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CHARGES OF ‘BIOPIRACY’ AND VIOLATION OF PROVISIONS OF THE INDIAN BIODIVERSITY ACT C Kameswara Rao For the past two years, the developers of Bt brinjal have been challenged by two developments. One is a Writ Petition (WP) filed in the High Court of Karnataka in October 2012, by the Environment Support Group, Bangalore, against the National Biodiversity Authority (NBA), the Ministry of Environment and Forests, Government of India (GoI), State of Karnataka and GoI, for failing to take appropriate action against the four developers of Bt brinjal for ‘egregious biopiracy’. Three public sector institutions (the Tamil Nadu Agricultural University, Coimbatore (TNAU), the University of Agricultural Sciences, Dharwad (UASD) and the Indian Institute of Vegetable Research, Varanasi (IIVR) have developed Bt brinjal varieties and one private company (Maharashtra Hybrid Seed Company, Mahyco) has developed Bt brinjal hybrids. Although these four players were not made respondents in the WP, they are the real target. I have circulated an article on January 15, 2012, detailing this WP. (This article, ‘A new public interest litigation threatens the future of genetically engineered crops in India’ , is also posted on the website http://plantbiotechnology.org.in/issues.html). The second development is the move by the NBA to take legal action against the developers of Bt brinjal, more specifically the Mahyco, for alleged violation of the provisions of the Indian Biodiversity Act (BDA). This issue has been simmering for a couple of years and is now becoming a real threat to not just the developers of Bt brinjal but to the developers of all transgenic crops. On account of a general lack of awareness about the issue of biopiracy and the moves by the NBA, many in agricultural biotechnology have not been conscious of the seriousness of the situation that would hamper all agribiotech R&D. Worse is that some people in the field even believe that there have been transgressions as alleged by the activists and the NBA. It has now become a matter of urgency that we publicize the import of the two complex issues and take concerted action to stem the tide. The following is an effort in this direction. 1. The concept of Biodiversity has three components: a) Agricultural, b) Ruderal (roadside) and c) Wild (land, rivers, lakes, and seas). Agricultural biodiversity is constituted of, a) the crop species, b) varieties of a particular crop, c) the pests, diseases and weeds associated with the crop, and d) insects and birds that feed on the crops, weeds and insects (including pests). The agricultural biodiversity is largely unconnected with the other two components. 2. Most of our field crops are self-pollinated and have extremely low frequencies of natural hybridization (gene flow) even among the varieties of the same crop and even when they were grown on neighbouring fields. If there are wild relatives of a crop species, the issue of gene flow arises only if the cultivated and the wild species grow in the same neighbourhood and get into the reproductive phase at the same time. Since this did not happen too often for most of the crops, we now have 100,000 varieties of rice, 75,000 varieties of potato, 75,000 varieties of beans, etc. If there was free gene flow, we would not have had so many varieties of different crops. Farmers have grown different varieties of the same crop on neighbouring fields and have not complained about their not breeding true. There is no scientific basis to argue that genetically engineered (GE) crops behave differently from the parental varieties, to affect biodiversity. (Visit http://www.plantbiotechnology.org.in for a series of articles on ‘Crop reproductive biology, genetically engineered crops and environmental safety’). 3. Crop varieties have been continuously replaced by farmers opting for new and better varieties. Over time, thousands of varieties of different crops fallen into disuse as farmers did not want to cultivate unprofitable varieties. Conservation of crop varieties is necessary to benefit from the useful genes in them. We need not prevent development of new beneficial varieties to conserve old ones. Beside chest beating about our rich crop genetic resources, we have not used any of these genes for crop improvement in any appreciable manner. ( Visit http://www.plantbiotechnology.org.in for a series of articles on ‘Conservation of crop plant species’). 4. The issue of biodiversity and its conservation has moved out of the scientific arena and now reduced to only a political slogan and a tool to hamper modern agricultural biotechnology. (Visit http://www.plantbiotechnology.org.in, for an essay on the scientific basis of ‘Biodiversity and problems of conservation’). 