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such as health, socio-economic impact, environmental/biodiversity impact, accessibility to farmers, proper control and marking of such modified crops etc. would be required to be in place.

38Copy pinpoint38. In continuation to the above, reference has also to be made to Article 51A(h) of the Constitution of India which imposes a fundamental duty upon all in the following terms: “h) to develop the scientific temper, humanism and the spirit of inquiry and reform;” 38.1 This Court in AIIMS Students’ Union v. AIIMS (3-Judge Bench)44 observed: “58. … Fundamental duties, as defined in Article 51-A, are not made enforceable by a writ of court just as the fundamental rights are, but it cannot be lost sight of that “duties” in Part IV-A Article 51-A are prefixed by the same word “fundamental” which was prefixed by the founding fathers of the Constitution to “rights” in Part III. Every citizen of India is fundamentally obligated to develop a scientific temper and humanism. He is fundamentally duty-bound to strive towards excellence in all spheres of individual and collective activity so that the nation constantly rises to higher levels of endeavour and achievements. State is, all the citizens placed together and hence though Article 51-A does not expressly cast any fundamental duty on the State, the fact remains that the duty of every citizen of India is the collective duty of the State. … In the era of globalisation, where the nation as a whole has to compete with other nations of the world so as to survive, excellence cannot be given an unreasonable go-by and certainly not compromised in its entirety. Fundamental duties, though not enforceable by a writ of the court, yet provide a valuable guide and aid to interpretation of constitutional and legal issues. In case of doubt or choice, people’s wish as manifested

44 [2001] Supp. 2 SCR 79 : (2002) 1 SCC 428

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through Article 51-A, can serve as a guide not only for resolving the issue but also for constructing or moulding the relief to be given by the courts. Constitutional enactment of fundamental duties, if it has to have any meaning, must be used by courts as a tool to tab, even a taboo, on State action drifting away from constitutional values.” (Emphasis supplied) 38.2 Similarly, in Charu Khurana v. Union of India (2-Judge Bench),45 this Court observed: “32. The purpose of referring to the same is to understand and appreciate how the directive principles of State policy and the fundamental duties enshrined under Article 51-A have been elevated by the interpretative process of this Court. The directive principles have been regarded as the soul of the Constitution as India is a welfare State. At this juncture, it is apt to notice the view expressed by a two-Judge Bench of this Court in Ashoka Smokeless Coal India (P) Ltd. v. Union of India [(2007) 2 SCC 640] wherein it has been laid down that: (SCC p. 683, para 106) “106. … the directive principles of State policy provide for a guidance to interpretation of fundamental rights of a citizen as also the statutory rights.” (Emphasis supplied)

39Copy pinpoint39. The Union of India has submitted that comprehensive risk assessment qua GMOs cannot be done at the initial research stage and all consultations cannot take place for each application on GM crops at an early stage. It was further submitted that toxicology studies are varied on product by product basis, as per international best practices and therefore toxicity studies are undertaken as per guidelines on a case-by-case basis.

45 [2014] 12 SCR 259 : (2015) 1 SCC 192

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40Copy pinpoint40. The experimentation in respect of GMOs, i.e. field trials, lab testing etc. would be in line with the development of a scientific temper along with the precautionary principle which has found its place within Article 21 of the Constitution of India. Field trials are a significant step in the development of crop varieties as the data representing the plant’s response to a particular agro-ecological environment can be collected only when such plant is grown outside in confined field trials. Without field trials, the performance of the plant in the field or environmental safety of such plant cannot be known. Studies, being conducted in open environment is necessary for studying the impact on human health and biodiversity, for the performance of a GM crop is dependent on a host environment. This would be essential to developing appropriate biosafety mechanisms as well.

41Copy pinpoint41. The judgments referred above recognise fundamental duties as an important guide to interpretation of the Constitution, which obviously would apply to the understanding of Article 21 as well. In Ramlila Maidan Incident, In re (2-Judge Bench),46 the interdependency of the three parts of the constitution was highlighted by Swatanter Kumar J. (as he then was) in the following words: “22. Thus, a common thread runs through Parts III, IV and IV-A of the Constitution of India. One Part enumerates the fundamental rights, the second declares the fundamental principles of governance and the third lays down the fundamental duties of the citizens. While interpreting any of these provisions, it shall always be advisable to examine the scope and impact of such interpretation on all the three constitutional aspects emerging from these Parts.” (Emphasis supplied)

42Copy pinpoint42. The development of scientific temper is to be read with another limb of the DPSPs and Fundamental Duties enshrined in the Constitution that is Article 48A and Article 51A(g) respectively which speaks of protection of the environment. As already noticed above, these three parts forming the heart and soul of the Constitution have to be read as a whole and as such any and all considerations of modernising agriculture or building a scientific temper would also be required to necessarily consider and abide by the duty to protect the environment.

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43Copy pinpoint43. It is also to be noted that, similar to when a legislative body enacts a legislation there is a presumption of constitutionality unless proven otherwise, similarly, a policy decision when taken by the competent authority enters the fray of enforcement with a presumption in its favour of being in public interest, unless otherwise shown, demonstarted and proven to be among other grounds, manifestly arbitrary. This presumption extends, subject of course to just exceptions, to the authority having considered duties as discussed above in framing policies for GMOs.

44Copy pinpoint44. It must be kept in mind that India is a global agricultural powerhouse and from an economic standpoint, rural India is still largely dependent on agriculture. This court has stated in Electrosteels (supra) that the Court cannot be oblivious to the economy. Therefore, informed agricultural policy decisions must be viewed in that conspectus, which is to further and supplement India’s development, growth and self-sustenance. The relevance of such policy decisions being that, for instance, as submitted by the Union of India, India has been dependent on imports to meet more than half of the edible oil demand [55.76%, 155.33 Lakh Tonnes (2022-23) – Rs.1,15,000/- crores in 2020-21]. Therefore, in my view, the use of GM technology has to be seen in this backdrop.

45Copy pinpoint45. On numerous occassions, this Court has reiterated the view discussed in the preceding paragraphs. 45.1 This Court in State of U.P. v. Abhay Nandan Inter College47 (2-Judge Bench) observed: “36. A policy decision is presumed to be in public interest, and such a decision once made is not amenable to challenge, until and unless there is manifest or extreme arbitrariness, a constitutional court is expected to keep its hands off.” 45.2 In State of Punjab v. Khan Chand48 (5-Judge Bench), KK Mathew J. dissenting, observed: “23. … Courts and parties all assume that the Legislature always wants protection of the public interest, to serve public cause and do things for public good or to exercise

47 [2021] 10 SCR 693 : (2021) 15 SCC 600 48 [1974] 2 SCR 768 : (1974) 1 SCC 549

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powers for public purpose and always intends that administrators act justly and reasonably whether the Legislature says so in the statute or not [see Kenneth Culp Davis, “Administrative Law Treatise”, (1958) Vol. I, p. 87]. Every legislative body must be presumed to favour the true, the good and above all the public interest and public good and whether it says so or not is of absolutely no consequence. …Government exists and its only title to exist is its claim to advance the public good and serve the public interest….” 45.3 On similar lines, in Central Inland Water Transport Corpn. v. Brojo Nath Ganguly49 (2-Judge Bench) this Court observed: “92. …Public policy, however, is not the policy of a particular government. It connotes some matter which concerns the public good and the public interest. The concept of what is for the public good or in the public interest or what would be injurious or harmful to the public good or the public interest has varied from time to time…” (Emphasis supplied) 45.4 In Premium Granites v. State of T.N50 (2-Judge Bench), it was observed: “54. It is not the domain of the court to embark upon unchartered ocean of public policy in an exercise to consider as to whether a particular public policy is wise or a better public policy can be evolved. Such exercise must be left to the discretion of the executive and legislative authorities as the case may be. The court is called upon to consider the validity of a public policy only when a challenge is made that such policy decision infringes fundamental rights guaranteed by the Constitution of India or any other statutory right…” 45.5 In the well-known, Narmada Bachao Andolan v. Union of India,51 (3-Judge Bench), this Court held:

49 [1986] 2 SCR 278 : (1986) 3 SCC 156 50 [1994] 1 SCR 579 : (1994) 2 SCC 691 51 [2000] Supp. 4 SCR 94 : (2000) 10 SCC 664

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“229. It is now well settled that the courts, in the exercise of their jurisdiction, will not transgress into the field of policy decision. Whether to have an infrastructural project or not and what is the type of project to be undertaken and how it has to be executed, are part of policy-making process and the courts are ill-equipped to adjudicate on a policy decision so undertaken. The court, no doubt, has a duty to see that in the undertaking of a decision, no law is violated and people’s fundamental rights are not transgressed upon except to the extent permissible under the Constitution. x x x

233. …The courts must, therefore, act within their judicially permissible limitations to uphold the rule of law and harness their power in public interest. It is precisely for this reason that it has been consistently held by this Court that in matters of policy the court will not interfere. When there is a valid law requiring the Government to act in a particular manner the court ought not to, without striking down the law, give any direction which is not in accordance with law. In other words the court itself is not above the law.” (Emphasis supplied) 45.6 Therefore, on this ground, interference by this Court would only be justified if it can be proven that the effect of such a decision standing would be detrimental to the public, against its interest and would ultimately impact the enjoyment of fundamental rights guaranteed by the Constitution, to a degree which would be impermissible. As has been demonstrated in the preceding paragraphs, that threshold cannot be said to have been breached.

