Supreme Court of India
Gene Campaign vs Union Of India on 23 July, 2024
Author: B.V. Nagarathna
Bench: Sanjay Karol, B.V. Nagarathna
2024 INSC 545
REPORTABLE
IN THE SUPREME COURT OF INDIA
CIVIL ORIGINAL/APPELLATE/INHERENT JURISDICTION
WRIT PETITION (CIVIL) NO.115 OF 2004
GENE CAMPAIGN & ANOTHER … PETITIONERS
VERSUS
UNION OF INDIA & OTHERS … RESPONDENTS
WITH
WRIT PETITION (CIVIL) NO.260 of 2005
WRIT PETITION (CIVIL) NO.840 OF 2016
CIVIL APPEAL NO.4086 OF 2006
CONTEMPT PETITION (CIVIL) NO.295 OF 2007
IN
WRIT PETITION (CIVIL) NO.260 of 2005
CONTEMPT PETITION (CIVIL) NO.6 OF 2016
IN
WRIT PETITION (CIVIL) NO.260 of 2005Signature Not Verified
Digitally signed by
Neetu Sachdeva
Date: 2024.07.23
17:32:57 IST
Reason:
Writ Petition (Civil) No.115 of 2004 Etc. Page 1 of 260JUDGMENT
NAGARATHNA, J
Table of ContentsAcronyms ……………………………………………………………………………………………………………. 4
Preface: ……………………………………………………………………………………………………………….. 7
Bird’s eye view of the controversy: ………………………………………………………………….. 9
Pleadings: …………………………………………………………………………………………………………. 10
Writ Petition (Civil) No.115 of 2004: ……………………………………………………………. 10
Writ Petition (Civil) No.260 of 2005: ……………………………………………………………. 18
Writ Petition (Civil) No.840 of 2016: ……………………………………………………………. 23
Civil Appeal No.4086 of 2006: …………………………………………………………………….. 29
Contempt Petition (Civil) No.295 of 2007 in Writ Petition (Civil) No.260 Of
2005; and, Contempt Petition (Civil) No.6 of 2016 in Writ Petition (Civil)
No.260 Of 2005: ……………………………………………………………………………………………. 30
Significant Orders passed by this Court in Writ Petitions: …………………………… 30
Constitution of the Technical Expert Committee (TEC): ………………………………… 32
Final Report of TEC: …………………………………………………………………………………………. 34
Parliamentary Standing Committee (PSC) on Agriculture’s Report on
“Cultivation of Genetically Modified Food Crops – Prospects and Effects” –
2012: …………………………………………………………………………………………………………………. 54
Parliamentary Standing Committee (PSC) on Science and Technology,
Environment and Forests’ Report titled “Genetically Modified Crops and its
impact on Environment” – 2017:……………………………………………………………………… 60
Conditional approval by Government of India for Environmental Release of
DMH-11: ……………………………………………………………………………………………………………. 66
Sub-committee meetings:…………………………………………………………………………………. 71
Interlocutory Applications filed by the petitioners: ……………………………………….. 88
Writ Petition (Civil) No.115 of 2004 Etc. Page 2 of 260
Additional Affidavit of Union of India: ……………………………………………………………. 89
Submissions:…………………………………………………………………………………………………….. 95
Submissions of the petitioners: ………………………………………………………………………. 95
Submissions of the Respondents: …………………………………………………………………. 111
Submissions of Learned Solicitor General: ………………………………………………….. 122
Reply Arguments: …………………………………………………………………………………………… 125
Points for Consideration: ……………………………………………………………………………….. 134
Legal Framework:…………………………………………………………………………………………… 136
Environment (Protection) Act, 1986 (EP Act, 1986): …………………………………….. 146
1989 Rules: …………………………………………………………………………………………………….. 147
Regulatory Framework: …………………………………………………………………………………. 156
Constitutional Court and the Environmental Rule of Law:…………………………. 168
Public Trust Doctrine: …………………………………………………………………………………….. 173
Precautionary Principle: …………………………………………………………………………………. 176
Analysis and Findings: ………………………………………………………………………………….. 182
Re: Point No.1: Whether GEAC approval dated 18.10.2022 and the
consequent decision dated 25.10.2022 for the environmental release of DMH-
11 is in accordance with law? ………………………………………………………………………. 198
Public Trust Doctrine: …………………………………………………………………………………….. 211
Re: Point No.2: Whether the decision to grant approval for environmental
release of DMH-11 violates the right to safe and healthy environment under
Article 21? ……………………………………………………………………………………………………….. 221
Right to safe and healthy Environment: ………………………………………………………. 221
Re: Point No.3: Whether GEAC’s grant of approval dated 18.10.2022 and the
decision dated 25.10.2022 for the environmental release of DMH-11 violate
the precautionary principle? ………………………………………………………………………….. 234
Precautionary Principle: …………………………………………………………………………………. 234
Conclusion: ……………………………………………………………………………………………………… 254
Writ Petition (Civil) No.115 of 2004 Etc. Page 3 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 4 of 260
ERA Environmental Risk Assessment
FAO Food and Agriculture Organization
FSSA, Food Safety and Standards Act, 2006
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 5 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 6 of 260
Preface:
The ideas drawn from sacred texts of the world haveproffered 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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 7 of 260
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’.”
- 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.” - 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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 8 of 260
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:
- 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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 9 of 260
5.2 In these cases, the said controversy has been considered
from several angles. Arguments at length have been heard by us.
Therefore, we propose to encapsulate the pleadings, arguments
and voluminous materials that has been submitted during the
course of the hearing while arriving at the findings and
conclusion in this matter.
Pleadings:
Writ Petition (Civil) No.115 of 2004:
- 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:
Writ Petition (Civil) No.115 of 2004 Etc. Page 10 of 260
“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 multi-
stakeholder consultation process;
iii) direct the Respondents to observe a moratorium on
various permissions/approvals/trials concerning GEOs,
in particular of commercial nature, particularly of crops
for which India is a Centre of Origin/Diversity, till the
Rules are amended and a sound Regulatory and
Monitoring System is put in place;
iv) pass such other and further orders as this Hon’ble
Court may deem fit and proper in the facts and
circumstances of the case.”
- 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
Writ Petition (Civil) No.115 of 2004 Etc. Page 11 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 12 of 260
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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 13 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 14 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 15 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 16 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 17 of 260
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.
Writ Petition (Civil) No.260 of 2005:
- 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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 18 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 19 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 20 of 260
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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 21 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 22 of 260
likely to have significant adverse effects on biodiversity and to
allow public participation in the procedure.
8.3 That in addition to implementing a moratorium on the
release of any GMO into the domestic environment until
adequate biosafety tests demonstrate safety beyond reasonable
doubt, labelling for imports sourced from countries which
produce GM crops and foods should be mandated. Therefore,
both moratorium and labelling must be concurrent mandatory
requirements.
8.4 That farmers have the right to save seed for sowing in the
next season, which a patent-based regime of GM seeds will
effectively deny. This choice is a fundamental right and must be
retained as such for better farming prospects and livelihoods.
Therefore, the petitioner has sought the aforesaid reliefs.
Writ Petition (Civil) No.840 of 2016:
8.5 The petitioner is stated to be a public-spirited citizen based
in Chennai and is involved in a consumer movement in Tamil
Nadu called ‘Safe Food Alliance’. The petitioner is stated to be
one of the National Convenors of Alliance for Sustainable and
Holistic Agriculture (ASHA), which is an organization that has
been actively involved in the cause of the genetic modification of
crops and its effects on human health.
8.6 It is averred by the petitioner that in September 2015, the
Centre for Genetic Manipulation of Crop Plants (CGMCP)
Writ Petition (Civil) No.115 of 2004 Etc. Page 23 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 24 of 260
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,
Writ Petition (Civil) No.115 of 2004 Etc. Page 25 of 260
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 thefailure to disclose crucial information, including the biosafety
dossier, and the opaque nature of the consultation process,
Writ Petition (Civil) No.115 of 2004 Etc. Page 26 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 27 of 260
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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 28 of 260
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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 29 of 260
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:
- 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
Writ Petition (Civil) No.115 of 2004 Etc. Page 30 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 31 of 260
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):
- 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.
- Dr. Imran Siddiqui, Group Leader, Centre for
Cellular & Molecular Biology (CCMB). - Prof. P.S. Ramakrishnan, Emeritus Prof. JNU.
- Dr. P.C. Chauhan, D. Phil (Sci).
- Prof. P.C. Kesavan, Distinguished Fellow, MS SRF
(Research Foundation), Emeritus Professor, CSD,
IGNOU, New Delhi. - Dr. B. Sivakumar, Former Director, National
Institute of Nutrition (NIN), Hyderabad.”
- Dr. Imran Siddiqui, Group Leader, Centre for
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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 32 of 260
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.”
Writ Petition (Civil) No.115 of 2004 Etc. Page 33 of 260
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:
Writ Petition (Civil) No.115 of 2004 Etc. Page 34 of 260
✓ 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
Writ Petition (Civil) No.115 of 2004 Etc. Page 35 of 260
considered, till such time it would not be advisable
to conduct more field trials:
1. A secretariat comprising dedicated scientists
with area expertise as well as expertise in
biosafety needs to be established. This will
require consultation with experts having
experience at the international level in biosafety
testing and evaluation of GM safety dossiers in
reputed regulatory bodies. The TEC
recommends doing it in collaboration with the
Norwegian Government and GM regulatory body
since the Norwegian system has an established
commitment and experience in, is one of the few
that are attuned to considering socio-economic
issues that would be important in the Indian
context. The regulatory body should have area-
wise subcommittees/expert groups in for
example:
• Health (human and animal)
• Environment and Ecology
• Agroeconomics and Socioeconomics
• 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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 36 of 260
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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 37 of 260
(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
Writ Petition (Civil) No.115 of 2004 Etc. Page 38 of 260
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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 39 of 260
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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 40 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 41 of 260
the present conditions, it recommended that release of
GM crops for which India is a centre of origin or diversity
should not be allowed at all.
(ii) Secondly, as for, when environmental release through open-
field trials should be permitted, the majority recommended
that the sequence of testing should be carried out in order of
increasing environmental exposure required to perform the
test. Tests should be done under the minimum conditions of
exposure required for the test. In other words, the testing
should proceed in a progressive manner that increases
confidence with regard to safety. While not covering all
possible tests for all crops, it laid down certain minimum
tests possible to carry out under contained conditions within
the laboratory of greenhouse, before the GMO is taken out of
containment. These include tests based on bioinformatics
such as possible allergenicity and toxicity; acute toxicity of
the purified protein; in-vitro digestibility and any other
biochemical tests on the purified protein. Where appropriate
and necessary, tests such as those for general growth
characteristics and plant habit as part of event selections
may be performed under confined conditions in consultation
with the regulator. Those tests on the plant that can be
performed under contained conditions as judged by the
regulator on a case-wise basis should be performed under
contained conditions.
Writ Petition (Civil) No.115 of 2004 Etc. Page 42 of 260
(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
Writ Petition (Civil) No.115 of 2004 Etc. Page 43 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 44 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 45 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 46 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 47 of 260
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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 48 of 260
(ii) Secondly, as to when environmental release through open-
field trials should be permitted, the dissenting report noted
that “open-field trial” is a misnomer in the 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:
Writ Petition (Civil) No.115 of 2004 Etc. Page 49 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 50 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 51 of 260
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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 52 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 53 of 260
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:
- The aforesaid Report, submitted on 09.08.2012, has been
relied upon by the learned counsel Sri Prashant Bhushan. The
Writ Petition (Civil) No.115 of 2004 Etc. Page 54 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 55 of 260
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 decision-
making process.Writ Petition (Civil) No.115 of 2004 Etc. Page 56 of 260
c. The Vice-Chairman is again a civil servant,
simultaneously discharging a few more
responsibilities in another role in the MoEF.
d. GEAC being an entity created under the Rules
rather than an Act of Parliament deprives it of
the status, powers and more importantly,
autonomy and independence that a statutory
regulator ought to have.
iii. The Committee noted the findings of several scientific
reports, including the International Assessment of
Agricultural Knowledge, Science and Technology for
Development (IAASTD) Report – ‘Agriculture at a
Crossroads’, and underlined the following shortcomings of
modern biotechnology in agriculture:
a. Modern biotechnologies have yet to prove their
efficacy, safety and sustainability in the case of
GM crops. There are significant limitations in its
ability to conserve the resilience of small and
subsistence agricultural systems, etc.
b. Containment of harm would be a very
challenging task even for some of the most well-
equipped developed countries and simply
impossible in a country like India.
c. The integration of biotechnology must be within
an enabling environment, supported by local
Writ Petition (Civil) No.115 of 2004 Etc. Page 57 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 58 of 260
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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 59 of 260
Parliamentary Standing Committee (PSC) on Science and
Technology, Environment and Forests’ Report titled
“Genetically Modified Crops and its impact on
Environment” – 2017:
- 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 non-
adherence. 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 Writ Petition (Civil) No.115 of 2004 Etc. Page 60 of 260
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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 61 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 62 of 260
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 agro-
ecosystem.
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 63 of 260
conducted but chronic and transgenerational
studies have not been conducted, therefore,
risking the health of future generations.
- 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
Writ Petition (Civil) No.115 of 2004 Etc. Page 64 of 260
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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 65 of 260
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:
- 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:
Writ Petition (Civil) No.115 of 2004 Etc. Page 66 of 260
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 112 meeting On
th 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
Writ Petition (Civil) No.115 of 2004 Etc. Page 67 of 260
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 DMH-
11) under the
coordination of
Directorate of
Rapeseed Mustard
Research,
Bharatpur during
the appropriate
season in 2011-12.
18.07.2014 121 meeting On
st 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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 68 of 260
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:
Writ Petition (Civil) No.115 of 2004 Etc. Page 69 of 260
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 sub-
committee.
(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
Writ Petition (Civil) No.115 of 2004 Etc. Page 70 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 71 of 260
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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 72 of 260
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
as under:
“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
Writ Petition (Civil) No.115 of 2004 Etc. Page 73 of 260
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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 74 of 260
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
technology.
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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 75 of 260
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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 76 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 77 of 260
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.”
Writ Petition (Civil) No.115 of 2004 Etc. Page 78 of 260
Soon thereafter, ICAR by its letter dated 30.07.2022 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. 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
technology.
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)
Writ Petition (Civil) No.115 of 2004 Etc. Page 79 of 260
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 agro-
climatic 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
Writ Petition (Civil) No.115 of 2004 Etc. Page 80 of 260
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 post-
environmental release simultaneously by the
Writ Petition (Civil) No.115 of 2004 Etc. Page 81 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 82 of 260
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:
Writ Petition (Civil) No.115 of 2004 Etc. Page 83 of 260
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 DMH-
11 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 post-
environmental 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 followingconditions:
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 84 of 260
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 ICAR-
National Bureau of Plant Genetic Resources (ICAR-
NBPGR) 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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 85 of 260
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:
Writ Petition (Civil) No.115 of 2004 Etc. Page 86 of 260
• 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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 87 of 260
XV. MoEF&CC/ GEAC may prescribe any additional
conditions/ requirements or constitute any Sub-
Committees 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:
- 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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 88 of 260
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
environmental release of transgenic mustard hybrid DMH-11
would be taken.
Additional Affidavit of Union of India:
- 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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 89 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 90 of 260
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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 91 of 260
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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 92 of 260
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
demonstration studies.
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
demonstration studies.
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 93 of 260
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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 94 of 260
Submissions:
- 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).
Writ Petition (Civil) No.115 of 2004 Etc. Page 95 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 96 of 260
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.
Writ Petition (Civil) No.115 of 2004 Etc. Page 97 of 260
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
Writ Petition (Civil) No.115 of 2004 Etc. Page 98 of 260
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”
Writ Petition (Civil) No.115 of 2004 Etc. Page 99 of 260
(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
Writ Petition (Civil) No.115 of 2004 Etc. Page 100 of 260
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 &
Writ Petition (Civil) No.115 of 2004 Etc. Page 101 of 260
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
organophosphorus compound (toxic to biology) very similar in
structure to glyphosate and as weeds become more resistant,
they will eventually be resistant to all known herbicides.
17.10 It was lastly submitted that the DBT, Ministry of
Science & Technology is an active partner and funder in this
venture of HT DMH-11. The DBT directly oversees the regulation
of GMOs including HT mustard and houses the Regulators and
Writ Petition (Civil) No.115 of 2004 Etc. Page 102 of 260
the RCGM. The conflict of interest in GMO Regulators and
relevant Ministry has not been recognised as unconscionable
and an ethical breach of public trust doctrine. Attention was
drawn to the fact that Prof. Pental himself had been involved in
the regulatory oversight of Bt brinjal and there is a tied-in
relationship that obscures the line of separation that must be
rigorously maintained between the Regulators and the regulated,
if stringent norms of GMO risk assessment and biosafety are to
be maintained for this hazardous technology. There cannot be a
partnership between the Regulator and the Developer which is
invested in the HT mustard GMOs. Therefore, the submission
was that the environmental release of DMH-11/GM mustard/HT
mustard needs to be halted in line with the precautionary
principle.
17.11 Learned senior counsel Sri Sanjay Parikh contended
that one of the reliefs sought for in the writ petition is for the
formulation of a National Policy on GM by a High-Powered
Committee till a sound regulatory and monitoring system is put
in place and till then there should be a moratorium on release of
GM. Although, the Union of India in its counter affidavit, filed in
November, 2004, attempted to justify the 1989 Rules, till date,
there is no National Policy on GM food and “Inter-Ministerial
Task Force” under the Chairmanship of Dr. M.S. Swaminathan,
which has submitted a final report, is still under consideration.
Writ Petition (Civil) No.115 of 2004 Etc. Page 103 of 260
It was contended that in the absence of a National Policy, the
regulatory system, at present, continues to be deficient.
17.12 It was also contended that while transgenic mustard
hybrid DMH-11 is an HT crop, the Government of India has
proceeded on the basis that it is not an HT crop. The question of
the consequences, if transgenic mustard hybrid DMH-11 is
indeed an HT crop, remains unanswered. The Union of India in
its additional affidavit dated 09.11.2022 has acknowledged that
transgenic mustard hybrid DMH-11 possesses HT through the
inherited bar gene from both parents, making it fully HT. Yet, the
Government asserts that it cannot be officially labelled as such,
and therefore, it should not be referred to as a HT crop.
17.13 The crucial inquiry remains regarding the impact of
herbicide spraying on a transgenic mustard hybrid DMH-11 field
— whether the crop will exhibit herbicide tolerance or succumb
to the herbicide. The definition of an HT crop hinges on the
introduction of a new trait, in this case, HT via the bar genes in
the mustard plant. This trait specifically confers tolerance to the
herbicide glufosinate ammonium, as also acknowledged in the
approval letter number F.No.C-12013/35/2010-CSIII dated
25.10.2022. That despite GEAC imposing conditions and
warning against unauthorized herbicide use, initiating legal
action against farmers is impractical, given that farmers may use
herbicides believing that DMH-11 is an HT crop. Consequently,
the Government is unable to pursue legal action based on this
Writ Petition (Civil) No.115 of 2004 Etc. Page 104 of 260
misunderstanding amongst farmers. In the case of HT-Bt cotton,
extensively grown nationwide since 2017 along with the
unauthorized herbicide glyphosate, the Government has failed to
undertake any legal or corrective measures against entities
endorsing and facilitating its cultivation. The cultivation of Bt
cotton has led to the development of resistance to the Bt toxin,
giving rise to robust secondary pests. This, in turn, has resulted
in an increased application of pesticides, contradicting the initial
purpose of Bt cotton. Consequently, it is doubtful that control
over herbicide use and the penalization of farmers employing
herbicides will be effective in the case of DMH-11. It was further
contended that the potential adverse impacts of using HT crops
along with their matching herbicides have to be understood and
are enumerated as under:
a. Herbicide use destroys all the vegetation in and around the
fields where the HT crop is cultivated, which is used by the
rural community in significant ways.
b. In India, the biodiversity found in and around fields is not
considered “weeds” and therefore, not useless, as they are in
the west. These plants, so called “weeds”, provide:
i. leafy green vegetables and many kinds of saag like
chaulai and bathua that provide valuable nutrition for
free to poor rural families;
ii. they also provide green fodder for rural livestock;
Writ Petition (Civil) No.115 of 2004 Etc. Page 105 of 260
iii. such “weeds” are also medicinal plants that traditional
healers such as vaids and hakeems use in the
treatment of human and animal diseases.
c. Introduction of the HT trait will destroy the opportunity to
do mixed farming which is prevalent in Indian agriculture.
d. The HT trait will also strike against any efforts to promote
organic agriculture, since it involves heavy chemical use of
herbicides.
e. The use of herbicides and their accumulation in the soil will
damage soil health and the chemicals will enter the food
chain to the detriment of human health.
17.14 It was also contended that GM has never been tested
as an HT crop, despite having HT properties and in fact, India
does not have any regulatory guidelines and protocols for testing
of HT crops. Reliance has been placed on the TEC Report and
our attention was drawn to various portions thereof, which we
shall consider later. Similarly, reference was made to the 301st
Report of the PSC.
17.15 Sri Parikh also submitted that the manner in which
the conditional clearance was granted makes apparent the
loopholes in the regulatory system. In this regard, it was
submitted that on 21.03.2018, a decision was taken by GEAC in
its 134th meeting to generate additional data on honey bees and
other pollinators on soil microbial diversity. The same was given
a go by subsequently after receipt of a letter from Prof. Deepak
Writ Petition (Civil) No.115 of 2004 Etc. Page 106 of 260
Pental dated 10.05.2022 and contrary to precautionary
principles, it was decided by GEAC in its 147th Meeting dated
18.10.2022 that the field demonstration studies with respect to
the effect of GE mustard on honey bees and other pollinators
may be conducted post-environmental release. The said
decision, besides causing adverse effects on the environment,
would also be against the principle of assessing any harmful
socio-economic impact in time, i.e., before granting approval.
17.16 Our attention was also drawn to various points
regarding conflict of interest, details of which have also been
given in the written submissions, which we shall advert to during
the course of our discussion.
17.17 It was next submitted that the 1989 Rules are not
compliant with the CPB, which was ratified by India on
17.01.2003 and which came into effect on 11.09.2003. This is
because the question of liability and redress are not addressed
by the 1989 Rules. Sri Parekh noted that the CPB reaffirms the
precautionary approach, which is also contained in Principle 15
of the Rio Declaration on Environment and Development.
Therefore, the decision of GEAC dated 25.10.2022 that tests with
regard to the environmental impact of the release would be done
post-release and not prior thereto, violates the aforesaid
precautionary principle.
Writ Petition (Civil) No.115 of 2004 Etc. Page 107 of 260
17.18 Finally, it was urged that HT seeds of transgenic
mustard hybrid DMH-11 have been sown in five locations and in
the absence of a proper and lawful approval of the same, the
plants should be uprooted and destroyed immediately, so that
no environmental contamination takes place.
17.19 Learned senior counsel, Sri Trideep Pais submitted
that the procedure adopted by GEAC in the instant case,
culminating in the order dated 25.10.2022, is not in accordance
with law. In this regard, it was submitted that GEAC is a
Committee which has been constituted under the 1989 Rules
and is therefore, a statutory body. The said body cannot further
delegate its functions to sub-committees or Expert Committees.
Even if the assistance of such sub-committees or Expert
Committees is taken, there has to be detailed deliberations of the
recommendations made by the said Expert Committees and not
simply accepted without any application of mind as has
happened in the instant case.
17.20 It was further submitted that the health expert was
consistently absent in all the crucial meetings of GEAC, and
thereafter, the said expert sent an e-mail simply concurring with
the deliberations of GEAC without any application of mind and
in the absence of any participation in the deliberations.
Consequently, the health aspect in the context of granting
approval for environmental release of transgenic mustard hybrid
DMH-11 has been totally ignored and kept apart, which is the
Writ Petition (Civil) No.115 of 2004 Etc. Page 108 of 260
reason why the petitioners as well as the interveners are pressing
for appropriate reliefs on quashing of the decision dated
25.10.2022. In this regard, learned senior counsel drew our
attention to the various deliberations of the meetings with
reference to the compilation of documents that he submitted.
17.21 Learned senior counsel Sri Pais further submitted that
despite the order of this Court dated 12.08.2008 and the earlier
order dated 08.04.2008 stating that the primary data pertaining
to field trials must be placed in the public domain and on the
website of GEAC, there has been absolute non-compliance of the
same and as a result, it is neither in the public domain nor
placed on record.
17.22 It was further contended that on the reconstitution of
GEAC dated 17.07.2022, one of the members, Dr. Geeta Jotwani,
was not present in the meeting held on 18.10.2022. GEAC simply
approved the agenda Item No.4 on the said date. As already noted
on 02.02.2016 in the 1st meeting of the sub-Committee of GEAC,
Dr. B. Sesikeran, the Nutrition and Food Safety expert, was
absent. The said expert was continuously absent thereafter on
11.04.2016, 20.06.2016 and 11.08.2016 in the meetings of the
sub-committee. Learned senior counsel therefore, submitted that
GEAC, not having complied with the requisite procedures, has
arrived at a decision to grant approval of the environmental
release of transgenic mustard hybrid DMH-11 without taking
Writ Petition (Civil) No.115 of 2004 Etc. Page 109 of 260
into consideration all aspects of the matter in a comprehensive
manner.
17.23 Sri Dhruv Dwivedi learned counsel submitted that the
recommendation of the Parliamentary Committee on agriculture
has not been considered by GEAC in its proper perspective.
Further, the sub-committee of GEAC had recommended that the
adverse impacts on honeybees and other pollinators had to be
studied prior to the environmental release. However, the said
decision was given a go by and it was decided that the said study
would be conducted subsequent to the environmental release of
DMH-11. This volte-face in the stand of GEAC is without any
reason and also not in consonance with the precautionary
principles which are relevant in the instant case.
17.24 Dr. Ravindra Chingale learned counsel appearing on
behalf of Bharatiya Kisan Sangh as an intervenor, at the outset,
submitted that these matters cannot be considered to be an
adversarial litigation but wholly in public interest. Therefore, the
respondent Union of India would have to adhere to the directions
issued and to be issued by this Court in the matter. He further
drew our attention to three unstarred questions answered in the
Rajya Sabha by Hon’ble Minister of State for Environment. One
of them was with regard to Section 22 of the FSSA, 2006, that
the Central Government has not yet conducted any study on GM
food and therefore, has not issued a notification under the
aforesaid provision. In the absence of such a notification, there
Writ Petition (Civil) No.115 of 2004 Etc. Page 110 of 260
can be no steps taken having regard to the provisions of the
FSSA, 2006. As per Section 2 of the said Act, the Union has
declared that the food industry is taken under its control, which
is expedient in the public interest in view of Entry 52, List I of
the Seventh Schedule of the Constitution. The same shall be
considered later.
17.25 He also drew our attention to Section 3(b) of the
Patents Act, 1970, which states that an invention, the primary
or intended use or commercial exploitation of which could be
contrary to public order or morality or which causes serious
prejudice to human, animal or plant life or health or to the
environment, is not an invention within the meaning of the said
Act and therefore, not patentable.
Submissions of the Respondents:
PART-I
- Sri R. Venkataramani, learned Attorney General, while
defending the action of GEAC, contended that the petitioners
have raised two concerns, namely, (i) the non-negotiable
importance of having credible regulatory procedures, mechanism
and institutions which are free from commercial incentives to
ensure that proposals for release and use of GM crops and plants
are subject to strict scrutiny through well-accepted regimes; and,
(ii) all information and materials in relation to the regulatory
procedures be made public to ensure participation of the public
in order to bring about transparency and informed debate.
Writ Petition (Civil) No.115 of 2004 Etc. Page 111 of 260
18.1 Based on the above contentions, the petitioners have
sought that unless certain precautions are taken, the Union of
India shall not release GMOs into the environment by way of
import, manufacture, use or any other manner. More specifically,
the petitioners have sought directions with regard to approval
dated 25.10.2022 recommended by GEAC by clearing for
environmental release transgenic mustard hybrid DMH-11
following fairly long stages of trial conducted by ICAR, CGMCP;
Institute of Microbial Technology, Chandigarh (IMTECH), NIN,
Hyderabad, Amar Immunodiagnostics Pvt. Ltd., Hyderabad and
Premas Biotech Pvt. Ltd., Manesar.
18.2 It was submitted by learned Attorney General that by order
dated 10.05.2012 in Writ Petition (Civil) No.260 of 2005, this
Court was pleased to appoint an expert committee (TEC)
consisting of technical experts to submit a report with certain
terms of reference. TEC submitted an interim report on
07.10.2012 and Union of India raised objections in response to
the said report, which were referred to TEC on 09.11.2012. On
30.06.2013, the TEC submitted its final report making certain
suggestions. According to the learned Attorney General, the TEC
Report goes beyond the terms of reference, to the extreme extent
of observing that HT crops are completely unsuitable in the
Indian context. But, Dr. Paroda has filed a separate dissenting
report raising serious objections to the procedures and
Writ Petition (Civil) No.115 of 2004 Etc. Page 112 of 260
deliberations of the TEC that virtually worked with a closed
mind.
18.3 It was then submitted that these writ petitions were filed in
2004-2005 respectively and since then, there has been
development in the regulatory framework governing the field and
the following guidelines and protocols are applicable to the
research and testing of GMOs:
i. Guidelines and SOPs for Conduct of Confined Field Trials of
Regulated GE Plants, 2008.
ii. Revised Guidelines for Research in Transgenic Plants, 1998.
iii. Guidelines for Safety Assessment of Foods Derived from GE
plants, 2008 (updated in 2012).
iv. Protocols for Food and Feed Safety Assessment of GE Crops,
2008.
v. Guidelines for the Environmental Risk Assessment (ERA) of
GE Plants, 2016.
vi. Environmental Risk Assessment (ERA) of GE Plants: A Guide
for Stakeholders, 2016.
vii. Risk Analysis Framework, 2016.
18.4 The aforesaid regulatory framework has been developed
after the filing of the present petitions and in view of these
developments, these petitions have been rendered infructuous.
That in view of the adequacy of the current regulatory regime in
place, the petitions have lost their efficacy inasmuch there is no
challenge to the constitutionality of the statute, rules or
Writ Petition (Civil) No.115 of 2004 Etc. Page 113 of 260
executive action and that a writ court cannot embark on a roving
and fishing inquiry in a public interest litigation.
18.5 Emphasising that the focus of the writ petition is now
confined to the environmental release of transgenic mustard
DMH-11, it was submitted that on receipt of the application
requesting a trial of DMH-11 to be conducted, approval was given
by GEAC on 29.09.2010 and subsequently, approvals were
granted to conduct BRL-I and BRL-II trials. Only after several
meetings, deliberations and consideration of the reports of the
trials, on 18.10.2022, GEAC recommended environmental
release of DMH-11 subject to strict conditions and safeguards
and accordingly, permission for environmental release of DMH-
11 was issued on 25.10.2022.
18.6 It was further submitted that the regulatory requirements
are adequate to address all aspects of the concerns voiced by the
petitioners and the rules and guidelines are in consonance with
the CPB and Codex principles and guidelines on foods derived
from biotechnology.
18.7 It was further argued that even the concerns expressed by
the TEC Report have since been adequately addressed by the
Union of India. The TEC Report was written in the background
of the existing regulatory regime, which as noted above, has
subsequently been updated. The regulatory regime in place has
been strengthened to ensure that a comprehensive, transparent
and science-based framework of GM crops is in place for ERA of
Writ Petition (Civil) No.115 of 2004 Etc. Page 114 of 260
GM crops. That rigorous risk analysis approach has been applied
to ensure the safety of both the environmental and health risks
vis-à-vis transgenic mustard hybrid DMH-11 for the past ten
years.
18.8 Therefore, learned Attorney General submitted that the
scope of adjudication now stands confined to the question of due
procedure being followed under the relevant rules and the
guidelines and there is no need to traverse beyond this limited
inquiry. It was emphasised that the question that should be
addressed by this Court would revolve around due processes
being followed and deliberations on the varying understandings
on applications of science and technology would lie in the domain
of the Government alone and mere differences of opinions cannot
invite the Court’s attention into the evaluation of views and
adopting or rejecting any one of them.
18.9 Learned Attorney General then proceeded to argue that the
petitioners’ concern regarding risk with regard to environmental
release of transgenic mustard hybrid DMH-11 is purely
hypothetical and there is a distinction between a risk which is
clearly known and demonstrated and presumption of risk on
unproven hypotheses. Even under the precautionary principle
approach, a rigid and uncompromising approach is not
encouraged insofar as it stifles technological advancement. That
the Food and Agriculture Organization (FAO) describes risk
assessment as a scientific process consisting of the following
Writ Petition (Civil) No.115 of 2004 Etc. Page 115 of 260
steps: (i) hazard identification, (ii) hazard characterisation, (iii)
exposure assessment, and (iv) risk categorization. There is also a
principle that an analysis of benefit versus risk is undertaken to
determine the actions that provide the greatest benefits while
encountering the least risk. In the instant case, the procedures
adopted for the environmental clearance are argued to be in
consonance with the above said steps. To seek judicial scrutiny
of the same would, thus, be inappropriate and will amount to
dislodging governance responsibility in taking decisions on a
consideration of all relevant factors. Therefore, this Court ought
not to enter into any evaluation of rival views on the subject of
GMOs in general and the issue of environmental release of DMH-
11 in particular.
PART-II
I. Overview of the Technology:
18.10 It was contended that the conditional approval was
given on 25.10.2022 to the CGMCP, University of Delhi, for
environmental release of transgenic mustard hybrid DMH-11
and parental lines bn.36 and modbs 2.99 containing barnase,
barstar and bar genes. The object was to create DMH-11 – a
hybrid obtained by crossing Varuna bn 3.6 (containing bar,
barnase genes) with EH-2 modbs 2.99 (containing bar, barstar
genes). The three relevant genes used in the process of creating
DMH-11 are as follows: barnase gene which makes the plant
Writ Petition (Civil) No.115 of 2004 Etc. Page 116 of 260
male sterile; barstar gene which restores male fertility; and bar
gene which confers HT.
Presently, Varuna mustard seed contains both male and
female parts and is self-pollinating (self-fertilization). It is first
made male sterile so that it can be pollinated and crossed with
another variety. This is achieved by introducing the barnase
gene. Hence, a male sterile Varuna bn 3.6 is created (containing
bar, barnase genes). Since Varuna bn 3.6 is male sterile, it cannot
self-pollinate to reproduce. For multiplying this parental line, it
is crossed with normal Varuna which produces a crop which is
50% Varuna bn 3.6 (male sterile) and 50% normal Varuna
(fertile). This progeny crop is then planted in an alternating
arrangement with EH-2 modbs 2.99 plants (containing bar,
barstar genes). At this stage, herbicide is sprayed at the site
which eliminates the fertile (normal varuna) portion of the
progeny crop (since it does not have HT) leaving behind the
portion of the progeny crop which is male sterile, i.e. Varuna bn
3.6 (since it contains the bar gene which confers HT). This is
termed a selection event. The male sterile Varuna bn 3.6
remaining from the progeny crop gets fertilized by the adjacent
EH-2 modbs 2.99 crop (which also contains the bar gene and
survives the herbicide) and produces the hybrid seed DMH-11.
18.11 Thus, DMH-11 is produced, containing all three genes
i.e. barnase, barstar and bar. It is fully fertile since the barnase
gene inherited from EH-2 modbs 2.99 restores the male fertility
Writ Petition (Civil) No.115 of 2004 Etc. Page 117 of 260
of the resulting hybrid. The bar gene inherited in DMH-11 is of
no utility in the hybrid. Its utility is at the selection event,
namely, to multiply the male sterile Varuna bn 3.6. This male
sterility/restorer system is a highly promising technology which
can be used to produce new hybrids with higher yields in future,
thereby increasing agricultural output and farmer income.
II. Herbicide Tolerance (HT):
18.12 It was contended that a crop is referred to as an HT
variety if its commercial trait is HT, but DMH-11 is not such a
crop since the HT trait in DMH-11 is of no commercial utility. In
fact, transgenic mustard hybrid DMH-11 is not developed as HT
Technology and it is unnecessary to use herbicide in the
cultivation of transgenic mustard hybrid DMH-11. In fact, the
HT trait is useful only at the selection event during the
development phase of the event and is of no utility when the crop
is being cultivated by a farmer.
18.13 It was also pointed out that under the EP Act, 1986,
and the Insecticides Act, 1968, use of herbicide is, anyway, not
permitted in the field for cultivation of transgenic mustard hybrid
DMH-11.
III. Yield:
18.14 Learned Attorney General contended that in the BRL-
I and BRL-II trials, an increase in per-hectare yield by 25-30 per
cent has been demonstrated against national check Varuna and
zonal check RL1359. Only after the environmental release of
Writ Petition (Civil) No.115 of 2004 Etc. Page 118 of 260
DMH-11, significant clarity would emerge from the trials that are
conducted by ICAR. Therefore, environmental release is the first
step in a long process of evolution of this technology which will
lead to even better hybrids in future.
18.15 According to the learned Attorney General, there is
proven use and safety of genes used in transgenic mustard
hybrid DMH-11. The three genes, barnase, barstar and bar have
more than twenty years of safe history of being in the food chain
in GE rapeseed, a sister crop of transgenic mustard hybrid DMH-
- The regulatory authorities in the USA, Canada and Australia
have allowed the cultivation of GE rapeseed containing the bar,
barnase and barstar genes. Between 1996 – 2003, parental lines
and hybrids were released for cultivation in Canada, USA and
Australia.
18.16 It was submitted that under Rule 4 of the 1989 Rules,
the following bodies namely, GEAC, Recombinant DNA Advisory
Committee (RDAC), RCGM, IBSC and SBCC have been
constituted and the applicable guidelines have been enumerated
above.
18.17 Emphasising that the RCGM and GEAC together
examine the safety assessment data submitted by the applicant
at every step of the regulatory process, the learned Attorney
General noted that the regulatory mechanism is completely
transparent. All the data, reports, decisions etc. are made
publicly available. Therefore, the conditional approval for
Writ Petition (Civil) No.115 of 2004 Etc. Page 119 of 260
environmental release prior to commercial release is subject to
necessary regulatory and technical oversight and the approval
has been granted after following detailed and exhaustive
procedure in law, including after considering biosafety data and
rigorous scrutiny over a period of twelve years. GEAC considered
the application for environmental release only when the
applicant had completed three years of BRL Trials (two years of
BRL-I trials and one year of BRL-II trials) and a 3251 page dossier
containing results of all the biosafety studies was submitted to
GEAC and its sub-committees. As per the public consultation
process prescribed in the Risk Analysis Framework 2016, the
AFES Report was uploaded on the official website of MoEF&CC
for inviting comments from 05.09.2016 to 05.10.2016 and about
twenty-nine persons personally inspected the complete dossier
at the premises and provided their comments.
18.18 It was submitted that in fact, the permission for
environment release of transgenic mustard hybrid DMH-11 is
granted for following limited purpose:
i. To use the events of environmental release of transgenic
mustard hybrid DMH-11 for developing new parental lines
and hybrids under the supervision of ICAR.
ii. To undertake seed production of transgenic mustard hybrid
DMH-11 and its testing as per existing ICAR guidelines and
other extant rules/regulations prior to its commercial
release.
Writ Petition (Civil) No.115 of 2004 Etc. Page 120 of 260
iii. To generate scientific evidence in the Indian agro-climatic
situation of the environment release.
iv. As a precautionary mechanism, post-environmental release,
conduct the field demonstration studies with respect to the
effect of GE mustard on honeybees and other pollinators, as
recommended in the 136th GEAC meeting within two years
under supervision of ICAR, as per its guidelines and other
extant rules, guidelines and regulations and the report be
submitted to GEAC.
However, the above is subjected to stringent terms and
conditions to ensure environmental safeguards.
18.19 On the TEC Report, learned Attorney General
submitted that though HT crops were not a part of terms of
reference, the five-member TEC report has referred to the same
and recommended against the use thereof in India. The Union of
India too had filed objections stating that this recommendation
was beyond the scope of terms of references and such a decision
must be left to the regulatory system. In any case, the focus in
the instant matter is only on DMH-11, which is not an HT crop.
According to the learned Attorney General, since 2012, the
regulatory regime has been strengthened to ensure that a
comprehensive transparent and science-based framework of GM
crops is in place for ERA of GM crops.
Writ Petition (Civil) No.115 of 2004 Etc. Page 121 of 260
18.20 Finally, it was contended that mustard is the most
important edible oil and seed meal crop of India and at present,
55-60 percent of the edible oil demand is met through imports.
It was stated that canola oil is made from GM canola seeds; and
soyabean oil largely comprises GM soyabean oil. Thus, the
petitioners have voiced unfounded fears of adverse impact of GM
crops, even when India is already importing and consuming oil
derived from said GM crops. The transgenic mustard hybrid
DMH-11 has shown an increase per-hectare yield by 25-30 per
cent over the traditional varieties due to exploitation of hybrid
vigour. As mustard is one of the highest oil-bearing of oilseeds
utilised in India, the domestic production of edible oil would
considerably increase if DMH-11 hybrid technology is employed.
Hence, learned Attorney General sought for dismissal of
the writ petitions.
Submissions of Learned Solicitor General:
- Learned Solicitor General Sri Tushar Mehta, while
supporting the arguments of the learned Attorney General, at the
outset contended that any ban on commercial/public release of
GM crops in India will be against public and national interest.
55-60 percent of the edible oil in India is imported and mustard
oil is one of the most important edible oils. In order to ensure
food security and reduction of foreign dependency, it is necessary
to strengthen the plant breeding programmes in India, including
use of new genetic technologies such as GE technology.
Writ Petition (Civil) No.115 of 2004 Etc. Page 122 of 260
19.1 Drawing our attention to statistics regarding the demand for
total edible oil in India, it was submitted that 55.76 per cent of
the total demand of edible oil is made through import, out of
which palm oil, soyabean oil, sunflower oil and a small quantity
of canola quality mustard oil are being imported. It was
contended that owing to increasing population and oil
consumption over the years, the imports have significantly
increased in India.
19.2 Reiterating that globally around 80 percent of soyabean is
GM soyabean variety, it was underlined that the petitioners were
only voicing unfounded fears. The transgenic mustard hybrid
DMH-11 having shown increased per-hectare yield over the
traditional varieties, domestic production of edible oil is bound
to rise considerably through the GM variety.
19.3 It was next submitted that competing fundamental rights of
different sections of the society would have to be balanced. On
the one hand, essential food including edible oil at affordable
prices has to be made available, while at the same time, the
dependency on import has to be reduced. That owing to the
increasing demand for edible oil in India, making available the
same at an economic price is a fundamental right of the citizens.
Therefore, the production of indigenous edible oil is necessary to
meet the increasing demand for such oil. It was argued by the
learned Solicitor General that there were certain sections of the
population who did not wish that India should be self-sufficient
Writ Petition (Civil) No.115 of 2004 Etc. Page 123 of 260
and self-reliant in essential food and instead encouraged
importing edible oil, which is not in the interest of the Indian
economy.
19.4 It was submitted that the petitioners have failed to satisfy
as to how restricting the trials would, in any way, have an
adverse impact on the environment or otherwise. The public
interest and fundamental rights of the citizens of the country to
have the benefit of reasonable price of mustard oil has to
outweigh the so-called concerns expressed by the petitioners
herein. The learned Solicitor General accused that the petitions
have been filed only to arm twist the State and in order to support
greater imports of the essential commodities. In this context, it
was submitted by him that the Union of India is committed to
increasing crop productivity and the income of farmers through
development of low input – high output agriculture and making
the country self-sufficient in edible oil and grain legumes and
that the strengthening of plant breeding programme, including
the use of new genetic technologies, is critical for that purpose.
19.5 He noted that an elaborate statutory scheme exists to
ensure effective regulatory review for the research, development
and commercial use of GE technologies. The petitioners have not,
however, pointed out a single flaw on record in the existing
statutory regime or its implementation in the trial of DMH-11.
Therefore, the writ petitions have to be dismissed with heavy
costs. In this regard, reliance was placed on a recent judgment
Writ Petition (Civil) No.115 of 2004 Etc. Page 124 of 260
of this Court in the case of Jacob Puliye vs. Union of India,
(2022) SCC OnLine SC 533 (“Jacob Puliye”) with special
reference to paragraph Nos.21, 22, 62 and 80-81, and three other
judgments of this Court, namely, National High Speed Rail
Corporation Limited vs. Montecarlo Limited, (2022) 6 SCC
401 (“Montecarlo Limited”), Narmada Bachao Andolan vs.
Union of India, (2000) 10 SCC 664 (“Narmada Bachao”) and
Uflex Limited vs. Government of Tamil Nadu, (2022) 1 SCC
165 (“Uflex Limited”) to contend that frivolous public interest
litigation must be dismissed with heavy costs, particularly, when
an interim injunction affects the public interest. This is because,
in the instant case, there is no material produced to demonstrate
as to how the existing statutory regime relating to GM crops
violates the fundamental rights of the citizens or is opposed to
the provisions of the Constitution, or is opposed to any statutory
provisions, or is otherwise manifestly arbitrary. Hence, the writ
petitions may be dismissed with costs.
