Holding

The Supreme Court, due to a difference of opinion between the two judges, referred the matter to the Chief Justice of India for constituting an appropriate bench to decide the validity of the GEAC's approval for environmental release of DMH-11.

Summary

The case concerns a challenge to the Genetic Engineering Appraisal Committee (GEAC) approval dated 18.10.2022 and the consequent decision dated 25.10.2022 for the environmental release of transgenic mustard hybrid DMH-11. The petitioners argued that the approval suffered from procedural abnormalities, violated the right to a safe and healthy environment under Article 21, and contravened the precautionary principle. The two-judge bench delivered divergent opinions: Justice B.V. Nagarathna held that the approval was vitiated due to lack of proper deliberation, ignoring prior recommendations, and failure to assess risks, thereby violating the precautionary principle and public trust doctrine. Justice Sanjay Karol upheld the approval, finding that the GEAC acted within its powers, applied its mind, and that the decision was a policy matter not warranting judicial interference. Due to the difference of opinion, the matter has been referred to the Chief Justice of India for constitution of an appropriate bench to decide the validity of the approval. The court also issued common directions for evolving a national policy on GM crops, ensuring transparency, and compliance with labelling requirements under the Food Safety and Standards Act, 2006.

Issues considered

Whether GEAC approval dated 18.10.2022 and the consequent decision dated 25.10.2022 for the environmental release of DMH-11 was in accordance with law
Whether the decision to grant approval for environmental release of DMH-11 violated the right to safe and healthy environment under Article 21 of the Constitution
Whether GEAC’s grant of approval dated 18.10.2022 and the decision dated 25.10.2022 for the environmental release of DMH-11 violated the precautionary principle

Legislation cited

Cartagena Protocol on Biosafety
Constitution of Indias. 14, s. 21, s. 48, s. 48A, s. 51A
Environment (Protection) Act, 1986s. 25, s. 6, s. 8
Food Safety and Standards Act, 2006s. 22, s. 23
Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Micro-Organisms, Genetically Engineered Organisms or Cells, 1989s. 10, s. 13, s. 14, s. 15, s. 18, s. 19, s. 4, s. 7, s. 9
United Nations Convention on Biological Diversity (CBD), 1992

Subjects

Genetically Modified CropsGenetically Modified OrganismsTransgenic mustard hybridDhara Mustard Hybrid-11Environmental releaseConditional approvalRight to safe and healthy environmentPublic Trust doctrinePrecautionary principleJudicial ReviewNational PolicyBiosafetyBiological DiversityGenetic Engineering Appraisal Committee (GEAC)Ministry of Environment, Forest and Climate Change (MoEF)National consultationProcedural abnormalities in approvalHerbicide Tolerant (HT) cropTechnical Expert Committee (TEC)Parliamentary Standing Committees’ ReportsField trialsTrans-generational studiesRisk assessmentGenetic engineeringEcological impactEnvironmental constitutionalismEnvironmental governance

Judgment

[2024] 7 S.C.R. 1847 : 2024 INSC 545

Gene Campaign & Anr.
v.
Union of India & Ors.
(Writ Petition (Civil) No. 115 of 2004)
23 July 2024
[B.V. Nagarathna* and Sanjay Karol,* JJ.]

Issue for Consideration
Genetic Engineering Appraisal Committee (GEAC), a body under
the Department of Environment, Forest and Wildlife, in its 147th
meeting held on 18.10.2022, recommended environmental release
of transgenic mustard hybrid, Dhara Mustard Hybrid-11 (DMH-11),
which was accepted by the Central Government on 25.10.2022.
The issues for consideration were: (1) Whether GEAC approval
dated 18.10.2022 and the consequent decision dated 25.10.2022
for the environmental release of DMH-11 was in accordance with
law; (2) Whether the decision to grant approval for environmental
release of DMH-11 violated the right to safe and healthy environment
under Article 21 of the Constitution; and (3) Whether GEAC’s grant
of approval dated 18.10.2022 and the decision dated 25.10.2022
for environmental release of DMH-11 violated the precautionary
principle.

Headnotes†
Genetically Modified Organisms (GMO) – Judicial Review of
the decision taken by the bodies concerned in the matter of
GMOs – Held: Is permissible.
Genetically Modified (GM) crops – Directions issued to evolve
a National Policy with regard to GM crops in the realm of
research, cultivation, trade and commerce in the country
in consultation with all stakeholders, such as, experts in
the field of agriculture, biotechnology, State Governments,
representatives of the farmers, etc. and to be given due
publicity – Ministry of Environment, Forest and Climate Change
(MoEF&CC) to conduct a national consultation with the aim
of formulating the National Policy – State Governments shall
be involved in evolving the Policy – Respondent – Union
of India to ensure that all credentials and past records of
* Author
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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 – In the matter
of importing of GM food and more particularly GM edible oil,
the respondent shall comply with the requirements of s.23
of FSSA, 2006, which deals with packaging and labelling of
foods – Food Safety and Standards Act, 2006.
Genetically Engineered (GE) Crop – Transgenic mustard hybrid
(DMH-11) – Decision of GEAC and MoEF granting conditional
approval for environmental release of DMH-11 – Challenge to,
on grounds of procedural abnormalities in approval; violation
of right to safe and healthy environment; and violation of
precautionary principle – Difference of opinion between
Hon’ble Judges – Per Nagarathna, J., held, approval and
consequent decision for environmental release of transgenic
mustard hybrid DMH-11 violated the precautionary principle
inasmuch as no determination was made, as to, whether,
transgenic mustard hybrid DMH-11 is a Herbicide Tolerant
(HT) crop and if so, the nature of risk that would be caused
by the said plant to the environment including other plants as
well as to human beings and animals – The deliberations did
not focus inter alia, on aspects of biosafety, risk assessment,
soil health, micro-biology and socioeconomic aspects etc. –
Moreover, recommendations of Technical Expert Committee
(TEC) set up by Supreme Court and Parliamentary Standing
Committees’ Reports on Agriculture and on Science and
Technology, Environment and Forest were not considered –
Recommendations of GEAC as well as decision taken
by respondent-Union of India with regard to approving
environmental release of transgenic mustard hybrid DMH-11
were vitiated and hence, quashed – Per Karol, J., held, the
question of ban on HT crops is not warranted in view of the
precautionary principle and it is a decision squarely within the
domain of policy – Composition of GEAC was in accordance
with the Rules, to which the challenge of constitutionality,
has failed, and in the absence of any change in the Rules,
no fault can be found with the same – Decision of GEAC to
grant conditional approval is not vitiated by non-application of
[2024] 7 S.C.R. 1849

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

mind, or any other principle of law, on part of the body, which
itself is an expert body – Matter to be placed before Hon’ble
Chief Justice of India for constituting appropriate Bench to
consider said aspect afresh – Rules for the Manufacture, Use,
Import, Export and Storage of Hazardous Micro-Organisms,
Genetically Engineered Organisms or Cells, 1989 [framed
under ss.6, 8 and 25 of Environment (Protection) Act, 1986]
Held [per B.V. Nagarathna, J.]:
1.1. GEAC simply recommended the environmental release of transgenic
mustard hybrid DMH-11 without any deliberation as such, which
recommendation was accepted by the Central Government – All
the previous deliberations and decisions of GEAC as well as the
recommendations and suggestions of the sub-committee to GEAC
were given a go by and totally ignored – The deferring of the field
demonstration between the years 2018 to 2021, which was for valid
reasons, was also ignored – There is no reason forthcoming as to
why GEAC completely changed its stance in the 147th meeting
held on 18.10.2022 – This resulted in the decision of the Union
Government on 25.10.2022 impugned herein – There is no material
put forth for the sudden decision taken by the Union Government
on receiving the changed recommendation of GEAC, when earlier,
it was submitted before this Court that the Union Government
was still deliberating on the matter, which aspect is evident from
the orders passed by this Court when in fact field demonstration
was also put on hold by GEAC – Such being the position from
the year 2018 onwards, all of a sudden environmental release
of DMH-11 was approved even in the absence of field trials for
conducting studies on the impact of honeybees and other pollinators.
[Paras 42.5 and 42.6]
1.2. Furthermore, while granting permission of the environmental release
of transgenic mustard hybrid DMH-11, the condition imposed was
that usage of any formulation or herbicide would not be permitted
for cultivation in the farmer’s field and any such use in the farmer’s
field without due approval would attract appropriate legal action
under various enactments – There is no indication as to how the
use of any herbicide could be prevented, rather, the condition not
to use any herbicide was open-ended without having any means
to check whether any herbicide would be used in the farmer’s
field pursuant to the environmental release – The adverse effects
1850 [2024] 7 S.C.R.

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of use of herbicide were also totally given a go by – Further, any
evidence of harmful effects or damage to the environment, nature
and health owing to non-compliance of conditions stipulated by
GEAC was also left open-ended. [Paras 42.13 and 42.15]
1.3. Moreover, GEAC’s proposal was simply accepted by the MoEF&CC
and immediately notified without any further consideration at the
level of the Ministry and without having any inter-departmental
consultation with the Ministry of Health, MoA and DBT in the
Ministry of Science and Technology. [Para 42.16]
1.4. Also, no consultation was held with the States wherein mustard is
grown, although agriculture is a State subject under Entry 14 of
List II of the Constitution – The other concerned stakeholders also
ought to have been consulted before a decision was taken by the
Union of India in terms of the recommendation of GEAC – The
Union of India could not have unilaterally acted on such a serious
matter without bringing to the notice of the States, particularly in
the northern and northwestern States of the country where mustard
is being grown. [Para 42.17]
1.5. Further, no material has been brought out as to how the decision
of GEAC was accepted by MoEF&CC and the recommendation
of the environmental release of transgenic mustard hybrid
DMH-11 was simply permitted – The grant of approval by GEAC
is governed by Rule 13 – The said Rule does not contemplate
any role for the Ministry of Environment, Forest and Climate
Change (MoEF&CC) in the decision-making process – Therefore,
the lateral intervention by the said Ministry seriously undermines
the credibility and integrity of the decision making as well as the
regulatory process. [Para 42.18]
1.6. When a statute contemplates a specific procedure to be adhered
to in order to arrive at a desired end, such procedure cannot be
substituted by an alternative procedure which is not contemplated
under the statute – At the crucial 147th meeting of GEAC held on
18.10.2022, there was no representative of the ICMR, Ministry of
Health – Hence, the matter was not considered from the paradigm
of the adverse effect on the health of human beings and animals
as well as on other plants in the event of environmental release.
[Paras 42.20 and 42.21]
1.7. Recommendations of the Technical Expert Committee (TEC)
submitted to this Court have been completely ignored by
[2024] 7 S.C.R. 1851

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

GEAC – Pursuant to the intervention of the Ministry, GEAC
constituted another Expert Committee and simply accepted its
recommendations for the environmental release of DMH-11 hybrid
mustard – This was by ignoring all previous deliberation made
by GEAC, its sub-committee constituted earlier and its decision
to proceed with precaution – GEAC approval dated 18.10.2022
and the consequent decision dated 25.10.2022 regarding the
environmental release of transgenic mustard hybrid DMH-11 is
vitiated – The impugned approval was in gross violation of the
principle of public trust. [Paras 42.22 and 43]
2. The failure to conduct chronic and trans-generational studies to
study the impact on human health is a significant omission within
the risk assessment process in the instant case – The asymmetry
between probable benefits and adverse consequences cannot be
adequately counter-balanced by economic or policy safeguards
because of the serious and irreversible public and environmental
health effects if such consequences occur – The failure to
publish the biosafety dossier on the website reveals a deficiency
in the Guidelines for Environmental Risk Assessment (ERA) for
Genetically Engineered (GE) Plants, 2016 – Furthermore, the failure
to furnish cogent reasons for giving a go by to field demonstration
studies to study the impact on honeybees also reveals the lack of
safeguards against misuse of discretion – The failure to adequately
assess health and environmental impact of GM crops seriously
infringes upon intergenerational equity as it potentially endangers
the ability of future citizens to enjoy the highest attainable standard
of health – The decision to grant approval for environmental release
of transgenic mustard hybrid DMH-11 violates the right to safe and
healthy environment under Article 21 of the Constitution of India
because the safeguards which were necessary to be taken prior
to the grant of the approval have not been taken in the instant
case. [Paras 43.1(iii), 44.1, 44.3 and 44.5]
3.1. Given the fact that genetic engineering has made what was
inconceivable a reality, precaution is the need of the hour – For
billions of years, each living organism would exchange DNA with
others of its kind – Genetic engineering transcends this natural
principle by combining genes sourced from widely different species
and transferring genes between organisms that had no natural
possibility of interbreeding – Scientific research of such a novel
nature must therefore happen under supervision and in a manner
that inspires public confidence. [Para 45]
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3.2. Having regard to the conclusions of the TEC, the apprehensions
of the petitioners that HT crops would exert a highly adverse
impact over time on sustainable agriculture, rural livelihoods, and
the environment are not unfounded – It is reasonable to infer that
there is a potential of loss of species of indigenous mustard crop,
as India is the centre of origin and diversity, which fact cannot
be doubted – The concerns about the impact on other beneficial
organisms, such as honeybees, earthworms etc. are also 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 Convention on Biological Diversity (CBD) and Article
26 of the Cartagena Protocol on Biosafety (CPB) – Therefore,
GEAC is duty bound, both under domestic and international law,
to sanction long-term chronic and inter-generational studies, as
recommended by the TEC – The reluctance to conduct such
studies would risk the health of future generations as well as the
farmers’ right to conduct their agricultural activities in the most
suitable manner. [Para 46]
3.3. The ability to conduct robust risk assessment hinges upon the
availability of indigenous and independent studies and research –
Conclusions about safety assessment and ecological impact cannot
be transplanted from research conducted in a foreign context –
Crucially, the recommendation of Expert Committee constituted by
GEAC in the year 2022, which is the basis of GEAC’s impugned
approval, is entirely premised upon foreign studies and research
and not on indigenous research or studies – This is a serious
omission on the part of GEAC in not applying its mind to research
studies to be conducted within the country as India has a unique
biodiversity and a socio-economic structure of society which
is directly related to land holdings and conduct of agricultural
operations. [Para 47.3]
3.4. It is apparent that the precautionary principle has been seriously
undermined in Condition VI and VII prescribed by GEAC for the
impugned release – Although Condition VII prohibits farmers from
using any formulation of herbicide in the fields, it is unclear how
such a prohibition would be enforced – Given the nature of the
DMH-11 which according to the petitioners has HT characteristics,
[2024] 7 S.C.R. 1853

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

the impact upon non-target organisms and beneficial organisms
could be seriously detrimental to agrarian ecology – The proposed
conditions for approval are neither adequate nor feasible to limit
these consequences – GEAC failed to take into consideration the
precautionary principles while approving the environmental release
of the transgenic mustard DMH-11 hybrid. [Para 47.6]
3.5. The evolution of the right to a safe and healthy environment
and the concomitant duty of the State to uphold public trust and
abide by inter-generational equity and the precautionary principle
in environmental regulation is the bedrock of environmental
constitutionalism – The environmental rights regime is a product
of decades of environmental litigation by civil society, social
movements, affected communities and the general citizenry – In that
sense, environmental constitutionalism is a facet of transformative
constitutionalism touching upon the socio-economic lives of
citizens – In other words, the affected communities must have a
substantive role in environmental governance. [Para 48.7]
3.6. The aspiration of transformative environmental governance
cannot be realised merely through an effective bureaucracy
and sound technical expertise – Environmental democracy
and environmental rights are two sides of the same coin –
Environmental decision-making in a rapidly changing climate
requires healthy contestation of alternative worldviews, interests
and rights – Only through such contestation can a fine and
sustainable balance between development and the environment be
arrived at – Open and transparent deliberation on expert knowledge
increases accountability and acts as a safeguard against conflict
of interest but not a closed door decision making process.
[Paras 48.8 and 48.9]
Held [per Sanjay Karol, J.]:
1. The power of the GEAC, to grant approvals, necessarily carries
with it the power to regulate the manner, in which the approvals
are so granted – The mere absence of a specific statement in
the 1989 Rules allowing assistance of expert committees, would
not preclude the GEAC from doing so, in furtherance of its main
objective – The decision of the GEAC cannot be said to be vitiated
by delegation – GEAC had constituted a sub-committee and
expert committee respectively, in its 126th and 146th meeting, with
1854 [2024] 7 S.C.R.

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a specific purpose on each occasion – This cannot be said to be
delegating its core function – The present factual circumstance is
not a case, where the approval process itself has been delegated
to the sub-committee/expert committee – The conditional approval
of DMH-11 granted by the GEAC, is upheld as being independent,
reasoned and in consonance with the rules. [Paras 25(a) 23,
25(a) 21, 25(a) 14, 25(a) 17, 25(b) 5].
2. Even if the TEC and parliamentary standing committees have
found certain issues with the procedures governing GM crops,
that cannot automatically lead to the conclusion that gaps in
the impugned procedures result in a violation of Part III of the
Constitution of India and must be invalidated or that the impugned
action be stalled. [Para 29.5]
3. Whether or not the State allows or disallows the scientific
experimentation of a particular kind of crop, particularly when the
Central Government is the primary authority entrusted with such
function, is a decision squarely within their domain and the role of
the Courts therein is circumscribed to the violation of fundamental
rights; manifest arbitrariness; conflict with any other law and/or
other grounds of similar nature. [Para 35]
4. The experimentation in respect of GMOs, i.e. field trials, lab testing
etc. would be in line with the development of a scientific temper along
with the precautionary principle which has found its place within
Article 21 of the Constitution of India – Field trials are a significant
step in the development of crop varieties as the data representing
the plant’s response to a particular agroecological environment can
be collected only when such plant is grown outside in confined field
trials – Without field trials, the performance of the plant in the field
or environmental safety of such plant cannot be known – Studies,
being conducted in open environment is necessary for studying
the impact on human health and biodiversity, for the performance
of a GM crop is dependent on a host environment – This would
be essential to developing appropriate biosafety mechanisms as
well. [Para 40]
5. Similar to when a legislative body enacts a legislation there is a
presumption of constitutionality unless proven otherwise, a policy
decision when taken by the competent authority enters the fray
of enforcement with a presumption in its favour of being in public
interest, unless otherwise shown, demonstrated and proven to
[2024] 7 S.C.R. 1855

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

be among other grounds, manifestly arbitrary – This presumption
extends, subject of course to just exceptions, to the authority
having considered duties in framing policies for GMOs. [Para 43]
6. Interference by this Court would only be justified if it can be proven
that the effect of a decision standing would be detrimental to the
public, against its interest and would ultimately impact the enjoyment
of fundamental rights guaranteed by the Constitution, to a degree
which would be impermissible – That threshold cannot be said to
have been breached – The field testing of DMH11, pursuant to the
conditional approval of the GEAC, with sufficient safeguards and
precautions, ought to continue and cannot be said to be violative
of the precautionary principle and therefore, the constitutional
challenge thereto, fails. [Paras 45.6 and 46]
7. It is clear that whether or not there should be a complete ban on
Ht crops is not something this Court can issue a direction on –
Such a decision has to be taken, keeping in view the opinion of
various experts who have the knowledge and ability to comprehend
scientific literature on the point as also the views of those persons
specifically tasked with taking decisions in such matters – Courts,
only on the basis of material placed on record or the indirect
understanding passed on to it through counsel, is not in a position
to take an informed decision – If such a decision is taken, it would
be completely foreign to the standards of judicial review, for it is
not within the Court’s purview to undertake cost benefit analysis
of a policy decision of the executive. [Para 47]

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768 : (1974) 1 SCC 549; Central Inland Water Transport Corpn.
v. Brojo Nath Ganguly [1986] 2 SCR 278 : (1986) 3 SCC 156;
Premium Granites v. State of T.N. [1994] 1 SCR 579 : (1994) 2
SCC 691 and Narmada Bachao Andolan v. Union of India [2000]
Supp. 4 SCR 94 : (2000) 10 SCC 664 – relied on.
State of U.P. v. Batuk Deo Patil Tripathi [1978] 3 SCR 131 : (1978)
2 SCC 102 – followed.
Delhi Development Authority v. Joint Action Committee, Allottee of
SFS Flats [2007] 13 SCR 811 : (2007) 4 SCC 737; Kantha Vibhag
Yuva Koli Samaj Parivartan Trust v. State of Gujarat [2022] 1 SCR
1006; Singrauli Super Thermal Power Station v. Ashwani Kumar
Dubey [2023] 10 SCR 440 : (2023) 8 SCC 35; E.P. Royappa
v. State of T.N. [1974] 2 SCR 348 : (1974) 4 SCC 3; State of
T. N. & Ors. v. Ananthi Ammal [1994] Supp. 5 SCR 666 : (1995)
1 SCC 519; State of A.P. v. McDowell & Co. [1996] 3 SCR 721 :
(1996) 3 SCC 709; Onkar Lal Bajaj v. Union of India [2002] Supp.
5 SCR 605 : (2003) 2 SCC 673; 5 M & T Consultants v. S.Y.
Nawab (2-Judge Bench) [2003] Supp. 4 SCR 187 : (2003) 8 SCC
100; Delhi Science Forum v. Union of India [1996] 2 SCR 767 :
(1996) 2 SCC 405; Bombay Dyeing & Mfg. Co. Ltd. (3) v. Bombay
Environmental Action Group [2006] 2 SCR 920 : (2006) 3 SCC 434;
A.P. Dairy Development Corpn. Federation v. B. Narasimha Reddy
[2011] 14 SCR 1 : (2011) 9 SCC 286; State of T.N. v. K. Shyam
Sunder [2011] 11 SCR 1094 : (2011) 8 SCC 737; Association for
Democratic Reforms & Anr v. Union of India & Ors. [2024] 2 SCR
420; Dharam Dutt v. Union of India [2003] Supp. 6 SCR 151 :
(2004) 1 SCC 712; K.S. Puttaswamy v. Union of India [2018] 8
SCR 1 : (2019) 1 SCC 1; Madras Bar Association v. Union of India
& Anr. [2021] 5 SCR 791 : (2022) 12 SCC 455; Indian Express
Newspaper v. Union of India [1985] 2 SCR 287 : (1985) 1 SCC
641; Khoday Distilleries Ltd. v. State of Karnataka [1995] Supp.
6 SCR 759 : (1996) 10 SCC 304; Shayara Bano v. Union of India
& Ors. [2017] 9 SCR 797 : (2017) 9 SCC 1; Kalpana Mehta v.
Union of India [2018] 4 SCR 1 : (2018) 7 SCC 1; Vellore Citizens
[2024] 7 S.C.R. 1859

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

Welfare Forum v. Union of India [1996] Supp. 5 SCR 241 : (1996)
5 SCC 647; Hospitality Association of Mudumalai v. In Defence
of Environment & Animals [2020] 10 SCR 273 : (2020) 10 SCC
589; M.C. Mehta v. Union of India [2003] 3 SCR 925 : (2002) 4
SCC 356; State of Gujarat v. Mirzapur Moti Kureshi Kassab Jamat
[2005] Supp. 4 SCR 582 : (2005) 8 SCC 534; AIIMS Students’
Union v. AIIMS [2001] Supp. 2 SCR 79 : (2002) 1 SCC 428; Charu
Khurana v. Union of India [2014] 12 SCR 259 : (2015) 1 SCC
192; Ramlila Maidan Incident, In re: [2012] 4 SCR 971: (2012) 5
SCC 1 – referred to.

Books and Periodicals Cited
In the judgment of B.V. Nagarathna, J.
Erskine May’s Treatise on The Law, Privileges, Proceedings
and Usage of Parliament, (Lexis Nexis, 24th Edn. 2011, p.37.]
and Justice G.P. Singh, in Principles of Statutory Interpretation
(14th Edn.) – referred to.
In the judgment of Sanjay Karol, J.
Merriam Webster dictionary https://www.merriam-webster.com/
dictionary/Bt; https://www.du.ac.in/index.php?page=centre-for-
genetic-manipulation-of-crop-plants – referred to.

List of Acts
Food Safety and Standards Act, 2006; Environment (Protection)
Act, 1986; Rules for the Manufacture, Use, Import, Export and
Storage of Hazardous Micro-Organisms, Genetically Engineered
Organisms or Cells, 1989; Constitution of India; United Nations
Convention on Biological Diversity (CBD), 1992; Cartagena
Protocol on Biosafety.

List of Keywords
Genetically Modified Crops; Genetically Modified Organisms;
Transgenic mustard hybrid; Dhara Mustard Hybrid-11; Environmental
release; Conditional approval; Right to safe and healthy
environment; Public Trust doctrine; Precautionary principle; Judicial
Review; National Policy; Biosafety; Biological Diversity; Genetic
Engineering Appraisal Committee (GEAC); Ministry of Environment,
Forest and Climate Change (MoEF); National consultation;
Procedural abnormalities in approval; Herbicide Tolerant (HT)
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crop; Technical Expert Committee (TEC); Parliamentary Standing
Committees’ Reports; Field trials; Trans-generational studies; Risk
assessment; Genetic engineering; Ecological impact; Environmental
constitutionalism; Environmental governance.

Case Arising From
CIVIL ORIGINAL/APPELLATE/INHERENT JURISDICTION: Writ
Petition (Civil) No. 115 of 2004
(Under Article 32 of The Constitution of India)
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 and Contempt
Petition (Civil) No. 6 of 2016 In Writ Petition (Civil) No. 260 of 2005

Appearances for Parties
Trideep Pais, Sanjay Parikh, Sr. Adv., V. Shyamohan, Ms. Priyam
Cherian, Ms. Anshika Bajpai, Ms. Gargi Sethi, Prashant Bhushan,
Rahul Gupta, Ms. Aparna Bhat, Ms. Karishma Maria, Advs. for the
Petitioners.
R. Venkataramani, Attorney General for India, Tushar Mehta,
Solicitor General, Ms. Aishwarya Bhati, A.S.G., R. Bala, Sr. Adv., Mrs.
Anil Katiyar, Gurmeet Singh Makker, Devashish Bharuka, Nishesh
Sharma, Ms. Archana Pathak Dave, Ketan Paul, Mayank Pandey,
Ms. Sonali Jain, Ms. Sunita Singh Chuhan, Hitesh Kumar Sharma,
Akhileshwar Jha, Amit Kumar Chawla, Virendra Mohan, Ms. Niharika
Dewivedi, Ajay Mishra, Anil Kumar Mishra-i, S. Hariharan, Jitendra
Mohan Sharma, Raman Yadav, Abhishek Kumar Pandey, Kartikay
Aggarwal, Chitvan Singhal, Dr. N. Visakamurthy, Dr. Arun Kumar
Yadav, Abhay Kumar, Amrish Kumar, Devashish Bharukha, Atulesh
Kumar, Mrs. Preeti Rani, Rajat Nair, Narendra Bahadur Tiwari, N.
Narasimha Murthy, Kumari Nidhi Tripathi, Mrs. D. Bharathi Reddy,
Ms. Prity Kumari, Ravindra Sadanand Chingale, Dr. Ravindra
Chingale, Ashish Sonawane, Ms. Deeplaxmi Matawankar, Ms.
Sumbul Ausaf, Bonny Mehra , Dhruv Dwivedi, Kushal Sharma,
Pranav Sachdeva, Krishna Kumar, B. Vinodh Kanna, Advs. for the
Respondents.
[2024] 7 S.C.R. 1861

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

Judgment / Order of the Supreme Court

Judgment
Sanjay 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

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
2. 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).

