Friday, December 10, 2010

The Bt Brinjal Story

Suman Sahai & Carly Nichols
Bt brinjal was developed by India's Maharashtra Hybrid Seeds Company (Mahyco) using the modified gene Cry1Ac, under license from Monsanto. The modified Cry1Ac gene, found in the soil bacterium Bacillus thuringiensis, along with two other supporting genes, nptII and aad, are assembled in such a way that they work to produce an artificial insecticidal protein that is toxic to the targeted insect, in this case the fruit and shoot borer. Thus the intended effect is that the fruit and shoot borer is killed after ingesting any part of the Bt brinjal plant but that other organisms such as secondary insects, animals, and humans are unaffected. Field trials which must be performed before the release of GM crops are done to evaluate (a) the effectiveness of the insecticidal properties against the targeted insect; and (b) the safety of human, animal, and environmental health upon exposure to or consumption of the modified plant containing the transgenic construct.

Confined trials of Bt brinjal were first carried out between 2002 and 2004 and the data from these trials was submitted to the Review Committee of Genetic Modification (RCGM) in April 2006. On the basis of this data, generated and reported by Mahyco, RCGM recommended that GEAC should consider granting approval for large scale field trials of Bt brinjal.

In June 2006 Mahyco submitted bio-safety data to the Genetic Engineering Approval Committee (GEAC), the statutory and regulatory body for all genetically modified technology in India, and sought permission for large scale trials. GEAC decided to create a sub committee, called the Bt Brinjal Expert Committee I (EC-I), to look into the concerns raised by civil society on the accuracy of the submitted bio-safety data along with other overriding concerns such as cross contamination of normal brinjal by genes from Bt brinjal. These civil society concerns found expression in a May 2005 Public Interest Litigation (PIL) petition filed by four activists, Aruna Rodrigues, Devinder Sharma, PV Satheesh, Rajeev Baruah (Writ Petition (Civil) No. 260 of 2005). The petition requested that field trials should only be allowed once “comprehensive, scientific, reliable and transparent bio-safety tests have been carried out” (Sreelata. 2006). This PIL eventually resulted in the Supreme Court issuing a ban on all GM field trials on September 22, 2006, pending scientific consensus on the risks involved with such field trials.

In July 2007 the EC-I submitted its report to GEAC, which recommended that 7 more studies on bio-safety be repeated to verify data which had been generated during the confined trials. Despite this, the EC-I gave the recommendation to go forward with large scale field trials. In August 2007 GEAC accepted this report and gave approval to begin large scale field trials. The Supreme Court subsequently lifted the ban on GM crop field trials so long as they abided by certain regulations such as isolation distance to prevent the risk of cross-breeding. As per GEAC direction, the Indian Institute of Vegetable Research (IIVR) implemented large scale trials of Bt brinjal at 10 research institutions across the country in 2007 and 11 in 2008. (Decisions taken in the 79th Meeting of the Genetic Engineering Approval Committee held on 8.8.2007. <http://moef.gov.in/divisions/csurv/geac/geac-aug-79.pdf> ).

On a separate front, Gene Campaign, followed by Greenpeace, had asked under the Right to Information (RTI) Act for data to be released on toxicity and allergenicity tests conducted on Bt brinjal. The Department of Biotechnology (DBT) refused to release this data saying it was Confidential Business Information. Gene Campaign approached the Supreme Court submitting that data having a bearing on public health could not be considered Confidential Business Information. In March 2008 the Supreme Court directed the Government to release allergenicity and toxicity data obtained from Bt brinjal.

Once the field studies carried out by Mahyco were obtained by civil society organizations data from them were sent to several expert scientists for independent reviews. These reviews yielded several reports by eminent scientists which questioned Mahyco’s experiment protocols as well as their interpretation of the data collected from trials (Carman 2009, Seralini 2009, Gurian-Sherman 2009, Heinemann 2009).

One notable report was authored by Gilles Eric Seralini in January 2009 just prior to the GEAC session slated to decide on the commercialization of Bt brinjal. Seralini, a biochemist with the Institute of Basic and Applied Biology (IFBA) at the University of Caen, found numerous discrepancies in Mahyco’s reporting of statistically significant data. For example, in goats which were fed Bt brinjal, blood took longer to coagulate and the bilirubin count had increased which indicates liver damage. Other adverse reactions were found in tests conducted on rabbits, cows, chickens, and rats which were fed Bt brinjal. These ranged from decrease in liver weight to changes in red blood cell profiles. Moreover the longest toxicity test which was conducted was for a 90 day duration which is far too short to gauge the risk of long-term effects such as cancer or tumour development. The overall validity of the trials has also brought into question as Seralini reports that Bt brinjal was modified to produce an insecticide toxin containing Cry1Ab and Cry1Ac modified sequences. However, in the toxicity tests (against target and non-target insects) a different Cry1Ac toxin was used instead.

