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of the Government that if two views are possible and the Government takes one of it, it would not be amenable to judicial review on the ground that the other view, according to the court, is a better view.” (Emphasis supplied) 26.5. In 5 M & T Consultants v. S.Y. Nawab (2-Judge Bench)22 this Court reiterated the principle given in Delhi Science Forum v. Union of India (3-Judge Bench)23 wherein it was observed: “…parting with privilege exclusively vested with the Government must be reasonably rational and in the public interest besides conforming to law governing the same and the decision pertaining to the same can be questioned only on grounds of bad faith, being based on irrational or irrelevant considerations, non-compliance with the prescribed procedure or violation of any constitutional or statutory provision and the onus in respect of establishing the same not only heavily rests on the person alleging it but it is not satisfied by merely raising a doubt in the mind of the Court as to the validity of the decision.” 26.⁶. In order to declare a legislation violative of Article 14 of the Constitution of India, arbitrariness on the part of the legislature should, ordinarily, be manifest arbitrariness, as has been held by this Court in Bombay Dyeing & Mfg. Co. Ltd. (3) v. Bombay Environmental Action Group (2-Judge Bench),24 26.⁷. Similarly, in A.P. Dairy Development Corpn. Federation v. B. Narasimha Reddy, (2-Judge Bench),25 this Court held that substantive unreasonableness should be shown in the statute itself in order to declare it ultra vires the Constitution. It has been held that “A party has to satisfy that the action was reasonable, not done in unreasonable manner or capriciously or

22 [2003] Supp. 4 SCR 187 : (2003) 8 SCC 100 23 [1996] 2 SCR 767 : (1996) 2 SCC 405 24 [2006] 2 SCR 920 : (2006) 3 SCC 434 25 [2011] 14 SCR 1 : (2011) 9 SCC 286

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at pleasure without adequate determining principle, rational, and has been done according to reason or judgment, and certainly does not depend on the will alone. However, the action of the legislature, violative of Article 14 of the Constitution, should ordinarily be manifestly arbitrary.” 26.⁸. The principle that to declare an Act ultra vires under Article 14, the Court must be satisfied in respect of substantive unreasonableness in the statute itself stood reiterated by this Court in State of T.N. v. K. Shyam Sunder (3-Judge Bench).26 26.9. Recently, this Court in Association for Democratic Reforms & Anr v. Union of India & Ors. (5-Judge Bench),27 while relying on Dharam Dutt v. Union of India (2-Judge Bench)28 extensively discussed this principle. It held as follows: “44. The presumption of constitutionality is based on two premises. First, it is based on democratic accountability, that is, legislators are elected representatives who are aware of the needs of the citizens and are best placed to frame policies to resolve them. Second, legislators are privy to information necessary for policy making which the Courts as an adjudicating authority are not. However, the policy underlying the legislation must not violate the freedoms and rights which are entrenched in Part III of the Constitution and other constitutional provisions. It is for this reason that previous judgments of this Court have held that the presumption of constitutionality is rebutted when a prima facie case of violation of a fundamental right is established. The onus then shifts on the State to prove that the violation of the fundamental right is justified.” (Emphasis supplied)

26 [2011] 11 SCR 1094 : (2011) 8 SCC 737 27 [2024] 2 SCR 420 : 2024 SCCOnline SC 661 28 [2003] Supp. 6 SCR 151 : (2004) 1 SCC 712

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26.10. A perusal of the judgments referred to supra shows two primary grounds upon which the validity of a legislation or, in our case Rules made under a legislation, may be put to challenge. One is legislative competence and the second is manifest arbitrariness. The former is not an aspect of challenge. In view of S.⁶ (rules to regulate environmental pollution), S.⁸ (persons handling hazardous substances to comply with procedural safeguards) and S.25 (empowers the Central Government for making rules to carry out the purposes of the EPA) of the EPA 1986, 1989 Rules were made to protect the environment, nature and health, in connection with the application of gene-technology and micro-organisms. 26.11. The latter, that is manifest arbitrariness, has been recognized as a ground upon which a legislative enactment can be judicially reviewed. [See: K.S. Puttaswamy v. Union of India (5-Judge Bench)29 and Madras Bar Association v. Union of India & Anr. (3-Judge Bench)30] Equally, it is to be noticed that in Indian Express Newspaper v. Union of India (3-Judge Bench)31 it was stated that subordinate legislation can be challenged on any ground available against the plenary legislation. In other words, the distinction between subordinate and plenary legislation is erased when it comes to a challenge under Article 14 of the Constitution of India. 26.12. In Khoday Distilleries Ltd. v. State of Karnataka (3-Judge Bench),32 this Court held : “13. It is next submitted before us that the amended Rules are arbitrary, unreasonable and cause undue hardship and, therefore, violate Article 14 of the Constitution. Although the protection of Article 19(1)(g) may not be available to the appellants, the Rules must, undoubtedly, satisfy the test of Article 14, which is a guarantee against arbitrary action. However, one must bear in mind that what is being challenged here under Article 14 is not executive

29 [2018] 8 SCR 1 : (2019) 1 SCC 1 30 [2021] 5 SCR 791 : (2022) 12 SCC 455 31 [1985] 2 SCR 287 : (1985) 1 SCC 641 32 [1995] Supp. 6 SCR 759 : (1996) 10 SCC 304

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action but delegated legislation. The tests of arbitrary action which apply to executive actions do not necessarily apply to delegated legislation. In order that delegated legislation can be struck down, such legislation must be manifestly arbitrary; a law which could not be reasonably expected to emanate from an authority delegated with the law-making power. In Indian Express Newspapers (Bombay) (P) Ltd. v. Union of India [(1985) 1 SCC 641 : 1985 SCC (Tax) 121], this Court said that a piece of subordinate legislation does not carry the same degree of immunity which is enjoyed by a statute passed by a competent legislature. A subordinate legislation may be questioned under Article 14 on the ground that it is unreasonable; ‘unreasonable not in the sense of not being reasonable, but in the sense that it is manifestly arbitrary’. Drawing a comparison between the law in England and in India, the Court further observed that in England the Judges would say, ‘Parliament never intended the authority to make such Rules; they are unreasonable and ultra vires’. In India, arbitrariness is not a separate ground since it will come within the embargo of Article 14 of the Constitution. But subordinate legislation must be so arbitrary that it could not be said to be in conformity with the statute or that it offends Article 14 of the Constitution.” (Emphasis supplied) 26.13. In Shayara Bano v. Union of India & Ors. (5-Judge Bench),33 RF Nariman J., while dissenting with the majority, observed : “Manifest arbitrariness, therefore, must be something done by the legislature capriciously, irrationally and/ or without adequate determining principle. Also, when something is done which is excessive and disproportionate, such legislation would be manifestly arbitrary.” (Emphasis supplied)

33 [2017] 9 SCR 797 : (2017) 9 SCC 1

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26.14. Neither in the limited pleadings made before this Court nor in the extensive oral arguments advanced was the point of the rules being allegedly manifestly arbitrary, addressed adequately. On an independent analysis, I am unable to find any of the aspects of manifest arbitrariness to have been met, much less on the ground that bureaucratic influence taints the functioning of the GEAC. This aspect further stands amplified herein, later.

27Copy pinpoint27. On a further count, this challenge, in my view fails. The 1989 Rules present a well-rounded mechanism to deal with GMOs and their introduction into fields of common usage. 27.1. Rule 4 of the 1989 Rules provide for the six different competent authorities to oversee the research and regulations in the field of GMOs, whose functions are elaborated herein. i. Recombinant DNA Advisory Committee (RDAC) is responsible to review developments in Biotechnology at national and international levels and recommend safety regulations in recombinant research, use and applications from time to time. ii. The committee - Review Committee on Genetic Manipulation (RCGM) - is made responsible to monitor the safety related aspect in respect of on-going research projects and activities involving genetically engineered organisms/hazardous microorganisms. It is further tasked with bringing out manuals of guidelines specifying procedure for regulatory process with respect to activities involving GMOs in research, use and applications including industry with a view to ensure environmental safety. They are responsible to review all ongoing projects involving high risk category and controlled field experiments and to ensure that adequate precautions and containment conditions are followed as per the guidelines. iii. Institutional Biosafety Committee (IBSC) - They are given the responsibility to assist the occupier or any person (including research institutions handling microorganisms/ genetically engineered organisms) in preparing an up to date on site emergency plan according to the manuals/ guidelines of the RCGM and make available copies to the DLC/SBCC and the GEAC.

