• 7 October 2010
  • News
  • By Narayan Kulkarni

Bt brinjal: Still in freezer

A year ago, India's biotech regulator, GEAC, gave its nod for the country's first genetically-modified (GM) food crop, a transgenic variety of Bt brinjal. However, the GM food era did not begin even with the regulatory approval. Stringent opposition and an activist minister stalled in further progress to the fields and eventually to consumer's tables. A year later, though there has been some key developments on this front, Bt brinjal is nowhere close to reaching the consumers. A Special Report.

Exactly 12 months after the regulatory approval, all that the country has now on the Bt brinjal front is a “disputed” scientific report  brought out by some of India's leading science academies. The scientific view is that the moratorium on the introduction of Bt brinjal should be lifted because there is no evidence of any safety hazard. However, the environment minister, Jairam Ramesh, who was instrumental in stalling the progress of Bt brinjal is not convinced, terming the experts' report as one lacking in depth.

So the Bt brinjal issue remains frozen. When will it be unfreezed ? 

On October 14, 2009, the Genetic Engineering Approval Committee (GEAC) under the aegis of the Ministry of Environment and Forests (MoEF) concluded that Bt Brinjal is safe for environmental release. In normal circumstances, this approval is good enough. But as the clearance was for the country's first GM food product,  the ministry was cautious. The activist-environment minister, Jairam Ramesh, took over the regulatory role upon himself. 
Expert committee says Bt Brinjal is safe for environmental release
  • Dr Swapan Kumar Dutta, Deputy Director General, Indian Council of Agricultural Research.
  • Dr BM Khadi, Principal Scientist & Head, RS, University of Agriculture Science, Dharwad.
  • Dr P Ananda Kumar, Project Director, National Research Centre on Plant Biotechnology (NRCPB), Indian Agriculture Research Institute, New Delhi.
  • Dr Lalitha R Gowda, Central Food Technology and Research Institute (CFTRI), Mysore.
  • Dr MN Murthy, Institute of Economic Growth, Delhi University, New Delhi.
  • Dr K Satyanarayana, Scientist Indian Council of Medical Research, New Delhi.
  • Mr SP Sahani, AD, Drug Controller General of India, New Delhi.
  • Mr DS Mishra, Assistant Commissioner (Seeds), Ministry of Agriculture.
  • Mr SB Dongre, Director (F&VP) Food Safety and Standards Authority of India (FSSA), New Delhi.
  • Dr B Sesikaran, National Institute of Nutrition (NIN), Hyderabad.
  • Dr. KK Tripathi, Advisor, Department of Biotechnology, New Delhi.
  • Mr AK Goyal, Joint Secretary, MoEF and Vice Chairman, GEAC.
  • Dr. R Warrier, Director, MoEF & Member Secretary, GEAC.
  • Dr CM Gupta, former Director Central Drug Research Institute.
  • Dr Vasantha Muthuswamy, former BMS, AIIMS, New Delhi; and
  • Dr Uday Kumar, Emeritus Scientist, University of Agricultural Sciences, Dharwad

Recommendations of INTER-ACADEMY* report on GM Crops
1. After taking into consideration all available evidences and opinions, the overwhelming view is that transgenic crops, along with traditional breeding, molecular breeding and other innovative alternatives, should be used for sustainable agriculture to meet the increasing food, feed and fiber demand of the growing population of India. GM crops are not a panacea, but they should be an important component of our strategy. Decisions have to be made on a case-to-case basis.

2. GM crops which are already in use, and which are proposed to be introduced, should be continuously studied for environmental and health effects. Post-introduction monitoring is as important as studies, prior to introduction. Particularly, in relation to food crops, perceptions are nearly as important as facts. Sometimes, it is difficult to easily distinguish between the two. Therefore, facts as well as perceptions, need to be adequately addressed. For instance, while the use of antibiotic-resistant selection markers in present day transgenic plants do not seem to compromise biosafety, use of alternative as well as marker-free technology, should be encouraged.

3. Though the role of the private sector in the development of GM crops is important, food security is too critical and strategic an area, to be left wholly or predominantly in private hands. The main responsibility for the development of transgenic technology in the country should rest with publicly-funded institutions. This calls for massive government investment in these programs. The capacity should be expanded, and further strengthened for designing and implementing different biosafety tests of international standards, including those for long-term effects, where necessary. Mechanisms should also exist for sharing experience and expertise among different institutions. A PPP model may be considered for commercialization.

4. The available scientific evidence does not indicate any appreciable effect of GM crops on biodiversity. However, it is necessary to address the perceptions in relation to this issue. In any case, biodiversity is seriously threatened on account of other human activities. Therefore, the effort at collection, conservation and preservation in relation to biodiversity needs to be further strengthened.

