Gene Campaign & Anr. v. Union of India & Ors.

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prevention of plant diseases” to the States. However, it observed that for a thing as crucial as field trials, the State Governments were not even consulted till recently. vii. The Committee concluded that in a regulatory set-up where the promoter has an overwhelming say and presence in the regulatory mechanism, an element of subjectivity in assessment and evaluation is unavoidable. The entire system, therefore, reflects a pro-DBT/pro-industry tilt which is best avoided. Apart from this major shortcoming, the Committee’s examination has revealed that the extant system is grossly inadequate and antiquated to face the typical challenges a population-intensive, agrarian economy (primarily) like India poses when the question of introduction of such modern technologies in the agriculture sector crops up. Parliamentary Standing Committee (PSC) on Science and Technology, Environment and Forests’ Report titled “Genetically Modified Crops and its impact on Environment” - 2017:

12. The aforesaid Report has been perused by us. The salient observations and recommendations of the said Committee are encapsulated in the following paragraphs: i. The Committee considered the legal and administrative architecture for the regulation of biotechnology and GE techniques and the extant process of health and environmental safety assessment. ii. It observed that as a party to several International Conventions, India should ensure the safe usage of GM crops through the “Precautionary Approach”. In line with the same, India ratified International Protocols like the CBD, the CPB and the Nagoya Kuala Lumpur Supplementary Protocol on Liability and Redress (NKSPLR). iii. The Committee took note of the divergent views on the efficacy of the existing regulatory mechanism. It expressed certain apprehensions about the stance of the MoEF&CC that the existing regulatory regime left no scope for any non-adherence. It also observed that the MoEF&CC and GEAC’s casual

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approach indicated indifference towards the environmental safety and health hazards of humans and animals. Specifically, it concluded that the regulatory agencies had turned a blind eye to the negative impact of GM crops on the environment. It was observed that the existing regulatory mechanism was susceptible to manipulation, due to the following processual infirmities and substantive deficiencies: a. The whole process of regulation depends upon the data made available to the regulators by the technology developers. b. None of the Committees established under the 1989 Rules conduct the closed field trials on their own but are solely dependent on the data provided to them by the technology developer. c. There was a scope for the technology developers to manipulate the data to suit their own requirements. d. The Government failed to put in place the desired protocols as late as 2011, while the GM crops were introduced in 2002. e. Two of the top three positions of GEAC are held by the bureaucrats of the MoEF&CC. There is a conflict of interest in the appointment of some of the members of GEAC. f. The members of GEAC were mostly from the Government and Government-aided institutions and there was hardly any representation of the civil society or the State Governments on the Board. g. Even though the DLCs are provided for in the 1989 Rules, the importance of this Committee had not been realised, thereby further weakening the confidence level of farmers, civil societies, environmentalists, etc. h. There was lack of clarity on the impact of the adoption of Bt cotton on crop yield. Therefore, the Committee was not persuaded about the claims of success of

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Bt cotton as India’s cotton yields increased by 69% in the five years (2000-2005) when Bt cotton was less than 6% of total cotton area, but by only 10% in the ten years from 2005 to 2015 when Bt cotton grew to 94% of the total cotton area. There was also lack of clarity on whether traditional methods of farming could achieve better outcomes. i. It also expressed its apprehensions about the stated benefit of reduced dependence on chemical pesticides. Based on consultations with members of civil society, it observed that after the advent of Bt cotton, the insecticide use on bollworm, both sucking and secondary pests took over the ecological niche vacated by the bollworm. Therefore, the per hectare insecticide use had almost doubled. The issue of pesticide resistivity was also a matter of concern, as it was observed that the pink bollworm had developed resistance to Bt cotton variety, i.e., Bollgard-II (BG-II). j. Since transgenic mustard hybrid DMH-11 is a HT GMO, there exists clear evidence of the adverse impacts thereof from elsewhere in the world. In the case of transgenic mustard hybrid DMH-11, thus, there are serious unanswered questions. k. The cultivation of GM crops in the midst of other indigenous farming would cause unstoppable contamination and cross-pollination. It would also adversely affect non-target organisms like soil microbes, insects, bees, butterflies, birds or even mammals which are critical to the agro-ecosystem. l. There is a glaring lack of indigenous study on the impact of GM crops on human health. It is particularly worrying because certain studies on animals revealed complications including infertility, immune problems, accelerated aging, insulin regulation, and changes in major organs. The Department of Health Research

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has accorded its approval for commercial release without scrutinising any indigenous study. Only acute and sub-chronic studies have been conducted but chronic and transgenerational studies have not been conducted, therefore, risking the health of future generations.

13. As is well-settled, the Parliamentary Select Committees are entities through which Parliament scrutinises the policies and actions of the Government and enforces executive accountability. Select Committees are constituted with specifically nominated Members of Parliament and exercise the authority delegated by the House. The role of Select Committees has been outlined in Erskine May’s Treatise on The Law, Privileges, Proceedings and Usage of Parliament, (Lexis Nexis, 24th Edn. 2011, p.37.] as under: “Select Committees are appointed by the House to perform a wide range of functions on the House’s behalf. Most notably they have become over recent years the principal mechanism by which the House discharges its responsibilities for the scrutiny of government policy and actions. Increasingly this scrutiny work has become the most widely recognised and public means by which Parliament holds Government Ministers and their departments to account.” 13.1 Parliamentary material, such as the reports submitted by Select Committees, is an aid to the construction of legislation, as such material may disclose the legislative intention lying behind the ambiguous words and expressions, vide Pepper (Inspector of Taxes) vs. Hart, 1992 UKHL 3 (HL) (“Pepper”). Noting the evolution of Indian law, Justice G.P. Singh, in Principles of Statutory Interpretation (14th Edn.), has stated that this Court has pressed the parliamentary materials as an aid in resolving questions of construction. This Court has clarified that courts may seek recourse to background parliamentary material, including a statement of position by the Government, to understand the reasons of the enactment of a law and the problems sought to be remedied vide Kalpana Mehta vs. Union of India, (2018) 7 SCC 1 (“Kalpana Mehta”).

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13.2 The pertinent facts in Kalpana Mehta were that a writ petitioner, who had challenged the grant of approval to an HPV (Human Papilloma Virus) vaccine by the Drugs Controller General of India, had invited the attention of this Court to a report of the PSC and this Court had directed the Government to file an affidavit about the status of compliance with the contents of the report. At that stage, the State and private respondents raised doubts about the appropriateness of adverting to a report of the PSC while exercising jurisdiction under Article 32 in a public interest litigation. Therefore, the core question raised therein that came to be referred to the Constitution Bench was whether a PSC report can be placed reliance upon for adjudication of a fact in issue and also for what other purposes it can be taken aid of. 13.3 It was concluded that the reports of the Parliamentary Committee can be relied upon to adduce the position adopted by the Government. In this respect, reliance can be placed upon the responses given by the Government to the queries raised by the Parliamentary Committee. The Union of India has filed Action Taken Reports with respect to the recommendations made by the Standing Committee. Conditional approval by Government of India for Environmental Release of DMH-11:

14. We shall now proceed to the actual controversy. According to Union of India, the conditional approval for environmental release of transgenic mustard hybrid DMH-11 and parental lines bn 3.6 and modbs 2.99 containing barnase, barstar and bar genes has been made after following the detailed procedure in law and after considering the biosafety data accumulated over several years. Also, the conditional approval has been made in accordance with the guidelines and framework which enable a consistent and rigorous risk-analysis approach to evaluating applications for the environmental release of GE plants is the contention of the Union of India. 14.1 That in the instant case, after recommendation of RCGM, GEAC had considered the recommendations of RCGM in the following meetings in regard to confined field trials:

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Date of Meeting Purpose of Trial Permission GEAC under which Granted Meeting considered

29.09.2010 103rd meeting Study under confined conditions 1st year for environmental and food BRL-I and feed safety assessments application at three locations namely dated Agricultural Research 20.08.2010 station experimental Farm, to RCGM. Navgaon, Agricultural Research Station, Sriganganagar and KVK, Kumher during Oct, 2010. Also, gave approval for experimental seed production under confined condition at Jaunti Village, Delhi and Environmental safety studies (Crossability Studies) at Bawana, Delhi during Oct, 2010.

21.09.2011 112th meeting On transgenic mustard (Brassica 2nd year Juncea) containing bar, barnase BRL-I and barstar genes [Events bn application 3.6 (Barnase Line), modbs 2.99 dated (Barstar Line) and bn 3.6x modbs 15.07.2011 2.99 (Hybrid DMH-11) under the to RCGM. coordination of Directorate of Rapeseed Mustard Research, Bharatpur during the appropriate season in 2011-12.

18.07.2014 121st meeting On transgenic mustard hybrid BRL-II trials (DMH-11) (Brassica juncea) application Events bn 3.6 (Barnase Line), dated modbs 2.99 (Barstar Line) & 17.08.2012. bn 3.6 x modbs 2.99 containing bar, barnase and barstar genes at Navgaon, Sriganganagar, Kumher, Delhi, Bawal, Ludhiana, Bhatinda, Bharatpur, Morena, Kanpur and Faizabad during appropriate season.