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iv. Genetic Engineering Approval Committee (GEAC) - This committee is constituted for approval of activities involving large scale use of hazardous microorganisms and recombinants in research and industrial production from the environmental angle. It shall be responsible for approval of proposals relating to release of genetically engineered organisms and products into the environment including experimental field trials. The committee or any person authorised by it, is empowered to take punitive action under the EPA, 1986. v. State Biotechnology Co-Ordination Committee (SBCC) - At State level, this Committee has powers to inspect, investigate and take punitive action in case of violations of statutory provisions. It shall also periodically review the safety and control measures in various industries/institutions handling genetically engineered organisms/hazardous microorganisms. vi. District Level Committee (DLC) - At the district level, in order to supervise the safety measures, this Committee is constituted wherever necessary under the District Collectors to monitor the safety regulations in installations engaged in the use of genetically modified organisms/ hazardous microorganisms and its applications in the environment. It shall visit the installation engaged in activity involving genetically engineered organisms, hazardous microorganisms, formulate information chart, find out hazards and risks associated with each of these installations and coordinate activities with a view to meeting any emergency. This Committee shall regularly submit its report to the SBCC/GEAC. 27.². Rule 7 of the 1989 Rules deals with approval and prohibitions. It reads thus: “(1) No person shall import, export, transport, manufacture, process, use or sell any hazardous microorganisms or genetically engineered organisms/ substances or cells except with the approval of the Genetic Engineering Approval Committee.

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(2) Use of pathogenic microorganism or any genetically engineered organisms or cell for the purpose of research shall only be allowed in laboratories or inside laboratory areas notified by the Ministry of Environment and Forests for this purpose under the Environment (Protection) Act, 1986. (3) The Genetic Engineering Approval Committee shall give directions to the occupier to determine or take measures concerning the discharge of micro- organisms/genetically engineered organisms or cells mentioned in the schedule from the laboratories, hospitals and other areas including prohibition of such discharges and laying down measures to be taken to prevent such discharges. (4) Any person operating or using genetically engineered organism microorganisms mentioned in the schedule for scale up or pilot operations shall have to obtain licence issued by the Genetic Engineering Approval Committee for any such activity. The possessor shall have to apply for licence in prescribed proforma. (5) Certain experiments for the purpose of education within the field of gene technology or microorganism may be carried out outside the laboratories and laboratory areas mentioned in subrule (2) and will be looked after by the Institutional Biosafety Committee.” (Emphasis supplied) 27.3. Rule 10 states that except with the approval GEAC, no substances and products containing genetically engineered organisms or cells or microorganisms shall be produced, sold, imported or used. 27.⁴. Rule 12 provides for guidelines wherein person who applies for approval under the Rules 8-11 is obligated to submit information and make examinations or cause examinations to be made to elucidate its case, including examinations according to specific directions and at specific laboratories. Before obtaining the approval, it is his responsibility to make

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available an on-site emergency plan to the GEAC. Further, an obligation is imposed upon the person to whom an approval has been granted, to notify the GEAC of any change in or addition to the information already submitted. 27.5. Rule 13 provides for grant of approval and the same is reproduced herein: “(1) In connection with the granting of approval under rules 8 to 11 above, terms and conditions shall be stipulated, including terms and conditions as to the control to be excercised by the applicant, supervision, restriction on use, the layout of the enterprise and as to the submission of information to the State Biotechnology Co-ordination Committee or to the District Level Committee (2) All approvals of the Genetic Engineering Approval Committee shall be for a specified period not exceeding four years at the first instance renewable for 2 years at a time. The Genetic Engineering Approval Committee shall have powers to revoke such approval in the following situations: (a) If there is any new information as to the harmful effects of the genetically engineered organisms or cells. (b) If the genetically engineered organisms or cells cause such damage to the environment, nature or health as could not be envisaged when the approval was given, or (c) Non compliance of any condition stipulated by Genetic Engineering Approval Committee.” (Emphasis supplied) 27.⁶. Rule 14 deals with general supervision of GEAC in the implementation of the terms and conditions laid down in connection with the approvals accorded by it and such supervision could be carried out through the SBCC or the State Pollution Control Boards/DLC or through any person authorised in this behalf.

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27.⁷. Rule 15 deals with penalties which can be imposed. It reads as: “(1) If an order is not complied with, the District Level Committee or State Biotechnology Coordination Committee may take measures at the expenses of the person who is responsible. (2) In cases where immediate interventions is required in order to prevent any damage to the environment, nature or health, the District level Committee or State Biotechnology Coordination Committee may take the necessary steps without issuing any orders or notice. The expenses incurred for this purpose will be repayable by the person responsible for such damage. (3) The State Biotechnology Co-ordination Committee /District Level Committee may take samples for a more detailed examination of organisms and cells. (4) The State Biotechnology Co-ordination Committee/ District Level Committee shall be competent to ask for assistance from any other Government authority to carry out its instructions.” 27.⁸. Rule 19, as noted above, provides for mechanism of appeal from the decision of GEAC. 27.9. The above extracted rules, as is evident lay down a clear mandate for functioning in respect of approvals that are to be granted by the GEAC. All aspects of immediate relevance are covered thereunder, i.e., the monitoring of safety regulations, preparing on-site emergency plans, research, inspection, release, penalties, use and approval with respect to GMOs/ hazardous microorganisms/cells. The existence of various committees with certain, specified responsibilities, their composition; the providing of procedure for the most essential function which is the grant of approvals; appeals on being dissatisfied therefrom (grant or denial) shows that each body within the Rules has a role to play and the fate of an application is not solely in the hands of one body. In none of these Rules could I find even the slightest hint of manifest arbitrariness. None of the parts of the Rules can be said to be irrational, capricious or without adequate determining principle, on the contrary, as displayed, a clear rationale is discernible.

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27.10. In particular, the primary ground of challenge by the Petitioner as noticed above must be addressed. To do so, notice must also be taken of the Union of India’s submission that it is mandatory for all expert/members/Government officials of GEAC and RCGM to sign a declaration of independence, confirming that they have no involvement or financial interest in the development, promotion or commercialisation of GM/ transgenic crops. Members are also required to inform the RCGM and GEAC in case they have a conflict of interest, in such cases, the member involved does not participate in the deliberations. It has to be said that the composition of one of the Committees framed under the Rules allegedly suffering from some infirmity is not sufficient ground in the least, to vitiate the Rules on the whole. At the same time, it is also recognised that the GEAC is the apex body and its constitution therefrom assumes importance. Therefore, if the Petitioners had any qualms about its members, their objections should have been limited only thereto. As a secondary aide, a sweeping submission has been made that the 1989 Rules violates the Precautionary Principle however, how that is so is yet unclear. 27.11. Adverting particularly to the composition of the GEAC, the relevant rule reads as under: “The composition of the Committee shall be i. Chairman-Additional Secretary, Department of Environment, Forests and Wild life Co-Chairman-Representative of Department of Bio-technology ii. Members: Representative of concerned Agencies and Departments, namely, Ministry of Industrial Development, Department of Biotechnology and the Department of Atomic Energy. iii. Expert members: Director General Indian Council of Agricultural Research, Director General-Indian Council of Medical Research, Director General-Council of Scientific and Industrial Research, Director General-Health

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Services, Plant Protection Adviser, Directorate of Plant Protection, Quarantine and storage, Chairman, Central Pollution Control Board and three outside experts in individual capacity. iv. Member Secretary: An official of the Department or Environment, Forest and Wild life. The committee may co-opt other members/ experts as necessary.” (Emphasis supplied) 27.12. It is evident that the top position in the GEAC is occupied by a person of the rank of Additional Secretary to the Government of India and the Vice Chairman is the member of the Department of Biotechnology, however, other members such as in Clause (iii) while being Government employees, possibly are still members working in specialized departments whose knowledge and expertise would be relevant to the functioning of GEAC. Expert members are those who are directors/heads of eminent institutions as also others in individual capacity. The GEAC is also given the freedom to co-opt other members as and when may be required. The constitution of this Committee itself ensures that bureaucrats, in stricto senso, do not outweigh the presence of experts therein. 27.13. The Petitioner(s) contend that since the experts made part of the process, are members of Government bodies, therefore, they arguably would be unfit to be appointed. Conversely, it is averred by the Union of India that there exists a three- tier safety assessment process which involves around 60 experts most of whom are external experts from public sector institutions and universities. The effect of accepting the submission of the Petitioner(s) would mean that a person of science, by being a member simpliciter of the Government body, would be discounted as an ‘expert’. In other words, the effect would be that working for the Government is made equal to a curse, for experts who otherwise would have been inducted to the GEAC without batting so much as an eyelid. 27.14. Additionally, nowhere in the Rules can it be seen that the Chairman of the GEAC or any other ‘bureaucratic member’

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possesses any additional power in the functioning of the body, nor has it come on record that without the Chairman or any other Government member, the quorum with which a decision is to be reached, is incomplete. 27.15. As such, challenge to the 1989 Rules, as a consequence of the above discussion fails. Precautionary Principle

28Copy pinpoint28. I now proceed to examine, the second principle issue, which is as to whether in view of the precautionary principle, a complete ban on Ht crops is warranted or if not, what are the suitable directions that are required to be given by this Court? TEC 28.1. Before discussing the precautionary principle, the view of the TEC appointed by this Court must be brought on record when probing the issue at hand. As discussed above, vide Order dated 10.05.2012, this Court appointed a TEC with 6 members. The terms of reference (hereinafter referred to as ‘Tor’) given to the TEC were: a. To review and recommend the nature of sequencing of risk assessment (environment and health safety) studies that need to be done for all GM crops before they are released into the environment. [Tor A] b. To recommend the sequencing of these tests in order to specify the point at which environmental release though Open Field Trials can be permitted. [Tor B] c. To advise on whether a proper evaluation of the genetically engineered crop/plants is scientifically tenable in the greenhouse conditions and whether it is possible to replicate the conditions for testing under different agro ecological regions and seasons in greenhouse. [Tor C] d. To advise on whether specific conditions imposed by the regulatory agencies for Open Field Trials are adequate. If not, recommend what additional measures/safeguards are required to prevent potential risks to the environment. [Tor D]