5. An independent high-power expert committee, with a strong component of scientists, should be in place to oversee efforts involving transgenic crops in the country. This committee should be entrusted with the responsibility of strategic planning and establishing priorities in the area. For example, transgenic crops to improve nutrition and combat abiotic and biotic stresses are a priority for India.

6. The regulatory mechanism in place in India for approval of release of transgenic crops is strong. However, the same is not true about monitoring after release. A specific mechanism should be created for post-release monitoring, which should include provisions for providing effective technical advice to the farmer.

7. The issue of Bt brinjal deserves special attention in terms of its immediate relevance. The overwhelming view is that the available evidence has shown, adequately and beyond reasonable doubt, that Bt brinjal is safe for human consumption, and that its environmental effects are negligible. It is appropriate now to release Bt brinjal for cultivation in specific farmers' fields in identified States. Appropriate distance-isolation needs to be maintained, although no deleterious environmental effect is anticipated. The performance in the field, in all its aspects, should be monitored by an independent committee, which should not include the suppliers or their representatives. The limited release of Bt brinjal need not wait for the establishment of Biotechnology Regulatory Authority of India.

8. Development of resistance to Bt is a real concern. Therefore, in parallel with the introduction of Bt brinjal, efforts for gene stacking should be seriously pursued, preferably in publicly-funded organizations. Improvements such as the elimination of antibiotic resistance selection markers, should be seriously explored. Efforts should also be made to treat Bt as part of the Integrated Pest Management strategy.

9. Immediate steps should be taken to restore confidence and allay fears that the moratorium would influence research on transgenic crops and their use on individual merit. Spreading public awareness on Bt brinjal, indeed transgenic crops in general, is important, and mechanisms for doing so, should be set up. Transparency should be maintained in methods of testing, different procedures, results and impact assessment.

10. The National Bureau of Plant Genetic Resources (NBPGR) already holds 4350 accessions of brinjal germplasm. In parallel to the limited release of Bt brinjal, NBPGR along with other concerned persons, should work towards ensuring that the collection is as exhaustive as possible. 11. As indicated earlier, there does not seem to exist any reasonable
doubt on the biosafety of Bt brinjal. However, particularly to address public concerns as well as to doubly ensure biosafety, a group of experts or/and institutions should be constituted for conducting post-market surveillance study of short, medium or long term health hazards, if any, of Bt brinjal and other genetically modified food items. This group should regularly submit its follow up report to the Government/Regulatory Body.

* INTER-ACADEMY comprises of six sciences academies namely Indian Academy of Sciences, (Dr AK Sood), the Indian National Science Academy (Dr M Vijayan), the National Academy of Agricultural Sciences (Dr Mangala Rai), the National Academy of Medical Sciences (Dr KK Talwar), the National Academy of Sciences (Prof Asis Datta) and the Indian National Academy of Engineering ( Dr PS Goel)
And the minister went on a two-month nationwide tour for public consultation on the issue. In February 2010, Ramesh, announced a ban on Bt brinjal's commercial introduction.

Announcing the ban on February 9, 2010, Ramesh stated that it was in the  national interest to adopt a cautious, precautionary principle-based approach; and imposed a moratorium on the release of Bt brinjal till such time, and the moratorium will continue for as long as it is needed to establish public trust and confidence. 
Further the minister asked  the GEAC to consult scientists like Prof M S Swaminathan, Dr P M Bhargava, Dr G Padmanabhan, Dr M Viyayan, Dr Keshav Kranthi and Dr Madhav Gadgil among others, to draw up fresh protocols for specific tests that will have to be conducted, to generate public confidence. 
Reacting to this, the GEAC noted that, in addition to the experts/scientists suggested by the minister, it would seek the views of other scientists like Dr Raghavendra Gadagkar, IISc, Bangalore; Dr V L Chopra, member, Planning Commission; Dr Sudhir Sopory, ICGEB; Dr Satayajt Rath, National Institute of Immunology; and Dr Amitabh Joshi, Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR), Bangalore.

The GEAC also used  the Development of Crop-Specific Biology Documents prepared by MoEF and the Department of Biotechnology on cotton, brinjal, maize, okra and rice, for use as reference, in evaluation of genetically engineered (GE) crops in India, with the suggestion that various types of alkaloids present in brinjal should be indicated.

Though some progress has been made in gathering views of the scientists and academic institutions, still on some issues, GEAC has been unable to find sufficient time for discussion on the draft proposal, for setting up a National Centre for Assessment of genetically modified organisms (GMOs) prepared by Dr PM Bhargava, and on the report of the sub-committee constituted by the GEAC, to examine the “Guidance document for information/data generation and documentation for safety assessment of GE Plants” during biosafety research trials BRL-I and II trials. These will go a long way in providing guidance to the organizations focusing on R&D of Bt food crops.

