The transformation of Brazil into an agricultural powerhouse is relatively new. In the 1970s the country was a net importer of food. [Ref 1].
The route to its transformation lay in legumes. Soybean was the key crop – its cultivated area increased from around 6.8 million hectares in the 1970s to 38.26 million hectares in 2021 [Ref 2], paving the way for inoculant development in Brazil. Inoculated soybean area in the 2017-18 growing season was 26 million hectares, equivalent to 78 percent of the total soybean area grown. More recent data showed that 85 percent of the soybean-growing area in Brazil is inoculated. [Ref 3].
Another driver was the reliance on imported fertilizer. As well as demonstrating the efficacy of biological nitrogen fixation (BNF) provided by inoculants, the research was also geared towards showing the economic benefit of not importing such large quantities of nitrogen (N) fertilizers. BNF provided by inoculants provided a more cost-effective alternative, particularly for soybeans. One academic paper stated that Brazil saves approximately US$7 billion per year due to benefits of BNF. [Ref 2].
Inoculant emergenceThe catalyst for inoculants were nationwide experiments from the 1960s that revealed the prevalence of yellowing plant leaves among the N-poor soils. A national soybean commission pinpointed BNF as an important trait, and this started research efforts to find the best strains to interact with localsoybean genotypes.
A key figure in this research effort was a female scientist from Czechoslovakia – Dr. Johanna Döbereiner – who studied inoculants in Brazil during the 1960s. She led the research at the then National Agronomic Research Service's Institute of Ecology and Agricultural Experimentation – the forerunner to Brazil’s agriculture research organization Embrapa. [Ref 4].
The Brazilian Soybean Improvement Program incorporated the study of BNF based on Döbereiner’s work with rhizobium bacterium. [Ref 5]. The BNF is so efficient that “attempts to increase grain yields by adding nitrogenous fertilizers are not successful in plants effectively inoculated with the recommended Bradyrhizobium strains.” [Ref 2].
Taking the strain Commercial inoculants were brought to Brazil, mainly from the U.S. and Australia, but these often failed because of inappropriate storage, delays in custom clearance and strain-variety interaction. [Ref 6]. This prompted the development of domestic strains, which are authorized for production by Ministry of Agriculture, Livestock and Supply (MAPA).
Four strains dominate the use in commercial inoculants: Bradyrhizobium japonicum strains SEMIA 5079 (=CPAC15) and SEMIA 5080 (=CPAC7), and Bradyrhizobium elkanii strains SEMIA 587 and SEMIA 5019 (=29W). Inoculants can carry one or two of those strains in a single product. [Ref 2].
It has been shown that “the four strains can supply all plant’s needs of the cultivars available today, allowing yields of up to 5,000 kg/ha with rates of BNF as high as 300 kg N/ha and providing from 69 to 94 percent of total plant N. Benefits due to the release of N to the following (year’s) crop have also been reported.” [Ref 7].
The usage also spread beyond soybeans to non-leguminous plants. Azospirillum species have demonstrated plant growth promoting properties. In 2009, the first commercial inoculant carrying the plant-growth-promoting Azospirillum brasilense strains Ab-V5 and Ab-V6 went on the market. “One decade after the release of these two strains, 10.5 million doses were commercialized for grasses, including corn, wheat, rice and pastures of Brachiaria grass, andco-inoculation of legumes, such as soybean and common bean.”[Ref 2].
Legal footingThe starting point for biologicals from a regulatory viewpoint can be traced to Brazil’s fertilizer law # 6894 from 1980. The fertilizer law provided for a biofertilizer category [Ref 8] that was then regulated by decree #4954 in 2004.
As well as norms on specifications, registrations, packaging and labelling, these two pieces of legislation set the terminologies down for inoculants and biofertilizers. Inoculants were defined as products containing microorganisms that have a favourable impact on plant growth. Biofertilizers are defined as “products containing an active ingredient or organic agent free from agrochemical substances capable of acting directly or indirectly on all or part of cultivated plants, enhancing their productivity (yield), regardless of their hormonal or stimulant value.” [Ref 9]. The definition for biofertilizer would later have implications for biostimulants.
