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

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petitioners’ concern is the irreversible risk of contamination that the country faces, if environmental release of GMOs is permitted in the absence of any chronic studies vis-à-vis human health, livestock, environment, biodiversity etc. It was pointed out that Union of India was silent as to the measures undertaken to ensure non-contamination. The Union of India was also silent about the measures undertaken in respect of labelling of GM foods, in light of the fact that no chronic studies have been commissioned as regards the consumption of GM foods. Also, the Union of India was silent as to the liability of the applicant and GEAC for potential losses to farmers and consumers on account of irreversible contamination. 20.8 In this regard, the TEC Report was referred to, wherein it has been stated that currently eighteen new food crop species, for which applications for field trial have been received in the Indian system, are - cauliflower, cabbage, corn, rice, wheat, tomato, groundnut, potato, sorghum, okra, brinjal, mustard, papaya, watermelon, sugarcane, etc. Also, the growth of GM crop would impact organic food producers and given the difficulties in segregation of GM and non-GM foods, it would be difficult to meet the criteria for organic food. This was said to have potential adverse impact on export of organic food, as the importers would closely examine the conditions under which organic food is being grown and any concern about contamination could lead to an adverse impact and loss of markets for organic food producers. 20.9 It was further submitted that GEAC, the regulator, has failed to deal with the illegal plantation of HT Bt cotton and the same is being grown in the country illegally on commercial basis. In fact, the intervenor in the present proceedings, Shetkari Sangathan, has also been illegally planting Bt brinjal and has been encouraging farmers to do so, and GEAC has failed to check the same. 20.10 It was next submitted that large quantities of GM processed oil was being imported in the form of canola oil sourced largely from GM canola seeds and soyabean oil sourced from GM soyabean seeds. It was argued that this is in violation of the law.

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20.11 Section 22 of the FSSA, 2006 prohibits manufacture, distribution, sale or import of any GMO products, except in accordance with the regulations which the Central Government may notify. This has been a subject matter of a judgment of this Court in Writ Petition (Civil) No.173 of 2006, Vandana Shiva vs. Union of India, disposed of on 11.08.2017, wherein it was recorded that there was no notification or regulation allowing any activity in connection with GE and modified food and such activity was permissible only under the regulations framed under Section 22 of the FSSA, 2006. The said writ petition was disposed of by allowing liberty to the petitioner therein to approach this Court again after regulations framed in connection with GE and modified food under Section 22 of the FSSA, 2006, are placed for consideration by the Parliament, in order to test their legality upon constitutional sustainability. However, till date, no notification has been issued by the Union of India. 20.12 In addition, it was pointed out that GEAC in their communication addressed to Directorate General of Foreign Trade (DGFT), dated 23.02.2018, had informed that it had not authorised or approved GM soyabean or any other products derived from GM soyabean seeds for import or cultivation in India. That being the case, it is not known on what basis is GM food being imported to India. 20.13 It was next submitted that there was a failure to undertake any socio-economic risk analysis by GEAC with regard to the failure of Bt cotton in accordance with the CBD and CPB. The need for such an assessment was also highlighted by TEC. 20.14 In this regard, reference was made to Mahyco Monsanto Biotec (India) Private Ltd. vs. Union of India, Writ Petition (Civil) No.12069 of 2015, filed before the Delhi High Court, in which the petitioner therein had challenged the price control order issued by the Union of India under the Essential Commodities Act, 1955 as regards Bt cotton seeds. The challenge is pending before the Delhi High Court. Pertinently, the Ministry of Agriculture and Farmers Welfare, Government of India, in the said case, has stated that the farmers across the country have been financially burdened due to the increasing

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prices of Bt cotton seeds. They have also to spend on pesticides and other resources to make the crops more pest resistant and high-yielding. This has resulted in escalated expenses and reduced the margin of profit for the farmers. 20.15 It was also brought to our notice that the pink bollworm, a major pest to the cotton crop, has developed resistance in the last two or three years and has worried the farmers who have sown Bt cotton seeds. That, the cotton yields were stagnant in the last five years due to the fact that the technology was used not for yield improvement but only for prevention of loss. 20.16 Referring to Article 14(1)(b) of the Argentina Convention, it was submitted that a duty is cast on the Government of India to assess the impact of its policies and minimize adverse impacts, as India is a signatory to the said convention. 20.17 It was, thus, argued that the 1989 Rules, which are prior in time to the CPB, have to be brought in line with the said protocol. Similarly, the Biological Diversity Act, 2002, casts a duty on the Central Government to protect biodiversity as per Section 36 of the said Act. In this regard, reference was made to the judgment of this Court in Gramophone Company of India Ltd. vs. Birendra Bahadur Pandey, (1984) 2 SCC 534 (“Gramophone Co. of India Ltd.”), and Vishaka vs. State of Rajasthan, (1997) 6 SCC 241 (“Vishaka”), which dealt with the doctrine of incorporation of international law into Indian law and how the same could be read to be part of national law unless they are in conflict with an Act of Parliament. 20.18 Further, any international convention not inconsistent with the fundamental rights and in harmony with its spirit must be read into these provisions to enlarge the meaning and content thereof, so as to promote the object of the constitutional guarantee. 20.19 Similarly, reference was made to Nilabati Behera vs. State of Orissa, (1993) 2 SCC 746 (“Nilabati Behera”), wherein the absence of an enacted law to provide for effective enforcement of the basic human right of gender equality was held to give the basis for using international conventions and norms to construe and give meaning to fundamental rights guaranteed under the Constitution of India.

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20.20 It was also submitted that the present regulatory system continues to be deficient and therefore, there is a need for putting in place a suitable regulatory system which would work within the framework of its mandate. 20.21 In conclusion, it was submitted that the petitioners were seeking implementation of the recommendations of the TEC. That the TEC Report has been given a go-by by GEAC in consideration of the application made by Prof. Pental, Former Professor of Genetics and Vice-Chancellor, University of Delhi, South Campus, New Delhi. Therefore, the petitioners have sought the aforesaid reliefs. Points for Consideration:

21. Before framing the points for consideration, we make it clear that this case does not decide the competing claims made in the scientific literature about the desirability of GMOs, their impact on increasing crop yield in the short or long term and other subjects that belong to the domain of scientific and agricultural experts. This Court is not conducting a review or an evaluation of various scientific studies submitted by the petitioners and the respondents on GMOs. This Court does not have the institutional competence and therefore any conclusion raised on that basis would be a futile exercise. 21.1 The purpose of our adjudication is to satisfy our judicial conscience on the subject of critical public interest. We have viewed the matter from the perspective of compliances of the principles of exercise of discretion and use of administrative power in a niche area where opinions of scientists and experts in the field would determine the course of action to be taken in a matter as significant as the steps leading to the decision for environmental release of DMH-11 mustard in an altered technology. 21.2 This case also does not decide on the divergent substantive content and recommendations made by the TEC or GEAC. The ambit of the present case is strictly limited to compliance with constitutional and legal requirements in the decision-making process impugned herein. In light of the aforesaid, and the

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submissions advanced by learned senior counsel and counsel for respective parties, the following points would arise for our consideration: (i) 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? (ii) Whether the decision to grant approval for environmental release of DMH-11 violates the right to safe and healthy environment under Article 21? (iii) 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? (iv) What order? Since there is a difference of opinion between the Members of this Bench vis-à-vis the validity of the decision taken for environmental release of DMH-11, from this stage onwards, I propose to opine for myself while my learned brother Karol, J. has prepared his separate opinion. Legal Framework:

22. Before I proceed further, it would be useful to note that agriculture, including agricultural education and research, protection against pests and prevention of plant diseases, is a State subject enumerated as Entry 14 in List II (State List). Trade and commerce in, and the production, supply and distribution of, inter alia, foodstuffs, including edible oil seeds and oils, is in Entry 33(b) in List III (Concurrent List) of the Seventh Schedule. Rules and regulations made under the EP Act, 1986 are possibly referrable to Entry 97 of List I (Union List) since environment protection has not been specifically mentioned in either List II or List III of the Seventh Schedule, except for forest. For ease of reference, the aforesaid Entries of the Seventh Schedule as well as others are extracted as under: “Entry 52, List I:

52. Industries, the control of which by the Union is declared by Parliament by law to be expedient in the public interest.

