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MY REBUTTAL TO PESTICIDE INDUSTRY ASSOCIATION CCFI’S ADVERTORIAL IN BUSINESS STANDARD ON JULY 29TH 2020

On 29th July 2020, a full page ‘advertorial’ paid for by the Crop Care Federation of India (CCFI), an NGO of the pesticides industry in India, was published by Business Standard. The website of CCFI says that one of its objectives is to “build a responsible industry image”. 

Advertorial spaces – which are neither advertisements nor opinion pieces nor journalistic news coverage – seem to be unfair spaces given to particular entities for publishing whatever the entities want by paying a fee, without editorial oversight, when such an oversight has to apply to everything that a paper publishes. When used with malicious intent, such a space becomes a paid space for slander and defamation, with the accused parties not getting a chance to present their views and evidences.

CCFI in this case put out a screaming headline “Beware of Foreign Funded Environmental NGOs – They are paid to malign Indian agriculture”. There are at least four things wrong with the headline itself as connected with the rest of the article. 

To begin with, it insinuated that foreign funding was only and always a sinister thing and that “foreign funding” should be interpreted in only one way —- only in the context of NGOs receiving such funds, and not when foreign markets are built for revenues of corporations or when political parties receive such funding or when even governments receive bilateral and multilateral funding or when an economy itself is built by inviting FDI and FII. All the latter contexts of receiving foreign finances are seen as benign and only the first as sinister! In fact, the pesticides industry itself was one of the first beneficiaries of foreign funding by philanthropies when the Green Revolution was ushered into India. CCFI as a non-profit association is probably supported by business revenues earned in foreign lands. Let us not forget that the Indian pesticide industry has a larger foreign market than a domestic market! This red herring around ‘foreign funding’ therefore is irrational to say the least and foreign funding being a measure of patriotism and nationalism is highly questionable.

Two, it lists out funded organisations and individuals along with non-funded ones without making a distinction between the two, other than clubbing foreign-funded ones with Indian-funded. 

Three, it does not limit its objectionable tirade to just NGOs but begins naming scientists in public sector research bodies which are not foreign funded or environmental NGOs. 

Four, the names listed have people who, far from maligning Indian agriculture, are working closely with farmers to provide sustainable livelihoods to them. Farmers who are associated with Kheti Virasat Mission in Punjab stand as silent testimonies to this for instance.  

The advertorial says that spreading ‘fake news’ about ‘excessive agro-chemical use’ and ‘high pesticide residues’ in our agricultural commodities with false and fabricated studies and stories are how these ‘foreign funded (that too EU) environmental NGOs indulge in scare-mongering. Well, Mr Rajju Shroff and CCFI might as well have accused the Prime Minister of India of scare-mongering then, when from the ramparts of the Red Fort on India’s Independence Day in 2019, he gave a clarion call to farmers to reduce and phase out agro-chemicals and save Mother Earth. State governments are asking for bans and rigorous regulation, and are investing in non-chemical farming. Judges and Courts are taking suo-motu notice of the menace of pesticides. I invite CCFI to brand them all as foreign-funded forces out to please their donors, as it foolishly branded others in this advertorial.  

CCFI, as it usually does, presented comparative picture of volume of pesticide consumption in India forgetting that activists are not talking about ‘excessive agro-chemical use’ but about the adverse impacts of deadly pesticides. So, it is about quantities as well as which pesticides, the conditions of use, which exposure routes for farmers and consumers including when. In a country where farming operations are mostly manual, and where most consumers are in fact in rural India, exposure to pesticides is more direct and through more routes (it is not just about contaminated food). And if those pesticides are also known for their health and environmental effects, that too in the context of a significant proportion of malnourished population that is more vulnerable to such environmental toxins, there is a definite cause for concern which cannot be brushed aside as scare-mongering. Evidence around pesticide bans leading to a decline in suicide rates related to intentional ingestion of pesticides cannot be brushed aside. The fact that this chemical agriculture paradigm exists and is promoted by the industry and its lobby bodies, even after the science of non-chemical agriculture has emerged strongly, is unwise as well as unscientific. 

Coming specifically to allegations against me – the fact that I was associated with Greenpeace India is being thrown as an accusation, ignoring the fact that this international environmental organisation has indeed been instrumental and successful in establishing environmental governance internationally and nationally in accepted scientific and legal frameworks. I was associated with it for around 17 months, way back in 2002-03 and I am proud of my association with the organisation, however brief it was. 

For about a decade now, I am associated with a volunteer-driven informal network which is committed to Indian farmers’ rights and in improving their livelihoods sustainably. Alliance for Sustainable & Holistic Agriculture (ASHA) is not funded and is not even a legal entity. It is not an NGO and for certain activities and events, crowd-funding from Indians is adopted. The network does not take up funded/projectised work, but collects money only when needed. This money does not get used to pay any of us or volunteers, and accounts are shared with donors within a month as a norm. There are no paid employees in ASHA.

Another accusation is around the “un-restricted access and ease with which India’s foreign-funded activists gain confidential documents from the government departments”. With the illustration cited, CCFI is presuming that I gained access to the Pesticides Management Bill 2020 (PMB2020) through the Agriculture Ministry. It is laughable to think that someone like me who often gets very critical of government policies will get access to a Bill in that manner in a country like India. The Agriculture Ministry looks at activists like me as a thorn in their side rather than critically engage with me and take inputs in a healthy fashion. 

As an advocacy platform, we keep an active watch on policy-making and legislative-making processes in the country, and feed on-ground experiences into these. We keep ourselves informed about important Bills to be debated and acted upon. A legislative Bill being accessed from Parliamentarians does not involve any wrong-doing and MPs who would like to contribute meaningfully to the debate in legislative processes do seek inputs from experts on the subject. All of this is legitimate democratic processes at work. It was the same that happened with the PMB2020. This is what a healthy democracy is about, and CCFI cannot tarnish this as excessive reach and influence by attributing some sinister donor-driven motivations in this case.   

About the bold decision of Indonesia to ban numerous pesticides under President Suharto – this was mentioned by me to point out that the overnight Indonesian ban on 57 pesticides in 1986 did not lead to productivity declines, whereas the industry indulges in scare-mongering by presenting prospects of starvation without pesticides. Talking about Indonesian use of pesticides in dollar terms is very unscientific of CCFI in this advertorial and critiques of other studies that measured consumption in similar terms from Indonesia pointed out the same. The CCFI’s misinterpretation of what was actually said is similar to the earlier-mentioned accusation around “excessive use of pesticides”. There are numerous published papers in the public domain that show that Indonesia gained in yields after the bold decision to ban. 

Indonesian experience with incentivising and promoting pesticide use is quite negative and documented by FAO amongst others. It was only with an IPM approach that followed the overnight bans from the 1986 decree that their rice production was saved and improved. Papers by Pingali, Kenmore, Ooi and others exist for more information on this. 

There was no half-truth in what was argued by me – that yields were not affected after the ban. And that happened because of the institutional approaches adopted by Indonesia in the form of Farmer Field Schools that improve pest literacy of farmers. That is the kind of agro-ecological approach that advocates like me in India are asking for, and are in fact arguing that we can go some steps further than IPM with existing science and experiential evidence – those approaches include NPM and organic/natural farming methods. 

In fact, what is questionable is CCFI’s argument that Indonesia has more pesticide use now by citing some pesticide expenditure figures in dollars. In terms of volume data of pesticide consumption, FAO shows a decline. Mariyono et al (2010) showed pesticide use declines, after pesticide subsidies were removed, 57 chemicals banned and IPM scaled up.

Pesticide industry’s ignorance/disregard for science and scientific research is apparent from the tools it deploys to raise questions about published papers. The regular practice for advancement of science is peer reviewing before publishing which in itself is supposed to screen fake science. And if there are glaring errors despite this mechanism, counters and comments can always be published in the same journal and journals ought not to turn down such requests in ordinary course. In this day and age of digital media, the industry can choose to publish detailed critiques on a separate website and also send letters to the scientist concerned and the research institution. But that is not how the industry chooses to advance science. It shows its unscientific attitude by seeking to intimidate not just activists but scientists and researchers. Veterans in the pesticides industry exhibit a certain vicious and vindictive response by resorting to SLAPP suits to silence even scientific research. And now, this tool of “advertorials” to peddle their fake news, to intimidate and slander. 

All in all, the advertorial of CCFI is full of lies and falsehoods. I (and several others named in the advertorial) am not foreign-funded, supporting Indian farmers and farming has been my life’s mission, ASHA is not an NGO and I don’t represent any NGO, the references to me in two places in the advertorial are incorrect and importantly, foreign funding is not sinister as is sought to be portrayed with screaming, scaremongering headlines.    

It is clear that the industry is scared of losing its markets as aware farmers and other citizens shun pesticides and seek to tighten regulation. It is fearful of the impending ban on 27 deadly pesticides and the new regulatory regime that is likely to emerge after Pesticides Management Bill 2020 is discussed and passed – it is essentially scared of democratic citizen action and post-modern science. 

But that does not justify the publishing of the advertorial in any way. Business Standard providing the space for the advertorial for earning some revenue is totally unacceptable. A brief “correction” published on the front page did nothing to correct the wrongdoing by the paper and this author will continue to pursue all options available to her to seek redressal not just against personal defamation, but for a public interest matter related to advertorial spaces themselves. 

  • Kavitha Kuruganti, a non-foreign-funded activist out to support Indian farmers and farming as her life’s mission along with several like-minded committed co-travellers, who does not believe that foreign funding has only sinister motivations and outcomes

Response from Business Standard – Letters to Business Standard Editors – CCFI advertorial episode

———- Forwarded message ———
From: Shyamal Majumdar <shyamal.majumdar@bsmail.in>
Date: Mon, 3 Aug 2020 at 19:29
Subject: Re: Fw: Seeking an apology and an equal space for counter views to be published by BS
To: Kavitha Kuruganti <kavitakuruganti@gmail.com>


Thanks, Ms Kuruganti. We will get back tomorrow.
Regards

 

———- Forwarded message ———
From: Kavitha Kuruganti <kavitakuruganti@gmail.com>
Date: Mon, 3 Aug 2020 at 18:11
Subject: Re: Fw: Seeking an apology and an equal space for counter views to be published by BS
To: Shyamal Majumdar <shyamal.majumdar@bsmail.in>


Dear Mr Shyamal Majumdar,

Thanks for your mail. I am attaching a piece in response to the full page advertorial to defend myself against the 2-3 specific allegations made against me, but also on the general line of attack that the advertorial took, because that also covers me. This word length of my piece is an average opinion piece length and I am sure Business Standard would not shy away from publishing it in full.

I also got to see BS’s letter to another concerned person wherein you mentioned that you have decided not to take any revenue for the advertorial published; you had already confirmed that the advertorial has been withdrawn from your website. I would like to place on record my appreciation of these actions taken by Business Standard.

I will wait for the final version of the attached article before it goes for printing – I expect that it will be edited only for syntax and other matters, like any other opinion piece or advertorial that you publish would be. Thank you.
 
 
Kavitha Kuruganti

On Sun, 2 Aug 2020 at 16:22, Shyamal Majumdar <shyamal.majumdar@bsmail.in> wrote:
Dear Ms Kuruganti,
Thanks for your mail.
The word length should be 350 words.
After editing at our end, we would play it back to you before use.
As per our policy, we will carry it on an inside page where the advertorial had appeared.
The advertorial, which was part of the Business Standard e-paper, has been withdrawn from our website.
Regards
Shyamal Majumdar
 
 
From: Kavitha Kuruganti <kavitakuruganti@gmail.com>
To: Shyamal Majumdar <shyamal.majumdar@bsmail.in>
Date: 31-07-2020 12:01
Subject: Re: Fw: Seeking an apology and an equal space for counter views to be published by BS




Dear Mr Majumdar,

One more thing, pls. This correspondence – my letters to you and your responses – will be in the public domain since this is not just a matter of personal defamation, but a matter of greater public interest in terms of media ethics, this tool called “advertorial” that is in the hands of people with deep pockets etc. I thought I should inform you about this. Thank you. 


Kavitha

——— Forwarded message ———
From: Kavitha Kuruganti <kavitakuruganti@gmail.com>
Date: Fri, 31 Jul 2020 at 11:59
Subject: Re: Fw: Seeking an apology and an equal space for counter views to be published by BS
To: Shyamal Majumdar <shyamal.majumdar@bsmail.in>

Dear Mr Majumdar,

One more thing, pls. This correspondence – my letters to you and your responses – will be in the public domain since this is not just a matter of personal defamation, but a matter of greater public interest in terms of media ethics, this tool called “advertorial” that is in the hands of people with deep pockets etc. I thought I should inform you about this. Thank you. 

Kavitha

———- Forwarded message ———
From: Kavitha Kuruganti <kavitakuruganti@gmail.com>
Date: Fri, 31 Jul 2020 at 10:59
Subject: Re: Fw: Seeking an apology and an equal space for counter views to be published by BS
To: Shyamal Majumdar <shyamal.majumdar@bsmail.in>

Dear Mr Majumdar,

Thank you for your mail.

Can you please let me know the following details before we proceed further:

1. What is the word length for my response;
2. Will the piece be shown to me for my sign-off after BS’s editing before publishing;
3. In which page were you thinking of publishing it;  
4. Will the CCFI advertorial be withdrawn from the website, since it continues to cause damage by being there – if not, how do you propose to address this- for instance, by linking the rejoinder piece to the advertorial?;
5. Will BS reach out proactively to other people/organisations named in the advertorial or not;
6. Is BS contemplating about sharing publicly the revenue earned from the advertorial and also if the same will be returned to CCFI. This then will be in line with Business Standard’s Code of Conduct, I feel.

I believe that what I am asking above are perfectly legitimate questions given that Business Standard is trying to be a fair media organisation with its own high standards, while that fairness cannot be achieved just by some cosmetic actions. Thank you.

Kavitha Kuruganti

On Thu, 30 Jul 2020 at 20:40, Shyamal Majumdar <shyamal.majumdar@bsmail.in> wrote:

Dear Ms Kuruganti,
Thanks for your mail. We will be happy to carry your response to the advertorial from Crop Care Federation of India, to the extent it pertained to you and your work. Your response will be subject to editing for length and stylistic reasons as also to legal vetting. Please send us your response to the advertorial.
Regards

Shyamal Majumdar
Editor

———- Forwarded message ———
From: Kavitha Kuruganti <kavitakuruganti@gmail.com>
Date: Thu, 30 Jul 2020 at 10:55
Subject: Seeking an apology and an equal space for counter views to be published by BS
To: <tn.ninan@bsmail.in>, <shailesh.dobhal@bsmail.in>

To:
Mr TN Ninan, Chairperson, Board of Directors, Business Standard Pvt Ltd
Mr Shailesh Dobhal, Team Leader, Editorial Team, Business Standard.

Dear Mr Ninan and Mr Dobhal,

Greetings! It was indeed sad to see Business Standard publish a full page “advertorial” from the pesticides industry’s association called Crop Care Federation of India yesterday (29th July 2020). I was one of the people named in the so-called advertorial and am therefore writing to you for corrective action.

I assume that as a paper that has its own well-spelt-out Code of Conduct (https://www.business-standard.com/code-of-conduct) which in turn champions standards and principles around Correctness, Gifts & Favours, Accuracy, Public Interest etc., you will extend the Code of Conduct to Advertorials also and not debase yourself even inadvertently by compromising on this code for the sake of earning revenue. 
It is one thing that advertisements might talk about a business entity’s product and present that entity’s own research on the product’s superior qualities of some kind or another – it is yet another matter that advertorial spaces are used for slander and defamation.

Crop Care Federation of India’s advertorial in the name of Nirmala Pathrawal, Executive Director of CCFI is incorrect on many counts and what is equally objectionable is the naming of people with their pictures without any counter or defence possible from those individuals. It is the modality as well as the content of what got published that I am objecting to.

For instance, I challenge Business Standard and CCFI to prove that I am a foreign funded activist and that I got access to a confidential document like the Pesticides Management Bill through the Agriculture Ministry contacts that I have “reach to”. I represent a volunteer-driven network which is not a legal entity, which does not have or accept any project funding, not even Indian project funding. We only do crowd-funding for any isolated events/activities that we take up.

I also challenge both BS and CCFI to prove that foreign funding itself is indicative of having “only objective to influence our policies to suit the interests of donors abroad”.

In terms of other persons and entities named, it is amazing that CCFI got away by not only lumping together several committed, experienced and credible civil society activists and organisations who are funded, non-funded and non-foreign-funded but also brought in several reputed public sector research bodies and their scientists into the same slandering banner. The fact that the pesticides industry is out to stifle even scientific research by SLAPP cases is well known – that these unscientific methods of the industry got space provided by Business Standard is quite unfortunate and condemnable.

These kinds of allegations imperil public spirited citizens like me in numerous ways and it was highly irresponsible of Business Standard to have published such an advertorial for some revenue to be earned.

Further, this space provided by BS to unscientific arguments ignores the very need for sustainable agriculture to be established on a large scale to regenerate environmental resources, to ensure safe food, to secure profitable and sustainable livelihoods for our farmers and to address climate change. It ignores international and national commitments towards sustainable development goals.

While I appreciate the brief front page “correction” that Business Standard put out in today’s paper, this is inadequate and will not suffice. It is not enough that you state that you dissociate yourself from the allegations, apart from saying that you regret the publication of the allegations. The allegations and other misinformation are themselves not acceptable, and you providing space for the same is not acceptable.I now ask Business Standard to publish a front page statement that admits that the advertorial went against BS’s own Code of Conduct, return back the revenue earned for setting a high bar of media ethics, and certainly give us an equal space to publish our counter-view to the industry’s advertorial. Needless to say, I also reserve all legal and other options available to me to ensure that ones who can throw money do not occupy public debate spaces through slander and misinformation just by virtue of paying for such spaces. This is against the very spirit of public interest that Business Standard espouses in its Code of Conduct.

Sincerely,

Kavitha Kuruganti
8880067772

 

WILL THE FARMERS’ PRODUCE TRADE AND COMMERCE (PROMOTION AND FACILITATION) ORDINANCE 2020 BE A GAME-CHANGER FOR INDIAN FARMERS?

An Ordinance to provide for the creation of an eco-system where the farmers and traders enjoy the freedom of choice relating to sale and purchase of farmers’ produce which facilitates remunerative prices through competitive alternative trading channels; to promote efficient, transparent and barrier free inter-state and intra-state trade and commerce of farmers’ produce outside the physical premises of markets or deemed markets notifed under various state agricultural produce market legislations; to provide a facilitative framework for electronic trading and for matters connected therewith or incidental thereto. – Preamble to “The Farmers’ Produce Trade and Commerce (Promotion and Facilitation) Ordinance 2020” (No.10 of 2020), promulgated by the President of India on 5/6/2020)

FIRST, SOME FACTS.

  • The largest portion of marketable surplus of agricultural produce in India is sold outside the regulated market yard spaces and NSSO data reflects this. Only around 40% or lesser number of farmers go to mandis (regulated markets) for marketing.
  • The number of regulated markets in India are less than 6700 for its 14 crore agricultural households – 2284 APMCs which operate 2339 principal markets and 4276 sub-market yards. There are 23000 rural haats which are weekly markets on designated days.
  • The marketable surplus with small and marginal holders is quite low to begin with and given the lack of institutional credit coverage, these farmers resort to selling to local traders who also often double up as input dealers for seeds and agro-chemicals.
  • There are a diversity of marketing channels that exist and are possible for farmers; however, not all of them receive required emphasis and interventions. These include APMC markets and licensed traders and commission agents there, state procurement agencies which also operate through women’s SHGs and their federations in some states, farmgate traders, processors (like sugar mills in the case of sugarcane or rice mills or cotton ginners or spinning mills), input dealers/moneylenders, rural haats, direct marketing to consumers through rythu bazaars/uzhavar santhai/apni mandi etc., cooperative societies and new age FPOs, direct marketing to retailers, contract farming entities etc.
  • e-NAM portal had 1.55 crore farmers/sellers, 68000+ commission agents and 1.22+ lakh traders/buyers registered by March 2019, including 650+ FPCs/FPOs. However, the inter-state trade through this portal has been dismally low, and MSPs (Minimum Support Prices) are not always secured in this channel either by farmers.
  • The number of new age FPOs (Farmer Producer Organisations) that actually function for their members is a contested figure and the number appears to be significantly lower than what is usually cited, which is six thousand.

