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

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

(viii) that large quantities of GM processed oil is being imported in the form of canola oil and soyabean oil, which is in violation of the constitutional and legal rights of the citizens under Articles 21 and 14 of the Constitution. That GEAC, in their communication dated 23.02.2018 addressed to the DGFT, had informed that it had not authorised or approved GM soyabean or any other product derived from GM soyabean seeds for import or cultivation in India. If that is so, as to how, subsequently, GM food is being imported to India is not known; (ix) that the Union of India is silent about the measures undertaken in respect of labelling of GM foods, as there are no studies which have been commissioned as regards the consumption of GM foods. 41.2 The petitioners have contended that there is a need for formulation of a national policy of GM crops for the following reasons: (i) that apart from South Western China, North Western Himalayas constitute an important centre where there is enormous diversity in Brassica Juncea forms. Therefore, there are two geographical races of Brassica Juncea, the Chinese pool and the Indian pool. The share of holding by the Chinese pool is 17 per cent and by the Indian pool is 15 per cent; (ii) that the growth of GM crops in India would impact organic food producers having regard to the difficulties in segregation of GM and non-GM foods. This would have an adverse effect on export of organic food as importers would closely examine the conditions under which organic food is being grown and any concerns about contamination could lead to an adverse impact and loss of markets for organic food producers; (iii) that India is a signatory to the CPB, therefore, a duty is cast on the Government to assess the impact of its policies and minimize adverse impacts of the same vide Article 26 thereof.

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(iv) that the 1989 Rules were framed prior to the coming into force of the CPB but there is a distinct inconsistency between the same and therefore, the 1989 Rules should be amended in line with the said protocol, otherwise, international law could be applied as part of the national law, unless it is in conflict with any Act of Parliament. (v) In sum and substance, it was contended that there is a need for putting in place a suitable policy and an effective regulatory mechanism which would work within the framework of its mandate. 41.3 Per contra, the Union of India urged this Court to not intervene in the matter as the questions involved are highly technical and polycentric in character. This proposition is indeed attractive at a first blush, for it invites the Court to trust the process of the grant of approval for the environmental release of GMOs under the applicable legal regime. But, it is settled law that expert opinion is not beyond the pale of judicial review, especially when there are serious infirmities in the decision-making process, vide Institute of Chartered Financial Analysts of India vs. Council of The Institute of Chartered Accountants of India, (2007) 12 SCC 210 (“Institute of Chartered Financial Analysts of India”). 41.4 In the above backdrop, the points for consideration shall be answered. Re: Point No.1: Whether GEAC approval dated 18.10.2022 and the consequent decision dated 25.10.2022 for the environmental release of DMH-11 is in accordance with law?

42. I have adverted to in detail several meetings of GEAC held with regard to the application submitted by the applicant, namely, CGMCP, University of Delhi (South Campus) on 15.09.2015 seeking approval for environmental release of the GE mustard hybrid DMH-11. This was after conclusion of the closed or confined trials and was accompanied with a dossier of 3285 pages compiling the results of the food and environmental safety studies that were carried out at the time of the confined trials for the environmental release of transgenic mustard hybrid DMH-11, parental lines bn 3.6 and modbs 2.99 containing barnase, barstar and bar genes. In the 125th

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meeting held on 11.12.2015, GEAC requested the applicant to give a presentation and thereafter on 04.01.2016, a sub-committee was constituted for examination of the dossier. 42.1 The sub-committee held two meetings. After the first meeting, it recommended revision of the biosafety dossier by incorporating additional information regarding certain lacunae or gaps which it had identified and were also identified by the BSU. GEAC decided that if the biosafety dossier is found to be complete in all respects, then the same excluding confidential information, could be put in the public domain for comments. After the first sub-committee meeting, several submissions and recommendations were made which are detailed above. Thereafter, the second sub-committee meeting was held and the sub-committee sought time to analyse and review the revised dossier and results obtained in 129th GEAC meeting held on 20.06.2016. The sub-committee suggested that the AFES report, prepared upon evaluation of biosafety data, be placed on the MoEF&CC website for thirty days to invite comments from stakeholders and the dossier also be made available in GEAC Secretariat for any person interested in studying the same. A total of 759 comments were received between 05.09.2016 and 05.10.2016 and 29 persons personally inspected the dossier at the premises of the MoEF&CC and provided their comments. However, the dossier was not put up on the website of GEAC. This is in fact a violation of the order of this Court dated 08.04.2008 in respect of which contempt petition has been filed. 42.2 On 07.10.2016, this Court recorded the submission of the Union of India that no release of GMOs shall take place till 17.10.2016 because the Government had sought views from the public and upon receipt of such views and objections, the matter was to be considered by a Committee of experts, which process could not be completed by 17.10.2016. However on 11.05.2017, GEAC, in its 133rd Meeting, made the recommendation for the commercial release of DMH-11. However, on 31.07.2017, this Court recorded the submission of the Union of India that the Government has not yet taken a final decision, whether or not to permit the plantation of

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transgenic mustard hybrid DMH-11, and a final decision with reference to the approval would be taken by the Government in September, 2017. It was also pointed out that the plantation is likely to commence in October 2017. At a subsequent hearing on 22.11.2017, this Court recorded the Union of India’s submission that the Government of India had not yet taken a decision in the matter and that all the representations of the stakeholders would be considered before taking the final decision. 42.3 Thereafter, in its 136 th Meeting on 20.09.2018, GEAC re-examined the matter in light of the representations received and on a detailed discussion, 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 honeybees and other pollinators and on soil microbial diversity. Thereafter, in the 137th GEAC meeting held on 20.03.2019, there was a deferment of field demonstration studies on transgenic mustard during the year 2018-19 and it was extended for the seasons 2019-20 and 2020-21. Thus, it is significant to note that GEAC itself had deferred field demonstration studies on transgenic mustard and this was in supersession of the earlier decision taken on 20.09.2018 in the 136th meeting of GEAC wherein the applicant was advised to undertake field demonstration in an area of five acres at two to three different locations. Therefore, till the year 2020-2021, the stage of field demonstration within an area of five acres at two or three different locations had not yet been cleared by GEAC with regard to transgenic mustard hybrid DMH-11. 42.4 When the matter stood thus, Prof. Deepak Pental, on behalf of CGMCP, Delhi University (South Campus), the applicant, vide his letter dated 10.05.2022, wrote directly to the Hon’ble Minister for Environment, Forest and Climate Change seeking acceptance of the recommendations for environmental release of transgenic mustard hybrid DMH- 11 made in the 133rd GEAC meeting. The aforesaid letter is extracted as under:

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“CENTRE FOR GENETIC MANIPULATION OF CROP PLANT (CGMCP) UNIVERSITY OF DELHI SOUTH CAMPUS BENTO JUAREZ ROAD, NEW DELHI-110021, INDIA Phone : 91-11-24112609, 24116392 Fax: 91-11-24116392

Shri Bhupender Yadav May 10, 2022 Hon’ble Minister Minister of Environment, Forest & Climate Change (MoEFCC) Indira Paryavaran Bhawan Aliganj Road, Jorbagh New Delhi – 110 003 Subject: Request for environmental release of GE mustard Respected Minister, I am writing to you on the environmental release of the Genetic Engineering-based technology for hybrid seed production in mustard, a major oilseed crop of our country. Some recent positive, as well as negative developments, have induced me to write to you on the matter which is pending with MoEFCC. The positive development is the Union Governments’ decision to put SDN-1 and SDN-2 types of gene edited crops out of the biosafety regimes stipulated for the Generally Engineered (GE) crops. This is indeed a major step forward. Barring the EU, most of the development countries have already reduced biosafety requirements for genome-edited crops. The negative development is continuing stagnation of the edible oil sector in India. While the demand for edible oils is increasing globally, the supplies are under stress leading to a spurt in the prices of edible oils in the international markets. As our country imports more than fifty per cent of its edible oil requirement there is an urgency to increase our domestic production.