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Entry 97, List I:

97. Any other matter not enumerated in List II or List III including any tax not mentioned in either of those Lists. Entry 6, List II:

6. Public health and sanitation; hospitals and dispensaries. Entry 14, List II:

14. Agriculture, including agricultural education and research, protection against pests and prevention of plant diseases. Entry 33(b), List III:

33. Trade and commerce in, and the production, supply and distribution of,- ……… (b) foodstuffs, including edible oilseeds and oils;” 22.1 Article 48A of the Constitution of India is a Directive Principle of State Policy which speaks about protection and improvement of environment and safeguarding of forests and wild life. Likewise, Article 51A(g) casts upon citizens a fundamental duty to protect and improve the natural environment including forests, lakes, rivers and wildlife. These Articles have to be read in the context of Article 21 of the Constitution, which has been expansively interpreted by this Court to include within its scope and ambit of the right to health and clean environment and ecology. For ready reference, the aforesaid Articles are extracted as under: “21. Protection of life and personal liberty.— No person shall be deprived of his life or personal liberty except according to procedure established by law. xxx 48A. Protection and improvement of environment and safeguarding of forests and wild life.—The State shall endeavour to protect and improve the

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environment and to safeguard the forests and wild life of the country. xxx 51A. Fundamental duties.—It shall be the duty of every citizen of India— xxx (g) to protect and improve the natural environment including forests, lakes, rivers and wild life, and to have compassion for living creatures;”

23. At this point, it is also observed that Article 21 also encompasses the right to food safety. It is in this context that the FSSA, 2006 has been enacted and I would now advert to the provisions contained therein as well. 23.1 FSSA, 2006 has been enacted pursuant to Entry 52, List I of the Seventh Schedule of the Constitution. Section 2 of the said Act has declared that it is expedient in the public interest that the Union should take under its control the food industry. 23.2 The Preamble of the FSSA, 2006, inter alia, states that it is an Act to consolidate the laws relating to food and to establish the FSSAI for laying down science-based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import, to ensure availability of safe and wholesome food for human consumption. The following provisions under the FSSA, 2006 could be adverted to: “2. Declaration as to expediency of control by the Union.- It is hereby declared that it is expedient in the public interest that the Union should take under its control the food industry.

3. Definitions. (1) In this Act, unless the context otherwise requires, – (a) “adulterant” means any material which is or could be employed for making the food unsafe or sub- standard or mis-branded or containing extraneous matter; xxx

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(j) “Food” means any substance, whether processed, partially processed or unprocessed, which is intended for human consumption and includes primary food, to the extent defined in clause (ZK) genetically modified or engineered food or food containing such ingredients, infant food, packaged drinking water, alcoholic drink, chewing gum, and any substance, including water used into the food during its manufacture, preparation or treatment but does not include any animal feed, live animals unless they are prepared or processed for placing on the market for human consumption, plants, prior to harvesting, drugs and medicinal products, cosmetics, narcotic or psychotropic substances : Provided that the Central Government may declare, by notification in the Official Gazette, any other article as food for the purposes of this Act having regards to its use, nature, substance or quality; xxx (q) “food safety” means assurance that food is acceptable for human consumption according to its intended use; xxx (u) “hazard” means a biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect; xxx (v) “import” means bringing into India any article of food by land, sea or air; xxx (zk) “primary food” means an article of food, being a produce of agriculture or horticulture or animal husbandry and dairying or aquaculture in its natural form, resulting from the growing, raising, cultivation,

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picking, harvesting, collection or catching in the hands of a person other than a farmer or fisherman; xxx (zm) “risk”, in relation to any article of food, means the probability of an adverse effect on the health of consumers of such food and the severity of that effect, consequential to a food hazard; (zn) “risk analysis”, in relation to any article of food, means a process consisting of three components, i.e. risk assessment, risk management and risk communication; (zo) “risk assessment” means a scientifically based process consisting of the following steps: (i) hazard identification, (ii) hazard characterisation; (iii) exposure assessment, and (iv) risk characterisation; (zp) “risk communication” means the interactive exchange of information and opinions throughout the risk analysis process concerning risks, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions; (zq) “risk management” means the process, distinct from risk assessment, of evaluating policy alternatives, in consultation with all interested parties considering risk assessment and other factors relevant for the protection of health of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options; xxx (zu) “standard”, in relation to any article of food, means the standards notified by the Food Authority; xxx

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(zw) “substance” includes any natural or artificial substance or other matter, whether it is in a solid state or in liquid form or in the form of gas or vapour; (zx) “Sub-standard” - an article of food shall be deemed to be sub-standard if it does not meet the specified standards but not so as to render the article of food unsafe;” 23.3 It would be necessary to refer to Section 22 of the said Act, which deals with GM foods, organic foods, functional foods, proprietary foods, etc. The said Section reads as under: “22. Genetically modified foods, organic foods, functional foods, proprietary foods, etc. - Save as otherwise provided under this Act and regulations made thereunder, no person shall manufacture, distribute, sell or import any novel food, genetically modified articles of food, irradiated food, organic foods, foods for special dietary uses, functional foods, neutraceuticals, health supplements, proprietary foods and such other articles of food which the Central Government may notify in this behalf. Explanation.– For the purposes of this section,– (1) “foods for special dietary uses or functional foods or nutraceuticals or health supplements” means: (a) foods which are specially processed or formulated to satisfy particular dietary requirements which exist because of a particular physical or physiological condition or specific diseases and disorders and which are presented as such, wherein the composition of these foodstuffs must differ significantly from the composition of ordinary foods of comparable nature, if such ordinary foods exist, and may contain one or more of the following ingredients, namely:- (i) plants or botanicals or their parts in the form of powder, concentrate or extract in water, ethyl alcohol or hydro alcoholic extract, single or in combination;

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(ii) minerals or vitamins or proteins or metals or their compounds or amino acids (in amounts not exceeding the Recommended Daily Allowance for Indians) or enzymes (within permissible limits); (iii) substances from animal origin; (iv) a dietary substance for use by human beings to supplement the diet by increasing the total dietary intake; (b) (i) a product that is labelled as a “Food for special dietary uses or functional foods or nutraceuticals or health supplements or similar such foods” which is not represented for use as a conventional food and whereby such products may be formulated in the form of powders, granules, tablets, capsules, liquids, jelly and other dosage forms but not parenterals, and are meant for oral administration; (ii) such product does not include a drug as defined in clause (b) and ayurvedic, sidha and unani drugs as defined in clauses (a) and (h) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and rules made thereunder; (iii) does not claim to cure or mitigate any specific disease, disorder or condition (except for certain health benefit or such promotion claims) as may be permitted by the regulations made under this Act; (iv) does not include a narcotic drug or a psychotropic substance as defined in the Schedule of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985) and rules made thereunder and substances listed in Schedules E and EI of the Drugs and Cosmetics Rules, 1945;

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(2) “genetically engineered or modified food” means food and food ingredients composed of or containing genetically modified or engineered organisms obtained through modern biotechnology, or food and food ingredients produced from but not containing genetically modified or engineered organisms obtained through modern biotechnology; (3) “organic food” means food products that have been produced in accordance with specified organic production standards; (4) “proprietary and novel food” means an article of food for which standards have not been specified but is not unsafe: Provided that such food does not contain any of the foods and ingredients prohibited under this Act and regulations made thereunder.” 23.4 Since I am dealing with GE or modified food, it would be useful to note the definition thereof under sub-section (2) of Section 22, which defines it as food and food ingredients composed of or containing GM or engineered organisms obtained through modern biotechnology, or food and food ingredients produced from but not containing GM or engineered organisms obtained through modern biotechnology. 23.5 The Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 (hereinafter referred to as, “the Food Safety Regulations, 2011”) have been framed under Section 92(2)(e) read with Section 16 of the FSSA, 2006 by the FSSAI. In Regulation 2.9.13(1), details regarding mustard (Rai, Sarson) are mentioned as under: “2.9.13: Mustard (Rai, Sarson)

1. Mustard (Rai, Sarson) Whole means the dried, clean mature seeds of one or more of the plants of Brassica alba. (L). Boiss (Safed rai), Brassica compestris L.var, dichotoma (Kali Sarson), Brasssica Compestris, L. Var, yellow Sarson, Syn, Brassica compestris L, var glauca (Pili Sarson), Brassica, compestris L. Var. toria (Toria), Barassicajuncea,

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(L). Coss et Czern (Rai, Lotni) and Brassica nigra (L); Koch (Benarasi rai). It shall be free from mould, living and dead insects, insect fragments, rodent contamination. The product shall be free from the seeds of Argemone Maxicana L, any other harmful substances and added colouring matter. It shall conform to the following standards:

(i) Extraneous matter Not more than 2.0 percent by weight. (ii) Damaged or Not more than Shrivelled Seeds 2.0 percent by weight. (iii) Moisture Not more than 10.0 percent by weight. (iv) Total ash on dry Not more than basis 6.5 percent by weight. (v) Ash insoluble in Not more than dilute HCl on dry 1.0 percent by weight. basis (vi) Non volatile ether Not less than extract on dry basis 28.0 percent by weight. (vii) Violatile oil content Not less than on dry basis 0.3 percent by v/w. (viii) Insect damaged Not more than matter 1.0 percent by weight. (ix) Allyl iso thiocyanate (m/m) on dry basis (a) B nigra Not less than 1.0 percent by Weight. (b) B Juncea Not less than 0.7 percent by Weight. (x) P-hydroxybenzyl Not less than 2.3 iso-thiocyanate percent by weight. (m/m) on dry basis in sinapist alba (xi) Argemone seeds Absent.”

