———- Forwarded message ———
From: Kavitha Kuruganti <kavitakuruganti@gmail.com>
Date: Sun, 14 Jul 2019 at 06:21
Subject: Thank you for meeting with us – our letter and key proposals
To: O/o A.K. Jain <asaj.moefcc@gov.in>, <sricha@ias.nic.in>
Cc: Kapil Shah <jatantrust@gmail.com>, Rajinder Chaudhary <rajinderc@gmail.com>, ananthoo organic <organicananthoo@gmail.com>, Ajay Etikala <ajayaero18@gmail.com>, BKU Delhi <yudhvir55@yahoo.com>

 

To:

Shri AK Jain,

Chairperson,

Genetic Engineering Appraisal Committee,

Ministry of Environment, Forest & Climate Change,

Government of India.

Dear Sir,

Thank you for meeting with our delegation on July 12th 2019 and for listening to various proposals for regulatory improvements that we put forward. I am attaching the soft copy of the letter we submitted to you. Some of the key issues we raised were:

1. that a Rule be instituted under the EPA 1986 making the Event Developer as the one who is legally liable for any unapproved releases of GMOs into the environment, including illegal cultivation of GMOs, which in itself will go a long way in preventing leakage of seeds.
2. that the FISEC on illegal Bt brinjal cultivation be re-constituted with civil society representatives included, with shorter time period and changed Terms of Reference, led by your Ministry which is the competent authority and to include a detailed investigation into illegal HT soy cultivation in Gujarat (and any other state). Such a FISEC should also address itself to the issue of cleaning up of contamination.
3. that event-specific test protocols with primers be deposited by all event developers, starting from the event selection stage itself, with these being available with all accredited laboratories notified as designated labs for testing by authorities enforcing EPA 1986 as well as other regulations in India (under Foreign Trade Act, Food Safety & Standards Act etc.).
4. that standard operating procedures (SOPs) be put into place for every complaint related to illegal GM cultivation which are rigorous and lead quickly to liability-fixing, assessment of contamination and remediation of the same.
5. that all imports from GM crop cultivating countries and of all known GM crops which are under field testing and cultivation in the world be tested rigorously, without a dependence only on “declarations” of GM consignments.
6. that an inter-ministerial, inter-agency empowered body be set up with GEAC facilitating the creation of such a body, so that illegal GM imports do not become the route to breach India’s bio-safety and bio-security.
7. that an applicant’s dossier on a particular GM crop application (event based approval), have a time period validity and not be kept open for any number of seasons/years, and that Mahyco’s Bt brinjal dossier be rejected given that it has been ten years since it was submitted with no additional test done despite the moratorium decision note asking for such tests.
8. that GEAC re-look at the fact that it has not put out the GM mustard biosafety dossier in the public domain like it did for Bt cotton and Bt brinjal, and that it did not review the feedback given by many experts despite the Ministry asking for the same. (http://indiagminfo.org/gm-mustard-expertspeak/)
9. that GEAC, as part of its own mandate of stopping illegal GM crop cultivation as in the case of HT cotton, write to the Ministry of Agriculture & Farmers’ Welfare, to ban the use of herbicides like Glyphosate and Glufosinate.
10. that GEAC notify that all genome editing techniques come under the purview of EPA 1989 rules and regulation therefore applies. Anything taken up in terms of R&D or imports or exports or commercial production/use without approvals of GEAC should be considered illegal and liability fixed accordingly. (Our earlier letter to you on this subject is available here: http://indiagminfo.org/gene-editing-techniques-and-other-new-gene-technologies-have-to-be-regulated-as-per-epa-1989-rules/)

We hope all these will receive a positive consideration and action from your side, as discussed in the meeting. Thank you.

Sincerely,

Kavitha Kuruganti

=======================================

To:                                                                                                  July 12^th 2019

 

Shri A K Jain,

Chairperson,

Genetic Engineering Appraisal Committee,

Ministry of Environment, Forest & Climate Change,

Government of India.

 

Dear Sir,

 

Sub: Concerns with regard to failure of regulators with regard to GMOs in India – reg.

 

Greetings! Thank you for meeting with us today on various issues of concern with regard to GM regulation in the country that we wanted to raise with you. We are engaging with GEAC on the state of regulation of GM technology in the country after a long time and please bear with us for the lengthy nature of this communication.