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e. Examine the feasibility of prescribing validated protocols and active testing for contamination at a level that would preclude any escaped material from causing an adverse effect on the environment. [Tor E] f. To advise on whether institutions/laboratories in India have the state-of-art testing facilities and professional expertise to conduct various bio safety tests and recommend mechanism to strengthen the same. If no such institutions are available in India, recommend setting up an independent testing laboratory/institution. [Tor F] 28.². The interim report of the TEC was received on 07.10.2012. In this interim report the TEC stated: i. Three major issues were highlighted in the evaluation process which require attention: a) Apparent lack of qualified full-time personnel in the regulatory bodies: The TEC was not convinced that the regulatory bodies in their present form are in a position to rigorously evaluate all data that comes before them. Further, many of the field trials seem to have been delegated or left to the applicant (applying for approval to GEAC) and there is very limited mechanism to ensure compliance and accountability. b) Need for removing conflicts of interest c) Increasing inclusiveness of stakeholders with regard to decision making on GM products ii. All members unanimously felt that the present regulatory system and protocol(s) for conducting field trials was unsatisfactory and inadequate, requiring major changes, restructuring and strengthening. iii. Introduction of transgenics in crops for which India is a centre of origin or diversity will contaminate the biodiversity and it should not be allowed to happen. iv. Field Trials should be stopped until the above conditions are addressed.

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v. The TEC further recommends a 10 year moratorium on field trials of Bt transgenics in all food crops in accordance with the precautionary principle. 28.3. The final report of the TEC was received by this Court thereafter, wherein it was stated: (i) Bt technology involves engineering plants for insect resistance by incorporating the gene for the toxin within the plant’s genetic constitution, so that the plant becomes naturally resistant to the insect. The benefit of this is a reduced requirement for externally applied chemical pesticides, most of which are toxic and cause environmental damage. (ii) The other major usage of genetically modified crops has been for Ht crops, which is herbicide tolerance which makes the plant genetically engineered to be resistant to the herbicide. The use of Ht technology allows more extensive application of the herbicide leading to more complete elimination of weeds without killing the crop. (iii) GM technology comes with the promise of a number of benefits as well as associated risks with regard to health and environmental safety. (iv) The TEC was informed that it will not be possible to segregate genetically modified from non-genetically modified material during collection and storage in India, which would have serious implications when it comes to labelling of food. (v) Most countries such as China and those in Europe are approaching this issue with a fair amount of caution. Bt Crops (vi) The TEC has noted that in several cases that they examined, the characterization of the inserted DNA is limited and insufficient for comprehensively addressing the issues to regulatory approval. Overall the quality of information in several of the applications is far below what would be expected, and required for rigorous evaluation by a regulatory body and is unlikely to meet international regulatory guidelines.

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(vii) The TEC examined the approved Bt Cotton and Bt Brinjal files relating to toxicity and what emerged from this examination is that in several cases, the methodology and results are not clearly reported. (viii) The TEC considered the process of Environmental Risk Assessments (hereinafter “ERA”) in India. It referred to the report of Prof. David Andow on ERA for Bt Brinjal wherein it was stated that the GEAC set too narrow a scope for the ERA and further, much of the effort towards the ERA was misdirected, which did not assess the actual adverse environmental consequences in India. The TEC concluded that ERAs are inadequately understood and addressed in Indian guidelines and regulatory system. The deficiencies are likely to be a consequence of the way in which ERA has been treated in the guidelines as a set of tests to be carried out instead of issues to be investigated and addressed. This kind of treatment has resulted in oversimplification, omission, and the real purpose of an ERA being missed. (ix) The precautionary principle as present in the CPB international guidelines would strongly point towards erring on the side of caution. The TEC highlighted the critical importance of having as complete and comprehensive information as possible on the biology of the species when considering release of GMOs. It was further pointed out that no GMO intended directly as food has been commercially introduced into its Centre of Origin, which was happening with the case of Bt Brinjal until ministerial intervention took place. (x) There are serious deficiencies in reporting of the data in the dossiers and more importantly in the way in which these have been examined and the conclusions accepted by the Regulatory Body. The deficiencies are serious enough that several of the dossiers are unlikely to meet international guidelines. The regulator (GEAC) has frequently accepted conclusions based on incompletely reported data or without appropriate statistical analysis. (xi) Some tests need to be carried out for longer duration in order to increase the time, of exposure so as to detect possible effects with greater confidence.

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Ht Crops (xii) Information relating to long term chronic toxicity is limited for most herbicides. Soybean accounts for the major share of Ht crops. (xiii) The use of Ht crops would encourage increased use of the herbicides with likely negative consequences for biodiversity in agricultural fields and the environment. Experimental studies of the possible impact that Ht crops can have on the biodiversity and abundance of wildlife have been limited. (xiv) Another consideration in the Indian context is a socioeconomic one wherein a significant part of the agricultural workforce is employed for manual labour in the fields. Introduction of Ht crops would be likely to reduce access to employment for some of the vulnerable sections of rural society. Recommendations (xv) It is apparent that there are major gaps in the regulatory system. These need to be addressed before issues related to tests can be meaningfully considered. (xvi) A secretariat comprising dedicated scientists with area expertise as well as expertise in biosafety needs to be established, with consultation with experts having experience at the international level in biosafety testing evaluation of GM safety. (xvii) Conflict of interest in terms of location of the regulatory body needs to be addressed. (xviii) Specific sites for conducting confined field trials need to be designated, certified, and sufficient mechanisms put in place for monitoring the trials and ensuring restricted access, disposal of material, associated testing and other facilities. (xix) Stakeholder participation, socioeconomic considerations, societal impact and sustainability should be incorporated at an early stage in the risk assessment process.

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28.⁴. After the above observations and discussion, the TEC answered the terms of reference in the following manner:

1. Tor A The TEC reiterated its recommendation made in the Interim Report that there should be a moratorium on field trials for Bt in food crops intended for commercialization until there is more definitive information as to long term safety of Bt in food crops. The TEC stated that it has examined the issues in relation to Ht with regard to sustainability and the likely socioeconomic impact on major sections of rural society. It reached the conclusion that Ht crops would most likely exert a highly adverse impact on sustainable agriculture, rural livelihoods and environment. The TEC found them completely unsuitable in the Indian Context. It is pertinent here to notice the corrigendum brought by the TEC dated 12.⁷.2013 wherein the above line was expanded and a complete ban on Ht crops in India was recommended by the TEC. The TEC further recommended that release of genetically modified crops for which India is a centre of origin or diversity should not be allowed.

2. Tor B The sequence of testing should be carried out in order of increasing environmental exposure required to perform the test. Tests should be done under the minimum conditions of exposure required for the test. The testing therefore proceeds in a progressive manner.

3. Tor C There is published evidence that the characteristics of a GMO can differ significantly depending upon whether it is grown in the greenhouse or in the field. It cannot be said that it is possible to replicate the conditions for testing under different agro-ecological regions and conditions in the greenhouse.

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4. Tor D Specific sites for conducting field trials need to be designated, certified and sufficient mechanisms put in place for monitoring the trials and ensuring restricted access, associated testing and other facilities. The trials should not be conducted on leased land.

5. Tor E There are several ways in which contamination can occur and it probably will not be possible to deploy the tests at a level that will preclude the possibility of escape.

6. Tor F Based on the review of the dossiers, the professional expertise and standards across the institutions appear unsatisfactory. The TEC has found in unambiguous terms that at present, the regulatory system has major gaps and these will require rethinking, investment and relearning to fix. 28.5. As noted above, the TEC consisted of six members, with Dr. Rajendra Paroda substituting Prof. VL Chopra on 09.11.2012 which is post submission of the interim report, the findings of which have been noted above. 28.⁶. Unable to agree with the conclusions of the majority, Dr. Paroda submitted his dissent to the final report of the majority, alleging various lapses in the decision-making process. Those lapses, as pointed out are: “…. • To my surprise, the TEC members were not willing to take cognizance of any objections/ submissions to the Interim Report made by different respondents, despite clear directive by the Hon’ble Supreme Court. As mentioned earlier, a compilation of all objections received was shared (Annex-IV) but members seemed to have serious reservations to discuss these on the plea that there was nothing new, including in fresh submissions by UOI, NAAS, NSAI, Prof. Deepak Pental etc. • On having gone through the minutes of the earlier meetings of TEC, prior to my becoming a

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member (Annex-Ill), and the submissions made by various respondents, it became apparent that TEC members had possibly taken one sided view in their Interim Report. • The TEC members seemed to take an ideological stance favouring an anti GM as well as an anti transnational approach and possibly believed that imposing moratorium on field trials of GM crops was the only way to move forward. On the contrary, any such move will harm Indian science enormously. • At the same time, members seemed to have proceeded with an assumption that the Indian regulatory system was faulty and full of lapses. Accordingly, all deliberations of TEC sounded to me like a fault finding mission. • Some members continued relying solely on reports of contrarian scientists and propounded their views/opinions, while ignoring the fact that such - isolated research claims had been examined thoroughly and rejected by a wide section of scientific community as well as by the regulatory authorities of their respective countries as well as other well reputed regulatory bodies. • As mentioned earlier, no other member provided any input on the TOR nor did they respond to any of the write-ups provided by me. As a result, no substantive evidence-based discussion could take place during the meetings in order to arrive at general consensus/understanding. • The only shared document was the part draft report (26 pages), which did not reflect general deliberations held nor did it follow the agreed format. I did convey my concern over adopting this entirely different approach with utter disregard to decisions taken in earlier meetings, but with no positive output.