Reply Arguments:
- Sri Prashant Bhushan submitted his rejoinder arguments
with reference to the arguments of the learned Attorney General
by contending that DMH-11 is a HT Crop, as is evident from the
admission of the Union of India in the note submitted by the
learned Attorney General himself to the effect that “the presence
of the third HT gene (Bar) is essential for hybrid seed production”.
Therefore, the presence of the HT gene (Bar) makes DMH-11 an
Writ Petition (Civil) No.115 of 2004 Etc. Page 125 of 260
HT Crop. This was also said to be in accordance with the finding
of the 2017 PSC Report which stated that transgenic mustard
hybrid DMH-11 is an HT Crop.
20.1 It was then pointed out that there is clear evidence on the
adverse impacts of such GMOs from other places in the world. In
this regard, reference was made to various experts’ opinions as
under:
(i) Dr. Jack Heinemann, Director, Centre for Integrated
Research in Biosafety, University of Canterbury,
Christchurch, Netherlands, who served as an advisor to the
Food & Agriculture Organisation, stated that DMH-11 is an
HT crop.
(ii) In an “Open Statement on Bar Gene in GM Mustard”
published on 10.12.2022, by Dr. Soma Sundar Marla,
Former Principal Scientist, Crop Bioinformatics & Genomics,
ICAR-NBPGR, New Delhi and other scientists and experts, it
was stated that DMH-11 is an HT crop in the following
words:
“Technically, it is the presence of the gene construct
the Bar gene which defines whether a crop is
Herbicide Tolerant (HT) or not. Given that both
parents of DMH-11 carry gene constructs containing
Bar, which confers herbicide tolerance towards
glufosinate, any offspring from such parents
including DMH-11 shall carry the HT trait. Therefore
not only parental lines, but DMH-11 is also tolerant
to herbicide without any doubt.”
Writ Petition (Civil) No.115 of 2004 Etc. Page 126 of 260
(iii) Further, in the article titled, “Long-term ecological,
environmental effects of herbicide tolerant crops haven’t been
considered” published on 29.11.2022 in the Indian Express,
by Dr. Renee Borges and other distinguished professors and
scientists, DMH-11 was confirmed as an HT crop. It was
stated as under:
“A central feature of DMH-11 is that it carries a gene
for herbicide resistance (also termed herbicide
tolerance or HT). This fact has not received
appropriate consideration. The deployment of
herbicide-resistant or HT crops has been
accompanied by deleterious outcomes in several
places including the US, Australia, and Canada (so-
called developed countries) as well as Argentina (a
developing country). The most well-established
harmful consequences have been the spread of
herbicide-resistant weeds across large tracts of
agricultural land, which can spell disaster for the
normal crop.
Thus, notwithstanding the statement of the
developers and its implicit acceptance by GEAC,
DMH-11 does meet the definition of an HT crop. The
answers to two questions show this. Is DMH-11
herbicide tolerant? Yes. Is it a crop? Yes. The intent
of the developer on how it is actually likely to be
used, especially if that usage appears to confer
obvious advantages.”
(iv) It was contended that as DMH-11 is an HT crop, all hybrids
produced therefrom will also be HT crops and the TEC
appointed by this Court has in its detailed report submitted
to this Court recommended a complete ban on all HT crops.
Writ Petition (Civil) No.115 of 2004 Etc. Page 127 of 260
20.2 It was further submitted that the report titled, “Biology of
Brassica Juncea (Indian mustard)” prepared by the MoEF&CC
and DRMR, Bharatpur under United Nations Environment
Programme (UNEP)/ Global Environment Facility (GEF)
supported the regions of South Western China and North
Western Himalayas, which constitute two secondary centres
where there is enormous diversity in Brassica Juncea forms; that
there is evidence for the existence of two geographical races of
Brassica Juncea, the Chinese pool and the Indian pool. Further,
five countries share nearly 60% of Brassica germplasm holdings
led by China (17%) and followed by India (15%), United Kingdom
(UK) (10%), USA (9%) and Germany (8%). India presents a rich
diversity of rapeseed- mustard group of crops.
20.3 It was next submitted that glufosinate is banned for all
other uses except for tea plantations and is specifically banned
for use on DMH-11 by farmers; this is because glufosinate
causes toxicity which would lead to resistance. However,
glufosinate is otherwise available to farmers who have access to
it.
20.4 That, the TEC report has pointed to the acute toxicity and
health concerns such as carcinogenicity, reproductive and
developmental toxicity, and endocrine disruption. That, long
term studies show that an exposure to glufosinate would have
adverse effects, which may not be evident in short term studies.
That, even as per the information made available by Bayer,
Writ Petition (Civil) No.115 of 2004 Etc. Page 128 of 260
BASTA containing glufosinate ammonium is neurotoxic and has
adverse effect on aquatic life.
20.5 It was reiterated that in the biosafety dossier of HT
mustard, the primary data dossier, is, in fact, not in the public
domain. The biosafety dossier contains the primary data on the
basis of which the AFES Report was prepared. However, the
biosafety dossier containing 3251 pages was only available for
physical inspection at the MoEF&CC headquarters and in
response, petitioner’s counsel had written to GEAC requesting
the dossier to be put on the website so that it could be examined
by independent experts. It was replied that in no country with
functional regulatory system is the full dossier made available
publicly due to reasons of protection of intellectual property.
20.6 That, in fact Dr. P.M. Bhargava, in his critique of the AFES
Report, had pointed out that it was not possible to evaluate the
statements made in the said Report as the primary data had not
been provided in the Report. Therefore, it is all the more
necessary that the biosafety dossier be put in the public domain
so as to enable independent experts to review the same.
20.7 It was next submitted that no chronic/long term studies
have been conducted on HT mustard. It was stressed that the
petitioners’ concern is the irreversible risk of contamination that
the country faces, if environmental release of GMOs is permitted
in the absence of any chronic studies vis-à-vis human health,
livestock, environment, biodiversity etc. It was pointed out that
Writ Petition (Civil) No.115 of 2004 Etc. Page 129 of 260
Union of India was silent as to the measures undertaken to
ensure non-contamination. The Union of India was also silent
about the measures undertaken in respect of labelling of GM
foods, in light of the fact that no chronic studies have been
commissioned as regards the consumption of GM foods. Also, the
Union of India was silent as to the liability of the applicant and
GEAC for potential losses to farmers and consumers on account
of irreversible contamination.
20.8 In this regard, the TEC Report was referred to, wherein it
has been stated that currently eighteen new food crop species,
for which applications for field trial have been received in the
Indian system, are – cauliflower, cabbage, corn, rice, wheat,
tomato, groundnut, potato, sorghum, okra, brinjal, mustard,
papaya, watermelon, sugarcane, etc. Also, the growth of GM crop
would impact organic food producers and given the difficulties in
segregation of GM and non-GM foods, it would be difficult to meet
the criteria for organic food. This was said to have potential
adverse impact on export of organic food, as the importers would
closely examine the conditions under which organic food is being
grown and any concern about contamination could lead to an
adverse impact and loss of markets for organic food producers.
20.9 It was further submitted that GEAC, the regulator, has
failed to deal with the illegal plantation of HT Bt cotton and the
same is being grown in the country illegally on commercial basis.
In fact, the intervenor in the present proceedings, Shetkari
Writ Petition (Civil) No.115 of 2004 Etc. Page 130 of 260
Sangathan, has also been illegally planting Bt brinjal and has
been encouraging farmers to do so, and GEAC has failed to check
the same.
20.10 It was next submitted that large quantities of GM
processed oil was being imported in the form of canola oil
sourced largely from GM canola seeds and soyabean oil sourced
from GM soyabean seeds. It was argued that this is in violation
of the law.
20.11 Section 22 of the FSSA, 2006 prohibits manufacture,
distribution, sale or import of any GMO products, except in
accordance with the regulations which the Central Government
may notify. This has been a subject matter of a judgment of this
Court in Writ Petition (Civil) No.173 of 2006, Vandana Shiva
vs. Union of India, disposed of on 11.08.2017, wherein it was
recorded that there was no notification or regulation allowing any
activity in connection with GE and modified food and such
activity was permissible only under the regulations framed under
Section 22 of the FSSA, 2006. The said writ petition was
disposed of by allowing liberty to the petitioner therein to
approach this Court again after regulations framed in connection
with GE and modified food under Section 22 of the FSSA, 2006,
are placed for consideration by the Parliament, in order to test
their legality upon constitutional sustainability. However, till
date, no notification has been issued by the Union of India.
Writ Petition (Civil) No.115 of 2004 Etc. Page 131 of 260
20.12 In addition, it was pointed out that GEAC in their
communication addressed to Directorate General of Foreign
Trade (DGFT), dated 23.02.2018, had informed that it had not
authorised or approved GM soyabean or any other products
derived from GM soyabean seeds for import or cultivation in
India. That being the case, it is not known on what basis is GM
food being imported to India.
20.13 It was next submitted that there was a failure to undertake
any socio-economic risk analysis by GEAC with regard to the
failure of Bt cotton in accordance with the CBD and CPB. The
need for such an assessment was also highlighted by TEC.
20.14 In this regard, reference was made to Mahyco Monsanto
Biotec (India) Private Ltd. vs. Union of India, Writ Petition
(Civil) No.12069 of 2015, filed before the Delhi High Court, in
which the petitioner therein had challenged the price control
order issued by the Union of India under the Essential
Commodities Act, 1955 as regards Bt cotton seeds. The challenge
is pending before the Delhi High Court. Pertinently, the Ministry
of Agriculture and Farmers Welfare, Government of India, in the
said case, has stated that the farmers across the country have
been financially burdened due to the increasing prices of Bt
cotton seeds. They have also to spend on pesticides and other
resources to make the crops more pest resistant and high-
yielding. This has resulted in escalated expenses and reduced
the margin of profit for the farmers.
Writ Petition (Civil) No.115 of 2004 Etc. Page 132 of 260
20.15 It was also brought to our notice that the pink bollworm,
a major pest to the cotton crop, has developed resistance in the
last two or three years and has worried the farmers who have
sown Bt cotton seeds. That, the cotton yields were stagnant in
the last five years due to the fact that the technology was used
not for yield improvement but only for prevention of loss.
20.16 Referring to Article 14(1)(b) of the Argentina Convention, it
was submitted that a duty is cast on the Government of India to
assess the impact of its policies and minimize adverse impacts,
as India is a signatory to the said convention.
20.17 It was, thus, argued that the 1989 Rules, which are prior
in time to the CPB, have to be brought in line with the said
protocol. Similarly, the Biological Diversity Act, 2002, casts a
duty on the Central Government to protect biodiversity as per
Section 36 of the said Act. In this regard, reference was made to
the judgment of this Court in Gramophone Company of India
Ltd. vs. Birendra Bahadur Pandey, (1984) 2 SCC 534
(“Gramophone Co. of India Ltd.”), and Vishaka vs. State of
Rajasthan, (1997) 6 SCC 241 (“Vishaka”), which dealt with
the doctrine of incorporation of international law into Indian law
and how the same could be read to be part of national law unless
they are in conflict with an Act of Parliament.
20.18 Further, any international convention not inconsistent
with the fundamental rights and in harmony with its spirit must
Writ Petition (Civil) No.115 of 2004 Etc. Page 133 of 260
be read into these provisions to enlarge the meaning and content
thereof, so as to promote the object of the constitutional
guarantee.
20.19 Similarly, reference was made to Nilabati Behera vs.
State of Orissa, (1993) 2 SCC 746 (“Nilabati Behera”),
wherein the absence of an enacted law to provide for effective
enforcement of the basic human right of gender equality was held
to give the basis for using international conventions and norms
to construe and give meaning to fundamental rights guaranteed
under the Constitution of India.
20.20 It was also submitted that the present regulatory system
continues to be deficient and therefore, there is a need for putting
in place a suitable regulatory system which would work within
the framework of its mandate.
20.21 In conclusion, it was submitted that the petitioners were
seeking implementation of the recommendations of the TEC.
That the TEC Report has been given a go-by by GEAC in
consideration of the application made by Prof. Pental, Former
Professor of Genetics and Vice-Chancellor, University of Delhi,
South Campus, New Delhi. Therefore, the petitioners have
sought the aforesaid reliefs.
Points for Consideration:
- Before framing the points for consideration, we make it
clear that this case does not decide the competing claims made
Writ Petition (Civil) No.115 of 2004 Etc. Page 134 of 260
in the scientific literature about the desirability of GMOs, their
impact on increasing crop yield in the short or long term and
other subjects that belong to the domain of scientific and
agricultural experts. This Court is not conducting a review or an
evaluation of various scientific studies submitted by the
petitioners and the respondents on GMOs. This Court does not
have the institutional competence and therefore any conclusion
raised on that basis would be a futile exercise.
21.1 The purpose of our adjudication is to satisfy our judicial
conscience on the subject of critical public interest. We have
viewed the matter from the perspective of compliances of the
principles of exercise of discretion and use of administrative
power in a niche area where opinions of scientists and experts in
the field would determine the course of action to be taken in a
matter as significant as the steps leading to the decision for
environmental release of DMH-11 mustard in an altered
technology.
21.2 This case also does not decide on the divergent substantive
content and recommendations made by the TEC or GEAC. The
ambit of the present case is strictly limited to compliance with
constitutional and legal requirements in the decision-making
process impugned herein. In light of the aforesaid, and the
submissions advanced by learned senior counsel and counsel for
respective parties, the following points would arise for our
consideration:
Writ Petition (Civil) No.115 of 2004 Etc. Page 135 of 260
(i) Whether GEAC approval dated 18.10.2022 and the
consequent decision dated 25.10.2022 for the environmental
release of DMH-11 is in accordance with law?
(ii) Whether the decision to grant approval for environmental
release of DMH-11 violates the right to safe and healthy
environment under Article 21?
(iii) Whether GEAC’s grant of approval dated 18.10.2022 and the
decision dated 25.10.2022 for the environmental release of
DMH-11 violate the precautionary principle?
(iv) What order?
Since there is a difference of opinion between the Membersof this Bench vis-à-vis the validity of the decision taken for
environmental release of DMH-11, from this stage onwards, I
propose to opine for myself while my learned brother Karol, J.
has prepared his separate opinion.
Legal Framework:
- Before I proceed further, it would be useful to note that
agriculture, including agricultural education and research,
protection against pests and prevention of plant diseases, is a
State subject enumerated as Entry 14 in List II (State List). Trade
and commerce in, and the production, supply and distribution
of, inter alia, foodstuffs, including edible oil seeds and oils, is in
Entry 33(b) in List III (Concurrent List) of the Seventh Schedule.
Rules and regulations made under the EP Act, 1986 are possibly
referrable to Entry 97 of List I (Union List) since environment
Writ Petition (Civil) No.115 of 2004 Etc. Page 136 of 260
protection has not been specifically mentioned in either List II or
List III of the Seventh Schedule, except for forest. For ease of
reference, the aforesaid Entries of the Seventh Schedule as well
as others are extracted as under:
“Entry 52, List I:
52. Industries, the control of which by the Union is
declared by Parliament by law to be expedient in
the public interest.
Entry 97, List I:
97. Any other matter not enumerated in List II or
List III including any tax not mentioned in either
of those Lists.
Entry 6, List II:
6. Public health and sanitation; hospitals and
dispensaries.
Entry 14, List II:
14. Agriculture, including agricultural education
and research, protection against pests and
prevention of plant diseases.
Entry 33(b), List III:
33. Trade and commerce in, and the production,
supply and distribution of,-
… … …
(b) foodstuffs, including edible oilseeds and oils;”
22.1 Article 48A of the Constitution of India is a Directive
Principle of State Policy which speaks about protection and
improvement of environment and safeguarding of forests and
wild life. Likewise, Article 51A(g) casts upon citizens a
Writ Petition (Civil) No.115 of 2004 Etc. Page 137 of 260
fundamental duty to protect and improve the natural
environment including forests, lakes, rivers and wildlife. These
Articles have to be read in the context of Article 21 of the
Constitution, which has been expansively interpreted by this
Court to include within its scope and ambit of the right to health
and clean environment and ecology. For ready reference, the
aforesaid Articles are extracted as under:
“21. Protection of life and personal liberty.—No
person shall be deprived of his life or personal liberty
except according to procedure established by law.
x x x
48A. Protection and improvement of environment
and safeguarding of forests and wild life.—The State
shall endeavour to protect and improve the environment
and to safeguard the forests and wild life of the country.
x x x
51A. Fundamental duties.—It shall be the duty of every
citizen of India—
x x x
(g) to protect and improve the natural environment
including forests, lakes, rivers and wild life, and to have
compassion for living creatures;”
- At this point, it is also observed that Article 21 also
encompasses the right to food safety. It is in this context that
the FSSA, 2006 has been enacted and I would now advert to the
provisions contained therein as well.
23.1 FSSA, 2006 has been enacted pursuant to Entry 52, List I
of the Seventh Schedule of the Constitution.
Writ Petition (Civil) No.115 of 2004 Etc. Page 138 of 260
Section 2 of the said Act has declared that it is expedient in
the public interest that the Union should take under its control
the food industry.
23.2 The Preamble of the FSSA, 2006, inter alia, states that it is
an Act to consolidate the laws relating to food and to establish
the FSSAI for laying down science-based standards for articles of
food and to regulate their manufacture, storage, distribution,
sale and import, to ensure availability of safe and wholesome
food for human consumption. The following provisions under the
FSSA, 2006 could be adverted to:
“2. Declaration as to expediency of control by the
Union.- It is hereby declared that it is expedient in the
public interest that the Union should take under its
control the food industry.
3. Definitions. (1) In this Act, unless the context
otherwise requires, –
(a) “adulterant” means any material which is or could be
employed for making the food unsafe or sub-standard or
mis-branded or containing extraneous matter;
x x x
(j) “Food” means any substance, whether processed,
partially processed or unprocessed, which is intended
for human consumption and includes primary food, to
the extent defined in clause (ZK) genetically modified or
engineered food or food containing such ingredients,
infant food, packaged drinking water, alcoholic drink,
chewing gum, and any substance, including water used
into the food during its manufacture, preparation or
treatment but does not include any animal feed, live
animals unless they are prepared or processed for
placing on the market for human consumption, plants,Writ Petition (Civil) No.115 of 2004 Etc. Page 139 of 260
prior to harvesting, drugs and medicinal products,
cosmetics, narcotic or psychotropic substances :
Provided that the Central Government may declare, by
notification in the Official Gazette, any other article as
food for the purposes of this Act having regards to its
use, nature, substance or quality;
x x x
(q) “food safety” means assurance that food is acceptable
for human consumption according to its intended use;
x x x
(u) “hazard” means a biological, chemical or physical
agent in, or condition of, food with the potential to cause
an adverse health effect;
x x x
(v) “import” means bringing into India any article of food
by land, sea or air;
x x x
(zk) “primary food” means an article of food, being a
produce of agriculture or horticulture or animal
husbandry and dairying or aquaculture in its natural
form, resulting from the growing, raising, cultivation,
picking, harvesting, collection or catching in the hands
of a person other than a farmer or fisherman;
x x x
(zm) “risk”, in relation to any article of food, means the
probability of an adverse effect on the health of
consumers of such food and the severity of that effect,
consequential to a food hazard;
(zn) “risk analysis”, in relation to any article of food,
means a process consisting of three components, i.e.
risk assessment, risk management and risk
communication;
(zo) “risk assessment” means a scientifically based
process consisting of the following steps: (i) hazardWrit Petition (Civil) No.115 of 2004 Etc. Page 140 of 260
identification, (ii) hazard characterisation; (iii) exposure
assessment, and (iv) risk characterisation;
(zp) “risk communication” means the interactive
exchange of information and opinions throughout the
risk analysis process concerning risks, risk-related
factors and risk perceptions, among risk assessors, risk
managers, consumers, industry, the academic
community and other interested parties, including the
explanation of risk assessment findings and the basis of
risk management decisions;
(zq) “risk management” means the process, distinct from
risk assessment, of evaluating policy alternatives, in
consultation with all interested parties considering risk
assessment and other factors relevant for the protection
of health of consumers and for the promotion of fair
trade practices, and, if needed, selecting appropriate
prevention and control options;
x x x
(zu) “standard”, in relation to any article of food, means
the standards notified by the Food Authority;
x x x
(zw) “substance” includes any natural or artificial
substance or other matter, whether it is in a solid state
or in liquid form or in the form of gas or vapour;
(zx) “Sub-standard” - an article of food shall be deemed
to be sub-standard if it does not meet the specified
standards but not so as to render the article of food
unsafe;”23.3 It would be necessary to refer to Section 22 of the said Act,
which deals with GM foods, organic foods, functional foods,
proprietary foods, etc. The said Section reads as under:
Writ Petition (Civil) No.115 of 2004 Etc. Page 141 of 260
“22. Genetically modified foods, organic foods,
functional foods, proprietary foods, etc. – Save as
otherwise provided under this Act and regulations made
thereunder, no person shall manufacture, distribute,
sell or import any novel food, genetically modified
articles of food, irradiated food, organic foods, foods for
special dietary uses, functional foods, neutraceuticals,
health supplements, proprietary foods and such other
articles of food which the Central Government may notify
in this behalf.
Explanation.– For the purposes of this section,–
(1) “foods for special dietary uses or functional foods or
nutraceuticals or health supplements” means:
(a) foods which are specially processed or
formulated to satisfy particular dietary
requirements which exist because of a
particular physical or physiological condition or
specific diseases and disorders and which are
presented as such, wherein the composition of
these foodstuffs must differ significantly from
the composition of ordinary foods of comparable
nature, if such ordinary foods exist, and may
contain one or more of the following ingredients,
namely:-
(i) plants or botanicals or their parts in the
form of powder, concentrate or extract in
water, ethyl alcohol or hydro alcoholic
extract, single or in combination;
(ii) minerals or vitamins or proteins or metals
or their compounds or amino acids (in
amounts not exceeding the Recommended
Daily Allowance for Indians) or enzymes
(within permissible limits);Writ Petition (Civil) No.115 of 2004 Etc. Page 142 of 260
(iii) substances from animal origin;
(iv) a dietary substance for use by human
beings to supplement the diet by increasing
the total dietary intake;
(b) (i) a product that is labelled as a “Food for
special dietary uses or functional foods or
nutraceuticals or health supplements or
similar such foods” which is not represented
for use as a conventional food and whereby
such products may be formulated in the
form of powders, granules, tablets, capsules,
liquids, jelly and other dosage forms but not
parenterals, and are meant for oral
administration;
(ii) such product does not include a drug as
defined in clause (b) and ayurvedic, sidha
and unani drugs as defined in clauses (a)
and (h) of section 3 of the Drugs and
Cosmetics Act, 1940 (23 of 1940) and rules
made thereunder;
(iii) does not claim to cure or mitigate any
specific disease, disorder or condition
(except for certain health benefit or such
promotion claims) as may be permitted by
the regulations made under this Act;
(iv) does not include a narcotic drug or a
psychotropic substance as defined in the
Schedule of the Narcotic Drugs and
Psychotropic Substances Act, 1985 (61 of
1985) and rules made thereunder and
substances listed in Schedules E and EI of
the Drugs and Cosmetics Rules, 1945;Writ Petition (Civil) No.115 of 2004 Etc. Page 143 of 260
(2) “genetically engineered or modified food” means food
and food ingredients composed of or containing
genetically modified or engineered organisms obtained
through modern biotechnology, or food and food
ingredients produced from but not containing
genetically modified or engineered organisms obtained
through modern biotechnology;
(3) “organic food” means food products that have been
produced in accordance with specified organic
production standards;
(4) “proprietary and novel food” means an article of food
for which standards have not been specified but is not
unsafe:
Provided that such food does not contain any of the foods
and ingredients prohibited under this Act and
regulations made thereunder.”
23.4 Since I am dealing with GE or modified food, it would be
useful to note the definition thereof under sub-section (2) of
Section 22, which defines it as food and food ingredients
composed of or containing GM or engineered organisms obtained
through modern biotechnology, or food and food ingredients
produced from but not containing GM or engineered organisms
obtained through modern biotechnology.
23.5 The Food Safety and Standards (Food Products Standards
and Food Additives) Regulations, 2011 (hereinafter referred to as,
“the Food Safety Regulations, 2011”) have been framed under
Section 92(2)(e) read with Section 16 of the FSSA, 2006 by the
FSSAI. In Regulation 2.9.13(1), details regarding mustard (Rai,
Sarson) are mentioned as under:
Writ Petition (Civil) No.115 of 2004 Etc. Page 144 of 260
“2.9.13: Mustard (Rai, Sarson)
1. Mustard (Rai, Sarson) Whole means the dried,
clean mature seeds of one or more of the plants of
Brassica alba. (L). Boiss (Safed rai), Brassica
compestris L.var, dichotoma (Kali Sarson),
Brasssica Compestris, L. Var, yellow Sarson, Syn,
Brassica compestris L, var glauca (Pili Sarson),
Brassica, compestris L. Var. toria (Toria),
Barassicajuncea, (L). Coss et Czern (Rai, Lotni) and
Brassica nigra (L); Koch (Benarasi rai). It shall be
free from mould, living and dead insects, insect
fragments, rodent contamination. The product shall
be free from the seeds of Argemone Maxicana L, any
other harmful substances and added colouring
matter.
It shall conform to the following standards:
(i) Extraneous matter Not more than 2.0
percent by weight.
(ii) Damaged or Shrivelled Not more than 2.0 percent
Seeds by weight.
(iii) Moisture Not more than 10.0
percent by weight.
(iv) Total ash on dry basis Not more than 6.5
percent by weight.
(v) Ash insoluble in dilute Not more than 1.0
HCl on dry basis percent by weight.
(vi) Non volatile ether Not less than 28.0
extract on dry basis percent by weight.Writ Petition (Civil) No.115 of 2004 Etc. Page 145 of 260
(vii) Violatile oil content Not less than 0.3
on dry basis percent by v/w.
(viii) Insect damaged matter Not more than 1.0
percent by weight.
(ix) Allyl iso thiocyanate (m/m)
on dry basis
(a) B nigra Not less than 1.0
percent by Weight.
(b) B Juncea Not less than 0.7
percent by Weight.
(x) P-hydroxybenzyl Not less than 2.3
percent by weight.
iso-thiocyanate (m/m)
on dry basis in
sinapist alba
(xi) Argemone seeds Absent.”Environment (Protection) Act, 1986 (EP Act, 1986):
- EP Act, 1986 has been enacted to provide for the protection
and improvement of environment and for matters connected
therewith. The relevant provisions of the said Act are extracted
as under:
“2. Definitions.- In this Act, unless the context
otherwise requires,-
(a) “environment” includes water, air and land and the
inter-relationship which exists among and between
water, air and land, and human beings, other living
creatures, plants, micro-organism and property;
Writ Petition (Civil) No.115 of 2004 Etc. Page 146 of 260
(b) “environmental pollutant” means any solid, liquid or
gaseous substance present in such concentration as
may be, or tend to be, injurious to environment;
(c) "environmental pollution" means the presence in the
environment of any environmental pollutant;”1989 Rules:
- In exercise of the powers conferred by Sections 6, 8 and 25
of the EP Act, 1986 and with a view to protect the environment,
nature and health in connection with the application of gene-
technology and micro-organisms, the Central Government has
framed the 1989 Rules. The said Rules dealing with
manufacture, use, import, export and storage of hazardous
micro-organisms/GE organisms or cells were notified with a view
to protect the environment, nature and health in connection with
the application of gene-technology and micro-organisms. These
Rules were gazetted on 05.12.1989 and are applicable to
Genetically Engineered Organisms (GEOs)/micro-organisms and
cells and correspondingly to any substances and products and
food stuffs, etc., of which such cells, organisms or tissues thereof
form part. The Rules also apply to new gene-technologies, apart
from those referred to in clause (ii) and (iv) of Rule 3, and to
organisms/micro-organisms and cells generated by the
utilisation of such other gene-technologies and to substances
and products of which such organisms and cells form part. The
conditions under which the Rules are applicable have been
stated in sub-paragraph (4) of Rule 2 of the said Rules.
Writ Petition (Civil) No.115 of 2004 Etc. Page 147 of 260
25.1 Rule 3 defines, inter alia, the expressions, “biotechnology”,
“gene technology” and “genetic engineering”, which read as
under:
“3. Definitions:- In these rules unless the context
requires.
(i) “Biotechnology” means the application of scientific
and engineering principles to the processing of materials
by biological agents to produce goods and services;
(ii) x x x
(iii) “Gene Technology” means the application of the gene
technique called genetic engineering, include self cloning
and deletion as well as cell hybridisation;
(iv) “Genetic engineering” means the technique by which
heritable material, which does not usually occur or will
not occur naturally in the organism or cell concerned,
generated outside the organism or the cell is inserted
into the said cell or organism. It shall also mean the
formation of new combinations of genetic material by
incorporation of a cell into a host cell, where they occur
naturally (self cloning) as well as modification of an
organism or in a cell by deletion and removal of parts of
the heritable material;”
25.2 Rule 4 speaks of the competent authorities constituted
under the Rules and the said Rule reads as under:
“4. Competent Authorities:-
(1) Recombinant DNA Advisory Committee (RDAC).
This Committee shall review developments in
Biotechnology at national and international levels and
shall recommend suitable and appropriate safety
regulations for India in recombinant research, use andWrit Petition (Civil) No.115 of 2004 Etc. Page 148 of 260
applications from time to time. The Committee shall
function in the Department of Biotechnology.
(2) Review Committee on Genetic Manipulation
(RCGM).
This committee shall function in the Department of
Biotechnology to monitor the safety related aspects in
respect of on-going research projects and activities
involving genetically engineered organisms/hazardous
microorganisms. The Review Committee on Genetic
Manipulation shall include representatives (a)
Department of Biotechnology (b) Indian Council of
Medical Research (c) Indian Council of Agricultural
Research (d) Council of Scientific and Industrial
Research (e) other experts in their individual capacity.
Review Committee on Genetic Manipulation may appoint
sub-groups.
It shall bring out Manuals of guidelines specifying
procedure for regulatory process with respect to
activities involving genetically engineered organisms in
research, use and applications including industry with
a view to ensure environmental safety. All on-going
projects involving high risk category and controlled field
experiments shall be reviewed to ensure that adequate
precautions and containment conditions are followed as
per the guidelines.
The Review Committee on Genetic Manipulation
shall lay down procedures restricting or prohibiting
production, sale, importation and use of such genetically
engineered organism or cells as are mentioned in the
Schedule.
(3) Institutional Biosafety Committee (IBSC).
This Committee shall be constituted by an occupier
or any person including research institutions handling
microorganism/genetically engineered organisms. TheWrit Petition (Civil) No.115 of 2004 Etc. Page 149 of 260
committee shall comprise the Head of the Institution,
Scientists engaged in DNA work, a medical expert and a
nominee of the Department of Biotechnology. The
occupier or any person including research institutions
handling microorganism/genetically engineered
organisms shall prepare, with the assistance of the
Institutional Biosafety Committee (IBSC) an uptodate
on-site emergency plan according to the
manuals/guidelines of the RCGM and make available
copies to the District Level Committee/State
Biotechnology Co-ordination Committee and the Genetic
Engineering Approval Committee
(4) Genetic Engineering Approval Committee
(GEAC).
This committee shall function as a body under the
Department of Environment, Forest and Wildlife for
approval of activities involving large scale use of
hazardous microorganisms and recombinants in
research and industrial production from the
environmental angle. The committee shall also be
responsible for approval of proposals relating to release
of genetically engineered organisms and products into
the environment including experimental field trials.
The composition of the Committee shall be -
(i) Chairman – Additional Secretary, Department of
Environment, Forests and Wildlife.
Co-Chairman – Representative of Department of
Biotechnology.
(ii) Members : Representatives of concerned Agencies
and Departments, namely, Ministry of Industrial
Development, Department of Biotechnology and the
Department of Atomic Energy.Writ Petition (Civil) No.115 of 2004 Etc. Page 150 of 260
(iii) Expert members : Director General – Indian Council
of Agricultural Research, Director General – Indian
Council of Medical Research, Director General –
Council of Scientific and Industrial Research,
Director General – Health Servies, Plant Protection
Adviser, Directorate of Plant Protection, Quarantine
and storage, Chairman, Central Pollution Control
Board and three outside experts in individual
capacity.
(iv) Member Secretary : An official of the Department or
Environment, Forest and Wildlife.
The committee may co-opt other members/experts
as necessary.
The committee or any person/s authorised by it
shall have powers to take punitive action under the
Environment (Protection) Act.
(5) State Biotechnology Co-ordination Committee
(SBCC).
There shall be a State Biotechnology Coordination
Committee in the States wherever necessary. It shall
have powers to inspect, investigate and take punitive
action in case of violations of statutory provisions
through the Nodal Department and the State Pollution
Control Board/Directorate of Health/Medical Services.
The Committee shall review periodically the safety and
control measures in the various industries/institutions
handling genetically engineered organisms/hazardous
microorganisms. The composition of the Coordination
Committee shall be:
(i) Chief Secretary – Chairman
(ii) Secretary, Department of
Environment – Member Secretary
(iii) Secretary, Department of Health – Member
(iv) Secretary, Department of Agriculture – MemberWrit Petition (Civil) No.115 of 2004 Etc. Page 151 of 260
(v) Secretary, Department of Industries
and Commerce – Member
(vi) Secretary, Department of Forests – Member
(vii) Secretary, Department of
Public Works/Chief Engineer,
Department of Public Health Engineering – Member
(viii) State Microbiologists and Pathologists – Member
(ix) Chairman of State Pollution Control Board
The Committee may co-opt other members/experts
as necessary.
(6) District Level Committee (DLC).
There shall be a District Level Biotechnology
Committee (DLC) in the districts wherever necessary
under the District Collectors to monitor the safety
regulations in installations engaged in the use of
genetically modified organisms/hazardous
microorganisms and its applications in the environment.
The District Level Committee/or any other
persons/s authorised in this behalf shall visit the
installation engaged in activity involving genetically
engineered organisms, hazardous microorganisms,
formulate information chart, find out hazards and risks
associated with each of these installations and
coordinate activities with a view to meeting any
emergency. They shall also prepare an off-site
emergency plan. The District Level Committee shall
regularly submits its report to the State Biotechnology
Co-ordination Committee/Genetic Engineering Approval
Committee.
The District Level Committee shall comprise of:-
(i) District Collector – Chairman
(ii) Factory Inspector – Member
(iii) A representative of the
Pollution Control Board – Member
(iv) Chief Medical Officer
(District Health Officer) –Member (Convenor)
Writ Petition (Civil) No.115 of 2004 Etc. Page 152 of 260
(v) District Agricultural Officer – Member
(vi) A representative of the
Public Health Engineering Department – Member
(vii) District Microbiologists/
Pathologist (technical expert) – Member
(viii) Commissioner Municipal Corporation – Member
The Committee may co-opt other members/experts
as necessary.”
25.3 Rule 5 speaks of classification of micro-organisms or
GE products, while Rule 7 deals with approval and
prohibitions. The same read as under:
“5. Classification of microorganisms or genetically
engineered product – (1) For the purpose of these rules,
microorganisms or genetically engineered organisms,
products or cells shall be dealt with under two major
heads; animal pathogens and plant pests and these shall
be classified in the manner specified in the Schedule.
(2) If any of the microorganism, genetically
engineered organism or cell falls within the limits of
more than one risk class as specified in the Schedule, it
shall be deemed to belong exclusively to the last in
number of such classes.
x x x
7. Approval and Prohibitions, etc. :- (1) No person shall
import, export, transport, manufacture, process, use or
cell any hazardous microorganisms or genetically
engineered organisms/substances or cells except with
the approval of the Genetic Engineering Approval
Committee.
(2) Use of pathogenic microorganism or any
genetically engineered organisms or cell for the purpose
of research shall only be allowed in laboratories or inside
laboratory areas notified by the Ministry of Environment
Writ Petition (Civil) No.115 of 2004 Etc. Page 153 of 260
and Forests for this purpose under the Environment
(Protection) Act, 1986.
(3) The Genetic Engineering Approval Committee
shall give directions to the occupier to determine or take
measures concerning the discharge of
microorganisms/genetically engineered organisms or
cells mentioned in the Schedule from the laboratories,
hospitals and other areas including prohibition of such
discharges and laying down measures to be taken to
prevent such discharges.
(4) Any person operating or using genetically
engineered organisms/microorganisms mentioned in
the schedule for scale up or pilot operations shall have
to obtain licence issued by the Genetic Engineering
Approval Committee for any such activity. The possessor
shall have to apply for licence in prescribed proforma.
(5) Certain experiments for the purpose of
education within the field of gene technology or
microorganism may be carried out outside the
laboratories and laboratory areas mentioned in sub-rule
(2) and will be looked after by the Institutional Biosafety
Committee.”
25.4 Rule 8 deals with production, while Rule 11 deals with
permission and approval for food stuffs. The same are
extracted as under:
“8. Production:- Production in which genetically
engineered organisms or cells or micro-organism are
generated or used shall not be commenced except with
the consent of Genetic Engineering Approval Committee
with respect of discharge of genetically engineered
organisms or cells into the environment. This shall also
apply to production taking place in connection with
development, testing and experiments where such
production, etc., is not subject to rule 7.
Writ Petition (Civil) No.115 of 2004 Etc. Page 154 of 260
x x x
11. Permission and Approval for Food Stuffs :- Food
stuffs, ingredients in food stuffs and additives including
processing and containing or consisting of genetically
engineered organisms or cells, shall not be produced,
sold, imported or used except with the approval of the
Genetic Engineering Approval Committee.”
25.5 The guidelines and grant of approval are as per Rules 12
and 13, which read as under:
“12. Guidelines :- (1) Any person who applies for
approval under rules 8-11 shall, as determined by the
Genetic Engineering Approval Committee submit
information and make examinations or cause
examinations to be made to elucidate the case, including
examinations according to specific directions and at
specific laboratories. He shall also make available an on-
site emergency plan to GEAC before obtaining the
approval. If the authority makes examination itself, it
may order the applicant to defray the expenses incurred
by it in so doing.
(2) Any person to whom an approval has been
granted under rules 8-11 above shall notify the Genetic
Engineering Approval Committee of any change in or
addition to the information already submitted.
13. Grant of Approval :- (1) In connection with the
granting of approval under rules 8 to 11 above, terms
and conditions shall be stipulated, including terms and
conditions as to the control to be exercised by the
applicant, supervision, restriction on use, the layout of
the enterprise and as to the submission of information
to the State Biotechnology Coordination Committee or to
the District Level Committee.
Writ Petition (Civil) No.115 of 2004 Etc. Page 155 of 260
(2) All approvals of the Genetic Engineering
Approval Committee shall be for a specific period not
exceeding four year at the first instance renewable for 2
years at a time. The Genetic Engineering Approval
Committee shall have powers to revoke such approval in
the following situations:-
(a) If there is any new information as to the harmful
effects of the genetically engineered organisms
or cells.
(b) If the genetically engineered organisms or cells
cause such damage to the environment, nature
or health as could not be envisaged when the
approval was given, or
(c) Non compliance of any condition stipulated by
Genetic Engineering Approval Committee.”
Regulatory Framework:
- MoEF&CC is the nodal ministry for regulation of GMOs
including GE plants. 1989 Rules under the EP Act, 1986 provide
the statutory scheme for regulation of GE technologies. The 1989
Rules are implemented by the MoEF&CC, the DBT, Ministry of
Science & Technology and State Governments.
26.1 The following authorities/committees are created under the
1989 Rules:
(i) Recombinant DNA Advisory Committee (RDAC):
The RDAC is involved in reviewing the developments in
biotechnology, both at national as well as international levels,
and recommending safety regulations as per the indigenous
requirements of our country in recombinant research, use and
Writ Petition (Civil) No.115 of 2004 Etc. Page 156 of 260
applications from time to time. The RDAC’s functions are
advisory in nature.
(ii) Genetic Engineering Appraisal Committee (GEAC):
GEAC is the apex body to accord approval of activities
involving large scale use of hazardous micro-organisms and
recombinants in research and industrial production from the
environmental perspective. GEAC is also responsible for granting
approvals relating to release of GE organisms and products into
the environment, including experimental field trials (BRL-II). This
Committee functions as a body under the Department of
Environment, Forest and Wildlife for approval of activities
involving large scale use of hazardous micro-organisms and
recombinants in research and industrial production from the
environmental angle delineated under Rule 4.
Rules 7, 8 and 10 of the 1989 Rules state that no research,
development, import, export, manufacture, process, use or sale
of any GE technology or products/substances derived therefrom
can be attempted without the approval of GEAC.
(iii) Review Committee on Genetic Manipulation (RCGM):
The RCGM is established under the DBT and is mandated to
monitor the safety-related aspects in respect of on-going research
projects and activities and bring out manuals and guidelines
specifying procedure for regulatory process with respect to
activities involving GEO in research, use and applications,
including industry, with a view to ensure environmental safety.
The RCGM is the authority for BRL-I trials. This Committee
Writ Petition (Civil) No.115 of 2004 Etc. Page 157 of 260
includes representatives of the DBT, Indian Council of Medical
Research (ICMR), ICAR, CSIR and other experts in their
individual capacity. The Committee may appoint sub groups.
This Committee also lays down procedures for restricting or
prohibiting production, sale, importation and use of such GEOs
of cells as are mentioned in the Schedule to the 1989 Rules.
(iv) Institutional Biosafety Committee (IBSC):
The IBSC is established under the institution engaged in
GMO research, to oversee such research and to interface with
the RCGM in regulating it.
This Committee is constituted by the research institutions
handling micro-organism/GEO. The Committee comprises of the
Head of the Institution, scientists engaged in DNA work, a
medical expert and a nominee of the DBT. The research
institutions handling micro-organisms/GEOs are mandated to
prepare, with the assistance of the IBSC, an up to date on-site
emergency plan according to the manuals/guidelines of the
RCGM and make available copies to the DLC/SBCC and GEAC.
(v) State Biotechnology Co-Ordination Committee (SBCC):
The SBCC plays a major role in monitoring and has powers
to inspect, investigate and take punitive action in case of
violations of statutory provisions.
This Committee is constituted in the States to periodically
review the safety and control measures in the various industries/
institutions handling GEOs/hazardous micro-organisms. It has
power to inspect, investigate and take punitive action in case of
Writ Petition (Civil) No.115 of 2004 Etc. Page 158 of 260
violations of statutory provisions, through the Nodal Department
and the State Pollution Control Board/Directorate of
Health/Medical Services. The Committee is chaired by the Chief
Secretary of the State Government. The Members of the
Committee include Secretaries from the Departments of Health,
Agriculture, Industries & Commerce, Forests, Public Works/
Chief Engineer, Public Health Engineering, State Microbiologists
and Pathologists, Chairman of State Pollution Control Board. The
Secretary, Department of Environment is the Member Secretary
of the Committee. The Committee may co-opt other
members/experts as necessary.
(vi) District Level Committee (DLC):
The DLC has a major role in monitoring the safety
regulations in installations engaged in the use of GMOs/
hazardous micro-organisms and its application in the
environment.
This Committee is constituted in the districts to monitor the
safety regulations in installations engaged in the use of GMOs/
hazardous micro-organisms and its applications in the
environment. This Committee is chaired by the District Collector.
The Chief Medical Officer (District Health Officer) is the Member
(Convenor). The Members of the Committee include Factory
Inspector, a representative from Pollution Control Board, District
Agricultural Officer, a representative of the Public Health
Engineering Department, District Microbiologists, Pathologist
Writ Petition (Civil) No.115 of 2004 Etc. Page 159 of 260
(Technical expert), and Commissioner of Municipal Corporation.
The Committee may co-opt other members/experts as necessary.
26.2 According to learned Attorney General, the 1989 Rules are
implemented by the aforesaid competent authorities through a
series of biosafety guidelines issued from time to time. The
Guidelines applicable to GE plants are:
(i) Guidelines and SOP for Conduct of Confined Field
Trials of Regulated GE Plants, 2008.
(ii) Revised Guidelines for Research in Transgenic
Plants, 1998;
(iii) Regulations and Guidelines for Recombinant DNA
Research and Biocontainment, 2017.
(iv) Guidelines for Safety Assessment of Foods Derived
from GE Plants, 2008 (updated in 2012)
(v) Protocols for Food and Feed Safety Assessment of
GE Crops, 2008.
(vi) Environmental Risk Assessment (ERA) of GE Plants:
A Guide for Stakeholders, 2016.
(vii) Risk Analysis Framework, 2016.
(vii) Guidelines for the Environmental Risk Assessment
of GE Plants, 2016.
26.3 The research and development (R&D) with respect to GE
plants has to be conducted in accordance with the Revised
Guidelines for Research in Transgenic Plants, 1998. As per these
Guidelines, the experiments conducted on research of transgenic
plants are broadly categorized into three categories based on the
risk involved, namely, Category I that involves routine rDNA
Writ Petition (Civil) No.115 of 2004 Etc. Page 160 of 260
experiments, Category II involving evaluation of transgenic
plants in green house/net house, and Category III that pertains
to high-risk experiments. These experiments have to be regulated
by the IBSC and/or the RCGM, as prescribed in the Guidelines.
