subject to the conditions proposed in recommendations of Sub-committee on GM Mustard, accepted by GEAC in its 133rd meeting, for the purpose of generating additional data on effect of GM Mustard on honey bees and other pollinators and honey, and on soil microbial diversity. Towards this, the applicant may submit a detailed protocol to GEAC for its consideration and approval”. This was clearly GEAC trying to ignore all the serious concerns with GM mustard and bring down the debate to narrow points of ‘field demonstration’ and effect on honeybees/other pollinators and on soil microbial diversity.
- The Coalition for a GM-Free India immediately wrote to the Government of India, objecting to the so-called review of GM mustard by GEAC, and copy of the same is available here: IndiaGMInfo - Our letter to GEAC on its (facetious) so-called Review of GM mustard in its 134th meeting.
- The next meeting of GEAC (135th meeting) on 25/07/2018 records that GEAC decides to exempt the applicant from studies related to soil microflora! It is important to note that the sub-committee members themselves have expressed their views on the limitations of the protocols adopted to look at soil impact studies taken up on GM mustard. We have also pointed out that while bar protein gets expressed highest in the root zone, it was not tested for HGT and other parameters in soil impact studies. Importantly, the soil impact studies were never taken up keeping in mind that GM mustard is actually a herbicide tolerant crop, with the herbicide also adding to the harmful effects on soil. GEAC also allowed the so-called “demonstration studies” to be taken up without an NOC from state governments (it is worth noting that during the field trials’ stage, major mustard growing states did not give NOCs). This is in effect the apex regulatory body allowing deliberate environmental release of GM crops, under the guise of “demonstration studies” (even when state governments have objection). However, a decision on allowing the actual demonstration studies to proceed was hindered by the fact that a couple of members submitted comments on the protocols that were submitted by the applicant.
- In the next GEAC meeting on 20/09/2018, the field demonstration studies were given a go-ahead. The applicant is recorded to have reverted to the GEAC with reasons for deferment of the studies during 2018-19, however (Agenda Item 7.1 of GEAC’s 137th meeting on 20/3/2019). The studies were proposed for 2019-20 growing season, and the Committee agreed to the same.
- The latest recording is from the 146th meeting of GEAC where CGMCP has claimed that adequate evidence is available and that no additional studies are required. This is particularly critical in this instance as the tests prescribed were to assess the impact of GM mustard on honey bees. As you are aware, mustard is an important foraging crop for honey bees and honey export is an important source of income. Bee-keeping as a livelihood is majorly dependent on mustard crop, as you would know. Studies from around the world have shown how herbicide tolerant GM crops and the associated herbicide usage have adverse impacts on honeybees. Beekeepers in India have repeatedly spoken about adverse impact on honeybees from even Bt cotton as experienced by them.
- It has been observed and pointed out by us over the years that various expert committees set up by GEAC have crop developers whose opinions are not balanced with experts on the other side. This leads to a situation where the applicants are waved in without serious, critical review of applications. The Chair of the Expert Committee (Dr Sanjay Kumar Mishra) is from DBT, when DBT is the funder of GM mustard; one more member of the Expert Committee is from DBT, it is noted. Dr KC Bansal is a GM crop developer and his presence and participation in GEAC decision-making in the past has raised objections and resistance.
We conclude that the process of review of GM mustard is not rigorous enough, and GEAC doesn't seem to be really serious about either assessing its safety or efficacy. To this day, the full biosafety dossier of GM mustard has not been put out for independent scientific scrutiny.
It is quite objectionable that the regulatory body prescribes some studies, which the applicant repeatedly refuses to conduct, and GEAC takes back its own recommendations, repeatedly. It is also important to note that these tests themselves are inadequate because larger concerns about GM mustard have remained unaddressed. GM mustard has never been compared with ecologically-sustainable alternatives that can be supported and promoted to improve India’s mustard yields. Relevant data with regard to these sustainable, safe and farmer-controlled alternatives has also been placed by this Coalition in the past.
