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BIOTECHNOLOGY

Transgenics under the magnifying glass

Over the last 25 years, CTNBio has approved more than 150 genetically modified products for use in Brazil

A soybean field at Bom Retiro farm, in Rondonópolis, Mato Grosso: almost 95% of the farmland planted with grain in Brazil uses genetically modified seeds

Paulo Fridman / Corbis via Getty Images

Every month, a group of 54 specialists from different disciplines meets in Brasilia, where they evaluate technical information that is frequently on the scientific frontiers of genetics and biotechnology. At these meetings they make decisions that, for the past 25 years, have influenced Brazil’s economy and the food and health of its citizens. These experts, with training in areas such as biosafety, biology, medicine, veterinary medicine, and the environment, are part of the National Biosafety Technical Commission (CTNBio), which is responsible for regulating the use of genetically modified products, establishing standards for research, and deliberating about how transgenics will be commercialized in Brazil.

From 1998 through 2019, 152 genetically modified products were approved in Brazil, including plants, vaccines, medicines, microorganisms, and even insects, such as a transgenic mosquito to help combat the spread of dengue (see panel below). Agriculture was one of the economic sectors that benefited most. A survey carried out in 2019 by the International Service for the Acquisition of Agri-biotech Applications (ISAAA) showed that 53 million hectares are cultivated in Brazil using transgenics, second only to the United States, with 75 million hectares. Transgenics account for almost 95% of the planted area of soy, 88% of corn, and 85% of cotton, and are now making advances in crops such as sugarcane and eucalyptus. “It’s practically impossible for a Brazilian to avoid consuming at least some genetically modified plant product every day,” points out agronomist Paulo Barroso, the current president of CTNBio and a researcher at the Brazilian Agricultural Research Corporation (EMBRAPA). “The consumption of the foods that were evaluated by the commission haven’t caused any health problems, which proves the care with which CTNBio’s deliberations were made over the last 25 years.”

The impact has also been widely seen in livestock. CTNBio is also responsible for evaluating the safety of genetically modified vaccines used to immunize hundreds of millions of animals destined for human consumption each year, such as chicken, cattle, and pigs. In recent times the scope of the commission’s work has expanded. In March 2020, the first gene therapy product was approved in Brazil. Developed by the company Novartis, the drug corrects a genetic mutation that leads to blindness.

During the pandemic, the commission convened nine special meetings to review the safety of transgenic-based vaccines against Covid-19. Two vaccines produced by AstraZeneca and Janssen have been approved, while the Russian vaccine Sputnik V is under evaluation.

CTNBio’s role is not limited to assessing whether genetically modified products are safe. The commission’s statutes cite 22 different responsibilities, such as authorizing imports, carrying out risk assessments, and granting biosafety-quality certificates to any institution that researches or produces transgenics. Locations where field research is to be conducted require the commission’s approval in order to prevent contamination to the surrounding area and other undesirable environmental impacts. “While a plant has no legs, it does have pollen and seeds, which can be dispersed by insects, wind, and rain,” Barroso explains.

The agenda for the last plenary meeting, held on April 8, was extensive, with an emphasis on discussions involving the release of a type of drought-resistant wheat and a dengue vaccine. During the pandemic the meetings went to a virtual format. A technological platform needed to be adapted to reproduce normal commission functions according to the rules required in face-to-face meetings. The debates must be open, and all 54 members have the right to speak, but the 27 alternates can only vote if their respective member is absent.

Paulo Fridman / Corbis via Getty Images In Brazil, 88% of the corn planted is transgenic. Now, varieties modified using gene editing tools are beginning to emergePaulo Fridman / Corbis via Getty Images

“The participation of alternates is essential to the committee’s performance. They analyze and report processes, and are at the ready to vote if their respective member isn’t available,” explains Flavio Finardi, a researcher at the Department of Food and Experimental Nutrition at the School of Pharmaceutical Sciences of the University of São Paulo (USP), who chaired CTNBio from 2012 to 2014 and is currently its vice president.

The routine goes beyond the monthly meetings. “The demands of the commission took me at least ten days a month,” says biochemist Maria Sueli Soares Felipe, a retired professor at the University of Brasília, who participated in the commission from 2014 to 2020 and was its president for two years. The members are divided among four subcommittees responsible for analyzing processes in the environmental, plant, animal, and human health fields and referring them to the deliberation of ordinary sessions. Tasks are voluntary, and members aren’t paid. “It is extremely interesting work. The processes involve state-of-the-art biotechnology,” explains Soares Felipe.