 

1. ILLEGAL GM CROP CULTIVATION IN THE COUNTRY

 

As you would be aware, the discovery of illegal cultivation of GM brinjal in Haryana is the fourth time that such illegal cultivation is being discovered in India. Bt cotton illegal cultivation found on very large tracts of land in Gujarat is what led to a hasty approval of Bt cotton for commercial cultivation in India in 2002. By 2009, illegal herbicide tolerant cotton seed began to be sold in India. One packet of such seed with video footage was sent to GEAC along with a complaint which was discussed for the first time in GEAC’s 98^th meeting in December 2009. Subsequently, a fact finding report was also sent about such unapproved HT cotton cultivation from Andhra Pradesh. However, the regulators turned a blind eye to HT cotton spreading into lakhs of hectares without any attempt to crack down on this illegal activity. In November 2017, unapproved HT soy cultivation was discovered in Gujarat and there was no concrete action taken up on this either. In the recent past, the fourth such instance of illegal GM crop cultivation came to light in Haryana. Once again, we found the regulators floundering or unwilling to act decisively. It is in this context that we bring up the following actionable points with you:

 

1. Constitution of Field Inspection & Scientific Evaluation Committee (FISEC) by DBT on 21/6/2019:

 

• It was on April 25^th 2019 that the first complaint was lodged about illegal GM brinjal cultivation along with a sample, with the GEAC. There was no action subsequently for a long time, not even in terms of acknowledging the receipt of the complaint. After several reminders by Dr Rajinder Chaudhary, there was a routine response sent and there was no alacrity apparent from the regulatory apparatus of the kind expected.
• Now, nearly two months later, a FISEC has been set up with a term of six months! It is not apparent why this Committee would need six months’ time to address the terms of reference given to it when this can be done, and should be done, in an intense time period of one month’s time.
• The Terms of Reference make no mention of verification for contamination and extent of such contamination, as well as remediation to be taken to clean it up.
• It is not clear why data and information collected by FISEC should be confidential, and the same in the ToR requires to be removed.
• It is not clear why a similar FISEC or the same FISEC mechanism has not been put into place for the illegal HT soy discovered in Gujarat in 2017, and why it is being assumed that such soy is not being cultivated elsewhere. Further, the likely source and methodology of spread of illegal GM soy has not been ascertained so far, and no liability fixed.
• We also believe that this Office Memorandum should have been issued by GEAC in fact, as per Rules 7 (1), 8 and 10 of the EPA 1989 Rules, which make GEAC the competent authority in all such approved and unapproved deliberate releases of GMOs, and not the RCGM or DBT. This is important given that the DBT is a promoter of modern biotechnology.

 

Given the above, we would like the FISEC terms of reference to be changed, including GEAC taking a lead in the process, and civil society representatives also to be included into the FISEC composition.

 

1. Event-validated test protocols, primers and testing:

 

We are appalled by the fact that the NBPGR (National Bureau of Plant Genetic Resources) report has not been put out in the public domain. Be that as it may, it is clear that other than confirming that the samples picked up in Haryana’s Fatehabad brinjal field were indeed genetically modified, based on the promoter sequences and other sequences identified, the test did not provide any information on LOD, nor the event for which the GM brinjal tested positive. It is not clear whether the testing was rigorous in terms of positive controls (against the specific DNA for which the test is looking out for), negative controls, extraction controls (of reagents used), environment controls (for presence of contaminant DNA in the lab’s atmosphere) and template controls.

 

What such testing requires is known and verified primers to be provided (both pure DNA and plant material containing the gene) to all the accredited labs to which samples will be sent along with proper testing protocols (like the controls mentioned above). In the absence of this, identification and zeroing in on a particular event will not be possible. It is shocking that despite so many capacity building and other programmes run by the MoEFCC related to biosafety with World Bank and GEF funding, and despite so much public fund being spent on the various projects by DBT, that we have not equipped our laboratories to have all event validated test protocols with known and verified primers, for ALL GM events that the event-developers are dabbling with!

 

The tests done by NBPGR are unreliable as far as we can see, and have no pointers towards the next action to be taken. (Incidentally, our initial complaint was based on a lateral flow strip test finding on Cry1Ac protein). It is pathetic that this country’s regulatory regime is in this shape, even though “scientific regulatory regime” is something that is touted in the Supreme Court and elsewhere by the Government of India.