* Ed. Note: Pagination as per the original Judgment.
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3. 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 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.
4. 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.
(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.
[2024] 7 S.C.R. 1863

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

5. 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.
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.
6. 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.
7. 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.
8. 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 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.
9. 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
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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 founded concerns and interests which are
ostensibly at variance with one another.
10. 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
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]

1 Merriam Webster dictionary https://www.merriam-webster.com/dictionary/Bt
2 https://extensionpubs.unl.edu/publication/g1484/html/view#target2
[2024] 7 S.C.R. 1865

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

10.3 Genetic Engineering Approval 3 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 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
11. 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 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

3 The name of GEAC, Genetic Engineering Approval Committee, stands substituted by Genetic
Engineering Appraisal Committee vide Gazette Notification dated 22.7.2010.
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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 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.
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.
[2024] 7 S.C.R. 1867

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

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.
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; 2. 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 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:
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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.
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
12. 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.
[2024] 7 S.C.R. 1869

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

13. 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 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.”
14. 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
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:
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“…..
(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;”
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;
[2024] 7 S.C.R. 1871

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

(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.
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.
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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;”
15. The 1989 Rules were enacted by the Central Government under
the EPA, 1986 with a view to protecting the environment, nature
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.”
[2024] 7 S.C.R. 1873

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

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.”
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.
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
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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 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.
16. 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.
17. The Food Safety and Standards Act, 2006 is aimed at laying down
science based standards for articles of food and to ensure 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
18. 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,
[2024] 7 S.C.R. 1875

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

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?
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
19. 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 brassicas.4 Before adverting to the challenges made, this
Court must note the timeline leading up to the impugned approval.
20. 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, 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.

4 https://www.du.ac.in/index.php?page=centre-for-genetic-manipulation-of-crop-plants
1876 [2024] 7 S.C.R.

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21. 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 environmental release of DMH-11
and advised the applicant to undertake field demonstration studies
on GM Mustard to generate additional data.
22. 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.
23. 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.
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.
[2024] 7 S.C.R. 1877

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

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.
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
25. 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. 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

5 [2003] Supp. 3 SCR 152 : (2004) 9 SCC 362
1878 [2024] 7 S.C.R.

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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 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]
17. 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
21. 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.

6 [2005] 3 SCR 151 : (2005) 5 SCC 181
[2024] 7 S.C.R. 1879

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

22. 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 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.
…
169. 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

7 [2006] Supp. 10 SCR 606 : (2007) 14 SCC 517
8 [2009] 9 SCR 225 : (2009) 7 SCC 561
1880 [2024] 7 S.C.R.

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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.
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)
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:

9 [2011] 8 SCR 680 : (2011) 8 SCC 274
10 [2011] 7 SCR 954 : (2011) 7 SCC 338
[2024] 7 S.C.R. 1881

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

“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)
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

11 [2022] 3 S.C.R. 471 : 2022 SCCOnline SC 533
12 [2007] 13 SCR 811 : (2007) 4 SCC 737
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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.
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.
25 (a) 9. Keeping in mind the above standard of judicial review, I now
proceed to examine the first issue at hand.
[2024] 7 S.C.R. 1883

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

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…
134. NGT is an expert adjudicatory body on the
environment.”
17. The NGT does not have a dearth of ‘expertise’ when
it comes to the issues of environment.
18. 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)

13 [2022] 1 SCR 1006 : 2022 SCC Online SC 120
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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
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.
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.

14 [2023] 10 SCR 440 : (2023) 8 SCC 35
[2024] 7 S.C.R. 1885

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

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.”
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:

15 [1978] 3 SCR 131 : (1978) 2 SCC 102
16 [1987] 2 SCR 1207 : (1987) 3 SCC 82
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“5…. It had earlier been laid down by a Constitution Bench
in the case of State of U.P. v. Batuk Deo Pati 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:
“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

17 [2020] 11 SCR 345 : (2020) 14 SCC 345
[2024] 7 S.C.R. 1887

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

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 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.
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Department of Biotechnology under the Ministry of Science
and Technology:
“Mission
…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),
[2024] 7 S.C.R. 1889

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

the premier research organisation for co-ordinating, guiding
and managing research and education in 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
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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, 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 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.
[2024] 7 S.C.R. 1891

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Constitutionality of the 1989 Rules
26. 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 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

18 [1974] 2 SCR 348 : (1974) 4 SCC 3
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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)
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:
“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

19 [1994] Supp. 5 SCR 666 : (1995) 1 SCC 519
20 [1996] 3 SCR 721 : (1996) 3 SCC 709
[2024] 7 S.C.R. 1893

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

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.
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

21 [2002] Supp. 5 SCR 605 : (2003) 2 SCC 673
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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.”
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

22 [2003] Supp. 4 SCR 187 : (2003) 8 SCC 100
23 [1996] 2 SCR 767 : (1996) 2 SCC 405
24 [2006] 2 SCR 920 : (2006) 3 SCC 434
25 [2011] 14 SCR 1 : (2011) 9 SCC 286
[2024] 7 S.C.R. 1895

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

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
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] 11 SCR 1094 : (2011) 8 SCC 737
27 [2024] 2 SCR 420 : 2024 SCCOnline SC 661
28 [2003] Supp. 6 SCR 151 : (2004) 1 SCC 712
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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 (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

29 [2018] 8 SCR 1 : (2019) 1 SCC 1
30 [2021] 5 SCR 791 : (2022) 12 SCC 455
31 [1985] 2 SCR 287 : (1985) 1 SCC 641
32 [1995] Supp. 6 SCR 759 : (1996) 10 SCC 304
[2024] 7 S.C.R. 1897

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

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
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)

33 [2017] 9 SCR 797 : (2017) 9 SCC 1
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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 functioning
of the GEAC. This aspect further stands amplified herein, later.
27. 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 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.
[2024] 7 S.C.R. 1899

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

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 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 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.
1900 [2024] 7 S.C.R.

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(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.
(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
[2024] 7 S.C.R. 1901

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

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.
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 Pollution Control Boards/DLC or through any person
authorised in this behalf.
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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
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.
[2024] 7 S.C.R. 1903

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

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
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:
“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
1904 [2024] 7 S.C.R.

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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 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.
27.14. Additionally, nowhere in the Rules can it be seen that the
Chairman of the GEAC or any other ‘bureaucratic member’
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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
28. 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
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, 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.
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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.
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 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.
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(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 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 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.
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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 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.
(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.
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28.4. After the above observations and discussion, the TEC
answered the terms of reference in the following manner:
1. 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.
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.
2. 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 exposure required for the test. The testing therefore
proceeds in a progressive manner.
3. 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.
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4. 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.
5. 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.
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 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
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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 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 should follow assessment there is an
the flowchart for the Risk urgent need for developing
Assessment process in the comprehensive guidelines
Guidance on Risk assessment in consultation with all
of Living Modified Organisms stakeholders and general public.
of the Cartagena Protocol on There should be establishment
Biosafety. of risk assessment unit which
should be permanently staffed
by a multi-disciplinary team.
It is generally not possible Proper evaluation of GE plants
to replicate the conditions is not scientifically tenable in
for testing under different contained greenhouses as
agro-ecological regions and natural, varying conditions
conditions in the greenhouse. representing different agro-
ecological regions and growing
seasons cannot be feasibly
replicated.
Specific sites for conducting No trials should be allowed in
field trials need to be non-notified fields, leased or
designated, certified and otherwise. A system should
sufficient mechanism put be evolved for notification of
in place for monitoring the confined field trial sites which
trials and ensuring restricted should include both public
access, disposal of material, and private sector institutions
associated testing and other subject to certain conditions.
facilities. These sites should
be used only for field trials of
GM crops. Trials should not
be conducted on leased land.
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A requisite understanding There is a need to strengthen
of the process of Risk the public sector laboratories
assessment be developed through funding in order to have
through consultation, required infrastructure and
collaboration and capacity human resource development.
building as the regulatory There should be a major
system has gaps and require human resource development
rethinking, investment and initiative for training in national
relearning. 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
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
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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 abdicating
its own adjudicatory function and replacing its wisdom with
that of the expert committee.
Parliamentary Standing Committee Reports
29. 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-
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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:
“(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.
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.
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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 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
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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”.
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.”
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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 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.”
ii. The Committee noticed that the production of GM crops
was concentrated only in a select few countries, India
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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 technology by
these developed countries viz-a-viz the reasons
led to its acceptance.”
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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 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 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
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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 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

34 [2018] 4 SCR 1 : (2018) 7 SCC 1
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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 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
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upon independently on the basis of the evidence
adduced in accordance with law.
276. 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 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
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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
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
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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)
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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 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
30. 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.

35 [1996] Supp. 5 SCR 241 : (1996) 5 SCC 647
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ii. Where there are threats of serious and irreversible
damage, lack of scientific certainty should not be
used as a reason for postponing measures to
prevent environmental degradation.
iii. The “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 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

36 [2020] 10 SCR 273 : (2020) 10 SCC 589
37 [2003] Supp. 3 SCR 925 : (2002) 4 SCC 356
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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, 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.

38 [2006] Supp. 2 SCR 362 : (2006) 6 SCC 371
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62. 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
67. 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. 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

39 [2021] 14 SCR 863 : (2023) 6 SCC 615
40 (2021) 6 SCC 693
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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
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.

41 [2021] 15 SCR 283 : (2022) 11 SCC 1
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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
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
524. 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.
525. 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
528. 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
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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
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
31. 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:
i. Guidelines for Environmental Risk Assessment of
Genetically Engineered Plants, 2016 and Environmental
Risk Assessment of Genetically Engineered Plants- A Guide

42 [2024] 3 SCR 1320 : 2024 SCC Online SC 570
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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 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
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(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 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.
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(e) Another relevant aspect dealt in this document is Risk
Communication which is a two-way process ‘to provide,
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:
“ …..
3. 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.
4. 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.
5. 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
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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.
6. 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;
(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,
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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 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.
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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 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)
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(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.
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.”
32. 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.
33. 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.
34. 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 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
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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:
“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
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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-
“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
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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 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
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
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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.
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.
36. 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 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”.”
37. 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

43 [2005] Supp. 4 SCR 582 : (2005) 8 SCC 534
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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.
38. 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;”
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

44 [2001] Supp. 2 SCR 79 : (2002) 1 SCC 428
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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)
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)
39. 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 [2014] 12 SCR 259 : (2015) 1 SCC 192
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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.
41. 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 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)
42. 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.

46 [2012] 4 SCR 971 : (2012) 5 SCC 1
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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.
44. 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 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.
45. 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

47 [2021] 10 SCR 693 : (2021) 15 SCC 600
48 [1974] 2 SCR 768 : (1974) 1 SCC 549
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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 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…”
45.5 In the well-known, Narmada Bachao Andolan v. Union of
India,51 (3-Judge Bench), this Court held:

49 [1986] 2 SCR 278 : (1986) 3 SCC 156
50 [1994] 1 SCR 579 : (1994) 2 SCC 691
51 [2000] Supp. 4 SCR 94 : (2000) 10 SCC 664
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“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
233. …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
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.
46. 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 con-
stitutional challenge thereto, fails.
47. Two additional aspects need to be clarified. Pursuant to the above
discussion, when I consider the prayer made on behalf of the
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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 understand-
ing passed on to it through counsel, is not in a position to take an
informed decision. If such a decision is taken, it would be completely
foreign to the standards of judicial review as discussed above, for it
is not within the Court’s purview to undertake cost benefit analysis
of a policy decision of the executive.
48. 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
49. In view of the above discussion, the conclusions arrived at in the
discussion above are that:
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.
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50. 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
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.
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.
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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.
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.
51. 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:
“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
576. There is ample support to the proposition that when
larger national interest is involved and concerns of public
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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 may have to play is to see that the system
works in the manner it was envisaged.”
(Emphasis supplied)
52. 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.
53. 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.
54. 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.
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Judgment
Nagarathna, J.
Table of Contents*

Acronyms ................................................................................... 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

* Ed. Note: Pagination as per the original Judgment.
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Gene Campaign & Anr. v. Union of India & Ors.

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
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Acronyms

AFES Assessment of Food/Feed and Environmental Safety
AICRP All India Coordinated Research Project
ASHA Alliance for Sustainable and Holistic Agriculture
BG-II Bollgard-II
BRAI Biotechnology Regulatory Authority of India
BRL Biosafety Research Level
BSU Biosafety Support Unit
Bt Bacillus thuringiensis
CAC Codex Alimentarius Commission
CBD Convention on Biological Diversity
CCMB Centre for Cellular & Molecular Biology
CGMCP Centre for Genetic Manipulation of Crop Plants
CIB&RC Central Insecticide Board & Registration Committee
CPB Cartagena Protocol on Biosafety
CSIR Council of Scientific and Industrial Research
DARE Department of Agricultural Research and Education
DBT Department of Biotechnology
DGFT Directorate General of Foreign Trade
DLC District Level Committee
DMH-11 Dhara Mustard Hybrid-11
DoAC Department of Agriculture and Cooperation
DRMR Directorate of Rapeseed and Mustard Research
ECHR European Convention on Human Rights
ERA Environmental Risk Assessment
FAO Food and Agriculture Organization
FSSA, 2006 Food Safety and Standards Act, 2006
FSSAI Food Safety and Standards Authority of India
GE Genetically Engineered
GEAC Genetic Engineering Appraisal Committee
GEF Global Environment Facility
GEO Genetically Engineered Organism
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GM Gene Modification or Genetically Modified
GMO Genetically Modified Organisms
HPV Human Papilloma Virus
HT Herbicide Tolerant or Tolerance
IAASTD International Assessment of Agricultural Knowledge,
Science and Technology for Development
IARI Indian Agricultural Research Institute
IBSC Institutional Biosafety Committee
ICAR Indian Council of Agricultural Research
ICMR Indian Council of Medical Research
IMTECH Institute Of Microbial Technology
IPR Intellectual Property Rights
LMO Living Modified Organism
MoA Ministry of Agriculture
MoEF Ministry of Environment and Forests
MoEF&CC Ministry of Environment, Forest and Climate Change
MoHFW Ministry of Health and Family Welfare
NARS National Agricultural Research System
NBPGR National Bureau of Plant Genetic Resources
NGO Non-Governmental Organisation
NGT National Green Tribunal
NIN National Institute of Nutrition
NKSPLR Nagoya Kuala Lumpur Supplementary Protocol on
Liability and Redress
PAU Punjab Agricultural University
PRMC Post Release Monitoring Committee
PSC Parliamentary Standing Committee
R&D Research and Development
RARM Risk Assessment and Risk Management
RAU Risk Assessment Unit
RCGM Review Committee on Genetic Manipulation
RDAC Recombinant DNA Advisory Committee
rDNA recombinant DNA
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SBCC State Biotechnology Co-ordination Committee
SOP Standard Operating Procedures
TEC Technical Expert Committee
UK United Kingdom
UNEP United Nations Environment Programme
USA United States of America

