1.GEAC to decide on Bt brinjal at April 27 meet with Expert Panel
2.Letter to Jairam Ramesh on the Bt brinjal committee
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1.GEAC to decide on Bt Brinjal at April 27 meet with Expert Panel
Manjushree Naik, Mumbai
FnBNews,  April 22 2011
http://www.fnbnews.com/article/detnews.asp?articleid=29704§ionid=1

"The Genetic Engineering Action Committee (GEAC), which is going to meet a 19-member Expert Panel on April 27, 2011, may accept the proposal for introduction of Bt Brinjal in the country," states an optimistic Dr Usha Barwale Zehr, Joint Director, Research, Maharashtra Hybrid Seeds Co. Ltd (Mahyco), while speaking to FnB News on Wednesday at the company's research & development centre in Jalna.

Bt Brinjal, genetically-modified (GM) or transgenic brinjal plant with cry 1Ac gene from Bacillus thuringiensis, tolerant to the fruit and shoot borer, one of the major pests which attack the brinjal crop, developed by the company, has been awaiting clearance since the declaration of moratorium on GM crops by environment minister Jairam Ramesh last year.

The GEAC has been studying the possibility of a way forward, following protests over its long-term effects. But the GEAC itself is mired in various controversies. The latest being resignation of some of its members. The news has also put a question mark over Bt Brinjal. Zehr admits, "Yes, I am aware that some members resigned recently. But I do not know if that would have an impact on the meeting."

She adds, "I can only hope that the GEAC debates, discusses, decides, recommends, and proposes a path forward."
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From: Aruna Rodrigues, Sunray Harvesters
To: The Hon’ble Jairam Ramesh, Minister of State (Independent Charge) Ministry of Environment & Forests Government of India Paryavaran Bhavan

Dear Shri Jairam Ramesh

THE REVIEW COMMITTEE FOR BT BRINJAL AS OF 27 APRIL 2011

I have just received the list of appointees to this Committee. I note with considerable unease that there are neither genetics toxicologists, nor experts in animal feeding studies, nor independent experts in socio-economics and scientists with a track record and expertise in GMO environmental risk assessment (ERA) represented. I note with even more unease that in addition to these gaps, we also have members with a proven conflict of interest. Furthermore, some have declined to participate, most notably Dr MS Swaminathan. And we have the GEAC as well part of this Committee, who despite a change of name by you has not given any evidence of a change of intent to act instead of its proven ‘Industry’ bias, in the interests of the biosafety of India as a first order of priority. Therefore, this is a Committee with a significant imbalance and misrepresentation. Its report will be of little relevance.

We are all keenly aware that the work to be undertaken of risk assessment and hazard identification protocols for Bt brinjal (the two are not the same thing) will thereafter, act as guidance protocols for GM crops. Thus far, we have had the significant advantage of independent assessments received in your review process of Monsanto’s Dossier and the Bt brinjal EC II Report, as well as subsequent to it. With one or two exceptions and keeping aside the appointment of representatives from Unani and Ayush (quite rightly), but who are not GE crops experts, none of the remaining members is known to have analysed the raw data of the Dossier. If they had done so, would they not have been aware of the major gaps in the Dossier and EC II Report, even cover-up and fraud, with flawed study design and statistical analyses? May I elucidate with significant examples that demonstrate what our scientific institutions should have analysed, zeroed in on and documented?

1. Is Bt brinjal (the GM crop) required: The authoritative Andow ERA states that the EC II and the Dossier “vastly” overstate the problem of the BFSB (brinjal fruit and shoot borer). At 30% yield loss rather than Monsanto’s figure of 60-70%, the BFSB is managed effectively by alternative systems of agriculture, including IPM.

*As you Minister, recognised and stated that there doesn’t seem to be a major pest and food security problem with Bt brinjal.

2. The genetic construct, EE 1 transgene: At least 3 scientists observed that The EE 1 transgene was an old construct (of the 80s or early 90s). A proper Molecular Characterisation and genomic analyses were not done. “Since this is the starting point of any risk assessment, the downstream effects on the analysis can be significant” (Heinemann, response to EC II).