 

It is important that STARTING FROM THE EVENT SELECTION STAGE, that the event / crop developer is made to deposit event-validated test protocols with the regulator, which are to be passed on immediately to all the accredited testing laboratories. The primers should be available with all labs which are expected to receive samples for testing, for all GM events that the country’s regulators have allowed R&D on. Standard and world class testing SOPs have to be put down for the accredited labs that they have to adhere to.

 

1. Standard Operating Procedures (SOPs) to be evolved and issued immediately about what should be done whenever there is a complaint about illegal GM discovery:

 

There are no SOPs laid down for state governments and GEAC when a complaint of illegal GM cultivation is made. We have found that state governments and the local authorities are often clueless and unequipped about the procedures to follow, legal or technical. There is a need for standard operating procedures to just kick in, as soon as the first complaint comes in. This should obviously include keeping several samples before destroying the field confirmed to be illegal GM. Such SOPs should have rapid timelines laid down. Such SOPs should also include procedures to be followed with the farmer, seed suppliers, event developer, testing laboratory, which Sections and Rules of different Acts to be used etc. etc. We have found that time and time again, it is the farmers that the system is able crack down upon, while the seed suppliers and event developers go scot-free!

 

1. Liability to be fixed on the Event Developer for any Illegal GM cultivation:

 

No GM seed is ever supposed to leak out if event developers and applicants follow the biosafety norms laid down for various kinds of trials, starting from the institutional labs for R&D etc. If there is any such leakage of seeds that leads to illegal GM crop cultivation, it is obvious that it is because of the failure of the event developer to follow and adhere to norms laid down. It clearly follows that any liability for illegal GM crop cultivation should be fixed squarely, first and foremost, on the event developer. It is very simply a case of “polluter pays” of environmental jurisprudence. Using Sec. 3 (2) (vii) (“laying down procedures and safeguards for the handling of hazardous substances”), Sec. 5 (“Power to give Directions”) and/or Sec. 6 (“Rules to regulate environmental pollution”) of the Environment Protection Act 1986, a new Rule should be notified in India, to make the event developer liable for any illegal GM crop cultivation in the country.

2. ON IMPORTS FROM GM CULTIVATING COUNTRIES AND OF KNOWN COMMERCIALISED GM CROPS

Our concerns with regard to GM imports are related to both the illegal, unapproved kind, as well as the fact that GEAC appears to be evolving guidelines and considering approvals for GM feed imports.

1. Some of the illegal GM crop cultivation that we witnessed in India has originated through illegal GM imports, and not always from GM R&D and field trials that have been allowed in India. The GM HT soy found being illegally cultivated in Gujarat has not been approved for field trials in India, for example.

 

1. There is clearly a problem with imports coming in from known GM producing countries (USA, Canada, Brazil, Argentina, Paraguay etc.), where a substantial part of the produce is of the GM variants of the crop, of known commercialised GM crops like soy, corn/maize, canola, cotton, papaya, apples, sugarbeet etc. What is even more dangerous is that SEEDS are being imported from those countries which grow GM variants of crops for which such seeds are being imported into India routinely, in large and small quantities. Despite this being a possible source of illegal imports and contamination of our seed stocks and environment, much produce comes in from these countries in the form of seeds (live GMOs), as well as grains and feed. To this day, the GEAC and other regulators have not put into place, any system of random sample testing of such imports to ensure that non-declared GM material does not come in clandestinely and are relying on importers to declare their consignments to be GM, and to walk up to the regulators for approvals if it is GM! This is obviously totally inadequate to check clandestine imports. There is absolutely no risk anticipation and management that exists on this front.

 

1. Legally declared GM is supposed to come in only after approval from GEAC (for GMOs and GM grain/feed) or FSSAI (for GM foods). However, it is seen that approvals do not happen after a full spate of independent scientific tests within the country as was seen in 2007 when GM soy oil was allowed to be imported. This then jeopardises the health of the consumers, and the regulators are clearly failing in their mandate of risk assessment and management. Why should Indian regulators rely on regulatory clearances elsewhere when our conditions are vastly different in the country? This is also in clear violation of the guidelines laid down by the regulators for safety assessment for GE food and feed which then makes the whole procedure illegal.

 

1. GM import applications seem to consist of DDGS (Dried Distillers Grain Solubles), GM grain, GM sugar (raw and refined), GM oils (soy and canola) and other GM (livestock) feed. GEAC had decided to pass on the applications for GM oils and GM sugar to FSSAI. From its March 2018 meeting, GEAC has been discussing these matters over several meetings trying to evolve procedures, with a sub-committee under Dr Veluthambi formed first, followed by another under Dr Lalitha Gowda.