LEGAL REALITY AND FACT-CHECK ON THE PR SPIN:

As part of the so-called “historic” agricultural reforms package, using the Covid-19 scenario as an opening for this and riding rough-shod over federal polity in India, the Government of India has announced some major changes in the statutory frameworks governing agricultural marketing in India. The Ordinance that reforms the supposed grip of APMCs over agricultural marketing is called “The Farmers’ Produce Trade and Commerce (Promotion and Facilitation) Ordinance 2020”. It has been touted as that reform which will give freedom to farmers to sell anywhere in the country conveniently lying about the fact that farmers are already free to sell anywhere – all APMC Acts had exclusion or exemption clauses that kept farmers/agriculturists out of the purview of the Acts. They were never criminalised in any Act and had freedom to sell wherever they could.

When this is pointed out, the advocates of the current reforms point out that the restrictions on traders, as a corollary, mean restrictions on farmers. This is not legally or even practically true however. Other than exclusions and exemptions given to farmers, some APMC Acts also allow for turnover-based exemptions for buyers.

It is nobody’s case to pretend that farmers have been waiting for these reforms to go to other states, that too with their small volumes of produce to sell with great knowledge of distant markets, and that this historic reform now allows that.

So, let us get this out of the way first and foremost – farmers’ freedom to sell was never in question and no point in framing it as such for the PR spin since it obscures real interventions to be made.

WERE MANDIS EVER THE CENTRAL MARKETING SPACES FOR A MAJORITY OF FARMERS?

Going by NSSO data as well as data on arrivals and trading in regulated markets in the country, it is clear that mandis at best feature as marketing channel for around 35% of our farmers on an average, that too depending on the commodity. This clearly shows that much trading was happening in channels outside the laid-down areas of regulation, but was criminalised.

It should be remembered regulation was brought in for a reason – exploitation related to price fixing, actual payments, grading related exploitation, procedural and transactional opaqueness, cheating in weighment etc., are all real experiences of farmers, and this has not always been addressed despite the numerous regulations.

Cartelisation of traders/monopsonies and lack of true ‘contestability’, the questionable role of commission agents who mainly ensure cash flows for traders and who very often are family members of licensed traders (whose fees have been made into the burden of the buyer rather than the farmer after many years of fleecing the farmers), the politicisation of the institutions of regulation/APMCs which act as springboards for electoral politics in the country, lack of enough number of market yards or required infrastructure in the yards, the lack of remunerative price realisation for farmers even in regulated markets where even MSPs are not obtained as modal prices are all well-known. It is clear that big players in the agri-supply chains are not going to incur the transaction costs of buying directly from many smallholders of India, and they will continue relying on intermediaries/aggregators in any case.

Having said that, several areas of functioning of mandis can be improved and it will not serve farmers’ interests to ignore this channel of marketing. We do need density of mandis to be improved, without full control of marketing in scheduled areas and commodities in the hands of APMCs. We do need licensed traders to be able to operate across mandis. We do need the intermediary costs to be reduced in the APMC transactions. APMCs should be de-politicised, run mainly by concerned line department. It is no secret that even regulated markets have not ensured MSPs being realised by farmers. Floor prices for auctioning should be over and above the MSPs announced for a particular commodity, and if required a deficiency payment system for traders instituted. If not the traders, farmer-sellers need a proper price deficiency payment system. Amendments and investments to this effect will help.

It is clear from Bihar and Kerala which have no APMCs and have de-regulated agricultural marketing that farmers have not benefited in such a system either.

MARKET INTERVENTION AND PROCUREMENT:

The power of the state procurement agencies to initiate procurement operations and boost market prices cannot be overstated. It is of course not being advocated that the state should procure all agricultural produce of all farmers. What is being advocated is smart and prompt intervention operations that take care of low market prices for farmers, so that other buyers are also forced to increase the price on offer. This should be done without dumping the procured material into the open markets at the time of large arrivals from farmers again at the end of the season.

Further, in the Covid-19 world where the lockdown affected millions of Indians whose lives can be described as “hand-to-mouth” existence, there is an urgent need to ensure a “food security basket” for all households. This requires an expended PDS to be set up both in terms of diversity of grains as well as quantity. Procurement for food schemes is always at MSP in any case, and can include local CBOs (cooperative societies, women’s SHGs, FPOs etc.) for grassroots and localised procurement operations.

IGNORED INITIATIVES – THIS APATHY AND NEGLECT DOES NOT HELP FARMERS:

Government of India under NDA rule has shown how it is more interested in PR spins than serious, stable interventions by moving from one scheme to the other, one announcement to the other without serious addressal of design and implementation issues. This applies to PM-AASHA for instance. No investments were made on the scheme announced with fanfare. No investments made for procuring at new MSPs which according to the government is cost of production plus 50% margin, which of course is not true. While the GRAM scheme was announced with 2000 crore rupees’ outlay, very little implementation was witnessed to improve the rural haats was seen. Not even 150 haats were upgraded the last one heard about this scheme’s implementation. The concept of Rythu Bazaars was not scaled up in all states. The announcement about support to 10,000 FPOs was made, but the fact that a private consultant with very little presence on the ground with farmers was entrusted with the implementation tells us that this is one more scheme already going down the drain. 

THE CURRENT ORDINANCE:

The current ordinance allows freedom to buyers to purchase “farmers’ produce” from farmers or other traders (outside the physical spaces of markets managed/regulated by APMCs) in any “trade area” including farm-gates, factory premises, warehouses, silos, cold storages and other places. Strangely enough, trader definition consists of end-user or consumer also!

The Ordinance specifies “farmers’ produce” and “scheduled farmers’ produce”, with the latter being produce specified for regulation under any state APMC Act. For the latter – scheduled farmers’ produce – only those traders who have a PAN number allotted under IT Act or such other document which may be notified by Central Government can take up trading. Further, there may be a requirement to register in an electronic registration system for traders dealing with ‘scheduled farmers’ produce’ and compliance to modalities of trade transactions and modes of payments that could be notified.

For scheduled farmers’ produce, the Ordinance specifies that farmers have to be paid on the same day, or within a maximum period of three working days with a receipt of delivery that mentions the due payment amount being issued to the farmer on the same day of delivery.

It has to be noted that nothing of this sort has been mentioned for “farmers’ produce” and it is unclear why farmers who are selling “unscheduled” farmers’ produce will not be protected. 

Given the “may” legalese that was used in the Ordinance with regard to registration requirements and compliance to some transaction modalities, it is not clear who will be monitoring or over-seeing the trade transactions or at least be able to enumerate the players involved.

Without a licensing system, there should at least have been an insistence on registration to at least have a database of buyers, that too integrated across states. However, this does not appear to be the case. In an unequal market setting where most farmers are desperate to dispose off their harvested produce so that cash flows can be managed, including in terms of debt management, will they be able to insist on same day payment, or document-based proof of delivery and payment that is due to them, or will they even be able to find entirely new buyers that they can trust and give their produce to?

DISPUTE RESOLUTION:

In the June 2020 Ordinance, the dispute resolution mechanism has been kept simple and may be overly-simple! It envisages that recovery of amount and imposing of penalties will be possible by a 3- or 5-member Conciliation Board consisting of a Chairperson and equal representatives of both parties (farmer and trader). The fact that this has been limited to a farmer and trader, it is more manageable than all disputes arising out of the new trading transactions that have been allowed including between traders. What is unclear is if this SDM-led dispute resolution with this Conciliation Board with a 30-day time limit, followed by a Sub-Divisional Authority if needed with another 30-day time limit (with an additional power to restrain the trader from undertaking further trade and commerce for any specified period), and an Appellate Authority consisting of the Collector or Additional Collector who are again expected to dispose off the appeal within 30 days, will actually be able to deal with the potential volume of litigation brought to their notice.

Importantly, where is the dispute resolution application to be made, at the place of residence of farmer or where the trade transaction took place (across states, as is being projected by the advocates)? What kind of documentary evidence will be asked if unequal power relations result in the farmer not having any documentary proof of the transaction? The details have been left to the rules and are awaited.

Critically, it appears that justice to the farmer is conceptualised only as payment to be made to the farmer at any price that might have been fixed, depending on the power relations between the trader and farmer. Justice, it appears, is not about any unfair weighment for instance, or unfair grading by the buyer, or unreasonably low prices that might have been fixed etc.  

STATE GOVERNMENTS, THEIR REVENUES AND ROLES:

The Constitutional propriety of the Ordinance is being debated. It is not just about the legality of whether this is a state subject or a concurrent subject, but about the spirit of federal polity. Entry 26 of the Seventh Schedule of the Constitution of India in the State List is about Trade and Commerce within the state, but subject to the provisions of Entry 33 of List III (Concurrent List). Similarly, Entry 27 of the State List is about Production, Supply and Distribution of Goods subject to provisions of Entry 33 of List III. Entry 33 of the Concurrent List is about trade and commerce in, and the production, supply and distribution of industrial products, food stuffs including edible oilseeds and oils, cattle fodder including oilcakes and other concentrates, raw cotton and cotton seed and raw jute. Here, the law passed by the Parliament will prevail and not the Legislature of a State if any provision of the latter’s is repugnant to any provision of the law made by the Parliament. Having said that, it is clear that the Entry 33 of the Concurrent List is not exhaustive in its coverage of all kinds of “farmers’ produce”. Punjab government is arguing that it is about industrial goods in fact, and agri-based raw materials for industry.

It is also clear intra-state trading is under the purview of state governments whereas even this has been usurped by the Centre now. This Ordinance’s constitutional validity will probably be determined by the judiciary now when it is challenged by possibly a state government like Punjab’s. Punjab for instance will be losing significant revenues with the current Ordinance kicking in since the Ordinance says that no market fee or cess or levy shall be levied on any farmer or trader or electronic trading and transaction platform for trade and commerce in scheduled farmers’ produce in a trade area. If trade moves into “trade areas” outside the physical premises of markets regulated by APMCs in Punjab, revenues will be affected. On the other hand, if procurement agencies continue to operate from the mandi infrastructure, and therefore, within the APMC jurisdiction, this may not be so.

The Ordinance’s Section 14 lays down that the provisions therein will have an over-riding effect over other Acts. Whether this means that state APMC Acts will also continue to exist without being repealed needs to be seen. Meanwhile, while we are debating this Ordinance, several states have already used their own Ordinance routes to change the APMC regulations in their states, and to de-regulate agricultural produce trade in various ways.

Further, as another analyst has pointed out, legal reforms of this kind alone are not likely to ensure economic improvements for farmers, given the deep structural constraints of Indian farmers that are playing out here. She points out that to overcome these constraints, a great deal of consensus, coordination and capacity are needed, and this cannot be addressed without state governments being actively involved. The current Ordinance really leaves no space for state governments!

THE BOTTOMLINE FOR FARMERS

In the end, for the farmers, it is not so much about “markets” being created but about prices. Prices have to be remunerative, to cover not just the cost of production but leave a profit margin for dignified living (which is why the demand for Kisan Ayog’s formula of comprehensive C2+50% as the MSP resonates with farmers). Even in regulated markets, farmers did not get remunerative prices. Nor did they obtain such prices in de-regulated markets. Nor in e-NAM. The fact that markets and prices for a majority of smallholder farmers are tied in with credit, with small volumes, with an acute need for immediate returns after harvests and lack of advantages that aggregation brings in is what will ensure that no single measure can be considered to be a silver bullet. And the said Ordinance is certainly no silver bullet while it may open more avenues for marketing of farmers’ produce. However, those avenues need to have some oversight and protective mechanisms for farmers given that it is a completely unequal playing field right now when individual farmers interface with markets.

Realising the criticality of remunerative prices for farmers, All India Kisan Sangharsh Coordination Committee (AIKSCC) of which the author is a part of, has evolved a statutory framework to guarantee remunerative prices to all farmers. It is high time that governments considered conferring such a legal entitlement on all farmers of the country and enacted such a statute as The Farmers’ Right To Guaranteed Remunerative Minimum Support Prices For Agricultural Commodities Bill, 2018.

  • Kavitha Kuruganti is associated with the Alliance for Sustainable & Holistic Agriculture (ASHA, www.kisanswaraj.in)

De-Feminisation of Indian Agriculture

These days, very often, we get to hear about “feminisation of agriculture” in India in policy-making circles, apart from the academic and activist circles. Media headlines buzzed with this concept last year, after the Economic Survey of 2018 made a mention of this. “Move over men, Economic Survey 2018 talks about feminisation of agriculture”, said one headline, and “Need women centric policy with feminisation of agriculture” said another. While there is no contention on the need for women-centric agriculture policies, this article will discuss whether there is indeed a “feminisation” of Indian agriculture, and if so, in what areas.

In Vol.2 of the Economic Survey 2017-18, on page 104, there is a box item which begins by stating that “with growing rural to urban migration by men, there is ‘feminisation’ of agriculture sector, with increasing number of women in multiple roles as cultivators, entrepreneurs and labourers”. That is the only reference to this so-called feminisation phenomenon, without any data supporting this claim. That is not to take away from the right arguments in this box article which also state that “with women predominant at all levels – production, pre-harvest, post-harvest processing, packaging, marketing – of the agricultural value chain, to increase productivity in agriculture, it is imperative to adopt gender specific interventions. An “inclusive transformative agricultural policy” should aim at gender-specific interventions to raise productivity of small farm holdings, integrate women as active agents in rural transformation, and engage men and women in extension services with gender expertise”.

What is feminisation of agriculture? Feminisation of agriculture is seen as a broadening and deepening of the involvement of women in agriculture. It is understood as a measurable increase of women’s participation in the agricultural sector. This is either an increase in the percentage of women in the agricultural workforce within overall female workforce, or an increase of women relative to men, because fewer men are working in agriculture. It is also sometimes seen as women taking over those gendered agricultural tasks which were once done only by men. Another aspect to “feminisation” can be understood to be explicit visibilisation of women’s involvement and participation in agriculture.

Macro-data points to “de-feminisation”: While it might indeed be true that there is feminisation in the above sense in some pockets of India, with men migrating out of agriculture, or even from villages in search of, or responding to opportunities outside agriculture or in urban centres, the national picture based on macro-economic data belies any feminisation phenomenon in India. The NSSO and Census data clearly point towards a de-feminisation of our agriculture, whereas it is only the quinquennial Agriculture Census surveys which point to some slow feminisation trends when it comes to the picture of operational land holdings.

NSSO data: A monograph by Vikas Rawal and Partha Saha (2015) called “Women’s Employment in India – What do recent NSS Surveys of Employment and Unemployment Show?” looked at trends in employment of women between 1999-2000 and 2011-12, using the 55th, 66th and 68th rounds of NSSO’s Employment and Unemployment Surveys (keeping out the 61st Round)[1]. The following are the main points and conclusions of Rawal and Saha:

  • It is well noted that a smaller proportion of working age women are in the work force than working age men – but it is noteworthy that the gap between work participation rates among men and women increased significantly between 1999-2000 and 2011-12 (the difference grew to over 48 percentage points in 2011-12 compared to 44 percentage points in 1999).
  • This is mainly due to collapse of rural employment, which has particularly hit rural women as women are primarily employed in rural areas, with limited opportunities in an urban economy.
  • The contraction of employment among rural women was driven almost entirely by a drop in availability of employment in agriculture, which is the mainstay of women workers in rural India. In 1999-2000, about 41 per cent of rural working-age women were employed in agriculture. This fell to less than 28 per cent in 2011-12. The small increase in other sectors was too small compared to the steep decline in work availability for women in agriculture. In contrast, employment for men declined by 11 percentage points in agriculture and increased by about 6 percentage points in construction in the same time period.
  • The sharp decline in proportion of women who were self-employed was primarily driven by a sharp increase in landlessness among rural households, which drove a large proportion of women who worked on their own lands out of the labour force (a decline from 22.8% in 1999-2000 to 17.7% in 2011-12 of proportion of working-age women who worked on their own household landholdings).
  • There was also a decline in the proportion of working age women who worked as wage labourers in agriculture declined from 18 percent in 1999-2000 to less than 10 per cent in 2011-12. The authors assume that greater adoption of labour displacing technology (in particular, increasing use of machines and weedicides), caused by increasing concentration of landholdings and increasing cost advantage of using labour displacing techniques, among other factors, may have been an important factor behind the decline in overall level of labour absorption in agriculture.

Coupled with barriers to mobility of women workers, including safety, these push factors in agriculture have led to a decline in employment of women. This then, is clearly a de-feminisation of agriculture in India, and not feminisation.

Meanwhile, the ones getting pushed out of this “counted” workforce are reporting themselves to be primarily engaged in household work. In the NSSO categories, Code 92 and 93 represent this “household work” and as Rawal & Saha point out, the clear distinction between these two is not very apparent. Here, maintenance of Kitchen Gardens, work in household poultry and dairy, food gathering, food processing etc., are all listed. The number of women workers in these categories has swelled and corresponds very well to the decline in the ‘counted’ workers, who themselves were invisible as Farmers even though they were counted in the SNA (system of national accounts). “About 45 per cent of the rural household worker women were engaged in various activities for obtaining food for the household. About 24 per cent rural household workers worked in maintenance of kitchen gardens for household use, about 22 per cent regularly worked to maintain household animal resources, about 19 per cent were engaged in collection of food, and about 14 per cent regularly worked in specified food processing activities”, as per Rawal & Saha. Going by the definition of a FARMER as per the National Policy for Farmers in India (2007), all these women are indeed Farmers, but not recognised or supported as such.

Census 2011: The other source of data which is reflecting the de-feminisation trends in Indian agriculture is the Census data. Here, the population data is further presented as a segment called “Workers”. As per Census 2011, 39.79% of India’s population is classified as Working Population – within this, 53.26% was male workers and 25.51% was female. In Rural India, the working population was 41.83% of the total population with 53.03% of men being ‘workers’ and 30.02 women in the population classified as ‘workers’. In 2001, the corresponding figures were 52.11 for men and 30.79 for women (this is the work participation rate).

Within Workers, for those engaged in Agriculture, there are two categories used based on self-reporting from the workers in the household – Cultivators, who are those who take a risk for the agricultural enterprise they are undertaking, and Agriculture Labourers, who are working in agriculture without any risk but for (daily) wage earnings.

Here, the following is the picture in absolute numbers and percentages between 2001 and 2011 of Cultivators and Agriculture Labourers, men and women.

  2001 Census 2011 Census
  Total Male Female Total Male Female
Cultivators, absolute Nos. 127312851 85416498 41896353 118692640 82706724 35985916
Out of total cultivators 100 67.1 32.9 100 69.7 30.3
Agri Labourers, absolute Nos 106775330 57329100 49446230 144329833 82740351 61589482
Out of total agriculture labourers 100 53.7 46.3 100 57.33 42.67
TOTAL workers in Agriculture 234088181 142745598 91342583 263022473 165447075 97575398
Out of total workers in agriculture 100.0 61.0 39.0 100 63 37
Cultivators’ percentage within M/F 60% 46% 50% 37%

Source: compiled by the author from Census 2001 and 2011 data

It can be seen clearly that out of the total workers in agriculture, 39% were women in 2001, and 61% were men. However, one decade later, out of the total workers in agriculture, only 37% were women and 63% were men. This then, is a taking over by men of the proportion of space that women used to occupy in this field, and is de-feminisation. Within male workers, while 60% used to be Cultivators as per Census 2001, by 2011, this percentage fell to 50%. Amongst women in agriculture, while 46% reported themselves as Cultivators in 2001, by 2011, this proportion fell to only 37%.

Agriculture Census 2015-16: It appears that this is the only macro data set that is pointing towards feminisation of Indian agriculture.  Here, number of female-operated operational holdings in India have increased to 13.87% of all operational holdings at the all India level (2.02 crore holdings, when compared to men with 12.52 crore holdings). In 2010-11 Agriculture Census, it was 12.79%, which itself increased from 11.70% in 2005-06. The female-operated area in India in 2015-16 stood at 11.57% of all operational area, up from 10.36% in 2010-11. In absolute numbers, this is 1.82 crore hectares, while men operated 13.7 crore hectares. In terms of average landholding size, men held 1.10 hectares while women held 0.90 hectares as per Agriculture Census 2015-16.