Preface:
The ideas drawn from sacred texts of the world have proffered to
worship and respect nature and impel mankind to preserve the same.
This, in essence, is the doctrine of intergenerational equity.
(i) The verses in Srimad Bhagavata Mahapurana depict nature
and its creations to embody the divine, as it states ‘Ether, air,
fire, water, earth, planets, all creatures, trees and plants, rivers,
and seas, they all are organs of God’s body, remembering this,
a devotee respects all species”.
(ii) In all other faiths practised in India, the earth is deemed to be
the sacred creation of God.
(iii) Nature and all her elements are considered sacred. Human
beings are said to be composed of five elements of nature,
which teach lessons and inspire strength in the formulation of
our character:
“Earth teaches us patience, love; Air teaches us
mobility, liberty; Fire teaches us warmth, courage;
Sky teaches us equality, broad-mindedness; Water
teaches us purity, cleanliness.”
1.1 Faced with the widespread destruction of the environment, people
everywhere are coming together to understand that we cannot
continue to use the benefits of the earth as we have in the past.
A new ecological awareness is beginning to emerge which, rather
than being downplayed, ought to be encouraged to develop into
concrete programs and initiatives.
2. This Court, in State of Bihar vs. Murad Ali Khan, (1988) 4 SCC
655 (“Murad Ali Khan”) speaking through Venkatachaliah, J.
(as the learned Chief Justice then was) observed that “the tragedy of
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the predicament of the civilised man is that, ‘Every source from which
man has increased his power on earth has been used to diminish
the prospects of his successors. All his progress is being made at
the expense of damage to the environment which he cannot repair
and cannot foresee’.”
3. This Court in M.C. Mehta vs. Kamal Nath, (1997) 1 SCC 388
(“M.C. Mehta”), speaking through Kuldip Singh, J. observed that, “…
the executive acting under the doctrine of public trust cannot abdicate
the natural resources and convert them into private ownership, or
for commercial use. The aesthetic use and the pristine glory of the
natural resources, the environment and the ecosystems of our country
cannot be permitted to be eroded for private, commercial or any other
use unless the courts find it necessary, in good faith, for the public
good and in public interest to encroach upon the said resources.”
4. These writ petitions, filed in public interest in the years 2004 and
2005, have been pending since then. However, IA No.47 of 2016 and
IA No. 122182 of 2021 were filed by the petitioner (Aruna Rodrigues)
in Writ Petition (Civil) No.260 of 2005, leading to the hearing of the
said applications and consequently, the writ petitions also.
The catalyst for considering these writ petitions on merits is the
approval of Genetic Engineering Approval (now Appraisal) Committee
(GEAC) dated 18.10.2022 culminating in the decision dated
25.10.2022 being questioned by the petitioners. It would therefore
be useful to initially state the bird’s eye view of the controversy.
Bird’s eye view of the controversy:
5. What does it mean to preserve, protect and respect the citizens’
right to a safe and healthy environment while exploring and
experimenting with era-altering novel technologies? That is the
crux of the controversy in these cases. The factual aspects of the
controversy were crystallised to some extent when this Court had
set up Technical Expert Committee (TEC) on 10.05.2012.
5.1 In the immediate context, these cases impugn the decision
taken by GEAC to grant approval for environmental release
of Dhara Mustard Hybrid-11 (DMH-11) mustard at the 147th
meeting held on 18.10.2022. Whether the said approval was
in compliance or in derogation of the recommendations of the
TEC Report is a foundational aspect. Whether the said decision
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is in consonance with due process of law, as understood in the
context of the public trust doctrine? There is also the question
whether the right to a safe and healthy environment under Article
21 has been violated and whether there has been a violation
of the precautionary principle.
5.2 In these cases, the said controversy has been considered
from several angles. Arguments at length have been heard
by us. Therefore, we propose to encapsulate the pleadings,
arguments and voluminous materials that has been submitted
during the course of the hearing while arriving at the findings
and conclusion in this matter.
Pleadings:
Writ Petition (Civil) No.115 of 2004:
6. According to petitioner in Writ Petition (Civil) No.115 of 2004, namely,
Gene Campaign, it is a society registered under the Societies
Registration Act, 1860. It consists of lawyers, geneticists, social
scientists, agriculturalists, economists, environmentalists, farmers
etc. who work towards the cause of protecting genetic resources
and ensuring that the rights of rural and tribal communities to access
the same are not infringed. Petitioner No.2, Dr. Suman Sahai is the
President of Gene Campaign, a researcher and instructor in several
institutions in India and abroad. It is his considered opinion that the
use of Gene Modification (GM) technology must not be permissible
without having the requisite safeguards and regulatory regimes in
place.
6.1 The prayers in Writ Petition (Civil) No.115 of 2004 filed by the
petitioners read as under:
“The petitioner therefore, prays that in the facts and
circumstances of the present case, this Hon’ble Court
may be pleased to issue a writ of mandamus or writ
or direction of like nature to:
i) direct the respondents to bring the Rules
for Manufacture, Use, Import, Export and
the Storage of Hazardous Micro-organisms,
Genetically Engineered Organisms or Cells,
1989 in consonance with Article 14, 19, 21, 38,
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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.”
7. The pleadings in the aforesaid writ petition could be encapsulated
as under:
7.1 Writ Petition (Civil) No.115 of 2004 has been filed for the
issuance of a writ of mandamus or similar writ directing the
respondent-State to bring the Rules for the Manufacture, Use,
Import, Export and Storage of Hazardous Micro-Organisms,
Genetically Engineered Organisms or Cells, 1989 (“the 1989
Rules”, for the sake of convenience), which have been framed
under Sections 6, 8 and 25 of the Environment (Protection) Act,
1986 (“EP Act, 1986”, for short) in consonance with Articles
14, 19, 21, 38, 47, 48, 48A read with Article 51-A(g) of the
Constitution and if there is a failure to do so, to declare the
said Rules as unconstitutional. It is averred that this Court has
on various occasions interpreted Article 21 of the Constitution
to include the right to health of the individual as well as to a
clean and safe environment. That tenets of the precautionary
principle, sustainable development, polluter pays principle
and inter-generational equity doctrine have been held by this
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Court to form a part of Articles 14 and 21 of the Constitution.
That there is a need for the 1989 Rules to be in accordance
with the aforesaid principles so as to be held constitutional.
That the public need to be provided sufficient opportunity to
participate in the process of decision-making when there is
an actual or likely possibility of their fundamental rights being
affected and necessary information needs to be made available
to facilitate the same. The said right has been recognized by
the decision of this Court in Research Foundation for Science
Technology National Resource Policy vs. Union of India,
(2003) 9 SCALE 303 : (2005) 10 SCC 510 (“RFSTE”).
7.2 It is further averred that the 1989 Rules as they exist are not
in conformity with established principles of environmental law
as elucidated by this Court. The 1989 Rules are also stated to
be not in conformity with international instruments such as the
Convention on Biological Diversity (CBD) and the Cartagena
Protocol on Biosafety (CPB), that have been ratified by India.
That, a reading of these along with the fundamental rights
conferred by the Constitution would serve the purpose of
furthering the said rights and such an approach should be
adopted by this Court.
7.3 That Genetically Modified Organisms (GMOs) are an emerging
area of research and study but the 1989 Rules are still
inadequate to meet the challenges of the limited findings and
evidence that are a product of this research. That overseas
jurisdictions have established robust regimes that regulate
GMOs, in recognition of the risk they may pose to the
environment. But the 1989 Rules as they stand do not appear
to contain any of the safeguards found in the regulatory regimes
of other jurisdictions. The aforesaid absence of safeguards has
contributed to India being used as a “dumping ground” and
the Country being used to test experimental crop varieties that
have not been sufficiently studied, with these possibly posing
a serious risk to the country’s biodiversity. That this would
directly impact the economic prospects of a large section of
the population that works in the agricultural sector and could
further harm the country’s food security. Small and marginal
farmers are to be the most disadvantaged in the aforesaid
scenario.
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7.4 That the 1989 Rules were enacted owing to mounting evidence
of the possible adverse effects of GMOs on agricultural
ecosystems and the country’s biodiversity as well as on
human and animal health. It is the petitioners’ case that the
said Rules are riddled with lacunae that lead to them being
applied arbitrarily and in violation of the Constitution. That the
said Rules do not bear any mention as to the qualifications
required to be eligible for membership in the various regulatory
agencies constituted thereunder. This renders the functioning
of these agencies largely ineffective as they often lack the
necessary technical competence, particularly in the fields of
Risk Assessment and Risk Management (RARM).
7.5 Further, the prescribed constitution of various agencies,
in particular those of the Review Committee on Genetic
Manipulation (RCGM), GEAC, the State Biotechnology Co-
ordination Committees (SBCC) and District Level Committees
(DLC), include representatives of various authorities who do
not possess the necessary qualifications, technical expertise,
competence, skills and knowledge to carry out the respective
mandates of each agency. Majority of the members are only in
ex-officio capacity and lack competence in the field of operation.
7.6 That, there is a complete lack of transparency at each stage
of the regulatory process. The 1989 Rules do not allow for
public to access information despite GMOs having possible
adverse effects on human and animal health, socio-economic
conditions as well as the environment which directly pertains
to the public’s rights and interests. These Rules do not allow
public to sufficiently participate in the decision-making at
any stage, viz. grant of approval for research, field trials or
commercial-scale cultivation of a GM crop. Public participation
is needed to both accurately gauge the risks and benefits as
well as to increase the confidence of public in GMOs.
7.7 That the 1989 Rules do not require taking prior informed consent
from those farmers and Gram Sabhas which are located in
the vicinity where a field trial would be conducted. This is in
violation of the 73rd and 74th Constitutional Amendments which
make the involvement of Gram Sabhas and Gram Panchayats
in such decisions necessary and non-optional.
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7.8 That the Rules envision a regulatory regime that lacks
accountability and there is no indication as to who would
bear the liability in case of an erroneous decision being made
that has an adverse impact on human and animal health, the
environment and the socio-economic conditions of the country.
Such harm may take the form of personal injury, property
damage or financial loss, however, the liability corresponding
to each of these has not been considered in the 1989 Rules
at all.
7.9 Further, the penal provisions contained in the said Rules do
not sufficiently deter prospective offenders as these provisions
just mention “measures” that may be taken by the concerned
agency, which do not include the description of a penalty of
any kind. The actions that can be taken by the concerned
agencies are only in a corrective capacity to ensure damage
is minimized.
7.10 That neither SBCC nor DLC had been made functional at the
time of filing of this Petition despite the commercial cultivation
of the Bacillus thuringiensis (Bt) cotton crop which is a GMO.
7.11 That GM technology is an emerging technology that enables
outcomes that were hitherto unimagined such as the
transposition of the genes of fish into those of tomatoes,
genes of bacteria into those of plants etc. There is an inherent
uncertainty to this technology and its effect on the environment
and on human life. This necessitates the re-examination of
extant regulations and regulatory regimes so as to mould them
in light of newer developments.
7.12 That till these uncertainties have been clarified through the
process of scientific research thereby enabling a thorough
consideration of the risks and benefits, there must be a
moratorium on the commercial release of GMOs.
7.13 That the impact of GM technology would vary based on the
socio-economic, cultural, and ecological context of each country
and any research conducted must evaluate the specific impact
of such technology in the Indian context. On the other hand,
GM technology have evolved in industrialized and developed
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economies with highly mechanized agricultural processes and
vast monocultural tracts that are generally isolated from natural
ecosystems. Unlike India, these countries do not possess
similarly rich biodiversity.
7.14 That India, being the centre of origin for many food crops,
has to be more vigilant and cautious in adopting this
new technology which is still in the process of evolution.
In particular, transgenic varieties of crops for which India is
the centre of origin should not be released for commercial
cultivation until its impact is adequately assessed. That there
are serious concerns about contamination of the natural
gene pool of crops originating in India. These are some of
the potential consequences:
i. Contamination of non-GM crops and their wild relatives;
ii. Proliferation of weeds and creation of new weeds due to
flow of foreign genes from GM crops to non-GM crops
and their wild relatives;
iii. The likely formation of difficult-to control novel weed types
due to transfer of foreign genes that confer hardiness;
iv. Destruction of soil micro-organisms due to release of
toxins from genes, like Bt gene, leading to adverse impact
on crop productivity.
7.15 That farm lands in India are small and closely packed
together as agriculture is practiced in close proximity to
natural biodiversity, often bordering forest areas or even within
forest areas, where natural gene pools are found. A GM crop
cultivated in one field is likely to impact other fields as well as
the natural ecosystems. No research has been undertaken to
assess the adverse effects of such transfers.
7.16 Moreover, GM crops could directly impact the economic
prospects of a large section of the population that works in
the agricultural sector. Small and marginal farmers are likely
to be the most disadvantaged. Other socio-economic risks
include market concentration, the loss of livelihood of small
farmers, and restriction on the consumers’ right to choose.
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Writ Petition (Civil) No.260 of 2005:
8. The petitioner who is a public-spirited citizen in this case has made
the following prayers and has averred as follows in the context of
GM Technology and GM Crops:
“The petitioners therefore, pray that in the facts and
circumstances of the case, this Hon’ble Court may be
pleased to issue appropriate writs or directions to:
A) Direct the Union of India not to allow any release
of GMOs into the environment by way of import,
manufacture, use or any other manner unless the
following precautions are taken.
(a) a protocol for all the required bio-safety tests of
the GMOs proposed to be released is prepared
by the GEAC after processes of public notice
and public hearing.
(b) The GMO has been subjected to all the required
bio-safety tests, prepared on the basis of the
required Biosafety tests on the basis of the
above protocol, by agencies of independent
expert bodies, and results of which have been
made public.
B) Direct the Union of India to ban the import of any
biological organism, food or animal feed unless they
have been certified and labelled to be GM free, by
the exporting country.
C) Direct the Union of India to put in place rules to ensure
that it shall be compulsory for any dealer or grower
selling GMOs to label them as such.
D) Pass such other and further orders as this Hon’ble
Court may deem fit and proper in the facts and
circumstances of the case.”
(i) According to this petitioner, there are outstanding safety
concerns linked with Genetically Engineered (GE) technology.
Transgenic contamination is unavoidable and there can be no
co-existence between GM and Non-GM agriculture.
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(ii) That research shows that Bt proteins, incorporated into 25%
of all transgenic crops worldwide, to be harmful to a range of
non-target insects, worms and amphibians. Some of them are
potent immunogens and allergens. In fact, glyphosate and the
Roundup herbicide used on most herbicide resistant crops is
shown by studies to be lethal to amphibians.
(iii) That GM crops have led to an increase in pesticide use,
financially hurting farmers and harming the environment.
(iv) That GE technology is a fit case for the application of the
precautionary principle which necessitates that if there are
reasonable scientific grounds for believing that a new process
or product may not be safe, it should not be introduced until
convincing evidence of reasonable certainty of no harm is
obtained. In addition, if the dangers are considered serious
enough, then the principle may require withdrawal of GM
products or impose a ban or a moratorium on further use
thereof.
(v) That safety testing for GE food is absolutely necessary for India
before the release of any GMO into the Indian environment.
However, there are very few established protocols for assessing
the potential health impacts of GE crops. All one finds is loose
guidelines that in most cases only list certain tests or procedures
without specifying how they are to be conducted.
(vi) That biotechnology companies frequently deny access or
allow strictly conditioned access, to data on crop materials
on the basis of confidentiality and IP concerns, making
it very difficult for regulatory authorities and independent
researchers to verify or review test claims on the safety of
GE crops and foods.
(vii) That the extant regulatory system in India is ill-equipped to
handle challenges outlined above, as past experience also
confirms. Circumstances surrounding the initial approvals of
Bt cotton in India is a good example. The RCGM, under the
Department of Biotechnology (DBT), is a body that did not have
the jurisdiction to grant permission for the release of GMOs into
the environment. Yet, it was originally the RCGM which illegally
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permitted the release of the GMOs into the country for the
first time. It was only when there was a public outcry over the
serious illegality of these clearances that attempts were made
to get the release of GMOs cleared retrospectively.
(viii) That even for technologies which have been tried and tested,
and found to be far safer than GE, for instance Hydro-electric
projects, the relevant statutes mandate a public notice and public
hearing as well as Environmental Impact Assessment. Hence,
it is arbitrary and unreasonable not to have a mandatory public
notice and public hearing before approvals for the release of
GMOs are granted.
(ix) That as per current practice, the applicant company itself is
asked to do testing. The test results are not available for public
scrutiny. This is entirely without logic and is a clear conflict
of interest involving the same biotech company that has a
commercial interest in the approval of the GMO.
(x) That in India, like many other developing countries, organizations
which are substantially funded by the biotech industry have
sought to influence regulatory and other decision-making
processes by conducting “awareness” and “educational”
programmes. The Governments of advanced countries too,
have been a handmaiden to GE Industry, often arm-twisting
developing countries to adopt pro-GM stances.
8.1 It is further averred that the CPB was adopted in 2002 and came
into force on 11.09.2003. It is a binding International agreement
on Biosafety and India being a signatory, is bound to implement
its provisions. According to Article 10(6) of the Protocol, the lack
of scientific certainty due to relevant scientific information and
knowledge regarding the extent of potential adverse effects
shall not prevent the contracting party from taking a decision, as
appropriate, in order to avoid and/or minimize potential adverse
effects. In addition, Annexure-III of the said protocol includes,
inter alia, the general principles of risk assessment. It states
that risk assessment should be carried out in a scientifically
sound and transparent manner and implores states to take
into account expert advice as well as guidelines developed by
relevant international organizations. Further, Article 21(6) of
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the said Protocol prescribes that the information about the risk
assessment cannot be kept confidential.
8.2 That the United Nations Convention on Biological Diversity
(CBD), 1992, to which India is a party, inter alia, requires that
the contracting parties shall domestically regulate or manage
the risks associated with the use and release of Living Modified
Organisms (LMOs) resulting from Biotechnology and which
are likely to have adverse environmental impacts and risks to
human health. It also implores states to introduce appropriate
procedures to require impact assessment of proposed projects
likely to have significant adverse effects on biodiversity and to
allow public participation in the procedure.
8.3 That in addition to implementing a moratorium on the release of
any GMO into the domestic environment until adequate biosafety
tests demonstrate safety beyond reasonable doubt, labelling for
imports sourced from countries which produce GM crops and
foods should be mandated. Therefore, both moratorium and
labelling must be concurrent mandatory requirements.
8.4 That farmers have the right to save seed for sowing in the next
season, which a patent-based regime of GM seeds will effectively
deny. This choice is a fundamental right and must be retained
as such for better farming prospects and livelihoods. Therefore,
the petitioner has sought the aforesaid reliefs.
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) 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
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development of new generation hybrids. Upon receipt of the
application, GEAC, in its 125th meeting held on 11.12.2015,
appraised the same and decided that the CGMCP will be
invited to give a presentation before GEAC in the subsequent
meeting. Pursuant to the same, the CGMCP made a presentation
before GEAC in the 126th meeting held on 04.01.2016 and the
CGMCP was directed to furnish clarifications with respect to
some issues in para 3.3 of the Minutes of the Meeting. It was
further decided in the meeting that a sub-committee would
be constituted under the chairmanship of Dr. K. Veluthambi,
Co-Chair of GEAC, and the said sub-committee would have
the duty of examining the issues raised by GEAC in para 3.3
and submit a report with recommendations to GEAC.
8.7 On 02.02.2016, the sub-committee appointed by GEAC
convened its first meeting and in that meeting, it voiced concerns
over the clarifications furnished by the CGMCP on the issues
mentioned in para 3.3. However, in the 127th meeting of GEAC
held on 05.02.2016, GEAC adopted the recommendations of the
sub-committee and directed the CGMCP to revise the biosafety
dossier, in light of the comments of the sub-committee and
the biosafety unit, and prepare an RARM document for further
review. It is stated that GEAC had decided to put the biosafety
dossier in the public domain, but this was not carried out.
8.8 In its 128th Meeting held on 04.03.2016, GEAC decided to
await the completion of the Biosafety Support Unit’s (BSU)
review of the revised dossier before further consideration. On
11.04.2016, the sub-committee, in its 2nd Meeting, recommended
incorporating expert comments and remarks from the Biosafety
Unit into its report. The report was to be presented to GEAC
and uploaded onto its website. In its 129 th 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.
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8.9 On 07.09.2016, Dr. Bhargava, a member of GEAC, made a
startling revelation. He stated that the so-called Report of the
sub-committee titled “Assessment of Food and Environmental
Safety” was never shared or discussed before GEAC. Following
this revelation, on 22.09.2016, various scholars and public
activists endorsed an email addressed to the Hon’ble Minister
of Environment, Forest and Climate Change. The email raised
serious objections to the conduct of the appraisal process,
particularly the refusal to disclose the biosafety dossier to the
general public. It urged the Ministry of Environment, Forest
and Climate Change (MoEF&CC) to extend the consultation
process by another 120 days. In addition to the email, on
24.09.2016, eminent scholars and experts sent a letter to the
Hon’ble Minister of Environment, Forests and Climate Change,
expressing grave concerns regarding GEAC’s blatant refusal
to disclose the biosafety data to the general public, hindering
a meaningful exercise of public consultation. It also requested
an extension of the consultation process for another 120 days.
Despite objections and requests for transparency, it is stated
that GEAC continued the consultation process, culminating in
a comment note published on 30.09.2016, refusing to extend
the consultation period and setting the deadline for receiving
comments as 05.10.2016.
8.10 Challenging the appraisal procedure adopted by GEAC, the
petitioner has preferred the writ petition before this Court, under
Article 32 of the Constitution of India, primarily contending
that the aforesaid procedure adopted by GEAC was not only
arbitrary but also lacked proper application of mind, rendering it
illegal and violative of the fundamental rights enshrined under
Articles 14 and 21 of the Constitution.
This assertion was underscored by instances such as the
failure to disclose crucial information, including the biosafety
dossier, and the opaque nature of the consultation process,
which impedes meaningful public participation. Further, the
petitioner has emphasized the statutory obligations of GEAC
to exercise its power of granting approvals for environmental
release of GE products in a fair, transparent, and reasonable
manner, especially considering the lack of any procedure laid
down under the 1989 Rules for the exercise of its powers by
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GEAC. It is stated that the potential impact of the GM crops
on health and environment can only be known after a long
gestation period and therefore, a stricter scrutiny ought to
have been undertaken.
8.11 Furthermore, the petitioner has criticized the sub-committee
formed by GEAC, arguing that such delegation of statutory
functions to another body is ultra vires the 1989 Rules.
Additionally, concerns regarding the non-disclosure of the
biosafety dossier despite assurances and directives from
authorities has been raised, which undermine the transparency
and integrity of the decision-making process.
8.12 The petitioner has also questioned the validity and adequacy of
the AFES Report uploaded by GEAC, highlighting discrepancies
in its findings, the lack of application of mind and the lack of
comprehensive scientific scrutiny. It is averred that the said
document was merely a 133-page summary document that
does not explain to the public the data collected and the
studies/tests conducted by the CGMCP. It is further pointed
out from the AFES report that no study was conducted to
examine the physiological impact of the transgene products
from the transgenic mustard hybrid DMH-11 on the insects,
no testing was done under the herbicide-sprayed conditions
on an HT crop, and no testing was done on the honey quality,
despite the questionable study of the impact on honey bees
by the crop developers having vested interests in the subject.
8.13 Moreover, the restricted access to the biosafety dossier,
despite assurances and directives to disclose it, has also been
criticized, since it impedes meaningful public engagement
and violates the rights of stakeholders to be informed and
participate effectively in the consultation process. In terms of
the consultation process, the petitioner has contended that
GEAC ought to have adhered to the principles of fairness and
transparency and ought not to have made a mockery of the
entire process of public consultation to defeat the valuable
rights of the general public to be informed about the critical
date pertaining to the transgenic mustard hybrid DMH-11 crop.
It was asserted that the present consultation process couldn’t
be completed without making available to the public the critical
scientific data. Further, the petitioner avers that it was also
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highly arbitrary to expect all the interest stakeholders from all
corners of the country to travel to New Delhi and conduct a
physical examination of the 3000 odd pages at the premises
of the MoEF&CC and submit meaningful inputs.
8.14 It is averred that there has also been a failure to involve
State Governments in the process, despite agriculture being
a state subject and mustard being a highly important crop for
the country.
8.15 Finally, the petitioner has drawn attention to the comparative
inadequacy of the testing and consultation processes for
genetically modified (GM) mustard, compared to previous
cases like Bt brinjal.
8.16 Overall, the petitioner has contended that the appraisal process
for transgenic mustard hybrid DMH-11 lacks transparency,
has violated legal mandates, and fails to adequately consider
the concerns of stakeholders, thereby warranting judicial
intervention to ensure procedural fairness and safeguard
public interest.
Civil Appeal No.4086 of 2006:
8.17 This appeal assails order dated 08.10.2003 passed by the
Appellate Authority in Appeal No.2 of 2002, constituted
under Rule 19 of the 1989 Rules notified under the EP Act,
1986. The Appeal No.2 of 2002 was filed against the order
dated 05.04.2002 of GEAC granting conditional clearance to
M/s. Maharashtra Hybrid Seeds Co. Ltd. for three transgenic
Bt hybrid cotton varieties, namely, Bt MECH 12, Bt MECH 162
and Bt MECH 184. By the impugned order, the appeal was
dismissed by the Appellate Authority.
8.18 Vide Order dated 08.09.2006, leave was granted and vide
order dated 13.07.2017, the appeal was directed to be tagged
with Writ Petition (Civil) No.260 of 2005.
Contempt Petition (Civil) No.295 of 2007 in Writ Petition (Civil)
No.260 Of 2005; and, Contempt Petition (Civil) No.6 of 2016 in
Writ Petition (Civil) No.260 Of 2005:
8.19 These contempt petitions have been filed alleging violation of
orders dated 22.09.2006, 08.05.2007, 01.08.2007; and orders
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dated 15.02.2007, 08.05.2007, 08.04.2008 and 12.08.2008
respectively passed by this Court in Writ Petition (Civil) No.260
of 2005.
Significant Orders passed by this Court in Writ Petitions:
9. By order dated 01.05.2006, this Court had directed that until further
orders, field trials of GMOs shall be conducted only with the approval
of GEAC. Order dated 10.05.2012 referred to above also notes that
as of the year 2007, nearly 91 varieties of plants, i.e., GMOs, were
being subjected to open-field tests. However, in terms of the aforesaid
order of this Court, no further open-field tests were permitted nor
had GEAC granted any such approval except with the authorization
of this Court. This had given rise to serious controversies before
this Court as to, whether, or not, the field tests of GMOs should be
banned, wholly or partially, in the country.
9.1 This Court, feeling that it had no expertise to determine such
an issue, which, besides being a scientific question, would
have very serious and far-reaching policy consequences, by
order dated 08.05.2007 lifted the moratorium on open-field
trials, subject, however, to certain conditions. These included a
directive in regard to the maintenance of 200 metres isolation
distance while performing field tests of GMOs.
9.2 A further clarification was given vide order dated 08.04.2008, by
which all concerned were directed to comply with the specific
protocol of Level of Detection of 0.01 per cent. Since there
was non-adherence to the said protocol and in the face of the
report of one of the independent Experts, Dr. P.M. Bhargava,
who was appointed to meet GEAC by the order of this Court
dated 30.04.2009, the Government of India, on its own, imposed
a complete ban on Bt brinjal.
9.3 Later, while hearing the Additional Solicitor General for Union
of India as well as the learned counsel for the petitioners, this
Court found that there was a consensus on the constitution of
an Expert Committee on certain terms of reference as suggested
in the Minutes of the Ministry’s meeting dated 15.03.2011 as
there was a joint prayer for its constitution.
9.4 In these writ petitions, vide order dated 10.05.2012, this Court
had noted the prayers of the petitioners seeking issuance of
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directions or order to the respondent, namely the Union of India,
inter alia, not to allow the release of GMOs into the environment
by way of import, manufacture, use or any other manner. An
ancillary prayer was for the prescription of a protocol to which all
the GMOs release would be subjected to. In addition, a direction
was sought to the Union of India to frame relevant Rules in this
regard and to ensure its implementation was sought.
Constitution of the Technical Expert Committee (TEC):
10. In view of the above plea, this Court, after several dates of hearing,
vide order dated 10.05.2012 constituted a Technical Expert Committee
(TEC), the constitution of which was as follows:
“1. Prof. V.L. Chopra, Former Member, Planning
Commission and Former Member, Science &
Advisory Committee to the PMO, Recipient of
Padma Bhushan.
2. Dr. Imran Siddiqui, Group Leader, Centre for
Cellular & Molecular Biology (CCMB).
3. Prof. P.S. Ramakrishnan, Emeritus Prof. JNU.
4. Dr. P.C. Chauhan, D. Phil (Sci).
5. Prof. P.C. Kesavan, Distinguished Fellow, MS SRF
(Research Foundation), Emeritus Professor, CSD,
IGNOU, New Delhi.
6. Dr. B. Sivakumar, Former Director, National Institute
of Nutrition (NIN), Hyderabad.”
10.1 The Terms of Reference of the TEC were as follows:
“A. To review and recommend the nature of sequencing
of risk assessment (environment and health safety)
studies that need to be done for all GM crops before
they are released into the environment.
B. To recommend the sequencing of these tests in
order to specify the point at which environmental
release though Open Field Trials can be permitted.
C. To advise on whether a proper evaluation of the
genetically engineered crop/plants is scientifically
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tenable in the greenhouse conditions and whether
it is possible to replicate the conditions for testing
under different agro ecological regions and seasons
in greenhouse?
D. To advise on whether specific conditions imposed
by the regulatory agencies for Open Field Trials
are adequate. If not, recommend what additional
measures/safeguards are required to prevent
potential risks to the environment.
E. Examine the feasibility of prescribing validated
protocols and active testing for contamination at
a level that would preclude any escaped material
from causing an adverse effect on the environment.
F. To advise on whether institutions/laboratories in
India have the state-of-art testing facilities and
professional expertise to conduct various biosafety
tests and recommend mechanisms to strengthen
the same. If no such institutions are available in
India, recommend setting up an independent testing
laboratory/institution.
G. The Expert Committee would be free to review
reports or studies authored by national and
international scientists if deemed necessary. The
petitioners opined that they would like to formally
propose three Expert Reports from Prof. David
Andow, Prof. Jack Heinemann and Dr. Doug Gurian
Sherman to be a formal part of the Committee’s
deliberations. The MoEF may similarly nominate
which experts they choose in this exercise.”
10.2 This Court directed the TEC to hear the Government, petitioners
and any other intervenor, who, in the opinion of the TEC, could
assist the cause of expeditious and accurate finalization of