While GEAC is considering applications and evolving procedures and guidelines, we draw your attention to two facts: (i) that GM animal feed, in published studies, is recorded to have adverse impact on animals fed with such feed. (ii) such imports also jeopardise our farmers’ livelihoods in India when they are priced out by such imports.

What is worrying is that GEAC and other regulatory agencies do not have a testing or institutional mechanism to have a rigorous and active surveillance on every consignment of imports for crops and crop products for which GM variants exist in the world. How is GEAC sure, for instance, that the applicants who asked for GM feed import permission in 2015 and so on have not found ways and means to import such feed into the country?

1. There is institutional coordination missing between different ministries and agencies right now. Customs Department is not in the picture in any regulation right now – Department of Revenue or Ministry of Finance are not in the regulatory regime of any kind, despite being the frontline people for imports. Similarly, Agriculture Ministry is not in the regulatory regimes of DGFT or MoEFCC in any clear fashion at this point of time, though the PPQS (Plant Protection & Quarantine Services) division has its own legal regulation around GM crop imports, which require prior approval from GEAC. It is not clear how they enforce their regulations without coordination with other ministries and regulatory bodies. When it comes to imports, FSSAI, DBT/RCGM and NBPGR also come into the picture on occasion, other than the fact that DGFT is not supposed to allow the import of any GM material without the explicit approval of GEAC and without an explicit declaration by the importer. It has been seen that GM food materials have been brought in without the permission of GEAC or FSSAI and without any declarations to the DGFT but with the labels sometimes claiming that a food product could be GM!

 

It is apparent that there is a need to have one inter-ministerial and inter-agency body that is tasked with monitoring all imports into India, with scientific sampling and testing, to ensure that no GM material gets in. GEAC itself was visualised to be that body with representation from DGFT, PPQS, FSSAI etc., but from the proceedings of the meetings of GEAC, it is clear that it is not focusing on the dangers of illegal GM imports, nor does it in reality have any power to enforcestoppage of illegalities and GEAC should address itself to recommending mechanisms to ensure this.

 

3. ON GM MUSTARD

While the GEAC in its 133^rd meeting in May 2017 recommended the “environmental release”  of GM HT mustard developed by Delhi University, the decision of the Government was clearly to keep the matters of environmental release of transgenic mustard pending, for further review.

The  process that GEAC then undertook and called as a “further review”, in its 134^th meeting in March 2018 was shocking.  GEAC brushed aside all the concerns and scientific issues raised with regard to HT DMH-11 hybrid mustard, with regard to its claims of superior yields, hybrid vigour, stable sterility trait induced etc., as well as its environmental and health safety, and asked for “field demonstrations” by the applicant and for additional data to be generated. What’s worse, even on this decision, there was a rollback on some tests prescribed. It is another matter that such “field demonstrations” were not undertaken by the applicant for some reason.

This is to point out once again that the GM HT hybrid dossier of Delhi University has no merit whatsoever in the need for such a GM crop, nor the veracity and scientificity of the biosafety and other data produced so far. There are  detailed analyses of independent experts to show this, which was done despite the fact that the biosafety dossier was actively hidden by the regulator from public scientific scrutiny and a farcical process was instituted of providing a one month window for scientists and others to come to Delhi and refer to thousands of pages of data without the right to copy any of it for proper study. This dossier needs to be rejected in toto by the GEAC and all testing and biosafety data needs to be permanently put up on the GEAC website for proper peer review. It was such scrutiny that revealed the serious flaws in the testing of Bt brinjal and the GEAC should welcome, not avoid, such scrutiny and feedback if it wishes to do objective and scientifically acceptable appraisals.

4. ON MAHYCO’S BT BRINJAL APPLICATION

We were appalled that GEAC in its 136^th meeting in September 2018 actually considered an application from M/s Mahyco for “large scale environmental release”/”demonstration” of Bt brinjal in India. What is more, GEAC was more eager than the crop applicant, to get Department of Agriculture Research & Education to seek information from Bangladesh, on which to base its further decisions! The indefinite moratorium decision note of the Government of India in February 2010 clearly asked for Bt brinjal to be established, through independent scientific studies and to the satisfaction of both the public and professionals, as safe from the point of view of its long term impact on human health and environment, including the rich genetic wealth existing in brinjal in our country. Not a single additional study has been undertaken to prove Bt brinjal’s safety, while the regulator is keen on bypassing the terms and conditions of the moratorium decision. We demand that GEAC reject the application and biosafety dossier of Mahyco in toto with regard to its Bt brinjal containing EE-1 event straightaway. In fact, the current system of applicants being able to re-open their long pending applications (one decade in the case of Bt brinjal) with this kind of ease is not acceptable. The earlier biosafety dossier has to be rejected formally by GEAC without any more delay.