46Copy pinpoint46. In view of the entire conspectus above, the field testing of DMH-11, pursuant to the conditional approval of the GEAC, with sufficient safeguards and precautions, ought to continue and cannot be said to be violative of the precautionary principle and therefore, the con- stitutional challenge thereto, fails.

47Copy pinpoint47. Two additional aspects need to be clarified. Pursuant to the above discussion, when I consider the prayer made on behalf of the

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Petitioners, it is clear that whether or not there should be a complete ban on Ht crops is not something this Court can issue a direction on. Such a decision has to be taken, keeping in view the opinion of various experts who have the knowledge and ability to comprehend scientific literature on the point as also the views of those persons specifically tasked with taking decisions in such matters. Courts, only on the basis of material placed on record or the indirect understand- ing passed on to it through counsel, is not in a position to take an informed decision. If such a decision is taken, it would be completely foreign to the standards of judicial review as discussed above, for it is not within the Court’s purview to undertake cost benefit analysis of a policy decision of the executive.

48Copy pinpoint48. The aspect of India being a centre of origin or diversity qua mustard was laid considerable emphasis on by the learned counsel for the Petitioners, however this, in my considered view, is another prayer with which this Court cannot do justice by returning or not returning a finding. Counsel on both sides supplied research material to support their own stand which argued contrarian viewpoints in this regard and so, it would be best if minds equipped to undertake detailed studies to come to a conclusion, would be the ones to decide this important issue. Conclusions & Directions

49Copy pinpoint49. In view of the above discussion, the conclusions arrived at in the discussion above are that: i. Judicial review into the decision making of all bodies concerned with GMOs, is possible. ii. The question of ban on Ht crops is not warranted in view of the precautionary principle and it is a decision squarely within the domain of policy. iii. The composition of the GEAC is in accordance with the Rules, to which the challenge of constitutionality, has failed, and in the absence of any change in the Rules, no fault can be found with the same. iv. The decision of the GEAC to grant conditional approval is not vitiated by non-application of mind, or any other principle of law, on part of the body, which itself is an expert body.

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50Copy pinpoint50. In view of the above, I deem it appropriate to give the following directions: 50.1. Field trials of DMH-11, shall continue in strict consonance with the conditions imposed. The Union of India and statutory authorities shall continue to strictly monitor the same. In case of any adverse change in circumstances, the decision for field trials can be reviewed. 50.2. GEAC to ensure that the conditions mentioned in the conditional approval of DMH-11 are strictly complied with by the applicant in letter and spirit. 50.3. The GEAC to take into account all environmental factors before granting future approvals and make an endeavour to have specifically designated farms for field testing, in collaboration with the Union of India. 50.4. All studies conducted and received while granting such approvals, to be uploaded on the website of the GEAC in a time-bound manner, in accordance with the mandate of law. The GEAC to ensure public participation in this process and wider publicity of the same to be facilitated. 50.5. That apart, wider publicity should also be given to GMOs in general, enabling people to take a decision in regard thereto, keeping in view all factors and specifications. 50.6. All decisions to be taken in regard to GMOs should endeavour to strictly follow “wholistically aware” approach which takes the preservation of naturally occurring seeds hand in hand with popularising Genetically Modified seeds. 50.7. The condition imposed in this Court’s order dated 08.05.2007 in respect of 200 meters distance being maintained between fields hosting GM crops versus those wherein regular seeds are planted, has to be strictly maintained. 50.8. The Post-Release Monitoring Committee be provided with adequate infrastructural and administrative facilities to closely monitor the field testing. 50.9. The Union of India may consider constituting a special cell under the MoEFCC to monitor all studies being undertaken with respect to GMO’s.

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50.10. Before commercial release of DMH-11 and other GMOs in the future, specific testing on their impact on human health must be conducted prior thereto. 50.11. The GEAC or any other body, possessing sufficient expertise, duly notified by the government, to consider conducting independent studies on GMOs to ascertain the veracity of the data submitted by the applicant(s) so as to ensure that the approval so granted are bolstered by independent data informing such decision. 50.12. The Union of India should consider implementing a national, all-encompassing policy in respect of GMOs so as to ensure a streamlined approach to this important issue. Connected thereto, is the setting up of infrastructure including laboratories with state of the art facilities, to aid the interplay of biotechnology and agriculture and the advancement thereof. 50.13. Union of India to ensure strict compliance qua labelling of GM foods, in accordance with the Food Safety and Security Act.

51Copy pinpoint51. Before parting with the present lis, I lament the delay with which the present writ petition has come to be disposed. The genesis of this case was 20 years ago from the present day. The detrimental effect of such prolonged litigation was noted by this Court in Rajeev Suri (supra) wherein it was observed: “574…the underlying principle at play is the duty of this Court to do complete justice as envisaged under Article 142 and to obviate the possibility of project of national importance being stuck, embroiled and delayed due to engagement of the project proponent before multiple legal forums/proceedings. We have had plethora of cases in the post-PIL period wherein prolonged litigation against infrastructural projects resulted in inordinate delays to the extent that the projects got buried forever or became unviable owing to excessive burden on the public exchequer (honest taxpayers’ money). That is where this Court’s power to do not only complete but substantial justice gets triggered. x x x

576. There is ample support to the proposition that when larger national interest is involved and concerns of public

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exchequer are directly involved in the lis, the Court must act at the earliest opportunity. For, each day’s delay has a direct impact on the exchequer. In Narmada Bachao Andolan v. Union of India [Narmada Bachao Andolan v. Union of India, (2000) 10 SCC 664] , the Court resonated this position and observed thus : (SCC pp. 761-62, para 227) “227. There are three stages with regard to the undertaking of an infrastructural project. One is conception or planning, second is decision to undertake the project and the third is the execution of the project. The conception and the decision to undertake a project is to be regarded as a policy decision. While there is always a need for such projects not being unduly delayed, it is at the same time expected that a thorough possible study will be undertaken before a decision is taken to start a project. Once such a considered decision is taken, the proper execution of the same should be undertaken expeditiously. It is for the Government to decide how to do its job. When it has put a system in place for the execution of a project and such a system cannot be said to be arbitrary, then the only role which a court may have to play is to see that the system works in the manner it was envisaged.” (Emphasis supplied)

52Copy pinpoint52. The above proposition resonates with the present case. Unfortunately, despite the national and public interest involved, this case remained pending for two decades, which must lead to introspection on both sides of the bench.

53Copy pinpoint53. I would like to place on record appreciation for all the counsel for taking us through the voluminous record and providing us with detailed hand-outs on the case file, which are purely a substance of their hard work.

54Copy pinpoint54. The writ petitions are dismissed and disposed of in terms of the above judgment. The contempt petitions stand closed in the above terms. The Civil Appeal stands disposed of in light of the above. Pending applications, if any, stand disposed of.

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Judgment Nagarathna, J. Table of Contents*

Acronyms ................................................................................... 4 Preface: ...................................................................................... 7 Bird’s eye view of the controversy: ............................................. 9 Pleadings: ................................................................................... 10 Writ Petition (Civil) No. 115 of 2004: ................................. 10 Writ Petition (Civil) No. 260 of 2005: ................................ 18 Writ Petition (Civil) No. 840 of 2016: ................................ 23 Civil Appeal No. 4086 of 2006: ......................................... 29 Contempt Petition (Civil) No.295 of 2007 in Writ Petition (Civil) No.260 Of 2005; and, Contempt Petition (Civil) No.6 of 2016 in Writ Petition (Civil) No.260 Of 2005: ... 30 Significant Orders passed by this Court in Writ Petitions: .......... 30 Constitution of the Technical Expert Committee (TEC): .............. 32 Final Report of TEC: ................................................................... 34 Parliamentary Standing Committee (PSC) on Agriculture’s Report on “Cultivation of Genetically Modified Food Crops – Prospects and Effects” – 2012: ................................................... 54 Parliamentary Standing Committee (PSC) on Science and Technology, Environment and Forests’ Report titled “Genetically Modified Crops and its impact on Environment” - 2017: ........... 60 Conditional approval by Government of India for Environmental Release of DMH-11: .................................................................... 66 Sub-committee meetings: ........................................................... 71 Interlocutory Applications filed by the petitioners: ...................... 88

* Ed. Note: Pagination as per the original Judgment.