Mahyco claims they disregarded the findings mentioned by Seralini for a variety of reasons. For example, deviations which did not show a linear dose response or a time response were disregarded, as were differences which showed up in either males or females, but not both. This omission of statistically significant results is contrary to standard scientific procedures. Seralini concluded his analysis of the mammalian biosafety trials by stating, “Clear significant differences [between Bt and non-Bt brinjal] were seen that raise food safety concerns and warrant further investigation. The GM Bt brinjal cannot be considered as safe as its non GM counterpart…it should be considered as unsuitable for human and animal consumption.”(Seralini. 2009).

Seralini also analyzed the environmental risks associated with the release of Bt brinjal. He characterized experiments done on the effect of Bt brinjal on non-target organisms, beneficial insects, and soil health as “woefully inadequate and give no assurances for the environmental safety of growing Bt brinjal.”(Seralini.2009). This is because indirect effects are not taken into account, such as the effects of Bt brinjal as it moves up the food chain. Seralini found that the gene flow studies performed were also inadequate as they failed to assess the risks of other methods of contamination, such as through the mixing of seeds. Based on these insufficient experiments Seralini recommended that Bt brinjal not be released into the environment for field trials or commercialization.

In January 2009 the IIVR submitted the results of the large scale trials. Due to concerns raised by several stakeholders, including experts such as Seralini, GEAC decided to constitute a second sub-committee (EC-II) to look into the adequacy of biosafety data which had been submitted as well as the broader concerns raised by stakeholders. The EC-II was to be overseen by Dr. P.M. Bhargava, a retired scientist with expertise in cell biology, who had been recommended by the Supreme Court as an observer in GEAC.

On October 14th, 2009 the Bt brinjal EC-II submitted its report, dated October 8, 2009, at the 97th meeting of GEAC. GEAC accepted the report and approved the environmental release of Bt Brinjal containing the event EE1 for commercialization. However, this approval was qualified by stating, "..as this decision of the GEAC has very important policy implication at the national level, the GEAC decided its recommendation for environmental release may be put up to the Government for taking final view on the matter"(GEAC 97th Meeting. October 14, 2009).

Within 48 hours of GEAC’s approval Minister of Environment and Forests, Jairam Ramesh, intervened and halted the approval for commercialization. Responding to strong views expressed both for and against the release of Bt Brinjal, he extended an invitation to the public for comments. He further said that a decision regarding Bt brinjal’s release would only be made pending a nationwide consultation in January and February 2010.

From January 13th, 2010 to February 6th, 2010 seven public hearings on Bt-brinjal were organised by the Center for Environment Education (CEE) supported by the Ministry of Environment and Forests (MoE&F). These were held in Kolkata, Bhubaneshwar, Ahmedabad, Nagpur, Chandigarh, Hyderabad and Bangalore. Almost 8000 people from different sections of society participated in these seven public hearings. Participants included farmer organizations, scientists, seed suppliers, state agriculture department officials, NGOs, allopathic and ayurvedic doctors, students and housewives.

On February 9, 2010, after concluding the public hearings, Minister Ramesh announced a moratorium on the release of Bt brinjal. This, he said, was done in response not only to public concern but also significant input from national experts and the international scientific community, pressure from an active and civil society, and opposition from ten State governments, including all the major brinjal producing ones (Decision on Commercialisation of Bt-Brinjal. 2010). He said this moratorium would remain until there was further safety testing and a regulatory system specifically for genetically modified crops set in place. The Minister further said that the moratorium period would be used to commission fresh scientific studies and improve the testing process. Ramesh stated “If you need long term toxicity tests, then you must do it, no matter how long it takes… There is no hurry. There is no overriding urgency or food security argument for [release of] Bt brinjal.”(Decision on Commercialisation of Bt-Brinjal. 2010). Ramesh also made clear that the moratorium period should also be used to implement a functioning independent regulatory authority and hold a parliamentary debate on private investment in agricultural biotechnology.

This decision by Ramesh was followed by a request from civil society for a report to be drawn up to further assess the EC-II report. David A Andow, an eminent scientist at the University of Minnesota, was requested to assess the EC-II report and the environmental risk assessment (ERA) of Bt brinjal. In his report Andow said that the ERA which was submitted to GEAC had a too narrow scope to adequately gauge the risks posed by the commercial release of Bt brinjal. Andow states, “the EC-II is criticized not for whether it has accomplished what it set out to do, but whether it set out to do the right thing in the first place”(Andow. 2010). Andow’s main conclusion from his analysis of the EC-II report along with the original Mahyco bio-safety dossier is that the EC-II has not effectively characterized the risks associated with the release of Bt brinjal. These risks include not only environmental contamination and bio-safety hazards but also socio-economic risks to smallholder farmers which comprise a large part of Indian agriculture. Andow recommended that the risks posed by Bt brinjal need to first be adequately characterized, after which a proper risk management analysis can be performed.

