GEAC SUB-COMMITTEE’S BIOSAFETY CLEARANCE OF GM MUSTARD: HOW RELIABLE[1]?

India’s apex regulatory body called Genetic Engineering Appraisal Committee or GEAC has recently (on September 5th 2016) put out an announcement inviting public feedback till October 5th, on its assessment of GM mustard. The following pages are the analysis of the Coalition for a GM-Free India which present the picture with regard to a regulatory Sub-Committee’s risk assessment processes and their AFES (Assessment of Food & Environmental Safety) document’s (lack of) reliability with regard to GM mustard. Please note that we have many comments to make on what the AFES document concludes on many aspects and importantly, what it ignores in terms of key risk assessment parameters. But that is for another day, for analysis after the full biosafety data is accessed. In this note, we limit ourselves to some illustrations of how the Sub-Committee & Biosafety Support Unit raise some serious questions, and then walk away meekly from those very questions without any scientific or satisfactory responses, going by the AFES document.

• Hasty processes for assessment were adopted (please don’t be misled by how many months went by since the application, but look at the actual assessment time put in) by initially giving only 15 days to the Sub-Committee. The rest of the processes of receiving responses from CGMCP were apparently based on just this work and nothing else – why?
• GEAC violated its own decision that the RARM and full biosafety dossier would be reviewed first in the GEAC. GEAC did not discuss the document but is inviting public comments on a ‘proposal on authorization of environmental release’ of GM mustard – is this appropriate?
• The queries raised by citizen representatives based on their access to limited information went unanswered and unaddressed by Sub Committee – is that because there are no real answers?
• The Sub-Committee of 7 was constituted with at least 3 members having conflicting interests – why should the public trust the work of this Committee, especially given that the biosafety dossier is being kept away from the public?
• MOST IMPORTANTLY, THERE WAS NO HEALTH SAFETY EXPERT in the Sub-Committee processes – and the report still gives a green signal to biosafety – is this reliable and scientific?
• The Sub-Committee made some hard observations after its 15-day “assessment” and even hinted at additional studies required. However, there is no evidence in the AFES that all such questions have been answered, observations responded to, and newer analysis presented. So what happened in between for the Sub-Committee to give an unqualified clean chit on the biosafety of GM mustard? Doesn’t the regulatory body have a responsibility to tabulate and share the comments of the sub-committee incl. DBT Biosafety Support Unit’s comments, the CGMCP response and then conclusion about how the safety inference was made?
• Readers might remember how GEAC tried to do similar things with its EC-2 (Expert Committee 2) of Bt brinjal, where at least half of the members who were also part of EC-1 and recommended several additional tests went back on their own recommendations and started claiming that everything was safe with Bt brinjal. However, the rest is history as they say.

 

A document was uploaded on MoEFCC/GEAC’s website (http://envfor.nic.in/major-initiatives/geac-clearances) on September 5^th 2016, called “Assessment of Food & Environmental Safety” (AFES document), inviting comments for “the proposal on authorization of environmental release of Genetically Engineered Mustard (Brassica juncea) hybrid DMH-11 and use of parental events (Varuna bn3.6 and EH-1 modbs 2.99) for development of new generation hybrids” (http://www.moef.gov.in/sites/default/files/Note%20inviting%20comments_0.pdf). This note is not the GM mustard biosafety dossier, but a pre-concluded document that gives a clean chit to the biosafety of GM mustard. This note was put up in a format that cannot be printed (altered after public pressure), and feedback is being sought within a month (deadline of October 5^th 2016) in a prescribed format. Further, GEAC announced that those who are interested in accessing the full biosafety dossier of the GMOs in question could come to their office in Delhi, by prior appointment and access the same!

As pointed out in a letter to the GEAC Chairperson by Alliance for Sustainable & Holistic Agriculture (ASHA) on September 5^th 2016 night, it is apparent that this “proposal on authorization” was not discussed in the GEAC and it is unclear when and how this became such a proposal. (http://indiagminfo.org/?p=1438). On September 7^th, a media story appeared to show that this report was not shared with GEAC members before it was released for public feedback. This revelation was made by none other than the Supreme Court appointee in the GEAC, Padma Vibhushan Dr Pushpa Mittra Bhargava. (http://timesofindia.indiatimes.com/city/delhi/GM-Mustard-report-was-not-shared-with-GEAC-members-before-it-was-released-Scientist/articleshow/54042063.cms)

In this document, we show you what this AFES document is really about, so that citizens can conclude how this green signal came about.