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Additional Affidavit of Union of India: ........................................ 89 Submissions: .............................................................................. 95 Submissions of the petitioners: ................................................. 95 Submissions of the Respondents: ............................................. 111 Submissions of Learned Solicitor General: ............................... 122 Reply Arguments: ...................................................................... 125 Points for Consideration: ........................................................... 134 Legal Framework: ...................................................................... 136 Environment (Protection) Act, 1986 (EP Act, 1986): .................. 146 1989 Rules: ................................................................................ 147 Regulatory Framework: ............................................................... 156 Constitutional Court and the Environmental Rule of Law: ........... 168 Public Trust Doctrine: ................................................................ 173 Precautionary Principle: .............................................................. 176 Analysis and Findings: ............................................................... 182 Re: Point No.1: Whether GEAC approval dated 18.10.2022 and the consequent decision dated 25.10.2022 for the environmental release of DMH-11 is in accordance with law? ......................... 198 Public Trust Doctrine: ................................................................ 211 Re: Point No.2: Whether the decision to grant approval for environmental release of DMH-11 violates the right to safe and healthy environment under Article 21? ............................... 221 Right to safe and healthy Environment: ................................. 221 Re: Point No.3: Whether GEAC’s grant of approval dated 18.10.2022 and the decision dated 25.10.2022 for the environmental release of DMH-11 violate the precautionary principle? ................................................................................... 234 Precautionary Principle: ............................................................. 234 Conclusion: ................................................................................ 254

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Acronyms

AFES Assessment of Food/Feed and Environmental Safety AICRP All India Coordinated Research Project ASHA Alliance for Sustainable and Holistic Agriculture BG-II Bollgard-II BRAI Biotechnology Regulatory Authority of India BRL Biosafety Research Level BSU Biosafety Support Unit Bt Bacillus thuringiensis CAC Codex Alimentarius Commission CBD Convention on Biological Diversity CCMB Centre for Cellular & Molecular Biology CGMCP Centre for Genetic Manipulation of Crop Plants CIB&RC Central Insecticide Board & Registration Committee CPB Cartagena Protocol on Biosafety CSIR Council of Scientific and Industrial Research DARE Department of Agricultural Research and Education DBT Department of Biotechnology DGFT Directorate General of Foreign Trade DLC District Level Committee DMH-11 Dhara Mustard Hybrid-11 DoAC Department of Agriculture and Cooperation DRMR Directorate of Rapeseed and Mustard Research ECHR European Convention on Human Rights ERA Environmental Risk Assessment FAO Food and Agriculture Organization FSSA, 2006 Food Safety and Standards Act, 2006 FSSAI Food Safety and Standards Authority of India GE Genetically Engineered GEAC Genetic Engineering Appraisal Committee GEF Global Environment Facility GEO Genetically Engineered Organism

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GM Gene Modification or Genetically Modified GMO Genetically Modified Organisms HPV Human Papilloma Virus HT Herbicide Tolerant or Tolerance IAASTD International Assessment of Agricultural Knowledge, Science and Technology for Development IARI Indian Agricultural Research Institute IBSC Institutional Biosafety Committee ICAR Indian Council of Agricultural Research ICMR Indian Council of Medical Research IMTECH Institute Of Microbial Technology IPR Intellectual Property Rights LMO Living Modified Organism MoA Ministry of Agriculture MoEF Ministry of Environment and Forests MoEF&CC Ministry of Environment, Forest and Climate Change MoHFW Ministry of Health and Family Welfare NARS National Agricultural Research System NBPGR National Bureau of Plant Genetic Resources NGO Non-Governmental Organisation NGT National Green Tribunal NIN National Institute of Nutrition NKSPLR Nagoya Kuala Lumpur Supplementary Protocol on Liability and Redress PAU Punjab Agricultural University PRMC Post Release Monitoring Committee PSC Parliamentary Standing Committee R&D Research and Development RARM Risk Assessment and Risk Management RAU Risk Assessment Unit RCGM Review Committee on Genetic Manipulation RDAC Recombinant DNA Advisory Committee rDNA recombinant DNA

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SBCC State Biotechnology Co-ordination Committee SOP Standard Operating Procedures TEC Technical Expert Committee UK United Kingdom UNEP United Nations Environment Programme USA United States of America

Preface: The ideas drawn from sacred texts of the world have proffered to worship and respect nature and impel mankind to preserve the same. This, in essence, is the doctrine of intergenerational equity. (i) The verses in Srimad Bhagavata Mahapurana depict nature and its creations to embody the divine, as it states ‘Ether, air, fire, water, earth, planets, all creatures, trees and plants, rivers, and seas, they all are organs of God’s body, remembering this, a devotee respects all species”. (ii) In all other faiths practised in India, the earth is deemed to be the sacred creation of God. (iii) Nature and all her elements are considered sacred. Human beings are said to be composed of five elements of nature, which teach lessons and inspire strength in the formulation of our character: “Earth teaches us patience, love; Air teaches us mobility, liberty; Fire teaches us warmth, courage; Sky teaches us equality, broad-mindedness; Water teaches us purity, cleanliness.” 1.1 Faced with the widespread destruction of the environment, people everywhere are coming together to understand that we cannot continue to use the benefits of the earth as we have in the past. A new ecological awareness is beginning to emerge which, rather than being downplayed, ought to be encouraged to develop into concrete programs and initiatives.

2. This Court, in State of Bihar vs. Murad Ali Khan, (1988) 4 SCC 655 (“Murad Ali Khan”) speaking through Venkatachaliah, J. (as the learned Chief Justice then was) observed that “the tragedy of

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the predicament of the civilised man is that, ‘Every source from which man has increased his power on earth has been used to diminish the prospects of his successors. All his progress is being made at the expense of damage to the environment which he cannot repair and cannot foresee’.”

3. This Court in M.C. Mehta vs. Kamal Nath, (1997) 1 SCC 388 (“M.C. Mehta”), speaking through Kuldip Singh, J. observed that, “… the executive acting under the doctrine of public trust cannot abdicate the natural resources and convert them into private ownership, or for commercial use. The aesthetic use and the pristine glory of the natural resources, the environment and the ecosystems of our country cannot be permitted to be eroded for private, commercial or any other use unless the courts find it necessary, in good faith, for the public good and in public interest to encroach upon the said resources.”

4. These writ petitions, filed in public interest in the years 2004 and 2005, have been pending since then. However, IA No.47 of 2016 and IA No. 122182 of 2021 were filed by the petitioner (Aruna Rodrigues) in Writ Petition (Civil) No.260 of 2005, leading to the hearing of the said applications and consequently, the writ petitions also. The catalyst for considering these writ petitions on merits is the approval of Genetic Engineering Approval (now Appraisal) Committee (GEAC) dated 18.10.2022 culminating in the decision dated 25.10.2022 being questioned by the petitioners. It would therefore be useful to initially state the bird’s eye view of the controversy. Bird’s eye view of the controversy:

5. What does it mean to preserve, protect and respect the citizens’ right to a safe and healthy environment while exploring and experimenting with era-altering novel technologies? That is the crux of the controversy in these cases. The factual aspects of the controversy were crystallised to some extent when this Court had set up Technical Expert Committee (TEC) on 10.05.2012. 5.1 In the immediate context, these cases impugn the decision taken by GEAC to grant approval for environmental release of Dhara Mustard Hybrid-11 (DMH-11) mustard at the 147th meeting held on 18.10.2022. Whether the said approval was in compliance or in derogation of the recommendations of the TEC Report is a foundational aspect. Whether the said decision

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is in consonance with due process of law, as understood in the context of the public trust doctrine? There is also the question whether the right to a safe and healthy environment under Article 21 has been violated and whether there has been a violation of the precautionary principle. 5.2 In these cases, the said controversy has been considered from several angles. Arguments at length have been heard by us. Therefore, we propose to encapsulate the pleadings, arguments and voluminous materials that has been submitted during the course of the hearing while arriving at the findings and conclusion in this matter. Pleadings: Writ Petition (Civil) No.115 of 2004:

6. According to petitioner in Writ Petition (Civil) No.115 of 2004, namely, Gene Campaign, it is a society registered under the Societies Registration Act, 1860. It consists of lawyers, geneticists, social scientists, agriculturalists, economists, environmentalists, farmers etc. who work towards the cause of protecting genetic resources and ensuring that the rights of rural and tribal communities to access the same are not infringed. Petitioner No.2, Dr. Suman Sahai is the President of Gene Campaign, a researcher and instructor in several institutions in India and abroad. It is his considered opinion that the use of Gene Modification (GM) technology must not be permissible without having the requisite safeguards and regulatory regimes in place. 6.1 The prayers in Writ Petition (Civil) No.115 of 2004 filed by the petitioners read as under: “The petitioner therefore, prays that in the facts and circumstances of the present case, this Hon’ble Court may be pleased to issue a writ of mandamus or writ or direction of like nature to: i) direct the respondents to bring the Rules for Manufacture, Use, Import, Export and the Storage of Hazardous Micro-organisms, Genetically Engineered Organisms or Cells, 1989 in consonance with Article 14, 19, 21, 38,

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47, 48, 48A read with 51-A(g) of the Constitution and in the eventuality of the respondents failing to do so, declare the Rules of 1989 as unconstitutional; ii) direct the Respondents to set-up a High-Power Committee to formulate a National Policy on Genetically Engineered Organisms (GEOs) through a multi-stakeholder consultation process; iii) direct the Respondents to observe a moratorium on various permissions/approvals/trials concerning GEOs, in particular of commercial nature, particularly of crops for which India is a Centre of Origin/Diversity, till the Rules are amended and a sound Regulatory and Monitoring System is put in place; iv) pass such other and further orders as this Hon’ble Court may deem fit and proper in the facts and circumstances of the case.”

