GM Food: “Regulatory Vacuum” But Sale Not “Disallowed” says FSSAI

Responding the CSE study, FSSAI says sale of GM foods is not disallowed but there is a regulatory vacuum.

5 min read

Pawan Agarwal, the CEO of the Food Safety and Standards Authority of India (FSSAI), admits there is a “regulatory vacuum” governing food containing material from genetically-engineered (GE) plants. He, however, shares that their manufacture, import and sale in India is not “disallowed.”

Responding the CSE study,  FSSAI says sale of GM foods is not disallowed but there is a regulatory vacuum.
Pawan Agarwal,CEO, Food Safety and Standards Authority of India
Photo: Vivian Fernandes

“The view of the authority is, based on scientific evidence across the world, that there is no verifiable health impact of GM (genetically-modified) food vis-à-via conventional food on humans,” Agarwal told The Quint.

Agarwal made that clarification after the Delhi-based Center for Science and Environment (CSE) published a report at the end of July that of 65 food samples it had examined, 21 had tested positive for GM material and of these, 16 were imported.


Alarm Versus Reality

The CSE report said various brands of imported canola oil, corn kernels, puffs and syrup, tofu, infant feeds and domestic brands of cottonseed oil were found to contain material from GE plants. CSE has raised an alarm, calling their sale without FSSAI approval as “illegal.” CSE’s director-general Sunita Narain was worried about food safety, because “GM food involves taking genes (DNA) from different organisms and inserting them in food crops. There is concern that this ‘foreign’ DNA can lead to risks such as toxicity, allergic reactions, nutritional and unintended impacts.”

The US Food and Drug Administration (FDA) says on its website, that “it is not aware of any information showing that bio engine-ed foods differ from other foods in any meaningful or uniform way, or that, as a class, foods developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding.”

US FDA also does not use the term “genetically modified” when referring to food, because technically, it is the plant that is genetically engineered and not the food. It prefers the phrase “food derived from genetically-engineered plants.”

GE crops have to meet a higher standard of proof for the absence of toxins and allergy-causing substances than those obtained through conventional breeding, before they are approved for cultivation.

Regulatory Vacuum in India

India’s Genetic Engineering Appraisal Committee (GEAC) requires these crops to pass two levels of bio- safety trials in confined conditions before they are recommended for mass cultivation. In India only GE cotton has been allowed to be cultivated since 2002.

The cottonseed oil and meal that India produces is derived almost entirely from cotton that has been bioengineered to kill boll worms. But six centres of the Indian Council of Agricultural Research (ICAR) told a parliamentary committee last year that they did find GE cottonseed or oil cake derived from it harming goats, lamb, fish, chicken or cows.

The manufacture, import and sale of food products derived from GE crops are regulated by the Environment Protection Act. But these are no longer under the purview of the environment ministry, its adviser Sujata Arora said, as the powers have been transferred to FSSAI.

Explaining the regulatory vacuum, Agarwal said the law establishing the authority was enacted in 2006. It became operational in 2011 but till 2016, the environment ministry, through an order, kept the FSSAI’s regulatory powers in abeyance. FSSAI’s scientific committee has now made draft regulations for food containing GM material which will have to be approved by the government before the public comments are invited.


The ‘Label’ Issue

B.V. Mehta, director-general of the Solvent Extractors Association of India, an edible oil industry lobby, said it had applied and obtained open-ended permission in 2007 to import GE soybean oil, in place of six-monthly approvals till then.

Though rapeseed oil imported from Canada, United States and Australia is obtained from GE hybrids and sold in India as canola, Indian law does not require it to be labelled as GM.

The language on the labels it insists on is, “Imported Rapeseed ─ low erucic acid oil. Canola oil. (In addition trade name can also be used.)”

Erucic acid is the substance that gives mustard its pungency, which is why consumers in north and eastern Indian prefer Kacchhi Gani or cold-pressed mustard oil. (Rapeseed is related to mustard). In canola, the erucic acid content has to be less than 2 percent, while in mustard it is 48-50 percent. Lower the erucic acid level, higher is the oleic acid content, which makes it good for the heart, like olive oil. Rupinder Pal Singh Kohli, director of the company that sells Jivo, a popular canola oil brand, said FSSAI’s 2018 draft regulations have proposed labeling when GM material in edible oil exceeds 5 percent by weight. He said Jivo is processed at a temperature of 200-240 degrees centigrade before it is bottled and it unlikely that any GE protein fragments would remain in the oil.


Experts Find Lacunae in Methodology

Deepak Pental, geneticist and former vice-chancellor of Delhi University opposed labeling as it would unnecessarily prejudice consumers against food obtained from GE plants. Pental led the team that developed the GE mustard hybrid, DMH-11, which the GEAC recommended last year for cultivation. But it has not received the go-ahead from environment minister Harsh Vardhan.

Pradeep Burma, professor and head of the department of genetics, Delhi University, said the CSE study “lacks rigor in experimental design and analysis.” The methodology it has used ─ Polymerase Chain Reaction (PCR) ─ is extremely sensitive and can pick up minuscule traces of DNA from all kinds of samples, he said. So robust controls should be in place to ensure it does not pick up contaminants. The manual for the test kit used in the CSE investigation recommends three control reactions: negative control, positive control and extraction control. While negative control has been used there is no extraction control, he said.

Responding the CSE study,  FSSAI says sale of GM foods is not disallowed but there is a regulatory vacuum.
Pradeep Burma, professor and head of the department of genetics, Delhi University
Photo: Vivian Fernandes

Burma said most samples in the study have thrown up similar Ct values. This is not possible because different material – Bt cotton leaf, food containing material obtained from GE plants like corn, and oil derived from transgenic crops – will carry different amounts of transgenic DNA. For example, the Ct value of 27.7 for 35S P (a promoter derived from the Cauliflower Mosaic Virus and found in most GE plants) in Hudson brand canola oil and of 28.5 in Bt cotton leaf does not reflect the expected differences. (Ct value is inversely proportional to the DNA/RNA present in a sample).

The yield of DNA from a transgenic plant where all the cells will have genetically engineered DNA is expected to be much higher than in oil where most of the DNA will get degraded and fragmented in the course of processing. In the CSE study the Ct values of the oil sample show more amount of 35SP DNA in comparison to those in Bt cotton leaf samples.

CSE has been asked to comment on Burma’s comments. This story will be updated when we receive them.

(Vivian Fernandes is editor of This is an opinion piece and the views expressed above are the author’s own. The Quint neither endorses nor is responsible for the same.)

(At The Quint, we are answerable only to our audience. Play an active role in shaping our journalism by becoming a member. Because the truth is worth it.)

Speaking truth to power requires allies like you.
Become a Member
Read More