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• In a scenario like this, reflecting considerable lack of transparency, I am left with no other alternative but to submit this report separately - the last thing I would have wished otherwise.” 28.⁷. While these lapses pointed out by Dr. Paroda pertained to procedural aspects of the TEC however among other minor differences, twin substantial differences in respect of a) conducting field trials which the former recommends continuation in the interest of scientific development and the latter recommends against given numerous regulatory lacunae; and b) the former does not oppose the development of HT crops while the latter, once again in view of the lacunae, bats for a wholesale ban. 28.⁸. Dr. Paroda recommended that there should be development of comprehensive guidelines for Environmental Risk Assessment (ERA) with consultation with all stakeholders and the general public. A full time Risk Assessment Unit with permanent staff consisting of a multidisciplinary team of scientists should be established. National Agriculture Research System (NARS) should lead agronomic performance testing and release of GM varieties/hybrids in line with the National Seed Policy while making use of already existing procedures under AICRP. 28.9. He was further of the view that the proper evaluation of a Genetically Engineered plant is scientifically not tenable in a contained greenhouse and confined field testing is the right option for a realistic evaluation of any GE plant. Each confined field trial must be monitored by a ‘site specific monitoring committee’. A well-designed case-to-case post-release monitoring system must be put in place to address specific post-release issues identified during the event approval by GEAC. RCGM and GEAC should review isolation distances for confined field trials and suitability of additional measures. Research projects must be funded by DBT, ICAR and relevant arm of the Government. Accredited laboratories must be notified for detection of GM crops. The regulatory authorities should develop a system of examining papers or reports about the adverse effects of GM crops and communicate the same to public. Special fund allocation is desirable for the purpose of creating public awareness.

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28.10. I am not inclined to accept the objections raised by the Petitioners, for consideration of the report of Dr. Paroda. Given that the substance in issue is scientific in nature, the minority report cannot be ignored entirely. After perusing both the reports, while there are certain differences, one also finds substantial similarities. They may be noted:

TEC Dr. Paroda (5 Members) The overall process of risk For environmental risk assessment should follow assessment there is an the flowchart for the Risk urgent need for developing Assessment process in the comprehensive guidelines Guidance on Risk assessment in consultation with all of Living Modified Organisms stakeholders and general public. of the Cartagena Protocol on There should be establishment Biosafety. of risk assessment unit which should be permanently staffed by a multi-disciplinary team. It is generally not possible Proper evaluation of GE plants to replicate the conditions is not scientifically tenable in for testing under different contained greenhouses as agro-ecological regions and natural, varying conditions conditions in the greenhouse. representing different agro- ecological regions and growing seasons cannot be feasibly replicated. Specific sites for conducting No trials should be allowed in field trials need to be non-notified fields, leased or designated, certified and otherwise. A system should sufficient mechanism put be evolved for notification of in place for monitoring the confined field trial sites which trials and ensuring restricted should include both public access, disposal of material, and private sector institutions associated testing and other subject to certain conditions. facilities. These sites should be used only for field trials of GM crops. Trials should not be conducted on leased land.

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A requisite understanding There is a need to strengthen of the process of Risk the public sector laboratories assessment be developed through funding in order to have through consultation, required infrastructure and collaboration and capacity human resource development. building as the regulatory There should be a major system has gaps and require human resource development rethinking, investment and initiative for training in national relearning. and international institutions. Government may establish inter-ministerial coordination and monitoring mechanism to create/strengthen public research institutions for regulatory process. 28.11. With respect to the objections raised by the Union of India, to the TEC report, that the TEC went beyond its scope, a perusal of the recommendations made, juxtaposed with the Tor, one finds that the latter are largely within the scope of the question that had been put to them. The TEC has confined itself only to issues relevant to answering Tors. 28.12. As discussed earlier, in Kantha Vibhag (supra), this Court observed that: “15. It is first important to differentiate expert committees which are set by the courts/tribunals from those set up by the Government in exercise of executive powers or under a particular statute. The latter are set up due to their technical expertise in a given area, and their reports are, subject to judicially observed restraints, open to judicial review before courts when decisions are taken solely based upon them. The precedents of this court unanimously note that courts should be circumspect in rejecting the opinion of these committees, unless they find their decision to be manifestly arbitrary or mala fide. On the other hand, courts/tribunals themselves set up expert committees on occasion. These committees are set up because the fact-finding exercise in

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many matters can be complex, technical and time- consuming, and may often require the committees to conduct field visits. These committees are set up with specific terms of reference outlining their mandate, and their reports have to conform to the mandate. Once these committees submit their final reports to the court/tribunal, it is open to the parties to object to them, which is then adjudicated upon. The role of these expert committees does not substitute the adjudicatory role of the court or tribunal. The role of an expert committee appointed by an adjudicatory forum is only to assist it in the exercise of adjudicatory functions by providing them better data and factual clarity, which is also open to challenge by all concerned parties. Allowing for objections to be raised and considered makes the process fair and participatory for all stakeholders.” (Emphasis supplied) 28.13. The above observations make it abundantly clear that this Court is not bound by the conclusions reached by its own expert committee. The report of the expert committee is important for the court to be apprised of the technical aspects of a particular dispute by independent experts. For a court or tribunal to rely entirely on the report of an expert committee would be improper as this would amount to the court abdicating its own adjudicatory function and replacing its wisdom with that of the expert committee. Parliamentary Standing Committee Reports

29Copy pinpoint29. There are two reports of Parliamentary Standing Committees on this issue. The first one being, the 37th Report of the Committee on Agriculture (2011-2012) titled ‘Cultivation of Genetically Modified Food Crops - Prospects and Effects’ dated 09.⁸.2012. The Committee considered oral and documentary evidence, thereafter made the following observations: i. Bio-technology offers many advantages over traditional techniques of plant breeding in major food crops such as low production cost, conservation of bio-diversity and economic-

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social benefits including poverty alleviation. This technology (transgenics/genetic engineering) is environmentally friendly, sustainable and affordable. ii. In respect of field trials which is a highly contested issue before us it is observed that they serve a multiplicity of purposes: “(i) For the plant breeder, they provide the first opportunity to evaluate the agronomic potential of novel-plant trait combinations in open environment which is not possible in contained conditions of greenhouse. (ii) It is necessary to measure the level of protein expression from any newly introduced genes in the plant tissues to assess its efficacy in the open environment and impact on the target and non target organisms consuming the genetically modified plant. (iii) It allows the production of sufficient quantities of plant material for use in livestock feeding studies/trials and to conduct compositional analyses, which are necessary for human food safety assessment. (iv) Such trials are also necessary to collect the agronomic and ecological data required to complete the environment safety assessment of genetically modified plant.” iii. The views of Dr. P.M. Bhargava were taken by the Committee and his stand was not a permanent ban on release of GMOs but ensuring that they are adequately tested before any such release take place. At the same time he stated that the refusal to do chronic toxicity studies was against the interest of the nation and that despite the technological advancements, there is not an Indian lab in which testing can be done. iv. It was noted that the GEAC does not directly perform studies of safety assessment and it is the applicant who is to submit data of its studies to the RCGM and GEAC, and after comments thereon final decision is taken.