7. The pleadings in the aforesaid writ petition could be encapsulated as under: 7.1 Writ Petition (Civil) No.115 of 2004 has been filed for the issuance of a writ of mandamus or similar writ directing the respondent-State to bring the Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Micro-Organisms, Genetically Engineered Organisms or Cells, 1989 (“the 1989 Rules”, for the sake of convenience), which have been framed under Sections 6, 8 and 25 of the Environment (Protection) Act, 1986 (“EP Act, 1986”, for short) in consonance with Articles 14, 19, 21, 38, 47, 48, 48A read with Article 51-A(g) of the Constitution and if there is a failure to do so, to declare the said Rules as unconstitutional. It is averred that this Court has on various occasions interpreted Article 21 of the Constitution to include the right to health of the individual as well as to a clean and safe environment. That tenets of the precautionary principle, sustainable development, polluter pays principle and inter-generational equity doctrine have been held by this

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7.4 That the 1989 Rules were enacted owing to mounting evidence of the possible adverse effects of GMOs on agricultural ecosystems and the country’s biodiversity as well as on human and animal health. It is the petitioners’ case that the said Rules are riddled with lacunae that lead to them being applied arbitrarily and in violation of the Constitution. That the said Rules do not bear any mention as to the qualifications required to be eligible for membership in the various regulatory agencies constituted thereunder. This renders the functioning of these agencies largely ineffective as they often lack the necessary technical competence, particularly in the fields of Risk Assessment and Risk Management (RARM). 7.5 Further, the prescribed constitution of various agencies, in particular those of the Review Committee on Genetic Manipulation (RCGM), GEAC, the State Biotechnology Co- ordination Committees (SBCC) and District Level Committees (DLC), include representatives of various authorities who do not possess the necessary qualifications, technical expertise, competence, skills and knowledge to carry out the respective mandates of each agency. Majority of the members are only in ex-officio capacity and lack competence in the field of operation. 7.6 That, there is a complete lack of transparency at each stage of the regulatory process. The 1989 Rules do not allow for public to access information despite GMOs having possible adverse effects on human and animal health, socio-economic conditions as well as the environment which directly pertains to the public’s rights and interests. These Rules do not allow public to sufficiently participate in the decision-making at any stage, viz. grant of approval for research, field trials or commercial-scale cultivation of a GM crop. Public participation is needed to both accurately gauge the risks and benefits as well as to increase the confidence of public in GMOs. 7.7 That the 1989 Rules do not require taking prior informed consent from those farmers and Gram Sabhas which are located in the vicinity where a field trial would be conducted. This is in violation of the 73rd and 74th Constitutional Amendments which make the involvement of Gram Sabhas and Gram Panchayats in such decisions necessary and non-optional.

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7.8 That the Rules envision a regulatory regime that lacks accountability and there is no indication as to who would bear the liability in case of an erroneous decision being made that has an adverse impact on human and animal health, the environment and the socio-economic conditions of the country. Such harm may take the form of personal injury, property damage or financial loss, however, the liability corresponding to each of these has not been considered in the 1989 Rules at all. 7.9 Further, the penal provisions contained in the said Rules do not sufficiently deter prospective offenders as these provisions just mention “measures” that may be taken by the concerned agency, which do not include the description of a penalty of any kind. The actions that can be taken by the concerned agencies are only in a corrective capacity to ensure damage is minimized. 7.10 That neither SBCC nor DLC had been made functional at the time of filing of this Petition despite the commercial cultivation of the Bacillus thuringiensis (Bt) cotton crop which is a GMO. 7.11 That GM technology is an emerging technology that enables outcomes that were hitherto unimagined such as the transposition of the genes of fish into those of tomatoes, genes of bacteria into those of plants etc. There is an inherent uncertainty to this technology and its effect on the environment and on human life. This necessitates the re-examination of extant regulations and regulatory regimes so as to mould them in light of newer developments. 7.12 That till these uncertainties have been clarified through the process of scientific research thereby enabling a thorough consideration of the risks and benefits, there must be a moratorium on the commercial release of GMOs. 7.13 That the impact of GM technology would vary based on the socio-economic, cultural, and ecological context of each country and any research conducted must evaluate the specific impact of such technology in the Indian context. On the other hand, GM technology have evolved in industrialized and developed

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economies with highly mechanized agricultural processes and vast monocultural tracts that are generally isolated from natural ecosystems. Unlike India, these countries do not possess similarly rich biodiversity. 7.14 That India, being the centre of origin for many food crops, has to be more vigilant and cautious in adopting this new technology which is still in the process of evolution. In particular, transgenic varieties of crops for which India is the centre of origin should not be released for commercial cultivation until its impact is adequately assessed. That there are serious concerns about contamination of the natural gene pool of crops originating in India. These are some of the potential consequences: i. Contamination of non-GM crops and their wild relatives; ii. Proliferation of weeds and creation of new weeds due to flow of foreign genes from GM crops to non-GM crops and their wild relatives; iii. The likely formation of difficult-to control novel weed types due to transfer of foreign genes that confer hardiness; iv. Destruction of soil micro-organisms due to release of toxins from genes, like Bt gene, leading to adverse impact on crop productivity. 7.15 That farm lands in India are small and closely packed together as agriculture is practiced in close proximity to natural biodiversity, often bordering forest areas or even within forest areas, where natural gene pools are found. A GM crop cultivated in one field is likely to impact other fields as well as the natural ecosystems. No research has been undertaken to assess the adverse effects of such transfers. 7.16 Moreover, GM crops could directly impact the economic prospects of a large section of the population that works in the agricultural sector. Small and marginal farmers are likely to be the most disadvantaged. Other socio-economic risks include market concentration, the loss of livelihood of small farmers, and restriction on the consumers’ right to choose.

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Writ Petition (Civil) No.260 of 2005:

8. The petitioner who is a public-spirited citizen in this case has made the following prayers and has averred as follows in the context of GM Technology and GM Crops: “The petitioners therefore, pray that in the facts and circumstances of the case, this Hon’ble Court may be pleased to issue appropriate writs or directions to: A) Direct the Union of India not to allow any release of GMOs into the environment by way of import, manufacture, use or any other manner unless the following precautions are taken. (a) a protocol for all the required bio-safety tests of the GMOs proposed to be released is prepared by the GEAC after processes of public notice and public hearing. (b) The GMO has been subjected to all the required bio-safety tests, prepared on the basis of the required Biosafety tests on the basis of the above protocol, by agencies of independent expert bodies, and results of which have been made public. B) Direct the Union of India to ban the import of any biological organism, food or animal feed unless they have been certified and labelled to be GM free, by the exporting country. C) Direct the Union of India to put in place rules to ensure that it shall be compulsory for any dealer or grower selling GMOs to label them as such. D) Pass such other and further orders as this Hon’ble Court may deem fit and proper in the facts and circumstances of the case.” (i) According to this petitioner, there are outstanding safety concerns linked with Genetically Engineered (GE) technology. Transgenic contamination is unavoidable and there can be no co-existence between GM and Non-GM agriculture.

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(ii) That research shows that Bt proteins, incorporated into 25% of all transgenic crops worldwide, to be harmful to a range of non-target insects, worms and amphibians. Some of them are potent immunogens and allergens. In fact, glyphosate and the Roundup herbicide used on most herbicide resistant crops is shown by studies to be lethal to amphibians. (iii) That GM crops have led to an increase in pesticide use, financially hurting farmers and harming the environment. (iv) That GE technology is a fit case for the application of the precautionary principle which necessitates that if there are reasonable scientific grounds for believing that a new process or product may not be safe, it should not be introduced until convincing evidence of reasonable certainty of no harm is obtained. In addition, if the dangers are considered serious enough, then the principle may require withdrawal of GM products or impose a ban or a moratorium on further use thereof. (v) That safety testing for GE food is absolutely necessary for India before the release of any GMO into the Indian environment. However, there are very few established protocols for assessing the potential health impacts of GE crops. All one finds is loose guidelines that in most cases only list certain tests or procedures without specifying how they are to be conducted. (vi) That biotechnology companies frequently deny access or allow strictly conditioned access, to data on crop materials on the basis of confidentiality and IP concerns, making it very difficult for regulatory authorities and independent researchers to verify or review test claims on the safety of GE crops and foods. (vii) That the extant regulatory system in India is ill-equipped to handle challenges outlined above, as past experience also confirms. Circumstances surrounding the initial approvals of Bt cotton in India is a good example. The RCGM, under the Department of Biotechnology (DBT), is a body that did not have the jurisdiction to grant permission for the release of GMOs into the environment. Yet, it was originally the RCGM which illegally

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permitted the release of the GMOs into the country for the first time. It was only when there was a public outcry over the serious illegality of these clearances that attempts were made to get the release of GMOs cleared retrospectively. (viii) That even for technologies which have been tried and tested, and found to be far safer than GE, for instance Hydro-electric projects, the relevant statutes mandate a public notice and public hearing as well as Environmental Impact Assessment. Hence, it is arbitrary and unreasonable not to have a mandatory public notice and public hearing before approvals for the release of GMOs are granted. (ix) That as per current practice, the applicant company itself is asked to do testing. The test results are not available for public scrutiny. This is entirely without logic and is a clear conflict of interest involving the same biotech company that has a commercial interest in the approval of the GMO. (x) That in India, like many other developing countries, organizations which are substantially funded by the biotech industry have sought to influence regulatory and other decision-making processes by conducting “awareness” and “educational” programmes. The Governments of advanced countries too, have been a handmaiden to GE Industry, often arm-twisting developing countries to adopt pro-GM stances. 8.1 It is further averred that the CPB was adopted in 2002 and came into force on 11.09.2003. It is a binding International agreement on Biosafety and India being a signatory, is bound to implement its provisions. According to Article 10(6) of the Protocol, the lack of scientific certainty due to relevant scientific information and knowledge regarding the extent of potential adverse effects shall not prevent the contracting party from taking a decision, as appropriate, in order to avoid and/or minimize potential adverse effects. In addition, Annexure-III of the said protocol includes, inter alia, the general principles of risk assessment. It states that risk assessment should be carried out in a scientifically sound and transparent manner and implores states to take into account expert advice as well as guidelines developed by relevant international organizations. Further, Article 21(6) of