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Our group at the Centre for Genetic Manipulation of Crop Plants (CGMCP), University of Delhi South Campus has been working on increasing the yield of mustard for the past 30 years. A report on the research work being caried out at the Centre is being attached with this letter. The most appropriate technology for yield increase in mustard is hybrid breeding for which a robust hybrid seed production system is foundational; our GE-based hybrid seed production system meets the need. I believe the time has come for MoEFCC to permit environmental release of the GE technology for hybrid seed production to increase edible oil production in the country. To brief you on the past developments, the biosafety studies on the transgenic parental lines Varuna bn 3.6 and EH2 modbs 2.99 and the first generation hybrid DMH-11 were initiated in the year 2010. All the stipulated biosafety studies including field testing under isolation were carried out and a 3251-page dossier was submitted to GEAC on September 15, 2015. The biosafety studies were supported by public funding of around Rs.8 crores. The GEAC in its 133rd meeting held on May 11, 2017, recommended the environmental release of the parental lines and the first generation hybrid DMH-11 and permitted the development of a new generation of hybrids. Unfortunately, a few days later the MoEFCC website displayed the Ministry’s decision – ‘matters related to environmental release of Mustard transgenic are kept pending for further review’. Later in communication from GEAC, some additional experiments on honey bees were sought but no efforts were made to facilitate the execution of those experiments. We pointed out to GEAC that such tests were not required. The technology we have used for hybrid seed production in mustard was first deployed in rapeseed, a sister crop of mustard – in 1996 in Canada, in 2002 in the USA, and in 2003 in Australia. Rapeseed hybrids developed using the GE technologies are currently being cultivated in Canada on almost 9-10 million hectares. No untoward effect of GE rapeseed has been reported either from Canada or from USA and Australia. Canada is a big exporter of rapeseed

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oil and meal to all parts of the world as well as honey. There is no record of any harm to apiculture in Canada or from any other country that has released the GE hybrid seed production system. The point I want to make for your kind consideration is that the GE technology for hybrid seed production developed by us for mustard is well tested, has been used for more than 20 years in rapeseed, and over and above – we have carried out all the necessary biosafety tests on the transgenic mustard lines. I request that the MoEFCC may accept the recommendations of the 133 rd meeting of GEAC recommending the environmental release of the GE-based technology for hybrid seed production in mustard. If required, GEAC could meet again. We would be very happy to interact with GEAC to resolve any lingering doubts or questions. I would be most grateful for your kind help in resolving the issue of the environmental release of GE-based hybrid seed production technology. With kind regards, Yours sincerely, Deepak Pental SERB-National Science Chair Former Professor of Genetics and Vice-Chancellor, University of Delhi Cc: Chairman, GEAC” On receiving the said communication, immediately comments were sought from the DBT, DARE and ICAR. On 25.08.2022, the applicant once again made a presentation of the proposal for environmental release of DMH-11 to GEAC at its 146th meeting. At that meeting, GEAC once again constituted another Expert Committee to examine the request letter dated 10.05.2022 with respect to availability of adequate evidence about impact of transgenic mustard on honeybees and other pollinators in order to assess the need for conducting field demonstration studies on honeybees and other pollinators. The reason for constitution of another Expert Committee is not known or forthcoming. This Expert Committee, headed by

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Dr. Sanjay Kumar Mishra, Scientist H, DBT, Government of India and Co-Chairman, GEAC, held two meetings in September, 2022 and it outrightly recommended environmental release of transgenic mustard hybrid DMH-11. Also, further evaluation was to be carried out as per ICAR guidelines. Thus, the Expert Committee took a dramatically opposite view as compared to GEAC with regard to the field demonstration studies on the effect of GE mustard on honeybees and other pollinators. In the 136th GEAC meeting, it was recommended by GEAC that the same be conducted prior to the environmental release. This Expert Committee, on the other hand, suggested that within two years, post-environmental release under the supervision of ICAR, the effect of GE mustard on honeybees and other pollinators may be studied and a report be submitted to GEAC. For immediate reference, the relevant extracts of the Expert Committee recommendation is extracted as under: “The Expert Committee had deliberations and in-depth consideration of the scientific evidences, including data available on GM Canola cultivation & honey production in other countries and correlated all the concerned issues of contemporary relevance under Indian scenario. Additionally, inputs on the above issues from Members of the Expert Committee, Department of Biotechnology (DBT), Ministry of Science and Technology; and Department of Agriculture Research & Education (DARE), Ministry of Agriculture and Farmers Welfare were also considered and deliberated. The DBT opined that “it seems likely that there were no major deviations in the behaviour of honey bees when compared among the transgenic and non-transgenic comparator lines. GEAC may consider its recommendations of the 133rd meeting on the environmental release of GE mustard”. The DARE opined that “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 honey as decided in its 136th meeting and the recommendation of the 133rd meeting of GEAC may be considered”. 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

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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.” (underlining by me) 42.5 Further, on 18.10.2022, when the 147th Meeting of the GEAC was convened, as many as seven members communicated their inability to attend the meeting and Dr. Geeta Jotwani, Scientist ‘G’ at Indian Council of Medica Research (ICMR) did not attend the meeting. Consequently, eight persons remained absent and only fourteen members participated i.e. almost one-third of the GEAC did not attend the crucial meeting, the GEAC took into consideration only the recommendations of the Expert Committee constituted few weeks before which had given its recommendations on 08.10.2022 and noting the same, the recommendations were accepted by pursuing the comments received from DBT and DARE. The above is evident on perusal of the Minutes of the 147th Meeting of the GEAC held on 18.10.2022 as well as the Agenda Item No.4 which concerns the application relating to environmental release made by the applicant. Thus, GEAC simply recommended the environmental release of transgenic mustard hybrid DMH-11 without any deliberation as such, which recommendation was accepted by the Central Government. As a result, the following consequences are noted: (i) all the previous deliberations and decisions of GEAC as well as the recommendations and suggestions of the sub-committee to GEAC were given a go by and totally ignored.

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(ii) the deferring of the field demonstration between the years 2018 to 2021, which was for valid reasons, was also ignored. (iii) on 25.10.2022, no reason was assigned for the change in stance, insofar as conducting studies on the effect of GE mustard on honeybees and other pollinators post-environmental release. This was contrary to what was decided earlier by GEAC. (iv) thus, on the basis of the opinion of this Expert Committee, GEAC brushed aside its earlier decision taken in the 134th and 136th meetings to undertake field demonstration and restrict the area to only five acres at two to three different locations with a view to generate additional data on honeybees and other pollinators, and on soil microbial diversity, which decision was also put on hold by GEAC. 42.6 There is no reason forthcoming as to why GEAC completely changed its stance in the 147th meeting held on 18.10.2022. This resulted in the decision of the Union Government on 25.10.2022 impugned herein. However, it is apparent that the trigger for this volte-face in the stand of GEAC was the letter dated 10.05.2022 written by Prof. Deepak Pental to the Hon’ble Union Minister for Environment, Forest and Climate Change. There is no material put forth for the sudden decision taken by the Union Government on receiving the changed recommendation of GEAC, when earlier, it was submitted before this Court that the Union Government was still deliberating on the matter, which aspect is evident from the orders passed by this Court when in fact field demonstration was also put on hold by GEAC. Such being the position from the year 2018 onwards, all of a sudden environmental release of DMH-11 was approved even in the absence of field trials for conducting studies on the impact of honeybees and other pollinators. 42.7 I observe that a statutory functionary entrusted or authorised to carry out certain functions contemplated under a statute must do so in accordance with law and known procedure. Where a statutory authority exercises its jurisdiction, conferred

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public trust doctrine applicable in the instant case, which holds immense significance when a decision impacting environmental and ecological vitality is impugned. The public trust doctrine enjoins upon the Government to protect the natural resources as well as the environment for the enjoyment of the general public rather than to permit their use for private ownership or commercial purposes. In M.C. Mehta vs. Kamal Nath, 1996 (9) Scale 141, this Court has observed that there is no reason why the public trust doctrine should not be expanded to include all ecosystems operating in our natural resources. The State is the trustee of all natural resources and the public at large is the beneficiary of the same. The State is, therefore, under a legal duty to protect the natural resources. Similarly, in Lal Bahadur vs. State of U.P., (2018) 15 SCC 407 (“Lal Bahadur”), this Court held that the Government has a duty to protect the environment and the Courts also must bear in mind that in cases concerning environmental governance, it has to discharge its duties by assessing the case on the basis of the material placed before it. This is because matters concerning environmental governance concern not just the living, but also generations to come, which is the basis of the doctrine of inter-generational equity. 42.11 Similarly, in Centre for Public Interest Litigation vs. Union of India, (2012) 3 SCC 1 (“Centre for Public Interest Litigation”), it was observed that the doctrine of equality which emerges from the concept of justice and fairness, must guide the State in determining the actual mechanism for distribution of natural resources. This Court has further observed that every holder of public office by virtue of which he acts on behalf of the State or public body is ultimately accountable to the people in whom the sovereignty vests. As such, all powers so vested in a public officer are meant to be exercised for public good and promoting the public interest. Every holder of a public office is therefore a trustee. If a decision is taken without any principle or without any rule, it is unpredictable and such a decision is an antithesis to the decision taken in accordance with the rule of law. This Court had further observed that the public trust doctrine is a part of the law of the land and it has grown from Article 21 of the Constitution

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of India. This implies that the power vested by the State in a public authority should be used as a trust coupled with duty to be exercised in larger public and social interest. Power is to be exercised strictly adhering to the statutory provisions and fact situation of a case. 42.12 It is observed that in the instant case, while the Union of India made a submission before this Court that no final decision had been taken by it regarding the environmental release of transgenic mustard hybrid DMH-11, yet, pursuant to the letter written on behalf of the applicant to the Hon’ble Minister for Environment, the matter moved swiftly possibly “from the top” and GEAC responded by constituting another Expert Committee which gave its recommendation to GEAC as desired. 42.13 Furthermore, while granting permission of the environmental release of transgenic mustard hybrid DMH-11, the condition imposed was that usage of any formulation or herbicide would not be permitted for cultivation in the farmer’s field and any such use in the farmer’s field without due approval would attract appropriate legal action under various enactments. There is no indication as to how the use of any herbicide could be prevented, rather, the condition not to use any herbicide was open-ended without having any means to check whether any herbicide would be used in the farmer’s field pursuant to the environmental release. The adverse effects of use of herbicide were also totally given a go by. 42.14 I also note that on granting permission for the environmental release of transgenic mustard hybrid DMH-11, there was no procedure envisaged for any study or research on the impact on non-target organisms and soil microbes to be conducted prior to the commercial cultivation of transgenic mustard hybrid DMH-11. I find that it was necessary to have requisite studies and research carried out on the experimental environmental release of transgenic mustard hybrid DMH-11, not only prior to the environmental release but, if permitted, subsequently before commercial cultivation of the said crop. I find this to be a serious lacuna under Rule 13(2) of the 1989 Rules.

