THE GROWING NEED FOR A DEDICATED REGULATORY FRAMEWORK FOR GENETICALLY MODIFIED FOODS IN INDIA BY: THEJA DIKSHITH
THE GROWING NEED FOR A DEDICATED
REGULATORY FRAMEWORK FOR GENETICALLY MODIFIED FOODS IN INDIA
AUTHORED BY: THEJA DIKSHITH
Institution: School of Law, Christ
(Deemed to be University)
Abstract:
The rapid
advancement in genetically modified foods (GMFs) offers a promising solution to
enhance crop yields, improve food security, and address nutritional
deficiencies. Originating from organisms with modified DNA to exhibit traits
not naturally occurring, such as increased resistance to environmental
stressors, GMFs carry the potential to revolutionize agricultural practices.
However, alongside their benefits, GMFs present significant health and
ecological risks, including potential allergenicity, gene disruption, and
ecological imbalance, necessitating a careful examination of their long-term
impacts. In India, the regulation of GMFs is in its infancy, characterized by a
fragmented legal framework governed by multiple authorities with overlapping
jurisdictions. The current regulatory regime, underpinned by the Genetic
Engineering Appraisal Committee (GEAC), Food Safety and Standards Authority of
India (FSSAI), and guidelines from the Indian Council of Medical Research
(ICMR), struggles to keep pace with the rapid advancements in biotechnology,
leading to inconsistencies and gaps in governance. This paper underscores the
urgent need for a cohesive, comprehensive regulatory framework for GMFs in
India, one that balances the benefits of genetic modification with the
imperative to safeguard public health and the environment. It advocates for the
establishment of a dedicated regulatory body to oversee GMF governance,
ensuring that regulations evolve in tandem with biotechnological innovations
and are aligned with international biosafety standards. Moreover, it highlights
the importance of transparent labelling and strict traceability measures to
inform consumer choice and facilitate responsible trade. Ultimately, a
balanced, forward-looking regulatory approach is essential to harness the
potential of GMFs while mitigating their risks, thereby contributing to
sustainable agricultural development and food security.
Keywords: Genetically
Modified Foods (GMFs), Regulatory Framework, Agricultural Practices, Food
Security, Biosafety Standards
Introduction:
Foods that have been genetically
modified (GM) are those that come from creatures whose DNA has undergone
changes that do not occur normally, such as the insertion of a gene from
another organism are referred to as genetically modified foods. The majority of
GM foods currently on the market come from plants that have been engineered to
increase crop yields, lower costs for food or drug production, reduce need for
pesticides, improve nutrient composition and quality, greater food security,
and medical benefits for the world's expanding population are a few advantages
of genetic engineering in agriculture.[1]
These GM crops mature more quickly and can withstand environmental stresses
like drought and frost. This enables plants to grow in environments where they could
not normally thrive.[2]
While GMOs are beneficial for
consumers of their nutritional value and shelf life, there are risks associated
with them which include health risks and ecological risks. Health risks here
are those associated with the functioning of the human body. Such risks can
cause allergies, disrupt the natural genes in an organism, and cause the
inability to conceive among individuals. Ecological risks mean killing
non-target weeds which actually help the plant and the constant use of GMOs can
disrupt the food web. While the biggest problem in the use of GMOs is
resistance to antibiotics, which can usually kill the good bacteria which are
needed to protect from harmful antibiotics. [3]
The regulatory aspects relating to
genetically modified foods is limited as the concept is new and evolving. The
environmental risks that the genetically modified crops impose are regulated by
the “Rules for the Manufacture/Use/Import/Export and Storage of Hazardous
Microorganisms, Genetically Engineered Organisms or Cells, 1989 which are
notified under the Environment (Protection) Act, 1986. Additionally, the
Genetic Engineering Appraisal Committee (GEAC) was the only competent authority
which dealt specifically with genetically modified foods until the enactment of
the Food Standards and Safety Act in 2006. The FSSAI has a dedicated scientific
panel that deals with GMFs. The Indian Council of Medical Research (ICMR) has
also released “Guidelines for Safety Assessment of Foods derived from GE
Plants, 2008”.[4]
While the general concept of GMF
remains the same, it is ever-evolving with the invention of newer and more
sophisticated techniques. For this, there needs to be a dedicated body that is
tasked with the governance of the GMFs. Currently, in India, GMFs have regulations
made by multiple authorities.[5] Sometimes,
they are conflicting with each other and since the regulations are made and
implemented through multiple agencies, the regulations are not comprehensive.