Masculinisation of Agriculture:

As agriculture gets more oriented towards markets both at the input and output end, it is not difficult to imagine that in an already asymmetrical access that exists to markets, due to a variety of socio-cultural-economic reasons, men are likely to take over more and more decision-making spaces – which seed to sow, which brand to opt for, which chemical to use, who to bring credit from to finance cultivation costs, where to sell, at what price and even what to do with the income that comes into his hand. Patriarchal norms that govern mobility, education levels, capacity to interface with the external world etc., push women to more marginal roles in this market-oriented paradigm of farming. Meanwhile, monocropping that goes with such market orientation would increase the burden of practical needs of women in terms of food and fodder security.

While farming does not constitute only cultivation, but is also about livestock farming too, which is increasingly contributing more incomes to Indian agricultural households, though women put in more work than men in livestock rearing too, their assertive presence is not concomitant or more at least in this sector. Dairy cooperatives often have more men as members, and this is all the more so at the governance level of these cooperatives and their federations.

In the recent past, evidence is emerging that with good investments that are going into FPOs, but with gender blindness that accompanies them, there might be an inadvertent widening of the gap between men and women farmers on numerous fronts.

RECOGNISE AND ADDRESS THIS DE-FEMINISATION: It is time that policy makers and grassroots workers both paid more attention to this de-feminisation trends in Indian agriculture. Part of the problem lies in women who are retreating into household (unpaid) work not being counted as Workers. The fact that they are being pushed back is a problem in itself, but explicitly identifying them as Farmers even in their household roles is important, so that they receive various services and support systems from the government. Another important part of the problem is that women who were earlier counted as workers in agriculture, are also losing their space to men.

Women farmers’ groups have been asking for a complete registry of all women farmers in this country, through a process of self and multiple identification of all women farmers (the woman herself opting to call herself as an agricultural worker and/or tenant cultivator and/or land owner farmer and/or livestock farmer and/or forest-dependent farmer, and/or beekeeper and/or primary processor etc. etc).  This is the only way that explicit identity and recognition can be provided to all women farmers, and access to various entitlements ensured for them, so that they find their farming viable and dignifying.

  • Kavitha Kuruganti is one of the Convenors of Alliance for Sustainable & Holistic Agriculture (ASHA) and is also associated with Mahila Kisan Adhikaar Manch (MAKAAM). This is a piece written for Farmers Forum, February-March 2019

[1] Vikas Rawal and Partha Saha (2015):  Women’s Employment in India – what do recent NSS surveys of employment and unemployment show? – Society for Social and Economic Research Monograph 15/1

WAS THERE A VICTORY FOR MONSANTO IN INDIA’S SUPREME COURT ON A PATENT MATTER?

Media headlines, especially from business media houses and American media, continue to scream that Monsanto has had a “patent victory” in the Supreme Court of India which will in turn boost biotech investment in India. The news stories claim that Monsanto won a patent-related legal battle and that the Court ruled that Monsanto can claim patents on its GM cotton seeds. This is even after five full days after the judgement has been uploaded onto the Court’s website.

Supreme Court overturns Delhi HC judgement of April 2018, but does not pronounce its own stand on Monsanto’s patent:

Yes, it is true that the Supreme Court on 08/01/2019 overturned an earlier ruling in the Delhi High Court by a Division Bench on 11.04.2018 wherein Justice S Ravindra Bhat and Justice Yogesh Khanna of the Delhi HC recorded one of their conclusions thus – “the subject patent falls within the exclusion spelt out by Section 3 (j) of the Patents Act; the subject patent and the claims covered by it are consequently held to be unpatentable”, speaking about Monsanto’s Patent No. 214436, pertaining to the (Bt Cry2Ab) genetic sequence which is the basis of its Bollgard II Bt cotton business. The Division Bench incidentally upheld the Single Judge’s directions to Monsanto to continue with its obligations which caused Monsanto to appeal against the March 2017 single judge’s orders in the first instance.

To the extent that the Supreme Court overturned the Division Bench judgement which pronounced the patent and its claims unpatentable, the patent of Monsanto can be assumed to be restored. However, it is not correct to say that Supreme Court’s Justices Rohintan Fali Nariman and Navin Sinha pronounced that Monsanto can claim patents on its GM cotton seeds.

Supreme Court points to lacunae in Division Bench’s pronouncement on patentability of a genetic sequence, and asks parties to get the original suit heard by the single judge bench of Delhi HC:

The SC judgement said the following in fact about the Division Bench judgement: “Summary adjudication of a technically complex suit requiring expert evidence also, at the stage of injunction in the manner done, was certainly neither desirable or permissible in the law. The suit involved complicated mixed questions of law and facts with regard to patentability and exclusion of patent which could be examined in the suit on basis of evidence…. There is no gain saying that the issues raised were complicated requiring technological and expert evidence with regard to issues of chemical process, biochemical, biotechnical and micro biological processes and more importantly, whether the nucleic acid sequence trait once inserted could be removed from that variety or not, and whether the patented DNA sequence was a plant or a part of a plant etc., are again all matters which were required to be considered at the final hearing of the suit…. The Division Bench ought to have confined itself to the examination of the validity of the order of injunction granted by the Single Judge….The order of the Division Bench is set aside. The order of the Single Judge dated 28.03.2017 is restored and the suit is remanded to the learned Single Judge for disposal in accordance with law”.  Therefore, the Supreme Court merely ordered that the dispute(s) be taken back to the Single Judge bench of the Delhi High Court, while showcasing what it pronounced as procedural/legal lapses by the Division Bench. By no stretch of imagination can it be claimed that the Supreme Court has pronounced its stand on the validity of Monsanto’s patent and even upheld it.

Long standing dispute between Monsanto and Nuziveedu:

The dispute between Monsanto and Nuziveedu goes back a long way. To around 2003 in fact, when Nuziveedu had to face India’s de-facto patent regime in the form of its biosafety regulatory regime under the Ministry of Environment & Forests, which compelled Nuziveedu to get into sub-licensing agreements with Monsanto (Monsanto Mahyco Biotech), to be able to use the Bt technology in its cotton hybrids. That was for Bollgard I technology or Cry1Ac gene which did not even have a patent in India. Trouble has been brewing since then.

The original disputes that brought the parties to the Delhi High Court in 2016 pertained to the fact that Monsanto contends that Nuziveedu is still to pay its dues with regard to trait/license fees, while Nuziveedu contends that Monsanto has illegally terminated their sub-license agreement on 14.11.2015 in an unjustified manner and that it is not bound to pay anything more than the trait value fixed by states and centre. There was also the matter of whether trademarks of Bollgard can be used or not, or even the use of abbreviations like “BGII” by Nuziveedu which denies any infringement.

Single Judge Bench did not delve into the patentability matters:

On 28.03.2017, a Single Judge Bench of Delhi High Court, while adjudicating on an application for injunction, did not actually decide on the patentability question and kept it for examination until after the pleadings were complete. Judge R.K. Gauba only ordered that during the pendency of the suit, the parties shall remain bound by their respective obligations under the sub-license agreement that the parties got into. Monsanto et al preferred an appeal against the injunctive relief provided by the single judge bench.

The Supreme Court now pointed out that even though the single judge bench did not deal with, or consider the counter claim of Nuziveedu Seeds (defendants) with regard to the patentability, the Division Bench’s judgement that the Patent of Monsanto was subject to patent exclusion under Section 3(j) of Indian Patents Act and thereby invalidating the patent, in effect made the defendants counter claim succeed.

Is this merely a mercantile matter as being debated in India’s Courts?

The issue of patentability of nucleic acid sequences came up in the context of whether there is an patent infringement by Nuziveedu.

The entire dispute and legal debate between the two (groups of) parties make it look as though it is a matter of mercantile laws whereas the core of the issue affects farmers and their livelihoods. Going by an affidavit filed by the Union of India in a related case in the Delhi High Court, wherein they state that farm suicides were caused by Bt cotton, high seed prices and losses incurred by farmers, it is a matter of life and death for farmers! At the end of the day, the disputed royalties, license and trait fees etc., are all being shelled out by farmers of this country and not coming from the pockets of Monsanto or Nuziveedu. In the USA and Canada, it is well known that Monsanto had sued, fined and jailed farmers in the name of patent infringement. The recent Supreme Court judgement records Monsanto’s counsel submitting in the Court that the plaintiffs (Monsanto et al) have no intention to sue any Indian farmer for violation of patent. That Monsanto cannot and will not is obvious, without a riot breaking out on the streets of India.

But that is not the only black and white way to look at patents on ostensible “nucleic acid sequences which are chemical compounds” as though they have no bearing on seeds, seed monopolies and exorbitantly high prices of such seeds, which have a direct bearing on farmers’ net returns and livelihoods. Elsewhere, it is well documented that farmers have limited choices with regard to seeds and planting material due to patent enforcement and resulting monopolies. In the end, seed companies benefit enormously at the expense of farmers – it is reported that Monsanto would have realised trait value of around US$ 240 millions between 2010-2015 and it is obvious that this came from poor Indian farmers’ pockets. It would therefore be useful for Indian courts to keep this in mind and not look at it as a mere mercantile matter.

Is the genetic sequence patented under Patent No. 214436 merely a chemical compound?

Patent No. 214436 vis-à-vis the Indian Patents Act…

A look at the entire patent filing episode by Monsanto shows very clearly that the claims were manipulated opportunistically between process and product claims, so that it somehow fits into the Indian patent laws prevalent at a particular point of time.

While looking at Monsanto’s claim that its Patent No. 214436 is essentially about a “nucleic acid sequence” which is a chemical created in a laboratory, the Court has to remember that if that is the case, this chemical compound would be regulated within the pesticides regulatory regime in India, not the GMOs regime. It is after all this genetic sequence which makes ordinary cotton varieties into Bt cotton, which consequently get regulated as living organisms, under the EPA 1986 and not as a pesticide.

The nucleic acid sequence is indeed heritable when embedded into a plant cell, and heritability is a trait connected with a living organism. However, it is not capable of reproducing itself and therefore, is not a micro-organism which is specified as a patentable matter in the Indian law.

The Indian Patents Act had a sub-section (2) added under Section 5 in 2002, which gave an explanation for “chemical processes” allowing for patenting of chemical processes which was significantly deleted when the Parliament amended the Act in 2005. The legislative intent of the Indian Parliament is clear – it denied protection under Patents Act for such genes and genetic materials, and brought such seeds under the Protection of Plant Varieties and Farmers Rights Act of 2001, and is reflected also in the National Seeds Policy of 2002. This is consistent with India’s international stand too, which however the Indian Patent Office did not always uphold since it began granting several patents on genetic materials.

Claims with regard to the disputed patent show that it is both about a DNA sequence as well as its linking to other sequences (process) and placement in a plant cell (process). Claim 25 in this patent is not merely describing a product but is about a process for making a product of certain functions. The said nucleic acid sequence can be functional only after becoming a part of the plant cell.

Amongst the many parties that intervened and are on the defendants’ side in the case, the argument is that the patented product is an inherent, intrinsic and integral part of a plant as it exists at the sub-cellular level (and a part of a plant is excluded from patentability), and that the claim is not about a chemical sequence in a vial but about having a plant produce a high level of expression of an endotoxin protein etc.

Can there be a patent without fulfilling the “industrial application” criterion?

For any invention to be patented, an essential criterion to be fulfilled is that of industrial application. Monsanto’s NAS (nucleic acid sequence), described by it as a chemical product, is not capable of industrial application until it is first integrated into a plant cell where it can express itself through essentially biological processes of transcription, translation and replication; until it stabilises into the plant through repeated back-crossing processes which are also essentially biological processes and until the NAS is heritable to the next generation of seeds which are sold as F1 hybrids, which happens through essentially biological processes. There is no industrial application of a mere NAS by itself without essentially biological processes, which then make the NAS unpatentable under Indian law.

Precedence of citing public interest and revocation of patents exists

It is clear that there is no reason for grant of patents which have even an indirect bearing on plants, because the Indian law has explicitly kept them out of patentability. Giving patents on genes and nucleic acid sequences will have such an indirect bearing and should therefore not be allowed.

Incidentally, Sec. 66, which allows for revocation of a patent in public interest, has indeed been used in the past in the case of revocation of Indian Patent No. 168950 granted initially to Agracetus Inc. for a “method of producing transformed cotton cells by tissue culture”. The then ICAR DG argued that the patent was incontrovertibly detrimental to our farmers and our people at large, and the Law Ministry concurred. One of the grounds was on safety of such genetically engineered cotton. The revocation was not on technical grounds of process vs product or non patentable subject matter etc., but on the simple fact that certain patents are generally prejudicial to the public. The same approach should be applied to Monsanto’s disputed patent as well as all other such patents in India, and such patent grants be revoked.

Inventions that are prejudicial to public interest are not patentable

This approach is reinforced by Section 3(b) which also specifies ‘inventions not patentable’ – Sec. 3(b) states, “an invention the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment”. Given the Government of India’s own admission in a court of law on the lack of efficacy of Monsanto’s proprietary technology (which is the patent subject matter), that farmers were being forced to commit suicides, and given that Bt cotton farmers (90-95% of India‟s Bt cotton is planted to this “event” of Monsanto) are incurring large scale losses due to uncontrollable pest attacks, this ‘invention’ is a fit case to be declared as “not patentable”.

REFUNDING THE COLLECTIONS MADE SO FAR TO INDIAN FARMERS

It is not just a revocation of the patent that is called for, but a refund of the amounts collected from Indian farmers as part of seed prices from the seed companies involved in the sub-licenses. The only way justice can be meted out to them is by getting the Appellants and Respondents in this case to collectively pay back what they have collected from our farmers, as fund to be returned to them.

–          Kavitha Kuruganti is one of the Convenors of Alliance for Sustainable & Holistic Agriculture (ASHA)

Traditional Economy of Kondh Adivasi Community of Rayagada, Odisha

IMG_20170721_182950991

Landi Sikoka with Sukumati Sukoka

“Try throwing a currency note at the hen – it won’t even peck at it. Of what use is such money? One whiff of wind can take away all the (currency) notes, but if you take away our forest, we will not be able to survive”, said Landi Sikoka dramatically, gesturing at a hen happily running around the village. The other women with her like Tulasa Kurangalika, Bolo Sikoka and Tinmoli Kurungalika along with Sukumati Sukoka, who is the Bejuni of the village, nodded their heads vigorously in strong agreement. We went to Khalpadar village in Kumudabali panchayat near Muniguda, Rayagada district of Odisha to understand the economy of Kondh communities here better.

Kondhas are a tribal community in the southern region of Odisha (amongst other places). They were a hunter-gatherer community, now divided into those who choose to live on the foothills and the ones who are hill-dwelling (Dongrias). Kui is their mother tongue. Shifting cultivation on the hills, forest-gathering and hunting, cultivation of lowlands and even migration out of the villages for work are all part of the Kondh lives. This piece draws on the lives of both the hill-dwelling Kondhs and the ones in the plains.

In Khalpadar, a question around de-monetisation evoked much laughter from the women. “How does that affect us? We don’t have such notes with us and it does not matter what the sarkaar does with such notes”, they said, bursting into giggles.

Over the next two hours, we discovered how life is still predominantly non-monetised in the Kondh communities here. What is remarkable is not just about the non-monetary systems by which the “economy” – production of goods and services and exchange or trading of the same, property arrangements, ‘financial systems’ etc. – is organised and run, but the communitarian and nature-centric ethos that underpins the economy of the Kondhs. Admittedly, things are changing rapidly, and youth who participated in the discussion kept talking about the need for greater cash incomes, mainly in the context of health emergencies and fares for transportation. It is also true that the Kondhs up in the hills continue to have a fairly independent economy of their own, except for a few needs like salt and dry fish for which they depend on the local haats and towns. In mixed villages where Kondhs live along with other communities, in the plains, the economy is different.

Jagannath Majhi, 32 years, shared with us how he has seen the Kondh economy change in some respects but remain unchanged in several others. “There was no currency that we used in our childhood, though there are greater money flows now in our hands too. It was mainly produce from the hill-farming that would be given away for various services provided by fellow Kondhs. For instance, cowherd services would be rendered by a few persons (it could be men or women, young or old, and mixed) for the entire ‘kutumb’ (a ‘family’ of all the members of a village or habitation), where they would take animals of all households grazing (it could be cows, even buffaloes, sheep and goats) and in return, would be paid an apportionment of the agricultural harvests”, he explained. The local measures continue to be used for this – gidda (25 kgs), adda (1 kg), mano (4 kg) and podi (0.5 kg). Cowherds could also be given cooked food and clothes, in return for their services, he explained.

Jagannath feels that it is the Panchayat Raj system which brought in money, along with telugu money lenders.  Electricity and television disrupted several societal systems and norms, including economic, he feels.

It is apparent from our interactions that there is nothing that is generalizable about the Kondh economy as of today. It is different for different villages, depending mainly on distance from an urban centre, it appears, as well as whether it is a largely mixed-community habitation in the plains or predominantly-Kondh habitation in the hills. However, what can be talked about is an economy as it existed, and an economy that is fast eroding.

Changes in dongar cultivation with the entry of market-dependent horticulture/monoculture of some tree plantations have brought in significant changes in the economy. Dongar cultivation is shifting cultivation (also called podu) on the hillside, with patches of forest land cleared through burning (but with an ability to control the fire to a limited area in the earlier days, with fruit trees and some specific species protected from the felling and burning, and also with long fallows for regeneration of the land after the plot is used for agriculture). On these plots of lands, implements run by the hand are used, for multiple millets-based crops that cover millets, oilseeds and pulses needed for subsistence of the household.

In fact, changes in cultivation patterns and practices here have also brought about changes in the communal aspects of the Kondh lives, related to rituals around cultivation (seed festivals like Bihanu Parab[i] or harvest festival like Kandulo Parab etc.).

PROPERTY OWNERSHIP:

Village

A typical Kondh village, nestled along forested hills

In the past, when (hill) Kondhs had to establish a settlement in the forest, they would look for signs that indicate that their Goddess Dharni Penu wanted them to settle down somewhere – in the way rocks were arranged, or later, in the outcome after a puja performed to test out a location. However, there appears to be a belief that the forests and mountains in Rayagada where the Kondh settlements exist, belong to the King of Jeypore. Anthropological accounts show that a solid ball of earth, placed in the headman’s house, is the mark of the King’s right over the habitation land.

When it comes to houses, land and livestock, the Kondhs didn’t have a rigid sense of private property.The habitation site is finalised in a manner that houses can be added. These houses are row houses, and in a sense, reduce the use of additional building material. It is assumed that such housing was also a requisite in a hostile setting with tigers and other wild animals. Each house has space kept for livestock.

When a newly married couple want to set up a house of their own, the entire village would help them in building their house, without expecting any wages. It will be an addition to the existing row of houses and if a village grows large, may be another street is added with similar features.

It is only in the recent past that individual house pattas and newer kinds of housing are coming into the Kondh lives, mainly due to government housing schemes.

When it comes to land ownership, the Kondhs in the plains who have lowlands, would have land titles that are usually outdated and not updated (sometimes even 2-3 generations old). Land ownership for women is not part of the customary laws. However, when a woman returns back to her maternal village for some reason or the other, the community will certainly allot a plot of land to her for her to enjoy usufruct rights over it.

However, the Dongar lands have a different arrangement. For the shifting cultivation on the hillside, the entire community / “Kutumb” sits down and decides on which plot to be allotted to who, and ultimately, the size of the operational holding taken by any particular household depends completely on their ability to manage a particular size of land, or even the multiple plots they can manage.

After Forest Rights Act 2006 started to get implemented, individual land titles are being allotted, but in far lower extent and holdings than claimed for, and not as Community Forest Rights.