5. ON ILLEGAL HT COTTON

The current regulatory collapse with illegal HT cotton being grown on lakhs of hectares is clearly the result of GEAC’s lackadaisical approach to fulfilling its mandate. GEAC should now write to the Ministry of Agriculture & Farmers’ Welfare to ban glyphosate all over the country because one of the key factors aiding the spread of such illegal HT cotton is the easy availability, illegal at that, of glyphosate. Stopping glyphosate sales completely will lead to not only better health and environmental outcomes but also in curbing illegal HT cotton cultivation. We request GEAC to formally write to the MoA&FW seeking a complete ban on glyphosate usage in the country as well as similar herbicides like Glufosinate.

6. ON NEW GENOME EDITING TECHNOLOGIES

We are seriously concerned that GEAC is right now not taking the responsibility for regulating gene editing technologies being deployed in India too. There is much scientific evidence emerging on the unpredictable changes that emerge from gene editing techniques. We had written to GEAC way back in August 2018 about this, but received no response so far. (Ref. http://indiagminfo.org/gene-editing-techniques-and-other-new-gene-technologies-have-to-be-regulated-as-per-epa-1989-rules/).

IN CLOSING,

We demand:

* that a Rule be instituted under the EPA 1986 making the Event Developer as the one who is legally liable for any unapproved releases of GMOs into the environment, including illegal cultivation of GMOs which in itself will go a long way in preventing leakage of seeds.

* that the FISEC on illegal Bt brinjal cultivation be re-constituted with civil society representatives included, with shorter time period and changed Terms of Reference, led by your Ministry which is the competent authority and to include a detailed investigation into illegal HT soy cultivation in Gujarat (and any other state). Such a FISEC should also address itself to the issue of cleaning up of contamination.

* that event-specific test protocols with primers be deposited by all event developers, starting from the event selection stage itself, with these being available with all accredited laboratories notified as designated labs for testing by authorities enforcing EPA 1986 as well as other regulations in India (under Foreign Trade Act, Food Safety & Standards Act etc.).

* that standard operating procedures be put into place for every complaint related to illegal GM cultivation which are rigorous and lead quickly to liability-fixing, assessment of contamination and remediation of the same.

* that all imports from GM crop cultivating countries and of all known GM crops which are under field testing and cultivation in the world be tested rigorously, without a dependence only on “declarations” of GM consignments.

* that an inter-ministerial, inter-agency empowered body be set up with GEAC facilitating the creation of such a body, so that illegal GM imports do not become the route to breach India’s bio-safety and bio-security.

* that Delhi University’s GM mustard and Mahyco’s Bt brinjal dossiers be rejected in toto for reasons explained above.

* that GEAC, as part of its own mandate of stopping illegal GM crop cultivation, write to the Ministry of Agriculture & Farmers’ Welfare, to ban the use of herbicides like Glyphosate and Glufosinate.

* that GEAC notify that all genome editing techniques come under the purview of EPA 1989 rules and regulation therefore applies. Anything taken up in terms of R&D or imports or exports or commercial production/use without approvals of GEAC should be considered illegal and liability fixed accordingly.

We request that GEAC take up all the suggestions provided in this letter for the numerous regulatory failures that are apparent all around, and provide citizens with an action taken report on the same in a time bound manner to build public confidence in its sincerity of intent in discharging its mandate. Thank you.

 

Sincerely,

Sd/-

 

Kavitha Kuruganti                           Yudhvir Singh                      Kapil Shah

ASHA                                            ICCFM/BKU                         Jatan

8880067772                                  9899435968                        7567916751

 

 

 

Rajinder Chaudhary                         Ananthoo

Kudrati Kheti Abhiyan                      Safe Food Alliance

9416182061                                  9444166779

 

 

Copy:

1. Shri Prakash Javadekar, Union Minister for Environment, Forest & Climate Change
2. Shri Narendra Modi, Prime Minister of India