Sub Committee of GEAC:

In the 125^th Meeting of the GEAC on 11^th December 2015, Dr Deepak Pental of CGMCP of Delhi University was invited by the regulatory body to make a detailed presentation on his application related to 3 GMOs of mustard. Following this, in the 126^th meeting on 04.01.2016, GEAC discussed the permission sought for “environmental release” again, and sought some clarifications from the applicant.

It also constituted a Sub-Committee “to further deliberate on issues raised during the deliberations in the Committee (GEAC) and other issues that may crop up during the sub-Committee’s deliberations”, and asked it to submit the report to GEAC within 15 days for further consideration. (Minutes of the 126^th meeting).

The constitution of the sub-committee was:

1. Dr K Veluthambi, Chairperson;
2. Dr S R Rao, Adviser, DBT, Member;
3. Dr S K Apte, Member;
4. Dr Ramesh V Sonti, Member;
5. Dr B Sesikeran, Member;
6. Dr C R Babu, Member;
7. Dr K V Prabhu, Joint Director (Research), IARI, Member;
8. Member Secretary, GEAC, to facilitate the sub-Committee.

Apart from a January meeting (2/2/2016) that reviewed the clarifications submitted by the CGMCP in response to additional information sought by the GEAC in an earlier meeting, the Sub-Committee also met just before the 127^th GEAC meeting on 5^th February 2016, which also witnessed a protest outside the Indira Paryavaran Bhawan when the meeting was underway inside the Ministry. This 127^th meeting considered the report submitted by the Sub-Committee to the GEAC. The Chairman of the sub-committee, who is also the Co-Chair of GEAC, was invited to make a presentation in detail to the GEAC on the findings and recommendations of the Sub-Committee. It appears that the queries were raised by Prof Veluthambi, Dr SK Apte and Dr Ramesh Sonti, in addition to a review by the Biosafety Support Unit of the DBT. It was apparent from this meeting itself, that the Sub-Committee was not looking into major discrepancies found by civil society later, including violations of GEAC decisions, or discrepancies in data submitted etc. It was also apparent that they were not going to look into the yield increase claims being made by the applicant even though that was the very raison d’etre for this GMO to be created!

The sub-committee recommended revision of the Biosafety Dossier by incorporating additional information/clarifications/gaps, so that a Risk Assessment and Risk Management (RARM) document can be prepared for the consideration of GEAC. CGMCP was given a time of 2 weeks in which to do this. It was decided that this “RARM report would be put up for consideration of the GEAC. It was decided that subsequent to that review, and if the biosafety dosser is found to be complete in all respects, the biosafety dossier/RARM report excluding confidential information will be put in the public domain for comments. A detailed response to the comments received would be prepared and considered before a final decision is taken by the GEAC”. (Agenda 4.2 of 127^th GEAC meeting minutes).

The 128^th meeting of GEAC on 4^th of March 2016 took note of the fact that the CGMCP has sent its revised document, and that a draft RARM being reviewed by the Biosafety Support Unit of DBT at that point of time will be circulated to the Sub-Committee soon. In the 129^th meeting of the GEAC on 20^th June 2016, under a new Chairperson of GEAC, it is recorded that the Sub-Committee requested for an additional duration of one month before it can submit its final recommendations to GEAC.

Subsequently, after a Special Meeting convened by GEAC to listen to presentations made by scientists, activists and farm union leaders against GM mustard and its approval on July 18^th 2016, in which some of the Sub-Committee members were present, the GEAC had its 130^th Meeting on August 11^th 2016. In this meeting, a 5.5 page note is circulated from the Sub-Committee, which summarises that “in the opinion of the sub-committee, the environmental release of the parental lines and the hybrid assessed here is safe and effective following good stewardship practices in handling production of hybrids and their cultivation. However, in order to have wider inputs from various stakeholders, the sub-committee recommends that the AFES document be made public before the final decision by the GEAC is arrived at”. The AFES document itself was not shared in the GEAC meeting nor discussed by them. However, the GEAC minutes record the following: “GEAC reviewed this (AFES) and suggested that the report may be placed in MoEFCC website for a period of 30 days from the date of placing on the website, for inviting comments from stakeholders”.

