GENE CAMPAIGN vs UNION OF INDIA on 23 July, 2024

NAGARATHNA, J

Table of Contents

Contempt Petition (Civil) No.295 of 2007 in Writ Petition (Civil) No.260 Of 2005; and, Contempt Petition (Civil) No.6 of 2016 in Writ Petition (Civil)

Significant Orders passed by this Court in Writ Petitions: ................................. 30

Constitution of the Technical Expert Committee (TEC): ....................................... 32 Parliamentary Standing Committee (PSC) on Agriculture’s Report on “Cultivation of Genetically Modified Food Crops – Prospects and Effects” – Parliamentary Standing Committee (PSC) on Science and Technology, Environment and Forests’ Report titled “Genetically Modified Crops and its Conditional approval by Government of India for Environmental Release of

Interlocutory Applications filed by the petitioners: ............................................... 88

Environment (Protection) Act, 1986 (EP Act, 1986): ............................................ 146

Constitutional Court and the Environmental Rule of Law: ............................... 168 Re: Point No.1: Whether GEAC approval dated 18.10.2022 and the consequent decision dated 25.10.2022 for the environmental release of DMHRe: Point No.2: Whether the decision to grant approval for environmental release of DMH-11 violates the right to safe and healthy environment under Re: Point No.3: Whether GEAC’s grant of approval dated 18.10.2022 and the decision dated 25.10.2022 for the environmental release of DMH-11 violate

Acronyms

AFES Assessment of Food/Feed and Environmental

Safety AICRP All India Coordinated Research Project

ASHA Alliance for Sustainable and Holistic Agriculture

BG-II Bollgard-II

BRAI Biotechnology Regulatory Authority of India

BRL Biosafety Research Level

BSU Biosafety Support Unit

Bt Bacillus thuringiensis

CAC Codex Alimentarius Commission

CBD Convention on Biological Diversity

CCMB Centre for Cellular & Molecular Biology

CGMCP Centre for Genetic Manipulation of Crop Plants

CIB&RC Central Insecticide Board & Registration

Committee CPB Cartagena Protocol on Biosafety

CSIR Council of Scientific and Industrial Research

DARE Department of Agricultural Research and

Education DBT Department of Biotechnology

DGFT Directorate General of Foreign Trade

DLC District Level Committee

DMH-11 Dhara Mustard Hybrid-11

DoAC Department of Agriculture and Cooperation

DRMR Directorate of Rapeseed and Mustard Research

ECHR European Convention on Human Rights

ERA Environmental Risk Assessment

FAO Food and Agriculture Organization

FSSA, Food Safety and Standards Act, 2006

FSSAI Food Safety and Standards Authority of India

GE Genetically Engineered

GEAC Genetic Engineering Appraisal Committee

GEF Global Environment Facility

GEO Genetically Engineered Organism

GM Gene Modification or Genetically Modified

GMO Genetically Modified Organisms

HPV Human Papilloma Virus

HT Herbicide Tolerant or Tolerance

IAASTD International Assessment of Agricultural

Knowledge, Science and Technology for

Development IARI Indian Agricultural Research Institute

IBSC Institutional Biosafety Committee

ICAR Indian Council of Agricultural Research

ICMR Indian Council of Medical Research

IMTECH Institute Of Microbial Technology

IPR Intellectual Property Rights

LMO Living Modified Organism

MoA Ministry of Agriculture

MoEF Ministry of Environment and Forests

MoEF&CC Ministry of Environment, Forest and Climate

Change

MoHFW Ministry of Health and Family Welfare

NARS National Agricultural Research System

NBPGR National Bureau of Plant Genetic Resources

NGO Non-Governmental Organisation

NGT National Green Tribunal

NIN National Institute of Nutrition

NKSPLR Nagoya Kuala Lumpur Supplementary Protocol on

Liability and Redress PAU Punjab Agricultural University

PRMC Post Release Monitoring Committee

PSC Parliamentary Standing Committee

R&D Research and Development

RARM Risk Assessment and Risk Management

RAU Risk Assessment Unit

RCGM Review Committee on Genetic Manipulation

RDAC Recombinant DNA Advisory Committee

rDNA recombinant DNA

SBCC State Biotechnology Co-ordination Committee

SOP Standard Operating Procedures

TEC Technical Expert Committee

UK United Kingdom

UNEP United Nations Environment Programme

USA United States of America

Preface:

The ideas drawn from sacred texts of the world have

proffered to worship and respect nature and impel mankind to

preserve the same. This, in essence, is the doctrine of

intergenerational equity.

(i) The verses in Srimad Bhagavata Mahapurana depict nature

and its creations to embody the divine, as it states ‘Ether,

air, fire, water, earth, planets, all creatures, trees and plants,

rivers, and seas, they all are organs of God’s body,

remembering this, a devotee respects all species”.

(ii) In all other faiths practised in India, the earth is deemed to

be the sacred creation of God.

(iii) Nature and all her elements are considered sacred. Human

beings are said to be composed of five elements of nature,

which teach lessons and inspire strength in the formulation

of our character:

“Earth teaches us patience, love; Air teaches us

mobility, liberty; Fire teaches us warmth, courage;

Sky teaches us equality, broad-mindedness; Water

teaches us purity, cleanliness.”

1.1 Faced with the widespread destruction of the environment,

people everywhere are coming together to understand that we

cannot continue to use the benefits of the earth as we have in the

past. A new ecological awareness is beginning to emerge which,

rather than being downplayed, ought to be encouraged to develop

into concrete programs and initiatives.

2.This Court, in State of Bihar vs. Murad Ali Khan, (1988) 4 SCC 655 (“Murad Ali Khan”) speaking through Venkatachaliah, J. (as the learned Chief Justice then was) observed that “the tragedy of the predicament of the civilised man is that, ‘Every source from which man has increased his power on earth has been used to diminish the prospects of his successors. All his progress is being made at the expense of damage to the environment which he cannot repair and cannot foresee’.”

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

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

5.What does it mean to preserve, protect and respect the citizens’ right to a safe and healthy environment while exploring and experimenting with era-altering novel technologies? That is the crux of the controversy in these cases. The factual aspects of the controversy were crystallised to some extent when this Court had set up Technical Expert Committee (TEC) on 10.05.2012. 5.1 In the immediate context, these cases impugn the decision taken by GEAC to grant approval for environmental release of Dhara Mustard Hybrid-11 (DMH-11) mustard at the 147th meeting held on 18.10.2022. Whether the said approval was in compliance or in derogation of the recommendations of the TEC Report is a foundational aspect. Whether the said decision is in consonance with due process of law, as understood in the context of the public trust doctrine? There is also the question whether the right to a safe and healthy environment under Article 21 has been violated and whether there has been a violation of the precautionary principle. 5.2 In these cases, the said controversy has been considered from several angles. Arguments at length have been heard by us. Therefore, we propose to encapsulate the pleadings, arguments and voluminous materials that has been submitted during the course of the hearing while arriving at the findings and conclusion in this matter. Pleadings:

6.According to petitioner in Writ Petition (Civil) No.115 of 2004, namely, Gene Campaign, it is a society registered under the Societies Registration Act, 1860. It consists of lawyers, geneticists, social scientists, agriculturalists, economists, environmentalists, farmers etc. who work towards the cause of protecting genetic resources and ensuring that the rights of rural and tribal communities to access the same are not infringed. Petitioner No.2, Dr. Suman Sahai is the President of Gene Campaign, a researcher and instructor in several institutions in India and abroad. It is his considered opinion that the use of Gene Modification (GM) technology must not be permissible without having the requisite safeguards and regulatory regimes in place. 6.1 The prayers in Writ Petition (Civil) No.115 of 2004 filed by the petitioners read as under: “The petitioner therefore, prays that in the facts and circumstances of the present case, this Hon’ble Court may be pleased to issue a writ of mandamus or writ or direction of like nature to: i) direct the respondents to bring the Rules for Manufacture, Use, Import, Export and the Storage of Hazardous Micro-organisms, Genetically Engineered Organisms or Cells, 1989 in consonance with Article 14, 19, 21, 38, 47, 48, 48A read with 51-A(g) of the Constitution and in the eventuality of the respondents failing to do so, declare the Rules of 1989 as unconstitutional; ii) direct the Respondents to set-up a High-Power Committee to formulate a National Policy on Genetically Engineered Organisms (GEOs) through a multistakeholder consultation process; iii) direct the Respondents to observe a moratorium on various permissions/approvals/trials concerning GEOs, in particular of commercial nature, particularly of crops for which India is a Centre of Origin/Diversity, till the Rules are amended and a sound Regulatory and Monitoring System is put in place; iv) pass such other and further orders as this Hon’ble Court may deem fit and proper in the facts and circumstances of the case.”

7.The pleadings in the aforesaid writ petition could be

encapsulated as under:

7.1 Writ Petition (Civil) No.115 of 2004 has been filed for the

issuance of a writ of mandamus or similar writ directing the

respondent-State to bring the Rules for the Manufacture, Use,

Import, Export and Storage of Hazardous Micro-Organisms,

Genetically Engineered Organisms or Cells, 1989 (“the 1989

Rules”, for the sake of convenience), which have been framed

under Sections 6, 8 and 25 of the Environment (Protection) Act,

1986 (“EP Act, 1986”, for short) in consonance with Articles 14,

19, 21, 38, 47, 48, 48A read with Article 51-A(g) of the

Constitution and if there is a failure to do so, to declare the said

Rules as unconstitutional. It is averred that this Court has on

various occasions interpreted Article 21 of the Constitution to

include the right to health of the individual as well as to a clean

and safe environment. That tenets of the precautionary principle,

sustainable development, polluter pays principle and inter-

generational equity doctrine have been held by this Court to form

a part of Articles 14 and 21 of the Constitution. That there is a

need for the 1989 Rules to be in accordance with the aforesaid

principles so as to be held constitutional. That the public need

to be provided sufficient opportunity to participate in the process

of decision-making when there is an actual or likely possibility of

their fundamental rights being affected and necessary

information needs to be made available to facilitate the same.

The said right has been recognized by the decision of this Court

in Research Foundation for Science Technology National

Resource Policy vs. Union of India, (2003) 9 SCALE 303 : (2005) 10 SCC 510 (“RFSTE”).

7.2 It is further averred that the 1989 Rules as they exist are

not in conformity with established principles of environmental

law as elucidated by this Court. The 1989 Rules are also stated

to be not in conformity with international instruments such as

the Convention on Biological Diversity (CBD) and the Cartagena

Protocol on Biosafety (CPB), that have been ratified by India.

That, a reading of these along with the fundamental rights

conferred by the Constitution would serve the purpose of

furthering the said rights and such an approach should be

adopted by this Court.

7.3 That Genetically Modified Organisms (GMOs) are an

emerging area of research and study but the 1989 Rules are still

inadequate to meet the challenges of the limited findings and

evidence that are a product of this research. That overseas

jurisdictions have established robust regimes that regulate

GMOs, in recognition of the risk they may pose to the

environment. But the 1989 Rules as they stand do not appear to

contain any of the safeguards found in the regulatory regimes of

other jurisdictions. The aforesaid absence of safeguards has

contributed to India being used as a “dumping ground” and the

Country being used to test experimental crop varieties that have

not been sufficiently studied, with these possibly posing a

serious risk to the country’s biodiversity. That this would directly

impact the economic prospects of a large section of the

population that works in the agricultural sector and could

further harm the country’s food security. Small and marginal

farmers are to be the most disadvantaged in the aforesaid

scenario.

7.4 That the 1989 Rules were enacted owing to mounting

evidence of the possible adverse effects of GMOs on agricultural

ecosystems and the country’s biodiversity as well as on human

and animal health. It is the petitioners’ case that the said Rules

are riddled with lacunae that lead to them being applied

arbitrarily and in violation of the Constitution. That the said

Rules do not bear any mention as to the qualifications required

to be eligible for membership in the various regulatory agencies

constituted thereunder. This renders the functioning of these

agencies largely ineffective as they often lack the necessary

technical competence, particularly in the fields of Risk

Assessment and Risk Management (RARM).

7.5 Further, the prescribed constitution of various agencies, in

particular those of the Review Committee on Genetic

Manipulation (RCGM), GEAC, the State Biotechnology Co-

ordination Committees (SBCC) and District Level Committees

(DLC), include representatives of various authorities who do not

possess the necessary qualifications, technical expertise,

competence, skills and knowledge to carry out the respective

mandates of each agency. Majority of the members are only in

ex-officio capacity and lack competence in the field of operation.

7.6 That, there is a complete lack of transparency at each stage

of the regulatory process. The 1989 Rules do not allow for public

to access information despite GMOs having possible adverse

effects on human and animal health, socio-economic conditions

as well as the environment which directly pertains to the public’s

rights and interests. These Rules do not allow public to

sufficiently participate in the decision-making at any stage, viz. grant of approval for research, field trials or commercial-scale

cultivation of a GM crop. Public participation is needed to both

accurately gauge the risks and benefits as well as to increase the

confidence of public in GMOs.

7.7 That the 1989 Rules do not require taking prior informed

consent from those farmers and Gram Sabhas which are located

in the vicinity where a field trial would be conducted. This is in

violation of the 73rd and 74th Constitutional Amendments which

make the involvement of Gram Sabhas and Gram Panchayats in

such decisions necessary and non-optional.

7.8 That the Rules envision a regulatory regime that lacks

accountability and there is no indication as to who would bear

the liability in case of an erroneous decision being made that has

an adverse impact on human and animal health, the

environment and the socio-economic conditions of the country.