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Environment (Protection) Act, 1986 (EP Act, 1986):

24. EP Act, 1986 has been enacted to provide for the protection and improvement of environment and for matters connected therewith. The relevant provisions of the said Act are extracted as under: “2. Definitions.- In this Act, unless the context otherwise requires,- (a) “environment” includes water, air and land and the inter-relationship which exists among and between water, air and land, and human beings, other living creatures, plants, micro-organism and property; (b) “environmental pollutant” means any solid, liquid or gaseous substance present in such concentration as may be, or tend to be, injurious to environment; (c) “environmental pollution” means the presence in the environment of any environmental pollutant;” 1989 Rules:

25. In exercise of the powers conferred by Sections 6, 8 and 25 of the EP Act, 1986 and with a view to protect the environment, nature and health in connection with the application of gene-technology and micro-organisms, the Central Government has framed the 1989 Rules. The said Rules dealing with manufacture, use, import, export and storage of hazardous micro-organisms/GE organisms or cells were notified with a view to protect the environment, nature and health in connection with the application of gene-technology and micro-organisms. These Rules were gazetted on 05.12.1989 and are applicable to Genetically Engineered Organisms (GEOs)/ micro-organisms and cells and correspondingly to any substances and products and food stuffs, etc., of which such cells, organisms or tissues thereof form part. The Rules also apply to new gene- technologies, apart from those referred to in clause (ii) and (iv) of Rule 3, and to organisms/micro-organisms and cells generated by the utilisation of such other gene-technologies and to substances and products of which such organisms and cells form part. The conditions under which the Rules are applicable have been stated in sub-paragraph (4) of Rule 2 of the said Rules.

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25.1 Rule 3 defines, inter alia, the expressions, “biotechnology”, “gene technology” and “genetic engineering”, which read as under: “3. Definitions:- In these rules unless the context requires. (i) “Biotechnology” means the application of scientific and engineering principles to the processing of materials by biological agents to produce goods and services; (ii) x x x (iii) “Gene Technology” means the application of the gene technique called genetic engineering, include self cloning and deletion as well as cell hybridisation; (iv) “Genetic engineering” means the technique by which heritable material, which does not usually occur or will not occur naturally in the organism or cell concerned, generated outside the organism or the cell is inserted into the said cell or organism. It shall also mean the formation of new combinations of genetic material by incorporation of a cell into a host cell, where they occur naturally (self cloning) as well as modification of an organism or in a cell by deletion and removal of parts of the heritable material;” 25.2 Rule 4 speaks of the competent authorities constituted under the Rules and the said Rule reads as under: “4. Competent Authorities:- (1) Recombinant DNA Advisory Committee (RDAC). This Committee shall review developments in Biotechnology at national and international levels and shall recommend suitable and appropriate safety regulations for India in recombinant research, use and applications from time to time. The Committee shall function in the Department of Biotechnology.

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(2) Review Committee on Genetic Manipulation (RCGM). This committee shall function in the Department of Biotechnology to monitor the safety related aspects in respect of on-going research projects and activities involving genetically engineered organisms/ hazardous microorganisms. The Review Committee on Genetic Manipulation shall include representatives (a) Department of Biotechnology (b) Indian Council of Medical Research (c) Indian Council of Agricultural Research (d) Council of Scientific and Industrial Research (e) other experts in their individual capacity. Review Committee on Genetic Manipulation may appoint sub-groups. It shall bring out Manuals of guidelines specifying procedure for regulatory process with respect to activities involving genetically engineered organisms in research, use and applications including industry with a view to ensure environmental safety. All on-going projects involving high risk category and controlled field experiments shall be reviewed to ensure that adequate precautions and containment conditions are followed as per the guidelines. The Review Committee on Genetic Manipulation shall lay down procedures restricting or prohibiting production, sale, importation and use of such genetically engineered organism or cells as are mentioned in the Schedule. (3) Institutional Biosafety Committee (IBSC). This Committee shall be constituted by an occupier or any person including research institutions handling microorganism/genetically engineered organisms. The committee shall comprise the Head of the Institution, Scientists engaged in DNA work, a medical expert and a nominee of the Department of Biotechnology. The occupier or any person including research institutions handling microorganism/genetically engineered

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organisms shall prepare, with the assistance of the Institutional Biosafety Committee (IBSC) an uptodate on-site emergency plan according to the manuals/ guidelines of the RCGM and make available copies to the District Level Committee/State Biotechnology Co-ordination Committee and the Genetic Engineering Approval Committee (4) Genetic Engineering Approval Committee (GEAC). This committee shall function as a body under the Department of Environment, Forest and Wildlife for approval of activities involving large scale use of hazardous microorganisms and recombinants in research and industrial production from the environmental angle. The committee shall also be responsible for approval of proposals relating to release of genetically engineered organisms and products into the environment including experimental field trials. The composition of the Committee shall be - (i) Chairman – Additional Secretary, Department of Environment, Forests and Wildlife. Co-Chairman – Representative of Department of Biotechnology. (ii) Members : Representatives of concerned Agencies and Departments, namely, Ministry of Industrial Development, Department of Biotechnology and the Department of Atomic Energy. (iii) Expert members : Director General – Indian Council of Agricultural Research, Director General – Indian Council of Medical Research, Director General – Council of Scientific and Industrial Research, Director General – Health Servies, Plant Protection Adviser, Directorate

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of Plant Protection, Quarantine and storage, Chairman, Central Pollution Control Board and three outside experts in individual capacity. (iv) Member Secretary : An official of the Department or Environment, Forest and Wildlife. The committee may co-opt other members/experts as necessary. The committee or any person/s authorised by it shall have powers to take punitive action under the Environment (Protection) Act. (5) State Biotechnology Co-ordination Committee (SBCC). There shall be a State Biotechnology Coordination Committee in the States wherever necessary. It shall have powers to inspect, investigate and take punitive action in case of violations of statutory provisions through the Nodal Department and the State Pollution Control Board/Directorate of Health/Medical Services. The Committee shall review periodically the safety and control measures in the various industries/institutions handling genetically engineered organisms/hazardous microorganisms. The composition of the Coordination Committee shall be:

(i) Chief Secretary – Chairman (ii) Secretary, Department of – Member Environment Secretary (iii) Secretary, Department of – Member Health (iv) Secretary, Department of – Member Agriculture (v) Secretary, Department of – Member Industries and Commerce (vi) Secretary, Department of – Member Forests

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(vii) Secretary, Department – Member of Public Works/Chief Engineer, Department of Public Health Engineering (viii) State Microbiologists and – Member Pathologists (ix) Chairman of State Pollution Control Board The Committee may co-opt other members/experts as necessary. (6) District Level Committee (DLC). There shall be a District Level Biotechnology Committee (DLC) in the districts wherever necessary under the District Collectors to monitor the safety regulations in installations engaged in the use of genetically modified organisms/hazardous microorganisms and its applications in the environment. The District Level Committee/or any other persons/s authorised in this behalf shall visit the installation engaged in activity involving genetically engineered organisms, hazardous microorganisms, formulate information chart, find out hazards and risks associated with each of these installations and coordinate activities with a view to meeting any emergency. They shall also prepare an off-site emergency plan. The District Level Committee shall regularly submits its report to the State Biotechnology Co-ordination Committee/Genetic Engineering Approval Committee. The District Level Committee shall comprise of:-

(i) District Collector – Chairman (ii) Factory Inspector – Member (iii) A representative of the – Member Pollution Control Board (iv) Chief Medical Officer – Member (District Health Officer) (Convenor)

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(v) District Agricultural Officer – Member (vi) A representative of the – Member Public Health Engineering Department (vii) District Microbiologists/ – Member Pathologist (technical expert) (viii) Commissioner Municipal – Member Corporation The Committee may co-opt other members/experts as necessary.” 25.3 Rule 5 speaks of classification of micro-organisms or GE products, while Rule 7 deals with approval and prohibitions. The same read as under: “5. Classification of microorganisms or genetically engineered product - (1) For the purpose of these rules, microorganisms or genetically engineered organisms, products or cells shall be dealt with under two major heads; animal pathogens and plant pests and these shall be classified in the manner specified in the Schedule. (2) If any of the microorganism, genetically engineered organism or cell falls within the limits of more than one risk class as specified in the Schedule, it shall be deemed to belong exclusively to the last in number of such classes. xxx

7. Approval and Prohibitions, etc. :- (1) No person shall import, export, transport, manufacture, process, use or cell any hazardous microorganisms or genetically engineered organisms/substances or cells except with the approval of the Genetic Engineering Approval Committee. (2) Use of pathogenic microorganism or any genetically engineered organisms or cell for the purpose of

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research shall only be allowed in laboratories or inside laboratory areas notified by the Ministry of Environment and Forests for this purpose under the Environment (Protection) Act, 1986. (3) The Genetic Engineering Approval Committee shall give directions to the occupier to determine or take measures concerning the discharge of microorganisms/genetically engineered organisms or cells mentioned in the Schedule from the laboratories, hospitals and other areas including prohibition of such discharges and laying down measures to be taken to prevent such discharges. (4) Any person operating or using genetically engineered organisms/microorganisms mentioned in the schedule for scale up or pilot operations shall have to obtain licence issued by the Genetic Engineering Approval Committee for any such activity. The possessor shall have to apply for licence in prescribed proforma. (5) Certain experiments for the purpose of education within the field of gene technology or microorganism may be carried out outside the laboratories and laboratory areas mentioned in sub-rule (2) and will be looked after by the Institutional Biosafety Committee.” 25.4 Rule 8 deals with production, while Rule 11 deals with permission and approval for food stuffs. The same are extracted as under: “8. Production:- Production in which genetically engineered organisms or cells or micro-organism are generated or used shall not be commenced except with the consent of Genetic Engineering Approval Committee with respect of discharge of genetically engineered organisms or cells into the environment. This shall also apply to production taking place in connection with development, testing and experiments where such production, etc., is not subject to rule 7. xxx

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11. Permission and Approval for Food Stuffs:- Food stuffs, ingredients in food stuffs and additives including processing and containing or consisting of genetically engineered organisms or cells, shall not be produced, sold, imported or used except with the approval of the Genetic Engineering Approval Committee.” 25.5 The guidelines and grant of approval are as per Rules 12 and 13, which read as under: “12. Guidelines:- (1) Any person who applies for approval under rules 8-11 shall, as determined by the Genetic Engineering Approval Committee submit information and make examinations or cause examinations to be made to elucidate the case, including examinations according to specific directions and at specific laboratories. He shall also make available an on-site emergency plan to GEAC before obtaining the approval. If the authority makes examination itself, it may order the applicant to defray the expenses incurred by it in so doing. (2) Any person to whom an approval has been granted under rules 8-11 above shall notify the Genetic Engineering Approval Committee of any change in or addition to the information already submitted.