*“the dossier and the subsequent GEAC analysis (ECII) fail to meet fundamental and even routine hazard assessment standards for molecular characterization. Mahyco-Monsanto have not properly demonstrated that no unanticipated or unexpected additional inserts exist. India has several reasons to be concerned by the possibility that additional sequences exist. First, there is the biological rationale for characterising all inserts as part of proper hazard identification. Second, all inserts constitute new “events”, and events may be patented. This second reason has important trade implications. Mahyco has provided no information whatsoever on novel RNAs. This is a significant omission.---- all novel RNA species in Bt binjal must be reported for a proper safety assessment -- --to adhere to the full extent of Codex Alimentarius guidelines, and not be picking and choosing which standards to enforce and which to excuse”(Heinemann)

*Profiling techniques/Non-targeted approaches: proteomics, transcriptomics (high throughput sequencing), metabolomics, 2D gel electrophoresis, are required for hazard identification or identifying unintended effects. These were not done for reasons of cost; an extraordinary explanation surely that only serves to highlight the regulators sympathy for savings to the Industry and indifference to the cost to the nation?

*“non-targeted analytical approaches at the gene, transcript, protein and metabolite levels are the methods-of-choice for investigating the physiology of the GM plants as comprehensively as possible, thus increasing the chances of detecting unintended effects,(not assumption-based reasoning of the kind used intheECI)ie:
-“proper and full profiling of the genome by a combination of techniques and
-transcriptome and proteome profiling”. (Heinemann, response to EC II)

*The ‘comparator’ crop was not verified and/or disclosed. This kind of research smacks of cover-up and fraud and it would not be the first time. (The major defect in the LY038 dossier was the use of the wrong comparator.

Monsanto used another GE variety against Codex Alimentarius and EU
rules).

*The apex Regulator didn’t even know that the Bt brinjal Event EE1 encodes for a chimeric (Cry1 Ac and Cry1 Ab) or fusion gene. Under pressure, the admission finally came in the EC II Report (pg 57-58). The Report dismisses its importance by stating that this amounts to just a single amino acid difference, which is insignificant. In fact, the difference is 7 amino acids.

3. Feeding studies: In the rat feeding studies, (the longest was a sub-chronic 90 day study) Monsanto’s own data is shown to cause organ and system damage. Neurological function, behavioural effects, reproductive performance and biological resilience of test animals were not evaluated in these studies. Females who were fed Bt brinjal had smaller ovaries than both groups of controls. Study design was significantly flawed and served to mask statistically significant results. Results which were significant, demonstrating toxicity were glossed over or simply ignored. There were significant procedural shortcomings and gaps. (Seralini, Gallagher, Carman)

4. Performance Yield: Since there is no intrinsic yield gain from either Bt or HT (GM) crops, there might even be a decrease if the varieties/hybrids used to carry the Bt or HT genes are not the highest yielding cultivars (USDA report 2002), the question of yield revolves around ‘performance yield’.

*“it may be a second rate product whose control of the BFSB is low. It provides only 73% control of BFSB in the MST (multi-site trials) field trials (Dossier vol. 6). Given these considerations, it seems clear that the applicant has invested little in the development of a useful Bt brinjal product for India. Indeed, an inflammatory characterisation of the process so far would be a case of “transgene dumping.” (Andow ERA 2010)

*Resistance: Performance yield then depends on the efficacy of the Bt toxin and the measures in place, (essentially refuges) to combat resistance. ‘Resistance’doesnotgetamentionintheECIIreport;therisk is not acknowledged and the Dossier does not propose effective means to manage it. “ (Andow)
Any major pest control practice will select for resistant individuals in the target pest population. “If enough individuals become resistant, the control fails, the pest becomes abundant and crop yields decline. The evolution of resistance to Bt crops is a real risk and is treated as such throughout the world and the evolution of resistance in BFSB to overcome Bt brinjal is a real risk that must be managed. EC-II does not acknowledge this risk and the Dossier does not propose effective means to manage it. ---Event EE-1 Bt brinjal poses several unique challenges because the likelihood of resistance evolving quickly is high. Without any management of resistance evolution, Bt brinjal is projected to fail in 4-12 years”. (Andow)