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42.15 Further, any evidence of harmful effects or damage to the environment, nature and health owing to non-compliance of conditions stipulated by GEAC was also left open-ended. While recommending environmental release of transgenic mustard hybrid DMH-11 parental lines bn 3.6 carrying barnase and bar genes, and modbs 2.99 containing barstar and bar genes, it is not clear whether the conditions imposed by GEAC were adequate and sufficient and in the interest of environment, particularly in light of the sub-committee’s recommendations to GEAC as the same were to be acted upon as the matter was seized by this Court and was being monitored. 42.16 Moreover, I find that GEAC’s proposal was simply accepted by the MoEF&CC and immediately notified without any further consideration at the level of the Ministry and without having any inter-departmental consultation with the Ministry of Health, MoA and DBT in the Ministry of Science and Technology. It appears that GEAC recommended what MoEF&CC wanted pursuant to Prof. Pental’s letter to the Hon’ble Minister himself in May, 2022. 42.17 Also, no consultation was held with the States wherein mustard is grown, although agriculture is a State subject under Entry 14 of List II of the Constitution. The other concerned stakeholders also ought to have been consulted before a decision was taken by the Union of India in terms of the recommendation of GEAC. The Union of India could not have unilaterally acted on such a serious matter without bringing to the notice of the States, particularly in the northern and northwestern States of the country where mustard is being grown. I also record that the States of Bihar, Kerala, Madhya Pradesh, Haryana, Tamil Nadu, Delhi, Andhra Pradesh, Rajasthan, Odisha, West Bengal and Karnataka had earlier expressed reservations against field testing and release of transgenic mustard hybrid DMH-11. In my view, the States cannot be treated as satellites of the Union of India as they have constitutional identity and powers and responsibilities conferred under the Constitution of India and therefore, their views in the matter are of significance, vide S.R. Bommai vs. Union of India, (1994) 3 SCC 1, Para 99 (“S.R. Bommai”), reiterated in State (NCT of Delhi) vs. Union of India, (2018) 8 SCC 501. The consideration of

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the views of the pertinent States by a regional or national consultation would have made the decision-making process wholesome, as a wider consultation in matters such as the one under consideration would make the decision to be taken less vulnerable to attack and less arbitrary. But the impugned decision of the Union of India, based on a flawed procedure adopted by GEAC at the instance of the applicant, is arbitrary and liable to be interfered with by this Court when it is justified. In these circumstances, the decision of the respondent-Union of India dated 25.10.2022, as well as the recommendation of GEAC dated 18.10.2022, are liable to be set aside. 42.18 Further, no material has been brought before us to point out as to how the decision of GEAC was accepted by MoEF&CC and the recommendation of the environmental release of transgenic mustard hybrid DMH-11 was simply permitted. As discussed hereinabove, the grant of approval by GEAC is governed by Rule13. The said Rule does not contemplate any role for the Ministry of Environment, Forest and Climate Change (MoEF&CC) in the decision-making process. Therefore, the lateral intervention by the said Ministry seriously undermines the credibility and integrity of the decision making as well as the regulatory process. Although the applicant is not a private entity but a Centre in Delhi University (South Campus), the status of the applicant would not matter in arriving at a decision as in the instant case. 42.19 I observe that the principle of public accountability and transparency in State action are applicable to the cases of execution or statutory exercise of power. Every officer in the hierarchy of the State by virtue of his being a public officer/ servant is accountable for his decisions to the public as well as to the State. The concept of dual responsibility should be applied in larger public interest and proper governance. In other words, where a power is given to do a certain thing in a certain way, the thing must be done in that way or not at all and other methods of performance are necessarily forbidden. This principle has also been expressed in terms of the Latin maxim expressio unius est exclusio alterius, which means that when a manner is specified for doing a certain thing, then all other modes for carrying out such act are expressly excluded.

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Vide, Taylor vs. Taylor, (1875) LR 1 Ch D 426 (“Taylor”) and Nazir Ahmad vs. King-Emperor, 1936 SCC OnLine PC 41 : (1935-36) 63 IA 372 (“Nazir Ahmad”). This Court too has applied this maxim in the following cases: (i) Parbhani Transport Cooperative Society Ltd. vs. Regional Transport Authority Aurangabad, (1960) 3 SCR 177 : AIR 1960 SC 801 (“Parbhani Transport Coop. Society”), wherein it was observed that the rule provides that an expressly laid down mode of doing something necessarily implies a prohibition of doing it in any other way. (ii) In Dipak Babaria vs. State of Gujarat, (2014) 3 SCC 502 (“Dipak Babaria”), this Court set aside the sale of agricultural land on the ground that the sale was not in compliance with the statutory procedure prescribed in that regard under the Bombay Tenancy and Agricultural Lands (Vidarbha Region and Kutch area) Act, 1958. The matter was examined on the anvil of the aforestated maxim and it was held that alienation of agricultural land by adopting any alternate procedure to the one prescribed under the Act was necessarily forbidden. (iii) In Kameng Dolo vs. Atum Welly, (2017) 7 SCC 512 (“Kameng Dolo”), election of an unopposed candidate was declared as invalid on the ground that the nomination of his opponent was not withdrawn as per the procedure statutorily mandated. It was held that the nomination of the opposite candidate ought to have been withdrawn in the manner provided for under the relevant statute and withdrawing the same in any other manner was necessarily forbidden. Hence, his election was declared as void. (iv) Similarly, in Tahsildar, Taluk Office, Thanjore vs. G. Thambidurai, (2017) 12 SCC 642 (“Tahsildar”), the assignment of land was cancelled on the ground that statutory requirements were not followed in assigning the land. It was held that when a statute prescribes that a certain Act is to be carried out in

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a given manner, the said Act could not be carried out through any mode other than the one statutorily prescribed. (v) It may also be apposite to refer to the decision of this Court in Union of India vs. Charanjit S. Gill, (2000) 5 SCC 742 (“Charanjit S. Gill”), wherein this Court held that any provisions introduced by way of “Notes” appended to the sections of the Army Act, 1950, could not be read as a part of the Act and therefore such “Notes” could not take away any right vested under the said Act. It was observed that issuance of an administrative order or a “Note” pertaining to a special type of weapon to bring it within the ambit of the Army Act, which was hitherto not included therein, could not be said to have been included in the manner in which it was supposed to be included. It was noted that the Army Act empowers the Central Government to make rules and regulations for carrying into effect the provisions of the Act; however, no power was conferred upon the Central Government of issuing “Notes” or “issuing orders” which could have the effect of the Rules made under the Act. As Rules and Regulations or administrative instructions can neither be supplemented nor substituted by “Notes”, administrative instructions issued or the “Notes” attached to the Rules which are not referable to any statutory authority were not be permitted to bring about a result, which is supposed to be achieved through enactment of Rules. 42.20 What emerges from the above discussion is that when a statute contemplates a specific procedure to be adhered to in order to arrive at a desired end, such procedure cannot be substituted by an alternative procedure which is not contemplated under the statute. Further, if an action is to be carried out by way of issuance of a particular statutory instrument on the basis of certain requirements, such action cannot be validly carried out by way of issuance of an instrument when the same is not contemplated under the statute.