Such harm may take the form of personal injury, property

damage or financial loss, however, the liability corresponding to

each of these has not been considered in the 1989 Rules at all.

7.9 Further, the penal provisions contained in the said Rules

do not sufficiently deter prospective offenders as these provisions

just mention “measures” that may be taken by the concerned

agency, which do not include the description of a penalty of any

kind. The actions that can be taken by the concerned agencies

are only in a corrective capacity to ensure damage is minimized.

7.10 That neither SBCC nor DLC had been made functional at

the time of filing of this Petition despite the commercial

cultivation of the Bacillus thuringiensis (Bt) cotton crop which is a GMO.

7.11 That GM technology is an emerging technology that

enables outcomes that were hitherto unimagined such as the

transposition of the genes of fish into those of tomatoes, genes of

bacteria into those of plants etc. There is an inherent uncertainty

to this technology and its effect on the environment and on

human life. This necessitates the re-examination of extant

regulations and regulatory regimes so as to mould them in light

of newer developments.

7.12 That till these uncertainties have been clarified through the

process of scientific research thereby enabling a thorough

consideration of the risks and benefits, there must be a

moratorium on the commercial release of GMOs.

7.13 That the impact of GM technology would vary based on the

socio-economic, cultural, and ecological context of each country

and any research conducted must evaluate the specific impact of

such technology in the Indian context. On the other hand, GM

technology have evolved in industrialized and developed

economies with highly mechanized agricultural processes and

vast monocultural tracts that are generally isolated from natural

ecosystems. Unlike India, these countries do not possess

similarly rich biodiversity.

7.14 That India, being the centre of origin for many food crops,

has to be more vigilant and cautious in adopting this new

technology which is still in the process of evolution. In particular,

transgenic varieties of crops for which India is the centre of origin

should not be released for commercial cultivation until its impact

is adequately assessed. That there are serious concerns about

contamination of the natural gene pool of crops originating in

India. These are some of the potential consequences:

i. Contamination of non-GM crops and their wild relatives;

ii. Proliferation of weeds and creation of new weeds due to flow

of foreign genes from GM crops to non-GM crops and their

wild relatives;

iii. The likely formation of difficult-to control novel weed types

due to transfer of foreign genes that confer hardiness;

iv. Destruction of soil micro-organisms due to release of toxins

from genes, like Bt gene, leading to adverse impact on crop

productivity.

7.15 That farm lands in India are small and closely packed

together as agriculture is practiced in close proximity to natural

biodiversity, often bordering forest areas or even within forest

areas, where natural gene pools are found. A GM crop cultivated

in one field is likely to impact other fields as well as the natural

ecosystems. No research has been undertaken to assess the

adverse effects of such transfers.

7.16 Moreover, GM crops could directly impact the economic

prospects of a large section of the population that works in the

agricultural sector. Small and marginal farmers are likely to be

the most disadvantaged. Other socio-economic risks include

market concentration, the loss of livelihood of small farmers, and

restriction on the consumers' right to choose.

8.The petitioner who is a public-spirited citizen in this case

has made the following prayers and has averred as follows in the

context of GM Technology and GM Crops:

“The petitioners therefore, pray that in the facts and

circumstances of the case, this Hon’ble Court may be

pleased to issue appropriate writs or directions to:

A) Direct the Union of India not to allow any release of

GMOs into the environment by way of import,

manufacture, use or any other manner unless the

following precautions are taken.

(a) a protocol for all the required bio-safety tests of

the GMOs proposed to be released is prepared by the

GEAC after processes of public notice and public

hearing.

(b) The GMO has been subjected to all the required

bio-safety tests, prepared on the basis of the

required Biosafety tests on the basis of the above

protocol, by agencies of independent expert bodies,

and results of which have been made public.

B) Direct the Union of India to ban the import of any

biological organism, food or animal feed unless they have

been certified and labelled to be GM free, by the exporting

country.

C) Direct the Union of India to put in place rules to

ensure that it shall be compulsory for any dealer or

grower selling GMOs to label them as such.

D) Pass such other and further orders as this Hon’ble

Court may deem fit and proper in the facts and

circumstances of the case.”

(i) According to this petitioner, there are outstanding safety

concerns linked with Genetically Engineered (GE)

technology. Transgenic contamination is unavoidable and

there can be no co-existence between GM and Non-GM

agriculture.

(ii) That research shows that Bt proteins, incorporated into

25% of all transgenic crops worldwide, to be harmful to a

range of non-target insects, worms and amphibians. Some

of them are potent immunogens and allergens. In fact,

glyphosate and the Roundup herbicide used on most

herbicide resistant crops is shown by studies to be lethal to

amphibians.

(iii) That GM crops have led to an increase in pesticide use,

financially hurting farmers and harming the environment.

(iv) That GE technology is a fit case for the application of the

precautionary principle which necessitates that if there are

reasonable scientific grounds for believing that a new

process or product may not be safe, it should not be

introduced until convincing evidence of reasonable

certainty of no harm is obtained. In addition, if the dangers

are considered serious enough, then the principle may

require withdrawal of GM products or impose a ban or a

moratorium on further use thereof.

(v) That safety testing for GE food is absolutely necessary for

India before the release of any GMO into the Indian

environment. However, there are very few established

protocols for assessing the potential health impacts of GE

crops. All one finds is loose guidelines that in most cases

only list certain tests or procedures without specifying how

they are to be conducted.

(vi) That biotechnology companies frequently deny access or

allow strictly conditioned access, to data on crop materials

on the basis of confidentiality and IP concerns, making it

very difficult for regulatory authorities and independent

researchers to verify or review test claims on the safety of

GE crops and foods.

(vii) That the extant regulatory system in India is ill-equipped to

handle challenges outlined above, as past experience also

confirms. Circumstances surrounding the initial approvals

of Bt cotton in India is a good example. The RCGM, under

the Department of Biotechnology (DBT), is a body that did

not have the jurisdiction to grant permission for the release

of GMOs into the environment. Yet, it was originally the

RCGM which illegally permitted the release of the GMOs

into the country for the first time. It was only when there

was a public outcry over the serious illegality of these

clearances that attempts were made to get the release of

GMOs cleared retrospectively.

(viii) That even for technologies which have been tried and

tested, and found to be far safer than GE, for instance

Hydro-electric projects, the relevant statutes mandate a

public notice and public hearing as well as Environmental

Impact Assessment. Hence, it is arbitrary and unreasonable

not to have a mandatory public notice and public hearing

before approvals for the release of GMOs are granted.

(ix) That as per current practice, the applicant company itself

is asked to do testing. The test results are not available for

public scrutiny. This is entirely without logic and is a clear

conflict of interest involving the same biotech company that

has a commercial interest in the approval of the GMO.

(x) That in India, like many other developing countries,

organizations which are substantially funded by the biotech

industry have sought to influence regulatory and other

decision-making processes by conducting "awareness" and

"educational" programmes. The Governments of advanced

countries too, have been a handmaiden to GE Industry,

often arm-twisting developing countries to adopt pro-GM

stances.

8.1 It is further averred that the CPB was adopted in 2002 and

came into force on 11.09.2003. It is a binding International

agreement on Biosafety and India being a signatory, is bound to

implement its provisions. According to Article 10(6) of the

Protocol, the lack of scientific certainty due to relevant scientific

information and knowledge regarding the extent of potential

adverse effects shall not prevent the contracting party from

taking a decision, as appropriate, in order to avoid and/or

minimize potential adverse effects. In addition, Annexure-III of

the said protocol includes, inter alia, the general principles of risk assessment. It states that risk assessment should be carried out

in a scientifically sound and transparent manner and implores

states to take into account expert advice as well as guidelines

developed by relevant international organizations. Further,

Article 21(6) of the said Protocol prescribes that the information

about the risk assessment cannot be kept confidential.

8.2 That the United Nations Convention on Biological Diversity

(CBD), 1992, to which India is a party, inter alia, requires that the contracting parties shall domestically regulate or manage the

risks associated with the use and release of Living Modified

Organisms (LMOs) resulting from Biotechnology and which are

likely to have adverse environmental impacts and risks to human

health. It also implores states to introduce appropriate

procedures to require impact assessment of proposed projects

likely to have significant adverse effects on biodiversity and to

allow public participation in the procedure.

8.3 That in addition to implementing a moratorium on the

release of any GMO into the domestic environment until

adequate biosafety tests demonstrate safety beyond reasonable

doubt, labelling for imports sourced from countries which

produce GM crops and foods should be mandated. Therefore,

both moratorium and labelling must be concurrent mandatory

requirements.

8.4 That farmers have the right to save seed for sowing in the

next season, which a patent-based regime of GM seeds will

effectively deny. This choice is a fundamental right and must be

retained as such for better farming prospects and livelihoods.

Therefore, the petitioner has sought the aforesaid reliefs.

8.5 The petitioner is stated to be a public-spirited citizen based

in Chennai and is involved in a consumer movement in Tamil

Nadu called ‘Safe Food Alliance’. The petitioner is stated to be

one of the National Convenors of Alliance for Sustainable and

Holistic Agriculture (ASHA), which is an organization that has

been actively involved in the cause of the genetic modification of

crops and its effects on human health.

8.6 It is averred by the petitioner that in September 2015, the

Centre for Genetic Manipulation of Crop Plants (CGMCP)

submitted an application to GEAC, seeking approval for the

environmental release of GE mustard hybrid (DMH-11) seeds

and the use of parental events, i.e., Varuna bn 3.6 and EH-2

modbs 2.99, for development of new generation hybrids. Upon

receipt of the application, GEAC, in its 125th meeting held on

11.12.2015, appraised the same and decided that the CGMCP

will be invited to give a presentation before GEAC in the

subsequent meeting. Pursuant to the same, the CGMCP made a

presentation before GEAC in the 126th meeting held on

04.01.2016 and the CGMCP was directed to furnish clarifications

with respect to some issues in para 3.3 of the Minutes of the

Meeting. It was further decided in the meeting that a sub-

committee would be constituted under the chairmanship of Dr.

K. Veluthambi, Co-Chair of GEAC, and the said sub-committee

would have the duty of examining the issues raised by GEAC in

para 3.3 and submit a report with recommendations to GEAC.

8.7 On 02.02.2016, the sub-committee appointed by GEAC

convened its first meeting and in that meeting, it voiced concerns

over the clarifications furnished by the CGMCP on the issues

mentioned in para 3.3. However, in the 127th meeting of GEAC

held on 05.02.2016, GEAC adopted the recommendations of the

sub-committee and directed the CGMCP to revise the biosafety

dossier, in light of the comments of the sub-committee and the

biosafety unit, and prepare an RARM document for further

review. It is stated that GEAC had decided to put the biosafety

dossier in the public domain, but this was not carried out.

8.8 In its 128th Meeting held on 04.03.2016, GEAC decided to

await the completion of the Biosafety Support Unit's (BSU) review

of the revised dossier before further consideration. On

11.04.2016, the sub-committee, in its 2nd Meeting, recommended

incorporating expert comments and remarks from the Biosafety

Unit into its report. The report was to be presented to GEAC and

uploaded onto its website. In its 129th Meeting on 20.06.2016,

GEAC noted the Sub-Committee's request for an additional

month to finalize recommendations. Subsequently, in its 130th

Meeting, GEAC concluded that a report had been submitted by

the sub-committee, titled "Assessment of Food and

Environmental Safety (AFES)". It was published on GEAC's

website for stakeholder comments within a period of 30 days.

However, it was complained that the biosafety dossier was

deliberately not disclosed on the website for public scrutiny.

8.9 On 07.09.2016, Dr. Bhargava, a member of GEAC, made a

startling revelation. He stated that the so-called Report of the

sub-committee titled "Assessment of Food and Environmental

Safety" was never shared or discussed before GEAC. Following

this revelation, on 22.09.2016, various scholars and public

activists endorsed an email addressed to the Hon’ble Minister of

Environment, Forest and Climate Change. The email raised

serious objections to the conduct of the appraisal process,

particularly the refusal to disclose the biosafety dossier to the

general public. It urged the Ministry of Environment, Forest and

Climate Change (MoEF&CC) to extend the consultation process

by another 120 days. In addition to the email, on 24.09.2016,

eminent scholars and experts sent a letter to the Hon’ble Minister

of Environment, Forests and Climate Change, expressing grave

concerns regarding GEAC’s blatant refusal to disclose the

biosafety data to the general public, hindering a meaningful

exercise of public consultation. It also requested an extension of

the consultation process for another 120 days. Despite

objections and requests for transparency, it is stated that GEAC

continued the consultation process, culminating in a comment

note published on 30.09.2016, refusing to extend the

consultation period and setting the deadline for receiving

comments as 05.10.2016.

8.10 Challenging the appraisal procedure adopted by GEAC, the

petitioner has preferred the writ petition before this Court, under

Article 32 of the Constitution of India, primarily contending that

the aforesaid procedure adopted by GEAC was not only arbitrary

but also lacked proper application of mind, rendering it illegal

and violative of the fundamental rights enshrined under Articles

14 and 21 of the Constitution.

This assertion was underscored by instances such as the

failure to disclose crucial information, including the biosafety

dossier, and the opaque nature of the consultation process,

which impedes meaningful public participation. Further, the

petitioner has emphasized the statutory obligations of GEAC to

exercise its power of granting approvals for environmental

release of GE products in a fair, transparent, and reasonable

manner, especially considering the lack of any procedure laid

down under the 1989 Rules for the exercise of its powers by

GEAC. It is stated that the potential impact of the GM crops on

health and environment can only be known after a long gestation

period and therefore, a stricter scrutiny ought to have been

undertaken.