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the said Protocol prescribes that the information about the risk assessment cannot be kept confidential. 8.2 That the United Nations Convention on Biological Diversity (CBD), 1992, to which India is a party, inter alia, requires that the contracting parties shall domestically regulate or manage the risks associated with the use and release of Living Modified Organisms (LMOs) resulting from Biotechnology and which are likely to have adverse environmental impacts and risks to human health. It also implores states to introduce appropriate procedures to require impact assessment of proposed projects likely to have significant adverse effects on biodiversity and to allow public participation in the procedure. 8.3 That in addition to implementing a moratorium on the release of any GMO into the domestic environment until adequate biosafety tests demonstrate safety beyond reasonable doubt, labelling for imports sourced from countries which produce GM crops and foods should be mandated. Therefore, both moratorium and labelling must be concurrent mandatory requirements. 8.4 That farmers have the right to save seed for sowing in the next season, which a patent-based regime of GM seeds will effectively deny. This choice is a fundamental right and must be retained as such for better farming prospects and livelihoods. Therefore, the petitioner has sought the aforesaid reliefs. Writ Petition (Civil) No.840 of 2016: 8.5 The petitioner is stated to be a public-spirited citizen based in Chennai and is involved in a consumer movement in Tamil Nadu called ‘Safe Food Alliance’. The petitioner is stated to be one of the National Convenors of Alliance for Sustainable and Holistic Agriculture (ASHA), which is an organization that has been actively involved in the cause of the genetic modification of crops and its effects on human health. 8.6 It is averred by the petitioner that in September 2015, the Centre for Genetic Manipulation of Crop Plants (CGMCP) submitted an application to GEAC, seeking approval for the environmental release of GE mustard hybrid (DMH-11) seeds and the use of parental events, i.e., Varuna bn 3.6 and EH-2 modbs 2.99, for

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development of new generation hybrids. Upon receipt of the application, GEAC, in its 125th meeting held on 11.12.2015, appraised the same and decided that the CGMCP will be invited to give a presentation before GEAC in the subsequent meeting. Pursuant to the same, the CGMCP made a presentation before GEAC in the 126th meeting held on 04.01.2016 and the CGMCP was directed to furnish clarifications with respect to some issues in para 3.3 of the Minutes of the Meeting. It was further decided in the meeting that a sub-committee would be constituted under the chairmanship of Dr. K. Veluthambi, Co-Chair of GEAC, and the said sub-committee would have the duty of examining the issues raised by GEAC in para 3.3 and submit a report with recommendations to GEAC. 8.7 On 02.02.2016, the sub-committee appointed by GEAC convened its first meeting and in that meeting, it voiced concerns over the clarifications furnished by the CGMCP on the issues mentioned in para 3.3. However, in the 127th meeting of GEAC held on 05.02.2016, GEAC adopted the recommendations of the sub-committee and directed the CGMCP to revise the biosafety dossier, in light of the comments of the sub-committee and the biosafety unit, and prepare an RARM document for further review. It is stated that GEAC had decided to put the biosafety dossier in the public domain, but this was not carried out. 8.8 In its 128th Meeting held on 04.03.2016, GEAC decided to await the completion of the Biosafety Support Unit’s (BSU) review of the revised dossier before further consideration. On 11.04.2016, the sub-committee, in its 2nd Meeting, recommended incorporating expert comments and remarks from the Biosafety Unit into its report. The report was to be presented to GEAC and uploaded onto its website. In its 129 th Meeting on 20.06.2016, GEAC noted the Sub-Committee’s request for an additional month to finalize recommendations. Subsequently, in its 130th Meeting, GEAC concluded that a report had been submitted by the sub-committee, titled “Assessment of Food and Environmental Safety (AFES)”. It was published on GEAC’s website for stakeholder comments within a period of 30 days. However, it was complained that the biosafety dossier was deliberately not disclosed on the website for public scrutiny.

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8.9 On 07.09.2016, Dr. Bhargava, a member of GEAC, made a startling revelation. He stated that the so-called Report of the sub-committee titled “Assessment of Food and Environmental Safety” was never shared or discussed before GEAC. Following this revelation, on 22.09.2016, various scholars and public activists endorsed an email addressed to the Hon’ble Minister of Environment, Forest and Climate Change. The email raised serious objections to the conduct of the appraisal process, particularly the refusal to disclose the biosafety dossier to the general public. It urged the Ministry of Environment, Forest and Climate Change (MoEF&CC) to extend the consultation process by another 120 days. In addition to the email, on 24.09.2016, eminent scholars and experts sent a letter to the Hon’ble Minister of Environment, Forests and Climate Change, expressing grave concerns regarding GEAC’s blatant refusal to disclose the biosafety data to the general public, hindering a meaningful exercise of public consultation. It also requested an extension of the consultation process for another 120 days. Despite objections and requests for transparency, it is stated that GEAC continued the consultation process, culminating in a comment note published on 30.09.2016, refusing to extend the consultation period and setting the deadline for receiving comments as 05.10.2016. 8.10 Challenging the appraisal procedure adopted by GEAC, the petitioner has preferred the writ petition before this Court, under Article 32 of the Constitution of India, primarily contending that the aforesaid procedure adopted by GEAC was not only arbitrary but also lacked proper application of mind, rendering it illegal and violative of the fundamental rights enshrined under Articles 14 and 21 of the Constitution. This assertion was underscored by instances such as the failure to disclose crucial information, including the biosafety dossier, and the opaque nature of the consultation process, which impedes meaningful public participation. Further, the petitioner has emphasized the statutory obligations of GEAC to exercise its power of granting approvals for environmental release of GE products in a fair, transparent, and reasonable manner, especially considering the lack of any procedure laid down under the 1989 Rules for the exercise of its powers by

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GEAC. It is stated that the potential impact of the GM crops on health and environment can only be known after a long gestation period and therefore, a stricter scrutiny ought to have been undertaken. 8.11 Furthermore, the petitioner has criticized the sub-committee formed by GEAC, arguing that such delegation of statutory functions to another body is ultra vires the 1989 Rules. Additionally, concerns regarding the non-disclosure of the biosafety dossier despite assurances and directives from authorities has been raised, which undermine the transparency and integrity of the decision-making process. 8.12 The petitioner has also questioned the validity and adequacy of the AFES Report uploaded by GEAC, highlighting discrepancies in its findings, the lack of application of mind and the lack of comprehensive scientific scrutiny. It is averred that the said document was merely a 133-page summary document that does not explain to the public the data collected and the studies/tests conducted by the CGMCP. It is further pointed out from the AFES report that no study was conducted to examine the physiological impact of the transgene products from the transgenic mustard hybrid DMH-11 on the insects, no testing was done under the herbicide-sprayed conditions on an HT crop, and no testing was done on the honey quality, despite the questionable study of the impact on honey bees by the crop developers having vested interests in the subject. 8.13 Moreover, the restricted access to the biosafety dossier, despite assurances and directives to disclose it, has also been criticized, since it impedes meaningful public engagement and violates the rights of stakeholders to be informed and participate effectively in the consultation process. In terms of the consultation process, the petitioner has contended that GEAC ought to have adhered to the principles of fairness and transparency and ought not to have made a mockery of the entire process of public consultation to defeat the valuable rights of the general public to be informed about the critical date pertaining to the transgenic mustard hybrid DMH-11 crop. It was asserted that the present consultation process couldn’t be completed without making available to the public the critical scientific data. Further, the petitioner avers that it was also

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highly arbitrary to expect all the interest stakeholders from all corners of the country to travel to New Delhi and conduct a physical examination of the 3000 odd pages at the premises of the MoEF&CC and submit meaningful inputs. 8.14 It is averred that there has also been a failure to involve State Governments in the process, despite agriculture being a state subject and mustard being a highly important crop for the country. 8.15 Finally, the petitioner has drawn attention to the comparative inadequacy of the testing and consultation processes for genetically modified (GM) mustard, compared to previous cases like Bt brinjal. 8.16 Overall, the petitioner has contended that the appraisal process for transgenic mustard hybrid DMH-11 lacks transparency, has violated legal mandates, and fails to adequately consider the concerns of stakeholders, thereby warranting judicial intervention to ensure procedural fairness and safeguard public interest. Civil Appeal No.4086 of 2006: 8.17 This appeal assails order dated 08.10.2003 passed by the Appellate Authority in Appeal No.2 of 2002, constituted under Rule 19 of the 1989 Rules notified under the EP Act,

1986. The Appeal No.2 of 2002 was filed against the order dated 05.04.2002 of GEAC granting conditional clearance to M/s. Maharashtra Hybrid Seeds Co. Ltd. for three transgenic Bt hybrid cotton varieties, namely, Bt MECH 12, Bt MECH 162 and Bt MECH 184. By the impugned order, the appeal was dismissed by the Appellate Authority. 8.18 Vide Order dated 08.09.2006, leave was granted and vide order dated 13.07.2017, the appeal was directed to be tagged with Writ Petition (Civil) No.260 of 2005. Contempt Petition (Civil) No.295 of 2007 in Writ Petition (Civil) No.260 Of 2005; and, Contempt Petition (Civil) No.6 of 2016 in Writ Petition (Civil) No.260 Of 2005: 8.19 These contempt petitions have been filed alleging violation of orders dated 22.09.2006, 08.05.2007, 01.08.2007; and orders