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42.21 It is also noted that at the crucial 147th meeting of GEAC held on 18.10.2022, there was no representative of the ICMR, Ministry of Health. Hence, the matter was not considered from the paradigm of the adverse effect on the health of human beings and animals as well as on other plants in the event of environmental release. Dr. Geeta Jotwani, Scientist F, ICMR, who did not participate in the meeting of GEAC held on 18.10.2022, simply sent an e-mail to the effect that she had concurred with the recommendation of GEAC even in the absence of knowledge about the deliberations of the GEAC. 42.22 In this regard, I also find that the recommendations of the TEC submitted to this Court have been completely ignored by GEAC, as another Expert Committee was constituted by it pursuant to the letter dated 10.05.2022 submitted by Prof. Pental to the Hon’ble Minister for Environment, Forest and Climate Change. It is also not known whether the TEC report was placed before GEAC as well as the Expert Committee or that they had ever been apprised of the same. I observe that Prof. Pental’s letter dated 10.05.2022 to the Hon’ble Minister of Environment, Forest and Climate Change is a classic case of seeking a lateral intervention by the Minister of the Union of India, bypassing what had been decided by GEAC in its 137th meeting held on 20.03.2019. It is clear that pursuant to the intervention of the Ministry, GEAC constituted another Expert Committee and simply accepted its recommendations for the environmental release of DMH-11 hybrid mustard. This was by ignoring all previous deliberation made by GEAC, its sub-committee constituted earlier and its decision to proceed with precaution.

43. Having regard to the aforesaid discussion, I am of the view that the GEAC approval dated 18.10.2022 and the consequent decision dated 25.10.2022 regarding the environmental release of transgenic mustard hybrid DMH-11 is vitiated. I also find that the impugned approval was in gross violation of the principle of public trust. Re: Point No.2: Whether the decision to grant approval for environmental release of DMH-11 violates the right to safe and healthy environment under Article 21?

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Right to safe and healthy Environment: 43.1 I next consider whether the right to safe and healthy environment would be violated by unanticipated adverse effects of the impugned approval for environmental release of DMH-11. While I am cognizant of the submission of the learned Attorney General that the Court cannot go into the nuances of science and technology and give a finding on their merits, at the same time, I do not find substance in his argument that the petitioners’ apprehensions are only a baseless hypothesis. In the instant case, the complexity of reasonable risk assessment in the context of preserving the right to a safe and healthy environment can be understood with reference to some comparative perspectives. (i) The judgment of the Supreme Court of the Netherlands in State of the Netherlands (Ministry of Economic Affairs and Climate Policy) vs. Stichting Urgenda, 19/00135 dated 20.12.2019 is apposite to appreciate the scope of judicial review, when the State, as in the present case, argued that the decision to fulfil obligations under environmental law is within the policy domain and cannot be interfered with by courts of law. The controversy raised by the State of the Netherlands before the Netherland’s Supreme Court was that the Hague District Court ought not to have directed the State to limit the combined volume of Dutch annual greenhouse gas emissions in such a manner that they have reduced by at least 25% at the end of 2020 compared to the level of the year

1990. The Netherland’s Supreme Court dismissed the State’s challenge by applying the precautionary principle. The Netherland’s Supreme Court took note of the real risks of dangerous climate change which necessitate more stringent measures. It reasoned that mere lack of complete scientific certainty about the efficacy of the ordered reduction scenario does not exempt the State from its duty to undertake sufficient measures. Also, in the absence of certainty, a high degree of plausibility of the efficacy of the more stringent pathway was sufficient. The Netherland’s Supreme Court held that the obligation to take measures exists if there is a risk

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that serious environmental contamination may affect people’s well-being and prevent them from enjoying their homes in such a way as to affect their private and family life adversely. The Netherland’s Supreme Court specifically repelled the argument that in the system of the separation of powers, courts should not interfere with the democratically legitimised Government’s attendant policy choices. It proffered the reason that in the given context, the State’s violation of the right to life and right to respect for private and family life necessitated judicial direction for remedial measures. Therefore, disputes seeking review of administrative decisions impacting the environment turn on the relative weight that a decision maker accorded to competing considerations while perceiving the larger public interest. Environmental regulation is supposed to be a reasoning process that takes account of the social context in which the putative environmental effects could occur, the reliability of available information regarding the consequences, the existing institutional history of prevention and containment, and the probability of perceived consequences. It was concluded that while an excessive focus on probabilities can benefit the proponent of a potentially hazardous activity, the imbalanced deference to consequences can give way to the prohibition of such activities. (ii) The judgment of the European Court of Human Rights (ECHR) in Fadeyeva vs. Russia, [2005] ECHR 376: (2007) 45 EHRR 10 (“Fadeyeva”) is apposite in this regard. The case concerned an application filed by a Russian citizen who averred that the operation of a steel plant in close proximity to her home endangered her health and well-being and thereby violated Article 8 of the ECHR. Article 8 guarantees the right to respect private and family life. The ECHR considered Article 42 of the Constitution of the Russian Federation which states, “Everyone has the right to a favourable environment, to reliable information about its state, and to compensation for damage caused to his health or property by ecological offences.” The ECHR acknowledged that given the

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information asymmetry between the claimant of a rights violation and the State, it would be impossible to apply the rule of affirmanti, non neganti, incumbit probation (the burden of proof is upon him who affirms - not on him who denies) rigorously. It was held that the very strong combination of indirect evidence and presumptions makes it possible to conclude that the applicant’s health deteriorated as a result of her prolonged exposure to the industrial emissions from the Severstal steel plant. Even assuming that the pollution did not cause any quantifiable harm to her health, it inevitably made the applicant therein more vulnerable to various illnesses. Moreover, there can be no doubt that it adversely affected her quality of life at home. Therefore, the ECHR accepted that the actual detriment to the applicant’s health and well-being reached a level sufficient to bring it within the scope of Article 8 of the Convention and cast a positive duty on the State to take reasonable and appropriate measures. Having held so, it was concluded that the State had failed to design or apply effective measures to protect the local population from pollution. (iii) Therefore, the application of a rigorous reasoning process that emphasizes potential consequences, as manifested in the final report of the TEC, is expedient when there exists a fundamental asymmetry between the probability and consequences of the activity, such as the environmental release of GMOs. The failure to conduct chronic and transgenerational studies to study the impact on human health is a significant omission within the risk assessment process in the instant case. As noted hereinabove, conducting the said studies was a critical facet of the TEC’s recommendations and the same was fortified by the PSC Report, 2017. In my view, this asymmetry between probable benefits and adverse consequences cannot be adequately counter- balanced by economic or policy safeguards because of the serious and irreversible public and environmental health effects if such consequences occur. In this regard, the reasoning of this Court in T.N. Godavarman

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the citizenry at large, thereby, seriously undermining the right to environmental information. This is more so because such denial of access to environmental information is in contravention of the order of this Court dated 08.04.2008 and subsequent order dated 12.08.2008. The order dated 08.04.2008 records that in the absence of toxicity and allergenicity data, the members of the public and the scientists would not be able to make effective representations to the concerned authorities. It was on the solemn assurance of the then ASG - that the said primary data pertaining to field trials will be placed in the public domain and on the website of GEAC - that this Court had disposed of the applications made by the petitioner. There has been absolute non-adherence of the said assurance. I also note that the Reply Affidavit filed by the Union of India had specifically stated that the full dossier could not be made available on the website and that an independent review of such a dossier by members of the public would undermine the credibility of the extant regulatory regime. 43.3 I observe that the right to environmental information comes within the scope of the right to information, which came to be articulated by this court in State of Uttar Pradesh vs. Raj Narain, (1975) 4 SCC 428, para 74 (“Raj Narain”), as the public’s right to know every public act that is done by public functionaries subject, of course, to absolute secrecy to be maintained in certain circumstances. It is also a critical aspect of the right to freedom of speech and expression, vide Chief Information Commissioner vs. State of Manipur, (2011) 15 SCC 1 (“Chief Information Commissioner”). Disclosure of information is the rule in our system of open governance, and secrecy is an exception vide S. P. Gupta vs. Union of India, (1981) Supp SCC 87 (para 67) (“S. P. Gupta”). Transparency is critical to preserve the integrity of the decision-making process. Public scrutiny would be crucial to evaluate the putative separation of interests and influence between scientific research and regulatory policy formulation. 43.4 The access to environmental information facilitates ‘meaningful engagement’ and rights-conscious decision-making. The engagement with stakeholders through the participative process inspires confidence in the decision-making process

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and leads to more sound outcomes which are less vulnerable to legal challenge. 43.5 The presence of sufficient safeguards such as transparency, accountability and public participation wherever permissible within the decision-making process is critical to ensure that regulatory decisions are not made on partial and uncontested scientific evidence. In this context, I take note of the dicta in Harvester Co. vs. Ruckelshaus, 478 F.2d 615, 652 (D.C. Cir. 1973) (“Harvester Co.”), wherein the US Court of Appeal, DC Circuit held that prior to adjudicating difficult technological questions, the judiciary ought to be assured that such questions are first “resolved in the crucible of debate through the clash of informed but opposing scientific and technological viewpoints.” But the approach of GEAC has been quite contrary to the approach explained above. The record shows that on 22.09.2016, various scholars and public activists endorsed an email addressed to the Hon’ble Minister of Environment, Forest and Climate Change raising serious objections to the conduct of the appraisal process, particularly the refusal to disclose the biosafety dossier to the general public. They urged the MoEF&CC to extend the consultation process by another 120 days. In addition to the email, on 24.09.2016, scholars, experts, and eminent citizens sent a letter to the Hon’ble Minister of Environment, Forest and Climate Change, expressing grave concerns regarding GEAC’s refusal to disclose the biosafety data to the general public, hindering a meaningful exercise of public consultation. These objections initially weighed with GEAC to defer environmental release of DMH-11 in the years 2019-2021. But in the year 2022, things moved with an undue haste and speed and thereby GEAC ignored all precautionary measures suggested by TEC as well as by the sub-committee constituted by it and simply leaf frogged into the impugned decision dated 18.10.2022. This, I find, has adverse legal and environmental consequences. The other critical right is that of public participation in environmental decision-making.