its report. A direction was also given to the TEC to submit an
interim report on the following issue:
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“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:
9 Biotechnology and Agriculture
9 Usage of GM Crops
9 International Agreements and Instruments
for Food Safety, Conservation and
Regulation
9 The Indian GMO Regulatory Structure
9 Discussion of Recommendation of the
Interim Report (IR) in the Context of the
Terms of Reference for the TEC
9 Deliberations of the TEC Following
Submission of the Interim Report
9 Issues that were discussed in the course
of deliberations by the TEC
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9 Examination/Study of the Safety Dossiers
9 Molecular data
9 Health Safety Data
9 Examples of differences
9 Environmental Risk Assessments
9 Summary
9 Recommendations
10.5 The recommendations contained in the majority report are
as follows:
“Recommendations
Based on the deliberations of the TEC and particularly the
examination/study of the safety dossiers, it is apparent
that there are major gaps in the regulatory system. These
need to be addressed before issues related to tests can
be meaningfully considered, till such time it would not
be advisable to conduct more field trials:
1. A secretariat comprising dedicated scientists
with area expertise as well as expertise in
biosafety needs to be established. This will require
consultation with experts having experience at
the international level in biosafety testing and
evaluation of GM safety dossiers in reputed
regulatory bodies. The TEC recommends doing it in
collaboration with the Norwegian Government and
GM regulatory body since the Norwegian system
has an established commitment and experience in,
is one of the few that are attuned to considering
socio-economic issues that would be important
in the Indian context. The regulatory body should
have area-wise subcommittees/expert groups in
for example:
• Health (human and animal)
• Environment and Ecology
• Agroeconomics and Socioeconomics
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• Molecular biology
• Entomology
• Agricultural and Aquacultural Systems
• Public Health
• Soil science and microbiology
• Plant biology
• Regulatory toxicology
• Plant and animal breeding and genetics
A single committee such as the GEAC or RCGM doing
all the valuation is not sufficient.
2. Conflict of interest in terms of location of the
regulatory body needs to be addressed. The
suggestion of the TEC is that the regulatory bodies
to be located in the MoEF (environmental safety)
and the MoHFW (health safety). At a different level,
it is evident that members of the regulatory bodies
should also be free of conflict of interest.
3. Specific sites for conducting confined field trials
need to be designated, certified, and sufficient
mechanisms put in place for monitoring the trials
and ensuring restricted access, disposal of material,
associated testing and other facilities, These sites
should be used only for field trials of GM crops
(GM and control material). The sites could be in
ICAR institutes or State Agricultural Universities
and required conditions for isolation should be
established and supported appropriately by ICAR.
Sites in company premises may also be considered
for certification for trials, however the land should
be permanently owned by the applicant/tester.
Trials should not be conducted on leased land so
as to avoid the possibility that it may be used for
a different purpose following the trials.
4. Stakeholder participation, need, socio-economic
considerations, societal impact, and sustainability
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should be some of the dimensions to be incorporated
in the risk assessment and this should be done at
an early stage in the risk assessment process.”
10.6 The specific findings of the Report of the majority of TEC on
the terms of reference may be discussed at this stage.
(i) Firstly, as to the nature of sequencing of risk assessment
studies that need to be done for GM crops before
they are released into the environment, the majority
recommended the following:
a. The majority recommended consultation, ideally
prior to the development of the GM product intended
for field trials, wherein the applicant would provide
information to the regulator about the product,
its purpose (including whether it is intended for
research only or commercialization), and how it is
to be deployed in India. At this stage, the scope
of issues that needs to be addressed relating to
health and environmental safety can be discussed
and defined on a case-wise basis keeping in
mind the overall phases of risk assessment:
hazard identification; hazard characterization;
exposure assessment; risk characterization; and
mitigation options. Need, socio-economic factors
and sustainability should also be considered and
thoroughly discussed at this stage. If a GMO is
initially declared for research and at a later stage
it is to be considered for commercialization then
that would be treated as a fresh application. The
overall process of risk assessment should follow
the Flowchart for the Risk Assessment Process
in the Guidance on Risk Assessment of LMIOs
(UNEP/CBD/BS/COP MOP/6/13/Add.1) of the
Cartagena Protocol on Biosafety (CPB). In the
case of health safety, the regulator should expect a
suitable response to all relevant paragraphs of the
Codex Alimentarius Commission (CAC) Guideline
for the Conduct of Food Safety Assessment of
Foods Derived from Recombinant DNA (rDNA)
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Plants (CAC/GL 45-2003) and any other chosen
risk assessment procedure. In doing so the
regulator establishes a minimum expectation
of the risk assessment meeting international
requirements. It was pointed out that both the CPB
and CAC guidelines provide guidance with regard
to principles and issues that are to be addressed.
They leave open the details of specific tests to be
carried out which is left to the national system and
the regulator.
b. The majority, thus, noted the need to include
chronic and transgenerational toxicity testing in
feeding studies of rodents based on the fact that
food is consumed over the entire lifetime and
that nutritional stress can also lead to adverse or
unintended effects over long-term exposure. The
sensitive stages of reproduction also need to be
included.
c. In addition, the majority emphasized that the
regulatory process should be open to new scientific
information that may have a bearing on the risk
assessment, if necessary, even after deregulation
of an event.
d. The majority also emphasised that the applicant
should be responsible for providing to the regulator,
all information that has a bearing on the risk
assessment, regardless of whether it was obtained
for the purpose of the risk assessment. In cases
where the applicant is a collaborator/partner/
subsidiary in the development of the GMO, the
applicant should provide this information along
with the consent of all parties.
e. With regard to the nature of tests for Bt in food
crops, the majority was of the view that the safety
of Bt transgenics with regard to chronic toxicity has
not been established and this needs to be done
before it can be considered safe. In this regard, it
was pointed out that by far, the largest deployment
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of transgenics worldwide is in soyabean, corn,
cotton, and canola, all of which are used primarily
for oil or feed after processing. Nowhere are
Bt transgenics being widely consumed in large
amounts for any major food crop, that is, directly
used for human consumption. The majority could
not find any compelling reason for India to be the
first to do so. It, therefore recommended that there
should be a moratorium on field trials for Bt in
food crops (those that are directly used for food)
intended for commercialization (not research) until
there is more definitive information from sufficient
number of studies as to the long-term safety of
Bt in food crops.
f. The majority also examined issues in relation to
Herbicide Tolerant (HT) crops. The conclusion here
was that HT crops would most likely exert a highly
adverse impact over time on sustainable agriculture,
rural livelihoods, and environment. The majority,
therefore, found them completely unsuitable in the
Indian context.
g. The majority also highlighted how crops in
their centres of origin and diversity often have
a deep cultural significance that can get lost
when utilitarian considerations predominate the
discourse. Ceremonial and medicinal varieties can
also be put at risk from GM crops by reduction of
diversity and genetic purity. For example, in the
case of brinjal, the Malapur variety in Karnataka
is an essential accompaniment at temple festivals
and religious ceremonies. Likewise, Oryza nivara,
a medicinal rice, can also be at risk if GM rice
comes to dominate the crop as has happened for
example, in the case of cotton, in India.
h. The release of a GM crop into its area of origin or
diversity has far greater ramifications and potential
for negative impact than for other species. To
justify this, the majority suggested a requirement
of extraordinarily compelling reasons. GM crops
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that offer incremental advantages or solutions
to specific and limited problems were not to be
deemed sufficient reasons to justify such release.
Not finding any such compelling reasons under the
present conditions, it recommended that release
of GM crops for which India is a centre of origin
or diversity should not be allowed at all.
(ii) Secondly, as for, when environmental release through
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.
(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.
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(iv) Fourthly, the majority noted the need to develop specific
sites for conducting field trials. It also emphasised the
need for sufficient mechanisms for monitoring the trials
and ensuring restricted access, disposal of material,
associated testing and other facilities. These sites were
recommended to be used only for field trials of GM crops
(GM and control material). The sites could be in Indian
Council of Agricultural Research (ICAR) Institutes or
State Agricultural Universities and required conditions
for isolation should be established and supported
appropriately by ICAR. Sites in company premises may
also be considered for certification for trials, however
the land should be permanently owned by the applicant/
tester. Trials should not be conducted on leased land
so as to avoid the possibility that it may be used for a
different purpose following the trials.
(v) Fifthly, on the feasibility of prescribing validated protocols
and active testing for contamination with the view to
preclude any escaped material from causing an adverse
effect on the environment, the majority noted that the
tests for detecting contamination at the stipulated level
(0.01 %) are possible and have been demonstrated
in some of the dossiers. However, it was emphasized
that these in themselves do not preclude material from
escaping. There are several ways in which contamination
can occur and it probably will not be possible to deploy the
tests at a level that will preclude the possibility of escape.
Even in the most careful of conditions, contamination can
occur. There are well-known examples of contamination
having occurred as well.
(vi) Finally, on whether institutions and laboratories in India
have the state-of-art testing facilities and professional
expertise to conduct various biosafety tests, the majority
noted that the professional expertise and standards
across the institutions appeared unsatisfactory. However,
it noted that it is ultimately the expertise available in the
regulatory system that sets the standards for conducting
and evaluating the biosafety tests. Unless this expertise
and capacity is present, no amount of facility creation
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will be able to address the issues. Based on the
examination of the safety dossiers the majority found that
at present, the regulatory system has major gaps and
these will require rethinking, investment, and re-learning
to fix. A deeper understanding of the process of Risk
Assessment is needed within the regulatory system for
it to meet the needs of a proper biosafety evaluation.
This is not available in the country as per the majority. It,
therefore, recommended that the requisite understanding
be developed through consultation, collaboration, and
capacity building. It is of critical importance that the
Indian regulatory system develops the ability to assess
how any GM product is likely to impact different sections
of society.
10.7 Dr. R.S. Paroda submitted a separate dissenting report. A brief
discussion of the Report may be adverted to.
(i) Firstly, as for the nature of sequencing of risk assessment
studies that need to be done for GM crops before they
are released into the environment, Dr. Paroda, in his
dissenting report recommended the following:
a. The sequencing of studies provided in the
“Guidance for Information/Data Generation
and Documentation for Safety Assessment
of Regulated, Genetically Engineered (GE)
Plants”, which is in draft stage, should
henceforth be adopted quickly by the RCGM
and GEAC.
b. The sequencing of studies presented in
“Guidance for Information Generation and
Documentation for Safety Assessment of
Regulated, Genetically Engineered (GE)
Plants” should, in future, be reviewed at
regular intervals of no less than three years to
ensure that these guidelines remain consistent
with internationally accepted best practices
and standards.
c. Guidelines for the conduct of confined field
trials and for GM food safety assessment that
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meet the international norms have currently
been adopted by RCGM and GEAC. However,
it was noted that the present approach for
the environmental risk assessment (ERA)
in the guidelines for research in transgenic
plants was rather broad, whereas there is
an urgent need for developing and adopting
comprehensive guidelines for the ERA by
RCGM and GEAC. The process for the
same should be transparent and consultative,
involving all stakeholders and it must start
immediately.
d. A Risk Assessment Unit (RAU), as also
suggested in the “Draft Establishment Plan
for the National Biotechnology Regulatory
Authority” should be established. Further, the
RAU should serve both RCGM and GEAC and
be permanently staffed by a multi-disciplinary
team of scientists/experts competent enough
and responsible for undertaking science-
based risk assessments, including but not
limited to those required to approve clinical
or confined field trials for the experimental
GMOs as well as for their commercial
release of GMOs (i.e., product specific risk
assessments). The proposed RAU could be
transitioned to the Biotechnology Regulatory
Authority of India (BRAI), as and when the
BRAI Bill is promulgated by the Parliament.
e. In addition to establishing the RAU, RCGM
and GEAC should immediately establish a
roster of qualified scientific experts in relevant
disciplines to provide sound scientific advice/
information on biosafety issues that could
impact on human and animal health as well
as the environment. The issue concerning
conflict of interest should also be addressed
while including experienced scientists to the
roster.
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f. Although, the safety assessment is completed
after GEAC approval and subsequently the GM
crops are to be treated in the same manner as
their non-GM counterparts for the purpose of
variety/hybrid release and registration, seed
multiplication and cultivation; as a measure
to ensure quality products for the farmers, the
National Agricultural Research System (NARS)
should have an assigned responsibility for the
conduct of confined field trials for assessing
the agronomic performance, an essential
requirement for the release of GM varieties/
hybrids in accordance with the National
Seed Policy as well as National Seed Act.
For this, ICAR Delhi can make good use of
established infrastructure under the All India
Crop Coordinated Programmes. It is advised
that a single window system for managing
the testing and release of GM varieties and
hybrids should be established taking into
account special considerations involved with
GM crops viz. expression levels of inserted
proteins, confirmation of the events etc.,
irrespective of whether these are produced
by the private or public sector. In this context,
the Ministry of Agriculture (MoA) should
consider establishing a high-level committee of
experts: including socio-economists, tanners,
Non-Governmental Organisations (NGOs)
and the representative of the private sector
to review finally, for commercial release, the
cases that are cleared by GEAC.
g. Once a GM variety hybrid is released, a
post-release monitoring mechanism must be
put in place.
(ii) Secondly, as to when environmental release through
open-field trials should be permitted, the dissenting
report noted that “open-field trial” is a misnomer in the
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context of trials of GM crops. This is because even
though the trial is done in the open field, the GM plants
and genetic material being tested are confined to the
field trial site using measures to ensure that the “genes
in pollen or seed do not escape from the trial site”.
Thus, the right term is “Confined Field Trials”. It, then
proceeded to suggest that Confined Field Trials should
only be permitted by RCGM and GEAC after careful
consideration of submissions that adhere exactly to the
“Application for Confined Field Trial” form. This form, in
combination with the “Guidelines and Standard Operating
Procedures for Confined Field Trials of Regulated,
Genetically Engineered Plants”, clearly specifies the
information required by the competent authorities to
determine if a Confined Field Trial should be permitted
or not. The application form was developed through a
transparent, consultative process that included a period
for public review and comment. Hence, both the approach
and procedure for permitting Confined Field Trials in India
have already been peer-reviewed and public-reviewed.
In sum, the tests that are required prior to obtaining a
permit for a confined field trial are:
a. Amino acid sequence homology comparisons
to assess the extent to which the transgenic
protein is similar in structure to known toxins;
b. Amino acid sequence homology comparisons
to assess the extent to which the transgenic
protein is similar in structure to known
allergens.
It was also considered desirable, but not mandatory,
to determine the maximum level of expression of the
transgenic protein in the edible portions of the plant.
(iii) Thirdly, as to whether a proper evaluation of the
GE plant is scientifically tenable in the greenhouse
conditions, the dissenting report answered in the
negative. It noted that a proper evaluation of a GE plant
is scientifically not tenable in a contained greenhouse
since it would not be feasible to replicate the conditions
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prevailing under natural field conditions representing
different agro-ecological regions and growing seasons.
Therefore, it was advised that confined field testing, as
recommended under the present regulatory system,
is the right option for a realistic evaluation of any GE
plant to know its suitability for any agronomic trait of
economic importance.
(iv) Fourthly, whether specific conditions imposed by the
regulatory agencies for open-field trials (or “Confined
Field Tests”, as Dr. Paroda prefers) are adequate, the
dissenting report expressed concerns about the existing
system in India and recommended, among other things,
the following:
a. The RCGM, GEAC and ICAR must work
hand in hand to conduct the confined field
trials at the specified sites as well as improve
the quality and timeliness of inspections by
qualified monitoring teams. A roster of such
monitors, with required expertise needs to be
maintained and updated regularly by these
agencies.
b. Crop-specific Standard Operating Procedures
(SOP) should be developed and made available
online. Such SOPs should incorporate, in
addition to the existing procedures, i) methods
for reproductive isolation of the confined field
trial site, ii) schedules for monitoring the field
trial during and after the growing season, iii)
required duration of post-harvest restrictions
on the trial site, and iv) methods for on-site/
off-site disposal of regulated plant materials.
c. A system for notification of confined field trial
sites located in different agro-ecological zones
should be developed by RCGM and GEAC
in consultation with the ICAR. These sites
could include both public and private sector
institutions/facilities, meeting the specified
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conditions. However, no trials should be
allowed on farmers’ fields, leased or otherwise.
d. Integrate the existing system of testing
and standard protocols under All India
Coordinated Research Project (AICRP) with
the three years of confined field testing in
Biosafety Research Level (BRL)-I and BRL-II.
The agronomic evaluation should be against
the best national check, regional check, and
the latest released variety or hybrid in the
state concerned. For all the new events, the
decision of RCGM and GEAC on biosafety
and environmental concerns must be final at
either of the testing stages (BRL-I or BRL-II),
irrespective of good agronomic performance
of the variety.
e. Monitoring for biosafety compliance as well
as agronomic performance of each confined
field trial must be made mandatory, and
should be carried out by GEAC through
an inter-ministerial monitoring compliance
committee including people drawn from a
roster of experts. In addition, each confined
field trial must be monitored by a site-specific
monitoring committee.
f. In cases where an already approved event is
incorporated into a new genetic background,
after being verified for its stability, such variety
or hybrid shall be evaluated independently by
the AICRP protocol for agronomic performance
and the expression of the event concerned
for a period of two years, as per the existing
practice under the New Seed Policy.
g. Varieties or hybrids evaluated by the above
process shall then be approved for general
cultivation by a Central GM-Crop Release
Committee at par with the Variety Release
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Committee under the MoA. This committee
shall include experts from the disciplines
concerned including the Crop Project
Coordinators or Director, officials of Seed
or Crops Divisions of DAC and ICAR, socio-
economists, progressive farmers, NGOs and
the private sector representatives.
h. Once a GM crop variety/hybrid is released,
a well-designed case-by-case post-release
monitoring system must be put in place
jointly by the Department of Agriculture and
Cooperation (DoAC) and ICAR to address
specific post-release issues identified during
the event approval by GEAC. Such a system
should also monitor the long term effects from
the point of view of food safety, soil health,
environment and agronomic performance.
i. Finally, the MoA may also consider issuing a
separate notification on priority for the general
release of GM crops at par with New Seeds
Policy, while legally ensuring much needed
harmonization of both EPA under Ministry
of Environment and Forests (MoEF) and the
Seed Act under MoA.
10.8 A corrigendum was issued to the final report of TEC on
12.07.2013. Paragraph 6 of the Majority Report is modified
by the corrigendum, which reads as under:
“6. page 71, lines 3-5: “… exert a highly adverse
impact over time on sustainable agriculture, rural
livelihoods, and environment. The TEC finds them
completely unsuitable in the Indian context.”
Corrected: “… exert a highly adverse impact on
sustainable agriculture, rural livelihoods, and
environment. The TEC finds them completely
unsuitable in the Indian context and recommends that
field trials and release of HT crops not be allowed
in India.”
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Parliamentary Standing Committee (PSC) on Agriculture’s Report
on “Cultivation of Genetically Modified Food Crops – Prospects
and Effects” – 2012:
11. The aforesaid Report, submitted on 09.08.2012, has been relied
upon by the learned counsel Sri Prashant Bhushan. The salient
observations and recommendations of the said Committee are
encapsulated in the following paragraphs:
i. To ascertain the efficacy of the extant system in general and the
role of GEAC as the apex regulator in particular, the Committee
sought the views of Dr. P.M. Bhargava, founder Director of
CCMB, Hyderabad and then the Supreme Court nominee on
GEAC. The gist of the testimony of Dr. P.M. Bhargava given on
22.12.2010 can be crystallised in the following points:
a. All the tests on Bt cotton have either been conducted
by the concerned applicant for approval, or by an
accredited laboratory on the samples given by the
applicant. The Bt cotton was tested and approved
surreptitiously without adequate information being
available to the public.
b. The Bt brinjal was approved on the basis of an expert
committee report, which lacked in scientific quality,
credibility, consistency and rigour. Relying upon a
private conversation with the then Co-Chairman of
GEAC, Prof. Arjula Reddy, Dr. Bhargava claimed that
the former was under pressure to approve Bt brinjal
and to give a go by to the chronic toxicity and other
tests which had been proposed by the latter. He also
claimed that the Co-Chairman confided in him that
even the tests undertaken were performed badly.
c. That no chronic toxic studies have been conducted
on GM crops.
d. Despite a specific proposal for establishing a lab to
conduct indigenous and independent assessment
studies, the erstwhile Director General of ICAR, Dr.
R.S. Paroda, the erstwhile Director General of Council
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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.
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.
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c. The integration of biotechnology must be within an
enabling environment, supported by local research
and education that empowers local communities.
iv. With respect to regulation and labelling of GM foodstuffs, the
Committee observed the casual approach on the part of both
MoEF and Ministry of Health and Family Welfare (MoHFW).
While the MoEF, on 23.08.2007, exempted all GM food
categories from regulations under Rule 11 if the end product
was not an LMO, the MoHFW did not include GM foods from
the restrictions on manufacture, distribution and selling when
it issued the notification under Section 22, Food Safety and
Standards Act, 2006 (for short, “FSSA, 2006”). The Committee
noted that the Food Safety and Standards Authority of India
(FSSAI) regulation for GM processed food was nowhere in sight,
even though so many years had gone by. While noting that
Section 23 of FSSA, 2006 requires FSSAI to notify labelling, the
Committee observed that FSSAI had not been able to do so.
v. It was concluded that the tendency of the regulatory mechanism,
in the absence of specialized infrastructure and research and
development (R&D) facilities in India, is to base their decision-
making on practices and studies elsewhere, as also on the
assessments and data generated by the applicant concerned.
This was particularly concerning in light of the testimony of Dr.
Bhargava, as the contents of his testimony were “not merely
slippages due to oversight or human error but indicative of
collusion of the worst kind”. By its very composition, GEAC does
not have regular existence and meets monthly only when some
decisions are to be taken. It is also a sad reality that modern
biotechnology being a nascent discipline in the Country, we
have a serious dearth of scientists of eminence in sufficient
numbers, therefore, more or less the same set of people sit
on both the sides, i.e., to develop technologies and products,
as also to assess, evaluate and approve them.
vi. The Committee noted that Article 246 of the Constitution of
India, read with Entry 14, List II, assigns “agriculture, including
agricultural education and research, protection against pest and
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prevention of plant diseases” to the States. However, it observed
that for a thing as crucial as field trials, the State Governments
were not even consulted till recently.
vii. The Committee concluded that in a regulatory set-up where
the promoter has an overwhelming say and presence in the
regulatory mechanism, an element of subjectivity in assessment
and evaluation is unavoidable. The entire system, therefore,
reflects a pro-DBT/pro-industry tilt which is best avoided. Apart
from this major shortcoming, the Committee’s examination
has revealed that the extant system is grossly inadequate and
antiquated to face the typical challenges a population-intensive,
agrarian economy (primarily) like India poses when the question
of introduction of such modern technologies in the agriculture
sector crops up.
Parliamentary Standing Committee (PSC) on Science and
Technology, Environment and Forests’ Report titled “Genetically
Modified Crops and its impact on Environment” - 2017:
12. The aforesaid Report has been perused by us. The salient observations
and recommendations of the said Committee are encapsulated in
the following paragraphs:
i. The Committee considered the legal and administrative
architecture for the regulation of biotechnology and GE
techniques and the extant process of health and environmental
safety assessment.
ii. It observed that as a party to several International Conventions,
India should ensure the safe usage of GM crops through the
“Precautionary Approach”. In line with the same, India ratified
International Protocols like the CBD, the CPB and the Nagoya
Kuala Lumpur Supplementary Protocol on Liability and Redress
(NKSPLR).
iii. The Committee took note of the divergent views on the efficacy
of the existing regulatory mechanism. It expressed certain
apprehensions about the stance of the MoEF&CC that the
existing regulatory regime left no scope for any non-adherence.
It also observed that the MoEF&CC and GEAC’s casual
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approach indicated indifference towards the environmental
safety and health hazards of humans and animals. Specifically,
it concluded that the regulatory agencies had turned a blind
eye to the negative impact of GM crops on the environment.
It was observed that the existing regulatory mechanism was
susceptible to manipulation, due to the following processual
infirmities and substantive deficiencies:
a. The whole process of regulation depends upon
the data made available to the regulators by the
technology developers.
b. None of the Committees established under the 1989
Rules conduct the closed field trials on their own but
are solely dependent on the data provided to them
by the technology developer.
c. There was a scope for the technology developers to
manipulate the data to suit their own requirements.
d. The Government failed to put in place the desired
protocols as late as 2011, while the GM crops were
introduced in 2002.
e. Two of the top three positions of GEAC are held
by the bureaucrats of the MoEF&CC. There is a
conflict of interest in the appointment of some of the
members of GEAC.
f. The members of GEAC were mostly from the
Government and Government-aided institutions and
there was hardly any representation of the civil society
or the State Governments on the Board.
g. Even though the DLCs are provided for in the 1989
Rules, the importance of this Committee had not been
realised, thereby further weakening the confidence
level of farmers, civil societies, environmentalists, etc.
h. There was lack of clarity on the impact of the adoption
of Bt cotton on crop yield. Therefore, the Committee
was not persuaded about the claims of success of
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Bt cotton as India’s cotton yields increased by 69% in
the five years (2000-2005) when Bt cotton was less
than 6% of total cotton area, but by only 10% in the
ten years from 2005 to 2015 when Bt cotton grew
to 94% of the total cotton area. There was also lack
of clarity on whether traditional methods of farming
could achieve better outcomes.
i. It also expressed its apprehensions about the
stated benefit of reduced dependence on chemical
pesticides. Based on consultations with members
of civil society, it observed that after the advent of
Bt cotton, the insecticide use on bollworm, both
sucking and secondary pests took over the ecological
niche vacated by the bollworm. Therefore, the per
hectare insecticide use had almost doubled. The
issue of pesticide resistivity was also a matter of
concern, as it was observed that the pink bollworm
had developed resistance to Bt cotton variety,
i.e., Bollgard-II (BG-II).
j. Since transgenic mustard hybrid DMH-11 is 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
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has accorded its approval for commercial release
without scrutinising any indigenous study. Only acute
and sub-chronic studies have been conducted but
chronic and transgenerational studies have not been
conducted, therefore, risking the health of future
generations.
13. As is well-settled, the Parliamentary Select Committees are entities
through which Parliament scrutinises the policies and actions of
the Government and enforces executive accountability. Select
Committees are constituted with specifically nominated Members of
Parliament and exercise the authority delegated by the House. The
role of Select Committees has been outlined in Erskine May’s Treatise
on The Law, Privileges, Proceedings and Usage of Parliament, (Lexis
Nexis, 24th Edn. 2011, p.37.] as under:
“Select Committees are appointed by the House to
perform a wide range of functions on the House’s behalf.
Most notably they have become over recent years the
principal mechanism by which the House discharges
its responsibilities for the scrutiny of government policy
and actions. Increasingly this scrutiny work has become
the most widely recognised and public means by which
Parliament holds Government Ministers and their
departments to account.”
13.1 Parliamentary material, such as the reports submitted by Select
Committees, is an aid to the construction of legislation, as such
material may disclose the legislative intention lying behind the
ambiguous words and expressions, vide Pepper (Inspector
of Taxes) vs. Hart, 1992 UKHL 3 (HL) (“Pepper”). Noting
the evolution of Indian law, Justice G.P. Singh, in Principles of
Statutory Interpretation (14th Edn.), has stated that this Court
has pressed the parliamentary materials as an aid in resolving
questions of construction. This Court has clarified that courts may
seek recourse to background parliamentary material, including
a statement of position by the Government, to understand the
reasons of the enactment of a law and the problems sought to
be remedied vide Kalpana Mehta vs. Union of India, (2018)
7 SCC 1 (“Kalpana Mehta”).
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13.2 The pertinent facts in Kalpana Mehta were that a writ petitioner,
who had challenged the grant of approval to an HPV (Human
Papilloma Virus) vaccine by the Drugs Controller General of
India, had invited the attention of this Court to a report of the
PSC and this Court had directed the Government to file an
affidavit about the status of compliance with the contents of
the report. At that stage, the State and private respondents
raised doubts about the appropriateness of adverting to a report
of the PSC while exercising jurisdiction under Article 32 in a
public interest litigation. Therefore, the core question raised
therein that came to be referred to the Constitution Bench
was whether a PSC report can be placed reliance upon for
adjudication of a fact in issue and also for what other purposes
it can be taken aid of.
13.3 It was concluded that the reports of the Parliamentary Committee
can be relied upon to adduce the position adopted by the
Government. In this respect, reliance can be placed upon the
responses given by the Government to the queries raised by the
Parliamentary Committee. The Union of India has filed Action
Taken Reports with respect to the recommendations made by
the Standing Committee.
Conditional approval by Government of India for Environmental
Release of DMH-11:
14. We shall now proceed to the actual controversy. According to
Union of India, the conditional approval for environmental release
of transgenic mustard hybrid DMH-11 and parental lines bn 3.6
and modbs 2.99 containing barnase, barstar and bar genes has
been made after following the detailed procedure in law and after
considering the biosafety data accumulated over several years.
Also, the conditional approval has been made in accordance
with the guidelines and framework which enable a consistent and
rigorous risk-analysis approach to evaluating applications for the
environmental release of GE plants is the contention of the Union
of India.
14.1 That in the instant case, after recommendation of RCGM, GEAC
had considered the recommendations of RCGM in the following
meetings in regard to confined field trials:
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Date of Meeting Purpose of Trial Permission
GEAC under which Granted
Meeting considered

