Brazil is a continental country, being the 5th largest in extension. Aligned to a significant availability of natural resources and favorable weather, the country is one of the greatest powers in agriculture in the world. In the last 40 years, grain production alone increased over 5 times, reaching a mark of over 250 million tons in 2020 1. In this scenario, modern agricultural practices combined – such as better adapted plant varieties, more effective crop protection, plant nutrition products, high-tech machines, and equipment – made possible a more sustainable usage of natural resources, allowing an expressive increase in production, while using the same agricultural areas. And the leading role of biotech crops in this successful achievement is undeniable, notably considering traits that facilitate their management, such as herbicide tolerance and insect resistance.
Despite the troubles considering the legal uncertainty with biosafety issues at the time, the cultivation of biotech crops was implemented in Brazil in the early 2000s, with an herbicide-tolerant soybean variety. In 2006 and 2008, the cultivation of Genetically Modified (GM) cotton and maize, respectively, was also established and ushered in a new era in Brazilian agriculture. Now, more than 20 years later of the first GM harvest, the benefits of using biotech seeds in agriculture are diverse. This success is evidenced by the adoption rate of over 90% for row crops and a cultivated area exceeding 52 million hectares, being the 2nd largest in the world – after the USA, which accounted for over 71 million hectares (ISAAA, 2019) .2
Following a strict and distinguished regulatory pathway, genetically modified seeds in Brazil must undergo a biosafety approval by the National Technical Commission on Biosafety (CTNBio) prior to other specific registrations and commercialization. Throughout its 25 years of existence, this Commission has already approved 216 events of biotech crops, including maize, soybean, cotton, sugarcane, eucalyptus, and wheat – this last one exclusively for food use3. Herbicide tolerance and insect resistance traits (either alone or stacked) are present in over 90% of the approved events.
But the biosafety approval by CTNBio is one of the last regulatory steps for commercializing and planting Genetically Modified Organism (GMO) crops in Brazil, especially for events with herbicide tolerance traits. In this case, field trials with regulated events require authorization first from CTNBio, to grow the GMO crop, and then from the Ministry of Agriculture (MAPA), the Brazilian Health Regulatory Agency (ANVISA), and the Brazilian Institute of Environment and Renewable Natural Resources (IBAMA) to test an herbicide in the new GMO crop.
On CTNBio’s side, field trials with regulated GMOs, which are not yet approved for commercialization, are categorized as ″Planned Release into the Environment″, or LPMA (Portuguese acronym), and are regulated under Resolution No. 06/2008 and, more recently, under Resolution No. 35/2021, in a simplified procedure for known events with previously approved confined field trials. Planned Releases into the Environment are designed to assess the potential effects of the GMO on other organisms, such as target and non-target organisms and soil microorganisms, as well as other features of the plant biology, such as nutritional equivalence and stability of the genetic modification throughout generations.
Planned Releases into the Environment must be conducted under controlled conditions defined in the legislation, that aim at reducing the risks associated with the unintentional dispersal of the GMO, according to the characteristics of the plant. For example, maize trials should be submitted respecting the following: I) spatial isolation, containing borders with at least ten lines or seven meters of non-genetically modified maize, or genetically modified maize approved by CTNBio, around the experimental plots, and keeping a minimum distance of 200 meters of other commercial and experimental maize plantations; and/or II) temporal isolation, containing borders with at least 20 lines or 14 meters of non-genetically modified maize, or genetically modified maize approved by CTNBio, around the experimental plots, and respecting a minimum period of 40 days between the flowering dates of the Planned Release into the Environment and other commercial and experimental maize plantations. In case the experimental area is located next to the cultivation of maize landraces, spatial and temporal isolation must be applied. To that, other specific biosafety measures should be attended, such as grain traceability and plant destruction after harvesting.