5. Bt Brinjal ERA essentially not done: “The EC-II is not an adequate Environmental Risk Assessment--- the EC II replied on dubious scientific assumptions”. (Andow ERA 2010)

*Gene Flow: Most of the possible environmental risks of Bt brinjal have not been adequately evaluated, including the risks to local varieties of brinjal and wild relatives, and risks to biological diversity. India’s brinjal varieties will be contaminated. India is the centre of the world’s biological diversity in brinjal with over 2500 varieties grown in the country and as many as 29 wild species. Some local varieties have significant religious and cultural value. (Andow ERA 2010, Gurian- Sherman Bt brinjal gene flow assessment)

*Soil studies “were not designed to evaluating effects on soil health, brinjal productivity, or the productivity of other crops grown by brinjal farmers, which are the real concerns for Indian farmers. Instead, they measure microbial populations, which have little relevance for assessing these real concerns”. (Andow ERA 2010)

6. Socio economics: Nearly all brinjal farmers in India are small-scale resource-poor farmers, who farm <1ha for all of their crops (DES 2008). They grow brinjal in small (~65 m2) plots, and sell to local village and town markets. For these farmers, brinjal production is essential for their overall economic security and well-being.

*EE-1 Bt brinjal is proposed as a hybrid, and is unlikely to fit well in the small-scale production systems relying on open-pollinated varieties (OPVs) of brinjal. For small-scale resource-poor farmers brinjal is critical for creating economic security. Farmers are expected to retain only 10% of the increase in profitability from Bt brinjal, but are expected to retain 63% of the increase from brinjal IPM.

*The potential for secondary pests in Bt brinjal has been examined only “cursorily” by EC II despite the “common occurrence of secondary pests on Bt crops around the world. ---Imagine if the government claims there are no risks of secondary pests, and then a secondary pest arises. The government might be perceived as favouring GM seed companies at the expense of small-scale farmers”.

*Insecticide use: Useful alternative production systems for control of BFSB are being tested, actively used, and promoted in India: IPM, traditional pest management, organic production and other locally-derived methods that reduce costs associated with external inputs. (Andow ERA 2010).

7. International Guidelines of Codex and the spirit of the CBD have not been complied with.

The above are critical scientific analyses and form the crux of the Bt brinjal risk assessment, yet they were missed by our institutional scientists. It is therefore, not surprising that the Bt brinjal Dossier remains on record, its presence being a dangerous distraction for India’s bio-safety and public interest. Furthermore, the current Committee will do little to rectify the situation and does not inspire confidence for the reasons given in the opening paragraphs.

Yet, Minister you are bound by your assurance to us that your moratorium on Bt brinjal would remain “till such time independent scientific studies establish, to the satisfaction of BOTH the public and professionals, the safety of the product from the point of view of its long term impact on human health and the environment, including the rich genetic wealth existing in brinjal in our country”. (emphasis mine).

I would earnestly request you to reconstitute the Committee to redress its shortcomings. It would appear that India does not have specific scientific expertise for robust and rigorous risk assessment and hazard identification analyses and protocols for GM crops. This is not a criticism or a shortcoming, given that GM crops are an American invention commercialised a bare 15 years ago. There is no reason why we should not consult widely as the CBD recognises should be the case.

Any such committee must be represented by our experts in alternative agri-ecological systems; also active civil society participation. May I suggest for starters that the MoEF formally invite Prof Andow for wide consultations on the Bt brinjal ERA. Clearly, there is no reason to rush a decision in this matter that has such enormous consequences for India on multiple dimensions of the impacts of GM crops.

With my best regards
Yours sincerely
Aruna Rodrigues