GM crops, food safety case referred to Supreme Court's larger bench, Union govt forms secret committee on Biosafety

In the aftermath of the Supreme Court's 409 page long judgement of July 23, 2024, Mint reported on September 24, 2024 that the Union government has begun the process of drafting its policy on genetically modified (GM) crops. The agriculture ministry in consultation with the ministries of environment, forest and climate change, health and family welfare, and the department of biotechnology has set up a panel of agriculture scientists that will also evaluate the GM crop research done in other countries and submit its report in the next couple of months. The members of the committee are scientists with expertise in rice, cotton, and plant protection. The names of the committee members have not been disclosed. 

In her 260 page long judgement in Gene Campaign vs. Union of India, as part of a Division Bench of the Supreme Court, Justice B.V. Nagarathna recorded that States like Bihar, Kerala, Madhya Pradesh, Haryana, Tamil Nadu, Delhi, Andhra Pradesh, Rajasthan, Odisha, West Bengal and Karnataka have expressed reservations against field testing and release of transgenic mustard hybrid Dhara Mustard Hybrid (DMH)-11. She underlined that "the States cannot be treated as satellites of the Union of India as they have constitutional identity and powers and responsibilities conferred under the Constitution of India and therefore, their views in the matter are of significance". 

In her judgement, she drew on Articles 14 and 21 of the Fundamental Rights, Article 48A of the Directive Principles of State Policy of the Constitution of India and several case laws to give certain general directions in relation to GM crops. These are as under:

(i) The Union of India is directed to evolve a National Policy with regard to GM crops in the realm of research, cultivation, trade and commerce in the country. The said National Policy shall be formulated in consultation with all stakeholders, such as, experts in the field of agriculture, biotechnology, State Governments, representatives of the farmers, etc. The National Policy to be formulated shall be given due publicity.

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

(iii) That the composition of Genetic Engineering Appraisal Committee (GEAC) shall be suitably reformed bearing in mind the recommendations of the Supreme Court's Technical Expert Committee (TEC) and the Parliamentary Standing Committee (PSC) Reports and the dictum of the Supreme Court in the case of T.N. Godavarman Thirumulpad vs. Union of India. The reformed composition shall comprise of experts in the field of agriculture, biotechnology, ethics, sociology, health as well as experts in the field of environment and shall be an independent and autonomous body. This could be done either by a statute or amendments being brought to the existing Rules as thought fit by the Union of India.

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

(v) The specific guidance documents have been adopted in conformity with the Cartagena Protocol on Biosafety (CPB) shall be complied with in letter and spirit insofar as they are applicable to the Indian context. These guidance documents shall be accorded statutory status by framing and issuing appropriate Rules under Section 25 of the Environment Protection Act (EPA), 1986.

(vi) In the matter of importing of GM food and more particularly GM edible oil, the respondent shall comply with the requirements of Section 23 of Food Safety and Standards Act (FSSA), 2006, which deals with packaging and labelling of foods.

Her order reads:"I hold that the approval dated 18.10.2022 and consequent decision dated 25.10.2022 for environmental release of transgenic mustard hybrid DMH-11 violate the precautionary principle inasmuch as there has been no determination made, as to, whether, transgenic mustard hybrid DMH-11 is a HT crop and if so, the nature of risk that would be caused by the said plant to the environment including other plants as well as to human beings and animals." She observed that deliberations of the GEAC have not focussed on the aspects of biosafety, risk assessment, soil health, micro-biology and socio-economic aspects etc. It did not consider the recommendations of the TEC and Parliamentary Standing Committees’ Reports on Agriculture and on Science and Technology, Environment and Forest. She also observed that the recommendation of the Expert Committee constituted by the GEAC in the year 2022 is of no consequence and not binding.

She concluded:"the recommendations of GEAC dated 18.10.2022 as well as the decision taken by the respondent Union of India on 25.10.2022 with regard to approving environmental release of transgenic mustard hybrid DMH-11 on the application made by the applicant, namely, CGMCP, University of Delhi (South Campus’) are vitiated and hence, they are liable to be quashed and are quashed." 

The writ petitions on the subject have been pending since 2004 and 2005. The instant reason for considering these writ petitions was the approval of Genetic Engineering Approval (now Appraisal) Committee (GEAC) dated 18.10.2022 culminating in the decision dated 25.10.2022 which was found questionable by the petitioners. 

