Genetically Modified Crops Biosafety Concerns and Regulations

Over 30 years ago, plant genetic engineering technologies were created, and since then, genetically modified (GM) or transgenic crops have been commercially accessible and extensively embraced in many countries. One or more genes coding for desired features have been introduced into these plants. The genes might come from the same plant species or from completely different organisms. The qualities sought through genetic engineering are frequently the same as those sought by traditional breeding. However, because genetic engineering allows for direct gene transfer across species borders, several formerly difficult or impossible-to-breed features may now be generated very easily.

Herbicide-resistant crops (soybeans and maize), pest resistance, and other features have been enhanced in first-generation GM crops (Cotton and corn). Second-generation GM crops have increased nutritional content and better quality features. One of the earliest GM crops, “Golden Rice,” is biofortified to combat vitamin A deficiency. Corn, sorghum, cassava, and banana plants have also been biofortified with added minerals and vitamins. Crops can also be genetically engineered to resist plant viruses and fungus. Even though the seed is more expensive, these GM crops save production costs by lowering the amount of machinery, fuel, and pesticides used. Reduced spraying of chemical pesticides and extremely toxic herbicides has important environmental benefits, such as limiting farm runoff that might otherwise poison water systems.

Countries are now authorising several genetically modified crops for commercial release and agricultural production, thanks to fast advances in agricultural biotechnology research and development. According to ISAA, 189.8 million hectares of biotech crops were planted by up to 17 million farmers in 24 countries in 2017, the 21st year of commercialization of biotech crops. The 189.8 million hectares planted in 2017 represents a 112-fold growth from the inaugural planting of 1.7 million hectares in 1996, when the first biotech crop was introduced.

Though it is widely claimed that transgenic crops hold great promise for addressing some of the world’s most pressing issues, they, like all new technologies, come with risks. Transgenic crops can bring together new gene combinations that are not found in nature, potentially causing harm to human health, the environment, and non-target species. Concerns have been raised concerning the possible hazards connected with transgenic crops’ influence on human health, the environment, and biological diversity as more transgenic crops are issued for field testing and commercialization.

Biosafety concerns

Concerns have been raised about possible hazards to human health and the environment as more transgenic crops are issued for field testing and commercialization. Biosafety refers to the concepts, processes, and regulations that must be followed in order to protect the environment and people. Recognizing the importance of biosafety in GE research and development, 167 nations, including 165 United Nations countries, Niue, and the European Union, have signed the Cartagena Protocol on Biosafety (CPB), an international multilateral agreement on biosafety. The Protocol went into effect on September 11, 2003, with the following major goals:

1.Establishing guidelines for the safe trans-border transport of live modified organisms

2. Through the Biosafety Clearing House, harmonise risk assessment concepts and methods, and create a framework for information sharing (BCH).

Prior authorisation from the country’s competent regulatory authorities is required for research on GE and GMOs. It is necessary to follow the specified rules in order to avoid biosafety risks. The Institutional Biosafety Committee (IBSC) or its similar entity, made up of specialists from many fields, is the key regulating body at the research institute level. The IBSC guarantees that the basic biosafety equipment necessary for the studies to be undertaken is available. Biosafety is becoming more widely recognised by researchers, manufacturers, and consumers of GMOs, administrators, policymakers, environmentalists, and the general public across the world. Transgenic crops are neither poisonous nor do they have a high likelihood of spreading in the environment. Specific crops, on the other hand, may be detrimental due to unique combinations of characteristics. As a result, the risks connected with the usage of GMOs might vary substantially depending on the gene organism combination, necessitating a case-by-case approach to risk assessment and management.

The major biosafety concerns falls into these categories:

Bio-safety of human and animal health

1.Toxicity risk owing to the product’s nature or changes in the metabolism and composition of the organisms as a result of gene transfer.

2.Newer proteins in transgenic crops derived from creatures that have not been used as foods have the potential to become allergies.

3.Antibiotic resistance genes employed as selectable markers have also prompted concerns about their transfer to microbes, potentially worsening health issues caused by antibiotic resistance in disease-causing organisms.

Ecological concerns

1.For features affecting resistance, gene flow due to cross pollination might result in the establishment of tolerant or resistant weeds that are difficult to remove.

2.GM crops have the potential to deplete biodiversity and contaminate vulnerable plant species’ gene pools.

3.Farmers have replaced indigenous types with monocultures, which has resulted in genetic loss.

Environmental concerns

1.Effect of transgenic plants on target and non-target pest population dynamics, secondary pest issues, insect sensitivity, evolution of novel insect biotypes, environmental influence on gene expression, insect resistance development, herbicide resistance development

2.Accidental cross breeding of GMP plants and traditional kinds through pollen transfer can infect traditional local varieties with GMO genes, leading in the farmers’ traditional variety being lost.

Public attitude

Consumer reactions are influenced by their views on the hazards and advantages of genetically modified foods. The media, individuals, scientists and administrators, politicians and non-governmental organisations (NGOs) are all responsible for informing the public about the benefits of genetically modified foods.

Socio economic and ethical consideration

1.Consumers and farmers might gain from this. As the seed industry grows, emerging countries may become reliant on a few providers.

2.Gene Use Restriction Technologies (GURT) is an acronym for Gene Use Restriction Technologies. Under the PPV & FRA, 2001, India has outlawed the use of GURT in plant variety registration.

Regulatory Mechanisms in India

Biosafety rules involve risk assessments as well as the policies and processes in place to guarantee that biotechnology applications are environmentally safe. The following regulations and guidelines make up India’s regulatory framework for transgenic crops.

a) Rules and policies

Rules, 1989 under Environment Protection Act (1986)
Seed Policy, 2002

b) Guidelines

Recombinant DNA guidelines, 1990
Guidelines for research in transgenic crops, 1998

The Ministry of Environment, Forests and Climate Change, as well as the Government of India’s Department of Biotechnology, are the two major authorities charged with enforcing the restrictions. The regulations also specify the authorities that will handle various parts of the rules, as well as their composition. According to the regulations, there are six competent authorities.

Recombinant DNA Advisory Committee (RDAC)
Review Committee on Genetic Manipulation (RCGM)
Genetic Engineering Approval Committee (GEAC)
Institutional Biosafety Committees (IBSC)
State Biosafety Coordination Committees (SBCC)
District Level Committees (DLC).

Out of these, the three agencies that are involved in approval of new transgenic crops are:

IBSC – set-up at each institution for monitoring institute level research in genetically modified organisms.
RCGM – set-up at DBT to monitor ongoing research activities in GMOs and small scale field trials.
GEAC – set-up in the Ministry of Environment, Forests and Climate Change to authorize large-scale trials and environmental release of genetically modified organisms.

DBT’s Recombinant DNA Advisory Committee (RDAC) monitors biotechnology advancements on a national and international level and makes appropriate suggestions. State Biotechnology Coordination Committees (SBCCs), which are established in each state where GMO research and application are being considered, coordinate GMO-related activities in the state with the federal government. SBCCs have monitoring responsibilities and so have the authority to inspect, investigate, and take corrective action in the event of noncompliance. Similarly, at the district level, District Level Committees (DLCs) are formed to oversee the safety requirements at facilities that employ GMOs in research and application.

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