Genetic Engineering Appraisal Committee (GEAC),
Ministry of Environment, Forests & Climate Change,
Government of India.
Dear Chairperson, Members and SC’s Appointee in GEAC,
In the Special Meeting of the GEAC on July 18th 2016, you assured us that the doors for dialogue are open and that we should send any additional material that we might have to the GEAC, or the Sub-Committee. We sincerely thank you for keeping the process open and ongoing.
Further, there was a specific question that Dr SK Apte had asked, about what our specific objections with regard to the parental lines and their biosafety were. We would like to take this opportunity to share some points on this matter.
REASONS TO REJECT APPLICATION OF TRANSGENIC PARENTAL LINES:
We got to hear (informally mostly) following arguments in favour of release of transgenic parental lines, which are also up for approval with the regulators at this point of time.
1. “They provide good heterosis”: However, GE cannot and does not add to heterosis.
2. “Transgenic Male Sterility is stable”: However, BRL trials show it is unstable; moreover, proven stable CMS lines are deliberately ignored.
3. “They can be used for further breeding for other purposes – we will release the parental lines”: For this alternatives exist, and further research does not require environmental release by GEAC.
As shown above, we consider that none of the above reasoning has valid scientific footing. Current testing undertaken does not support any of these arguments. We elaborate on this, along with other objections below.
1. These parental lines will generate nothing but HT hybrid:
The parental lines are also Herbicide Tolerant (HT). They will generate 100% HT hybrids, as both parents are needed for Barnase-Bar-Barstar system to work. Approving BBB means approving generation of a HT crop. This will be truer in the case of private sector entities using any released parental lines for creating newer hybrids. In this context, policy directives should be applied on whether we can allow GM HT crops to come in into India, that too as a backdoor entry, when there are huge health, environmental and socio-economic implications and when this matter is sub-judice. At least three credible Committees (executive, law-making and judicial) have warned / recommended against the introduction of HT crops in Indian agriculture.
2. Farmers WILL use Herbicides:
We heard from some GEAC members that glufosinate (against which these mustard GMOs are designed) is expensive and will not be used by farmers. This appears to be a wrong assumption – we have information that UPL is now into manufacture of glufosinate and is about launch its brands along with Bayer’s brands that the company is planning to re-launch in a big way sensing the market potential that exists now, if GM mustard is approved. When there are more brands in the market, prices will come down. Farmers will also compare the price vis-à-vis labour costs and having to deal with labourers. This is witnessed in the case of illegal HT cotton being grown in many parts of the country. So, this cosmetic distinction between use of herbicide tolerant genes as marker genes not being the same as herbicide tolerant crops being applied for/approved is only a cosmetic explanation and does not hold good in reality. All 3 GMOs ARE herbicide-tolerant and need to be rejected just on those grounds.
3. Intention of the developer is clear- “to develop a HT crop”:
Some people in GEAC feel that there is no hidden agenda to bring in a HT crop through the back door. As we pointed out earlier, the double enhancer promoter for very high expressions of bar gene in the barstar line, to be subsequently passed on to the transgenic hybrid, is a clear intention for developing a HT crop. It is also important to note that use of bar as marker in both lines can also be avoided, which is not done. As another proof, we attach here a paper by the applicant published way back in 2000, which clearly advocates the need and use of Glufosinate tolerant (HT) mustard in India, which is two years before the first field testing of this HT mustard. Another paper from same developer published in 2007 describes the development of the Barnase-Barstar system in conjunction with ALSdm gene which confers resistance to imidazolinone (imazethapyr), a cheaper herbicide. Beyond this, we have confirmed news about development of controversial Glyphosate Tolerant (Roundup Ready) lines at CGMCP. These are all clear evidences of developers’ intention to come up with HT crops, and we do not see any reason why the regulators are turning a blind eye to these facts and believe otherwise – on what grounds and for whose interest?
4. Even though these are HT lines, all testing done without spraying herbicide:
Results of trials of HT crop and its parental lines (producing ONLY HT crop) conducted without spraying herbicide are scientifically invalid. It is highly surprising and unacceptable that all testing was done without the spray of Glufosinate. Considering the fact that many farmers in India cultivate HT cotton illegally, there should not be any reason to believe that farmers will not use herbicide. In such a case, any field testing related to impact on ecology MUST be rejected as it is not done in REAL situation. This is important given that mustard crop is a major source of sustence for honey bees and it is this crop, which is the main source of food to produce honey.