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v. In conclusion, with respect to the regulatory mechanism, it was observed: “2.92 … The Committee can safely conclude that all is not well with the regulatory mechanism put in place by the Government for oversight of cutting edge technology as sensitive as GMOs and products thereof. Firstly, GEAC being an entity created under rules rather than an Act of Parliament deprives it of the status, powers and more importantly autonomy and independence that a statutory regulator ought to have. The enforceability of Rules, albeit made under some Act only, does not have as much definitiveness and clarity as under an Act. Furthermore, unlike an Act, there is a lot of scope for varied interpretation of Rules as also flexibility to implement them. The confusion about the recommendatory/approving authority of GEAC whether due to genuine confusion or deliberate; the confession of the Co-Chairman of GEAC, the only technocrat in the top three positions of GEAC, about minister/GEAC/industry pressuring him to favour a bad technology; the various acts of omission and commission of GEAC that have been documented in various chapters of this Report, all go on to cement the view of the Committee that the regulatory mechanism definitely requires the protection and support of an Act of the Parliament which leaves no scope for ambiguity or complacency.” vi. The Committee lamented that even after the Cartagena Protocol on Biosafety was adopted on 17.01.2003, many key issues such as risk assessment, liability and redress, identification of living modified organisms etc. are still in the discussion stage. vii. Having taken note of the various shortcomings and gaps in the regulatory mechanism, the Committee expressed a desire that all research and development be done in containment and field trial be discontinued forthwith. viii. Labelling of GM and non-GM products was also an issue considered by the Committee and it was recommended that

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such labelling be made mandatory so that a consumer can make an informed choice. ix. Referring to the Dr. M.S. Swaminathan Report, the Department of Agriculture stated that: “biotechnology provides an opportunity to convert bio resources into economic wealth. This has to be done in a manner that there is no adverse impact either on the environment or on human or animal health. The guiding principle for following the National agricultural biotechnology policy should be the economic well-being of farm families, food security of the nation, health security of the consumer, protection of the environment and security of our national and international trade in farm commodities”. x. The Committee recorded the admission of the concerned official of the Department of the Agriculture that if the dependence on Bt crops goes beyond a point, it would “be a gigantic task to revive the traditional cotton varieties from the gene bank and may take years together” at the same time it was recorded that, efforts and the direction were proceeding and it was not that the ship had sailed. xi. Certain other observations recorded by the Committee are essential: “8.97 India also entered the scene in developing and deploying transgenic crops (genetically modified crops) since early 1990s, with very good intentions and preparations to deal with ensuring the safety of such technology so that it does not harm the environment and human health. The policy and regulatory frameworks suggested, developed and implemented had all the good provisions to ensure public safety and ensure food sovereignty of the country. The policy and regulatory frameworks were put in place using well thought-out plans. However, the developments in technology and deployment over- took the speed of policy implementation which caused apprehensions in the minds of general public about the technology and the over-sight for its deployment.”

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29.1. At this stage, the Petitioners have placed reliance on the 301st Report of the Parliamentary Standing Committee on Science and Technology, Environment and Forest titled “Genetically Modified Crops and its Impact on Environment” dated 25.⁸.2017. i. The Committee after taking an overview of the regulatory mechanism as also taking note of the official and non- official witnesses recorded as under: “The Committee takes note of the divergent views on the efficacy of existing regulatory mechanism. On the one hand, the Government claims that are very stringent regulatory mechanism has been put in place leaving no scope for any non- whatsoever by the technology developer whereas on the contrary, the Committee has been given to understand by some representatives of the civil society that the existing regulatory mechanism is stringent on paper only and the whole process of regulation depends upon the data made available to the regulators by the technology developers. The Committee is surprised to know that none of the Committees referred to in the preceding paragraphs conduct the closed field trials on their own but are solely dependent on the data provided to them by the technology developer. The Committee feels that this leaves the scope for the technology developers to fudge the data to suit their own requirements. The existing regulatory mechanism is, therefore, susceptible to manipulations. The Committee, therefore, recommends that the Central Government should, in consultation with the State Governments and Administrations of the Union Territories ensure that the whole process of field trials should be done in close environment keeping biosafety and health safety in mind and in collaboration with agricultural universities so as to minimise the scope of fudging the primary data.” ii. The Committee noticed that the production of GM crops was concentrated only in a select few countries, India

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being one of them but also noted the general hesitation of developed economies to use this technology at a wide scale. The observation in this regard is as extracted hereunder: “The Committee notes that 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%, 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.”

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iii. The Committee has noted that despite the tiered regulatory system in place, there is no scrutiny of the process of Environmental Impact Assessment and reliance is predominantly on the data supplied by the Applicant. It was recommended that an independent agency consisting of persons with impeccable credentials should carry out the process of evaluation to ensure that there is no violation of the existing regulations. iv. The Committee has come out in support of placing every piece of information, in public scrutiny. It is wise to ensure that the entire process reflects the values of participation and transparency with the overall goal being to clear out the doubts in the mind of the public. v. In respect of cross-contamination of GM and non-GM crops the acceptance of the Department of Agricultural Research and Education was noted, that a herbicide tolerant gene may escape by way of pollination to another farm that is to another GM or non-GM crop and, therefore, the committee was of the view that if cultivation, side- by-side or in other words simultaneously, was allowed there would be no way to stop contamination. It therefore recommended that the MoEFCC undertake a study in that regard and take “desired measures”. vi. The Committee underscored the need for India based studies to be undertaken to examine the effect of GM crops on “our environment on account of GM crops” keeping in view the “topography of our country and its diversity”. It was also noted that the impact of these crops on human as well as animal health has not been adequately studied. 29.². In response to the above reports, the Union of India has submitted a compliance chart, stating that most of the lacunae that has been pointed out by the Committees, has been complied with and that the present regulatory system is in consonance with international standards and safeguards, to ensure that the precautionary approach is complied with. Another argument that has been put forth on behalf of the Union of India is that these reports are from the year 2012 and 2017, respectively and thereafter, in the past 7 years, the

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scientific research has come a long way. 29.3. The evidentiary value of such reports is no longer res integra and was clarified by a Constitution Bench of this Court in Kalpana Mehta v. Union of India (5-Judge Bench).34 Dipak Misra, CJI (as he then was), observed: “159.1. Parliamentary Standing Committee report can be taken aid of for the purpose of interpretation of a statutory provision wherever it is so necessary and also it can be taken note of as existence of a historical fact. 159.². Judicial notice can be taken of the Parliamentary Standing Committee report under Section 57(4) of the Evidence Act and it is admissible under Section 74 of the said Act. 159.3. In a litigation filed either under Article 32 or Article 136 of the Constitution of India, this Court can take on record the report of the Parliamentary Standing Committee. However, the report cannot be impinged or challenged in a court of law. 159.⁴. Where the fact is contentious, the petitioner can always collect the facts from many a source and produce such facts by way of affidavits, and the court can render its verdict by way of independent adjudication 159.5. The Parliamentary Standing Committee report being in the public domain can invite fair comments and criticism from the citizens as in such a situation, the citizens do not really comment upon any Member of Parliament to invite the hazard of violation of parliamentary privilege.” Dr D.Y. Chandrachud, J. (as he then was) in his detailed consideration of the issue at hand, observed: “275. Parliamentary Committees are an intrinsic part of the process by which the elected legislature

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in a democracy exacts accountability on the part of the Government. Department related Parliamentary Standing Committees undertake the meticulous exercise of scrutinising the implementation of law, including welfare legislation and the performance of the departments of the State. The purpose of law is to promote order for the benefit of the citizen and to protect rights and entitlements guaranteed by the Constitution and by statute. Access to justice as a means of securing fundamental freedoms and realising socio-economic entitlements is complementary to the work of other organs of the State. The modern doctrine of separation of powers has moved away from a “one organ - one function” approach, to a more realistic perspective which recognises the complementarity in the work which is performed by institutions of governance. Judicial review is founded on the need to ensure accountable governance in the administration of law as an instrument of realising the rights guaranteed by the Constitution. If the function of judicial review in facilitating the realisation of socio-economic rights is construed in the context of the modern notion of separation of powers, there is no real conflict between the independence of the judicial process and its reliance on published reports of Parliamentary Committees. Ultimately it is for the court in each case to determine the relevance of a report to the case at hand and the extent to which reliance can be placed upon it to facilitate access to justice. Reports of Parliamentary Committees become part of the published record of the State. As a matter of principle, there is no reason or justification to exclude them from the purview of the judicial process, for purposes such as understanding the historical background of a law, the nature of the problem, the causes of a social evil and the remedies which may provide answers to intractable problems of governance. The court will in the facts of a case determine when a matter which is contentious between the parties would have to be adjudicated

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upon independently on the basis of the evidence adduced in accordance with law.

276. In the circumstances, the reference is answered by holding that: 276.1. As a matter of principle, there is no reason why reliance upon the report of a Parliamentary Standing Committee cannot be placed in proceedings under Article 32 or Article 136 of the Constitution; 276.². Once the report of a Parliamentary Committee has been published, reference to it in the course of judicial proceedings will not constitute a breach of parliamentary privilege; 276.3. The validity of the report of a Parliamentary Committee cannot be called into question in the court. No Member of Parliament or person can be made liable for what is stated in the course of the proceedings before a Parliamentary Committee or for a vote tendered or given; and 276.⁴. When a matter before the court assumes a contentious character, a finding of fact by the court must be premised on the evidence adduced in the judicial proceeding as explained in paras 265 and 274.” The final conclusions of the Bench were as follows: “449.1. According to clause (2) of Article 105 of Constitution of India no Member of Parliament can be held liable for anything said by him in Parliament or in any committee. The reports submitted by Members of Parliament are also fully covered by protection extended under clause (2) of Article 105 of the Constitution of India. 449.². The publication of the reports not being only permitted, but also are being encouraged by Parliament. The general public is keenly interested in knowing about the parliamentary proceedings including parliamentary reports which are steps towards the governance of the country. The right to