It may be noted that at the October 14, 2009 GEAC meeting, Dr PM Bhargava, a special invitee to the meeting, on the orders of the Supreme Court of India, had expressed his reservations over the environmental safety issue of Bt binjal along with Dr Ramesh Sonti, scientist, Centre for Cellular & Molecular Biology (CCMB), Hyderabad.  Dr Bhargava opined that though he was not against GM crops, he cannot support the proposal as the safety assessment in his view was not complete; and he did  not support the recommendations of the Expert Committee on the following grounds:  Brinjal is a widely consumed food in India.  It is not proper to accept international guidelines for safety assessment. Biosafety assessment should be based on national guidelines which take into consideration new insights and evidences.  In matters of such importance, independent verification should be mandatory. More time is needed to review the Expert Committee document. He opined that a minimum of one month should be given followed by a debate in which international experts who have commented on the Bt brinjal data should be invited.  There is a disagreement in the primary data. There are several gaps in the safety assessment.  Analysis of the safety data is not correct.

Inter-Academy report on GM crops
After working for six months, six top science academies of India - Indian Academy of Sciences, the Indian National Science Academy, the National Academy of Agricultural Sciences, the National Academy of Medical Sciences, the National Academy of Sciences and the Indian National Academy of Engineering - have come up with the report and 11 recommendations related to the  release of Bt brinjal in late September 2010, based on the request from Ramesh and Dr K Kasturirangan, member of Planning Commission.

The inter-academy report noted that safety aspects and possible health hazards of GM crops have been studied and discussed in detail. The evidences so far suggest that they are no more deleterious than ordinary crops. The US experience on GM corn is a case in point. There is no evidence to suggest that GM food is more allergic than other forms of food. It is unlikely that biodiversity, which has resulted from large-scale vertical and horizontal transfer of genes, can be affected by the insertion of one or a handful of genes in a few genomes. Hybrid maize varieties have been in cultivation for decades. There does not appear to be any evidence to suggest that they have affected biodiversity. The extent of usage of different varieties would, of course, depend on the choice of farmers. All the same, safety and health issues should be continuously examined, before and after the introduction of each GM crop. The same applies to biodiversity. The interest of the farmer and the consumer, besides the national interest, particularly in relation to food security, should always be kept in mind.

After taking into consideration all available evidences and opinions, one of the recommendations made by the panel of science academies is that transgenic crops, along with traditional breeding, molecular breeding and other innovative alternatives, should be used for sustainable agriculture to meet the increasing food, feed and fiber demand of the growing population of India. GM crops are not a panacea, but they should be an important component of our strategy. Decisions have to be made on a case-to-case basis.

Minister Debunks Academy Report
Reacting to this report, on September 29, 2010 the Minister reportedly said, “It does not give a larger scientific view, and is focused only on findings of a scientist. ”
Looking at the sensitivity of the issue, the concerned agencies should take more concentrated efforts in mobilizing and spreading public awareness on the benefits of transgenic crops, while keeping in mind,  transparency related to methods of testing, different procedures, results and impact assessment. This will go a long way in providing fruits of long-term research taking place in Bt food crops, to the end consumers, who are ready to use the best, and the farmers.

However, a report published by an industry lobby organization,  the International Service for the Acquisition of Agri-biotech Applications (ISAAA), titled, “The dawn of new era Biotech crops in India”, noted that a  2007 study reported that 70 percent of the middle class in India accept biotech foods, and further, more are prepared to pay a premium of upto 20 percent for superior biotech foods, such as 'golden rice', with enhanced levels of pro-vitamin A.

The bio-agri companies have come together and made occasional noises in the corridors of Delhi, to push their case. However, the supporters of GM foods have yet to create public awareness about the importance of transgenic crops, and continue to hope that eventually the GM technology will triumph. The consumers too are indifferent as the industry is yet to demonstrate what benefits will a Bt brinjal crop provide, except reducing the cost of production for the farmers.
Will this winter see any thaw in the rigid stands taken by both pro- and anti-GM groups?