29.09.2010 103rd meeting Study under confined conditions 1st year
for environmental and food BRL-I
and feed safety assessments application
at three locations namely dated
Agricultural Research 20.08.2010
station experimental Farm, to RCGM.
Navgaon, Agricultural Research
Station, Sriganganagar and KVK,
Kumher during Oct, 2010. Also,
gave approval for experimental
seed production under confined
condition at Jaunti Village,
Delhi and Environmental safety
studies (Crossability Studies) at
Bawana, Delhi during Oct, 2010.

21.09.2011 112th meeting On transgenic mustard (Brassica 2nd year
Juncea) containing bar, barnase BRL-I
and barstar genes [Events bn application
3.6 (Barnase Line), modbs 2.99 dated
(Barstar Line) and bn 3.6x modbs 15.07.2011
2.99 (Hybrid DMH-11) under the to RCGM.
coordination of Directorate of
Rapeseed Mustard Research,
Bharatpur during the appropriate
season in 2011-12.

18.07.2014 121st meeting On transgenic mustard hybrid BRL-II trials
(DMH-11) (Brassica juncea) application
Events bn 3.6 (Barnase Line), dated
modbs 2.99 (Barstar Line) & 17.08.2012.
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.
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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 125 th 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 126 th meeting held on 04.01.2016, GEAC
constituted a sub-committee under the Chairmanship of
Dr. K. Veluthambi, Co-Chair of GEAC, with the following
members for examination of the dossier:
a. Dr. K. Veluthambi, Chairman (Biotechnologist)
b. Dr. S R Rao, Adivser, DBT, Member (Agriculture
Expert)
c. Dr. S.K. Apte Member (Molecular Biology Expert)
d. Dr. Ramesh V Sonti Member (Plant Genetics
Expert)
e. Dr. B. Sesikeran, Member (Nutritional Pathologist
and Food Safety Expert)
f. Dr. C R Babu Member (Environmental Science
Expert)
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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 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.
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b) That Dr. S.R. Rao Advisor, DBT informed that the biosafety
dossier had been examined in detail by the BSU set up in
DBT and points for further clarification and dossier revision
had been prepared for consideration and discussion.
c) That on the application submitted by the applicant CGMCP,
University of Delhi, South Campus, for environmental
release of transgenic mustard hybrid DMH-11 and parental
lines containing events bn 3.6 and modbs 2.99 developed
using barnase, barstar and bar genes, was taken up.
d) That discussion was held with the applicant and the sub-
committee advised for continuous monitoring and further
investigation for fitness and the transfer of transgenic trait
from DMH-11 to their progenies and feral populations that
will be essential for implementing management strategies
to minimize persistence and dissemination from release
site. The sub-committee also advised that a suitable post-
release management strategy should be implemented.
e) That certain data had to be incorporated in the revised
dossier, along with the details of oil content and other
measured parameters in the revised dossier.
f) That the data suggested that the activities of barnase
need to be presented quantitatively and UDSC-barnase
specific activity can be compared with any other over
expressed barnase specific activity to compare activity
status of the proteins.
g) That the updated statistics data from National Institute of
Nutrition (NIN) may be included in the revised dossier.
h) That Intellectual Property Rights (IPR) for Barnase
promoter has not been registered in India.
i) Requested the University to check whether DMH-11 hybrid
accumulated complexes of barnase + barstar.
j) Questioned whether grazing of transgenic mustard by farm
animals would affect them.
k) That the bar gene is present in the two parental varieties
and continues to be present in the hybrid but release of
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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 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
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relatives, (iii) the impact on beneficial insects, and (iv) the
impact on beneficial soil microbes, if any.
14.2.2 The second sub-committee meeting of GEAC was
held on 11.04.2016. In the said meeting, Dr. S.R. Rao
briefed the sub-committee members on the follow up actions
taken by BSU pursuant to the 128th GEAC meeting held
on 04.03.2016 regarding the application for environmental
release of transgenic mustard (Brassica juncea) hybrid
DMH-11 by the CGMCP, University of Delhi (South Campus).
The sub-committee was made aware of the fact that the
128th GEAC meeting held on 04.03.2016, had sought further
information/clarifications from CGMCP and accordingly, a
revised document was submitted by the applicant. Accordingly,
the revised biosafety dossier and draft RARM report of the
sub-committee was circulated amongst the sub-committee
members and comments of the experts were tabulated along
with remarks of the BSU.
14.2.3 Observation of one of the members of the sub-committee
was regarding the sustainable use of deregulated GE mustard
in future and as to how honey derived from GE mustard be
tested for the absence of barnase for a definite period as a part
of post-release monitoring.
14.2.4 The sub-committee opined that one of the members of
the sub-committee explained that self-reproducible populations
of mustard (Brassica juncea) may get established in the hills (not
in the plains) and though probability of such occurrence may be
low, this question needs to be addressed. The sub-committee
opined that this should be taken as a scientific question, which
should be addressed from a research angle in the interest of
long-term sustainability of transgenic mustard hybrid DMH-11
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.
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14.2.7 The sub-committee constituted by GEAC suggested a
report being placed on the MoEF&CC website for thirty days, to
invite comments from stakeholders in the 130th GEAC meeting
held on 11.08.2016.
14.2.8 Accordingly, the AFES Report was uploaded on the
website of MoEF&CC, inviting comments from all stakeholders.
The comments received were to be reviewed by the sub-
committee and GEAC prior to taking an appropriate decision. The
full biosafety dossier submitted by the applicant was available
in GEAC Secretariat and any person interested in studying the
same could access the dossier during working hours in person,
by prior appointment during the public consultation period, at
Indira Paryavaran Bhawan, Jorbagh, New Delhi – 110 003, till
the closing of working hours, i.e., 05:30 PM on 05.10.2016. A
total of 759 comments were received between 05.09.2016 and
05.10.2016.
14.2.9 It is also to be noted that about 29 persons (including
from places other than Delhi) personally inspected the dossier
at the premises of the MoEF&CC and provided their comments.
It is stated that thereafter, all these comments were analyzed
and deliberated by the sub-committee of GEAC.
14.2.10 The instant proposal was again considered on
11.05.2017 in the 133rd GEAC meeting, wherein the report
submitted by the sub-committee was examined in detail and
GEAC recommended the proposal with certain terms and
conditions for further approval by the Competent Authority. But
pursuant to receipt of various representations from different
stakeholders, matters related to environmental release of
transgenic mustard were kept pending for further review.
14.2.11 In the 134th meeting of GEAC held on 21.03.2018, it was
recorded that the instant proposal was referred back to GEAC for
its re-examination, pursuant to receipt of several representations,
both in support and against, after the 133rd meeting of GEAC
held on 11.05.2017. In this meeting, GEAC examined all the
representations and reiterated that these representations were
already deliberated extensively while taking the decision in the
133rd meeting of GEAC. After a detailed discussion, GEAC
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agreed that the applicant may be advised to undertake field
demonstration on transgenic mustard hybrid DMH-11 in an area
of five acres at two to three different locations, with a view to
generate additional data on honey bees and other pollinators
and on soil microbial diversity.
14.2.12 The instant matter was re-examined in the 136th meeting
of GEAC held on 20.09.2018, wherein the said Committee
accorded permission for conduct of field demonstration studies
on honey bees and other pollinators at two locations of up to
five acres in each location namely Punjab Agricultural University
(PAU), Ludhiana and Indian Agricultural Research Institute
(IARI), New Delhi.
14.2.13 Thereafter, in the 137th meeting of GEAC held on
20.03.2019, the Committee noted the response from the applicant
regarding the reasons for deferment of field demonstration
studies on transgenic mustard during the season 2018-19 and
the deferment was further extended for the seasons 2019-20
and 2020-21.
14.2.14 At this stage, Prof. Deepak Pental, Former Professor
of Genetics and Vice-Chancellor, University of Delhi, on behalf
of CGMCP, University of Delhi, South Campus, New Delhi,
made a representation on 10.05.2022 to the Hon’ble Minister
for Environment, Forest and Climate Change, to accept the
recommendations for environmental release of transgenic
mustard hybrid DMH-11 made in 133 rd 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
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the proposed events will broaden the scope for
developing many high yielding mustard hybrids in
future.
The comments received from DBT: Based on the
scientific evidence and the available data from
various international agencies, it seems likely that
there were no major deviations in the behavior of
honey bees when compared among the transgenic
and non-transgenic comparator lines; and suggested
that GEAC may consider its recommendations of
the 133rd meeting on the environmental release of
GE mustard.”
Soon thereafter, ICAR by its letter dated 30.07.2022 wrote
to MoEF&CC for GEAC to consider the recommendation
for 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)
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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 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
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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 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:
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(i) It provides that during the period of approval, a
Post-Release Monitoring Committee (PRMC) would
be constituted by GEAC, consisting of two subject
matter external experts and a nominee each from
the RCGM, GEAC and the PRMC, who will visit the
growing sites of the approved biological material(s)
at least once during each season and submit their
report to GEAC on the matters of compliance.
(ii) Usage of any formulation or herbicide is not
permitted for cultivation in the farmer’s field under
any situation and such use would require necessary
permission as per the procedures and protocols for
safety assessment of insecticides/herbicides by the
Central Insecticide Board & Registration Committee
(CIB&RC). Any such use in the farmer’s field
without due approval from the CIB&RC would attract
appropriate legal action under the Insecticides Act,
1968 and the Rules, 1971, made under the said Act
and the EP Act, 1986, and the Rules made thereunder.
(iii) The production of seeds of transgenic mustard hybrid
DMH-11 will take place under the supervision of
ICAR, as per the existing ICAR guidelines and other
extant rules/regulations, after which the commercial
cultivation of mustard will start. Commercial use will
be subject to the Seeds Act, 1966 and the related
rules and regulations.
(iv) As a precautionary mechanism, the data in regard to
the impact of transgenic mustard hybrid DMH-11 on
honey bees and other pollinators will be generated
during these two years under the supervision of
ICAR. This may help create additional data in regard
to the impact of transgenic mustard hybrid DMH-11
on honey bees and other pollinators.
(v) The approval may be revoked under Rule 13(2) of
the 1989 Rules, if any evidences regarding harmful
effects of the approved GE mustard, such as damage
to the environment, nature or health as could not
be envisaged when the approval was given, come
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under notice of GEAC and on non-compliance of any
condition stipulated by GEAC.
14.6 Within two months, on 18.10.2022, at the 147th GEAC meeting,
it was recommended that environmental release of DMH-11
be approved subject to some conditions and safeguards. The
recommendations and the conditions were communicated by the
MoEF&CC to the applicant-Prof. Deepak Pental on 25.10.2022
and the same are extracted as under:
“… the Genetic Engineering Appraisal Committee (GEAC)
in its 147th meeting held on 18.10.2022, has recommended
the following:
I. The environmental release of genetically engineered
mustard parental lines bn 3.6 carrying barnase and
bar genes, and modbs 2.99 containing barstar and
bar genes, so that these events can be used for
developing new parental lines and hybrids under
supervision of ICAR.
II. The environmental release of mustard hybrid
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 following
conditions:
I. The approval is for a limited period of four years from
the date of issue of approval letter as per clause 13
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of Rules 1989 and is renewable for two years at a
time based on compliance report.
II. During the period of approval, a Post Release
Monitoring Committee (PRMC) would be constituted
by GEAC consisting of 2 subject matter external
experts and a nominee each from RCGM and GEAC
and PRMC will visit the growing sites of the approved
biological material(s) at least once during each season
and submit their report to GEAC on the matters of
compliance. Chairperson, GEAC is authorized to
constitute the Committee.
III. Applicant shall deposit 100 grams each of approved
hybrids as well as their parental lines with the
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.
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Any such use in the farmer’s field without due approval
from CIB&RC would attract appropriate legal action
under Central Insecticides Act 1968 and Rules 1971,
EP Act 1986 and the Rules made there under.
VIII. Commercial use of DMH-11 hybrid shall be subject
to Seed Act 1966 and related rules and regulations,
its amendments and Gazette notifications from time
to time as applicable.
IX. The applicant shall prepare and submit the annual/
seasonal reports on acreage, yield and states/ regions
where the transgenic mustard is sown during the
approval period to the GEAC.
X. It is mandatory that all seed packets of GE mustard
Hybrid DMH-11 and subsequent hybrids derived
from the technology should be appropriately labelled
indicating the contents including the name of the
transgenes, physical and genetic purity of the
seeds etc. Each packet should also contain detailed
description for use including sowing pattern, pest
management, suitability of agro-climatic conditions
etc. in English, Hindi and vernacular language.
XI. All efforts should be made by applicant and licensees
to undertake an awareness and education programme
interlaid through development and distribution of
educational material on GE Mustard Hybrid DMH-11
for farmers, dealers and others.
XII. Indian Council of Agricultural Research (ICAR)
would be the authorized agency to accord necessary
permissions for development of any other Brassica
juncea hybrids resulting from events approved and
their descendants, provided the intended use is similar.
However, all hybrids released using this technology
shall also be regulated under Seed Act 1966 and
related rules and regulations, its amendments and
Gazette notification from time to time as applicable.
ICAR shall also ensure the following conditions prior
to release of any new hybrids:
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• Confirmation of events through molecular
characterization to be submitted from accredited
lab, in original, as notified for the purpose.
• Data on level of transgenes (Barnase, Barstar
and Bar) expression in the events/ hybrids at
seedling stage from accredited lab, in original,
as notified for the purpose.
• Morphological characters using Distinctiveness,
Uniformity and Stability (DUS) descriptors as
per Protection of Plant Varieties and Farmers
Rights Act, (PPVFRA) guidelines for the hybrids.
• Source of germplasm/ pedigree and biotech
traits must be provided with self-declaration by
the applicant.
• Affidavit on the ownership of hybrid/ variety/
events.
• Performance trial report including agronomic
parameters, yield with coefficient of variation
(CV) and critical difference (CD), pest & disease
reaction etc. as per ICAR guidelines.
XIII. If at any time, the applicant or the responsible parties
become aware of any information regarding risk to the
environment, or risk to animal or human health, that
could result from release of these materials in India,
or elsewhere, the applicant must immediately provide
in writing such information to regulatory bodies.
XIV. The approval may be revoked under Rule 13(2) of
Rules, 1989, if any evidences regarding harmful
effects of the approved GE mustard, such as damage
to the environment, nature or health as could not
be envisaged when the approval was given comes
under notice of GEAC and on noncompliance of any
condition stipulated by GEAC.
XV. MoEF&CC/ GEAC may prescribe any additional
conditions/ requirements or constitute any Sub-
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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:
15. I.A. No.185604 of 2022 has been filed by the petitioner in Writ
Petition (Civil) No.840 of 2016 seeking quashing of the approval letter
F.No.C-12013/35/2010-CSIII dated 25.10.2022 issued by respondent
Nos.1 and 2 to respondent No.3 therein being void ab initio; secondly,
to disclose all the sites/locations where the environmental release
of transgenic mustard hybrid DMH-11 is planned/commenced;
thirdly, to direct the respondents to immediately uproot/remove/
destroy all transgenic mustard hybrid DMH-11 that has been planted
pursuant to the environment clearance issued in 147th meeting of
respondent No.2 held on 18.10.2022 and the subsequent approval
letter number F.No.C-12013/35/2010-CSIII dated 25.10.2022; and,
fourthly, a direction is sought that the TEC report recommendation
be adopted and to ban all HT crops and crops for which India is a
Centre of Origin/Diversity. It is unnecessary to narrate the pleadings
accompanying the aforesaid prayers as the same shall be dealt with
while considering the main petition.
I.A. No.209550 of 2023 has been filed in Writ Petition (Civil) No.115
of 2004 by the petitioner therein, seeking a direction to the respondent
Union of India to destroy the planted material of transgenic mustard
hybrid DMH-11 in view of the undertaking given to this Court and
there being violations of the same.
The aforesaid prayer made by the petitioner has also to be considered
in light of the prayer made by the Union of India, which has also filed
an application (I.A. No.167110 of 2023), seeking discharge from the
oral statement made before this Court on 08.11.2022 to the effect
that no precipitative steps for environmental release of transgenic
mustard hybrid DMH-11 would be taken.
Additional Affidavit of Union of India:
16. It would be useful to refer to the additional affidavit dated 09.11.2022
filed by the Union of India through Scientist ‘G’ in the MoEF&CC,
New Delhi.
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16.1 That on 03.11.2022, it was brought to the notice of this Court
that permission of environmental release of transgenic mustard
hybrid DMH-11 had been granted by the Government of India
to the CGMCP at the University of Delhi on 25.10.2022.
Pursuant to the said order, the Union of India has sought to
place on record the decision-making process employed by the
Government of India and the regulatory framework under which
this permission was granted.
16.2 In addition to the above, the Union of India has stated in
its Additional Affidavit dated 09.11.2022 that the research,
development, and use of GE technologies is a highly technical
matter guided by the views of subject experts. As such, the
inquiry before this court is limited to whether there exists an
adequate regulatory mechanism governing this field and whether
material compliance with the same has been made.
16.3 The conditional approval for environmental release of transgenic
mustard hybrid DMH-11 and its parental lines Varuna bn 3.6 and
EH-2 modbs 2.99 containing barnase, barstar, and bar genes
prior to commercial release has been made after a long and
exhaustive regulatory process which commenced as far back
as in 2010 and is outlined as below:
i. The initial R&D was conducted by the CGMCP in
accordance with the Revised Guidelines for Research
in Transgenic Plants, 1998 in the laboratory as well as
greenhouse conditions. The R&D was regulated by the
Institutional Biosafety Committee (IBSC) and RCGM as
prescribed by the Guidelines.
ii. Based on the information generated, an application was
made to the IBSC for permission to conduct a confined
field trial. After the recommendation of the IBSC, the
CGMCP submitted a further application to RCGM. After
the recommendation of the RCGM, GEAC considered
the recommendation of the RCGM in its meetings dated
29.09.2010, 21.09.2011, and 18.07.2014.
iii. After the completion of confined field tests, the CGMCP
submitted an application dated 15.09.2015, along with a
dossier of 3285 pages, seeking approval for environmental
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release of the GE mustard hybrid DMH-11 and its parental
lines Varuna bn 3.6 and EH-2 modbs 2.99.
iv. The said application was considered by GEAC in its 125th
meeting dated 11.12.2015. After a detailed discussion, the
applicant was invited to give a presentation to GEAC on
04.01.2016. Accordingly, on 04.01.2016, GEAC formed
an eight-member sub-committee under the chairmanship
of Dr. K. Veluthambi, Co-chair, GEAC.
v. The meeting of the sub-committee took place on
02.02.2016 and the sub-committee recommended revision
of the biosafety dossier by the applicant. Considering
the above, GEAC, in its 127th meeting dated 05.02.2016,
adopted the recommendations of the sub-committee and
directed the revision of the dossier. In addition, GEAC
directed preparation of the Biosafety RARM Report.
vi. The sub-committee requested GEAC for an additional one
month’s time to submit its final recommendations. The
request was granted by GEAC in its 129th meeting dated
20.06.2016. GEAC also invited two groups of NGOs to
present their views on the release of transgenic mustard
hybrid DMH-11 in India.
vii. Thereafter, on 11.08.2016, GEAC considered the report
titled “Assessment of Food and Environmental Safety”,
incorporating the evaluation of biosafety data generated by
the applicant CGMCP and prepared by the sub-committee
along with the inputs of RAU of the RCGM. The report was
then placed on MoEF&CC website for a period of 30 days,
from 05.09.2016 to 05.10.2016, for inviting comments.
viii. A total of 759 comments were received on the AFES Report
and the sub-committee proceeded to analyse the same.
ix. In the 133rd meeting of GEAC dated 11.05.2017, the report
submitted by the sub-committee was examined in detail. In
the 134th meeting of GEAC dated 21.03.2018, the proposal
was referred back to GEAC for re-examination. GEAC also
advised the applicant to undertake field demonstration on
transgenic mustard hybrid DMH-11 in an area of five acres
at two-three different locations, with a view to generate
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additional data on honey bees and other pollinators and
on soil microbial diversity.
x. The proposal came up for re-examination by GEAC in its
136th meeting dated 20.09.2018, wherein GEAC accorded
permission for conducting field demonstration studies at
two locations of up to five acres each in PAU, Ludhiana
and IARI, New Delhi.
xi. In the 137th meeting of GEAC dated 20.03.2019, GEAC
deferred field demonstration studies to the seasons
2019-20 and 2020-21.
xii. Thereafter, Prof. Deepak Pental, vide letter dated
10.05.2022 requested the MoEF&CC to okay the
environmental release of GE mustard.
xiii. GEAC sought comments from the DBT and the DARE.
Both opined that GEAC may consider exempting additional
field 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 rules and
regulations. As a precautionary measure, the data with regard
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to the impact of transgenic mustard hybrid DMH-11 on honey
bees and other pollinators is to be generated during these two
years of supervision by ICAR and approval could be revoked
under Rule 13 (2) of the 1989 Rules, if any harmful effects are
found. In addition, during the period of approval, a PRMC would
visit the growing sites at least once during each season and
submit its report to GEAC. Only after this elaborate process
would the commercial cultivation of transgenic mustard hybrid
DMH-11 start. Commercial cultivation, too, shall be subject
to the Seeds Act, 1966 and the rules and regulations made
thereunder.
16.5 Finally, emphasizing the importance of mustard as a prominent
edible oil and seed meal crop of India, the economic need to
increase its domestic yield was highlighted. It was also submitted
that internationally, the United States of America (USA), Canada,
and Australia have allowed cultivation of GE rapeseed containing
the bar, barnase, and barstar genes. Parental lines and hybrids
were also released for cultivation in Canada (1996), the USA
(2002), and Australia (2003). In all three countries, yields
of rapeseed increased with the introduction of GM hybrids.
Therefore, if employed, the DMH-11 hybrid technology would
contribute to increase in the domestic yield of mustard in India.
Submissions:
17. Elaborate submissions have been advanced by the learned senior
counsel, Sri Sanjay Parekh and learned counsel, Sri Prashant
Bhushan for the petitioners as well as learned Senior Counsel Sri
Pais and other learned Counsel for other petitioners and intervenors.
Learned Attorney General and the learned Solicitor General have
appeared for the respondents. A summary of the submissions is set
out hereinbelow.
Submissions of the petitioners:
17.1 Sri Prashant Bhushan, learned counsel has made the following
submissions:
The decision dated 18.10.2022 of GEAC to approve environmental
and commercial release of DMH-11/GM mustard/ HT mustard
is violative of Articles 14 and 21 of the Constitution as it suffers
from non-application of mind and is, therefore, arbitrary and
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unreasonable. Elaborating on the same, it was contended that
the said decision would lead to irreversible contamination of the
environment and threaten biodiversity. The decision was also
said to violate the choice of consumers to consume non-GM
food and that of farmers to grow non-GM crops in violation of
Article 21 of the Constitution. In this regard, the following points
were highlighted:
a. It is an admitted fact that DMH-11 is an HT crop (vide para
16 page 12 of the Additional Affidavit of Union of India).
b. The TEC appointed by this Court, in its detailed report,
recommended a complete ban on all HT crops.
c. It is an admitted fact that DMH-11 has no yield advantage
over non-GM/HT mustard hybrids/varieties.
d. The sole advantage for environmental release of
DMH-11 is that it is robust at cross pollination and there are
absolutely no immediate advantages to the environmental
release of DMH-11, rather there are attendant risks that
come with the environment release of HT crops and it is
only a hope that the same could be used to produce new
hybrids with better yield in future. If that is the hope, then
the new hybrids with better yield could be developed in
hybrid conditions and not be released into the environment,
as there would be no rational nexus to the object sought
to be achieved by the release.
e. Condition Nos. VI and VII of the order or decision dated
18.10.2022 directed that the farmers may not lawfully
spray herbicide/glufosinate on DMH-11, thereby ensuring
that there can be no lawful beneficial effect therefrom in
terms of weed management from HT crops to farmers.
f. If there is no real yield advantage, DMH-11 cannot be
marketed to the farmers as having yield advantage, as
this would be misleading for supporting its environmental
and commercial release.
g. In the 134th meeting of GEAC, the applicant of DMH-11
was advised to conduct research on the effect thereof on
honey bees. The said advisory was given a go by and the
study was directed to be done after environmental release
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of DMH-11. It is submitted that the DBT has funded the
development of DMH-11 and therefore, its recommendation
to forego studies on honey bees is a case of conflict of
interest and ignores all precautionary principles.
h. That even though there is no immediate advantage from
the environmental release of DMH-11, the immediate and
irreversible disadvantage from its release is the scientific
certainty of contamination of non-GM/non-HT mustard
hybrids/varieties through cross pollination from bees,
thereby:
− irreversibly threatening biodiversity, as eventually all
non-GM/non-HT mustard will be contaminated;
− irreversibly eliminating choice of consumers to eat
non-GM/non-HT mustard, in the absence of any
mechanism to prevent pollination by bees, which is
accentuated by the absence of any laws for labelling;
− irreversibly coercing farmers who do not wish to
grow GM crops to be susceptible to their crops being
contaminated with transgenic mustard hybrid DMH-11
with no legal mechanism for redress or liability for
losses suffered;
− irreversibly causing loss to organic farmers and the
entire agro-economic system relying on non-GM
crops as their products can no longer be certified
as GM-free. For instance, honey, which is produced
in the country from mustard flowers, can no longer
be certified as organic or GM-free in the absence
of elaborate testing for each and every product.
Hence, there is a need for studies with regard to
long-term effects on biosafety and the hazards from
environmental release of DMH-11.
i. The present writ petition has been filed seeking to put in
place a comprehensive, stringent, scientifically rigorous and
transparent biosafety test protocol in the public domain for
GMOs before they may be released into the environment.
This is because GMOs are a serious potential hazard and
several dimensions of biosafety are necessary before their
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release into the environment. The proper and independent
testing of GMOs is essential in view of the concern of the
irreversible contamination of non-GMOs crops and the
environment at large. This is unlike a drug, which when
tested to be unsafe, can be recalled. It is contended that
the GMO contamination of the environment would affect the
nation’s foundational seed stock and change the structure
of the food at the molecular level without recourse.
j. The right to health being a fundamental right, it is necessary
that the Union Government and the Regulators put in
place a rigorous mechanism so as to avoid the harm
caused by GMOs, such as chronic toxicity and other
unattended effects including health hazards. Therefore,
the precautionary principles must be purposefully applied
to insulate from the scientific uncertainty about hazardous
GMOs in future.
17.2 On the decision of GEAC to approve HT mustard/GM mustard/
DMH-11 for environmental and commercial release, learned
counsel contended that GEAC in its 147th meeting decided
to permit environmental release/commercial cultivation of
HT mustard. Based on the recommendation of the Expert
Committee as well as the comments received from DBT and
DARE, the Committee recommended the following:
“VI. Usage of any formulation of herbicide is
recommended only under controlled and specified
conditions exclusively for hybrid seed production
after obtaining label claim and approval from Central
Insecticide Board & Registration Committee (CIB&RC).
VII. Usage of any formulation of herbicide is not
permitted for cultivation in the farmer’s field under any
situation and such use would require the necessary
permission as per the procedures and protocols
of safety assessment of insecticides/herbides by
CIB&RC. Any such use in the farmer’s field without
due approval from CIB&RC would attract appropriate
legal action under Central Insecticides Act 1968
and Rules 1971, EP Act 1986 and the Rules made
thereunder.”
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17.3 It is learnt by the petitioners that HT transgenic mustard
hybrid DMH-11 seed was sown for seed selection in Kanpur
and Bharatpur at the Directorate of Rapeseed and Mustard
Research (DRMR). The 301st report of the Department related
PSC on Science and Technology, Environment & Forests, titled
“Genetically Modified Crops and its impact on Environment”
(2017) (“301st Report of PSC”, for the sake of convenience) noted
that the Government put on hold the earlier approval given by
GEAC to DMH-11 (vide Page 26 of the 301st PSC report/Pg.672,
Compilation). This is because in undertaking seed selection,
it would be necessary to spray illegal glufosinate on the seedlings,
for it is only seedlings which have been successfully engineered
for resistance to the herbicide which could be selected for seed
production. The concomitant advisory to farmers not to spray
would then go meaningless, as the farmers would definitely
spray for the short-term gain to kill weeds. In this regard, it is
mentioned that planting of HT – Bt cotton and Bt brinjal and
other such crops on commercial scale have gone on despite
illegal effects of the same.
17.4 It was also submitted that the National Bureau of Plant Genetic
Resources (NBPGR) had stated that India has rich biodiversity
in mustard. The Indian Gene Banks have 5477 Brassica juncea
(“Indian mustard”) accessions, which would all be at the risk
of contamination.
17.5 On the recommendations of the TEC as regards HT/GM crops,
it was submitted that HT crops being a potent carcinogen may
lead to breast cancer. Therefore, the TEC recommended a
complete ban on HT crops.
17.6 It was next contended that the first crop given de facto approval
by GEAC was Bt cotton, followed by Bt brinjal, in respect of
which there was a moratorium vide order dated 09.02.2010 of
the Ministry of Science, Environment & Forests. In the case
of transgenic mustard hybrid DMH-11 (HT crop), the technical
dossier running into thousands of pages was made available for
30 days at the headquarters of GEAC in New Delhi for physical
inspection. This was contrary to the earlier process, wherein
biosafety dossier as regards Bt cotton and Bt brinjal was put in
the public domain on the website of GEAC upon being directed by
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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 (37 th ) report of PSC on Agriculture
(2011-2012) titled “Cultivation of Genetically Modified Food
Crops – Prospects and Effects” (hereinafter referred to as
the “37th Report of PSC”).
b. Final Report of the five original members of the TEC
submitted to this Court on 30.06.2013.
c. Three Hundred and First (301st) report of the Department
related PSC on Science and Technology, Environment &
Forests, titled, “Genetically Modified Crops and its impact
on Environment” (2017).
17.8 The deposition of Dr. P.M. Bhargava, Molecular Biologist,
Founder Director, CCMB, Hyderabad, appointed as an
independent expert on GEAC by this Court vide order dated
13.02.2008, as recorded in the 37th report of PSC, was also read
out to us. Similarly, the observations and recommendations of
the TEC as regards GEAC being the regulator have been read
out to us during the course of the submissions. We shall refer
to the relevant portions of these reports a little later.
17.9 It was next contended that although the ubiquitous glyphosate
has been used for over four decades as the safest herbicide,
glufosinate is acknowledged as more toxic than glyphosate as
it kills indiscriminately soil organisms, beneficial insects etc.
It was also submitted that neurotoxin can cause birth defects
and damage to most plants that it comes into contact with.
It is banned in Europe and not permitted in India under the
Insecticides Act, 1968 for mustard. It is an 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.
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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
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.
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.
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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 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;
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ii. they also provide green fodder for rural livestock;
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 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
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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.
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
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is the 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 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.
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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 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
18. 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.
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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 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).
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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
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,
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transparent and science-based framework of GM crops is
in place for ERA of 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
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.
[2024] 7 S.C.R. 2037

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

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
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 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,
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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
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-11. 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.
[2024] 7 S.C.R. 2039

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

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 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.
iii. To generate scientific evidence in the Indian agro-climatic
situation of the environment release.
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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.
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.
[2024] 7 S.C.R. 2041

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

Submissions of Learned Solicitor General:
19. 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.
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 and self-reliant in essential food and
instead encouraged importing edible oil, which is not in the
interest of the Indian economy.
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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
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.
[2024] 7 S.C.R. 2043