Nearly all Kondh families rear some animal or the other – cows, buffaloes, hens, goats or sheep. It is interesting to note that the animals are mainly used for farming operations (ploughing, mainly, where even cows are used) or for ritualistic purposes (feasts after a puja, or for sacrifice for a puja) – however, there is no culture of milking animals and drinking the milk or selling the milk for income.

The bottomline with regard to property in the Kondh community was: property of some kind can belong to an individual, but it can be used by anyone! This applies to jewellery or even a new shirt or sari. This applies to winnows, ploughs or even a pair of bullocks, and there is no fee to be paid for such use. There is no great worry about class inequities due to unequal property ownership, since operations on larger plots of land depend on capabilities of a household, but the produce is ultimately treated as one that belongs to the entire community and not just one household!

PRODUCTION AND TRADING OF GOODS AND SERVICES

Till the recent past – when rapid changes in the Kondh villages like entry of electricity, access roads, mobile phones and cable television have begun changing the needs and lifestyle of the community members – the economy was centred mainly around food production and consumption, along with activities that catered to socio-cultural beliefs and practices.

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Weekly haat in Jagdalpur near Muniguda

Self-reliance is the major principle adopted within farming, along with cooperative labour groups for some tasks. Family’s own labour is relied upon predominantly. In the dongar cultivation, even weeding is not taken up very often. It is mainly centred around loosening the soil by hand implements, sowing mixed crops and harvesting. Where more labour is required, exchange labour system is adopted where families help out each other without any cash or wage payment being involved.

Services like the carpenter’s and blacksmith’s are important –the payment until the recent past consisted of payment in kind, of grains and sometimes even an animal.

The Kondhs didn’t have a culture of weaving – the cloth worn by them used to be called nachi (kui term), made from jalga tree bark. Even this was not the occupation of any one sub-caste or clan, but each family would create their own. From that stage, the community moved directly into buying garments from the outside world, including saris that come from TN’s textile pockets into the weekly haats that dot the Kondh region!

About livestock-rearing, as mentioned already, 5-6 young boys and girls could be assigned to a herd and they would be paid in kind for managing the livestock of all households. There is no milking culture. Animals are killed for sacrifices/feasts, or sold for any cash needs.

Potters either exist within the Kondhs, or pottery ware is purchased from potters in other villages or in haats. There might be one potter per village, a settler usually, if at all. They also used to be paid in kind.

The other services on offer are those of the Disari or healer/astrologer, the Bejuni or priestess and the Bareek or the messenger, who would usually be a dalit from the Domb community.

The former two are important to this day, and Kondhs pay them in kind for their services. While the Disari and Bejuni services are not hereditary, the services of the Bareek/Domb are hereditary.

Overall, it is seen that Kondhs, especially the Dongrias spurn wage-earning, as they feel it denigrates the self- esteem of a self-sufficient community such as theirs[ii].

There are of course households that have had to migrate out in search of employment and higher wages, but they also undertake seasonal migration, usually to pay off debts that have built up (often linked to being cheated after taking an advance against the pledging of a crop harvest with an external trader) and come back during the farming season.

SOCIAL RELATIONS IN RELATION TO THE ECONOMY

DALITS: The social relation of the Kondhs with the co-dwelling Dombas or dalits is very interesting. In almost all Kondh villages, there will be a few Domb households, and sometimes, they can even be equal in numbers. These dalits have been co-settling with the Kondhs since long. It is said that while they began as petty traders who brought to Kondh settlements valuable commodities like tobacco, salt, dry fish and match boxes, they ended up in several habitations as messengers for revenue and forest departments and other government departments. They were also messengers deployed to go to other villages by the Saonta or head of the Kutumb or other households, to their kind with regard to marriage, death, birth related messages etc.. They would provide these services in exchange for agricultural and forest products given by the Kondhs.

It is seen that the Kondhs practise untouchability towards the Dombs, and do not allow them into their homes, or eat along with them. On the other hand, the Dombs are known to be resourceful, worldly-wise (legal, official and market matters) and it is often reported that they hold more land titles than the (Dongria) Kondhs who actually cultivate the lands. They are also known to have traded the produce gathered from the forest by the Kondhs in a better fashion (by paying very small amounts to the Kondhs, but by further selling it at much higher margins), becoming more prosperous than the Kondhs.

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Dongria Kondh women in a weekly haat

WOMEN: Women have greater autonomy here than in other communities and this could be correlated to dependence on commons that are not owned by men as private property, and the mobility that women have, to go and sell/barter what they have produced or gathered, in the local haats. It is seen that women are the ones who are mainly trading at the haats and interacting with others in the weekly markets, and either bartering their materials for other materials that they need, or doing cash transactions.

Young girls are independent to choose their partners in life, except in the case of socially acceptable practice of kidnapping a girl for marriage. The greater autonomy of women can be linked to their access to nature’s common resources, in addition to the social norms that clearly accord greater social status to women, in the household as well as in the community.

Secondly, there is a bride price paid to the girl’s family and there is no dowry system that exists with the Kondhs, though things are changing on this front too. The girl is not therefore considered an economic burden in the Kondh community, and the sex ratio is favourable to girls.

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Traditional Granary

VILLAGE FUND AND GRAIN BANK: There are various kinds of village funds that exist for emergencies. These may not always be in the form of orderly and equal donations collected from all households, but even ad-hoc pooling of whatever is available as and when an emergency arises. The village of the groom gives to the village of the bride various gifts, mainly in kind – grains, hens, cows etc. These are kept as village fund too. Sometimes, it is a certain set of trees, cut on a rotational basis if required, that are used for emergencies.

Several Kondh villages have the tradition of grain banks, where every family has to give kalki, their share of grain after harvest. In the Bihanu Parab, seeds saved by all households are brought out and placed in the centre of the village, as open source material for anyone to use. No seed is distributed or sown before the festival, however.

FOREST AS THE MOTHER: Even though forest degradation has been rapid in the region, most Kondhs swear by the forest as their mother, and declare that they cannot survive without the forest. There is a respectful, symbiotic relationship that the Kondhs have with the forest. This is a relationship that is not just economic, but is part of the culture and ethos of the community. It is a deep understanding of the inter-connectedness of various things in their eco-system that the Kondhs have imbibed. It is indeed true that the forest provides numerous products free to the Kondhs for their survival – fruits, berries, mushrooms, tubers, leaves and greens, fuel wood, grazing for animals, thatch, bamboo, poles and such building material (in addition to crop residues) etc. Uncultivated foods are a significant part of the diets of the Kondhs. Forest produce is also gathered for trading in exchange of other materials or for cash. Fishing is done in forest streams in addition to hunting through snares and traps. Honey is collected from hives and consumed as well as sold.

CHANGING ETHOS:

COMMUNITARIAN ETHOS: The principle of saving up and acquiring private property as security for the future or old age is not required in the Kondh community. Life is about every day survival, in any case. Life is also built around the knowledge and security that others in the Kutumbwill certainly take care of a fellow community person in bad days and in times of need. Food and drink will be shared, whether the quantity is meagre or large. When women go to the forest to gather fruits and bring them back, all children in the village have access to the same, and not just the children of a particular household from where the mother brought back forest fruits, for example. “A child in a house is the child of the entire community”, is the philosophy put into action.

Kondhs are generous with their sharing attitude not just with fellow Kondhs but with outsiders too. Houses are given as also land for cultivation, for settlers in the village. Visitors are welcomed and treated with warmth and hospitality, and verandahs are cordoned and given to them for staying.

A Sahitya Akademi award-winning novel in Odia called Amrutara Santana (“The Dynasty of the Immortals”) by famous writer Gopinath Mohanty, which centres around the travails and joys and the worldviews of the Kondh community, depicts scenes where even paying bribes to difficult government officials from revenue and forest departments is undertaken as a joint effort by the members of a village, for instance!

“The world of the Kondhs mainly runs on “sundi”/trust and “mitho”/friendship and that certainly applies to our economy too”, explained Jagannath Majhi. “’I will think about tomorrow later’, is the other attitude that an adivasi carries”, he said. For any emergency in the community, one pools whatever resources exist, for a community member to tide over the crisis.

Gopinath Mohanty describes poignantly, and this is also seen in reality amongst the Kondhs, that while there appear to be no material needs for the Kondhs to borrow from moneylenders like Komtis from Andhra, the collective exploitation of officials from the forest and revenue departments citing some violation or the other of some rule/law or the other, in addition to the advances paid by Komtis against crop to be harvested would essentially leave the Kondh with produce that would not be enough to stay afloat through the year. Lack of literacy meant signing on legal papers, the implications of which were not known to the Kondhs, but which became weapons in the hands of outsiders.

mixed cropping fields (9)

Mixed Cropping

While the Kondhs interviewed as part of this paper-writing had no bank loans that they had borrowed, some had borrowed loans from private moneylenders.  It was apparent that new kinds of lures were being laid in the form of Andhra people coming and offering high lease rents for land on which they want to grow cotton or eucalyptus; SHGs are being formed for thrift as well as credit; schooling of children, not just to residential schools but private schools which need to be paid ill-afforded fees is a new reality. NGOs coming in, and giving freebies as well as loans, including to those who have not been indebted to anyone so far is a new threat. Plantations of monocultures like eucalyptus and cashew, – that too in the name of curbing unsustainable cultivation practices (of podu) or improvement of livelihoods – are affecting the ecology, economy and culture of the Kondhs today.

SPEND WHEN YOU HAVE: In the Kondhs, a family which has had a birth, or a death or a wedding can give its feast to the community only at a time when they have some income/resources in their hands. For instance, after a death, cremation might be performed immediately, but the actual ritualistic funeral service/puja, accompanied by a feast might happen even one year later, after a good harvest in farming, for example. Jagannath Majhi gives the example of Balram Majhi in his village who gave his wedding feast after the birth of a son and daughter, only when he felt economically comfortable doing so! There is no pressure on the individual or household to borrow and spend on such social rituals and rites of passage.

In fact, whenever there is such a feast, or festivals related to farming, the entire community contributes in some form or the other – it could be grains, it could be mahua wine, or some forest produce. Every household brings whatever it has, and therefore, a feast does not become the financial burden of one household.

“We try not to buy products from outside, which need us to spend cash. However, clothes, transportation and ticket costs when children are to be visited in residential schools, salt, dry fish, tobacco, medicines and hospitals etc., are what we need cash for”, the women of Khalpadar explained.These days, people have taken to borrowing for purchase of cycles, TV, “godrej” (almirah), beds etc., they said.

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Jagannath Majhi

“It is true that new inequities are creeping into our society from new age possessions like bikes and TVs, and the elders are worried and angry about these changes, since it is not just about economy but about our ethos”, explained Jagannath. “We used to have norms of social regulation that kept even greedy and erring individuals controlled earlier. The biggest, deterrent punishment would be social boycott and suspension from the samaaj. There would be no relationship maintained for a week or so with a household, no talking, no sharing of materials or services etc., once the Kutumb or Samaj adjudicates in this manner. However, even this system is rapidly eroding”, he said.

“In the Kondhs, dependency on each other continues to be high. In fact, it is not even dependency. It is a sense of togetherness”, he felt.

All in all, that is what the Kondh economy is ultimately about: togetherness, fulfilment of basic needs and social regulation around greed, sharing and cooperation, collective responsibilities, autonomy that stems from close dependence on Nature and not asymmetrical markets, self-reliance as a value, and joint decision-making in the community.

 

 

  • Kavitha Kuruganti and Ananthoo, ASHA (Alliance for Sustainable & Holistic Agriculture) put together this article for Vikalp Sangam, with the help of Debjeet Sarangi of Living Farms.

[i] Aditi Pinto: “There will be a seed for everyone”, The Hindu, April 23, 2017

[ii] Mihir K Jena et al (2002): “The Dongaria Economy” chapter of “The Dongaria Kondh: Forest Tribes of Orissa – Lifestyles and Social Conditions of Select Orissan Tribes”, DK Printworld, New Delhi.

DEFENDING THE INDEFENSIBLE

Lately, there has been this funny clamour on online petition sites and twitter, though it is quite feeble, in that it did not actually mobilise numbers. The clamour apparently is for Technology. “Give me technology. I want technology. I want your patented technology because others have some other patented technology in their lives. It is ok if the patent-holder has monopolies and gets to determine when I plant, for how much will he sell, whether he will sell or pull out like a sulking kid, and whether seeds will be available in the quantities that I need. I still want patented technology in agriculture, because that urban activist has a patented i-Phone or other technology. It does not matter if it becomes a life and death question in my livelihood. All agricultural technologies have only been good to me as a farmer and the suicides that I see around me have got nothing to do with technologies, their political economy, their impact, their cost, my investment on them, and my debts because of them”. This seems to be the gist of it. Some agriculture correspondents in some national dailies act as mouthpieces for this clamour.

Sorry, did I hear that right? You want technology and any technology, even though it is not going to deliver anything other than damage? And to hear farmers say that they don’t want any hybrids, but want only GM hybrids is indeed suspect. Really? In the past 24 years of working with farmers, I have never come across a real smallholder farmer who is saying ‘give me technology’. They are certainly saying ‘give me better prices; give me risk cover; don’t take away my land, how do I deal with my high-interest debt’ etc. etc. Why would a farmer ask for hybrids made only through the GM route, unless you are parroting some PR agency’s lines or the industry’s? You are not concerned about your end-profitability but only about GM technology being cleared? Is there any evidence that it is better than existing hybrids, and provides better options for us all? No, none at all! And that is the crux of the matter with GM mustard DMH-11 and its parental lines which are on the verge of approval for commercial cultivation in India. This is exactly where the proponents feel cornered and are therefore coming up with all kinds of obscure and obdurate arguments.

I am reminded of Jairam Ramesh’s famous lines during the Bt brinjal debate that “Bt is a technological solution going around looking for a problem” which is indeed true. Just because you have mastered the technician’s job of tinkering around with genes does not mean that you will begin arguing without any proof that your technology is indeed needed, and that there is a farmer’s right to technology, even if it is living, unstable, irreversible and uncontrollable. And those are precisely the characteristics of transgenic technology however differently the proponents might want to project it. It is a living technology in that it is playing around with the DNA of living organisms and since they are self-propagating especially in the case of plants with the pollen spreading around irreversibly and uncontrollably, there is enormous caution required before any environmental release.

It is in the very nature of this technology that one farmer’s choice of this technology also impinges on another farmer’s choice of not wanting this technology. In the case of herbicide tolerant GM mustard, we are not talking about just contamination of non-GM or even organic crops in neighboring fields, but also herbicide drift possibly damaging the neighboring crop. Both the GM mustard sowing farmer, and the neighboring farmer – if they want to use farm-saved seed for the next crop – will find a certain proportion of their produce as sterile seeds. If the non-GM farmer wants to continue with her/his seed for the next generation too, this proportion is likely to increase. Which means yields affected. So, herbicide drift damage as well as sterile seeds and decreased yields. Wait, that’s not all.

When the HT crop starts impacting unintended beneficial organisms like bees (and there is evidence that they do, while there is clear proof that in India, this has not been tested at all even though GM mustard is a HT crop), yields of farmers will in turn get affected. It will also be a blow to the livelihoods of many bee-keepers and the honey industry.

Now, why would any one want to take these risks? What for? Is there one good reason why GM HT mustard should be released? None. And that is why these defensive arguments which may sound pious on behalf of farmers, but are outright unfounded in terms of their real interests.

There are numerous public sector scientists who are breeding mustard hybrids using CMS technology, which is non-transgenic inducement of male sterility. These are performing quite well, and there is no proof that transgenic hybrids perform better. Further, around the world, the best yields are in countries where CMS hybrids have been used and GM technology has been shunned. Isn’t that technology enough for you?

When the yield claims were busted with meticulous evidence of the scientific fraud adopted to show favorable results in support of GM mustard, the latest argument of all the proponents, drawing mainly from the crop developers, is that this is only a beginning and give us time to improve the performance. Can other Indian scientists say that too, and pass off their researched-varieties and hybrids in the evaluation and seed release system saying, pass it now and release it, notify it and I will improve it later?

Then comes this oft-heard argument from some authors which they repeat ad nauseum since their newspaper gives them space to repeat the same stuff again and again (incidentally, these papers refuse to carry any counterview like this one, because they are too biased) – that we are eating GM edible oil in India, and therefore, we must also allow production of GM oilseeds right here. Unfortunately, there are many who are repeating and saying, ‘yes, there’s a valid point there’. Sorry. It is foolish to equate that risks with consuming 20% of our edible oil in its GM version are similar to cultivating a HT GM crop in the country, with associated environmental and health risks. The health risks are obviously more direct both from the herbicide and the fact that GM mustard is going to be eaten in its leaf and seed forms too, not just oil.

What about the fact that GM HT mustard cultivation here will jeopardise employment to a tune of at least 4 crore women-days, for poor rural women in India, who will never be provided any alternatives? Who will think for them?

And to say that farmers will be the ones to decide is ridiculous. There are farmers and farmers, with agricultural workers also being farmers, and organic farmers also being farmers. Who amongst them will decide? What about consumers, since they will ultimately be the buyers of what the farmers produce and without them, farmers are not likely to find markets? Don’t they have a choice? It is so very obvious that this is a policy decision. To think that some meager dressed up so-called scientific data should be the basis of taking a decision on this is unacceptable. And yes, state governments will engage with this issue and take a stand. Yes, citizens will present their case. All of these factors weighing into any decision-making is being called as “politics”. I think such an understanding undermines the need for responsible and responsive decision-making. Narendra Modi should realize that science is definitely on his side on this one, when he chooses to reject this GMO. States are certainly on his side. His own allies and associates are on his side. Most importantly, there are many successful solutions on his side, that can be deployed with commitment and political will, to resolve India’s oilseeds crisis. It has been done before, and it is possible again. All of this is in policy-making domain, and policies have to have a vision for sustainable development, a vision that creates a win-win-win for all – farmers, agricultural workers and consumers, along with the environment.

Time that

The curious case of the AFES document on GM mustard put out by GEAC for public comments….

kavitha-kuruganti-comments-on-afes-document-15th-nov-8-am_formatted.

THE CURIOUS CASE OF THE “AFES DOCUMENT” ON GM MUSTARD[1]

Summary

  • The Assessment of Food/Feed and Environmental Safety (AFES) document on GM mustard was created by the Biosafety Support Unit of Dept of Bio-Technology. DBT is one of the main funders of this GM mustard project. The Sub-Committee might have created only a brief 5.5 pages document, if at all. It is unclear if the AFES document was signed off by GEAC before being put out for public comments for 30 days. It is also unclear if this AFES document is legally valid in the first instance.
  • The biosafety appraisal of GM mustard clearly did not have various areas of expertise required for such an appraisal (even within the limited numbers of safety parameters tested for).
  • The study protocols were designed by the crop developers and a majority of the studies were done by themselves. One of the studies passed off as having been done by National Institute of Nutrition has been outsourced to a private laboratory.
  • The progress of GM mustard this far has been in the absence of any regulatory guidelines for environmental risk assessment in the Indian regulatory regime! ERA 2016 was created only now.
  • Where the sub-committee could have prescribed several tests to be undertaken by the crop developers (the need for such studies is expressed in their meeting minutes), they push various such studies to post-release monitoring of GM mustard. We present a list of such studies.
  • Many illustrations are shared that show GEAC in other cases going into details of various protocols to be adopted and additional studies to be taken up. They chose not to do this with GM mustard.
  • The GEAC meeting minutes 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. The regulators show no consistency in following up on their own discussions on these matters.
  • Most importantly, the AFES document’s lack of reliability is exposed. While individual test reports have concluded something, the AFES concludes something else. We show with illustrations how data from weediness studies are inconclusive in the first instance, how certain claims of some tests done by the AFES document 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 are being brushed aside and attributed to agro-climatic changes which should not have been allowed firstly in a rigorous experiment. Based on falsely-established-equivalence, several other tests are being denied on GM mustard.
  • Sub-Chronic Toxicity Studies reveal statistically significant differences in biochemistry parameters, histo-pathological differences and body weight gains. However, these are being brushed aside too.

WE SHOW ONCE AGAIN HOW THE AFES DOCUMENT IS UNSCIENTIFIC, UNRELIABLE, DECEPTIVE, FALSE IN SEVERAL ASSERTIONS AND INVALID IN ITS PROCESSES AND CONCLUSIONS.

