“Environmental reassessment stems from the appearance of indications that products, after entering the market, pose a greater risk than what was measured at the time the substance was analyzed for registration…”
Interview with Ibama‘s Technical Department Team. Ibama is a Federal Institute under the Ministry of Environment, and one of it’s atributions is the environmental evaluation of pesticides.
AgriBrasilis – What is Ibama’s role in the pesticide registration process? What are the interactions with MAPA and Anvisa?
Ibama – Ibama is responsible for carrying out the environmental assessment of pesticides – that is, assessing the possible environmental impacts of these products once they are released into the environment – within the process of registering these products, required by Federal Law No. 7802/1989 and Decree No. 4074/2002.
Legislation establishes that pesticides can only be manufactured, exported, imported, sold and used after being registered with a federal agency, in accordance with the guidelines and requirements of the federal agencies responsible for the health, environment and agriculture sectors. It is Ibama, therefore, the body that defines the “guidelines and requirements” regarding the environment.
Pesticide registration is complex, involving the action of three Ministries, each with different roles.
The law says that it is up to the Ministry of the Environment and Climate Change to carry out the environmental assessment of pesticides, however this competence was delegated to Ibama, as this is the executing body of environmental policy actions related to Federal attributions.
Anvisa is responsible for carrying out the toxicological assessment, so that the health risks resulting from the use of pesticides are analyzed.
MAPA’s role is to evaluate the agronomic efficiency of pesticides and, as most products are intended for agricultural use, it is MAPA that completes the process, granting registration to products that obtain favorable analysis from Ibama and Anvisa.
Thus, considering the mandatory consent of the three agencies for granting a pesticide registration, there are several interactions between Ibama, MAPA and Anvisa with the objective of harmonizing understandings, proposing criteria and technical-scientific and administrative procedures in the registration processes and in registration changes.
Interaction between agencies is also necessary to analyze proposals for editing and amending normative acts, that can be observed in the various Joint Normative Instructions published.
AgriBrasilis – How is the environmental hazard assessment of pesticides carried out? What aspects are considered?
IBAMA – Environmental hazard assessment is an analysis process that demands specialized knowledge. It is focused on the danger, that is, on the toxicity (ability to do harm to a living being) of that substance or product to the environment. For this analysis to be carried out, those interested in obtaining the registration must present a series of environmental studies, that will constitute the “product dossier”, or product file.
From the dossier analysis, it is possible to know the intrinsic characteristics of each product, such as chemical and physical properties, inherent toxicity (toxicity to soil microorganisms, earthworms, algae, fish, microcrustaceans, bees, birds and mammals) persistence in the environment, bioaccumulation and transport. Based on this knowledge, it is possible to predict the behavior of the product in the environment and what its effects may be on non-target organisms. In this way, it is possible to assess the level of danger of that substance to the environment, to classify it among 4 possible classes, as follows:
Class I – EXTREMELY DANGEROUS product to the environment;
Class II – VERY DANGEROUS product to the environment;
Class III – DANGEROUS product to the environment; and,
Class IV – SLIGHTLY DANGEROUS product to the environment.
The purpose of the PPA classification is to provide objectivity in the selection of substances, to allow comparison between them and, depending on the classifications obtained for each product, to warn the user regarding their safe use, through warning phrases on the label and package leaflet, in order to avoid accidents resulting from improper use of the product.
AgriBrasilis – What is considered for prioritizing registration assessment?
IBAMA – Priority is given to products considered to be of low toxicity – such as biological, microbiological and semiochemical products, products intended for organic agriculture, and new, unprecedented technical products (active ingredients), to encourage the registration of new molecules, that tend to have a lower environmental impact.
Priority is also given to products that MAPA indicates, based on § 3 of Art. 15 of Decree 4074/2002, the processes listed by MAPA within the scope of Ordinance SDA No. 581, from May 26th, 2022.
AgriBrasilis – What are the criteria for an active ingredient to be reassessed from an environmental aspect and why? What are the responsibilities of the registration holders?
IBAMA – Environmental reassessment stems from indications that the products, after entering the market, pose a greater risk than what was measured when the substance was analyzed for registration.
According to item VI of article 2 of Decree No. 4074/2002, the environmental reassessment of pesticides must be carried out when there are indications of the occurrence of risks that advise against the use of registered products or when the country receives an alert issued by international health, food, or environmental organizations responsible for agreements in which Brazil appears as a signatory.
Administrative procedures for the environmental reassessment of pesticides, their components, and related products, within the scope of Ibama, are available in Normative Instruction No. 17/2009.
Depending on the indications that may come from scientific articles, occurrences of deaths, denouncements, inspection, restriction of the product in other countries, etc., indicating that the authorized use of pesticides is offering unacceptable risks to some non-target organisms, the active ingredient is subject to reassessment, that is, Ibama can start the process of reviewing that registration based on new indications.