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know about the reports only arises when they have been published for use of the public in general. 449.3. Section 57(4) of the Evidence Act, 1872 makes it clear that the course of proceedings of Parliament and the Legislature, established under any law are facts of which judicial notice shall be taken by the Court. 449.⁴. Parliament has already adopted a report of “privilege committee”, that for those documents which are public documents within the meaning of the Evidence Act, there is no requirement of any permission of the Speaker of Lok Sabha for producing such documents as evidence in court. 449.5. That mere fact that document is admissible in evidence whether a public or private document does not lead to draw any presumption that the contents of the documents are also true and correct. 449.⁶. When a party relies on any fact stated in the Parliamentary Committee report as the matter of noticing an event or history no exception can be taken on such reliance of the report. However, no party can be allowed to “question” or “impeach” report of Parliamentary Committee. The parliamentary privilege, that it shall not be impeached or questioned outside Parliament shall equally apply both to a party who files claim in the court and other who objects to it. Any observation in the report or inference of the Committee cannot be held to be binding between the parties. The parties are at liberty to lead evidence independently to prove their stand in a court of law. 449.⁷. Both the parties have not disputed that parliamentary reports can be used for the purposes of legislative history of a statute as well as for considering the statement made by a minister. When there is no breach of privilege in considering the parliamentary materials and reports of the Committee by the Court for the above two purposes, we fail to see any valid reason for not accepting the submission

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of the petitioner that courts are not debarred from accepting the parliamentary materials and reports, on record, before it, provided the court does not proceed to permit the parties to question and impeach the reports. 449.⁸. The Constitution does not envisage supremacy of any of the three organs of the State. But, functioning of all the three organs is controlled by the Constitution. Wherever, interaction and deliberations among the three organs have been envisaged, a delicate balance and mutual respect are contemplated. All the three organs have to strive to achieve the constitutional goal set out for “We the People”. Mutual harmony and respect have to be maintained by all the three organs to serve the Constitution under which we all live. 449.9. We are of the view that fair comments on report of the Parliamentary Committee are fully protected under the rights guaranteed under Article 19(1)(a). However, the comments when turn into personal attack on the individual Member of Parliament or the House or made in vulgar or abusive language tarnishing the image of the Member or the House, the said comments amount to contempt of the House and breach of privilege. 449.10. The function of adjudicating rights of the parties has been entrusted to the constituted courts as per constitutional scheme, which adjudication has to be made after observing the procedural safeguards which include the right to be heard and the right to produce evidence. Parliament, however, is not vested with any adjudicatory jurisdiction which belongs to judicature under the constitutional scheme. 449.11. Admissibility of a Parliamentary Committee report in evidence does not mean that facts stated in the Report stand proved. When issues of facts come before a court of law for adjudication, the court is to decide the issues on the basis of evidence and materials brought before it.” (Emphasis supplied)

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29.⁴. The detailed discussion on the value of Parliamentary Committee reports as undertaken by the Constitution Bench sheds light by holding that there is no bar in taking into consideration such reports under Article 32 or Article 136 of the Constitution of India. At the same time, it has been observed that they are not to be taken as conclusive proof of fact and the Court in performing its adjudicatory functions has to decide on the basis of materials before it, however the latter should not be taken to mean that credit of such report is impeached. 29.5. The question at hand is the adequacy of the assessment and approval procedures for GM Crops. The task of this Court, is therefore to examine whether the impugned procedures rise to the level of a violation of fundamental rights. This is a legal determination to be made by this Court, based on all materials placed before it and a wholistic view of the matter. Even if the TEC and parliamentary standing committees have found certain issues with the procedures governing GM crops, that cannot automatically lead to the conclusion that gaps in the impugned procedures result in a violation of Part III of the Constitution of India and must be invalidated or that the impugned action be stalled. Therefore, I now proceed to examine, whether the gaps pointed out in the abovementioned reports, would reach the threshold of violating the precautionary principle and in that view of the matter, what directions must be given. Scope of Precautionary Principle

30Copy pinpoint30. The genesis of the precautionary principle in India can be traced back to the decision of this Court in Vellore Citizens Welfare Forum v. Union of India (3-Judge Bench),35 wherein it was held that the precautionary principle is an essential feature of the principle of sustainable development. It went on to explain the precautionary principle in the following terms: “i. Environmental measures - by the State Government and the statutory authorities - must anticipate, prevent, and attack the causes of environmental degradation.

35 [1996] Supp. 5 SCR 241 : (1996) 5 SCC 647

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ii. Where there are threats of serious and irreversible damage, lack of scientific certainty should not be used as a reason for postponing measures to prevent environmental degradation. iii. The “onus of proof” is on the actor or the developer/ industrialist to show that his action is environmentally benign.” 30.1. This principle over the years, has been developed further and recognised as an integral part of the Indian Constitution. Recently, in Hospitality Association of Mudumalai v. In Defence of Environment & Animals (3-Judge Bench),36 this Court reiterated that the precautionary principle forms part of the Constitution of India under Articles 21, 47, 48 and 51-A(g). The requirement placed on the Government under the precautionary principle to “anticipate, prevent and attack the causes of environmental degradation” was emphatically reiterated. 30.². This Court has clarified that a precautionary approach, is not one which is opposed to development. In N.D. Jayal (Supra) while relying on Vellore Citizens’ Welfare Forum (Supra) and M.C. Mehta v. Union of India (3-Judge Bench),37 emphasis was laid on sustainable development. This Court observed that the balance between environmental protection and developmental activities could only be maintained by strictly following the principle of “sustainable development”. This is a development strategy that caters to the needs of the present without negotiating the ability of upcoming generations to satisfy their needs. The strict observance of sustainable development will put us on a path that ensures development while protecting the environment, a path that works for all people and for all generations. It is a guarantee to the present and a bequeath to the future. All environment-related developmental activities should benefit more people while maintaining the environmental

36 [2020] 10 SCR 273 : (2020) 10 SCC 589 37 [2003] Supp. 3 SCR 925 : (2002) 4 SCC 356

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balance. This could be ensured only by strict adherence to sustainable development without which the life of the coming generations will be in jeopardy. Further it was opined that: “24. The right to development cannot be treated as a mere right to economic betterment or cannot be limited as a misnomer to simple construction activities. The right to development encompasses much more than economic well-being, and includes within its definition the guarantee of fundamental human rights. The “development” is not related only to the growth of GNP. In the classic work, Development As Freedom, the Nobel prize winner Amartya Sen pointed out that “the issue of development cannot be separated from the conceptual framework of human right”. This idea is also part of the UN Declaration on the Right to Development. The right to development includes the whole spectrum of civil, cultural, economic, political and social process, for the improvement of peoples’ well-being and realization of their full potential. It is an integral part of human rights. Of course, construction of a dam or a mega project is definitely an attempt to achieve the goal of wholesome development. Such works could very well be treated as integral component for development.” 30.3. The necessity to strike a balance between development and ecology was reiterated by this Court in Karnataka Industrial Areas Development Board v. C. Kenchappa (2-Judge Bench)38 wherein it was observed: “61. The priority of developing nations is urgent industrialisation and development. We have reached at a point where it is necessary to strike a golden balance between development and ecology.

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62. The development should be such as it can be sustained by ecology. All this has given rise to the concept of sustainable development. x x x x

67. A nation’s progress largely depends on development, therefore, the development cannot be stopped, but we need to control it rationally. No Government can cope with the problem of environmental repair by itself alone; people’s voluntary participation in environmental management is a must for sustainable development. There is a need to create environmental awareness which may be propagated through formal and informal education. We must scientifically assess the ecological impact of various developmental schemes. To meet the challenge of current environmental issues, the entire globe should be considered the proper arena for environmental adjustment. Unity of mankind is not just a dream of the enlightenment but a biophysical fact.” (Emphasis supplied) 30.⁴. In Electrosteel Steels Limited v. Union of India and Ors. (2-Judge Bench)39 while dealing with ex-post facto environmental clearances, this Court observed that the Court cannot be oblivious to the economy or others dependent on a project, if the project in question complies with environmental considerations. 30.5. Recently, in NHAI v. Pandarinathan Govindarajulu (3-Judge Bench),40 it was observed: “18. While economic development should not be allowed at the cost of ecology or by causing widespread environmental destruction, the necessity to preserve ecology and environment should not

39 [2021] 14 SCR 863 : (2023) 6 SCC 615 40 (2021) 6 SCC 693

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hamper economic and other development. Both development and environment must go hand in hand. In other words, there should not be development at the cost of environment and vice versa, but there should be development while taking due care and ensuring the protection of environment [Indian Council For Enviro-Legal Action v. Union of India, (1996) 5 SCC 281]. The traditional concept that development and ecology are opposed to each other is no longer acceptable [Vellore Citizens’ Welfare Forum v. Union of India, (1996) 5 SCC 647].” (Emphasis supplied) 30.⁶. A similar approach was taken in Rajeev Suri v. DDA (3-Judge Bench)41 wherein judicial review of the Central Vista Project was sought. The majority, in this case, observed: “519. Indubitably, environment and development are not sworn enemies of each other. It would be an anomalous approach to consider environment as a hurdle in development and vice versa. The entities like EAC and NGT are created to strike a just balance between two competing interests and a time-tested principle of striking this balance is timely invocation of mitigating environmental measures amidst a development activity. True that mere application of certain mitigating measures may not alleviate environmental concerns in all matters and in some circumstances, the project is simply incomprehensible with the environment. But as long as a legitimate development activity can be carried on in harmony with the idea of environmental protection and preservation including sustainable development, the Courts as well as expert bodies should make their best endeavour to ensure that harmony is upheld and hurdles are minimised by resorting to active mitigating measures.

