An Impact Of Genetically Modified Foods And The Rights Of Farmers

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Category: General Law

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AN IMPACT OF GENETICALLY MODIFIED FOODS AND

THE RIGHTS OF FARMERS

Sasmita D S, Christ (Deemed to be University)

ABSTRACT

This study focuses on the regulations governing GM foods and assesses their impact on farmers' economic security, seed sovereignty, and the environment. Genetic modification of plants involves adding new DNA to a plant's genome to alter its characteristics. It emphasizes the importance of striking a balance between innovation and safeguarding farmers' rights. Agricultural biotechnology innovation has led to changes in intellectual property systems by extending protection to life forms.

The principal transgenic crops grown commercially in the field are herbicide and insecticide-resistant soybeans, corn, and cotton other crops grown commercially and/or field-tested are sweet potatoes resistant to a virus that could destroy most of the African harvest, rice with increased iron and vitamins that may alleviate chronic malnutrition in Asian countries and a variety of plants that can survive weather extremes. Some bananas produce human vaccines against infectious diseases such as hepatitis B, fish that mature more quickly, fruit and nut trees that yield years earlier and plants that produce new plastics with unique properties Plant Genetic Resources have always been valuable economic assets and a source of livelihood for many people, including those in India.

Genetically modified crops can potentially help conserve biodiversity and enable crops to thrive in various environmental conditions. These crops are primarily protected by the “TRIPS” Agreement and the “Protection of Plant Varieties and Farmers' Rights Act, 2001” in India, which grants intellectual property rights. The Protection of Plant Varieties and Farmers’ Rights Act, 2001 is India's sui generis legislation that directly addresses the protection of plant varieties and the rights of farmers and plant breeders. The proposed research aims to study the necessity, feasibility, and implications of incorporating international intellectual property standards for biological resources such as seeds and plants and the potential impacts on the country’s food security.

It will also explore the important role played by farmers in the conservation, enrichment, and sustainable use of plant genetic resources in India. This review will also address some major concerns about the safety, environmental and ecological risks and health hazards involved with GM

foods and recombinant technology. Current laws need to be dynamic in addressing the sustainability of modified crops and farmers' rights in the IPR regime. Keywords: Genetically modified foods, biodiversity, food security, farmers rights, biotechnology, environment.

INTRODUCTION

Genetically modified crops are manmade biological products, developed by intentional alteration in genetic material by using biotechnological methods to get the desired characteristics or product in a plant species or any living organism. Foods produced from or using GM organisms are often referred to as GM foods. In India, where agriculture remains the backbone of the economy and the primary source of livelihood for a significant portion of the population, the introduction of GM crops has particularly profound implications for farmers’ rights. An international legal instrument, the Convention on Biological Diversity (CBD) dealing with biological resources/biodiversity defines biotechnology under, Article 2 as "Any technological application that uses biological systems, living organisms, or derivatives thereof to make or modify products or processes for specific use.

" 1 The first produced GM plant in the laboratory was tobacco in 1983. Since then, the RDT gained momentum in the mid-1990s in various countries but focused on crops such as canola, maize, cotton, soybean, etc. Currently, there are several food species in which a genetically modified version exists (Johnson 2008). Some of the foods that are available in the market include cotton, soybean, canola, potatoes, eggplant, strawberries, corn, tomatoes, lettuce, cantaloupe, carrots, etc. 2 Since the stupendous growth, there has been an increase in the use of GM crop technology to meet the growing population's food productivity needs. Also, adopting eco-friendly and sustainable measures is necessary to reduce crop loss caused by factors such as diseases, pests, and insects.

Addressing issues like crop diversification, malnutrition, and increased production requires effective resource management to ensure that crops are both nutritious and less resource-demanding. Genetically modified technologies have been introduced to tackle these challenges and have significantly contributed to increased food productivity, sustainable development, and reduced environmental degradation. This paper aims to explore the intersection of genetically modified

1 CURRENT LEGAL STATUS OF GM CROPS IN INDIA WITH SPECIAL REFERENCE TO

INTELLECTUAL PROPERTY LAWS. Dr. Arun kumar Maurya 2 Genetically modified foods: safety, risks and public concerns—a review A. S. Bawa - K. R. Anilakumar

foods and farmers' rights, examining the economic, environmental, human health, and legal dimensions of this issue.

SIGNIFICANCE OF THE STUDY

This study is significant as it explores the critical impact of genetically modified (GM) foods on farmers' rights in India, a country where agriculture forms the backbone of the economy. There is a great need to study this because even though there are legislations and recommendations of various committees all these are not enough to overcome. So, this study is an attempt to explore the impact of farmers' rights in genetically modified foods in India.