For this review, more studies will be required, that should be conducted by the companies that own the products, to confirm or refute the indications.
Faced with the indication of adverse effects on bees, observed in scientific studies and in different parts of the world, Ibama reassessed the active ingredients imidacloprid and clothianidin, and is carrying out the reassessment of thiamethoxam and fipronil.
In the process of environmental reassessment, it is up to the companies holding the registration: to present the documents and information set out in Annex II of Normative Instruction Ibama No. 17; carry out tests or experimental studies/trials, especially in Brazilian environmental conditions, as requested by Ibama; present scientifically supported technical arguments relating to the initial technical opinion; participate in the public consultation; and comply with the reassessment findings.
AgriBrasilis – What are the differences for the evaluation of equivalent products; biological products; and for organic agriculture?
Ibama – A brief explanation of the different types of registration that can be granted follows. These records have different requirements, complexities, and rites. They are:
Technical Product (TP): Active ingredient in its highest degree of purity, that will form the basis of various formulated products. It is what gives the pesticide its expected action (herbicide, insecticide, fungicide, etc.), therefore, it is the substance that produces the toxicity of the products. PT can only be used in the industrial environment, for the manufacture of formulated products. Of all the record types, it is the most time-consuming and complex analysis, and the one that requires the most study. For the registration of a PT with Ibama, it is required the presentation of at least 41 environmental studies, that will help to define the environmental profile of the molecule, its probable behavior in the environment and the possible effects on non-target organisms, in addition to the evaluation of environmental risk, for the new molecules cases.
Formulated product (FP): these are “off-the-shelf” products, intended for sale to farmers. Formulated products consist of a TP + other components, that confer different properties to the product (such as, for example, greater adhesion, better distribution on the leaves, etc.). For the analysis of a FP at Ibama, the person interested in obtaining the registration needs to present a set of (at least) 19 more studies, in addition to the 41 environmental studies required for the technical product that supports the registration of the formula.
Equivalent Technical Product (ETP): Product whose analysis is carried out through chemical comparison and, when necessary, the toxicological/ecotoxicological profile with a PT with a complete dossier already registered and considered a reference product, that is the one that has the complete dossier of the studies. It is, therefore, a faster analysis, as only a few key studies are presented that provide the basis for comparison with the reference technical product.
Formulated Product Based on Equivalent Technical Product (FET, or “generic”): these are “off-the-shelf” products, that are intended for sale to farmers, consisting of ETP + components, that confer different properties to the product (such as, for example, greater adhesion, better distribution on the leaves, etc.). For the analysis of a FET at Ibama, the person interested in obtaining the registration needs to present a set of at least 19 more studies, with exemption from the 41 environmental studies required for the technical product, since this formulation is based on an ETP.
Formulated Product with Data Transfer Authorization Letter (FPL): product with qualitative and quantitative composition equal to another FP already evaluated by Ibama, therefore studies referring to the product that is applying for registration have already been evaluated. The only changes allowed are: registrant, brand name, packaging, formulator, handler, technical product, crops and usage recommendations, respecting the maximum doses used in studies of soil microorganisms.
Formulated Product Equivalent with Data Transfer Authorization Letter (FETL): consists of a product with qualitative and quantitative composition equal to another FET already evaluated by Ibama, that is, that obtained registration by equivalence (comparison). Changes allowed are: applicant company, brand name, packaging, formulator, handler, technical product, crops and indication for use, respecting the maximum doses used in studies of soil microorganisms.
The legal concept of pesticides applies not only to chemicals, but also to various products of biological origin used for the purpose of controlling “living beings considered harmful”, that is, agricultural pests. Thus, all low-hazardous products (whether they are microbiological, biological control agents, semiochemicals or biochemicals) will comply with pesticide legislation.
Products for organic agriculture follow a specific procedure for registration. Evaluation of biological products (conventional use) and phytosanitary products for use in organic agriculture (FITORG) is different, even though they are subject to the concept of pesticides and related products, defined by Law No. 7.802/89. These products have peculiarities, as they are less aggressive to the environment (in general), due, for example, to low environmental contamination by waste. There are less requirements for registering these products.
AgriBrasilis – What percentage of products are not approved, rejected, or have pending issues?
Ibama – There is no survey on the number of products that had some type of pending issue during evaluation.
Regarding the percentage of products rejected for registration purposes, there is systematized data from 2018, as shown in the following table:
Registration rejection occurs after the completion of all administrative procedures, such as requirements, contradictory and broad defense. Many requirements are harmonized or archived during these procedures, that generates a low percentage of rejection.
For biological and FITORG products, rejection usually happens for administrative reasons such as lack of documents, not because of technical reasons that prevent registration.