26.4 Subsequent to the above experiments conducted under the
contained conditions, the confined field trials have to be
conducted as prescribed under the Guidelines and SOP for the
Conduct of Confined Field Trials of Regulated GE Plants, 2008.
26.5 The initial assessment of an application for a confined field
trial begins at the institutional level itself. Based on information
generated by the applicant in the laboratory and the greenhouse,
an application is made to the IBSC for permission to conduct a
confined field trial. The IBSC evaluates the proposal for
conducting a field trial and further recommends it to the other
Regulatory Authorities. The confined field trials are categorized
as under:
(i) Biosafety Research Level-I (BRL-I) Trials: These trials are
limited in size to no more than 1 acre (0.4 ha) per trial site
location and a maximum cumulative total of 20 acres (8.1
ha) for all locations for each plant species/construct
combination (e.g., one or more events originating from
transformation of a plant species with the same genetic
construct), per applicant, per crop season.
(ii) Biosafety Research Level-II (BRL-II) Trials: These are
limited in size to no more than 2.5 acres (1 ha) per trial site
Writ Petition (Civil) No.115 of 2004 Etc. Page 161 of 260
location and number of locations to be decided on a case by
case basis for each plant species/construct combination
(e.g., one or more events originating from transformation of
a plant species with the same genetic construct), per
applicant, per crop season.
The RCGM is the regulatory authority for BRL-I trials and
GEAC is the regulatory authority for BRL-II trials, as per the
Guidelines for the Conduct of Confined Field Trials of Regulated
GE Plants, 2008.
26.6 Applications for environmental release are processed in
accordance with Guidelines for the Environmental Risk
Assessment (ERA) of GE Plants, 2016.
26.7 The Risk Analysis Framework, 2016 prescribes the
Regulatory Agency’s approach to risk analysis. It is based on
national and international standards and guidance, including
the CPB to which India is a party. In accordance with the Risk
Analysis Framework, 2016, assessment of safety of GM plants is
a comprehensive process involving subject experts and ensures
transparency in the regulatory decision-making process by
incorporating stakeholder consultations.
26.8 As per this framework, regulatory agencies seek views from
various stakeholders and the steps followed in this consultation
process include:
Writ Petition (Civil) No.115 of 2004 Etc. Page 162 of 260
(i) The communication of information about submission of
applications for environmental release of GE plants to
the regulatory agency.
(ii) Preparation of a RARM plan for each application by the
regulatory agencies.
(iii) RARM plan uploaded on the official website for receiving
comments from the stakeholders for a period of 30 days.
(iv) The regulatory agency gives its recommendations after
due consideration of the responses received from the
stakeholders.
26.9 That in line with the above, the applicant has to follow a
clearly laid out step by step process for biosafety data generation
from laboratory to field trials, safety tests and submission of
application for environmental release. The biosafety data is
generated in laboratories and by confined field trials under
conditions authorized by the RCGM and GEAC, as per the
guidelines and protocols and in recognized laboratories/
institutions/universities.
- In the context of the crucial role of the regulatory bodies,
particularly with regard to food safety and environment, this
Court in Writ Petition (Civil) No.202 of 1995 (In Re: T.N.
Godavarman Thirumulpad vs. Union of India), order dated
31.01.2024, speaking through Gavai, J. in paragraphs 22-25
and 28-32, has observed as under:
Writ Petition (Civil) No.115 of 2004 Etc. Page 163 of 260
“22. As new bodies, authorities, and regulators for
environmental governance emerge from time to time,
their institutionalisation assumes extraordinary
importance. Institutionalisation means that these bodies
must work in compliance with institutional norms of
efficiency, integrity and certainty. In this context, the
role of the constitutional courts is even greater.
23. Environmental Rule of Law: Environmental rule of
law refers to environmental governance that is
undergirded by the fundamental tenets of rule of law.
The rule of law regime is one that has effective,
accountable, and transparent institutions; responsive,
inclusive, participatory, and representative decision
making; and public access to information. It recognises
the vital role that institutions play in governance and
focuses on defining the structural norms and processes
that guide institutional decision making.
24. While several laws, rules, and regulations exist for
protection of the environment, their objective is not
achieved as there is a considerable gap as these laws
remain unenforced or ineffectively implemented. Rule of
law in environmental governance seeks to redress this
issue as the implementation gap has a direct bearing on
the protection of the environment, forests, wildlife,
sustainable development, and public health, eventually
affecting fundamental human rights to a clean
environment that are intrinsically tied to right to life.
Accountability of the authorities impressed with the
duty to enforce and implement environmental and other
ecological laws is an important feature of judicial
governance. In the context of accountability, this Court
in Vijay Rajmohan vs. CBI, (2023) 1 SCC 329 has held:
“34. Accountability in itself is an essential principle
of administrative law. Judicial review of
administrative action will be effective andWrit Petition (Civil) No.115 of 2004 Etc. Page 164 of 260
meaningful by ensuring accountability of the officer
or authority in charge.
35. The principle of accountability is considered as
a cornerstone of the human rights framework. It is
a crucial feature that must govern the relationship
between “duty bearers” in authority and “right
holders” affected by their actions. Accountability of
institutions is also one of the development goals
adopted by the United Nations in 2015 and is also
recognised as one of the six principles of the Citizens
Charter Movement.
36. Accountability has three essential constituent
dimensions: (i) responsibility, (ii) answerability, and
(iii) enforceability. Responsibility requires the
identification of duties and performance obligations
of individuals in authority and with authorities.
Answerability requires reasoned decision making so
that those affected by their decisions, including the
public, are aware of the same. Enforceability
requires appropriate corrective and remedial action
against lack of responsibility and accountability to
be taken. Accountability has a corrective function,
making it possible to address individual or collective
grievances. It enables action against officials or
institutions for dereliction of duty. It also has a
preventive function that helps to identify the
procedure or policy which has become non-
functional and to improve upon it.”
25. In India, environmental rule of law must draw
attention to the existing legal regime, rules, processes,
and norms that environmental regulatory institutions
follow to achieve the goal of effective and good
governance and implementation of environmental laws.
More importantly, the focus must be on the policy and
regulatory and implementation agencies. In doing so,
environmental rule of law fosters open, accountable, and
transparent decision making and participatory
Writ Petition (Civil) No.115 of 2004 Etc. Page 165 of 260
governance. The renewed role of constitutional courts
will be to undertake judicial review to ensure that
institutions and regulatory bodies comply with the
principles of environmental rule of law.
x x x
28. We may ask a simple question – how effectively are
these environmental bodies functioning today? This
question has a direct bearing on the protection and
restoration of ecological balance.
29. As environmental governance through these bodies
emerges, the obligation of the constitutional courts is
even greater. Hitherto, the constitutional courts focused
on decisions and actions taken by the executive or
private persons impacting the environment and ecology
because the scrutiny by regulators was felt to be
insufficient. Their judgment, review, and consideration
did not inspire confidence and therefore, the Court took
up the issue and would decide the case. In this process,
a large number of decisions rendered by this Court on
sensitive environmental, forest, and ecological matters
constitute the critical mass of our environmental
jurisprudence. This Court would continue to exercise
judicial review, particularly in environmental matters,
whenever necessary.
30. We however seek to emphasise and reiterate the
importance of ensuring the effective functioning of these
environmental bodies as this is imperative for the
protection, restitution, and development of the ecology.
The role of the constitutional courts is therefore to
monitor the proper institutionalisation of environmental
regulatory bodies and authorities.
31. In furtherance of the principles of environmental rule
of law, the bodies, authorities, regulators, and executive
offices entrusted with environmental duties must
function with the following institutional features:Writ Petition (Civil) No.115 of 2004 Etc. Page 166 of 260
i. The composition, qualifications, tenure, method of
appointment and removal of the members of these
authorities must be clearly laid down. Further, the
appointments must be regularly made to ensure
continuity and these bodies must be staffed with
persons who have the requisite knowledge, technical
expertise, and specialisation to ensure their efficient
functioning.
ii. The authorities and bodies must receive adequate
funding and their finances must be certain and
clear.
iii. The mandate and role of each authority and body
must be clearly demarcated so as to avoid overlap
and duplication of work and the method for
constructive coordination between institutions must
be prescribed.
iv. The authorities and bodies must notify and make
available the rules, regulations, and other guidelines
and make them accessible by providing them on the
website, including in regional languages, to the
extent possible. If the authority or body does not
have the power to frame rules or regulations, it may
issue comprehensive guidelines in a standardised
form and notify them rather than office memoranda.
v. These bodies must clearly lay down the applicable
rules and regulations in detail and the procedure for
application, consideration, and grant of
permissions, consent, and approvals.
vi. The authorities and bodies must notify norms for
public hearing, the process of decision-making,
prescription of right to appeal, and timelines.
vii. These bodies must prescribe the method of
accountability by clearly indicating the allocation of
duties and responsibilities of their officers.
Writ Petition (Civil) No.115 of 2004 Etc. Page 167 of 260
viii. There must be regular and systematic audit of
the functioning of these authorities.
32. The role of the constitutional courts is to ensure that
such environmental bodies function vibrantly, and are
assisted by robust infrastructure and human resources.
The constitutional courts will monitor the functioning of
these institutions so that the environment and ecology
is not only protected but also enriched.Constitutional Court and the Environmental Rule of Law:
- Before I proceed further in the matter, it would be necessary
to know the role of the Constitutional Court in matters
concerning science and technology and environment. The
observations of this Court in the following cases are noted as
under:
(i) On the aspect of the approach of the Constitutional Courts
towards questions arising in the realm of science and
environment, this Court has time and again struck a balance
between exercising restraint and answering questions
arising in the realm of pure science by, inter alia, placing
reliance on the principle of sustainable development,
precautionary principle and polluter pays principle. This
Court has not only incorporated progressive ideals and
frameworks to strengthen the process of sustainable
development but has repeatedly emphasised the contours of
its adjudication in concerns touching upon environment.
However, growth of jurisprudence in environmental rule of
law provides ample guidance for the present adjudication.
Writ Petition (Civil) No.115 of 2004 Etc. Page 168 of 260
(ii) In Hanuman Laxman Aroskar vs. Union of India, (2019)
15 SCC 401 (“Hanuman Laxman Aroskar”), this Court
recognised the need to imbue institutional decision-making
on questions of environment with the central precepts of the
rule of law to achieve the lofty goal of sustainable
development. Placing reliance upon the United Nations
Environment Programme’s First Global Report on
Environmental Rule of Law, this Court articulated the
following seven components of the framework of
Environmental Rule of Law:
i. Fair, clear, and implementable environmental laws;
ii. Access to information, public participation, and
access to justice through courts, tribunals,
commissions, and other bodies;
iii. Accountability and integrity of decision-makers and
institutions;
iv. Clear and coordinated mandates and roles, across
and within institutions;
v. Accessible, fair, impartial, timely and responsive
dispute resolution mechanisms;
vi. Recognition of the mutually reinforcing relationship
between rights and environmental rule of law; and
vii. Specific criteria for the interpretation of
environmental law.
It further acknowledged how the contemporary
environmental challenges such as the climate change crisis
could be effectively addressed through a creative synergy of
constitutional values of fairness, accountability andWrit Petition (Civil) No.115 of 2004 Etc. Page 169 of 260
transparency with core ideals of environmental protection in
the following words:
“156. The rule of law requires a regime which has
effective, accountable and transparent institutions.
Responsive, inclusive, participatory and
representative decision making are key ingredients
to the rule of law. Public access to information is, in
similar terms, fundamental to the preservation of
the rule of law. In a domestic context, environmental
governance that is founded on the rule of law
emerges from the values of our Constitution. The
health of the environment is key to preserving the
right to life as a constitutionally recognised value
under Article 21 of the Constitution. Proper
structures for environmental decision making find
expression in the guarantee against arbitrary action
and the affirmative duty of fair treatment under
Article 14 of the Constitution.”
(iii) The judgment in Himachal Pradesh Bus-Stand
Management & Development Authority vs. Central
Empowered Committee, (2021) 4 SCC 309 (“H.P. Bus-
Stand”) expanded the framework of environmental rule of
law to include within it the State’s positive obligations to
create conceptual, procedural and institutional structures
that guide environmental regulation in furtherance of the
environmental rule of law. Emphasising the critical need for
multi-disciplinary perspectives, this Court held that:
“49. The environmental rule of law, at a certain level,
is a facet of the concept of the rule of law. But it
includes specific features that are unique to
environmental governance, features which are sui
generis. The environmental rule of law seeks to
Writ Petition (Civil) No.115 of 2004 Etc. Page 170 of 260
create essential tools — conceptual, procedural and
institutional to bring structure to the discourse on
environmental protection. It does so to enhance our
understanding of environmental challenges — of
how they have been shaped by humanity’s interface
with nature in the past, how they continue to be
affected by its engagement with nature in the
present and the prospects for the future, if we were
not to radically alter the course of destruction which
humanity’s actions have charted. The environmental
rule of law seeks to facilitate a multi-disciplinary
analysis of the nature and consequences of carbon
footprints and in doing so it brings a shared
understanding between science, regulatory
decisions and policy perspectives in the field of
environmental protection. It recognises that the
“law” element in the environmental rule of law does
not make the concept peculiarly the preserve of
lawyers and Judges. On the contrary, it seeks to
draw within the fold all stakeholders in formulating
strategies to deal with current challenges posed by
environmental degradation, climate change and the
destruction of habitats. The environmental rule of
law seeks a unified understanding of these concepts.
There are significant linkages between concepts
such as sustainable development, the polluter pays
principle and the trust doctrine. The universe of
nature is indivisible and integrated. The state of the
environment in one part of the earth affects and is
fundamentally affected by what occurs in another
part. Every element of the environment shares a
symbiotic relationship with the others. It is this
inseparable bond and connect which the
environmental rule of law seeks to explore and
understand in order to find solutions to the pressing
problems which threaten the existence of
humanity. The environmental rule of law is founded
on the need to understand the consequences of our
Writ Petition (Civil) No.115 of 2004 Etc. Page 171 of 260
actions going beyond local, State and national
boundaries. The rise in the oceans threatens not just
maritime communities. The rise in temperatures,
dilution of glaciers and growing desertification have
consequences which go beyond the communities
and creatures whose habitats are threatened. They
affect the future survival of the entire ecosystem. The
environmental rule of law attempts to weave an
understanding of the connections in the natural
environment which make the issue of survival a
unified challenge which confronts human societies
everywhere. It seeks to build on experiential
learnings of the past to formulate principles which
must become the building pillars of environmental
regulation in the present and future. The
environmental rule of law recognises the overlap
between and seeks to amalgamate scientific
learning, legal principle and policy intervention.
Significantly, it brings attention to the rules,
processes and norms followed by institutions which
provide regulatory governance on the environment.
In doing so, it fosters a regime of open, accountable
and transparent decision making on concerns of the
environment. It fosters the importance of
participatory governance — of the value in giving a
voice to those who are most affected by
environmental policies and public projects. The
structural design of the environmental rule of law
composes of substantive, procedural and
institutional elements. The tools of analysis go
beyond legal concepts. The result of the framework
is more than just the sum total of its parts. Together,
the elements which it embodies aspire to safeguard
the bounties of nature against existential threats.
For it is founded on the universal recognition that
the future of human existence depends on how we
conserve, protect and regenerate the environment
today.”
Writ Petition (Civil) No.115 of 2004 Etc. Page 172 of 260
This Court distilled the challenges that confront a
constitutional court in using the framework of an environmental
rule of law. Noting the often-intractable problem of adjudicating
environmental infractions in the absence of precise, quantifiable
and concrete evidence, this Court appreciated the valuable
principled guidance rendered by environmental rule of law in the
following words:
“54. … The point, therefore, is simply this — the
environmental rule of law calls on us, as Judges, to
marshal the knowledge emerging from the record,
limited though it may sometimes be, to respond in a
stern and decisive fashion to violations of environmental
law. We cannot be stupefied into inaction by not having
access to complete details about the manner in which an
environmental law violation has occurred or its full
implications. Instead, the framework, acknowledging the
imperfect world that we inhabit, provides a roadmap to
deal with environmental law violations, an absence of
clear evidence of consequences notwithstanding.”
(emphasis supplied)
Public Trust Doctrine:
- At this stage, I shall refer to certain observations made by
this Court in the context of preservation of environment and on
public trust doctrine. According to this Court, all environment-
related developmental activities should benefit more people while
maintaining the environmental balance. This could be ensured
only by strict adherence to sustainable development, without
which the lives of the coming generations will be in jeopardy. In
M.C. Mehta vs. Union of India, (1991) 2 SCC 353, it was
Writ Petition (Civil) No.115 of 2004 Etc. Page 173 of 260
observed that law alone also cannot help in restoring a balance
in the biospheric disturbance. Nor can funds help effectively. The
situation requires a clear perception and imaginative planning.
It also requires sustained effort and result oriented strategic
action.
- This Court’s jurisprudence on the right to a safe and
healthy environment is a firewall against unscrupulous and
unsustainable decision-making. It encapsulates a concomitant
duty for the State, as understood in light of Articles 48 and 51A(g)
of the Constitution of India. In Charan Lal Sahu vs. Union of
India, (1990) 1 SCC 613 (“Charan Lal Sahu”) and Subhash
Kumar vs. State of Bihar, (1991) 1 SCC 598 (“Subhash
Kumar”), this Court expressly observed that Article 21 includes
the right of enjoyment of pollution-free water and air. Virender
Gaur vs. State of Haryana, (1995) 2 SCC 577 (“Virender
Gaur”) expanded the scope of the right to the effect that a
hygienic environment is an integral facet of the right to a healthy
life. The right was so construed in terms of the State’s duty under
Articles 48 and 51A(g) to forge policies to maintain ecological
balance by taking concrete measures to ‘promote, protect and
improve’ the environment.
30.1 Thereafter, in M.C. Mehta vs. Kamal Nath, (2000) 6 SCC
213 (“Kamal Nath”), it was expounded that the fundamental
right to life under Article 21 would take within its breadth a
protection against disturbance of basic environmental elements
Writ Petition (Civil) No.115 of 2004 Etc. Page 174 of 260
such as air, water and soil. This Court articulated the positive
duties of the State to take all necessary measures for the
protection and promotion of the environment under the EP Act,
1986 in Indian Council for Enviro-Legal Action vs. Union of
India, (1996) 3 SCC 212 (“Enviro-Legal Action”). It was also
held that if the Central Government omits to fulfil any of its
duties under the Sections 3 and 5 of the EP Act, 1986, this Court
could issue appropriate directions to it to take necessary
measures.
30.2 Therefore, the right to a safe and healthy environment
encompasses a corresponding duty on the State to faithfully
implement the environmental statutes and take all necessary
measures.
30.3 The substantive concern of the right to environmental
protection now also encompasses the adverse effects of climate
change. This Court, speaking through Hon’ble Dr. Justice D.Y.
Chandrachud in M.K. Ranjitsinh vs. Union of India, 2024 (4)
Scale 779 : 2024 INSC 280 (“M.K. Ranjitsinh”) has explicitly
recognised that adverse environmental consequences, such as
sea level rise, have a disproportionate impact on socially,
geographically and economically marginalised classes of citizens.
30.4 The aforesaid elucidation of the right to a safe and healthy
environment and the concept of environmental rule of law as
applied in the Indian jurisprudential context reveals that the
concept is one of the ways of embedding a consciousness about
Writ Petition (Civil) No.115 of 2004 Etc. Page 175 of 260
adverse effects on the environment into the sub-structure of the
legal framework to inform an environment-protecting legal
reasoning. Therefore, environmental legislation such as the EP
Act, 1986 and the 1989 Rules ought to be interpreted so as not
to infringe the fundamental right to a safe and healthy
environment under Article 21. Where there is a choice of
statutory construction, this Court would be bound to proffer an
interpretation that effectively protects the right to a safe and
healthy environment.
Precautionary Principle:
- The essence of the precautionary principle lies in the notion
that ‘decision makers should act in advance of scientific certainty
to protect the environment.’ [Source: Andrew Jordan and
Timothy O’ Riordan, ‘The Precautionary Principle in
Contemporary Environmental Politics’ (1995) 4(3) Environmental
Values 191, 194]. The adoption of the precautionary principle
reflects a paradigm shift from the traditional reactive approach,
wherein the environmental regulator responded to apparent
environmental hazards. It is a significant shift even from the
preventive approach that sought to prevent the environmental
damage arising from risks that are bound to actualize in the
foreseeable future. On the other hand, the precautionary
principle seeks to avoid such future environmental damage
which may arise from uncertain eventualities. In other words,
the precautionary principle mandates cautiously taking
Writ Petition (Civil) No.115 of 2004 Etc. Page 176 of 260
appropriate measures to identify potentially harmful activities
even in the face of scientific uncertainty. Precaution, in other
words, is the expression of a well-founded fear of the unknown
and the unknowable environmental consequences of certain
human actions. For a fear to be well-founded, it must emerge
from a robust risk analysis of potentially hazardous
consequences for environmental health.
- The 1982 World Charter for Nature first articulated the idea
of the precautionary principle in General Principle 11, which
postulates the control of activities which might have an impact
on nature and the use of the best available technologies that
minimize significant risks to nature or other adverse effects. The
General Principle 11 recommends a graded approach to varying
levels of environmental risks and damage, while instantiating
that:
i. those activities which are likely to cause irreversible damage
to nature shall be avoided;
ii. those activities which cause a significant risk to nature shall
only be permitted upon exhaustive examination if the
proponents of such activities would demonstrate that the
expected benefits outweigh the potential damage to nature;
and
iii. those activities which cause a significant risk to nature but
where the potential adverse effects are not fully understood
should not be proceeded with;
Writ Petition (Civil) No.115 of 2004 Etc. Page 177 of 260
iv. those activities which may disturb nature shall be proceeded
only upon ex-ante assessment of their consequences through
environmental impact studies and requisite planning to
minimize potential adverse effects.
32.1 Thereafter, the principle was enshrined in Principle 15 of
the Rio Declaration on Environment and Development 1992,
which states:
“In order to protect the environment, the precautionary
approach shall be widely applied by States according to
their capabilities. Where there are threats of serious or
irreversible damage, lack of full scientific certainty shall
not be used as a reason for postponing cost-effective
measures to prevent environmental degradation.”
32.2 It also finds expression in Article 10(6) of the CPB to the
CBD, which states that:
“6. Lack of scientific certainty due to insufficient relevant
scientific information and knowledge regarding the
extent of the potential adverse effects of a living modified
organism on the conservation and sustainable use of
biological diversity in the Party of import, taking also into
account risks to human health, shall not prevent that
Party from taking a decision, as appropriate, with regard
to the import of the living modified organism in question
as referred to in paragraph 3 above, in order to avoid or
minimize such potential adverse effects.”
32.3 While Section 20 of the National Green Tribunal Act, 2010
exhorts the National Green Tribunal (NGT) to take precaution
into account in passing orders, this Court’s jurisprudence, as
Writ Petition (Civil) No.115 of 2004 Etc. Page 178 of 260
explained below, had long recognized and deepened the
precautionary principle.
- This Court in the following cases has discussed at length
the precautionary principle, which are adverted to at this stage.
(i) In Vellore Citizens’ Welfare Forum vs. Union of India,
(1996) 5 SCC 647 (“Vellore Citizens”), this Court was
seized of a Writ Petition filed by a citizens’ group to seek
enforcement of the provisions of the Water (Prevention and
Control of Pollution) Act, 1974 against tanneries that were
discharging untreated effluent into nearby lands. While
directing strict enforcement of environmental law and
holding the authorities accountable for their failure to
exercise statutory powers, this Court expounded on the
significance of the precautionary principle. It traced the
origins of the precautionary principle in international law
and located the same in domestic environmental law. This
Court’s formulation of the precautionary principle
constitutes three propositions:
i. The environmental measures undertaken by the
State Government and the statutory authorities
must anticipate, prevent and attack the causes of
environmental degradation.
ii. Where there are threats of serious and irreversible
damage, lack of scientific certainty should not be
used as a reason for postponing measures to
Writ Petition (Civil) No.115 of 2004 Etc. Page 179 of 260
prevent environmental degradation.
iii. The reversal of the “burden of proof” to the
proponent of a potentially hazardous activity
which could disrupt the natural environment was
critical for ecologically balanced and sustainable
development.
This Court construed the precautionary principle in light
of Articles 47, 48A and 51A(g) of the Constitution. Further,
it was concluded that the extant legislative framework,
specifically the EP Act, 1986, included the application of the
precautionary principle in addition to the polluter pays
principle. Consequently, this Court passed a direction to the
authority to be appointed under Section 3(3) of the EP Act,
1986 to implement the ‘precautionary principle.’(ii) The precautionary principle was explained in greater detail
by this Court in A.P. Pollution Control Board vs. Prof. M.V.
Nayudu, (1999) 2 SCC 718 (“A.P. Pollution Control
Board”) from the lens of international environmental law.
Here, this Court was considering whether the establishment
of a hazardous industry could be countenanced within ten
kilometre of reservoirs used for drinking water. This Court
noted that the “assimilative capacity” rule was embedded in
Principle 6 of the Stockholm Declaration of the U.N.
Conference on Human Environment, 1972. This
“assimilative capacity” principle was premised on the
Writ Petition (Civil) No.115 of 2004 Etc. Page 180 of 260
assumption of perfect scientific predictability that would
allow the internalisation of ecological risks within industrial
processes. It was reasoned that the preponderance of
unpredictability of adverse environmental effects led to the
adoption of the 11th Principle of the U.N. General Assembly
Resolution on World Charter for Nature, 1982, and the
Principle 15 of the Rio Conference of 1992.
Quite axiomatically, precautionary principle changes
the role and significance of scientific data in environmental
disputes. Once a threat to the environment has been
identified, action should be taken to abate environmental
interference, even though there may be scientific uncertainty
as to the effects of the activities. [Source: Lavanya Rajamani,
‘The precautionary principle’ in Shibani Ghosh (ed.) Indian
Environmental Law (Orient Blackswan, 1994]. Certain
anticipated environmental harms and available
environmental data may warrant a strong and strict
application, i.e., the potentially hazardous activity is banned
until the proponent of the activity demonstrates that it poses
no (or acceptable) risk. In such a case, the burden to prove
the acceptable standard of risk shifts to the proponent of
such an activity. In this context, reliance was placed upon
an article authored by Charmian Barton, in Volume 22 of
Harvard Environmental Law Review (1998) and inferred that
the environmental decision-makers must acknowledge the
inadequacy of information about environmental risks and
Writ Petition (Civil) No.115 of 2004 Etc. Page 181 of 260
‘err on the side of caution’ to prevent serious and irreversible
harm.
(iii) In M.C. Mehta vs. Union of India, (2004) 12 SCC 118
(“M.C. Mehta”), this Court advanced the view that the
precautionary principle enjoined the State to take affirmative
action to prevent environmental harm, even when the nature
and extent of such harm could not be anticipated with
scientific precision and certainty. It was reasoned that when
it was difficult to strike a balance between the protection of
the environment and economic development due to
prevailing uncertainty and lack of direct evidence of actual
harm, reasonable suspicion of harm would be adequate to
press the precautionary principle into service and take
anticipatory action.
Analysis and Findings:
- In light of the aforesaid observations, the PSC Report, 2012
made a range of recommendations. The MoEF&CC responded to
each of the recommendations in the Action Taken Report. The
pertinent recommendations and the action taken are explained
in the table below: S. No. Recommendation Action Taken Report- Conduct a thorough Views of Dr. Bhargava
probe into the Bt brinjal are his personal views
matter from the and are not subscribed
beginning till the by most of the scientists.
imposing of moratorium Prof. Reddy has clarified
that the pressure he
- Conduct a thorough Views of Dr. Bhargava
Writ Petition (Civil) No.115 of 2004 Etc. Page 182 of 260
S. No. Recommendation Action Taken Report
on its commercialization adverted to was for
in 09.02.2010. meeting the deadline as
he had been pre-
occupied with his other
responsibilities.
2. Review the organisational GEAC comprises of both
set-up of GEAC. experts and bureaucrats,
and takes aid of expert
committees.
3. Sought information about IAASTD Report has been
concrete action taken by criticised by an
the Government on each independent evaluation
of the findings contained group at the World Bank
in IAASTD Report during in its Global Programme
the four years after the Review. The Government
release of the Report. of India recognises the
importance of biosafety
and sustainable
agriculture and these
goals remain its policy
priority.
4. Fix responsibility for the The Department of
laxity in regulating and Consumer Affairs has
labelling GM foods, and issued a notification on
issue regulations for the labelling of GM foods.
labelling of GM products
including food crops, food
and food products
5. Upon consultation with The BRAI Bill, 2013 has
all stakeholders, been pending in
immediately evolve an all- Parliament. Such an Act
encompassing umbrella would establish the
legislation on biosafety, National Biotechnology
which is focused on Regulatory Authority.
ensuring the biosafety,Writ Petition (Civil) No.115 of 2004 Etc. Page 183 of 260
S. No. Recommendation Action Taken Report
biodiversity, human and Administrative and other
livestock health, support continues to be
environmental protection, expected to RCGM and
and which specifically GEAC.
describes the extent to
which biotechnology,
including modern
biotechnology, fits in the
scheme of things without
compromising with the
safety of any of the
elements mentioned
above.- Similarly, the PSC Report, 2017 made a range of
recommendations. The MoEF&CC responded to each of the
recommendations in the Action Taken Report. The pertinent
recommendations and the action taken are explained in the table
below:
S. Recommendation Action Taken Report
No. - The Central Government Confined-field trials are
should, in consultation with conducted as per detailed
the State Governments and guidance documents and
Administrations of Union protocols framed for the
Territories, ensure that the purpose. Conduct of
whole process of field trials confined field trials is
should be done in closed inspected by members of
environment, keeping regulatory committees,
biosafety and health safety in experts, State
mind and in collaboration Government and State
with the agricultural Agricultural Universities.
universities so as to minimise
Writ Petition (Civil) No.115 of 2004 Etc. Page 184 of 260
S. Recommendation Action Taken Report
No.
the scope of fudging the
primary data.
- GEAC should be headed by GEAC comprises of both
an expert from the field of experts and
Biotechnology, given the representatives of
understanding of scientific respective ministries.
data and analysis of research Sub-committees are
and its implication, before routinely engaged to
coming to a conclusion in the render technical inputs.
matter. - The MoEF&CC should review Minutes of all the
the functioning of GEAC meetings of GEAC are
along with the organisational regularly published on
set up of GEAC and take the website, along with
necessary corrective all the relevant regulatory
measures to make the whole formats. Various
process of assessment and stakeholders such as
approval more transparent, farmers and civil society
so as to ensure have given inputs on
environmental safety, transgenic mustard
biodiversity safety, health hybrid DMH-11 by way of
safety, food and feed safety of comments on the AFES
our country. study and as part of
special hearings. - Members of Parliament DLCs are only mandated
should be nominated as to play a role in
members in the DLCs, so that monitoring of the
the activities of these facilities. Inclusion of
Committees are also shared MPs would not be
with the public. commensurate with the
tasks of the Committee,
as the Committee reports
to the Deputy Collector. - MoEF&CC should undertake The adoption of Bt cotton
a comprehensive study and has nearly doubled the
bring clarity on the issue of yield and substantially
Writ Petition (Civil) No.115 of 2004 Etc. Page 185 of 260
S. Recommendation Action Taken Report
No.
increase in the yield of cotton increased productivity
after its commercialisation in from 308 kgs. per Ha. in
the country. 2001-2002 to 568 kgs.
per Ha. in 2016-2017.
- MoEF&CC should obtain The aforementioned data
results of Ministry of shows that Bt cotton has
Agriculture’s scientific study successfully countered
about the impact of adopting the menace of American
Bt cotton on use of chemical bollworm and
herbicides and pesticides. significantly increased
Thereafter, the MoEF&CC the yield.
should bring out a
comprehensive note on
usages of pesticide details
state wise after the increase
in area cultivated under Bt
cotton. - MoEF&CC should Gene flow from GM crops
scientifically evaluate the to wild relatives poses no
impact of GM crops on risk to the environment.
sustainability, safety and The regulatory process
competitive advantage of has addressed each and
Indian agriculture. every concern pertaining
to environmental safety.
i. It should specifically Genes that make GM
inform the nation crops HT have very
whether the cultivation minimal quantity of Bt
is not going to have any proteins. Studies on the
negative impact on the impact on non-target
microbes, soil and organisms and beneficial
water. organisms are part of the
ii. It should specially study regulatory process.
the impact on beneficial
organisms like bees,
earthworms and
monarch butterflies.
Writ Petition (Civil) No.115 of 2004 Etc. Page 186 of 260
S. Recommendation Action Taken Report
No.
- Assessment of threats and Similar to other
adverse effects of GM crops in regulatory processes, the
foreign countries should not developer/applicant
be mechanically transplanted furnishes studies about
by agencies. The Government safety assessment of
agencies conduct indigenous crops. In case of DMH-
studies to substantiate their 11, developed by Delhi
claim that there is no threat University, all studies
posed to our environment on have been funded by
account of GM crops. Any DBT.
study that conducts impact
assessment should be funded
by DBT for sheer credibility. - The hasty decision to There is no scientific
commercialise GM crops evidence to justify the
should be reconsidered in need for such studies as
light of lack of scientific there exists no
evidence about chronic and biologically relevant
transgenerational impact of difference between GM
such crops. crops and their non-GM
counterparts. - I have perused and discussed the contents of the PSC
Reports, their recommendations of critical import to the
regulatory framework as well as the action taken and observe on
the following aspects:
I. Thorough Probe into Bt Brinjal Approval: Although the Report
of the PSC, 2012, had recommended that the MoEF&CC
should conduct a thorough probe into the concerns raised
by Dr. P.M. Bhargava regarding the approval for
commercialisation of Bt brinjal till the imposition of the
moratorium on 09.02.2010, the Action Taken Report does
Writ Petition (Civil) No.115 of 2004 Etc. Page 187 of 260
not point to the particulars of any enquiry or investigation.
It appears that the justification offered by the erstwhile Co-
Chairman, GEAC, Prof. Reddy, has been accepted without a
fair and comprehensive investigation.
II. Institutional Architecture of GEAC: Although both the PSC
Reports recommended reforms in the institutional
architecture of GEAC, by way of having a full-time body with
a leadership that is competent to conduct impartial and
sound scrutiny of applications for approval under the 1989
Rules, the Action Taken Report denies the very need for such
reforms. I infer that the Government is reluctant to reform
the composition and criteria for appointment to GEAC. No
response is forthcoming on the PSC’s recommendation that
the conflict of interest in the composition, caused by the
presence of a nominee of DBT, should be minimised. This
accentuates the concern about the lack of indigenous and
independent research institutions.
III. Labelling and Regulation of GM Foods: The Action Taken
Report does not address the question of labelling of GM foods
under Section 23 of the FSSA, 2006. There is inadequate
clarity about the issuance of the notification under Section
22 for regulating sale, distribution and consumption of GM
food.
IV. Legislation: With respect to the recommendation to initiate
the process of consultation to enact a comprehensive
legislation on regulation of biotechnology, I note that the
Writ Petition (Civil) No.115 of 2004 Etc. Page 188 of 260
Action Taken Report refers to the Biotechnology Regulatory
Authority of India, 2013 (“BRAI Bill, 2013”). On 28.08.2013,
this Court noted that Sri K.K. Venugopal, learned senior
counsel, appearing for one of the contesting respondents had
informed that the Central Government has prepared a Bill
bearing Bill No.57 of 2013, which is named the BRAI Bill,
2013. However, this Bill lapsed at the end of the 15th Lok
Sabha. Therefore, there is no statutory regulatory framework
in the form of a Parliamentary law that is in place. The 1989
Rules govern the existing procedure which are in fact
subordinate legislation, which is contented to be inadequate.
V. Impact on Agricultural Ecosystem: The blanket denial of
adverse ecological effects by way of cross-pollination or
otherwise is mostly on the basis of research conducted in
foreign contexts. This may not at all be relevant in the Indian
context and ecosystem. The PSC has rightly observed that
the role of non-target organisms and beneficial organisms is
critical to the agricultural ecosystem.
- My understanding is that GM crops are those crops whose
genomes have been modified by the insertion of usually foreign
(for example, bacterial) genes through rDNA technology. Such
modification serves to incorporate traits into plants that are
either absent or rare in their domesticated and/or wild varieties.
For instance, Bt cotton is cotton modified with a set of genes (or
a gene construct) that codes for the Bt toxin. Bt toxin acts as an
Writ Petition (Civil) No.115 of 2004 Etc. Page 189 of 260
insecticide against pink and American bollworms. This specific
insecticidal trait is absent in wild as well as domesticated
varieties of cotton.
- According to the petitioners, two traits dominate
commercialized GM crops – HT (47 percent of the acreage), and
insect resistance or Bt (12 percent). Another 41 percent is under
stacked traits, i.e., both HT and Bt HT crops that obviate manual
weeding and one can simply spray the corresponding herbicide
(glyphosate, glufosinate, and dicamba) on the entire field, and
everything other than the HT crop will perish. In theory, the Bt
crop reduces the applications of external insecticides. Thus,
most of the GM crops commercialized globally, in particular HT
and stacked crops, are tailored for the routines of capital-
intensive agriculture, i.e., agriculture that relies on monoculture
(rather than mixed and intercropping), purchased seeds, fossil
fuels, and intensive applications of synthetic chemicals which in
effect is not sustainable in the long run.
- In my view, the controversy in these writ petitions converges
upon a foundational aspect, which is, the extent of
implementation of the recommendations of the TEC constituted
by this Court. Only upon considering this foundational aspect
can I proceed to determine the points for consideration. I cannot
ignore the TEC Report as suggested by learned Attorney General,
for it would result in undermining the earlier orders of this Court,
which would be an improper approach in the matter.
Writ Petition (Civil) No.115 of 2004 Etc. Page 190 of 260
39.1 The subject matter of this case is indeed technical, as it
involves scrutinising the adoption of a technology that would
enable the modification of genomes through the insertion of
foreign genes. The aim of the modification is often to craft hybrid
varieties that have certain desirable characteristics from the
point of view of agricultural productivity, sustainability and
resilience.
- At the outset, learned Attorney General submitted that the
TEC Report submitted to this Court goes beyond the terms of
reference to the extent of observing that HT crops are completely
unsuitable in the Indian context which is not just and proper.
Dr. Paroda, also a member of TEC, has filed a separate report
raising objections to the TEC report submitted by the majority of
the members which could be considered by this Court.
40.1 In the backdrop of identifying the actual controversy in
these matters, at the outset, the terms of reference of TEC, inter
alia, could be revisited as follows:
(i) to review and recommend the nature of sequencing of risk
assessment (environment and health safety) vis-à-vis all GM
crops before they are released into the environment;
(ii) to recommend the point at which environmental release
through open-field trials can be permitted;
(iii) to advise whether GE crops or plants could be replicated
under different agro-ecological regions and different seasons
as compared to greenhouse conditions;
Writ Petition (Civil) No.115 of 2004 Etc. Page 191 of 260
(iv) to advise measures or safeguards required to prevent
potential risks to the environment vis-à-vis open-field trials
and to recommend protocols necessary to preclude any
escaped material from causing an adverse effect on the
environment;
(v) to advise whether in India, there are state-of-the-art testing
facilities and professional expertise available to conduct
various biosafety tests and if not, recommend setting up an
independent testing laboratory and institutions.
40.2 An interim report, and thereafter, a final report were
submitted by the TEC. As already noted, the final report was in
two parts: the first part of the report was by a majority of five
members of the TEC and a separate note was submitted by Dr.
R.S. Paroda. Since the views of the majority and the separate
note have been recorded hereinabove, I would only discuss
whether the TEC did indeed breach the terms of reference.
40.3 A perusal of the terms of the reference reveals an emphasis
on four aspects: sequencing; scientific tenability; adequacy of
regulatory conditions and availability of technological facilities.
The direction of this Court regarding the interim report was
specifically to seek recommendations on the desirability of a
partial or complete ban on open-field tests and what biosafety
protocol ought to be followed and under what conditions.
40.4 It is clear that the terms of reference relate to this Court’s
concern about the regulatory conditions for the release of GMO
Writ Petition (Civil) No.115 of 2004 Etc. Page 192 of 260
crops and the existence, or otherwise, of any gaps in the same.
It is discernable that the final recommendations responded to
these queries regarding the adequacy of regulatory conditions,
biosafety protocols and available technological framework, by
recommending various measures to fill the gaps that existed in
the regulatory regime at a general level. The first gap, as I
understand is that of technical expertise. The TEC inter alia,
recommended as under:
(i) Constitution of sub-committees with domain expertise in the
fields of health, environment, agro-economics and
socioeconomics, molecular biology, etc. which could replace
the single committee structure devised by the 1989 Rules.
(ii) Another recommendation pointed to the elimination of
conflict of interest, earmarking of specific sites for field trials
and stakeholder participation.
(iii) It also stated that there is a need to develop consultation,
collaboration and capacity building, and that the Indian
regulatory system must develop the ability to assess as to
how any GM product is likely to impact different sections of
the society.
Therefore, having regard to the discussion made by it, I find
that the TEC did not breach its Terms of Reference.
- The petitioners herein have sought for implementation of
the aforesaid recommendations of the majority by contending
that the question of the consequences of transgenic mustard
Writ Petition (Civil) No.115 of 2004 Etc. Page 193 of 260
hybrid DMH-11 being an HT crop remains unanswered. This is
because the Union of India, in its additional affidavit dated
09.11.2022, has acknowledged that transgenic mustard hybrid
DMH-11 possesses HT characteristics. Yet, the Union of India
asserts that it cannot be officially labelled as such and therefore,
it should not be referred to as HT corp. That transgenic mustard
hybrid DMH-11 has never been tested as a HT crop because India
does not have any regulatory guidelines and protocols for testing
of HT crops, is the contention of the petitioners.
41.1 The petitioners have further countered the stand of the
Union of India by submitting as under:
(i) “… that the presence of third HT gene (Bar) is essential for
hybrid seed production”, according to the Union of India. The
presence of HT gene (Bar) makes DMH-11 an HT crop. This
is also the finding of the PSC Reports which have stated that
transgenic mustard hybrid DMH-11 is a HT crop. There is
clear evidence on the adverse impacts of environmental
release of DMH-11, which is a HT crop in various writings
which have been ignored by GEAC;
(ii) that the Union of India is silent as to the measures
undertaken to ensure non-contamination, in case
environmental release of GMOs is permitted, as irreversible
risk of contamination on human health is enormous;
Writ Petition (Civil) No.115 of 2004 Etc. Page 194 of 260
(iii) that the Union of India is also silent on the liability of the
applicant for potential losses to farmers and consumers on
account of irreversible contamination;
(iv) that glufosinate is banned for all other uses except for tea
plantations and is specifically banned for use on DMH-11 by
farmers. This is because of the acute toxicity and health
concerns. That, long term studies would show the adverse
effects of glufosinate which may not show up in short term
studies. Hence, it is necessary to have adequate studies on
the use of glufosinate on plants;
(v) that GEAC has failed to deal with illegal plantation of Bt
cotton and the same is being grown in the country illegally
on commercial basis. That organisations such as Shetkari
Sangathan have been encouraging farmers to do illegal
planting of Bt brinjal, which GEAC as a regulator has failed
to check;
(vi) that there is a failure to undertake any socio-economic risk
analysis by GEAC with regard to the failure of Bt cotton in
accordance with the CBD and the CPB. The need for such an
assessment was also highlighted by TEC in its report. Such
an assessment was required because farmers across the
country have been financially burdened due to the
increasing prices of Bt cotton seeds and they have to spend
on pesticides and other resources to make the crops more
pest-resistant and high-yielding. This has resulted in
Writ Petition (Civil) No.115 of 2004 Etc. Page 195 of 260
escalated expenses and has reduced the margin of profit for
the farmers;
(vii) that the pink bollworm, a major pest to the cotton crop, has
developed resistance in last few years which has worried the
farmers who have sown Bt cotton seeds. Therefore, cotton
yields were stagnant in the last five years due to the fact that
the technology was used for yield improvement but not for
loss prevention;
(viii)that large quantities of GM processed oil is being imported
in the form of canola oil and soyabean oil, which is in
violation of the constitutional and legal rights of the citizens
under Articles 21 and 14 of the Constitution. That GEAC, in
their communication dated 23.02.2018 addressed to the
DGFT, had informed that it had not authorised or approved
GM soyabean or any other product derived from GM
soyabean seeds for import or cultivation in India. If that is
so, as to how, subsequently, GM food is being imported to
India is not known;
(ix) that the Union of India is silent about the measures
undertaken in respect of labelling of GM foods, as there are
no studies which have been commissioned as regards the
consumption of GM foods.
41.2 The petitioners have contended that there is a need for
formulation of a national policy of GM crops for the following
reasons:
Writ Petition (Civil) No.115 of 2004 Etc. Page 196 of 260
(i) that apart from South Western China, North Western
Himalayas constitute an important centre where there is
enormous diversity in Brassica Juncea forms. Therefore,
there are two geographical races of Brassica Juncea, the
Chinese pool and the Indian pool. The share of holding by
the Chinese pool is 17 per cent and by the Indian pool is 15
per cent;
(ii) that the growth of GM crops in India would impact organic
food producers having regard to the difficulties in
segregation of GM and non-GM foods. This would have an
adverse effect on export of organic food as importers would
closely examine the conditions under which organic food is
being grown and any concerns about contamination could
lead to an adverse impact and loss of markets for organic
food producers;
(iii) that India is a signatory to the CPB, therefore, a duty is cast
on the Government to assess the impact of its policies and
minimize adverse impacts of the same vide Article 26 thereof.