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

It was pointed out that the Review Committee on Genetic Manipulation (RCGM), under the Department of Biotechnology (DBT) did not have the jurisdiction to grant permission for the release of GMOs into the environment. It was originally the RCGM which illegally permitted the release of the GMOs into the country for the first time. Owing to public outcry over the serious illegality of these clearances, attempts were made to get the release of GMOs cleared retrospectively. 

It was arbitrary and unreasonable do away with a mandatory public notice and public hearing before approvals for the release of GMOs are granted.

Alliance for Sustainable and Holistic Agriculture (ASHA), one of the petitioners submitted to the Court that in September 2015, the Centre for Genetic Manipulation of Crop Plants (CGMCP) had submitted an application to GEAC, seeking approval for the environmental release of GE mustard hybrid (DMH-11) seeds and the use of parental events, i.e., Varuna bn 3.6 and EH-2 modbs 2.99, for development of new generation hybrids.

The petitioners submitted that as per current practice, the applicant company itself asks to do testing. The test results are not available for public scrutiny. This is entirely without logic and is a clear conflict of interest involving the same biotech company that has a commercial interest in the approval of the GMO. In India, organizations which are substantially funded by the biotech industry have sought to influence regulatory and other decision-making processes by conducting "awareness" and "educational" programmes. 

Notably Cartagena Protocol on Biosafety to the Convention on Biological Diversity, a binding international agreement on Biosafety was adopted in 2002 and came into force on 11.09.2003. India being a signatory, is bound to implement its provisions. According to Article 10(6) of the Protocol, the lack of scientific certainty due to relevant scientific information and knowledge regarding the extent of potential adverse effects shall not prevent the contracting party from taking a decision, as appropriate, in order to avoid and/or minimize potential adverse effects. Annexure-III of the protocol includes, the general principles of risk assessment. It states that risk assessment should be carried out in a scientifically sound and transparent manner and implores states to take into account expert advice as well as guidelines developed by relevant international organizations. Article 21(6) of the Protocol prescribes that the information about the risk assessment cannot be kept confidential.

India is a party to UN's Convention on Biological Diversity (CBD), 1992, which requires that the contracting parties shall domestically regulate or manage the risks associated with the use and release of Living Modified Organisms (LMOs) resulting from Biotechnology and which are likely to have adverse environmental impacts and risks to human health. It also implores states to introduce appropriate procedures to require impact assessment of proposed projects likely to have significant adverse effects on biodiversity and to allow public participation in the procedure.

 

Justice Sanjay Karol disagreed with the findings, conclusions and certain directions given by Justice  Nagarathna. He authored a 146 page long dissenting judgement.

 

But there is consensus on the Division Bench on some aspects. Their 3 page long joint order dated July 23, 2024 on these aspects reads:

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

2. We issue the following directions:
i. The respondent-Union of India is directed to evolve a National Policy with regard to GM crops in the realm of research, cultivation, trade and commerce in the country. The said National Policy shall be formulated in consultation with all stakeholders, such as, experts in the field of agriculture, biotechnology, State Governments, representatives of the farmers, etc. The National Policy to be formulated shall be given due publicity.
ii. For the aforesaid purpose, the MoEF&CC shall conduct a national consultation, preferably within the next four months, with the aim of formulating the National Policy on GM crops. The State Governments shall be involved in evolving the National Policy on GM crops.
iii. Respondent – Union of India must ensure that all credentials and past records of any expert who participates in the decision-making process should be scrupulously verified and conflict of interest, if any, should be declared and suitably mitigated by ensuring representation to wide range of interests. Rules in this regard may be formulated having a statutory force.

iv. In the matter of importing of GM food and more particularly GM edible oil, the respondent shall comply with the requirements of Section 23 of FSSA, 2006, which deals with packaging and labelling of foods.
3. Having regard to the difference of opinion expressed by us on the decision of the GEAC and MoEF granting conditional approval for environmental release of DMH-11, the Registry shall place the matter before Hon’ble the Chief Justice of India for constituting an appropriate Bench to consider the said aspect afresh."

