FSSAI guidelines on GMO Crops

Context:

FSSAI issued an order on February 8 setting the permissible limit for genetically modified organisms (GMO) in imported food crops at 1%.

• However, trade organizations have said that this threshold is unacceptably high.
• It amounts to an advocacy for zero presence of GMO in food and some other consumables.

GMO regulation in India:

In India, genetically modified organisms (GMOs) and the products thereof are regulated under the “Rules for the manufacture, use, import, export & storage of hazardous microorganisms, genetically engineered organisms or cells, 1989” (referred to as Rules, 1989) notified under the Environment (Protection) Act, 1986. These Rules are implemented by the Ministry of Environment, Forest and Climate Change, Department of Biotechnology and State Governments though six competent authorities. The Rules, 1989 are supported by series of guidelines on contained research, biologics, confined field trials, food safety assessment, environmental risk assessment etc.

The definition of genetic engineering in the Rules, 1989 implies that new genome engineering technologies including gene editing and gene drives. May be covered under the rules. India is a signatory to the Cartagena Protocol on Biosafety (CPB), however, the definition of modern biotechnology, as in CPB is yet to be adopted in the national regulations. The regulatory authorities review and take into account the experience by other countries in dealing with new technologies. However, there is yet no clarity on how the emerging technologies will be dealt with in India, though research has been initiated in several leading institutions.

The task of regulating GMO levels in imported consumables was initially with the Genetic Engineering Appraisal Committee (GEAC) under the Union environment ministry.

Its role in this was diluted with the enactment of the Food Safety and Standards Act, 2006 and FSSAI was asked to take over approvals of imported goods.

An overview of biosafety regulations is presented below:

Rules, 1989

In India, Ministry of Environment, Forest and Climate Change (MoEFCC) introduced the Environment (Protection) Act, 1986 as an umbrella legislation to provide a holistic framework for the protection and improvement to the environment. Thereafter, a series of Rules were notified to address various problems such as hazardous chemicals, hazardous wastes, solid wastes, biomedical wastes, etc.

In connection with the use of micro-organisms and application of gene technology, the MoEFCC notified the “Rules for manufacture, use/import/export & storage of hazardous microorganisms/genetically engineered organisms or cells, 1989” as per powers conferred by Sections “Regulation of Genome Engineering Technologies in India”, 8 and 25 of Environment (Protection) Act, 1986. These rules are very broad in scope essentially covering entire spectrum of activities involving GMOs and products thereof. They also apply to any substances, products, and food stuffs, etc., of which such cells, organisms or tissues hereof form part. New gene technologies apart from genetic engineering have also been included. The gene technology and genetic engineering have been defined as follows in the text of the Rules, 1989.

1. “Gene Technology” means the application of the gene technique called genetic engineering, include self-cloning and deletion as well as cell hybridization.
2. “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 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.

Rules, 1989 are implemented by MoEFCC jointly with the Department of Biotechnology (DBT), Ministry of Science & Technology and state governments. Six Competent Authorities and their composition have been notified under these Rules that includes:

1. rDNA Advisory Committee (RDAC)
2. Institutional Biosafety Committee (IBSC)
3. Review Committee on Genetic Manipulation (RCGM)
4. Genetic Engineering Appraisal Committee (GEAC)
5. State Biotechnology Coordination committee (SBCC)
6. District Level Committee (DLC)

While the RDAC is advisory in function, the IBSC, RCGM, and GEAC are responsible for regulating function. SBCC and DLC are for monitoring purposes.

GM techniques are used in:

1. Biological and medical research,
2. Production of pharmaceutical drugs,
3. Experimental medicine (e.g. gene therapy),
4. Agriculture (e.g. golden rice, Bt cotton etc.),
5. Genetically modified bacteria to produce the protein insulin,
6. To produce biofuels from some GM bacteria, etc.

Genetically Modified Crops in India

Bt Cotton, Bt Brinjal, GM-mustard etc.          

Controversies and Moratoriums associated with GM Crops in India – Timeline

• 2002 – Bt cotton introduced in India.
• 2006 – Activists filed a PIL against GM crops in the Supreme Court.
• 2010 – The then environmental minister Jairam Ramesh blocked the release of Bt Brinjal until further notice owing to a lack of consensus among scientists and opposition from brinjal-growing states. No objection certificates from states were made mandatory for field trials.
• 2012 – Parliamentary standing committee on agriculture, in its 37th report asked for an end to all GM field trials in the country.
• 2013 July – New crop trials have been effectively on hold since late 2012, after a supreme court-appointed expert panel recommended suspension for 10 years until regulatory and monitoring systems could be strengthened. Though the SC panel suggested moratorium on GM trails, there was no official verdict from the Supreme Court on this issue.
• 2013 July – Environment minister Jayanthi Natarajan put on hold all trials following SC panel suggestions.
• 2014 – Her successor, Veerappa Moili cleared the way for trails. (NB: Two of Manmohan Singh’s own environment ministers had stalled GM trials earlier, but Veerappa Moily took an opposite stand and the process of approving the one-acre field trials restarted.)
• 2014 March – GEAC (UPA government) approved field trials for 11 crops, including maize, rice, sorghum, wheat, groundnut and cotton.
• 2014 July – 21 new varities of genetically modified (GM) crops such as rice, wheat, maize and cotton have been approved for field trials by the NDA government in July 2014. The Genetic Engineering Appraisal Committee (GEAC) — consisting mostly of bio-technology supporters — rejected just one out of the 28 proposals up for consideration. Six proposals were rejected for want of more information.
• 2016: GEAC gave green signal to GM Mustard for field trial, but SC stayed the order and sought public opinion on the same.
• There are as many as 20 GM crops already undergoing trails at various stages.