Agnes Asagbra is the Director-General and CEO of the National Biosafety Management Agency (NBMA). She is the former director of the Federal Institute of Industrial Research (FIIRO), Oshodi, Lagos. Asagbra holds a doctorate degree in food and industrial microbiology from the University of Ibadan, Nigeria’s premier university. In this interview with the Abuja BusinessDay Media team led by John Osadolor, managing editor, and Patrick-Okwoli, correspondent, Asagbra explains her plans to restructure the Biosafety Management agency into one of the top five biosafety institutions globally, as well as ensure the safe use of genetically modified organisms (GMOs) to avoid adverse impact or risk to human health.
Excerpts:
Talk us through the mandate of the National Biosafety Management Agency.
The National Biosafety Management Agency (NBMA) came into existence in April 2015 with the mandate to provide a regulatory framework and institutional and administrative mechanisms for safety measures in the application of modern biotechnology. We regulate modern biotechnology, which is the scientific tool used to alter the gene composition or include a new gene in another organism to effect a particular change. Scientists felt that there was a need for this technology to be regulated so that it would not be abused or used for the development of organisms that would be harmful to human health and the environment. The NBMA also ensures that the processes of modern biotechnology and the use of genetically modified organisms (GMOs) do 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. So this establishment is to ensure that these institutions carry out their activities without coming out with products that will have negative effects on people and the environment. Biotechnology is not static; our Act had to be amended to include things to ensure that measures are in place for biosecurity, which refers to the measures taken to ensure that harmful biological viruses, bacteria, and other microorganisms are not maliciously used to cause harm. Mind you, biological agents cause diseases like Ebola and COVID-19, and the goal of biosecurity is to minimise or avoid those biological threats.
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“The essence of this agency is to ensure that these GMO products are modified in such a way that they don’t cause harm.”
What is the difference between biotechnology and biosafety?
Biotechnology is simply the use of microorganisms to process raw materials in order to get better materials. You have the basic biotechnology, which includes things like fermentation, which is how we get beer, alcohol, and all that. But then, modern biotechnology uses molecular biology. Biosafety is the set of laws, policies, regulations, guidelines, practices, and procedures that you use to ensure that the processes you are adopting for biotechnology are safe for human health, animals, plant life, and the environment. That one is a process. So, we are a regulatory agency dealing with biosafety. It is the policies, guidelines, and instruments that you use to make sure that the processes of modern biotechnology do not have adverse effects on human health, animals, plants, or the environment.
Many people seem to oppose the use of genetically modified organisms (GMOs), even though science says they are safe. As a regulator, how safe are GMOs for human consumption?
As I said earlier, NBMA is a regulatory agency, and we regulate the practice of modern biotechnology, including GMOs, whether they are imported or exported. In biology, there are processes, and there are certain experimental processes that must take place. So, as a regulatory body, if anybody wants to carry out an experiment or import a GMO, we have to certify it safe. If it is something we know about—something that has been certified—then we know it is safe. So, they are the ones that NBMA will say, ‘Yes, we know of this’, and it will not have any adverse effect on human health, plant life, animals, or the environment. Having said that, there is no product in this world that you can say is entirely safe. Everything has the potential to cause harm. The essence of this agency is to ensure that these GMO products are modified in such a way that they don’t cause harm. Before we certify any GMO product as safe, we carry out what we call a risk assessment. We have the competence to do that. We do not make a blanket statement that GMOs are safe. We look at each product on a 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 approved or that are currently undergoing experimental processes are the ones we are confident about. The essence of regulation is to ensure that these products are safe.
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Do you think that the acceptance of GMOs will address the food insecurity bedevilling the nation?
Nigeria is institutionalising GMOs. Our responsibility is to ensure that they are safe, and no matter how viable they are, if there are risks and management strategies to address them, we may allow them with some conditions. But if not, we reject it. It is not about how good it is, but how safe it is. And yes, it can address food insecurity. We have approved for commercial production BT cotton, Tela maize, and then PPR cowpea. So, there are certain problems that these crops usually have with farmers. About 70–90 percent of Tela Maize or PPR Cowpea may have maruca. It is an insect-like worm. At that larva stage, it ravages the seed, the cow pod, so that by the end of the farming period, you do not have anything. Also, during a drought, it is able to cool off where there is so much water. So you could lose all your crops, but with modern biotechnology techniques, all these can be handled. There is this soil microorganism called Bacillus thuringiensis, or BT. This organism is in the soil and can affect maruca; it will impede it so that it does not affect the crop. So scientists tried to get the BT; they sprayed it on the crop, but it was not effective enough. You know, during the rains, it is washed off. So, they needed something more useful and effective. In every organism, whether human, plant, or animal, there are genes. So that is what scientists did: this toxin that is producing this thing, let us put it in the gene of the seed, so that when it grows, automatically it will kill it off.
In biotechnology, for alcohol production, the yeast secretes alcohol. So alcohol is also used as an antiseptic, but in this case, you put it in the gene of the crop. We have already approved these three as germ-tolerant, insect-resistant, or, regarding some of the soil’s adverse production, as having immunity against them. Definitely, if insects do not ravage it and the farmer has more yield, it will lead to food security.
Which GMO products has the agency certified as safe?