It is also known that the Sub-Committee met briefly in an unscheduled manner after the GEAC meeting on August 11^th 2016. In the end, only two meetings of the Sub Committee took place, before arriving at their clearance. Now, some information about the Sub-Committee members:

Sl	Name	Some details
1	Dr K Veluthambi, Chair of Sub-Committee & Co-Chair of GEAC	WAS A GM CROP DEVELOPER till his retirement recently, working on GM rice development for disease-resistant transgenic rice, with DBT and Rockefeller support. https://sites.google.com/site/symposium2013kv/prof-k-veluthambi
2	Dr S R Rao, Adviser, DBT	He is on the Golden Rice Humanitarian Board, funded by Syngenta. From an agriculture science background. http://www.goldenrice.org/Content1-Who/who1_humbo.php;  http://bioasia.in/speaker-profile/pdf/2010/sr-rao.pdf
3	Dr B Sesikeran, Member	Former Director of National Institute of Nutrition – a Board Member of ILSI, which is International Life Sciences Institute, which has Bayer, BASF, Monsanto and others as Members. It is important to note that he was a member of the Expert Committee headed by Anupam Verma for the CGMCP project, advising on what studies to take up for health safety assessment of GM mustard, also then conducted the studies as former Director of NIN, then also gave a green signal as chairperson of RCGM in DBT, and now sits in GEAC as a Member and was included the sub-committee! He however did not attend the 2nd February meeting. From all information available, did not take part in the sub-committee processes. http://www.dnaindia.com/india/report-gmos-regulator-on-mosanto-funded-institute-s-payroll-2171346 ; http://ilsi.org/about/leadership-support/ ; http://ilsi.org/wp-content/uploads/2016/01/Members.pdf
4	Dr C R Babu	Was a colleague of Dr Pental in Delhi University (was former Pro-VC when Pental was VC of DU). A member of many Committees in the MoEFCC. In the case of Bt brinjal Expert Committee 1, he was a member first with Pental as the Chair and then became the Chair. Long personal association with Pental as anyone in DU will vouch for. http://www.nbrienvis.nic.in/WriteReadData/CMS/Prof.%20C.R.%20Babu.pdf
5	Dr SK Apte	http://www.che.iitb.ac.in/faculty/pw/DrApte_Biosketch.htm
6	Dr Ramesh V Sonti	http://www.ccmb.res.in/index.php?view=scientist&mid=0&id=63&grpid=2
7	Dr K V Prabhu, IARI	http://iari.res.in/?option=com_content&view=article&id=127&Itemid=611

It is seen that Dr Ranjini Warrier, former Member Secretary of GEAC, also took part in the Sub Committee meeting in addition to the Member Secretary Madhumita Biswas (on 2^nd Feb. 2016).

For a long time now, we have been saying that the only reason why regulation of gene technology is required is that to protect environment and citizens from the risks of modern biotechnology. To that extent, regulation is not about GM crop developers’ technical abilities but about biosafety science and assessment of the same for GMOs. The readers can judge for themselves if this kind of expertise exists in the team above.

Importantly, it is learnt that no health safety expert was part of the Sub-Committee’s assessment processes. HOW WAS A CLEAN CHIT PROVIDED ON THE SAFETY OF GM MUSTARD AND ON WHAT BASIS? (In fact, how can a Herbicide Tolerant GM crop’s assessment of safety happen in the absence of testing it as a HT crop?)

ON THE SAFETY OF GM MUSTARD: EARLIER VIEWS & NOW (AFES DOCUMENT)

In the table below, we give some illustrations about what the biosafety assessment stated in February 2016, and how a complete clean chit has been provided by August 2016 without any reasonable explanation apparent for the change in the assessment. Are not the citizens entitled to know what exactly transpired for this safety conclusion that was given to GM mustard?