13. Grant of Approval:- (1) In connection with the granting of approval under rules 8 to 11 above, terms and conditions shall be stipulated, including terms and conditions as to the control to be exercised by the applicant, supervision, restriction on use, the layout of the enterprise and as to the submission of information to the State Biotechnology Coordination Committee or to the District Level Committee. (2) All approvals of the Genetic Engineering Approval Committee shall be for a specific period not exceeding four year at the first instance renewable for 2 years at a time. The Genetic Engineering Approval Committee shall have powers to revoke such approval in the following situations:-

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(a) If there is any new information as to the harmful effects of the genetically engineered organisms or cells. (b) If the genetically engineered organisms or cells cause such damage to the environment, nature or health as could not be envisaged when the approval was given, or (c) Non compliance of any condition stipulated by Genetic Engineering Approval Committee.” Regulatory Framework:

26. MoEF&CC is the nodal ministry for regulation of GMOs including GE plants. 1989 Rules under the EP Act, 1986 provide the statutory scheme for regulation of GE technologies. The 1989 Rules are implemented by the MoEF&CC, the DBT, Ministry of Science & Technology and State Governments. 26.1 The following authorities/committees are created under the 1989 Rules: (i) Recombinant DNA Advisory Committee (RDAC): The RDAC is involved in reviewing the developments in biotechnology, both at national as well as international levels, and recommending safety regulations as per the indigenous requirements of our country in recombinant research, use and applications from time to time. The RDAC’s functions are advisory in nature. (ii) Genetic Engineering Appraisal Committee (GEAC): GEAC is the apex body to accord approval of activities involving large scale use of hazardous micro-organisms and recombinants in research and industrial production from the environmental perspective. GEAC is also responsible for granting approvals relating to release of GE organisms and products into the environment, including experimental field trials (BRL-II). This Committee functions as a body under the Department of Environment, Forest and Wildlife for approval of activities involving large scale use of hazardous micro-organisms and recombinants in research and industrial production from the environmental angle delineated under Rule 4.

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Rules 7, 8 and 10 of the 1989 Rules state that no research, development, import, export, manufacture, process, use or sale of any GE technology or products/substances derived therefrom can be attempted without the approval of GEAC. (iii) Review Committee on Genetic Manipulation (RCGM): The RCGM is established under the DBT and is mandated to monitor the safety-related aspects in respect of on-going research projects and activities and bring out manuals and guidelines specifying procedure for regulatory process with respect to activities involving GEO in research, use and applications, including industry, with a view to ensure environmental safety. The RCGM is the authority for BRL-I trials. This Committee includes representatives of the DBT, Indian Council of Medical Research (ICMR), ICAR, CSIR and other experts in their individual capacity. The Committee may appoint sub groups. This Committee also lays down procedures for restricting or prohibiting production, sale, importation and use of such GEOs of cells as are mentioned in the Schedule to the 1989 Rules. (iv) Institutional Biosafety Committee (IBSC): The IBSC is established under the institution engaged in GMO research, to oversee such research and to interface with the RCGM in regulating it. This Committee is constituted by the research institutions handling micro-organism/GEO. The Committee comprises of the Head of the Institution, scientists engaged in DNA work, a medical expert and a nominee of the DBT. The research institutions handling micro-organisms/GEOs are mandated to prepare, with the assistance of the IBSC, an up to date on-site emergency plan according to the manuals/guidelines of the RCGM and make available copies to the DLC/SBCC and GEAC. (v) State Biotechnology Co-Ordination Committee (SBCC): The SBCC plays a major role in monitoring and has powers to inspect, investigate and take punitive action in case of violations of statutory provisions.

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This Committee is constituted in the States to periodically review the safety and control measures in the various industries/ institutions handling GEOs/hazardous micro-organisms. It has power to inspect, investigate and take punitive action in case of violations of statutory provisions, through the Nodal Department and the State Pollution Control Board/Directorate of Health/Medical Services. The Committee is chaired by the Chief Secretary of the State Government. The Members of the Committee include Secretaries from the Departments of Health, Agriculture, Industries & Commerce, Forests, Public Works/ Chief Engineer, Public Health Engineering, State Microbiologists and Pathologists, Chairman of State Pollution Control Board. The Secretary, Department of Environment is the Member Secretary of the Committee. The Committee may co-opt other members/experts as necessary. (vi) District Level Committee (DLC): The DLC has a major role in monitoring the safety regulations in installations engaged in the use of GMOs/ hazardous micro- organisms and its application in the environment. This Committee is constituted in the districts to monitor the safety regulations in installations engaged in the use of GMOs/hazardous micro-organisms and its applications in the environment. This Committee is chaired by the District Collector. The Chief Medical Officer (District Health Officer) is the Member (Convenor). The Members of the Committee include Factory Inspector, a representative from Pollution Control Board, District Agricultural Officer, a representative of the Public Health Engineering Department, District Microbiologists, Pathologist (Technical expert), and Commissioner of Municipal Corporation. The Committee may co-opt other members/ experts as necessary. 26.2 According to learned Attorney General, the 1989 Rules are implemented by the aforesaid competent authorities through a series of biosafety guidelines issued from time to time. The Guidelines applicable to GE plants are: (i) Guidelines and SOP for Conduct of Confined Field Trials of Regulated GE Plants, 2008.

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(ii) Revised Guidelines for Research in Transgenic Plants, 1998; (iii) Regulations and Guidelines for Recombinant DNA Research and Biocontainment, 2017. (iv) Guidelines for Safety Assessment of Foods Derived from GE Plants, 2008 (updated in 2012) (v) Protocols for Food and Feed Safety Assessment of GE Crops, 2008. (vi) Environmental Risk Assessment (ERA) of GE Plants: A Guide for Stakeholders, 2016. (vii) Risk Analysis Framework, 2016. (viii) Guidelines for the Environmental Risk Assessment of GE Plants, 2016. 26.3 The research and development (R&D) with respect to GE plants has to be conducted in accordance with the Revised Guidelines for Research in Transgenic Plants, 1998. As per these Guidelines, the experiments conducted on research of transgenic plants are broadly categorized into three categories based on the risk involved, namely, Category I that involves routine rDNA experiments, Category II involving evaluation of transgenic plants in green house/net house, and Category III that pertains to high-risk experiments. These experiments have to be regulated by the IBSC and/or the RCGM, as prescribed in the Guidelines. 26.4 Subsequent to the above experiments conducted under the contained conditions, the confined field trials have to be conducted as prescribed under the Guidelines and SOP for the Conduct of Confined Field Trials of Regulated GE Plants, 2008. 26.5 The initial assessment of an application for a confined field trial begins at the institutional level itself. Based on information generated by the applicant in the laboratory and the greenhouse, an application is made to the IBSC for permission to conduct a confined field trial. The IBSC evaluates the proposal for conducting a field trial and further recommends

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it to the other Regulatory Authorities. The confined field trials are categorized as under: (i) Biosafety Research Level-I (BRL-I) Trials: These trials are limited in size to no more than 1 acre (0.4 ha) per trial site location and a maximum cumulative total of 20 acres (8.1 ha) for all locations for each plant species/construct combination (e.g., one or more events originating from transformation of a plant species with the same genetic construct), per applicant, per crop season. (ii) Biosafety Research Level-II (BRL-II) Trials: These are limited in size to no more than 2.5 acres (1 ha) per trial site location and number of locations to be decided on a case by case basis for each plant species/construct combination (e.g., one or more events originating from transformation of a plant species with the same genetic construct), per applicant, per crop season. The RCGM is the regulatory authority for BRL-I trials and GEAC is the regulatory authority for BRL-II trials, as per the Guidelines for the Conduct of Confined Field Trials of Regulated GE Plants, 2008. 26.6 Applications for environmental release are processed in accordance with Guidelines for the Environmental Risk Assessment (ERA) of GE Plants, 2016. 26.7 The Risk Analysis Framework, 2016 prescribes the Regulatory Agency’s approach to risk analysis. It is based on national and international standards and guidance, including the CPB to which India is a party. In accordance with the Risk Analysis Framework, 2016, assessment of safety of GM plants is a comprehensive process involving subject experts and ensures transparency in the regulatory decision-making process by incorporating stakeholder consultations. 26.8 As per this framework, regulatory agencies seek views from various stakeholders and the steps followed in this consultation process include: (i) The communication of information about submission of applications for environmental release of GE plants to the regulatory agency.

