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

Genetically Engineered (GE) Crop – Transgenic mustard hybrid (DMH-11) – Decision of GEAC and MoEF granting conditional approval for environmental release of DMH-11 – Challenge to, on grounds of procedural abnormalities in approval; violation of right to safe and healthy environment; and violation of precautionary principle – Difference of opinion between Hon’ble Judges – Per Nagarathna, J., held, approval and consequent decision for environmental release of transgenic mustard hybrid DMH-11 violated the precautionary principle inasmuch as no determination was made, as to, whether, transgenic mustard hybrid DMH-11 is a Herbicide Tolerant (HT) crop and if so, the nature of risk that would be caused by the said plant to the environment including other plants as well as to human beings and animals – The deliberations did not focus inter alia, on aspects of biosafety, risk assessment, soil health, micro-biology and socioeconomic aspects etc. – Moreover, recommendations of Technical Expert Committee (TEC) set up by Supreme Court and Parliamentary Standing Committees’ Reports on Agriculture and on Science and Technology, Environment and Forest were not considered – Recommendations of GEAC as well as decision taken by respondent-Union of India with regard to approving environmental release of transgenic mustard hybrid DMH-11 were vitiated and hence, quashed – Per Karol, J., held, the question of ban on HT crops is not warranted in view of the precautionary principle and it is a decision squarely within the domain of policy – Composition of GEAC was in accordance with the Rules, to which the challenge of constitutionality, has failed, and in the absence of any change in the Rules, no fault can be found with the same – Decision of GEAC to grant conditional approval is not vitiated by non-application of mind, or any other principle of law, on part of the body, which itself is an expert body – Matter to be placed before Hon’ble Chief Justice of India for constituting appropriate Bench to consider said aspect afresh – Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Micro-Organisms, Genetically Engineered Organisms or Cells, 1989 [framed under ss.6, 8 and 25 of Environment (Protection) Act, 1986] Held [per B.V. Nagarathna, J.]:

1.1. GEAC simply recommended the environmental release of transgenic mustard hybrid DMH-11 without any deliberation as such, which recommendation was accepted by the Central Government – All the previous deliberations and decisions of GEAC as well as the recommendations and suggestions of the sub-committee to GEAC were given a go by and totally ignored – The deferring of the field demonstration between the years 2018 to 2021, which was for valid reasons, was also ignored – There is no reason forthcoming as to why GEAC completely changed its stance in the 147th meeting held on 18.10.2022 – This resulted in the decision of the Union Government on 25.10.2022 impugned herein – There is no material put forth for the sudden decision taken by the Union Government on receiving the changed recommendation of GEAC, when earlier, it was submitted before this Court that the Union Government was still deliberating on the matter, which aspect is evident from the orders passed by this Court when in fact field demonstration was also put on hold by GEAC – Such being the position from the year 2018 onwards, all of a sudden environmental release of DMH-11 was approved even in the absence of field trials for conducting studies on the impact of honeybees and other pollinators. [Paras 42.5 and 42.6]

1.2. Furthermore, while granting permission of the environmental release of transgenic mustard hybrid DMH-11, the condition imposed was that usage of any formulation or herbicide would not be permitted for cultivation in the farmer’s field and any such use in the farmer’s field without due approval would attract appropriate legal action under various enactments – There is no indication as to how the use of any herbicide could be prevented, rather, the condition not to use any herbicide was open-ended without having any means to check whether any herbicide would be used in the farmer’s field pursuant to the environmental release – The adverse effects of use of herbicide were also totally given a go by – Further, any evidence of harmful effects or damage to the environment, nature and health owing to non-compliance of conditions stipulated by GEAC was also left open-ended. [Paras 42.13 and 42.15]

1.3. Moreover, GEAC’s proposal was simply accepted by the MoEF&CC and immediately notified without any further consideration at the level of the Ministry and without having any inter-departmental consultation with the Ministry of Health, MoA and DBT in the Ministry of Science and Technology. [Para 42.16]

1.4. Also, no consultation was held with the States wherein mustard is grown, although agriculture is a State subject under Entry 14 of List II of the Constitution – The other concerned stakeholders also ought to have been consulted before a decision was taken by the Union of India in terms of the recommendation of GEAC – The Union of India could not have unilaterally acted on such a serious matter without bringing to the notice of the States, particularly in the northern and northwestern States of the country where mustard is being grown. [Para 42.17]