STATEMENT OF HYPOTHESIS

The thesis argues that genetically modified foods, intended to improve agricultural efficiency, have caused unintended socio-economic and environmental consequences for small-scale farmers in India. The existing legal mechanisms, including the PPVFR Act, are inadequate in addressing the inequalities created by the increasing dominance of GM seed corporations. This dominance poses a threat to both farmers' livelihoods and the country's biodiversity.

METHODOLOGY ADOPTED

The data for the study have been collected from primary and secondary sources. Primary data have been accumulated from Legislation and Government reports. The secondary data and appropriate literature have been derived from published and documented sources. For the incentive insight on the topic the previous study surveys and published literature have been reviewed. The method used for research is predominantly doctrinal. The data so collected have been tabulated and charted for analysis.

GENETICALLY MODIFIED FOODS AND THEIR IMPACT

Genetically modified (GM) foods are created from organisms that have had their DNA altered using genetic engineering techniques to introduce desirable traits such as pest resistance, drought tolerance, or increased nutritional value. While GM foods offer potential benefits such as improved crop yields and reduced dependency on chemical pesticides, they also raise significant concerns regarding the rights of farmers, particularly in developing countries like India.

In India, while the Protection of Plant Varieties and Farmers’ Rights (PPVFR) Act, 2001 offers some protections by allowing farmers to save and sell seeds, these provisions do not apply to patented GM crops, such as Bt cotton, creating legal and financial challenges for farmers. The commercialization of GM crops has also led to concerns about environmental impacts, such as reduced biodiversity and the development of herbicide-resistant weeds. Cross-pollination between GM and non-GM crops can result in contamination, potentially affecting organic farming and leading to legal disputes over seed patents. Additionally, the long-term environmental consequences of GM crops, including soil degradation and the loss of native seed varieties, further threaten the sustainability of agricultural systems.

Furthermore, GM foods raise ethical and socio-economic concerns, as they disproportionately benefit large-scale farmers and multinational corporations, while small-scale farmers struggle with higher production costs and limited access to alternative seed sources. This imbalance exacerbates rural poverty and undermines food sovereignty. The impact of GM crops on farmers' rights highlights the need for stronger legal frameworks and regulatory measures to ensure that the benefits of agricultural biotechnology are distributed equitably, without compromising the livelihood and rights of farmers. Farmers' Rights Adopting nations are developing IPR regimes to protect breeders and farmers. TRIPS don’t recognise farmers' rights but allows PVP-specific laws.

Sections 39 to 46 deal with it The farmer has the right to breed or develop a new variety and register under this Act and can claim protection over the new variety. The farmer has various rights which include sow, resow, share, sell, exchange, and so on. When he is involved in preserving genetic resources the reward shall be given to him by the gene fund. When varieties like propagating materials have been distributed or sold to farmers, the breeders of that variety must explain the performance of that variety, but when it fails to provide performance as mentioned at that time farmers can claim compensation by appearing before the competent authority. The opportunity is given to the other side to oppose the claim. 3 The Protection can be claimed by the farmer for the innocent infringement done. When the

3 "The Protection of Plant Varieties and Farmer's Rights Act, 2001"

farmer is not aware of the existence right it leads to infringement. The relief-providing court must look into matters placed before and intends to prove it by the innocent infringer. 4 When the breeders develop an essentially derived variety from a Farmer's variety at that time no authorization shall be permitted without the consent of the farmers who have preserved, protected, or developed that variety. 5 Farmers and their groups are exempted from paying fees in any proceedings before the competent authority. 6 The "Gene fund" is constituted by the Central government for crediting compensation, contributions, and so on. 7 UPOV Conventions and Farmers' Rights There have been concerns raised about the protection of intellectual property in the field of agriculture. Historically, farmers in developing nations have had the freedom to keep, share, exchange, and sell farm food and seeds.