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14.2 After confined field trials, the facts leading to conditional approval for grant of environmental release by GEAC are as under: (i) The CGMCP, University of Delhi, New Delhi, on 15.09.2015, submitted an application for approval of environmental release of the GE mustard (Brassica juncea) hybrid DMH-11 and use of parental events (Varuna bn 3.6 and EH-2 modbs2.99) for development of new generation of hybrids, along with a dossier of 3285 pages as a compilation of the results of the food and environmental safety studies that were carried out at the time of research/ experiments/ confined field trials and the application for the environmental release of transgenic mustard DMH-11 hybrid and parental lines bn 3.6 and modbs 2.99 containing barnase, barstar and bar genes to GEAC. (ii) The said application for environmental release was considered in the 125 th meeting of GEAC held on 11.12.2015, wherein GEAC deliberated on the application submitted by CGMCP for environmental release of mustard. After a detailed deliberation, it was decided that the applicant may be invited to give a presentation to GEAC on 04.01.2016. (iii) In its 126 th meeting held on 04.01.2016, GEAC constituted a sub-committee under the Chairmanship of Dr. K. Veluthambi, Co-Chair of GEAC, with the following members for examination of the dossier: a. Dr. K. Veluthambi, Chairman (Biotechnologist) b. Dr. S R Rao, Adivser, DBT, Member (Agriculture Expert) c. Dr. S.K. Apte Member (Molecular Biology Expert) d. Dr. Ramesh V Sonti Member (Plant Genetics Expert) e. Dr. B. Sesikeran, Member (Nutritional Pathologist and Food Safety Expert) f. Dr. C R Babu Member (Environmental Science Expert)

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g. Dr. K V Prabhu, Joint Director (Research), IARI Member (Plant Breeding Expert) h. Member Secretary, GEAC to facilitate the sub- committee. (iv) Pursuant to the recommendation of the above-mentioned meeting, GEAC was informed in its 127th meeting held on 05.02.2016, that the 1st meeting of the sub-committee was held on 02.02.2016. The Chair of the sub-committee also informed GEAC that the outcome of the review of the biosafety dossier submitted by the BSU set-up by DBT was also deliberated in detail. It was further informed that the sub-committee recommended revision of the biosafety dossier by incorporating additional information/ clarifications/gaps identified by the sub- committee and the BSU. Considering the above, GEAC, in its 127th meeting, adopted the recommendations of the sub-committee and directed for the revision of biosafety dossier. GEAC also discussed the procedure for further review and consultation on the biosafety data in respect of transgenic mustard hybrid DMH-11 developed by CGMCP and Biosafety RARM report to be prepared for consideration of GEAC. It was also decided that if the biosafety dossier 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. Thereafter, a detailed response to the comments received would be prepared and considered before a final decision is taken by GEAC. (v) The first meeting of the sub-committee was held on 02.02.2016 and the second meeting of the sub-committee was held on 11.04.2016. Sub-committee meetings: 14.2.1 In the first sub-committee meeting, held on 02.02.2016, the sub-committee made the following submissions: a) That the mandate given to it included review of the biosafety dossier for its adequacy and accuracy in all respects, and indicate gaps, if any.

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b) That Dr. S.R. Rao Advisor, DBT informed that the biosafety dossier had been examined in detail by the BSU set up in DBT and points for further clarification and dossier revision had been prepared for consideration and discussion. c) That on the application submitted by the applicant CGMCP, University of Delhi, South Campus, for environmental release of transgenic mustard hybrid DMH-11 and parental lines containing events bn 3.6 and modbs 2.99 developed using barnase, barstar and bar genes, was taken up. d) That discussion was held with the applicant and the sub- committee advised for continuous monitoring and further investigation for fitness and the transfer of transgenic trait from DMH-11 to their progenies and feral populations that will be essential for implementing management strategies to minimize persistence and dissemination from release site. The sub-committee also advised that a suitable post- release management strategy should be implemented. e) That certain data had to be incorporated in the revised dossier, along with the details of oil content and other measured parameters in the revised dossier. f) That the data suggested that the activities of barnase need to be presented quantitatively and UDSC-barnase specific activity can be compared with any other over expressed barnase specific activity to compare activity status of the proteins. g) That the updated statistics data from National Institute of Nutrition (NIN) may be included in the revised dossier. h) That Intellectual Property Rights (IPR) for Barnase promoter has not been registered in India. i) Requested the University to check whether DMH-11 hybrid accumulated complexes of barnase + barstar. j) Questioned whether grazing of transgenic mustard by farm animals would affect them. k) That the bar gene is present in the two parental varieties and continues to be present in the hybrid but release of

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marker free hybrid would have been desirable. For that, reply by the applicant was that barnase/barstar technology requires a herbicide gene for hybrid seed production and for maintaining the male sterile line. l) 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. m) That sub-chronic toxicity was evaluated in rats, though it would have been much more relevant to do so in rabbits, goats and other cattle which are likely to consume mustard leaves. n) That issues regarding deliberate introduction of a protein that induces cell death into our food were raised/discussed. o) That in the case of canola, only oil is consumed, but mustard leaves and seeds are consumed as food by humans and this is a matter of concern. To this, the reply of the applicant was as under: “It is a fact that a fear-psychosis has been created around transgenic crops. Transgenic technologies are heavily patented and mainly with transnationals-many fear that dependence on proprietary technologies may jeopardize food security of developing countries like India. Although European continent is scientifically very advanced – they seem to have opted for chemical control rather than biological control. Europe is a huge importer of food and has no ambition of increasing food production. They are only interested in high-value agriculture. Europe has not released even any cisgenic event. Japan gave biosafety clearance for environmental release of barnase/ barstar Canola in 1996 – but has chosen not to grow it. However, Japan is the largest importer of Canola seed, oil and meal. Decisions on not growing GM crops are political and economic in nature – rather than related to biosafety.” p) That long-term post-release monitoring should be implemented to study (i) weediness, (ii) pollen flow to wild

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relatives, (iii) the impact on beneficial insects, and (iv) the impact on beneficial soil microbes, if any. 14.2.2 The second sub-committee meeting of GEAC was held on 11.04.2016. In the said meeting, Dr. S.R. Rao briefed the sub-committee members on the follow up actions taken by BSU pursuant to the 128th GEAC meeting held on 04.03.2016 regarding the application for environmental release of transgenic mustard (Brassica juncea) hybrid DMH-11 by the CGMCP, University of Delhi (South Campus). The sub-committee was made aware of the fact that the 128th GEAC meeting held on 04.03.2016, had sought further information/clarifications from CGMCP and accordingly, a revised document was submitted by the applicant. Accordingly, the revised biosafety dossier and draft RARM report of the sub-committee was circulated amongst the sub-committee members and comments of the experts were tabulated along with remarks of the BSU. 14.2.3 Observation of one of the members of the sub-committee was regarding the sustainable use of deregulated GE mustard in future and as to how honey derived from GE mustard be tested for the absence of barnase for a definite period as a part of post-release monitoring. 14.2.4 The sub-committee opined that one of the members of the sub-committee explained that self-reproducible populations of mustard (Brassica juncea) may get established in the hills (not in the plains) and though probability of such occurrence may be low, this question needs to be addressed. The sub-committee opined that this should be taken as a scientific question, which should be addressed from a research angle in the interest of long-term sustainability of transgenic mustard hybrid DMH-11 technology. 14.2.5 The sub-committee sought time to analyse and review the revised dossier and results obtained in the 129th GEAC meeting, which was held on 20.06.2016. 14.2.6 In the meantime, GEAC invited two groups of NGOs for presenting their views/concerns regarding release of transgenic mustard hybrid DMH-11 in India.

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14.2.7 The sub-committee constituted by GEAC suggested a report being placed on the MoEF&CC website for thirty days, to invite comments from stakeholders in the 130th GEAC meeting held on 11.08.2016. 14.2.8 Accordingly, the AFES Report was uploaded on the website of MoEF&CC, inviting comments from all stakeholders. The comments received were to be reviewed by the sub- committee and GEAC prior to taking an appropriate decision. The full biosafety dossier submitted by the applicant was available in GEAC Secretariat and any person interested in studying the same could access the dossier during working hours in person, by prior appointment during the public consultation period, at Indira Paryavaran Bhawan, Jorbagh, New Delhi – 110 003, till the closing of working hours, i.e., 05:30 PM on 05.10.2016. A total of 759 comments were received between 05.09.2016 and 05.10.2016. 14.2.9 It is also to be noted that about 29 persons (including from places other than Delhi) personally inspected the dossier at the premises of the MoEF&CC and provided their comments. It is stated that thereafter, all these comments were analyzed and deliberated by the sub-committee of GEAC. 14.2.10 The instant proposal was again considered on 11.05.2017 in the 133rd GEAC meeting, wherein the report submitted by the sub-committee was examined in detail and GEAC recommended the proposal with certain terms and conditions for further approval by the Competent Authority. But pursuant to receipt of various representations from different stakeholders, matters related to environmental release of transgenic mustard were kept pending for further review. 14.2.11 In the 134th meeting of GEAC held on 21.03.2018, it was recorded that the instant proposal was referred back to GEAC for its re-examination, pursuant to receipt of several representations, both in support and against, after the 133rd meeting of GEAC held on 11.05.2017. In this meeting, GEAC examined all the representations and reiterated that these representations were already deliberated extensively while taking the decision in the 133rd meeting of GEAC. After a detailed discussion, GEAC

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agreed that the applicant may be advised to undertake field demonstration on transgenic mustard hybrid DMH-11 in an area of five acres at two to three different locations, with a view to generate additional data on honey bees and other pollinators and on soil microbial diversity. 14.2.12 The instant matter was re-examined in the 136th meeting of GEAC held on 20.09.2018, wherein the said Committee accorded permission for conduct of field demonstration studies on honey bees and other pollinators at two locations of up to five acres in each location namely Punjab Agricultural University (PAU), Ludhiana and Indian Agricultural Research Institute (IARI), New Delhi. 14.2.13 Thereafter, in the 137th meeting of GEAC held on 20.03.2019, the Committee noted the response from the applicant regarding the reasons for deferment of field demonstration studies on transgenic mustard during the season 2018-19 and the deferment was further extended for the seasons 2019-20 and 2020-21. 14.2.14 At this stage, Prof. Deepak Pental, Former Professor of Genetics and Vice-Chancellor, University of Delhi, on behalf of CGMCP, University of Delhi, South Campus, New Delhi, made a representation on 10.05.2022 to the Hon’ble Minister for Environment, Forest and Climate Change, to accept the recommendations for environmental release of transgenic mustard hybrid DMH-11 made in 133 rd GEAC meeting. Accordingly, comments were sought from the concerned Department, namely DBT and Department of Agricultural Research and Education (DARE). Some of the relevant comments related to the present matter are reproduced herein below: “The comments received from DARE: “GEAC may consider exempting additional studies on the impact of GM Mustard hybrid DMH-11 containing the bar, barnase, and barstar genes on honey bees and other pollinators as decided in its 136th meeting and the recommendation of the 133rd meeting of GEAC may be considered. The environmental release of