8.11 Furthermore, the petitioner has criticized the sub-

committee formed by GEAC, arguing that such delegation of

statutory functions to another body is ultra vires the 1989 Rules. Additionally, concerns regarding the non-disclosure of the

biosafety dossier despite assurances and directives from

authorities has been raised, which undermine the transparency

and integrity of the decision-making process.

8.12 The petitioner has also questioned the validity and

adequacy of the AFES Report uploaded by GEAC, highlighting

discrepancies in its findings, the lack of application of mind and

the lack of comprehensive scientific scrutiny. It is averred that

the said document was merely a 133-page summary document

that does not explain to the public the data collected and the

studies/tests conducted by the CGMCP. It is further pointed out

from the AFES report that no study was conducted to examine

the physiological impact of the transgene products from the

transgenic mustard hybrid DMH-11 on the insects, no testing

was done under the herbicide-sprayed conditions on an HT crop,

and no testing was done on the honey quality, despite the

questionable study of the impact on honey bees by the crop

developers having vested interests in the subject.

8.13 Moreover, the restricted access to the biosafety dossier,

despite assurances and directives to disclose it, has also been

criticized, since it impedes meaningful public engagement and

violates the rights of stakeholders to be informed and participate

effectively in the consultation process. In terms of the

consultation process, the petitioner has contended that GEAC

ought to have adhered to the principles of fairness and

transparency and ought not to have made a mockery of the entire

process of public consultation to defeat the valuable rights of the

general public to be informed about the critical date pertaining

to the transgenic mustard hybrid DMH-11 crop. It was asserted

that the present consultation process couldn’t be completed

without making available to the public the critical scientific data.

Further, the petitioner avers that it was also highly arbitrary to

expect all the interest stakeholders from all corners of the

country to travel to New Delhi and conduct a physical

examination of the 3000 odd pages at the premises of the

MoEF&CC and submit meaningful inputs.

8.14 It is averred that there has also been a failure to involve

State Governments in the process, despite agriculture being a

state subject and mustard being a highly important crop for the

country.

8.15 Finally, the petitioner has drawn attention to the

comparative inadequacy of the testing and consultation

processes for genetically modified (GM) mustard, compared to

previous cases like Bt brinjal.

8.16 Overall, the petitioner has contended that the appraisal

process for transgenic mustard hybrid DMH-11 lacks

transparency, has violated legal mandates, and fails to

adequately consider the concerns of stakeholders, thereby

warranting judicial intervention to ensure procedural fairness

and safeguard public interest.

Civil Appeal No.4086 of 2006:

8.17 This appeal assails order dated 08.10.2003 passed by the

Appellate Authority in Appeal No.2 of 2002, constituted under

Rule 19 of the 1989 Rules notified under the EP Act, 1986. The

Appeal No.2 of 2002 was filed against the order dated 05.04.2002

of GEAC granting conditional clearance to M/s. Maharashtra

Hybrid Seeds Co. Ltd. for three transgenic Bt hybrid cotton

varieties, namely, Bt MECH 12, Bt MECH 162 and Bt MECH 184.

By the impugned order, the appeal was dismissed by the

Appellate Authority.

8.18 Vide Order dated 08.09.2006, leave was granted and vide order dated 13.07.2017, the appeal was directed to be tagged

with Writ Petition (Civil) No.260 of 2005.

Contempt Petition (Civil) No.295 of 2007 in Writ Petition (Civil) No.260 Of 2005; and, Contempt Petition (Civil) No.6 of 2016 in Writ Petition (Civil) No.260 Of 2005:

8.19 These contempt petitions have been filed alleging violation

of orders dated 22.09.2006, 08.05.2007, 01.08.2007; and orders

dated 15.02.2007, 08.05.2007, 08.04.2008 and 12.08.2008

respectively passed by this Court in Writ Petition (Civil) No.260

of 2005.

Significant Orders passed by this Court in Writ Petitions:

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

10.In view of the above plea, this Court, after several dates of

hearing, vide order dated 10.05.2012 constituted a Technical Expert Committee (TEC), the constitution of which was as

follows:

“1. Prof. V.L. Chopra, Former Member, Planning Commission and Former Member, Science & Advisory Committee to the PMO, Recipient of Padma Bhushan.

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

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

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

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

6. Dr. B. Sivakumar, Former Director, National Institute of Nutrition (NIN), Hyderabad.”

10.1 The Terms of Reference of the TEC were as follows:

“A. To review and recommend the nature of sequencing of risk assessment (environment and health safety) studies that need to be done for all GM crops before they are released into the environment.

B. To recommend the sequencing of these tests in order to specify the point at which environmental release though Open Field Trials can be permitted.

C. To advise on whether a proper evaluation of the genetically engineered crop/plants is scientifically tenable in the greenhouse conditions and whether it is possible to replicate the conditions for testing under different agro ecological regions and seasons in greenhouse?

D. To advise on whether specific conditions imposed by the regulatory agencies for Open Field Trials are adequate. If not, recommend what additional measures/safeguards are required to prevent potential risks to the environment.

E. Examine the feasibility of prescribing validated protocols and active testing for contamination at a level that would preclude any escaped material from causing an adverse effect on the environment.

F. To advise on whether institutions/laboratories in India have the state-of-art testing facilities and professional expertise to conduct various biosafety tests and recommend mechanisms to strengthen the same. If no such institutions are available in India, recommend setting up an independent testing laboratory/institution.

G. The Expert Committee would be free to review reports or studies authored by national and international scientists if deemed necessary. The petitioners opined that they would like to formally propose three Expert Reports from Prof. David Andow, Prof. Jack Heinemann and Dr. Doug Gurian Sherman to be a formal part of the Committee’s deliberations. The MoEF may similarly nominate which experts they choose in this exercise.”

10.2 This Court directed the TEC to hear the Government,

petitioners and any other intervenor, who, in the opinion of the

TEC, could assist the cause of expeditious and accurate

finalization of its report. A direction was also given to the TEC to

submit an interim report on the following issue:

“Whether there should or should not be any ban, partial or otherwise, on conducting open field tests of GMOs? In the event open field trials are permitted, what protocol should be followed and conditions, if any, that may be imposed by the Court for implementation of open field trials.”

10.3 Thereafter, an order was passed by this Court on

09.11.2012 recording the filing of an interim report dated

07.12.2012 and the objections filed to the said Report by the

Union of India and others. Six weeks’ time was granted to the

TEC to finalise and submit its final report. In the meantime, Dr.

R.S. Paroda was appointed as a sixth member to the TEC in place

of Prof. V.L. Chopra by order dated 09.11.2012. The TEC

submitted its final report dated 30.06.2013. This included two

reports, one, by the majority of five members of the TEC, and a

separate note by Dr. R.S. Paroda.

Final Report of TEC:

10.4 The Final Report of TEC is divided into following two topics:

I. Background and Context of the TEC's Recommendations in the Interim Report; and

II. Agricultural Policy Considerations in Relation to Knowledge and Practices:

✓ Biotechnology and Agriculture

✓ Usage of GM Crops

✓ International Agreements and Instruments for Food Safety, Conservation and Regulation

✓ The Indian GMO Regulatory Structure

✓ Discussion of Recommendation of the Interim Report (IR) in the Context of the Terms of Reference for the TEC

✓ Deliberations of the TEC Following Submission of the Interim Report

✓ Issues that were discussed in the course of deliberations by the TEC

✓ Examination/Study of the Safety Dossiers

✓ Molecular data

✓ Health Safety Data

✓ Examples of differences

✓ Environmental Risk Assessments

✓ Summary

✓ Recommendations

10.5 The recommendations contained in the majority report are

as follows:

“Recommendations Based on the deliberations of the TEC and particularly the examination/study of the safety dossiers, it is apparent that there are major gaps in the regulatory system. These need to be addressed before issues related to tests can be meaningfully

considered, till such time it would not be advisable to conduct more field trials:

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

• Health (human and animal)

• Environment and Ecology

• Agroeconomics and Socioeconomics

• Molecular biology

• Entomology

• Agricultural and Aquacultural Systems

• Public Health

• Soil science and microbiology

• Plant biology

• Regulatory toxicology

• Plant and animal breeding and genetics

A single committee such as the GEAC or RCGM doing all the valuation is not sufficient.

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

3. Specific sites for conducting confined field trials need to be designated, certified, and sufficient mechanisms put in place for monitoring the trials and ensuring restricted access, disposal of material, associated testing and other facilities, These sites should be used only for field trials of GM crops (GM and control material). The sites could be in ICAR institutes or State Agricultural Universities and required conditions for isolation should be established and supported appropriately by ICAR. Sites in company premises may also be considered for certification for trials, however the land should be permanently owned by the applicant/tester. Trials should not be conducted on leased land so as to avoid the possibility that it may be used for a different purpose following the trials.

4. Stakeholder participation, need, socio-economic considerations, societal impact, and sustainability should be some of the dimensions to be incorporated in the risk assessment and this should be done at an early stage in the risk assessment process.”

10.6 The specific findings of the Report of the majority of TEC on

the terms of reference may be discussed at this stage.

(i) Firstly, as to the nature of sequencing of risk assessment studies that need to be done for GM crops before they are

released into the environment, the majority recommended

the following:

a. The majority recommended consultation, ideally prior to

the development of the GM product intended for field

trials, wherein the applicant would provide information

to the regulator about the product, its purpose

(including whether it is intended for research only or

commercialization), and how it is to be deployed in India.

At this stage, the scope of issues that needs to be

addressed relating to health and environmental safety

can be discussed and defined on a case-wise basis

keeping in mind the overall phases of risk assessment:

hazard identification; hazard characterization; exposure

assessment; risk characterization; and mitigation

options. Need, socio-economic factors and sustainability

should also be considered and thoroughly discussed at

this stage. If a GMO is initially declared for research and

at a later stage it is to be considered for

commercialization then that would be treated as a fresh

application. The overall process of risk assessment

should follow the Flowchart for the Risk Assessment

Process in the Guidance on Risk Assessment of LMIOs

(UNEP/CBD/BS/COP MOP/6/13/Add.1) of the

Cartagena Protocol on Biosafety (CPB). In the case of

health safety, the regulator should expect a suitable

response to all relevant paragraphs of the Codex

Alimentarius Commission (CAC) Guideline for the

Conduct of Food Safety Assessment of Foods Derived

from Recombinant DNA (rDNA) Plants (CAC/GL 45-

2003) and any other chosen risk assessment procedure.

In doing so the regulator establishes a minimum

expectation of the risk assessment meeting international

requirements. It was pointed out that both the CPB and

CAC guidelines provide guidance with regard to

principles and issues that are to be addressed. They

leave open the details of specific tests to be carried out

which is left to the national system and the regulator.

b. The majority, thus, noted the need to include chronic

and transgenerational toxicity testing in feeding studies

of rodents based on the fact that food is consumed over

the entire lifetime and that nutritional stress can also

lead to adverse or unintended effects over long-term

exposure. The sensitive stages of reproduction also need

to be included.

c. In addition, the majority emphasized that the regulatory

process should be open to new scientific information

that may have a bearing on the risk assessment, if

necessary, even after deregulation of an event.

d. The majority also emphasised that the applicant should

be responsible for providing to the regulator, all

information that has a bearing on the risk assessment,

regardless of whether it was obtained for the purpose of

the risk assessment. In cases where the applicant is a

collaborator/partner/ subsidiary in the development of

the GMO, the applicant should provide this information

along with the consent of all parties.

e. With regard to the nature of tests for Bt in food crops,

the majority was of the view that the safety of Bt

transgenics with regard to chronic toxicity has not been

established and this needs to be done before it can be

considered safe. In this regard, it was pointed out that

by far, the largest deployment of transgenics worldwide

is in soyabean, corn, cotton, and canola, all of which are

used primarily for oil or feed after processing. Nowhere

are Bt transgenics being widely consumed in large

amounts for any major food crop, that is, directly used

for human consumption. The majority could not find any

compelling reason for India to be the first to do so. It,

therefore recommended that there should be a

moratorium on field trials for Bt in food crops (those that

are directly used for food) intended for commercialization

(not research) until there is more definitive information

from sufficient number of studies as to the long-term

safety of Bt in food crops.

f. The majority also examined issues in relation to

Herbicide Tolerant (HT) crops. The conclusion here was

that HT crops would most likely exert a highly adverse

impact over time on sustainable agriculture, rural

livelihoods, and environment. The majority, therefore,

found them completely unsuitable in the Indian context.

g. The majority also highlighted how crops in their centres

of origin and diversity often have a deep cultural

significance that can get lost when utilitarian

considerations predominate the discourse. Ceremonial

and medicinal varieties can also be put at risk from GM

crops by reduction of diversity and genetic purity. For

example, in the case of brinjal, the Malapur variety in

Karnataka is an essential accompaniment at temple

festivals and religious ceremonies. Likewise, Oryza

nivara, a medicinal rice, can also be at risk if GM rice

comes to dominate the crop as has happened for

example, in the case of cotton, in India.

h. The release of a GM crop into its area of origin or

diversity has far greater ramifications and potential for

negative impact than for other species. To justify this,

the majority suggested a requirement of extraordinarily

compelling reasons. GM crops that offer incremental

advantages or solutions to specific and limited problems

were not to be deemed sufficient reasons to justify such

release. Not finding any such compelling reasons under

the present conditions, it recommended that release of

GM crops for which India is a centre of origin or diversity

should not be allowed at all.