However, the implementation of intellectual property rights (IPR) on plant types could jeopardize these rights. The UPOV Act reflects Europe's commitment to ensuring plant breeders' rights, while the FAO International Undertaking on Plant Genetic Resources was renegotiated and ratified as the International Treaty on Plant Genetic Resources for Food and Agriculture. The third amendment to the UPOV Act in 1991 made farmers' privileges optional, allowing them to propagate protected varieties from their crops. However, it was also required that farmers' privileges be limited "within reasonable limits and subject to breeders' legitimate interests. "

REGULATORY FRAMEWORK CONCERNING GM FOODS IN INDIA

(A) The Environment (Protection) Act, 1986 It is the central legislative authority concerning biosafety regulations. The Act under its various provisions as contained under Sections 6, 8, and 25 forms the basis for all other biosafety regulations in India. Under the Act, GMOs and foods are categorized as hazardous substances for which rules and regulations should be laid down.8 This act grants the Indian government

4 Id.$ 42

5 Id.$ 43

6 Id.$ 44

7 Id $45

8 Genetically Modified Food: A Critique of The Existing Regulatory Framework in India DOLLY GUPTAI

the authority to establish rules and regulations to manage environmental hazards. Under its provisions, several key regulations govern the use and release of GMOs, which indirectly affect GM foods. This act also mandates that any activity involving GM organisms, including GM foods, undergo an environmental impact assessment. It specifically empowers the government to issue safeguards and procedures for handling such substances and place the necessary restrictions for their handling in different areas9. Chapter 3 provides for the prevention, control, and abatement of environmental pollution. It imposes a restriction on the handling of any substances considered hazardous under the Act except when the procedure and safeguards as provided have been duly complied with by the person involved in such handling.

10 It also confers upon the Central government the power to make rules for fulfilling the purposes of the Act. 11 Through its provisions on risk assessment, biodiversity protection, and pollution control, the Act provides a legal framework to ensure that the introduction of GM crops does not pose a significant risk to the environment or public health. While the Act does not directly address GM foods, it is instrumental in managing the potential environmental challenges associated with their cultivation, thereby safeguarding the country’s ecological balance. (B) Recombinant DNA Guidelines, 1990 Due to the advancement of biotechnological research worldwide, many institutes and industries in India have shown keen interest in this field. This has made it necessary to regulate the development of these research activities.

As a result, the Department of Biotechnology formulated Recombinant DNA Guidelines in 1990. These guidelines were created to regulate research and development activities on GMOs, transgenic crops, large-scale production, deliberate release of GMOs, plants, animals, and products into the environment, as well as the shipment and importation of GMOs for laboratory research. The guidelines were further revised in 1994. (C) Biosafety Rules, 1989 The Genetic Engineering Appraisal Committee (GEAC), established under the 1989 Rules, is the apex body responsible for approving GM organisms for research, field trials, and commercialization. The GEAC ensures that all biosafety measures are in place before granting

9 Environment (Protection) Act, 1986, sec. 6

10 Id. sec. 8

11 Id. sec.25

approval, conducting risk assessments that consider environmental impact, food safety, and human health. Provisions of the EPA led to the adoption of Biosafety Rules, in 1989. These rules have been given statutory recognition. The rules extend to the whole of the territory of India. It applies to the manufacturing, import, and storage of microorganisms, gene technology products, genetically engineered micro-organisms, cells, and other substances forming a part of such organisms and cells. It has a specific application to the cases relating to the sale, exportation, importation, production, manufacturing, storage, packaging, research, etc of GMOs and drugs, pharmaceuticals, distilleries, tanneries, etc which use microorganisms or GMOs. It mandates the prior approval of the regulatory body called the GEAC for the production and discharge of GMOs or cells into the environment.

12 The 1989 Rules designate several key regulatory bodies for overseeing the use of GM organisms, including GM foods: RDAC - It forms a part of DBT. The committee has been entrusted with the duty to review and recommend expedient safety regulations with respect to development, use and application of genetic engineering at both the national and international levels from time to time. 13 Genetic Engineering Appraisal Committee (GEAC): The apex body responsible for approving GM organisms for research, field trials, and commercial release. It evaluates the environmental and health risks associated with GM organisms. Review Committee on Genetic Manipulation (RCGM): Under the Department of Biotechnology, RCGM monitors ongoing research and development in GM organisms, including their use in food production.

Institutional Biosafety Committees (IBSCs): These committees are established at the institutional level (research institutes, universities, etc. ) to ensure compliance with biosafety rules at the research stage.

12 Biosafety Rules, 1989, Rule 8

13 Genetically Modified Food: A Critique of The Existing Regulatory Framework in India DOLLY GUPTAI

The Biosafety Rules, 1989 are implemented by the competent authorities through various biosafety guidelines. These guidelines aim at reducing the ill effects and adverse impact that GMOs and related substances would have on the environment, human health as well as animals. (D) Biological Diversity Act, 2002 It was adopted by the Ministry of Law and Justice on 5th February 2003 in pursuance of India being a signatory of the United Nations Convention on Biological Diversity, 1992. To achieve the objectives of The Convention on Biological Diversity, India enacted “The Biological Diversity Act, of 2002” to balance intellectual property rights, biodiversity conservation, and species rehabilitation in India. India, being rich in biological diversity, holds sovereign rights over its biological resources according to the “Convention on Biological Diversity”.