(iv) that the 1989 Rules were framed prior to the coming into
force of the CPB but there is a distinct inconsistency between
the same and therefore, the 1989 Rules should be amended
in line with the said protocol, otherwise, international law
could be applied as part of the national law, unless it is in
conflict with any Act of Parliament.
(v) In sum and substance, it was contended that there is a need
for putting in place a suitable policy and an effective
Writ Petition (Civil) No.115 of 2004 Etc. Page 197 of 260
regulatory mechanism which would work within the
framework of its mandate.
41.3 Per contra, the Union of India urged this Court to not
intervene in the matter as the questions involved are highly
technical and polycentric in character. This proposition is indeed
attractive at a first blush, for it invites the Court to trust the
process of the grant of approval for the environmental release of
GMOs under the applicable legal regime. But, it is settled law
that expert opinion is not beyond the pale of judicial review,
especially when there are serious infirmities in the decision-
making process, vide Institute of Chartered Financial
Analysts of India vs. Council of The Institute of Chartered
Accountants of India, (2007) 12 SCC 210 (“Institute of
Chartered Financial Analysts of India”).
41.4 In the above backdrop, the points for consideration shall be
answered.
Re: Point No.1: Whether GEAC approval dated 18.10.2022
and the consequent decision dated 25.10.2022 for the
environmental release of DMH-11 is in accordance with
law?
- I have adverted to in detail several meetings of GEAC held
with regard to the application submitted by the applicant,
namely, CGMCP, University of Delhi (South Campus) on
15.09.2015 seeking approval for environmental release of the GE
mustard hybrid DMH-11. This was after conclusion of the closed
or confined trials and was accompanied with a dossier of 3285
Writ Petition (Civil) No.115 of 2004 Etc. Page 198 of 260
pages compiling the results of the food and environmental safety
studies that were carried out at the time of the confined trials for
the environmental release of transgenic mustard hybrid DMH-
11, parental lines bn 3.6 and modbs 2.99 containing barnase,
barstar and bar genes. In the 125th meeting held on 11.12.2015,
GEAC requested the applicant to give a presentation and
thereafter on 04.01.2016, a sub-committee was constituted for
examination of the dossier.
42.1 The sub-committee held two meetings. After the first
meeting, it recommended revision of the biosafety dossier by
incorporating additional information regarding certain lacunae
or gaps which it had identified and were also identified by the
BSU. GEAC decided that if the biosafety dossier is found to be
complete in all respects, then the same excluding confidential
information, could be put in the public domain for comments.
After the first sub-committee meeting, several submissions and
recommendations were made which are detailed above.
Thereafter, the second sub-committee meeting was held and the
sub-committee sought time to analyse and review the revised
dossier and results obtained in 129th GEAC meeting held on
20.06.2016. The sub-committee suggested that the AFES report,
prepared upon evaluation of biosafety data, be placed on the
MoEF&CC website for thirty days to invite comments from
stakeholders and the dossier also be made available in GEAC
Secretariat for any person interested in studying the same. A
Writ Petition (Civil) No.115 of 2004 Etc. Page 199 of 260
total of 759 comments were received between 05.09.2016 and
05.10.2016 and 29 persons personally inspected the dossier at
the premises of the MoEF&CC and provided their comments.
However, the dossier was not put up on the website of GEAC.
This is in fact a violation of the order of this Court dated
08.04.2008 in respect of which contempt petition has been filed.
42.2 On 07.10.2016, this Court recorded the submission of the
Union of India that no release of GMOs shall take place till
17.10.2016 because the Government had sought views from the
public and upon receipt of such views and objections, the matter
was to be considered by a Committee of experts, which process
could not be completed by 17.10.2016. However on 11.05.2017,
GEAC, in its 133rd Meeting, made the recommendation for the
commercial release of DMH-11. However, on 31.07.2017, this
Court recorded the submission of the Union of India that the
Government has not yet taken a final decision, whether or not to
permit the plantation of transgenic mustard hybrid DMH-11, and
a final decision with reference to the approval would be taken by
the Government in September, 2017. It was also pointed out that
the plantation is likely to commence in October 2017. At a
subsequent hearing on 22.11.2017, this Court recorded the
Union of India’s submission that the Government of India had
not yet taken a decision in the matter and that all the
representations of the stakeholders would be considered before
taking the final decision.
Writ Petition (Civil) No.115 of 2004 Etc. Page 200 of 260
42.3 Thereafter, in its 136th Meeting on 20.09.2018, GEAC re-
examined the matter in light of the representations received and
on a detailed discussion, 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 honeybees
and other pollinators and on soil microbial diversity. Thereafter,
in the 137th GEAC meeting held on 20.03.2019, there was a
deferment of field demonstration studies on transgenic mustard
during the year 2018-19 and it was extended for the seasons
2019-20 and 2020-21. Thus, it is significant to note that GEAC
itself had deferred field demonstration studies on transgenic
mustard and this was in supersession of the earlier decision
taken on 20.09.2018 in the 136th meeting of GEAC wherein the
applicant was advised to undertake field demonstration in an
area of five acres at two to three different locations. Therefore, till
the year 2020-2021, the stage of field demonstration within an
area of five acres at two or three different locations had not yet
been cleared by GEAC with regard to transgenic mustard hybrid
DMH-11.
42.4 When the matter stood thus, Prof. Deepak Pental, on behalf
of CGMCP, Delhi University (South Campus), the applicant, vide
his letter dated 10.05.2022, wrote directly to the Hon’ble Minister
for Environment, Forest and Climate Change seeking acceptance
of the recommendations for environmental release of transgenic
Writ Petition (Civil) No.115 of 2004 Etc. Page 201 of 260
mustard hybrid DMH-11 made in the 133rd GEAC meeting. The
aforesaid letter is extracted as under:
“CENTRE FOR GENETIC MANIPULATION OF CROP
PLANT (CGMCP)
UNIVERSITY OF DELHI SOUTH CAMPUS
BENTO JUAREZ ROAD, NEW DELHI-110021, INDIA
Phone : 91-11-24112609, 24116392 Fax: 91-11-
24116392
Shri Bhupender Yadav May 10, 2022
Hon’ble Minister
Minister of Environment, Forest & Climate Change
(MoEFCC)
Indira Paryavaran Bhawan
Aliganj Road, Jorbagh
New Delhi – 110 003
Subject: Request for environmental release of GE mustard
Respected Minister,
I am writing to you on the environmental release of the
Genetic Engineering-based technology for hybrid seed
production in mustard, a major oilseed crop of our
country. Some recent positive, as well as negative
developments, have induced me to write to you on the
matter which is pending with MoEFCC.
The positive development is the Union Governments’
decision to put SDN-1 and SDN-2 types of gene edited
crops out of the biosafety regimes stipulated for the
Generally Engineered (GE) crops. This is indeed a major
step forward. Barring the EU, most of the development
countries have already reduced biosafety requirements for
genome-edited crops. The negative development is
continuing stagnation of the edible oil sector in India.
While the demand for edible oils is increasing globally, theWrit Petition (Civil) No.115 of 2004 Etc. Page 202 of 260
supplies are under stress leading to a spurt in the prices
of edible oils in the international markets. As our country
imports more than fifty per cent of its edible oil
requirement there is an urgency to increase our domestic
production.
Our group at the Centre for Genetic Manipulation of Crop
Plants (CGMCP), University of Delhi South Campus has
been working on increasing the yield of mustard for the
past 30 years. A report on the research work being caried
out at the Centre is being attached with this letter. The
most appropriate technology for yield increase in mustard
is hybrid breeding for which a robust hybrid seed
production system is foundational; our GE-based hybrid
seed production system meets the need. I believe the time
has come for MoEFCC to permit environmental release of
the GE technology for hybrid seed production to increase
edible oil production in the country.
To brief you on the past developments, the biosafety
studies on the transgenic parental lines Varuna bn 3.6 and
EH2 modbs 2.99 and the first generation hybrid DMH-11
were initiated in the year 2010. All the stipulated biosafety
studies including field testing under isolation were carried
out and a 3251-page dossier was submitted to GEAC on
September 15, 2015. The biosafety studies were supported
by public funding of around Rs.8 crores. The GEAC in its
133rd meeting held on May 11, 2017, recommended the
environmental release of the parental lines and the first
generation hybrid DMH-11 and permitted the development
of a new generation of hybrids. Unfortunately, a few days
later the MoEFCC website displayed the Ministry’s
decision – ‘matters related to environmental release of
Mustard transgenic are kept pending for further review’.
Later in communication from GEAC, some additional
experiments on honey bees were sought but no efforts were
made to facilitate the execution of those experiments. We
pointed out to GEAC that such tests were not required.
Writ Petition (Civil) No.115 of 2004 Etc. Page 203 of 260
The technology we have used for hybrid seed production
in mustard was first deployed in rapeseed, a sister crop of
mustard – in 1996 in Canada, in 2002 in the USA, and in
2003 in Australia. Rapeseed hybrids developed using the
GE technologies are currently being cultivated in Canada
on almost 9-10 million hectares. No untoward effect of GE
rapeseed has been reported either from Canada or from
USA and Australia. Canada is a big exporter of rapeseed
oil and meal to all parts of the world as well as honey.
There is no record of any harm to apiculture in Canada or
from any other country that has released the GE hybrid
seed production system.
The point I want to make for your kind consideration is
that the GE technology for hybrid seed production
developed by us for mustard is well tested, has been used
for more than 20 years in rapeseed, and over and above –
we have carried out all the necessary biosafety tests on the
transgenic mustard lines.
I request that the MoEFCC may accept the
recommendations of the 133rd meeting of GEAC
recommending the environmental release of the GE-based
technology for hybrid seed production in mustard. If
required, GEAC could meet again. We would be very happy
to interact with GEAC to resolve any lingering doubts or
questions.
I would be most grateful for your kind help in resolving the
issue of the environmental release of GE-based hybrid
seed production technology.
With kind regards,
Yours sincerely,
Deepak Pental
SERB-National Science Chair
Former Professor of Genetics and Vice-Chancellor,
University of Delhi
Cc: Chairman, GEAC”
Writ Petition (Civil) No.115 of 2004 Etc. Page 204 of 260
On receiving the said communication, immediately
comments were sought from the DBT, DARE and ICAR. On
25.08.2022, the applicant once again made a presentation of the
proposal for environmental release of DMH-11 to GEAC at its
146th meeting. At that meeting, GEAC once again constituted
another Expert Committee to examine the request letter dated
10.05.2022 with respect to availability of adequate evidence
about impact of transgenic mustard on honeybees and other
pollinators in order to assess the need for conducting field
demonstration studies on honeybees and other pollinators. The
reason for constitution of another Expert Committee is not
known or forthcoming. This Expert Committee, headed by Dr.
Sanjay Kumar Mishra, Scientist H, DBT, Government of India
and Co-Chairman, GEAC, held two meetings in September, 2022
and it outrightly recommended environmental release of
transgenic mustard hybrid DMH-11. Also, further evaluation
was to be carried out as per ICAR guidelines. Thus, the Expert
Committee took a dramatically opposite view as compared to
GEAC with regard to the field demonstration studies on the effect
of GE mustard on honeybees and other pollinators. In the 136th
GEAC meeting, it was recommended by GEAC that the same be
conducted prior to the environmental release. This Expert
Committee, on the other hand, suggested that within two years,
post-environmental release under the supervision of ICAR, the
effect of GE mustard on honeybees and other pollinators may be
Writ Petition (Civil) No.115 of 2004 Etc. Page 205 of 260
studied and a report be submitted to GEAC. For immediate
reference, the relevant extracts of the Expert Committee
recommendation is extracted as under:
“The Expert Committee had deliberations and in-depth
consideration of the scientific evidences, including data
available on GM Canola cultivation & honey production
in other countries and correlated all the concerned
issues of contemporary relevance under Indian scenario.
Additionally, inputs on the above issues from Members
of the Expert Committee, Department of Biotechnology
(DBT), Ministry of Science and Technology; and
Department of Agriculture Research & Education
(DARE), Ministry of Agriculture and Farmers Welfare
were also considered and deliberated. The DBT opined
that “it seems likely that there were no major deviations
in the behaviour of honey bees when compared among
the transgenic and non-transgenic comparator lines.
GEAC may consider its recommendations of the 133rd
meeting on the environmental release of GE mustard”.
The DARE opined that “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 honey as decided in its 136th meeting
and the recommendation of the 133rd meeting of GEAC
may be considered”.
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.Writ Petition (Civil) No.115 of 2004 Etc. Page 206 of 260
However, to generate scientific evidences in Indian agro-
climatic 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.”
(underlining by me)
42.5 Further, on 18.10.2022, when the 147th Meeting of the
GEAC was convened, as many as seven members communicated
their inability to attend the meeting and Dr. Geeta Jotwani,
Scientist ‘G’ at Indian Council of Medica Research (ICMR) did not
attend the meeting. Consequently, eight persons remained
absent and only fourteen members participated i.e. almost one-
third of the GEAC did not attend the crucial meeting, the GEAC
took into consideration only the recommendations of the Expert
Committee constituted few weeks before which had given its
recommendations on 08.10.2022 and noting the same, the
recommendations were accepted by pursuing the comments
received from DBT and DARE. The above is evident on perusal of
the Minutes of the 147th Meeting of the GEAC held on 18.10.2022
as well as the Agenda Item No.4 which concerns the application
relating to environmental release made by the applicant. Thus,
GEAC simply recommended the environmental release of
transgenic mustard hybrid DMH-11 without any deliberation as
such, which recommendation was accepted by the Central
Government. As a result, the following consequences are noted:
Writ Petition (Civil) No.115 of 2004 Etc. Page 207 of 260
(i) all the previous deliberations and decisions of GEAC
as well as the recommendations and suggestions of
the sub-committee to GEAC were given a go by and
totally ignored.
(ii) the deferring of the field demonstration between the
years 2018 to 2021, which was for valid reasons,
was also ignored.
(iii) on 25.10.2022, no reason was assigned for the
change in stance, insofar as conducting studies on
the effect of GE mustard on honeybees and other
pollinators post-environmental release. This was
contrary to what was decided earlier by GEAC.
(iv) thus, on the basis of the opinion of this Expert
Committee, GEAC brushed aside its earlier decision
taken in the 134th and 136th meetings to undertake
field demonstration and restrict the area to only five
acres at two to three different locations with a view
to generate additional data on honeybees and other
pollinators, and on soil microbial diversity, which
decision was also put on hold by GEAC.
42.6 There is no reason forthcoming as to why GEAC completely
changed its stance in the 147th meeting held on 18.10.2022. This
resulted in the decision of the Union Government on 25.10.2022
impugned herein. However, it is apparent that the trigger for this
volte-face in the stand of GEAC was the letter dated 10.05.2022
Writ Petition (Civil) No.115 of 2004 Etc. Page 208 of 260
written by Prof. Deepak Pental to the Hon’ble Union Minister for
Environment, Forest and Climate Change. There is no material
put forth for the sudden decision taken by the Union Government
on receiving the changed recommendation of GEAC, when
earlier, it was submitted before this Court that the Union
Government was still deliberating on the matter, which aspect is
evident from the orders passed by this Court when in fact field
demonstration was also put on hold by GEAC. Such being the
position from the year 2018 onwards, all of a sudden
environmental release of DMH-11 was approved even in the
absence of field trials for conducting studies on the impact of
honeybees and other pollinators.
42.7 I observe that a statutory functionary entrusted or
authorised to carry out certain functions contemplated under a
statute must do so in accordance with law and known procedure.
Where a statutory authority exercises its jurisdiction, conferred
on it by a statute or rules made thereunder, it has to apply its
own mind and the procedures laid, therefore, must be
scrupulously followed. (vide V.K. Ashokan vs. Assistant Excise
Commissioner, (2009) 14 SCC 85 (paras 52 and 54). Every
statutory authority is also bound by the rule of reasonableness
and fairness and its action must be free from arbitrariness.
42.8 Moreover, when an authority changes its policy decision, it
is expected to give valid reasons and act in the larger interest of
the entire community. The persons representing a public body
Writ Petition (Civil) No.115 of 2004 Etc. Page 209 of 260
are expected to discharge their functions faithfully and in
keeping with the trust reposed in them. A statutory body, when
it acts in terms of a statute, is bound by its action. It cannot
supplement or supplant the reasons later on by way of an
affidavit. It is well settled that while a power is exercised by an
authority, ordinarily the reasons contained in the order should
be supported by the material on record. It is absolutely essential
that the authority making the order is alive to the material on
the basis of which it purports to take the decision. It cannot act
mechanically or under an impulse, but after due and proper
application of mind. A statutory authority exercising its power
does so in trust, only to be exercised for a legitimate purpose and
along the settled principles of administrative law. Application of
mind is best demonstrated by disclosure of mind by the authority
making the order and said disclosure is best done through
recording the reasons that led the authority to pass the order in
question. Absence of reasons either in the order passed by the
authority or in the record contemporaneously maintained, is
clearly suggestive of the order being arbitrary, hence legally
unsustainable.
42.9 The authority cannot neglect to do that which the law
mandates and requires doing. It is necessary that an executive
or administrative function should be exercised with clarity, so as
to enable legal certainty in the decision-making process bearing
in mind the requisites for a valid exercise of power.
Writ Petition (Civil) No.115 of 2004 Etc. Page 210 of 260
Public Trust Doctrine:
42.10 The aforementioned curious lapses of procedure and
propriety are especially acute because they are in the teeth of the
public trust doctrine applicable in the instant case, which holds
immense significance when a decision impacting environmental
and ecological vitality is impugned. The public trust doctrine
enjoins upon the Government to protect the natural resources as
well as the environment for the enjoyment of the general public
rather than to permit their use for private ownership or
commercial purposes. In M.C. Mehta vs. Kamal Nath, 1996 (9)
Scale 141, this Court has observed that there is no reason why
the public trust doctrine should not be expanded to include all
ecosystems operating in our natural resources. The State is the
trustee of all natural resources and the public at large is the
beneficiary of the same. The State is, therefore, under a legal
duty to protect the natural resources. Similarly, in Lal Bahadur
vs. State of U.P., (2018) 15 SCC 407 (“Lal Bahadur”), this
Court held that the Government has a duty to protect the
environment and the Courts also must bear in mind that in cases
concerning environmental governance, it has to discharge its
duties by assessing the case on the basis of the material placed
before it. This is because matters concerning environmental
governance concern not just the living, but also generations to
come, which is the basis of the doctrine of inter-generational
equity.
Writ Petition (Civil) No.115 of 2004 Etc. Page 211 of 260
42.11 Similarly, in Centre for Public Interest Litigation
vs. Union of India, (2012) 3 SCC 1 (“Centre for Public Interest
Litigation”), it was observed that the doctrine of equality which
emerges from the concept of justice and fairness, must guide the
State in determining the actual mechanism for distribution of
natural resources. This Court has further observed that every
holder of public office by virtue of which he acts on behalf of the
State or public body is ultimately accountable to the people in
whom the sovereignty vests. As such, all powers so vested in a
public officer are meant to be exercised for public good and
promoting the public interest. Every holder of a public office is
therefore a trustee. If a decision is taken without any principle
or without any rule, it is unpredictable and such a decision is an
antithesis to the decision taken in accordance with the rule of
law. This Court had further observed that the public trust
doctrine is a part of the law of the land and it has grown from
Article 21 of the Constitution of India. This implies that the
power vested by the State in a public authority should be used
as a trust coupled with duty to be exercised in larger public and
social interest. Power is to be exercised strictly adhering to the
statutory provisions and fact situation of a case.
42.12 It is observed that in the instant case, while the Union
of India made a submission before this Court that no final
decision had been taken by it regarding the environmental
release of transgenic mustard hybrid DMH-11, yet, pursuant to
Writ Petition (Civil) No.115 of 2004 Etc. Page 212 of 260
the letter written on behalf of the applicant to the Hon’ble
Minister for Environment, the matter moved swiftly possibly
“from the top” and GEAC responded by constituting another
Expert Committee which gave its recommendation to GEAC as
desired.
42.13 Furthermore, while granting permission of the
environmental release of transgenic mustard hybrid DMH-11,
the condition imposed was that usage of any formulation or
herbicide would not be permitted for cultivation in the farmer’s
field and any such use in the farmer’s field without due approval
would attract appropriate legal action under various enactments.
There is no indication as to how the use of any herbicide could
be prevented, rather, the condition not to use any herbicide was
open-ended without having any means to check whether any
herbicide would be used in the farmer’s field pursuant to the
environmental release. The adverse effects of use of herbicide
were also totally given a go by.
42.14 I also note that on granting permission for the
environmental release of transgenic mustard hybrid DMH-11,
there was no procedure envisaged for any study or research on
the impact on non-target organisms and soil microbes to be
conducted prior to the commercial cultivation of transgenic
mustard hybrid DMH-11. I find that it was necessary to have
requisite studies and research carried out on the experimental
environmental release of transgenic mustard hybrid DMH-11,
Writ Petition (Civil) No.115 of 2004 Etc. Page 213 of 260
not only prior to the environmental release but, if permitted,
subsequently before commercial cultivation of the said crop. I
find this to be a serious lacuna under Rule 13(2) of the 1989
Rules.
42.15 Further, any evidence of harmful effects or damage to
the environment, nature and health owing to non-compliance of
conditions stipulated by GEAC was also left open-ended. While
recommending environmental release of transgenic mustard
hybrid DMH-11 parental lines bn 3.6 carrying barnase and bar
genes, and modbs 2.99 containing barstar and bar genes, it is
not clear whether the conditions imposed by GEAC were
adequate and sufficient and in the interest of environment,
particularly in light of the sub-committee’s recommendations to
GEAC as the same were to be acted upon as the matter was
seized by this Court and was being monitored.
42.16 Moreover, I find that GEAC’s proposal was simply
accepted by the MoEF&CC and immediately notified without any
further consideration at the level of the Ministry and without
having any inter-departmental consultation with the Ministry of
Health, MoA and DBT in the Ministry of Science and Technology.
It appears that GEAC recommended what MoEF&CC wanted
pursuant to Prof. Pental’s letter to the Hon’ble Minister himself
in May, 2022.
42.17 Also, no consultation was held with the States wherein
mustard is grown, although agriculture is a State subject under
Writ Petition (Civil) No.115 of 2004 Etc. Page 214 of 260
Entry 14 of List II of the Constitution. The other concerned
stakeholders also ought to have been consulted before a decision
was taken by the Union of India in terms of the recommendation
of GEAC. The Union of India could not have unilaterally acted on
such a serious matter without bringing to the notice of the
States, particularly in the northern and northwestern States of
the country where mustard is being grown. I also record that the
States of Bihar, Kerala, Madhya Pradesh, Haryana, Tamil Nadu,
Delhi, Andhra Pradesh, Rajasthan, Odisha, West Bengal and
Karnataka had earlier expressed reservations against field
testing and release of transgenic mustard hybrid DMH-11. In my
view, the States cannot be treated as satellites of the Union of
India as they have constitutional identity and powers and
responsibilities conferred under the Constitution of India and
therefore, their views in the matter are of significance, vide S.R.
Bommai vs. Union of India, (1994) 3 SCC 1, Para 99 (“S.R.
Bommai”), reiterated in State (NCT of Delhi) vs. Union of
India, (2018) 8 SCC 501. The consideration of the views of the
pertinent States by a regional or national consultation would
have made the decision-making process wholesome, as a wider
consultation in matters such as the one under consideration
would make the decision to be taken less vulnerable to attack
and less arbitrary. But the impugned decision of the Union of
India, based on a flawed procedure adopted by GEAC at the
instance of the applicant, is arbitrary and liable to be interfered
with by this Court when it is justified. In these circumstances,
Writ Petition (Civil) No.115 of 2004 Etc. Page 215 of 260
the decision of the respondent-Union of India dated 25.10.2022,
as well as the recommendation of GEAC dated 18.10.2022, are
liable to be set aside.
42.18 Further, no material has been brought before us to
point out as to how the decision of GEAC was accepted by
MoEF&CC and the recommendation of the environmental release
of transgenic mustard hybrid DMH-11 was simply permitted. As
discussed hereinabove, the grant of approval by GEAC is
governed by Rule13. The said Rule does not contemplate any role
for the Ministry of Environment, Forest and Climate Change
(MoEF&CC) in the decision-making process. Therefore, the
lateral intervention by the said Ministry seriously undermines
the credibility and integrity of the decision making as well as the
regulatory process. Although the applicant is not a private entity
but a Centre in Delhi University (South Campus), the status of
the applicant would not matter in arriving at a decision as in the
instant case.
42.19 I observe that the principle of public accountability
and transparency in State action are applicable to the cases of
execution or statutory exercise of power. Every officer in the
hierarchy of the State by virtue of his being a public
officer/servant is accountable for his decisions to the public as
well as to the State. The concept of dual responsibility should be
applied in larger public interest and proper governance. In other
words, where a power is given to do a certain thing in a certain
Writ Petition (Civil) No.115 of 2004 Etc. Page 216 of 260
way, the thing must be done in that way or not at all and other
methods of performance are necessarily forbidden. This principle
has also been expressed in terms of the Latin maxim expressio
unius est exclusio alterius, which means that when a manner is
specified for doing a certain thing, then all other modes for
carrying out such act are expressly excluded.
Vide, Taylor vs. Taylor, (1875) LR 1 Ch D 426 (“Taylor”)
and Nazir Ahmad vs. King-Emperor, 1936 SCC OnLine PC 41
: (1935-36) 63 IA 372 (“Nazir Ahmad”). This Court too has
applied this maxim in the following cases:
(i) Parbhani Transport Cooperative Society
Ltd. vs. Regional Transport Authority
Aurangabad, (1960) 3 SCR 177 : AIR 1960 SC
801 (“Parbhani Transport Coop. Society”),
wherein it was observed that the rule provides that
an expressly laid down mode of doing something
necessarily implies a prohibition of doing it in any
other way.
(ii) In Dipak Babaria vs. State of Gujarat, (2014) 3
SCC 502 (“Dipak Babaria”), this Court set aside
the sale of agricultural land on the ground that the
sale was not in compliance with the statutory
procedure prescribed in that regard under the
Bombay Tenancy and Agricultural Lands (Vidarbha
Region and Kutch area) Act, 1958. The matter was
examined on the anvil of the aforestated maxim and
Writ Petition (Civil) No.115 of 2004 Etc. Page 217 of 260
it was held that alienation of agricultural land by
adopting any alternate procedure to the one
prescribed under the Act was necessarily forbidden.
(iii) In Kameng Dolo vs. Atum Welly, (2017) 7 SCC
512 (“Kameng Dolo”), election of an unopposed
candidate was declared as invalid on the ground
that the nomination of his opponent was not
withdrawn as per the procedure statutorily
mandated. It was held that the nomination of the
opposite candidate ought to have been withdrawn in
the manner provided for under the relevant statute
and withdrawing the same in any other manner was
necessarily forbidden. Hence, his election was
declared as void.
(iv) Similarly, in Tahsildar, Taluk Office,
Thanjore vs. G. Thambidurai, (2017) 12 SCC 642
(“Tahsildar”), the assignment of land was cancelled
on the ground that statutory requirements were not
followed in assigning the land. It was held that when
a statute prescribes that a certain Act is to be
carried out in a given manner, the said Act could not
be carried out through any mode other than the one
statutorily prescribed.
(v) It may also be apposite to refer to the decision of this
Court in Union of India vs. Charanjit S. Gill,
(2000) 5 SCC 742 (“Charanjit S. Gill”), wherein
Writ Petition (Civil) No.115 of 2004 Etc. Page 218 of 260
this Court held that any provisions introduced by
way of “Notes” appended to the sections of the Army
Act, 1950, could not be read as a part of the Act and
therefore such “Notes” could not take away any right
vested under the said Act. It was observed that
issuance of an administrative order or a “Note”
pertaining to a special type of weapon to bring it
within the ambit of the Army Act, which was hitherto
not included therein, could not be said to have been
included in the manner in which it was supposed to
be included. It was noted that the Army Act
empowers the Central Government to make rules
and regulations for carrying into effect the
provisions of the Act; however, no power was
conferred upon the Central Government of issuing
“Notes” or “issuing orders” which could have the
effect of the Rules made under the Act. As Rules and
Regulations or administrative instructions can
neither be supplemented nor substituted by “Notes”,
administrative instructions issued or the “Notes”
attached to the Rules which are not referable to any
statutory authority were not be permitted to bring
about a result, which is supposed to be achieved
through enactment of Rules.
Writ Petition (Civil) No.115 of 2004 Etc. Page 219 of 260
42.20 What emerges from the above discussion is that when
a statute contemplates a specific procedure to be adhered to in
order to arrive at a desired end, such procedure cannot be
substituted by an alternative procedure which is not
contemplated under the statute. Further, if an action is to be
carried out by way of issuance of a particular statutory
instrument on the basis of certain requirements, such action
cannot be validly carried out by way of issuance of an instrument
when the same is not contemplated under the statute.
42.21 It is also noted that at the crucial 147th meeting of
GEAC held on 18.10.2022, there was no representative of the
ICMR, Ministry of Health. Hence, the matter was not considered
from the paradigm of the adverse effect on the health of human
beings and animals as well as on other plants in the event of
environmental release. Dr. Geeta Jotwani, Scientist F, ICMR,
who did not participate in the meeting of GEAC held on
18.10.2022, simply sent an e-mail to the effect that she had
concurred with the recommendation of GEAC even in the
absence of knowledge about the deliberations of the GEAC.
42.22 In this regard, I also find that the recommendations of
the TEC submitted to this Court have been completely ignored
by GEAC, as another Expert Committee was constituted by it
pursuant to the letter dated 10.05.2022 submitted by Prof.
Pental to the Hon’ble Minister for Environment, Forest and
Climate Change. It is also not known whether the TEC report was
Writ Petition (Civil) No.115 of 2004 Etc. Page 220 of 260
placed before GEAC as well as the Expert Committee or that they
had ever been apprised of the same. I observe that Prof. Pental’s
letter dated 10.05.2022 to the Hon’ble Minister of Environment,
Forest and Climate Change is a classic case of seeking a lateral
intervention by the Minister of the Union of India, bypassing
what had been decided by GEAC in its 137th meeting held on
20.03.2019. It is clear that pursuant to the intervention of the
Ministry, GEAC constituted another Expert Committee and
simply accepted its recommendations for the environmental
release of DMH-11 hybrid mustard. This was by ignoring all
previous deliberation made by GEAC, its sub-committee
constituted earlier and its decision to proceed with precaution.
- Having regard to the aforesaid discussion, I am of the view
that the GEAC approval dated 18.10.2022 and the consequent
decision dated 25.10.2022 regarding the environmental release
of transgenic mustard hybrid DMH-11 is vitiated. I also find that
the impugned approval was in gross violation of the principle of
public trust.
Re: Point No.2: Whether the decision to grant approval for
environmental release of DMH-11 violates the right to safe
and healthy environment under Article 21?
Right to safe and healthy Environment:
43.1 I next consider whether the right to safe and healthy
environment would be violated by unanticipated adverse effects
of the impugned approval for environmental release of DMH-11.
Writ Petition (Civil) No.115 of 2004 Etc. Page 221 of 260
While I am cognizant of the submission of the learned Attorney
General that the Court cannot go into the nuances of science and
technology and give a finding on their merits, at the same time,
I do not find substance in his argument that the petitioners’
apprehensions are only a baseless hypothesis. In the instant
case, the complexity of reasonable risk assessment in the context
of preserving the right to a safe and healthy environment can be
understood with reference to some comparative perspectives.
(i) The judgment of the Supreme Court of the Netherlands in
State of the Netherlands (Ministry of Economic Affairs
and Climate Policy) vs. Stichting Urgenda, 19/00135
dated 20.12.2019 is apposite to appreciate the scope of
judicial review, when the State, as in the present case,
argued that the decision to fulfil obligations under
environmental law is within the policy domain and cannot
be interfered with by courts of law. The controversy raised
by the State of the Netherlands before the Netherland’s
Supreme Court was that the Hague District Court ought not
to have directed the State to limit the combined volume of
Dutch annual greenhouse gas emissions in such a manner
that they have reduced by at least 25% at the end of 2020
compared to the level of the year 1990. The Netherland’s
Supreme Court dismissed the State’s challenge by applying
the precautionary principle. The Netherland’s Supreme
Court took note of the real risks of dangerous climate change
which necessitate more stringent measures. It reasoned that
Writ Petition (Civil) No.115 of 2004 Etc. Page 222 of 260
mere lack of complete scientific certainty about the efficacy
of the ordered reduction scenario does not exempt the State
from its duty to undertake sufficient measures. Also, in the
absence of certainty, a high degree of plausibility of the
efficacy of the more stringent pathway was sufficient. The
Netherland’s Supreme Court held that the obligation to take
measures exists if there is a risk that serious environmental
contamination may affect people’s well-being and prevent
them from enjoying their homes in such a way as to affect
their private and family life adversely. The Netherland’s
Supreme Court specifically repelled the argument that in the
system of the separation of powers, courts should not
interfere with the democratically legitimised Government’s
attendant policy choices. It proffered the reason that in the
given context, the State’s violation of the right to life and
right to respect for private and family life necessitated
judicial direction for remedial measures.
Therefore, disputes seeking review of administrative
decisions impacting the environment turn on the relative
weight that a decision maker accorded to competing
considerations while perceiving the larger public interest.
Environmental regulation is supposed to be a reasoning
process that takes account of the social context in which the
putative environmental effects could occur, the reliability of
available information regarding the consequences, the
existing institutional history of prevention and containment,
Writ Petition (Civil) No.115 of 2004 Etc. Page 223 of 260
and the probability of perceived consequences. It was
concluded that while an excessive focus on probabilities can
benefit the proponent of a potentially hazardous activity, the
imbalanced deference to consequences can give way to the
prohibition of such activities.
(ii) The judgment of the European Court of Human Rights
(ECHR) in Fadeyeva vs. Russia, [2005] ECHR 376: (2007)
45 EHRR 10 (“Fadeyeva”) is apposite in this regard. The
case concerned an application filed by a Russian citizen who
averred that the operation of a steel plant in close proximity
to her home endangered her health and well-being and
thereby violated Article 8 of the ECHR. Article 8 guarantees
the right to respect private and family life. The ECHR
considered Article 42 of the Constitution of the Russian
Federation which states, “Everyone has the right to a
favourable environment, to reliable information about its
state, and to compensation for damage caused to his health
or property by ecological offences.” The ECHR acknowledged
that given the information asymmetry between the claimant
of a rights violation and the State, it would be impossible to
apply the rule of affirmanti, non neganti, incumbit probation
(the burden of proof is upon him who affirms – not on him
who denies) rigorously. It was held that the very strong
combination of indirect evidence and presumptions makes it
possible to conclude that the applicant’s health deteriorated
as a result of her prolonged exposure to the industrial
Writ Petition (Civil) No.115 of 2004 Etc. Page 224 of 260
emissions from the Severstal steel plant. Even assuming that
the pollution did not cause any quantifiable harm to her
health, it inevitably made the applicant therein more
vulnerable to various illnesses. Moreover, there can be no
doubt that it adversely affected her quality of life at home.
Therefore, the ECHR accepted that the actual detriment to
the applicant’s health and well-being reached a level
sufficient to bring it within the scope of Article 8 of the
Convention and cast a positive duty on the State to take
reasonable and appropriate measures. Having held so, it was
concluded that the State had failed to design or apply
effective measures to protect the local population from
pollution.
(iii) Therefore, the application of a rigorous reasoning process
that emphasizes potential consequences, as manifested in
the final report of the TEC, is expedient when there exists a
fundamental asymmetry between the probability and
consequences of the activity, such as the environmental
release of GMOs. The failure to conduct chronic and
transgenerational studies to study the impact on human
health is a significant omission within the risk assessment
process in the instant case. As noted hereinabove,
conducting the said studies was a critical facet of the TEC’s
recommendations and the same was fortified by the PSC
Report, 2017. In my view, this asymmetry between probable
benefits and adverse consequences cannot be adequately
Writ Petition (Civil) No.115 of 2004 Etc. Page 225 of 260
counter-balanced by economic or policy safeguards because
of the serious and irreversible public and environmental
health effects if such consequences occur. In this regard, the
reasoning of this Court in T.N. Godavarman Thirumulpad
(104) vs. Union of India, (2008) 2 SCC 222 (“T.N.
Godavarman”) fortifies my view. It was reasoned therein
that while mining was a revenue generating industry, the
constitutional requirement of sustainable development could
not be lost sight of. It was held that courts are required to
balance development needs with the protection of the
environment and ecology. It is the duty of the State under
our Constitution to devise and implement a coherent and
coordinated programme to meet its obligation of sustainable
development based on inter-generational equity.
(iv) Such asymmetry becomes especially acute in light of the long
acknowledged disparity between polluters and those
adversely affected by pollution. A reference to this Court’s
judgment in Municipal Corporation of Greater Mumbai
vs. Ankita Sinha, (2022) 13 SCC 401 (“Ankita Sinha”)
would be relevant as it recognized the asymmetrical
relationship between the polluters and those affected by
their actions in the following words:
“78. When substantive justice is elusive for a large
segment, disengaging with substantive rights at the
very altar, for a perceived procedural lacuna, would
surely bring in a process, which furthers inequality,
both economic and social. An “equal footing”
Writ Petition (Civil) No.115 of 2004 Etc. Page 226 of 260
conception may not therefore be feasible to
adequately address the asymmetrical relationship
between the polluters and those affected by their
actions. Instead, a recognition of the historical
experience of marginalised classes of persons while
accessing and effectively using the legal system, will
allow for necessary appreciation of social realities
and balancing the arm of justice.”
43.2 Nothing explains this asymmetry better than the subsisting
grievance of the petitioners about the failure to make the
biosafety dossier, i.e., the primary data on which the AFES report
is based, accessible to affected parties, i.e., the farmers, the farm
workers, the consumers, other experts in the field and the
citizenry at large, thereby, seriously undermining the right to
environmental information. This is more so because such denial
of access to environmental information is in contravention of the
order of this Court dated 08.04.2008 and subsequent order
dated 12.08.2008. The order dated 08.04.2008 records that in
the absence of toxicity and allergenicity data, the members of the
public and the scientists would not be able to make effective
representations to the concerned authorities. It was on the
solemn assurance of the then ASG – that the said primary data
pertaining to field trials will be placed in the public domain and
on the website of GEAC – that this Court had disposed of the
applications made by the petitioner. There has been absolute
non-adherence of the said assurance. I also note that the Reply
Affidavit filed by the Union of India had specifically stated that
the full dossier could not be made available on the website and
Writ Petition (Civil) No.115 of 2004 Etc. Page 227 of 260
that an independent review of such a dossier by members of the
public would undermine the credibility of the extant regulatory
regime.
43.3 I observe that the right to environmental information comes
within the scope of the right to information, which came to be
articulated by this court in State of Uttar Pradesh vs. Raj
Narain, (1975) 4 SCC 428, para 74 (“Raj Narain”), as the
public’s right to know every public act that is done by public
functionaries subject, of course, to absolute secrecy to be
maintained in certain circumstances. It is also a critical aspect
of the right to freedom of speech and expression, vide Chief
Information Commissioner vs. State of Manipur, (2011) 15
SCC 1 (“Chief Information Commissioner”). Disclosure of
information is the rule in our system of open governance, and
secrecy is an exception vide S. P. Gupta vs. Union of India,
(1981) Supp SCC 87 (para 67) (“S. P. Gupta”). Transparency
is critical to preserve the integrity of the decision-making
process. Public scrutiny would be crucial to evaluate the putative
separation of interests and influence between scientific research
and regulatory policy formulation.
43.4 The access to environmental information facilitates
‘meaningful engagement’ and rights-conscious decision-making.
The engagement with stakeholders through the participative
process inspires confidence in the decision-making process and
Writ Petition (Civil) No.115 of 2004 Etc. Page 228 of 260
leads to more sound outcomes which are less vulnerable to legal
challenge.
43.5 The presence of sufficient safeguards such as transparency,
accountability and public participation wherever permissible
within the decision-making process is critical to ensure that
regulatory decisions are not made on partial and uncontested
scientific evidence. In this context, I take note of the dicta in
Harvester Co. vs. Ruckelshaus, 478 F.2d 615, 652 (D.C. Cir.
1973) (“Harvester Co.”), wherein the US Court of Appeal, DC
Circuit held that prior to adjudicating difficult technological
questions, the judiciary ought to be assured that such questions
are first “resolved in the crucible of debate through the clash of
informed but opposing scientific and technological viewpoints.”
But the approach of GEAC has been quite contrary to the
approach explained above. The record shows that on
22.09.2016, various scholars and public activists endorsed an
email addressed to the Hon’ble Minister of Environment, Forest
and Climate Change raising serious objections to the conduct of
the appraisal process, particularly the refusal to disclose the
biosafety dossier to the general public. They urged the MoEF&CC
to extend the consultation process by another 120 days. In
addition to the email, on 24.09.2016, scholars, experts, and
eminent citizens sent a letter to the Hon’ble Minister of
Environment, Forest and Climate Change, expressing grave
concerns regarding GEAC’s refusal to disclose the biosafety data
Writ Petition (Civil) No.115 of 2004 Etc. Page 229 of 260
to the general public, hindering a meaningful exercise of public
consultation. These objections initially weighed with GEAC to
defer environmental release of DMH-11 in the years 2019-2021.
But in the year 2022, things moved with an undue haste and
speed and thereby GEAC ignored all precautionary measures
suggested by TEC as well as by the sub-committee constituted
by it and simply leaf frogged into the impugned decision dated
18.10.2022. This, I find, has adverse legal and environmental
consequences.
The other critical right is that of public participation in
environmental decision-making.
- Moving further, learned Attorney General submitted that
pursuant to the TEC Report submitted to this Court, several
guidelines and a legal framework were put in place. In this
regard, I have perused the specific guidance documents issued
in the year 2016, said to be in accordance with the CPB, to
further strengthen the risk assessment procedure.
The same are discussed as under:
i. Risk Analysis Framework, 2016 provides a step-by-step
consultation process for seeking views from stakeholders:
a) Information about submission of applications is
communicated through the minutes of the meetings.
b) A RARM plan for each application is prepared by the
regulatory agencies and is uploaded on the official
website for receiving comments for a period of 30 days.
Writ Petition (Civil) No.115 of 2004 Etc. Page 230 of 260
c) Regulatory agencies give recommendations after duly
considering the responses.
ii. Guidelines for Environmental Risk Assessment (ERA) for
Genetically Engineered Plants, 2016:
a) The guidelines require that a risk assessment be
performed prior to the commercial release of a GE plant
in India.
b) The purpose of the risk assessment is to identify risks to
the health and safety of people and the environment
from the cultivation of the GE plant, when compared
with the cultivation of the non-GE version of the plant.
c) Information requirements include characteristics of
genetic modification, cultivation practices and post-
release environmental monitoring.
iii. Regulations and Guidelines for Recombinant DNA Research
and Biocontainment, 2017 seek to ensure appropriate
containment strategy ensuring safety to laboratory workers
as well as others and the environment from hazardous
micro-organisms, GE organisms or cells.
iv. Guidelines and SOPs for the Conduct of Confined Field
Trials: Confined Field Trials are monitored by RCGM/GEAC-
appointed Central Compliance Committees which are site-
specific and comprise subject experts.
44.1 Given their import to the issue at hand, I limit my analysis
to the Risk Analysis Framework, 2016 and the Guidelines for
Writ Petition (Civil) No.115 of 2004 Etc. Page 231 of 260
Environmental Risk Assessment (ERA) for Genetically
Engineered (GE) Plants, 2016. While one of the stated purposes
of the Risk Analysis Framework includes provision of
transparency on the use of risk analysis to support decision-
making, the continued reluctance to publish the biosafety
dossier and respond to concerns about long-term effects by
provisioning requisite chronic and transgenerational toxicity
studies shows that it is inadequate. The modalities of
communicating the RARM plan must be inclusive and
transparent. The failure to publish the biosafety dossier on the
website reveals a deficiency in the Guidelines for Environmental
Risk Assessment (ERA) for Genetically Engineered (GE) Plants,
- Furthermore, the failure to furnish cogent reasons for
giving a go by to field demonstration studies to study the impact
on honeybees also reveals the lack of safeguards against misuse
of discretion. With respect to post-release monitoring, I note that
the MoEF&CC issued an office order on 10.11.2022 to constitute
an Expert Committee of four members for Post Release
Monitoring Committee (PRMC). The terms of reference are to visit
the growing sites of DMH-11 at least once during each season.
However, the term of its functioning is limited to a period of four
years from the date of issue.