(ii) Secondly, as for, when environmental release through openfield trials should be permitted, the majority recommended

that the sequence of testing should be carried out in order of

increasing environmental exposure required to perform the

test. Tests should be done under the minimum conditions of

exposure required for the test. In other words, the testing

should proceed in a progressive manner that increases

confidence with regard to safety. While not covering all

possible tests for all crops, it laid down certain minimum

tests possible to carry out under contained conditions within

the laboratory of greenhouse, before the GMO is taken out of

containment. These include tests based on bioinformatics

such as possible allergenicity and toxicity; acute toxicity of

the purified protein; in-vitro digestibility and any other

biochemical tests on the purified protein. Where appropriate

and necessary, tests such as those for general growth

characteristics and plant habit as part of event selections

may be performed under confined conditions in consultation

with the regulator. Those tests on the plant that can be

performed under contained conditions as judged by the

regulator on a case-wise basis should be performed under

contained conditions.

(iii) Thirdly, as for whether a proper evaluation of the GE plant is scientifically tenable in greenhouse conditions and

whether it is possible to replicate the conditions for testing

under different agro-ecological regions and seasons in

greenhouse, the majority noted that it cannot be said that it

is generally possible to replicate the conditions for testing

under different agro-ecological regions and conditions in the

greenhouse.

(iv) Fourthly, the majority noted the need to develop specific sites for conducting field trials. It also emphasised the need for

sufficient mechanisms for monitoring the trials and ensuring

restricted access, disposal of material, associated testing and

other facilities. These sites were recommended to be used

only for field trials of GM crops (GM and control material).

The sites could be in Indian Council of Agricultural Research

(ICAR) Institutes or State Agricultural Universities and

required conditions for isolation should be established and

supported appropriately by ICAR. Sites in company premises

may also be considered for certification for trials, however

the land should be permanently owned by the

applicant/tester. Trials should not be conducted on leased

land so as to avoid the possibility that it may be used for a

different purpose following the trials.

(v) Fifthly, on the feasibility of prescribing validated protocols and active testing for contamination with the view to

preclude any escaped material from causing an adverse

effect on the environment, the majority noted that the tests

for detecting contamination at the stipulated level (0.01 %)

are possible and have been demonstrated in some of the

dossiers. However, it was emphasized that these in

themselves do not preclude material from escaping. There

are several ways in which contamination can occur and it

probably will not be possible to deploy the tests at a level that

will preclude the possibility of escape. Even in the most

careful of conditions, contamination can occur. There are

well-known examples of contamination having occurred as

well.

(vi) Finally, on whether institutions and laboratories in India have the state-of-art testing facilities and professional

expertise to conduct various biosafety tests, the majority

noted that the professional expertise and standards across

the institutions appeared unsatisfactory. However, it noted

that it is ultimately the expertise available in the regulatory

system that sets the standards for conducting and

evaluating the biosafety tests. Unless this expertise and

capacity is present, no amount of facility creation will be able

to address the issues. Based on the examination of the safety

dossiers the majority found that at present, the regulatory

system has major gaps and these will require rethinking,

investment, and re-learning to fix. A deeper understanding

of the process of Risk Assessment is needed within the

regulatory system for it to meet the needs of a proper

biosafety evaluation. This is not available in the country as

per the majority. It, therefore, recommended that the

requisite understanding be developed through consultation,

collaboration, and capacity building. It is of critical

importance that the Indian regulatory system develops the

ability to assess how any GM product is likely to impact

different sections of society.

10.7 Dr. R.S. Paroda submitted a separate dissenting report. A

brief discussion of the Report may be adverted to.

(i) Firstly, as for the nature of sequencing of risk assessment studies that need to be done for GM crops before they are

released into the environment, Dr. Paroda, in his dissenting

report recommended the following:

a. The sequencing of studies provided in the

"Guidance for Information/Data Generation

and Documentation for Safety Assessment of

Regulated, Genetically Engineered (GE) Plants",

which is in draft stage, should henceforth be

adopted quickly by the RCGM and GEAC.

b. The sequencing of studies presented in

"Guidance for Information Generation and

Documentation for Safety Assessment of

Regulated, Genetically Engineered (GE) Plants"

should, in future, be reviewed at regular

intervals of no less than three years to ensure

that these guidelines remain consistent with

internationally accepted best practices and

standards.

c. Guidelines for the conduct of confined field

trials and for GM food safety assessment that

meet the international norms have currently

been adopted by RCGM and GEAC. However, it

was noted that the present approach for the

environmental risk assessment (ERA) in the

guidelines for research in transgenic plants was

rather broad, whereas there is an urgent need

for developing and adopting comprehensive

guidelines for the ERA by RCGM and GEAC. The

process for the same should be transparent and

consultative, involving all stakeholders and it

must start immediately.

d. A Risk Assessment Unit (RAU), as also

suggested in the "Draft Establishment Plan for

the National Biotechnology Regulatory

Authority" should be established. Further, the

RAU should serve both RCGM and GEAC and be

permanently staffed by a multi-disciplinary

team of scientists/experts competent enough

and responsible for undertaking science-based

risk assessments, including but not limited to

those required to approve clinical or confined

field trials for the experimental GMOs as well as

for their commercial release of GMOs (i.e.,

product specific risk assessments). The

proposed RAU could be transitioned to the

Biotechnology Regulatory Authority of India

(BRAI), as and when the BRAI Bill is

promulgated by the Parliament.

e. In addition to establishing the RAU, RCGM and

GEAC should immediately establish a roster of

qualified scientific experts in relevant

disciplines to provide sound scientific

advice/information on biosafety issues that

could impact on human and animal health as

well as the environment. The issue concerning

conflict of interest should also be addressed

while including experienced scientists to the

roster.

f. Although, the safety assessment is completed

after GEAC approval and subsequently the GM

crops are to be treated in the same manner as

their non-GM counterparts for the purpose of

variety/hybrid release and registration, seed

multiplication and cultivation; as a measure to

ensure quality products for the farmers, the

National Agricultural Research System (NARS)

should have an assigned responsibility for the

conduct of confined field trials for assessing the

agronomic performance, an essential

requirement for the release of GM varieties/

hybrids in accordance with the National Seed

Policy as well as National Seed Act. For this,

ICAR Delhi can make good use of established

infrastructure under the All India Crop

Coordinated Programmes. It is advised that a

single window system for managing the testing

and release of GM varieties and hybrids should

be established taking into account special

considerations involved with GM crops viz. expression levels of inserted proteins,

confirmation of the events etc., irrespective of

whether these are produced by the private or

public sector. In this context, the Ministry of

Agriculture (MoA) should consider establishing

a high-level committee of experts: including

socio-economists, tanners, Non-Governmental

Organisations (NGOs) and the representative of

the private sector to review finally, for

commercial release, the cases that are cleared

by GEAC.

g. Once a GM variety hybrid is released, a post-

release monitoring mechanism must be put in

place.

(ii) Secondly, as to when environmental release through openfield trials should be permitted, the dissenting report noted

that “open-field trial" is a misnomer in the context of trials of

GM crops. This is because even though the trial is done in

the open field, the GM plants and genetic material being

tested are confined to the field trial site using measures to

ensure that the “genes in pollen or seed do not escape from

the trial site”. Thus, the right term is “Confined Field Trials”.

It, then proceeded to suggest that Confined Field Trials

should only be permitted by RCGM and GEAC after careful

consideration of submissions that adhere exactly to the

"Application for Confined Field Trial" form. This form, in

combination with the "Guidelines and Standard Operating

Procedures for Confined Field Trials of Regulated,

Genetically Engineered Plants", clearly specifies the

information required by the competent authorities to

determine if a Confined Field Trial should be permitted or

not. The application form was developed through a

transparent, consultative process that included a period for

public review and comment. Hence, both the approach and

procedure for permitting Confined Field Trials in India have

already been peer-reviewed and public-reviewed. In sum, the

tests that are required prior to obtaining a permit for a

confined field trial are:

a. Amino acid sequence homology comparisons to

assess the extent to which the transgenic

protein is similar in structure to known toxins;

b. Amino acid sequence homology comparisons to

assess the extent to which the transgenic

protein is similar in structure to known

allergens.

It was also considered desirable, but not mandatory, to

determine the maximum level of expression of the transgenic

protein in the edible portions of the plant.

(iii) Thirdly, as to whether a proper evaluation of the GE plant is scientifically tenable in the greenhouse conditions, the

dissenting report answered in the negative. It noted that a

proper evaluation of a GE plant is scientifically not tenable

in a contained greenhouse since it would not be feasible to

replicate the conditions prevailing under natural field

conditions representing different agro-ecological regions and

growing seasons. Therefore, it was advised that confined field

testing, as recommended under the present regulatory

system, is the right option for a realistic evaluation of any

GE plant to know its suitability for any agronomic trait of

economic importance.

(iv) Fourthly, whether specific conditions imposed by the regulatory agencies for open-field trials (or “Confined Field

Tests”, as Dr. Paroda prefers) are adequate, the dissenting

report expressed concerns about the existing system in India

and recommended, among other things, the following:

a. The RCGM, GEAC and ICAR must work hand in

hand to conduct the confined field trials at the

specified sites as well as improve the quality and

timeliness of inspections by qualified

monitoring teams. A roster of such monitors,

with required expertise needs to be maintained

and updated regularly by these agencies.

b. Crop-specific Standard Operating Procedures

(SOP) should be developed and made available

online. Such SOPs should incorporate, in

addition to the existing procedures, i) methods

for reproductive isolation of the confined field

trial site, ii) schedules for monitoring the field

trial during and after the growing season, iii)

required duration of post-harvest restrictions on

the trial site, and iv) methods for on-site/off-site

disposal of regulated plant materials.

c. A system for notification of confined field trial

sites located in different agro-ecological zones

should be developed by RCGM and GEAC in

consultation with the ICAR. These sites could

include both public and private sector

institutions/facilities, meeting the specified

conditions. However, no trials should be allowed

on farmers' fields, leased or otherwise.

d. Integrate the existing system of testing and

standard protocols under All India Coordinated

Research Project (AICRP) with the three years of

confined field testing in Biosafety Research

Level (BRL)-I and BRL-II. The agronomic

evaluation should be against the best national

check, regional check, and the latest released

variety or hybrid in the state concerned. For all

the new events, the decision of RCGM and

GEAC on biosafety and environmental concerns

must be final at either of the testing stages

(BRL-I or BRL-II), irrespective of good agronomic

performance of the variety.

e. Monitoring for biosafety compliance as well as

agronomic performance of each confined field

trial must be made mandatory, and should be

carried out by GEAC through an inter-

ministerial monitoring compliance committee

including people drawn from a roster of experts.

In addition, each confined field trial must be

monitored by a site-specific monitoring

committee.

f. In cases where an already approved event is

incorporated into a new genetic background,

after being verified for its stability, such variety

or hybrid shall be evaluated independently by

the AICRP protocol for agronomic performance

and the expression of the event concerned for a

period of two years, as per the existing practice

under the New Seed Policy.

g. Varieties or hybrids evaluated by the above

process shall then be approved for general

cultivation by a Central GM-Crop Release

Committee at par with the Variety Release

Committee under the MoA. This committee shall

include experts from the disciplines concerned

including the Crop Project Coordinators or

Director, officials of Seed or Crops Divisions of

DAC and ICAR, socio-economists, progressive

farmers, NGOs and the private sector

representatives.

h. Once a GM crop variety/hybrid is released, a

well-designed case-by-case post-release

monitoring system must be put in place jointly

by the Department of Agriculture and

Cooperation (DoAC) and ICAR to address

specific post-release issues identified during the

event approval by GEAC. Such a system should

also monitor the long term effects from the point

of view of food safety, soil health, environment

and agronomic performance.

i. Finally, the MoA may also consider issuing a

separate notification on priority for the general

release of GM crops at par with New Seeds

Policy, while legally ensuring much needed

harmonization of both EPA under Ministry of

Environment and Forests (MoEF) and the Seed

Act under MoA.

10.8 A corrigendum was issued to the final report of TEC on

12.07.2013. Paragraph 6 of the Majority Report is modified by

the corrigendum, which reads as under:

“6. page 71, lines 3-5: “… exert a highly adverse impact over time on sustainable agriculture, rural livelihoods, and environment. The TEC finds them completely unsuitable in the Indian context.”

Corrected: “… exert a highly adverse impact on sustainable agriculture, rural livelihoods, and environment. The TEC finds them completely unsuitable in the Indian context and recommends that field trials and release of HT crops not be allowed in India.”

