“…the Brazilian Lower House of Congress approved on 11/27/2024 the Evaluation of Bill No. 658 of 2021…”
Luis Rangel (right) is an agricultural engineer, former Secretary of Agricultural Defense and former Director of Economic Analysis and Public Policies at the Ministry of Agriculture.
Carlos Venâncio (left) is an agronomist, former general coordinator of pesticides and similar products at the Ministry of Agriculture.
Rangel and Venâncio are members of the Sustainable Agriculture Scientific Council (CCAS), a Civil Society organization, created on April 15th of 2011, with headquarters in the city of São Paulo, with the aim of discussing topics related to the sustainability of agriculture.
The use of biological organisms in crops is nothing new, but it has been increasing to surprising proportions. The basic foundation of Integrated Pest Management, the use of combined strategies has always considered microorganisms as necessary alternatives for the success of the practice. However, the number of alternatives available on the market was very small until 10 years ago.
Several biofactories have been implemented to breed natural enemies for pest control, such as the cases in sugarcane with Cotesia flavipes and Trichogramma spp., covering more than 3 million hectares in Brazil. This reality began to be consolidated in the old pesticide law (7802/1989), since biological control organisms were always considered pesticides.
There are around 629 biological products registered in Brazil for pest control. Approximately 20% of farmers around the world adopt these bioinputs, with 55% of farmers using them in Brazil, compared to 6% in the USA. Considering biostimulants, the ratio is 50% versus 16%. Brazil has at least 170 biofactories, capable of treating 25 million hectares, with a market growing by up to 20% per year.
Data from the Ministry of Agriculture shows 803 registered low-risk products, including biologicals and products approved for organic agriculture. This includes pheromones and other products that would not be capable of being produced “on farm”.
Recently, the standards for microbiological inputs were updated through Joint Ordinance MAPA/IBAMA/ANVISA No. 1/2023. In addition to these, in 2009, phytosanitary products for organic agriculture were included in a different way in the registration procedures of the old Law, allowing for the “on farm” production of pesticides.
The case for inoculants is different. Regulated by the fertilizer legislation, it is not possible to find explicit legal mention about the “on farm” production of these inputs. However, composting has traditionally been used to recycle waste and create organic fertilizers, in line with greenhouse gas mitigation policies. For commercialization, however, inoculants require registration with the Ministry of Agriculture.
The exemption from registration for the “on farm” production of pesticides for personal use was originally regulated through Decree No. 6913/2009. In Decree No. 10833/2021, the exemption was clarified in order to also specify cropping systems where the “on farm” production of phytosanitary products with approved use for organic agriculture would be accepted, including “in organic or conventional production systems”.
The concept of “on farm” production was established by the current National Bioinput Program, as: “production of soil conditioners, inoculants, phytosanitary products, community of microorganisms with approved use for organic agriculture or biological control agents, regulated in a specific standard by the Ministry of Agriculture, Livestock and Supply, to be used exclusively in an agricultural production area belonging to the same individual or legal entity or in areas of farmers under an association established for this purpose”.
Even with these definitions, the selling of such products has always been prohibited, even if they are exempt from registration. Registration is fundamental and inseparable from the right to sell these substances. Registration must ensure fair trade, in a suitable relationship between producers and consumers, guided by rules of identity and quality.
Under current legislation, in the case of phytosanitary products, only products approved for organic agriculture can be exempt from registration, when produced for the farmer’s own use. And they must be listed in the Ministry of Agriculture’s standards through “Reference Specifications”.
The new pesticide legislation (Law No. 14785/23) makes it mandatory to register “establishments that produce, handle, import and export, institutions dedicated to research and experimentation, distributors, legally qualified professionals, users, farmers and service providers for third parties in the application of pesticides”. The need for registration of biofactories is also clear, even if for “on farm” production.
Law No. 14785/23 established the Unified Electronic Information, Petition and Assessment System, which seeks to implement, maintain and make available data and information on ALL products and farmers, whether commercialized or not (Art. 58, Law No. 14785/23) which covers the foundations of Article 22 of the same law, creating the Unified System for Registration and Use of Pesticides. Farmers who produce phytosanitary products for their own use, even those exempt from registration, need to be registered in the Ministry of Agriculture’s integrated system.
However, the expectation that SISPA will finish, in 360 days, the data transaction environment between all actors specified in the Law, considering the chain of production, trade, use of pesticides, is just utopian.
Manufacturers, dealers , agronomists who prescribe product recommendations, trained applicators and farmers must be registered from December of 2024. Probably, any solution that is to be presented will not include all the functionalities provided for in Law No. 14785/23, in its first version. Certainly, the registration of farmers with their “on farm” facilities will not be among the priorities.
When such a thing happens, even though it is understandable, we must consider what the other legislation available proposes on the matter.
Law No. 9784 of 01/29/1999 dictates that principles of legality, purpose, motivation, reasonableness, proportionality, morality, broad defense, contradictory, legal certainty, public interest and efficiency must be obeyed. In particular, we consider compliance with formalities essential to guaranteeing the rights of those being administered, in this case the right to registration under the New Pesticides Law.
Recently, with Law No. 13874, of 09/20/2019, it became necessary to “grant the license, authorization, concession, registration (emphasis by the author), permission, accreditation, after the deadline established here, considering that the silence of the competent authority will be reflected in tacit approval for all purposes”.