5. Honey quality should also be checked not only for novel protein or any compositional change, but also for pesticide residue.
This has not been done for all 3 GMOs under consideration.
6. No proof of advantage of transgenic male sterility over (other) stable CMS system:
There should be a clear scientific basis as to why (other) CMS lines are not considered suitable for (future) breeding by the Delhi University scientists whereas public sector scientists have access to stable CMS lines. Many public sector mustard breeders are quite satisfied with proven and stable CMS lines which seem to have NOT been used by developer of transgenic mustard. Can the fact that the DU scientists want to work with their own exclusive CMS lines with any deficiencies therein be a generic reasoning that CMS lines are not good enough and therefore transgenic male sterility technology is needed? Is this a tenable argument for a risky technology which should be considered as a last option?
7. Breakage of male sterility in Varuna barnase and its implications are NOT studied:
Parental line Varuna barnase should be tested rigorously for male sterility breakdown with standardised protocols to understand the efficacy of the technology in different situations – after all, risks are being taken here, and we need to understand if the benefits being projected are reliable. And such testing should be vis-à-vis comparative benefit over CMS system.
8. CMS parental lines are not used as comparator:
Parental lines in the current application should be compared with CMS parents to check what is the added advantage, if any, against the presently available system both in terms of stability of male sterility as well as heterosis. GEAC should first evolve protocols for such testing , especially if the claim for the BBB system is that it is more stable than the CMS system. Such protocols and tests are non-existent in the current application.
There should also be data generated on comparison of heterotic vigour from genetic modification technology based on bar-barnase-barstar complex, with heterosis of CMS lines to see if the heterosis obtained in this method is indeed equal to or superior to CMS-based heterosis.Hybrid developed using CMS system has shown 32.6% and 29% heterosis in multisite Farmers’ Field Demonstrations in 2004-05 (10 trials) and 2005-06 (27 trials) respectively. These figures are higher than what is claimed (28.4%) heterosis for hybrid produced from these transgenic parental lines. Heterosis has no connection with type of male sterility. Transgenics cannot add to the heterosis, and is only a means to it; there is no reason to believe that same parents prepared with CMS will not bring same level of heterosis.
To reduce the risk assessment processes to just proving the possibility of transgenics-based heterosis is not acceptable.
9. The testing of parental lines is incomplete in several ways:
For instance, Crossability and Pollen flow studies become very important for parental lines which have not been performed. The dossier is incomplete without this important aspect assessed.
10. Samples for health safety studies collected from crop which is not sprayed with herbicide are inconclusive:
It is obvious that health safety studies should be taken up in a context where the cultivar is sprayed with glufosinate ammonium.
This is especially so for Varuna barnase line, given that herbicide application is indeed recommended in seed production. However, the dossier does not mention about the herbicide application protocols, the dosages, the impact of such herbicide etc. Such testing has not taken place. This applies to the transgenic hybrid too which is indeed a herbicide tolerant crop and should have been assessed as such.
11. Incomplete and unscientific presentation of data:
All data and results from existing studies should be presented in proper comparison with statistical analysis in an aggregated fashion across all trials. Presenting absolute numbers, year by year, location by location will not help regulators take a decision, especially when it comes to environmental safety studies, and this applies as much to parental lines as hybrid progeny.
12. Many studies NOT done:
Further, in our presentations, we pointed out various studies that have not been done Eg. chronic health studies, impacts on Indian Systems of Medicine, on honey (honey having transgene proteins as well as honey production levels) and honeybees (more rigorous studies) etc. This applies to all three GMOs in question including the parental lines.
Similarly, impact on wild relatives not studied. This should have formed an important part of the risk assessment in this dossier.
13. Protocols used are not rigorous enough to actually capture impact or risk:
For instance, an adequate long term study on the impact of the BBB system on diverse insects which represent key functional groups in the mustard agro-ecosystem – there should be a study on diversity, abundance and behavior of a few generations of insects like honeybees, gryllids, hoppers, spiders, lacewings and beetles compared to non-GM mustard field and CMS lines, in replicates, in the same agro-climatic zones and any shifts in predator:prey ratios should be captured. What were passed off as environmental safety studies are quite inadequate in their protocols and presentations, as we have noted in our presentations including issue of conflict of interest, and this obviously applies to parental lines too.