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the proposed events will broaden the scope for developing many high yielding mustard hybrids in future. The comments received from DBT: Based on the scientific evidence and the available data from various international agencies, it seems likely that there were no major deviations in the behavior of honey bees when compared among the transgenic and non-transgenic comparator lines; and suggested that GEAC may consider its recommendations of the 133rd meeting on the environmental release of GE mustard.” Soon thereafter, ICAR by its letter dated 30.07.2022 wrote to MoEF&CC for GEAC to consider the recommendation for environmental release of transgenic mustard hybrid DMH-11 made in its 133rd GEAC meeting. DBT, by its letter dated 01.08.2022, also wrote to MoEF&CC for GEAC to consider the recommendation for environmental release of transgenic mustard hybrid DMH-11 made in its 133rd GEAC meeting, in light of the biosafety data received from the applicant as well as reviewing the international evidence of safety of the concerned technology. 14.2.15 Thereafter, on 25.08.2022, at the 146th GEAC meeting, the applicant made a detailed presentation on all aspects of the proposal for environmental release of DMH-11. In this meeting of GEAC, it was recommended that an Expert Committee be constituted to examine the request letter dated 10.05.2022, with respect to availability of adequate evidence about impact of transgenic mustard on honey bees and other pollinators, in order to assess the need for conducting field demonstration studies on honey bees and other pollinators. The composition of this Expert Committee was as follows: a. Dr. Sanjay Kumar Mishra, Chairman b. Dr. Ashok Kumar Singh, Member (Expertise in Molecular Genetics and Breeding) c. Dr. D.K. Yadav, Member (Expertise in Plant Breeding and Seed)

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d. Dr. A.H. Prakash, Member (Expertise in Plant Physiology) e. Dr. K. Annapurna, Member (Expertise in Microbiology) f. Dr. S. J. Rahman, Member (Expertise in Entomology) g. Dr. Nitin K. Jain, Member (Present Member Secretary of RCGM) h. Dr. K. C. Bansal, Member (Expertise in Plant Biotechnology, Functional Genomics) i. Dr. Abhilasha Singh Mathuriya, Member Secretary. 14.2.16 First and second meeting of this Expert Committee were convened on 23.09.2022 and 30.09.2022 respectively. The recommendations of the Expert Committee constituted in 146th meeting were submitted to GEAC and were as under: “Based on the examination of scientific evidences available globally, and as per the recommendations of concerned ministries, it seems unlikely that the bar, barnase, and barstar system will pose an adverse impact on honey bees and other pollinators. Therefore, the Committee was of the view that GEAC may consider the environmental release of GE mustard and further evaluation to be carried out as per ICAR guidelines for release and notification. However, to generate scientific evidences in Indian agro-climatic situation and also as a precautionary mechanism, the Expert Committee suggests that the field demonstration studies with respect to the effect of GE mustard on honey bees and other pollinators, as recommended in the 136th GEAC meeting, may also be conducted post-environmental release, simultaneously by the applicant, within two years under supervision of ICAR and the report be submitted to the GEAC.” 14.2.17 Based on the comments of the DARE and the DBT, and recommendations of the sub-committee, GEAC, in its 147th meeting held on 18.10.2022, recommended environmental

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release of transgenic mustard hybrid DMH-11, which was accepted by the Central Government on 25.10.2022. 14.3 It is clear from a bare perusal of the abovementioned events that the Union of India has taken the decision on the environmental release on the basis of the aforesaid procedure which was followed by GEAC. That the conditional permission granted by Union of India to the CGMCP for environmental release of transgenic mustard hybrid DMH-11 is said to be for the following purposes: a. The environmental release of GE mustard parental lines bn 3.6 carrying barnase and bar genes and modbs 2.99 containing barstar and bar genes, is to use the developing new parental lines and hybrids under supervision of ICAR. The environmental release of mustard hybrid DMH-11 for its seed production and testing, as per existing ICAR guidelines and other extant rules/regulations, is prior to commercial release. b. Further, to generate scientific evidences in Indian agro-climatic situation and also as a precautionary mechanism, the field demonstration studies with respect to the effect of GE mustard on honey bees and other pollinators, as recommended in the 136th GEAC meeting, shall also be conducted post-environmental release simultaneously by the applicant, within two years, under the supervision of ICAR, as per ICAR guidelines and other extant rules/guidelines/ regulations and the report be submitted to GEAC. 14.4 The environmental release of transgenic mustard hybrid DMH-11 hybrid DMH-11 for its seed production and testing as per ICAR guidelines was recommended by GEAC in its 147th meeting. The seed production and testing was to require three crop seasons, unless otherwise decided by ICAR, before the seeds are commercially available to the farmers. 14.5 It is further pertinent to note that the permission for environmental release was to be subjected to terms and conditions to ensure environmental safeguards, for example:

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(i) It provides that during the period of approval, a Post-Release Monitoring Committee (PRMC) would be constituted by GEAC, consisting of two subject matter external experts and a nominee each from the RCGM, GEAC and the PRMC, who will visit the growing sites of the approved biological material(s) at least once during each season and submit their report to GEAC on the matters of compliance. (ii) Usage of any formulation or herbicide is not permitted for cultivation in the farmer’s field under any situation and such use would require necessary permission as per the procedures and protocols for safety assessment of insecticides/herbicides by the Central Insecticide Board & Registration Committee (CIB&RC). Any such use in the farmer’s field without due approval from the CIB&RC would attract appropriate legal action under the Insecticides Act, 1968 and the Rules, 1971, made under the said Act and the EP Act, 1986, and the Rules made thereunder. (iii) The production of seeds of transgenic mustard hybrid DMH-11 will take place under the supervision of ICAR, as per the existing ICAR guidelines and other extant rules/regulations, after which the commercial cultivation of mustard will start. Commercial use will be subject to the Seeds Act, 1966 and the related rules and regulations. (iv) As a precautionary mechanism, the data in regard to the impact of transgenic mustard hybrid DMH-11 on honey bees and other pollinators will be generated during these two years under the supervision of ICAR. This may help create additional data in regard to the impact of transgenic mustard hybrid DMH-11 on honey bees and other pollinators. (v) The approval may be revoked under Rule 13(2) of the 1989 Rules, if any evidences regarding harmful effects of the approved GE mustard, such as damage to the environment, nature or health as could not be envisaged when the approval was given, come

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under notice of GEAC and on non-compliance of any condition stipulated by GEAC. 14.6 Within two months, on 18.10.2022, at the 147th GEAC meeting, it was recommended that environmental release of DMH-11 be approved subject to some conditions and safeguards. The recommendations and the conditions were communicated by the MoEF&CC to the applicant-Prof. Deepak Pental on 25.10.2022 and the same are extracted as under: “… the Genetic Engineering Appraisal Committee (GEAC) in its 147th meeting held on 18.10.2022, has recommended the following: I. The environmental release of genetically engineered mustard parental lines bn 3.6 carrying barnase and bar genes, and modbs 2.99 containing barstar and bar genes, so that these events can be used for developing new parental lines and hybrids under supervision of ICAR. II. The environmental release of mustard hybrid DMH-11 for undertaking its seed production and testing as per existing ICAR guidelines and other extant rules/regulations prior to commercial release. III. Further, to generate scientific evidences in Indian agro-climatic situation and also as a precautionary mechanism, the field demonstration studies with respect to the effect of GE mustard on honey bees and other pollinators, as recommended in the 136th GEAC meeting, shall also be conducted post-environmental release, simultaneously by the applicant, within two years under supervision of ICAR, as per ICAR guidelines and other extant rules/ guidelines/regulations and the report be submitted to the GEAC. These recommendations are subject to the following conditions: I. The approval is for a limited period of four years from the date of issue of approval letter as per clause 13

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of Rules 1989 and is renewable for two years at a time based on compliance report. II. During the period of approval, a Post Release Monitoring Committee (PRMC) would be constituted by GEAC consisting of 2 subject matter external experts and a nominee each from RCGM and GEAC and PRMC will visit the growing sites of the approved biological material(s) at least once during each season and submit their report to GEAC on the matters of compliance. Chairperson, GEAC is authorized to constitute the Committee. III. Applicant shall deposit 100 grams each of approved hybrids as well as their parental lines with the ICAR-National Bureau of Plant Genetic Resources (ICAR-NBPGR) and communicate the same to GEAC within 30 days of issue of this clearance letter for purposes of future reference in case of trade, traceability and dispute on account of ownership. IV. The applicant shall provide detailed step-by-step testing procedures for identifying approved event in the transgenic hybrids (bar, barnase and barstar) and parental lines, to the GEAC within 30 days from the receipt of approval letter. V. Applicant shall develop and deposit the DNA fingerprints of the approved Transgenic Mustard varieties within 30 days from the receipt of approval letter to the ICAR-NBPGR. VI. Usage of any formulation of herbicide is recommended only under controlled and specified conditions exclusively for hybrid seed production after obtaining label claim and approval from Central Insecticide Board & Registration Committee (CIB&RC). VII. Usage of any formulation of herbicide is not permitted for cultivation in the farmer’s field under any situation and such use would require the necessary permission as per the procedures and protocols of safety assessment of insecticides/ herbicides by CIB&RC.