5. The issue of ‘biopiracy’ was originally raised in the context of commercial development from naturally occurring biological materials, such as plant substances or genetic cell lines, by a technologically advanced country or organization (for example, from North America or Europe), to develop and market pharmaceutical and other chemicals, without a fair compensation paid to the peoples or nations (for example, in South America or Africa), from whose territory the materials were originally discovered. 6. The term ‘biopiracy’ is now being mischievously used as a weapon by the activists, to instill apprehension on the public mind that someone is stealing very valuable crop resources from the poor countries and making money cheating the ‘rightful owners’ of the species/varieties, denying them the material benefits and financial rewards they are entitled to. Such an assumption is inapplicable to Indian agriculture, as it has never been established that any farmer had developed any widely cultivated crop variety, in over half a century. 7. Rabble rousing is a matter of livelihood for most of the NGOs, and not a calling. 8. The term ‘biopiracy’ has no official standing. The official documents of, a) the Convention on Biodiversity (CBD), b) Cartagena Protocol (CP) and c) the Indian Biodiversity Act (BDA) have not recognized the term, to consider it as a criminal act. I have letters from the CBD and the Indian National Biodiversity Authority (NBA) saying that the term biopiracy is not recorded in any of their official documents, and it is also not found in standard dictionaries (for example, Chambers). 9. The term biopiracy was coined by the NGO, ‘Erosion, Technology and Concentration’ (ETC, earlier called ‘Rural Advancement Foundation International’, RAFI). ETC has also coined the obnoxious term ‘terminator gene’ which is not a scientific name for this technology, and which should be called ‘Genetic Use Restriction Technologies’ (GURT). GURT includes several useful protocols. Gene silencing, which is used to develop several GE agricultural products, is one of them. Both the terms, biopiracy and terminator technology, are the products of mischievous and vicious mind and rake up public apprehensions against science and scientists. The unthinking scientific community has often used these terms adding credibility, which led the public to believe them as hazardous scientific protocols developed by wicked scientists to make enormous profits. 10. One cannot make biopiracy a crime without it being officially and legally recognized as a crime. 11. The question then arises is ‘benefit sharing’, if and when one uses someone’s proprietary biological resources or genetic material for commercial purposes, for which ownership has to be firmly established. 12. In the case of Bt brinjal, the Tamil Nadu Agricultural University, Coimbatore (TNAU), University of Agricultural Sciences, Dharwad (UASD), and the Indian Institute of Vegetable Research, Varanasi (IIVR), who are involved in the R & D of the products, are all public sector institutions. The varieties of brinjal (isogenics) they used to develop Bt brinjal were developed by them and were made available for cultivation for several decades. The three public sector institutions have also exchanged their material among themselves. They have submitted letters to the NBA on the geneaology of the brinjal varieties they are using, to establish their rights on them. 13. The isogenic material of Bt brinjal hybrids developed by Maharashtra Hybrid Seed Company (Mahyco) was secured from Rahauri University way back in 1970s. These non-Bt hybrids were marketed for decades by Mahyco. The NBA has been notified about this and NBA has granted permission to Mahyco expressly for using this parent material to develop their Bt brinjal hybrids. 14. The use of Monsanto’s EE1 Event in brinjal is all legal between Mahyco and Monsanto, as is the sublicensing of it to the Indian developers by Mahyco. 15. The terms of sublicense from Mahyco for the use of the EE1 Event of Bt brinjal prohibit the three public sector partners to sell the seeds for profit and permit them only to distribute them to resource poor farmers. Generally these seeds would be distributed by the public sector institutions below cost and they would not be able to recover the full developmental or even farmer seed costs, when they make seeds available to the farmers. As they are all varieties, the agreements specifically recognize the farmers' right to save the seeds and sow them in their own right for subsequent seasons, which is not the case with hybrids. Therefore, there is no benefit accruing to any of the public sector developers of Bt brinjal in this transaction, to be shared with others. 16. Section 40 of the Biological Diversity Act, 2002 (18 of 2003) reads “40. Notwithstanding anything contained in this Act, the Central Government may, in consultation with the National Biodiversity Authority, by notification in the Official Gazette, declare that the provisions of this Act shall not apply to any items, including biological resources normally traded as commodities”. 