Numerous instances from all over the world, as well as the statements of the GM mustard crop developer himself, are evidence that containment of this GM mustard will be impossible, and contamination is inevitable. This then has serious implications for organic farmers and their organic status, amongst other issues like persistence, weediness, superweeds emerging etc. As much as 12 to 19% of the neighboring non-GM/organic crop could be contaminated depending upon the level of outcrossing. In fact, even mustard oil-cake for soil amendments will be affected, once GM mustard is approved, which will also jeopardize the organic certification of a farmer. Sir, this will jeopardise and compromise the government’s right push in the recent past of ecological agriculture in the country in the form of organic and natural farming.
Mustard is used both as food and medicine in Ayurveda. Mustard seeds and oil are used singly as well as in various formulations for a variety of treatments. The impact of GM mustard on such uses is unstudied and unclear.
The same story of Bt brinjal is repeating itself with GM mustard where safety testing is simply not taken up by the applicants even when narrow testing is prescribed. However, the regulators keep an application alive for years, without closing it firmly, once and for all.
Meanwhile, for tackling the import dependence of India for oilseeds/edible oils, numerous solutions are needed, which include farmer-centric exim policies in addition to various agronomic practices to be adopted (like SMI). Provision of emergency/protective irrigation systems coupled with participatory water management at the community level will improve and stabilize production of oilseed crops like groundnut and soybean. On the policy front, export-import policies related to oilseeds and edible oil should favour Indian producers for higher production to accrue, not price our producers out. Further, land use policies should incentivize cultivation of oilseeds on larger areas; there is also a need to revise the price support and procurement policies related to all oilseeds, to encourage farmers to grow more. On the institutional front, plugging the last mile extension gaps with the existing technologies should lead to significant production improvements. If the Indian government is indeed keen on improving oilseeds production, all these options should be explored seriously for sustainable results, rather than a hazardous technology like GM mustard.
Given the above, and given the fact that you have pro-actively objected to fast-tracking of approvals of GM crops in the past, understanding and appreciating the hazards of modern biotechnology as well as the serious deficiencies in our regulatory regime, we urge you to kindly intervene urgently with the following actions:
It is quite objectionable that the regulatory body prescribes some studies, which the applicant repeatedly refuses to conduct, and GEAC takes back its own recommendations, repeatedly. It is also important to note that these tests themselves are inadequate because larger concerns about GM mustard have remained unaddressed. GM mustard has never been compared with ecologically-sustainable alternatives that can be supported and promoted to improve India’s mustard yields. Relevant data with regard to these sustainable, safe and farmer-controlled alternatives has also been placed by this Coalition in the past.
Mustard is used both as food and medicine in Ayurveda. Mustard seeds and oil are used singly as well as in various formulations for a variety of treatments. The impact of GM mustard on such uses is unstudied and unclear.
The same story of Bt brinjal is repeating itself with GM mustard where safety testing is simply not taken up by the applicants even when narrow testing is prescribed. However, the regulators keep an application alive for years, without closing it firmly, once and for all.
Meanwhile, for tackling the import dependence of India for oilseeds/edible oils, numerous solutions are needed, which include farmer-centric exim policies in addition to various agronomic practices to be adopted (like SMI). Provision of emergency/protective irrigation systems coupled with participatory water management at the community level will improve and stabilize production of oilseed crops like groundnut and soybean. On the policy front, export-import policies related to oilseeds and edible oil should favour Indian producers for higher production to accrue, not price our producers out. Further, land use policies should incentivize cultivation of oilseeds on larger areas; there is also a need to revise the price support and procurement policies related to all oilseeds, to encourage farmers to grow more. On the institutional front, plugging the last mile extension gaps with the existing technologies should lead to significant production improvements. If the Indian government is indeed keen on improving oilseeds production, all these options should be explored seriously for sustainable results, rather than a hazardous technology like GM mustard.
Given the above, and given the fact that you have pro-actively objected to fast-tracking of approvals of GM crops in the past, understanding and appreciating the hazards of modern biotechnology as well as the serious deficiencies in our regulatory regime, we urge you to kindly intervene urgently with the following actions:
- Do not allow GEAC to short-circuit the need for rigorous assessment of GM mustard, including on the fact that it is a herbicide-tolerant crop, for which it was never tested.
- Adopt a policy decision for India that herbicide tolerant crop applications will not even be processed by the regulators. In fact, India needs a firm policy to be made that stops gene technologies in our food and farming systems, and not a case-by-case approach to this hazardous technology.
Comments