Deceptive IRRI strategy to get Golden Rice approved

On March 7, 2019 the director general of the International Rice Research Institute, Dr Matthew Morell visited Bangladesh Rice Research Institute. He discussed with the director general Dr Md Shahjahan Kabir on ways and means to strengthen collaboration on some frontier technologies and projects such as Golden Rice, C4 Rice, Zinc Enriched Rice, and Transforming Rice Breeding etc.
In the next few days, Dr Morell visited other institutions such as Krishibid Gobeshona Foundation at the Bangladesh Agricultural Research Council and ACI Agribusiness. He also met the prime minister Sheikh Hasina at the prime minister’s office. His visit received wide media coverage mostly in the English dailies of the country. Indeed it was a high level visit by the IRRI chief. 

IRRI activities to earth the approval of Golden Rice started in January 2019 as the application for approval was lodged to the ministry of environment in November 2017. On January 30 2019, the agriculture minister Dr Abdur Razzak told journalists after a meeting with International Rice Research Institute that ‘Golden rice, a new variety of rice enriched with Vitamin A will be available soon in Bangladesh’. He said, ‘A committee of the environment ministry will give clearance to the rice for production. We will be able to start cultivation in Bangladesh within two to three months upon getting the clearance.’ He further said ‘Golden rice is more important than other varieties as it will help fight Vitamin A deficiency. The rice variety has already got clearance in USA, Canada and Australia.

This visit of Dr Mathew Morell in March was indeed a step forward to push the process of approval of Golden Rice. Since the announcement of the agriculture minister announced about the potential approval in March, there have been protests and concerns by environmental and farmers groups not only in Bangladesh but also at international level.

The Dhaka Tribune published an exclusive interview of Dr Mathew Morell. He said ‘both Bangladesh and the Philippines have taken the vitamin-A enriched ‘Golden Rice’ varietal development to an advanced stage now. Once the last steps of the bio-safety regulatory process are completed, he hoped vitamin-A enriched rice would hit the market and address to a large extent, the acute problem of vitamin-A deficiency.’

In another interview with the Daily Star he said the variety (Golden Rice) has got approval from regulatory agencies from the US, Australia, New Zealand and Canada. It is currently going through the regulatory process in Bangladesh and in the Philippines. He also responded on concerns related to Golden Rice, and said ‘the IRRI has very rigorous criteria for releasing the variety. This is why we went to go through the regulation process in the US, Australia, Canada and New Zealand. These are some of the toughest regulatory agencies in the world and Golden Rice met the criteria set by them.’ 

According to the Daily Star report the application for approval for commercial release was lodged to the National Committee of Biosafety in November, 2017. IRRI DG remarked, ‘It’s about 15 months. They are examining the dossier. So, we would hope that they will make their decision in the coming months.’

The agricultural minister expected that the clearance will be given by March, 2019. So far, there has been no media report about the clearance. In March 2019, Bangladesh Environmental Lawyers Association using the Right to Information Act lodged an application to the ministry of environment seeking more information on the issue; the response was that since this is still under experimental stage, the ministry cannot provide any information on the status of the approval.

The IRRI chief, Dr Matthew Morell in his exclusive interview to the Daily Star has made several misleading statements regarding the Golden Rice approval from regulatory agencies in USA, Australia, New Zealand and Canada. Referring to approval from regulatory agencies in the developed countries is irrelevant for Bangladesh and the Philippines. This reference is also meant to influence, rather mislead, the National Committee of Bio-safety of Bangladesh. 

Rice producing countries of Asia, such as the Philippines, where International Rice Research Institute is situated could not introduce the field cultivation of this rice because of concerns from the environmental groups, while non-rice producing countries such as USA, Canada and Australia have given the clearance. It is indeed ironic. Bangladesh being a rice producing country with huge population of rice-eaters, known as ‘Bheto Bangalee’ has no relevance to the clearance in the non–rice producing developed countries. 

Since there have been protests against the Golden Rice worldwide, particularly in the Philippines and Bangladesh, over last few years and concerns about its safety were expressed, Dr Mathew addressed the issue creating more confusion. He said ‘the IRRI has very rigorous criteria for releasing the variety. This is why we went to go through the regulation process in the US, Australia, Canada and New Zealand. These are some of the toughest regulatory agencies in the world and Golden Rice met the criteria set by them.’ It gives an impression that the IRRI went to these agencies seeking approval for cultivation of Golden Rice in these countries. This is far from the truth and is meant to deceive the common people and the policy makers in Bangladesh on the issue that if developed countries like USA, Australia, New Zealand and Canada can give regulatory clearance for ‘cultivation/commercial release’ of Golden Rice, why can’t Bangladesh, especially when the country’s National Committee of Biosafety is evaluating the issue of commercial release of golden rice since November 2017. Should the National Committee on Bio-safety decide only on the basis of what the non-rice producing countries are doing, or it should take into consideration the bio-safety issues applicable to Bangladesh? If that is the case, then why did NCB decide to approve Bt Brinjal in 2013, despite the fact that India and the Philippines did not approve it on environmental considerations? 