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(ii) Preparation of a RARM plan for each application by the regulatory agencies. (iii) RARM plan uploaded on the official website for receiving comments from the stakeholders for a period of 30 days. (iv) The regulatory agency gives its recommendations after due consideration of the responses received from the stakeholders. 26.9 That in line with the above, the applicant has to follow a clearly laid out step by step process for biosafety data generation from laboratory to field trials, safety tests and submission of application for environmental release. The biosafety data is generated in laboratories and by confined field trials under conditions authorized by the RCGM and GEAC, as per the guidelines and protocols and in recognized laboratories/ institutions/universities.

27. In the context of the crucial role of the regulatory bodies, particularly with regard to food safety and environment, this Court in Writ Petition (Civil) No.202 of 1995 (In Re: T.N. Godavarman Thirumulpad vs. Union of India), order dated 31.01.2024, speaking through Gavai, J. in paragraphs 22-25 and 28-32, has observed as under: “22. As new bodies, authorities, and regulators for environmental governance emerge from time to time, their institutionalisation assumes extraordinary importance. Institutionalisation means that these bodies must work in compliance with institutional norms of efficiency, integrity and certainty. In this context, the role of the constitutional courts is even greater.

23. Environmental Rule of Law: Environmental rule of law refers to environmental governance that is undergirded by the fundamental tenets of rule of law. The rule of law regime is one that has effective, accountable, and transparent institutions; responsive, inclusive, participatory, and representative decision making; and public access to information. It recognises the vital role that institutions play in governance and focuses on defining the structural norms and processes that guide institutional decision making.

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24. While several laws, rules, and regulations exist for protection of the environment, their objective is not achieved as there is a considerable gap as these laws remain unenforced or ineffectively implemented. Rule of law in environmental governance seeks to redress this issue as the implementation gap has a direct bearing on the protection of the environment, forests, wildlife, sustainable development, and public health, eventually affecting fundamental human rights to a clean environment that are intrinsically tied to right to life. Accountability of the authorities impressed with the duty to enforce and implement environmental and other ecological laws is an important feature of judicial governance. In the context of accountability, this Court in Vijay Rajmohan vs. CBI, (2023) 1 SCC 329 has held: “34. Accountability in itself is an essential principle of administrative law. Judicial review of administrative action will be effective and meaningful by ensuring accountability of the officer or authority in charge.

35. The principle of accountability is considered as a cornerstone of the human rights framework. It is a crucial feature that must govern the relationship between “duty bearers” in authority and “right holders” affected by their actions. Accountability of institutions is also one of the development goals adopted by the United Nations in 2015 and is also recognised as one of the six principles of the Citizens Charter Movement.

36. Accountability has three essential constituent dimensions: (i) responsibility, (ii) answerability, and (iii) enforceability. Responsibility requires the identification of duties and performance obligations of individuals in authority and with authorities. Answerability requires reasoned decision making so that those affected by their decisions, including the public, are aware of the same. Enforceability requires appropriate corrective and remedial action against lack of responsibility and accountability to be taken. Accountability has a corrective function, making it possible to address

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individual or collective grievances. It enables action against officials or institutions for dereliction of duty. It also has a preventive function that helps to identify the procedure or policy which has become nonfunctional and to improve upon it.”

25. In India, environmental rule of law must draw attention to the existing legal regime, rules, processes, and norms that environmental regulatory institutions follow to achieve the goal of effective and good governance and implementation of environmental laws. More importantly, the focus must be on the policy and regulatory and implementation agencies. In doing so, environmental rule of law fosters open, accountable, and transparent decision making and participatory governance. The renewed role of constitutional courts will be to undertake judicial review to ensure that institutions and regulatory bodies comply with the principles of environmental rule of law. xxx

28. We may ask a simple question – how effectively are these environmental bodies functioning today? This question has a direct bearing on the protection and restoration of ecological balance.

29. As environmental governance through these bodies emerges, the obligation of the constitutional courts is even greater. Hitherto, the constitutional courts focused on decisions and actions taken by the executive or private persons impacting the environment and ecology because the scrutiny by regulators was felt to be insufficient. Their judgment, review, and consideration did not inspire confidence and therefore, the Court took up the issue and would decide the case. In this process, a large number of decisions rendered by this Court on sensitive environmental, forest, and ecological matters constitute the critical mass of our environmental jurisprudence. This Court would continue to exercise judicial review, particularly in environmental matters, whenever necessary.

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30. We however seek to emphasise and reiterate the importance of ensuring the effective functioning of these environmental bodies as this is imperative for the protection, restitution, and development of the ecology. The role of the constitutional courts is therefore to monitor the proper institutionalisation of environmental regulatory bodies and authorities.

31. In furtherance of the principles of environmental rule of law, the bodies, authorities, regulators, and executive offices entrusted with environmental duties must function with the following institutional features: i. The composition, qualifications, tenure, method of appointment and removal of the members of these authorities must be clearly laid down. Further, the appointments must be regularly made to ensure continuity and these bodies must be staffed with persons who have the requisite knowledge, technical expertise, and specialisation to ensure their efficient functioning. ii. The authorities and bodies must receive adequate funding and their finances must be certain and clear. iii. The mandate and role of each authority and body must be clearly demarcated so as to avoid overlap and duplication of work and the method for constructive coordination between institutions must be prescribed. iv. The authorities and bodies must notify and make available the rules, regulations, and other guidelines and make them accessible by providing them on the website, including in regional languages, to the extent possible. If the authority or body does not have the power to frame rules or regulations, it may issue comprehensive guidelines in a standardised form and notify them rather than office memoranda. v. These bodies must clearly lay down the applicable rules and regulations in detail and the procedure for application, consideration, and grant of permissions, consent, and approvals.

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vi. The authorities and bodies must notify norms for public hearing, the process of decision-making, prescription of right to appeal, and timelines. vii. These bodies must prescribe the method of accountability by clearly indicating the allocation of duties and responsibilities of their officers. viii. There must be regular and systematic audit of the functioning of these authorities.

32. The role of the constitutional courts is to ensure that such environmental bodies function vibrantly, and are assisted by robust infrastructure and human resources. The constitutional courts will monitor the functioning of these institutions so that the environment and ecology is not only protected but also enriched. Constitutional Court and the Environmental Rule of Law:

28. Before I proceed further in the matter, it would be necessary to know the role of the Constitutional Court in matters concerning science and technology and environment. The observations of this Court in the following cases are noted as under: (i) On the aspect of the approach of the Constitutional Courts towards questions arising in the realm of science and environment, this Court has time and again struck a balance between exercising restraint and answering questions arising in the realm of pure science by, inter alia, placing reliance on the principle of sustainable development, precautionary principle and polluter pays principle. This Court has not only incorporated progressive ideals and frameworks to strengthen the process of sustainable development but has repeatedly emphasised the contours of its adjudication in concerns touching upon environment. However, growth of jurisprudence in environmental rule of law provides ample guidance for the present adjudication. (ii) In Hanuman Laxman Aroskar vs. Union of India, (2019) 15 SCC 401 (“Hanuman Laxman Aroskar”), this Court recognised the need to imbue institutional decision-making on questions of environment with the central precepts of the rule of law to

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achieve the lofty goal of sustainable development. Placing reliance upon the United Nations Environment Programme’s First Global Report on Environmental Rule of Law, this Court articulated the following seven components of the framework of Environmental Rule of Law: i. Fair, clear, and implementable environmental laws; ii. Access to information, public participation, and access to justice through courts, tribunals, commissions, and other bodies; iii. Accountability and integrity of decision-makers and institutions; iv. Clear and coordinated mandates and roles, across and within institutions; v. Accessible, fair, impartial, timely and responsive dispute resolution mechanisms; vi. Recognition of the mutually reinforcing relationship between rights and environmental rule of law; and vii. Specific criteria for the interpretation of environmental law. It further acknowledged how the contemporary environmental challenges such as the climate change crisis could be effectively addressed through a creative synergy of constitutional values of fairness, accountability and transparency with core ideals of environmental protection in the following words: “156. The rule of law requires a regime which has effective, accountable and transparent institutions. Responsive, inclusive, participatory and representative decision making are key ingredients to the rule of law. Public access to information is, in similar terms, fundamental to the preservation of the rule of law. In a domestic context, environmental governance that is founded on the rule of law emerges from the values of our Constitution. The

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health of the environment is key to preserving the right to life as a constitutionally recognised value under Article 21 of the Constitution. Proper structures for environmental decision making find expression in the guarantee against arbitrary action and the affirmative duty of fair treatment under Article 14 of the Constitution.” (iii) The judgment in Himachal Pradesh Bus-Stand Management & Development Authority vs. Central Empowered Committee, (2021) 4 SCC 309 (“H.P. Bus-Stand”) expanded the framework of environmental rule of law to include within it the State’s positive obligations to create conceptual, procedural and institutional structures that guide environmental regulation in furtherance of the environmental rule of law. Emphasising the critical need for multi-disciplinary perspectives, this Court held that: “49. The environmental rule of law, at a certain level, is a facet of the concept of the rule of law. But it includes specific features that are unique to environmental governance, features which are sui generis. The environmental rule of law seeks to create essential tools — conceptual, procedural and institutional to bring structure to the discourse on environmental protection. It does so to enhance our understanding of environmental challenges — of how they have been shaped by humanity’s interface with nature in the past, how they continue to be affected by its engagement with nature in the present and the prospects for the future, if we were not to radically alter the course of destruction which humanity’s actions have charted. The environmental rule of law seeks to facilitate a multi-disciplinary analysis of the nature and consequences of carbon footprints and in doing so it brings a shared understanding between science, regulatory decisions and policy perspectives in the field of environmental protection. It recognises that the “law” element in the environmental rule of law does not make the concept peculiarly the

