On October 14, The Reporters’ Collective published the investigation into how the Union government removed the requirement for a health warning label on chemically fortified rice, based on spurious expert opinion.

Though The Collective sent detailed queries on October 10 to the Department of Food and Public Distribution, the Ministry of Health and Family Welfare and to the Food Safety and Standards Authority of India, none of them responded before publishing the investigation, despite repeated reminders. But three days after the report was published, the Union government responded with a rebuttal.

In its rebuttal, the Union government has asserted that “claims” made in the report “lack merit” and are “completely baseless”. It has further alleged that the article fails “to reflect the comprehensive scientific assessments and regulatory processes involved”. The full text of the rebuttal by the Union government can be read here.

The Reporters’ Collective stands by its investigation and all the assertions made in the report, which are based on official records that have been made public.

We are publishing the government’s rebuttal along with The Collective’s response.

Background

The Collective in its recent investigation, Modi Gov’t Produces Spurious Expert Opinion To Remove Health Warning on Fortified Rice, showed how the government set up a committee to review the need for warning labels on gunny sacks carrying fortified rice. This review came amid a Supreme Court case calling for amplifying the safety regulations for the fortified rice, which is supplied to an estimated 66% of the country’s population under welfare schemes.

Fortified rice is regular rice that is ground into powder, mixed with iron, vitamin B12 and folic acid, and then shaped back into rice grains using a machine. These artificial grains, called fortified rice kernels, are blended with normal rice.

In 2021, the Prime Minister announced that fortified rice would be mandatorily supplied under all government-run welfare schemes by 2024. This included meals supplied to infants, children, pregnant women and lactating mothers.

The Collective has been publishing investigative reports exposing the conflicts of interest and risks of the scheme since May 2023. We have previously shown, based on official documents, how the scheme was launched despite internal warnings that the move was “premature, and the fact that the pilot projects launched to test the rice’s nutritional impact had failed. Top officials had asked the government to look into possible “adverse effects” of iron fortified rice on the people, especially children, but the government pushed ahead and launched the scheme.

Government claim 1: “Recent media articles have raised concerns about the labelling of fortified rice products, particularly regarding the absence of health advisories for individuals with Thalassemia and Sickle Cell Anemia….these claims lack merit, are completely baseless and fail to reflect the comprehensive scientific assessments and regulatory processes involved.”

The Collective’s response: The Collective’s investigation is based on the documents that the Union government has filed in the Supreme Court in response to a case filed by a civil society organisation. The activists of the organisation challenged the government’s decision to supply fortified rice on the grounds that crores of poor people are not being adequately and properly warned about its impact. The petitioners called for better safety measures for people suffering from diseases such as thalassemia and sickle cell anaemia because they are advised not to consume iron since they are at risk of ‘iron overload’ in their body. The incidence of these genetic diseases is high among India’s tribal population. 

The government began looking into the safety of the fortified rice scheme a year after the cabinet had already approved universal supply of the rice under welfare schemes. First, a white paper from the Institute of Nutrition, a research institute affiliated with ICMR, pointed towards possible risks to people with the genetic diseases and suggested that the warning labels stay on. This was followed by an internal report of the Department of Food and Public Distribution which suggested to the contrary: warning labels can be done away with since no other country mandates them.

To overcome the problem of two conflicting conclusions, the government set up a committee with a three-week deadline to review the need for warning labels. This committee noted that some sections of society were indeed at risk but dismissed it as a “very small proportion” of population. It spoke to US FDA’s India officials who informed the Director General of ICMR that the US does not mandate warning labels since people with diseases such as thalassemia and sickle cell anaemia would be advised by their doctors to not eat food fortified with iron. The committee noted this as a key piece of evidence to finally recommend doing away with warning labels.

Every single piece of information we have reported is based on the government’s own submissions.

Government claim 2: These articles also suggest favouritism towards a single manufacturer of Fortified Rice Kernels (FRK) or premix suppliers…these claims lack merit, are completely baseless and fail to reflect the comprehensive scientific assessments and regulatory processes involved.

The Collective’s response: The Collective has never used the word “favouritism” in its recent or earlier investigations on fortified rice. However, we presented evidence showcasing conflicts of interest in how the scheme was launched in the first place.

In one of our articles published on May 24, 2023, we showed how a network of global NGOs linked directly and indirectly to Dutch multinational Royal DSM had been involved in every stage of the fortified rice scheme.

Royal DSM manufactures and supplies the premix powder used in fortification. Its India-registered company is among the top premix suppliers in the country. They played a part in the initial advocacy, finalised the scheme’s details such as quality standards, supervised pilot projects and were even part of a special committee set up by the government’s food safety regulator to oversee the government policy on fortified rice. One of the NGOs, with ties to DSM, even informed the Union government that it had been funded by the Dutch government specifically to push fortification in India.

One of Royal DSM’s top officials told Indian media, “We are very thankful that Prime Minister Modi’s government has mandated the fortification of rice, at least in the social safety nets part of the rice pipeline in India”. 

Within 18 months of Modi’s announcement, Royal DSM set up a 3,600-tonne capacity fortified rice kernel plant in Hyderabad. Its top official had told The Print that Royal DSM is working with the Indian government, NGOs and rice millers in India to expand its production. 

More recently, members of the Prime Minister’s Economic Advisory Council have admitted that one of the main drivers of the policy are international donors and NGOs.

Government claim 3: The regulatory processes followed by FSSAI, in collaboration with top scientific institutions, have been rigorous and transparent.

The Collective’s response: The conduct of Food Safety and Standards Authority of India or FSSAI belies this claim.

One, the FSSAI created the Food Fortification Resource Centre in partnership with global NGOs to act as a one-stop resource centre for the public. However, once our investigation on conflict of interest was published last year, it removed all references of NGOs from the resource centre website. The website no longer cites the research papers that the government used to justify the fortified rice scheme after it was exposed that many of the research papers were linked to NGOs advocating fortification.

Govrnment claim 4: Based on global scientific review, the committee found no evidence suggesting that iron-fortified rice poses a health risk to individuals with these conditions (thalassemia and sickle cell anemia).

The Collective’s response: Even the committee that finally recommended doing away with warning labels noted that some people are at risk. “For a small proportion of the population that has thalassemia intermedia, increased iron absorption from food may be of some concern. These patients may need monitoring for iron overload and chelation as required.”

The government’s rebuttal omits any mention of the ICMR-NIN white paper we reported on. This paper, submitted first to the Ministry of Health in June 2023, clearly recommended that the warning labels should continue. It also recommended that both fortified and unfortified rice be distributed under the public distribution system. 

However, when this paper was published online in December 2023, it was wiped clean of any references to warning labels altogether. Its recommendation on supplying unfortified rice was done away with as well.