CTNBio began operations in July 1996, linked to the Ministry of Science, Technology and Innovations. At that time, inserting genes from one organism into another was opening new horizons in plant breeding, while simultaneously arousing fears regarding long-term health and environmental effects. Aware of the potential for technological innovation, several countries soon regulated the research, while others, notably in Europe, opted for restrictive legislation.

In 1998, an injunction granted to the organization Greenpeace and the Institute for Consumer Defense (IDEC) reduced CTNBio’s reach. The bone of contention was the commission’s authorization of Monsanto’s transgenic Roundup-Ready soybean, which is resistant to the agrochemical glyphosate. In 2005, after the advent of the new Biosafety Law, CTNBio was reestablished with its current configuration. Among its 54 members are representatives from various governmental ministries, researchers in the fields of human and animal health, agronomy, and the environment, as well as specialists in occupational health, consumer rights, and family farming.

The commission’s work continued to be the subject of challenges advanced by environmental organizations and, internally, by members appointed by the Ministries of Environment and Agrarian Development. They held that in the light of any uncertainty regarding its long-term effects, a transgenic product should be vetoed. The concept is based on what’s known as the precautionary principle, which is cited in the Biosafety Law.

Meanwhile, committee members linked to academia and those appointed by the ministries of Science and Agriculture warned that it would be impossible in any scientific endeavor to eliminate every uncertainty. However, they maintained that rigorous risk assessments could prevent problems, thus ensuring the benefits of the technology. “The security they demanded would render any research on transgenics unfeasible and was unnecessary, as demonstrated later,” says biochemist Walter Colli, CTNBio chairman from 2006 to 2009 and a professor emeritus at USP. “Transgenics simply consist of taking a gene from one living being and putting it into another. It is up to the committee to verify whether there will be any problems. And that’s all.”

In the assessment of economist Antonio Marcio Buainain, from the Center for Agricultural and Environmental Economics at the University of Campinas (UNICAMP), the precautionary principle has been misused. “It’s a wise principle, but it needs to be used wisely. Any radical innovation carries risks. If it’s possible to control them, it’s worth going forward. If this concept were taken to the extremes, society today would be without innovations that have saved millions of lives and were important for the march of civilization.”

The clashes at CTNBio echoed an international controversy. According to Buainain, when the first transgenic agricultural products emerged in the 1990s, there was a reaction against the seeds from the multinational corporation Monsanto, which was ahead in the technology race. “In the reading I was doing at the time, that reaction, especially in Europe, had to do with the fear their big companies had about being left behind,” he says. Today, Buainain has a different viewpoint. “What happened was that a coalition of societal interests formed against GMOs and that coalition became stronger in Europe. It brought together environmental organizations, consumer rights groups, and healthy-eating evangelicals around the topic of empowering organic agriculture,” he observes. GMO technology has not been successful in overcoming barriers raised by certain sectors of society. “It’s not enough that the technologies are good. They need to go through a social screening process and in Europe that screen has become rigorous,” he adds.

For agricultural economist Decio Zylbersztajn, from the USP School of Economics, Administration, and Accounting, the way in which transgenic soy was launched broke with market practices and generated controversy. “They created a tie-in selling arrangement consisting of a pesticide and a transgenic seed that was tolerant to it,” he says. Farmers were pressured to pay an additional fee. “Instead of charging royalties on the sale of its seeds, Monsanto identified the use of GM soybeans during the harvest and charged an additional fee for the use of their technology. Producers didn’t like this innovation.” In his assessment, the imperious manner in which Monsanto introduced its technology hindered a balanced discussion surrounding transgenics. One result, he says, was a reaction from consumers, especially in Europe. “Consumers in Brazil and the United States don’t express the same concern as Europeans regarding transgenics. But consumers always have to be respected. You can’t obligate them to buy what they don’t want.”

The view that transgenics can be used safely is shared by the majority of CTNBio members, but the issue is not without contention. Engineer-agronomist Leonardo Melgarejo, from the Agroecosystems Graduate Program at the Federal University of Santa Catarina (UFSC), represented the Ministry of Agrarian Development at CTNBio from 2008 to 2014, and believes certain assumptions regarding the impacts of GMOs remain valid. “When a gene is transferred, it can affect expressions other than the intended characteristics and have long-term consequences that need to be monitored,” he says. Melgarejo states that contrary to what was promised, transgenics have not reduced the use of agrochemicals in agriculture. “We now have transgenic plants that are resistant to various herbicides, and the release of toxic mixtures into the soil about which we have little data,” he adds. In his evaluation, the use of transgenics can produce impacts that have yet to be measured. “Imagine a plant with an insecticidal gene that kills caterpillars. When you plant millions of hectares, the caterpillars and their natural enemies die. Subsequently, these caterpillars may acquire resistance to the poison and find themselves in an environment with few enemies. Then, because the insects don’t die, a higher quantity of insecticide is used,” he says. He also calls attention to the social impacts. “For small farms, buying transgenic seeds imposes an additional cost that’s not offset by an increase in yield. They then end up selling their land to larger, corporate producers.”