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

11.The aforesaid Report, submitted on 09.08.2012, has been relied upon by the learned counsel Sri Prashant Bhushan. The salient observations and recommendations of the said Committee are encapsulated in the following paragraphs: i. To ascertain the efficacy of the extant system in general and the role of GEAC as the apex regulator in particular, the Committee sought the views of Dr. P.M. Bhargava, founder Director of CCMB, Hyderabad and then the Supreme Court nominee on GEAC. The gist of the testimony of Dr. P.M. Bhargava given on 22.12.2010 can be crystallised in the following points: a. All the tests on Bt cotton have either been conducted by the concerned applicant for approval, or by an accredited laboratory on the samples given by the applicant. The Bt cotton was tested and approved surreptitiously without adequate information being available to the public. b. The Bt brinjal was approved on the basis of an expert committee report, which lacked in scientific quality, credibility, consistency and rigour. Relying upon a private conversation with the then Co-Chairman of GEAC, Prof. Arjula Reddy, Dr. Bhargava claimed that the former was under pressure to approve Bt brinjal and to give a go by to the chronic toxicity and other tests which had been proposed by the latter. He also claimed that the Co-Chairman confided in him that even the tests undertaken were performed badly. c. That no chronic toxic studies have been conducted on GM crops. d. Despite a specific proposal for establishing a lab to conduct indigenous and independent assessment studies, the erstwhile Director General of ICAR, Dr. R.S. Paroda, the erstwhile Director General of Council of Scientific and Industrial Research (CSIR), Dr. R.A. Mashelkar and GEAC were reluctant to support the same. ii. The Committee, discussing the status, composition and functioning of GEAC, highlighted the following deficiencies: a. GEAC is headed by a civil servant, who is also functioning in another capacity in the MoEF, the controlling authority of GEAC. b. The Co-Chairman of GEAC is a biotechnologist who, though purportedly from outside, is nominated by the DBT, the Department that funds and promotes projects on transgenic products. Therefore, primacy is accorded to the DBT nominated Co-Chair in the decisionmaking process. c. The Vice-Chairman is again a civil servant, simultaneously discharging a few more responsibilities in another role in the MoEF. d. GEAC being an entity created under the Rules rather than an Act of Parliament deprives it of the status, powers and more importantly, autonomy and independence that a statutory regulator ought to have. iii. The Committee noted the findings of several scientific reports, including the International Assessment of Agricultural Knowledge, Science and Technology for Development (IAASTD) Report – ‘Agriculture at a Crossroads’, and underlined the following shortcomings of modern biotechnology in agriculture: a. Modern biotechnologies have yet to prove their efficacy, safety and sustainability in the case of GM crops. There are significant limitations in its ability to conserve the resilience of small and subsistence agricultural systems, etc. b. Containment of harm would be a very challenging task even for some of the most wellequipped developed countries and simply impossible in a country like India. c. The integration of biotechnology must be within an enabling environment, supported by local research and education that empowers local communities. iv. With respect to regulation and labelling of GM foodstuffs, the Committee observed the casual approach on the part of both MoEF and Ministry of Health and Family Welfare (MoHFW). While the MoEF, on 23.08.2007, exempted all GM food categories from regulations under Rule 11 if the end product was not an LMO, the MoHFW did not include GM foods from the restrictions on manufacture, distribution and selling when it issued the notification under Section 22, Food Safety and Standards Act, 2006 (for short, “FSSA, 2006”). The Committee noted that the Food Safety and Standards Authority of India (FSSAI) regulation for GM processed food was nowhere in sight, even though so many years had gone by. While noting that Section 23 of FSSA, 2006 requires FSSAI to notify labelling, the Committee observed that FSSAI had not been able to do so. v. It was concluded that the tendency of the regulatory mechanism, in the absence of specialized infrastructure and research and development (R&D) facilities in India, is to base their decision-making on practices and studies elsewhere, as also on the assessments and data generated by the applicant concerned. This was particularly concerning in light of the testimony of Dr. Bhargava, as the contents of his testimony were “not merely slippages due to oversight or human error but indicative of collusion of the worst kind”. By its very composition, GEAC does not have regular existence and meets monthly only when some decisions are to be taken. It is also a sad reality that modern biotechnology being a nascent discipline in the Country, we have a serious dearth of scientists of eminence in sufficient numbers, therefore, more or less the same set of people sit on both the sides, i.e., to develop technologies and products, as also to assess, evaluate and approve them. vi. The Committee noted that Article 246 of the Constitution of India, read with Entry 14, List II, assigns “agriculture, including agricultural education and research, protection against pest and prevention of plant diseases” to the States. However, it observed that for a thing as crucial as field trials, the State Governments were not even consulted till recently. vii. The Committee concluded that in a regulatory set-up where the promoter has an overwhelming say and presence in the regulatory mechanism, an element of subjectivity in assessment and evaluation is unavoidable. The entire system, therefore, reflects a pro-DBT/pro-industry tilt which is best avoided. Apart from this major shortcoming, the Committee’s examination has revealed that the extant system is grossly inadequate and antiquated to face the typical challenges a population-intensive, agrarian economy (primarily) like India poses when the question of introduction of such modern technologies in the agriculture sector crops up. Parliamentary Standing Committee (PSC) on Science and Technology, Environment and Forests’ Report titled “Genetically Modified Crops and its impact on Environment” - 2017:

12.The aforesaid Report has been perused by us. The salient observations and recommendations of the said Committee are encapsulated in the following paragraphs: i. The Committee considered the legal and administrative architecture for the regulation of biotechnology and GE techniques and the extant process of health and environmental safety assessment. ii. It observed that as a party to several International Conventions, India should ensure the safe usage of GM crops through the “Precautionary Approach”. In line with the same, India ratified International Protocols like the CBD, the CPB and the Nagoya Kuala Lumpur Supplementary Protocol on Liability and Redress (NKSPLR). iii. The Committee took note of the divergent views on the efficacy of the existing regulatory mechanism. It expressed certain apprehensions about the stance of the MoEF&CC that the existing regulatory regime left no scope for any nonadherence. It also observed that the MoEF&CC and GEAC’s casual approach indicated indifference towards the environmental safety and health hazards of humans and animals. Specifically, it concluded that the regulatory agencies had turned a blind eye to the negative impact of GM crops on the environment. It was observed that the existing regulatory mechanism was susceptible to manipulation, due to the following processual infirmities and substantive deficiencies: a. The whole process of regulation depends upon the data made available to the regulators by the technology developers. b. None of the Committees established under the 1989 Rules conduct the closed field trials on their own but are solely dependent on the data provided to them by the technology developer. c. There was a scope for the technology developers to manipulate the data to suit their own requirements. d. The Government failed to put in place the desired protocols as late as 2011, while the GM crops were introduced in 2002. e. Two of the top three positions of GEAC are held by the bureaucrats of the MoEF&CC. There is a conflict of interest in the appointment of some of the members of GEAC. f. The members of GEAC were mostly from the Government and Government-aided institutions and there was hardly any representation of the civil society or the State Governments on the Board. g. Even though the DLCs are provided for in the 1989 Rules, the importance of this Committee had not been realised, thereby further weakening the confidence level of farmers, civil societies, environmentalists, etc. h. There was lack of clarity on the impact of the adoption of Bt cotton on crop yield. Therefore, the Committee was not persuaded about the claims of success of Bt cotton as India’s cotton yields increased by 69% in the five years (2000-2005) when Bt cotton was less than 6% of total cotton area, but by only 10% in the ten years from 2005 to 2015 when Bt cotton grew to 94% of the total cotton area. There was also lack of clarity on whether traditional methods of farming could achieve better outcomes. i. It also expressed its apprehensions about the stated benefit of reduced dependence on chemical pesticides. Based on consultations with members of civil society, it observed that after the advent of Bt cotton, the insecticide use on bollworm, both sucking and secondary pests took over the ecological niche vacated by the bollworm. Therefore, the per hectare insecticide use had almost doubled. The issue of pesticide resistivity was also a matter of concern, as it was observed that the pink bollworm had developed resistance to Bt cotton variety, i.e., Bollgard-II (BG-II). j. Since transgenic mustard hybrid DMH-11is a HT GMO, there exists clear evidence of the adverse impacts thereof from elsewhere in the world. In the case of transgenic mustard hybrid DMH-11, thus, there are serious unanswered questions. k. The cultivation of GM crops in the midst of other indigenous farming would cause unstoppable contamination and cross-pollination. It would also adversely affect non-target organisms like soil microbes, insects, bees, butterflies, birds or even mammals which are critical to the agroecosystem. l. There is a glaring lack of indigenous study on the impact of GM crops on human health. It is particularly worrying because certain studies on animals revealed complications including infertility, immune problems, accelerated aging, insulin regulation, and changes in major organs. The Department of Health Research has accorded its approval for commercial release without scrutinising any indigenous study. Only acute and sub-chronic studies have been conducted but chronic and transgenerational studies have not been conducted, therefore, risking the health of future generations.

13.As is well-settled, the Parliamentary Select Committees are entities through which Parliament scrutinises the policies and actions of the Government and enforces executive accountability. Select Committees are constituted with specifically nominated Members of Parliament and exercise the authority delegated by the House. The role of Select Committees has been outlined in Erskine May's Treatise on The Law, Privileges, Proceedings and Usage of Parliament, (Lexis Nexis, 24th Edn. 2011, p.37.] as under: “Select Committees are appointed by the House to perform a wide range of functions on the House's behalf. Most notably they have become over recent years the principal mechanism by which the House discharges its responsibilities for the scrutiny of government policy and actions. Increasingly this scrutiny work has become the most widely recognised and public means by which Parliament holds Government Ministers and their departments to account.” 13.1 Parliamentary material, such as the reports submitted by Select Committees, is an aid to the construction of legislation, as such material may disclose the legislative intention lying behind the ambiguous words and expressions, vide Pepper (Inspector of Taxes) vs. Hart, 1992 UKHL 3 (HL) (“Pepper”). Noting the evolution of Indian law, Justice G.P. Singh, in Principles of Statutory Interpretation (14th Edn.), has stated that this Court has pressed the parliamentary materials as an aid in resolving questions of construction. This Court has clarified that courts may seek recourse to background parliamentary material, including a statement of position by the Government, to understand the reasons of the enactment of a law and the problems sought to be remedied vide Kalpana Mehta vs. Union of India, (2018) 7 SCC 1 (“Kalpana Mehta”). 13.2 The pertinent facts in Kalpana Mehta were that a writ petitioner, who had challenged the grant of approval to an HPV (Human Papilloma Virus) vaccine by the Drugs Controller General of India, had invited the attention of this Court to a report of the PSC and this Court had directed the Government to file an affidavit about the status of compliance with the contents of the report. At that stage, the State and private respondents raised doubts about the appropriateness of adverting to a report of the PSC while exercising jurisdiction under Article 32 in a public interest litigation. Therefore, the core question raised therein that came to be referred to the Constitution Bench was whether a PSC report can be placed reliance upon for adjudication of a fact in issue and also for what other purposes it can be taken aid of. 13.3 It was concluded that the reports of the Parliamentary Committee can be relied upon to adduce the position adopted by the Government. In this respect, reliance can be placed upon the responses given by the Government to the queries raised by the Parliamentary Committee. The Union of India has filed Action Taken Reports with respect to the recommendations made by the Standing Committee. Conditional approval by Government of India for Environmental Release of DMH-11:

14.We shall now proceed to the actual controversy. According

to Union of India, the conditional approval for environmental

release of transgenic mustard hybrid DMH-11 and parental lines

bn 3.6 and modbs 2.99 containing barnase, barstar and bar genes has been made after following the detailed procedure in law

and after considering the biosafety data accumulated over several

years. Also, the conditional approval has been made in

accordance with the guidelines and framework which enable a

consistent and rigorous risk-analysis approach to evaluating

applications for the environmental release of GE plants is the

contention of the Union of India.

14.1 That in the instant case, after recommendation of RCGM,

GEAC had considered the recommendations of RCGM in the

following meetings in regard to confined field trials:

Date of Meeting Purpose of Trial Permission GEAC under which Granted Meeting considered 29.09.2010 103rd meeting Study under 1st year BRL-I confined application conditions for dated environmental and 20.08.2010 to food and feed RCGM.

safety assessments at three locations namely Agricultural Research station experimental Farm, Navgaon, Agricultural Research Station, Sriganganagar and KVK, Kumher during Oct, 2010.

Also, gave approval for experimental seed production under confined condition at Jaunti Village, Delhi and Environmental safety studies (Crossability Studies) at Bawana, Delhi during Oct, 2010.

21.09.2011 112th meeting On transgenic 2nd year BRL-I mustard (Brassica application Juncea) containing dated bar, barnase and 15.07.2011 to barstar genes RCGM. [Events bn 3.6

Date of Meeting Purpose of Trial Permission GEAC under which Granted Meeting considered (Barnase Line), modbs 2.99 (Barstar Line) and bn 3.6x modbs 2.99 (Hybrid DMH11) under the coordination of Directorate of Rapeseed Mustard Research, Bharatpur during the appropriate season in 2011-12.

18.07.2014 121st meeting On transgenic BRL-II trials mustard hybrid application (DMH-11) dated (Brassica juncea) 17.08.2012. Events bn 3.6 (Barnase Line), modbs 2.99 (Barstar Line) & bn 3.6 x modbs 2.99 containing bar, barnase and barstar genes at Navgaon, Sriganganagar, Kumher, Delhi, Bawal, Ludhiana, Bhatinda, Bharatpur, Morena, Kanpur and Faizabad during appropriate season.

14.2 After confined field trials, the facts leading to conditional

approval for grant of environmental release by GEAC are as

under:

(i) The CGMCP, University of Delhi, New Delhi, on 15.09.2015,

submitted an application for approval of environmental

release of the GE mustard (Brassica juncea) hybrid DMH-11 and use of parental events (Varuna bn 3.6 and EH-2

modbs2.99) for development of new generation of hybrids,

along with a dossier of 3285 pages as a compilation of the

results of the food and environmental safety studies that

were carried out at the time of research/experiments/

confined field trials and the application for the environmental

release of transgenic mustard DMH-11 hybrid and parental

lines bn 3.6 and modbs 2.99 containing barnase, barstar and

bar genes to GEAC.