In the Pesticide Law, it is clear that there must be a simplification and de-bureaucratization of procedures and a reduction in costs and time required to complete process evaluations.
In a recent published article, experts have analyzed how the regulatory transition could be carried out, considering that more than 51 infralegal normative acts still effectively address topics in the New Pesticides Law. Considering the authors’ conclusions, it is possible to understand that administrative rites that are more oriented to specific issues must remain valid, in order to safeguard the efficiency of public administration and legal certainty.
The only possible conclusion is that there is nothing prohibiting “on farm” production. Pesticides products approved for organic agriculture that are produced for their own use, even after the 360-day period for implementing SISPA in Law No. 14785/2023 of 12/21/2024 has ended are not prevented from being produced. Guarantees to farmers to keep them producing their bioinputs must consider laws and infra-legal norms in an interpretation regarding their specialty or temporality, but mainly regarding their connection with the State’s objectives.
Considering the absence of specific regulations regarding the registration of biofactories for “on farm” production, it is appropriate for the owner of such a structure to present an electronic protocol within the scope of the Ministry of Agriculture. This procedure must comply with the legal requirement present in Article 22, § 1, of Law No. 14875/2023, and fully guarantee “on farm” production, as long as there is no specific ystem or at administrative guidelines for registration.
There is still one issue to note, which could resolve this problem. In compliance with Decree No. 10139, of 11/28/2019, the Federal Technical Registration of Potentially Polluting Activities and/or Users of Environmental Resources provides for the registration of companies that would fit into this situation.
This procedure, which can be carried out by the competent agency (federal, district, state or municipal), in the case of a license to install or operate an enterprise and to carry out activities, as in the case of bioinputs, would resolve the issue.
In this case, an analysis of regulatory redundancy would be worthwhile. Although there is no prohibition against redundant registrations or licenses, it is recommended that public agencies should coordinate actions to avoid competing registrations on the same product.
With all this, the Brazilian Lower House of Congress approved on 11/27/2024 the Evaluation of Bill No. 658 of 2021, which consolidates discussions on the topic, advancing with necessary regulation on Bioinputs. With the approval of this legal framework, it will be possible to separate biological control products and dozens of other products of natural origin from the list of pesticides or synthetic fertilizers. The new law will bring rules for processing and will deal with cases of the farmers production of bioinputs for their own use (“on farm”) as exempt from registration. The text provides for this exemption in cases where there is no commercialization.
In this same text, we can observe different approaches to “on farm” production. In addition to the registration of biofactories, a requirement that does not apply to family farming and to traditional communities, several rules for the transport of bioinputs were established, in addition to exceptions for access to Sisgen.
The user’s own production of bioinputs must be documented (and must be stored for 5 years), it should follow rules that are yet to be defined for good manufacturing practices and the farmers cannot use commercial products for multiplication purposes, with the exception of inoculants registered for this purpose.
This legal framework brings important changes to pesticide and fertilizer laws, but mainly to data protection law, including protections against unfair commercial use of information relating to test results or other undisclosed data presented to the competent authorities.
Even though there is a legitimate discussion about the need for specific regulation on these products, they continue to be considered fundamental to several Brazilian policies that are already in progress. In other words, even if there is a considerable level of legal uncertainty being communicated by experts, it is not reasonable to think about the risk of discontinuing the advancement of the adoption of established sustainable practices, which is the case of bioinputs.
The greater clarity that the new bioinput legislation will bring to “on farm” production does not eliminate the need for regulation by the Executive Branch of several articles, including the construction of a registration system for biofactories.
It will not be the lack of an electronic system for registration that will interrupt the upward trajectory of production and use of biological inputs by farmers. Nor will the new legislation, which is in the final stages of discussions in Congress, define all the guidelines of the regulatory process.
Note that in the text of the new law there will be a reference to “guaranteeing the continuity of the production of bioinputs for the farmer’s own use, as well as the supply of inputs necessary for production for their own use, until the regulations and instructions on good practices are published”.
Many issued will still be addressed on the topic. The own use of bioinputs should be subject to a new risk analysis model, considering issues of impact on health and the environment, when introducing exotic organisms, biotechnology, or even matters of intellectual protection.
However, only with the publication of the regulation will there be a proper ruling over the analysis process for each type of product, including, at the discretion of the Federal agricultural defense agency, possible support from health or environmental surveillance agencies, and research institutions.
The new law will waive the need for agronomic recommendations for “the sale or use of bioinputs classified as low toxicity”, a fact that was already foreseen by previous regulations, but which requires further analysis, considering the essence of the agronomic recommendation as an instrument for guarantying good practices.
It would be unthinkable to consider that the technological development of bioinputs, which consumed millions from private or public companies (Embrapa is one of the largest holders of bioinput technologies), does not have an adequate remuneration system.
The dynamics of regulation must be proportional to the need for the establishment of the market, in this case, for a continued investment in sustainable solutions for agriculture, but mainly, for their universal adoption.
Good products sitting on shelves do not change the reality of agriculture. Farmers want efficiency in the use of inputs and more income from their harvests. Bioinputs will certainly be on the market and business models will adapt to the reality of agriculture, respecting intellectual protection and health security.