THE CURIOUS CASE OF THE “AFES DOCUMENT” ON GM MUSTARD

On September 5th 2016, the Genetic Engineering Appraisal Committee (GEAC) put out a document on the website of the Ministry for Environment, Forests & Climate Change (MoEFCC) called the AFES (Assessment of Food and Environmental Safety) for environmental release of Genetically Engineered Mustard (Brassica juncea) hybrid DMH-11 and use of parental events (Varuna bn3.6 and EH2 modbs2.99) for development of new generation hybrids. While doing so, they asked for public comments on the AFES document within 30 days’ time and stated that if somebody wants to review the biosafety data, they can come all the way to Delhi and get a “dekho”. Not to be photocopied or photographed, but for any concerned citizen or expert to sit in the Ministry’s office, guarded by a designated person from the department, to do any memorizing and mental analyses to enrich the comments to be given. Provided you believed that the GEAC is serious about taking any feedback on board in the first instance. They went out of their way to stick to their modus operandi and provided no extension to the timelines nor published the biosafety data despite many senior scientists and eminent citizens writing to them.

Several of us refused to engage with their farcical process and this document is an attempt to show why it is futile to engage with a deceitful and unscientific regulator who is under pressure to clear this GMO whatever the compromise to scientific integrity in the process.

Things have come to such a pass that in a Rejoinder to an interlocutory application in an ongoing PIL on GMOs in the Supreme Court (WP260/2005), the Government has no qualms in saying that the AFES report posted by GEAC is adequate to meet the public’s interest and need for transparency. Additional detail will not provide any greater value to the public…..The petitioners want to engage in an independent review of the dossier. In no functional regulatory system anywhere in the world such independent review is entertained. The claim for independent review by the petitioners is misleading for general public by questioning credibility of Indian scientific community and demeaning of the regulatory system”. It is obvious that they don’t want the world to know how inefficient and unscientific they are.

What the government does not know or does not want to acknowledge is that it is also the scientific community in India which has been engaging with the issue of GM mustard, which is indeed questioning the credibility of the regulatory system. Numerous experts and senior scientists from different fields, from within the NARS system who do not want to come out into the open but who have many valid questions to raise, have been supplying people like me with pointers about inaccuracies and inadequacies of GM mustard safety testing and assessment. It is upto the regulators whether they will interpret it as demeaning the regulatory system, or will be grateful for the support from independent scrutiny of data, which will help the regulators fulfill their obligation in a robust fashion. The current state of affairs is also a reflection on a scientific establishment in India where dissenting views and evidence cannot be presented where the government has decided in an unscientific fashion that GM mustard is needed and safe. As inside reports reveal of a recent GEAC meeting with state government representatives ostensibly to discuss future research and field trials of transgenic crops in the country, officials of government departments are not averse to arm-twisting state governments with threats of finance cuts if everyone does not fall in line with the blind promotion of transgenics in the name of ‘biotechnology development’. It is time that the regulatory biases are exposed fully.

WHAT IS THIS AFES DOCUMENT, ITS SANCTITY AND VALIDITY? WHO WROTE IT?

The GEAC, on its website, claims that this AFES document is the “Safety Assessment Report of the Sub Committee on GE Mustard”. It says that the “sub committee has examined the dossier on food safety, environmental safety, compliance etc. and has prepared a document “Assessment of Food and Environmental Safety”.

However, we know that the Sub-Committee has probably only created a 5-page report from its assessment, and not the AFES document as put out on the regulators’ website. Information available from GEAC’s 128th meeting minutes (Agenda 4.1.1.), along with an RTI application through which two reports of the only two meetings of the Sub-Committee were obtained (On February 2nd when they finished their main work hastily within 15 days from the time of creation of the Sub-Committee, and on April 11th 2016 when they wrapped up their work) show that it is the Biosafety Support Unit of DBT which wrote this AFES document.

In the normal course of such a (sub-)committee functioning in any regulatory system, there would be a mention of the Terms of Reference, the members of the committee, their meetings and their attendance, the methodology adopted and even signatures of the members, or at least the Chair. In the normal course, such a sub-committee would have first obtained public feedback after putting out all biosafety data and then come up with its own conclusions and recommendations. GEAC’s own earlier sub-committee/expert committee reports are an illustration in case. This so-called sub-committee report-cum-RARM (Risk Assessment Risk Management) document-cum-AFES document was not your normal appraisal and review document with recommendations, however. It was not written by the sub-committee to begin with, but the BSU.

The BSU is supposed to have 16 multi-disciplinary scientists, with a couple of years’ of experience on an average each. They apparently are the ones who will suggest which guidelines should be followed, and which can be dispensed with, on a case by case basis!! They were reportedly briefed by American officials, and an Australian team trained them in document writing for risk assessment, we understand.

In the first meeting of the Sub-Committee, it is seen that the Committee recommends that the GEAC direct Delhi University to prepare the Risk Assessment and Risk Management document for consideration of the GEAC. In the second meeting of the Sub-Committee, on 11/4/2016, they decide to call the RARM document authored by the BSU as AFES, upon the recommendation from Dr S R Rao of DBT. In the end, both the names suit the purpose of Rao and others – to call something as an assessment document, and also name it as a document that has figured out future risk management too, with a pre-concluded assumption that approval will take place, and post-release risk management has to be brought into the picture!

The AFES document itself is a shoddy document which selectively puts out some bits and pieces of information, where convenient, in a manner that is opportunistic and not scientific and is mostly a weak defence document for the regulators’ lack of rigour. It is clear that those sections which have been excessively elaborated upon are those where some critical sub-committee comments have been received, and are being responded to in a pre-emptive fashion. Some such portions are also in anticipation of criticism from civil society groups too, given that some such detailed analysis was shared by a delegation on July 18th 2016.

In the end, it’s clear that the sub-committee’s main feedback came in a rushed manner within 15 days, followed by going back and forth through the BSU with the crop developer team and finally coming up with a 5.5 page report and may be not even with a signing-off the AFES document that was put out on the website. It is unclear why the GEAC did not discuss the AFES document in its full meeting before putting it out on the website – was it pressure from the PMO?

We had already pointed out to how GM mustard’s appraisal and public consultation processes are vastly different from Bt brinjal’s. It is only such scrutiny that showed that Bt brinjal cannot be claimed to be safe. It is clear that the regulators did not want to take such a risk this time. Hiding the biosafety dossier and putting out a shady document called AFES suited their purpose immensely. Meanwhile, it is insulting for any serious scientist to be reacting to the limited information available in the AFES document for any meaningful or intelligent feedback to be provided.

Some questions will not go away. What after all is the sanctity of this AFES document, even by the rule book? Is GEAC allowed to have sub-committees and should such documents be signed off by them? Should it have been put out for public feedback at all? 


 

EXPERTISE NEEDED FOR APPRAISAL AND WHAT THE SUB-COMMITTEE HAD WITH IT

The collective arrogance of the sub-committee and GEAC, in not welcoming any independent scrutiny of the biosafety data and their arguments in the Supreme Court right now is worth going into briefly.

In the environmental safety studies, it is clear that soil scientists, plant pathologists, entomologists and within that, specialists on bees and other pollinators, mustard breeders, agronomists etc., should have been present. That is the only way that weediness and aggressiveness potential, agronomic evaluation, crossability and pollen flow potential, impact on soil microbiota, pests, diseases and beneficial organisms could have been appraised soundly by the Sub-Committee in a scenario when the rest of the GEAC is not either consulted, or has abdicated its duties of appraisal.

On the food safety front, genetic toxicologists, clinical toxicologists and pathologists to interpret the study findings properly, public health experts and nutrition scientists were important to have for reliable appraisal of safety. On the molecular studies’ front, there was a need for a molecular biologist/plant biotechnologist/geneticist.

Risk assessment does not end there. There are of course other risks related to modern biotechnology, and this GM mustard too. Therefore, there is a need for trade experts, IPR experts, sociologists, rural livelihoods experts etc.

Expertise that was needed Expertise that was available in the Sub-Committee
1.       Plant Biotechnology/ Genetics/ Molecular Biology

2.       Mustard breeding

3.       Plant pathology

4.       Soil science

5.       Entomology

6.       Agronomy

7.       Bee expertise (given India’s case by case approach in regulation, GM mustard appraisal should have drawn in a bee and honey quality expert)

8.       Genetic Toxicology

9.       Clinical pathology

10.   Toxicology

11.   Nutrition Science

12.   Trade expertise

13.   Social sciences/agrarian studies

14.   Livelihoods expertise

15.   Any other required area of expertise

1.       Botany/Molecular Biology/Biochemistry*

2.       Plant pathology

3.       Ecology/Environmental Studies

4.       Plant Genetics and breeding*

 

(in fact two experts each as indicated by the * above had similar academic training/qualifications)

 

When a sub-committee with a limited combination of expertise appraises this GM mustard in a hasty fashion and when several of them also hold conflict of interest, would there be reliable risk assessment? Does their certification of safety of GM mustard actually indicate any safety at all?

SUB-COMMITTEE PUSHES STUDIES THAT OUGHT TO BE DONE NOW, TO POST-RELEASE MONITORING!

One of the most striking aspects of the sub-committee’s assessment is that they obviously find the testing inadequate, think that sticking to only the guidelines laid down is “untenable”, and then recommend several studies to be done in the post-release monitoring phase. Now, how is this justified? What is the tearing hurry to approve GM mustard now and postpone these studies? What benefits are being expected and what risks are being taken in this shortcut adopted by the sub-committee? Will planting of GM mustard in Rabi 2016 make such an impact on India’s oilseed scenario, if that is the unfounded belief? What justifies the haste? Here are some illustrations:

  1. “The Committee advised for continuous monitoring and further investigation for fitness and transfer of transgenic trait from DMH-11 to their progenies and feral populations that will be essential for implementing management strategies to minimize persistence and dissemination from release site…. The Committee advised that a suitable Post Release management strategy should be implemented”. (Point iv of Sub Committee’s February report)
  2. “Can we address the question of whether grazing of transgenic mustard by farm animals would affect them? ‘DU Reply: Only transgenic hybrid DMH-11 will be grown extensively. Barnase expresses only in the tapetum. Barstar expresses in the tapetum but also at very low levels in the leaves. However, both Barstar and Barnase have been found to be safe in sub-chronic and acute toxicity studies on model animals. Seed meal derived from GM canola lines is being fed to farm animals for more than 13 years without any ill effect’. The (sub-)Committee reviewed the reply and noted that the above answer may be taken as a post-release monitoring component” (Point 4. Of Prof K Veluthambi’s questions, Page 7 of Sub Committee’s February report). THIS OF COURSE IGNORES THE FACT THAT THE REPLY IS UNSCIENTIFIC, IGNORES HERBICIDE USE ON GM MUSTARD, IGNORES BAR GENE EXPRESSION, IGNORES THAT GM CANOLA REFERENCE IS TO A DIFFERENT SPECIES ETC.!
  3. “Honey made from barnase expressing Varuna and DMH-11 needs to be tested for barnase levels and biosafety. ‘DU Reply: As nectaries are well developed in barnase lines, we do not expect expression of the barnase gene. This can be checked post-release to allay any concerns’. The Committee requested that honey be collected from the vicinity of cultivated area and check whether honey accumulates barnase, barstar and bar gene proteins. This is suggested as a post release management requirement”. (Point No. 17. Dr S K Apte’s questions, Page 13 of Sub Committee’s February report). IT IS MYSTERIOUS WHY THIS STUDY COULD NOT HAVE BEEN PRESCRIBED RIGHT NOW. IT IS IMPORTANT THAT HERBICIDE CONTAMINATION IS BEING IGNORED AGAIN.
  4. “Prof C R Babu recommended to the Committee that long term Post release monitoring should be implemented to study (i) weediness; (ii) pollen flow to wild relatives; (iii) the impact on beneficial insects and (iv) the impact on beneficial soil microbes if any”. (Point e, Page 15 of Sub Committee’s February 2016 report). NOT CLEAR HOW THE SUB COMMITTEE WAS HAPPY WITH ONE SEASON, ONE LOCATION STUDIES IN THE FIRST INSTANCE, AS IN THE CASE OF POLLEN FLOW STUDY!
  5. “Effect on beneficial soil micro-organisms (as per 1989 guidelines of RCGM document) may be evaluated as a part of Post Release Monitoring”. (Sub Committee’s 2nd Meeting on April 11th 2016, Page 2). THE COMMITTEE NOTES THE SERIOUS LIMITATIONS OF THE STUDY ON SOIL IMPACTS BUT DOES NOT GO THE ADDITIONAL REQUIRED STEP OF ACTUALLY PRESCRIBING SOUND TESTING!
  6. “As part of sustainable use of de-regulated GE mustard in future, it is important to demonstrate that honey derived from GE mustard be tested for the absence of barnase for a definite period as a part of Post Release Monitoring”. (Sub Committee’s 2nd Meeting on April 11th 2016, Page 2).
  7. “The Committee opined that ‘establishment of self reproducible populations of Brassica juncea in the hills’ may be taken as a scientific question which should be addressed from a research angle in the interest of long term sustainability of GM mustard technology”. (Sub Committee’s 2nd Meeting on April 11th 2016, Page 2).

Although food and environmental biosafety elaborated in this document did not reveal any measurable risk, for sustained use of technology in breeding for newer hybrids, some post-release monitoring / stewardship is suggested as a precautionary measure. These measures include: monitoring honey bee behavior particularly with respect to presence of target proteins in honey; impact on non-target organisms and intra and inter-specific interactions. Additional measures should be taken not to include any chemicals for weed control in the package of practices.  (AFES document, Page 112).

It is worth noting that it is bad enough that several important safety considerations are pushed as recommended studies to be taken up as part of post-release monitoring. In the final AFES document, even these (7 points above) are not repeated faithfully, but only selectively (italics, above).

The important question here is why should the crop developer be not asked to take up these tests now? Why should this be done after release?

Who will be made responsible for any liability for these willful shortcuts and shortcomings?


 

WHO CREATED THE PROTOCOLS AND WHO DID THE TESTS?

As per an RTI response obtained from CGMCP, all the study protocols were designed by Delhi University (the applicants), in association with testing labs and institutions (RTI reply included as an Annexure 1 to this note). In terms of actual conducting of tests, the following seems to be the picture:

Environmental safety assessment:

  1. Weediness potential: Crop Applicant CGMCP, Delhi University
  2. Crossability and gene flow studies: Crop Applicant CGMCP, Delhi University
  3. Studies on soil microbial community: IMTECH, Chandigarh (a CSIR body)
  4. Studies on pests, diseases and beneficial organisms: Crop Applicant CGMCP, Delhi University
  5. Agronomic evaluation: Crop Applicant CGMCP, Delhi University*

Food safety assessment**:

  1. Allergenicity assessment: Food and Drug Toxicology Research Centre, National Institute of Nutrition, Hyderabad
  2. Toxicity assessment (acute oral toxicity, sub chronic toxicity): Food and Drug Toxicology Research Centre, National Institute of Nutrition, Hyderabad (M/s Premas Biotech Private Limited, Manesar was involved in preparation of purified proteins for some testing.
  3. Nutritional and compositional analysis: Outsourced to M/s QPS Bioserve India Private Limited, though claimed and signed off as study by Food and Drug Toxicology Research Centre, National Institute of Nutrition, Hyderabad

Molecular level characterization/studies:

  1. Expression levels of proteins: Crop Applicant CGMCP, Delhi University
  2. Molecular characterization: Crop Applicant CGMCP, Delhi University

*AFES claims that these were supervised by DRMR, an ICAR body. But a DRMR RTI response indicates otherwise.

** We have already brought out a report that points out that these studies are not reliable as far as we can see – it is the same person who advised CGMCP on the studies to be taken up as part of an institutional expert committee [DR B Sesikeran] who also has a formal association with a industry-funded body called ILSI, who headed NIN at the time that these studies were done. What’s more, he also was a regulator deciding on the results of studies conducted in his institute on his own advice!

6 of the above 10 aspects of safety assessment were not only designed by the crop developers themselves but were undertaken by them. 3 other studies on the health front were done by National Institute of Nutrition, including one outsourced study (GEAC in fact has discussed in one of its meetings that such outsourcing is not to be allowed). We will let the reader decide for herself/himself whether they would like to rely on the tests and results.

 

 

HAS GEAC ALWAYS LEFT EVERYTHING TO GUIDELINES?

The 2008 guidelines created in India, in the name of harmonization with international guidelines, and supported by USAID and industry lobby groups are clearly a case of lax regulatory guidelines, and are no protection from the risks of modern biotechnology. (http://igmoris.nic.in/files/Documents%20for%20IGMORIS%2014%20july/International%20Conference%20on%20GM%20foods/Proceedings%20of%20the%20Intl.%20conference%20on%20GM%20Foods.pdf, http://www.cera-gmc.org/files/cera/docs/sabp_activities/report_fs_2006_07.pdf)

GM mustard crop developers and the unknown authors of the AFES document hide behind the 2008 guidelines for safety assessment time and again. It is interesting to note that the Sub-Committee in its first meeting said that it is untenable for the crop developer to justify lack of some pertinent studies by taking recourse to the fact that such tests were not prescribed. It is also interesting to note that the Sub-Committee ends up prescribing a test to be taken up using the 1998 guidelines in its second meeting, but in a post-release setup!

117th meeting, 119th meeting, 120th meeting, 121st meeting and 122nd meeting minutes are good examples of what GEAC can discuss and decide upon, if the members want to, irrespective of what the Guidelines say. These are also useful illustrations of how GEAC abdicated its responsibilities when it came to GM mustard.

These are meetings where GEAC is seen laying down detailed study protocols – rightly so – in the case of Monsanto, Mahyco, Metahelix, Bayer et al applications for different GMOs, both for field trials and agronomic evaluation, for environmental studies and for molecular characterization.

For instance, only commercial check hybrids are insisted upon for certain crops like maize, rice and brinjal (even for event selection trials) – 117th, 119th, 121st meetings. Here, GEAC does not hide behind unscientific and silly arguments that the proof of concept is only around herbicide tolerance or insect resistance and that better hybrids can be bred later, as is being done with GM mustard.

As another example, GEAC insists on expanding pollen flow study protocols beyond a 50 meter radius to include additional lines in an additional 50 m, after the proposed pollen trap in one case (117th GEAC meeting minutes).

Agronomic practices are discussed in detail, including chemical sprays and fertilizer use.

GEAC also did not leave soil micro-biota studies to some microbial abundance studies but insisted upon a careful assessment of impact on collembola species and earthworms too, amongst other organisms. This was however not done with GM mustard. In fact, the protocol did not even cover agriculturally important species when it comes to GM mustard safety evaluation on soil microbiota, and this has been noted by the sub-committee, but meekly pushed aside to post-release monitoring studies.

GEAC in the past has changed protocols proposed from Randomised Block Design to Alpha design where appropriate, prescribed the exact amount/quantities and numbers of samples to be tested for some parameters etc.

For herbicide tolerant crops, GEAC had prescribed tests on bio-efficacy of the herbicide, residue analysis in HT crop soil, effect of leftover residues on succeeding crops, untreated controls etc. (117th meeting). Protein expression data was prescribed to be recorded at the time of each herbicide application in one case (119th meeting). Data related to soil microflora, earthworms and soil insects related to soil rhizosphere was also prescribed to be recorded during pre- and post-spray of herbicide in an instance. (119th meeting). Visual observations on herbicide treated plots for yellowing, scorching and wilting were prescribed to be recorded. Control treatments will be manually weeded in this case. Dosage of herbicide sprays, approval of CIBRC, nature and extent of bio-degradation, residue estimations etc., were all areas of additional information sought for HT crops.

Feeding studies on broiler chicken and dairy animals were also prescribed (121st meeting).

It is clear that all of this has not been done in the case of GM mustard and has been left to the crop developers fully. The GEAC has to justify why this is so and whether safety of the technology will improve all by itself just because a public-funded, public-sector GMO comes into the picture.