(ii) The said application for environmental release was

considered in the 125th meeting of GEAC held on 11.12.2015,

wherein GEAC deliberated on the application submitted by

CGMCP for environmental release of mustard. After a

detailed deliberation, it was decided that the applicant may

be invited to give a presentation to GEAC on 04.01.2016.

(iii) In its 126th meeting held on 04.01.2016, GEAC constituted a

sub-committee under the Chairmanship of Dr. K.

Veluthambi, Co-Chair of GEAC, with the following members

for examination of the dossier:

a. Dr. K. Veluthambi, Chairman (Biotechnologist)

b. Dr. S R Rao, Adivser, DBT, Member (Agriculture Expert)

c. Dr. S.K. Apte Member (Molecular Biology Expert)

d. Dr. Ramesh V Sonti Member (Plant Genetics Expert)

e. Dr. B. Sesikeran, Member (Nutritional Pathologist and Food Safety Expert)

f. Dr. C R Babu Member (Environmental Science

Expert)

g. Dr. K V Prabhu, Joint Director (Research), IARI Member (Plant Breeding Expert)

h. Member Secretary, GEAC to facilitate the subcommittee.

(iv) Pursuant to the recommendation of the above-mentioned

meeting, GEAC was informed in its 127th meeting held on

05.02.2016, that the 1st meeting of the sub-committee was

held on 02.02.2016. The Chair of the sub-committee also

informed GEAC that the outcome of the review of the

biosafety dossier submitted by the BSU set-up by DBT was

also deliberated in detail. It was further informed that the

sub-committee recommended revision of the biosafety

dossier by incorporating additional information/

clarifications/gaps identified by the sub-committee and the

BSU. Considering the above, GEAC, in its 127th meeting,

adopted the recommendations of the sub-committee and

directed for the revision of biosafety dossier. GEAC also

discussed the procedure for further review and consultation

on the biosafety data in respect of transgenic mustard hybrid

DMH-11 developed by CGMCP and Biosafety RARM report to

be prepared for consideration of GEAC. It was also decided

that if the biosafety dossier is found to be complete in all

respects, the biosafety dossier/RARM report, excluding

confidential information, will be put in the public domain for

comments. Thereafter, a detailed response to the comments

received would be prepared and considered before a final

decision is taken by GEAC.

(v) The first meeting of the sub-committee was held on

02.02.2016 and the second meeting of the sub-committee

was held on 11.04.2016.

Sub-committee meetings:

14.2.1 In the first sub-committee meeting, held on

02.02.2016, the sub-committee made the following submissions:

a) That the mandate given to it included review of the biosafety

dossier for its adequacy and accuracy in all respects, and

indicate gaps, if any.

b) That Dr. S.R. Rao Advisor, DBT informed that the biosafety

dossier had been examined in detail by the BSU set up in

DBT and points for further clarification and dossier revision

had been prepared for consideration and discussion.

c) That on the application submitted by the applicant CGMCP,

University of Delhi, South Campus, for environmental

release of transgenic mustard hybrid DMH-11 and parental

lines containing events bn 3.6 and modbs 2.99 developed

using barnase, barstar and bar genes, was taken up. d) That discussion was held with the applicant and the sub-

committee advised for continuous monitoring and further

investigation for fitness and the transfer of transgenic trait

from DMH-11 to their progenies and feral populations that

will be essential for implementing management strategies to

minimize persistence and dissemination from release site.

The sub-committee also advised that a suitable post-release

management strategy should be implemented.

e) That certain data had to be incorporated in the revised

dossier, along with the details of oil content and other

measured parameters in the revised dossier.

f) That the data suggested that the activities of barnase need

to be presented quantitatively and UDSC-barnase specific activity can be compared with any other over expressed

barnase specific activity to compare activity status of the proteins.

g) That the updated statistics data from National Institute of

Nutrition (NIN) may be included in the revised dossier.

h) That Intellectual Property Rights (IPR) for Barnase promoter has not been registered in India.

i) Requested the University to check whether DMH-11 hybrid

accumulated complexes of barnase + barstar.

j) Questioned whether grazing of transgenic mustard by farm

animals would affect them.

k) That the bar gene is present in the two parental varieties and continues to be present in the hybrid but release of marker

free hybrid would have been desirable. For that, reply by the

applicant was that barnase/barstar technology requires a herbicide gene for hybrid seed production and for

maintaining the male sterile line.

l) That the regulatory guidelines provide an overall list of

principles for conducting biosafety studies and therefore,

case specific issues need to be addressed by the applicant.

m) That sub-chronic toxicity was evaluated in rats, though it

would have been much more relevant to do so in rabbits,

goats and other cattle which are likely to consume mustard

leaves.

n) That issues regarding deliberate introduction of a protein

that induces cell death into our food were raised/discussed.

o) That in the case of canola, only oil is consumed, but mustard

leaves and seeds are consumed as food by humans and this

is a matter of concern. To this, the reply of the applicant was

“It is a fact that a fear-psychosis has been created around transgenic crops. Transgenic technologies are heavily patented and mainly with transnationals-many fear that dependence on proprietary technologies may jeopardize food security of developing countries like India. Although European continent is scientifically very advanced – they seem to have opted for chemical control rather than biological control. Europe is a huge importer of food and has no ambition of increasing food

production. They are only interested in high-value agriculture. Europe has not released even any cisgenic event. Japan gave biosafety clearance for environmental release of barnase/barstar Canola in 1996 – but has chosen not to grow it. However, Japan is the largest importer of Canola seed, oil and meal. Decisions on not growing GM crops are political and economic in nature – rather than related to biosafety.”

p) That long-term post-release monitoring should be

implemented to study (i) weediness, (ii) pollen flow to wild

relatives, (iii) the impact on beneficial insects, and (iv) the

impact on beneficial soil microbes, if any.

14.2.2 The second sub-committee meeting of GEAC was held

on 11.04.2016. In the said meeting, Dr. S.R. Rao briefed the sub-

committee members on the follow up actions taken by BSU

pursuant to the 128th GEAC meeting held on 04.03.2016

regarding the application for environmental release of transgenic

mustard (Brassica juncea) hybrid DMH-11 by the CGMCP, University of Delhi (South Campus). The sub-committee was

made aware of the fact that the 128th GEAC meeting held on

04.03.2016, had sought further information/clarifications from

CGMCP and accordingly, a revised document was submitted by

the applicant. Accordingly, the revised biosafety dossier and draft

RARM report of the sub-committee was circulated amongst the

sub-committee members and comments of the experts were

tabulated along with remarks of the BSU.

14.2.3 Observation of one of the members of the sub-

committee was regarding the sustainable use of deregulated GE

mustard in future and as to how honey derived from GE mustard

be tested for the absence of barnase for a definite period as a part of post-release monitoring.

14.2.4 The sub-committee opined that one of the members of

the sub-committee explained that self-reproducible populations

of mustard (Brassica juncea) may get established in the hills (not in the plains) and though probability of such occurrence may be

low, this question needs to be addressed. The sub-committee

opined that this should be taken as a scientific question, which

should be addressed from a research angle in the interest of long-

term sustainability of transgenic mustard hybrid DMH-11

14.2.5 The sub-committee sought time to analyse and review

the revised dossier and results obtained in the 129th GEAC

meeting, which was held on 20.06.2016.

14.2.6 In the meantime, GEAC invited two groups of NGOs

for presenting their views/concerns regarding release of

transgenic mustard hybrid DMH-11 in India.

14.2.7 The sub-committee constituted by GEAC suggested a

report being placed on the MoEF&CC website for thirty days, to

invite comments from stakeholders in the 130th GEAC meeting

held on 11.08.2016.

14.2.8 Accordingly, the AFES Report was uploaded on the

website of MoEF&CC, inviting comments from all stakeholders.

The comments received were to be reviewed by the sub-

committee and GEAC prior to taking an appropriate decision.

The full biosafety dossier submitted by the applicant was

available in GEAC Secretariat and any person interested in

studying the same could access the dossier during working

hours in person, by prior appointment during the public

consultation period, at Indira Paryavaran Bhawan, Jorbagh, New

Delhi – 110 003, till the closing of working hours, i.e., 05:30 PM

on 05.10.2016. A total of 759 comments were received between

05.09.2016 and 05.10.2016.

14.2.9 It is also to be noted that about 29 persons (including

from places other than Delhi) personally inspected the dossier at

the premises of the MoEF&CC and provided their comments. It

is stated that thereafter, all these comments were analyzed and

deliberated by the sub-committee of GEAC.

14.2.10 The instant proposal was again considered on

11.05.2017 in the 133rd GEAC meeting, wherein the report

submitted by the sub-committee was examined in detail and

GEAC recommended the proposal with certain terms and

conditions for further approval by the Competent Authority. But

pursuant to receipt of various representations from different

stakeholders, matters related to environmental release of

transgenic mustard were kept pending for further review.

14.2.11 In the 134th meeting of GEAC held on 21.03.2018, it

was recorded that the instant proposal was referred back to

GEAC for its re-examination, pursuant to receipt of several

representations, both in support and against, after the 133rd

meeting of GEAC held on 11.05.2017. In this meeting, GEAC

examined all the representations and reiterated that these

representations were already deliberated extensively while taking

the decision in the 133rd meeting of GEAC. After a detailed

discussion, GEAC agreed that the applicant may be advised to

undertake field demonstration on transgenic mustard hybrid

DMH-11 in an area of five acres at two to three different locations,

with a view to generate additional data on honey bees and other

pollinators and on soil microbial diversity.

14.2.12 The instant matter was re-examined in the 136th

meeting of GEAC held on 20.09.2018, wherein the said

Committee accorded permission for conduct of field

demonstration studies on honey bees and other pollinators at two

locations of up to five acres in each location namely Punjab

Agricultural University (PAU), Ludhiana and Indian Agricultural

Research Institute (IARI), New Delhi.

14.2.13 Thereafter, in the 137th meeting of GEAC held on

20.03.2019, the Committee noted the response from the

applicant regarding the reasons for deferment of field

demonstration studies on transgenic mustard during the season

2018-19 and the deferment was further extended for the seasons

2019-20 and 2020-21.

14.2.14 At this stage, Prof. Deepak Pental, Former Professor of

Genetics and Vice-Chancellor, University of Delhi, on behalf of

CGMCP, University of Delhi, South Campus, New Delhi, made a

representation on 10.05.2022 to the Hon’ble Minister for

Environment, Forest and Climate Change, to accept the

recommendations for environmental release of transgenic

mustard hybrid DMH-11 made in 133rd GEAC meeting.

Accordingly, comments were sought from the concerned

Department, namely DBT and Department of Agricultural

Research and Education (DARE). Some of the relevant comments

related to the present matter are reproduced herein below:

“The comments received from DARE: “GEAC may consider exempting additional studies on the impact of GM Mustard hybrid DMH-11 containing the bar, barnase, and barstar genes on honey bees and other pollinators as decided in its 136th meeting and the recommendation of the 133rd meeting of GEAC may be considered. The environmental release of the proposed events will broaden the scope for developing many high yielding mustard hybrids in future.

The comments received from DBT: Based on the scientific evidence and the available data from various international agencies, it seems likely that there were no major deviations in the behavior of honey bees when compared among the transgenic and non-transgenic comparator lines; and suggested that GEAC may consider its recommendations of the 133rd meeting on the environmental release of GE mustard.”

Soon thereafter, ICAR by its letter dated 30.07.2022 wrote

to MoEF&CC for GEAC to consider the recommendation for

made in its 133rd GEAC meeting. DBT, by its letter dated

01.08.2022, also wrote to MoEF&CC for GEAC to consider the

recommendation for environmental release of transgenic

mustard hybrid DMH-11 made in its 133rd GEAC meeting, in

light of the biosafety data received from the applicant as well as

reviewing the international evidence of safety of the concerned

14.2.15 Thereafter, on 25.08.2022, at the 146th GEAC meeting,

the applicant made a detailed presentation on all aspects of the

proposal for environmental release of DMH-11. In this meeting of

GEAC, it was recommended that an Expert Committee be

constituted to examine the request letter dated 10.05.2022, with

respect to availability of adequate evidence about impact of

transgenic mustard on honey bees and other pollinators, in order

to assess the need for conducting field demonstration studies on

honey bees and other pollinators. The composition of this Expert

Committee was as follows:

a. Dr. Sanjay Kumar Mishra, Chairman

b. Dr. Ashok Kumar Singh, Member (Expertise in Molecular Genetics and Breeding)

c. Dr. D.K. Yadav, Member (Expertise in Plant Breeding and Seed)

d. Dr. A.H. Prakash, Member (Expertise in Plant Physiology)

e. Dr. K. Annapurna, Member (Expertise in Microbiology)

f. Dr. S. J. Rahman, Member (Expertise in Entomology)

g. Dr. Nitin K. Jain, Member (Present Member Secretary of RCGM)

h. Dr. K. C. Bansal, Member (Expertise in Plant Biotechnology, Functional Genomics)

i. Dr. Abhilasha Singh Mathuriya, Member Secretary.

14.2.16 First and second meeting of this Expert Committee

were convened on 23.09.2022 and 30.09.2022 respectively. The

recommendations of the Expert Committee constituted in 146th

meeting were submitted to GEAC and were as under:

“Based on the examination of scientific evidences available globally, and as per the recommendations of concerned ministries, it seems unlikely that the bar, barnase, and barstar system will pose an adverse impact on honey bees and other pollinators. Therefore, the Committee was of the view that GEAC may consider the environmental release of GE mustard and further evaluation to be carried out as per ICAR guidelines for release and notification.