44.2 Given the fact that the unanticipated consequences of the
environmental release of DMH-11 remain in the sphere of
uncertainty, I am impelled to construe the failure to undertake
Writ Petition (Civil) No.115 of 2004 Etc. Page 232 of 260
necessary measures in light of the TEC and the PSC
recommendations and the non-compliance with directions of this
Court as a violation of the right to a safe and healthy
environment. The violation is particularly serious in light of the
benchmarks of environmental regulation prescribed by this
Court in T.N. Godavarman.
44.3 The failure to adequately assess health and environmental
impact of GM crops seriously infringes upon intergenerational
equity as it potentially endangers the ability of future citizens
to enjoy the highest attainable standard of health. This Court
in State of Himachal Pradesh vs. Ganesh Wood Products
(1995) 6 SCC 363 (“Ganesh Wood Products”) had invoked
intergenerational equity while taking cognizance of the ‘totally
faulty and a myopic approach’ of the State towards forest
management and regulation. This Court held that mechanically
granting approvals for manufacturing ‘katha’ by felling khair
trees was ‘contrary to public interest involved in preserving forest
wealth, maintenance of environment and ecology and
considerations of sustainable growth and inter-generational
equity.’ This Court reasoned that ‘the present generation has no
right to deplete all the existing forests and leave nothing for the
next and future generations’ and therefore, the approvals were
vitiated. This Court also emphasized that the obligation of
sustainable development mandates proper assessment and
Writ Petition (Civil) No.115 of 2004 Etc. Page 233 of 260
monitoring so that forest industries function in a balanced
manner.
44.4 The State’s obligation to ensure intergenerational equity
was also invoked while directing the preparation of appropriate
management plans for regulating the use of fragile
coastlines vide Indian Council for Enviro-legal Action vs.
Union of India (1996) 5 SCC 281.
44.5 In view of the aforesaid discussion, I am of the view that the
decision to grant approval for environmental release of
transgenic mustard hybrid DMH-11 violates the right to safe and
healthy environment under Article 21 of the Constitution of India
because the safeguards which were necessary to be taken prior
to the grant of the approval have not been taken in the instant
case.
Consequently, directions have been issued in the
succeeding paragraphs.
Re: Point No.3: Whether GEAC’s grant of approval dated
18.10.2022 and the decision dated 25.10.2022 for the
environmental release of DMH-11 violate the precautionary
principle?
Precautionary Principle:
- As discussed earlier, the precautionary principle is one of
the doctrinal foundations of Indian environmental law. The
principle is an instance of distillation of ecological wisdom. Given
the fact that genetic engineering has made what was
inconceivable a reality, precaution is the need of the hour. For
Writ Petition (Civil) No.115 of 2004 Etc. Page 234 of 260
billions of years, each living organism would exchange DNA with
others of its kind. Genetic engineering transcends this natural
principle by combining genes sourced from widely different
species and transferring genes between organisms that had no
natural possibility of interbreeding. Scientific research of such a
novel nature must therefore happen under supervision and in a
manner that inspires public confidence.
45.1 It is said that the regulatory regime should recognize
sufficiently the limits of scientific knowledge, and adopt a wider
system-based interdisciplinary analysis. A diversity of expert
opinions ranging from the disciplines of biotechnology,
environmental law, ethics, sociology, agriculture, and
sustainable economics should engage in open and public
dialogue. Such an open dialogue is necessary in order to mitigate
the possibility of regulatory agencies and applicants exaggerating
the benefits of a proposed technology or diluting the rigours of
environmental safety or health standards.
- Having regard to the conclusions of the TEC, I find that the
apprehensions of the petitioners that HT crops would exert a
highly adverse impact over time on sustainable agriculture, rural
livelihoods, and the environment are not unfounded. It is
reasonable to infer that there is a potential of loss of species of
indigenous mustard crop, as India is the centre of origin and
diversity, which fact cannot be doubted. The concerns about the
impact on other beneficial organisms, such as honeybees,
Writ Petition (Civil) No.115 of 2004 Etc. Page 235 of 260
earthworms etc. are also well-founded and serious. As per the
precautionary principle, those activities which may disturb
nature shall be proceeded only upon ex-ante assessment of their
consequences. Such a sound risk and impact assessment is also
a binding obligation under Article 14(1)(b) of the CBD and Article
26 of the CPB. Therefore, GEAC is duty bound, both under
domestic and international law, to sanction long-term chronic
and intergenerational studies, as recommended by the TEC. The
reluctance to conduct such studies would risk the health of
future generations as well as the farmers’ right to conduct their
agricultural activities in the most suitable manner. In this
regard, it would be pertinent to quote the paragraph 28 of the
301st Report of PSC as under:
“28. The Committee notes that the currently, twenty
years after their introduction in 1996, only 6 countries
continue to account for over 90% of all GM crop area
globally (USA 40%, Brazil 23%, Argentina 14%, India
6%, Canada 6%, China 2%). The Committee was
informed by the members of civil society during the
deliberation on the subject that there was a decline in
GM crop area in 2015. The Committee notes with
surprise that inspite of the fact that GM technology is
being propagated as the most advanced agricultural
technology, 17 of the 20 most developed countries (HDI)
do not grow it which includes most of Europe, Japan,
Russia, Israel etc. The Committee opines that there is
increasing evidence about the lack of safety of GM crops
and little or no benefits to justify the risks, most
countries in the world do not grow GM crops. The
Committee also feels that the policy makers of these
countries, as custodians for both present and future
generations, have seen that GM organisms spread
Writ Petition (Civil) No.115 of 2004 Etc. Page 236 of 260
rapidly, that the impacts have been unpredictable,
potentially hazardous, uncontrollable and irreversible,
assessed the benefits and risks, taken note of emerging
evidence of harm, and therefore do not permit GM crops.
The non acceptance of the most advanced agricultural
technology, GM technology, by the most developed
countries raises doubts about the efficacy of the
technology. The Committee, therefore, feels that the
Government of India should conduct a comparative
study to examine the reasons for not accepting this
technology by these developed countries viz-a-viz the
reasons led to its acceptance.”
(underlining by me)
- There are considerable concerns that the HT GM technology
depends on huge chemical spraying. In this regard, learned
counsel Dr. Ravindra Chingale brought to my notice the three
unstarred questions raised before the Rajya Sabha on
15.03.2021, 22.03.2021 and 08.12.2022 (the latest being after
the decision taken by GEAC and the MoEF&CC for
environmental release of transgenic mustard DMH-11 hybrid).
Law courts under Section 57(4) of the Indian Evidence Act, 1872,
can take judicial notice of the course of proceedings of the
Parliament. The answering of parliamentary questions is a part
of the conduct of business of the Parliament. Therefore, no
question about its admissibility under Section 74, the Indian
Evidence Act, 1872 would arise.
For ease of reference, the said questions and answers are
extracted as under:
Writ Petition (Civil) No.115 of 2004 Etc. Page 237 of 260
“GOVERNMENT OF INDIA
MINISTRY OF ENVIRONMENT, FOREST AND
CLIMATE CHANGE
RAJYA SABHA
UNSTARRED QUESTION No.2118
TO BE ANSWERED ON 15.03.2021
Commercial cultivation of GM crops and foods
made from GM ingredients
2118. SHRI KANAKAMEDALA RAVINDRA KUMAR:
Will the Minister of ENVIRONMENT, FOREST AND CLIMATE
CHANGE be pleased to state:
(a) Whether it is a fact that Government has approved
commercial cultivation of Genetically Modified (GM)
crops and also manufacturing, import and selling of
processed foods made from GM ingredients;
(b) If so, the details thereof;
(c) Whether Government has undertaken any study
regarding impact of GM crops cultivation on
environment and impact of GM foods on health of
individuals in the country;
(d) If so, the details thereof; and
(e) If not, the reasons therefore?
ANSWER
MINISTER OF STATE IN THE MINISTRY OF
ENVIRONMENT, FOREST AND CLIMATE CHANGE
(SHRI BABUL SUPRIYO)
(a) and (b) Bt cotton is the only genetically modified (GM)
crop that has been approved for commercial
cultivation. Further, at present matters related
to processed GM foods is being dealt under
Section 22 of the Food Safety and Standards Act
(2006), which has not yet been operationalised.
(c) to (e) Long term studies conducted by Indian Council
of Agricultural Research (ICAR) on the impact of
Writ Petition (Civil) No.115 of 2004 Etc. Page 238 of 260
Bt cotton cultivation found no adverse effect on
soil, microflora and animal health. Food Safety
and Standards Authority of India (FSSAI) has
not undertaken any study on impact of GM
foods on health of individuals in the country.
***
GOVERNMENT OF INDIA
MINISTRY OF ENVIRONMENT, FOREST AND
CLIMATE CHANGE
RAJYA SABHA
UNSTARRED QUESTION No.2931
TO BE ANSWERED ON 22.03.2021
Genetically Modified seeds
2931. SHRI PRASANNA ACHARYA:
Will the Minister of ENVIRONMENT, FOREST AND CLIMATE
CHANGE be pleased to state:
(a) whether Government has assessed the outcome of the
Genetically Modified (GM) seeds so far its impact on
production, cost of production, environment and public
health is concerned;
(b) the other items that the Genetic Engineering Appraisal
Committee has recommended for commercial use of GM
seeds; and
(c) whether Government taken any final decision in this
regard, if so, by when it will be implemented, if not, the
reasons therefor?
ANSWER
MINISTER OF STATE IN THE MINISTRY OF
ENVIRONMENT, FOREST AND CLIMATE CHANGE
(SHRI BABUL SUPRIYO)
(a) to (c) Bt cotton is the only genetically modified (GM)
crop that has been approved for commercial
cultivation in India.Writ Petition (Civil) No.115 of 2004 Etc. Page 239 of 260
As per the information received from Ministry of
Agriculture and Farmers Welfare, around 90% of
the cotton area is under the cultivation of Bt
cotton and the productivity has increased from
191 Kg per hectare in 2002-03 to 455.00 Kg per
hectare in 2019-20. Per hectare income of the
farmer has also increased. There has also been
a reduction in the usage of insecticide for
bollworm damage from 24 sprays to 2-3 sprays
in a season.
Long term studies conducted by Indian Council
of Agricultural Research (ICAR) on the impact of
Bt cotton cultivating states has not reported any
adverse effect on soil, microflora and animal
health.
***
GOVERNMENT OF INDIA
MINISTRY OF ENVIRONMENT, FOREST AND CLIMATE
CHANGE
RAJYA SABHA
UNSTARRED QUESTION No.222
TO BE ANSWERED ON 18.12.2022
Conferment of herbicide tolerance to genetically
modified mustard
222. SHRI ANEEL PRASAD HEGDE:
Will the Minister of ENVIRONMENT, FOREST AND CLIMATE
CHANGE be pleased to state:
(a) whether the bar gene in parental lines and hybrid
offspring of Delhi University’s GM mustard confers
herbicide tolerance to genetically modified mustard
plants, even as it is useful as a marker gene;
(b) whether India has put into place regulatory protocols to
specifically test for the safety of HT GM crops as opposed
to any other GM crop, and whether the parental lines of
DMH-11 and DMH-11 itself have been tested for this
Writ Petition (Civil) No.115 of 2004 Etc. Page 240 of 260
herbicide tolerance trait, even if only for seed production
purposes; and
(c) if not, the reason thereof?
ANSWER
MINISTER OF STATE IN THE MINISTRY OF
ENVIRONMENT, FOREST AND CLIMATE CHANGE
(SHRI ASHWINI KUMAR CHOUBEY)
(a) to (c) The bar gene in Mustard hybrid DMH-11 is
expressed which encodes phosphinothricin N-
acetyl transferase enzyme that confers
resistant to herbicide glufosinate ammonium.
Genetically Modified (GM) Hybrid Mustard
DMH-11 has not been approved for Herbicide
Tolerant (HT) trait but for a GM technology for
hybrid seed production. The HT
characteristic/trait present in the GM
Mustard hybrid seed is essential for
eliminating fertile plants that are not
transgenic in the hybrid seed production plots
to maintain the purity of hybrid seed. The use
of herbicide will be limited to seed production
stage by the seed producing
company/institute and not during the
commercial cultivation of DMH-11 by the
farmers. The use of herbicide will be after
obtaining label claim and approval from
Central Insecticide Board and Registration
Committee (CIB&RC).
The biosafety research trials including
environmental safety studies have been
conducted for transgenic mustard hybrid
DMH-11 containing barnase, barstar and bar
genes, events bn 3.6 (Barnase line) and modbs
2.99 (Barstarline).Writ Petition (Civil) No.115 of 2004 Etc. Page 241 of 260
The issue of environmental release of GM
Mustard is under adjudication in the Writ
Petition (Civil) 115/2004 and Writ Petition
(Civil) 260 of 2005 titled as Gene Campaign
vs. UoI & Ors. and Aruna Rodrigues vs. UoI &
Ors., respectively before the Hon’ble Supreme
Court of India.
(underlining by us)
47.1 It is needless to observe that taking note of the said
questions and answers so as to appreciate the stance of the
Government at the particular point of time would be in line with
the constitutional scheme in general and the Rules of Procedure
and Conduct of Business in the Council of States (Rajya Sabha)
(‘Rajya Sabha Rules’).
47.2 On a reading of the above, it is clear that the stand of the
MoEF&CC before the Parliament has been as follows:
(i) that processed GM foods is dealt with under Section 22 of
the FSSA, 2006, which had not yet been operationalised.
This was as on 15.03.2021, but thereafter on 02.11.2021,
the Central Government has appointed the said date as the
date on which clause (2) of Explanation of Section 2 of the
FSSA, 2006 shall come into force. The said clause deals with
GM or engineered organisms obtained through modern
biotechnology.
(ii) More critically, it is also admitted by the MoEF&CC that the
FSSAI has not undertaken any study on impact of GM foods
on the health of individuals in the country.
Writ Petition (Civil) No.115 of 2004 Etc. Page 242 of 260
(iii) Subsequently, on 22.03.2021, it has been stated that Bt
cotton is the only GM crop that has been approved for
commercial cultivation in India.
(iv) Thereafter, on 08.12.2022 a specific question, namely,
whether the bar gene in parental lines and hybrid offspring
of Delhi University’s transgenic mustard hybrid DMH-
11confers HT to transgenic mustard hybrid DMH-11 plants,
even as it is useful as a marker gene was asked. The answer
given was that the bar gene in mustard hybrid DMH-11 is
expressed which encodes enzyme that confers resistance to
herbicide glufosinate ammonium.
(v) But it is stated in the same answer that Genetically Modified
(GM) hybrid mustard DMH-11 has not been approved for
herbicide tolerant (HT) trait but for a GM technology for
hybrid seed production. The HT characteristic/trait present
in the transgenic mustard hybrid DMH-11 seed is essential
for eliminating fertile plants that are not transgenic in hybrid
seed production plots to maintain the purity of hybrid seeds.
It was also stated that the use of herbicide will be limited at
the time of seed production stage and not during the
commercial cultivation of DMH-11 by the farmers. Such use
of herbicide, it was stated, will be after obtaining label claim
approval from the Central Insecticide Board and Registration
Committee (CIB&RC). The Minister noted that the biosafety
research trials including environmental safety studies had
been conducted for transgenic mustard hybrid DMH-11
Writ Petition (Civil) No.115 of 2004 Etc. Page 243 of 260
containing barnase, barstar and bar genes, events bn 3.6
(Barnase line) and modbs 2.99 (Barstarline).
(vi) Further, he noted that the issue of environmental release of
transgenic mustard hybrid DMH-11 is under adjudication in
the present cases.
47.3 Having given my anxious consideration to the report of the
TEC and the PSCs, I am convinced that the ability to conduct
robust risk assessment hinges upon the availability of
indigenous and independent studies and research. It follows that
conclusions about safety assessment and ecological impact
cannot be transplanted from research conducted in a foreign
context. Crucially, the recommendation of Expert Committee
constituted by GEAC in the year 2022 after Prof. Pental’s letter
to the Hon’ble Minister of Environment, which is the basis of
GEAC’s impugned approval, is entirely premised upon foreign
studies and research and not on indigenous research or studies.
This, I find, is a serious omission, on the part of GEAC in not
applying its mind to research studies to be conducted within the
country as India has a unique biodiversity and a socio-economic
structure of society which is directly related to land holdings and
conduct of agricultural operations.
47.4 It is also noted that Dr. Sanjay Kumar Mishra, Scientist ‘H’,
DBT, New Delhi, who is one of the members of GEAC (Co-
Chairman), was made Chairman of the Expert Committee
constituted by GEAC in the 146th meeting which was held
Writ Petition (Civil) No.115 of 2004 Etc. Page 244 of 260
pursuant to the letter written by Prof. Deepak Pental on behalf
of the CGMCP, University of Delhi (South Campus) to the Hon’ble
Minister of Environment. The crucial portions of the
recommendations have been extracted above.
On a reading of the same, it is evident that the Expert
Committee has made its recommendations on the opinion of the
DBT and the DARE which are bodies within the Ministries of the
Government. They are not independent scientific bodies.
Therefore, the Expert Committee could not have relied upon the
opinion of the DBT and the DARE. Also, based on the
examination of scientific evidences available globally, and as per
the recommendations of concerned Ministries, it was observed
by the Expert Committee that it was unlikely that the bar,
barnase, and barstar system would pose an adverse impact on
honeybees and other pollinators. What is the pertinent scientific
evidence available globally or in other countries and how the said
evidence was co-related to all the concerned issues of
contemporary relevance under Indian scenario, has not been
explained. That the Expert Committee has been swayed by the
opinion of the DBT and the DARE is opponent. DBT opined that,
“it seems likely that there were no major deviations in the
behaviour of honeybees when compared among the transgenic
and non-transgenic comparator lines. GEAC may consider its
recommendations of the 133rd meeting on the environmental
release of GE mustard.” The aforesaid opinion is contrary to what
was expressed by the sub-committee constituted by the GEAC
Writ Petition (Civil) No.115 of 2004 Etc. Page 245 of 260
when the matter was being considered prior to the 133rd meeting.
DARE opined that, “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 honey as
decided in its 136th meeting and the recommendation of the 133rd
meeting of GEAC may be considered.” There is no reason
expressed as to why GEAC should exempt additional studies on
the impact of transgenic mustard hybrid DMH-11 on honeybees
and honey as decided in 136th meeting. In other words, the
Expert Committee has recommended what exactly was required
by the applicant i.e. to give effect to the recommendations of the
133rd meeting of GEAC.
47.5 In fact, the constitution of Expert Committee in the year
2022 itself is an eye-wash, inasmuch as the Ministry of
Environment required the report of the so-called Expert
Committee in order to approve the application given by CGMCP,
University of Delhi (South Campus), which is contrary to the
stand of GEAC in its earlier meetings. The report of this Expert
Committee therefore was tailor-made and “suitable” in order that
GEAC could accord approval to the application submitted by
CGMCP. As already observed, the Expert Committee relied upon
scientific evidence available globally and not based upon the
agro-ecological realities in India. Therefore, not much credence
can be given to the recognition of this Expert Committee which
Writ Petition (Civil) No.115 of 2004 Etc. Page 246 of 260
was the basis of the decision/recommendation dated 18.10.2022
made to MoEF&CC.
47.6 Next, I have perused the conditions imposed by GEAC while
according approval to CGMCP, University of Delhi (South
Campus), the applicant. It is apparent that the precautionary
principle has been seriously undermined in Condition VI and VII
that have been prescribed by GEAC for the impugned release.
Although Condition VII prohibits farmers from using any
formulation of herbicide in the fields, it is unclear how such a
prohibition would be enforced. Given the nature of the DMH-11
which according to the petitioners has HT characteristics, the
impact upon non-target organisms and beneficial organisms
could be seriously detrimental to agrarian ecology. The proposed
conditions for approval are neither adequate nor feasible to limit
these consequences. I observe that GEAC has failed to take into
consideration the precautionary principles while approving the
environmental release of the transgenic mustard DMH-11
hybrid.
- Wisdom lies in precaution. As the upholder and protector
of constitutional wisdom and values, this Court has no option
but to hold that the decision-making process for the grant of
approval for the environmental release of DMH-11 has violated
the precautionary principle. Reiterating Vellore Citizens and
A.P. Pollution Control Board, this Court in RFSTE, noted that
the position of the precautionary principle is well-entrenched in
Writ Petition (Civil) No.115 of 2004 Etc. Page 247 of 260
our jurisprudence and would govern the law of the land in light
of Articles 47, 48A and 51A(g) of the Constitution. Thereafter, in
T. N. Godavarman Thirumulpad vs. Union of India, (2006) 1
SCC 1, this Court applied the precautionary principle while
directing that all precautionary measures must be taken when
forest lands are diverted for non-forest use.
48.1 Karnataka Industrial Areas Development Board vs. C.
Kenchappa, (2006) 6 SCC 371 (“C. Kenchappa”) is another
case where this Court applied the precautionary principle to
emphasize on the requirement of carrying on an impact
assessment and obtaining necessary environmental clearance
before execution of an industrial activity. It was directed that, in
future, before acquisition of lands for development, the
consequence and adverse impact of development on the
environment must be properly comprehended and the lands be
acquired for development so that they do not gravely impair the
ecology and environment.
48.2 The precautionary principle was pressed into service in
Democratic Youth Federation of India vs. Union of India
(2011) 15 SCC 530 (“Democratic Youth Foundation of India”)
to ban the use of the endosulfan pesticide until a court-appointed
committee conducted a risk assessment of the same. It was also
applied in Hospitality Association of Mudumalai vs. In
Defence of Environment & Animals, (2020) 10 SCC 589
Writ Petition (Civil) No.115 of 2004 Etc. Page 248 of 260
(“Hospitality Association of Mudumalai”) where it was held
that:
“39. … The precautionary principle makes it mandatory
for the State Government to anticipate, prevent and
attack the causes of environmental degradation. In this
light, we have no hesitation in holding that in order to
protect the elephant population in the Sigur Plateau
region, it was necessary and appropriate for the State
Government to limit commercial activity in the areas
falling within the elephant corridor.”
48.3 Furthermore as noted above, this Court gave an expansive
scope to the application of the precautionary principle beyond
adjudicatory orders to any decision, administrative or
commercial ought to be made by the Government or private
parties in anticipation of serious environmental harm. In
Pragnesh Shah vs. Dr. Arun Kumar Sharma, (2022) 11 SCC
493 (“Pragnesh Shah”), it was explained that the precautionary
principle requires the State to act in advance
to prevent environmental harm from taking place, rather than
by adopting measures once the harm has taken place. In
deciding when to adopt such action, the State cannot hide
behind the veil of scientific uncertainty in calculating the exact
scientific harm by observing as under:
“36. The precautionary principle envisages that the
State cannot refuse to act to preserve the environment
simply because all the scientific data may not be
available. If there is some data to suggest that
environmental degradation is possible, the State must
step into action to prevent it from taking place. Indeed,
it was this thought that compelled this Court in T.N.
Writ Petition (Civil) No.115 of 2004 Etc. Page 249 of 260
Godavarman [T.N. Godavarman Thirumulpad v. Union of
India Writ Petition No. 202 of 1995] to direct the State to
identify ESZs across India, so that steps can be taken to
identify areas where there is a greater possibility of
environmental degradation and a plan is put in place
to prevent such degradation before it actually makes the
harm irreversible.”
48.4 Relying upon H.P. Bus-Stand, this Court held that
actualising the framework of environmental rule of law requires
that the courts cannot be stupefied into inaction due to scientific
uncertainty but must take decisions to protect the environment
based on whatever information is available.
48.5 Recently this Court in M.K. Ranjitsinh while considering
protection of the Great Indian Bustard and the Lesser Florican
both kinds of birds which are on the verge of extinction, observed
as under:
“35. India faces a number of pressing near-term
challenges that directly impact the right to a healthy
environment, particularly for vulnerable and indigenous
communities including forest dwellers. The lack of
reliable electricity supply for many citizens not only
hinders economic development but also
disproportionately affects communities, including
women and low-income households, further
perpetuating inequalities. Therefore, the right to a
healthy environment encapsulates the principle that
every individual has the entitlement to live in an
environment that is clean, safe, and conducive to their
well-being. By recognizing the right to a healthy
environment and the right to be free from the adverse
effects of climate change, states are compelled to
prioritize environmental protection and sustainable
development, thereby addressing the root causes of
Writ Petition (Civil) No.115 of 2004 Etc. Page 250 of 260
climate change and safeguarding the wellbeing of
present and future generations. It is imperative for states
like India, to uphold their obligations under
international law, including their responsibilities to
mitigate greenhouse gas emissions, adapt to climate
impacts, and protect the fundamental rights of all
individuals to live in a healthy and sustainable
environment.”
48.6 In this context, I would also like to refer to the relevant
Articles of the Cartagena Protocol on Biosafety to the Convention
on Biological Diversity which specifically deals with living
modified organisms to mean any living organism that possesses
a novel combination of genetic material obtained through the use
of modern biotechnology (Article 3g) as well as Articles 15 and 16
of the said Protocol which deal with risk assessment and risk
management respectively. It is necessary to refer to the said
Articles as India is a signatory to the said Protocol and
Convention.
I may further refer to the Convention on BiologicalDiversity and particularly, on Article 8(g) which states that each
contracting party shall, as far as possible and as appropriate
establish or maintain means to regulate, manage or control the
risks associated with the use of release of living modified
organisms resulting from biotechnology which are likely to have
adverse environmental impacts that could affect the
conservation and sustainable use of biological diversity, taking
also into account the risks to human health.
Writ Petition (Civil) No.115 of 2004 Etc. Page 251 of 260
48.7 It is too late in the day to even entertain the proposition that
the protection of our natural environment and ecology is not a
constitutional imperative. The evolution of the right to a safe and
healthy environment and the concomitant duty of the State to
uphold public trust and abide by inter-generational equity and
the precautionary principle in environmental regulation is the
bedrock of environmental constitutionalism. The environmental
rights regime is a product of decades of environmental litigation
by civil society, social movements, affected communities and the
general citizenry. In that sense, environmental constitutionalism
is a facet of transformative constitutionalism touching upon the
socio-economic lives of citizens. In other words, the affected
communities must have a substantive role in environmental
governance.
48.8 While this court in T.N. Godavarman has crystallised the
role of environmental regulators and the Executive arm of the
State since it mandates adequate technical capacity and
effectiveness so as to attain optimal environmental performance,
a weak regulatory regime can render environmental rights
illusory. At the same time, technical capacity and effective
regulation cannot be realised without democratic engagement,
dialogue and deliberation. The aspiration of transformative
environmental governance cannot be realised merely through an
effective bureaucracy and sound technical expertise.
Environmental democracy and environmental rights are two
Writ Petition (Civil) No.115 of 2004 Etc. Page 252 of 260
sides of the same coin. In this regard, the facts of this case shed
light on the salience of the legislative role in preserving
environmental democracy.
48.9 Environmental decision-making in a rapidly changing
climate requires healthy contestation of alternative worldviews,
interests and rights. Only through such contestation can a fine
and sustainable balance between development and the
environment be arrived at. The Department-related
Parliamentary Standing Committees and other legislative
committees discharge important functions. In the context of the
environment, these committees are mandated to scrutinise
public issues from multiple perspectives, appreciate available
evidence, consult experts and the members of the affected
communities and thereafter render a principled and considered
report. Open and transparent deliberation on expert knowledge
increases accountability and acts as a safeguard against conflict
of interest but not a closed door decision making process.
48.10 Consequently, I hold that the approval dated
18.10.2022 and consequent decision dated 25.10.2022 for
environmental release of transgenic mustard hybrid DMH-11
violate the precautionary principle inasmuch as there has been
no determination made, as to, whether, transgenic mustard
hybrid DMH-11 is a HT crop and if so, the nature of risk that
would be caused by the said plant to the environment including
other plants as well as to human beings and animals. The
Writ Petition (Civil) No.115 of 2004 Etc. Page 253 of 260
deliberations have not focussed inter alia, on the aspects of
biosafety, risk assessment, soil health, micro-biology and socio-
economic aspects etc. Moreover, the recommendations of the
TEC and Parliamentary Standing Committees’ Reports on
Agriculture and on Science and Technology, Environment and
Forest have not been considered. Consequently, directions have
been issued in the succeeding paragraphs.
Conclusion:
- In view of the aforesaid discussion and findings, I conclude
as under:
(i) the recommendations of GEAC dated 18.10.2022 as well as
the decision taken by the respondent Union of India on
25.10.2022 with regard to approving environmental release
of transgenic mustard hybrid DMH-11 on the application
made by the applicant, namely, CGMCP, University of Delhi
(South Campus’) are vitiated and hence, they are liable to be
quashed and are quashed.
(ii) I further observe that the recommendation of the Expert
Committee constituted by the GEAC in the year 2022 is of
no consequence and not binding.
- Consequently, I issue the following directions:
(a) With regard to approving environmental release of transgenic
mustard hybrid in future on the application made by the
applicant, namely, CGMCP, University of Delhi (South
Campus) or by any other applicant:
Writ Petition (Civil) No.115 of 2004 Etc. Page 254 of 260
(i) there shall be a decision taken by GEAC, in the first
instance, on whether, transgenic mustard hybrid
DMH-11 is a HT crop or not, by having a wide and
meaningful consultation on the report of TEC
submitted to this Court with all stakeholders,
including experts in the field of agriculture,
biotechnology, health experts and other
scientists/experts preferably within a period of four
months from today. A report on this aspect must
be submitted by GEAC to MoEF&CC.
(ii) MoEF&CC must publish an official report, with
adequate publicity to the said report, on whether
the GE mustard hybrid DMH-11 is indeed a HT
crop or not, preferably within a period of one month
from the date of receipt from GEAC.
(iii) for the aforesaid purposes, GEAC is directed to
upload the applicant’s biosafety dossier comprising
3285 pages on its website after prior intimation to
the applicant CGMCP, University of Delhi (South
Campus) within a period of two weeks from today.
This is with a view to bring in transparency in the
matter.
(iv) The aforesaid biosafety dossier shall remain on the
website of GEAC for a minimum period of 30 days
from the date it is uploaded so as to enable the
stakeholders to respond to the said dossier. On
Writ Petition (Civil) No.115 of 2004 Etc. Page 255 of 260
receipt of such response, if any, GEAC shall collate
the said responses, and take the same into
consideration for its future course of action.
(v) In the event, GEAC and MoEF&CC conclude that
transgenic mustard hybrid DMH-11 is a HT crop,
then the nature of risk that would be caused by the
said plant to the environment including other
plants as well as to human beings and animals
must be researched and deliberated upon. The
deliberations must take into consideration different
aspects, such as biosafety, risk assessment, soil
health, micro-biology and socio-economic aspects
etc.
(vi) After taking a decision on the nature and
characteristic of transgenic mustard hybrid DMH-
11, the respondent shall take a policy decision in
the matter afresh on environmental release of
transgenic mustard hybrid DMH-11 on receipt of
the report from GEAC in future bearing in mind
health and environmental aspects of transgenic
mustard hybrid DMH-11.
(vii) In the above context, the respondent-Union of India
shall also comply with the recommendations made
by Technical Expert Committee (TEC) on
Agriculture, Science and Technology, discussed
above to the extent they are not contrary to the
Writ Petition (Civil) No.115 of 2004 Etc. Page 256 of 260
aforesaid directions and if not already complied
with.
(viii) The respondent-Union of India shall also comply
with the recommendations made by the
Parliamentary Standing Committees (PSCs) on
Agriculture and on Science and Technology,
Environment and Forest, to the extent they are not
contrary to the aforesaid directions if not already
complied with.
(ix) With regard to import of GM edible oil such as
mustard or canola being made, the requirements of
Section 23 of FSSA, 2006 in the matter of
packaging and labelling shall be complied with by
the respondent-Union of India as early as
practicable.
I also issue certain general directions in relation to GM cropsas under:
(b) The respondent-Union of India is directed to evolve
a National Policy with regard to GM crops in the
realm of research, cultivation, trade and commerce
in the country. The said National Policy shall be
formulated in consultation with all stakeholders,
such as, experts in the field of agriculture,
biotechnology, State Governments, representatives
Writ Petition (Civil) No.115 of 2004 Etc. Page 257 of 260
of the farmers, etc. The National Policy to be
formulated shall be given due publicity.
(c) For the aforesaid purpose, the MoEF&CC shall
conduct a national consultation, preferably within
the next four months, with the aim of formulating
the National Policy on GM crops. The State
Governments shall be involved in evolving the
National Policy on GM crops.
(d) That the composition of GEAC shall be suitably
reformed bearing in mind the recommendations of
the TEC and the PSC Reports and the dictum of
this Court in the case of T.N. Godavarman
discussed above. The reformed composition shall
comprise of experts in the field of agriculture,
biotechnology, ethics, sociology, health as well as
experts in the field of environment and shall be an
independent and autonomous body. This could be
done either by a statute or amendments being
brought to the existing Rules as thought fit by the
respondent-Union.
(e) Respondent – Union of India must ensure that all
credentials and past records of any expert who
participates in the decision-making process should
be scrupulously verified and conflict of interest, if
any, should be declared and suitably mitigated by
ensuring representation to wide range of interests.
Writ Petition (Civil) No.115 of 2004 Etc. Page 258 of 260
Rules in this regard may be formulated having
statutory force.
(f) The specific guidance documents referred to above
in paragraph No.42 that have been adopted in
conformity with the Cartagena Protocol on
Biosafety (CPB) shall be complied with in letter and
spirit insofar as they are applicable to the Indian
context. These guidance documents shall be
accorded statutory status by framing and issuing
appropriate Rules under Section 25 of the EP Act,
1986.
(g) In the matter of importing of GM food and more
particularly GM edible oil, the respondent shall
comply with the requirements of Section 23 of
FSSA, 2006, which deals with packaging and
labelling of foods.
The aforesaid directions have been issued by me bearing in
mind, Articles 14 and 21 of the Fundamental Rights; Article 48A
of the Directive Principles of State Policy of the Constitution as
well as the statutory framework applicable to the controversy
under consideration.
- The writ petitions are disposed of in the aforesaid terms and
the civil appeal does not survive for any further consideration
and hence stands disposed of.
Writ Petition (Civil) No.115 of 2004 Etc. Page 259 of 260
The contempt proceedings are dropped without expressing
any opinion on the merits of those petitions.
..………..………….………J.
(B.V. NAGARATHNA)New Delhi;
July 23, 2024.
Writ Petition (Civil) No.115 of 2004 Etc. Page 260 of 260
REPORTABLE
IN THE SUPREME COURT OF INDIA
EXTRAORDINARY CIVIL ORIGINAL JURISDICTION
WRIT PETITION (C) NO. 115/2004GENE CAMPAIGN & ANR. …PETITIONER(S)
VERSUSUNION OF INDIA & ORS. …RESPONDENT(S)
WITH
WRIT PETITION (C) NO. 260/2005
WRIT PETITION (C) NO. 840/2016CONTEMPT PETITION (C) NO. 295/2007 IN WRIT PETITION (C)
NO. 260/2005CONTEMPT PETITION (C) NO. 6/2016 IN WRIT PETITION (C)
NO. 260/2005
CIVIL APPEAL NO. 4086/2006
JUDGMENTSANJAY KAROL J.
Table of Contents Preface ……………………………………………………………………….. 3 Procedural History ………………………………………………………. 10 Statutory Framework …………………………………………………… 17 Issues for Consideration ……………………………………………….. 27 Conditional Approval of the GEAC ………………………………….. 28 Judicial Review of the Impugned Decision …………………………… 32 Constitutionality of the 1989 Rules …………………………………….. 51 Precautionary Principle ………………………………………………… 72 TEC ………………………………………………………………………………. 72 Parliamentary Standing Committee Reports …………………………. 91 Scope of Precautionary Principle ………………………………………. 106 Additional Guidelines……………………………………………………… 113 Conclusions & Directions ……………………………………………. 140 2 | W.P. (C) 115 of 2004 & Ors.
1. I have perused the erudite opinion of my sister, Hon’ble Mrs. Justice B.V. Nagarathna. However, I am unable to agree with the findings, conclusions so drawn and certain directions given, therefore I deem it appropriate to pen down my independent opinion and issue directions.
Preface
- The present lis concerns 6 petitions: 3 Writ Petitions (W.P. (C) No. 115 of 2004; W.P. (C) No. 260 of 2005 and W.P. (C) No. 840 of 2016), 2 Contempt Petitions (Contempt Petition (C) No. 295 of 2007 and Contempt Petition No.6 of 2016) and 1 Civil Appeal (Civil Appeal No. 4086 of 2006).
- In the batch of Writ Petitions, under Article 32 of the Constitution of India, the lead matter was filed in 2004 (W.P. (C) No.115 of 2004) praying for issuance of the Writ of Mandamus to the Respondents directing them to:
i. Bring the Rules for Manufacture, Use, Import, Export and Storage of Hazardous Micro-organisms, Genetically Engineered Organisms or Cells, 1989, in consonance with Articles 14, 19, 21, 38, 47, 48, 48A read with 51-A(g) of the 3 | W.P. (C) 115 of 2004 & Ors.
Constitution of India and in alternative, declaration of the above rules as unconstitutional.
ii. Set-up a High Power Committee to formulate a National Policy on genetically engineered organisms through a multi- stakeholder consultation process.
iii. Observe a moratorium on various trials/approvals concerning genetically engineered organisms, particularly 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.
- Writ Petition (C) No.260 of 2005 came to be filed seeking the following directions to the Union of India:
i. To not allow any release of GMO’s 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.
4 | W.P. (C) 115 of 2004 & Ors.
(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.
ii. 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.
iii. To put in place rules to ensure that it shall be compulsory for any dealer or grower selling GMOs to label them as such.
- Writ Petition (C) No.840 of 2016 was filed seeking a Writ of Mandamus or direction to the effect of:
i. Quashing the Notice dated 05.09.2016 issued by Union of India inviting comments from stakeholders and general public within 30 days as being violative of Article 14 and Article 21 of the Constitution of India.
ii. The process adopted by GEAC as arbitrary and violative of Article 14 and Article 21 of the Constitution of India.
5 | W.P. (C) 115 of 2004 & Ors.
iii. Union of India to frame appropriate procedural guidelines for appraisal of application seeking environmental release under Rules for Manufacture, Use, Import, Export and Storage of Hazardous Micro-organisms, Genetically Engineered Organisms or Cells, 1989.
- Contempt Petition (C) No.295 of 2007 was filed alleging contempt of orders of this Court dated 22.09.2006, 08.05.2007 and 01.08.2007. Contempt Petition (C) No.06 of 2016 was filed alleging contempt of orders of this Court dated 15.02.2007, 08.05.2007, 08.04.2008 and 12.08.2008. These orders come to be discussed in the foregoing paragraphs.
- Civil Appeal No.4086 of 2006 came to be filed against order of the Appellate Authority dated 08.10.2003, dismissing the appeal filed by the Appellant in Appeal No.2 of 2002, whereby the approval granted to Bt Cotton dated 05.04.2002 was assailed.
- This Court is often presented with situations where two competent interests call upon it to undertake a balancing act which is akin to threading a needle or, in other words, undertake 6 | W.P. (C) 115 of 2004 & Ors. a task of considerable difficulty. This case is one such task. On the one hand, is a group of concerned, informed individuals and organisations apprehensive about the potential impacts of new technology on the environment, agriculture, health and other socio-economic parameters; and on the other, is the government/competent authority batting for a cautious but optimistic approach furthering scientific and agricultural development, underscoring its importance in line with growing concerns of food security, population, economics and other matters of national interest.
- The former argues the dangers of unpredictability, unknowability of the effect of human intervention in seed production and otherwise pushes for the adoption of a precautionary approach while the latter insists on a stand which is not governed by fear of the unknown and the importance of backing scientific advancement and adventures, exploring its positive aspects and their integration into human society. This Court now hangs in the balance, upon being asked to adjudicate these prima facie well 7 | W.P. (C) 115 of 2004 & Ors. founded concerns and interests which are ostensibly at variance with one another.
- Throughout this judgment, certain terms will form the mainstay of the discussion, and adequate understanding of which, is imperative for arriving at a just conclusion. At the core, the question revolves around genetically modified organisms, their regulation and release into the environment. For ease of understanding, some of those terms are defined at the outset. 10.1 Genetically Modified Organisms (hereinafter referred to as ‘GMOs’) have been defined by the World Health Organisation (WHO) as follows:
“Genetically modified organisms (GMOs) can be defined as organisms (i.e. plants, animals or microorganisms) in which the genetic material (DNA) has been altered in a way that does not occur naturally by mating and/or natural recombination. The technology is often called “modern biotechnology” or “gene technology”, sometimes also “recombinant DNA technology” or “genetic engineering”. It allows selected individual genes to be transferred from one organism into another, also between nonrelated species.” 10.2 GMOs, for our purposes, have two types- Bt (Bacillus thuringiensis) [a preparation of a bacterium (Bacillus 8 | W.P. (C) 115 of 2004 & Ors.
Thuringiensis) often modified by genetic engineering for use as a biopesticide against insects and especially lepidopteran larvae1], and Ht (Herbicide Tolerant). [Herbicide-tolerant crops can be produced by either insertion of a “foreign” gene from another organism into a crop, or by regenerating herbicide-tolerant mutants from existing crop germplasm.2] 10.3 Genetic Engineering Approval3 Committee (hereinafter referred to as ‘GEAC’) is a committee constituted under The Manufacture, Use, Import, Export And Storage Of Hazardous Micro Organisms Genetically Engineered Organisms Or Cells Rules, 1989 (hereinafter referred to as ‘1989 Rules’) which are in turn framed under the Environment Protection Act, 1986 (hereinafter referred to as EPA, 1986) responsible for approval of proposals relating to release of genetically engineered organisms 1 Merriam Webster dictionary https://www.merriam-webster.com/dictionary/Bt 2 https://extensionpubs.unl.edu/publication/g1484/html/view#target2 3 The name of GEAC, Genetic Engineering Approval Committee, stands substituted by Genetic Engineering Appraisal Committee vide Gazette Notification dated 22.7.2010.
9 | W.P. (C) 115 of 2004 & Ors.
and products into the environment including experiment Field trials.
10.4 Review Committee on Genetic Manipulation (hereinafter referred to as ‘RCGM’) is a committee under 1989 Rules tasked with monitoring the safety related aspects in respect of on-going research projects and activities involving genetically engineered organisms/hazardous microorganisms.
Procedural History
- This Court has been actively engaged since 2004, with regard to the trial of GMOs, which is the subject matter at hand. Over the intervening years, this Court has issued a slew of orders and accordingly, in the subsequent paragraphs, I have traced the brief history of them.
11.1 On 29.03.2004, notice was issued in the matter.
Thereafter, on 01.05.2006, this Court directed that the field trials of GMOs shall be conducted only with the express approval of the GEAC. On 22.09.2006, it was 10 | W.P. (C) 115 of 2004 & Ors.
directed that the GEAC will withhold approvals until further orders of this Court and it was suggested to the Union of India, that they should consider associating independent experts in the GEAC.
11.2 On 13.10.2006, this Court granted permission to plant the newly developed DMH-11 (Mustard) for experimental purpose in specifically identified fields. Thereafter, on 15.12.2006, the attention of this Court was drawn to Clause (23) of the Convention on Biological Diversity, which recommended that there is inadequate basis to assess the potential risks of genetic use technologies due to which the use of products involving this technology or field testing should not be approved till there is appropriate scientific data, in accordance with the precautionary principle. Taking note of this, the Court directed the GEAC to consider the impact of field testing being carried out.
11.3 On 15.02.2007, this Court recorded the submission of the Union of India that within 6 weeks, it would bring on 11 | W.P. (C) 115 of 2004 & Ors.
record the implications and the biological results of the field tests being conducted.
11.4 Thereafter, on 08.05.2007, the Union of India sought modification of the order dated 22.09.2006 whereby further approvals by GEAC were halted. This Court allowed the GEAC to consider applications for use of Bt Cotton varieties for commercial use, subject to the usual conditions imposed provided that the GEAC verifies the creation of any toxicity with the use of varieties of Bt Cotton. It further directed the GEAC:
a. To take sufficient precautions to see that the trials are not causing any contamination to the cultivation of neighbouring fields.
b. Distance of at least 200 meters to be maintained from the neighbouring fields having the same type of cultivations.
c. Names of scientists and other details of the person responsible for all aspects of the trial should be recorded with the GEAC.
12 | W.P. (C) 115 of 2004 & Ors.
11.5 On 01.08.2007, this Court recorded the submission of the learned Additional Solicitor General, that allergenicity and toxicity tests have been conducted on Bt Cotton and the information would be put on the website of the GEAC. 11.6 On 08.04.2008, the Petitioners sought modification of order dated 08.05.2007, to the effect that the distance between fields must depend on the nature of the crop. Further, the Petitioners contended that the validated protocol for field testing should be 0.01%. This Court directed the GEAC to examine both these issues and recorded the submission of the learned Additional Solicitor General that the data qua Bt brinjal and Bt cotton has been put on the website of the GEAC. 11.7 On 12.08.2008, the Petitioners raised objection to non-
compliance of Order dated 08.04.2008, thereafter, this Court directed the Union of India to file proof regarding compliance of the said order.
13 | W.P. (C) 115 of 2004 & Ors.