17. On October 26, 2009, the Ministry of Environment and Forests, Government of India (GoI), issued a Gazette Notification (No. SO 2725(E) ‘in consultation with the National Biodiversity Authority’. In this notification, there is a list of 190 species which are normally traded as commodities and to which the ‘provisions of the Biological Diversity Act, 2002 (18 of 2003) shall not apply’. Solanum melongena (brinjal) is at position 105, under ‘B. Vegetables’. Brinjal is certainly a commodity regularly traded daily in regional, national and international markets (many websites post daily updates, as for example, http://www.agmarknet.nic.in/ and http://www.agmarknet.nic.in/SearchCmmMkt.asp), and so by this Gazette Notification brinjal is exempted by the GoI, from the provisions of the BDA. 18. On November 6, 2012, the NBA reconstituted the Expert Committee on Normally Traded Commodities (NTC) ‘as a response to issues raised by stakeholders so as to work out the modalities for re-notifying the NTCs’. In a quick response to my seeking a clarification, the Secretary, NBA, wrote that the NBA had communicated the list of NTCs in its revised format as recommended by the EC, to the Administrative Ministry (MoEF?) in August, 2013 for further action (letter No. F.No. NBA/2/9/2002-Admin/12/12-13/, of November 4, 2013, sent to me by e-mail). It is further stated that a) ‘brinjal (Solanum melongena) is enlisted (sl.no. 105 of S.O 2726 (E) dated 26th Oct, 2009 gazette notification) as NTC and hence, when traded as a commodity, it is exempted from the purview of the Biological Diversity Act, 2002, and b) the October, 2009 19. ‘Surprisingly, corn (maize) which has an enormously more national and international trade volume than brinjal is not in the present NTC list! As all the crops in development are NTCs, we better approach the MoEF to see that nothing is missed from the revised NTC list before it is gazetted. Not including common crop species, which are NTCs but also in active R&D through diverse technologies is perverse and would upset marketing practices and international trade agreements, and can become an international issue. 20. The ‘Convention on International Trade in Endangered Species of Wild Flora and Fauna’ (CITES) publishes three Appendices listing endangered wild species in which trade is regulated. Either deliberately or out of ignorance, activists throw CITES at us in the context of agricultural crops too. CITES is only about wild species and that too those officially recognized as under threat. Brinjal does not occur in the wild and it is a cultivated species developed through human intervention and neither brinjal nor Bt brinjal hybridize with the presumed wild relatives of brinjal in nature. Brinjal is under no threat of extinction and so Bt brinjal development does not attract the provisions of CITES. 21. Section 40 (2) of the BDA reads ‘The decision of the Central Government whether a question is one of policy or not shall be final’, which empowers the Central Government, in addition to the other powers it has, to take decisions on any matter . As a matter of policy, the Central Government has established a statutory regulatory regime for biosecurity evaluation of genetically engineered crops, principally managed by the Review Committee for Genetic Modification (RCGM) and the Genetic Engineering Approval Committee (GEAC), a statutory body. This means that the Central Government is exercising its power through this regulatory regime. The product developers have routed Bt brinjal through this rigid system. The decisions of the GEAC are hence decisions of the Central Government and so final. 22. The then Minister for Environment and Forests (MoEF) has conducted public consultations on Bt brinjal before imposing an indefinite moratorium on its commercial release and brought everything about Bt brinjal into the public domain. If there was any infringement of the BDA, it would have been brought out by the activists and/or suo motu by the NBA, a long time ago. At the Bangalore public consultation meeting, the activists have objected to the inclusion of brinjal in the NTC list but said nothing about any alleged violations of the BDA. The then MoEF had also not raised any such issues. 23. Any Act is prospective and not retrospective unless expressly stated in the Act. The BDA was approved by the Parliament in 2003 and the Rules came on July 1, 2004, while the process of Bt brinjal development started much earlier than 2003. 24. The Food and Agricultural Organization's (FAO) ‘International Treaty on Plant Genetic Resources for Food and Agriculture’ (the Seed Treaty) provides for a ‘Multilateral System (MLS) of sharing plant genetic resources’. Having ratified the Treaty on June 10, 2002, India is a party to the FAO's Seed Treaty, which came into force on June 29, 2004, earlier than the Rules under the Indian BDA (July 1, 2004). 