Open Access Research Article
REGULATION OF NOVEL GENETIC ENGINEERING IN CROPS
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Article Details
REGULATION OF
NOVEL GENETIC ENGINEERING IN CROPS
AUTHORED
BY - ABHISVARA KANDALAM[1]
In view of the novel
technological development in the Indian agricultural sector, there is a need for the pragmatic regulation of
agricultural biotechnology. Agricultural biotechnology's advancement has sparked a widespread discussion about its
potential to revitalise Indian agriculture, but, also its possible hazards
on accounts of biosafety, biodiversity, and the environment. In India, for example,
there have been numerous discussions around genetically modified crops, particularly, Bt Cotton and Bt Brinjal.
Additionally, these case studies have
shown that India's current legal and regulatory framework for agricultural
biotechnology is inadequate. A Bill
- The Biotechnology Regulatory Authority Bill was proposed, but it has been pending in the Parliament since 2013. Nevertheless, the Bill is deficient in a number
of areas in its current form. A wide
number of concerns regarding agricultural biotechnology have not been adequately addressed by the law, including those
related to the environment, intellectual
property, ethics, the balance between public and private interests, etc.
Several leading research institutes
in India have developed new varieties of crops by using latest technologies by genetic engineering. For
instance, a recent breakthrough gene editing tool, known as CRISPR, has opened new avenues for crop development. In
this technology, the gene that is
already present in a plant is edited without bringing in any foreign gene. As
the new protein doesn’t come from an
outside organism, the need for safety tests doesn’t arise, unlike in the case of transgenic crops
like Bt Cotton. However, due to the lack of guidelines, and due to regulatory
issues, these varieties are yet to be
tested in the open fields before their release to the farmers. The author aims
to offer insight into Genetically Modified Crops and their impact on
the environment in the aforementioned context. In the process, the author
attempts to illustrate the legal framework in place in India that govern
Genetically Modified crops, and its shortcomings. Finally, the author endeavors to put forward suggestions for the
government to take a proactive stand to bring about the proposed legislation while incorporating the suggestions to the inherent
shortcomings in order to effectively utilise, and
regulate the novel gene editing technologies for the benefit of Indian farmers.
Key words: Agricultural biotechnology, CRISPR, Gene editing
Technologies, Genetic Engineering,
The Biotechnology Regulatory Authority Bill
INTRODUCTION
Genetically modified
(GM) or genetically engineered crops are plants used in agriculture, in
which the DNA has been modified for a specific purpose by using genetic
engineering techniques.[2] In most cases of genetic engineering, the aim is to
introduce a new trait to the plant which does not occur naturally in the
species like resistance to certain pests (insect
resistance), diseases, environmental conditions, herbicides (herbicide tolerance), stacked traits, etc.[3] However, certain associated risks
like that to the human health by the introduction of new food allergens,
environment through the flow of genes to non-target species as a result of
cross pollination resulting in the creation of super weeds and super pests,[4] loss to the genetic makeup and
diversity in species,[5] etc are present.
International Regime Relating to the biosafety in
GM Plants
India is a party to the Convention on
Biological Diversity (CBD), 1992 and ratified the Cartagena Protocol on Biosafety in 2003
which protects biodiversity from potential risks of GMOs and the products of modern
biotechnology.
Advance
Informed Agreement[6] is
a significant feature of the Protocol, which enshrines the precautionary
principle.[7]
Under the Agreement, the exporting nation is required to notify the importing
nation of its intention to export GMOs.[8] The
importing country can base their decision to ban an import due to the potential
risk it poses to human health and environment, even in the absence of
sufficient scientific information about the kinds and extent if risk.[9] The
Protocol, however, does not outline any method of dispute resolution procedure
or liability for environmental harm brought on by the GM technologies.
Indian
Biosafety Regime for regulating GM crops
In light of the above discussion, it
would be appropriate to assess the domestic regulatory system. The first major
regulation was the Environment (Protection) Act of 1986 to provide a holistic
framework to protect and improve the environment. Under Section 25 of the Act,
specific provisions were made in 1989 for the Manufacture, Use/Import/Export
and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells.[10] They are popularly known as the ‘Rules of 1989’.[11] They are meant to be the apex provision
for regulation of all activities related to genetic engineering. They cover
areas of research as well as large scale application of genetically modified
organisms and their products. Further, they provide for dispute resolution and
penalties in cases of non-compliance.
These Rules are
implemented by the Ministry of Environment, Forest, and Climate Change; Department
of Biotechnology; and State governments though six competent authorities,
namely; rDNA Advisory Committee (RDAC), Institutional
Biosafety Committee (IBSC), Review Committee on Genetic Manipulation (RCGM),
Genetic Engineering Appraisal Committee (GEAC), State Biotechnology Coordination
Committee (SBCC), District Level Committee (DLC). The major roles of these authorities are
as follows: RDAC has an advisory function; the IBSC, RCGM, and GEAC are
responsible for the regulating function. The SBCC and DLC are for monitoring
purposes. The interaction mechanism among these provides that all IBSCs are
required to review the applications and submit their recommendations and
reports to RCGM from time to time. The release of guidelines by Indian
regulatory authorities includes in their ambit research and development
activities.