11.8 Pertinently, vide Order dated 10.05.2012, this Court appointed a Technical Expert Committee (hereinafter “TEC”) to look into various issues raised in the pleadings before the Court and submit a report within 3 months. The members of this Committee were: 1. Prof. VL Chopra;
- Dr. Imran Siddiqui; 3. Dr. PS Ramakrishna; 4. Prof. PC Chauhan; 5. Prof. PC Kesavan and 6. Dr. B Siva Kumar. Vide this Order, the Court also granted TEC the liberty to file an interim report, in case the final report is not prepared within the abovementioned time period. The terms of reference and the report of the TEC will be discussed in detail in the discussion which follows. 11.9 The interim report of the TEC was received by this Court on 07.10.2012. Vide order dated 09.11.2012, the Union of India was directed to file its objections to the interim report, with the TEC itself for consideration. Furthermore, in place of Prof. VL Chopra, Dr. Rajendra Singh Paroda was appointed as a member of the Committee. On 14 | W.P. (C) 115 of 2004 & Ors. 23.08.2013, this Court acknowledged receipt of the final report of the TEC.
11.10 Thereafter, on 07.10.2016, the Union of India submitted that no release of GMOs will be made till 17.10.2016 since the Government has sought views from the public and on receipt of such views, they will be considered by a committee of experts. On 22.11.2017, when this matter was taken up for consideration, the Union of India apprised the Court that it had not taken a final decision, on the issue of plantation of GM Mustard and that all stakeholders shall be considered before taking a final decision.
11.11 Coming to the present timeline, on 18.10.2022 the GEAC granted conditional approval for conducting trials of DMH-11/GM Mustard. The same was communicated to the applicants on 25.10.2022. In terms of the above developments, the Petitioners have handed over updated prayers in Court seeking:
15 | W.P. (C) 115 of 2004 & Ors.
i. Complete ban on Ht Crops. The decision of GEAC to approve release of DMH-11 is violative of Article 14 and Article 21 of the Constitution of India being vitiated by non-application of mind.
ii. The overall process of risk assessment must be in conformity with the Cartagena Protocol on Biosafety. iii. Stakeholder participation, socioeconomic considerations, societal impact and sustainability should be incorporated in the risk assessment process at an early stage.
iv. Studies must be conducted by the Regulatory Body itself and the regulator must not depend solely on the data provided by the applicant itself.
v. The Biosafety Dossier containing results of these studies must be published on the website of the GEAC. vi. Confined Field Trials should be only in isolated conditions to prevent any contamination in ICAR institutes/State Agricultural Universities. vii. No Genetically Modified Crops should be permitted where India is the centre of origin or diversity.
16 | W.P. (C) 115 of 2004 & Ors.
viii. There should be chronic toxicity testing in terms of long-
term exposure before declaring those crops safe. ix. State of the art bio-regulatory systems must be set up in collaboration with countries having the necessary expertise in socio-economic risk assessment. Statutory Framework
- At the outset, it is imperative to discuss the statutory framework relating to GMOs. The Seeds Act enacted by the Legislature in 1966, notified on 29.12.1966, regulates the quality of seeds for sale and other connected matters. S.3 of this Act, created the Central Seed Committee to advise the Government on matters relating to the said Act. S.4 mandates creation of the Central Seed Laboratory and State Seed Laboratory. S.7 regulates the sale of certain varieties of seeds, which have been so notified.
- The Insecticides Act, 1968 was enacted to regulate the use of insecticides with a view to prevent risk to human beings or animals. S.4 of this Act, constitutes the Central Insecticides Board to “advise the Central Government and State Government 17 | W.P. (C) 115 of 2004 & Ors. on technical matters arising out of the administration of this Act.” S.5 constitutes a Registration Committee, to “register insecticides after scrutinising their formulae and verifying claims made by the importer or the manufacturer, as the case may be, as regards their efficacy and safety to human beings and animals.”
- The EPA, 1986 was enacted with a view to improve the environment and its protection mechanisms. i. Under the definition Clause, S.2, certain terms require reference:
“(a) “environment” includes water, air and land and the inter- relationship which exists among and between water, air and land, and human beings, other living creatures, plants, micro-organism and property;
(b) “environmental pollutant” means any solid, liquid or gaseous substance present in such concentration as may be, or tend to be, injurious to environment;
(c) “environmental pollution” means the presence in the environment of any environmental pollutant;
x x x
(e) “hazardous substance” means any substance or preparation which, by reason of its chemical or physico-chemical properties or handling, is liable to cause harm to human beings, other living creatures, plant, micro-organism, property or the environment;
(f) “occupier”, in relation to any factory or premises, means a person who has, control over the affairs of 18 | W.P. (C) 115 of 2004 & Ors.
the factory or the premises and includes in relation to any substance, the person in possession of the substance;” ii. S.3 of the Act empowers the Central Government to undertake wide-ranging measures for the protection and improvement of the environment. S.3(2) lays down the matters wherein such measures are to be exercised. Some pertinent areas are:
“…..
(vi) laying down procedures and safeguards for the prevention of accidents which may cause environmental pollution and remedial measures for such accidents;
(vii) laying down procedures and safeguards for the handling of hazardous substances;
(viii) examination of such manufacturing processes, materials and substances as are likely to cause environmental pollution;
(x) inspection of any premises, plant, equipment, machinery, manufacturing or other processes, materials or substances and giving, by order, of such directions to such authorities, officers or persons as it may consider necessary to take steps for the prevention, control and abatement of environmental pollution;
(xi) establishment or recognition of environmental laboratories and institutes to carry out the functions entrusted to such environmental laboratories and institutes under this Act;” 19 | W.P. (C) 115 of 2004 & Ors.
iii. S.5 empowers the Central Government to issue directions to any person for the purposes of the Act, and such person will be bound to comply with such directions.
iv. S.6 further provides the Central Government with the power to make rules for the matters enumerated in S.3. Particularly, the following have been expressly laid down in S.6(2), amongst others:
“…
(b) the maximum allowable limits of concentration of various environmental pollutants (including noise) for different areas;
(c) the procedures and safeguards for the handling of hazardous substances;
(d) the prohibition and restrictions on the handling of hazardous substances in different areas;” v. S.7 prohibits the discharge of environmental pollutants in excess of the standards as may be prescribed under S.3. S.8 provides that those persons handling hazardous substances shall not do so except in accordance with the procedure and safeguards prescribed in respect thereto.
20 | W.P. (C) 115 of 2004 & Ors.
vi. S.10 empowers the Central Government or any person empowered under it with the power of entry and inspection at all reasonable times, for the following purposes:
“(a) for the purpose of performing any of the functions of the Central Government entrusted to him;
(b) for the purpose of determining whether and if so in what manner, any such functions are to be performed or whether any provisions of this Act or the rules made thereunder or any notice, order, direction or authorisation served, made, given or granted under this Act is being or has been complied with;
(c) for the purpose of examining and testing any equipment, industrial plant, record, register, document or any other material object or for conducting a search of any building in which he has reason to believe that an offence under this Act or the rules made thereunder has been or is being or is about to be committed and for seizing any such equipment, industrial plant, record, register, document or other material object if he has reason to believe that it may furnish evidence of the commission of an offence punishable under this Act or the rules made thereunder or that such seizure is necessary to prevent or mitigate environmental pollution.” vii. S.11 empowers the Central Government or any person empowered under it with the power to take samples of air, water, soil or other substances and lays down detailed procedure to be followed for this purpose.
21 | W.P. (C) 115 of 2004 & Ors.
viii. S.12 permits the Central Government to establish and recognise laboratories or institutes to carry out functions enumerated for such laboratories which have to be notified in the gazette in accordance with S.12(2). ix. S.25 empowers the Central Government to make rules for carrying out the purposes of the Act. In particular, under S.25(2):
“(a) the standards in excess of which environmental pollutants shall not be discharged or emitted under section 7;
(b) the procedure in accordance with and the safeguards in compliance with which hazardous substances shall be handled or caused to be handled under section 8;
x x x
(e) the form in which notice of intention to have a sample analysed shall be served under clause (a) of sub section (3) of section 11;
(f) the functions of the environmental laboratories, the procedure for the submission to such laboratories of samples of air, water, soil and other substances for analysis or test; the form of laboratory report; the fees payable for such report and other matters to enable such laboratories to carry out their functions under sub-section (2) of section 12;”
- The 1989 Rules were enacted by the Central Government under the EPA, 1986 with a view to protecting the environment, nature
22 | W.P. (C) 115 of 2004 & Ors. and health, in connection with the application of gene-technology and micro-organisms.
i. Rule 2 specifies the application of these rules. Clause 2 specifies that “These shall apply to genetically engineered organisms micro-organisms and cells and correspondingly to any substances and products and food stuffs, etc. of which such cells, organisms or tissues hereof form part.” ii.Rule 3(3) defines Gene Technology as “the application of the gene technique called genetic engineering, include self-cloning and deletion as well as cell hybridisation.” iii.Rule 3(4) defines Genetic Engineering as “the technique by which heritable material, which does not usually occur or will not occur naturally in the organism or cell concerned, generated outside the organism or the cell is inserted into said cell or organism. It shall also mean the formation of new combinations of genetic material by incorporation of a cell into a host cell, where they occur naturally (self-cloning) as well as modification of an organism or in a cell by deletion and removal of parts of the heritable material.” 23 | W.P. (C) 115 of 2004 & Ors.
iv. Rule 4(4) of the aforesaid rules, provide for setting up of the GEAC as a body under the Department of Environment, Forests and Wildlife, for approval of proposals relating to release of genetically engineered organisms and products into the environment, including experimental field trials. These proposals are to be examined from the environmental angle. Other committees therein, the membership of the GEAC and other aspects will come to be discussed in the foregoing paragraphs.
v. Rule 7 prohibits any import, export, manufacture, process or use of genetically engineered organisms except with the approval of the GEAC. It also provides that genetically engineered organisms for the purpose of research are only allowed in areas notified by the Ministry of Environment and Forests for this purpose under the EPA, 1986. vi. Rule 9 empowers the GEAC to grant special approval for deliberate release of genetically engineered organisms. vii. Rule 10 extends the requirement of approval of GEAC to all substances and products that contain genetically engineered organisms.
24 | W.P. (C) 115 of 2004 & Ors.
viii. Rule 13 provides for stipulation of terms and conditions while granting approval including terms and conditions as to the control to be exercised by the applicant, supervision, restriction on use, the layout of the enterprise and as to the submission of information to the State Biosafety Co-ordination Committee (hereinafter referred to as ‘SBCC’) or to the District Level Committee (hereinafter referred to as ‘DLC’). It lays down the time period for GEAC approval (cannot exceed 4 years) and specific criteria wherein the GEAC can revoke approval granted for a genetically engineered organism. Rule 14 gives an authority to GEAC for supervising the implementation of the conditions laid down while granting approval.
ix. Further, Rule 15 provides for penalties imposed for non- compliance of orders. The DLC or SBCC is empowered to take actions against person who is responsible for non-compliance. In situations which require immediate interference, DLC or SBCC could take action even without issuing any order or notice. DLC or SBCC are also empowered to take samples for a more detailed examination of organisms and cells and for 25 | W.P. (C) 115 of 2004 & Ors.
these purposes, these Committees could take assistance from any Government authority.
x. Rule 18 grants the GEAC and other committees, the power to carry out inspections.
xi. Rule 19 allows for appeal from the any decision made by the GEAC or the SBCC to the Appellate Authority (as may be appointed by the Ministry of Environment, Forests and Climate Change (hereinafter referred to as ‘MoEFCC’) within 30 days of such decisions.
- In furtherance of the United Nations Convention on Biological Diversity, which has been ratified by India, The Biological Diversity Act, 2002 came to be introduced into the statute book. The aim and objective of this Act is to provide for conservation of biological diversity and its sustainable use. S.36 of this Act directs the Central Government to take measures for protection of biological diversity, its resources and habitats from environmental degradation and neglect.
- The Food Safety and Standards Act, 2006 is aimed at laying down science based standards for articles of food and to ensure 26 | W.P. (C) 115 of 2004 & Ors. availability of safe and wholesome food for human consumption. S.22 provides that no person shall manufacture, distribute or import any genetically modified articles of food or other articles of food enumerated therein.
Issues for Consideration
- I have heard extensive arguments on both sides, Mr. Sanjay Parikh, Mr. Trideep Pais, learned senior counsel, learned Advocates-on-Record Mr. Prashant Bhushan and Dr. Ravindra Chingale for the Petitioners and, Mr. R. Venkatramani learned Attorney General, Mr. Tushar Mehta learned Solicitor General and Ms. Preeti Kumari for the Respondents. The judgment proposed by my esteemed colleague, Hon’ble Mrs. Justice B.V. Nagarathna, records in detail the submissions advanced by all the learned counsel and so, for the sake of brevity I avoid doing the same. Principally, following issues are to be considered :
a. Whether the conditional approval of DMH-11 by the GEAC is vitiated be it by arbitrariness/delegation/non-
application of mind or any other principle of law?
27 | W.P. (C) 115 of 2004 & Ors.
b. Whether in view of the precautionary principle, a complete ban on Ht Crops is warranted or if not, the suitable directions that are required to be given by this Court? Here, it stands clarified that sub-issues/ancillary aspects to the above questions, have been dealt with as the opinion progresses. Conditional Approval of the GEAC
- The pressing challenge raised by the Petitioners, is the decision of the GEAC to conditionally approve environmental release of transgenic mustard, DMH-11 on varied grounds granted to the applicant namely the Centre for Genetic Manipulation of Crop Plants (CGMCP), University of Delhi, New Delhi. This Centre was set up to undertake research on genetic engineering and molecular breeding of oilseed brassicas4. Before adverting to the challenges made, this Court must note the timeline leading up to the impugned approval.
- On 29.09.2010, in the 103rd GEAC Meeting was where for the first time approval was granted for BRL-I level trials at 3 locations, 4 https://www.du.ac.in/index.php?page=centre-for-genetic-manipulation-of-crop-plants 28 | W.P. (C) 115 of 2004 & Ors. namely, Krishi Vigyan Kendra, Kumher, Bharatpur, Rajasthan; Agricultural Research Station, Navgaon, Alwar, Rajasthan; Agricultural Research Station, Sriganganagar, Rajasthan. The Committee also approved the conduct of crossibility studies and limited seed production within the institutional research farm located at Jaunti village and Bawana, Delhi respectively. Thereafter on 21.09.2011, the GEAC granted further approval to conduct environmental safety studies on DMH-11. In the 121st meeting dated 18.07.2014, BRL-II trials in respect of DMH-11 were approved at different locations subject to submission of NOC from the State Government.
- In the 126th Meeting of the GEAC, on 04.01.2016, a sub- committee was constituted to further deliberate on the issues raised during deliberations of DMH-11. This was followed by the GEAC on 11.05.2017, examining the report of this sub-committee and recommending the proposal for environmental release of DMH-11 with terms and conditions for further approval by Competent Authority. In the next meeting on 21.03.2018, the GEAC re-examined its decision to grant permission for 29 | W.P. (C) 115 of 2004 & Ors. environmental release of DMH-11 and advised the applicant to undertake field demonstration studies on GM Mustard to generate additional data.
- On 20.09.2018 in its 136th meeting GEAC approved the application and the protocols for conduct of field demonstration studies on honeybees and other pollinators prepared by University of Delhi and ICAR-AICRP on honeybees at two locations up to 5 acres in each location namely PAU, Ludhiana and IARI, New Delhi and, for conduct of two field studies to assess hybrid seed efficiency and for maintenance of male sterile barnase line bn 3.6.
- This brings us to the 146th Meeting of GEAC held on 25.08.2022, wherein pursuant to a presentation by the applicant, the GEAC constituted a committee to examine availability of adequate evidence about impact of transgenic mustard on honeybees and other pollinators to assess the need for conducting field demonstration studies.
30 | W.P. (C) 115 of 2004 & Ors.
24. On 18.10.2022, the 147th Meeting of the GEAC was held wherein it considered the report of the Committee and recommended environmental release of DMH-11. Thereafter on 25.10.2022, a letter was issued to the Applicant stating that the environmental release of genetically engineered mustard/DMH-11 has been recommended. The following conditions, amongst others, were imposed on this release:
i. The approval is for 4 years and renewable for two years at a time based on compliance report pursuant to Clause 13 of the 1989 Rules.
ii. A Post-Release Monitoring Committee would be constituted by GEAC consisting of 2 subject matter external experts who will visit the growing sites of the approved biological material.
iii. The Applicant shall provide detailed step by step testing procedures to the GEAC.
iv. Usage of any formulation of herbicide is not permitted for cultivation in farmers’ fields under any situation.
v. Commercial use of DMH-11 hybrid shall be subject to Seeds Act, 1966.
31 | W.P. (C) 115 of 2004 & Ors.
vi. It is mandatory that all seed packets of 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 etc., in English, Hindi and vernacular language(s). Judicial Review of the Impugned Decision
- The challenges raised by the Petitioners to this decision can be summarised as follows:
a. The GEAC could not have delegated its function to a sub-
committee/expert committee, since it is not within the scope of the 1989 Rules.
b. Further, in any case, that the GEAC has not independently applied its mind to the report of its expert committee and has not considered other independent scientific reports.
25 (a) 1. At the outset, I must consider, the scope of judicial review to be exercised in such matters. This Court in the case of N.D. 32 | W.P. (C) 115 of 2004 & Ors.
Jayal v. Union of India (3-Judge Bench)5, which related to the safety of dams, observed that:
“…This Court cannot sit in judgment over the cutting edge of scientific analysis relating to the safety of any project. Experts in science may themselves differ in their opinions while taking decisions on matters related to safety and allied aspects. The opposing viewpoints of the experts will also have to be given due consideration after full application of mind. When the Government or the authorities concerned after due consideration of all viewpoints and full application of mind took a decision, then it is not appropriate for the court to interfere. Such matters must be left to the mature wisdom of the Government or the implementing agency. It is their forte. In such cases, if the situation demands, the courts should take only a detached decision based on the pattern of the well- settled principles of administrative law. If any such decision is based on irrelevant consideration or non- consideration of material or is thoroughly arbitrary, then the court will get in the way. Here the only point to consider is whether the decision-making agency took a well-informed decision or not. If the answer is “yes”, then there is no need to interfere. The consideration in such cases is in the process of decision and not in its merits.” (Emphasis supplied) 25 (a) 2. Furthermore, this Court in the case State of NCT of Delhi v. Sanjeev (2-Judge Bench)6 elaborated on when judicial 5 (2004) 9 SCC 362 6 (2005) 5 SCC 181 33 | W.P. (C) 115 of 2004 & Ors.
review should be exercised vis-à-vis decisions of the Government. It was observed:
“16. If the power has been exercised on a non- consideration or non-application of mind to relevant factors, the exercise of power will be regarded as manifestly erroneous. If a power (whether legislative or administrative) is exercised on the basis of facts which do not exist and which are patently erroneous, such exercise of power will stand vitiated. (See CIT v. Mahindra and Mahindra Ltd. [(1983) 4 SCC 392 :
1983 SCC (Tax) 336 : AIR 1984 SC 1182]
- The court will be slow to interfere in such matters relating to administrative functions unless decision is tainted by any vulnerability enumerated above; like illegality, irrationality and procedural impropriety. Whether action falls within any of the categories has to be established. Mere assertion in that regard would not be sufficient.
x x x x - In other words, to characterise a decision of the administrator as “irrational” the court has to hold, on material, that it is a decision “so outrageous” as to be in total defiance of logic or moral standards.
Adoption of “proportionality” into administrative law was left for the future. - These principles have been noted in the aforesaid terms in Union of India v. G. Ganayutham [(1997) 7 SCC 463 : 1997 SCC (L&S) 1806]. In essence, the test is to see whether there is any infirmity in the decision-making process and not in the decision itself. (See Indian Rly. Construction Co. Ltd. v. Ajay Kumar [(2003) 4 SCC 579 : 2003 SCC (L&S) 528].” (Emphasis supplied) 25 (a) 3. The scope of this judicial review of administrative action was also discussed by this Court in Jagdish Mandal v. State 34 | W.P. (C) 115 of 2004 & Ors. of Orissa (2 – Judge Bench)7. In this case, the Court held that the purpose of judicial review is to check whether the decision has been made lawfully and not as to whether such decision is sound or not.
25 (a) 4. This Court in Villianur Iyarkkai Padukappu Maiyam v.
Union of India, (3-Judge Bench)8 observed that:
“167. In the matter of policy decisions and economic tests the scope of judicial review is very limited. Unless the decision is shown to be contrary to any statutory provision or the Constitution, the Court would not interfere with an economic decision taken by the State. The court cannot examine the relative merits of different economic policies and cannot strike down the same merely on ground that another policy would have been fairer and better.
…
- It is neither within the domain of the courts nor the scope of judicial review to embark upon an inquiry as to whether a particular public policy is wise or whether better public policy can be evolved. Nor are the courts inclined to strike down a policy at the behest of a petitioner merely because it has been urged that a different policy would have been fairer or wiser or more scientific or more logical. Wisdom and advisability of economic policy are ordinarily not amenable to judicial review. In matters relating to economic issues the Government has, while taking a decision, right to “trial and error” as long as both trial and error are bona fide and within the limits of the authority. For testing the correctness of a policy, the appropriate forum is Parliament and not the courts.
7 (2007) 14 SCC 517 8 (2009) 7 SCC 561 35 | W.P. (C) 115 of 2004 & Ors.
170. Normally, there is always a presumption that the governmental action is reasonable and in public interest and it is for the party challenging its validity to show that it is wanting in reasonableness or is not informed with public interest. This burden is a heavy one and it has to be discharged to the satisfaction of the court by proper and adequate material. The court cannot lightly assume that the action taken by the Government is unreasonable or against public interest because there are a large number of considerations, which necessarily weigh with the Government in taking an action.” (Emphasis supplied) 25 (a) 5. In Academy of Nutrition Improvement v. Union of India, (2-Judge Bench)9 where the challenge to iodised salt was made and it was reiterated that:
“…. courts should not rush in where even scientists and medical experts are careful to tread. The rule of prudence is that courts will be reluctant to interfere with policy decisions taken by the Government, in matters of public health, after collecting and analysing inputs from surveys and research. Nor will courts attempt to substitute their own views as to what is wise, safe, prudent or proper, in relation to technical issues relating to public health in preference of those formulated by persons said to possess technical expertise and rich experience.” (Emphasis supplied) 9 (2011) 8 SCC 274 36 | W.P. (C) 115 of 2004 & Ors.
25 (a) 6. A similar view was taken in Lafarge Umiam Mining (P) Ltd.
v. Union of India (3-Judge Bench)10, wherein this Court observed:
“119. The time has come for us to apply the constitutional “doctrine of proportionality” to the matters concerning environment as a part of the process of judicial review in contradistinction to merit review. It cannot be gainsaid that utilisation of the environment and its natural resources has to be in a way that is consistent with principles of sustainable development and intergenerational equity, but balancing of these equities may entail policy choices. In the circumstances, barring exceptions, decisions relating to utilisation of natural resources have to be tested on the anvil of the well-recognised principles of judicial review. Have all the relevant factors been taken into account? Have any extraneous factors influenced the decision? Is the decision strictly in accordance with the legislative policy underlying the law (if any) that governs the field? Is the decision consistent with the principles of sustainable development in the sense that has the decision-maker taken into account the said principle and, on the basis of relevant considerations, arrived at a balanced decision? Thus, the Court should review the decision- making process to ensure that the decision of MoEF is fair and fully informed, based on the correct principles, and free from any bias or restraint. Once this is ensured, then the doctrine of “margin of appreciation” in favour of the decision-maker would come into play.” (Emphasis supplied) 10 (2011) 7 SCC 338 37 | W.P. (C) 115 of 2004 & Ors.
25 (a) 7. Recently in Jacob Puliyel v. Union of India and Ors.11 (2-
Judge Bench), while considering the vaccination policy due to COVID-19, this Court reiterated the scope of judicial review with policy decisions of the executive. Arbitrariness, irrationality, perversity and mala fide will render the policy unconstitutional. Relying on Delhi Development Authority v. Joint Action Committee, Allottee of SFS Flats (2-Judge Bench)12, this Court explained that a policy decisions can be subject to judicial review (a) if it is unconstitutional; (b) if it is dehors the provisions of the Act and the regulations; (c) if the delegatee has acted beyond its powers of delegation; (d) if the executive policy is contrary to the statutory or a larger policy. It was further stated:
“22. This Court in a series of decisions has reiterated that courts should not rush in where even scientists and medical experts are careful to tread. The rule of prudence is that courts will be reluctant to interfere with policy decisions taken by the Government, in matters of public health, after collecting and analysing inputs from surveys and research. Nor will courts attempt to substitute their own views as to what is wise, safe, prudent or proper, in relation to technical issues relating to public health in preference to those formulated by persons said to possess technical expertise and rich experience. 11 2022 SCCOnline SC 533 12 (2007) 4 SCC 737 38 | W.P. (C) 115 of 2004 & Ors.
Where expertise of a complex nature is expected of the State in framing rules, the exercise of that power not demonstrated as arbitrary must be presumed to be valid as a reasonable restriction on the fundamental right of the citizen and judicial review must halt at the frontiers. The Court cannot re-weigh and substitute its notion of expedient solution.” 25 (a) 8. A perusal of the above decisions makes clear two important factors. It is evident that judicial review so far as economic or policy matters is concerned is circumscribed but at the same time it is also apparent that the scope of the possibility of the Court’s intervention has been expanded over time. The generally accepted yardstick would be that the merits of a decision are ordinarily not examined to accommodate the possibility of a better alternative nor does it scuttle the government’s ability to achieve the best outcome through trial and error but at the same time if any of the decisions made are such that the vires of the process would be affected or in other words, that the decision taken is compromised in regard to the manner in which it was arrived at, then, the Courts would be within terms to exercise its jurisdiction of judicial review.
39 | W.P. (C) 115 of 2004 & Ors.
25 (a) 9. Keeping in mind the above standard of judicial review, I now proceed to examine the first issue at hand. 25 (a) 10. Adverting to the first contention, the Petitioners have sought to place reliance on the judgment of this Court in Kantha Vibhag Yuva Koli Samaj Parivartan Trust v. State of Gujarat (2-Judge Bench)13, wherein this Court while considering the functions of the NGT observed:
“16. Sections 14 and Section 15 entrust adjudicatory functions to the NGT. The NGT is a specialized body comprising of judicial and expert members. Judicial members bring to bear their experience in adjudicating cases. On the other hand, expert members bring into the decision-making process scientific knowledge on issues concerning the environment. In Hanuman Laxman Aroskar v. Union of India (2019) 15 SCC 401, a two-Judge Bench of this Court noted that the NGT is an expert adjudicatory body on the environment. The Court held:
“133. The NGT Act provides for the constitution of a tribunal consisting both of judicial and expert members. The mix of judicial and technical members envisaged by the statute is for the reason that the Tribunal is called upon to consider questions which involve the application and assessment of science and its interface with the environment…
- NGT is an expert adjudicatory body on the environment.” 13 2022 SCC Online SC 120 40 | W.P. (C) 115 of 2004 & Ors.
17. The NGT does not have a dearth of ‘expertise’ when it comes to the issues of environment. - Section 15 empowers the NGT to award compensation to the victims of pollution and for environmental damage, to provide for restitution of property which has been damaged and for the restitution of the environment. The NGT cannot abdicate its jurisdiction by entrusting these core adjudicatory functions to administrative expert committees. Expert committees may be appointed to assist the NGT in the performance of its task and as an adjunct to its fact-
finding role.” (Emphasis supplied) 25 (a) 11. This decision has come to be followed by this Court in Singrauli Super Thermal Power Station v. Ashwani Kumar Dubey (2-Judge Bench)14.
25 (a) 12. Keeping in view of the above, what this Court must examine is whether in the appointment and acceptance of the recommendation of the expert committee, the GEAC has delegated its core function, in view of the 1989 Rules. 25 (a) 13. Under the 1989 Rules, the GEAC functioning as a body under the Department of Environment, Forests and Wildlife has been made responsible for approval of proposals relating to release of genetically engineered organisms and products 14 (2023) 8 SCC 35 41 | W.P. (C) 115 of 2004 & Ors.
into the environment including experimental field trials.
Therefore, the primary function that has been given to the GEAC, is this process of granting approvals. The composition of this Committee, along with representatives from different departments of the executive, has to include three outside experts in individual capacity.
25 (a) 14. On a perusal of the timeline for conditional approval of DMH-11, the GEAC has constituted a sub-committee and expert committee respectively, in its 126th and 146th meeting, with a specific purpose on each occasion. In my considered view, this cannot be said to be delegating its core function. 25 (a) 15. In Kantha Vibhag Yuva Koli Samaj (supra), which the Petitioners place reliance on, the body involved, i.e., the NGT exercises judicial functions, which is clearly distinct from the GEAC which is responsible for granting approvals for the release of GMOs and not performing any quasi-judicial function. Therefore, it cannot be said that the exposition in the above case, applies squarely to the case at hand.
42 | W.P. (C) 115 of 2004 & Ors.
25 (a) 16. Furthermore, in the said decision, it was explicitly stated in paragraph 22 that “expert committees may be appointed to assist the NGT in the performance of its task and as an adjunct to its fact-finding role”. In my view, this is squarely, the function performed by the sub-committee/expert committee constituted by the GEAC, i.e., assistance in granting approvals.
25 (a) 17. The present factual circumstance is not a case, where the approval process itself has been delegated to the sub- committee/expert committee. A specific purpose was set out for the committee, on which a report was submitted back to the GEAC. Illustratively, the mandate of the expert committee may be referred to, the relevant extract is as under:
“…In accordance with the decision taken in the aforementioned meeting of the GEAC, the Expert Committee has been constituted to examine the claim of CGMCP, University of Delhi in respect of 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 honeybees and other pollinators.” 43 | W.P. (C) 115 of 2004 & Ors.
25 (a) 18. It is evident from the above extract that the expert committee was constituted for a limited purpose and was only a part of the larger decision-making process. On the perusal of said report and other materials, the impugned decision came to be passed.
25 (a) 19. As submitted on behalf of Union of India, a Constitution Bench of this Court in State of U.P. v. Batuk Deo Pati Tripathi (5-Judge Bench)15 expounded that:
“10… The power to do a thing necessarily carries with it the power to regulate the manner in which the thing may be done. It is an incident of the power itself and indeed, without it, the exercise of the power may in practice be fraught with difficulties which will frustrate, rather than further, the object of the power. It is undoubtedly true that the rules framed for prescribing the manner in which a power may be exercised have to be truly regulatory in character.” (Emphasis supplied) 25 (a) 20. This decision was followed in Khargram Panchayat Samiti v. State of West Bengal (2-Judge Bench)16, wherein it was observed:
“5…. It had earlier been laid down by a Constitution Bench in the case of State of U.P. v. Batuk Deo Pati 15 (1978) 2 SCC 102 16 (1987) 3 SCC 82 44 | W.P. (C) 115 of 2004 & Ors.
Tripathi [(1978) 2 SCC 102 : 1978 SCC (L & S) 147] that a power to do a thing necessarily carries with it the power to regulate the manner in which the thing may be done. The High Court failed to appreciate that the power to grant a licence for the holding of a hat or fair under Section 117 of the Act necessarily carries with it the power to specify a day on which such hat or fair shall be held. Such power to specify a day must be held to be a power incidental to or consequential upon the principal power of issuing a licence under Section 117 of the Act for holding of a hat or fair. The Rules or the absence of it do not detract from the substantive power conferred by a statute.” (Emphasis supplied) 25 (a) 21. Applying the above observations of this Court, would mean that the power of the GEAC, to grant approvals, necessarily carries with it the power to regulate the manner, in which the approvals are so granted. The mere absence of a specific statement in the 1989 Rules allowing assistance of expert committees, would not preclude the GEAC from doing so, in furtherance of its main objective. 25 (a) 22. Reference must also be made to the decision of this Court in Inspector General of Registration v. K. Baskaran (2- Judge Bench)17, wherein after consideration of a number of judgments concluded as under:
17 (2020) 14 SCC 345 45 | W.P. (C) 115 of 2004 & Ors.
“14. The following principles can thus be culled out from the decisions of this Court: (i) A statutory functionary exercising a power cannot be said to have delegated his functions merely by deputing a responsible and competent official to enquire and report, as that is the ordinary mode of exercise of any administrative power; (ii) If a statutory authority empowers a delegate to undertake preparatory work, and to take an initial decision in matters entrusted to it, but retains in its own hands the power to approve or disapprove the decision after it has been taken, the decision will be held to have been validly made if the degree of control maintained by the authority is close enough for the decision to be regarded as the authority’s own; (iii) Even in cases of sub-delegation, so long as the essential function of decision-making is performed by the delegate, the burden of performing the ancillary and clerical task need not be shouldered by the primary delegate and it is not necessary that the primary delegate himself should perform the ministerial acts as well; and (iv) Practical necessities or exigencies of administration require that the decision-making authority who has been conferred with statutory power, be able to delegate tasks when the situation so requires.” (Emphasis supplied) 25 (a) 23. Therefore, in view of the above conspectus, the decision of the GEAC cannot be said to be vitiated by delegation. 25 (b) 1. Another challenge that has been laid by the Petitioners to the impugned decision, is non-application of mind. In my considered view, this submission does not stand. 25 (b) 2. The expert committee appointed in the 146th meeting of the GEAC dated 25.08.2022, submitted its report and a reading 46 | W.P. (C) 115 of 2004 & Ors.
of the same would show that a barnase/barstar proteins introduced in GE Mustard are not novel to honeybees and thus they do not discriminate between GE and non GE canola, it further relied on data collected from Canada and Australia. Pursuant to which it recommended the environmental release of GE Mustard. The conditional approval granted vide letter dated 08.10.2022 of the MoEFCC shows that the approval so granted was on the basis of multiple documents and not only the comments of the expert committee, as alleged by the Petitioners. Considering the importance of the issue, the potential magnitude of its (the decision of the GEAC’s) impact, it was found prudent by the decision-making authority to call for the comments of the Department of Biotechnology (received on 01.08.2022) and the Department of Agricultural Research and Education (received on 30.07.2022), which are departments under their respective Ministries. It would be apposite to briefly advert to their mission, roles, responsibilities and mandates.
Department of Biotechnology under the Ministry of Science and Technology:
“Mission 47 | W.P. (C) 115 of 2004 & Ors.
…The Department shall provide services in the areas of research, infrastructure, generation of human resource, popularization of biotechnology, promotion of industries, creation of centers of excellence, implementation of biosafety guidelines for genetically modified organisms and recombinant DNA products and biotechnology-based programs for societal benefits. Bioinformatics is a major mission to establish an information network for the scientific community, nationally and internationally. Mandate … • Promote large scale use of Biotechnology • Support R&D and manufacturing in Biology … • Serve as Nodal Point for specific International Collaborations • Establishment of Infrastructure Facilities to support R&D and production … • Evolve Bio Safety Guidelines, manufacture and application of cell based vaccines • Serve as nodal point for the collection and dissemination of information relating to biotechnology.” (Emphasis supplied) Department of Agricultural Research and Education under the Ministry of Agriculture “About the Departments … DARE provides the necessary government linkages for the Indian Council of Agricultural Research (ICAR), the premier research organisation for co-ordinating, guiding and managing research and education in 48 | W.P. (C) 115 of 2004 & Ors.
agriculture including horticulture, fisheries and animal sciences in the entire country. With over 97 ICAR institutes, 53 agricultural universities, 6 Bureaux, 18 National Research Centres, 25 Project Directorates, and 89 All India Coordinated Research Projects spread across the country this is one of the largest national agricultural research systems in the world.
Mission Interfacing agricultural research and technology, higher education and frontline extension initiatives with institutional, infrastructural and policy support for sustainable growth of agriculture.
Major Functions • To look after all aspects of the agricultural research and Education (including horticulture, natural resources management, agriculture engineering, agricultural extension, animal science, economic statistics and marketing and fisheries) involving coordination between the central and state agencies. • To attend all matters relating to Indian Council of Agricultural Research.
- To attend all matters concerning the development of new technology in agriculture, horticulture, natural resources management, agriculture engineering, agricultural extension, animal science, economic statistics and marketing and fisheries, including such functions as plant and animal introduction and exploration and soil and land use survey and planning.
- International co-operation in the field of agricultural research and education including relations with foreign and international agricultural research and educational institutions and organizations, including participation in international conferences, associations and other bodies dealing with agricultural research and education and follow-up decisions at such international conferences etc. • Fundamental, applied and operational research and higher education including co-ordination of such research and higher education in agriculture including agro forestry, animal husbandry, dairying, 49 | W.P. (C) 115 of 2004 & Ors. fisheries, agricultural statistics, economics and marketing.” (Emphasis Supplied) 25 (b) 3. Taking in consideration all the above aspects, one cannot possibly fault the GEAC in asking for the opinion and understanding of these two departments. Having so received their comments, an expert committee within the GEAC was formed to evaluate the presence/absence of sufficient literature regarding the effect of GM crops on honeybees, exemption from further trial for which, was sought by the applicant. This Committee then, also considered such comments and gave its finding, in conformity with the mandate given to it.
25 (b) 4. Also, it is to be noted that the conditional release of DMH- 11 was made subject to several conditions including, among others, that the MoEFCC/GEAC may impose further conditions as may be necessary. Such conditions include the revocation of approval in case adverse impact is shown on environment or human health; it is made subject to other statutory clearances including the clearance from Food Safety and Standards Authority of India, Seeds Act. Additionally, it imposes certain 50 | W.P. (C) 115 of 2004 & Ors.
obligations on the applicant including obligation to inform regulatory bodies as soon as any adverse impact is shown; obligation to submit annual/seasonal report of the yield etc. to the GEAC.
25 (b) 5. Therefore, the contentions that the primary function of the GEAC has been delegated to the expert committee and that it was granted without application of mind is sufficiently contravened by record. In that view of the matter, the conditional approval of DMH-11 granted by the GEAC, is upheld as being independent, reasoned and in consonance with the rules. Constitutionality of the 1989 Rules
- The Petitioners have also laid challenge to the constitutional validity of the 1989 Rules on the ground that they are violative of Article 14 and Article 21 of the Constitution of India. The primary prong of this attack is that the constitution of the GEAC, in the submission of the Petitioners is lopsided with bureaucratic influence with the same being evidenced by the top three positions therein being occupied by such persons. Before delving into the substance of the challenge, it would be apposite to appreciate 51 | W.P. (C) 115 of 2004 & Ors. certain pronouncements of this Court wherein such challenges were adjudicated.
26.1. In the landmark case of E.P. Royappa v. State of T.N. 18 (5- Judge Bench), this Court while dealing with Article 14 and Article 16 observed that :
“In fact equality and arbitrariness are sworn enemies; one belongs to the rule of law in a republic while the other, to the whim and caprice of an absolute monarch. Where an act is arbitrary, it is implicit in it that it is unequal both according to political logic and constitutional law and is therefore violative of Article 14, and if it effects any matter relating to public employment, it is also violative of Article 16. Articles 14 and 16 strike at arbitrariness in State action and ensure fairness and equality of treatment. They require that State action must be based on valid relevant principles applicable alike to all similarly situate and it must not be guided by any extraneous or irrelevant considerations because that would be denial of equality. Where the operative reason for State action, as distinguished from motive inducing from the antechamber of the mind, is not legitimate and relevant but is extraneous and outside the area of permissible considerations, it would amount to mala fide exercise of power and that is hit by Articles 14 and 16. Mala fide exercise of power and arbitrariness are different lethal radiations emanating from the same vice: in fact the latter comprehends the former. Both are inhibited by Articles 14 and 16.” (Emphasis supplied) 18 (1974) 4 SCC 3 52 | W.P. (C) 115 of 2004 & Ors.
26.2. On similar lines, in State of T. N. & Ors. v. Ananthi Ammal19 (3-Judge Bench) this Court observed:
“7. When a statute is impugned under Article 14 what the court has to decide is whether the statute is so arbitrary or unreasonable that it must be struck down. At best, a statute upon a similar subject which derives its authority from another source can be referred to, if its provisions have been held to be reasonable or have stood the test of time, only for the purpose of indicating what may be said to be reasonable in the context…” (Emphasis supplied) 26.3. Furthermore, in State of A.P. v. McDowell & Co.,20 (3-Judge Bench), this Court observed that the restrictions on the law-
making power of legislatures is similar to those under the Federal Constitution of the United States of America. The two grounds on which a law made by the Parliament or the legislature can be struck down are – (1) lack of legislative competence; and (2) violation of any of the fundamental rights guaranteed in Part III of the Constitution or of any other constitutional provision. There is no third ground. It held:
19 (1995) 1 SCC 519 20 (1996) 3 SCC 709 53 | W.P. (C) 115 of 2004 & Ors.
“43. … The main criticism against the ground of substantive due process being that it seeks to set up the courts as arbiters of the wisdom of the legislature in enacting the particular piece of legislation. It is enough for us to say that by whatever name it is characterised, the ground of invalidation must fall within the four corners of the two grounds mentioned above. In other words, say, if an enactment is challenged as violative of Article 14, it can be struck down only if it is found that it is violative of the equality clause/equal protection clause enshrined therein. Similarly, if an enactment is challenged as violative of any of the fundamental rights guaranteed by sub-clauses (a) to (g) of Article 19(1), it can be struck down only if it is found not saved by any of the clauses (2) to (6) of Article 19 and so on. No enactment can be struck down by just saying that it is arbitrary or unreasonable. Some or other constitutional infirmity has to be found before invalidating an Act. An enactment cannot be struck down on the ground that the court thinks it unjustified. Parliament and the legislatures, composed as they are of the representatives of the people, are supposed to know and be aware of the needs of the people and what is good and bad for them. The court cannot sit in judgment over their wisdom. In this connection, it should be remembered that even in the case of administrative action, the scope of judicial review is limited to three grounds, viz., (i) unreasonableness, which can more appropriately be called irrationality,
(ii) illegality and (iii) procedural impropriety.” (Emphasis supplied) 26.4. In Onkar Lal Bajaj v. Union of India21 (2-Judge Bench), it was held:
“27. Article 14 guarantees to everyone equality before law. Unequals cannot be clubbed. The proposition is well settled and does not require reference to any precedent though many decisions were cited. 21 (2003) 2 SCC 673 54 | W.P. (C) 115 of 2004 & Ors.
Likewise, an arbitrary exercise of executive power deserves to be quashed, is a proposition which again does not require support of any precedent. It is equally well settled that an order passed without application of mind deserves to be annulled being an arbitrary exercise of power. At the same time, we have no difficulty in accepting the proposition urged on behalf of the Government that if two views are possible and the Government takes one of it, it would not be amenable to judicial review on the ground that the other view, according to the court, is a better view.” (Emphasis supplied) 26.5. In 5 M & T Consultants v. S.Y. Nawab (2-Judge Bench)22 this Court reiterated the principle given in Delhi Science Forum v. Union of India (3-Judge Bench)23 wherein it was observed:
“…parting with privilege exclusively vested with the Government must be reasonably rational and in the public interest besides conforming to law governing the same and the decision pertaining to the same can be questioned only on grounds of bad faith, being based on irrational or irrelevant considerations, non- compliance with the prescribed procedure or violation of any constitutional or statutory provision and the onus in respect of establishing the same not only heavily rests on the person alleging it but it is not satisfied by merely raising a doubt in the mind of the Court as to the validity of the decision.” 22 (2003) 8 SCC 100 23 (1996) 2 SCC 405 55 | W.P. (C) 115 of 2004 & Ors.
26.6. In order to declare a legislation violative of Article 14 of the Constitution of India, arbitrariness on the part of the legislature should, ordinarily, be manifest arbitrariness, as has been held by this Court in Bombay Dyeing & Mfg. Co. Ltd.
(3) v. Bombay Environmental Action Group (2-Judge Bench)24.
26.7. Similarly, in A.P. Dairy Development Corpn. Federation v.
B. Narasimha Reddy, (2-Judge Bench)25, this Court held that substantive unreasonableness should be shown in the statute itself in order to declare it ultra vires the Constitution. It has been held that “A party has to satisfy that the action was reasonable, not done in unreasonable manner or capriciously or at pleasure without adequate determining principle, rational, and has been done according to reason or judgment, and certainly does not depend on the will alone. However, the action of the legislature, violative of Article 14 of the Constitution, should ordinarily be manifestly arbitrary.” 26.8. The principle that to declare an Act ultra vires under Article 14, the Court must be satisfied in respect of substantive 24 (2006) 3 SCC 434 25 (2011) 9 SCC 286 56 | W.P. (C) 115 of 2004 & Ors.
unreasonableness in the statute itself stood reiterated by this Court in State of T.N. v. K. Shyam Sunder (3-Judge Bench)26.