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Any such use in the farmer’s field without due approval from CIB&RC would attract appropriate legal action under Central Insecticides Act 1968 and Rules 1971, EP Act 1986 and the Rules made there under. VIII. Commercial use of DMH-11 hybrid shall be subject to Seed Act 1966 and related rules and regulations, its amendments and Gazette notifications from time to time as applicable. IX. The applicant shall prepare and submit the annual/ seasonal reports on acreage, yield and states/ regions where the transgenic mustard is sown during the approval period to the GEAC. X. It is mandatory that all seed packets of GE mustard Hybrid DMH-11 and subsequent hybrids derived from the technology should be appropriately labelled indicating the contents including the name of the transgenes, physical and genetic purity of the seeds etc. Each packet should also contain detailed description for use including sowing pattern, pest management, suitability of agro-climatic conditions etc. in English, Hindi and vernacular language. XI. All efforts should be made by applicant and licensees to undertake an awareness and education programme interlaid through development and distribution of educational material on GE Mustard Hybrid DMH-11 for farmers, dealers and others. XII. Indian Council of Agricultural Research (ICAR) would be the authorized agency to accord necessary permissions for development of any other Brassica juncea hybrids resulting from events approved and their descendants, provided the intended use is similar. However, all hybrids released using this technology shall also be regulated under Seed Act 1966 and related rules and regulations, its amendments and Gazette notification from time to time as applicable. ICAR shall also ensure the following conditions prior to release of any new hybrids:

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• Confirmation of events through molecular characterization to be submitted from accredited lab, in original, as notified for the purpose. • Data on level of transgenes (Barnase, Barstar and Bar) expression in the events/ hybrids at seedling stage from accredited lab, in original, as notified for the purpose. • Morphological characters using Distinctiveness, Uniformity and Stability (DUS) descriptors as per Protection of Plant Varieties and Farmers Rights Act, (PPVFRA) guidelines for the hybrids. • Source of germplasm/ pedigree and biotech traits must be provided with self-declaration by the applicant. • Affidavit on the ownership of hybrid/ variety/ events. • Performance trial report including agronomic parameters, yield with coefficient of variation (CV) and critical difference (CD), pest & disease reaction etc. as per ICAR guidelines. XIII. If at any time, the applicant or the responsible parties become aware of any information regarding risk to the environment, or risk to animal or human health, that could result from release of these materials in India, or elsewhere, the applicant must immediately provide in writing such information to regulatory bodies. XIV. The approval may be revoked under Rule 13(2) of Rules, 1989, if any evidences regarding harmful effects of the approved GE mustard, such as damage to the environment, nature or health as could not be envisaged when the approval was given comes under notice of GEAC and on noncompliance of any condition stipulated by GEAC. XV. MoEF&CC/ GEAC may prescribe any additional conditions/ requirements or constitute any Sub-

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Committees or commission any studies if felt appropriate during the period of approval. XVI. The recommendations are subject to other statuary clearances, as applicable, including the clearance from FSSAI.” Interlocutory Applications filed by the petitioners:

15. I.A. No.185604 of 2022 has been filed by the petitioner in Writ Petition (Civil) No.840 of 2016 seeking quashing of the approval letter F.No.C-12013/35/2010-CSIII dated 25.10.2022 issued by respondent Nos.1 and 2 to respondent No.3 therein being void ab initio; secondly, to disclose all the sites/locations where the environmental release of transgenic mustard hybrid DMH-11 is planned/commenced; thirdly, to direct the respondents to immediately uproot/remove/ destroy all transgenic mustard hybrid DMH-11 that has been planted pursuant to the environment clearance issued in 147th meeting of respondent No.2 held on 18.10.2022 and the subsequent approval letter number F.No.C-12013/35/2010-CSIII dated 25.10.2022; and, fourthly, a direction is sought that the TEC report recommendation be adopted and to ban all HT crops and crops for which India is a Centre of Origin/Diversity. It is unnecessary to narrate the pleadings accompanying the aforesaid prayers as the same shall be dealt with while considering the main petition. I.A. No.209550 of 2023 has been filed in Writ Petition (Civil) No.115 of 2004 by the petitioner therein, seeking a direction to the respondent Union of India to destroy the planted material of transgenic mustard hybrid DMH-11 in view of the undertaking given to this Court and there being violations of the same. The aforesaid prayer made by the petitioner has also to be considered in light of the prayer made by the Union of India, which has also filed an application (I.A. No.167110 of 2023), seeking discharge from the oral statement made before this Court on 08.11.2022 to the effect that no precipitative steps for environmental release of transgenic mustard hybrid DMH-11 would be taken. Additional Affidavit of Union of India:

16. It would be useful to refer to the additional affidavit dated 09.11.2022 filed by the Union of India through Scientist ‘G’ in the MoEF&CC, New Delhi.

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16.1 That on 03.11.2022, it was brought to the notice of this Court that permission of environmental release of transgenic mustard hybrid DMH-11 had been granted by the Government of India to the CGMCP at the University of Delhi on 25.10.2022. Pursuant to the said order, the Union of India has sought to place on record the decision-making process employed by the Government of India and the regulatory framework under which this permission was granted. 16.2 In addition to the above, the Union of India has stated in its Additional Affidavit dated 09.11.2022 that the research, development, and use of GE technologies is a highly technical matter guided by the views of subject experts. As such, the inquiry before this court is limited to whether there exists an adequate regulatory mechanism governing this field and whether material compliance with the same has been made. 16.3 The conditional approval for environmental release of transgenic mustard hybrid DMH-11 and its parental lines Varuna bn 3.6 and EH-2 modbs 2.99 containing barnase, barstar, and bar genes prior to commercial release has been made after a long and exhaustive regulatory process which commenced as far back as in 2010 and is outlined as below: i. The initial R&D was conducted by the CGMCP in accordance with the Revised Guidelines for Research in Transgenic Plants, 1998 in the laboratory as well as greenhouse conditions. The R&D was regulated by the Institutional Biosafety Committee (IBSC) and RCGM as prescribed by the Guidelines. ii. Based on the information generated, an application was made to the IBSC for permission to conduct a confined field trial. After the recommendation of the IBSC, the CGMCP submitted a further application to RCGM. After the recommendation of the RCGM, GEAC considered the recommendation of the RCGM in its meetings dated 29.09.2010, 21.09.2011, and 18.07.2014. iii. After the completion of confined field tests, the CGMCP submitted an application dated 15.09.2015, along with a dossier of 3285 pages, seeking approval for environmental

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release of the GE mustard hybrid DMH-11 and its parental lines Varuna bn 3.6 and EH-2 modbs 2.99. iv. The said application was considered by GEAC in its 125th meeting dated 11.12.2015. After a detailed discussion, the applicant was invited to give a presentation to GEAC on 04.01.2016. Accordingly, on 04.01.2016, GEAC formed an eight-member sub-committee under the chairmanship of Dr. K. Veluthambi, Co-chair, GEAC. v. The meeting of the sub-committee took place on 02.02.2016 and the sub-committee recommended revision of the biosafety dossier by the applicant. Considering the above, GEAC, in its 127th meeting dated 05.02.2016, adopted the recommendations of the sub-committee and directed the revision of the dossier. In addition, GEAC directed preparation of the Biosafety RARM Report. vi. The sub-committee requested GEAC for an additional one month’s time to submit its final recommendations. The request was granted by GEAC in its 129th meeting dated 20.06.2016. GEAC also invited two groups of NGOs to present their views on the release of transgenic mustard hybrid DMH-11 in India. vii. Thereafter, on 11.08.2016, GEAC considered the report titled “Assessment of Food and Environmental Safety”, incorporating the evaluation of biosafety data generated by the applicant CGMCP and prepared by the sub-committee along with the inputs of RAU of the RCGM. The report was then placed on MoEF&CC website for a period of 30 days, from 05.09.2016 to 05.10.2016, for inviting comments. viii. A total of 759 comments were received on the AFES Report and the sub-committee proceeded to analyse the same. ix. In the 133rd meeting of GEAC dated 11.05.2017, the report submitted by the sub-committee was examined in detail. In the 134th meeting of GEAC dated 21.03.2018, the proposal was referred back to GEAC for re-examination. GEAC also advised the applicant to undertake field demonstration on transgenic mustard hybrid DMH-11 in an area of five acres at two-three different locations, with a view to generate

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additional data on honey bees and other pollinators and on soil microbial diversity. x. The proposal came up for re-examination by GEAC in its 136th meeting dated 20.09.2018, wherein GEAC accorded permission for conducting field demonstration studies at two locations of up to five acres each in PAU, Ludhiana and IARI, New Delhi. xi. In the 137th meeting of GEAC dated 20.03.2019, GEAC deferred field demonstration studies to the seasons 2019-20 and 2020-21. xii. Thereafter, Prof. Deepak Pental, vide letter dated 10.05.2022 requested the MoEF&CC to okay the environmental release of GE mustard. xiii. GEAC sought comments from the DBT and the DARE. Both opined that GEAC may consider exempting additional field demonstration studies. xiv. In the 146th meeting of GEAC held on 25.08.2022, GEAC recommended that a nine-member expert committee be constituted to examine the request letter dated 10.05.2022 with respect to availability of adequate evidence about the impact of transgenic mustard on honey bees and other pollinators in order to assess the need for conducting field demonstration studies. xv. The abovesaid sub-committee met on 23.09.2022 and 30.09.2022 and submitted recommendations to GEAC, stating that the field demonstration studies may be conducted even after the environmental release of GE mustard. xvi. Finally, GEAC, in its 147th meeting held on 18.10.2022, recommended environmental release of transgenic mustard hybrid DMH-11, which came to be accepted by the Central Government on 25.10.2022. 16.4 It is further averred that the production of seeds of transgenic mustard hybrid DMH-11 would take place under the supervision of ICAR, as per existing guidelines and other extant rules and regulations. As a precautionary measure, the data with regard

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to the impact of transgenic mustard hybrid DMH-11 on honey bees and other pollinators is to be generated during these two years of supervision by ICAR and approval could be revoked under Rule 13 (2) of the 1989 Rules, if any harmful effects are found. In addition, during the period of approval, a PRMC would visit the growing sites at least once during each season and submit its report to GEAC. Only after this elaborate process would the commercial cultivation of transgenic mustard hybrid DMH-11 start. Commercial cultivation, too, shall be subject to the Seeds Act, 1966 and the rules and regulations made thereunder. 16.5 Finally, emphasizing the importance of mustard as a prominent edible oil and seed meal crop of India, the economic need to increase its domestic yield was highlighted. It was also submitted that internationally, the United States of America (USA), Canada, and Australia have allowed cultivation of GE rapeseed containing the bar, barnase, and barstar genes. Parental lines and hybrids were also released for cultivation in Canada (1996), the USA (2002), and Australia (2003). In all three countries, yields of rapeseed increased with the introduction of GM hybrids. Therefore, if employed, the DMH-11 hybrid technology would contribute to increase in the domestic yield of mustard in India. Submissions:

17. Elaborate submissions have been advanced by the learned senior counsel, Sri Sanjay Parekh and learned counsel, Sri Prashant Bhushan for the petitioners as well as learned Senior Counsel Sri Pais and other learned Counsel for other petitioners and intervenors. Learned Attorney General and the learned Solicitor General have appeared for the respondents. A summary of the submissions is set out hereinbelow. Submissions of the petitioners: 17.1 Sri Prashant Bhushan, learned counsel has made the following submissions: The decision dated 18.10.2022 of GEAC to approve environmental and commercial release of DMH-11/GM mustard/ HT mustard is violative of Articles 14 and 21 of the Constitution as it suffers from non-application of mind and is, therefore, arbitrary and

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unreasonable. Elaborating on the same, it was contended that the said decision would lead to irreversible contamination of the environment and threaten biodiversity. The decision was also said to violate the choice of consumers to consume non-GM food and that of farmers to grow non-GM crops in violation of Article 21 of the Constitution. In this regard, the following points were highlighted: a. It is an admitted fact that DMH-11 is an HT crop (vide para 16 page 12 of the Additional Affidavit of Union of India). b. The TEC appointed by this Court, in its detailed report, recommended a complete ban on all HT crops. c. It is an admitted fact that DMH-11 has no yield advantage over non-GM/HT mustard hybrids/varieties. d. The sole advantage for environmental release of DMH-11 is that it is robust at cross pollination and there are absolutely no immediate advantages to the environmental release of DMH-11, rather there are attendant risks that come with the environment release of HT crops and it is only a hope that the same could be used to produce new hybrids with better yield in future. If that is the hope, then the new hybrids with better yield could be developed in hybrid conditions and not be released into the environment, as there would be no rational nexus to the object sought to be achieved by the release. e. Condition Nos. VI and VII of the order or decision dated 18.10.2022 directed that the farmers may not lawfully spray herbicide/glufosinate on DMH-11, thereby ensuring that there can be no lawful beneficial effect therefrom in terms of weed management from HT crops to farmers. f. If there is no real yield advantage, DMH-11 cannot be marketed to the farmers as having yield advantage, as this would be misleading for supporting its environmental and commercial release. g. In the 134th meeting of GEAC, the applicant of DMH-11 was advised to conduct research on the effect thereof on honey bees. The said advisory was given a go by and the study was directed to be done after environmental release

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of DMH-11. It is submitted that the DBT has funded the development of DMH-11 and therefore, its recommendation to forego studies on honey bees is a case of conflict of interest and ignores all precautionary principles. h. That even though there is no immediate advantage from the environmental release of DMH-11, the immediate and irreversible disadvantage from its release is the scientific certainty of contamination of non-GM/non-HT mustard hybrids/varieties through cross pollination from bees, thereby: − irreversibly threatening biodiversity, as eventually all non-GM/non-HT mustard will be contaminated; − irreversibly eliminating choice of consumers to eat non-GM/non-HT mustard, in the absence of any mechanism to prevent pollination by bees, which is accentuated by the absence of any laws for labelling; − irreversibly coercing farmers who do not wish to grow GM crops to be susceptible to their crops being contaminated with transgenic mustard hybrid DMH-11 with no legal mechanism for redress or liability for losses suffered; − irreversibly causing loss to organic farmers and the entire agro-economic system relying on non-GM crops as their products can no longer be certified as GM-free. For instance, honey, which is produced in the country from mustard flowers, can no longer be certified as organic or GM-free in the absence of elaborate testing for each and every product. Hence, there is a need for studies with regard to long-term effects on biosafety and the hazards from environmental release of DMH-11. i. The present writ petition has been filed seeking to put in place a comprehensive, stringent, scientifically rigorous and transparent biosafety test protocol in the public domain for GMOs before they may be released into the environment. This is because GMOs are a serious potential hazard and several dimensions of biosafety are necessary before their

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release into the environment. The proper and independent testing of GMOs is essential in view of the concern of the irreversible contamination of non-GMOs crops and the environment at large. This is unlike a drug, which when tested to be unsafe, can be recalled. It is contended that the GMO contamination of the environment would affect the nation’s foundational seed stock and change the structure of the food at the molecular level without recourse. j. The right to health being a fundamental right, it is necessary that the Union Government and the Regulators put in place a rigorous mechanism so as to avoid the harm caused by GMOs, such as chronic toxicity and other unattended effects including health hazards. Therefore, the precautionary principles must be purposefully applied to insulate from the scientific uncertainty about hazardous GMOs in future. 17.2 On the decision of GEAC to approve HT mustard/GM mustard/ DMH-11 for environmental and commercial release, learned counsel contended that GEAC in its 147th meeting decided to permit environmental release/commercial cultivation of HT mustard. Based on the recommendation of the Expert Committee as well as the comments received from DBT and DARE, the Committee recommended the following: “VI. Usage of any formulation of herbicide is recommended only under controlled and specified conditions exclusively for hybrid seed production after obtaining label claim and approval from Central Insecticide Board & Registration Committee (CIB&RC). VII. Usage of any formulation of herbicide is not permitted for cultivation in the farmer’s field under any situation and such use would require the necessary permission as per the procedures and protocols of safety assessment of insecticides/herbides by CIB&RC. Any such use in the farmer’s field without due approval from CIB&RC would attract appropriate legal action under Central Insecticides Act 1968 and Rules 1971, EP Act 1986 and the Rules made thereunder.”

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17.3 It is learnt by the petitioners that HT transgenic mustard hybrid DMH-11 seed was sown for seed selection in Kanpur and Bharatpur at the Directorate of Rapeseed and Mustard Research (DRMR). The 301st report of the Department related PSC on Science and Technology, Environment & Forests, titled “Genetically Modified Crops and its impact on Environment” (2017) (“301st Report of PSC”, for the sake of convenience) noted that the Government put on hold the earlier approval given by GEAC to DMH-11 (vide Page 26 of the 301st PSC report/Pg.672, Compilation). This is because in undertaking seed selection, it would be necessary to spray illegal glufosinate on the seedlings, for it is only seedlings which have been successfully engineered for resistance to the herbicide which could be selected for seed production. The concomitant advisory to farmers not to spray would then go meaningless, as the farmers would definitely spray for the short-term gain to kill weeds. In this regard, it is mentioned that planting of HT – Bt cotton and Bt brinjal and other such crops on commercial scale have gone on despite illegal effects of the same. 17.4 It was also submitted that the National Bureau of Plant Genetic Resources (NBPGR) had stated that India has rich biodiversity in mustard. The Indian Gene Banks have 5477 Brassica juncea (“Indian mustard”) accessions, which would all be at the risk of contamination. 17.5 On the recommendations of the TEC as regards HT/GM crops, it was submitted that HT crops being a potent carcinogen may lead to breast cancer. Therefore, the TEC recommended a complete ban on HT crops. 17.6 It was next contended that the first crop given de facto approval by GEAC was Bt cotton, followed by Bt brinjal, in respect of which there was a moratorium vide order dated 09.02.2010 of the Ministry of Science, Environment & Forests. In the case of transgenic mustard hybrid DMH-11 (HT crop), the technical dossier running into thousands of pages was made available for 30 days at the headquarters of GEAC in New Delhi for physical inspection. This was contrary to the earlier process, wherein biosafety dossier as regards Bt cotton and Bt brinjal was put in the public domain on the website of GEAC upon being directed by

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this Court and whereupon on critical examination of the same by national and international experts, the approval given by GEAC had to be put on hold by the Ministry, as it became apparent that GEAC had not complied with the regulatory mechanism and the biosafety and ERA of Bt brinjal was totally lacking. 17.7 Learned counsel also brought to our notice the following three reports which have discussed in detail the issue of GM crops: a. Thirty-Seventh (37 th ) report of PSC on Agriculture (2011-2012) titled “Cultivation of Genetically Modified Food Crops – Prospects and Effects” (hereinafter referred to as the “37th Report of PSC”). b. Final Report of the five original members of the TEC submitted to this Court on 30.06.2013. c. Three Hundred and First (301st) report of the Department related PSC on Science and Technology, Environment & Forests, titled, “Genetically Modified Crops and its impact on Environment” (2017). 17.8 The deposition of Dr. P.M. Bhargava, Molecular Biologist, Founder Director, CCMB, Hyderabad, appointed as an independent expert on GEAC by this Court vide order dated 13.02.2008, as recorded in the 37th report of PSC, was also read out to us. Similarly, the observations and recommendations of the TEC as regards GEAC being the regulator have been read out to us during the course of the submissions. We shall refer to the relevant portions of these reports a little later. 17.9 It was next contended that although the ubiquitous glyphosate has been used for over four decades as the safest herbicide, glufosinate is acknowledged as more toxic than glyphosate as it kills indiscriminately soil organisms, beneficial insects etc. It was also submitted that neurotoxin can cause birth defects and damage to most plants that it comes into contact with. It is banned in Europe and not permitted in India under the Insecticides Act, 1968 for mustard. It is an organophosphorus compound (toxic to biology) very similar in structure to glyphosate and as weeds become more resistant, they will eventually be resistant to all known herbicides.

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17.10 It was lastly submitted that the DBT, Ministry of Science & Technology is an active partner and funder in this venture of HT DMH-11. The DBT directly oversees the regulation of GMOs including HT mustard and houses the Regulators and the RCGM. The conflict of interest in GMO Regulators and relevant Ministry has not been recognised as unconscionable and an ethical breach of public trust doctrine. Attention was drawn to the fact that Prof. Pental himself had been involved in the regulatory oversight of Bt brinjal and there is a tied-in relationship that obscures the line of separation that must be rigorously maintained between the Regulators and the regulated, if stringent norms of GMO risk assessment and biosafety are to be maintained for this hazardous technology. There cannot be a partnership between the Regulator and the Developer which is invested in the HT mustard GMOs. Therefore, the submission was that the environmental release of DMH-11/GM mustard/HT mustard needs to be halted in line with the precautionary principle. 17.11 Learned senior counsel Sri Sanjay Parikh contended that one of the reliefs sought for in the writ petition is for the formulation of a National Policy on GM by a High-Powered Committee till a sound regulatory and monitoring system is put in place and till then there should be a moratorium on release of GM. Although, the Union of India in its counter affidavit, filed in November, 2004, attempted to justify the 1989 Rules, till date, there is no National Policy on GM food and “Inter-Ministerial Task Force” under the Chairmanship of Dr. M.S. Swaminathan, which has submitted a final report, is still under consideration. It was contended that in the absence of a National Policy, the regulatory system, at present, continues to be deficient. 17.12 It was also contended that while transgenic mustard hybrid DMH-11 is an HT crop, the Government of India has proceeded on the basis that it is not an HT crop. The question of the consequences, if transgenic mustard hybrid DMH-11 is indeed an HT crop, remains unanswered. The Union of India in its additional affidavit dated 09.11.2022 has acknowledged that transgenic mustard hybrid DMH-11 possesses HT through the inherited bar gene from both parents, making it fully HT.