41 [2021] 15 SCR 283 : (2022) 11 SCC 1

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520… The primary requirement underlying this principle is to ensure that every development work is sustainable; and this requirement of sustainability demands that the first attempt of every agency enforcing environmental rule of law in the country ought to be to alleviate environmental concerns by proper mitigating measures. The future generations have an equal stake in the environment and development. They are as much entitled to a developed society as they are to an environmentally secure society. x x x

524. The precautionary principle duly mandates that all agencies of the State, including Courts, must make their best endeavour to ensure that precaution is instilled in the process of development. The very requirement of prior EC is born out of this need for precaution. It is a manifestation of the precautionary principle in India and if development work is carried out in furtherance of prior EC and such EC is not vitiated by illegality, it would be a case of proper adherence with the precautionary principle.

525. In matters of balancing between competing environmental and development concerns, the Court has to be project-specific. In environmental matters, even one fact here or there may have the effect of attributing a totally distinct character to the project and accordingly, the scope of judicial review may vary. x x x

528. They must always look for a careful balance when two equally relevant interests compete with each other. The task may not be easy, but is the only reasonable recourse. For the proper application of these principles, the first and foremost thing to be kept in mind is the nature of the project. In the present case, the subject project is an independent building and construction project wherein one-time

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construction activity is to be carried out. It is not a perpetual or continuous activity like a running industry. It is absolutely incomprehensible to accept that a project of this nature would be unsustainable with the needs and aspirations of future generations. Furthermore, the increase in footprint is not shown to be substantial and the inclusion of new Members of Parliament after the delimitation exercise is anyway going to lead to an inevitable increase in footprint (floating though) that cannot be countenanced as a concern here.” (Emphasis supplied) 30.⁷. In M K Ranjitsinh & Ors. v. Union of India and Ors. (3-Judge Bench),42 the need for adopting a nuanced approach, balancing two environmental goals, i.e., fighting the climatic crisis as also protection of wildlife ecology was underscored in following words: “53… Unlike the conventional notion of sustainable development, which often pits economic growth against environmental conservation, the dilemma here involves a nuanced interplay between safeguarding biodiversity and mitigating the impact of climate change. It is not a binary choice between conservation and development but rather a dynamic interplay between protecting a critically endangered species and addressing the pressing global challenge of climate change.” Additional Guidelines

31Copy pinpoint31. We must also, at this point, make references to the guidelines that have been brought by the Union of India, to supplement the existing framework: i. Guidelines for Environmental Risk Assessment of Genetically Engineered Plants, 2016 and Environmental Risk Assessment of Genetically Engineered Plants- A Guide

42 [2024] 3 SCR 1320 : 2024 SCC Online SC 570

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for Stakeholders, 2016 - The objective of these Guidelines is to ensure safe development and use of plant resulting from modern biotechnology after assessment of any potential negative impacts through a comprehensive, transparent and science based framework of identification of harms using a conventional case to case approach. These guidelines profess to provide a practical elaboration of the risk assessment framework included in the Indian regulation and in Annex III of the Cartagena Protocol on Biosafety as also the Working Committee on Harmonisation of Regulatory Oversight in Biotechnology of the Organisation for Economic Cooperation and Development (OECD). They provide a detailed roadmap for Environmental Risk Assessment right from the approach to be adopted to problem formulation (development of risk hypothesis), to detailed instructions on data quality to informational requirement and description of the non-transgenic parental plants/donor organisms, characterization of genetic modification to cultivation practices to potential adverse non-target effects of GMOs on biodiversity to post release environmental monitoring. ii. Risk Analysis Framework 2016 - These guidelines provide the risk analysis method for the environmental release of GE plants and divides them into different stages which can be shown through a following chart:

Application for Environmental Release of GE plant

Decision Communication

Risk Context Risk

Stakeholders Risk Assessment

Risk Management

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(a) Risk Context being the preparatory stage defines the scope and boundaries, sets the criteria against which risk will be evaluated and describes the structures and process for the analysis. Decisions on application for the environmental release of a GE plant require case-by-case assessment and details of the GE plant and the proposed activities, including any proposed controls, limits or containment measures, form the specific risk context. (b) This framework includes Risk Assessment, Risk Management and Risk Communication. Risk Assessment and Risk Management form an essential part of decision making in respect to the applications for environmental release of GE plants. (c) The chapter on Risk Assessment provides comprehensive methodology to identify and characterize risks to the health and safety of people or to the environment from the release of GE plants. It includes risk identification (postulating risk scenarios); risk characterization (includes quantitative as well as qualitative assessment); ensuring the quality of data used in such assessment and risk evaluation. The risk assessor is obliged to search beyond the application to identify additional data and other information that will help in the completion of the risk assessment. (d) The next stage of Risk Management includes preparing a risk management plan; and monitoring/reviewing measures, if any, to assess the effectiveness of all steps in risk analysis, including post-release review. It further provides that in case of non-compliance of any condition considered necessary to manage the risk associated with the environmental release and imposed by the regulatory authorities, the Regulatory Authorities may investigate the nature and extent of such non-compliance. If proven, resort may be made to the EPA, 1986 which provides for a range of remedies, including provisions for criminal sanctions or large fines and/or imprisonment for failing to abide by the legislation, conditions or directions when significant damage occurs to health and safety of people or the environment.

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(e) Another relevant aspect dealt in this document is Risk Communication which is a two-way process ‘to provide, share or obtain information and to engage in dialogue with stakeholders regarding the analysis of risk’ and Risk perception. This is based on a principle that Risk Assessment should be ‘in a scientifically sound and transparent manner’. It includes engagement of ‘internal and external stakeholders in the risk analysis process through dialogue’; informing so as ‘to foster understanding of the risks amongst different constituencies (e.g., authorized parties and others from the regulated community, as well as researchers, farmers, health workers, industry, consumers, interest groups and the general community)’; and building trust ‘to promote trust and credibility in the ability of the Regulatory Agencies and the Indian government to effectively regulate modern biotechnology’. (f) At this juncture, it becomes pertinent to refer to the Cartagena Protocol and the Risk Analysis Framework provided under Annex-III of the said Protocol. The General Principles that are required to be followed by the Parties in developing risk assessment are: “ …..

3. Risk assessment should be carried out in a scientifically sound and transparent manner, and can take into account expert advice of, and guidelines developed by, relevant international organizations.

4. Lack of scientific knowledge or scientific consensus should not necessarily be interpreted as indicating a particular level of risk, an absence of risk, or an acceptable risk.

5. Risks associated with living modified organisms or products thereof, namely, processed materials that are of living modified organism origin, containing detectable novel combinations of replicable genetic material obtained through

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the use of modern biotechnology, should be considered in the context of the risks posed by the non-modified recipients or parental organisms in the likely potential receiving environment.

6. Risk assessment should be carried out on a case-by-case basis. The required information may vary in nature and level of detail from case to case, depending on the living modified organism concerned, its intended use and the likely potential receiving environment.” (Emphasis supplied) (g) The steps provided under this Protocol for risk assessment: “8. To fulfil its objective, risk assessment entails, as appropriate, the following steps: (a) An identification of any novel genotypic and phenotypic characteristics associated with the living modified organism that may have adverse effects on biological diversity in the likely potential receiving environment, taking also into account risks to human health; (b) An evaluation of the likelihood of these adverse effects being realized, taking into account the level and kind of exposure of the likely potential receiving environment to the living modified organism; (c) An evaluation of the consequences should these adverse effects be realized; (d) An estimation of the overall risk posed by the living modified organism based on the evaluation of the likelihood and consequences of the identified adverse effects being realized; (e) A recommendation as to whether or not the risks are acceptable or manageable, including,

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where necessary, identification of strategies to manage these risks; and (f) Where there is uncertainty regarding the level of risk, it may be addressed by requesting further information on the specific issues of concern or by implementing appropriate risk management strategies and/or monitoring the living modified organism in the receiving environment.” (Emphasis supplied) (h) After perusing the Cartagena Protocol and the Risk Analysis Framework developed by the concerned ministries, it is safe to deduce that Indian regulatory system has a sufficient and robust framework of risk analysis/assessment which can be used by the regulatory authorities to protect the health and ensure safety of the people as well as the environment, in accordance with EPA,1986 ; also to foster the research and development in the field of GE plants. iii. Regulations and Guidelines for Recombinant DNA and Biocontainment, 2017 (a) These guidelines were issued on 1st April 2018 with the following objectives: “i. Outline the general principles of containment and establish a minimum standard for laboratories that must be adopted pan India for all handling of genetically engineered (GE) organisms (organism includes microorganisms, animals, plants, arthropods, aquatic animals, etc.) and non-genetically engineered (non-GE) hazardous microorganisms (microorganism includes parasites, protozoa, algae, fungi, bacteria, virus, prions, etc.). ii. Identify the levels of risk(s) associated with GE organisms and non-GE hazardous microorganisms and classification of those organisms into their respective risk groups to select appropriate containment facilities. It also covers certification of containment facilities.