26.9. Recently, this Court in Association for Democratic Reforms & Anr v. Union of India & Ors. (5-Judge Bench)27, while relying on Dharam Dutt v. Union of India (2-Judge Bench)28 extensively discussed this principle. It held as follows:
“44. The presumption of constitutionality is based on two premises. First, it is based on democratic accountability, that is, legislators are elected representatives who are aware of the needs of the citizens and are best placed to frame policies to resolve them. Second, legislators are privy to information necessary for policy making which the Courts as an adjudicating authority are not. However, the policy underlying the legislation must not violate the freedoms and rights which are entrenched in Part III of the Constitution and other constitutional provisions. It is for this reason that previous judgments of this Court have held that the presumption of constitutionality is rebutted when a prima facie case of violation of a fundamental right is established. The onus then shifts on the State to prove that the violation of the fundamental right is justified.” (Emphasis supplied) 26 (2011) 8 SCC 737 27 2024 SCCOnline SC 661 28 (2004) 1 SCC 712 57 | W.P. (C) 115 of 2004 & Ors.
26.10. A perusal of the judgments referred to supra shows two primary grounds upon which the validity of a legislation or, in our case Rules made under a legislation, may be put to challenge. One is legislative competence and the second is manifest arbitrariness. The former is not an aspect of challenge. In view of S.6 (rules to regulate environmental pollution), S.8 (persons handling hazardous substances to comply with procedural safeguards) and S.25 (empowers the Central Government for making rules to carry out the purposes of the EPA) of the EPA 1986, 1989 Rules were made to protect the environment, nature and health, in connection with the application of gene-technology and micro-organisms.
26.11. The latter, that is manifest arbitrariness, has been recognized as a ground upon which a legislative enactment can be judicially reviewed. [See: K.S. Puttaswamy v. Union of India (5-Judge Bench)29 and Madras Bar Association v.
Union of India & Anr. (3-Judge Bench)30] Equally, it is to be noticed that in Indian Express Newspaper v. Union of India 29 (2019) 1 SCC 1 30 (2022) 12 SCC 455 58 | W.P. (C) 115 of 2004 & Ors.
(3-Judge Bench)31 it was stated that subordinate legislation can be challenged on any ground available against the plenary legislation. In other words, the distinction between subordinate and plenary legislation is erased when it comes to a challenge under Article 14 of the Constitution of India. 26.12. In Khoday Distilleries Ltd. v. State of Karnataka (3-Judge Bench)32, this Court held :
“13. It is next submitted before us that the amended Rules are arbitrary, unreasonable and cause undue hardship and, therefore, violate Article 14 of the Constitution. Although the protection of Article 19(1)(g) may not be available to the appellants, the Rules must, undoubtedly, satisfy the test of Article 14, which is a guarantee against arbitrary action. However, one must bear in mind that what is being challenged here under Article 14 is not executive action but delegated legislation. The tests of arbitrary action which apply to executive actions do not necessarily apply to delegated legislation. In order that delegated legislation can be struck down, such legislation must be manifestly arbitrary; a law which could not be reasonably expected to emanate from an authority delegated with the law-making power. In Indian Express Newspapers (Bombay) (P) Ltd. v. Union of India [(1985) 1 SCC 641 : 1985 SCC (Tax) 121], this Court said that a piece of subordinate legislation does not carry the same degree of immunity which is enjoyed by a statute passed by a competent legislature. A subordinate legislation may be questioned under Article 14 on the ground that it is unreasonable; ‘unreasonable not in the sense of not being reasonable, but in the sense that it is manifestly 31 (1985) 1 SCC 641 32 (1996) 10 SCC 304 59 | W.P. (C) 115 of 2004 & Ors.
arbitrary’. Drawing a comparison between the law in England and in India, the Court further observed that in England the Judges would say, ‘Parliament never intended the authority to make such Rules; they are unreasonable and ultra vires’. In India, arbitrariness is not a separate ground since it will come within the embargo of Article 14 of the Constitution. But subordinate legislation must be so arbitrary that it could not be said to be in conformity with the statute or that it offends Article 14 of the Constitution.” (Emphasis supplied) 26.13. In Shayara Bano v. Union of India & Ors. (5-Judge Bench)33, RF Nariman J., while dissenting with the majority, observed :
“Manifest arbitrariness, therefore, must be something done by the legislature capriciously, irrationally and/or without adequate determining principle. Also, when something is done which is excessive and disproportionate, such legislation would be manifestly arbitrary.” (Emphasis supplied) 26.14. Neither in the limited pleadings made before this Court nor in the extensive oral arguments advanced was the point of the rules being allegedly manifestly arbitrary, addressed adequately. On an independent analysis, I am unable to find any of the aspects of manifest arbitrariness to have been met, much less on the ground that bureaucratic influence taints the 33 (2017) 9 SCC 1 60 | W.P. (C) 115 of 2004 & Ors.
functioning of the GEAC. This aspect further stands amplified herein, later.
- On a further count, this challenge, in my view fails. The 1989 Rules present a well-rounded mechanism to deal with GMOs and their introduction into fields of common usage. 27.1. Rule 4 of the 1989 Rules provide for the six different competent authorities to oversee the research and regulations in the field of GMOs, whose functions are elaborated herein. i. Recombinant DNA Advisory Committee (RDAC) is responsible to review developments in Biotechnology at national and international levels and recommend safety regulations in recombinant research, use and applications from time to time.
ii. The committee – Review Committee on Genetic Manipulation (RCGM) – is made responsible to monitor the safety related aspect in respect of on-going research projects and activities involving genetically engineered organisms/hazardous microorganisms. It is further tasked with bringing out manuals of guidelines specifying procedure 61 | W.P. (C) 115 of 2004 & Ors.
for regulatory process with respect to activities involving GMOs in research, use and applications including industry with a view to ensure environmental safety. They are responsible to review all ongoing projects involving high risk category and controlled field experiments and to ensure that adequate precautions and containment conditions are followed as per the guidelines.
iii Institutional Biosafety Committee (IBSC) – They are given the responsibility to assist the occupier or any person (including research institutions handling microorganisms/genetically engineered organisms) in preparing an up to date on site emergency plan according to the manuals/guidelines of the RCGM and make available copies to the DLC/SBCC and the GEAC.
iv. Genetic Engineering Approval Committee (GEAC) – This committee is constituted for approval of activities involving large scale use of hazardous microorganisms and recombinants in research and industrial production from the environmental angle. It shall be responsible for approval of proposals relating to release of genetically engineered 62 | W.P. (C) 115 of 2004 & Ors.
organisms and products into the environment including experimental field trials. The committee or any person authorised by it, is empowered to take punitive action under the EPA, 1986.
v. State Biotechnology Co-Ordination Committee (SBCC) – At State level, this Committee has powers to inspect, investigate and take punitive action in case of violations of statutory provisions. It shall also periodically review the safety and control measures in various industries/institutions handling genetically engineered organisms/hazardous microorganisms. vi. District Level Committee (DLC) – At the district level, in order to supervise the safety measures, this Committee is constituted wherever necessary under the District Collectors to monitor the safety regulations in installations engaged in the use of genetically modified organisms/hazardous microorganisms and its applications in the environment. It shall visit the installation engaged in activity involving genetically engineered organisms, hazardous microorganisms, formulate information chart, find out hazards and risks associated with each of these installations and coordinate 63 | W.P. (C) 115 of 2004 & Ors.
activities with a view to meeting any emergency. This Committee shall regularly submit its report to the SBCC/GEAC.
27.2. Rule 7 of the 1989 Rules deals with approval and prohibitions.
It reads thus:
“(1) No person shall import, export, transport, manufacture, process, use or sell any hazardous microorganisms or genetically engineered organisms/substances or cells except with the approval of the Genetic Engineering Approval Committee.
(2) Use of pathogenic microorganism or any genetically engineered organisms or cell for the purpose of research shall only be allowed in laboratories or inside laboratory areas notified by the Ministry of Environment and Forests for this purpose under the Environment (Protection) Act, 1986.
(3) The Genetic Engineering Approval Committee shall give directions to the occupier to determine or take measures concerning the discharge of micro-
organisms/genetically engineered organisms or cells mentioned in the schedule from the laboratories, hospitals and other areas including prohibition of such discharges and laying down measures to be taken to prevent such discharges.
(4) Any person operating or using genetically engineered organism microorganisms mentioned in the schedule for scale up or pilot operations shall have to obtain licence issued by the Genetic Engineering Approval Committee for any such activity. The possessor shall have to apply for licence in prescribed proforma.
64 | W.P. (C) 115 of 2004 & Ors.
(5) Certain experiments for the purpose of education within the field of gene technology or microorganism may be carried out outside the laboratories and laboratory areas mentioned in subrule (2) and will be looked after by the Institutional Biosafety Committee.” (Emphasis supplied) 27.3. Rule 10 states that except with the approval GEAC, no substances and products containing genetically engineered organisms or cells or microorganisms shall be produced, sold, imported or used.
27.4. Rule 12 provides for guidelines wherein person who applies for approval under the Rules 8-11 is obligated to submit information and make examinations or cause examinations to be made to elucidate its case, including examinations according to specific directions and at specific laboratories. Before obtaining the approval, it is his responsibility to make available an on-site emergency plan to the GEAC. Further, an obligation is imposed upon the person to whom an approval has been granted, to notify the GEAC of any change in or addition to the information already submitted.
65 | W.P. (C) 115 of 2004 & Ors.
27.5. Rule 13 provides for grant of approval and the same is reproduced herein:
“(1) In connection with the granting of approval under rules 8 to 11 above, terms and conditions shall be stipulated, including terms and conditions as to the control to be excercised by the applicant, supervision, restriction on use, the layout of the enterprise and as to the submission of information to the State Biotechnology Co-ordination Committee or to the District Level Committee (2) All approvals of the Genetic Engineering Approval Committee shall be for a specified period not exceeding four years at the first instance renewable for 2 years at a time. The Genetic Engineering Approval Committee shall have powers to revoke such approval in the following situations:
(a) If there is any new information as to the harmful effects of the genetically engineered organisms or cells.
(b) If the genetically engineered organisms or cells cause such damage to the environment, nature or health as could not be envisaged when the approval was given, or
(c) Non compliance of any condition stipulated by Genetic Engineering Approval Committee.” (Emphasis supplied) 27.6. Rule 14 deals with general supervision of GEAC in the implementation of the terms and conditions laid down in connection with the approvals accorded by it and such supervision could be carried out through the SBCC or the State 66 | W.P. (C) 115 of 2004 & Ors.
Pollution Control Boards/DLC or through any person authorised in this behalf.
27.7. Rule 15 deals with penalties which can be imposed. It reads as:
“(1) If an order is not complied with, the District Level Committee or State Biotechnology Coordination Committee may take measures at the expenses of the person who is responsible.
(2) In cases where immediate interventions is required in order to prevent any damage to the environment, nature or health, the District level Committee or State Biotechnology Coordination Committee may take the necessary steps without issuing any orders or notice. The expenses incurred for this purpose will be repayable by the person responsible for such damage.
(3) The State Biotechnology Co-ordination Committee /District Level Committee may take samples for a more detailed examination of organisms and cells.
(4)The State Biotechnology Co-ordination Committee/District Level Committee shall be competent to ask for assistance from any other Government authority to carry out its instructions.” 27.8. Rule 19, as noted above, provides for mechanism of appeal from the decision of GEAC.
27.9. The above extracted rules, as is evident lay down a clear mandate for functioning in respect of approvals that are to be granted by the GEAC. All aspects of immediate relevance are 67 | W.P. (C) 115 of 2004 & Ors.
covered thereunder, i.e., the monitoring of safety regulations, preparing on-site emergency plans, research, inspection, release, penalties, use and approval with respect to GMOs/hazardous microorganisms/cells. The existence of various committees with certain, specified responsibilities, their composition; the providing of procedure for the most essential function which is the grant of approvals; appeals on being dissatisfied therefrom (grant or denial) shows that each body within the Rules has a role to play and the fate of an application is not solely in the hands of one body. In none of these Rules could I find even the slightest hint of manifest arbitrariness. None of the parts of the Rules can be said to be irrational, capricious or without adequate determining principle, on the contrary, as displayed, a clear rationale is discernible.
27.10. In particular, the primary ground of challenge by the Petitioner as noticed above must be addressed. To do so, notice must also be taken of the Union of India’s submission that it is mandatory for all expert/members/Government officials of 68 | W.P. (C) 115 of 2004 & Ors.
GEAC and RCGM to sign a declaration of independence, confirming that they have no involvement or financial interest in the development, promotion or commercialisation of GM/transgenic crops. Members are also required to inform the RCGM and GEAC in case they have a conflict of interest, in such cases, the member involved does not participate in the deliberations. It has to be said that the composition of one of the Committees framed under the Rules allegedly suffering from some infirmity is not sufficient ground in the least, to vitiate the Rules on the whole. At the same time, it is also recognised that the GEAC is the apex body and its constitution therefrom assumes importance. Therefore, if the Petitioners had any qualms about its members, their objections should have been limited only thereto. As a secondary aide, a sweeping submission has been made that the 1989 Rules violates the Precautionary Principle however, how that is so is yet unclear. 27.11. Adverting particularly to the composition of the GEAC, the relevant rule reads as under:
69 | W.P. (C) 115 of 2004 & Ors.
“The composition of the Committee shall be i. Chairman-Additional Secretary, Department of Environment, Forests and Wild life Co-Chairman-Representative of Department of Bio- technology ii. Members: Representative of concerned Agencies and Departments, namely, Ministry of Industrial Development, Department of Biotechnology and the Department of Atomic Energy.
iii. Expert members: Director General Indian Council of Agricultural Research, Director General-Indian Council of Medical Research, Director General-Council of Scientific and Industrial Research, Director General-Health Services, Plant Protection Adviser, Directorate of Plant Protection, Quarantine and storage, Chairman, Central Pollution Control Board and three outside experts in individual capacity.
iv. Member Secretary: An official of the Department or Environment, Forest and Wild life.
The committee may co-opt other members/experts as necessary.” (Emphasis supplied) 27.12. It is evident that the top position in the GEAC is occupied by a person of the rank of Additional Secretary to the Government of India and the Vice Chairman is the member of the Department of Biotechnology, however, other members such as in Clause (iii) while being Government employees, possibly are still members working in specialized departments whose knowledge and expertise would be relevant to the functioning 70 | W.P. (C) 115 of 2004 & Ors.
of GEAC. Expert members are those who are directors/heads of eminent institutions as also others in individual capacity. The GEAC is also given the freedom to co-opt other members as and when may be required. The constitution of this Committee itself ensures that bureaucrats, in stricto senso, do not outweigh the presence of experts therein. 27.13. The Petitioner(s) contend that since the experts made part of the process, are members of Government bodies, therefore, they arguably would be unfit to be appointed. Conversely, it is averred by the Union of India that there exists a three-tier safety assessment process which involves around 60 experts most of whom are external experts from public sector institutions and universities. The effect of accepting the submission of the Petitioner(s) would mean that a person of science, by being a member simpliciter of the Government body, would be discounted as an ‘expert’. In other words, the effect would be that working for the Government is made equal to a curse, for experts who otherwise would have been inducted to the GEAC without batting so much as an eyelid.
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27.14. Additionally, nowhere in the Rules can it be seen that the Chairman of the GEAC or any other ‘bureaucratic member’ possesses any additional power in the functioning of the body, nor has it come on record that without the Chairman or any other Government member, the quorum with which a decision is to be reached, is incomplete.
27.15. As such, challenge to the 1989 Rules, as a consequence of the above discussion fails.
Precautionary Principle
- I now proceed to examine, the second principle issue, which is as to whether in view of the precautionary principle, a complete ban on Ht crops is warranted or if not, what are the suitable directions that are required to be given by this Court? TEC 28.1. Before discussing the precautionary principle, the view of the TEC appointed by this Court must be brought on record when probing the issue at hand. As discussed above, vide Order dated 10.05.2012, this Court appointed a TEC with 6 72 | W.P. (C) 115 of 2004 & Ors. members. The terms of reference (hereinafter referred to as ‘Tor’) given to the TEC were:
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. [Tor A] 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. [Tor B] 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. [Tor C] 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. [Tor D]
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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. [Tor E] f. To advise on whether institutions/laboratories in India have the state-of-art testing facilities and professional expertise to conduct various bio safety tests and recommend mechanism to strengthen the same. If no such institutions are available in India, recommend setting up an independent testing laboratory/institution. [Tor F] 28.2. The interim report of the TEC was received on 07.10.2012. In this interim report the TEC stated:
i. Three major issues were highlighted in the evaluation process which require attention:
a) Apparent lack of qualified full-time personnel in the regulatory bodies: The TEC was not convinced that the regulatory bodies in their present form are in a position to rigorously evaluate all data that comes before them. Further, 74 | W.P. (C) 115 of 2004 & Ors.
many of the field trials seem to have been delegated or left to the applicant (applying for approval to GEAC) and there is very limited mechanism to ensure compliance and accountability.
b) Need for removing conflicts of interest
c) Increasing inclusiveness of stakeholders with regard to decision making on GM products ii. All members unanimously felt that the present regulatory system and protocol(s) for conducting field trials was unsatisfactory and inadequate, requiring major changes, restructuring and strengthening.
iii. Introduction of transgenics in crops for which India is a centre of origin or diversity will contaminate the biodiversity and it should not be allowed to happen.
iv. Field Trials should be stopped until the above conditions are addressed.
v. The TEC further recommends a 10 year moratorium on field trials of Bt transgenics in all food crops in accordance with the precautionary principle.
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28.3. The final report of the TEC was received by this Court thereafter, wherein it was stated:
(i) Bt technology involves engineering plants for insect resistance by incorporating the gene for the toxin within the plant’s genetic constitution, so that the plant becomes naturally resistant to the insect. The benefit of this is a reduced requirement for externally applied chemical pesticides, most of which are toxic and cause environmental damage.
(ii) The other major usage of genetically modified crops has been for Ht crops, which is herbicide tolerance which makes the plant genetically engineered to be resistant to the herbicide.
The use of Ht technology allows more extensive application of the herbicide leading to more complete elimination of weeds without killing the crop.
(iii) GM technology comes with the promise of a number of benefits as well as associated risks with regard to health and environmental safety.
(iv) The TEC was informed that it will not be possible to segregate genetically modified from non-genetically modified material 76 | W.P. (C) 115 of 2004 & Ors.
during collection and storage in India, which would have serious implications when it comes to labelling of food.
(v) Most countries such as China and those in Europe are approaching this issue with a fair amount of caution. Bt Crops
(vi) The TEC has noted that in several cases that they examined, the characterization of the inserted DNA is limited and insufficient for comprehensively addressing the issues to regulatory approval. Overall the quality of information in several of the applications is far below what would be expected, and required for rigorous evaluation by a regulatory body and is unlikely to meet international regulatory guidelines.
(vii) The TEC examined the approved Bt Cotton and Bt Brinjal files relating to toxicity and what emerged from this examination is that in several cases, the methodology and results are not clearly reported.
(viii) The TEC considered the process of Environmental Risk Assessments (hereinafter “ERA”) in India. It referred to the 77 | W.P. (C) 115 of 2004 & Ors.
report of Prof. David Andow on ERA for Bt Brinjal wherein it was stated that the GEAC set too narrow a scope for the ERA and further, much of the effort towards the ERA was misdirected, which did not assess the actual adverse environmental consequences in India. The TEC concluded that ERAs are inadequately understood and addressed in Indian guidelines and regulatory system. The deficiencies are likely to be a consequence of the way in which ERA has been treated in the guidelines as a set of tests to be carried out instead of issues to be investigated and addressed. This kind of treatment has resulted in oversimplification, omission, and the real purpose of an ERA being missed.
(ix) The precautionary principle as present in the CPB international guidelines would strongly point towards erring on the side of caution. The TEC highlighted the critical importance of having as complete and comprehensive information as possible on the biology of the species when considering release of GMOs. It was further pointed out that no GMO intended directly as food has been commercially introduced into its Centre of Origin, which was happening 78 | W.P. (C) 115 of 2004 & Ors.
with the case of Bt Brinjal until ministerial intervention took place.
(x) There are serious deficiencies in reporting of the data in the dossiers and more importantly in the way in which these have been examined and the conclusions accepted by the Regulatory Body. The deficiencies are serious enough that several of the dossiers are unlikely to meet international guidelines. The regulator (GEAC) has frequently accepted conclusions based on incompletely reported data or without appropriate statistical analysis.
(xi) Some tests need to be carried out for longer duration in order to increase the time, of exposure so as to detect possible effects with greater confidence.
Ht Crops
(xii) Information relating to long term chronic toxicity is limited for most herbicides. Soybean accounts for the major share of Ht crops.
(xiii) The use of Ht crops would encourage increased use of the herbicides with likely negative consequences for biodiversity 79 | W.P. (C) 115 of 2004 & Ors.
in agricultural fields and the environment. Experimental studies of the possible impact that Ht crops can have on the biodiversity and abundance of wildlife have been limited.
(xiv) Another consideration in the Indian context is a socioeconomic one wherein a significant part of the agricultural workforce is employed for manual labour in the fields. Introduction of Ht crops would be likely to reduce access to employment for some of the vulnerable sections of rural society.
Recommendations
(xv) 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.
(xvi) A secretariat comprising dedicated scientists with area expertise as well as expertise in biosafety needs to be established, with consultation with experts having experience at the international level in biosafety testing evaluation of GM safety.
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(xvii) Conflict of interest in terms of location of the regulatory body needs to be addressed.
(xviii) 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.
(xix) Stakeholder participation, socioeconomic considerations, societal impact and sustainability should be incorporated at an early stage in the risk assessment process. 28.4. After the above observations and discussion, the TEC answered the terms of reference in the following manner:
- Tor A The TEC reiterated its recommendation made in the Interim Report that there should be a moratorium on field trials for Bt in food crops intended for commercialization until there is more definitive information as to long term safety of Bt in food crops.
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The TEC stated that it has examined the issues in relation to Ht with regard to sustainability and the likely socioeconomic impact on major sections of rural society. It reached the conclusion that Ht crops would most likely exert a highly adverse impact on sustainable agriculture, rural livelihoods and environment. The TEC found them completely unsuitable in the Indian Context.
It is pertinent here to notice the corrigendum brought by the TEC dated 12.07.2013 wherein the above line was expanded and a complete ban on Ht crops in India was recommended by the TEC.
The TEC further recommended that release of genetically modified crops for which India is a centre of origin or diversity should not be allowed.
- Tor B 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 82 | W.P. (C) 115 of 2004 & Ors. exposure required for the test. The testing therefore proceeds in a progressive manner.
- Tor C There is published evidence that the characteristics of a GMO can differ significantly depending upon whether it is grown in the greenhouse or in the field. It cannot be said that it is possible to replicate the conditions for testing under different agro-ecological regions and conditions in the greenhouse.
- Tor D Specific sites for conducting field trials need to be designated, certified and sufficient mechanisms put in place for monitoring the trials and ensuring restricted access, associated testing and other facilities. The trials should not be conducted on leased land.
- Tor E 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.
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6. Tor F Based on the review of the dossiers, the professional expertise and standards across the institutions appear unsatisfactory. The TEC has found in unambiguous terms that at present, the regulatory system has major gaps and these will require rethinking, investment and relearning to fix. 28.5. As noted above, the TEC consisted of six members, with Dr. Rajendra Paroda substituting Prof. VL Chopra on 09.11.2012 which is post submission of the interim report, the findings of which have been noted above.
28.6. Unable to agree with the conclusions of the majority, Dr. Paroda submitted his dissent to the final report of the majority, alleging various lapses in the decision-making process. Those lapses, as pointed out are:
“….
- To my surprise, the TEC members were not willing to take cognizance of any objections/submissions to the Interim Report made by different respondents, despite clear directive by the Hon’ble Supreme Court. As mentioned earlier, a compilation of all objections received was shared (Annex-IV) but members seemed to have serious reservations to discuss these on the plea that there was nothing new, including in fresh 84 | W.P. (C) 115 of 2004 & Ors.
submissions by UOI, NAAS, NSAI, Prof. Deepak Pental etc. • On having gone through the minutes of the earlier meetings of TEC, prior to my becoming a member (Annex-Ill), and the submissions made by various respondents, it became apparent that TEC members had possibly taken one sided view in their Interim Report. - The TEC members seemed to take an ideological stance favouring an anti GM as well as an anti transnational approach and possibly believed that imposing moratorium on field trials of GM crops was the only way to move forward. On the contrary, any such move will harm Indian science enormously. • At the same time, members seemed to have proceeded with an assumption that the Indian regulatory system was faulty and full of lapses. Accordingly, all deliberations of TEC sounded to me like a fault finding mission.
- Some members continued relying solely on reports of contrarian scientists and propounded their views/opinions, while ignoring the fact that such – isolated research claims had been examined thoroughly and rejected by a wide section of scientific community as well as by the regulatory authorities of their respective countries as well as other well reputed regulatory bodies.
- As mentioned earlier, no other member provided any input on the TOR nor did they respond to any of the write-ups provided by me. As a result, no substantive evidence-based discussion could take place during the meetings in order to arrive at general consensus/understanding.
- The only shared document was the part draft report (26 pages), which did not reflect general deliberations held nor did it follow the agreed format. I did convey my concern over adopting this entirely different approach with utter disregard to decisions taken in earlier meetings, but with no positive output.
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• In a scenario like this, reflecting considerable lack of transparency, I am left with no other alternative but to submit this report separately – the last thing I would have wished otherwise.” 28.7. While these lapses pointed out by Dr. Paroda pertained to procedural aspects of the TEC however among other minor differences, twin substantial differences in respect of a) conducting field trials which the former recommends continuation in the interest of scientific development and the latter recommends against given numerous regulatory lacunae; and b) the former does not oppose the development of HT crops while the latter, once again in view of the lacunae, bats for a wholesale ban.
28.8. Dr. Paroda recommended that there should be development of comprehensive guidelines for Environmental Risk Assessment (ERA) with consultation with all stakeholders and the general public. A full time Risk Assessment Unit with permanent staff consisting of a multidisciplinary team of scientists should be established. National Agriculture Research System (NARS) should lead agronomic performance 86 | W.P. (C) 115 of 2004 & Ors.
testing and release of GM varieties/hybrids in line with the National Seed Policy while making use of already existing procedures under AICRP.
28.9. He was further of the view that the proper evaluation of a Genetically Engineered plant is scientifically not tenable in a contained greenhouse and confined field testing is the right option for a realistic evaluation of any GE plant. Each confined field trial must be monitored by a ‘site specific monitoring committee’. A well-designed case-to-case post- release monitoring system must be put in place to address specific post-release issues identified during the event approval by GEAC. RCGM and GEAC should review isolation distances for confined field trials and suitability of additional measures. Research projects must be funded by DBT, ICAR and relevant arm of the Government. Accredited laboratories must be notified for detection of GM crops. The regulatory authorities should develop a system of examining papers or reports about the adverse effects of GM crops and communicate the same to public. Special fund allocation is desirable for the purpose of creating public awareness.
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28.10. I am not inclined to accept the objections raised by the Petitioners, for consideration of the report of Dr. Paroda. Given that the substance in issue is scientific in nature, the minority report cannot be ignored entirely. After perusing both the reports, while there are certain differences, one also finds substantial similarities. They may be noted:
TEC Dr. Paroda
(5 Members)
The overall process of risk For environmental risk assessment
assessment should follow the there is an urgent need for
flowchart for the Risk Assessment developing comprehensive
process in the Guidance on Risk guidelines in consultation with all
assessment of Living Modified stakeholders and general public.
Organisms of the Cartagena There should be establishment of
Protocol on Biosafety. risk assessment unit which should
be permanently staffed by a multi-
disciplinary team.
It is generally not possible to Proper evaluation of GE plants is
replicate the conditions for testing not scientifically tenable in
under different agro-ecological contained greenhouses as natural,
regions and conditions in the varying conditions representing
greenhouse. different agro-ecological regions
and growing seasons cannot be
feasibly replicated.
Specific sites for conducting field No trials should be allowed in non-
trials need to be designated, notified fields, leased or otherwise.
certified and sufficient A system should be evolved for
mechanism put in place for notification of confined field trial
monitoring the trials and ensuring sites which should include both
restricted access, disposal of public and private sector
material, associated testing and institutions subject to certain
other facilities. These sites should conditions.
be used only for field trials of GM
crops. Trials should not be
conducted on leased land.
88 | W.P. (C) 115 of 2004 & Ors. A requisite understanding of the There is a need to strengthen the
process of Risk assessment be public sector laboratories through
developed through consultation, funding in order to have required
collaboration and capacity infrastructure and human resource
building as the regulatory system development. There should be a
has gaps and require rethinking, major human resource
investment and relearning. development initiative for training
in national and international
institutions. Government may
establish inter-ministerial
coordination and monitoring
mechanism to create/strengthen
public research institutions for
regulatory process.
28.11. With respect to the objections raised by the Union of India, to the TEC report, that the TEC went beyond its scope, a perusal of the recommendations made, juxtaposed with the Tor, one finds that the latter are largely within the scope of the question that had been put to them. The TEC has confined itself only to issues relevant to answering Tors. 28.12. As discussed earlier, in Kantha Vibhag (supra), this Court observed that:
“15. It is first important to differentiate expert committees which are set by the courts/tribunals from those set up by the Government in exercise of executive powers or under a particular statute. The latter are set up due to their technical expertise in a given area, and their reports are, subject to judicially observed restraints, open to judicial review before courts when decisions are taken solely based upon 89 | W.P. (C) 115 of 2004 & Ors.
them. The precedents of this court unanimously note that courts should be circumspect in rejecting the opinion of these committees, unless they find their decision to be manifestly arbitrary or mala fide. On the other hand, courts/tribunals themselves set up expert committees on occasion. These committees are set up because the fact-finding exercise in many matters can be complex, technical and time- consuming, and may often require the committees to conduct field visits. These committees are set up with specific terms of reference outlining their mandate, and their reports have to conform to the mandate. Once these committees submit their final reports to the court/tribunal, it is open to the parties to object to them, which is then adjudicated upon. The role of these expert committees does not substitute the adjudicatory role of the court or tribunal. The role of an expert committee appointed by an adjudicatory forum is only to assist it in the exercise of adjudicatory functions by providing them better data and factual clarity, which is also open to challenge by all concerned parties. Allowing for objections to be raised and considered makes the process fair and participatory for all stakeholders.” (Emphasis supplied) 28.13. The above observations make it abundantly clear that this Court is not bound by the conclusions reached by its own expert committee. The report of the expert committee is important for the court to be apprised of the technical aspects of a particular dispute by independent experts. For a court or tribunal to rely entirely on the report of an expert committee would be improper as this would amount to the court 90 | W.P. (C) 115 of 2004 & Ors.
abdicating its own adjudicatory function and replacing its wisdom with that of the expert committee. Parliamentary Standing Committee Reports
- There are two reports of Parliamentary Standing Committees on this issue. The first one being, the 37th Report of the Committee on Agriculture (2011-2012) titled ‘Cultivation of Genetically Modified Food Crops – Prospects and Effects’ dated 09.08.2012. The Committee considered oral and documentary evidence, thereafter made the following observations:
i. Bio-technology offers many advantages over traditional techniques of plant breeding in major food crops such as low production cost, conservation of bio-diversity and economic-social benefits including poverty alleviation. This technology (transgenics/genetic engineering) is environmentally friendly, sustainable and affordable.
ii. In respect of field trials which is a highly contested issue before us it is observed that they serve a multiplicity of purposes:
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“(i) For the plant breeder, they provide the first opportunity to evaluate the agronomic potential of novel-plant trait combinations in open environment which is not possible in contained conditions of greenhouse.
(ii) It is necessary to measure the level of protein expression from any newly introduced genes in the plant tissues to assess its efficacy in the open environment and impact on the target and non target organisms consuming the genetically modified plant.
(iii) It allows the production of sufficient quantities of plant material for use in livestock feeding studies/trials and to conduct compositional analyses, which are necessary for human food safety assessment.
(iv) Such trials are also necessary to collect the agronomic and ecological data required to complete the environment safety assessment of genetically modified plant.” iii. The views of Dr. P.M. Bhargava were taken by the Committee and his stand was not a permanent ban on release of GMOs but ensuring that they are adequately tested before any such release take place. At the same time he stated that the refusal to do chronic toxicity studies was against the interest of the nation and that despite the technological advancements, there is not an Indian lab in which testing can be done.
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iv. It was noted that the GEAC does not directly perform studies of safety assessment and it is the applicant who is to submit data of its studies to the RCGM and GEAC, and after comments thereon final decision is taken. v. In conclusion, with respect to the regulatory mechanism, it was observed:
“2.92 … The Committee can safely conclude that all is not well with the regulatory mechanism put in place by the Government for oversight of cutting edge technology as sensitive as GMOs and products thereof. Firstly, GEAC being an entity created under 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. The enforceability of Rules, albeit made under some Act only, does not have as much definitiveness and clarity as under an Act. Furthermore, unlike an Act, there is a lot of scope for varied interpretation of Rules as also flexibility to implement them. The confusion about the recommendatory/approving authority of GEAC whether due to genuine confusion or deliberate; the confession of the Co-Chairman of GEAC, the only technocrat in the top three positions of GEAC, about minister/GEAC/industry pressuring him to favour a bad technology; the various acts of omission and commission of GEAC that have been documented in various chapters of this Report, all go on to cement the view of the Committee that the regulatory mechanism definitely requires the protection and support of an Act of the Parliament which leaves no scope for ambiguity or complacency.” vi. The Committee lamented that even after the Cartagena Protocol on Biosafety was adopted on 17.01.2003, many
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key issues such as risk assessment, liability and redress, identification of living modified organisms etc. are still in the discussion stage.
vii. Having taken note of the various shortcomings and gaps in the regulatory mechanism, the Committee expressed a desire that all research and development be done in containment and field trial be discontinued forthwith. viii. Labelling of GM and non-GM products was also an issue considered by the Committee and it was recommended that such labelling be made mandatory so that a consumer can make an informed choice.
ix. Referring to the Dr. M.S. Swaminathan Report, the Department of Agriculture stated that:
“biotechnology provides an opportunity to convert bio resources into economic wealth. This has to be done in a manner that there is no adverse impact either on the environment or on human or animal health. The guiding principle for following the National agricultural biotechnology policy should be the economic well-being of farm families, food security of the nation, health security of the consumer, protection of the environment and security of our national and international trade in farm commodities”.
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x. The Committee recorded the admission of the concerned official of the Department of the Agriculture that if the dependence on Bt crops goes beyond a point, it would “be a gigantic task to revive the traditional cotton varieties from the gene bank and may take years together” at the same time it was recorded that, efforts and the direction were proceeding and it was not that the ship had sailed. xi. Certain other observations recorded by the Committee are essential:
“8.97 India also entered the scene in developing and deploying transgenic crops (genetically modified crops) since early 1990s, with very good intentions and preparations to deal with ensuring the safety of such technology so that it does not harm the environment and human health. The policy and regulatory frameworks suggested, developed and implemented had all the good provisions to ensure public safety and ensure food sovereignty of the country. The policy and regulatory frameworks were put in place using well thought-out plans. However, the developments in technology and deployment over-
took the speed of policy implementation which caused apprehensions in the minds of general public about the technology and the over-sight for its deployment.” 29.1. At this stage, the Petitioners have placed reliance on the 301st Report of the Parliamentary Standing Committee on Science and Technology, Environment and Forest titled “Genetically 95 | W.P. (C) 115 of 2004 & Ors.
Modified Crops and its Impact on Environment” dated 25.08.2017.
i. The Committee after taking an overview of the regulatory mechanism as also taking note of the official and non- official witnesses recorded as under:
“The Committee takes note of the divergent views on the efficacy of existing regulatory mechanism. On the one hand, the Government claims that are very stringent regulatory mechanism has been put in place leaving no scope for any non-whatsoever by the technology developer whereas on the contrary, the Committee has been given to understand by some representatives of the civil society that the existing regulatory mechanism is stringent on paper only and the whole process of regulation depends upon the data made available to the regulators by the technology developers. The Committee is surprised to know that none of the Committees referred to in the preceding paragraphs conduct the closed field trials on their own but are solely dependent on the data provided to them by the technology developer. The Committee feels that this leaves the scope for the technology developers to fudge the data to suit their own requirements. The existing regulatory mechanism is, therefore, susceptible to manipulations. The Committee, therefore, recommends that the Central Government should, in consultation with the State Governments and Administrations of the Union Territories ensure that the whole process of field trials should be done in close environment keeping biosafety and health safety in mind and in collaboration with agricultural universities so as to minimise the scope of fudging the primary data.” 96 | W.P. (C) 115 of 2004 & Ors.
ii. The Committee noticed that the production of GM crops was concentrated only in a select few countries, India being one of them but also noted the general hesitation of developed economies to use this technology at a wide scale. The observation in this regard is as extracted hereunder:
“The Committee notes that currently, twenty years after their introduction in 1996, only 6 countries continue to account for over 90% of all GM crop area globally (USA 40%, Brazil 23%, Argentina 14%, India 6%, Canada 6%, China 2%). The Committee was informed by the members of civil society during the deliberation on the subject that there was a decline in GM crop area in 2015. The Committee notes with surprise that inspite of the fact that GM technology is being propagated as the most advanced agricultural technology, 17 of the 20 most developed countries (HDI) do not grow it which includes most of Europe, Japan, Russia, Israel etc. The Committee opines that there is increasing evidence about the lack of safety of GM crops and little or no benefits to justify the risks, most countries in the world do not grow GM crops. The Committee also feels that the policy makers of these countries, as custodians for both present and future generations, have seen that GM organisms spread rapidly, that the impacts have been unpredictable, potentially hazardous, uncontrollable and irreversible, assessed the benefits and risks, taken note of emerging evidence of harm, and therefore do not permit GM crops. The non acceptance of the most advanced agricultural technology, GM technology, by the most developed countries raises doubts about the efficacy of the technology. The Committee, therefore, feels that the Government of India should conduct a comparative study to examine the reasons for not accepting this 97 | W.P. (C) 115 of 2004 & Ors.
technology by these developed countries viz-a-viz the reasons led to its acceptance.” iii. The Committee has noted that despite the tiered regulatory system in place, there is no scrutiny of the process of Environmental Impact Assessment and reliance is predominantly on the data supplied by the Applicant. It was recommended that an independent agency consisting of persons with impeccable credentials should carry out the process of evaluation to ensure that there is no violation of the existing regulations.
iv. The Committee has come out in support of placing every piece of information, in public scrutiny. It is wise to ensure that the entire process reflects the values of participation and transparency with the overall goal being to clear out the doubts in the mind of the public. v. In respect of cross-contamination of GM and non-GM crops the acceptance of the Department of Agricultural Research and Education was noted, that a herbicide tolerant gene may escape by way of pollination to 98 | W.P. (C) 115 of 2004 & Ors.
another farm that is to another GM or non-GM crop and, therefore, the committee was of the view that if cultivation, side-by-side or in other words simultaneously, was allowed there would be no way to stop contamination. It therefore recommended that the MoEFCC undertake a study in that regard and take “desired measures”.
vi. The Committee underscored the need for India based studies to be undertaken to examine the effect of GM crops on “our environment on account of GM crops” keeping in view the “topography of our country and its diversity”. It was also noted that the impact of these crops on human as well as animal health has not been adequately studied.
29.2. In response to the above reports, the Union of India has submitted a compliance chart, stating that most of the lacunae that has been pointed out by the Committees, has been complied with and that the present regulatory system is in consonance with international standards and safeguards, to 99 | W.P. (C) 115 of 2004 & Ors.
ensure that the precautionary approach is complied with.
Another argument that has been put forth on behalf of the Union of India is that these reports are from the year 2012 and 2017, respectively and thereafter, in the past 7 years, the scientific research has come a long way.
29.3. The evidentiary value of such reports is no longer res integra and was clarified by a Constitution Bench of this Court in Kalpana Mehta v. Union of India (5-Judge Bench)34. Dipak Misra, CJI (as he then was), observed:
“159.1. Parliamentary Standing Committee report can be taken aid of for the purpose of interpretation of a statutory provision wherever it is so necessary and also it can be taken note of as existence of a historical fact.
159.2. Judicial notice can be taken of the Parliamentary Standing Committee report under Section 57(4) of the Evidence Act and it is admissible under Section 74 of the said Act.
159.3. In a litigation filed either under Article 32 or Article 136 of the Constitution of India, this Court can take on record the report of the Parliamentary Standing Committee. However, the report cannot be impinged or challenged in a court of law.
159.4. Where the fact is contentious, the petitioner can always collect the facts from many a source and produce such facts by way of affidavits, and the court 34 (2018) 7 SCC 1 100 | W.P. (C) 115 of 2004 & Ors.
can render its verdict by way of independent adjudication 159.5. The Parliamentary Standing Committee report being in the public domain can invite fair comments and criticism from the citizens as in such a situation, the citizens do not really comment upon any Member of Parliament to invite the hazard of violation of parliamentary privilege.” Dr D.Y. Chandrachud, J. (as he then was) in his detailed consideration of the issue at hand, observed:
“275. Parliamentary Committees are an intrinsic part of the process by which the elected legislature in a democracy exacts accountability on the part of the Government. Department related Parliamentary Standing Committees undertake the meticulous exercise of scrutinising the implementation of law, including welfare legislation and the performance of the departments of the State. The purpose of law is to promote order for the benefit of the citizen and to protect rights and entitlements guaranteed by the Constitution and by statute. Access to justice as a means of securing fundamental freedoms and realising socio-economic entitlements is complementary to the work of other organs of the State. The modern doctrine of separation of powers has moved away from a “one organ – one function” approach, to a more realistic perspective which recognises the complementarity in the work which is performed by institutions of governance. Judicial review is founded on the need to ensure accountable governance in the administration of law as an instrument of realising the rights guaranteed by the Constitution. If the function of judicial review in facilitating the realisation of socio-economic rights is construed in the context of the modern notion of separation of powers, there is no real conflict between the independence of the judicial process and its reliance on published reports of Parliamentary 101 | W.P. (C) 115 of 2004 & Ors.
Committees. Ultimately it is for the court in each case to determine the relevance of a report to the case at hand and the extent to which reliance can be placed upon it to facilitate access to justice. Reports of Parliamentary Committees become part of the published record of the State. As a matter of principle, there is no reason or justification to exclude them from the purview of the judicial process, for purposes such as understanding the historical background of a law, the nature of the problem, the causes of a social evil and the remedies which may provide answers to intractable problems of governance. The court will in the facts of a case determine when a matter which is contentious between the parties would have to be adjudicated upon independently on the basis of the evidence adduced in accordance with law.
- In the circumstances, the reference is answered by holding that:
276.1. As a matter of principle, there is no reason why reliance upon the report of a Parliamentary Standing Committee cannot be placed in proceedings under Article 32 or Article 136 of the Constitution; 276.2. Once the report of a Parliamentary Committee has been published, reference to it in the course of judicial proceedings will not constitute a breach of parliamentary privilege;
276.3. The validity of the report of a Parliamentary Committee cannot be called into question in the court. No Member of Parliament or person can be made liable for what is stated in the course of the proceedings before a Parliamentary Committee or for a vote tendered or given; and 276.4. When a matter before the court assumes a contentious character, a finding of fact by the court must be premised on the evidence adduced in the judicial proceeding as explained in paras 265 and
274.” The final conclusions of the Bench were as follows:
“449.1. According to clause (2) of Article 105 of Constitution of India no Member of Parliament can be 102 | W.P. (C) 115 of 2004 & Ors.
held liable for anything said by him in Parliament or in any committee. The reports submitted by Members of Parliament are also fully covered by protection extended under clause (2) of Article 105 of the Constitution of India.
449.2. The publication of the reports not being only permitted, but also are being encouraged by Parliament. The general public is keenly interested in knowing about the parliamentary proceedings including parliamentary reports which are steps towards the governance of the country. The right to know about the reports only arises when they have been published for use of the public in general. 449.3. Section 57(4) of the Evidence Act, 1872 makes it clear that the course of proceedings of Parliament and the Legislature, established under any law are facts of which judicial notice shall be taken by the Court.
449.4. Parliament has already adopted a report of “privilege committee”, that for those documents which are public documents within the meaning of the Evidence Act, there is no requirement of any permission of the Speaker of Lok Sabha for producing such documents as evidence in court.
449.5. That mere fact that document is admissible in evidence whether a public or private document does not lead to draw any presumption that the contents of the documents are also true and correct. 449.6. When a party relies on any fact stated in the Parliamentary Committee report as the matter of noticing an event or history no exception can be taken on such reliance of the report. However, no party can be allowed to “question” or “impeach” report of Parliamentary Committee. The parliamentary privilege, that it shall not be impeached or questioned outside Parliament shall equally apply both to a party who files claim in the court and other who objects to it. Any observation in the report or inference of the Committee cannot be held to be binding between the parties. The parties are at liberty to lead evidence independently to prove their stand in a court of law. 449.7. Both the parties have not disputed that parliamentary reports can be used for the purposes of legislative history of a statute as well as for considering the statement made by a minister. When 103 | W.P. (C) 115 of 2004 & Ors.
there is no breach of privilege in considering the parliamentary materials and reports of the Committee by the Court for the above two purposes, we fail to see any valid reason for not accepting the submission of the petitioner that courts are not debarred from accepting the parliamentary materials and reports, on record, before it, provided the court does not proceed to permit the parties to question and impeach the reports.
449.8. The Constitution does not envisage supremacy of any of the three organs of the State. But, functioning of all the three organs is controlled by the Constitution. Wherever, interaction and deliberations among the three organs have been envisaged, a delicate balance and mutual respect are contemplated. All the three organs have to strive to achieve the constitutional goal set out for “We the People”. Mutual harmony and respect have to be maintained by all the three organs to serve the Constitution under which we all live.
