11 June 2018

Nigeria: How We Certify, Approve Genetically Modified Food in Nigeria - DG Biosafety Agency

Photo: Pixabay

Rufus Ebegba is the Director General of the National Biosafety Management Agency (NBMA). His agency is responsible for regulating biotechnology and Genetically Modified Organisms (GMOs). Basically the agency rejects or approves GMOs and its activities in Nigeria.

There has been a protracted debate over the application of genetically modified crops into the food system of the country. These debate has birthed two groups, pro-GMO and anti-GMO. The former is for while the latter is against the application.

Mr Ebegba's agency has been accused of bias on the burning issue. Chief among the criticisms leveled against the agency is that it does not 'consider' opinions of Nigerians before granting approval to GM products.

NBMA in 2016 issued two permits for GM cotton, and the confined field trial of maize, to Monsanto Agriculture Nigeria Limited. This move came despite concerted efforts of many Nigerians (comprising 100 groups of farmers, faith-based organisations, civil society groups, students and local farmers) to prevent the introduction.

In this interview with PREMIUM TIMES' Ebuka Onyeji, Mr Ebegba explains how the agency handles opinions of Nigerians on GMOs. He took questions on the various concerns raised about their operation. He further gave a breakdown on procedures involved in seeking or granting approvals for GM activities in the country as well as how the agency ensures the safety of GM products among other sundry issues.


PT: What is the responsibility of NBMA with regards to regulating Bio-safety and Biotechnology in Nigeria?

Ebegba: The National Bio-safety Management Agency was established under the NBMA Act 2015. In 2002 there was a national committee to draw up the framework on bio-safety in Nigeria and the first draft of the bill was sent to the government. In 2011 it was passed but not yet assented to, then it was like a transition period. It was however passed in April 2015 and the president assented to it. The act carries along the mandate to implement and ensure that NBMA regulates modern biotechnology which is the scientific tool used to alter the gene composition or include a new gene into another organism to effect a particular change. The scientists felt there was need for this technology to be regulated so that it will not be abused or used for the development of organisms that will be harmful to human health and environment. With the act, NBMA ensures that the processes of modern biotechnology and the use of Genetically Modified Organisms does not have any adverse impact or risk to human health. Nigeria has adopted science and technology as one of the major tools to enhance the economy.

Nigeria has established institutions that produce modern biotechnology products. We have the National Biotechnology Development Agency (NABDA) which was established to ensure that biotechnology is the hub of our economic drive. They promote research and develop products that can enhance economy both for agriculture, health and industrial raw materials. We also have about 156 agricultural research institute and universities that will be producing GMOs. So the establishment of this agency is to ensure that these institutions carry out their various activities without coming out with products that will have negative effect on the people and the environment.

PT: As a regulator, how would you rate the safety of GM foods and Products?

Ebegba: There is no product in this world that you can say is entirely safe. Everything has a potential to cause harm. The whole essence of this agency is to ensure that these GM products are modified in a way that they don't cause harm. Before we certify any GM product as safe, we carry out what we call risk assessment, we have the competence to do that. We don't give a blanket statement that GMOs are safe. We look at each product on case by case basis. If eventually the outcome of our assessment shows that the product is safe, then it is safe. The products we have so far approved as safe, and are undergoing experimental processes, are the ones we are confident about. The essence of regulation is to ensure that these products are safe so anyone we say is safe we will be sure they are actually safe.

PT: Can you explain the processes involved in certifying a GM product as safe?

Ebegba: The major potential fear about GM products we prevent is the risk to human health. The two important things we check in this regard is if the GM products are allergenic and or toxic in nature. We check whether the product will have allergens that might have adverse effects like rashes and burns on humans. We also look at the toxicity of the product. If when consumed, whether it will become toxic to people to the point that they start having reaction that may lead to serious ailments and or even death. We have to prevent this. From the environmental aspect, we check if the organism when exposed to the environment will displace other organisms that are related or if it will cause non-target effect. We also ask the companies the kind of trait they are inserting on the GM seeds and how it performs in the organisms. We evaluate where the gene is coming from, its history, how many years it has been in use. We also look at the socioeconomic importance of these products. Will it become a trade problem between Nigeria and other countries? Will it be accepted in some peculiar locations in the country? These are some of the things we check.

PT: Can you name some GM products the agency has certified as safe?