In the 121st meeting of the GEAC on 18/7/2014 (soon after the new government was formed at the Centre), there is a partial discussion on whether GEAC should ever be entertaining a HT crop application for commercial cultivation at all. This is obviously a pending matter even within the regulatory body (apart from this being a policy decision for the government and for judicial adjudication in the GMOs PIL), while the Committee is also rushing headlong towards GM mustard approval, which is a herbicide tolerant crop.

“2.1. Minutes (of the 120th meeting) were confirmed with the following editorial changes:

  1. The Committee also took note of the following observations made by Dr PM Bhargava during the 119th GEAC meeting: ‘At this meeting, we had an important and long discussion on whether or not we should entertain any applications that relate to the incorporation of herbicide-resistant gene. Many members were strongly of the opinion that such applications should not be normally entertained as the evidence against the use of herbicide resistant crops is overwhelming. We, of course, should not stop any research work in the area but we should make it clear that no permission would be granted for field trials of such crops. It was decided that all those who are against the release of herbicide-resistant crops (their names should be mentioned in the minutes) will present evidence in favour of their view at an appropriate meeting where this item would be an agenda item’”.

What is worth noting from all these minutes is the additional questions on Herbicide Tolerant crop applications and additional requirements on the applicant – for instance, whether CIBRC permission exists or not, and a copy of the same to be furnished. The bio-degradation details. Studies on the herbicide’s eco-toxicity and residue possibilities etc. In the case of GM mustard, all of this has been ignored and left unprescribed.

On the other hand, we also have conflict-of-interest-laden members like Dr Sesikeran, who took up health safety studies for applicants, explaining the study results to the rest of the GEAC on behalf of the applicants and declaring some product or the other to be safe (Agenda 4.3.1 of GEAC’s 121st meeting is a fine example of this unacceptable component of regulation)! Similarly, Dr Akshay Pradhan, a crop developer of the GM mustard in question and also a GEAC member, gets to provide explanations to the GEAC in the same meeting on GM mustard (Agenda 4.4.9, Page 14)! This is a classic illustration of why we keep talking about removing all such members from GEAC completely.

It is important to note that the Biology Document of Brassica juncea which is supposed to have guided the biosafety testing of crops like GM mustard was prepared only in 2016. The regulators have failed in their duty but want the nation to bear the consequences for their irresponsible functioning.

It is also worth noting that even the Environmental Risk Assessment guidelines were prepared and released only in 2016. Without such guidelines in place, how did GM mustard get tested in the first instance? Isn’t this the government’s falsehood in the Supreme Court way back in 2008 too, that guidelines exist and they will be uploaded on the website?

There is another matter which is worth mentioning here, pertaining to conclusions and inferences drawn from toxicity tests (acute and sub-chronic) where the reports often conclude that “some statistically significant differences were observed, but were also within the normal range and therefore, found not to be biologically significant”. In the 121st meeting of the GEAC, this was explicitly discussed.

4.3.11. Some of the Members were of the view, that the Protocols for 14-days acute oral toxicity study and 90 days sub-chronic toxicity study may need to be revisited as the number of days and sample size of 20 animals (10 male and 10 female ) may not be adequate. It was clarified that the animal numbers used in the study are accepted world-wide for pre-clinical or non-clinical evaluation of safety and as per WHO document on safety evaluation of vaccines. Principles of statistics are the same, it is just the test material which is different. It was further stated that the size of the treatment group depends on the animal model chosen, i.e., the number of animals included in studies using non-human primates would be expected to be less than in studies including rodents. For small animal models, e.g., rats and mice, it is recommended that approximately 10 animals/sex/group be studied.

 

4.3.12 As regards the acceptability of the statistical variations in the toxicity studies even in the absence of any biological significance, Dr Ramesh Sonti supported by three other Members were of the view that “In acute and sub-chronic toxicity studies, for parameters where there is a statistically significant difference between control and treatment, the test should be repeated for that particular parameter/s (and not for all parameters). If there is a statistically significant difference on repetition, the matter should be investigated further. The matter should be dropped if there is no difference upon repetition. This is being suggested as a matter of ‘precautionary principle’ because these are foods that will be consumed by a large number of individuals over a long period and we would like to minimize risks. Furthermore, we should go the extra mile to minimize concerns regarding GM foods, at least in the initial years of their commercialization.”

 

4.3.13 The Committee after a lengthy discussion, decided to constitute a sub-committee to review the toxicity data in the context of the above discussions.

It is clear that this is an inconclusive discussion within GEAC – however, the GEAC’s sub-committee steamrollered ahead, without an independent health safety expert participating, and concluded that GM mustard is safe even with statistically significant differences in various parameters as we show later on in this document.

 

 

WHAT IS THE WITHHELD-DATA SHOWING AND WHAT IS THE AFES CONCLUDING?

  1. Environmental Safety Studies:

 

  1. Environmental Studies: Weediness Potential

Chapter 6, Section 6.1, pg 75-80 of AFES concludes the following about weediness potential: “The weediness potential of GE mustard hybrid DMH-11 is similar to that of the varieties commonly grown in India. There is no risk of any aggressiveness or any weediness potential in the hybrid DMH-11”. Such weediness was measured by (i) seed germination; (ii) speed of seed germination; (iii) seedling vigour; (iv) small seed size; (v) long continuous seed production and (vi) pod shattering. We present more details here.

AFES document

(Permission Ref. BT/BS/17/30/97-PID dated 7/2/2011, as mentioned in Appendix Table on Pg114)

Data in the dossier

(Permission Ref. RCGM letter No. BT/BS/17/30/97-PID dated 7/2/2011)

Ref. Report: “Studies on weediness potential and aggressiveness parameters of transgenic Brassica juncea, during Rabi 2011”

Seed Germination:

“Seed germination percentage revealed that there was no difference between the GE and non-GE hybrid”

Lab studies showed handmade non-GE hybrid to have significantly higher percentage germination over transgenic hybrid at 10 days. (Table 1 of “Studies on weediness potential and aggressiveness parameters of transgenic Brassica juncea”, during Rabi 2011).
Speed of seed germination:

“The number of seedlings emerged after 5, 10 and 15 days of sowing showed that speed of germination had stabilized by 10 days in both GE and non-GE hybrid”

Table 4 of the report shows that by Day 5, DMH-11 had 84.7% germination as opposed to 70.3% in VEH2-F1, at Day 10, it was 94.7% vs. 88% and at Day 15, it was 95.3% for DMH-11 vs. 88.3% for non-transgenic hybrid. Is the conclusion drawn by AFES right?
Shoot and root weight:

“The data revealed significantly higher shoot and root weight in handmade non-GE hybrid as compared to the GE hybrid DMH-11 under field conditions”

Table 2 based on laboratory based studies, shows mean shoot length as 5.64 cms of 10 day old seedlings of VEH2-F1 as opposed to 5.21 of DMH-11. Table 3 shows 12.61 cms of mean root length of 10 day old seedlings of VEH2-F1 handmade hybrid, as opposed to 12.68 cms of DMH-11. This reveals no significant difference.

 

When it comes to mean shoot and root weight in gms of 15 day old seedlings grown under field conditions (Table 5), VEH2-F1 has 10.49 gms fresh shoot weight, 0.852 gms dry shoot weight, 0.141 fresh root weight and 0.043 dry root weight, as opposed to DMH-11 having 7.95 gms, 0.648 gms, 0.109 gms and 0.029 gms respectively. This reveals significant difference, with higher values in handmade non-GE hybrid.

Long continuous seed production:

“The data on seed production shows no difference among GE hybrid DMH-11 and non-GE hybrid VEH2-F1”

No such comparison was done between DMH-11 and VEH2-F1. AFES conclusion false.

During BRLII trials, such data on long continuous seed production for not recorded for all entries. Data presentation was left as year-wise, site-wise tables with no aggregation and no conclusions can be drawn, especially given that other hybrids were not used as comparators.

Seed size, Pod shattering:

“The seed size of two parents of the hybrid DMH-11 ie., Varuna and EH-2 are different”

No such comparison was done with pod shattering and no quantified data was collected. No conclusion can be drawn here, and the AFES document making it appear that it has been studied is misleading.
Given the above, the AFES conclusion on weediness potential is unreliable

 

  1. Environmental Safety Studies: Crossability & Pollen Flow Studies (inter-species and intra-species)
AFES Document

(Ref. Letter No. BT/BS/17/30/97-PID dated 15/10/2010 for crossability studies at Bawana as cited in Appendix Table on Pg.114)

Data in the biosafety dossier & other relevant documents

(Ref. permission letter no. BT/BS/17/30/97-PID dated 15/10/2010, for crossability studies in Rabi 2010 and 2011.

AFES document, outside the Appendix Table of Page 115 refers to only one experiment on intra-species pollen flow in the year 2010, in DU’s Research Farm in Bawana, New Delhi (page 83). However, the season/year of inter-species crossability experiment is not mentioned. While Bt brinjal and Bt cotton went through multiple seasons of such pollen flow studies, GM mustard was put through only one season pollen flow/crossability studies, that too in one location. Is this a reliable assessment?
AFES document, page 83:

 

Chances of escape of transgenes to related Brassica species may occur only if these are present in the receiving environment.

 

Successful crossability requires that the populations of donors and recipients must overlap temporally and spatially, and be sufficiently close biologically.

 

 

 

 

 

A Biology document of Brassica juncea is prepared by the Indian regulators in 2016 (carefully undated on the publication of course), years after the R&D and testing begins on GM mustard, ostensibly to become the baseline for safety testing (as Minister and AS messages confirm helpfully to us)!! It can only be assumed that some guidance was indeed taken from this document for safety assessment of GM mustard in the current instance. Table 6 in page 5 lists the rapeseed mustard crops grown in India. The description of rapeseed mustard collections for our gene banks also shows how many varieties are present in different states of India. It is noted that outcrossing varies from 7.6% to 22% even though it is a predominantly self pollinated crop. While extent of wind pollination was recorded upto 11-17.5%, insect pollination is an important component. It is further noted that bees may carry pollen over long distance and have been found foraging in fields more than 4 kms away from the hive, resulting in outcross seed set.

 

A very low frequency of natural hybridization amongst B. rapa, B. juncea and B. napus does occur if they are cultivated closely (4.1, Pg. 11). Such hybrids are partially fertile and can set a few open pollinated seeds. B. juncea shows the second highest crossability with B.napus after B.rapa.

 

Low introgression varied between species and existed to an extent with wild relatives.

“Hence, in the absence of synchronous flowering under growing season, the possibility of outcrossing with these (4) species is unlikely”.

 

 

 

“Seeds were harvested from the related species, germinated and sprayed with herbicide Basta. The study showed no Basta resistant plant in F1 generation – hence, it could be concluded that the likelihood of crossability of GE DMH-11 with other Brassica species under natural conditions is highly unlikely” (Pg. 85 of AFES document).

Data of 1000 seeds planted in 2011-12 from the harvested seeds of 2010-11 season from the experiment does show that all the plans of other species are susceptible to Basta and were destroyed (Table 3).

 

Our comment: Should the limitation of the experimental protocol, of planting all species at the same time, rather than synchronise flowering stage for different species, become the basis for inferring that possibility of outcrossing itself is unlikely?

 

Also, should this study have been done only in one location in one season for reliable conclusions to be drawn and to estimate the risk potential from inter-species crossability, given the literature evidence on inter-species crossability in northern hills?

Intra-species Crossability or Pollen Flow:

 

Study limitation cannot be the basis for concluding something incorrectly. The outer plot of non-GM mustard of Pusa bold was sown only upto a distance of 50m. Further, while an inner plot of GM crop with the outer plot being non-GE mustard presents estimates of pollen flow of one kind, in reality, non-GM plots could be sown in a long contiguous fashion next to GM mustard crop, depending on plot sizes and shapes.

 

The relevant report in the dossier shows pollen flow upto 20 mts. Further, 7 or 9 plants out of 1000 are seen to be herbicide tolerant.  This is a 0.7% to 0.9% contamination. However, nothing has been reported about bee abundance or activity here, nor the chemical treatment especially related to herbicides, if any, used in the experiment. This level of outcrossing is too low compared to the levels reported in literature.

 

The study being conducted in one location, in a small plot size, that too in only one season cannot be taken to be conclusive evidence on negligible outcrossing. The sub-committee of GEAC has to explain where they draw their confidence on their conclusions from.

 

Even while citing from the biology document of B juncea, the rate of outcrossing is being mentioned as 11 to 17.5% on page 86 of the AFES document, whereas the biology document mentions upto 22%. Literature also exists showing higher outcrossing than this, in addition to GEAC’s own assessment in the past with another GM mustard.

 

The Sub-Committee’s assessment in concluding that the crossing with B juncea will be similar with other non-GE hybrids is an incorrect statement since no transgenes spread from non-GE CMS based hybrids, to begin with.

 

Importantly, the conclusion that intra-specific crosses between DMH-11 and other varieties of B juncea would not have any selective advantage in the absence of Basta herbicide spray has no basis for that presumption (that there will be no Basta spray). There will indeed be herbicide usage by farmers.

 

In the box at the bottom of Page 86 it is stated, “progeny of such crosses will not have any survival advantage unless sprayed with a specific herbicide Basta”, and we contend strongly that this survival advantage does exist, and without accounting for this, any conclusion by the Sub Committee is invalid. The figure 6.2 is rendered invalid too, on these grounds.

 

Elaborate presentations have already been made to the GEAC on the impacts of such outcrossing and how farmers will lose out in the end, especially organic farmers.

The Sub-Committee’s conclusion of negligible risk is unscientific, unreliable and incorrect. The outcrossing figure presented is unreliable (see the box below for another GEAC discussion on the subject). The conclusion drawn about negligible risk is unscientific given that farmers will spray herbicide glufosinate conferring selection advantage.

 

 

It is worth noting that in 2002, Pro-Agro (a Bayer subsidiary) which walked up to the GEAC for commercial cultivation permission of a similar bar-barnase-barstar based GM mustard, reported “transgene escape” to a maximum distance of 35 meters, with an estimated 0.01% transfer at that distance. It had no information on level of contamination at distances of 1 to 5 meters. The GEAC records in its 34th meeting on 7th November 2002 that “considering the agro climatic conditions and small land holdings of Indian farmers, the Committee was of the view that the non-GM mustard seed from the adjoining fields is likely to get contaminated by male sterility barnase gene, barstar, neomycin and bar genes. This factor may affect the stability of the properties of the non-transgenic varieties. Trial studies conducted by the company also indicate the presence of male sterile plants in the progeny population of non-transgenic Brassica growing in the vicinity of transgenics. Further, in the 36th meeting of GEAC on 25th April 2003, under Agenda 3.0 A., the commercial release of transgenic mustard by M/s Proago Seeds Pvt Ltd is discussed again. Here, the following is recorded: ‘ICAR has conducted trials at only 4 locations which is not adequate. The ICAR trials indicate pollen flow upto 75 meters whereas the company has reported pollen flow upto 50 meters’”. (Relevant minutes can be accessed here)

 

  1. Environmental Studies: Impact on pests, diseases and beneficial organisms

There was detailed feedback provided in a special meeting of the GEAC on July 18th 2016 how the protocols for various studies are not rigorous enough, and how the data is unbelievable and appears cooked up. Those comments are unaddressed, and remain pertinent to the AFES section “6.4 on Studies on pests, diseases and beneficial organisms”, from page 94.

Trial Location Mustard Aphid Painted Bug Leaf

Miner

Cabbage Butterfly Mustard Sawfly Termites
BRL-I,

1st Year

(2010-11)

Kumher P All Nil All Nil All Nil All Nil All Nil
Alwar P P All Nil All Nil All Nil All Nil
SG nagar P All Nil All Nil All Nil All Nil All Nil
BRL-I,

2nd Year (2011-12)

Kumher P All Nil All Nil All Nil All Nil All Nil
Alwar P All Nil All Nil All Nil All Nil All Nil
SG nagar All Nil All Nil All Nil All Nil All Nil All Nil
BRL-II,

(2014-15)

Delhi P 0 0 0 0 0
Bhatinda 0 0 0 0 0 0
Ludhiana 0 0 0 0 0 0

 

The above table, presented to GEAC on July 18th 2016, is an illustration of the unbelievable data on insect pests generated from the field trials.

More specifically about beneficial organisms, and within that, pollinators like bees, the following are some specific comments.

  • What was essentially a rudimentary testing on bee abundance was concluded and stated to be a bee foraging study. It is not.
  • Within the bee abundance study, while eye observation is one methodology, given that there are serious doubts about the competence of the people who recorded the observations and conducted the study, this methodology is not foolproof and should have been supplemented by other superior tools like videography, sweep net, soap bowl etc.
  • The competence of the data enumerators during the trials is certainly under question given that the observations appear spurious and unbelievable. It is also a fact that none of the study locations have bee experts and the one location (PAU, Ludhiana) which does have a competent expert did not involve this expert in the biosafety testing.
  • The data appears to be bogus from the wide variation seen in the observations and even lack of consistency in findings. No inference can be drawn from such findings. The least that should have been done is to repeat the studies to further understand the observations captured. There appears to be a serious flaw both in terms of sample locations chosen and competence of data collectors. Together, they put a question mark on the reliability of even the limited testing that was done with weak protocols.
  • There is also a major contradiction in concluding that Mustard is a predominantly self-pollinating crop and showing results of yields in different treatments which actually demonstrate high outcrossing – it is obvious from the impact on yield increases that bee-keeping results in, that cross-pollination potential is very high with pollinators’ presence and activity. It is therefore important to fully acknowledge the high possibilities of cross-pollination, and therefore, the consequent impacts of GM mustard.
  • The studies are completely inadequate in that they did not treat GM mustard as a herbicide tolerant crop – once released, farmers will certainly use it as a HT crop. Today, they are not using herbicides on mustard essentially because there are no HT crops. Once this is introduced, they will rationalise that spraying a herbicide is easier and cheaper than dealing with agricultural labourers for manual de-weeding. This use of herbicide will leave its own impacts on honeybees and other pollinators. The assessment of GM mustard is completely inadequate in this context. The illegal use of HT GM cotton in India is a good illustration of the point being made.
  • Apart from the methodology adopted, and the inferences drawn from unreliable observations, there is the issue of the scope of the studies undertaken related to impact on Bees as well as Honey. Needless to say, mustard is a very important crop for bees and other pollinators in general, and these pollinators are in turn critical for our food security.

Impact on Pollinators and Bees:
* It is unclear why impact on other pollinator species was not studied – these are equally important in mustard pollination too.

* The tests should have included observations on diversity of species (with competent field enumerators who can distinguish between these).

* The tests should have studied actual foraging behaviour and not just abundance. This in turn should also make a distinction between nectar and pollen foraging.

* The tests should have been taken up with standard and essential protocols adopted for such assessment in EU, as per some bee experts.

* The tests should have been done on plots sown to DMH-11 farm saved seed too (with its segregation of traits in F2 generation) or on seed saved from DMH-11 X Non-transgenic mustard crop (with its outcrossing of traits).

Honey Production & Quality:
* Apart from studying impacts on several pollinators and within that, particular species of bees, there should have been studies on honey production – this then means studies that will last for several seasons and locations and not just few locations and seasons.

* Transgenic protein and herbicide residue levels should have been measured in the honey.

* Ex-ante impact assessment on trade security issues with honey from GM mustard fields should have been prescribed and done, given that our honey consignments will be rejected in some markets and would not be cost-effective/competitive in some other markets. On this hinges the livelihoods of around 5 lakh bee keeper households in the country.

 

Given all the above, the conclusion of the Sub Committee is irresponsible, unscientific and invalid. Even secondary literature-wise, studies do indicate significant impacts on non-target organisms, including beneficial organisms. In fact, it is unclear why the Sub-Committee hesitates to prescribe more tests that ought to have been done. There is no justification at all for not prescribing these tests right now or getting the testing done through independent capable organisations.

 

  1. Environmental Studies: Agronomic Evaluation

We have already given very detailed comments on many things that are unscientific and fraudulent about the agronomic evaluation of GM mustard, especially given that the very basis for coming up with transgenic pollination control is supposed to be claims around yield increases. Such yield increases being proven against parental lines is laughable. The only valid way of assessment is to test GM mustard against non-GM hybrids. The 121st meeting of the GEAC clearly prescribed the following: “Collect data regarding agronomic performance of the hybrid DMH-11 in comparison to national and zonal checks”. Please note that it did not say against the parents. There is absolutely no justification for GEAC to say anything opportunistic and unscientific at this point of time.