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dated 15.02.2007, 08.05.2007, 08.04.2008 and 12.08.2008 respectively passed by this Court in Writ Petition (Civil) No.260 of 2005. Significant Orders passed by this Court in Writ Petitions:

9. By order dated 01.05.2006, this Court had directed that until further orders, field trials of GMOs shall be conducted only with the approval of GEAC. Order dated 10.05.2012 referred to above also notes that as of the year 2007, nearly 91 varieties of plants, i.e., GMOs, were being subjected to open-field tests. However, in terms of the aforesaid order of this Court, no further open-field tests were permitted nor had GEAC granted any such approval except with the authorization of this Court. This had given rise to serious controversies before this Court as to, whether, or not, the field tests of GMOs should be banned, wholly or partially, in the country. 9.1 This Court, feeling that it had no expertise to determine such an issue, which, besides being a scientific question, would have very serious and far-reaching policy consequences, by order dated 08.05.2007 lifted the moratorium on open-field trials, subject, however, to certain conditions. These included a directive in regard to the maintenance of 200 metres isolation distance while performing field tests of GMOs. 9.2 A further clarification was given vide order dated 08.04.2008, by which all concerned were directed to comply with the specific protocol of Level of Detection of 0.01 per cent. Since there was non-adherence to the said protocol and in the face of the report of one of the independent Experts, Dr. P.M. Bhargava, who was appointed to meet GEAC by the order of this Court dated 30.04.2009, the Government of India, on its own, imposed a complete ban on Bt brinjal. 9.3 Later, while hearing the Additional Solicitor General for Union of India as well as the learned counsel for the petitioners, this Court found that there was a consensus on the constitution of an Expert Committee on certain terms of reference as suggested in the Minutes of the Ministry’s meeting dated 15.03.2011 as there was a joint prayer for its constitution. 9.4 In these writ petitions, vide order dated 10.05.2012, this Court had noted the prayers of the petitioners seeking issuance of

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directions or order to the respondent, namely the Union of India, inter alia, not to allow the release of GMOs into the environment by way of import, manufacture, use or any other manner. An ancillary prayer was for the prescription of a protocol to which all the GMOs release would be subjected to. In addition, a direction was sought to the Union of India to frame relevant Rules in this regard and to ensure its implementation was sought. Constitution of the Technical Expert Committee (TEC):

10. In view of the above plea, this Court, after several dates of hearing, vide order dated 10.05.2012 constituted a Technical Expert Committee (TEC), the constitution of which was as follows: “1. Prof. V.L. Chopra, Former Member, Planning Commission and Former Member, Science & Advisory Committee to the PMO, Recipient of Padma Bhushan.

2. Dr. Imran Siddiqui, Group Leader, Centre for Cellular & Molecular Biology (CCMB).

3. Prof. P.S. Ramakrishnan, Emeritus Prof. JNU.

4. Dr. P.C. Chauhan, D. Phil (Sci).

5. Prof. P.C. Kesavan, Distinguished Fellow, MS SRF (Research Foundation), Emeritus Professor, CSD, IGNOU, New Delhi.

6. Dr. B. Sivakumar, Former Director, National Institute of Nutrition (NIN), Hyderabad.” 10.1 The Terms of Reference of the TEC were as follows: “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. 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. C. To advise on whether a proper evaluation of the genetically engineered crop/plants is scientifically

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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? 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. 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. F. To advise on whether institutions/laboratories in India have the state-of-art testing facilities and professional expertise to conduct various biosafety tests and recommend mechanisms to strengthen the same. If no such institutions are available in India, recommend setting up an independent testing laboratory/institution. G. The Expert Committee would be free to review reports or studies authored by national and international scientists if deemed necessary. The petitioners opined that they would like to formally propose three Expert Reports from Prof. David Andow, Prof. Jack Heinemann and Dr. Doug Gurian Sherman to be a formal part of the Committee’s deliberations. The MoEF may similarly nominate which experts they choose in this exercise.” 10.2 This Court directed the TEC to hear the Government, petitioners and any other intervenor, who, in the opinion of the TEC, could assist the cause of expeditious and accurate finalization of its report. A direction was also given to the TEC to submit an interim report on the following issue:

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“Whether there should or should not be any ban, partial or otherwise, on conducting open field tests of GMOs? In the event open field trials are permitted, what protocol should be followed and conditions, if any, that may be imposed by the Court for implementation of open field trials.” 10.3 Thereafter, an order was passed by this Court on 09.11.2012 recording the filing of an interim report dated 07.12.2012 and the objections filed to the said Report by the Union of India and others. Six weeks’ time was granted to the TEC to finalise and submit its final report. In the meantime, Dr. R.S. Paroda was appointed as a sixth member to the TEC in place of Prof. V.L. Chopra by order dated 09.11.2012. The TEC submitted its final report dated 30.06.2013. This included two reports, one, by the majority of five members of the TEC, and a separate note by Dr. R.S. Paroda. Final Report of TEC: 10.4 The Final Report of TEC is divided into following two topics: “I. Background and Context of the TEC’s Recommendations in the Interim Report; and II. Agricultural Policy Considerations in Relation to Knowledge and Practices: 9 Biotechnology and Agriculture 9 Usage of GM Crops 9 International Agreements and Instruments for Food Safety, Conservation and Regulation 9 The Indian GMO Regulatory Structure 9 Discussion of Recommendation of the Interim Report (IR) in the Context of the Terms of Reference for the TEC 9 Deliberations of the TEC Following Submission of the Interim Report 9 Issues that were discussed in the course of deliberations by the TEC

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9 Examination/Study of the Safety Dossiers 9 Molecular data 9 Health Safety Data 9 Examples of differences 9 Environmental Risk Assessments 9 Summary 9 Recommendations 10.5 The recommendations contained in the majority report are as follows: “Recommendations Based on the deliberations of the TEC and particularly the examination/study of the safety dossiers, 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, till such time it would not be advisable to conduct more field trials:

1. A secretariat comprising dedicated scientists with area expertise as well as expertise in biosafety needs to be established. This will require consultation with experts having experience at the international level in biosafety testing and evaluation of GM safety dossiers in reputed regulatory bodies. The TEC recommends doing it in collaboration with the Norwegian Government and GM regulatory body since the Norwegian system has an established commitment and experience in, is one of the few that are attuned to considering socio-economic issues that would be important in the Indian context. The regulatory body should have area-wise subcommittees/expert groups in for example: • Health (human and animal) • Environment and Ecology • Agroeconomics and Socioeconomics

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• Molecular biology • Entomology • Agricultural and Aquacultural Systems • Public Health • Soil science and microbiology • Plant biology • Regulatory toxicology • Plant and animal breeding and genetics A single committee such as the GEAC or RCGM doing all the valuation is not sufficient.

2. Conflict of interest in terms of location of the regulatory body needs to be addressed. The suggestion of the TEC is that the regulatory bodies to be located in the MoEF (environmental safety) and the MoHFW (health safety). At a different level, it is evident that members of the regulatory bodies should also be free of conflict of interest.

3. 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, These sites should be used only for field trials of GM crops (GM and control material). The sites could be in ICAR institutes or State Agricultural Universities and required conditions for isolation should be established and supported appropriately by ICAR. Sites in company premises may also be considered for certification for trials, however the land should be permanently owned by the applicant/tester. Trials should not be conducted on leased land so as to avoid the possibility that it may be used for a different purpose following the trials.

4. Stakeholder participation, need, socio-economic considerations, societal impact, and sustainability

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should be some of the dimensions to be incorporated in the risk assessment and this should be done at an early stage in the risk assessment process.” 10.6 The specific findings of the Report of the majority of TEC on the terms of reference may be discussed at this stage. (i) Firstly, as to the nature of sequencing of risk assessment studies that need to be done for GM crops before they are released into the environment, the majority recommended the following: a. The majority recommended consultation, ideally prior to the development of the GM product intended for field trials, wherein the applicant would provide information to the regulator about the product, its purpose (including whether it is intended for research only or commercialization), and how it is to be deployed in India. At this stage, the scope of issues that needs to be addressed relating to health and environmental safety can be discussed and defined on a case-wise basis keeping in mind the overall phases of risk assessment: hazard identification; hazard characterization; exposure assessment; risk characterization; and mitigation options. Need, socio-economic factors and sustainability should also be considered and thoroughly discussed at this stage. If a GMO is initially declared for research and at a later stage it is to be considered for commercialization then that would be treated as a fresh application. The overall process of risk assessment should follow the Flowchart for the Risk Assessment Process in the Guidance on Risk Assessment of LMIOs (UNEP/CBD/BS/COP MOP/6/13/Add.1) of the Cartagena Protocol on Biosafety (CPB). In the case of health safety, the regulator should expect a suitable response to all relevant paragraphs of the Codex Alimentarius Commission (CAC) Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant DNA (rDNA)