At the same time that Andow was requested for an independent expert analysis, Ramesh commissioned six of India’s top scientific academies (The Indian Academy of Sciences, the Indian National Academy of Engineering, The National Academy of Sciences (India), The Indian National Academy of Agricultural Sciences, and The National Academy of Medical Sciences) to more broadly assess the feasibility and safety of genetically modified (GM) crops and their regulation. The report was supposed to specifically focus on the case of Bt brinjal.

On September 24th 2010 the Inter-Academy report was released which stated that Bt brinjal’s safety for human consumption had been established "adequately and beyond reasonable doubt"(Inter-academy Report on GM Crops. 2010). They supported the quick release of Bt brinjal at limited sites across the country provided that distance and isolation requirements were maintained. Countering the findings of Seralini and Andow, the Inter-academy Report said that environmental risks associated with Bt brinjal were “negligible” and that there would be “no appreciable effect of GM crops on biodiversity.” However, the Inter-academy Report quickly became embroiled in scandal as proven allegations of plagiarism and blatant pro-GM biases surfaced within days of the report’s release. (India Today. September 26, 2010. Indian Express. September 26, 2010)

By September 27, 2010, this report had been dismissed as unscientific and overtly influenced by pro-GM thinkers by not only civil society and activist groups but by Minister Ramesh, himself. It was found that significant sections of the text were plagiarised from an article published in 'Biotech News' magazine and authored by Dr. Ananda Kumar, a scientist who heads the National Research Centre on Plant Biotechnology. The report did not contain proper references and was criticized for using an unscientific tone rife with generalizations and clich├ęs. Minister Ramesh dismissed the report and stated that it did not “appear to be the product of rigorous scientific evaluation.” (Indian Express. September 28, 2010). The poor quality of the Inter-Academy report and the Minister’s response to it has further confused the matter of Bt brinjal in India. As it stands today, the moratorium on Bt brinjal continues.


References

Andow, David A. “Bt Brinjal: The Scope and Adequacy of the GEAC Environmental Risk Assessment”. Department of Entomology, University of Minnesota. August 2010.

“Bt Brinjal safe, says new report” Indian Express. September 26, 2010.
http://www.indianexpress.com/news/bt-brinjal-unsafe-says-new-report/688153/1 Accessed December 1, 2010.

Carman, Judy. “A Review of Mahyco’s GM Brinjal Food Safety Studies” Institute of Health and Environmental Research, Inc. January 2009

Decisions taken in the 79th Meeting of the Genetic Engineering Approval Committee held on 8.8.2007. <
http://moef.gov.in/divisions/csurv/geac/geac-aug-79.pdf>

Decisions taken in the 97th Meeting of the Genetic Engineering Approval Committee held on 14.10.2009 <
http://www.envfor.nic.in/divisions/csurv/geac/decision-oct-97.pdf>

Gurian-Sherman, Doug. “Comments on Possible Consequences of Gene Flow from Bt Brinjal to Brinjal Wild Relatives in India, and the Inadequacy of the Current Risk Assessment”. April 2009.

Heinnemann, Jack. “Summary of Analysis of Mahyco Fruit and Shoot Borer Tolerant Brinjal”. Centre for Integrated Research in Biosafety. July 2009.


Inter-Academy Report on GM Crops. September 2010. The Indian Academy of Sciences, The Indian National Academy of Engineering, The Indian National Science Academy, The National Academy of Agricultural Sciences The National Academy of Medical Sciences, The National Academy of Sciences (India). <
http://subharmonics.files.wordpress.com/2010/09/transgenic-report-sep2010.pdf>

“No scientific rigour in report on GM crops: Ramesh”. Indian Express. September 28, 2010.
http://www.indianexpress.com/news/No-scientific-rigour-in-report-on-GM-crops--Ramesh/689268 Accessed November 30, 2010

Ramesh, Jairam. Bt Brinjal: Note by Ministry of Environment and Forests. Decision on Commercialisation of Bt-Brinjal. February 9, 2010.
>

Seralini, Gilles-Eric. “Effects on Health and Environment of Transgenic (or GM) Bt Brinjal”. CRIIGEN. January 2009.

Sharma, Dinesh C.“Academies Copied to Push for Bt Brinjal” India Today. September 26, 2010. <
http://indiatoday.intoday.in/site/Story/114057/India/academies-copied-to-push-for-bt-brinjal.html> Accessed December 1, 2010.

Sreelata, M. “Indian Supreme Court Bans GM Crop Trials”. Science and Development Network. October 31, 2006. <
http://www.scidev.net/en/news/indian-supreme-court-bans-gm-crop-trials.html>. Accessed December 8, 2010.

Writ Petition (Civil) No. 115 of 2004. Gene Campaign & Another Versus Union of India & Others. Supreme Court of India. <
http://www.genecampaign.org/home_files/GM%20Writ%20Petition.pdf>

Writ Petition (Civil) No. 260 of 2005. Aruna Rodrigues & Ors. Versus Union of India & Ors. Supreme Court of India.

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