1.5. Further, no material has been brought out as to how the decision of GEAC was accepted by MoEF&CC and the recommendation of the environmental release of transgenic mustard hybrid DMH-11 was simply permitted – The grant of approval by GEAC is governed by Rule 13 – The said Rule does not contemplate any role for the Ministry of Environment, Forest and Climate Change (MoEF&CC) in the decision-making process – Therefore, the lateral intervention by the said Ministry seriously undermines the credibility and integrity of the decision making as well as the regulatory process. [Para 42.18]

1.6. When a statute contemplates a specific procedure to be adhered to in order to arrive at a desired end, such procedure cannot be substituted by an alternative procedure which is not contemplated under the statute – At the crucial 147th meeting of GEAC held on 18.10.2022, there was no representative of the ICMR, Ministry of Health – Hence, the matter was not considered from the paradigm of the adverse effect on the health of human beings and animals as well as on other plants in the event of environmental release. [Paras 42.20 and 42.21]

1.7. Recommendations of the Technical Expert Committee (TEC) submitted to this Court have been completely ignored by GEAC – Pursuant to the intervention of the Ministry, GEAC constituted another Expert Committee and simply accepted its recommendations for the environmental release of DMH-11 hybrid mustard – This was by ignoring all previous deliberation made by GEAC, its sub-committee constituted earlier and its decision to proceed with precaution – GEAC approval dated 18.10.2022 and the consequent decision dated 25.10.2022 regarding the environmental release of transgenic mustard hybrid DMH-11 is vitiated – The impugned approval was in gross violation of the principle of public trust. [Paras 42.22 and 43]

2. The failure to conduct chronic and trans-generational studies to study the impact on human health is a significant omission within the risk assessment process in the instant case – The asymmetry between probable benefits and adverse consequences cannot be adequately counter-balanced by economic or policy safeguards because of the serious and irreversible public and environmental health effects if such consequences occur – The failure to publish the biosafety dossier on the website reveals a deficiency in the Guidelines for Environmental Risk Assessment (ERA) for Genetically Engineered (GE) Plants, 2016 – Furthermore, the failure to furnish cogent reasons for giving a go by to field demonstration studies to study the impact on honeybees also reveals the lack of safeguards against misuse of discretion – The failure to adequately assess health and environmental impact of GM crops seriously infringes upon intergenerational equity as it potentially endangers the ability of future citizens to enjoy the highest attainable standard of health – The decision to grant approval for environmental release of transgenic mustard hybrid DMH-11 violates the right to safe and healthy environment under Article 21 of the Constitution of India because the safeguards which were necessary to be taken prior to the grant of the approval have not been taken in the instant case. [Paras 43.1(iii), 44.1, 44.3 and 44.5]

3.1. Given the fact that genetic engineering has made what was inconceivable a reality, precaution is the need of the hour – For billions of years, each living organism would exchange DNA with others of its kind – Genetic engineering transcends this natural principle by combining genes sourced from widely different species and transferring genes between organisms that had no natural possibility of interbreeding – Scientific research of such a novel nature must therefore happen under supervision and in a manner that inspires public confidence. [Para 45]

3.2. Having regard to the conclusions of the TEC, the apprehensions of the petitioners that HT crops would exert a highly adverse impact over time on sustainable agriculture, rural livelihoods, and the environment are not unfounded – It is reasonable to infer that there is a potential of loss of species of indigenous mustard crop, as India is the centre of origin and diversity, which fact cannot be doubted – The concerns about the impact on other beneficial organisms, such as honeybees, earthworms etc. are also wellfounded and serious – As per the precautionary principle, those activities which may disturb nature shall be proceeded only upon ex-ante assessment of their consequences – Such a sound risk and impact assessment is also a binding obligation under Article 14(1)(b) of the Convention on Biological Diversity (CBD) and Article

26 of the Cartagena Protocol on Biosafety (CPB) – Therefore, GEAC is duty bound, both under domestic and international law, to sanction long-term chronic and inter-generational studies, as recommended by the TEC – The reluctance to conduct such studies would risk the health of future generations as well as the farmers’ right to conduct their agricultural activities in the most suitable manner. [Para 46]

3.3. The ability to conduct robust risk assessment hinges upon the availability of indigenous and independent studies and research – Conclusions about safety assessment and ecological impact cannot be transplanted from research conducted in a foreign context – Crucially, the recommendation of Expert Committee constituted by GEAC in the year 2022, which is the basis of GEAC’s impugned approval, is entirely premised upon foreign studies and research and not on indigenous research or studies – This is a serious omission on the part of GEAC in not applying its mind to research studies to be conducted within the country as India has a unique biodiversity and a socio-economic structure of society which is directly related to land holdings and conduct of agricultural operations. [Para 47.3]