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Plants (CAC/GL 45-2003) and any other chosen risk assessment procedure. In doing so the regulator establishes a minimum expectation of the risk assessment meeting international requirements. It was pointed out that both the CPB and CAC guidelines provide guidance with regard to principles and issues that are to be addressed. They leave open the details of specific tests to be carried out which is left to the national system and the regulator. b. The majority, thus, noted the need to include chronic and transgenerational toxicity testing in feeding studies of rodents based on the fact that food is consumed over the entire lifetime and that nutritional stress can also lead to adverse or unintended effects over long-term exposure. The sensitive stages of reproduction also need to be included. c. In addition, the majority emphasized that the regulatory process should be open to new scientific information that may have a bearing on the risk assessment, if necessary, even after deregulation of an event. d. The majority also emphasised that the applicant should be responsible for providing to the regulator, all information that has a bearing on the risk assessment, regardless of whether it was obtained for the purpose of the risk assessment. In cases where the applicant is a collaborator/partner/ subsidiary in the development of the GMO, the applicant should provide this information along with the consent of all parties. e. With regard to the nature of tests for Bt in food crops, the majority was of the view that the safety of Bt transgenics with regard to chronic toxicity has not been established and this needs to be done before it can be considered safe. In this regard, it was pointed out that by far, the largest deployment

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of transgenics worldwide is in soyabean, corn, cotton, and canola, all of which are used primarily for oil or feed after processing. Nowhere are Bt transgenics being widely consumed in large amounts for any major food crop, that is, directly used for human consumption. The majority could not find any compelling reason for India to be the first to do so. It, therefore recommended that there should be a moratorium on field trials for Bt in food crops (those that are directly used for food) intended for commercialization (not research) until there is more definitive information from sufficient number of studies as to the long-term safety of Bt in food crops. f. The majority also examined issues in relation to Herbicide Tolerant (HT) crops. The conclusion here was that HT crops would most likely exert a highly adverse impact over time on sustainable agriculture, rural livelihoods, and environment. The majority, therefore, found them completely unsuitable in the Indian context. g. The majority also highlighted how crops in their centres of origin and diversity often have a deep cultural significance that can get lost when utilitarian considerations predominate the discourse. Ceremonial and medicinal varieties can also be put at risk from GM crops by reduction of diversity and genetic purity. For example, in the case of brinjal, the Malapur variety in Karnataka is an essential accompaniment at temple festivals and religious ceremonies. Likewise, Oryza nivara, a medicinal rice, can also be at risk if GM rice comes to dominate the crop as has happened for example, in the case of cotton, in India. h. The release of a GM crop into its area of origin or diversity has far greater ramifications and potential for negative impact than for other species. To justify this, the majority suggested a requirement of extraordinarily compelling reasons. GM crops

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that offer incremental advantages or solutions to specific and limited problems were not to be deemed sufficient reasons to justify such release. Not finding any such compelling reasons under the present conditions, it recommended that release of GM crops for which India is a centre of origin or diversity should not be allowed at all. (ii) Secondly, as for, when environmental release through open-field trials should be permitted, the majority recommended that 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. In other words, the testing should proceed in a progressive manner that increases confidence with regard to safety. While not covering all possible tests for all crops, it laid down certain minimum tests possible to carry out under contained conditions within the laboratory of greenhouse, before the GMO is taken out of containment. These include tests based on bioinformatics such as possible allergenicity and toxicity; acute toxicity of the purified protein; in-vitro digestibility and any other biochemical tests on the purified protein. Where appropriate and necessary, tests such as those for general growth characteristics and plant habit as part of event selections may be performed under confined conditions in consultation with the regulator. Those tests on the plant that can be performed under contained conditions as judged by the regulator on a case-wise basis should be performed under contained conditions. (iii) Thirdly, as for whether a proper evaluation of the GE plant is scientifically tenable in greenhouse conditions and whether it is possible to replicate the conditions for testing under different agro-ecological regions and seasons in greenhouse, the majority noted that it cannot be said that it is generally possible to replicate the conditions for testing under different agro-ecological regions and conditions in the greenhouse.

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(iv) Fourthly, the majority noted the need to develop specific sites for conducting field trials. It also emphasised the need for sufficient mechanisms for monitoring the trials and ensuring restricted access, disposal of material, associated testing and other facilities. These sites were recommended to be used only for field trials of GM crops (GM and control material). The sites could be in Indian Council of Agricultural Research (ICAR) Institutes or State Agricultural Universities and required conditions for isolation should be established and supported appropriately by ICAR. Sites in company premises may also be considered for certification for trials, however the land should be permanently owned by the applicant/ tester. Trials should not be conducted on leased land so as to avoid the possibility that it may be used for a different purpose following the trials. (v) Fifthly, on the feasibility of prescribing validated protocols and active testing for contamination with the view to preclude any escaped material from causing an adverse effect on the environment, the majority noted that the tests for detecting contamination at the stipulated level (0.01 %) are possible and have been demonstrated in some of the dossiers. However, it was emphasized that these in themselves do not preclude material from escaping. 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. Even in the most careful of conditions, contamination can occur. There are well-known examples of contamination having occurred as well. (vi) Finally, on whether institutions and laboratories in India have the state-of-art testing facilities and professional expertise to conduct various biosafety tests, the majority noted that the professional expertise and standards across the institutions appeared unsatisfactory. However, it noted that it is ultimately the expertise available in the regulatory system that sets the standards for conducting and evaluating the biosafety tests. Unless this expertise and capacity is present, no amount of facility creation

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will be able to address the issues. Based on the examination of the safety dossiers the majority found that at present, the regulatory system has major gaps and these will require rethinking, investment, and re-learning to fix. A deeper understanding of the process of Risk Assessment is needed within the regulatory system for it to meet the needs of a proper biosafety evaluation. This is not available in the country as per the majority. It, therefore, recommended that the requisite understanding be developed through consultation, collaboration, and capacity building. It is of critical importance that the Indian regulatory system develops the ability to assess how any GM product is likely to impact different sections of society. 10.7 Dr. R.S. Paroda submitted a separate dissenting report. A brief discussion of the Report may be adverted to. (i) Firstly, as for the nature of sequencing of risk assessment studies that need to be done for GM crops before they are released into the environment, Dr. Paroda, in his dissenting report recommended the following: a. The sequencing of studies provided in the “Guidance for Information/Data Generation and Documentation for Safety Assessment of Regulated, Genetically Engineered (GE) Plants”, which is in draft stage, should henceforth be adopted quickly by the RCGM and GEAC. b. The sequencing of studies presented in “Guidance for Information Generation and Documentation for Safety Assessment of Regulated, Genetically Engineered (GE) Plants” should, in future, be reviewed at regular intervals of no less than three years to ensure that these guidelines remain consistent with internationally accepted best practices and standards. c. Guidelines for the conduct of confined field trials and for GM food safety assessment that

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meet the international norms have currently been adopted by RCGM and GEAC. However, it was noted that the present approach for the environmental risk assessment (ERA) in the guidelines for research in transgenic plants was rather broad, whereas there is an urgent need for developing and adopting comprehensive guidelines for the ERA by RCGM and GEAC. The process for the same should be transparent and consultative, involving all stakeholders and it must start immediately. d. A Risk Assessment Unit (RAU), as also suggested in the “Draft Establishment Plan for the National Biotechnology Regulatory Authority” should be established. Further, the RAU should serve both RCGM and GEAC and be permanently staffed by a multi-disciplinary team of scientists/experts competent enough and responsible for undertaking science- based risk assessments, including but not limited to those required to approve clinical or confined field trials for the experimental GMOs as well as for their commercial release of GMOs (i.e., product specific risk assessments). The proposed RAU could be transitioned to the Biotechnology Regulatory Authority of India (BRAI), as and when the BRAI Bill is promulgated by the Parliament. e. In addition to establishing the RAU, RCGM and GEAC should immediately establish a roster of qualified scientific experts in relevant disciplines to provide sound scientific advice/ information on biosafety issues that could impact on human and animal health as well as the environment. The issue concerning conflict of interest should also be addressed while including experienced scientists to the roster.

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f. Although, the safety assessment is completed after GEAC approval and subsequently the GM crops are to be treated in the same manner as their non-GM counterparts for the purpose of variety/hybrid release and registration, seed multiplication and cultivation; as a measure to ensure quality products for the farmers, the National Agricultural Research System (NARS) should have an assigned responsibility for the conduct of confined field trials for assessing the agronomic performance, an essential requirement for the release of GM varieties/ hybrids in accordance with the National Seed Policy as well as National Seed Act. For this, ICAR Delhi can make good use of established infrastructure under the All India Crop Coordinated Programmes. It is advised that a single window system for managing the testing and release of GM varieties and hybrids should be established taking into account special considerations involved with GM crops viz. expression levels of inserted proteins, confirmation of the events etc., irrespective of whether these are produced by the private or public sector. In this context, the Ministry of Agriculture (MoA) should consider establishing a high-level committee of experts: including socio-economists, tanners, Non-Governmental Organisations (NGOs) and the representative of the private sector to review finally, for commercial release, the cases that are cleared by GEAC. g. Once a GM variety hybrid is released, a post-release monitoring mechanism must be put in place. (ii) Secondly, as to when environmental release through open-field trials should be permitted, the dissenting report noted that “open-field trial” is a misnomer in the