So far, besides maize, CTNBio has also established isolation conditions for Planned Releases into the Environment with soybean, cotton, sugarcane, sorghum, eucalyptus, and citrus, which also consider specificities of the biology of each crop. For citrus and eucalyptus, special attention is devoted to the proximity of beekeeping establishments, and confined field trials with these crops should be installed at least one kilometer apart from Apis mellifera beehives and three kilometers from beehives of Tribe Meliponini.
In addition, to obtain the authorization for the Planned Release into the Environment, the requester must have a Biosafety Quality Certificate, an accreditation granted by CTNBio, which certifies that the institution and its staff are qualified to perform activities with GMOs. If the trial is conducted in third-party fields, such as Contract Research Organizations (CROs), they also must be accredited by CTNBio with a Biosafety Quality Certificate.
On the side of MAPA/ANVISA/IBAMA, a Brazilian company must request an Experimental Use Permit (EUP or RET, in Portuguese) to test any new crop protection product or any new recommendation for an already registered product. The herbicide that will be tested on the new GMO crop needs an EUP since its application in this crop is considered off-label use.
To obtain the EUP, the requester must present some information about the product and the official technical opinion issued by CTNBio. An experimental project is also required, describing locations, area size, total of applications, and the total amount of product necessary to perform all the trials. Usually, the EUP is valid for 3 years.
For the registration dossier of the crop protection product, in general, the basic agrochemical legislation requires the registration of the end-use product and the corresponding Technical Product (TP or TGAI). To prepare a registration dossier, besides all the information and several GLP laboratory studies and data demonstrating the product’s safety for human and animal health and the environment, it is also necessary to perform local efficacy and residue trials with the formulated product. Usually, three efficacy trials per weed species and four residue trials per crop are required, both performed in different representative agroecological regions for the crop. Additionally, all the components (ingredients) used in the formulation must be registered, presenting the corresponding Safety Data Sheet (SDS) and disclosing the name of the manufacturers.
After having all data and studies available, the registration dossier can be submitted to the authorities. The whole registration dossier has basically three sections and they must be submitted at the same time to the three Ministries: Agriculture (MAPA), Health (ANVISA), and Environment (IBAMA).
The estimated time for the deliberation of a registration process of regular agrochemical products is about 5 years, from the date of the dossier submission, considering the government is not going to ask for any additional complex requirements. This deadline is mainly due to a large number of processes in the evaluation queue waiting for analysis. Thus, one of the most important points that the company must comply with is the quality of the dossier to be submitted, aiming at reducing as much as possible the possibility of receiving complex requirements from the authorities, which will demand more time for the company to meet them and also for the government to analyze it or even, with the chance of having the process rejected due to the lack of documents, studies and information.
For biopesticide products (biologicals, pheromones, biochemicals, natural PGR, and plant extracts), there is a fast-track queue, based on its low toxicity profile, and the registration process approval can take about 10-12 months. Also, some requisites could be waived, such as the need for registration of the technical product and residue trials. However, until now, there is no biopesticide product registered as an herbicide in Brazil, and, for sure, the market is looking forward to having it available!
Vigna Brasil Group is a 26-year-old CRO working as a facilitator in Brazil and worldwide, rendering services as a ″one-stop-shop″. Acting as a full-service provider, Vigna Brasil offers all kinds of support, from the establishment of a legal entity in Brazil, obtaining company licenses and product registrations (Regulatory Affairs), providing strategic and operational affairs and market intelligence studies (Business Intelligence), executing and managing field trials performed with crop protection products, fertilizers, inoculants, and GMO (Field Management). After obtaining all the pertinent licenses and registrations, Vigna Brasil can also provide support in keeping the company and product in full operation, maintaining all the mandatory documents and reports in force.
1 Croplife Brasil – Atlas do Agronegócio Brasileiro, 2021.
2 ISAAA. 2019. Global Status of Commercialized Biotech/GM Crops in 2019: Biotech Crops Drive Socio-Economic Development and Sustainable Environment in the New Frontier. ISAAA Brief No. 55. ISAAA:Ithaca, NY.
3 CTNBio - http://ctnbio.mctic.gov.br/