The New Legal Framework for Chemical Pesticides in Brazil
“Criticisms of MAPA’s leading role under the new law ignore the fact that the agency will continue to defer to health and environmental risk analyses carried out by ANVISA and IBAMA.”
At the end of 2023, Law 14,785/2023 was published in Brazil’s official gazette, creating a new regulatory framework for chemical pesticides and environmental control products. The result of decades of discussions in the National Congress, the new law brings provisions that represent improvements to the system, such as the mandatory use of risk analysis in the process of granting registration of products and the requirement to harmonize with internationally established standards, including the Globally Harmonized System of Classification and Labeling of Chemicals (GHS), the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) and the Codex Alimentarius.
The new law aims to regulate research, experimentation, production, packaging, labeling, transportation, storage, commercialization, use, import, export, destination of waste and packaging, registration, classification, control and inspection of these products. It replaces Law 7,802/1989, which is now repealed.
Key Provisions
While regulatory agencies like the National Health Surveillance Agency (ANVISA) and the Brazilian Institute of the Environment and Renewable Natural Resources (IBAMA) have already adopted risk analysis protocols, these have been technical criteria left to the discretion of the competent technical staff. The inclusion of these measures in the law brings legal certainty to all users of the system.
Other advances introduced by the law include: the implementation of the Unified System of Information, Petition and Electronic Evaluation (SISPA), for better procedural flow of petitions and communications; the Unified System for the Registration and Use of Pesticides and Computerized Environmental Control Products, in order to facilitate inspection activity; the adoption of legally established and reasonable deadlines for the evaluation and reanalysis of products; and stricter criminal sanctions for “smuggling” cases.
Another positive development is the competence conferred upon the Ministry of Agriculture and Livestock (MAPA), as the registration body for crop protection products, to coordinate the registration process. It is now the competent body to manage the procedures related to the granting of product registration, a complex administrative act, already within the principles of efficiency, legality, and transparency, recommended by the provisions on coordinated decisions of Law 9,784/1999, as amended by Law 14,210/2021. Criticisms of MAPA’s leading role ignore the fact that the agency will continue to defer to health and environmental risk analyses carried out by ANVISA and IBAMA. No product will be registered without their approval.
Future Challenges
Unfortunately, such criticisms were poorly clarified throughout the legislative process and culminated in the presidential sanction of a provision that would have given MAPA the role of coordinator of the reanalysis processes (the procedure by which a registration is reviewed in case there is any new evidence that the product may bring harm to human health or the environment). The phrase used in the legislation indicated that “the federal agency responsible for the agriculture sector is the coordinator of the process of reanalysis of pesticides and may request information from health and environmental agencies to complement its analysis.” This left the provision open to the interpretation that MAPA could decide not to involve ANVISA and IBAMA in the decision-making process, disregarding environmental or human health issues. Thus, the final text of the legislative proposal provided the critics of the new law with reasons that justified the veto.
This provision could have been interpreted in light of the whole statute and in accordance with the principles established by the Federal Constitution, since the law establishes the need for risk analysis in the reanalysis processes. This would describe a risk assessment process that is the purview of the federal agencies responsible for the health and environmental sectors, making it clear that both ANVISA’s and IBAMA’s interpretations would be part of the reanalysis process. However, since it was vetoed, a gap is left in the regulatory system.
Another important aspect of the legislative proposal that was also subject to a presidential veto had to do with the Evaluation and Registration Fee. It aimed to charge a single fee to subsidize the administrative activities resulting from the new regulatory system (replacing the various fees charged by ANVISA and IBAMA; MAPA did not charge a fee to carry out the evaluation of the agronomic efficacy of pesticides or grant their registrations). This is unfortunate, as such fee should be paid to the Federal Agricultural Fund and its resources destined exclusively to the supervision and promotion of the development of phytosanitary activities and technological innovation in the agricultural sector in plant health, which would bolster the development of all national agriculture. This is a setback for this sector that is so important to the Brazilian economy.
More to Come
The publication of Law 14,785/2023 certainly does not represent the end of the discourse related to the new regulatory framework for crop protection products. Many discussions are still to come during the process of issuing regulations to comply with the law, or even with the possibility of overturning presidential vetoes by the National Congress and actions before the judiciary regarding whether the text is constitutional. The hope is that such discussions will be accompanied by reasonableness in favor of an efficient regulatory system that safeguards the protection of health and the environment.
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Viviane Kunisawa
Viviane Kunisawa is a partner with Daniel Law. She is highly proficient in the field of Regulatory Law for Life Sciences, including Agribusiness, and in matters related to access to […see more]