Narayan Kulkarni in Bangalore
S. No. Crop Company Name Trial Trait Gene/Event
1. Watermelon Indian Institute of Horticultural Research Event selection Virus Resistance 8 events namely AMa112a-1, AMa412-20, AMa432-6, AMa173-5, AMa545-1, AMa546-216, AMa547-230 and AMa548-10
2. Tomato Indian Institute of Horticultural Research Event selection Virus Resistance 16 events namely PR 38-7, PR42-1, PR55-5, AS78-7, AS194-11, AV60-2, AV1-5, AVNv4A, AVNv4B, AM97-9, AM95-16, AM93-5, AM190-8, AM190-11, AM190-12 and AM190-14 30 events namely AM-188-4, AM188-26, AM-184-1, AM184-6, AM184-31, AM171-2, AM171-9, AM171-11, AM171-12, AM171-16, AM171-17, AM190-8, AM190-11, AM190-12, AM190-14, AS194-5, AS194-10, AS194-11, AS194-13, AS194-16, PR148-37, PR148-49, PR149-23, PR149-31, PR200-9, PR208-27, AV157-13, AV157-14, AV157-16, AV160-13, AV163-19 9 events namely ANMi, ANM2, ANM3, Av 225-7, ANV-9, ANV-1, PR130-13, PR 130-12, AS231-7
3. Papaya Indian Institute of Horticultural Research Event selection Virus Resistance 4 events namely TSolo4R, TSolo4Y, TSolo7-1and TSolo7-3 containing PRSV cp-gene
4. Hybrid rice SPT maintainer E.I. DuPont India Event selection Male sterile female inbred rice lines. 9 events namely DKC118, DKC45, JH02, JH04, JH11, JH15a, JH22, JH26b and JH34b containing Os-Msca1 gene
5. Rice Bayer Bioscience. Event selection Insect Resistance 56 Bt rice lines events namely RICE1502-RICE1509, RICE1515, RICE1526, RICE1551-52, RICE1555, RICE1557-58, RICE1576, RICE2111-12, RICE2114, RICE3105, RICE3107, RICE3130, RICE3301-17, RICE3401, RICE3403-19 and LLRICE62 containing cry1Ab, cry1Ca & bar genes
6. Cauliflower and Cabbage Nunhems India Net house Insect Resistance 6 events namely CF-3, CF-4, CF-5, CA-1, CA-2 and CA-6 of transgenic cauliflower and cabbage (3 events for cauliflower including hybrids of two of them and 3 events from cabbage including hybrids of two of them) containing cry1Ba, cry1Ca and bar genes.

Nunhems India Event selection in net house under contained condition Insect Resistance cry1Ba, cry1Ca and bar
7. Sugarcane Sugarcane Breeding Institute (ICAR) Event selection Insect Resistance 10 events namely Co 86032-Bt-7 (B), Co 86032-Bt-8 (B). Co 86032-Bt-10 (B), Co 86032-Bt-17(B), Co 86032-Bt-18(B), Co 86032-Apr-Bt-2(B), Co 86032-Apr-Bt-4(B), Co 86032-Apr-Bt-3(A), Co 86032-Bt-5(A), Co 86032- Bt-6(A) containing cry1Ab gene
8. Sorghum Central Research Institute for Dryland Agriculture Event selection Abiotic tolerance/drought resistance 7genotypes with Events namely pCAMBIA 1300: mtlD CRIDA 1-6-1-8-4, mtlD CRIDA 2-9-3-3-5, mtlD CRIDA 4-7-1-7-4, mtlD CRIDA 26-1-11-6-1, mtlD CRIDA 75-2-21-2-1 and Events with pCAMBIA 1305.1: mtlD CRIDA 3-3-18-7-2 and untransformed control: SPV-462 containing mtID gene
9. Maize Pioneer Overseas Corporation BRL-I second year Insect Resistance and Herbicide Tolerance cry1F & PAT and CP4EPS PS genes (TC1507 x NK603 (DAS-01507-1 x MON-00603-6)
10. Corn Dow AgroSciences India. BRL-I second year Insect resistance cry1F (event TC 1507) gene

Syngenta Biosciences BRL-I Insect Resistance cry1Ab gene (Event Bt11)

Monsanto India BRL-I second year Insect Resistance and Herbicide Tolerance stacked cry2Ab2 and cry1A.105 genes (Event MON 89034) & CP4EPSPS genes (Event NK603)
11. Groundnut ICRISAT Event Selection in net house under confined conditions Fungal Resistance 9 events namely RC-GN-12, RC-GN-23, RC-GN-24, RC-GN-27, RC-GN-29, RC-GN-30, RC-GN-31, RC-GN-36 and RC-GN-44 containing chitinase gene

ICRISAT Event selection in net house Virus Resistance 11events namely GN TSV 3, GN TSV 9, GN TSV 30, GN TSV 31, GN TSV 33, GN TSV 40, GN TSV 41, GN TSV 48, GN TSV 50, GN TSV 94, GN TSV 101, control (JL 24) and control (TMV 2) containing coat protein gene of tobacco streak virus

University of Agricultural Sciences,GKVK Campus Event selection Abiotic tolerance/drought resistance Events namely 166-4 (A1), 187-3-1-1 (A2) and 296-12-4-4 (A4) over expressing DREB1A for stress tolerance (Drought tolerance)

University of Agricultural Sciences,GKVK Campus Event selection Abiotic tolerance/drought resistance Events namely 475-1-6-1 (B9), 505-7-5-6 (B11), 525-10-2-3 (B14), 537-6-6-1 (B15), 526-6-1-4 (B16) over expressing DREB1B for stress tolerance (Drought tolerance)

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