25. By ratifying the MLS Treaty, party countries agree to make their genetic diversity and related information about the crops stored in their gene banks available to all, through the MLS. The MLS, an integral part of the Seed Treaty, does not recognize national or farmer ownership of varieties of crops listed in Appendix I of the Treaty, which includes 64 of our most important crops, comprising a pool of genetic resources that are accessible to everyone. Brinjal, as the egg plant (Section Melongena included), is listed in the appendix. Even as Article 9 of the Seed Treaty calls for Farmers’ Rights, it does not exclude the intellectual property of commercial plant breeders. Sections of the Treaty permit international exchange of germplasm and even encourage patenting of derivatives of species. Then, a tax on patented seeds would be levied and that would be a source of income to the Seed Treaty Establishment. 26. India has signed off its rights on the species in Appendix I of the Seed Treaty where the egg plant was included, by being a contracting party to the Treaty. Biopiracy is not recognized as an issue of crime in the Treaty. So it is perfectly in order if Bt brinjal was developed from proprietary stocks in the public or private sector and even if brinjal or Bt brinjal stocks have been sent to Philippines and Bangladesh for research and non-commercial development, both the countries being contracting partners of the Treaty. 27. The NBA specifically approved the exchange of the material between Mahyco and non-Indian institutions such as University of Philippines, La Banos (UPLB) and Bangladesh Agricultural Research Institute, Gazipur (BARI). GEAC has not stipulated any such condition (like NBA approval) for the domestic transfer of materials. It only required the materials to be deposited with the National Bureau of Plant Genetic Resources, New Delhi (NBPGR), which was complied promptly by the developers. 28. The Indo-US Biotechnology Cooperation Agreement was executed as a bilateral collaborative project in June 2004, before the Rules came into effect under the BDA on July 1, 2004. As per this agreement, the Bt brinjal project was approved as a national network project by the GoI and is being monitored by a Joint Working Group constituted of the representatives from the Ministry of Agriculture, Ministry of Environment and Forests, Department of Science and Technology, Department of Biotechnology, and ICAR/ DARE, all of who have written to the NBA categorically that this project does not fall under the purview of the NBA for prosecution and does not warrant prosecution. From the Minutes of NBA meetings posted on its website, it looks that these letters were delivered at the 23rd meeting of the NBA on February 28, 2012, by the representative of the DBT. 29. The BDA does not state who will notify such projects as Bt brinjal, approved by the GoI as collaborative projects. The bone of contention between DBT and ICAR on the one hand and the NBA on the other is that, NBA oddly does not take cognizance of collaborative projects notified by DBT or ICAR, and that ipso facto, they do not constitute collaborative projects unless they are taken cognizance by NBA! The ICAR and DBT have not agreed to this view. The Union Minister for Agriculture had indeed written to the Prime Minister of India that NBA has no jurisdiction over these collaborative projects. 30. The following is the response to the issues raised by the activists from time to time (some were also raised by the then MoEF in different contexts), to mould public opinion against Bt brinja and other GE crops: a) No biological material collected from the wild was used; b) The Bt gene isolated was from a universally occurring soil bacterium and no genes from any Indian biological resources were extracted and used; c) ‘Geographical Indication’ or ‘Traditional Knowledge’ is not involved; d) No ownership and benefit claims exist from any Indian organization or individuals on the isogenics used, and so the product developers themselves are the owners of the isogenics and should get any benefit out of the products developed by them; e) No IPR issues related to the commercializable product are involved; f) Bt brinjal is not a variety, it is a collective name for several varieties and hybrids that contain the same Bt gene construct and Bt brinjal is not an imported product, but only the pesticidal genes in it were imported; g) Bt brinjal does not destroy brinjal diversity, and in fact the Bt gene actually protects the varieties and hybrids used in its development from being devastated by the pest; h) Bt brinjal, when approved for commercial release, would be marketed within the country. i) Developed products or results are not transferred to a foreign company, foreign national or an NRI; j) Foreign company involvement is to the extent of providing the technology against payment of costs for an innovative patented gene construct, using