 

At present, Bt. cotton is the only Genetically Modified (GM) crop approved by the GEAC of Ministry of Environment, Forest and Climate Change in 2002 for commercial cultivation in the country, according to the written reply of Ramnath Thakur, Union Minister of State for Agriculture & Farmers’ Welfare in the Lok Sabha on August 6, 2024. Notably, Supreme Court's July 2024 verdict refers to Bt. cotton on 58 occasions. It records that circumstances surrounding the initial approval of Bt cotton in India were questionable. The RCGM did not have the jurisdiction to grant permission for the release of GMOs into the environment but it illegally permitted the release of the GMOs into the country for the first time. Notably, the Bt Cotton were cleared retrospectively.The verdict also refers to the testimony of Dr. P.M. Bhargava, founder Director of Centre for Cellular & Molecular Biology (CCMB), Hyderabad and the then Supreme Court nominee on GEAC. 

 

Dr. Bhargava  submitted that i) All the tests on Bt cotton have either been conducted by the concerned applicant for approval, or by an accredited laboratory on the samples given by the applicant. The Bt cotton was tested and approved surreptitiously without  adequate information being available to the public. ii). The Bt brinjal was approved on the basis of an expert committee report, which lacked in scientific quality, credibility, consistency and rigour. Relying upon a private conversation with the then Co-Chairman of GEAC, Prof. Arjula  Reddy, Dr. Bhargava claimed that the former was under pressure to approve Bt brinjal and to give a go by to the chronic toxicity and other tests which had been proposed by the latter. He also claimed that the Co-Chairman confided in him that even the tests undertaken were performed badly. iii). That no chronic toxic studies have been conducted on GM crops. iv) Despite a specific proposal for establishing a lab to conduct indigenous and independent assessment studies, the erstwhile Director  General of ICAR, Dr. R.S. Paroda, the erstwhile  Director General of Council of Scientific and  Industrial Research (CSIR), Dr. R.A. Mashelkar and GEAC were reluctant to support the same.

 

It also records that "The cultivation of Bt cotton has led to the development of resistance to the Bt toxin,  giving rise to robust secondary pests. This, in turn, has resulted in an increased application of pesticides, contradicting the initial purpose of Bt cotton."  Therefore, it is doubtful that control over herbicide use and the penalization of farmers employing  herbicides will be effective in the case of DMH-11. The potential adverse impacts of using Herbicide Tolerant (HT) crops include destruction of all the vegetation in and around the fields where the HT crop is cultivated, which is used by the rural community in significant ways. In India, the biodiversity found in and around fields is not considered “weeds” and therefore, not useless, as they are in the west. These plants, so called “weeds”, provide:i. leafy green vegetables and many kinds of saag like chaulai and bathua that provide valuable nutrition for free to poor rural families; they also provide green fodder for rural livestock; such “weeds” are also medicinal plants that traditional healers such as vaids and hakeems use in the treatment of human and animal diseases. The introduction of the HT trait will destroy the opportunity to do mixed farming which is prevalent in Indian agriculture. d. The HT trait will also strike against any efforts to promote organic agriculture, since it involves heavy chemical use of herbicides. The use of herbicides and their accumulation in the soil will damage soil health and the chemicals will enter the food chain to the detriment of human health.

 

The regulatory framework for approval of Genetically Modified (GM) crops has been established as per “Rules for the Manufacture/Use/Import/Export and Storage of Hazardous Microorganisms, Genetically Engineered Organisms or Cells, 1989” under the Environment (Protection) Act, 1986. A series of guidelines and protocols have been issued by Department of Biotechnology and Ministry of Environment, Forests and Climate Change relating to Genetically Modified Organisms and product thereof as under:
    1) Recombinant DNA Safety Guidelines, 1990
    2) Revised Guidelines for Research in Transgenic Plants, 1998
    3) Guidelines for the Safety Assessment of Foods Derived from Genetically Engineered Plants, 2008
   4) Guidelines for the monitoring of Confined Field Trials of Regulated, Genetically Engineered (GE) Plants, 2008
  5) Standard Operating Procedures (SOPs) for Confined Field Trials of Regulated, Genetically Engineered (GE) Plants, 2008
    6) Protocol for Food and Feed Safety Assessment of GE crops, 2008
    7) Guidelines and Handbook for Institutional Bio-safety Committees (IBSCs), 2011
    8)  Environmental Risk Assessment of Genetically Engineered Plants: A Guide for Stakeholders, 2016
    9) Guidelines for the Environmental Risk Assessment of Genetically Engineered Plants, 2016.
    10) Risk Analysis Framework, 2016.
 

GM has never been tested as an HT crop, despite having HT properties. In such a backdrop, the judgement by the larger bench assumes huge significance for food safety and ecosystem in the country.