IP rights for inventions using Indian biological resources have strict regulations under this Act. In 1992, the Earth Summit in Rio de Janeiro led to the adoption of the “Convention on Biological Diversity”, (CBD). The CBD includes articles with principles for sustainable development, access to genetic resources, and the handling of biotechnology. To ensure fair and equitable sharing of benefits, the “Nagoya Protocol” was established in 2010. Fig: Institutional framework for GM crops Regulation ‘in India14

14 CURRENT LEGAL STATUS OF GM CROPS IN INDIA WITH SPECIAL REFERENCE TO

INTELLECTUAL PROPERTY LAWS Dr. Arun Kumar Maurya, Dr. Ashwini Siwal

CASE LAWS

Diamond v. Chakrabarty (1980) The US Supreme Court delivered a landmark judgment on the patentability of life forms. The case involved scientist Anand Mohan Chakrabarty, who worked for General Electric (GE) and invented a genetically modified bacterium capable of degrading crude oils, with potential applications in cleaning up oil spills. In 1972, Chakrabarty filed a patent for his invention, but it was rejected by the patent examiner who argued that 'living things' were not patentable under Section 101 of Title 35 U. S. C. The Board of Patent Appeals and Interference agreed with the examiner's reasoning, leading Chakrabarty to appeal to the US Court of Customs and Appeals, which overturned the decision.

This led to an appeal in the Supreme Court, which ultimately ruled in Chakrabarty's Favor, stating that a human-made microorganism is patentable subject matter and constitutes a "manufacture" or "composition of matter" within the relevant statutes. Additionally, the Court clarified that newly discovered products of nature are not patentable. This judgment settled the dispute about what is patentable and opened the door for more biotechnology-based research using genetic resources to create genetically modified organisms (GMOs) of plants, animals, or microorganisms. Nuziveedu Seeds Ltd. v. Monsanto Technology Llc (2018) Monsanto developed transgenic Bt II cotton seed by inserting the Cry2Ab gene into the cotton genome and secured process patent rights. Later, Monsanto licensed seeds (donor seeds) of the cotton to seed companies, including Nuziveedu.

The companies then incorporated the traits from the donor seeds into local plants to develop hybrid cotton plants with Cry2Ab and paid royalty to Monsanto. Subsequently, Monsanto terminated the agreement with Nuziveedu over royalty payment issues, but Nuziveedu continued to use the seeds. Monsanto filed a suit alleging infringement of its patent rights, while Nuziveedu argued that Monsanto's claim was invalid on two grounds: first, the Patents Act prohibits a patent on a living organism (transgenic donor seeds); and second, Monsanto had been granted a process patent. The main issue before the Court was whether the process patent granted to Monsanto, resulting in donor transgenic Bt II seeds, was excluded under section 3(j) of the Patents Act.

The court affirmed and held that transgenic plants are not protected under the Patents Act and can instead be registered under the PPVFR (Protection of Plant Varieties and Farmers' Rights) Act. The case is currently

being appealed in the Supreme Court of India.

“BT BRINJAL”

Bt brinjal, also known as genetically modified eggplant, has been altered to include an insecticidal protein sourced from “Bacillus thuringiensis (Bt)”. Bt brinjal was developed by the Indian seed company “Mahyco (Maharashtra Hybrid Seeds Company)” in collaboration with “Monsanto (now part of Bayer)”, “Tamil Nadu Agricultural University”, Coimbatore, and ICAR – “Indian Institute of Vegetable Research”, Varanasi, and several Indian agricultural universities. In 2009, after nearly a decade of field trials and regulatory assessments, the Indian regulatory authority, “The Genetic Engineering Appraisal Committee (GEAC)”, approved the commercial cultivation of Bt brinjal. Commercialization of Bt brinjal may lead to increased reliance on GM seed companies, eroding farmers' traditional seed-saving practices and sovereignty over seeds.