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

Reply Arguments:
20. 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 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.”
(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
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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.
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
[2024] 7 S.C.R. 2045

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

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,
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
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petitioners’ concern is the irreversible risk of contamination
that the country faces, if environmental release of GMOs
is permitted in the absence of any chronic studies vis-à-vis
human health, livestock, environment, biodiversity etc. It was
pointed out that Union of India was silent as to the measures
undertaken to ensure non-contamination. The Union of India
was also silent about the measures undertaken in respect of
labelling of GM foods, in light of the fact that no chronic studies
have been commissioned as regards the consumption of GM
foods. Also, the Union of India was silent as to the liability of
the applicant and GEAC for potential losses to farmers and
consumers on account of irreversible contamination.
20.8 In this regard, the TEC Report was referred to, wherein it has
been stated that currently eighteen new food crop species,
for which applications for field trial have been received in the
Indian system, are - cauliflower, cabbage, corn, rice, wheat,
tomato, groundnut, potato, sorghum, okra, brinjal, mustard,
papaya, watermelon, sugarcane, etc. Also, the growth of
GM crop would impact organic food producers and given the
difficulties in segregation of GM and non-GM foods, it would
be difficult to meet the criteria for organic food. This was said
to have potential adverse impact on export of organic food,
as the importers would closely examine the conditions under
which organic food is being grown and any concern about
contamination could lead to an adverse impact and loss of
markets for organic food producers.
20.9 It was further submitted that GEAC, the regulator, has failed to
deal with the illegal plantation of HT Bt cotton and the same
is being grown in the country illegally on commercial basis.
In fact, the intervenor in the present proceedings, Shetkari
Sangathan, has also been illegally planting Bt brinjal and has
been encouraging farmers to do so, and GEAC has failed to
check the same.
20.10 It was next submitted that large quantities of GM processed oil
was being imported in the form of canola oil sourced largely
from GM canola seeds and soyabean oil sourced from GM
soyabean seeds. It was argued that this is in violation of the
law.
[2024] 7 S.C.R. 2047

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

20.11 Section 22 of the FSSA, 2006 prohibits manufacture,
distribution, sale or import of any GMO products, except in
accordance with the regulations which the Central Government
may notify. This has been a subject matter of a judgment of
this Court in Writ Petition (Civil) No.173 of 2006, Vandana
Shiva vs. Union of India, disposed of on 11.08.2017, wherein
it was recorded that there was no notification or regulation
allowing any activity in connection with GE and modified food
and such activity was permissible only under the regulations
framed under Section 22 of the FSSA, 2006. The said writ
petition was disposed of by allowing liberty to the petitioner
therein to approach this Court again after regulations framed in
connection with GE and modified food under Section 22 of the
FSSA, 2006, are placed for consideration by the Parliament,
in order to test their legality upon constitutional sustainability.
However, till date, no notification has been issued by the
Union of India.
20.12 In addition, it was pointed out that GEAC in their communication
addressed to Directorate General of Foreign Trade (DGFT),
dated 23.02.2018, had informed that it had not authorised or
approved GM soyabean or any other products derived from
GM soyabean seeds for import or cultivation in India. That
being the case, it is not known on what basis is GM food
being imported to India.
20.13 It was next submitted that there was a failure to undertake
any socio-economic risk analysis by GEAC with regard to the
failure of Bt cotton in accordance with the CBD and CPB. The
need for such an assessment was also highlighted by TEC.
20.14 In this regard, reference was made to Mahyco Monsanto
Biotec (India) Private Ltd. vs. Union of India, Writ Petition
(Civil) No.12069 of 2015, filed before the Delhi High Court,
in which the petitioner therein had challenged the price
control order issued by the Union of India under the Essential
Commodities Act, 1955 as regards Bt cotton seeds. The
challenge is pending before the Delhi High Court. Pertinently,
the Ministry of Agriculture and Farmers Welfare, Government of
India, in the said case, has stated that the farmers across the
country have been financially burdened due to the increasing
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prices of Bt cotton seeds. They have also to spend on pesticides
and other resources to make the crops more pest resistant
and high-yielding. This has resulted in escalated expenses
and reduced the margin of profit for the farmers.
20.15 It was also brought to our notice that the pink bollworm, a
major pest to the cotton crop, has developed resistance in the
last two or three years and has worried the farmers who have
sown Bt cotton seeds. That, the cotton yields were stagnant
in the last five years due to the fact that the technology was
used not for yield improvement but only for prevention of loss.
20.16 Referring to Article 14(1)(b) of the Argentina Convention, it was
submitted that a duty is cast on the Government of India to
assess the impact of its policies and minimize adverse impacts,
as India is a signatory to the said convention.
20.17 It was, thus, argued that the 1989 Rules, which are prior
in time to the CPB, have to be brought in line with the said
protocol. Similarly, the Biological Diversity Act, 2002, casts a
duty on the Central Government to protect biodiversity as per
Section 36 of the said Act. In this regard, reference was made
to the judgment of this Court in Gramophone Company of
India Ltd. vs. Birendra Bahadur Pandey, (1984) 2 SCC 534
(“Gramophone Co. of India Ltd.”), and Vishaka vs. State of
Rajasthan, (1997) 6 SCC 241 (“Vishaka”), which dealt with
the doctrine of incorporation of international law into Indian
law and how the same could be read to be part of national
law unless they are in conflict with an Act of Parliament.
20.18 Further, any international convention not inconsistent with
the fundamental rights and in harmony with its spirit must be
read into these provisions to enlarge the meaning and content
thereof, so as to promote the object of the constitutional
guarantee.
20.19 Similarly, reference was made to Nilabati Behera vs. State of
Orissa, (1993) 2 SCC 746 (“Nilabati Behera”), wherein the
absence of an enacted law to provide for effective enforcement
of the basic human right of gender equality was held to give
the basis for using international conventions and norms to
construe and give meaning to fundamental rights guaranteed
under the Constitution of India.
[2024] 7 S.C.R. 2049

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

20.20 It was also submitted that the present regulatory system
continues to be deficient and therefore, there is a need for
putting in place a suitable regulatory system which would work
within the framework of its mandate.
20.21 In conclusion, it was submitted that the petitioners were seeking
implementation of the recommendations of the TEC. That the
TEC Report has been given a go-by by GEAC in consideration
of the application made by Prof. Pental, Former Professor
of Genetics and Vice-Chancellor, University of Delhi, South
Campus, New Delhi. Therefore, the petitioners have sought
the aforesaid reliefs.
Points for Consideration:
21. Before framing the points for consideration, we make it clear that this
case does not decide the competing claims made in the scientific
literature about the desirability of GMOs, their impact on increasing
crop yield in the short or long term and other subjects that belong
to the domain of scientific and agricultural experts. This Court is not
conducting a review or an evaluation of various scientific studies
submitted by the petitioners and the respondents on GMOs. This
Court does not have the institutional competence and therefore any
conclusion raised on that basis would be a futile exercise.
21.1 The purpose of our adjudication is to satisfy our judicial
conscience on the subject of critical public interest. We have
viewed the matter from the perspective of compliances of the
principles of exercise of discretion and use of administrative
power in a niche area where opinions of scientists and experts
in the field would determine the course of action to be taken
in a matter as significant as the steps leading to the decision
for environmental release of DMH-11 mustard in an altered
technology.
21.2 This case also does not decide on the divergent substantive
content and recommendations made by the TEC or GEAC. The
ambit of the present case is strictly limited to compliance with
constitutional and legal requirements in the decision-making
process impugned herein. In light of the aforesaid, and the
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submissions advanced by learned senior counsel and counsel
for respective parties, the following points would arise for our
consideration:
(i) Whether GEAC approval dated 18.10.2022 and the
consequent decision dated 25.10.2022 for the environmental
release of DMH-11 is in accordance with law?
(ii) Whether the decision to grant approval for environmental
release of DMH-11 violates the right to safe and healthy
environment under Article 21?
(iii) Whether GEAC’s grant of approval dated 18.10.2022
and the decision dated 25.10.2022 for the environmental
release of DMH-11 violate the precautionary principle?
(iv) What order?
Since there is a difference of opinion between the Members
of this Bench vis-à-vis the validity of the decision taken for
environmental release of DMH-11, from this stage onwards,
I propose to opine for myself while my learned brother Karol,
J. has prepared his separate opinion.
Legal Framework:
22. Before I proceed further, it would be useful to note that agriculture,
including agricultural education and research, protection against pests
and prevention of plant diseases, is a State subject enumerated
as Entry 14 in List II (State List). Trade and commerce in, and the
production, supply and distribution of, inter alia, foodstuffs, including
edible oil seeds and oils, is in Entry 33(b) in List III (Concurrent List)
of the Seventh Schedule. Rules and regulations made under the EP
Act, 1986 are possibly referrable to Entry 97 of List I (Union List)
since environment protection has not been specifically mentioned
in either List II or List III of the Seventh Schedule, except for forest.
For ease of reference, the aforesaid Entries of the Seventh Schedule
as well as others are extracted as under:
“Entry 52, List I:
52. Industries, the control of which by the Union is
declared by Parliament by law to be expedient
in the public interest.
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Entry 97, List I:
97. Any other matter not enumerated in List II or
List III including any tax not mentioned in either
of those Lists.
Entry 6, List II:
6. Public health and sanitation; hospitals and
dispensaries.
Entry 14, List II:
14. Agriculture, including agricultural education
and research, protection against pests and
prevention of plant diseases.
Entry 33(b), List III:
33. Trade and commerce in, and the production,
supply and distribution of,-
………
(b) foodstuffs, including edible oilseeds and oils;”
22.1 Article 48A of the Constitution of India is a Directive Principle of
State Policy which speaks about protection and improvement
of environment and safeguarding of forests and wild life.
Likewise, Article 51A(g) casts upon citizens a fundamental
duty to protect and improve the natural environment including
forests, lakes, rivers and wildlife. These Articles have to be
read in the context of Article 21 of the Constitution, which has
been expansively interpreted by this Court to include within its
scope and ambit of the right to health and clean environment
and ecology. For ready reference, the aforesaid Articles are
extracted as under:
“21. Protection of life and personal liberty.—
No person shall be deprived of his life or personal
liberty except according to procedure established
by law.
xxx
48A. Protection and improvement of environment
and safeguarding of forests and wild life.—The
State shall endeavour to protect and improve the
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environment and to safeguard the forests and wild
life of the country.
xxx
51A. Fundamental duties.—It shall be the duty of
every citizen of India—
xxx
(g) to protect and improve the natural environment
including forests, lakes, rivers and wild life, and to
have compassion for living creatures;”
23. At this point, it is also observed that Article 21 also encompasses
the right to food safety. It is in this context that the FSSA, 2006 has
been enacted and I would now advert to the provisions contained
therein as well.
23.1 FSSA, 2006 has been enacted pursuant to Entry 52, List I of
the Seventh Schedule of the Constitution.
Section 2 of the said Act has declared that it is expedient in the public
interest that the Union should take under its control the food industry.
23.2 The Preamble of the FSSA, 2006, inter alia, states that it is an
Act to consolidate the laws relating to food and to establish the
FSSAI for laying down science-based standards for articles of
food and to regulate their manufacture, storage, distribution,
sale and import, to ensure availability of safe and wholesome
food for human consumption. The following provisions under
the FSSA, 2006 could be adverted to:
“2. Declaration as to expediency of control by the
Union.- It is hereby declared that it is expedient in
the public interest that the Union should take under
its control the food industry.
3. Definitions. (1) In this Act, unless the context
otherwise requires, –
(a) “adulterant” means any material which is or could
be employed for making the food unsafe or sub-
standard or mis-branded or containing extraneous
matter;
xxx
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(j) “Food” means any substance, whether processed,
partially processed or unprocessed, which is intended
for human consumption and includes primary food,
to the extent defined in clause (ZK) genetically
modified or engineered food or food containing such
ingredients, infant food, packaged drinking water,
alcoholic drink, chewing gum, and any substance,
including water used into the food during its
manufacture, preparation or treatment but does not
include any animal feed, live animals unless they
are prepared or processed for placing on the market
for human consumption, plants, prior to harvesting,
drugs and medicinal products, cosmetics, narcotic
or psychotropic substances :
Provided that the Central Government may declare,
by notification in the Official Gazette, any other article
as food for the purposes of this Act having regards
to its use, nature, substance or quality;
xxx
(q) “food safety” means assurance that food is
acceptable for human consumption according to its
intended use;
xxx
(u) “hazard” means a biological, chemical or physical
agent in, or condition of, food with the potential to
cause an adverse health effect;
xxx
(v) “import” means bringing into India any article of
food by land, sea or air;
xxx
(zk) “primary food” means an article of food, being
a produce of agriculture or horticulture or animal
husbandry and dairying or aquaculture in its natural
form, resulting from the growing, raising, cultivation,
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picking, harvesting, collection or catching in the hands
of a person other than a farmer or fisherman;
xxx
(zm) “risk”, in relation to any article of food, means
the probability of an adverse effect on the health
of consumers of such food and the severity of that
effect, consequential to a food hazard;
(zn) “risk analysis”, in relation to any article of food,
means a process consisting of three components,
i.e. risk assessment, risk management and risk
communication;
(zo) “risk assessment” means a scientifically based
process consisting of the following steps: (i) hazard
identification, (ii) hazard characterisation; (iii)
exposure assessment, and (iv) risk characterisation;
(zp) “risk communication” means the interactive
exchange of information and opinions throughout the
risk analysis process concerning risks, risk-related
factors and risk perceptions, among risk assessors,
risk managers, consumers, industry, the academic
community and other interested parties, including
the explanation of risk assessment findings and the
basis of risk management decisions;
(zq) “risk management” means the process,
distinct from risk assessment, of evaluating policy
alternatives, in consultation with all interested parties
considering risk assessment and other factors
relevant for the protection of health of consumers
and for the promotion of fair trade practices, and,
if needed, selecting appropriate prevention and
control options;
xxx
(zu) “standard”, in relation to any article of food,
means the standards notified by the Food Authority;
xxx
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(zw) “substance” includes any natural or artificial
substance or other matter, whether it is in a solid
state or in liquid form or in the form of gas or vapour;
(zx) “Sub-standard” - an article of food shall be
deemed to be sub-standard if it does not meet the
specified standards but not so as to render the article
of food unsafe;”
23.3 It would be necessary to refer to Section 22 of the said Act,
which deals with GM foods, organic foods, functional foods,
proprietary foods, etc. The said Section reads as under:
“22. Genetically modified foods, organic foods,
functional foods, proprietary foods, etc. - Save
as otherwise provided under this Act and regulations
made thereunder, no person shall manufacture,
distribute, sell or import any novel food, genetically
modified articles of food, irradiated food, organic
foods, foods for special dietary uses, functional foods,
neutraceuticals, health supplements, proprietary
foods and such other articles of food which the Central
Government may notify in this behalf.
Explanation.– For the purposes of this section,–
(1) “foods for special dietary uses or functional foods
or nutraceuticals or health supplements” means:
(a) foods which are specially processed or formulated
to satisfy particular dietary requirements which
exist because of a particular physical or
physiological condition or specific diseases and
disorders and which are presented as such,
wherein the composition of these foodstuffs
must differ significantly from the composition
of ordinary foods of comparable nature, if such
ordinary foods exist, and may contain one or
more of the following ingredients, namely:-
(i) plants or botanicals or their parts in the
form of powder, concentrate or extract
in water, ethyl alcohol or hydro alcoholic
extract, single or in combination;
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(ii) minerals or vitamins or proteins or metals
or their compounds or amino acids (in
amounts not exceeding the Recommended
Daily Allowance for Indians) or enzymes
(within permissible limits);
(iii) substances from animal origin;
(iv) a dietary substance for use by human
beings to supplement the diet by increasing
the total dietary intake;
(b) (i) a product that is labelled as a “Food for
special dietary uses or functional foods or
nutraceuticals or health supplements or
similar such foods” which is not represented
for use as a conventional food and whereby
such products may be formulated in
the form of powders, granules, tablets,
capsules, liquids, jelly and other dosage
forms but not parenterals, and are meant
for oral administration;
(ii) such product does not include a drug as
defined in clause (b) and ayurvedic, sidha
and unani drugs as defined in clauses
(a) and (h) of section 3 of the Drugs and
Cosmetics Act, 1940 (23 of 1940) and rules
made thereunder;
(iii) does not claim to cure or mitigate any
specific disease, disorder or condition
(except for certain health benefit or such
promotion claims) as may be permitted by
the regulations made under this Act;
(iv) does not include a narcotic drug or a
psychotropic substance as defined in
the Schedule of the Narcotic Drugs and
Psychotropic Substances Act, 1985 (61
of 1985) and rules made thereunder and
substances listed in Schedules E and EI
of the Drugs and Cosmetics Rules, 1945;
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(2) “genetically engineered or modified food” means
food and food ingredients composed of or containing
genetically modified or engineered organisms
obtained through modern biotechnology, or food and
food ingredients produced from but not containing
genetically modified or engineered organisms
obtained through modern biotechnology;
(3) “organic food” means food products that have
been produced in accordance with specified organic
production standards;
(4) “proprietary and novel food” means an article of
food for which standards have not been specified
but is not unsafe:
Provided that such food does not contain any of the
foods and ingredients prohibited under this Act and
regulations made thereunder.”
23.4 Since I am dealing with GE or modified food, it would be useful
to note the definition thereof under sub-section (2) of Section
22, which defines it as food and food ingredients composed of
or containing GM or engineered organisms obtained through
modern biotechnology, or food and food ingredients produced
from but not containing GM or engineered organisms obtained
through modern biotechnology.
23.5 The Food Safety and Standards (Food Products Standards
and Food Additives) Regulations, 2011 (hereinafter referred to
as, “the Food Safety Regulations, 2011”) have been framed
under Section 92(2)(e) read with Section 16 of the FSSA,
2006 by the FSSAI. In Regulation 2.9.13(1), details regarding
mustard (Rai, Sarson) are mentioned as under:
“2.9.13: Mustard (Rai, Sarson)
1. Mustard (Rai, Sarson) Whole means the dried,
clean mature seeds of one or more of the plants
of Brassica alba. (L). Boiss (Safed rai), Brassica
compestris L.var, dichotoma (Kali Sarson), Brasssica
Compestris, L. Var, yellow Sarson, Syn, Brassica
compestris L, var glauca (Pili Sarson), Brassica,
compestris L. Var. toria (Toria), Barassicajuncea,
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(L). Coss et Czern (Rai, Lotni) and Brassica nigra
(L); Koch (Benarasi rai). It shall be free from mould,
living and dead insects, insect fragments, rodent
contamination. The product shall be free from the
seeds of Argemone Maxicana L, any other harmful
substances and added colouring matter.
It shall conform to the following standards:

(i) Extraneous matter Not more than
2.0 percent by weight.
(ii) Damaged or Not more than
Shrivelled Seeds 2.0 percent by weight.
(iii) Moisture Not more than
10.0 percent by weight.
(iv) Total ash on dry Not more than
basis 6.5 percent by weight.
(v) Ash insoluble in Not more than
dilute HCl on dry 1.0 percent by weight.
basis
(vi) Non volatile ether Not less than
extract on dry basis 28.0 percent by weight.
(vii) Violatile oil content Not less than
on dry basis 0.3 percent by v/w.
(viii) Insect damaged Not more than
matter 1.0 percent by weight.
(ix) Allyl iso thiocyanate (m/m) on dry basis
(a) B nigra Not less than
1.0 percent by Weight.
(b) B Juncea Not less than
0.7 percent by Weight.
(x) P-hydroxybenzyl Not less than 2.3
iso-thiocyanate percent by weight.
(m/m) on dry basis
in sinapist alba
(xi) Argemone seeds Absent.”
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Environment (Protection) Act, 1986 (EP Act, 1986):
24. EP Act, 1986 has been enacted to provide for the protection and
improvement of environment and for matters connected therewith.
The relevant provisions of the said Act are extracted as under:
“2. Definitions.- In this Act, unless the context otherwise
requires,-
(a) “environment” includes water, air and land and the
inter-relationship which exists among and between
water, air and land, and human beings, other living
creatures, plants, micro-organism and property;
(b) “environmental pollutant” means any solid, liquid or
gaseous substance present in such concentration
as may be, or tend to be, injurious to environment;
(c) “environmental pollution” means the presence in the
environment of any environmental pollutant;”
1989 Rules:
25. In exercise of the powers conferred by Sections 6, 8 and 25 of the
EP Act, 1986 and with a view to protect the environment, nature
and health in connection with the application of gene-technology
and micro-organisms, the Central Government has framed the
1989 Rules. The said Rules dealing with manufacture, use, import,
export and storage of hazardous micro-organisms/GE organisms
or cells were notified with a view to protect the environment, nature
and health in connection with the application of gene-technology
and micro-organisms. These Rules were gazetted on 05.12.1989
and are applicable to Genetically Engineered Organisms (GEOs)/
micro-organisms and cells and correspondingly to any substances
and products and food stuffs, etc., of which such cells, organisms
or tissues thereof form part. The Rules also apply to new gene-
technologies, apart from those referred to in clause (ii) and (iv) of
Rule 3, and to organisms/micro-organisms and cells generated by
the utilisation of such other gene-technologies and to substances
and products of which such organisms and cells form part. The
conditions under which the Rules are applicable have been stated
in sub-paragraph (4) of Rule 2 of the said Rules.
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25.1 Rule 3 defines, inter alia, the expressions, “biotechnology”,
“gene technology” and “genetic engineering”, which read as
under:
“3. Definitions:- In these rules unless the context
requires.
(i) “Biotechnology” means the application of scientific
and engineering principles to the processing of
materials by biological agents to produce goods and
services;
(ii) x x x
(iii) “Gene Technology” means the application of the
gene technique called genetic engineering, include
self cloning and deletion as well as cell hybridisation;
(iv) “Genetic engineering” means the technique by
which heritable material, which does not usually
occur or will not occur naturally in the organism or
cell concerned, generated outside the organism or
the cell is inserted into the said cell or organism. It
shall also mean the formation of new combinations
of genetic material by incorporation of a cell into a
host cell, where they occur naturally (self cloning)
as well as modification of an organism or in a cell
by deletion and removal of parts of the heritable
material;”
25.2 Rule 4 speaks of the competent authorities constituted under
the Rules and the said Rule reads as under:
“4. Competent Authorities:-
(1) Recombinant DNA Advisory Committee
(RDAC).
This Committee shall review developments in
Biotechnology at national and international levels
and shall recommend suitable and appropriate safety
regulations for India in recombinant research, use
and applications from time to time. The Committee
shall function in the Department of Biotechnology.
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(2) Review Committee on Genetic Manipulation
(RCGM).
This committee shall function in the Department
of Biotechnology to monitor the safety related
aspects in respect of on-going research projects and
activities involving genetically engineered organisms/
hazardous microorganisms. The Review Committee
on Genetic Manipulation shall include representatives
(a) Department of Biotechnology (b) Indian Council
of Medical Research (c) Indian Council of Agricultural
Research (d) Council of Scientific and Industrial
Research (e) other experts in their individual capacity.
Review Committee on Genetic Manipulation may
appoint sub-groups.
It shall bring out Manuals of guidelines specifying
procedure for regulatory process with respect to
activities involving genetically engineered organisms
in research, use and applications including industry
with a view to ensure environmental safety. All
on-going projects involving high risk category and
controlled field experiments shall be reviewed to
ensure that adequate precautions and containment
conditions are followed as per the guidelines.
The Review Committee on Genetic Manipulation
shall lay down procedures restricting or prohibiting
production, sale, importation and use of such
genetically engineered organism or cells as are
mentioned in the Schedule.
(3) Institutional Biosafety Committee (IBSC).
This Committee shall be constituted by an occupier
or any person including research institutions handling
microorganism/genetically engineered organisms. The
committee shall comprise the Head of the Institution,
Scientists engaged in DNA work, a medical expert and
a nominee of the Department of Biotechnology. The
occupier or any person including research institutions
handling microorganism/genetically engineered
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organisms shall prepare, with the assistance of the
Institutional Biosafety Committee (IBSC) an uptodate
on-site emergency plan according to the manuals/
guidelines of the RCGM and make available copies
to the District Level Committee/State Biotechnology
Co-ordination Committee and the Genetic Engineering
Approval Committee
(4) Genetic Engineering Approval Committee
(GEAC).
This committee shall function as a body under the
Department of Environment, Forest and Wildlife
for approval of activities involving large scale use
of hazardous microorganisms and recombinants
in research and industrial production from the
environmental angle. The committee shall also be
responsible for approval of proposals relating to
release of genetically engineered organisms and
products into the environment including experimental
field trials.
The composition of the Committee shall be -
(i) Chairman – Additional Secretary, Department
of Environment, Forests and Wildlife.
Co-Chairman – Representative of Department
of Biotechnology.
(ii) Members : Representatives of concerned
Agencies and Departments, namely, Ministry
of Industrial Development, Department of
Biotechnology and the Department of Atomic
Energy.
(iii) Expert members : Director General – Indian
Council of Agricultural Research, Director
General – Indian Council of Medical Research,
Director General – Council of Scientific and
Industrial Research, Director General – Health
Servies, Plant Protection Adviser, Directorate
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of Plant Protection, Quarantine and storage,
Chairman, Central Pollution Control Board and
three outside experts in individual capacity.
(iv) Member Secretary : An official of the Department
or Environment, Forest and Wildlife.
The committee may co-opt other members/experts
as necessary.
The committee or any person/s authorised by it
shall have powers to take punitive action under the
Environment (Protection) Act.
(5) State Biotechnology Co-ordination Committee
(SBCC).
There shall be a State Biotechnology Coordination
Committee in the States wherever necessary. It shall
have powers to inspect, investigate and take punitive
action in case of violations of statutory provisions
through the Nodal Department and the State Pollution
Control Board/Directorate of Health/Medical Services.
The Committee shall review periodically the safety and
control measures in the various industries/institutions
handling genetically engineered organisms/hazardous
microorganisms. The composition of the Coordination
Committee shall be:

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

(i) District Collector – Chairman
(ii) Factory Inspector – Member
(iii) A representative of the – Member
Pollution Control Board
(iv) Chief Medical Officer – Member
(District Health Officer) (Convenor)
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(v) District Agricultural Officer – Member
(vi) A representative of the – Member
Public Health Engineering
Department
(vii) District Microbiologists/ – Member
Pathologist (technical
expert)
(viii) Commissioner Municipal – Member
Corporation
The Committee may co-opt other members/experts
as necessary.”
25.3 Rule 5 speaks of classification of micro-organisms or
GE products, while Rule 7 deals with approval and prohibitions.
The same read as under:
“5. Classification of microorganisms or genetically
engineered product - (1) For the purpose of these
rules, microorganisms or genetically engineered
organisms, products or cells shall be dealt with under
two major heads; animal pathogens and plant pests
and these shall be classified in the manner specified
in the Schedule.
(2) If any of the microorganism, genetically engineered
organism or cell falls within the limits of more than
one risk class as specified in the Schedule, it shall be
deemed to belong exclusively to the last in number
of such classes.
xxx
7. Approval and Prohibitions, etc. :- (1) No person
shall import, export, transport, manufacture, process,
use or cell any hazardous microorganisms or
genetically engineered organisms/substances or cells
except with the approval of the Genetic Engineering
Approval Committee.
(2) Use of pathogenic microorganism or any genetically
engineered organisms or cell for the purpose of
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research shall only be allowed in laboratories or
inside laboratory areas notified by the Ministry of
Environment and Forests for this purpose under the
Environment (Protection) Act, 1986.
(3) The Genetic Engineering Approval Committee
shall give directions to the occupier to determine
or take measures concerning the discharge of
microorganisms/genetically engineered organisms or
cells mentioned in the Schedule from the laboratories,
hospitals and other areas including prohibition of such
discharges and laying down measures to be taken
to prevent such discharges.
(4) Any person operating or using genetically
engineered organisms/microorganisms mentioned
in the schedule for scale up or pilot operations
shall have to obtain licence issued by the Genetic
Engineering Approval Committee for any such activity.
The possessor shall have to apply for licence in
prescribed proforma.
(5) Certain experiments for the purpose of education
within the field of gene technology or microorganism
may be carried out outside the laboratories and
laboratory areas mentioned in sub-rule (2) and will be
looked after by the Institutional Biosafety Committee.”
25.4 Rule 8 deals with production, while Rule 11 deals with
permission and approval for food stuffs. The same are extracted
as under:
“8. Production:- Production in which genetically
engineered organisms or cells or micro-organism are
generated or used shall not be commenced except
with the consent of Genetic Engineering Approval
Committee with respect of discharge of genetically
engineered organisms or cells into the environment.
This shall also apply to production taking place in
connection with development, testing and experiments
where such production, etc., is not subject to rule 7.
xxx
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11. Permission and Approval for Food Stuffs:-
Food stuffs, ingredients in food stuffs and additives
including processing and containing or consisting of
genetically engineered organisms or cells, shall not
be produced, sold, imported or used except with
the approval of the Genetic Engineering Approval
Committee.”
25.5 The guidelines and grant of approval are as per Rules 12 and
13, which read as under:
“12. Guidelines:- (1) Any person who applies for
approval under rules 8-11 shall, as determined
by the Genetic Engineering Approval Committee
submit information and make examinations or
cause examinations to be made to elucidate the
case, including examinations according to specific
directions and at specific laboratories. He shall also
make available an on-site emergency plan to GEAC
before obtaining the approval. If the authority makes
examination itself, it may order the applicant to defray
the expenses incurred by it in so doing.
(2) Any person to whom an approval has been granted
under rules 8-11 above shall notify the Genetic
Engineering Approval Committee of any change in
or addition to the information already submitted.
13. Grant of Approval:- (1) In connection with the
granting of approval under rules 8 to 11 above, terms
and conditions shall be stipulated, including terms
and conditions as to the control to be exercised by
the applicant, supervision, restriction on use, the
layout of the enterprise and as to the submission of
information to the State Biotechnology Coordination
Committee or to the District Level Committee.
(2) All approvals of the Genetic Engineering Approval
Committee shall be for a specific period not exceeding
four year at the first instance renewable for 2 years at
a time. The Genetic Engineering Approval Committee
shall have powers to revoke such approval in the
following situations:-
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(a) If there is any new information as to the harmful
effects of the genetically engineered organisms
or cells.
(b) If the genetically engineered organisms or cells
cause such damage to the environment, nature
or health as could not be envisaged when the
approval was given, or
(c) Non compliance of any condition stipulated by
Genetic Engineering Approval Committee.”
Regulatory Framework:
26. MoEF&CC is the nodal ministry for regulation of GMOs including
GE plants. 1989 Rules under the EP Act, 1986 provide the statutory
scheme for regulation of GE technologies. The 1989 Rules are
implemented by the MoEF&CC, the DBT, Ministry of Science &
Technology and State Governments.
26.1 The following authorities/committees are created under the
1989 Rules:
(i) Recombinant DNA Advisory Committee (RDAC):
The RDAC is involved in reviewing the developments in
biotechnology, both at national as well as international levels,
and recommending safety regulations as per the indigenous
requirements of our country in recombinant research, use
and applications from time to time. The RDAC’s functions are
advisory in nature.
(ii) Genetic Engineering Appraisal Committee (GEAC):
GEAC is the apex body to accord approval of activities involving
large scale use of hazardous micro-organisms and recombinants
in research and industrial production from the environmental
perspective. GEAC is also responsible for granting approvals
relating to release of GE organisms and products into the
environment, including experimental field trials (BRL-II). This
Committee functions as a body under the Department of
Environment, Forest and Wildlife for approval of activities
involving large scale use of hazardous micro-organisms and
recombinants in research and industrial production from the
environmental angle delineated under Rule 4.
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Rules 7, 8 and 10 of the 1989 Rules state that no research,
development, import, export, manufacture, process, use or
sale of any GE technology or products/substances derived
therefrom can be attempted without the approval of GEAC.
(iii) Review Committee on Genetic Manipulation (RCGM):
The RCGM is established under the DBT and is mandated
to monitor the safety-related aspects in respect of on-going
research projects and activities and bring out manuals
and guidelines specifying procedure for regulatory process
with respect to activities involving GEO in research, use
and applications, including industry, with a view to ensure
environmental safety. The RCGM is the authority for BRL-I
trials. This Committee includes representatives of the DBT,
Indian Council of Medical Research (ICMR), ICAR, CSIR and
other experts in their individual capacity. The Committee may
appoint sub groups. This Committee also lays down procedures
for restricting or prohibiting production, sale, importation and
use of such GEOs of cells as are mentioned in the Schedule
to the 1989 Rules.
(iv) Institutional Biosafety Committee (IBSC):
The IBSC is established under the institution engaged in GMO
research, to oversee such research and to interface with the
RCGM in regulating it.
This Committee is constituted by the research institutions
handling micro-organism/GEO. The Committee comprises of
the Head of the Institution, scientists engaged in DNA work,
a medical expert and a nominee of the DBT. The research
institutions handling micro-organisms/GEOs are mandated
to prepare, with the assistance of the IBSC, an up to date
on-site emergency plan according to the manuals/guidelines
of the RCGM and make available copies to the DLC/SBCC
and GEAC.
(v) State Biotechnology Co-Ordination Committee
(SBCC):
The SBCC plays a major role in monitoring and has powers
to inspect, investigate and take punitive action in case of
violations of statutory provisions.
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This Committee is constituted in the States to periodically
review the safety and control measures in the various industries/
institutions handling GEOs/hazardous micro-organisms. It
has power to inspect, investigate and take punitive action in
case of violations of statutory provisions, through the Nodal
Department and the State Pollution Control Board/Directorate
of Health/Medical Services. The Committee is chaired by the
Chief Secretary of the State Government. The Members of
the Committee include Secretaries from the Departments of
Health, Agriculture, Industries & Commerce, Forests, Public
Works/ Chief Engineer, Public Health Engineering, State
Microbiologists and Pathologists, Chairman of State Pollution
Control Board. The Secretary, Department of Environment is
the Member Secretary of the Committee. The Committee may
co-opt other members/experts as necessary.
(vi) District Level Committee (DLC):
The DLC has a major role in monitoring the safety regulations
in installations engaged in the use of GMOs/ hazardous micro-
organisms and its application in the environment.
This Committee is constituted in the districts to monitor the
safety regulations in installations engaged in the use of
GMOs/hazardous micro-organisms and its applications in the
environment. This Committee is chaired by the District Collector.
The Chief Medical Officer (District Health Officer) is the Member
(Convenor). The Members of the Committee include Factory
Inspector, a representative from Pollution Control Board,
District Agricultural Officer, a representative of the Public
Health Engineering Department, District Microbiologists,
Pathologist (Technical expert), and Commissioner of Municipal
Corporation. The Committee may co-opt other members/
experts as necessary.
26.2 According to learned Attorney General, the 1989 Rules are
implemented by the aforesaid competent authorities through
a series of biosafety guidelines issued from time to time. The
Guidelines applicable to GE plants are:
(i) Guidelines and SOP for Conduct of Confined Field Trials
of Regulated GE Plants, 2008.
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(ii) Revised Guidelines for Research in Transgenic Plants,
1998;
(iii) Regulations and Guidelines for Recombinant DNA
Research and Biocontainment, 2017.
(iv) Guidelines for Safety Assessment of Foods Derived from
GE Plants, 2008 (updated in 2012)
(v) Protocols for Food and Feed Safety Assessment of
GE Crops, 2008.
(vi) Environmental Risk Assessment (ERA) of GE Plants:
A Guide for Stakeholders, 2016.
(vii) Risk Analysis Framework, 2016.
(viii) Guidelines for the Environmental Risk Assessment of
GE Plants, 2016.
26.3 The research and development (R&D) with respect to
GE plants has to be conducted in accordance with the Revised
Guidelines for Research in Transgenic Plants, 1998. As per
these Guidelines, the experiments conducted on research of
transgenic plants are broadly categorized into three categories
based on the risk involved, namely, Category I that involves
routine rDNA experiments, Category II involving evaluation of
transgenic plants in green house/net house, and Category III
that pertains to high-risk experiments. These experiments have
to be regulated by the IBSC and/or the RCGM, as prescribed
in the Guidelines.
26.4 Subsequent to the above experiments conducted under
the contained conditions, the confined field trials have
to be conducted as prescribed under the Guidelines and
SOP for the Conduct of Confined Field Trials of Regulated
GE Plants, 2008.
26.5 The initial assessment of an application for a confined
field trial begins at the institutional level itself. Based on
information generated by the applicant in the laboratory and the
greenhouse, an application is made to the IBSC for permission
to conduct a confined field trial. The IBSC evaluates the
proposal for conducting a field trial and further recommends
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it to the other Regulatory Authorities. The confined field trials
are categorized as under:
(i) Biosafety Research Level-I (BRL-I) Trials: These trials
are limited in size to no more than 1 acre (0.4 ha) per trial
site location and a maximum cumulative total of 20 acres
(8.1 ha) for all locations for each plant species/construct
combination (e.g., one or more events originating from
transformation of a plant species with the same genetic
construct), per applicant, per crop season.
(ii) Biosafety Research Level-II (BRL-II) Trials: These are
limited in size to no more than 2.5 acres (1 ha) per trial
site location and number of locations to be decided on
a case by case basis for each plant species/construct
combination (e.g., one or more events originating from
transformation of a plant species with the same genetic
construct), per applicant, per crop season.
The RCGM is the regulatory authority for BRL-I trials and
GEAC is the regulatory authority for BRL-II trials, as per the
Guidelines for the Conduct of Confined Field Trials of Regulated
GE Plants, 2008.
26.6 Applications for environmental release are processed in
accordance with Guidelines for the Environmental Risk
Assessment (ERA) of GE Plants, 2016.
26.7 The Risk Analysis Framework, 2016 prescribes the Regulatory
Agency’s approach to risk analysis. It is based on national and
international standards and guidance, including the CPB to
which India is a party. In accordance with the Risk Analysis
Framework, 2016, assessment of safety of GM plants is a
comprehensive process involving subject experts and ensures
transparency in the regulatory decision-making process by
incorporating stakeholder consultations.
26.8 As per this framework, regulatory agencies seek views from
various stakeholders and the steps followed in this consultation
process include:
(i) The communication of information about submission of
applications for environmental release of GE plants to
the regulatory agency.
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(ii) Preparation of a RARM plan for each application by the
regulatory agencies.
(iii) RARM plan uploaded on the official website for receiving
comments from the stakeholders for a period of 30 days.
(iv) The regulatory agency gives its recommendations after
due consideration of the responses received from the
stakeholders.
26.9 That in line with the above, the applicant has to follow a clearly
laid out step by step process for biosafety data generation
from laboratory to field trials, safety tests and submission of
application for environmental release. The biosafety data is
generated in laboratories and by confined field trials under
conditions authorized by the RCGM and GEAC, as per the
guidelines and protocols and in recognized laboratories/
institutions/universities.
27. In the context of the crucial role of the regulatory bodies, particularly
with regard to food safety and environment, this Court in Writ Petition
(Civil) No.202 of 1995 (In Re: T.N. Godavarman Thirumulpad
vs. Union of India), order dated 31.01.2024, speaking through
Gavai, J. in paragraphs 22-25 and 28-32, has observed as under:
“22. As new bodies, authorities, and regulators for
environmental governance emerge from time to time, their
institutionalisation assumes extraordinary importance.
Institutionalisation means that these bodies must work in
compliance with institutional norms of efficiency, integrity
and certainty. In this context, the role of the constitutional
courts is even greater.
23. Environmental Rule of Law: Environmental rule of law
refers to environmental governance that is undergirded
by the fundamental tenets of rule of law. The rule of
law regime is one that has effective, accountable,
and transparent institutions; responsive, inclusive,
participatory, and representative decision making; and
public access to information. It recognises the vital role
that institutions play in governance and focuses on
defining the structural norms and processes that guide
institutional decision making.
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24. While several laws, rules, and regulations exist
for protection of the environment, their objective is not
achieved as there is a considerable gap as these laws
remain unenforced or ineffectively implemented. Rule of
law in environmental governance seeks to redress this
issue as the implementation gap has a direct bearing
on the protection of the environment, forests, wildlife,
sustainable development, and public health, eventually
affecting fundamental human rights to a clean environment
that are intrinsically tied to right to life. Accountability of
the authorities impressed with the duty to enforce and
implement environmental and other ecological laws is an
important feature of judicial governance. In the context
of accountability, this Court in Vijay Rajmohan vs. CBI,
(2023) 1 SCC 329 has held:
“34. Accountability in itself is an essential principle of
administrative law. Judicial review of administrative
action will be effective and meaningful by ensuring
accountability of the officer or authority in charge.
35. The principle of accountability is considered as
a cornerstone of the human rights framework. It is
a crucial feature that must govern the relationship
between “duty bearers” in authority and “right holders”
affected by their actions. Accountability of institutions
is also one of the development goals adopted by the
United Nations in 2015 and is also recognised as one
of the six principles of the Citizens Charter Movement.
36. Accountability has three essential constituent
dimensions: (i) responsibility, (ii) answerability, and (iii)
enforceability. Responsibility requires the identification
of duties and performance obligations of individuals in
authority and with authorities. Answerability requires
reasoned decision making so that those affected by
their decisions, including the public, are aware of the
same. Enforceability requires appropriate corrective
and remedial action against lack of responsibility
and accountability to be taken. Accountability has
a corrective function, making it possible to address
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individual or collective grievances. It enables action
against officials or institutions for dereliction of duty. It
also has a preventive function that helps to identify the
procedure or policy which has become nonfunctional
and to improve upon it.”
25. In India, environmental rule of law must draw attention
to the existing legal regime, rules, processes, and
norms that environmental regulatory institutions follow to
achieve the goal of effective and good governance and
implementation of environmental laws. More importantly,
the focus must be on the policy and regulatory and
implementation agencies. In doing so, environmental rule
of law fosters open, accountable, and transparent decision
making and participatory governance. The renewed role
of constitutional courts will be to undertake judicial review
to ensure that institutions and regulatory bodies comply
with the principles of environmental rule of law.
xxx
28. We may ask a simple question – how effectively
are these environmental bodies functioning today? This
question has a direct bearing on the protection and
restoration of ecological balance.
29. As environmental governance through these bodies
emerges, the obligation of the constitutional courts is
even greater. Hitherto, the constitutional courts focused
on decisions and actions taken by the executive or
private persons impacting the environment and ecology
because the scrutiny by regulators was felt to be
insufficient. Their judgment, review, and consideration
did not inspire confidence and therefore, the Court
took up the issue and would decide the case. In this
process, a large number of decisions rendered by this
Court on sensitive environmental, forest, and ecological
matters constitute the critical mass of our environmental
jurisprudence. This Court would continue to exercise
judicial review, particularly in environmental matters,
whenever necessary.
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30. We however seek to emphasise and reiterate the
importance of ensuring the effective functioning of
these environmental bodies as this is imperative for the
protection, restitution, and development of the ecology.
The role of the constitutional courts is therefore to monitor
the proper institutionalisation of environmental regulatory
bodies and authorities.
31. In furtherance of the principles of environmental rule
of law, the bodies, authorities, regulators, and executive
offices entrusted with environmental duties must function
with the following institutional features:
i. The composition, qualifications, tenure, method of
appointment and removal of the members of these
authorities must be clearly laid down. Further, the
appointments must be regularly made to ensure
continuity and these bodies must be staffed with
persons who have the requisite knowledge, technical
expertise, and specialisation to ensure their efficient
functioning.
ii. The authorities and bodies must receive adequate
funding and their finances must be certain and clear.
iii. The mandate and role of each authority and body
must be clearly demarcated so as to avoid overlap and
duplication of work and the method for constructive
coordination between institutions must be prescribed.
iv. The authorities and bodies must notify and make
available the rules, regulations, and other guidelines
and make them accessible by providing them on
the website, including in regional languages, to the
extent possible. If the authority or body does not
have the power to frame rules or regulations, it may
issue comprehensive guidelines in a standardised
form and notify them rather than office memoranda.
v. These bodies must clearly lay down the applicable
rules and regulations in detail and the procedure for
application, consideration, and grant of permissions,
consent, and approvals.
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vi. The authorities and bodies must notify norms for
public hearing, the process of decision-making,
prescription of right to appeal, and timelines.
vii. These bodies must prescribe the method of
accountability by clearly indicating the allocation of
duties and responsibilities of their officers.
viii. There must be regular and systematic audit of the
functioning of these authorities.
32. The role of the constitutional courts is to ensure that
such environmental bodies function vibrantly, and are
assisted by robust infrastructure and human resources.
The constitutional courts will monitor the functioning of
these institutions so that the environment and ecology is
not only protected but also enriched.
Constitutional Court and the Environmental Rule of Law:
28. Before I proceed further in the matter, it would be necessary to know
the role of the Constitutional Court in matters concerning science
and technology and environment. The observations of this Court in
the following cases are noted as under:
(i) On the aspect of the approach of the Constitutional Courts
towards questions arising in the realm of science and
environment, this Court has time and again struck a balance
between exercising restraint and answering questions arising
in the realm of pure science by, inter alia, placing reliance
on the principle of sustainable development, precautionary
principle and polluter pays principle. This Court has not only
incorporated progressive ideals and frameworks to strengthen
the process of sustainable development but has repeatedly
emphasised the contours of its adjudication in concerns
touching upon environment. However, growth of jurisprudence
in environmental rule of law provides ample guidance for the
present adjudication.
(ii) In Hanuman Laxman Aroskar vs. Union of India, (2019) 15
SCC 401 (“Hanuman Laxman Aroskar”), this Court recognised
the need to imbue institutional decision-making on questions
of environment with the central precepts of the rule of law to
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achieve the lofty goal of sustainable development. Placing
reliance upon the United Nations Environment Programme’s
First Global Report on Environmental Rule of Law, this Court
articulated the following seven components of the framework
of Environmental Rule of Law:
i. Fair, clear, and implementable environmental
laws;
ii. Access to information, public participation,
and access to justice through courts, tribunals,
commissions, and other bodies;
iii. Accountability and integrity of decision-makers
and institutions;
iv. Clear and coordinated mandates and roles,
across and within institutions;
v. Accessible, fair, impartial, timely and responsive
dispute resolution mechanisms;
vi. Recognition of the mutually reinforcing
relationship between rights and environmental
rule of law; and
vii. Specific criteria for the interpretation of
environmental law.
It further acknowledged how the contemporary environmental
challenges such as the climate change crisis could be effectively
addressed through a creative synergy of constitutional values
of fairness, accountability and transparency with core ideals of
environmental protection in the following words:
“156. The rule of law requires a regime which
has effective, accountable and transparent
institutions. Responsive, inclusive, participatory and
representative decision making are key ingredients
to the rule of law. Public access to information is,
in similar terms, fundamental to the preservation of
the rule of law. In a domestic context, environmental
governance that is founded on the rule of law
emerges from the values of our Constitution. The
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health of the environment is key to preserving the
right to life as a constitutionally recognised value
under Article 21 of the Constitution. Proper structures
for environmental decision making find expression
in the guarantee against arbitrary action and the
affirmative duty of fair treatment under Article 14
of the Constitution.”
(iii) The judgment in Himachal Pradesh Bus-Stand Management
& Development Authority vs. Central Empowered
Committee, (2021) 4 SCC 309 (“H.P. Bus-Stand”) expanded
the framework of environmental rule of law to include within it
the State’s positive obligations to create conceptual, procedural
and institutional structures that guide environmental regulation
in furtherance of the environmental rule of law. Emphasising
the critical need for multi-disciplinary perspectives, this Court
held that:
“49. The environmental rule of law, at a certain
level, is a facet of the concept of the rule of law.
But it includes specific features that are unique to
environmental governance, features which are sui
generis. The environmental rule of law seeks to
create essential tools — conceptual, procedural and
institutional to bring structure to the discourse on
environmental protection. It does so to enhance our
understanding of environmental challenges — of how
they have been shaped by humanity’s interface with
nature in the past, how they continue to be affected
by its engagement with nature in the present and the
prospects for the future, if we were not to radically
alter the course of destruction which humanity’s
actions have charted. The environmental rule of law
seeks to facilitate a multi-disciplinary analysis of the
nature and consequences of carbon footprints and in
doing so it brings a shared understanding between
science, regulatory decisions and policy perspectives
in the field of environmental protection. It recognises
that the “law” element in the environmental rule
of law does not make the concept peculiarly the
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preserve of lawyers and Judges. On the contrary,
it seeks to draw within the fold all stakeholders in
formulating strategies to deal with current challenges
posed by environmental degradation, climate change
and the destruction of habitats. The environmental
rule of law seeks a unified understanding of these
concepts. There are significant linkages between
concepts such as sustainable development, the
polluter pays principle and the trust doctrine. The
universe of nature is indivisible and integrated.
The state of the environment in one part of the
earth affects and is fundamentally affected by
what occurs in another part. Every element of the
environment shares a symbiotic relationship with
the others. It is this inseparable bond and connect
which the environmental rule of law seeks to explore
and understand in order to find solutions to the
pressing problems which threaten the existence of
humanity. The environmental rule of law is founded
on the need to understand the consequences of
our actions going beyond local, State and national
boundaries. The rise in the oceans threatens not
just maritime communities. The rise in temperatures,
dilution of glaciers and growing desertification have
consequences which go beyond the communities
and creatures whose habitats are threatened. They
affect the future survival of the entire ecosystem.
The environmental rule of law attempts to weave
an understanding of the connections in the natural
environment which make the issue of survival a
unified challenge which confronts human societies
everywhere. It seeks to build on experiential learnings
of the past to formulate principles which must become
the building pillars of environmental regulation in
the present and future. The environmental rule of
law recognises the overlap between and seeks to
amalgamate scientific learning, legal principle and
policy intervention. Significantly, it brings attention
to the rules, processes and norms followed by
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institutions which provide regulatory governance
on the environment. In doing so, it fosters a regime
of open, accountable and transparent decision
making on concerns of the environment. It fosters
the importance of participatory governance — of the
value in giving a voice to those who are most affected
by environmental policies and public projects. The
structural design of the environmental rule of law
composes of substantive, procedural and institutional
elements. The tools of analysis go beyond legal
concepts. The result of the framework is more than
just the sum total of its parts. Together, the elements
which it embodies aspire to safeguard the bounties
of nature against existential threats. For it is founded
on the universal recognition that the future of human
existence depends on how we conserve, protect and
regenerate the environment today.”
This Court distilled the challenges that confront a constitutional
court in using the framework of an environmental rule of
law. Noting the often-intractable problem of adjudicating
environmental infractions in the absence of precise, quantifiable
and concrete evidence, this Court appreciated the valuable
principled guidance rendered by environmental rule of law in
the following words:
“54. … The point, therefore, is simply this — the
environmental rule of law calls on us, as Judges, to
marshal the knowledge emerging from the record,
limited though it may sometimes be, to respond
in a stern and decisive fashion to violations of
environmental law. We cannot be stupefied into
inaction by not having access to complete details
about the manner in which an environmental law
violation has occurred or its full implications. Instead,
the framework, acknowledging the imperfect world
that we inhabit, provides a roadmap to deal with
environmental law violations, an absence of clear
evidence of consequences notwithstanding.”
(emphasis supplied)
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Public Trust Doctrine:
29. At this stage, I shall refer to certain observations made by this
Court in the context of preservation of environment and on public
trust doctrine. According to this Court, all environment-related
developmental activities should benefit more people while maintaining
the environmental balance. This could be ensured only by strict
adherence to sustainable development, without which the lives of
the coming generations will be in jeopardy. In M.C. Mehta vs. Union
of India, (1991) 2 SCC 353, it was observed that law alone also
cannot help in restoring a balance in the biospheric disturbance. Nor
can funds help effectively. The situation requires a clear perception
and imaginative planning. It also requires sustained effort and result
oriented strategic action.
30. This Court’s jurisprudence on the right to a safe and healthy environment
is a firewall against unscrupulous and unsustainable decision-making.
It encapsulates a concomitant duty for the State, as understood in light
of Articles 48 and 51A(g) of the Constitution of India. In Charan Lal
Sahu vs. Union of India, (1990) 1 SCC 613 (“Charan Lal Sahu”) and
Subhash Kumar vs. State of Bihar, (1991) 1 SCC 598 (“Subhash
Kumar”), this Court expressly observed that Article 21 includes the
right of enjoyment of pollution-free water and air. Virender Gaur vs.
State of Haryana, (1995) 2 SCC 577 (“Virender Gaur”) expanded
the scope of the right to the effect that a hygienic environment is an
integral facet of the right to a healthy life. The right was so construed
in terms of the State’s duty under Articles 48 and 51A(g) to forge
policies to maintain ecological balance by taking concrete measures
to ‘promote, protect and improve’ the environment.
30.1 Thereafter, in M.C. Mehta vs. Kamal Nath, (2000) 6 SCC
213 (“Kamal Nath”), it was expounded that the fundamental
right to life under Article 21 would take within its breadth
a protection against disturbance of basic environmental
elements such as air, water and soil. This Court articulated
the positive duties of the State to take all necessary measures
for the protection and promotion of the environment under the
EP Act, 1986 in Indian Council for Enviro-Legal Action vs.
Union of India, (1996) 3 SCC 212 (“Enviro-Legal Action”).
It was also held that if the Central Government omits to fulfil
any of its duties under the Sections 3 and 5 of the EP Act,
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1986, this Court could issue appropriate directions to it to
take necessary measures.
30.2 Therefore, the right to a safe and healthy environment
encompasses a corresponding duty on the State to faithfully
implement the environmental statutes and take all necessary
measures.
30.3 The substantive concern of the right to environmental protection
now also encompasses the adverse effects of climate
change. This Court, speaking through Hon’ble Dr. Justice D.Y.
Chandrachud in M.K. Ranjitsinh vs. Union of India, 2024 (4)
Scale 779 : 2024 INSC 280 (“M.K. Ranjitsinh”) has explicitly
recognised that adverse environmental consequences, such
as sea level rise, have a disproportionate impact on socially,
geographically and economically marginalised classes of
citizens.
30.4 The aforesaid elucidation of the right to a safe and healthy
environment and the concept of environmental rule of law as
applied in the Indian jurisprudential context reveals that the
concept is one of the ways of embedding a consciousness
about adverse effects on the environment into the sub-structure
of the legal framework to inform an environment-protecting legal
reasoning. Therefore, environmental legislation such as the
EP Act, 1986 and the 1989 Rules ought to be interpreted so
as not to infringe the fundamental right to a safe and healthy
environment under Article 21. Where there is a choice of
statutory construction, this Court would be bound to proffer
an interpretation that effectively protects the right to a safe
and healthy environment.
Precautionary Principle:
31. The essence of the precautionary principle lies in the notion
that ‘decision makers should act in advance of scientific certainty to
protect the environment.’ [Source: Andrew Jordan and Timothy O’
Riordan, ‘The Precautionary Principle in Contemporary Environmental
Politics’ (1995) 4(3) Environmental Values 191, 194]. The adoption
of the precautionary principle reflects a paradigm shift from the
traditional reactive approach, wherein the environmental regulator
responded to apparent environmental hazards. It is a significant
shift even from the preventive approach that sought to prevent the
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environmental damage arising from risks that are bound to actualize
in the foreseeable future. On the other hand, the precautionary
principle seeks to avoid such future environmental damage which may
arise from uncertain eventualities. In other words, the precautionary
principle mandates cautiously taking appropriate measures to identify
potentially harmful activities even in the face of scientific uncertainty.
Precaution, in other words, is the expression of a well-founded fear
of the unknown and the unknowable environmental consequences of
certain human actions. For a fear to be well-founded, it must emerge
from a robust risk analysis of potentially hazardous consequences
for environmental health.
32. The 1982 World Charter for Nature first articulated the idea of the
precautionary principle in General Principle 11, which postulates
the control of activities which might have an impact on nature and
the use of the best available technologies that minimize significant
risks to nature or other adverse effects. The General Principle 11
recommends a graded approach to varying levels of environmental
risks and damage, while instantiating that:
i. those activities which are likely to cause irreversible damage
to nature shall be avoided;
ii. those activities which cause a significant risk to nature shall only
be permitted upon exhaustive examination if the proponents of
such activities would demonstrate that the expected benefits
outweigh the potential damage to nature; and
iii. those activities which cause a significant risk to nature but
where the potential adverse effects are not fully understood
should not be proceeded with;
iv. those activities which may disturb nature shall be proceeded
only upon ex-ante assessment of their consequences through
environmental impact studies and requisite planning to
minimize potential adverse effects.
32.1 Thereafter, the principle was enshrined in Principle 15 of the
Rio Declaration on Environment and Development 1992,
which states:
“In order to protect the environment, the precautionary
approach shall be widely applied by States according
to their capabilities. Where there are threats of
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serious or irreversible damage, lack of full scientific
certainty shall not be used as a reason for postponing
cost-effective measures to prevent environmental
degradation.”
32.2 It also finds expression in Article 10(6) of the CPB to the CBD,
which states that:
“6. Lack of scientific certainty due to insufficient
relevant scientific information and knowledge
regarding the extent of the potential adverse effects
of a living modified organism on the conservation and
sustainable use of biological diversity in the Party
of import, taking also into account risks to human
health, shall not prevent that Party from taking a
decision, as appropriate, with regard to the import of
the living modified organism in question as referred to
in paragraph 3 above, in order to avoid or minimize
such potential adverse effects.”
32.3 While Section 20 of the National Green Tribunal Act, 2010
exhorts the National Green Tribunal (NGT) to take precaution
into account in passing orders, this Court’s jurisprudence,
as explained below, had long recognized and deepened the
precautionary principle.
33. This Court in the following cases has discussed at length the
precautionary principle, which are adverted to at this stage.
(i) In Vellore Citizens’ Welfare Forum vs. Union of India, (1996)
5 SCC 647 (“Vellore Citizens”), this Court was seized of a
Writ Petition filed by a citizens’ group to seek enforcement of
the provisions of the Water (Prevention and Control of Pollution)
Act, 1974 against tanneries that were discharging untreated
effluent into nearby lands. While directing strict enforcement of
environmental law and holding the authorities accountable for
their failure to exercise statutory powers, this Court expounded
on the significance of the precautionary principle. It traced the
origins of the precautionary principle in international law and
located the same in domestic environmental law. This Court’s
formulation of the precautionary principle constitutes three
propositions:
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i. The environmental measures undertaken by the
State Government and the statutory authorities
must anticipate, prevent and attack the causes of
environmental degradation.
ii. Where there are threats of serious and irreversible
damage, lack of scientific certainty should not be
used as a reason for postponing measures to prevent
environmental degradation.
iii. The reversal of the “burden of proof” to the proponent
of a potentially hazardous activity which could disrupt
the natural environment was critical for ecologically
balanced and sustainable development.
This Court construed the precautionary principle in light of
Articles 47, 48A and 51A(g) of the Constitution. Further, it was
concluded that the extant legislative framework, specifically
the EP Act, 1986, included the application of the precautionary
principle in addition to the polluter pays principle. Consequently,
this Court passed a direction to the authority to be appointed
under Section 3(3) of the EP Act, 1986 to implement the
‘precautionary principle.’
(ii) The precautionary principle was explained in greater detail by this
Court in A.P. Pollution Control Board vs. Prof. M.V. Nayudu,
(1999) 2 SCC 718 (“A.P. Pollution Control Board”) from the
lens of international environmental law. Here, this Court was
considering whether the establishment of a hazardous industry
could be countenanced within ten kilometre of reservoirs used for
drinking water. This Court noted that the “assimilative capacity”
rule was embedded in Principle 6 of the Stockholm Declaration
of the U.N. Conference on Human Environment, 1972. This
“assimilative capacity” principle was premised on the assumption
of perfect scientific predictability that would allow the internalisation
of ecological risks within industrial processes. It was reasoned that
the preponderance of unpredictability of adverse environmental
effects led to the adoption of the 11th Principle of the U.N. General
Assembly Resolution on World Charter for Nature, 1982, and the
Principle 15 of the Rio Conference of 1992.
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Quite axiomatically, precautionary principle changes the role
and significance of scientific data in environmental disputes.
Once a threat to the environment has been identified, action
should be taken to abate environmental interference, even
though there may be scientific uncertainty as to the effects of
the activities. [Source: Lavanya Rajamani, ‘The precautionary
principle’ in Shibani Ghosh (ed.) Indian Environmental Law
(Orient Blackswan, 1994]. Certain anticipated environmental
harms and available environmental data may warrant a strong
and strict application, i.e., the potentially hazardous activity is
banned until the proponent of the activity demonstrates that it
poses no (or acceptable) risk. In such a case, the burden to
prove the acceptable standard of risk shifts to the proponent
of such an activity. In this context, reliance was placed upon
an article authored by Charmian Barton, in Volume 22 of
Harvard Environmental Law Review (1998) and inferred that
the environmental decision-makers must acknowledge the
inadequacy of information about environmental risks and ‘err
on the side of caution’ to prevent serious and irreversible harm.
(iii) In M.C. Mehta vs. Union of India, (2004) 12 SCC 118 (“M.C.
Mehta”), this Court advanced the view that the precautionary
principle enjoined the State to take affirmative action to prevent
environmental harm, even when the nature and extent of such
harm could not be anticipated with scientific precision and
certainty. It was reasoned that when it was difficult to strike a
balance between the protection of the environment and economic
development due to prevailing uncertainty and lack of direct
evidence of actual harm, reasonable suspicion of harm would
be adequate to press the precautionary principle into service
and take anticipatory action.
Analysis and Findings:
34. In light of the aforesaid observations, the PSC Report, 2012 made
a range of recommendations. The MoEF&CC responded to each
of the recommendations in the Action Taken Report. The pertinent
recommendations and the action taken are explained in the table
below:
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S. Recommendation Action Taken Report
No.
1. Conduct a thorough probe into the Views of Dr. Bhargava are
Bt brinjal matter from the beginning his personal views and are
till the imposing of moratorium not subscribed by most of the
on its commercialization in scientists. Prof. Reddy has
09.02.2010. clarified that the pressure he
adverted to was for meeting
the deadline as he had been
pre-occupied with his other
responsibilities.
2. Review the organisational set-up GEAC comprises of both
of GEAC. experts and bureaucrats, and
takes aid of expert committees.
3. Sought information about IAASTD Report has been
concrete action taken by the criticised by an independent
Government on each of the evaluation group at the World
findings contained in IAASTD Bank in its Global Programme
Report during the four years after Review. The Government of
the release of the Report. India recognises the importance
of biosafety and sustainable
agriculture and these goals
remain its policy priority.
4. Fix responsibility for the laxity The Department of Consumer
in regulating and labelling GM Affairs has issued a notification
foods, and issue regulations on the labelling of GM foods.
for labelling of GM products
including food crops, food and
food products
5. Upon consultation with all The BRAI Bill, 2013 has been
stakeholders, immediately evolve pending in Parliament. Such an
an all-encompassing umbrella Act would establish the National
legislation on biosafety, which Biotechnology Regulatory
is focused on ensuring the Authority.
biosafety, biodiversity, human and
Administrative and other support
livestock health, environmental
continues to be expected to
protection, and which specifically
RCGM and GEAC.
describes the extent to which
biotechnology, including modern
biotechnology, fits in the scheme
of things without compromising
with the safety of any of the
elements mentioned above.
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35. Similarly, the PSC Report, 2017 made a range of recommendations.
The MoEF&CC responded to each of the recommendations in the
Action Taken Report. The pertinent recommendations and the action
taken are explained in the table below:

S. Recommendation Action Taken Report
No.
1. The Central Government should, Confined-field trials are
in consultation with the State conducted as per detailed
Governments and Administrations guidance documents and
of Union Territories, ensure protocols framed for the purpose.
that the whole process of field Conduct of confined field trials
trials should be done in closed is inspected by members of
environment, keeping biosafety regulatory committees, experts,
and health safety in mind and in State Government and State
collaboration with the agricultural Agricultural Universities.
universities so as to minimise the
scope of fudging the primary data.
2. GEAC should be headed by GEAC comprises of both
an expert from the field of experts and representatives
B i o t e c h n o l o g y, g i v e n t h e of respective ministries. Sub-
understanding of scientific data committees are routinely
and analysis of research and its engaged to render technical
implication, before coming to a inputs.
conclusion in the matter.
3. The MoEF&CC should review Minutes of all the meetings of
the functioning of GEAC along GEAC are regularly published
with the organisational set up on the website, along with all
of GEAC and take necessary the relevant regulatory formats.
corrective measures to make the Various stakeholders such as
whole process of assessment farmers and civil society have
and approval more transparent, given inputs on transgenic
so as to ensure environmental mustard hybrid DMH-11 by
safety, biodiversity safety, health way of comments on the AFES
safety, food and feed safety of study and as part of special
our country. hearings.
4. Members of Parliament should DLCs are only mandated to
be nominated as members in play a role in monitoring of
the DLCs, so that the activities the facilities. Inclusion of MPs
of these Committees are also would not be commensurate
shared with the public. with the tasks of the Committee,
as the Committee reports to the
Deputy Collector.
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S. Recommendation Action Taken Report
No.
5. MoEF&CC should undertake a The adoption of Bt cotton
comprehensive study and bring has nearly doubled the yield
clarity on the issue of increase and substantially increased
in the yield of cotton after its productivity from 308 kgs. per
commercialisation in the country. Ha. in 2001-2002 to 568 kgs.
per Ha. in 2016-2017.
6. MoEF&CC should obtain results of The aforementioned data
Ministry of Agriculture’s scientific shows that Bt cotton has
study about the impact of adopting successfully countered the
Bt cotton on use of chemical menace of American bollworm
herbicides and pesticides. and significantly increased the
Thereafter, the MoEF&CC should yield.
bring out a comprehensive note
on usages of pesticide details
state wise after the increase in
area cultivated under Bt cotton.
7. MoEF&CC should scientifically Gene flow from GM crops to
evaluate the impact of GM crops wild relatives poses no risk to
on sustainability, safety and the environment. The regulatory
competitive advantage of Indian process has addressed each
agriculture. and every concern pertaining
i. It should specifically inform to environmental safety. Genes
the nation whether the that make GM crops HT have
cultivation is not going to very minimal quantity of Bt
have any negative impact on proteins. Studies on the impact
the microbes, soil and water. on non-target organisms and
beneficial organisms are part
ii. It should specially study the
of the regulatory process.
impact on beneficial organisms
like bees, earthworms and
monarch butterflies.
8. Assessment of threats and Similar to other regulatory
adverse effects of GM crops processes, the developer/
in foreign countries should not applicant furnishes studies
be mechanically transplanted about safety assessment of
by agencies. The Government crops. In case of DMH-11,
agencies conduct indigenous developed by Delhi University,
studies to substantiate their claim all studies have been funded
that there is no threat posed to our by DBT.
environment on account of GM
crops. Any study that conducts
impact assessment should be
funded by DBT for sheer credibility.
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S. Recommendation Action Taken Report
No.
9. The hasty decision to There is no scientific evidence
commercialise GM crops should to justify the need for such
be reconsidered in light of lack of studies as there exists no
scientific evidence about chronic biologically relevant difference
and transgenerational impact of between GM crops and their
such crops. non-GM counterparts.

36. I have perused and discussed the contents of the PSC Reports,
their recommendations of critical import to the regulatory framework
as well as the action taken and observe on the following aspects:
I. Thorough Probe into Bt Brinjal Approval: Although the Report of
the PSC, 2012, had recommended that the MoEF&CC should
conduct a thorough probe into the concerns raised by Dr. P.M.
Bhargava regarding the approval for commercialisation of Bt
brinjal till the imposition of the moratorium on 09.02.2010, the
Action Taken Report does not point to the particulars of any
enquiry or investigation. It appears that the justification offered
by the erstwhile Co-Chairman, GEAC, Prof. Reddy, has been
accepted without a fair and comprehensive investigation.
II. Institutional Architecture of GEAC: Although both the PSC
Reports recommended reforms in the institutional architecture
of GEAC, by way of having a full-time body with a leadership
that is competent to conduct impartial and sound scrutiny of
applications for approval under the 1989 Rules, the Action
Taken Report denies the very need for such reforms. I infer
that the Government is reluctant to reform the composition
and criteria for appointment to GEAC. No response is
forthcoming on the PSC’s recommendation that the conflict
of interest in the composition, caused by the presence of
a nominee of DBT, should be minimised. This accentuates
the concern about the lack of indigenous and independent
research institutions.
III. Labelling and Regulation of GM Foods: The Action Taken Report
does not address the question of labelling of GM foods under
Section 23 of the FSSA, 2006. There is inadequate clarity about
the issuance of the notification under Section 22 for regulating
sale, distribution and consumption of GM food.
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IV. Legislation: With respect to the recommendation to initiate the
process of consultation to enact a comprehensive legislation
on regulation of biotechnology, I note that the Action Taken
Report refers to the Biotechnology Regulatory Authority of India,
2013 (“BRAI Bill, 2013”). On 28.08.2013, this Court noted that
Sri K.K. Venugopal, learned senior counsel, appearing for one
of the contesting respondents had informed that the Central
Government has prepared a Bill bearing Bill No.57 of 2013,
which is named the BRAI Bill, 2013. However, this Bill lapsed at
the end of the 15th Lok Sabha. Therefore, there is no statutory
regulatory framework in the form of a Parliamentary law that is
in place. The 1989 Rules govern the existing procedure which
are in fact subordinate legislation, which is contented to be
inadequate.
V. Impact on Agricultural Ecosystem: The blanket denial of adverse
ecological effects by way of cross-pollination or otherwise is
mostly on the basis of research conducted in foreign contexts.
This may not at all be relevant in the Indian context and
ecosystem. The PSC has rightly observed that the role of
non-target organisms and beneficial organisms is critical to the
agricultural ecosystem.
37. My understanding is that GM crops are those crops whose genomes
have been modified by the insertion of usually foreign (for example,
bacterial) genes through rDNA technology. Such modification serves
to incorporate traits into plants that are either absent or rare in their
domesticated and/or wild varieties. For instance, Bt cotton is cotton
modified with a set of genes (or a gene construct) that codes for the
Bt toxin. Bt toxin acts as an insecticide against pink and American
bollworms. This specific insecticidal trait is absent in wild as well as
domesticated varieties of cotton.
38. According to the petitioners, two traits dominate commercialized
GM crops - HT (47 percent of the acreage), and insect resistance
or Bt (12 percent). Another 41 percent is under stacked traits,
i.e., both HT and Bt HT crops that obviate manual weeding and one
can simply spray the corresponding herbicide (glyphosate, glufosinate,
and dicamba) on the entire field, and everything other than the HT
crop will perish. In theory, the Bt crop reduces the applications of
external insecticides. Thus, most of the GM crops commercialized
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globally, in particular HT and stacked crops, are tailored for the
routines of capital-intensive agriculture, i.e., agriculture that relies
on monoculture (rather than mixed and intercropping), purchased
seeds, fossil fuels, and intensive applications of synthetic chemicals
which in effect is not sustainable in the long run.
39. In my view, the controversy in these writ petitions converges upon
a foundational aspect, which is, the extent of implementation of the
recommendations of the TEC constituted by this Court. Only upon
considering this foundational aspect can I proceed to determine the
points for consideration. I cannot ignore the TEC Report as suggested
by learned Attorney General, for it would result in undermining the
earlier orders of this Court, which would be an improper approach
in the matter.
39.1 The subject matter of this case is indeed technical, as it involves
scrutinising the adoption of a technology that would enable the
modification of genomes through the insertion of foreign genes.
The aim of the modification is often to craft hybrid varieties
that have certain desirable characteristics from the point of
view of agricultural productivity, sustainability and resilience.
40. At the outset, learned Attorney General submitted that the
TEC Report submitted to this Court goes beyond the terms of
reference to the extent of observing that HT crops are completely
unsuitable in the Indian context which is not just and proper.
Dr. Paroda, also a member of TEC, has filed a separate report
raising objections to the TEC report submitted by the majority of the
members which could be considered by this Court.
40.1 In the backdrop of identifying the actual controversy in
these matters, at the outset, the terms of reference of TEC,
inter alia, could be revisited as follows:
(i) to review and recommend the nature of sequencing of risk
assessment (environment and health safety) vis-à-vis all
GM crops before they are released into the environment;
(ii) to recommend the point at which environmental release
through open-field trials can be permitted;
(iii) to advise whether GE crops or plants could be replicated
under different agro-ecological regions and different
seasons as compared to greenhouse conditions;
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(iv) to advise measures or safeguards required to prevent
potential risks to the environment vis-à-vis open-field
trials and to recommend protocols necessary to preclude
any escaped material from causing an adverse effect on
the environment;
(v) to advise whether in India, there are state-of-the-art testing
facilities and professional expertise available to conduct
various biosafety tests and if not, recommend setting up
an independent testing laboratory and institutions.
40.2 An interim report, and thereafter, a final report were submitted
by the TEC. As already noted, the final report was in two
parts: the first part of the report was by a majority of five
members of the TEC and a separate note was submitted
by Dr. R.S. Paroda. Since the views of the majority and the
separate note have been recorded hereinabove, I would
only discuss whether the TEC did indeed breach the terms
of reference.
40.3 A perusal of the terms of the reference reveals an emphasis
on four aspects: sequencing; scientific tenability; adequacy of
regulatory conditions and availability of technological facilities.
The direction of this Court regarding the interim report was
specifically to seek recommendations on the desirability of a
partial or complete ban on open-field tests and what biosafety
protocol ought to be followed and under what conditions.
40.4 It is clear that the terms of reference relate to this Court’s
concern about the regulatory conditions for the release of GMO
crops and the existence, or otherwise, of any gaps in the same.
It is discernable that the final recommendations responded to
these queries regarding the adequacy of regulatory conditions,
biosafety protocols and available technological framework, by
recommending various measures to fill the gaps that existed
in the regulatory regime at a general level. The first gap, as I
understand is that of technical expertise. The TEC inter alia,
recommended as under:
(i) Constitution of sub-committees with domain expertise in
the fields of health, environment, agro-economics and
socioeconomics, molecular biology, etc. which could
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replace the single committee structure devised by the
1989 Rules.
(ii) Another recommendation pointed to the elimination of
conflict of interest, earmarking of specific sites for field
trials and stakeholder participation.
(iii) It also stated that there is a need to develop consultation,
collaboration and capacity building, and that the Indian
regulatory system must develop the ability to assess
as to how any GM product is likely to impact different
sections of the society.
Therefore, having regard to the discussion made by it, I find that the
TEC did not breach its Terms of Reference.
41. The petitioners herein have sought for implementation of the aforesaid
recommendations of the majority by contending that the question of
the consequences of transgenic mustard hybrid DMH-11 being an
HT crop remains unanswered. This is because the Union of India,
in its additional affidavit dated 09.11.2022, has acknowledged that
transgenic mustard hybrid DMH-11 possesses HT characteristics.
Yet, the Union of India asserts that it cannot be officially labelled
as such and therefore, it should not be referred to as HT corp.
That transgenic mustard hybrid DMH-11 has never been tested as a
HT crop because India does not have any regulatory guidelines and
protocols for testing of HT crops, is the contention of the petitioners.
41.1 The petitioners have further countered the stand of the Union
of India by submitting as under:
(i) “… that the presence of third HT gene (Bar) is essential
for hybrid seed production”, according to the Union of
India. The presence of HT gene (Bar) makes DMH-11
an HT crop. This is also the finding of the PSC Reports
which have stated that transgenic mustard hybrid
DMH-11 is a HT crop. There is clear evidence on the
adverse impacts of environmental release of DMH-11,
which is a HT crop in various writings which have been
ignored by GEAC;
(ii) that the Union of India is silent as to the measures
undertaken to ensure non-contamination, in case
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environmental release of GMOs is permitted, as
irreversible risk of contamination on human health is
enormous;
(iii) that the Union of India is also silent on the liability of the
applicant for potential losses to farmers and consumers
on account of irreversible contamination;
(iv) that glufosinate is banned for all other uses except for
tea plantations and is specifically banned for use on
DMH-11 by farmers. This is because of the acute toxicity
and health concerns. That, long term studies would show
the adverse effects of glufosinate which may not show
up in short term studies. Hence, it is necessary to have
adequate studies on the use of glufosinate on plants;
(v) that GEAC has failed to deal with illegal plantation of
Bt cotton and the same is being grown in the country
illegally on commercial basis. That organisations such as
Shetkari Sangathan have been encouraging farmers to do
illegal planting of Bt brinjal, which GEAC as a regulator
has failed to check;
(vi) that there is a failure to undertake any socio-economic
risk analysis by GEAC with regard to the failure of Bt
cotton in accordance with the CBD and the CPB. The
need for such an assessment was also highlighted by
TEC in its report. Such an assessment was required
because farmers across the country have been financially
burdened due to the increasing prices of Bt cotton seeds
and they have to spend on pesticides and other resources
to make the crops more pest-resistant and high-yielding.
This has resulted in escalated expenses and has reduced
the margin of profit for the farmers;
(vii) that the pink bollworm, a major pest to the cotton crop,
has developed resistance in last few years which has
worried the farmers who have sown Bt cotton seeds.
Therefore, cotton yields were stagnant in the last five
years due to the fact that the technology was used for
yield improvement but not for loss prevention;
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(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:
(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.
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(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 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?
42. 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 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
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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 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
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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.
42.3 Thereafter, in its 136 th 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 mustard hybrid DMH-
11 made in the 133rd GEAC meeting. The aforesaid letter is
extracted as under:
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“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, the
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.
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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.
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
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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 133 rd 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”
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
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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 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
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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 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:
(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.
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(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 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
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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 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.
Public Trust Doctrine:
42.10 The aforementioned curious lapses of procedure and propriety
are especially acute because they are in the teeth of the
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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.
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
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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 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,
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.
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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 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
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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, 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 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.
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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 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
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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
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.
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.
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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 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.
43. 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?
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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. 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 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
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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,
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
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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 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 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
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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” 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
[2024] 7 S.C.R. 2119

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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 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
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and 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 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.
44. Moving further, learned Attorney General submitted that pursuant
to the TEC Report submitted to this Court, several guidelines and a
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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.
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.
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44.1 Given their import to the issue at hand, I limit my analysis
to the Risk Analysis Framework, 2016 and the Guidelines
for 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, 2016. Furthermore, the failure to furnish cogent reasons
for giving a go by to field demonstration studies to study the
impact on honeybees also reveals the lack of safeguards
against misuse of discretion. 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
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
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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 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:
45. 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 billions of years, each living organism
would exchange DNA with others of its kind. Genetic engineering
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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.
46. 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, 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%,
[2024] 7 S.C.R. 2125

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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 technology
by these developed countries viz-a-viz the reasons led to
its acceptance.”
(underlining by me)
47. 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.
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For ease of reference, the said questions and answers are extracted
as under:
“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.
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(c) to (e) Long term studies conducted by Indian
Council of Agricultural Research (ICAR) on
the impact of 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.
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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 herbicide tolerance trait, even if
only for seed production purposes; and
(c) if not, the reason thereof?
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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).
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)
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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.
(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-11
confers 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
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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 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
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.
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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 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
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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 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.
48. 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 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
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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 (“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:
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“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. 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
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prioritize environmental protection and sustainable
development, thereby addressing the root causes of
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 Biological Diversity 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.
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,
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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
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
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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 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:
49. 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.
50. 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:
(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.
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(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 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 aforesaid directions and if not already
complied with.
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(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 crops
as 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 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
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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 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.
51. 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.

The contempt proceedings are dropped without expressing any
opinion on the merits of those petitions.

Order

1. 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,
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such as, experts in the field of agriculture, biotechnology, State
Governments, representatives of the farmers, etc. The National
Policy to be formulated shall be given due publicity.

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

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

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

Result of the case: Matter placed before HCJI for constituting
appropriate Bench.

†
Headnotes prepared by: Bibhuti Bhushan Bose