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preserve of lawyers and Judges. On the contrary, it seeks to draw within the fold all stakeholders in formulating strategies to deal with current challenges posed by environmental degradation, climate change and the destruction of habitats. The environmental rule of law seeks a unified understanding of these concepts. There are significant linkages between concepts such as sustainable development, the polluter pays principle and the trust doctrine. The universe of nature is indivisible and integrated. The state of the environment in one part of the earth affects and is fundamentally affected by what occurs in another part. Every element of the environment shares a symbiotic relationship with the others. It is this inseparable bond and connect which the environmental rule of law seeks to explore and understand in order to find solutions to the pressing problems which threaten the existence of humanity. The environmental rule of law is founded on the need to understand the consequences of our actions going beyond local, State and national boundaries. The rise in the oceans threatens not just maritime communities. The rise in temperatures, dilution of glaciers and growing desertification have consequences which go beyond the communities and creatures whose habitats are threatened. They affect the future survival of the entire ecosystem. The environmental rule of law attempts to weave an understanding of the connections in the natural environment which make the issue of survival a unified challenge which confronts human societies everywhere. It seeks to build on experiential learnings of the past to formulate principles which must become the building pillars of environmental regulation in the present and future. The environmental rule of law recognises the overlap between and seeks to amalgamate scientific learning, legal principle and policy intervention. Significantly, it brings attention to the rules, processes and norms followed by

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institutions which provide regulatory governance on the environment. In doing so, it fosters a regime of open, accountable and transparent decision making on concerns of the environment. It fosters the importance of participatory governance — of the value in giving a voice to those who are most affected by environmental policies and public projects. The structural design of the environmental rule of law composes of substantive, procedural and institutional elements. The tools of analysis go beyond legal concepts. The result of the framework is more than just the sum total of its parts. Together, the elements which it embodies aspire to safeguard the bounties of nature against existential threats. For it is founded on the universal recognition that the future of human existence depends on how we conserve, protect and regenerate the environment today.” This Court distilled the challenges that confront a constitutional court in using the framework of an environmental rule of law. Noting the often-intractable problem of adjudicating environmental infractions in the absence of precise, quantifiable and concrete evidence, this Court appreciated the valuable principled guidance rendered by environmental rule of law in the following words: “54. … The point, therefore, is simply this — the environmental rule of law calls on us, as Judges, to marshal the knowledge emerging from the record, limited though it may sometimes be, to respond in a stern and decisive fashion to violations of environmental law. We cannot be stupefied into inaction by not having access to complete details about the manner in which an environmental law violation has occurred or its full implications. Instead, the framework, acknowledging the imperfect world that we inhabit, provides a roadmap to deal with environmental law violations, an absence of clear evidence of consequences notwithstanding.” (emphasis supplied)

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Public Trust Doctrine:

29. At this stage, I shall refer to certain observations made by this Court in the context of preservation of environment and on public trust doctrine. According to this Court, all environment-related developmental activities should benefit more people while maintaining the environmental balance. This could be ensured only by strict adherence to sustainable development, without which the lives of the coming generations will be in jeopardy. In M.C. Mehta vs. Union of India, (1991) 2 SCC 353, it was observed that law alone also cannot help in restoring a balance in the biospheric disturbance. Nor can funds help effectively. The situation requires a clear perception and imaginative planning. It also requires sustained effort and result oriented strategic action.

30. This Court’s jurisprudence on the right to a safe and healthy environment is a firewall against unscrupulous and unsustainable decision-making. It encapsulates a concomitant duty for the State, as understood in light of Articles 48 and 51A(g) of the Constitution of India. In Charan Lal Sahu vs. Union of India, (1990) 1 SCC 613 (“Charan Lal Sahu”) and Subhash Kumar vs. State of Bihar, (1991) 1 SCC 598 (“Subhash Kumar”), this Court expressly observed that Article 21 includes the right of enjoyment of pollution-free water and air. Virender Gaur vs. State of Haryana, (1995) 2 SCC 577 (“Virender Gaur”) expanded the scope of the right to the effect that a hygienic environment is an integral facet of the right to a healthy life. The right was so construed in terms of the State’s duty under Articles 48 and 51A(g) to forge policies to maintain ecological balance by taking concrete measures to ‘promote, protect and improve’ the environment. 30.1 Thereafter, in M.C. Mehta vs. Kamal Nath, (2000) 6 SCC 213 (“Kamal Nath”), it was expounded that the fundamental right to life under Article 21 would take within its breadth a protection against disturbance of basic environmental elements such as air, water and soil. This Court articulated the positive duties of the State to take all necessary measures for the protection and promotion of the environment under the EP Act, 1986 in Indian Council for Enviro-Legal Action vs. Union of India, (1996) 3 SCC 212 (“Enviro-Legal Action”). It was also held that if the Central Government omits to fulfil any of its duties under the Sections 3 and 5 of the EP Act,

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1986, this Court could issue appropriate directions to it to take necessary measures. 30.2 Therefore, the right to a safe and healthy environment encompasses a corresponding duty on the State to faithfully implement the environmental statutes and take all necessary measures. 30.3 The substantive concern of the right to environmental protection now also encompasses the adverse effects of climate change. This Court, speaking through Hon’ble Dr. Justice D.Y. Chandrachud in M.K. Ranjitsinh vs. Union of India, 2024 (4) Scale 779 : 2024 INSC 280 (“M.K. Ranjitsinh”) has explicitly recognised that adverse environmental consequences, such as sea level rise, have a disproportionate impact on socially, geographically and economically marginalised classes of citizens. 30.4 The aforesaid elucidation of the right to a safe and healthy environment and the concept of environmental rule of law as applied in the Indian jurisprudential context reveals that the concept is one of the ways of embedding a consciousness about adverse effects on the environment into the sub-structure of the legal framework to inform an environment-protecting legal reasoning. Therefore, environmental legislation such as the EP Act, 1986 and the 1989 Rules ought to be interpreted so as not to infringe the fundamental right to a safe and healthy environment under Article 21. Where there is a choice of statutory construction, this Court would be bound to proffer an interpretation that effectively protects the right to a safe and healthy environment. Precautionary Principle:

31. The essence of the precautionary principle lies in the notion that ‘decision makers should act in advance of scientific certainty to protect the environment.’ [Source: Andrew Jordan and Timothy O’ Riordan, ‘The Precautionary Principle in Contemporary Environmental Politics’ (1995) 4(3) Environmental Values 191, 194]. The adoption of the precautionary principle reflects a paradigm shift from the traditional reactive approach, wherein the environmental regulator responded to apparent environmental hazards. It is a significant shift even from the preventive approach that sought to prevent the

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environmental damage arising from risks that are bound to actualize in the foreseeable future. On the other hand, the precautionary principle seeks to avoid such future environmental damage which may arise from uncertain eventualities. In other words, the precautionary principle mandates cautiously taking appropriate measures to identify potentially harmful activities even in the face of scientific uncertainty. Precaution, in other words, is the expression of a well-founded fear of the unknown and the unknowable environmental consequences of certain human actions. For a fear to be well-founded, it must emerge from a robust risk analysis of potentially hazardous consequences for environmental health.

32. The 1982 World Charter for Nature first articulated the idea of the precautionary principle in General Principle 11, which postulates the control of activities which might have an impact on nature and the use of the best available technologies that minimize significant risks to nature or other adverse effects. The General Principle 11 recommends a graded approach to varying levels of environmental risks and damage, while instantiating that: i. those activities which are likely to cause irreversible damage to nature shall be avoided; ii. those activities which cause a significant risk to nature shall only be permitted upon exhaustive examination if the proponents of such activities would demonstrate that the expected benefits outweigh the potential damage to nature; and iii. those activities which cause a significant risk to nature but where the potential adverse effects are not fully understood should not be proceeded with; iv. those activities which may disturb nature shall be proceeded only upon ex-ante assessment of their consequences through environmental impact studies and requisite planning to minimize potential adverse effects. 32.1 Thereafter, the principle was enshrined in Principle 15 of the Rio Declaration on Environment and Development 1992, which states: “In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of

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serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.” 32.2 It also finds expression in Article 10(6) of the CPB to the CBD, which states that: “6. Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of a living modified organism on the conservation and sustainable use of biological diversity in the Party of import, taking also into account risks to human health, shall not prevent that Party from taking a decision, as appropriate, with regard to the import of the living modified organism in question as referred to in paragraph 3 above, in order to avoid or minimize such potential adverse effects.” 32.3 While Section 20 of the National Green Tribunal Act, 2010 exhorts the National Green Tribunal (NGT) to take precaution into account in passing orders, this Court’s jurisprudence, as explained below, had long recognized and deepened the precautionary principle.