44. Moving further, learned Attorney General submitted that pursuant to the TEC Report submitted to this Court, several guidelines and a

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legal framework were put in place. In this regard, I have perused the specific guidance documents issued in the year 2016, said to be in accordance with the CPB, to further strengthen the risk assessment procedure. The same are discussed as under: i. Risk Analysis Framework, 2016 provides a step-by-step consultation process for seeking views from stakeholders: a) Information about submission of applications is communicated through the minutes of the meetings. b) A RARM plan for each application is prepared by the regulatory agencies and is uploaded on the official website for receiving comments for a period of 30 days. c) Regulatory agencies give recommendations after duly considering the responses. ii. Guidelines for Environmental Risk Assessment (ERA) for Genetically Engineered Plants, 2016: a) The guidelines require that a risk assessment be performed prior to the commercial release of a GE plant in India. b) The purpose of the risk assessment is to identify risks to the health and safety of people and the environment from the cultivation of the GE plant, when compared with the cultivation of the non-GE version of the plant. c) Information requirements include characteristics of genetic modification, cultivation practices and post- release environmental monitoring. iii. Regulations and Guidelines for Recombinant DNA Research and Biocontainment, 2017 seek to ensure appropriate containment strategy ensuring safety to laboratory workers as well as others and the environment from hazardous micro- organisms, GE organisms or cells. iv. Guidelines and SOPs for the Conduct of Confined Field Trials: Confined Field Trials are monitored by RCGM/GEAC-appointed Central Compliance Committees which are site-specific and comprise subject experts.

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44.1 Given their import to the issue at hand, I limit my analysis to the Risk Analysis Framework, 2016 and the Guidelines for Environmental Risk Assessment (ERA) for Genetically Engineered (GE) Plants, 2016. While one of the stated purposes of the Risk Analysis Framework includes provision of transparency on the use of risk analysis to support decision-making, the continued reluctance to publish the biosafety dossier and respond to concerns about long-term effects by provisioning requisite chronic and transgenerational toxicity studies shows that it is inadequate. The modalities of communicating the RARM plan must be inclusive and transparent. The failure to publish the biosafety dossier on the website reveals a deficiency in the Guidelines for Environmental Risk Assessment (ERA) for Genetically Engineered (GE) Plants, 2016. Furthermore, the failure to furnish cogent reasons for giving a go by to field demonstration studies to study the impact on honeybees also reveals the lack of safeguards against misuse of discretion. With respect to post-release monitoring, I note that the MoEF&CC issued an office order on 10.11.2022 to constitute an Expert Committee of four members for Post Release Monitoring Committee (PRMC). The terms of reference are to visit the growing sites of DMH-11 at least once during each season. However, the term of its functioning is limited to a period of four years from the date of issue. 44.2 Given the fact that the unanticipated consequences of the environmental release of DMH-11 remain in the sphere of uncertainty, I am impelled to construe the failure to undertake necessary measures in light of the TEC and the PSC recommendations and the non-compliance with directions of this Court as a violation of the right to a safe and healthy environment. The violation is particularly serious in light of the benchmarks of environmental regulation prescribed by this Court in T.N. Godavarman. 44.3 The failure to adequately assess health and environmental impact of GM crops seriously infringes upon intergenerational equity as it potentially endangers the ability of future citizens to enjoy the highest attainable standard of health. This Court in State of Himachal Pradesh vs. Ganesh Wood Products (1995) 6 SCC 363 (“Ganesh Wood Products”) had invoked intergenerational

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equity while taking cognizance of the ‘totally faulty and a myopic approach’ of the State towards forest management and regulation. This Court held that mechanically granting approvals for manufacturing ‘katha’ by felling khair trees was ‘contrary to public interest involved in preserving forest wealth, maintenance of environment and ecology and considerations of sustainable growth and inter-generational equity.’ This Court reasoned that ‘the present generation has no right to deplete all the existing forests and leave nothing for the next and future generations’ and therefore, the approvals were vitiated. This Court also emphasized that the obligation of sustainable development mandates proper assessment and monitoring so that forest industries function in a balanced manner. 44.4 The State’s obligation to ensure intergenerational equity was also invoked while directing the preparation of appropriate management plans for regulating the use of fragile coastlines vide Indian Council for Enviro-legal Action vs. Union of India (1996) 5 SCC 281. 44.5 In view of the aforesaid discussion, I am of the view that the decision to grant approval for environmental release of transgenic mustard hybrid DMH-11 violates the right to safe and healthy environment under Article 21 of the Constitution of India because the safeguards which were necessary to be taken prior to the grant of the approval have not been taken in the instant case. Consequently, directions have been issued in the succeeding paragraphs. Re: Point No.3: Whether GEAC’s grant of approval dated 18.10.2022 and the decision dated 25.10.2022 for the environmental release of DMH-11 violate the precautionary principle? Precautionary Principle:

45. As discussed earlier, the precautionary principle is one of the doctrinal foundations of Indian environmental law. The principle is an instance of distillation of ecological wisdom. Given the fact that genetic engineering has made what was inconceivable a reality, precaution is the need of the hour. For billions of years, each living organism would exchange DNA with others of its kind. Genetic engineering

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transcends this natural principle by combining genes sourced from widely different species and transferring genes between organisms that had no natural possibility of interbreeding. Scientific research of such a novel nature must therefore happen under supervision and in a manner that inspires public confidence. 45.1 It is said that the regulatory regime should recognize sufficiently the limits of scientific knowledge, and adopt a wider system- based interdisciplinary analysis. A diversity of expert opinions ranging from the disciplines of biotechnology, environmental law, ethics, sociology, agriculture, and sustainable economics should engage in open and public dialogue. Such an open dialogue is necessary in order to mitigate the possibility of regulatory agencies and applicants exaggerating the benefits of a proposed technology or diluting the rigours of environmental safety or health standards.

46. Having regard to the conclusions of the TEC, I find that the apprehensions of the petitioners that HT crops would exert a highly adverse impact over time on sustainable agriculture, rural livelihoods, and the environment are not unfounded. It is reasonable to infer that there is a potential of loss of species of indigenous mustard crop, as India is the centre of origin and diversity, which fact cannot be doubted. The concerns about the impact on other beneficial organisms, such as honeybees, earthworms etc. are also well-founded and serious. As per the precautionary principle, those activities which may disturb nature shall be proceeded only upon ex-ante assessment of their consequences. Such a sound risk and impact assessment is also a binding obligation under Article 14(1) (b) of the CBD and Article 26 of the CPB. Therefore, GEAC is duty bound, both under domestic and international law, to sanction long- term chronic and intergenerational studies, as recommended by the TEC. The reluctance to conduct such studies would risk the health of future generations as well as the farmers’ right to conduct their agricultural activities in the most suitable manner. In this regard, it would be pertinent to quote the paragraph 28 of the 301st Report of PSC as under: “28. The Committee notes that the currently, twenty years after their introduction in 1996, only 6 countries continue to account for over 90% of all GM crop area globally (USA 40%, Brazil 23%, Argentina 14%, India 6%,

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Canada 6%, China 2%). The Committee was informed by the members of civil society during the deliberation on the subject that there was a decline in GM crop area in 2015. The Committee notes with surprise that inspite of the fact that GM technology is being propagated as the most advanced agricultural technology, 17 of the 20 most developed countries (HDI) do not grow it which includes most of Europe, Japan, Russia, Israel etc. The Committee opines that there is increasing evidence about the lack of safety of GM crops and little or no benefits to justify the risks, most countries in the world do not grow GM crops. The Committee also feels that the policy makers of these countries, as custodians for both present and future generations, have seen that GM organisms spread rapidly, that the impacts have been unpredictable, potentially hazardous, uncontrollable and irreversible, assessed the benefits and risks, taken note of emerging evidence of harm, and therefore do not permit GM crops. The non acceptance of the most advanced agricultural technology, GM technology, by the most developed countries raises doubts about the efficacy of the technology. The Committee, therefore, feels that the Government of India should conduct a comparative study to examine the reasons for not accepting this technology by these developed countries viz-a-viz the reasons led to its acceptance.” (underlining by me)

47. There are considerable concerns that the HT GM technology depends on huge chemical spraying. In this regard, learned counsel Dr. Ravindra Chingale brought to my notice the three unstarred questions raised before the Rajya Sabha on 15.03.2021, 22.03.2021 and 08.12.2022 (the latest being after the decision taken by GEAC and the MoEF&CC for environmental release of transgenic mustard DMH-11 hybrid). Law courts under Section 57(4) of the Indian Evidence Act, 1872, can take judicial notice of the course of proceedings of the Parliament. The answering of parliamentary questions is a part of the conduct of business of the Parliament. Therefore, no question about its admissibility under Section 74, the Indian Evidence Act, 1872 would arise.