 

We have also shown based on raw data accessed, that in any case, any findings even within a rigged protocol are unreliable given the lack of consistency in the data (Slide 34 and 35 of this presentation, for example).

If the sub-committee is still going ahead with its unreasonable clean chit on this front to GM mustard, it is irresponsible. The evaluation being termed as a proof of concept for heterosis and hybrid vigour as compared to the parents is laughable. From where an application claimed that its permission would lead to an increase in India’s mustard yields to the point of bringing down its edible oil import bill, for a sub-committee to reach a stage where it is only ready to say that there is “presence of hybrid vigour in the hybrid” that too against the parents, is quite an admission of the failure of this GMO to prove anything in its favour. Any proof of concept on pollination control cannot be an end in itself if distinct benefits cannot be proven – such benefits can only be tested in a comparative framework vis a vis other hybrids, both in terms of superior pollination control and thereby superior heterotic possibilities.

The famous lines of the former Environment Minister describing Bt brinjal as a solution going around looking for a problem apply equally well or better to this GM mustard. Proof of concept of pollination control is not proof of concept of heterotic superiority or even superior pollination control. This has simply not been tested for and no statements of benefit can be made in favour of GM mustard on this front. In fact, if the so called environmental release is meant to breed superior hybrids with further research, the crop applicants can very well get back to RCGM for the same, and it does not require GEAC to provide any approvals for ‘environmental release’! We also have pointed out in the past that even pollination control is not adequately or rigorously proven with varying test protocols adopted in different centres which point to male sterility breakdown.

  1. FOOD SAFETY STUDIES

 

  • To begin with, the acute toxicity study with purified proteins and the two sub-chronic toxicity studies with seeds and leaves are incomplete, invalid and unreliable since they did not treat GM mustard as a herbicide tolerant crop which will also carry toxic herbicide residues and would probably have combined effects of both GE and pesticides.
  • The biosafety of glufosinate has not been established in the pesticides-related regulatory regime in India. In fact, use of glufosinate in mustard crop is illegal.
  • No chronic health impacts assessment has been done with this GM mustard.
  • It is perplexing how the sub-committee without an independent health expert has pronounced GM mustard as being safe for human consumption.
  • It is also clear that the AFES green signal has come at a time when GEAC has not concluded any of its debates on related matters – related to herbicide tolerant crops, related to toxicity studies. Sub-Committees are referred to in different meeting minutes, but there is no evidence of such committees being constituted, or having come up with their final reports after comprehensive reviews.
  • Here, we present evidence on how the AFES document is presenting either outright lies or selective bits of information to camouflage the lack of safety of GM mustard.
AFES document Data in the biosafety dossier
Compositional Analysis:

 

The AFES document presents Table 5.1. on total glucosinolates and Table 5.2. on fatty acid composition. It is interesting to note that DMH-11 data is kept out of the tables.

 

“Thus the data submitted suggest that there are no significant differences in key fatty acid component levels in seeds or leaf of GE parental lines as well as hybrid GMH-11 as compared to their respective comparator”, claims the AFES document (page 58 and 59).

 

Table 5.3. presents data of glucosinolate and key fatty acids with DMH-11 compared with ‘normal range in commercially cultivated varieties’ and lists Varuna barnase and EH2 barstar also!

 

Further, it is claimed that values in hybrid DMH-11 are comparable with commercially cultivated Varuna and check RL 1359, and the nutrient compositions of DMH-11 are within the range of non-GE varuna and zonal check. How is this comparison valid?

 

“Conclusions: on the basis of data analysed, the compositional differences between GE line and their conventional comparators are within the range of natural variability encountered in mustard”.

 

“Also, hybrid DMH-11 is very similar in its composition, to the commercially cultivated varieties in India which have a history of safe use”. (page 61, AFES document)

 

Composition differences between leaves and seeds of six different cultivars was taken up with samples from 3 locations.

 

Report of NIN is dated 2/4/2014, numbered as Study No. 2/2012. (Last field trials would have been only in 2011-12. It is not clear if the report was released in a delayed fashion). The actual testing was undertaken at M/s QPS Bioserve India Private Limited.

 

The Results section (No. 7, pg 124/360 and 125/360) shows that under different parameters, there were indeed significant differences for various parameters (minerals, vitamins, secondary metabolites, amino acids etc. in either the leaf or the seed.

 

However, the conclusion section (8) says: “The compositional analysis includes macro, micro nutrients were substantially equivalent inspite of the significant changes which may be due to agro-climatic changes”!!

 

It is important to note that the entire reasoning behind not taking up feeding studies or other food safety tests was an argument that no significant changes were detected in the Compositional Analysis.

 

However, it is clear now, that there were significant changes, but have been discounted in an unreasonable fashion.

 

In any experiment, agro-climatic changes should have been controlled for, to begin with, for such compositional studies.

 

In fact, the only valid protocol for compositional studies is to compare GM mustard with isogenic non-GM lines. In this study too, handmade non-GM hybrid VEH-2 should have been used. However, this was not done.

 

Importantly, the conclusion reported in the study reports is very different from the conclusions being claimed in the AFES document.

Acute Oral Toxicity (5.5., page 64-65):

 

Recombinant proteins expressed in E. coli and purified, were used in this study, and each protein was administered orally, separately, to swiss albino mice.

 

“The data generated showed that none of the three proteins cause mortality or any adverse effect in the test animals when administered orally”.

 

“It may be noted that this gene (bar) is used as a selectable marker in the experiments and does not imply that basta spray is required during cultivation of the said hybrid”.

 

 

It is interesting to note that the Coordinator of PCT in NIN which took up the testing, till 31st August 2012 was Dr B Sesikeran.

 

The number of animals were 8 males and 8 females for study and control groups each (32 in all) for Bar and Barstar proteins, and only 6 males+6 females in each group (control and test protein group) for barnase, showing some inexplicable lack of standardisation. These sample sizes are also below the numbers discussed on the subject in a GEAC meeting.

 

Taken up in Swiss Albino Mice as oral route administration, for 14 days each, as tests of different individual recombinant proteins. Approved by RCGM in its meeting on 22/11/2011 and the permission letter was BT/BS/17/30/97-PID. A concentration of 1000 mg/kg body weight was used for this test, using purified test proteins of bar and barnase. For barstar, 1700 mg/kg was the concentration used.

 

In the study with barnase protein, it is seen that the control group animals (12) had a small body weight gain, whereas the barnase-protein fed animals had a small weight loss. This was seen more in the case of male mice.

 

This study was done separately for Recombinant Bar Protein, Barnase and Barstar. However, the proteins are bound together in DMH-11.  

 

Further, this study ignored the fact that GM mustard is herbicide tolerant and herbicide usage will be taken up by farmers.

 

The AFES document citing literature on pat gene to justify bar gene safety, after recording only 87% similarity between these two genes is unscientific.

Sub-chronic Toxicity (5.6, page 65):

 

“The sub chronic toxicity studies with leaf and seed material showed that there was no significant difference in body weights…urine analysis, biochemical parameters and haemotology was in the normal range and similar for animals fed with normal and GE materials. No toxicologically significant adverse effects were observed in necropsy and histopathology studies of the vital organs of the test animals”.

The sub-chronic toxicity study was 88 days’ long, done as two studies with leaves and seeds from three transgenic mustard lines, in Sprague Dawley Rats.

 

The relevant RCGM approval letter is BT/BS/17/30/97-PID dated 12/1/2012. Test material was received in April 2012 for leaves and actual administration was between 11th June 2012 and 8th September 2012. The test materials were lyophilized powder of leaves of 3 transgenic lines. The study was done using 120 sprague dawley rats (60 males, 60 females), divided into six groups fed with different test materials.

 

The results are recorded thus:

 

Although there was a significant difference in glucose levels in EH-2 (non transgenic) group when compared to transgenic group of DMH-11, as the values fall within the standard normal range, these variations are of no significance. (7.4.2. on Clinical Chemistry).

 

Except a significant difference was observed in weights of Lungs in Varuna (NT) and EH2 (NT) groups compared to transgenic DMH-11 group, all organ weights were normal in all six groups including control group. (7.5.1. on Organ Weights, under 7.5. Necropsy and Histopathology).

 

Focal interstitial nephritis in kidney was seen only in transgenic group animal but the occurrence was sparse and hence not considered significant. (7.5.3. on Histopathology).

 

Our Comment: It is unclear if the study is interpretable as equivalent to fresh leaves’ consumption.

 

Importantly, the study was not conducted on GM mustard with herbicide tolerant crop protocols.

Sub-Chronic Toxicity with Seeds

“The sub chronic toxicity studies with leaf and seed material showed that there was no significant difference in body weights…urine analysis, biochemical parameters and haemotology was in the normal range and similar for animals fed with normal and GE materials. No toxicologically significant adverse effects were observed in necropsy and histopathology studies of the vital organs of the test animals”.

Study permission letter from RCGM (No. BT/BS/17/30/97-PID) dated 12/1/2012.  Receipt of test material on 17th April 2012. Study was done between 18/6/2012 to 15/9/2012. 120 sprague dawley rats were used for the study (60 male, 60 female), randomly divided into 6 groups. Test material, of Brassica juncea seed powder, was administered at 20 mg/rat for 90 days.

 

The report presents its findings and conclusions in the following manner:

 

“There were significant changes in clinical chemistry parameters but were within normal range and hence of no significance” (There was a significant difference of TBILI level in EH-2 (NT) group with respect to transgenic group of DMH-11”.

 

“MCV in Varuna barnase and EH-2 barstar was found to be significantly decreased as compared to DMH-11 group. Monocyte counts in Varuna barnase and EH-2 barstar found to be significantly increased as compared to DMH-11 group”. “Although variations were observed, but as all these variations fall within a normal range for rats, these cannot be considered as significant”.

 

“Histopathological observations of all organs were unremarkable except lungs, liver, trachea, larynx and lymph nodes which showed changes in a few animals of each group. Few of those changes were also evidence in the control group”.

 

“The histopathological result was also seen to be unremarkable”. 

In all these tests, statistically significant differences were indeed recorded, even though study protocols themselves had limitations. However, all such differences were ignored and discounted in the conclusions of safety drawn.

 

  • Bioinformatics analysis was passed off as allergenicity study, along with pepsin digestibility and thermal stability of the 3 proteins. Further, an argument the protein expression levels of the introduced genes were low is not proof of health safety of GM mustard (entire 5.4 section of page 63). The lack of safety of GMOs is from the inherent changes created by the process of genetic modification, and in the case of GM mustard, additional risks from the herbicide tolerance trait and associated herbicide usage.
  • Rationalising the existence of safety based on “no reports of any observed ill effects from more than a decade of consumption, exports and trade in Canada” is unscientific. Lack of evidence is not proof of safety. If this were so, GM mustard can be approved in India straightaway without any regulatory assessment at all! Further, citing data on B napus opportunistically is not acceptable, and data on Brassica juncea should be presented.
  • Sections 5.7. (Toxicity assessment of transgene proteins for livestock and wildlife, including cattle, goats and pigs) is invalid in its arguments. It is not based on any testing. Arguments based on PAT protein not tenable. The claim that substantial equivalence has been established based on no difference between GE and their non-GE juncea lines through compositional analysis is an outright lie as the conclusion in the report in the biosafety dossier shows (as opposed to falsehoods stated in the AFES document). All bullet points on Page 68 are either outright falsehoods or scientifically untenable arguments.
  • We have already pointed out how ICMR guidelines as quoted on Page 68 are not the last word for safety assessment, and GEAC itself has taken various decisions in its past meetings to prove this.

 

  • The statement of AFES that “it may be noted that GE canola is being cultivated in several of these countries for more than 20 years” is an incorrect statement given that only 3 countries have been cultivating.

 

  • Section 5.9 is meaningless in its rationalization since no protocols have been evolved to actually test the impact of a GMO on Ayurveda or any other system of medicine.

 

  • Section 5.10, Page 73 ‘Potential allergenicity assessment of barnase, barstar and bar proteins’’s claim that “this analysis further confirmed lack of significant sequence similarly of barnase, barstar or bar proteins to any known allergenic protein” is a matter of concern. What does lack of significant similarity mean and how much similarity actually exists?

It is worth drawing the attention of the reader here that in the 121st meeting of the GEAC, the following has been decided upon:

“4.4.10. On the issue of the toxicology studies consensus were expressed that unlike in the west, GM Canola is used as oil where as in India mustard leaves and seeds are also consumed and therefore, toxicology data should be reviewed with great caution. The Committee decided to refer the matter to the sub-committee proposed under agenda item no 4.3.

4.4.11 In addition, it was decided to obtain the following additional information:

  • What are the other hybrids of Canola approved for commercial cultivation in the West and how much of the cultivated hybrids fall under barnase and barstar genes. ….

 

4.4.12.The Committee further decided to obtain additional information as indicated in para 4.4.11 above and also decided to refer the matter to the sub-committee proposed for the purpose of review to the toxicology data under agenda item 4.3.13 and 4.4.10”.

From all information available, no such sub-committee for reviewing toxicology data has been constituted whereas the GEAC put out an AFES document for public comments even without an independent health expert! No data has been shared, it appears, on other hybrids in the West and how much is under barnase-barstar technology.

It is also apparent from a perusal of the discussions and debates within the GEAC on this subject, that this is a matter pending to be resolved in India’s regulatory regime (on how toxicology data is to be interpreted).

The insistence that feeding studies will be taken up only if nothing is found in compositional analyses has also been violated in the context of GM mustard. Importantly, a decision on whether feeding studies are needed or not is pending, as per the same 121st GEAC meeting minutes, given below (it is worth noting that such a feeding study at NDRI, Karnal was actually proposed and discussed in the GEAC):

“4.5.2 The Member Secretary, RCGM informed that the applicant had sought exemption from feeding studies with leaves and seeds as they are not toxicological studies but basically meant to evaluate nutritional imbalance. As compositional equivalence of edible plant parts (leaf and seeds) has been established, and no Allergenicity has been observed, additional feeding studies may not be required. Further, the same genetic system has been in use for more than 15 years in several countries around the World. The matter was considered by the RCGM in its 133rd meeting held on 22.4.2014. While the RCGM agreed to the above, the Secretariat was advised to send a brief note to the GEAC with justification on why feeding studies are not required in the present case.

4.5.3 After a brief discussion on the matter, the Committee requested that the Note forwarded by RCGM may be circulated to all members of the GEAC for consideration of the case in the next meeting. Accordingly decision on the two proposals mentioned above were deferred”.

From all available information in the public domain of all subsequent meetings of GEAC and its sub-committee, such a discussion for a decision on the deferred proposals was not taken up subsequently by the GEAC.

The following reasoning is offered by us as to why the conclusions around ‘biological irrelevance of statistically substantial differences in any health safety parameter even when values are found within normal range’ are illogical and undependable:

  • If the objective of the study is to check whether consumption of a GM food leads to abnormal health parameters (biochemistry, histo-pathological, body weight related etc. etc.) and whether these values fall within normal range of values for a particular species, then it is obvious that such feeding tests can be conducted straightaway on one set of animals and results verified against the normal range without having to resort to a comparative framework in the protocol;
  • It is clear that the objective is not to verify only biological relevance of results, but to see in a comparative framework if GM-fed animals have significant differences in any parameter being studied, vis-à-vis the control group. Even here, it is important to note that chronic impact parameters like endocrine disruption or carcinogenic impacts are not likely to be captured in a linear, dose-dependent way. This will also be not applicable equally to both sexes whereas GEAC’s toxicology inferences have always sought to brush off early warnings of lack of safety by insisting that such differences should be dose-dependent and applicable to box sexes.

The only scientific and rational thing to be done in all such cases is to increase the number of assessments as well as do this for a long enough time to capture chronic impacts, until a reasonably reliable conclusion can be drawn, apart from more fundamental policy decisions to be taken on the subject.

In a discussion on the subject in the Sub-Committee (Page 4 of the February 2016 meeting), DU reply argues that it is important that even if there are significant differences found, such differences should be checked to see if they are in physiological range, and then one should correlate biochemical and haemotological data with histopathological changes. From available information, it appears that differences are indeed significant on all these fronts, and this should have been taken very seriously by the regulators and not ignored. If safety is being asserted by the regulators, they should justify the same by putting out all data in the public domain and explain the basis for their clean chit rather than present false conclusions as was done in the AFES document.

  • Protein Expression Studies

This was taken up during October 2011-March 2012. Some findings worth mentioning are:

BAR PROTEIN: Expression of bar protein was noted in all transgenic lines, in all the tissues tested.

  • Bar protein observed in the pollen of DMH-11 transgenic lines ranged between 0.159 to 0.363 µgm bar/mg of the total protein. This obviously has implications for honey quality/contamination. It is interesting to note that the sub-committee only keeps referring to barnase protein but not bar protein whose expression is driven by a double enhancer promoter in one of the parental lines.
  • In the leaves of GM mustard, bar gene expression was more than 1 µgm bar/mg of the total protein in the range observed across different days of crop growth and different locations. In fact, in Bharatpur in Rabi 2011, in EH2-barstar leaves at 60 days and 110 days, it was more than 3 µgm bar/mg of the total protein. The dosage fixed in toxicity studies however looked at the average expression levels. Given large variability, how have the health effects of this been assessed?
  • The highest expression levels of bar were observed in the root tissue. It is interesting to note that this was not looked at in the context of Horizontal Gene Transfer, soil pathogens or other organisms, use of herbicide glufosinate on the GM mustard crop and resultant implications.

BARNASE AND BARSTAR GENE EXPRESSION: It is seen that in DMH-11, low levels of expression of barnase are present in the whole bud. Further, barstar expression is also noted in different parts.

The following is excerpted from a GEAC discussion in the 121st meeting:

“4.4.9 Dr Sonti informed that the Barnase Protein is fundamentally a toxic protein and used as an anti-cancer drug. It was clarified that the protein is expressed only in the tapetum and is not expressed in any other tissue as per the analysis carried out in the report. Clarifications were also sought on why very low level of expression barstar is found in other tissues in addition to anthers but not barnase even though both the genes are expressed under the same tapetum specific promoter. At the request of the Committee, Dr Pradhan clarified that in the barstar construct the selection marker bar gene is driven by 35S double enhancer promoter (a stronger promoter than the normal 35S promoter) and the barstar gene by tapetum specific TA29 promoter. In the barnase construct the bar gene is driven by normal 35S promoter and barnase gene by TA29. The barstar expression observed in tissues other than the anthers could be due to the enhancer element of 35S double enhancer promoter influencing the TA29 promoter and thus resulting in very low expression of barstar in tissues other than anthers”.

It is apparent that when the DU scientists picked up the Bayer bar-barnase-barstar technology, they chose to tweak the technology to change the barnase construct ostensibly to avoid any leaky expression of the protein but also possibly to break the IPRs of Bayer in this sphere. Here, the barnase protein expression was regulated and controlled. However, when it comes to the barstar construct, the double enhancer promoter is a giveaway for the intent to commercialise herbicide tolerance trait with very high expression levels in the male parent. This is also driving the “leaky” expression of barstar in different tissues, however and the crop developers had absolutely no intent to address this.

Allergenicity testing: The low levels of protein expression in different tissues (bar gene expression is higher of course) and some bio-informatics based analysis of lack of similarity with known allergens has been used to present the safety of GM mustard in several parts of the AFES document, ignoring the fact that the health safety concerns around GMOs flow from 3-4 factors: the individual foreign genes, the changes due to the GE process, the additional risks from the chemical usage accompanying such GMOs and any combined effects, if any.

OTHER OBSERVATIONS AND COMMENTS ON THE AFES DOCUMENT:

  • General comment on the AFES document: The AFES document reveals anything about GM mustard, as selectively as it does, in only 70 pages or so, within a 133 page document. There is hardly anything that can be gleaned about the biosafety test results from these 70 pages and GEAC is being outright stubborn in not revealing more information in the name of protecting IPRs which is unreasonable as already explained in detail, in person by the Central Information Commissioner in the first hearing in case number CIC/SA/A/2015/901798 and by the government in arguing in the Supreme Court that the public does not need to know more.