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context of trials of GM crops. This is because even though the trial is done in the open field, the GM plants and genetic material being tested are confined to the field trial site using measures to ensure that the “genes in pollen or seed do not escape from the trial site”. Thus, the right term is “Confined Field Trials”. It, then proceeded to suggest that Confined Field Trials should only be permitted by RCGM and GEAC after careful consideration of submissions that adhere exactly to the “Application for Confined Field Trial” form. This form, in combination with the “Guidelines and Standard Operating Procedures for Confined Field Trials of Regulated, Genetically Engineered Plants”, clearly specifies the information required by the competent authorities to determine if a Confined Field Trial should be permitted or not. The application form was developed through a transparent, consultative process that included a period for public review and comment. Hence, both the approach and procedure for permitting Confined Field Trials in India have already been peer-reviewed and public-reviewed. In sum, the tests that are required prior to obtaining a permit for a confined field trial are: a. Amino acid sequence homology comparisons to assess the extent to which the transgenic protein is similar in structure to known toxins; b. Amino acid sequence homology comparisons to assess the extent to which the transgenic protein is similar in structure to known allergens. It was also considered desirable, but not mandatory, to determine the maximum level of expression of the transgenic protein in the edible portions of the plant. (iii) Thirdly, as to whether a proper evaluation of the GE plant is scientifically tenable in the greenhouse conditions, the dissenting report answered in the negative. It noted that a proper evaluation of a GE plant is scientifically not tenable in a contained greenhouse since it would not be feasible to replicate the conditions

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prevailing under natural field conditions representing different agro-ecological regions and growing seasons. Therefore, it was advised that confined field testing, as recommended under the present regulatory system, is the right option for a realistic evaluation of any GE plant to know its suitability for any agronomic trait of economic importance. (iv) Fourthly, whether specific conditions imposed by the regulatory agencies for open-field trials (or “Confined Field Tests”, as Dr. Paroda prefers) are adequate, the dissenting report expressed concerns about the existing system in India and recommended, among other things, the following: a. The RCGM, GEAC and ICAR must work hand in hand to conduct the confined field trials at the specified sites as well as improve the quality and timeliness of inspections by qualified monitoring teams. A roster of such monitors, with required expertise needs to be maintained and updated regularly by these agencies. b. Crop-specific Standard Operating Procedures (SOP) should be developed and made available online. Such SOPs should incorporate, in addition to the existing procedures, i) methods for reproductive isolation of the confined field trial site, ii) schedules for monitoring the field trial during and after the growing season, iii) required duration of post-harvest restrictions on the trial site, and iv) methods for on-site/ off-site disposal of regulated plant materials. c. A system for notification of confined field trial sites located in different agro-ecological zones should be developed by RCGM and GEAC in consultation with the ICAR. These sites could include both public and private sector institutions/facilities, meeting the specified

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conditions. However, no trials should be allowed on farmers’ fields, leased or otherwise. d. Integrate the existing system of testing and standard protocols under All India Coordinated Research Project (AICRP) with the three years of confined field testing in Biosafety Research Level (BRL)-I and BRL-II. The agronomic evaluation should be against the best national check, regional check, and the latest released variety or hybrid in the state concerned. For all the new events, the decision of RCGM and GEAC on biosafety and environmental concerns must be final at either of the testing stages (BRL-I or BRL-II), irrespective of good agronomic performance of the variety. e. Monitoring for biosafety compliance as well as agronomic performance of each confined field trial must be made mandatory, and should be carried out by GEAC through an inter-ministerial monitoring compliance committee including people drawn from a roster of experts. In addition, each confined field trial must be monitored by a site-specific monitoring committee. f. In cases where an already approved event is incorporated into a new genetic background, after being verified for its stability, such variety or hybrid shall be evaluated independently by the AICRP protocol for agronomic performance and the expression of the event concerned for a period of two years, as per the existing practice under the New Seed Policy. g. Varieties or hybrids evaluated by the above process shall then be approved for general cultivation by a Central GM-Crop Release Committee at par with the Variety Release

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Committee under the MoA. This committee shall include experts from the disciplines concerned including the Crop Project Coordinators or Director, officials of Seed or Crops Divisions of DAC and ICAR, socio- economists, progressive farmers, NGOs and the private sector representatives. h. Once a GM crop variety/hybrid is released, a well-designed case-by-case post-release monitoring system must be put in place jointly by the Department of Agriculture and Cooperation (DoAC) and ICAR to address specific post-release issues identified during the event approval by GEAC. Such a system should also monitor the long term effects from the point of view of food safety, soil health, environment and agronomic performance. i. Finally, the MoA may also consider issuing a separate notification on priority for the general release of GM crops at par with New Seeds Policy, while legally ensuring much needed harmonization of both EPA under Ministry of Environment and Forests (MoEF) and the Seed Act under MoA. 10.8 A corrigendum was issued to the final report of TEC on 12.07.2013. Paragraph 6 of the Majority Report is modified by the corrigendum, which reads as under: “6. page 71, lines 3-5: “… exert a highly adverse impact over time on sustainable agriculture, rural livelihoods, and environment. The TEC finds them completely unsuitable in the Indian context.” Corrected: “… exert a highly adverse impact on sustainable agriculture, rural livelihoods, and environment. The TEC finds them completely unsuitable in the Indian context and recommends that field trials and release of HT crops not be allowed in India.”

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Parliamentary Standing Committee (PSC) on Agriculture’s Report on “Cultivation of Genetically Modified Food Crops – Prospects and Effects” – 2012:

11. The aforesaid Report, submitted on 09.08.2012, has been relied upon by the learned counsel Sri Prashant Bhushan. The salient observations and recommendations of the said Committee are encapsulated in the following paragraphs: i. To ascertain the efficacy of the extant system in general and the role of GEAC as the apex regulator in particular, the Committee sought the views of Dr. P.M. Bhargava, founder Director of CCMB, Hyderabad and then the Supreme Court nominee on GEAC. The gist of the testimony of Dr. P.M. Bhargava given on 22.12.2010 can be crystallised in the following points: a. All the tests on Bt cotton have either been conducted by the concerned applicant for approval, or by an accredited laboratory on the samples given by the applicant. The Bt cotton was tested and approved surreptitiously without adequate information being available to the public. b. The Bt brinjal was approved on the basis of an expert committee report, which lacked in scientific quality, credibility, consistency and rigour. Relying upon a private conversation with the then Co-Chairman of GEAC, Prof. Arjula Reddy, Dr. Bhargava claimed that the former was under pressure to approve Bt brinjal and to give a go by to the chronic toxicity and other tests which had been proposed by the latter. He also claimed that the Co-Chairman confided in him that even the tests undertaken were performed badly. c. That no chronic toxic studies have been conducted on GM crops. d. Despite a specific proposal for establishing a lab to conduct indigenous and independent assessment studies, the erstwhile Director General of ICAR, Dr. R.S. Paroda, the erstwhile Director General of Council

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of Scientific and Industrial Research (CSIR), Dr. R.A. Mashelkar and GEAC were reluctant to support the same. ii. The Committee, discussing the status, composition and functioning of GEAC, highlighted the following deficiencies: a. GEAC is headed by a civil servant, who is also functioning in another capacity in the MoEF, the controlling authority of GEAC. b. The Co-Chairman of GEAC is a biotechnologist who, though purportedly from outside, is nominated by the DBT, the Department that funds and promotes projects on transgenic products. Therefore, primacy is accorded to the DBT nominated Co-Chair in the decision-making process. c. The Vice-Chairman is again a civil servant, simultaneously discharging a few more responsibilities in another role in the MoEF. d. GEAC being an entity created under the 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. iii. The Committee noted the findings of several scientific reports, including the International Assessment of Agricultural Knowledge, Science and Technology for Development (IAASTD) Report – ‘Agriculture at a Crossroads’, and underlined the following shortcomings of modern biotechnology in agriculture: a. Modern biotechnologies have yet to prove their efficacy, safety and sustainability in the case of GM crops. There are significant limitations in its ability to conserve the resilience of small and subsistence agricultural systems, etc. b. Containment of harm would be a very challenging task even for some of the most well-equipped developed countries and simply impossible in a country like India.

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c. The integration of biotechnology must be within an enabling environment, supported by local research and education that empowers local communities. iv. With respect to regulation and labelling of GM foodstuffs, the Committee observed the casual approach on the part of both MoEF and Ministry of Health and Family Welfare (MoHFW). While the MoEF, on 23.08.2007, exempted all GM food categories from regulations under Rule 11 if the end product was not an LMO, the MoHFW did not include GM foods from the restrictions on manufacture, distribution and selling when it issued the notification under Section 22, Food Safety and Standards Act, 2006 (for short, “FSSA, 2006”). The Committee noted that the Food Safety and Standards Authority of India (FSSAI) regulation for GM processed food was nowhere in sight, even though so many years had gone by. While noting that Section 23 of FSSA, 2006 requires FSSAI to notify labelling, the Committee observed that FSSAI had not been able to do so. v. It was concluded that the tendency of the regulatory mechanism, in the absence of specialized infrastructure and research and development (R&D) facilities in India, is to base their decision- making on practices and studies elsewhere, as also on the assessments and data generated by the applicant concerned. This was particularly concerning in light of the testimony of Dr. Bhargava, as the contents of his testimony were “not merely slippages due to oversight or human error but indicative of collusion of the worst kind”. By its very composition, GEAC does not have regular existence and meets monthly only when some decisions are to be taken. It is also a sad reality that modern biotechnology being a nascent discipline in the Country, we have a serious dearth of scientists of eminence in sufficient numbers, therefore, more or less the same set of people sit on both the sides, i.e., to develop technologies and products, as also to assess, evaluate and approve them. vi. The Committee noted that Article 246 of the Constitution of India, read with Entry 14, List II, assigns “agriculture, including agricultural education and research, protection against pest and