Paulo Fridman / Corbis via Getty Images In 2004, the commercialization of the first variety transgenic cotton was approvedPaulo Fridman / Corbis via Getty Images

Melgarejo criticizes the deliberative nature of CTNBio and states that the commission should have an advisory role. “What we have there are scientists, trained in very specific areas, making recommendations that don’t take into account their political and social impacts,” he says. “It’s difficult to sustain a differing stance on the committee. There is broad agreement that they’re working with cutting-edge science, but I find it alarming to contemplate a science that admits no doubt.”

Barroso, the current president of CTNBio, points out that the commission is not given the role of dealing with economic and social issues, but rather with analyzing safety for health and the environment. The National Biosafety Council, composed of ministers of state, is above the agency. The council has been called on only a few times to evaluate CTNBio recommendations and has approved them in each case.

In general, the debates in the committee seek to clarify whether the risk of a GMO is greater than that of a conventional product. Recently, the committee deliberated authorizing a wheat developed in Argentina that is resistant to water stress. There is uncertainty surrounding the possibility that GMO wheat is more allergenic than ordinary wheat. “We concluded that there is no methodology capable of removing this doubt,” says Finardi.

There are practically no cases of requests for commercialization being rejected. When the studies required by the commission produce unfavorable results, the proponents withdraw the cases before their conclusion. Such was the case with glyphosate-resistant sorghum. Because it’s capable of crossbreeding with various types of grasses, it could spread the herbicide tolerance to these species. “This also happened with projects involving citrus, rice, lettuce, sugar cane, papaya, potato, corn, beans, and many other species,” says Paulo Barroso. He adds that only projects whose proofs of concept guarantee safety and have a possibility of becoming a product reach a conclusion. “As long as there’s a lack of information, a product isn’t approved. When data is missing, the company needs to either supply it or repeat their experiments,” adds Maria Sueli Soares Felipe.

The regulation of GMOs in Brazil differs from regulation in other countries of similar size with comparable agriculture. In the United States, there is no committee to assess the biosafety of transgenics. These assessments are carried out separately by the environmental, agricultural, and health agencies. “In the U.S. system, preliminary discussions with companies interested in releasing a new product are institutionalized,” explains Flavio Finardi. They must show that the product has a ‘substantial equivalence’ to the same product coming from natural origins, and that’s sufficient for them to be able to commercialize it—in the event of problems, the creator of the technology is responsible. “Canada follows the same standard, with final approval by the health agency,” he says. In Argentina, there is a commission to evaluate applications, which has the participation of industry representatives among its members.

One of CTNBio’s duties is to monitor the progress of technologies and propose appropriate standards for changing conditions. In 2016, the commission issued Normative Resolution No. 16, establishing that changes in organisms created using gene editing tools, such as CRISPR-Cas9 techniques, do not constitute transgenics and hence don’t need CTNBio approval to be commercialized. Even so, the commission is required to carry out a prior analysis of the products and certify that they are not actually transgenic. In 2018, a plant modified by gene editing was given approval for the first time: a variety of corn that produces only one type of starch, amylopectin. Normal corn produces two types, amylopectin and amylose. Called waxy corn, it’s absorbed more quickly by the body and is used in food supplements.

Agronomist Alexandre Nepomuceno, current chief executive of EMBRAPA Soja, was until last year a representative from the Ministry of Agriculture at CTNBio. He explains that the modifications obtained through the gene editing are so specific that they could be achieved by a natural mutation. “But the CRISPR tool does it quickly and efficiently,” he explains. In his assessment, Resolution No. 16 should help in disseminating effective, less expensive technologies to producers. “The objective is to democratize access to agricultural innovations, something that hasn’t been achieved by commercial GMOs. The cost of obtaining regulatory approval for a plant is very high,” Nepomuceno adds. It’s no coincidence, he observes, that GMO commercialization approvals are concentrated among four large seed companies that have the financial wherewithal to finance the regulatory procedures, and focused only on major commodities such as corn, soybean, and cotton. “Farmers have become dependent on these companies and are required to return a fair amount of what they earn just paying royalties.”

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