Recombinant DNA Safety Guidelines with a
major emphasis on research and development activities on GMOs, shipment, and
importation for laboratory research etc. came into the existence in the year
1990.[12] As per the Rules, 1989, the Genetic
Engineering Approvals Committee (GEAC), a body under the Ministry of
Environment and Forests was given the responsibility for approval of
genetically engineered products in India.[13] The GEAC is chaired by the Special
Secretary/Additional Secretary of MoEF & CC and co-chaired by a
representative from the
Department of Biotechnology (DBT).
The guidelines for the safety assessment
of foods derived from genetically engineered plants were prepared by the Indian
Council of Medical Research (ICMR) and adopted by the RCGM and GEAC in the year
2008.[14] Similarly, MoEFCC along with the DBT has adopted a series of documents
to strengthen the environmental risk assessment of GM plants in India. These
include: Guidelines for the Environmental Risk Assessment of Genetically
Engineered Plants, 2016; Environmental Risk Assessment of Genetically
Engineered Plants: A Guide for Stakeholders and Risk Analysis Framework, 2016; Guidelines; User’s Guide and Risk
Analysis Framework In: Environmental Risk Assessment of GE Plants 2016.[15]
In 2014, the DBT constituted a dedicated
Task Force on “Genome Engineering Technologies and their Applications” with a
vision to foster innovation and promote development of Genome-wide Analysis and
Engineering Technologies to make them accessible and affordable for wider use
in life sciences.[16]
The Biotechnology Regulatory Authority of
India (BRAI) Bill, 2013, was introduced with an objective to promote the safe
use of modern biotechnology. BRAI was meant to regulate the research, transport,
import, containment, environmental release, manufacture, and use of
biotechnology products.[17] The National Biotechnology
Regulatory Authority (NBRA) was envisioned by the Bill, and it was proposed to
establish the NBRA under the DBT, therefore eliminating all other areas of
interest that have an impact on India's biotechnology sector; notably, the
social, agricultural, and economic realms.[18] However, this Bill lapsed and further
action on the same is awaited, affecting the pace of research work in the field
of genetic engineering of crop plants in the country.
Drawbacks Of The
Existing Framework
There is no apparent hierarchy or
distinction among the many bodies in the biosafety framework. Despite provisions
for authorities such as the SBCC and the DLC at the de-centralized level, these
regulatory bodies have not been set up in most of the states and districts of
the country.[19] Similar confusion exists with
legislations also; at least five existing legislations in force in India have a
potential impact on the regulation of GM products in the country.[20] It is paramount for the biosafety regulatory
bodies to recognize the shortcomings and come out with sensible solutions.
The regulatory bodies, primarily the
RCGM and the GEAC, are constituted mostly by members of public sector
institutions and government bureaucrats along with representation from the
scientific disciplines[21] excluding public participation,
which is in severe violation of the CBD[22] as well as Cartagena.[23] Our regulatory mechanism does not
take into consideration the value of the biodiversity to the indigenous and
local communities, thus choosing to ignore to assess the socio-economic impact
of GMOs.[24]
A poor liability regime is another
concern: firstly, non-compliance with the legal requirements, and secondly,
damage caused to the environment as well as socio-economic and other forms of
damages. The domestic regime completely fails to address the latter.[25] There is no provision for any sort
of compensation or confiscation, except under the EPA where there is a provision
for fine and imprisonment.[26] In the existing mechanism there is
no provision for labelling of GM products in order to segregate transgenic
crops from the non-transgenic ones.[27]
The Bill does not address any of the
prevailing lacunae in the regulatory mechanism, be it the lack of public
participation or the non-recognition of the Precautionary Principle as a
legally binding instrument. For instance, the provision which penalizes a
person who, without any scientific evidence or scientific record, 'misleads'
the public about the safety of the organisms and products with imprisonment and
fine.[28] It overrides State Authority and
gives them only an advisory role when agriculture is in reality a State Subject
under the Constitution.[29] This discourages state
participation and further weakens the monitoring mechanism.
Conclusion
Till date, Bt cotton is the only GM crop
approved for commercial cultivation in India. Regarding regulation of genome
engineering technologies, there is still a debate in the country. Clarity of
procedure and lack of unanimous opinion about the safety and precautions to be
taken for utilizing the recent genetic technologies is affecting the regulatory
mechanism of biotechnology in India.
It is important that we carry out
our international commitments, such as implementing the Precautionary
Principle, taking socioeconomic considerations into account, encouraging
public participation, requiring labelling, and similar concerns. One step in this
direction would be a stand-alone Gene Technology Legislation[30] inclusive of the above-mentioned
features as well as a strong liability clause, and dispute redressal mechanism.