The legislation of 2004 was updated in 2010 with the 30/2010 Normative Instruction that established the methods for official analysis for inoculants. Normative 53/2013gave accreditation to CROs to perform trials and produce reports on new products.
Moraes and Azevedo argued that the law from 1980 and the decree from 2004 did not provide instruction or regulatory guidelines to facilitate the registration of products under the biofertilizer category [Ref 8]. In addition, Moraes and Azevedo stated that the Normative Instruction No.53 from 2013 required new products or technologies to be validated by official research institutions and have conclusive results published
in an English-written scientific magazine, making the validation process even more difficult,they concluded.
In 2016, Moraes and Azevedo wrote:“Biofertilizers are part of the legislation since the publication of the first Fertilizer Law in 1980; however, there are no products registered under the biofertilizer category in Brazil since 1980.”
Setting standards Production of inoculants in Brazil had reached an industrial scale even by the 1960s. [Ref 6]. For the industry to grow, there needed to be standards to provide quality assurance for growers.
Inoculants contain plant growth promoting bacteria PGPB, or rhizobacteria PGPR. Quality control was a priority with official control established in 1975. The initial standard was 107 cells per gram, a concentration that would supply 7,000 cells per seed. [Ref 6].
In 1982, MAPA moderated slightly and made the requirement 108 viable cells per gram of product at the industry and 107 at the stores, creating penalties for lower levels.
One initiative was the creation in 1985 of RELARE, “Rede de Laboratórios para Recomendação de Estirpes de Rhizobium”, a group including researchers, members of the inoculant industry and MAPA. “This group gives technical support to the official decisions, as recommendation of strains, of inoculant quality, concentration of cells on the seeds, among others,” said Hungria. [Ref 6].
The decree from 2004 changed the quality requirement “to a minimum concentration of 1.0 x 10^9 viable cells per g or mL of the product at the shelf, with a commercial period of at least six months.” The recommended dosage should result in at least 1.2 x 10^6 cells/seed. [Ref 10].
Formulating productsInoculants were delivered as seed coatings or peat-based products, which is where the bacteria stick directly to the peat moss. The first liquid inoculant on the Brazilian market was released in the year 2000. A decade later, three-quarters of the inoculants sold in the country were in liquid formulations. In terms of actual doses, in 2016, soybean farmers in Brazil acquired 35 million
doses of liquid inoculants and 11 million doses of peat-based inoculants. [Ref 10].
The development in formulations can also be seen in the number of patents. These increased from seven in the first decade (1981-1990) to 37 for 2011-2020. [Ref 3].
According to the National Association of Inoculant Producers and Importers (Anpii, 2019), 20.2 million inoculant doses were sold in Brazil in 2009, increasing to 73.5 million in 2018, an increase of 263 percent. [Ref 3].
Biostimulant – without a routeUp until 2023, biostimulants did not really have a clear registration route. In 2016, Moraes and Azevedo stated: “The Brazilian legislation does not cover biostimulant inputs, but biofertilizers which cover most of the technologies under the biostimulant categories claimed by EBIC and the industry are.”
Broadly speaking, non-microbial biostimulants were considered as biofertilizers. However, “stimulants” were covered by the Pesticides law, #7802 1989, but without any reference to biostimulants. There have been specific normatives, such as 2005/06 related to biopesticides covering microbes, pheromones, natural enemies, biochemicals, organic use, and the use of microbes/metabolites for biostimulants. So, in short, when it comes to microbial biostimulants, they would be under biocontrol.
Bio-inputs programIn 2020, a new decree was introduced, #10375, which created the National Bio-inputs Program. This recognized biopesticides, inoculants and biofertilizers as bio-inputs. It did not, however, change the definition of any of these products.
As part of the program, there was analysis of the current legislation on bio-inputs, the release of ‘good practice’ manuals for bio-input production, and providing incentives for scientific research and credit lines to encourage bio-input production. It also created a strategic council to discuss the possibility of removing bio-inputs from bill #7082 (Lei dos Agrotoxicos), so removing biopesticides from the #7082 pesticides law.
