FSSAI notification lacks tests for potential toxicity, allergenicity and checking for long-term effects
A notification by the food safety regulatory body of India Food Safety and Standards Authority of India (FSSAI) over genetically modified organisms (GMO) has received several objections from a pan-Indian citizen’s platform. The experts recommended a list of studies to be added to strengthen the GMO approval process.
The FSSAI, on November 15, 2021, released a draft notification on the food safety and standards for GMOs and sought public comments for consideration by a scientific panel. The time period for public comments was extended by 30 days on January 2 2023.
The Coalition for a GM-Free India is an informal network of scientists, farmers, activists, environmentalists and consumers working to keep India GM Free. The group has opposed the nod to the GM mustard variety Dhara Mustard Hybrid (DMH-11), citing environmental concerns.
Read more: Centre’s response on GM mustard proves regulatory violations, claim activists
Genetic Engineering Appraisal Committee (GEAC), which functions in the Union Ministry of Environment, Forest and Climate Change, approved the environmental release of DMH-11 in October 2022.
The coalition has demanded certain amendments in the draft text. It has also asked for inclusion of tests that were conducted in the case of Bt brinjal.
Form 1A of the notification stated: “This form is applicable for food derived from genome-edited plants of the SDN3 category.” The group wants it to apply to food derived from all genome-edited plants.
It further demanded deletion of the clause, “Where a host other than the transgenic host is used to produce sufficient quantities of the newly expressed protein for toxicological analyses” and “of the non-plant expressed protein with the plant expressed protein” from form 2.5.
The original text in the form read: “Where a host other than the transgenic host is used to produce sufficient quantities of the newly expressed protein for toxicological analyses, demonstrate the structural, functional and biochemical equivalence of the non-plant expressed protein with the plant expressed protein.”
The notification has no definition for sufficient quantities provided, the coalition said. Also, cases exist where newly expressed proteins are produced unintentionally.
Long term and multi-generational tests, as the animals have a short life span, also need to be part of the approval process, it further said.
Apart from protein, fat, carbohydrate and other nutrient and non-nutrient metabolites are also crucial and there need to be ways to check them rather than a subset of cases, it added.
Other demands address the potential allergenicity and toxicity assessments. These tests describe the safety studies to check for potential toxicity or ability to induce an allergy by any new proteins in the GMO with no history of safe consumption.
Read more: Scientists write to PM against ICAR ‘gag order’ on GM mustard
The Coalition for a GM-Free India stated:
Newly expressed proteins, which supposedly show a history of safe consumption, sometimes have not been tested thoroughly. In many cases, tests have been of variable and even sub-standard quality. Hence such historical studies must not be allowed to determine FSSAI’s process.
Tests such as skin irritation test of animals, mucous member irritation on animals, sub-chronic oral toxicity, sub-chronic feeding studies, alkaloid tests, and chronic toxicity and carcinogenicity studies should be added to the process, the coalition said.
Impacts on physiology, hepatic, renal, haematological, immunologic, testicular, pancreatic, biochemical, organ weights and testosterone must also be studied before approval, it added.
Moreover, chronic feeding studies should also be included in the draft, which includes long-term animal feeding studies that will enable us to identify adverse health effects of GMO diet such as organ failure and cancer, the coalition added.
Read more: Activists cite violations of statutory regulations in GM mustard approval ahead of SC hearing
The suggestions also include assessments of growing the GM crop and its non-GM isogenic comparator alongside in the same conditions, bacteria tests and other tests to verify that the plant’s biochemistry has been altered in unintentional ways that pose a danger to human health.
Certain questions need to be added to check where the GM food intended to be produced or imported for India has alternatives and evaluate the consequences if not produced or imported, it said.
It also asked to check for alternatives and legalities and demanded the addition of transport and contingency procedures in case of detection of a health emergency. In the case of imports, GMOs need to be checked if the country is using them and has the necessary certificates to check authenticity.
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The tests suggested by activists for approval of GMOs were conducted in the case of Bt brinjal. Photo: iStock.png)
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