3.4. It is apparent that the precautionary principle has been seriously undermined in Condition VI and VII prescribed by GEAC for the impugned release – Although Condition VII prohibits farmers from using any formulation of herbicide in the fields, it is unclear how such a prohibition would be enforced – Given the nature of the DMH-11 which according to the petitioners has HT characteristics, the impact upon non-target organisms and beneficial organisms could be seriously detrimental to agrarian ecology – The proposed conditions for approval are neither adequate nor feasible to limit these consequences – GEAC failed to take into consideration the precautionary principles while approving the environmental release of the transgenic mustard DMH-11 hybrid. [Para 47.6]

3.5. The evolution of the right to a safe and healthy environment and the concomitant duty of the State to uphold public trust and abide by inter-generational equity and the precautionary principle in environmental regulation is the bedrock of environmental constitutionalism – The environmental rights regime is a product of decades of environmental litigation by civil society, social movements, affected communities and the general citizenry – In that sense, environmental constitutionalism is a facet of transformative constitutionalism touching upon the socio-economic lives of citizens – In other words, the affected communities must have a substantive role in environmental governance. [Para 48.7]

3.6. The aspiration of transformative environmental governance cannot be realised merely through an effective bureaucracy and sound technical expertise – Environmental democracy and environmental rights are two sides of the same coin – Environmental decision-making in a rapidly changing climate requires healthy contestation of alternative worldviews, interests and rights – Only through such contestation can a fine and sustainable balance between development and the environment be arrived at – Open and transparent deliberation on expert knowledge increases accountability and acts as a safeguard against conflict of interest but not a closed door decision making process. [Paras 48.8 and 48.9]

Held [per Sanjay Karol, J.]:

1. The power of the GEAC, to grant approvals, necessarily carries with it the power to regulate the manner, in which the approvals are so granted – The mere absence of a specific statement in the 1989 Rules allowing assistance of expert committees, would not preclude the GEAC from doing so, in furtherance of its main objective – The decision of the GEAC cannot be said to be vitiated by delegation – GEAC had constituted a sub-committee and expert committee respectively, in its 126th and 146th meeting, with a specific purpose on each occasion – This cannot be said to be delegating its core function – The present factual circumstance is not a case, where the approval process itself has been delegated to the sub-committee/expert committee – The conditional approval of DMH-11 granted by the GEAC, is upheld as being independent, reasoned and in consonance with the rules. [Paras 25(a) 23, 25(a) 21, 25(a) 14, 25(a) 17, 25(b) 5].

2. Even if the TEC and parliamentary standing committees have found certain issues with the procedures governing GM crops, that cannot automatically lead to the conclusion that gaps in the impugned procedures result in a violation of Part III of the Constitution of India and must be invalidated or that the impugned action be stalled. [Para 29.5]

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

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

5. Similar to when a legislative body enacts a legislation there is a presumption of constitutionality unless proven otherwise, a policy decision when taken by the competent authority enters the fray of enforcement with a presumption in its favour of being in public interest, unless otherwise shown, demonstrated and proven to be among other grounds, manifestly arbitrary – This presumption extends, subject of course to just exceptions, to the authority having considered duties in framing policies for GMOs. [Para 43]

6. Interference by this Court would only be justified if it can be proven that the effect of a decision standing would be detrimental to the public, against its interest and would ultimately impact the enjoyment of fundamental rights guaranteed by the Constitution, to a degree which would be impermissible – That threshold cannot be said to have been breached – The field testing of DMH11, pursuant to the conditional approval of the GEAC, with sufficient safeguards and precautions, ought to continue and cannot be said to be violative of the precautionary principle and therefore, the constitutional challenge thereto, fails. [Paras 45.6 and 46]

7. It is clear that whether or not there should be a complete ban on Ht crops is not something this Court can issue a direction on – Such a decision has to be taken, keeping in view the opinion of various experts who have the knowledge and ability to comprehend scientific literature on the point as also the views of those persons specifically tasked with taking decisions in such matters – Courts, only on the basis of material placed on record or the indirect understanding passed on to it through counsel, is not in a position to take an informed decision – If such a decision is taken, it would be completely foreign to the standards of judicial review, for it is not within the Court’s purview to undertake cost benefit analysis of a policy decision of the executive. [Para 47]