The decision to approve Bt brinjal was opposed by farmers where it leads to environmental impacts, loss of biodiversity, and other health issues. Opponents emphasize the need for more comprehensive safety assessments, transparency in decision-making, and consideration of alternative agricultural approaches. Small-scale farmers have implications in access to seeds, technology, and markets. Bt brinjal (genetically modified brinjal) has not been commercially licensed for cultivation in India. While it received approval from the Indian regulatory authorities for commercial cultivation in 2009, the government imposed a moratorium on its release in 2010 due to concerns raised by various stakeholders, including environmental activists, farmers, and civil society organizations.

Since then, the moratorium has remained in place, effectively prohibiting the commercial cultivation of Bt brinjal in India.

“GM MUSTARD”

GM mustard, specifically a variety called “DMH (DHARA MUSTARD HYBRID) -11”, was developed by scientists at the University of Delhi with support from the Indian government's Department of Biotechnology. The approval for genetically modified (GM) mustard in India was recommended by the “Genetic Engineering Appraisal Committee (GEAC)”.

GM mustard is not popular among beekeepers and honey cultivators, as bees are crucial for agriculture, and mustard flowers are essential for beekeeping. Indian farmers are not in favor of GM mustard as it poses a threat to their cultivation practices. Mustard is not just an oil seed, but also a significant part of Ayurvedic medicine. If GM mustard is allowed, it could lead to significant losses for beekeepers in India, which is the 5th largest exporter of honey. Exporters are also concerned that the “Herbicide Tolerant (HT)”, GM mustard could have a substantial impact on honey production and exports.

SUGGESTIONS

The suggestions for the impact of genetically modified foods and the rights of farmers in the IP regime • The IP Laws must be in a balanced approach to the rights of farmers. • The innocent infringers like farmers shall be safeguarded with their rights. • The opportunity for the farmers and their groups shall be widened because breeders who develop GM crops take away the opportunity of farmers. • Need stronger legal protections for farmers, including enhanced seed-saving rights, compensation for GM contamination, and restrictions on GM patents. • To ensure the rights of farmers, especially small and marginal farmers, a separate law or provisions of the 2001 Act should be revised to establish distinct procedures and criteria for safeguarding farmers' rights and registering farmers' varieties.

CONCLUSION

The risk associated with GM crops and foods cannot be dismissed. genetically modified (GM) foods present both opportunities and challenges for farmers. While they offer potential for higher yields and pest resistance, they also threaten seed sovereignty and increase economic dependency on multinational corporations. Environmental risks like biodiversity loss and cross-contamination further complicate the adoption of GM crops. To ensure the benefits of GM foods are equitably distributed, stronger legal protections for farmers, sustainable

practices, and balanced regulatory frameworks are essential. By addressing these concerns, GM crops can contribute to food security without undermining farmers' rights and environmental sustainability. The developed GM crops have both boon and bane which in turn has an impact on the rights of farmers provided under various legal instruments. The Laws and authorities must be vigilant in providing a balanced approach in matters of commercialization of IP and the rights of farmers.

REFERENCES

1. Current Legal Status of GM Crops in India with Special Reference to Intellectual Property Laws [article]

NUJS

Journal of Regulatory Studies Maurya, Arun Kumar; Siwal, Ashwini https://heinonline.org/HOL/PDFsearchable?handle=hein.journals/nujsjlry6&collection=journ als&section=11&id=55&print=section&sectioncount=1&ext=.pdf&nocover=&grab=G72mG 9657G&uname=christcollege.edu 2. Genetically modified foods: safety, risks and public concerns—a review A. S. Bawa and K. R. Anilakumar https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3791249/?ref=letsgetchecked-blog.ghost.io 3. A Review on Genetically Modified Food and Their Problems Dr. Arminder Kaur and

Krishna Raj Singh https://doi.org/10.55524/ijirem.2022.9.1.43 4. Farmers’ rights and the intellectual property dynamic in agriculture C. Oguamana – Sage Handbook of Intellectual Property, - torrossa.com https://www.academia.edu/download/48754468/Upload_143.pdf 5. Genetically Modified Food: A Critique of the Existing Regulatory Framework in India [article] International Journal of Law Management & Humanities Gupta, Dolly https://heinonline.org/HOL/PDFsearchable?handle=hein.journals/ijlmhs15&collection=journ als&section=201&id=2349&print=section&sectioncount=1&ext=.pdf&nocover=&grab=M72 g08gg62&uname=christcollege.edu 6. New Trend of Patenting Genetically Modified Foods - Its Issues and Regulation [article] Journal of the Patent and Trademark Office Society Mohan, Bhargavi https://heinonline.org/HOL/P?h=hein.journals/jpatos103&i=95