33. This Court in the following cases has discussed at length the precautionary principle, which are adverted to at this stage. (i) In Vellore Citizens’ Welfare Forum vs. Union of India, (1996) 5 SCC 647 (“Vellore Citizens”), this Court was seized of a Writ Petition filed by a citizens’ group to seek enforcement of the provisions of the Water (Prevention and Control of Pollution) Act, 1974 against tanneries that were discharging untreated effluent into nearby lands. While directing strict enforcement of environmental law and holding the authorities accountable for their failure to exercise statutory powers, this Court expounded on the significance of the precautionary principle. It traced the origins of the precautionary principle in international law and located the same in domestic environmental law. This Court’s formulation of the precautionary principle constitutes three propositions:

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i. The environmental measures undertaken by the State Government and the statutory authorities must anticipate, prevent and attack the causes of environmental degradation. ii. Where there are threats of serious and irreversible damage, lack of scientific certainty should not be used as a reason for postponing measures to prevent environmental degradation. iii. The reversal of the “burden of proof” to the proponent of a potentially hazardous activity which could disrupt the natural environment was critical for ecologically balanced and sustainable development. This Court construed the precautionary principle in light of Articles 47, 48A and 51A(g) of the Constitution. Further, it was concluded that the extant legislative framework, specifically the EP Act, 1986, included the application of the precautionary principle in addition to the polluter pays principle. Consequently, this Court passed a direction to the authority to be appointed under Section 3(3) of the EP Act, 1986 to implement the ‘precautionary principle.’ (ii) The precautionary principle was explained in greater detail by this Court in A.P. Pollution Control Board vs. Prof. M.V. Nayudu, (1999) 2 SCC 718 (“A.P. Pollution Control Board”) from the lens of international environmental law. Here, this Court was considering whether the establishment of a hazardous industry could be countenanced within ten kilometre of reservoirs used for drinking water. This Court noted that the “assimilative capacity” rule was embedded in Principle 6 of the Stockholm Declaration of the U.N. Conference on Human Environment, 1972. This “assimilative capacity” principle was premised on the assumption of perfect scientific predictability that would allow the internalisation of ecological risks within industrial processes. It was reasoned that the preponderance of unpredictability of adverse environmental effects led to the adoption of the 11th Principle of the U.N. General Assembly Resolution on World Charter for Nature, 1982, and the Principle 15 of the Rio Conference of 1992.

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Quite axiomatically, precautionary principle changes the role and significance of scientific data in environmental disputes. Once a threat to the environment has been identified, action should be taken to abate environmental interference, even though there may be scientific uncertainty as to the effects of the activities. [Source: Lavanya Rajamani, ‘The precautionary principle’ in Shibani Ghosh (ed.) Indian Environmental Law (Orient Blackswan, 1994]. Certain anticipated environmental harms and available environmental data may warrant a strong and strict application, i.e., the potentially hazardous activity is banned until the proponent of the activity demonstrates that it poses no (or acceptable) risk. In such a case, the burden to prove the acceptable standard of risk shifts to the proponent of such an activity. In this context, reliance was placed upon an article authored by Charmian Barton, in Volume 22 of Harvard Environmental Law Review (1998) and inferred that the environmental decision-makers must acknowledge the inadequacy of information about environmental risks and ‘err on the side of caution’ to prevent serious and irreversible harm. (iii) In M.C. Mehta vs. Union of India, (2004) 12 SCC 118 (“M.C. Mehta”), this Court advanced the view that the precautionary principle enjoined the State to take affirmative action to prevent environmental harm, even when the nature and extent of such harm could not be anticipated with scientific precision and certainty. It was reasoned that when it was difficult to strike a balance between the protection of the environment and economic development due to prevailing uncertainty and lack of direct evidence of actual harm, reasonable suspicion of harm would be adequate to press the precautionary principle into service and take anticipatory action. Analysis and Findings:

34. In light of the aforesaid observations, the PSC Report, 2012 made a range of recommendations. The MoEF&CC responded to each of the recommendations in the Action Taken Report. The pertinent recommendations and the action taken are explained in the table below:

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S. Recommendation Action Taken Report No.

1. Conduct a thorough probe into the Views of Dr. Bhargava are Bt brinjal matter from the beginning his personal views and are till the imposing of moratorium not subscribed by most of the on its commercialization in scientists. Prof. Reddy has 09.02.2010. clarified that the pressure he adverted to was for meeting the deadline as he had been pre-occupied with his other responsibilities.

2. Review the organisational set-up GEAC comprises of both of GEAC. experts and bureaucrats, and takes aid of expert committees.

3. Sought information about IAASTD Report has been concrete action taken by the criticised by an independent Government on each of the evaluation group at the World findings contained in IAASTD Bank in its Global Programme Report during the four years after Review. The Government of the release of the Report. India recognises the importance of biosafety and sustainable agriculture and these goals remain its policy priority.

4. Fix responsibility for the laxity The Department of Consumer in regulating and labelling GM Affairs has issued a notification foods, and issue regulations on the labelling of GM foods. for labelling of GM products including food crops, food and food products

5. Upon consultation with all The BRAI Bill, 2013 has been stakeholders, immediately evolve pending in Parliament. Such an an all-encompassing umbrella Act would establish the National legislation on biosafety, which Biotechnology Regulatory is focused on ensuring the Authority. biosafety, biodiversity, human and Administrative and other support livestock health, environmental continues to be expected to protection, and which specifically RCGM and GEAC. describes the extent to which biotechnology, including modern biotechnology, fits in the scheme of things without compromising with the safety of any of the elements mentioned above.

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35. Similarly, the PSC Report, 2017 made a range of recommendations. The MoEF&CC responded to each of the recommendations in the Action Taken Report. The pertinent recommendations and the action taken are explained in the table below:

S. Recommendation Action Taken Report No.

1. The Central Government should, Confined-field trials are in consultation with the State conducted as per detailed Governments and Administrations guidance documents and of Union Territories, ensure protocols framed for the purpose. that the whole process of field Conduct of confined field trials trials should be done in closed is inspected by members of environment, keeping biosafety regulatory committees, experts, and health safety in mind and in State Government and State collaboration with the agricultural Agricultural Universities. universities so as to minimise the scope of fudging the primary data.

2. GEAC should be headed by GEAC comprises of both an expert from the field of experts and representatives B i o t e c h n o l o g y, g i v e n t h e of respective ministries. Sub- understanding of scientific data committees are routinely and analysis of research and its engaged to render technical implication, before coming to a inputs. conclusion in the matter.

3. The MoEF&CC should review Minutes of all the meetings of the functioning of GEAC along GEAC are regularly published with the organisational set up on the website, along with all of GEAC and take necessary the relevant regulatory formats. corrective measures to make the Various stakeholders such as whole process of assessment farmers and civil society have and approval more transparent, given inputs on transgenic so as to ensure environmental mustard hybrid DMH-11 by safety, biodiversity safety, health way of comments on the AFES safety, food and feed safety of study and as part of special our country. hearings.

4. Members of Parliament should DLCs are only mandated to be nominated as members in play a role in monitoring of the DLCs, so that the activities the facilities. Inclusion of MPs of these Committees are also would not be commensurate shared with the public. with the tasks of the Committee, as the Committee reports to the Deputy Collector.

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S. Recommendation Action Taken Report No.

5. MoEF&CC should undertake a The adoption of Bt cotton comprehensive study and bring has nearly doubled the yield clarity on the issue of increase and substantially increased in the yield of cotton after its productivity from 308 kgs. per commercialisation in the country. Ha. in 2001-2002 to 568 kgs. per Ha. in 2016-2017.

6. MoEF&CC should obtain results of The aforementioned data Ministry of Agriculture’s scientific shows that Bt cotton has study about the impact of adopting successfully countered the Bt cotton on use of chemical menace of American bollworm herbicides and pesticides. and significantly increased the Thereafter, the MoEF&CC should yield. bring out a comprehensive note on usages of pesticide details state wise after the increase in area cultivated under Bt cotton.

7. MoEF&CC should scientifically Gene flow from GM crops to evaluate the impact of GM crops wild relatives poses no risk to on sustainability, safety and the environment. The regulatory competitive advantage of Indian process has addressed each agriculture. and every concern pertaining i. It should specifically inform to environmental safety. Genes the nation whether the that make GM crops HT have cultivation is not going to very minimal quantity of Bt have any negative impact on proteins. Studies on the impact the microbes, soil and water. on non-target organisms and beneficial organisms are part ii. It should specially study the of the regulatory process. impact on beneficial organisms like bees, earthworms and monarch butterflies.

8. Assessment of threats and Similar to other regulatory adverse effects of GM crops processes, the developer/ in foreign countries should not applicant furnishes studies be mechanically transplanted about safety assessment of by agencies. The Government crops. In case of DMH-11, agencies conduct indigenous developed by Delhi University, studies to substantiate their claim all studies have been funded that there is no threat posed to our by DBT. environment on account of GM crops. Any study that conducts impact assessment should be funded by DBT for sheer credibility.

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S. Recommendation Action Taken Report No.

9. The hasty decision to There is no scientific evidence commercialise GM crops should to justify the need for such be reconsidered in light of lack of studies as there exists no scientific evidence about chronic biologically relevant difference and transgenerational impact of between GM crops and their such crops. non-GM counterparts.