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Yet, the Government asserts that it cannot be officially labelled as such, and therefore, it should not be referred to as a HT crop. 17.13 The crucial inquiry remains regarding the impact of herbicide spraying on a transgenic mustard hybrid DMH-11 field — whether the crop will exhibit herbicide tolerance or succumb to the herbicide. The definition of an HT crop hinges on the introduction of a new trait, in this case, HT via the bar genes in the mustard plant. This trait specifically confers tolerance to the herbicide glufosinate ammonium, as also acknowledged in the approval letter number F.No.C-12013/35/2010-CSIII dated 25.10.2022. That despite GEAC imposing conditions and warning against unauthorized herbicide use, initiating legal action against farmers is impractical, given that farmers may use herbicides believing that DMH-11 is an HT crop. Consequently, the Government is unable to pursue legal action based on this misunderstanding amongst farmers. In the case of HT-Bt cotton, extensively grown nationwide since 2017 along with the unauthorized herbicide glyphosate, the Government has failed to undertake any legal or corrective measures against entities endorsing and facilitating its cultivation. The cultivation of Bt cotton has led to the development of resistance to the Bt toxin, giving rise to robust secondary pests. This, in turn, has resulted in an increased application of pesticides, contradicting the initial purpose of Bt cotton. Consequently, it is doubtful that control over herbicide use and the penalization of farmers employing herbicides will be effective in the case of DMH-11. It was further contended that the potential adverse impacts of using HT crops along with their matching herbicides have to be understood and are enumerated as under: a. Herbicide use destroys all the vegetation in and around the fields where the HT crop is cultivated, which is used by the rural community in significant ways. b. In India, the biodiversity found in and around fields is not considered “weeds” and therefore, not useless, as they are in the west. These plants, so called “weeds”, provide: i. leafy green vegetables and many kinds of saag like chaulai and bathua that provide valuable nutrition for free to poor rural families;

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ii. they also provide green fodder for rural livestock; iii. such “weeds” are also medicinal plants that traditional healers such as vaids and hakeems use in the treatment of human and animal diseases. c. Introduction of the HT trait will destroy the opportunity to do mixed farming which is prevalent in Indian agriculture. d. The HT trait will also strike against any efforts to promote organic agriculture, since it involves heavy chemical use of herbicides. e. The use of herbicides and their accumulation in the soil will damage soil health and the chemicals will enter the food chain to the detriment of human health. 17.14 It was also contended that GM has never been tested as an HT crop, despite having HT properties and in fact, India does not have any regulatory guidelines and protocols for testing of HT crops. Reliance has been placed on the TEC Report and our attention was drawn to various portions thereof, which we shall consider later. Similarly, reference was made to the 301st Report of the PSC. 17.15 Sri Parikh also submitted that the manner in which the conditional clearance was granted makes apparent the loopholes in the regulatory system. In this regard, it was submitted that on 21.03.2018, a decision was taken by GEAC in its 134th meeting to generate additional data on honey bees and other pollinators on soil microbial diversity. The same was given a go by subsequently after receipt of a letter from Prof. Deepak Pental dated 10.05.2022 and contrary to precautionary principles, it was decided by GEAC in its 147th Meeting dated 18.10.2022 that the field demonstration studies with respect to the effect of GE mustard on honey bees and other pollinators may be conducted post-environmental release. The said decision, besides causing adverse effects on the environment, would also be against the principle of assessing any harmful socio-economic impact in time, i.e., before granting approval. 17.16 Our attention was also drawn to various points regarding conflict of interest, details of which have also been given in

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the written submissions, which we shall advert to during the course of our discussion. 17.17 It was next submitted that the 1989 Rules are not compliant with the CPB, which was ratified by India on 17.01.2003 and which came into effect on 11.09.2003. This is because the question of liability and redress are not addressed by the 1989 Rules. Sri Parekh noted that the CPB reaffirms the precautionary approach, which is also contained in Principle 15 of the Rio Declaration on Environment and Development. Therefore, the decision of GEAC dated 25.10.2022 that tests with regard to the environmental impact of the release would be done post-release and not prior thereto, violates the aforesaid precautionary principle. 17.18 Finally, it was urged that HT seeds of transgenic mustard hybrid DMH-11 have been sown in five locations and in the absence of a proper and lawful approval of the same, the plants should be uprooted and destroyed immediately, so that no environmental contamination takes place. 17.19 Learned senior counsel, Sri Trideep Pais submitted that the procedure adopted by GEAC in the instant case, culminating in the order dated 25.10.2022, is not in accordance with law. In this regard, it was submitted that GEAC is a Committee which has been constituted under the 1989 Rules and is therefore, a statutory body. The said body cannot further delegate its functions to sub-committees or Expert Committees. Even if the assistance of such sub-committees or Expert Committees is taken, there has to be detailed deliberations of the recommendations made by the said Expert Committees and not simply accepted without any application of mind as has happened in the instant case. 17.20 It was further submitted that the health expert was consistently absent in all the crucial meetings of GEAC, and thereafter, the said expert sent an e-mail simply concurring with the deliberations of GEAC without any application of mind and in the absence of any participation in the deliberations. Consequently, the health aspect in the context of granting approval for environmental release of transgenic mustard hybrid DMH-11 has been totally ignored and kept apart, which

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is the reason why the petitioners as well as the interveners are pressing for appropriate reliefs on quashing of the decision dated 25.10.2022. In this regard, learned senior counsel drew our attention to the various deliberations of the meetings with reference to the compilation of documents that he submitted. 17.21 Learned senior counsel Sri Pais further submitted that despite the order of this Court dated 12.08.2008 and the earlier order dated 08.04.2008 stating that the primary data pertaining to field trials must be placed in the public domain and on the website of GEAC, there has been absolute non-compliance of the same and as a result, it is neither in the public domain nor placed on record. 17.22 It was further contended that on the reconstitution of GEAC dated 17.07.2022, one of the members, Dr. Geeta Jotwani, was not present in the meeting held on 18.10.2022. GEAC simply approved the agenda Item No.4 on the said date. As already noted on 02.02.2016 in the 1st meeting of the sub- Committee of GEAC, Dr. B. Sesikeran, the Nutrition and Food Safety expert, was absent. The said expert was continuously absent thereafter on 11.04.2016, 20.06.2016 and 11.08.2016 in the meetings of the sub-committee. Learned senior counsel therefore, submitted that GEAC, not having complied with the requisite procedures, has arrived at a decision to grant approval of the environmental release of transgenic mustard hybrid DMH-11 without taking into consideration all aspects of the matter in a comprehensive manner. 17.23 Sri Dhruv Dwivedi learned counsel submitted that the recommendation of the Parliamentary Committee on agriculture has not been considered by GEAC in its proper perspective. Further, the sub-committee of GEAC had recommended that the adverse impacts on honeybees and other pollinators had to be studied prior to the environmental release. However, the said decision was given a go by and it was decided that the said study would be conducted subsequent to the environmental release of DMH-11. This volte-face in the stand of GEAC is without any reason and also not in consonance with the precautionary principles which are relevant in the instant case.

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17.24 Dr. Ravindra Chingale learned counsel appearing on behalf of Bharatiya Kisan Sangh as an intervenor, at the outset, submitted that these matters cannot be considered to be an adversarial litigation but wholly in public interest. Therefore, the respondent Union of India would have to adhere to the directions issued and to be issued by this Court in the matter. He further drew our attention to three unstarred questions answered in the Rajya Sabha by Hon’ble Minister of State for Environment. One of them was with regard to Section 22 of the FSSA, 2006, that the Central Government has not yet conducted any study on GM food and therefore, has not issued a notification under the aforesaid provision. In the absence of such a notification, there can be no steps taken having regard to the provisions of the FSSA, 2006. As per Section 2 of the said Act, the Union has declared that the food industry is taken under its control, which is expedient in the public interest in view of Entry 52, List I of the Seventh Schedule of the Constitution. The same shall be considered later. 17.25 He also drew our attention to Section 3(b) of the Patents Act, 1970, which states that an invention, the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment, is not an invention within the meaning of the said Act and therefore, not patentable. Submissions of the Respondents: PART-I

18. Sri R. Venkataramani, learned Attorney General, while defending the action of GEAC, contended that the petitioners have raised two concerns, namely, (i) the non-negotiable importance of having credible regulatory procedures, mechanism and institutions which are free from commercial incentives to ensure that proposals for release and use of GM crops and plants are subject to strict scrutiny through well-accepted regimes; and, (ii) all information and materials in relation to the regulatory procedures be made public to ensure participation of the public in order to bring about transparency and informed debate.

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18.1 Based on the above contentions, the petitioners have sought that unless certain precautions are taken, the Union of India shall not release GMOs into the environment by way of import, manufacture, use or any other manner. More specifically, the petitioners have sought directions with regard to approval dated 25.10.2022 recommended by GEAC by clearing for environmental release transgenic mustard hybrid DMH-11 following fairly long stages of trial conducted by ICAR, CGMCP; Institute of Microbial Technology, Chandigarh (IMTECH), NIN, Hyderabad, Amar Immunodiagnostics Pvt. Ltd., Hyderabad and Premas Biotech Pvt. Ltd., Manesar. 18.2 It was submitted by learned Attorney General that by order dated 10.05.2012 in Writ Petition (Civil) No.260 of 2005, this Court was pleased to appoint an expert committee (TEC) consisting of technical experts to submit a report with certain terms of reference. TEC submitted an interim report on 07.10.2012 and Union of India raised objections in response to the said report, which were referred to TEC on 09.11.2012. On 30.06.2013, the TEC submitted its final report making certain suggestions. According to the learned Attorney General, the TEC Report goes beyond the terms of reference, to the extreme extent of observing that HT crops are completely unsuitable in the Indian context. But, Dr. Paroda has filed a separate dissenting report raising serious objections to the procedures and deliberations of the TEC that virtually worked with a closed mind. 18.3 It was then submitted that these writ petitions were filed in 2004-2005 respectively and since then, there has been development in the regulatory framework governing the field and the following guidelines and protocols are applicable to the research and testing of GMOs: i. Guidelines and SOPs for Conduct of Confined Field Trials of Regulated GE Plants, 2008. ii. Revised Guidelines for Research in Transgenic Plants, 1998. iii. Guidelines for Safety Assessment of Foods Derived from GE plants, 2008 (updated in 2012).