genes from a non-Indian source, and a similar gene construct is already in use in India since 2002 in several hundred commercialized hybrids of Bt cotton; k) The involvement of USAID and Cornell University, which facilitated cost free transfer of technology to the public sector institutions, does not entail any transfer or exchange of biological resources or information or IPR and so does not contravene any provisions of BDA; l) TNAU, UASD and IIVR are Indian public sector institutions whose scientists and other personnel are Indian citizens and the R & D is for the benefit of the Indian farmer and the consumer and the three developers do not derive any financial benefits; m) Brinjal does not occur in the wild and it is a cultivated crop developed through human intervention and provisions of the BDA do not apply to material that is in cultivation and particularly when the source and/or genealogy of the isogenics are tracked to the developers; o) The requirement of BDA (Sections 3 and 4 relating to obtaining Indian biological resources or transfer of results or apply for IPR abroad) shall not apply to collaborative research projects involving transfer or exchange of biological resources or information relating thereto between institutions, including Government sponsored Indian institutions, and such institutions in other countries, if such collaborative research projects satisfy the conditions specified in sub-section (3), which reads as ‘such collaborative research projects shall – (i) conform to the policy guidelines issued by the Central Government in this behalf, and (ii) be approved by the Central Government’, all of which has happened; and p) Section 18 of the BDA, which is often cited, refers to the Functions and Powers of the NBA and not to any mandatory responsibility on the part of the researchers. 31. The NBA is influenced by the activists in moving to prosecute Bt brinjal developers, leading to a very dangerous situation when no individual or organization, public or private or Indian or 32. If present spurious charges of biopiracy and NBA’s attitude are extended, Dr M S Swaminathan Research Foundation, Chennai, even as an Indian research organization, should take NBA’s permission since they have actually sourced the salinity tolerant gene from a species growing in the wild, and incorporated it into the rice genome, but I do not know if they did so. 34. The NBA is constituted of the Chairman and the Secretary, 10 official Members and four non-official Members, a total of 16. The 23rd Meeting of the NBA held on February 28, 2012, chose the voting route to decide on initiating legal proceedings against alleged violations of the BDA by Bt brinjal developers, Eight Members were present at the meeting, two with proxy forms. Several happenings at this meeting are strange, to say the least: a) Three members (two who did not have proxy forms and one proxy member representing a non-official member), were not allowed to vote; b) If any members did not have a proxy forms, why were they allowed into the meeting in the first place?; c) The decision to prosecute was taken by on a vote of 3:2 (against), obviously by two NGOs and the casting vote of the Chairman!; d) Denying voting right to three members present at a meeting attended only by half the strength of NBA and carrying the decision by voting and not taking a more sensible decision of deferring the issue; and e) It is generally believed that who voted for or against a motion is confidential, but it was noted in the minutes (recorded in the proceedings of the 24th meeting held on May 23, 2012) that two proxy members voted against the motion! There seems to be an anxiety to prosecute and what happened at the 23rd meeting raise the suspicion of a design to carry out the motion. ‘Members present and voting’ is a standard operative norm for voting at meetings but the decision to prosecute was carried out by a minority of three votes, against the eight present and the total NBA strength of 16. The two proxies without proxy forms are also to be blamed for the decision to prosecute, as it is their responsibility to carry proxy forms. 35 ‘The BDA and the NBA have become political instruments rooted in distorted science. The activists use 'biopiracy' as the principle thrust argument against modern agricultural research. All biodiversity laws are about wild vegetation and not man-made crops. 36. The little sense of function and authority the BDA and NBA had is ruined by over targeting the foreign element by the activists, which also affects the Indian institutions. The activists and the then MoEF who imposed an indefinite moratorium on Bt brinjal, repeatedly spoke of containing the domination of one foreign company, meaning Monsanto, which actually played no role in the development of Indian Bt brinjal. If the presumed involvement of Monsanto was not so prominently advertised, probably none of the present hurdles to agricultural biotechnology would have been in place. 