“The focus here will be on biofertilizers and biostimulants that are treated in Brazil as inoculants and biofertilizers, respectively,” Alessandro Cruvinel, National Program Coordinator Bio-Inputs Program (PNB), Brazilian Ministry of Agriculture (MAPA), told New AG International in its June-July 2021 issue.
Biostimulant – defining momentThe big step came in 2023 with a definition of biostimulants under the 01/2023 normative which established procedures for registration of microbiological products. This piece of legislation went beyond pest control and included microbes or metabolites that, when applied, stimulate physiological processes enabling the plant to avoid stress caused by insect or disease.
The new normative defined microbiological products as living or inactivated microorganisms including viruses, “as well as microorganisms created through techniques that involve modification of genetic material, and that are aimed at preventing, eliminating, repelling or mitigating pests, as well as being used as plant regulators, stimulants, defoliants or desiccants.” [Ref 11].
This point was also highlighted by Francys Vilella, consultant for CESIS, a regulatory consultancy in Brazil, when presenting at the Biostimulants World Congress 2023. “In addition to pest control, this normative included registration of defoliating agents, desiccants, growth stimulators and inhibitors, whose active ingredient is a microorganism or metabolism arising from its fermentation and/or growth,” wrote Vilella.
The normative offered a broad definition for biostimulant that included both biocontrol and plant stimulation attributes by either microorganisms or metabolites: “Microorganisms and/or metabolites applied with the function of simulating physiological processes of the plant that result in the prevention or response to plant stress, which may favour the control of a population or the action of another living organism considered hamful, or even, it may act as a defoliant or desiccant of plants (to accelerate the drying of plant), growth stimulator or inhibitor.”
Whereas inoculants are authorized solely under MAPA, for a biostimulant going through the biopesticide route, the list of all documents and information must be submitted to MAPA, to the Brazilian Health Regulatory Agency (ANVISA), and to the Brazilian Environment and Natural Resources Institute (IBAMA). [Ref 11].
Which route to take?The quotation from MAPA’s Cruvinel reveals the choice facing teams when registering a biostimulant product in Brazil. A biostimulant can be registered as a biofertilizer. But the 01/2023 normative gives an option for biostimulants under the biopesticide route.
When talking with New AG International, Vilella simplified it as follows: “If you have a fermentation product that helps to resist disease, then go the biocontrol route; if it interacts with the plant by biochemical route, then go for biochemical registration, if it interacts with the plant and the goal is increase productivity, go for biofertlizer.” The chosen route will also determine how many government entities are involved.
Biocontrol routeSimilar to inoculants, biocontrol has a long history in Brazil. From 1997 to 1999, nine Bacillus thuringiensis (Bt)-based products were registered. By 2021, 433 microbial products were active in Brazil. [Ref 12].
The number of biological products for crop protection registered in Brazil has now surpassed that of agrochemicals. This was data presented by Professor José Maurício Simões Bento, from Luiz de Queiroz College of Agriculture at the University of São Paulo (ESALQ-USP), in a panel discussion during FAPESP Week Illinois, on April 10, 2024 in Chicago, U.S. Bento added there are about 629 biological products registered in Brazil for pest control, involving microorganisms, macroorganisms, biochemicals and semiochemicals.
So which piece of legislation has been the most influential in creating markets for bioinputs in Brazil?
“In terms of biopesticides, in 2005 and 2006, Brazil created (and since then has been updating them) biopesticides “normatives,” stated Vilella. “This made it possible to have clear rules that placed biologicals on a different path from chemical products. For biologicals do not require registration of a technical product, no need to present a residue study and was included priority for analysis of biological dossiers. The analysis of chemical claims required seven years; a separate analysis line only for biologicals takes two years for a biological be registered.”
When talking to New AG International, Vilella highlighted the lower costs of biocontrol dossiers against those for conventional
chemist. “For me, this is the great milestone and has paved the way for a series of continuous improvements to facilitate more and more the registration and, consequently, the substantial increase of safe and efficient products on the market.”
Proposed changesOne of the key debates to come is on-farm production. There are also moves to simplify the registration process, which is one of the objectives of the bio-inputs program from 2020.