 

  • Chapter 1 Introduction: The AFES document deceptively lists out several years of work done on GM mustard – the actual biosafety testing has been condensed into very few studies, and packed into four years in all (2010-2014). Any statement that hints at studies conducted from 2003-04 or from 2008 as mentioned in Page 5 of the AFES document is outright incorrect (Chapter 1 Introduction: “Studies on the biosafety of the parental lines and the resultant hybrid DMH-11 have been carried out since 2008…..”).

 

  • Chapter 1 Introduction: The AFES document makes no mention of the fact that CMS technology exists for male sterility and hybridization possibilities. This is also a mischievous framing of the issue. Please note that CMS is included in the List of Abbreviations on Page 119 but not anywhere in the AFES document! (Chapter 1 Introduction, Page 1: “Since B. juncea is predominantly a self pollinating crop, a pollination control mechanism is required to facilitate cross-pollination for production of hybrid seeds. To achieve this, one of the parents has to be male sterile….”) (8.2. Summary: “….therefore, a transgenic technology based hybrid seed production system has been developed”.

 

  • Table 1.1.: Before this section, there should have been some description of who prepared this document, adopting what methodology, with what participation and attendance, over how many meetings, with what inputs etc.

 

  • Table 1.1.: “Selection marker bar required only for hybrid seed production” – ‘required’ does not mean anything when it comes to farmers using herbicide on the crop. This is a herbicide tolerant crop, period. Any lessons to be gleaned from large scale illegal cultivation of herbicide tolerant cotton should tell us about the reality of lack of regulation at the farmer level. This is a good example of regulatory incapability on the part of GEAC and mere statements like the one in Table 1.1. do not mean anything in reality.

 

  • Table 1.1: “Compositional Analysis conducted at Food and Drug Toxicology Research Centre of NIN”: outright lie. It had been outsourced to a private laboratory.
  • Table 1.1: Clearly shows that several studies have been conducted by the crop developers themselves. It also reveals that DRMR/ICAR not in the picture.
  • 2. Global status of hybrid seed production technology in Brassica napus using MS-RF system deploying genes used for B. juncea: Only 3 countries have approved transgenic canola for cultivation, even though there are numerous countries which grow rapeseed around the world as the regulators’ Biology Document of B.juncea reveals. Table 1.3. should make the sub-committee and GEAC ask a pertinent question based on the information provided: Why are most countries not opting for transgenic technology? Don’t they have scientists who can develop transgenic hybrids? How are they able to produce hybrids without the use of GM technology? What are their yields like? We give the response by presenting a graph below about the situation of rapeseed cultivation in different countries which are major producers of rapeseed, and their yields in the recent past. The data has been sourced from Food and Agriculture Organisation (FAO)’s statistics.

 

 

  • Table 1.4 on Rapeseed oil exports from Canada: Can the export figures of Canada be attributed to the adoption of transgenic technology, or is it to do with overall cultivation area, surplus production, and trade rules that came into being post-WTO? Are the regulators and crop developers right in putting forward Table 1.4 to defend an argument around GM canola? If yes, what is the argument and what is the evidence backing up the same?

 

Meanwhile, it is worth noting that the exports to India are quite negligible. This should be noted by those who think that GM canola oil imports into India justify and become the basis on which India should and can approve commercial cultivation of GM mustard within the country. Such an unsound argument ignores the fact that GM canola imports are minuscule compared to the overall edible oil consumption in India, and approval for commercial cultivation brings with it additional health and environmental risks, in addition to risks related to GM oil consumption which have not been tested by our regulators so far.

CONSUMPTION OF IMPORTED GM CANOLA OIL WITHIN INDIA’S OIL CONSUMPTION

(All oil figures in Million Metric Tons)

(LATEST 5 YEARS’ PICTURE)
Year Total Edible Oil Consumption Total Edible Oil Imports Largest Import: Palmolein Oil GM Oil Imports %age of GM Canola in total oil consumption %age of imported GM oils (soy & rapeseed in total consumption
Soybean oil Rapeseed/ Canola oil*
2016-17 22.4 15.5 9.8 3.4 0.350 1.6 16.7
2015-16 21.5 15.3 9.1 3.7 0.350 1.6 18.8
2014-15 20.4 12.4 9.4 1.5 0.300 1.5 8.8
2013-14 19.1 11.4 8.8 1.3 0.160 0.8 7.6
2012-13 17.4 9.1 7.1 1.0 0.015 0.1 5.8
Overall,

5 years

100.8 63.7 44.2 10.9 1.175 1.2 12.0
Source: USDA GAIN Annual Reports on Oilseeds & Products.
Reports IN6047, IN5049, IN4026, IN3034, IN2030

 

Table 1.4: GEAC has to be clarify whether all the imports listed against India have received permission from the regulators (including DGFT and whether such oil is being labeled in the market as per the Legal Metrology Act being implemented in the country). If yes, the permission details should be revealed to the nation and proof provided for regulatory clearances given and basis for the same.

 

  • Chapter 2: Biology of Indian Mustard – the fact that this document has been created and uploaded into the public domain only in 2016 is one more proof of serious regulatory failure in the country, given the fact that a document which is supposed to be a baseline for biosafety testing has been brought into existence years after all testing has been ostensibly completed!

 

  • 5. Weeds, major pests and diseases: “Weeds in rape and mustard crop are reported to cause approximately 20-30 per cent yield reduction”. The regulators have to make up their mind on whether they want to project weeds as a problem in mustard crop or not, since the crop developers downplay this in their anxiety to make sure that GM mustard is not rightly understood as a herbicide tolerant crop!

 

  • 5. Weeds, major pests and diseases: It is interesting to note that the data that emerged from field trials does not reflect the pest and disease reality summarized in this section of AFES document. This reinforces our doubt that data has been doctored in the field trial reports.

 

  • Chapter 3 Indian Biosafety Regulatory Framework: Listing out regulatory regimes from other countries does not suffice for the fact that our growing and consumption conditions are unique in themselves and we need sui generis, suitable and rigorous regulation. Further, the institutions listed out on pages 18 and 19 have proven themselves to be incapable of fulfilling the mandate of regulation capably. SBCCs and DLCs don’t exist in reality. Further, listing 1998 guidelines does not make sense since these have not been applied in the case of GM mustard. Same applies to the SOPs for field trials of 2008, which have been violated in the case of GM mustard trials. GEAC chose not to act on complaints and reports on the same.

 

  • Chapter 3 Indian Biosafety Regulatory Framework The ERA coming into existence only in 2016 reinforces the contention of many groups and citizens, including the SC PIL petitioners that approvals have been taking place without sound guidelines in place. In fact, in the AFES document, the 1998 guidelines have been referred to in a misleading fashion as Revised Guidelines for Research in Transgenic Plants, rather than the full nomenclature of these guidelines which is: Revised Guidelines for Research in Transgenic Plants and Guidelines for Toxicity and Allergenicity Evaluation of Transgenic Seeds, Plants and Plant Parts, 1998 (http://www.moef.gov.in/sites/default/files/geac/biosafety.html). These are only for toxicity and allergenicity evaluation and have nothing to do with environmental risk assessment. It means that GM mustard had proceeded this far in a vacuum of regulatory guidelines!

 

  • Chapter 3 Indian Biosafety Regulatory Framework (page 20): To argue that revised documents are subjected to wide ranging consultations is ironical for a government which is refusing to take cognizance of the recommendations made by the Supreme Court Technical Expert Committee’s independent report which includes Government’s nominees.

 

  • Figure 3.1.b Step by Step process followed by the applicant for regulatory approval: It is clear that GM mustard did not follow this process of approval when parents were swapped after 2006-07 trials. In the Supreme Court reply filed by the Government of India in IA 47 of 2016 (WP 260 of 2005), under “Reciprocal change in the parents of hybrid DMH-11”, the government fails to provide any proof for formal permission having been accorded. It states “100. It is submitted to the Honourable Court that the developers had informed the RCGM in the year 2006 that after the trials of 2006-07 for all the testing of barnase/barstar system and hybrid DMH-11, Varuna barnase line and EH-2 barstar line would be used”. This is one of those sections in the rejoinder when the government failed to produce any Annexure as proof and it is amply clear that no permission has been accorded (the claim is not about permission given but information provided by the applicant which can be cooked up any time like many other cooked up materials in this GM mustard dossier).

 

  • 2. Step by Step process followed by the applicant: This is a misleading heading since there is no clear sequence laid down or followed – tests happen in a parallel fashion as per convenience more than anything else. Further, page 23’s bullet point on confined trials’ conditions mitigating the ‘persistence of the GE plant and its progeny in the environment’ ignores and does not reveal the fact that GM mustard trials violated these conditions and we had provided photographic proof of the same to GEAC, which chose not to act on the complaint at all.

 

  • 2. Step by Step process followed by the applicant, Page 23:the data is generated to compare GE lines with their non-GE counterparts for various parameters” is an outright false statement since DMH-11 did not have any non-GE counterpart or equivalent control for several parameters.

 

  • 2. Step by Step process followed by the applicant, Page 23:In addition, the statutory bodies can exempt or prescribe generation of additional information or data on biosafety….”. It would be useful to know from the regulators why this provision was used only to exempt and not to prescribe additional data in the case of GM mustard?

 

  • 2. Step by Step process followed by the applicant, Page 24: CCC could not have ensured compliance as claimed in the AFES document, given the timing of monitoring visits. However, they pointed out to violations which were not taken seriously by GEAC and no action initiated.

 

  • 2. Step by Step process followed by the applicant, Page 24:The evaluation of food/feed and environmental safety is carried out by the RCGM” – why should this be done by RCGM in the first instance when DBT has funded the project and approved the protocols?

 

  • 3. Step by step regulatory compliance and data generation in the case of GE mustard parental lines and hybrid DMH-11, Page 24: “Based on the BRL I studies, approval was granted by GEAC for BRL II field trials in October 2014” – there was no appraisal of any data generated in the BRL I studies given that nearly all studies were claimed to be completed in the 2 years of BRLI studies as the list of studies given in the GEAC’s 121st meeting minutes show. All food safety and environmental safety studies were claimed to have been completed by then. However, GEAC does not study the results before proceeding forward and the minutes are a clear demonstration of this lack of responsible discharge of duties. It is also apparent that the final dossier was submitted in February 2016, as per the AFES document Page 25 description. This means that no further assessment, including of the many points made by civil society representatives were ever put to the developer or addressed.

 

  • 4. Assessment of Food/Feed and Environmental Safety (AFES) – Risk Assessment Process: Invoking relevant excerpts from the ERA 2016 guidelines is laughable given that this document was not in place when GM mustard appraisal took place!

 

  • Figure 3.2.: GEAC has to state explicitly who are the stakeholders who were involved in the decision-making process in the figure presented for “components of risk analysis” and also show proof of how they were involved in the case of GM mustard.

 

  • Risk Context, page 26: From a perusal of the AFES document and from knowing the way the GM mustard appraisal took place, it is clear that GEAC does not know about the Risk Context – this includes socio-economic realities of poor rural female agricultural workers, about chemical use in states like Punjab, about growing and consumption conditions in India, about the impact of environmental toxins on an already malnourished population etc. etc.

 

  • Risk Assessment, Page 26: It is apparent that GM mustard was not evaluated as a HT crop and the entire risk assessment stands invalid just on this count.

 

  • Figure 3.3 to describe an iterative process of risk assessment, page 30: Can GEAC demonstrate what iterative processes did they run at all, and why they did not take the opportunity of rigorous evaluation before the large scale trials or BRL II of GM mustard?

 

  • Risk assessment process for breeding stacked events, page 30: We have already shown that parental events did not undergo all studies and the claim in the last line on this page is incorrect.

 

  • Risk Communication: “…Indian government’s commitment to clarity, transparency and accountability for decision-making processes”. This is most ironical, these claims on transparency, clarity and accountability. Here is a classic illustration of how none of these are adhered to by the Indian government and its regulators!

 

  • Page 31: “However, such authorization shall also be subject to all other laws…relevant at that time”. The GM regulators are complicit along with the crop developers in violating the Insecticides Act in India by allowing glufosinate use on mustard crop. It is clear that no such conforming to other laws is being practiced.

 

  • Chapter 4, Molecular Characterisation: We have already shown how inconsistent protein expression levels data is across different reports. Does this indicate stability of the events?

 

  • Chapter 4, Molecular Characterisation: This is where the AFES document should also have provided information on all the IPRs on all the genetic materials used in GM mustard creation – the spacers, the promoters, the terminators, the desired transgenes, the constructs, the processes as well as the products, here in India and elsewhere. Any MTA terms and conditions should also have been revealed. This is where information on Glufosinate patent held by Bayer (through its subsidiary) in India should also have been revealed which is valid till 2018.

 

  • 2. The male sterility-fertility restorer technology: “The system has the potential of hybrid seed production to bring about a substantial increase in crop productivity…amount of yield increase depending upon the parental germplasm”. Where has this potential that makes claims on yield increases depending on parental germplasm been proven or established? Only pollination control potential has been shown, that too inadequately.

 

  • 2. The male sterility-fertility restorer technology: Claims on successful deployment of barnase-barstar system based heterosis breeding in 3 countries does not stand scrutiny from the fact that most other higher-yielding countries have not used this technology as we have already shown.

 

  • 2. The male sterility-fertility restorer technology: Brassica juncea being described as a predominantly self-pollinating crop demands a thorough justification for how Varuna barnase male sterile line produced such good yields in the GM mustard trials!

 

  • Page 34: “later, the elite barnase event was transferred to Varuna genotype of B.juncea while the barstar gene construct event was used to transfer the barstar gene to EH-2 genotype via backcross breeding” – GEAC has to produce evidence of permission granted for this.

 

  • Page 39 and 40, narrative description, Table 4.1. and Figure 4.4. on double enhancer promoter driving the bar gene: “In the barstar gene construct, the bar gene, used as a plant selectable marker, is controlled by CaMV35S double enhancer promoter. This promoter confers a 10-fold increase in the expression levels over the corresponding single enhancer counterpart”. GEAC has to explain what is the purpose of using a double enhancer promoter for bar gene expression. This alone is a dead giveaway for the herbicide tolerance trait intended to be exploited by the crop developer and there is absolutely no purpose for this double enhancer promoter, especially given that it is also causing the problem of barstar expression unnecessarily at higher ‘leaked’ levels.

 

  • Table 4.1. should be accompanied by IPRs related information on all these genetic materials/gene components introduced.

 

  • 4. Method of genetic transformation of B. juncea: “The combining ability studies earlier had shown that hybrids between these two lines are significantly more productive than the parental varieties and the national and/or regional checks– Outright lie. No national and regional checks were used as required and therefore, no significant productivity increase has been shown!

 

  • 5. Characterisation of the inserted genetic material and stability of the genetic modification: “The male sterile barnase line has been analysed over ten generations under containment/field conditions and shown to stably inherit the male sterile phenotype with no breakdown of sterility” – outright lie. Data from field trials shows that male sterility broke down given that seed setting happened in bagged male sterile branches also.

 

  • 6. Expression of the introduced genes: “Some level of expression (of barstar gene) was also observed in the leaf, stem and the root tissues. This could be due to the presence of a strong 35S double enhancer promoter driving the expression of bar gene”. This certainly has to be explained by GEAC as to why the double enhancer promoter had to be used, especially given that barstar is expressing in other parts because of this!

 

  • 6. Expression of the introduced genes: “In addition to anthers, low levels of barstar transcripts were also observed in other tissues of hybrid DMH-11”. What then are the implications for honey quality and contamination, for instance? GEAC should put out data on the protein levels detected.

 

  • Table 4.2. on Expression Levels of Barnase, Barstar and Bar proteins in the GE mustard lines: Interestingly, this is the only table where data is presented in a summarized fashion, across 3 BRL season trials from field grown plants, and one season of contained net house plants. However, this does not help a reader to understand the variability found across seasons and growing locations and to cross-verify whether the highest levels were taken into account when toxicity testing dosages were fixed. Given the obfuscation of data that GEAC indulges in, it is important that the full data is shared separately for each year and location for this parameter.

 

  • 6. Expression of the introduced genes, Page 49: While description of proteins in seed and edible oil is presented, there is no information on oil cake and impact of use of such oil cake for soil amendments. What impacts are present from the oil cake of a herbicide tolerant transgenic mustard crop, sprayed with herbicides by farmers? What about cold pressed oil and oil cake specifically from such processes? Is risk assessment complete without exploring these aspects?

 

  • 8. Functionality of the introduced proteins for male sterility and restored fertility: “…the functionality was confirmed by the absence of seed set upon self pollination by bagging the inflorescence”. Outright lie, as field trial data shows. In fact, protocols should have been standardized and this aspect tested further, rather than making false statements.

 

  • 10. Cloning, purification and production of pure Barstar, Barnase and Bar proteins for biosafety studies: It does not help to describe such production and use of pure proteins, given that in reality, individual proteins do not exist, but they move as bound complexes. Testing did not account for this and to that extent, the tests are invalid.

 

  • 11. Conclusions of this Chapter are questionable on how the transgene is inherited stably with no breakdown in sterility over many generations in the male sterile line.

 

  • Chapter 5 Food and Feed Safety Studies: In this Chapter, it is rationalized that animal feeding studies are required only if compositional analysis shows statistically significant differences, especially in comparison to values/ranges for conventional varieties available in literature or recognized databases (“weight of evidence approach”). However, such differences were ignored and discounted completely as we have shown in this note.

 

  • Page 79, Assessment of any potential weediness of GE hybrid DMH-11 and the parental lines: “The data also shows that GE hybrid DMH-11 is not prone to pod shattering”. We challenge GEAC to produce evidence for this, since no data on this has been collected other than a simple yes or no, that too not across all trials!

 

  • Page 79: “farmers are not required to spray Basta in the hybrid GE DMH-11 field for weed control as Basta is not a recommended herbicide in the package of practices for mustard cultivation in India” – this is either a naïve statement or an over-smart one. No farmer is waiting to use only recommended chemicals in this country!

 

  • Page 80: The statement that there is no evidence that GE herbicide tolerant crops are more invasive than their conventional counterparts is not borne out by the feral populations detected in various locations.

 

  • 3. Studies on soil microbial community: The tests and conclusions are invalid since GM mustard has not been tested as a herbicide tolerant crop. It is also unclear whey other species like collembolan and earthworms were not prescribed in soil impact studies. The rationalization of safety based on excessive discussion on barnase protein (Page 90) is not reliable given that bar protein gets expressed in high levels in root tissues. The unscientific justification that the proteins are already widely present in nature and their presence in GE mustard is not expected to present any new toxicity risks to soil micro-organisms is laughable given that it ignores the fact of increased proteins like bar in large quantities from cultivation of GM mustard. How is it possible that the proteins will be present at the same levels with and without GM mustard? “Overall, not a single physical or chemical stressor was introduced in soil by GE mustard” is untenable given that HT mustard will certainly add to the chemical stressors to be introduced in soil. Only bacterial count was taken up in these studies and even here, there were variations that were found but ignored.

 

  • Page 95 ignores studies that do exist of negative impacts on bees from GM crops.

SEVERAL OTHER ISSUES RAISED BY US IN THE PAST, OF A MORE FUNDAMENTAL NATURE AROUND GM MUSTARD, REMAIN UNANSWERED TO THIS DAY.

ALL THE ABOVE ARE ILLUSTRATIONS OF HOW THE AFES DOCUMENT IS UNRELIABLE IN ITS ANALYSIS AND CONCLUSIONS.

 

 

 

 

 

 

 

 

 

 

 


 

Annexure: RTI that shows that CGMCP evolved all the test protocols!

[1] This note has been prepared by Kavitha Kuruganti (kavitakuruganti@gmail.com). This note seeks to show how GMOs like GM mustard which are unneeded and unsafe, can be cleared only by compromising on scientific rigor. Utmost attention has been paid to be accurate & scientific and if there are any mistakes, request that the same be pointed out to me.