Part I: Existing Framework
Genetically
Modified Foods (GMFs) come under the umbrella of genetically modified organisms
and are specifically related to edible items. The Food and Agriculture
Organisation (FAO) of the United Nations defines genetically modified organisms
as “products that do not occur naturally either by mating or through natural
recombination” and genetically modified food as “food that is produced from the
genetically modified organisms”.[6]
Under Indian legislation, especially with regards to food safety, “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”[7] is
defined in the Food Safety and Standards Act,2006.
Since
there are various acts that govern GMOs, there are overlaps that take place,
many of which are contradictory. GMOs can also have negative effects that
necessitate a comprehensive regulatory framework to make sure that it does not
harm the environment. There is a gap that exists between the current guidelines
and rules on GMOs and the loopholes caused by emerging biotechnology. Further,
there should be mechanisms to ensure that evolution of the legislations keeps
up with the emerging biotechnology to ensure safety.
This
needs to be done with caution. The regulatory framework cannot give importance
to agriculture since that would be trespassing on the individual State’s
authority to frame guidelines as agriculture is in the state list. Further,
since the union and concurrent lists involve “agriculture-related” items, it is
intra vires of the Legislature to formulate such guidelines. One example
is item number 51, which states that “Establishment of standards of quality for
goods to be exported out of India or transported from one State to another”.[8]
Also, since India is a signatory to the existing Cartagena Protocol on
Biosafety, the measures that are taken should follow some of the guidelines
mentioned.
Currently,
only Bt Cotton can be grown in India, there are no GMFs that are allowed
to be grown or produced in the country. Further, any imported products have to
adhere to the packaging and labelling regulations specified under the Food
Safety and Standards Act,2006, as well as the notification from the Ministry of
Consumer Affairs, Food and Public Distribution that mandates the labelling of
genetically modified food.
Part
II: Necessity of Dedicated Regulations
Use
of GMFs in international trade poses a problem of traceability, making it
difficult to identify the real modifications made as well as the quantity and
quality of the modified crops used in the production of other food.[9]
It also makes it difficult to trace who should be held liable in case any
mishaps occur. International trade of GMFs also allows for adulterants to be
added to the food, potentially making it unsafe.
The
regulations are necessary to provide safeguards against the indiscriminate
spread of GM food, especially with the ill effects they can cause. Since the technology
involved in the genetic modification is still recent, there is not enough
credible data on what the long-term effects are, but some of the known include
fertility issues, allergies and possibly cancer.[10]
There has been research that shows that consuming certain GM crops like corn
and soy do cause hormonal imbalances and subsequent fertility issues in women,
that then passes on to the next generation due to genetics.[11]
There are also studies on the increase of disorders like attention deficit
hyperactivity disorder(ADHD) and autism as well as mental health issues like
depression and anxiety increasing due to the increase of genetically modified
food.[12]
However,
there are also those who advocate for the use of GM crops, since they can be
modified to increase crop yields and increase disease resistance. This could
help reduce the number of people who face extreme hunger, which is in line with
the sustainable development goals (SDG) set by the United Nations. Some of the
varieties that could be useful include increased herbicide tolerance, pest and
disease resistance, increased production and being able to handle greater
environmental changes without affecting the yield of the crops.[13]
Part
III: Possible Effects from Lack of Dedicated Regulations
If
there are no regulations, then those who have the means to get GM crops can use
them to cause resource drain for their competitors along with other nefarious
activities like spreading pest-infested species or other harmful modifications.
It is also necessary to take into account how the usage of such genetically
modified crops affects the environment. The crops modified to grow faster might
suck the nutrients from the soil as well as the groundwater, leaving the land
barren once the crops are grown. Also, the crops that are genetically modified
are like hybrid seeds. They can only be sown once and for the next season, the
farmers need to procure more seeds. This makes the entire process more
expensive, leading to the cost of food increasing, eventually defeating the
purpose of higher yield if not everyone can afford it. The GM crops also
consume more nutrients and water from the soil and make it difficult to then
replenish. Further, due to the increased pest resistance, there are higher
quantities of pesticides used which then harms the health of the people who
consume the food.
These
issues highlight the need for separate legislation that protects all the
players involved and is also able to keep up with the evolving biotechnology.