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iv. Protocols for Food and Feed Safety Assessment of GE Crops, 2008. v. Guidelines for the Environmental Risk Assessment (ERA) of GE Plants, 2016. vi. Environmental Risk Assessment (ERA) of GE Plants: A Guide for Stakeholders, 2016. vii. Risk Analysis Framework, 2016. 18.4 The aforesaid regulatory framework has been developed after the filing of the present petitions and in view of these developments, these petitions have been rendered infructuous. That in view of the adequacy of the current regulatory regime in place, the petitions have lost their efficacy inasmuch there is no challenge to the constitutionality of the statute, rules or executive action and that a writ court cannot embark on a roving and fishing inquiry in a public interest litigation. 18.5 Emphasising that the focus of the writ petition is now confined to the environmental release of transgenic mustard DMH-11, it was submitted that on receipt of the application requesting a trial of DMH-11 to be conducted, approval was given by GEAC on 29.09.2010 and subsequently, approvals were granted to conduct BRL-I and BRL-II trials. Only after several meetings, deliberations and consideration of the reports of the trials, on 18.10.2022, GEAC recommended environmental release of DMH-11 subject to strict conditions and safeguards and accordingly, permission for environmental release of DMH-11 was issued on 25.10.2022. 18.6 It was further submitted that the regulatory requirements are adequate to address all aspects of the concerns voiced by the petitioners and the rules and guidelines are in consonance with the CPB and Codex principles and guidelines on foods derived from biotechnology. 18.7 It was further argued that even the concerns expressed by the TEC Report have since been adequately addressed by the Union of India. The TEC Report was written in the background of the existing regulatory regime, which as noted above, has subsequently been updated. The regulatory regime in place has been strengthened to ensure that a comprehensive,

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transparent and science-based framework of GM crops is in place for ERA of GM crops. That rigorous risk analysis approach has been applied to ensure the safety of both the environmental and health risks vis-à-vis transgenic mustard hybrid DMH-11 for the past ten years. 18.8 Therefore, learned Attorney General submitted that the scope of adjudication now stands confined to the question of due procedure being followed under the relevant rules and the guidelines and there is no need to traverse beyond this limited inquiry. It was emphasised that the question that should be addressed by this Court would revolve around due processes being followed and deliberations on the varying understandings on applications of science and technology would lie in the domain of the Government alone and mere differences of opinions cannot invite the Court’s attention into the evaluation of views and adopting or rejecting any one of them. 18.9 Learned Attorney General then proceeded to argue that the petitioners’ concern regarding risk with regard to environmental release of transgenic mustard hybrid DMH-11 is purely hypothetical and there is a distinction between a risk which is clearly known and demonstrated and presumption of risk on unproven hypotheses. Even under the precautionary principle approach, a rigid and uncompromising approach is not encouraged insofar as it stifles technological advancement. That the Food and Agriculture Organization (FAO) describes risk assessment as a scientific process consisting of the following steps: (i) hazard identification, (ii) hazard characterisation, (iii) exposure assessment, and (iv) risk categorization. There is also a principle that an analysis of benefit versus risk is undertaken to determine the actions that provide the greatest benefits while encountering the least risk. In the instant case, the procedures adopted for the environmental clearance are argued to be in consonance with the above said steps. To seek judicial scrutiny of the same would, thus, be inappropriate and will amount to dislodging governance responsibility in taking decisions on a consideration of all relevant factors. Therefore, this Court ought not to enter into any evaluation of rival views on the subject of GMOs in general and the issue of environmental release of DMH-11 in particular.

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PART-II I. Overview of the Technology: 18.10 It was contended that the conditional approval was given on 25.10.2022 to the CGMCP, University of Delhi, for environmental release of transgenic mustard hybrid DMH-11 and parental lines bn.36 and modbs 2.99 containing barnase, barstar and bar genes. The object was to create DMH-11 – a hybrid obtained by crossing Varuna bn 3.6 (containing bar, barnase genes) with EH-2 modbs 2.99 (containing bar, barstar genes). The three relevant genes used in the process of creating DMH-11 are as follows: barnase gene which makes the plant male sterile; barstar gene which restores male fertility; and bar gene which confers HT. Presently, Varuna mustard seed contains both male and female parts and is self-pollinating (self-fertilization). It is first made male sterile so that it can be pollinated and crossed with another variety. This is achieved by introducing the barnase gene. Hence, a male sterile Varuna bn 3.6 is created (containing bar, barnase genes). Since Varuna bn 3.6 is male sterile, it cannot self-pollinate to reproduce. For multiplying this parental line, it is crossed with normal Varuna which produces a crop which is 50% Varuna bn 3.6 (male sterile) and 50% normal Varuna (fertile). This progeny crop is then planted in an alternating arrangement with EH-2 modbs 2.99 plants (containing bar, barstar genes). At this stage, herbicide is sprayed at the site which eliminates the fertile (normal varuna) portion of the progeny crop (since it does not have HT) leaving behind the portion of the progeny crop which is male sterile, i.e. Varuna bn 3.6 (since it contains the bar gene which confers HT). This is termed a selection event. The male sterile Varuna bn 3.6 remaining from the progeny crop gets fertilized by the adjacent EH-2 modbs 2.99 crop (which also contains the bar gene and survives the herbicide) and produces the hybrid seed DMH-11. 18.11 Thus, DMH-11 is produced, containing all three genes i.e. barnase, barstar and bar. It is fully fertile since the barnase gene inherited from EH-2 modbs 2.99 restores the male fertility of the resulting hybrid. The bar gene inherited in DMH-11 is of no utility in the hybrid. Its utility is at the selection event, namely,

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to multiply the male sterile Varuna bn 3.6. This male sterility/ restorer system is a highly promising technology which can be used to produce new hybrids with higher yields in future, thereby increasing agricultural output and farmer income. II. Herbicide Tolerance (HT): 18.12 It was contended that a crop is referred to as an HT variety if its commercial trait is HT, but DMH-11 is not such a crop since the HT trait in DMH-11 is of no commercial utility. In fact, transgenic mustard hybrid DMH-11 is not developed as HT Technology and it is unnecessary to use herbicide in the cultivation of transgenic mustard hybrid DMH-11. In fact, the HT trait is useful only at the selection event during the development phase of the event and is of no utility when the crop is being cultivated by a farmer. 18.13 It was also pointed out that under the EP Act, 1986, and the Insecticides Act, 1968, use of herbicide is, anyway, not permitted in the field for cultivation of transgenic mustard hybrid DMH-11. III. Yield: 18.14 Learned Attorney General contended that in the BRL-I and BRL-II trials, an increase in per-hectare yield by 25-30 per cent has been demonstrated against national check Varuna and zonal check RL1359. Only after the environmental release of DMH-11, significant clarity would emerge from the trials that are conducted by ICAR. Therefore, environmental release is the first step in a long process of evolution of this technology which will lead to even better hybrids in future. 18.15 According to the learned Attorney General, there is proven use and safety of genes used in transgenic mustard hybrid DMH-11. The three genes, barnase, barstar and bar have more than twenty years of safe history of being in the food chain in GE rapeseed, a sister crop of transgenic mustard hybrid DMH-11. The regulatory authorities in the USA, Canada and Australia have allowed the cultivation of GE rapeseed containing the bar, barnase and barstar genes. Between 1996 – 2003, parental lines and hybrids were released for cultivation in Canada, USA and Australia.

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18.16 It was submitted that under Rule 4 of the 1989 Rules, the following bodies namely, GEAC, Recombinant DNA Advisory Committee (RDAC), RCGM, IBSC and SBCC have been constituted and the applicable guidelines have been enumerated above. 18.17 Emphasising that the RCGM and GEAC together examine the safety assessment data submitted by the applicant at every step of the regulatory process, the learned Attorney General noted that the regulatory mechanism is completely transparent. All the data, reports, decisions etc. are made publicly available. Therefore, the conditional approval for environmental release prior to commercial release is subject to necessary regulatory and technical oversight and the approval has been granted after following detailed and exhaustive procedure in law, including after considering biosafety data and rigorous scrutiny over a period of twelve years. GEAC considered the application for environmental release only when the applicant had completed three years of BRL Trials (two years of BRL-I trials and one year of BRL-II trials) and a 3251 page dossier containing results of all the biosafety studies was submitted to GEAC and its sub-committees. As per the public consultation process prescribed in the Risk Analysis Framework 2016, the AFES Report was uploaded on the official website of MoEF&CC for inviting comments from 05.09.2016 to 05.10.2016 and about twenty-nine persons personally inspected the complete dossier at the premises and provided their comments. 18.18 It was submitted that in fact, the permission for environment release of transgenic mustard hybrid DMH-11 is granted for following limited purpose: i. To use the events of environmental release of transgenic mustard hybrid DMH-11 for developing new parental lines and hybrids under the supervision of ICAR. ii. To undertake seed production of transgenic mustard hybrid DMH-11 and its testing as per existing ICAR guidelines and other extant rules/regulations prior to its commercial release. iii. To generate scientific evidence in the Indian agro-climatic situation of the environment release.