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For ease of reference, the said questions and answers are extracted as under: “GOVERNMENT OF INDIA MINISTRY OF ENVIRONMENT, FOREST AND CLIMATE CHANGE RAJYA SABHA UNSTARRED QUESTION No.2118 TO BE ANSWERED ON 15.03.2021 Commercial cultivation of GM crops and foods made from GM ingredients

2118. SHRI KANAKAMEDALA RAVINDRA KUMAR: Will the Minister of ENVIRONMENT, FOREST AND CLIMATE CHANGE be pleased to state: (a) Whether it is a fact that Government has approved commercial cultivation of Genetically Modified (GM) crops and also manufacturing, import and selling of processed foods made from GM ingredients; (b) If so, the details thereof; (c) Whether Government has undertaken any study regarding impact of GM crops cultivation on environment and impact of GM foods on health of individuals in the country; (d) If so, the details thereof; and (e) If not, the reasons therefore? ANSWER MINISTER OF STATE IN THE MINISTRY OF ENVIRONMENT, FOREST AND CLIMATE CHANGE (SHRI BABUL SUPRIYO) (a) and (b) Bt cotton is the only genetically modified (GM) crop that has been approved for commercial cultivation. Further, at present matters related to processed GM foods is being dealt under Section 22 of the Food Safety and Standards Act (2006), which has not yet been operationalised.

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(c) to (e) Long term studies conducted by Indian Council of Agricultural Research (ICAR) on the impact of Bt cotton cultivation found no adverse effect on soil, microflora and animal health. Food Safety and Standards Authority of India (FSSAI) has not undertaken any study on impact of GM foods on health of individuals in the country. *** GOVERNMENT OF INDIA MINISTRY OF ENVIRONMENT, FOREST AND CLIMATE CHANGE RAJYA SABHA UNSTARRED QUESTION No.2931 TO BE ANSWERED ON 22.03.2021 Genetically Modified seeds

2931. SHRI PRASANNA ACHARYA: Will the Minister of ENVIRONMENT, FOREST AND CLIMATE CHANGE be pleased to state: (a) whether Government has assessed the outcome of the Genetically Modified (GM) seeds so far its impact on production, cost of production, environment and public health is concerned; (b) the other items that the Genetic Engineering Appraisal Committee has recommended for commercial use of GM seeds; and (c) whether Government taken any final decision in this regard, if so, by when it will be implemented, if not, the reasons therefor? ANSWER MINISTER OF STATE IN THE MINISTRY OF ENVIRONMENT, FOREST AND CLIMATE CHANGE (SHRI BABUL SUPRIYO) (a) to (c) Bt cotton is the only genetically modified (GM) crop that has been approved for commercial cultivation in India.

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As per the information received from Ministry of Agriculture and Farmers Welfare, around 90% of the cotton area is under the cultivation of Bt cotton and the productivity has increased from 191 Kg per hectare in 2002-03 to 455.00 Kg per hectare in 2019-20. Per hectare income of the farmer has also increased. There has also been a reduction in the usage of insecticide for bollworm damage from 24 sprays to 2-3 sprays in a season. Long term studies conducted by Indian Council of Agricultural Research (ICAR) on the impact of Bt cotton cultivating states has not reported any adverse effect on soil, microflora and animal health. *** GOVERNMENT OF INDIA MINISTRY OF ENVIRONMENT, FOREST AND CLIMATE CHANGE RAJYA SABHA UNSTARRED QUESTION No.222 TO BE ANSWERED ON 18.12.2022 Conferment of herbicide tolerance to genetically modified mustard

222. SHRI ANEEL PRASAD HEGDE: Will the Minister of ENVIRONMENT, FOREST AND CLIMATE CHANGE be pleased to state: (a) whether the bar gene in parental lines and hybrid offspring of Delhi University’s GM mustard confers herbicide tolerance to genetically modified mustard plants, even as it is useful as a marker gene; (b) whether India has put into place regulatory protocols to specifically test for the safety of HT GM crops as opposed to any other GM crop, and whether the parental lines of DMH-11 and DMH-11 itself have been tested for this herbicide tolerance trait, even if only for seed production purposes; and (c) if not, the reason thereof?

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ANSWER MINISTER OF STATE IN THE MINISTRY OF ENVIRONMENT, FOREST AND CLIMATE CHANGE (SHRI ASHWINI KUMAR CHOUBEY) (a) to (c) The bar gene in Mustard hybrid DMH-11 is expressed which encodes phosphinothricin N-acetyl transferase enzyme that confers resistant to herbicide glufosinate ammonium. Genetically Modified (GM) Hybrid Mustard DMH-11 has not been approved for Herbicide Tolerant (HT) trait but for a GM technology for hybrid seed production. The HT characteristic/ trait present in the GM Mustard hybrid seed is essential for eliminating fertile plants that are not transgenic in the hybrid seed production plots to maintain the purity of hybrid seed. The use of herbicide will be limited to seed production stage by the seed producing company/institute and not during the commercial cultivation of DMH-11 by the farmers. The use of herbicide will be after obtaining label claim and approval from Central Insecticide Board and Registration Committee (CIB&RC). The biosafety research trials including environmental safety studies have been conducted for transgenic mustard hybrid DMH- 11 containing barnase, barstar and bar genes, events bn 3.6 (Barnase line) and modbs 2.99 (Barstarline). The issue of environmental release of GM Mustard is under adjudication in the Writ Petition (Civil) 115/2004 and Writ Petition (Civil) 260 of 2005 titled as Gene Campaign vs. UoI & Ors. and Aruna Rodrigues vs. UoI & Ors., respectively before the Hon’ble Supreme Court of India. (underlining by us)

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47.1 It is needless to observe that taking note of the said questions and answers so as to appreciate the stance of the Government at the particular point of time would be in line with the constitutional scheme in general and the Rules of Procedure and Conduct of Business in the Council of States (Rajya Sabha) (‘Rajya Sabha Rules’). 47.2 On a reading of the above, it is clear that the stand of the MoEF&CC before the Parliament has been as follows: (i) that processed GM foods is dealt with under Section 22 of the FSSA, 2006, which had not yet been operationalised. This was as on 15.03.2021, but thereafter on 02.11.2021, the Central Government has appointed the said date as the date on which clause (2) of Explanation of Section 2 of the FSSA, 2006 shall come into force. The said clause deals with GM or engineered organisms obtained through modern biotechnology. (ii) More critically, it is also admitted by the MoEF&CC that the FSSAI has not undertaken any study on impact of GM foods on the health of individuals in the country. (iii) Subsequently, on 22.03.2021, it has been stated that Bt cotton is the only GM crop that has been approved for commercial cultivation in India. (iv) Thereafter, on 08.12.2022 a specific question, namely, whether the bar gene in parental lines and hybrid offspring of Delhi University’s transgenic mustard hybrid DMH-11 confers HT to transgenic mustard hybrid DMH-11 plants, even as it is useful as a marker gene was asked. The answer given was that the bar gene in mustard hybrid DMH-11 is expressed which encodes enzyme that confers resistance to herbicide glufosinate ammonium. (v) But it is stated in the same answer that Genetically Modified (GM) hybrid mustard DMH-11 has not been approved for herbicide tolerant (HT) trait but for a GM technology for hybrid seed production. The HT characteristic/trait present in the transgenic mustard hybrid DMH-11 seed is essential for eliminating fertile plants that are not transgenic in hybrid seed production