When looking at possible regulation changes, Vilella offers two suggestions: “For me, there are three critical points that must be faced: Regulation for on-farm in order to guarantee consumer safety; innovation investment; and intellectual property protection.”
Vilella also raises the possibility of a normative for products that have multiple uses. One example is Bacillus subtilis which can be registered under the inoculant route when the claim is for abiotic stress, and as biological control when the claim is for biotic stress. “This does not make sense,” she said.
One of the advantages of a multi-use registration, explained Vilella, is that the active ingredient would need one registration, besides safety data, a company would only need to prove efficacy for the different claims. Vilella makes the point that the microbe does not care what label is on it.
One example is the fungi Trichoderma, which can be used in biocontrol and as an inoculant for sugarcane. [Ref 13]. The benefits for companies would be a simpler and cheaper registration process. “This would also benefit farmers who buy just one product,” Vilella noted.
Of the bills put forward, one proposal is to unify the regulators of the different bio-inputs and regulates the ‘on-farm’ production of biopesticides (PL 658/2021).
“Under the proposal, MAPA would carry out all assessment and registration of all types of biopesticide. ANVISA and IBAMA would participate in product assessment of restricted cases of pesticides with microorganisms not yet registered in Brazil,” stated the USDA in a report on Brazil’s legislation on biopesticides from July 2022. [Ref 14]. Some of the proposals sitting with the Brazilian Congress take a different view of on-farm biopesticide production.
As the business strategist, Peter Drucker said change is the only constant. That looks set to apply to the Brazilian biological regulatory landscape in the coming years.
Ref 1: Food Security – the Brazilian Case – Weber Antonio Neves do Amaral and Alessandro Peduto, 2010
Ref 2: Plant growth-promoting bacteria as inoculants in agricultural soils, de Souza et al, Genetics and Molecular Biology, 2015
Ref 3: Brazilian scenario of inoculant production: A look at patents, de Oliveira et al, Revista Brasileira de Ciencia do Solo, 2021
Ref 4: Embrapa: https://www.embrapa.br/en/johanna-dobereiner/quem-foi
Ref 5: Brief history of biofertilizers in Brazil: from conventional approaches to new biotechnological solutions, Bomfim et al, Brazilian Journal of Microbiology, 2021
Ref 6:Biological nitrogen fixation as a key component of nutrition for the soybean crop in Brazil, Hungria et al, Embrapa, 2009.
Ref 7:Hungria and Vargas, 2000; Hungria et al., 2005, 2006a
Ref. 8:Biostimulants: identification of regulatory challenges and proposals to make this agri-input viable in Brazil, Moraes and Azevedo, Acta Hortic, ISHS 2016
Ref 9:Applications and Market of Micro-Organism-Based and Plant-Based Inputs in Brazilian Agriculture, Soares et al, Plants, MDPI, 2023
Ref 10:Soybean inoculants in Brazil: an overview of quality control, de Souza et al, Brazilian Journal of Microbiology, 2018
Ref 11:New registration procedures for microbiological products, Demarest, 2023 https://www.demarest.com.br/new-registration-procedures-for-microbiological-products/
Ref 12:Policies enabling biocontrol in Brazil Prof. Dr. Italo Delalibera Júnior ESALQ University of São Paulo Brazil ABIM 2021
Ref 13:Trichoderma asperellum Inoculation as a Tool for Attenuating Drought Stress in Sugarcane, Scudeletti, Frontiers in Plant Science, 2021
Ref 14:Brazilian Legislation for Biopesticides – On-farm Biopesticides Production USDA Foreign Agricultural Service, July 2022 ●
Dr. Johanna Döbereiner – led the research at the then National Agronomic Research Service's Institute of Ecology and Agricultural Experimentation
Wheat crops in Rio Grande do Sul, Brazil
The first liquid inoculant on the Brazilian marketwas released in the year 2000.
Alessandro Cruvinel, National Program Coordinator Bio-Inputs Program (PNB), Brazilian Ministry of Agriculture (MAPA)
Francys Vilella, consultant for CESIS, a regulatory consultancy in Brazil
The number of biological products for crop protection registered in Brazil has now surpassed that of agrochemicals.