They are BT cotton, PPR cowpea, and tela maize that we have granted approval for commercial purposes after going through rigorous analysis. Commercialization means it can now be brought into the market. The cowpea has been modified for insect resistance. So far, we have not found any reason to classify it as harmful. So, we have approved it. We also approved Tela Maize, which is under experimentation too. These approvals were granted with the hope that they would not cause any harm. However, at the end of the experiment, the products will be subjected to more risk analysis. Toxicity and allergy analyses will be done, and during the process of these trials, environmental safety checks will be conducted. It is a long process. It goes through rigorous assessments in the laboratory. When the gene is to be inserted, we are there to regulate it; we have protocols that must be followed.
After we move from the laboratory, we will do what we call a confinement draft, and then we go for environmental release, for farmers to plant it; if they refuse to plant it, then it will affect another person’s farm. We also check for nutrition; is it going to cause allergies? Is the nutrition as good as the conventional ones? Will it have things that are not supposed to be there? We do rigorous assessments when we are analysing what scientists bring to us. It is not just this agency; we have experts who are up and doing; you cannot be a judge in your own area. We have experts all over the country whom we invite, and then we have two committees. One is the National Biotechnology Committee, which is headed by a professor. If it is for Tela maize, we go for an expert; if it is for cowpea or cotton, we do the same thing. So, we just do not take everybody; if we say an expert, it has to be a professor in that field. We also have some international bodies that we consult.
What are the criteria and processes involved in certifying a GMO product as safe?
The major thing that we prevent is the risk to human health. The two important things we check in this regard are if the GMO product is allergic 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 consumed, it will become toxic to people to the point that they will start having reactions that may lead to serious ailments 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 a non-target effect. We also ask the companies what kind of trait they are inserting in the GMO seeds and how it performs in the organisms. We evaluate where the gene is coming from, its history, and how many years it has been in use. We also look at the socio-economic importance of these products. Will they become a trade problem between Nigeria and other countries? Will they be accepted in peculiar locations in the country? These are some of the things we check. We recently held a meeting with stakeholders, where a lot of issues were raised, including whether it was safe. With so many people saying it causes cancer, we needed to have a stakeholder meeting in order to enlighten the populace. We had to tell them that this is what is happening. Those who attended the meeting included scientists, regulators, promoters, and developers. We said, Let us talk; let us see the grey areas, and I believe that our ministers were quite in support of it. Four ministers were in attendance and gave their speeches. I believe that the president will be happy about this because food security is one of the priorities of his administration.
Are you saying that such fears are unfounded?
The ones that we have certified are safe. But you know that our borders are porous, and people travel out of the country. Don’t they eat where they travel? I do not know what they eat there, so you cannot say it is what we are doing here. But for the three that we certified, yes, they are safe. I cannot say for others. We have done thorough work.
What is your vision for the NBMA and your achievements so far?
I would like to appreciate and commend my predecessor, Dr. Rufus Ebegba.
He laid the foundation for this project with regard to regulations, guidelines, instruments, safety policies, and protocols. So, I am to sustain and ensure further implementation of the project. Like I said earlier about biosecurity, the action plan we have is from 2022 to 2026. Late last year, we started the implementation of biosecurity. We know what happened to us during COVID. We did not have measures to ensure the biosecurity of our nation. Also in the area of biosafety, we are second in Africa. Other countries have come to meet us to find out how we are doing it, and we have taught them and helped them build their systems to become better. So, part of the vision is to ensure that we are number one and even in the top five in the world.
Can you give a breakdown of the procedures involved in applying for approval, either for confined field trials, shipment, or commercialisation of GMO products?
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 the necessary information is there, we will acknowledge it and start processing it. An application must be acknowledged within 270 days, according to law, but it is 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 provide. Some people think that we have to wait 270 days to grant approval, but that is not how it works. For instance, when we receive an application for confined field trials, we advertise it in three national newspapers so that members of the public can, within 21 days, critically review the application and send in their opinions, observations, and objections. While we are receiving comments from them, we will constitute a National Biosafety Committee of Experts and a technical subcommittee. The two committees will work differently and come up with their own positions on the application, while we at the agency will do critical research on the seed and the firm seeking approval. After the 21 days given to the public to respond, we will now look at all the responses that came in, synthesise them, and then the committees will look at all the things we have gathered. They will communicate their findings to us so as to make the final decision. If the application scales through, we will put it on our website and even on the United Nations website. 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 to spread things that can cause harm to humans. The world stands against Ebola, so if these innovations (GMOs) are dangerous, the world will also stand against them. The essence of biosafety is to ensure that these technologies are not abused and wrong things are not produced.
What have been the critical challenges in carrying out these roles?
NBMA believes that nothing is impossible and that it can overcome obstacles and break down barriers. However, funding has been a constraint throughout the agency’s existence. Despite this, it has tried to make the most of the limited funds available to it over the years. Another challenge is the propaganda intended to distract it from its mission. Although this was initially a challenge, the agency now recognises that it is a sign of its growing relevance. Another issue is the fact that our Act permits us to be at the borders, but at the moment we are not there. So, it is difficult for us to know when some GMOs come into the country without our notice.
How does the Biosafety Management Agency partner with or relate to the agencies it regulates?
As a regulator of the sector, our partnership with most Ministries, Departments, and Agencies (MDAs) in Nigeria has been great. NBMA has one of the greatest outreaches in the areas of partnership, relationships, and synergy. We have a Memorandum of Understanding (MoU) with quite a number of MDAs, and we do not carry out any activity without carrying them along. Within the agency, we have manpower; like I said, nobody studies biosafety at the university. At least, when people come in, there is room for training. As a matter of fact, we have in-house training, and each department has its own regular training. We have training from stakeholders within and outside the country so that we can be up-to-date with modern trends.