37. For over two years the media publicized the statements of the Chairman of NBA targeting Monsanto. He was probably inspired by the frenzy built up by the activists and supported by some elements in the MoEF and NBA. Surprisingly, Monsanto was not made a party in any way in the cases of biopiracy or violation of provisions of BDA in the context of Bt brinjal but Mahyco was, in the latter. 38. The NBA Chairman ‘reiterated that the issue in question is not the use of biotechnology or issues related to collaborative research but it was about possible alleged violation of Biological Diversity Act in accessing local brinjal varieties’ (24th NBA meeting, May 23, 2012), but since actions speak louder than words, his assurance is hollow. 40. The Learned Judge of the High Court of Karnataka has not taken cognizance of the issues discussed here, while setting aside the request of UASD to quash the legal proceedings against them. 41. We should certainly have a sense of pride about our achievements in agriculture and some possessiveness about our crop genetic resources. The efforts of the NGOs and the NBA to protect our crop genetic resources are to be respected but not their vindictive and vicious attitudes and activities. While what crop genetic resources any country has at present is the result of efforts to introduce, modify and sustain them by hundreds of scientists and farmers, we should not also forget that crop genetic resources are a cumulative common global heritage and excessive claims of ownership are obscene. 42. When we look into the history of Green Revolution in India, we find that the Mexican semi-dwarf wheats (MSDW) made all the difference to enormously enhancing wheat production. The MSDW are traceable to one dwarf wheat, Norin 10, from Hokkaido in Japan, taken to the USA in 1940. Rather small batches of seed of two MSDW (Sonara-64 and Lerma Roja-64A) sent by Dr Norman Borlaug in 1964 were used to develop our high yielding semi-dwarf Pusa wheats (Kalyan Sona and Sonalika). In 1966 several thousand (18,000?) tonnes of Lerma Roja 64 wheat was imported from Mexico with financial support from the Rockefeller Foundation and sown in wheat growing areas. True, that there were no norms and rules to regulate sending out crop resources at that time. Even so, do we not owe our prosperity to Mexico, for the wheats used to develop our own? Do our NGOs consider benefit sharing with the Mexicans, as certainly we benefitted materially and financially from their contribution? We did not blink even once while appropriating Mexican wheats but harass indigenous developers whose R&D is aimed to benefit Indian agriculture. The Green Revolution was described by Dr MS Swaminathan as ‘the Golden Age of interdisciplinary and international collaboration’. We may have the genetic resources, but someone else has the technology to put them to an immensely beneficial use. If we stall scientific cooperation our resources would soon be lost. There would not be any progress without a global exchange of material, ideas and technologies. 43. Who is helping whom? a) Bt brinjal has passed through the regulatory regime and was approved by two Expert Committees and the GEAC, all involving over 200 scientists and other experts. Another Committee constituted by the GEAC on the express orders of the then MoEF, met on April 27, 2011, and concluded that ‘ the safety of Bt gene in brinjal had been established by the tests that had already been done and that more time must not be lost in conducting more tests and field trials’. Yet, the moratorium on Bt brinjal is still in place even after three and half years. This is the collective failure of the Ministry of Agriculture, Ministry of Environment and Forests, ICAR, DBT, the scientific community and the Bt brinjal developers, which helps only the activists. We should send to all these fennel seeds said to have been eaten by Roman Gladiators to instill courage, before going into the games. And, b) The activists are working to stop all field trials of GE crops, to block the whole GE crop development process at the first stage itself. By doing this, they are actually helping the present players marketing Bt cotton to make more profits without additional R&D investment, as blocking field trials prevents development of any new Events, even of Bt cotton. The previous and the present MoEFs too have a share of responsibility in this. 44. We should all be grateful to the Union Minister of Agriculture and Minister of State for Agriculture, for all the support they are extending to GE crops in the face of enormous antipathy in the Cabinet, the Parliament and outside, in dire contrast to the callous carpetbagger MoEFs, previous and present. Visit the website http://www.plantbiotechnology.org.in for several articles on agricultural biotechnology. November 11, 2013.
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