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iv. As a precautionary mechanism, post-environmental release, conduct the field demonstration studies with respect to the effect of GE mustard on honeybees and other pollinators, as recommended in the 136th GEAC meeting within two years under supervision of ICAR, as per its guidelines and other extant rules, guidelines and regulations and the report be submitted to GEAC. However, the above is subjected to stringent terms and conditions to ensure environmental safeguards. 18.19 On the TEC Report, learned Attorney General submitted that though HT crops were not a part of terms of reference, the five-member TEC report has referred to the same and recommended against the use thereof in India. The Union of India too had filed objections stating that this recommendation was beyond the scope of terms of references and such a decision must be left to the regulatory system. In any case, the focus in the instant matter is only on DMH-11, which is not an HT crop. According to the learned Attorney General, since 2012, the regulatory regime has been strengthened to ensure that a comprehensive transparent and science-based framework of GM crops is in place for ERA of GM crops. 18.20 Finally, it was contended that mustard is the most important edible oil and seed meal crop of India and at present, 55-60 percent of the edible oil demand is met through imports. It was stated that canola oil is made from GM canola seeds; and soyabean oil largely comprises GM soyabean oil. Thus, the petitioners have voiced unfounded fears of adverse impact of GM crops, even when India is already importing and consuming oil derived from said GM crops. The transgenic mustard hybrid DMH-11 has shown an increase per-hectare yield by 25-30 per cent over the traditional varieties due to exploitation of hybrid vigour. As mustard is one of the highest oil-bearing of oilseeds utilised in India, the domestic production of edible oil would considerably increase if DMH-11 hybrid technology is employed. Hence, learned Attorney General sought for dismissal of the writ petitions.

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Submissions of Learned Solicitor General:

19. Learned Solicitor General Sri Tushar Mehta, while supporting the arguments of the learned Attorney General, at the outset contended that any ban on commercial/public release of GM crops in India will be against public and national interest. 55-60 percent of the edible oil in India is imported and mustard oil is one of the most important edible oils. In order to ensure food security and reduction of foreign dependency, it is necessary to strengthen the plant breeding programmes in India, including use of new genetic technologies such as GE technology. 19.1 Drawing our attention to statistics regarding the demand for total edible oil in India, it was submitted that 55.76 per cent of the total demand of edible oil is made through import, out of which palm oil, soyabean oil, sunflower oil and a small quantity of canola quality mustard oil are being imported. It was contended that owing to increasing population and oil consumption over the years, the imports have significantly increased in India. 19.2 Reiterating that globally around 80 percent of soyabean is GM soyabean variety, it was underlined that the petitioners were only voicing unfounded fears. The transgenic mustard hybrid DMH-11 having shown increased per-hectare yield over the traditional varieties, domestic production of edible oil is bound to rise considerably through the GM variety. 19.3 It was next submitted that competing fundamental rights of different sections of the society would have to be balanced. On the one hand, essential food including edible oil at affordable prices has to be made available, while at the same time, the dependency on import has to be reduced. That owing to the increasing demand for edible oil in India, making available the same at an economic price is a fundamental right of the citizens. Therefore, the production of indigenous edible oil is necessary to meet the increasing demand for such oil. It was argued by the learned Solicitor General that there were certain sections of the population who did not wish that India should be self-sufficient and self-reliant in essential food and instead encouraged importing edible oil, which is not in the interest of the Indian economy.

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19.4 It was submitted that the petitioners have failed to satisfy as to how restricting the trials would, in any way, have an adverse impact on the environment or otherwise. The public interest and fundamental rights of the citizens of the country to have the benefit of reasonable price of mustard oil has to outweigh the so-called concerns expressed by the petitioners herein. The learned Solicitor General accused that the petitions have been filed only to arm twist the State and in order to support greater imports of the essential commodities. In this context, it was submitted by him that the Union of India is committed to increasing crop productivity and the income of farmers through development of low input – high output agriculture and making the country self-sufficient in edible oil and grain legumes and that the strengthening of plant breeding programme, including the use of new genetic technologies, is critical for that purpose. 19.5 He noted that an elaborate statutory scheme exists to ensure effective regulatory review for the research, development and commercial use of GE technologies. The petitioners have not, however, pointed out a single flaw on record in the existing statutory regime or its implementation in the trial of DMH-11. Therefore, the writ petitions have to be dismissed with heavy costs. In this regard, reliance was placed on a recent judgment of this Court in the case of Jacob Puliye vs. Union of India, (2022) SCC OnLine SC 533 (“Jacob Puliye”) with special reference to paragraph Nos.21, 22, 62 and 80-81, and three other judgments of this Court, namely, National High Speed Rail Corporation Limited vs. Montecarlo Limited, (2022) 6 SCC 401 (“Montecarlo Limited”), Narmada Bachao Andolan vs. Union of India, (2000) 10 SCC 664 (“Narmada Bachao”) and Uflex Limited vs. Government of Tamil Nadu, (2022) 1 SCC 165 (“Uflex Limited”) to contend that frivolous public interest litigation must be dismissed with heavy costs, particularly, when an interim injunction affects the public interest. This is because, in the instant case, there is no material produced to demonstrate as to how the existing statutory regime relating to GM crops violates the fundamental rights of the citizens or is opposed to the provisions of the Constitution, or is opposed to any statutory provisions, or is otherwise manifestly arbitrary. Hence, the writ petitions may be dismissed with costs.

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Reply Arguments:

20. Sri Prashant Bhushan submitted his rejoinder arguments with reference to the arguments of the learned Attorney General by contending that DMH-11 is a HT Crop, as is evident from the admission of the Union of India in the note submitted by the learned Attorney General himself to the effect that “the presence of the third HT gene (Bar) is essential for hybrid seed production”. Therefore, the presence of the HT gene (Bar) makes DMH-11 an HT Crop. This was also said to be in accordance with the finding of the 2017 PSC Report which stated that transgenic mustard hybrid DMH-11 is an HT Crop. 20.1 It was then pointed out that there is clear evidence on the adverse impacts of such GMOs from other places in the world. In this regard, reference was made to various experts’ opinions as under: (i) Dr. Jack Heinemann, Director, Centre for Integrated Research in Biosafety, University of Canterbury, Christchurch, Netherlands, who served as an advisor to the Food & Agriculture Organisation, stated that DMH-11 is an HT crop. (ii) In an “Open Statement on Bar Gene in GM Mustard” published on 10.12.2022, by Dr. Soma Sundar Marla, Former Principal Scientist, Crop Bioinformatics & Genomics, ICAR-NBPGR, New Delhi and other scientists and experts, it was stated that DMH-11 is an HT crop in the following words: “Technically, it is the presence of the gene construct the Bar gene which defines whether a crop is Herbicide Tolerant (HT) or not. Given that both parents of DMH-11 carry gene constructs containing Bar, which confers herbicide tolerance towards glufosinate, any offspring from such parents including DMH-11 shall carry the HT trait. Therefore not only parental lines, but DMH-11 is also tolerant to herbicide without any doubt.” (iii) Further, in the article titled, “Long-term ecological, environmental effects of herbicide tolerant crops haven’t been considered” published on 29.11.2022 in the Indian

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Express, by Dr. Renee Borges and other distinguished professors and scientists, DMH-11 was confirmed as an HT crop. It was stated as under: “A central feature of DMH-11 is that it carries a gene for herbicide resistance (also termed herbicide tolerance or HT). This fact has not received appropriate consideration. The deployment of herbicide-resistant or HT crops has been accompanied by deleterious outcomes in several places including the US, Australia, and Canada (so-called developed countries) as well as Argentina (a developing country). The most well-established harmful consequences have been the spread of herbicide-resistant weeds across large tracts of agricultural land, which can spell disaster for the normal crop. Thus, notwithstanding the statement of the developers and its implicit acceptance by GEAC, DMH-11 does meet the definition of an HT crop. The answers to two questions show this. Is DMH-11 herbicide tolerant? Yes. Is it a crop? Yes. The intent of the developer on how it is actually likely to be used, especially if that usage appears to confer obvious advantages.” (iv) It was contended that as DMH-11 is an HT crop, all hybrids produced therefrom will also be HT crops and the TEC appointed by this Court has in its detailed report submitted to this Court recommended a complete ban on all HT crops. 20.2 It was further submitted that the report titled, “Biology of Brassica Juncea (Indian mustard)” prepared by the MoEF&CC and DRMR, Bharatpur under United Nations Environment Programme (UNEP)/ Global Environment Facility (GEF) supported the regions of South Western China and North Western Himalayas, which constitute two secondary centres where there is enormous diversity in Brassica Juncea forms; that there is evidence for the existence of two geographical races of Brassica Juncea, the Chinese pool and the Indian

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pool. Further, five countries share nearly 60% of Brassica germplasm holdings led by China (17%) and followed by India (15%), United Kingdom (UK) (10%), USA (9%) and Germany (8%). India presents a rich diversity of rapeseed- mustard group of crops. 20.3 It was next submitted that glufosinate is banned for all other uses except for tea plantations and is specifically banned for use on DMH-11 by farmers; this is because glufosinate causes toxicity which would lead to resistance. However, glufosinate is otherwise available to farmers who have access to it. 20.4 That, the TEC report has pointed to the acute toxicity and health concerns such as carcinogenicity, reproductive and developmental toxicity, and endocrine disruption. That, long term studies show that an exposure to glufosinate would have adverse effects, which may not be evident in short term studies. That, even as per the information made available by Bayer, BASTA containing glufosinate ammonium is neurotoxic and has adverse effect on aquatic life. 20.5 It was reiterated that in the biosafety dossier of HT mustard, the primary data dossier, is, in fact, not in the public domain. The biosafety dossier contains the primary data on the basis of which the AFES Report was prepared. However, the biosafety dossier containing 3251 pages was only available for physical inspection at the MoEF&CC headquarters and in response, petitioner’s counsel had written to GEAC requesting the dossier to be put on the website so that it could be examined by independent experts. It was replied that in no country with functional regulatory system is the full dossier made available publicly due to reasons of protection of intellectual property. 20.6 That, in fact Dr. P.M. Bhargava, in his critique of the AFES Report, had pointed out that it was not possible to evaluate the statements made in the said Report as the primary data had not been provided in the Report. Therefore, it is all the more necessary that the biosafety dossier be put in the public domain so as to enable independent experts to review the same. 20.7 It was next submitted that no chronic/long term studies have been conducted on HT mustard. It was stressed that the