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plots to maintain the purity of hybrid seeds. It was also stated that the use of herbicide will be limited at the time of seed production stage and not during the commercial cultivation of DMH-11 by the farmers. Such use of herbicide, it was stated, will be after obtaining label claim approval from the Central Insecticide Board and Registration Committee (CIB&RC). The Minister noted that the biosafety research trials including environmental safety studies had been conducted for transgenic mustard hybrid DMH-11 containing barnase, barstar and bar genes, events bn 3.6 (Barnase line) and modbs 2.99 (Barstarline). (vi) Further, he noted that the issue of environmental release of transgenic mustard hybrid DMH-11 is under adjudication in the present cases. 47.3 Having given my anxious consideration to the report of the TEC and the PSCs, I am convinced that the ability to conduct robust risk assessment hinges upon the availability of indigenous and independent studies and research. It follows that conclusions about safety assessment and ecological impact cannot be transplanted from research conducted in a foreign context. Crucially, the recommendation of Expert Committee constituted by GEAC in the year 2022 after Prof. Pental’s letter to the Hon’ble Minister of Environment, which is the basis of GEAC’s impugned approval, is entirely premised upon foreign studies and research and not on indigenous research or studies. This, I find, is a serious omission, on the part of GEAC in not applying its mind to research studies to be conducted within the country as India has a unique biodiversity and a socio- economic structure of society which is directly related to land holdings and conduct of agricultural operations. 47.4 It is also noted that Dr. Sanjay Kumar Mishra, Scientist ‘H’, DBT, New Delhi, who is one of the members of GEAC (Co- Chairman), was made Chairman of the Expert Committee constituted by GEAC in the 146th meeting which was held pursuant to the letter written by Prof. Deepak Pental on behalf of the CGMCP, University of Delhi (South Campus) to the Hon’ble Minister of Environment. The crucial portions of the recommendations have been extracted above.

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On a reading of the same, it is evident that the Expert Committee has made its recommendations on the opinion of the DBT and the DARE which are bodies within the Ministries of the Government. They are not independent scientific bodies. Therefore, the Expert Committee could not have relied upon the opinion of the DBT and the DARE. Also, based on the examination of scientific evidences available globally, and as per the recommendations of concerned Ministries, it was observed by the Expert Committee that it was unlikely that the bar, barnase, and barstar system would pose an adverse impact on honeybees and other pollinators. What is the pertinent scientific evidence available globally or in other countries and how the said evidence was co-related to all the concerned issues of contemporary relevance under Indian scenario, has not been explained. That the Expert Committee has been swayed by the opinion of the DBT and the DARE is opponent. DBT opined that, “it seems likely that there were no major deviations in the behaviour of honeybees when compared among the transgenic and non-transgenic comparator lines. GEAC may consider its recommendations of the 133rd meeting on the environmental release of GE mustard.” The aforesaid opinion is contrary to what was expressed by the sub-committee constituted by the GEAC when the matter was being considered prior to the 133rd meeting. DARE opined that, “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 honey as decided in its 136th meeting and the recommendation of the 133rd meeting of GEAC may be considered.” There is no reason expressed as to why GEAC should exempt additional studies on the impact of transgenic mustard hybrid DMH-11 on honeybees and honey as decided in 136th meeting. In other words, the Expert Committee has recommended what exactly was required by the applicant i.e. to give effect to the recommendations of the 133rd meeting of GEAC. 47.5 In fact, the constitution of Expert Committee in the year 2022 itself is an eye-wash, inasmuch as the Ministry of Environment required the report of the so-called Expert Committee in order to approve the application given by CGMCP, University of Delhi (South Campus), which is contrary to the stand of GEAC in its earlier meetings. The report of this Expert Committee therefore was tailor-made and “suitable” in order that GEAC could accord approval to the application submitted by CGMCP. As already

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observed, the Expert Committee relied upon scientific evidence available globally and not based upon the agro-ecological realities in India. Therefore, not much credence can be given to the recognition of this Expert Committee which was the basis of the decision/recommendation dated 18.10.2022 made to MoEF&CC. 47.6 Next, I have perused the conditions imposed by GEAC while according approval to CGMCP, University of Delhi (South Campus), the applicant. It is apparent that the precautionary principle has been seriously undermined in Condition VI and VII that have been prescribed by GEAC for the impugned release. Although Condition VII prohibits farmers from using any formulation of herbicide in the fields, it is unclear how such a prohibition would be enforced. Given the nature of the DMH-11 which according to the petitioners has HT characteristics, the impact upon non-target organisms and beneficial organisms could be seriously detrimental to agrarian ecology. The proposed conditions for approval are neither adequate nor feasible to limit these consequences. I observe that GEAC has failed to take into consideration the precautionary principles while approving the environmental release of the transgenic mustard DMH-11 hybrid.

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assessment and obtaining necessary environmental clearance before execution of an industrial activity. It was directed that, in future, before acquisition of lands for development, the consequence and adverse impact of development on the environment must be properly comprehended and the lands be acquired for development so that they do not gravely impair the ecology and environment. 48.2 The precautionary principle was pressed into service in Democratic Youth Federation of India vs. Union of India (2011) 15 SCC 530 (“Democratic Youth Foundation of India”) to ban the use of the endosulfan pesticide until a court- appointed committee conducted a risk assessment of the same. It was also applied in Hospitality Association of Mudumalai vs. In Defence of Environment & Animals, (2020) 10 SCC 589 (“Hospitality Association of Mudumalai”) where it was held that: “39. … The precautionary principle makes it mandatory for the State Government to anticipate, prevent and attack the causes of environmental degradation. In this light, we have no hesitation in holding that in order to protect the elephant population in the Sigur Plateau region, it was necessary and appropriate for the State Government to limit commercial activity in the areas falling within the elephant corridor.” 48.3 Furthermore as noted above, this Court gave an expansive scope to the application of the precautionary principle beyond adjudicatory orders to any decision, administrative or commercial ought to be made by the Government or private parties in anticipation of serious environmental harm. In Pragnesh Shah vs. Dr. Arun Kumar Sharma, (2022) 11 SCC 493 (“Pragnesh Shah”), it was explained that the precautionary principle requires the State to act in advance to prevent environmental harm from taking place, rather than by adopting measures once the harm has taken place. In deciding when to adopt such action, the State cannot hide behind the veil of scientific uncertainty in calculating the exact scientific harm by observing as under:

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“36. The precautionary principle envisages that the State cannot refuse to act to preserve the environment simply because all the scientific data may not be available. If there is some data to suggest that environmental degradation is possible, the State must step into action to prevent it from taking place. Indeed, it was this thought that compelled this Court in T.N. Godavarman [T.N. Godavarman Thirumulpad v. Union of India Writ Petition No. 202 of 1995] to direct the State to identify ESZs across India, so that steps can be taken to identify areas where there is a greater possibility of environmental degradation and a plan is put in place to prevent such degradation before it actually makes the harm irreversible.” 48.4 Relying upon H.P. Bus-Stand, this Court held that actualising the framework of environmental rule of law requires that the courts cannot be stupefied into inaction due to scientific uncertainty but must take decisions to protect the environment based on whatever information is available. 48.5 Recently this Court in M.K. Ranjitsinh while considering protection of the Great Indian Bustard and the Lesser Florican both kinds of birds which are on the verge of extinction, observed as under: “35. India faces a number of pressing near-term challenges that directly impact the right to a healthy environment, particularly for vulnerable and indigenous communities including forest dwellers. The lack of reliable electricity supply for many citizens not only hinders economic development but also disproportionately affects communities, including women and low-income households, further perpetuating inequalities. Therefore, the right to a healthy environment encapsulates the principle that every individual has the entitlement to live in an environment that is clean, safe, and conducive to their well-being. By recognizing the right to a healthy environment and the right to be free from the adverse effects of climate change, states are compelled to

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prioritize environmental protection and sustainable development, thereby addressing the root causes of climate change and safeguarding the wellbeing of present and future generations. It is imperative for states like India, to uphold their obligations under international law, including their responsibilities to mitigate greenhouse gas emissions, adapt to climate impacts, and protect the fundamental rights of all individuals to live in a healthy and sustainable environment.” 48.6 In this context, I would also like to refer to the relevant Articles of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity which specifically deals with living modified organisms to mean any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology (Article 3g) as well as Articles 15 and 16 of the said Protocol which deal with risk assessment and risk management respectively. It is necessary to refer to the said Articles as India is a signatory to the said Protocol and Convention. I may further refer to the Convention on Biological Diversity and particularly, on Article 8(g) which states that each contracting party shall, as far as possible and as appropriate establish or maintain means to regulate, manage or control the risks associated with the use of release of living modified organisms resulting from biotechnology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity, taking also into account the risks to human health. 48.7 It is too late in the day to even entertain the proposition that the protection of our natural environment and ecology is not a constitutional imperative. The evolution of the right to a safe and healthy environment and the concomitant duty of the State to uphold public trust and abide by inter-generational equity and the precautionary principle in environmental regulation is the bedrock of environmental constitutionalism. The environmental rights regime is a product of decades of environmental litigation by civil society, social movements,

