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No Regulatory Vacuum on GM Food, Says Environment Ministry

Activists proteting against GM food outside FSSAI office in New Delhi. Courtesy CSE.

Is there is a regulatory vacuum as far as GM food is concerned? Pawan Agarwal, CEO of the Food Safety and Standards Authority of India (FSSAI) told this website that there is. But the environment ministry says there was none. It says the GEAC was clearing applications for import of food containing GM material till 2016. But what if the importers did not apply? The GEAC did not chase them not did the FSSAI have the regulations in place. That has given anti-GM activists a reason to say that Indian regulators are casual about the manufacture, import and sale of GM food. Vivian Fernandes reports. This story was first in

The Centre for Science and Environment (CSE) is passing off its detection of material from genetically-engineered (GE) plants in 21 of 65 food samples obtained from Punjab, Gujarat and the Delhi region as a surprise discovery. Sixteen of the 21 samples, it says, were imported. The Delhi-based NGO has raised a health alarm. It also says the manufacture, import and sale of such food is illegal. Both its assertions are wrong.

In 2002, India approved the cultivation of GE cotton made toxic to bollworms with the insertion of a gene from a soil bacterium, whose name is abridged as Bt. Indian regulations for the approval of GE crops are stringent. They are based on international protocols. The process is long and enervating. The crops have to undergo two levels of bio-safety research trials to ensure they are not toxic or allergy-causing and are safe to humans, animals and the environment. Only then does the Genetic Engineering Appraisal Committee (GEAC) recommend approval for their cultivation.

Currently, 96 percent of India’s cotton area is under Bt cotton. The cottonseed oil we consume is almost entirely from GE cotton plants. We have been doing this for about 15 years. So the presence of GM material in Indian food is not novel.  There are also no reported cases of Bt cottonseed oil harming human health. Last year, six institutes of the Indian Council of Agricultural Research (ICAR) told a parliamentary committee on GE crops that they had fed Bt cottonseed and oil meal to fish, chicken, lamb, cows and goats and none of them fell sick or died as a result.

Pawan Agarwal, the CEO of the Food Safety and Standards Authority of India (FSSA) told me there is a “regulatory vacuum” on food containing material from GE plants. But based on available scientific evidence, the view of the authority is that, there is no “verifiable health impact of GM (genetically-modified) food vis-à-vis conventional food on humans.”

FSSAI, which was formed by a law enacted in 2006 is supposed to regulate food derived from bio-engineered plantsl. The act became operational in 2011. But till 2016 the environment ministry kept FSSAI’s powers in abeyance, Agarwal says.

GEAC regulated the use, manufacture, sale, import and export of GE material. It derived authority from a provision under Rules 1989 framed under the Environment Protection Act (EPA). But in 2007, after FSSAI was formed, “GM processed food, ingredients, additives and processing aids,” were exempted from that provision, so long as the end product was not a living modified organism (LMO).

An official in the environment ministry said it has been urging FSSAI to regulate GM food but the latter, lacking capability, was reluctant to do so. Only after the Supreme Court’s direction did FSSAI, in 2016, set up a committee to prepare draft regulations, the official said. These Agarwal says, will be sent “shortly” to the government for approval, after which they will be placed on its website for public comments. The draft also has proposals for labelling.  Food containing GE plant material above 5 per cent by weight will have to be labelled as such.

The environment ministry official said there was no regulatory vacuum. GEAC was doing the regulation till FSSAI took over. B. V. Mehta, Executive Director of the Solvent Extractors’ Association (SEA) of India said it had obtained one-time permission in 2007 from GEAC to import oil derived from GE soybean, in place of six-monthly approvals till them.

Health Minister J P Nadda confirmed this in the Lok Sabha last December in reply to a question from Congress MP Mallikarjun Kharge.  Apart from SEA, he said GEAC had permitted Monsanto Holdings, Bayer Bioscience and BASF to import oil from GE soybean and GE Canola (rapeseed) till 2015.

CSE says it found GM material in samples of imported infant food and packaged corn snacks. From the health minster’s reply it can be inferred that these did not have the approval of FSSAI. If FSSAI had regulations in place and enforced them, anti-GM activists could not have accused it of laxity.

But it is hard to filter out GE material from imported food. Indian cannot be GM free because the world isn’t. The US Department of Agriculture says 90 percent and 82 per cent respectively of the country’s corn planted in 2018 is genetically-engineered for herbicide tolerance and insect resistance. Ninety-four per cent of its soybean this year is herbicide-tolerant. Such high shares of GE crops will be found in Canada, Argentina, Brazil, South Africa and Australia, as well.

The European Union (EU) does not allow the cultivation of GM crops. Anti-GM activists hold it as an example for India. But earlier this year, the EU authorized the import of GM soybean, maize and rapeseed for food and feed, according to ISAAA, an advocacy for GM technology, whose founding patron was Norman Borlaug, the catalyst of the Green Revolution happen. But the EU has strict labelling and traceability laws.

The US Food and Drug Administration (FDA) does not make labelling mandatory.  Its website says: “Credible evidence has demonstrated that foods from the GE plant varieties marketed to date are as safe as comparable non-GE foods.” That being the case, labelling would prejudice consumers against such foods.

The phrase “GM food” is a misnomer. The USFDA prefers “food derived from genetically-engineered plants” as the food itself is not genetically-engineered except, say, Golden Rice which has been fortified with genes obtained from a flower plant and a soil bacterium to enhance its Vitamin A content. But the rice is not available for consumption though Canada has approved it, and Bangladesh has successfully concluded the trials.

This correspondent asked Pradeep Burma, Professor and Head of the Department of Genetics to review CSE’s methodology and data. He said it “lacks rigour in experimental design, and analysis.” The Polymerase Chain Reaction (PCR) method used is extremely sensitive, he said, so it can throw up false positives, if contaminants are not checked. 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.

Burma said most samples in the study have thrown up similar 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. The study, according to him, found more of a promoter (used extensively in GE crops) in oil than in Bt cotton leaf. Oil should have had less of it because DNA will get degraded and fragmented  in the course of processing.

Burma’s comments were given to CSE for comment on 8 August. Its reply will be added when received.

(Top photo: Activists protesting outside the office of FSSAI in New Delhi demanding a ban on GM food. Photo credit: CSE).

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