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iii. Prescribe criteria for Manufacture, Use, Import, Export, Exchange and Storage of any hazardous microorganisms, GE organisms or cells and products) produce through exploration of such organisms. iv. Ensure that national authorities, institutions and all other stakeholders involved in research & development are well informed or have access to information on safety thereby facilitating the safe use and handling of hazardous microorganisms, GE organisms or cells and product(s) produce through exploration of such organisms. v. Emphasis the need and responsibility of all national authorities, institutions and all other stakeholders involved in research to ensure that the public is well informed about the containment strategies followed in India.” “SCOPE This document covers regulatory scope on rDNA research and handling of hazardous microorganisms and GE organisms or cells in India. Adoption of these guidelines shall be binding pan India for all public and private organisations involved in research, development and handling of GE organisms (organism includes microorganisms, animals, plants, arthropods, aquatic animals etc.) and non-GE hazardous microorganisms (microorganism includes parasites, protozoa, algae, fungi, bacteria, virus, prions, etc.) and products produced through exploration of such organisms. Note: These guidelines do not overwrite any other existing regulations or guidelines, unless specified here.” (Emphasis supplied)

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(b) These guidelines are divided into 4 chapters-Chapter 1: Regulations and Competent Authorities; Chapter 2: Principles and Components of Containment; Chapter 3: Operational Guides on Containment; Chapter 4: Containment Requirement for Import, Export and Exchange. Each of these issues covered in the Chapter is dealt with in considerable detail and I have perused the same however refrain from dealing with them in extenso. iv. Guidelines and SOPs for confined field trials of Regulated, GE plants 2008 - The scope of these guidelines is defined as under: “These guidelines are intended to provide guidance to applicants for the conduct of confined trials. They are not intended to explicitly define all the requirements for the conduct of a confined field trial, as further terms and conditions/requirements may be identified during the review process by the Regulatory Authorities. This document covers all GE/transgenic plants modified through recombinant DNA (rDNA) technology.”

32Copy pinpoint32. It is in this background, having taken note of and considered the law, the relevant documents and all other essentialities, that the challenge raised by the Petitioners must be seen.

33Copy pinpoint33. The conditional approval, leading to field trials for DMH-11 is in line with a developmental approach, of a scientific temper. The same has been supplemented with conditions imposed by the expert body, to facilitate mitigating measures qua the environment, which I have discussed above.

34Copy pinpoint34. While examining the propriety of the conditional approval granted by the GEAC (to DMH-11) qua the precautionary principle, it becomes essential to look to the past orders of this Court, in these petitions, in order to understand the position taken, thus far, qua the activities of this body. (a) On 22.09.2006, the Court observed that on 01.05.2006, while issuing orders in an Interlocutory Application, held that all trials will be conducted only with the approval of the GEAC. On this date, it was further observed that the Court was not inclined

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to direct the stoppage of field trials but, it did direct a pause on approvals, subject to having heard all sides. (b) On 13.10.2006, as an interim measure, the Court permitted the applicant to plant DMH-11 variety for experimental purpose in its field subject to all precautions. (c) On 15.12.2006, on being presented with some information which questioned the permission to plant the DMH-11 variety for testing, and a prayer regarding uprooting thereof, directions were issued to the GEAC to examine the impact of field tests being carried out, with reference to the experts referred to. An independent view was directed to be furnished by the GEAC. It was observed as under: “Today, our attention has been drawn by the learned counsel for the petitioner to clause (23) of the Convention on Biological Diversity which, inter alia, recommends that in the current absence of reliable data on genetic use restriction technologies [GURT], without which there is an inadequate basis on which to assess their potential risks, and in accordance with the precautionary approach, products incorporating such technologies should not be approved by parties or field testing until appropriate scientific data can justify such testing. Further, reliance has been placed on the expert opinion of Professor Joe Cummins, Professor Jack Heinemann and Professor Dough Gurian Sherman to contend that barnase unaccompanied by its specific inhibitor barstar is known to be a potent cell poison. Traces of barnase are toxic to the rat kidney and to human cell lines. Barnase is actually being exploited as a conditional suicide gene to cause cell death in mammalian and human cells when it is induced, and cell toxicity caused by barnase may be affected by RNA interference. Relying on these experts, learned counsel contends that, as indicated in the order dated 13th October, 2006, direction be issued for uprooting the plant otherwise risk is being run for permanent escape of the gene and other

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damages which it may cause. Before we consider this prayer further, we deem it appropriate to direct G.E.A.C. to examine in detail the impact of the field test being carried also with reference to the expert opinion. We may, however, note that the applicant’s case is that it has modified its technology and is not using GURT. We say nothing on this aspect. We expect independent expert opinion from G.E.A.C. on this subject.” (Emphasis supplied) (d) On 08.05.2007, it was observed that in total, 91 field testing operations were being undertaken. It was further directed that- “The GEAC shall take sufficient precautions to see that these trials are not causing any contamination to the cultivation of neighboring fields. There should be at least 200 meters distance from the trial fields from the neighboring field having same type of cultivations. All the trials which are being conducted, the name of the scientist and other details who will be responsible for all aspects of the trials should be reported to GEAC and they should be regular supervision by them. Prior to bringing out the GM material from the green house for conduct of open field trials, the approved institution should submit a validated event specific test protocol at an LOD of at least 0.01% to detect and confirm that there has been no contamination… GEAC should also verify whether these species by commercial use create any toxicity or allergenicity to any of the users in organic conducted with these varieties of Bt cotton. If any such test has been conducted, the data should be made available to this Court.” (Emphasis supplied) (e) On 13.².2008, the restriction placed by this Court upon granting approvals was lifted and GEAC was permitted to consider all applications. To assuage the worries of the

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Petitioner in regard to the proper constitution of the GEAC, the latter was requested to invite Dr. P.M. Bhargava and Prof. M.S. Swaminathan to its meetings. It was further observed that if any person was dissatisfied by the decision arrived at by the Committee, an appeal may be preferred to the Appellate Committee and, that the apprehensions in regard to negative effect of open field trials, be also considered by the Committee. It was further directed that the guidelines to grant approvals be published on the website of the Committee. (f) On 07.10.2016, this Court recorded the submission of the Additional Solicitor General, that release was not allowed till 17.10.2016 because the Government had sought views from the public and after receiving public views/objections, the committee of experts would consider such matter. 34.1 As the above referred orders point out, throughout the entire process of field testing, being taken stock of, at regular intervals by the Court, it has not, even for a moment doubted the authority of the GEAC and its ability to function properly. Repeatedly, it has been emphasised that the GEAC, being the apex body would be responsible for taking all precautions/ adopting safeguards and ensuring that no contamination takes place in planting of GM seeds. 34.² In one of the orders referred above, it has been noted that 91 field trials were underway at one point. In the extensive arguments made by the Petitioners, not even a single negative instance could be pointed out to show that the field trials impacted the agriculture, environment, biodiversity negatively or irrevocably. Furthermore, as pointed out by the Union of India, trials of DMH-11 have commenced in 6 out of the 8 sanctioned locations (seeds have been planted) and no adverse change therein has been reported thus far. The fears, raised by the Petitioners, therefore, are not substantiated by any negative occurrence. 34.3 The members of the GEAC under the 1989 Rules, are experts in their relevant fields. The approval has come, as discussed above, in consonance with the relevant statutory framework. Furthermore, adequate safeguards have been included in the

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approval itself, in accordance with the precautionary principle. There is an additional ground, upon whose anvil, the decision to grant conditional approval as also the general introduction of GMOs into the sphere of common consumption, which has been sought to be banned by the present petitions, has to be weighed.

35Copy pinpoint35. Whether or not the State allows or disallows the scientific experimentation of a particular kind of crop, particularly when the Central Government is the primary authority entrusted with such function, is a decision squarely within their domain and the role of the Courts therein is circumscribed to the violation of fundamental rights; manifest arbitrariness; conflict with any other law and/or other grounds of similar nature.

36Copy pinpoint36. In reference to public interest, in this particular context, Article 48 of the Directive Principle of the State Policy (hereinafter referred to as ‘DPSP’) would be instructive in order for the concerned branch of the Government to frame policy and take steps in this regard being whilst being entirely in line with the Constitution of India which undoubtedly is the source of all power, legitimacy and is the ultimate guide for all actions. It states that there shall be an endeavour to organise agriculture on modern and scientific lines. State of Gujarat v. Mirzapur Moti Kureshi Kassab Jamat (7-Judge Bench),43 observed: “Article 48 consists of two parts. The first part enjoins the State to “endeavour to organise agricultural and animal husbandry” and that too “on modern and scientific lines”. The emphasis is not only on “organisation” but also on “modern and scientific lines”. The subject is “agricultural and animal husbandry”.”

37Copy pinpoint37. A wholistically aware adoption of GMOs into agriculture appears to be in furtherance of this goal. The phrase ‘wholistically aware’ may require some exposition. What this means is that while GMOs are brought into the agricultural scene and eventually made available for commercial use, it should be so done keeping in mind the essentiality of preserving naturally occurring seeds, ensuring that all other factors

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