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affected communities and the general citizenry. In that sense, environmental constitutionalism is a facet of transformative constitutionalism touching upon the socio-economic lives of citizens. In other words, the affected communities must have a substantive role in environmental governance. 48.8 While this court in T.N. Godavarman has crystallised the role of environmental regulators and the Executive arm of the State since it mandates adequate technical capacity and effectiveness so as to attain optimal environmental performance, a weak regulatory regime can render environmental rights illusory. At the same time, technical capacity and effective regulation cannot be realised without democratic engagement, dialogue and deliberation. The aspiration of transformative environmental governance cannot be realised merely through an effective bureaucracy and sound technical expertise. Environmental democracy and environmental rights are two sides of the same coin. In this regard, the facts of this case shed light on the salience of the legislative role in preserving environmental democracy. 48.9 Environmental decision-making in a rapidly changing climate requires healthy contestation of alternative worldviews, interests and rights. Only through such contestation can a fine and sustainable balance between development and the environment be arrived at. The Department-related Parliamentary Standing Committees and other legislative committees discharge important functions. In the context of the environment, these committees are mandated to scrutinise public issues from multiple perspectives, appreciate available evidence, consult experts and the members of the affected communities and thereafter render a principled and considered report. Open and transparent deliberation on expert knowledge increases accountability and acts as a safeguard against conflict of interest but not a closed door decision making process. 48.10 Consequently, I hold that the approval dated 18.10.2022 and consequent decision dated 25.10.2022 for environmental release of transgenic mustard hybrid DMH-11 violate the precautionary principle inasmuch as there has been no determination made, as to, whether, transgenic mustard

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hybrid DMH-11 is a HT crop and if so, the nature of risk that would be caused by the said plant to the environment including other plants as well as to human beings and animals. The deliberations have not focussed inter alia, on the aspects of biosafety, risk assessment, soil health, micro-biology and socio-economic aspects etc. Moreover, the recommendations of the TEC and Parliamentary Standing Committees’ Reports on Agriculture and on Science and Technology, Environment and Forest have not been considered. Consequently, directions have been issued in the succeeding paragraphs. Conclusion:

49. In view of the aforesaid discussion and findings, I conclude as under: (i) the recommendations of GEAC dated 18.10.2022 as well as the decision taken by the respondent Union of India on 25.10.2022 with regard to approving environmental release of transgenic mustard hybrid DMH-11 on the application made by the applicant, namely, CGMCP, University of Delhi (South Campus’) are vitiated and hence, they are liable to be quashed and are quashed. (ii) I further observe that the recommendation of the Expert Committee constituted by the GEAC in the year 2022 is of no consequence and not binding.

50. Consequently, I issue the following directions: (a) With regard to approving environmental release of transgenic mustard hybrid in future on the application made by the applicant, namely, CGMCP, University of Delhi (South Campus) or by any other applicant: (i) there shall be a decision taken by GEAC, in the first instance, on whether, transgenic mustard hybrid DMH-11 is a HT crop or not, by having a wide and meaningful consultation on the report of TEC submitted to this Court with all stakeholders, including experts in the field of agriculture, biotechnology, health experts and other scientists/experts preferably within a period of four months from today. A report on this aspect must be submitted by GEAC to MoEF&CC.

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(ii) MoEF&CC must publish an official report, with adequate publicity to the said report, on whether the GE mustard hybrid DMH-11 is indeed a HT crop or not, preferably within a period of one month from the date of receipt from GEAC. (iii) for the aforesaid purposes, GEAC is directed to upload the applicant’s biosafety dossier comprising 3285 pages on its website after prior intimation to the applicant CGMCP, University of Delhi (South Campus) within a period of two weeks from today. This is with a view to bring in transparency in the matter. (iv) The aforesaid biosafety dossier shall remain on the website of GEAC for a minimum period of 30 days from the date it is uploaded so as to enable the stakeholders to respond to the said dossier. On receipt of such response, if any, GEAC shall collate the said responses, and take the same into consideration for its future course of action. (v) In the event, GEAC and MoEF&CC conclude that transgenic mustard hybrid DMH-11 is a HT crop, then the nature of risk that would be caused by the said plant to the environment including other plants as well as to human beings and animals must be researched and deliberated upon. The deliberations must take into consideration different aspects, such as biosafety, risk assessment, soil health, micro-biology and socio-economic aspects etc. (vi) After taking a decision on the nature and characteristic of transgenic mustard hybrid DMH-11, the respondent shall take a policy decision in the matter afresh on environmental release of transgenic mustard hybrid DMH-11 on receipt of the report from GEAC in future bearing in mind health and environmental aspects of transgenic mustard hybrid DMH-11. (vii) In the above context, the respondent-Union of India shall also comply with the recommendations made by Technical Expert Committee (TEC) on Agriculture, Science and Technology, discussed above to the extent they are not contrary to the aforesaid directions and if not already complied with.

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(viii) The respondent-Union of India shall also comply with the recommendations made by the Parliamentary Standing Committees (PSCs) on Agriculture and on Science and Technology, Environment and Forest, to the extent they are not contrary to the aforesaid directions if not already complied with. (ix) With regard to import of GM edible oil such as mustard or canola being made, the requirements of Section 23 of FSSA, 2006 in the matter of packaging and labelling shall be complied with by the respondent-Union of India as early as practicable. I also issue certain general directions in relation to GM crops as under: (b) The respondent-Union of India is directed to evolve a National Policy with regard to GM crops in the realm of research, cultivation, trade and commerce in the country. The said National Policy shall be formulated in consultation with all stakeholders, such as, experts in the field of agriculture, biotechnology, State Governments, representatives of the farmers, etc. The National Policy to be formulated shall be given due publicity. (c) For the aforesaid purpose, the MoEF&CC shall conduct a national consultation, preferably within the next four months, with the aim of formulating the National Policy on GM crops. The State Governments shall be involved in evolving the National Policy on GM crops. (d) That the composition of GEAC shall be suitably reformed bearing in mind the recommendations of the TEC and the PSC Reports and the dictum of this Court in the case of T.N. Godavarman discussed above. The reformed composition shall comprise of experts in the field of agriculture, biotechnology, ethics, sociology, health as well as experts in the field of environment and shall be an independent and autonomous body. This could be done either by a statute or amendments being brought to the existing Rules as thought fit by the respondent-Union. (e) Respondent – Union of India must ensure that all credentials and past records of any expert who participates in the decision- making process should be scrupulously verified and conflict of

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interest, if any, should be declared and suitably mitigated by ensuring representation to wide range of interests. Rules in this regard may be formulated having statutory force. (f) The specific guidance documents referred to above in paragraph No.42 that have been adopted in conformity with the Cartagena Protocol on Biosafety (CPB) shall be complied with in letter and spirit insofar as they are applicable to the Indian context. These guidance documents shall be accorded statutory status by framing and issuing appropriate Rules under Section 25 of the EP Act, 1986. (g) In the matter of importing of GM food and more particularly GM edible oil, the respondent shall comply with the requirements of Section 23 of FSSA, 2006, which deals with packaging and labelling of foods. The aforesaid directions have been issued by me bearing in mind, Articles 14 and 21 of the Fundamental Rights; Article 48A of the Directive Principles of State Policy of the Constitution as well as the statutory framework applicable to the controversy under consideration.

51. The writ petitions are disposed of in the aforesaid terms and the civil appeal does not survive for any further consideration and hence stands disposed of.

The contempt proceedings are dropped without expressing any opinion on the merits of those petitions.

Order

1. On the following aspects, there is consensus on the Bench:

That Judicial Review of the decision taken by the bodies concerned in the matter of GMOs is permissible.

2. We issue the following directions:

i. The respondent-Union of India is directed to evolve a National Policy with regard to GM crops in the realm of research, cultivation, trade and commerce in the country. The said National Policy shall be formulated in consultation with all stakeholders,

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such as, experts in the field of agriculture, biotechnology, State Governments, representatives of the farmers, etc. The National Policy to be formulated shall be given due publicity.

ii. For the aforesaid purpose, the MoEF&CC shall conduct a national consultation, preferably within the next four months, with the aim of formulating the National Policy on GM crops. The State Governments shall be involved in evolving the National Policy on GM crops.

iii. Respondent – Union of India must ensure that all credentials and past records of any expert who participates in the decision- making process should be scrupulously verified and conflict of interest, if any, should be declared and suitably mitigated by ensuring representation to wide range of interests. Rules in this regard may be formulated having a statutory force.

iv. In the matter of importing of GM food and more particularly GM edible oil, the respondent shall comply with the requirements of Section 23 of FSSA, 2006, which deals with packaging and labelling of foods.

3. Having regard to the difference of opinion expressed by us on the decision of the GEAC and MoEF granting conditional approval for environmental release of DMH-11, the Registry shall place the matter before Hon’ble the Chief Justice of India for constituting an appropriate Bench to consider the said aspect afresh.

Result of the case: M atter placed before HCJI for constituting appropriate Bench.

† Headnotes prepared by: Bibhuti Bhushan Bose