Another aspect which requires
consideration is the infrastructural setup. The fact that risk assessment tests
are carried out in the private laboratories of the biotech companies rather
than independent, publicly financed institutions could lead
to a conflict of interest.[31] Further, it may be prudent to
incorporate certain assessments, one being a performance assessment and the
other a need assessment.[32] Considering the early stages of
gene technology that India is in, it could be a good idea to set up a
performance assessment system after commercial release of GM crops.
[1]
Student, Third Year, BA, LLB (Hons.), School of Law, CHRIST (Deemed to
be University), Bangalore.
[2] What
is genetic modification (GM) of crops and how is it done?, The Royal Society (May, 2016), https://royalsociety.org/topics-policy/projects/gm-plants/what-is-gm-and-how-is-it-done/
accessed Oct. 5, 2022.
[3]
David. J. Schiner, Genetically modified organisms and the Cartagena Protocol
379 (Fordham Enytl. L.J., 2001).
[4]
David. J. Schiner, Genetically modified organisms and the Cartagena Protocol
394 (Fordham Enytl. L.J., 2001).
[5] A.
A. Snow et al., Genetically Engineered Organisms and the Environment:
Current Status and Recommendations, Ecological Applications 377
(Ecological Society of America, 2005).
[6] Cartagena
Protocol on Biosafety to the Convention on Biological Diversity, Art. 7 – 10,
12, 2000.
[7] Cartagena
Protocol on Biosafety to the Convention on Biological Diversity, Art. 10.6,
2000.
[8] Ibid.
[9]
Swati Singh & Upasana Rajaram, India’s Genetic Monsters (Envtl. L.
& Prac. Rev., Working Paper No. 86, 2011).
[11] Rules for
manufacture, use/import/export & storage of hazardous
microorganisms/genetically engineered organisms or cells, 1989, G.S.R. 1037
(E). (India).
[12] Recombinant
DNA Safety Guidelines, 1990.
[13] Supra
note 10.
[14] Guidelines
for the Safety Assessment of Foods Derived from Genetically Engineered Plants,
2008.
[15] Guidelines for the Environmental Risk
Assessment of Genetically Engineered Plants, 2016; Environmental Risk
Assessment of Genetically Engineered Plants: A Guide for Stakeholders and Risk
Analysis Framework, 2016;
Guidelines, User’s Guide and Risk Analysis Framework In: Environmental Risk
Assessment of GE Plants 2016.
[16] Vibha Ahuja, Regulation of
emerging gene technologies in India (BMC Proceedings, Working paper No. 12 (Suppl 8): 14, 2018).
[17] The Biotechnology Regulatory Authority of
India (BRAI) Bill, 2013, PRS Legislative
Research, https://prsindia.org/billtrack/the-biotechnology-regulatory-authority-of-india-bill-2013, accessed 3 October 2022.
[18] Ibid.
[19]
Suman Sahai, GMO Regulations in India and their Weakness, Gene Campaign, genecampaign.org/Publication/Article/gmo-reg-india-weakness-pl=ID1.htm,
accessed 3 October 2022.
[20] Prevention
of Food Adulteration Act, 1954, the Seed Act, 1966, the Biosecurity
Regulations, the National Biodiversity Act, 2002 and the Protection of Plant
Varieties and Farmers' Rights Act, 2001.
[21]
Aarti Gupta, Ensuring 'Safe Use' of Biotechnology: Key Challenges 2763
(Economic and Political Weekly, 2002).
[22]
Convention on Biological Diversity, Art.14(1), 1992, 1760 UNTS 79.
[23]
Cartagena Protocol on Biosafety to the Convention on Biological Diversity, Art.
23, 2000.
[24]
A. Damodaran, Re-Engineering Biosafety Regulations In India: Towards a
Critique of Policy, Law and Prescriptions (Environment and Development
Journal, 2005).
[27]
Alexander G. Haslberger, Monitoring and Labelling for Genetically Modfied
Products, (American
Association for the Advancement of Science, Working Paper No. 431,
2000).
[28] Supra
note 9.
[29]
Mahim Pratap Singh, Activists Voice Concern over Biotech Regulatory
Authority Bill, The Hindu
(Feb. 18, 2010), http://beta.thehindu.com/news/national/article108821.ece.
[30]
Suman Sahai, The BT Brinjal Case: Overhauling the Regulatory System must be
the First Step, Gene Campaign, http://www.genecampaign.org/Publication/Article/GMtech/the
Bt brinjal-caseoverhauling-the-regulatory-system-must-be-the-first-feb10=ID3.html,
accessed 3 October 2022.
[31]
R. Ramachandran, Global Spread, Frontline
(Mar. 12, 2010), https://frontline.thehindu.com/cover-story/article30179455.ece.
Article Information
REGULATION OF NOVEL GENETIC ENGINEERING IN CROPS
Authors: ABHISVARA KANDALAM
- Journal IJLRA
- ISSN 2582-6433
- Published 2023/04/26
- Volume 2
- Issue 7
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International Journal for Legal Research and Analysis
- Abbreviation IJLRA
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