This in turn will be beneficial to India and help regulate international and
domestic trade of such crops and foods while maintaining the labelling and
safety standards as prescribed. Dedicated legislation would also clarify the
traceability of food that is imported and contains some genetic modifications,
helping society to understand what it is that they are eating. It could also
help improve India’s food security due to increased yield as well as greater
resistance to changing temperatures and emerging diseases. It is important that
such a framework be made as soon as possible to take into account the
environmental risks associated with GMOs and then protect the natural resources
that India already possesses. It would reduce confusion for the authorities for
what regulations they should follow and at the same time, it closes the
loopholes that unscrupulous companies can use to harm the people, the
environment and the economy.
The
FSSAI also needs to follow through with the draft resolutions that they propose
and make sure that the policies that they propose do not become
counter-productive for society. The draft regulations of 2018 had several
lacunae, mostly with regard to specifying the details pertaining to the
standards that they were trying to set. This needs to be rectified to ensure
that any regulations that are made are actually useful and aid in safer food
reaching the people.
Part
IV: Recent Developments regarding GMO in India:
The
landmark case in India that is related to GMOs and their regulation is Aruna
Rodrigues v. Union of India[14].
In this case, the Supreme Court had laid down several guidelines that are to be
followed during the research process for creating a genetic modification to any
organism. The guidelines that the Committee has to follow for field trials of
the GMO are:
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.
1.
“To recommend the
sequencing of these tests in order to specify the point at which environmental
release though Open Field Trials can be permitted.
2.
To advise on whether a
proper evaluation of the genetically engineered crop/plants is scientifically
tenable in the green house conditions and whether it is possible to replicate
the conditions for testing under different agro-ecological regions and seasons
in greenhouse?
3.
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.
4.
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.
5.
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
mechanism to strengthen the same. If no such institutions are available in
India, recommend setting up an independent testing laboratory/institution.”[15]
Recently, there
have been discussions regarding the use of genetically modified mustard and
there is currently a case pending at the Supreme Court regarding the same.
Another
development in this regard is a Delhi High Court decision regarding the
restotation of the patent for a variety of potato that was owned by Pepsico.[16]
This brings in another authority for the regulation of GMO under the
intellectual property laws as well.
There can be
patents and protections that are granted under the Plant Varieties and Farmers
Rights Act, 2002, which results in further complications to the already
existing variety of regulatory mechanisms in India.
Part
V: Limitations
This research primarily focuses on
the legal aspects of GMFs in India. A more comprehensive analysis would include
a deeper dive into the scientific literature on the health and ecological risks
associated with GMFs. Additionally, the research could benefit from incorporating
the perspectives of stakeholders such as farmers, consumers, and biotechnology
companies. Finally, the limitations of the current scientific understanding
regarding the long-term effects of GMFs consumption should be acknowledged.
Conclusion:
Genetically modified foods (GMFs)
offer a potential solution to global food security challenges by increasing
crop yields and improving disease resistance. However, concerns exist regarding
their potential health risks and ecological impact. The current regulatory
framework in India for GMFs is fragmented and lacks comprehensiveness. This
research highlights the necessity for dedicated legislation to govern GMFs in
India. Such legislation should address traceability, long-term health effects,
environmental impact, and affordability. A well-defined regulatory framework
can ensure the safe and sustainable use of GMFs, contributing to India's food
security and economic well-being.
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Wunderlich, Kelsey A Gatto, Consumer Perception of Genetically Modified
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[2] Shukla, M., Al-Busaidi, K.T., Trivedi, M. and
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[3] Zhang, C., Wohlhueter, R. and Zhang, H., 2016.
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[4] T. Lang, J.,
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[5] Motasara, Namrata. (2019). Regulation of GMO release
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[8] Constitution
of India, Seventh Schedule
[9] Gautam, K. and Kushwaha, S., 2018. Genetically modified food
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[10] The
Negative Side Effects of Eating Genetically Modified Foods, Soapboxie, https://soapboxie.com/social-issues/What-Genetically-Modified-Foods-Do-to-Our-Bodies (Last visited Oct, 25
2022).
[11] Processed
or Genetically Modified Foods Affect Fertility, Fertility Factor.com,https://www.fertilityfactor.com/can-over-processed-or-genetically-modified-foods-affect-fertility.html
[12] Id
[13] Genetically
Modified Foods: Benefits and Risks, Healthpedian.org, https://www.healthpedian.org/genetically-modified-foods-benefits-and-risks/
[14] (2011) 12 SCC 477
[16] 2024 SCC OnLine Del 153