449.9. We are of the view that fair comments on report of the Parliamentary Committee are fully protected under the rights guaranteed under Article 19(1)(a). However, the comments when turn into personal attack on the individual Member of Parliament or the House or made in vulgar or abusive language tarnishing the image of the Member or the House, the said comments amount to contempt of the House and breach of privilege.
449.10. The function of adjudicating rights of the parties has been entrusted to the constituted courts as per constitutional scheme, which adjudication has to be made after observing the procedural safeguards which include the right to be heard and the right to produce evidence. Parliament, however, is not vested with any adjudicatory jurisdiction which belongs to judicature under the constitutional scheme. 449.11. Admissibility of a Parliamentary Committee report in evidence does not mean that facts stated in the Report stand proved. When issues of facts come before a court of law for adjudication, the court is to decide the issues on the basis of evidence and materials brought before it.” (Emphasis supplied) 104 | W.P. (C) 115 of 2004 & Ors.
29.4. The detailed discussion on the value of Parliamentary Committee reports as undertaken by the Constitution Bench sheds light by holding that there is no bar in taking into consideration such reports under Article 32 or Article 136 of the Constitution of India. At the same time, it has been observed that they are not to be taken as conclusive proof of fact and the Court in performing its adjudicatory functions has to decide on the basis of materials before it, however the latter should not be taken to mean that credit of such report is impeached.
29.5. The question at hand is the adequacy of the assessment and approval procedures for GM Crops. The task of this Court, is therefore to examine whether the impugned procedures rise to the level of a violation of fundamental rights. This is a legal determination to be made by this Court, based on all materials placed before it and a wholistic view of the matter. Even if the TEC and parliamentary standing committees have found certain issues with the procedures governing GM crops, that cannot automatically lead to the conclusion that gaps in the impugned procedures result in a violation of Part III of the 105 | W.P. (C) 115 of 2004 & Ors.
Constitution of India and must be invalidated or that the impugned action be stalled. Therefore, I now proceed to examine, whether the gaps pointed out in the abovementioned reports, would reach the threshold of violating the precautionary principle and in that view of the matter, what directions must be given.
Scope of Precautionary Principle
- The genesis of the precautionary principle in India can be traced back to the decision of this Court in Vellore Citizens Welfare Forum v. Union of India (3-Judge Bench)35, wherein it was held that the precautionary principle is an essential feature of the principle of sustainable development. It went on to explain the precautionary principle in the following terms:
“i. Environmental measures – by the State Government and the statutory authorities – must anticipate, prevent, and attack the causes of environmental degradation.
ii. Where there are threats of serious and irreversible damage, lack of scientific certainty should not be used as a reason for postponing measures to prevent environmental degradation.
35 (1996) 5 SCC 647 106 | W.P. (C) 115 of 2004 & Ors.
iii. The “onus of proof” is on the actor or the developer/industrialist to show that his action is environmentally benign.”
30.1. This principle over the years, has been developed further and recognised as an integral part of the Indian Constitution. Recently, in Hospitality Association of Mudumalai v. In Defence of Environment & Animals (3-Judge Bench)36, this Court reiterated that the precautionary principle forms part of the Constitution of India under Articles 21, 47, 48 and 51- A(g). The requirement placed on the Government under the precautionary principle to “anticipate, prevent and attack the causes of environmental degradation” was emphatically reiterated.
30.2. This Court has clarified that a precautionary approach, is not one which is opposed to development. In N.D. Jayal (Supra) while relying on Vellore Citizens’ Welfare Forum (Supra) and M.C. Mehta v. Union of India (3-Judge Bench)37, emphasis was laid on sustainable development. This Court 36 (2020) 10 SCC 589 37 (2002) 4 SCC 356 107 | W.P. (C) 115 of 2004 & Ors.
observed that the balance between environmental protection and developmental activities could only be maintained by strictly following the principle of “sustainable development”. This is a development strategy that caters to the needs of the present without negotiating the ability of upcoming generations to satisfy their needs. The strict observance of sustainable development will put us on a path that ensures development while protecting the environment, a path that works for all people and for all generations. It is a guarantee to the present and a bequeath to the future. All environment- related developmental activities should benefit more people while maintaining the environmental balance. This could be ensured only by strict adherence to sustainable development without which the life of the coming generations will be in jeopardy.
Further it was opined that:
“24. The right to development cannot be treated as a mere right to economic betterment or cannot be limited as a misnomer to simple construction activities. The right to development encompasses much more than economic well-being, and includes within its definition the guarantee of fundamental human rights. The “development” is not related only to the growth of GNP. In the classic work,
108 | W.P. (C) 115 of 2004 & Ors.
Development As Freedom, the Nobel prize winner Amartya Sen pointed out that “the issue of development cannot be separated from the conceptual framework of human right”. This idea is also part of the UN Declaration on the Right to Development. The right to development includes the whole spectrum of civil, cultural, economic, political and social process, for the improvement of peoples’ well-being and realization of their full potential. It is an integral part of human rights. Of course, construction of a dam or a mega project is definitely an attempt to achieve the goal of wholesome development. Such works could very well be treated as integral component for development.” 30.3. The necessity to strike a balance between development and ecology was reiterated by this Court in Karnataka Industrial Areas Development Board v. C. Kenchappa (2-Judge Bench)38 wherein it was observed:
“61. The priority of developing nations is urgent industrialisation and development. We have reached at a point where it is necessary to strike a golden balance between development and ecology.
- The development should be such as it can be sustained by ecology. All this has given rise to the concept of sustainable development.
x x x x - A nation’s progress largely depends on development, therefore, the development cannot be stopped, but we need to control it rationally. No Government can cope with the problem of environmental repair by itself alone; people’s voluntary participation in environmental management is a must for sustainable development.
38 (2006) 6 SCC 371 109 | W.P. (C) 115 of 2004 & Ors.
There is a need to create environmental awareness which may be propagated through formal and informal education. We must scientifically assess the ecological impact of various developmental schemes. To meet the challenge of current environmental issues, the entire globe should be considered the proper arena for environmental adjustment. Unity of mankind is not just a dream of the enlightenment but a biophysical fact.” (Emphasis supplied) 30.4. In Electrosteel Steels Limited v. Union of India and Ors.
(2-Judge Bench)39 while dealing with ex-post facto environmental clearances, this Court observed that the Court cannot be oblivious to the economy or others dependent on a project, if the project in question complies with environmental considerations.
30.5. Recently, in NHAI v. Pandarinathan Govindarajulu (3-Judge Bench)40, it was observed:
“18. While economic development should not be allowed at the cost of ecology or by causing widespread environmental destruction, the necessity to preserve ecology and environment should not hamper economic and other development. Both development and environment must go hand in hand. In other words, there should not be development at the cost of environment and vice versa, but there should be development while taking due care and 39 (2023) 6 SCC 615 40 (2021) 6 SCC 693 110 | W.P. (C) 115 of 2004 & Ors.
ensuring the protection of environment [Indian Council For Enviro-Legal Action v. Union of India, (1996) 5 SCC 281]. The traditional concept that development and ecology are opposed to each other is no longer acceptable [Vellore Citizens’ Welfare Forum v. Union of India, (1996) 5 SCC 647].” (Emphasis supplied) 30.6. A similar approach was taken in Rajeev Suri v. DDA (3-Judge Bench)41 wherein judicial review of the Central Vista Project was sought. The majority, in this case, observed:
“519. Indubitably, environment and development are not sworn enemies of each other. It would be an anomalous approach to consider environment as a hurdle in development and vice versa. The entities like EAC and NGT are created to strike a just balance between two competing interests and a time-tested principle of striking this balance is timely invocation of mitigating environmental measures amidst a development activity. True that mere application of certain mitigating measures may not alleviate environmental concerns in all matters and in some circumstances, the project is simply incomprehensible with the environment. But as long as a legitimate development activity can be carried on in harmony with the idea of environmental protection and preservation including sustainable development, the Courts as well as expert bodies should make their best endeavour to ensure that harmony is upheld and hurdles are minimised by resorting to active mitigating measures.
520… The primary requirement underlying this principle is to ensure that every development work is sustainable; and this requirement of sustainability demands that the first attempt of every agency enforcing environmental rule of law in the country 41 (2022) 11 SCC 1 111 | W.P. (C) 115 of 2004 & Ors.
ought to be to alleviate environmental concerns by proper mitigating measures. The future generations have an equal stake in the environment and development. They are as much entitled to a developed society as they are to an environmentally secure society.
x x x
- The precautionary principle duly mandates that all agencies of the State, including Courts, must make their best endeavour to ensure that precaution is instilled in the process of development. The very requirement of prior EC is born out of this need for precaution. It is a manifestation of the precautionary principle in India and if development work is carried out in furtherance of prior EC and such EC is not vitiated by illegality, it would be a case of proper adherence with the precautionary principle.
- In matters of balancing between competing environmental and development concerns, the Court has to be project-specific. In environmental matters, even one fact here or there may have the effect of attributing a totally distinct character to the project and accordingly, the scope of judicial review may vary.
x x x
- They must always look for a careful balance when two equally relevant interests compete with each other. The task may not be easy, but is the only reasonable recourse. For the proper application of these principles, the first and foremost thing to be kept in mind is the nature of the project. In the present case, the subject project is an independent building and construction project wherein one-time construction activity is to be carried out. It is not a perpetual or continuous activity like a running industry. It is absolutely incomprehensible to accept that a project of this nature would be unsustainable with the needs and aspirations of future generations. Furthermore, the increase in footprint is not shown to be substantial and the inclusion of new Members of Parliament after the delimitation exercise is anyway 112 | W.P. (C) 115 of 2004 & Ors. going to lead to an inevitable increase in footprint (floating though) that cannot be countenanced as a concern here.” (Emphasis supplied) 30.7. In M K Ranjitsinh & Ors. v. Union of India and Ors. (3- Judge Bench)42, the need for adopting a nuanced approach, balancing two environmental goals, i.e., fighting the climatic crisis as also protection of wildlife ecology was underscored in following words:
“53… Unlike the conventional notion of sustainable development, which often pits economic growth against environmental conservation, the dilemma here involves a nuanced interplay between safeguarding biodiversity and mitigating the impact of climate change. It is not a binary choice between conservation and development but rather a dynamic interplay between protecting a critically endangered species and addressing the pressing global challenge of climate change.” Additional Guidelines
- We must also, at this point, make references to the guidelines that have been brought by the Union of India, to supplement the existing framework:
42 2024 SCC Online SC 570 113 | W.P. (C) 115 of 2004 & Ors.
i. Guidelines for Environmental Risk Assessment of Genetically Engineered Plants, 2016 and Environmental Risk Assessment of Genetically Engineered Plants- A Guide for Stakeholders, 2016 – The objective of these Guidelines is to ensure safe development and use of plant resulting from modern biotechnology after assessment of any potential negative impacts through a comprehensive, transparent and science based framework of identification of harms using a conventional case to case approach. These guidelines profess to provide a practical elaboration of the risk assessment framework included in the Indian regulation and in Annex III of the Cartagena Protocol on Biosafety as also the Working Committee on Harmonisation of Regulatory Oversight in Biotechnology of the Organisation for Economic Cooperation and Development (OECD).
They provide a detailed roadmap for Environmental Risk Assessment right from the approach to be adopted to problem formulation (development of risk hypothesis), to detailed instructions on data quality to informational requirement and 114 | W.P. (C) 115 of 2004 & Ors.
description of the non-transgenic parental plants/donor organisms, characterization of genetic modification to cultivation practices to potential adverse non-target effects of GMOs on biodiversity to post release environmental monitoring.
ii. Risk Analysis Framework 2016 – These guidelines provide the risk analysis method for the environmental release of GE plants and divides them into different stages which can be shown through a following chart:
Application for Environmental Release of GE plant Decision Communication Risk Context Risk Stakeholders Risk Assessment Risk Management
115 | W.P. (C) 115 of 2004 & Ors.
(a) Risk Context being the preparatory stage defines the scope and boundaries, sets the criteria against which risk will be evaluated and describes the structures and process for the analysis. Decisions on application for the environmental release of a GE plant require case-by-case assessment and details of the GE plant and the proposed activities, including any proposed controls, limits or containment measures, form the specific risk context.
(b) This framework includes Risk Assessment, Risk Management and Risk Communication. Risk Assessment and Risk Management form an essential part of decision making in respect to the applications for environmental release of GE plants.
(c) The chapter on Risk Assessment provides comprehensive methodology to identify and characterize risks to the health and safety of people or to the environment from the release of GE plants. It includes risk identification (postulating risk scenarios); risk characterization (includes quantitative as well as qualitative assessment); ensuring the quality of data used in such assessment and risk evaluation. The risk 116 | W.P. (C) 115 of 2004 & Ors.
assessor is obliged to search beyond the application to identify additional data and other information that will help in the completion of the risk assessment.
(d) The next stage of Risk Management includes preparing a risk management plan; and monitoring/reviewing measures, if any, to assess the effectiveness of all steps in risk analysis, including post-release review. It further provides that in case of non-compliance of any condition considered necessary to manage the risk associated with the environmental release and imposed by the regulatory authorities, the Regulatory Authorities may investigate the nature and extent of such non-compliance. If proven, resort may be made to the EPA, 1986 which provides for a range of remedies, including provisions for criminal sanctions or large fines and/or imprisonment for failing to abide by the legislation, conditions or directions when significant damage occurs to health and safety of people or the environment.
(e) Another relevant aspect dealt in this document is Risk Communication which is a two-way process ‘to provide, 117 | W.P. (C) 115 of 2004 & Ors.
share or obtain information and to engage in dialogue with stakeholders regarding the analysis of risk’ and Risk perception. This is based on a principle that Risk Assessment should be ‘in a scientifically sound and transparent manner’. It includes engagement of ‘internal and external stakeholders in the risk analysis process through dialogue’; informing so as ‘to foster understanding of the risks amongst different constituencies (e.g., authorized parties and others from the regulated community, as well as researchers, farmers, health workers, industry, consumers, interest groups and the general community)’; and building trust ‘to promote trust and credibility in the ability of the Regulatory Agencies and the Indian government to effectively regulate modern biotechnology’.
(f) At this juncture, it becomes pertinent to refer to the Cartagena Protocol and the Risk Analysis Framework provided under Annex-III of the said Protocol. The General Principles that are required to be followed by the Parties in developing risk assessment are:
118 | W.P. (C) 115 of 2004 & Ors.
“ …..
- Risk assessment should be carried out in a scientifically sound and transparent manner, and can take into account expert advice of, and guidelines developed by, relevant international organizations.
- Lack of scientific knowledge or scientific consensus should not necessarily be interpreted as indicating a particular level of risk, an absence of risk, or an acceptable risk.
- Risks associated with living modified organisms or products thereof, namely, processed materials that are of living modified organism origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology, should be considered in the context of the risks posed by the non-modified recipients or parental organisms in the likely potential receiving environment.
- Risk assessment should be carried out on a case- by-case basis. The required information may vary in nature and level of detail from case to case, depending on the living modified organism concerned, its intended use and the likely potential receiving environment.” (Emphasis supplied)
(g) The steps provided under this Protocol for risk assessment:
“8. To fulfil its objective, risk assessment entails, as appropriate, the following steps:
(a) An identification of any novel genotypic and phenotypic characteristics associated with the living modified organism that may have adverse effects on biological diversity in the likely potential receiving environment, taking also into account risks to human health;
119 | W.P. (C) 115 of 2004 & Ors.
(b) An evaluation of the likelihood of these adverse effects being realized, taking into account the level and kind of exposure of the likely potential receiving environment to the living modified organism;
(c) An evaluation of the consequences should these adverse effects be realized;
(d) An estimation of the overall risk posed by the living modified organism based on the evaluation of the likelihood and consequences of the identified adverse effects being realized;
(e) A recommendation as to whether or not the risks are acceptable or manageable, including, where necessary, identification of strategies to manage these risks; and
(f) Where there is uncertainty regarding the level of risk, it may be addressed by requesting further information on the specific issues of concern or by implementing appropriate risk management strategies and/or monitoring the living modified organism in the receiving environment.” (Emphasis supplied)
(h)After perusing the Cartagena Protocol and the Risk Analysis Framework developed by the concerned ministries, it is safe to deduce that Indian regulatory system has a sufficient and robust framework of risk analysis/assessment which can be used by the regulatory authorities to protect the health and ensure safety of the people as well as the environment, in accordance with 120 | W.P. (C) 115 of 2004 & Ors.
EPA,1986 ; also to foster the research and development in the field of GE plants.
iii. Regulations and Guidelines for Recombinant DNA and Biocontainment, 2017
(a) These guidelines were issued on 1st April 2018 with the following objectives:
“i. Outline the general principles of containment and establish a minimum standard for laboratories that must be adopted pan India for all handling of genetically engineered (GE) organisms (organism includes microorganisms, animals, plants, arthropods, aquatic animals, etc.) and non-genetically engineered (non-GE) hazardous microorganisms (microorganism includes parasites, protozoa, algae, fungi, bacteria, virus, prions, etc.).
ii. Identify the levels of risk(s) associated with GE organisms and non-GE hazardous microorganisms and classification of those organisms into their respective risk groups to select appropriate containment facilities. It also covers certification of containment facilities.
iii. Prescribe criteria for Manufacture, Use, Import, Export, Exchange and Storage of any hazardous microorganisms, GE organisms or cells and products) produce through exploration of such organisms.
iv. Ensure that national authorities, institutions and all other stakeholders involved in research & development are well informed or have access to information on safety thereby facilitating the safe use and handling of hazardous microorganisms, GE organisms or cells and product(s) produce through exploration of such organisms.
v. Emphasis the need and responsibility of all national authorities, institutions and all other stakeholders
121 | W.P. (C) 115 of 2004 & Ors.
involved in research to ensure that the public is well informed about the containment strategies followed in India.” “SCOPE This document covers regulatory scope on rDNA research and handling of hazardous microorganisms and GE organisms or cells in India.
Adoption of these guidelines shall be binding pan India for all public and private organisations involved in research, development and handling of GE organisms (organism includes microorganisms, animals, plants, arthropods, aquatic animals etc.) and non-GE hazardous microorganisms (microorganism includes parasites, protozoa, algae, fungi, bacteria, virus, prions, etc.) and products produced through exploration of such organisms.
Note: These guidelines do not overwrite any other existing regulations or guidelines, unless specified here.” (Emphasis supplied)
(b) These guidelines are divided into 4 chapters- Chapter 1:
Regulations and Competent Authorities; Chapter 2:
Principles and Components of Containment; Chapter 3:
Operational Guides on Containment; Chapter 4:
Containment Requirement for Import, Export and Exchange. Each of these issues covered in the Chapter is dealt with in considerable detail and I have perused the same however refrain from dealing with them in extenso.
122 | W.P. (C) 115 of 2004 & Ors.
iv. Guidelines and SOPs for confined field trials of Regulated, GE plants 2008 – The scope of these guidelines is defined as under:
“These guidelines are intended to provide guidance to applicants for the conduct of confined trials. They are not intended to explicitly define all the requirements for the conduct of a confined field trial, as further terms and conditions/requirements may be identified during the review process by the Regulatory Authorities. This document covers all GE/transgenic plants modified through recombinant DNA (rDNA) technology.”
- It is in this background, having taken note of and considered the law, the relevant documents and all other essentialities, that the challenge raised by the Petitioners must be seen.
- The conditional approval, leading to field trials for DMH-11 is in line with a developmental approach, of a scientific temper. The same has been supplemented with conditions imposed by the expert body, to facilitate mitigating measures qua the environment, which I have discussed above.
- While examining the propriety of the conditional approval granted by the GEAC (to DMH-11) qua the precautionary principle, it becomes essential to look to the past orders of this Court, in these
123 | W.P. (C) 115 of 2004 & Ors. petitions, in order to understand the position taken, thus far, qua the activities of this body.
(a) On 22.09.2006, the Court observed that on 01.05.2006, while issuing orders in an Interlocutory Application, held that all trials will be conducted only with the approval of the GEAC. On this date, it was further observed that the Court was not inclined to direct the stoppage of field trials but, it did direct a pause on approvals, subject to having heard all sides.
(b) On 13.10.2006, as an interim measure, the Court permitted the applicant to plant DMH-11 variety for experimental purpose in its field subject to all precautions.
(c) On 15.12.2006, on being presented with some information which questioned the permission to plant the DMH-11 variety for testing, and a prayer regarding uprooting thereof, directions were issued to the GEAC to examine the impact of field tests being carried out, with reference to the experts referred to. An independent view was directed to be furnished by the GEAC. It was observed as under:
124 | W.P. (C) 115 of 2004 & Ors.
“Today, our attention has been drawn by the learned counsel for the petitioner to clause (23) of the Convention on Biological Diversity which, inter alia, recommends that in the current absence of reliable data on genetic use restriction technologies [GURT], without which there is an inadequate basis on which to assess their potential risks, and in accordance with the precautionary approach, products incorporating such technologies should not be approved by parties or field testing until appropriate scientific data can justify such testing. Further, reliance has been placed on the expert opinion of Professor Joe Cummins, Professor Jack Heinemann and Professor Dough Gurian Sherman to contend that barnase unaccompanied by its specific inhibitor barstar is known to be a potent cell poison. Traces of barnase are toxic to the rat kidney and to human cell lines. Barnase is actually being exploited as a conditional suicide gene to cause cell death in mammalian and human cells when it is induced, and cell toxicity caused by barnase may be affected by RNA interference. Relying on these experts, learned counsel contends that, as indicated in the order dated 13th October, 2006, direction be issued for uprooting the plant otherwise risk is being run for permanent escape of the gene and other damages which it may cause. Before we consider this prayer further, we deem it appropriate to direct G.E.A.C. to examine in detail the impact of the field test being carried also with reference to the expert opinion. We may, however, note that the applicant’s case is that it has modified its technology and is not using GURT. We say nothing on this aspect. We expect independent expert opinion from G.E.A.C. on this subject.” (Emphasis supplied)
(d) On 08.05.2007, it was observed that in total, 91 field testing operations were being undertaken. It was further directed that-
125 | W.P. (C) 115 of 2004 & Ors.
“The GEAC shall take sufficient precautions to see that these trials are not causing any contamination to the cultivation of neighboring fields. There should be at least 200 meters distance from the trial fields from the neighboring field having same type of cultivations. All the trials which are being conducted, the name of the scientist and other details who will be responsible for all aspects of the trials should be reported to GEAC and they should be regular supervision by them. Prior to bringing out the GM material from the green house for conduct of open field trials, the approved institution should submit a validated event specific test protocol at an LOD of at least 0.01% to detect and confirm that there has been no contamination… GEAC should also verify whether these species by commercial use create any toxicity or allergenicity to any of the users in organic conducted with these varieties of Bt cotton. If any such test has been conducted, the data should be made available to this Court.” (Emphasis supplied)
(e) On 13.02.2008, the restriction placed by this Court upon granting approvals was lifted and GEAC was permitted to consider all applications. To assuage the worries of the Petitioner in regard to the proper constitution of the GEAC, the latter was requested to invite Dr. P.M. Bhargava and Prof. M.S. Swaminathan to its meetings. It was further observed that if any person was dissatisfied by the decision arrived at by the Committee, an appeal may be preferred to the Appellate Committee and, that the apprehensions in 126 | W.P. (C) 115 of 2004 & Ors.
regard to negative effect of open field trials, be also considered by the Committee. It was further directed that the guidelines to grant approvals be published on the website of the Committee.
(f) On 07.10.2016, this Court recorded the submission of the Additional Solicitor General, that release was not allowed till 17.10.2016 because the Government had sought views from the public and after receiving public views/objections, the committee of experts would consider such matter. 34.1 As the above referred orders point out, throughout the entire process of field testing, being taken stock of, at regular intervals by the Court, it has not, even for a moment doubted the authority of the GEAC and its ability to function properly. Repeatedly, it has been emphasised that the GEAC, being the apex body would be responsible for taking all precautions/adopting safeguards and ensuring that no contamination takes place in planting of GM seeds. 34.2 In one of the orders referred above, it has been noted that 91 field trials were underway at one point. In the extensive 127 | W.P. (C) 115 of 2004 & Ors.
arguments made by the Petitioners, not even a single negative instance could be pointed out to show that the field trials impacted the agriculture, environment, biodiversity negatively or irrevocably. Furthermore, as pointed out by the Union of India, trials of DMH-11 have commenced in 6 out of the 8 sanctioned locations (seeds have been planted) and no adverse change therein has been reported thus far. The fears, raised by the Petitioners, therefore, are not substantiated by any negative occurrence.
34.3 The members of the GEAC under the 1989 Rules, are experts in their relevant fields. The approval has come, as discussed above, in consonance with the relevant statutory framework. Furthermore, adequate safeguards have been included in the approval itself, in accordance with the precautionary principle. There is an additional ground, upon whose anvil, the decision to grant conditional approval as also the general introduction of GMOs into the sphere of common consumption, which has been sought to be banned by the present petitions, has to be weighed.
128 | W.P. (C) 115 of 2004 & Ors.
35. Whether or not the State allows or disallows the scientific experimentation of a particular kind of crop, particularly when the Central Government is the primary authority entrusted with such function, is a decision squarely within their domain and the role of the Courts therein is circumscribed to the violation of fundamental rights; manifest arbitrariness; conflict with any other law and/or other grounds of similar nature.
- In reference to public interest, in this particular context, Article 48 of the Directive Principle of the State Policy (hereinafter referred to as ‘DPSP’) would be instructive in order for the concerned branch of the Government to frame policy and take steps in this regard being whilst being entirely in line with the Constitution of India which undoubtedly is the source of all power, legitimacy and is the ultimate guide for all actions. It states that there shall be an endeavour to organise agriculture on modern and scientific lines. State of Gujarat v. Mirzapur Moti Kureshi Kassab Jamat (7-Judge Bench)43, observed:
“Article 48 consists of two parts. The first part enjoins the State to “endeavour to organise agricultural and 43 (2005) 8 SCC 534 129 | W.P. (C) 115 of 2004 & Ors.
animal husbandry” and that too “on modern and scientific lines”. The emphasis is not only on “organisation” but also on “modern and scientific lines”. The subject is “agricultural and animal husbandry”.”
- A wholistically aware adoption of GMOs into agriculture appears to be in furtherance of this goal. The phrase ‘wholistically aware’ may require some exposition. What this means is that while GMOs are brought into the agricultural scene and eventually made available for commercial use, it should be so done keeping in mind the essentiality of preserving naturally occurring seeds, ensuring that all other factors such as health, socio-economic impact, environmental/biodiversity impact, accessibility to farmers, proper control and marking of such modified crops etc. would be required to be in place.
- In continuation to the above, reference has also to be made to Article 51A(h) of the Constitution of India which imposes a fundamental duty upon all in the following terms:
“h) to develop the scientific temper, humanism and the spirit of inquiry and reform;” 130 | W.P. (C) 115 of 2004 & Ors.
38.1 This Court in AIIMS Students’ Union v. AIIMS (3-Judge Bench)44 observed:
“58. … Fundamental duties, as defined in Article 51- A, are not made enforceable by a writ of court just as the fundamental rights are, but it cannot be lost sight of that “duties” in Part IV-A Article 51-A are prefixed by the same word “fundamental” which was prefixed by the founding fathers of the Constitution to “rights” in Part III. Every citizen of India is fundamentally obligated to develop a scientific temper and humanism. He is fundamentally duty-bound to strive towards excellence in all spheres of individual and collective activity so that the nation constantly rises to higher levels of endeavour and achievements. State is, all the citizens placed together and hence though Article 51-A does not expressly cast any fundamental duty on the State, the fact remains that the duty of every citizen of India is the collective duty of the State. … In the era of globalisation, where the nation as a whole has to compete with other nations of the world so as to survive, excellence cannot be given an unreasonable go-by and certainly not compromised in its entirety. Fundamental duties, though not enforceable by a writ of the court, yet provide a valuable guide and aid to interpretation of constitutional and legal issues. In case of doubt or choice, people’s wish as manifested through Article 51-A, can serve as a guide not only for resolving the issue but also for constructing or moulding the relief to be given by the courts. Constitutional enactment of fundamental duties, if it has to have any meaning, must be used by courts as a tool to tab, even a taboo, on State action drifting away from constitutional values.” (Emphasis supplied) 44 (2002) 1 SCC 428 131 | W.P. (C) 115 of 2004 & Ors.
38.2 Similarly, in Charu Khurana v. Union of India (2-Judge Bench)45 , this Court observed:
“32. The purpose of referring to the same is to understand and appreciate how the directive principles of State policy and the fundamental duties enshrined under Article 51-A have been elevated by the interpretative process of this Court. The directive principles have been regarded as the soul of the Constitution as India is a welfare State. At this juncture, it is apt to notice the view expressed by a two-Judge Bench of this Court in Ashoka Smokeless Coal India (P) Ltd. v. Union of India [(2007) 2 SCC 640] wherein it has been laid down that: (SCC p. 683, para
106) “106. … the directive principles of State policy provide for a guidance to interpretation of fundamental rights of a citizen as also the statutory rights.” (Emphasis supplied)
- The Union of India has submitted that comprehensive risk assessment qua GMOs cannot be done at the initial research stage and all consultations cannot take place for each application on GM crops at an early stage. It was further submitted that toxicology studies are varied on product by product basis, as per international best practices and therefore toxicity studies are undertaken as per guidelines on a case-by-case basis. 45 (2015) 1 SCC 192 132 | W.P. (C) 115 of 2004 & Ors. 40. The experimentation in respect of GMOs, i.e. field trials, lab testing etc. would be in line with the development of a scientific temper along with the precautionary principle which has found its place within Article 21 of the Constitution of India. Field trials are a significant step in the development of crop varieties as the data representing the plant’s response to a particular agro- ecological environment can be collected only when such plant is grown outside in confined field trials. Without field trials, the performance of the plant in the field or environmental safety of such plant cannot be known. Studies, being conducted in open environment is necessary for studying the impact on human health and biodiversity, for the performance of a GM crop is dependent on a host environment. This would be essential to developing appropriate biosafety mechanisms as well.
- The judgments referred above recognise fundamental duties as an important guide to interpretation of the Constitution, which obviously would apply to the understanding of Article 21 as well. In Ramlila Maidan Incident, In re (2-Judge Bench)46, the 46 (2012) 5 SCC 1 133 | W.P. (C) 115 of 2004 & Ors. interdependency of the three parts of the constitution was highlighted by Swatanter Kumar J. (as he then was) in the following words:
“22. Thus, a common thread runs through Parts III, IV and IV-A of the Constitution of India. One Part enumerates the fundamental rights, the second declares the fundamental principles of governance and the third lays down the fundamental duties of the citizens. While interpreting any of these provisions, it shall always be advisable to examine the scope and impact of such interpretation on all the three constitutional aspects emerging from these Parts.” (Emphasis supplied)
- The development of scientific temper is to be read with another limb of the DPSPs and Fundamental Duties enshrined in the Constitution that is Article 48A and Article 51A(g) respectively which speaks of protection of the environment. As already noticed above, these three parts forming the heart and soul of the Constitution have to be read as a whole and as such any and all considerations of modernising agriculture or building a scientific temper would also be required to necessarily consider and abide by the duty to protect the environment.
134 | W.P. (C) 115 of 2004 & Ors. 43. It is also to be noted that, similar to when a legislative body enacts a legislation there is a presumption of constitutionality unless proven otherwise, similarly, a policy decision when taken by the competent authority enters the fray of enforcement with a presumption in its favour of being in public interest, unless otherwise shown, demonstarted and proven to be among other grounds, manifestly arbitrary. This presumption extends, subject of course to just exceptions, to the authority having considered duties as discussed above in framing policies for GMOs. - It must be kept in mind that India is a global agricultural powerhouse and from an economic standpoint, rural India is still largely dependent on agriculture. This court has stated in Electrosteels (supra) that the Court cannot be oblivious to the economy. Therefore, informed agricultural policy decisions must be viewed in that conspectus, which is to further and supplement India’s development, growth and self-sustenance. The relevance of such policy decisions being that, for instance, as submitted by the Union of India, India has been dependent on imports to meet more than half of the edible oil demand [55.76%, 155.33 Lakh 135 | W.P. (C) 115 of 2004 & Ors. Tonnes (2022-23) – Rs.1,15,000/- crores in 2020-21]. Therefore, in my view, the use of GM technology has to be seen in this backdrop.
- On numerous occassions, this Court has reiterated the view discussed in the preceding paragraphs.
45.1 This Court in State of U.P. v. Abhay Nandan Inter College47 (2-Judge Bench) observed:
“36. A policy decision is presumed to be in public interest, and such a decision once made is not amenable to challenge, until and unless there is manifest or extreme arbitrariness, a constitutional court is expected to keep its hands off.” 45.2 In State of Punjab v. Khan Chand48 (5-Judge Bench), KK Mathew J. dissenting, observed:
“23. … Courts and parties all assume that the Legislature always wants protection of the public interest, to serve public cause and do things for public good or to exercise powers for public purpose and always intends that administrators act justly and reasonably whether the Legislature says so in the statute or not [see Kenneth Culp Davis, “Administrative Law Treatise”, (1958) Vol. I, p. 87]. Every legislative body must be presumed to favour the 47 (2021) 15 SCC 600 48 (1974) 1 SCC 549 136 | W.P. (C) 115 of 2004 & Ors.
true, the good and above all the public interest and public good and whether it says so or not is of absolutely no consequence. …Government exists and its only title to exist is its claim to advance the public good and serve the public interest….” 45.3 On similar lines, in Central Inland Water Transport Corpn.
v. Brojo Nath Ganguly49 (2-Judge Bench) this Court observed:
“92. …Public policy, however, is not the policy of a particular government. It connotes some matter which concerns the public good and the public interest. The concept of what is for the public good or in the public interest or what would be injurious or harmful to the public good or the public interest has varied from time to time…” (Emphasis supplied) 45.4 In Premium Granites v. State of T.N50 (2-Judge Bench), it was observed:
“54. It is not the domain of the court to embark upon unchartered ocean of public policy in an exercise to consider as to whether a particular public policy is wise or a better public policy can be evolved. Such exercise must be left to the discretion of the executive and legislative authorities as the case may be. The court is called upon to consider the validity of a public policy only when a challenge is made that such policy decision infringes fundamental rights guaranteed by the Constitution of India or any other statutory right…” 49 (1986) 3 SCC 156 50 (1994) 2 SCC 691 137 | W.P. (C) 115 of 2004 & Ors.
45.5 In the well-known, Narmada Bachao Andolan v. Union of India51, (3-Judge Bench), this Court held:
“229. It is now well settled that the courts, in the exercise of their jurisdiction, will not transgress into the field of policy decision. Whether to have an infrastructural project or not and what is the type of project to be undertaken and how it has to be executed, are part of policy-making process and the courts are ill-equipped to adjudicate on a policy decision so undertaken. The court, no doubt, has a duty to see that in the undertaking of a decision, no law is violated and people’s fundamental rights are not transgressed upon except to the extent permissible under the Constitution.
x x x
- …The courts must, therefore, act within their judicially permissible limitations to uphold the rule of law and harness their power in public interest. It is precisely for this reason that it has been consistently held by this Court that in matters of policy the court will not interfere. When there is a valid law requiring the Government to act in a particular manner the court ought not to, without striking down the law, give any direction which is not in accordance with law. In other words the court itself is not above the law.” (Emphasis supplied) 45.6 Therefore, on this ground, interference by this Court would only be justified if it can be proven that the effect of such a decision standing would be detrimental to the public, against its interest and would ultimately impact the enjoyment of 51 (2000) 10 SCC 664 138 | W.P. (C) 115 of 2004 & Ors.
fundamental rights guaranteed by the Constitution, to a degree which would be impermissible. As has been demonstrated in the preceding paragraphs, that threshold cannot be said to have been breached. - In view of the entire conspectus above, the field testing of DMH- 11, pursuant to the conditional approval of the GEAC, with sufficient safeguards and precautions, ought to continue and cannot be said to be violative of the precautionary principle and therefore, the constitutional challenge thereto, fails.
- Two additional aspects need to be clarified. Pursuant to the above discussion, when I consider the prayer made on behalf of the Petitioners, it is clear that whether or not there should be a complete ban on Ht crops is not something this Court can issue a direction on. Such a decision has to be taken, keeping in view the opinion of various experts who have the knowledge and ability to comprehend scientific literature on the point as also the views of those persons specifically tasked with taking decisions in such matters. Courts, only on the basis of material placed on record or the indirect understanding passed on to it through counsel, is not 139 | W.P. (C) 115 of 2004 & Ors. in a position to take an informed decision. If such a decision is taken, it would be completely foreign to the standards of judicial review as discussed above, for it is not within the Court’s purview to undertake cost benefit analysis of a policy decision of the executive.
- The aspect of India being a centre of origin or diversity qua mustard was laid considerable emphasis on by the learned counsel for the Petitioners, however this, in my considered view, is another prayer with which this Court cannot do justice by returning or not returning a finding. Counsel on both sides supplied research material to support their own stand which argued contrarian viewpoints in this regard and so, it would be best if minds equipped to undertake detailed studies to come to a conclusion, would be the ones to decide this important issue. Conclusions & Directions
- In view of the above discussion, the conclusions arrived at in the discussion above are that:
140 | W.P. (C) 115 of 2004 & Ors.
i. Judicial review into the decision making of all bodies concerned with GMOs, is possible.
ii. The question of ban on Ht crops is not warranted in view of the precautionary principle and it is a decision squarely within the domain of policy.
iii. The composition of the GEAC is in accordance with the Rules, to which the challenge of constitutionality, has failed, and in the absence of any change in the Rules, no fault can be found with the same.
iv. The decision of the GEAC to grant conditional approval is not vitiated by non-application of mind, or any other principle of law, on part of the body, which itself is an expert body.
- In view of the above, I deem it appropriate to give the following directions:
50.1. Field trials of DMH-11, shall continue in strict consonance with the conditions imposed. The Union of India and statutory authorities shall continue to strictly monitor the same. In case 141 | W.P. (C) 115 of 2004 & Ors.
of any adverse change in circumstances, the decision for field trials can be reviewed.
50.2. GEAC to ensure that the conditions mentioned in the conditional approval of DMH-11 are strictly complied with by the applicant in letter and spirit.
50.3. The GEAC to take into account all environmental factors before granting future approvals and make an endeavour to have specifically designated farms for field testing, in collaboration with the Union of India.
50.4. All studies conducted and received while granting such approvals, to be uploaded on the website of the GEAC in a time-bound manner, in accordance with the mandate of law. The GEAC to ensure public participation in this process and wider publicity of the same to be facilitated. 50.5. That apart, wider publicity should also be given to GMOs in general, enabling people to take a decision in regard thereto, keeping in view all factors and specifications.
142 | W.P. (C) 115 of 2004 & Ors.
50.6. All decisions to be taken in regard to GMOs should endeavour to strictly follow “wholistically aware” approach which takes the preservation of naturally occurring seeds hand in hand with popularising Genetically Modified seeds. 50.7. The condition imposed in this Court’s order dated 08.05.2007 in respect of 200 meters distance being maintained between fields hosting GM crops versus those wherein regular seeds are planted, has to be strictly maintained.
50.8. The Post-Release Monitoring Committee be provided with adequate infrastructural and administrative facilities to closely monitor the field testing.
50.9. The Union of India may consider constituting a special cell under the MoEFCC to monitor all studies being undertaken with respect to GMO’s.
50.10. Before commercial release of DMH-11 and other GMOs in the future, specific testing on their impact on human health must be conducted prior thereto.
143 | W.P. (C) 115 of 2004 & Ors.
50.11. The GEAC or any other body, possessing sufficient expertise, duly notified by the government, to consider conducting independent studies on GMOs to ascertain the veracity of the data submitted by the applicant(s) so as to ensure that the approval so granted are bolstered by independent data informing such decision.
50.12. The Union of India should consider implementing a national, all-encompassing policy in respect of GMOs so as to ensure a streamlined approach to this important issue. Connected thereto, is the setting up of infrastructure including laboratories with state of the art facilities, to aid the interplay of biotechnology and agriculture and the advancement thereof. 50.13. Union of India to ensure strict compliance qua labelling of GM foods, in accordance with the Food Safety and Security Act.
- Before parting with the present lis, I lament the delay with which the present writ petition has come to be disposed. The genesis of this case was 20 years ago from the present day. The detrimental effect of such prolonged litigation was noted by this Court in Rajeev Suri (supra) wherein it was observed:
144 | W.P. (C) 115 of 2004 & Ors.
“574…the underlying principle at play is the duty of this Court to do complete justice as envisaged under Article 142 and to obviate the possibility of project of national importance being stuck, embroiled and delayed due to engagement of the project proponent before multiple legal forums/proceedings. We have had plethora of cases in the post-PIL period wherein prolonged litigation against infrastructural projects resulted in inordinate delays to the extent that the projects got buried forever or became unviable owing to excessive burden on the public exchequer (honest taxpayers’ money). That is where this Court’s power to do not only complete but substantial justice gets triggered.
x x x
- There is ample support to the proposition that when larger national interest is involved and concerns of public exchequer are directly involved in the lis, the Court must act at the earliest opportunity. For, each day’s delay has a direct impact on the exchequer. In Narmada Bachao Andolan v. Union of India [Narmada Bachao Andolan v. Union of India, (2000) 10 SCC 664] , the Court resonated this position and observed thus : (SCC pp. 761-62, para 227) “227. There are three stages with regard to the undertaking of an infrastructural project. One is conception or planning, second is decision to undertake the project and the third is the execution of the project. The conception and the decision to undertake a project is to be regarded as a policy decision. While there is always a need for such projects not being unduly delayed, it is at the same time expected that a thorough possible study will be undertaken before a decision is taken to start a project. Once such a considered decision is taken, the proper execution of the same should be undertaken expeditiously. It is for the Government to decide how to do its job. When it has put a system in place for the execution of a project and such a system cannot be said to be arbitrary, then the only role which a court 145 | W.P. (C) 115 of 2004 & Ors. may have to play is to see that the system works in the manner it was envisaged.” (Emphasis supplied)
- The above proposition resonates with the present case. Unfortunately, despite the national and public interest involved, this case remained pending for two decades, which must lead to introspection on both sides of the bench.
- I would like to place on record appreciation for all the counsel for taking us through the voluminous record and providing us with detailed hand-outs on the case file, which are purely a substance of their hard work.
- The writ petitions are dismissed and disposed of in terms of the above judgment. The contempt petitions stand closed in the above terms. The Civil Appeal stands disposed of in light of the above. Pending applications, if any, stand disposed of.
…………………….J. (SANJAY KAROL) Dated: 23rd July 2024 Place : New Delhi 146 | W.P. (C) 115 of 2004 & Ors.
IN THE SUPREME COURT OF INDIA CIVIL ORIGINAL/APPELLATE/INHERENT JURISDICTION WRIT PETITION (CIVIL) NO.115 OF 2004 GENE CAMPAIGN & ANOTHER … PETITIONERS VERSUS UNION OF INDIA & OTHERS … RESPONDENTS WITH WRIT PETITION (CIVIL) NO.260 of 2005 WRIT PETITION (CIVIL) NO.840 OF 2016 CIVIL APPEAL NO.4086 OF 2006 CONTEMPT PETITION (CIVIL) NO.295 OF 2007 IN WRIT PETITION (CIVIL) NO.260 of 2005 CONTEMPT PETITION (CIVIL) NO.6 OF 2016 IN WRIT PETITION (CIVIL) NO.260 of 2005 ORDER
- On the following aspects, there is consensus on the Bench:
That Judicial Review of the decision taken by the bodies concerned in the matter of GMOs is permissible.
2. We issue the following directions:
i. The respondent-Union of India is directed to evolve a National Policy with regard to GM crops in the realm of research, cultivation, trade and commerce in the country. The said National Policy shall be formulated in consultation with all stakeholders, such as, experts in the field of agriculture, biotechnology, State Governments, representatives of the farmers, etc. The National Policy to be formulated shall be given due publicity. ii. For the aforesaid purpose, the MoEF&CC shall conduct a national consultation, preferably within the next four months, with the aim of formulating the National Policy on GM crops. The State Governments shall be involved in evolving the National Policy on GM crops.
iii. Respondent – Union of India must ensure that all credentials and past records of any expert who participates in the decision-making process should be scrupulously verified and conflict of interest, if any, should be declared and suitably mitigated by ensuring representation to wide range of interests. Rules in this regard may be formulated having a statutory force.
iv. In the matter of importing of GM food and more particularly GM edible oil, the respondent shall comply with the requirements of Section 23 of FSSA, 2006, which deals with packaging and labelling of foods.
- Having regard to the difference of opinion expressed by us on the decision of the GEAC and MoEF granting conditional approval for environmental release of DMH-11, the Registry shall place the matter before Hon’ble the Chief Justice of India for constituting an appropriate Bench to consider the said aspect afresh.
………..………….………J. (B.V. NAGARATHNA) ………..………….………J. (SANJAY KAROL) New Delhi;
July 23, 2024