36. I have perused and discussed the contents of the PSC Reports, their recommendations of critical import to the regulatory framework as well as the action taken and observe on the following aspects: I. Thorough Probe into Bt Brinjal Approval: Although the Report of the PSC, 2012, had recommended that the MoEF&CC should conduct a thorough probe into the concerns raised by Dr. P.M. Bhargava regarding the approval for commercialisation of Bt brinjal till the imposition of the moratorium on 09.02.2010, the Action Taken Report does not point to the particulars of any enquiry or investigation. It appears that the justification offered by the erstwhile Co-Chairman, GEAC, Prof. Reddy, has been accepted without a fair and comprehensive investigation. II. Institutional Architecture of GEAC: Although both the PSC Reports recommended reforms in the institutional architecture of GEAC, by way of having a full-time body with a leadership that is competent to conduct impartial and sound scrutiny of applications for approval under the 1989 Rules, the Action Taken Report denies the very need for such reforms. I infer that the Government is reluctant to reform the composition and criteria for appointment to GEAC. No response is forthcoming on the PSC’s recommendation that the conflict of interest in the composition, caused by the presence of a nominee of DBT, should be minimised. This accentuates the concern about the lack of indigenous and independent research institutions. III. Labelling and Regulation of GM Foods: The Action Taken Report does not address the question of labelling of GM foods under Section 23 of the FSSA, 2006. There is inadequate clarity about the issuance of the notification under Section 22 for regulating sale, distribution and consumption of GM food.

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IV. Legislation: With respect to the recommendation to initiate the process of consultation to enact a comprehensive legislation on regulation of biotechnology, I note that the Action Taken Report refers to the Biotechnology Regulatory Authority of India, 2013 (“BRAI Bill, 2013”). On 28.08.2013, this Court noted that Sri K.K. Venugopal, learned senior counsel, appearing for one of the contesting respondents had informed that the Central Government has prepared a Bill bearing Bill No.57 of 2013, which is named the BRAI Bill, 2013. However, this Bill lapsed at the end of the 15th Lok Sabha. Therefore, there is no statutory regulatory framework in the form of a Parliamentary law that is in place. The 1989 Rules govern the existing procedure which are in fact subordinate legislation, which is contented to be inadequate. V. Impact on Agricultural Ecosystem: The blanket denial of adverse ecological effects by way of cross-pollination or otherwise is mostly on the basis of research conducted in foreign contexts. This may not at all be relevant in the Indian context and ecosystem. The PSC has rightly observed that the role of non-target organisms and beneficial organisms is critical to the agricultural ecosystem.

37. My understanding is that GM crops are those crops whose genomes have been modified by the insertion of usually foreign (for example, bacterial) genes through rDNA technology. Such modification serves to incorporate traits into plants that are either absent or rare in their domesticated and/or wild varieties. For instance, Bt cotton is cotton modified with a set of genes (or a gene construct) that codes for the Bt toxin. Bt toxin acts as an insecticide against pink and American bollworms. This specific insecticidal trait is absent in wild as well as domesticated varieties of cotton.

38. According to the petitioners, two traits dominate commercialized GM crops - HT (47 percent of the acreage), and insect resistance or Bt (12 percent). Another 41 percent is under stacked traits, i.e., both HT and Bt HT crops that obviate manual weeding and one can simply spray the corresponding herbicide (glyphosate, glufosinate, and dicamba) on the entire field, and everything other than the HT crop will perish. In theory, the Bt crop reduces the applications of external insecticides. Thus, most of the GM crops commercialized

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globally, in particular HT and stacked crops, are tailored for the routines of capital-intensive agriculture, i.e., agriculture that relies on monoculture (rather than mixed and intercropping), purchased seeds, fossil fuels, and intensive applications of synthetic chemicals which in effect is not sustainable in the long run.

39. In my view, the controversy in these writ petitions converges upon a foundational aspect, which is, the extent of implementation of the recommendations of the TEC constituted by this Court. Only upon considering this foundational aspect can I proceed to determine the points for consideration. I cannot ignore the TEC Report as suggested by learned Attorney General, for it would result in undermining the earlier orders of this Court, which would be an improper approach in the matter. 39.1 The subject matter of this case is indeed technical, as it involves scrutinising the adoption of a technology that would enable the modification of genomes through the insertion of foreign genes. The aim of the modification is often to craft hybrid varieties that have certain desirable characteristics from the point of view of agricultural productivity, sustainability and resilience.

40. At the outset, learned Attorney General submitted that the TEC Report submitted to this Court goes beyond the terms of reference to the extent of observing that HT crops are completely unsuitable in the Indian context which is not just and proper. Dr. Paroda, also a member of TEC, has filed a separate report raising objections to the TEC report submitted by the majority of the members which could be considered by this Court. 40.1 In the backdrop of identifying the actual controversy in these matters, at the outset, the terms of reference of TEC, inter alia, could be revisited as follows: (i) to review and recommend the nature of sequencing of risk assessment (environment and health safety) vis-à-vis all GM crops before they are released into the environment; (ii) to recommend the point at which environmental release through open-field trials can be permitted; (iii) to advise whether GE crops or plants could be replicated under different agro-ecological regions and different seasons as compared to greenhouse conditions;

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(iv) to advise measures or safeguards required to prevent potential risks to the environment vis-à-vis open-field trials and to recommend protocols necessary to preclude any escaped material from causing an adverse effect on the environment; (v) to advise whether in India, there are state-of-the-art testing facilities and professional expertise available to conduct various biosafety tests and if not, recommend setting up an independent testing laboratory and institutions. 40.2 An interim report, and thereafter, a final report were submitted by the TEC. As already noted, the final report was in two parts: the first part of the report was by a majority of five members of the TEC and a separate note was submitted by Dr. R.S. Paroda. Since the views of the majority and the separate note have been recorded hereinabove, I would only discuss whether the TEC did indeed breach the terms of reference. 40.3 A perusal of the terms of the reference reveals an emphasis on four aspects: sequencing; scientific tenability; adequacy of regulatory conditions and availability of technological facilities. The direction of this Court regarding the interim report was specifically to seek recommendations on the desirability of a partial or complete ban on open-field tests and what biosafety protocol ought to be followed and under what conditions. 40.4 It is clear that the terms of reference relate to this Court’s concern about the regulatory conditions for the release of GMO crops and the existence, or otherwise, of any gaps in the same. It is discernable that the final recommendations responded to these queries regarding the adequacy of regulatory conditions, biosafety protocols and available technological framework, by recommending various measures to fill the gaps that existed in the regulatory regime at a general level. The first gap, as I understand is that of technical expertise. The TEC inter alia, recommended as under: (i) Constitution of sub-committees with domain expertise in the fields of health, environment, agro-economics and socioeconomics, molecular biology, etc. which could

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replace the single committee structure devised by the 1989 Rules. (ii) Another recommendation pointed to the elimination of conflict of interest, earmarking of specific sites for field trials and stakeholder participation. (iii) It also stated that there is a need to develop consultation, collaboration and capacity building, and that the Indian regulatory system must develop the ability to assess as to how any GM product is likely to impact different sections of the society. Therefore, having regard to the discussion made by it, I find that the TEC did not breach its Terms of Reference.

41. The petitioners herein have sought for implementation of the aforesaid recommendations of the majority by contending that the question of the consequences of transgenic mustard hybrid DMH-11 being an HT crop remains unanswered. This is because the Union of India, in its additional affidavit dated 09.11.2022, has acknowledged that transgenic mustard hybrid DMH-11 possesses HT characteristics. Yet, the Union of India asserts that it cannot be officially labelled as such and therefore, it should not be referred to as HT corp. That transgenic mustard hybrid DMH-11 has never been tested as a HT crop because India does not have any regulatory guidelines and protocols for testing of HT crops, is the contention of the petitioners. 41.1 The petitioners have further countered the stand of the Union of India by submitting as under: (i) “… that the presence of third HT gene (Bar) is essential for hybrid seed production”, according to the Union of India. The presence of HT gene (Bar) makes DMH-11 an HT crop. This is also the finding of the PSC Reports which have stated that transgenic mustard hybrid DMH-11 is a HT crop. There is clear evidence on the adverse impacts of environmental release of DMH-11, which is a HT crop in various writings which have been ignored by GEAC; (ii) that the Union of India is silent as to the measures undertaken to ensure non-contamination, in case

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environmental release of GMOs is permitted, as irreversible risk of contamination on human health is enormous; (iii) that the Union of India is also silent on the liability of the applicant for potential losses to farmers and consumers on account of irreversible contamination; (iv) that glufosinate is banned for all other uses except for tea plantations and is specifically banned for use on DMH-11 by farmers. This is because of the acute toxicity and health concerns. That, long term studies would show the adverse effects of glufosinate which may not show up in short term studies. Hence, it is necessary to have adequate studies on the use of glufosinate on plants; (v) that GEAC has failed to deal with illegal plantation of Bt cotton and the same is being grown in the country illegally on commercial basis. That organisations such as Shetkari Sangathan have been encouraging farmers to do illegal planting of Bt brinjal, which GEAC as a regulator has failed to check; (vi) that there is a failure to undertake any socio-economic risk analysis by GEAC with regard to the failure of Bt cotton in accordance with the CBD and the CPB. The need for such an assessment was also highlighted by TEC in its report. Such an assessment was required because farmers across the country have been financially burdened due to the increasing prices of Bt cotton seeds and they have to spend on pesticides and other resources to make the crops more pest-resistant and high-yielding. This has resulted in escalated expenses and has reduced the margin of profit for the farmers; (vii) that the pink bollworm, a major pest to the cotton crop, has developed resistance in last few years which has worried the farmers who have sown Bt cotton seeds. Therefore, cotton yields were stagnant in the last five years due to the fact that the technology was used for yield improvement but not for loss prevention;

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