Ebegba: They are the ones we have granted approval for. Like the GM cowpea which is under experimental fields since 2009 even before the existence of the agency. I was involved in the approval when I was in the ministry of environment. The cowpea is modified for insect resistance. So far, we have not found any reason to say it has caused any harm, so we have approved it. We also approved GM rice which is under experiment too. These approvals are granted with the hope that it will not cause any harm. However, at the end of the experiment, the products will further be subjected to more risk analysis. The toxicity and allergenity analysis will be done and during the process of these trials, environmental safety check will be conducted. It's a long process. I told you that GM cowpea has been on the field since 2009 and it is still at experimental field level after which it will be ready for commercialization. But before that, we will still do another rigorous analysis. Commercialisation means it can now be brought into the market.

PT: But available information shows that your agency has approved for the commercialisation of the BT cowpea you are talking about and BM cotton for 2018. Is that so?

Ebegba: Well, I will not say 2018 because it is when we finally grant approval for commercialisation that we can really be specific. The approval for BT cotton and cowpea has been an ongoing issue. We are still collecting data. Before the seeds can be certified safe for commercial release, they will undergo in depth safety analysis. BT cowpea (beans) will be compared with our normal home grown beans. We will profile the content inside the both of them. We are yet to release the seeds to the environment. Seed companies seeking approval from us will still meet the requirements of other government agencies such as the National Seed Council, Standard Organisation of Nigeria (SON), NAFDAC etc.

PT: Can you give a breakdown of the procedures involved in applying for approval, either for confined field trials, shipment or commercialisation of GM products?

Ebegba: If you want to carry out confined field trials, there is a form that you will complete. We will look at it critically and when we see that all necessary information are there, we now acknowledge and start processing it. An application must be acknowledged within 270 days according to the law but it's not a must that we wait till the end of 270 days. An approval can be granted in a week, a month or two months depending on how fast we are able to certify the seeds brought in by the company and the information they provided. Some people think we have to wait till 270 days to grant approval but it is not how it works. For instance when we receive an application for confined field trials, we advertise it on three national newspapers so that members of the public within 21 days can critically review the application and send in their opinions, observations as well as their objections. While we are receiving comments from them, we will constitute a National Bio-safety committee of experts and a technical subcommittee. The two committees will work differently to come up with their own position on the application while we at the agency will do a critical research on the seed and the firm seeking approval. After the 21 days given to the public to respond, will now look at all the responses that came in, we synthesize them, then the committees will now look at all the things we have gathered. They will communicate their findings back to us for us to take the final decision. If the application scaled through, we will put it on our website and even on the UN website that we granted such approval. While we do this, we also get information from the Food and Agriculture Organisation (FAO), and the World Health Organisation (WHO). The world has become a global village and will not allow people spread things that can cause harms to humans. The world stood against Ebola, so if these innovations (GMOs) are dangerous, the world will also stand against it. The essence of bio-safety is to ensure that these technology are not abused and wrong things are not produced.

PT: In giving the public 21 days' notice to comment on the application, some Nigerians argue that the agency is more eager to grant approvals and does not respond to comments and concerns raised, how would you react?

Ebegba: When we receive comments about an application from the public, we look at it critically, we subject it to different analysis. We even do literature review on it. Is it scientifically feasible? Is it valid? If it's valid then we use it as a basis for taking decision. We have management strategies to address it. First, we will brief the seed company seeking approval on the concerns raised. They will have to go back and address these concerns. But the truth is that most of these comments are made without facts. In the whole world, nobody has died from eating GMOs because rigorous steps are taking to make sure they are safe. This is based on scientific verifiable evidence. You also put into cognizance the socioeconomic importance of the product or the economic consequence if it is released to Nigerian farmers. When people say that Nigerian farmers will suffer with GMOs, can they protect the farmers more than the government? How many of them are farmers?

When they bring those complaints, it's not for us to start replying or engaging them, we will only tell you we have received your comments and be rest assured that it will guide our decision making process and we also assure you that our decision will be in the best interest of the people. At the end we still give reasons for granting any approval. Even if we are to respond to each comment one after the other, it's not possible to respond word for word, clause by clause. It is not done in administration. We only tell you we received your comment. Assuming your points are very flawed that they don't even show any scientific evidence and we write to you that your points are baseless, it will lead to altercations. We use administrative language to respond to some of these comments and remember we receive complaints, criticisms as well as compliments but we don't respond point by point. We investigate what you are saying, we look at the validity of what you are saying. If it is backed with enough facts and evidence, then we use it for taking decision.