Aspect of biosafety	February 2016	Current situation (AFES)
Toxicity of barnase-barstar complex	The Committee requested the University to check whether DMH-11 hybrid accumulated complexes of barnase + barstar	THE AFES DOCUMENT DOES NOT PRESENT EVIDENCE OF WHETHER THIS WAS ADDRESSED.
Toxicity and allergenicity of the 3 proteins : individual testing as well as combinations of 2 or 3 together	“Combinations Bar and Barnase, Bar and Barstar and Bar-Barnase-Barstar together should have been tested as relevant to the two parental lines and the hybrid”. Members of the Committee observed that the regulatory guidelines provide an overall list of principles for conducting biosafety studies and therefore, case specific issues need to be addressed by the applicant, and statements such as “Neither RCGM nor GEAC prescribe such studies” are not tenable.	NOT ADDRESSED, AS PER AFES.
Soil biota impact testing	Sub Committee Q: ‘why no assessment of effects on agriculturally important microbes particularly rhizobia, VAM or cyanobacteria was carried out?’ The Committee suggested that the data on 16S ribosomal RNA sequences may be analysed in detail to determine whether the population of useful bacteria such as phosphate solubilisers are altered in the soil of transgenic crop. Members observed that the regulatory guidelines provide an overall list of principles for conducting biosafety studies and therefore case specific issues need to be addressed by the applicant and statements such as “this was not suggested by GEAC/RCGM” is not tenable.	NOT ADDRESSED, APPARENTLY
On sub-chronic toxicity	An explanation is required to explain the gain of more weight in the rats fed with transgenic hybrid.	Unclear from AFES document if addressed.
	MCV and monocyte levels were altered in Varuna barnase and EH-2 barstar group. A justification should be given. Do these values fall in the normal range.	Unclear from AFES document if addressed.
On phenotypic attributes	Data generated under BRL-I 2nd year trial did not show comparable agronomic/phenotypic attributes to that of BRL-I 1st year despite test conducted in same location and season (Rabi).	Unclear from AFES if addressed.
On Yields	The dry matter yield is not correlating with yield-contributing components and overall seed yield, irrespective of trial and location. This requires reasonable explanation.	Unclear from AFES if addressed.
	Average number of primary/secondary branches per plant; average number of pods per plant; average number of seeds per plant and seed yield (kg/plot) are significantly higher in transgenic hybrid as compared to other counterparts. However, overall dry matter yield is less and also 1000 seed weight is less in the DMH-11 hybrid. Correlation between overall dry matter weight and overall yields needs to be reflected in the dossier.	Unclear from AFES if addressed.
	In BRL-II trial, out of 3 locations, statistical yield increase of transgenic to that of local check is observed in 2 locations. Need explanation for third location where its field performance is less.
	The mean value for three locations were reported in terms of yield/oil content, but considering multi location trials differing in soil/weather parameters, a pooled data analysis should be performed to establish actual yield performance.	Not done, going by the AFES data presentation.

 

The bias towards approving was clear from the beginning: Suitable post release management strategy was recommended to be implemented to avoid contamination, in the context of non-GM farm-saved seed. The Sub-Committee said the same thing with regard to effect on farm animals of grazing of transgenic mustard. Similar recommendation for post-release monitoring was given for weediness, pollen flow to wild relatives, if any; impact on beneficial insects and impact on beneficial soil microbes. On honey checking for barnase levels and biosafety, the Committee requested that honey be collected from the vicinity of cultivated area and checked whether honey accumulated barnase, barstar and bar gene proteins. However, this is suggested as a post-release management requirement. It is interesting to note that for a Sub-Committee which stated strongly that “current guidelines not prescribing a particular test” was an untenable response, most important studies were to be done after commercial release!

Based on contradictory views, they gave a clean chit to the biosafety of GM mustard. Should the country go by their assessment, especially when the full biosafety dossier is being hidden from public view and independent scrutiny? Citizens may decide for themselves.

 

For more information, contact: kavitakuruganti@gmail.com ; jatantrust@gmail.com

[1] This note points out to some seemingly fluid stands taken by the Sub-Committee and it is not our own assessment of the Sub-Committee’s technical arguments, about which we will bring out another analysis.