The international organisation, GRAIN has revealed the truth about the regulatory clearance in Australia and New Zealand. IRRI had made an application (A1138) to the Food Standards Australia New Zealand on November 16, 2016 requesting a variation to Schedule 26 in the Australia New Zealand Food Standards Code (the Code) to include food from a new genetically modified (GM) rice (Oryza sativa) line, GR2E. According to the approval report dated December 20, 2017, the Golden Rice (GR2E) is not intended for commercialisation in Australia or New Zealand i.e. neither for growing or intentional sale in the food supply. The applicant (IRRI) has however applied for food approval because it is possible the rice could inadvertently enter the food supply via exports from countries that may supply significant quantities of milled rice to Australia or New Zealand. So approving this crop will prevent trade disruption should GR2E be inadvertently present in imported shipments of milled rice. The report further says that the uncooked GR2E paddy or brown rice could not be imported into Australia or New Zealand without an environmental approval from the Office of the Gene Technology Regulator in Australia or the Environmental Protection Authority in New Zealand because the presence of the embryo means the rice could be germinated i.e. would be regarded as a viable genetically modified organism. 

The FSANZ approval report does not stop here. It further says that the whole rice and unrefined rice products derived from line GR2E would be required to carry the mandatory statement ‘genetically modified’ on the label of the package of food. This labeling requirement will apply to rice sold as a single ingredient food (e.g. a package of rice) and when the rice is used as an ingredient in another food (e.g. rice flour, rice milk).

Similarly, GRAIN also revealed the truth about the United States Food and Drug Administration regulatory approval to Golden Rice. It explicitly states that GR2E rice is not currently intended for cultivation or marketing and not intended for human or animal food uses in the United States. The FDA letter (dated 24 May 2018) to the IRRI clearly indicates that the Manila based International Rice institute submitted its documents to FDA (on November 14, 2016) for a ‘consultation’ on safety and nutritional assessment of GR2E (Golden Rice) with the FDA’s Centre for Food Safety and Applied Nutrition and Centre for Veterinary Medicine. The FDA says, ‘although GR2E rice is not intended for human or animal food uses in the United States, when present, it would be a producer’s or distributer’s responsibility to ensure that labeling of human and animal foods marketed in the United States, meets applicable legal requirements’. In fact FDA clearance, which Mr. Morell cites, rather questions the nutrient content in Golden Rice when it says, ‘although the concentration of Beta-carotene in GR2E rice is too low to warrant a nutrient content claim, the beta-carotene in GR2E rice results in grain that is yellow-golden in color.’ 

 
The so-called ‘clearance by the regulatory agency in Canada’, as boasted by the IRRI Director, is actually just an opinion from the Food Directorate, Health Products and Food Branch, Health Canada on the ‘food use’ of Provitamin A Biofortified Rice Event GR2E (Golden Rice) because it is possible that raw commodity or food products derived from GR2E rice may unintentionally enter Canada via imports from countries of production. As per the Novel Food Decisions dated March 16 2018, the Health Canada received a submission in 2017 to allow the sale of Golden Rice as food. The technical summary of this case clearly point out that if IRRI, in future, has an interest in selling golden rice in Canada, compliance with the Food and Drug Regulations regarding the addition of vitamins to foods would be required.

Another important point to mention here is that in all these cases where Golden rice has got clearance from the ‘toughest regulatory agencies in the world’, the decisions have been taken based on the data supplied by the IRRI and these foreign agencies have probably not conducted any field study or environmental studies on the golden rice. And it is mainly because the golden rice is not meant for cultivation or use as seeds in any of these countries which granted its approval. And it gets established by the fact that in all these countries the IRRI applied in 2016 and 2017 and within few months of the application, the approval in the forms of an opinion was granted. 

It is quite disgraceful that director general of IRRI is using the Bangladesh media to deceive the people and the policy of Bangladesh by presenting a half-truth about the regulatory clearance on golden rice in USA, Canada, Australia and New Zealand. 

This shows that the IRRI is desperate to get clearance in Bangladesh for commercial cultivation. They do not care about the potential risks it poses for the country and the major crop rice. It is also a threat to all other rice producing countries. Taking advantage of ‘weak’ regulatory agency and influencing of the authorities with misleading facts in unethical.
It is also very surprising that IRRI is showing more interest in getting it approved than the applicant organisation Bangladesh Rice Research Institute. It is IRRI which is trying so hard for the approval using Bangladeshi regulatory agencies on GMOs. Why?