PT: So are you saying that in issues relating to GMOs, opinions of Nigerians are well sort?

Ebegba: Very well sort. We make analytics from opinions of Nigerians. Those that criticise GMOs with other motives don't come to our office to get information. They just sit down in their office and write to the minister of health and the presidency just to mount pressure on us.

PT: Your agency has been criticised for promoting GMOs instead of sticking to regulation, how would you react?

Ebegba: The impression some people have is that this agency is established to stop GMOs but we are here to ensure that GMOs are safe to humans and the environment. People will always complain. It is just like INEC, if your party wins election you will say INEC is doing very well; but if they lose, you say INEC should be scrapped. They criticise us when we don't meet their expectations. Our mandate is to ensure the safety of these products. When you look at it, how many permits have we even granted? We don't grant permits anyhow. So far, we have not rejected any application even though we delay some of them if they don't meet necessary requirements. The truth is that there is a trade war going on and this agency is the only one with the power to allow or prevent GMOs so those who are against this technology for sure will not be happy with us because we granted some permits which is very clear. The question is what is their interest? You think if all these complaints they are making are true, the whole world will keep quiet? We have not even started consuming GMOs officially so there is no cause for alarm.

PT: If we start consuming and using GMOs 'officially' how would it impact on our economy and agricultural system?

Ebegba: Nigeria is institutionalising GMOs, our responsibility is to ensure they are safe and no matter how viable they are, if there are risks and there are management strategies to address them, we may allow them with some conditions. But if not, we reject. It is not about how good it is, but how safe it is.

PT: There are a lot of challenges with our agricultural system? Is there no other alternative to tackle them other than GMOs?

Ebegba: There are various approaches to this. From our own point of view, modern biotechnology is an intervention tool in areas that conventional ways cannot address. Applying GMOs does not mean all the problems are solved. The GM rice and maize which are going through trials in Nigeria have been modified for the use of less nitrate. The negative impact of nitrogen is that they form nitrous oxide which is one of the greenhouse gases causing climate change that leads to ozone layer depletion. If farmers will not benefit from GM products, we won't approve them.

PT: People have this other concern that GMOs will monopolize the seed market and further push the conventional agricultural system into extinction?

Ebegba: The current hybrid system is the same thing with GMOs. There is no seed that is still the way it is from creation. Science has altered them. We have a gene bank at Ibadan where we store and secure our indigenous conventional seeds. The way we handle hybrid is the same thing with GMOs. The conventional crops and system will coexist with GMOs. They only complement each other.

PT: What is your take on labelling of GM products? Do you think it will work in Nigeria considering our socio-cultural diversities, literacy level among others?

Ebegba: We already developed regulations on labelling and packaging of GM product as well identification. We developed it to make sure that every product is labelled in line with a particular pattern depending on the product. The woman in the village takes her drugs according to prescription through labelling. We cannot survive without science and technology.

PT: The agency - like you said is an unbiased umpire on GMOs and Biotechnology. You are the first director of this agency. Can you highlight your experience, successes and constraints on the job so far?

Ebegba: One of the major constraints is that there is still a lot of information gap and also a lot of misinformation. This is a new evolving technology. Sometime ago, we partnered with customs to repatriate a ship of about 90 thousand metric tonnes of maize. This is a new organisation and we are laying the foundation. In doing so you must understand that there are some peculiar problems particularly with the way the economy is right now.

Funding has not been very adequate. Government has tried to put the agency into the budget system so we are getting some funding to run our office. Another constraint is that we want our officials to be in the borders to assist in checking any food product entering the country. We need to work hand in hand with other agencies in monitoring what comes in. Some of the dealers of GMOs bring in things in to the country without our knowledge that is why we have an MOU with agencies such as Customs, SON, NAFDAC, Seed Council etc. to make sure we work with them. We also have issues of staffing and building capacity. This is a new technology that is advancing and we need to keep up.

We want Nigerians to know we have the necessary competence to protect them from the adverse impact of Biotechnology. Whatever we consider safe, they should have confidence in us that they are safe. There is no cause for alarm. We will take responsibility for any adverse effect.


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