However, to generate scientific evidences in Indian agroclimatic situation and also as a precautionary mechanism, the Expert Committee suggests that the field demonstration studies with respect to the effect of GE mustard on honey bees and other pollinators, as recommended in the 136th GEAC meeting, may also be conducted post-environmental release, simultaneously

by the applicant, within two years under supervision of ICAR and the report be submitted to the GEAC.”

14.2.17 Based on the comments of the DARE and the DBT, and

recommendations of the sub-committee, GEAC, in its 147th

meeting held on 18.10.2022, recommended environmental

release of transgenic mustard hybrid DMH-11, which was

accepted by the Central Government on 25.10.2022.

14.3 It is clear from a bare perusal of the abovementioned

events that the Union of India has taken the decision on the

environmental release on the basis of the aforesaid procedure

which was followed by GEAC. That the conditional permission

granted by Union of India to the CGMCP for environmental

release of transgenic mustard hybrid DMH-11 is said to be for

the following purposes:

a. The environmental release of GE mustard parental lines bn 3.6 carrying barnase and bar genes and modbs 2.99 containing barstar and bar genes, is to use the developing new parental lines and hybrids under supervision of ICAR. The environmental release of mustard hybrid DMH-11 for its seed production and testing, as per existing ICAR guidelines and other extant rules/regulations, is prior to commercial release.

b. Further, to generate scientific evidences in Indian agro-climatic situation and also as a precautionary mechanism, the field demonstration studies with respect to the effect of GE mustard on honey bees and other pollinators, as recommended in the 136th GEAC meeting, shall also be conducted postenvironmental release simultaneously by the

applicant, within two years, under the supervision of ICAR, as per ICAR guidelines and other extant rules/guidelines/regulations and the report be submitted to GEAC.

14.4 The environmental release of transgenic mustard hybrid

DMH-11 hybrid DMH-11 for its seed production and testing as

per ICAR guidelines was recommended by GEAC in its 147th

meeting. The seed production and testing was to require three

crop seasons, unless otherwise decided by ICAR, before the seeds

are commercially available to the farmers.

14.5 It is further pertinent to note that the permission for

environmental release was to be subjected to terms and

conditions to ensure environmental safeguards, for example:

(i) It provides that during the period of approval, a Post-Release Monitoring Committee (PRMC) would be constituted by GEAC, consisting of two subject matter external experts and a nominee each from the RCGM, GEAC and the PRMC, who will visit the growing sites of the approved biological material(s) at least once during each season and submit their report to GEAC on the matters of compliance.

(ii) Usage of any formulation or herbicide is not permitted for cultivation in the farmer’s field under any situation and such use would require necessary permission as per the procedures and protocols for safety assessment of insecticides/herbicides by the Central Insecticide Board & Registration Committee (CIB&RC). Any such use in the farmer's field without due approval from the CIB&RC would attract appropriate legal action under the Insecticides Act, 1968 and the Rules, 1971, made under the said Act

and the EP Act, 1986, and the Rules made thereunder.

(iii) The production of seeds of transgenic mustard hybrid DMH-11 will take place under the supervision of ICAR, as per the existing ICAR guidelines and other extant rules/regulations, after which the commercial cultivation of mustard will start. Commercial use will be subject to the Seeds Act, 1966 and the related rules and regulations.

(iv) As a precautionary mechanism, the data in regard to the impact of transgenic mustard hybrid DMH-11 on honey bees and other pollinators will be generated during these two years under the supervision of ICAR. This may help create additional data in regard to the impact of transgenic mustard hybrid DMH-11 on honey bees and other pollinators.

(v) The approval may be revoked under Rule 13(2) of the 1989 Rules, if any evidences regarding harmful effects of the approved GE mustard, such as damage to the environment, nature or health as could not be envisaged when the approval was given, come under notice of GEAC and on non-compliance of any condition stipulated by GEAC.

14.6 Within two months, on 18.10.2022, at the 147th GEAC

meeting, it was recommended that environmental release of

DMH-11 be approved subject to some conditions and safeguards.

The recommendations and the conditions were communicated by

the MoEF&CC to the applicant-Prof. Deepak Pental on

25.10.2022 and the same are extracted as under:

“… the Genetic Engineering Appraisal Committee (GEAC) in its 147th meeting held on 18.10.2022, has recommended the following:

I. The environmental release of genetically engineered mustard parental lines bn 3.6 carrying barnase and bar genes, and modbs 2.99 containing barstar and bar genes, so that these events can be used for developing new parental lines and hybrids under supervision of ICAR.

II. The environmental release of mustard hybrid DMH11 for undertaking its seed production and testing as per existing ICAR guidelines and other extant rules/regulations prior to commercial release.

III. Further, to generate scientific evidences in Indian agro-climatic situation and also as a precautionary mechanism, the field demonstration studies with respect to the effect of GE mustard on honey bees and other pollinators, as recommended in the 136th GEAC meeting, shall also be conducted postenvironmental release, simultaneously by the applicant, within two years under supervision of ICAR, as per ICAR guidelines and other extant rules/ guidelines/regulations and the report be submitted to the GEAC.

These recommendations are subject to the following

conditions:

I. The approval is for a limited period of four years from the date of issue of approval letter as per clause 13 of Rules 1989 and is renewable for two years at a time based on compliance report.

II. During the period of approval, a Post Release Monitoring Committee (PRMC) would be constituted by GEAC consisting of 2 subject matter external experts and a nominee each from RCGM and GEAC and PRMC will visit the growing sites of the approved biological material(s) at least once during each season and submit their report to GEAC on the

matters of compliance. Chairperson, GEAC is authorized to constitute the Committee.

III. Applicant shall deposit 100 grams each of approved hybrids as well as their parental lines with the ICARNational Bureau of Plant Genetic Resources (ICARNBPGR) and communicate the same to GEAC within 30 days of issue of this clearance letter for purposes of future reference in case of trade, traceability and dispute on account of ownership.

IV. The applicant shall provide detailed step-by-step testing procedures for identifying approved event in the transgenic hybrids (bar, barnase and barstar) and parental lines, to the GEAC within 30 days from the receipt of approval letter.

V. Applicant shall develop and deposit the DNA fingerprints of the approved Transgenic Mustard varieties within 30 days from the receipt of approval letter to the ICAR-NBPGR.

VI. Usage of any formulation of herbicide is recommended only under controlled and specified conditions exclusively for hybrid seed production after obtaining label claim and approval from Central Insecticide Board & Registration Committee (CIB&RC).

VII. Usage of any formulation of herbicide is not permitted for cultivation in the farmer's field under any situation and such use would require the necessary permission as per the procedures and protocols of safety assessment of insecticides/ herbicides by CIB&RC. Any such use in the farmer's field without due approval from CIB&RC would attract appropriate legal action under Central Insecticides Act 1968 and Rules 1971, EP Act 1986 and the Rules made there under.

VIII. Commercial use of DMH-11 hybrid shall be subject to Seed Act 1966 and related rules and regulations, its amendments and Gazette notifications from time to time as applicable.

IX. The applicant shall prepare and submit the annual/seasonal reports on acreage, yield and states/ regions where the transgenic mustard is sown during the approval period to the GEAC.

X. It is mandatory that all seed packets of GE mustard Hybrid DMH-11 and subsequent hybrids derived from the technology should be appropriately labelled indicating the contents including the name of the transgenes, physical and genetic purity of the seeds etc. Each packet should also contain detailed description for use including sowing pattern, pest management, suitability of agro-climatic conditions etc. in English, Hindi and vernacular language.

XI. All efforts should be made by applicant and licensees to undertake an awareness and education programme interlaid through development and distribution of educational material on GE Mustard Hybrid DMH-11 for farmers, dealers and others.

XII. Indian Council of Agricultural Research (ICAR) would be the authorized agency to accord necessary permissions for development of any other Brassica juncea hybrids resulting from events approved and their descendants, provided the intended use is similar. However, all hybrids released using this technology shall also be regulated under Seed Act 1966 and related rules and regulations, its amendments and Gazette notification from time to time as applicable. ICAR shall also ensure the following conditions prior to release of any new hybrids:

• Confirmation of events through molecular characterization to be submitted from accredited lab, in original, as notified for the purpose.

• Data on level of transgenes (Barnase, Barstar and Bar) expression in the events/ hybrids at seedling stage from accredited lab, in original, as notified for the purpose.

• Morphological characters using Distinctiveness, Uniformity and Stability (DUS) descriptors as per Protection of Plant Varieties and Farmers Rights Act, (PPVFRA) guidelines for the hybrids.

• Source of germplasm/ pedigree and biotech traits must be provided with self-declaration by the applicant.

• Affidavit on the ownership of hybrid/ variety/ events.

• Performance trial report including agronomic parameters, yield with coefficient of variation (CV) and critical difference (CD), pest & disease reaction etc. as per ICAR guidelines.

XIII. If at any time, the applicant or the responsible parties become aware of any information regarding risk to the environment, or risk to animal or human health, that could result from release of these materials in India, or elsewhere, the applicant must immediately provide in writing such information to regulatory bodies.

XIV. The approval may be revoked under Rule 13(2) of Rules, 1989, if any evidences regarding harmful effects of the approved GE mustard, such as damage to the environment, nature or health as could not be envisaged when the approval was given comes under notice of GEAC and on noncompliance of any condition stipulated by GEAC.

XV. MoEF&CC/ GEAC may prescribe any additional conditions/ requirements or constitute any SubCommittees or commission any studies if felt appropriate during the period of approval.

XVI. The recommendations are subject to other statuary clearances, as applicable, including the clearance from FSSAI.”

Interlocutory Applications filed by the petitioners:

15.I.A. No.185604 of 2022 has been filed by the petitioner in Writ Petition (Civil) No.840 of 2016 seeking quashing of the approval letter F.No.C-12013/35/2010-CSIII dated 25.10.2022 issued by respondent Nos.1 and 2 to respondent No.3 therein being void ab initio; secondly, to disclose all the sites/locations where the environmental release of transgenic mustard hybrid DMH-11 is planned/commenced; thirdly, to direct the respondents to immediately uproot/remove/destroy all transgenic mustard hybrid DMH-11 that has been planted pursuant to the environment clearance issued in 147th meeting of respondent No.2 held on 18.10.2022 and the subsequent approval letter number F.No.C-12013/35/2010-CSIII dated 25.10.2022; and, fourthly, a direction is sought that the TEC report recommendation be adopted and to ban all HT crops and crops for which India is a Centre of Origin/Diversity. It is unnecessary to narrate the pleadings accompanying the aforesaid prayers as the same shall be dealt with while considering the main petition. I.A. No.209550 of 2023 has been filed in Writ Petition (Civil) No.115 of 2004 by the petitioner therein, seeking a direction to the respondent Union of India to destroy the planted material of transgenic mustard hybrid DMH-11 in view of the undertaking given to this Court and there being violations of the same. The aforesaid prayer made by the petitioner has also to be considered in light of the prayer made by the Union of India, which has also filed an application (I.A. No.167110 of 2023), seeking discharge from the oral statement made before this Court on 08.11.2022 to the effect that no precipitative steps for would be taken. Additional Affidavit of Union of India:

16.It would be useful to refer to the additional affidavit dated 09.11.2022 filed by the Union of India through Scientist ‘G’ in the MoEF&CC, New Delhi. 16.1 That on 03.11.2022, it was brought to the notice of this Court that permission of environmental release of transgenic mustard hybrid DMH-11 had been granted by the Government of India to the CGMCP at the University of Delhi on 25.10.2022. Pursuant to the said order, the Union of India has sought to place on record the decision-making process employed by the Government of India and the regulatory framework under which this permission was granted. 16.2 In addition to the above, the Union of India has stated in its Additional Affidavit dated 09.11.2022 that the research, development, and use of GE technologies is a highly technical matter guided by the views of subject experts. As such, the inquiry before this court is limited to whether there exists an adequate regulatory mechanism governing this field and whether material compliance with the same has been made. 16.3 The conditional approval for environmental release of transgenic mustard hybrid DMH-11 and its parental lines Varuna bn 3.6 and EH-2 modbs 2.99 containing barnase, barstar, and bar genes prior to commercial release has been made after a long and exhaustive regulatory process which commenced as far back as in 2010 and is outlined as below: i. The initial R&D was conducted by the CGMCP in accordance with the Revised Guidelines for Research in Transgenic Plants, 1998 in the laboratory as well as greenhouse conditions. The R&D was regulated by the Institutional Biosafety Committee (IBSC) and RCGM as prescribed by the Guidelines. ii. Based on the information generated, an application was made to the IBSC for permission to conduct a confined field trial. After the recommendation of the IBSC, the CGMCP submitted a further application to RCGM. After the recommendation of the RCGM, GEAC considered the recommendation of the RCGM in its meetings dated 29.09.2010, 21.09.2011, and 18.07.2014. iii. After the completion of confined field tests, the CGMCP submitted an application dated 15.09.2015, along with a dossier of 3285 pages, seeking approval for environmental release of the GE mustard hybrid DMH-11 and its parental lines Varuna bn 3.6 and EH-2 modbs 2.99. iv. The said application was considered by GEAC in its 125th meeting dated 11.12.2015. After a detailed discussion, the applicant was invited to give a presentation to GEAC on 04.01.2016. Accordingly, on 04.01.2016, GEAC formed an eight-member sub-committee under the chairmanship of Dr. K. Veluthambi, Co-chair, GEAC. v. The meeting of the sub-committee took place on 02.02.2016 and the sub-committee recommended revision of the biosafety dossier by the applicant. Considering the above, GEAC, in its 127th meeting dated 05.02.2016, adopted the recommendations of the sub-committee and directed the revision of the dossier. In addition, GEAC directed preparation of the Biosafety RARM Report. vi. The sub-committee requested GEAC for an additional one month’s time to submit its final recommendations. The request was granted by GEAC in its 129th meeting dated 20.06.2016. GEAC also invited two groups of NGOs to present their views on the release of transgenic mustard hybrid DMH-11 in India. vii. Thereafter, on 11.08.2016, GEAC considered the report titled “Assessment of Food and Environmental Safety”, incorporating the evaluation of biosafety data generated by the applicant CGMCP and prepared by the sub-committee along with the inputs of RAU of the RCGM. The report was then placed on MoEF&CC website for a period of 30 days, from 05.09.2016 to 05.10.2016, for inviting comments. viii. A total of 759 comments were received on the AFES Report and the sub-committee proceeded to analyse the same. ix. In the 133rd meeting of GEAC dated 11.05.2017, the report submitted by the sub-committee was examined in detail. In the 134th meeting of GEAC dated 21.03.2018, the proposal was referred back to GEAC for re-examination. GEAC also advised the applicant to undertake field demonstration on transgenic mustard hybrid DMH-11 in an area of five acres at two-three different locations, with a view to generate additional data on honey bees and other pollinators and on soil microbial diversity. x. The proposal came up for re-examination by GEAC in its 136th meeting dated 20.09.2018, wherein GEAC accorded permission for conducting field demonstration studies at two locations of up to five acres each in PAU, Ludhiana and IARI, New Delhi. xi. In the 137th meeting of GEAC dated 20.03.2019, GEAC deferred field demonstration studies to the seasons 2019-20 and 2020-21. xii. Thereafter, Prof. Deepak Pental, vide letter dated 10.05.2022 requested the MoEF&CC to okay the environmental release of GE mustard. xiii. GEAC sought comments from the DBT and the DARE. Both opined that GEAC may consider exempting additional field xiv. In the 146th meeting of GEAC held on 25.08.2022, GEAC recommended that a nine-member expert committee be constituted to examine the request letter dated 10.05.2022 with respect to availability of adequate evidence about the impact of transgenic mustard on honey bees and other pollinators in order to assess the need for conducting field xv. The abovesaid sub-committee met on 23.09.2022 and 30.09.2022 and submitted recommendations to GEAC, stating that the field demonstration studies may be conducted even after the environmental release of GE mustard. xvi. Finally, GEAC, in its 147th meeting held on 18.10.2022, recommended environmental release of transgenic mustard hybrid DMH-11, which came to be accepted by the Central Government on 25.10.2022. 16.4 It is further averred that the production of seeds of transgenic mustard hybrid DMH-11 would take place under the supervision of ICAR, as per existing guidelines and other extant rules and regulations. As a precautionary measure, the data with regard to the impact of transgenic mustard hybrid DMH-11 on honey bees and other pollinators is to be generated during these two years of supervision by ICAR and approval could be revoked under Rule 13 (2) of the 1989 Rules, if any harmful effects are found. In addition, during the period of approval, a PRMC would visit the growing sites at least once during each season and submit its report to GEAC. Only after this elaborate process would the commercial cultivation of transgenic mustard hybrid DMH-11 start. Commercial cultivation, too, shall be subject to the Seeds Act, 1966 and the rules and regulations made thereunder. 16.5 Finally, emphasizing the importance of mustard as a prominent edible oil and seed meal crop of India, the economic need to increase its domestic yield was highlighted. It was also submitted that internationally, the United States of America (USA), Canada, and Australia have allowed cultivation of GE rapeseed containing the bar, barnase, and barstar genes. Parental lines and hybrids were also released for cultivation in Canada (1996), the USA (2002), and Australia (2003). In all three countries, yields of rapeseed increased with the introduction of GM hybrids. Therefore, if employed, the DMH-11 hybrid technology would contribute to increase in the domestic yield of mustard in India. Submissions:

17.Elaborate submissions have been advanced by the learned

senior counsel, Sri Sanjay Parekh and learned counsel, Sri

Prashant Bhushan for the petitioners as well as learned Senior

Counsel Sri Pais and other learned Counsel for other petitioners

and intervenors. Learned Attorney General and the learned

Solicitor General have appeared for the respondents. A summary

of the submissions is set out hereinbelow.

Submissions of the petitioners:

17.1 Sri Prashant Bhushan, learned counsel has made the

following submissions:

The decision dated 18.10.2022 of GEAC to approve

environmental and commercial release of DMH-11/GM

mustard/ HT mustard is violative of Articles 14 and 21 of the

Constitution as it suffers from non-application of mind and is,

therefore, arbitrary and unreasonable. Elaborating on the same,

it was contended that the said decision would lead to irreversible

contamination of the environment and threaten biodiversity. The

decision was also said to violate the choice of consumers to

consume non-GM food and that of farmers to grow non-GM crops

in violation of Article 21 of the Constitution. In this regard, the

following points were highlighted:

a. It is an admitted fact that DMH-11 is an HT crop (vide para

16 page 12 of the Additional Affidavit of Union of India).

b. The TEC appointed by this Court, in its detailed report,

recommended a complete ban on all HT crops.

c. It is an admitted fact that DMH-11 has no yield advantage

over non-GM/HT mustard hybrids/varieties.

d. The sole advantage for environmental release of DMH-11 is

that it is robust at cross pollination and there are absolutely

no immediate advantages to the environmental release of

DMH-11, rather there are attendant risks that come with the

environment release of HT crops and it is only a hope that

the same could be used to produce new hybrids with better

yield in future. If that is the hope, then the new hybrids with

better yield could be developed in hybrid conditions and not

be released into the environment, as there would be no

rational nexus to the object sought to be achieved by the

release.

e. Condition Nos. VI and VII of the order or decision dated

18.10.2022 directed that the farmers may not lawfully spray

herbicide/glufosinate on DMH-11, thereby ensuring that

there can be no lawful beneficial effect therefrom in terms of

weed management from HT crops to farmers.

f. If there is no real yield advantage, DMH-11 cannot be

marketed to the farmers as having yield advantage, as this

would be misleading for supporting its environmental and

commercial release.

g. In the 134th meeting of GEAC, the applicant of DMH-11 was

advised to conduct research on the effect thereof on honey

bees. The said advisory was given a go by and the study was

directed to be done after environmental release of DMH-11.

It is submitted that the DBT has funded the development of

DMH-11 and therefore, its recommendation to forego studies

on honey bees is a case of conflict of interest and ignores all

precautionary principles.

h. That even though there is no immediate advantage from the

environmental release of DMH-11, the immediate and

irreversible disadvantage from its release is the scientific

certainty of contamination of non-GM/non-HT mustard

hybrids/varieties through cross pollination from bees,

thereby:

- irreversibly threatening biodiversity, as eventually all

non-GM/non-HT mustard will be contaminated;

- irreversibly eliminating choice of consumers to eat non-

GM/non-HT mustard, in the absence of any mechanism

to prevent pollination by bees, which is accentuated by

the absence of any laws for labelling;

- irreversibly coercing farmers who do not wish to grow

GM crops to be susceptible to their crops being

contaminated with transgenic mustard hybrid DMH-11

with no legal mechanism for redress or liability for losses

suffered;

- irreversibly causing loss to organic farmers and the

entire agro-economic system relying on non-GM crops

as their products can no longer be certified as GM-free.

For instance, honey, which is produced in the country

from mustard flowers, can no longer be certified as

organic or GM-free in the absence of elaborate testing for

each and every product. Hence, there is a need for

studies with regard to long-term effects on biosafety and

the hazards from environmental release of DMH-11.

i. The present writ petition has been filed seeking to put in

place a comprehensive, stringent, scientifically rigorous and

transparent biosafety test protocol in the public domain for

GMOs before they may be released into the environment.

This is because GMOs are a serious potential hazard and

several dimensions of biosafety are necessary before their

release into the environment. The proper and independent

testing of GMOs is essential in view of the concern of the

irreversible contamination of non-GMOs crops and the

environment at large. This is unlike a drug, which when

tested to be unsafe, can be recalled. It is contended that the

GMO contamination of the environment would affect the

nation’s foundational seed stock and change the structure of

the food at the molecular level without recourse.

j. The right to health being a fundamental right, it is necessary

that the Union Government and the Regulators put in place

a rigorous mechanism so as to avoid the harm caused by

GMOs, such as chronic toxicity and other unattended effects

including health hazards. Therefore, the precautionary

principles must be purposefully applied to insulate from the

scientific uncertainty about hazardous GMOs in future.

17.2 On the decision of GEAC to approve HT mustard/GM

mustard/DMH-11 for environmental and commercial release,

learned counsel contended that GEAC in its 147th meeting

decided to permit environmental release/commercial cultivation

of HT mustard. Based on the recommendation of the Expert

Committee as well as the comments received from DBT and

DARE, the Committee recommended the following:

“VI. Usage of any formulation of herbicide is

recommended only under controlled and specified

conditions exclusively for hybrid seed production after

obtaining label claim and approval from Central

Insecticide Board & Registration Committee (CIB&RC).

VII. Usage of any formulation of herbicide is not

permitted for cultivation in the farmer’s field under any

situation and such use would require the necessary

permission as per the procedures and protocols of safety

assessment of insecticides/herbides by CIB&RC. Any

such use in the farmer’s field without due approval from

CIB&RC would attract appropriate legal action under

Central Insecticides Act 1968 and Rules 1971, EP Act

1986 and the Rules made thereunder.”

17.3 It is learnt by the petitioners that HT transgenic mustard

hybrid DMH-11 seed was sown for seed selection in Kanpur and

Bharatpur at the Directorate of Rapeseed and Mustard Research

(DRMR). The 301st report of the Department related PSC on

Science and Technology, Environment & Forests, titled

“Genetically Modified Crops and its impact on Environment”

(2017) (“301st Report of PSC”, for the sake of convenience) noted

that the Government put on hold the earlier approval given by

GEAC to DMH-11 (vide Page 26 of the 301st PSC report/Pg.672, Compilation). This is because in undertaking seed selection, it

would be necessary to spray illegal glufosinate on the seedlings,

for it is only seedlings which have been successfully engineered

for resistance to the herbicide which could be selected for seed

production. The concomitant advisory to farmers not to spray

would then go meaningless, as the farmers would definitely spray

for the short-term gain to kill weeds. In this regard, it is

mentioned that planting of HT – Bt cotton and Bt brinjal and

other such crops on commercial scale have gone on despite illegal

effects of the same.

17.4 It was also submitted that the National Bureau of Plant

Genetic Resources (NBPGR) had stated that India has rich

biodiversity in mustard. The Indian Gene Banks have 5477

Brassica juncea (“Indian mustard”) accessions, which would all be at the risk of contamination.

17.5 On the recommendations of the TEC as regards HT/GM

crops, it was submitted that HT crops being a potent carcinogen

may lead to breast cancer. Therefore, the TEC recommended a

complete ban on HT crops.

17.6 It was next contended that the first crop given de facto approval by GEAC was Bt cotton, followed by Bt brinjal, in

respect of which there was a moratorium vide order dated

09.02.2010 of the Ministry of Science, Environment & Forests.

In the case of transgenic mustard hybrid DMH-11 (HT crop), the

technical dossier running into thousands of pages was made

available for 30 days at the headquarters of GEAC in New Delhi

for physical inspection. This was contrary to the earlier process,

wherein biosafety dossier as regards Bt cotton and Bt brinjal was

put in the public domain on the website of GEAC upon being

directed by this Court and whereupon on critical examination of

the same by national and international experts, the approval

given by GEAC had to be put on hold by the Ministry, as it

became apparent that GEAC had not complied with the

regulatory mechanism and the biosafety and ERA of Bt brinjal

was totally lacking.

17.7 Learned counsel also brought to our notice the following

three reports which have discussed in detail the issue of GM

crops:

a. Thirty-Seventh (37th) report of PSC on Agriculture (2011-

2012) titled “Cultivation of Genetically Modified Food Crops

– Prospects and Effects” (hereinafter referred to as the “37th

Report of PSC”).

b. Final Report of the five original members of the TEC

submitted to this Court on 30.06.2013.

c. Three Hundred and First (301st) report of the Department

related PSC on Science and Technology, Environment &

Forests, titled, “Genetically Modified Crops and its impact on

Environment” (2017).

17.8 The deposition of Dr. P.M. Bhargava, Molecular Biologist,

Founder Director, CCMB, Hyderabad, appointed as an

independent expert on GEAC by this Court vide order dated 13.02.2008, as recorded in the 37th report of PSC, was also read

out to us. Similarly, the observations and recommendations of

the TEC as regards GEAC being the regulator have been read out

to us during the course of the submissions. We shall refer to the

relevant portions of these reports a little later.

17.9 It was next contended that although the ubiquitous

glyphosate has been used for over four decades as the safest

herbicide, glufosinate is acknowledged as more toxic than

glyphosate as it kills indiscriminately soil organisms, beneficial

insects etc. It was also submitted that neurotoxin can cause

birth defects and damage to most plants that it comes into

contact with. It is banned in Europe and not permitted in India

under the Insecticides Act, 1968 for mustard. It is an