14. Has permission been taken to develop EH-2 / Varuna barnase?:
It is important that GEAC investigates whether developer has taken permission to develop EH-2 barnase or not. This is a female parent of “so called” DMH-11 until 2006-07. If the permission was initially for that, was permission for Varuna barnase formally obtained?
15. No description of pre-BRL testing of parental lines:
The biosafety dossiers do not have any details about any pre-BRL testing of the parental lines. These parental lines have directly entered into such BRL level testing, it appears. We doubt whether Pre-BRL testing is REALLY done for all the 3 GMOs including both the parental lines. What are the pre-requisites for application for BRL testing? Have those been accomplished?
16. Safer alternatives DO exist and have been employed successfully to breed mustard for other objectives also:
The applicant claims that release of parental lines will help development of other transgenic cultivars for other traits like better oil quality, biotic and abiotic stress tolerance etc. It is worth noting that this has already been achieved to a significant extent through traditional breeding and the option of using stable CMS is worth exploring. In fact the oil and cake produced from GM mustard will be laden with herbicide residue and potential risk of novel proteins.
17. These lines will only produce small seed size, which is rejected by farmers:
It is important to note that EH-2 has extremely tiny seed size and hybrid produced using EH-2 (either male or female parent) will always have tiny seeds, which are not accepted by Indian farmers. This is one of the important reasons for active rejection of DMH-1 (the non-transgenic hybrid from the same developer) by the farmers. So, while approving any transgenic material (finally taking any risk), GEAC should also see farmers’ choice. On this, it is not acceptable that the regulators say that once they approve, the market preferences will in any case decide. By that time, contamination would have occurred and this is unacceptable. As experienced by many mustard breeders, the European genome (represented by EH-2 here) comes with many limitations of important agronomic characters like small seed size, high levels of shattering, prone to lodging, disease susceptibility etc.
18. Maintenance of the female parental line is illegal as per another regulatory system:
As the applicant reveals, the use of herbicide glufosinate will be needed for seed production of female GM mustard line, and such use is illegal and unapproved as per the pesticides-related regulatory regime in the country.
19. Limited release of parental lines is nothing but approving commercial cultivation:
In India, all the GM crops being cultivated today are introduced illegally and the obvious point of leakage/escape is the trials and seed production plots (this is apart from biological possibilities). It is also known that seed production of private and public entities actually happens in farmers’ fields mostly. Even if the seed development is kept in the hands of ONLY technical people, the parental lines will definitely escape into the hands of farmers and moneymakers by illegal routes as happened with Bt cotton and HT cotton. Release of these lines is not required to continue research. So thinking of limited release or approving only parental lines for seed production and backcrossing for newer hybrids to be evolved is nothing but approval for full blown commercial cultivation.
20. Information on Population Genetics through Gene Flow is missing:
On gene flow to neighbouring crop, and male sterility persistence over generations there, the most likely scenario which should have population genetics presented by the crop developer is that of the non-GM farmer trying to continue to use farm-saved seed with the transgenic mustard hybrid farmer opting for the GM F1 hybrid season after season, thereby introducing new male sterility in the population constantly. Such population genetics projections have not been made by the crop developer as part of the dossier, nor asked by the regulators.
21. Details of IPR are missing:
The IPRs scenario of these 3 GMOs along with full details of material transfer agreements involved should have been a part of the biosafety dossier submitted – the regulators should mandate this, along with copies of Material Transfer Agreements (MTAs) to understand the exact terms and conditions of the IPRs involved in each case. At least 5 genes/ techniques associated with these parental lines are patented and it is important to understand the full ramifications.
We request you all to consider all the above points in addition to numerous other points that we had made during the July 18th 2016 Special GEAC Meeting. We have not repeated those points here.
May I request a line of confirmation of receipt of this mail from each of you please? Your valuable opinion on this issue will be highly appreciated.
Jatan: A Mission for Organic Farming,
Vinoba Ashram, Gotri, Vadodara: 390 021