“Judicial decisions depend on the interpretation made by the judge in each case and there is no settled case law on the subject yet…”
Luciana Fabri Mazza is a partner at Mazza e Manente de Almeida Advogados, a lawyer graduated at Universidade Mackenzie, postgraduate in tax law and tax process at the Brazilian Institute of Tax Studies, and a specialist in public and business law.
AgriBrasilis – Why has the number of lawsuits made to speed up pesticide registration increased?
Luciana Mazza – According to Decree No. 4074/2002, article 15, the regulatory agencies should conclude the technical-scientific evaluation of pesticides within a period of up to 120 days after submission.
Registration requests, however, which today are already waiting four, five, or even six years, have not yet been analyzed, i.e., the legal deadline has not been met by the regulatory agencies and often there is not even a forecast for completion of the analysis.
Lawsuits are the means available to the companies applying for pesticide registrations to complete the analysis of their delayed pesticide registration requests.
Therefore, requests for injunctions are being made. The objective is for the judge to determine that the pesticide evaluations must be completed in an urgent manner (the deadlines granted have been of 30, 60, or even 90 days depending on the judge who analyzes the case).
AgriBrasilis – What is the legal basis for this type of lawsuit?
Luciana Mazza – The registration requests that are subject of the legal actions in question were made within the 120-day period proposed by Decree No. 4074/2002, but were not evaluated by the responsible agencies following this time-limit, meaning that the Government is incurring in an unjustified delay.
The regulatory agencies – Anvisa, Ibama, MAPA, argue that, after the entry into force of Decree No. 10833/2021, the 120-day period should no longer be considered. A transition rule was provided for this situation in article 3, according to which the Federal bodies involved in pesticide registration would have a period of four years, counting from the date of publication of the Decree, to analyze the pending registration processes for technical products, pre-mixtures, pesticides and similar products. Therefore, these regulatory agencies have concluded that they would have four years to analyze pending registration processes filed before the Decree No. 10833/2021.
The Judiciary’s understanding, however, has been predominantly in the sense that it is the right of the pesticide registration request applicant to have their request analyzed within a reasonable period, and a waiting period of up to 6 years, with no expected completion of the analysis, cannot be accepted.
Even if the transition rule is provided in Decree No. 10833/2021, the principle of reasonable duration of the process, which is provided by in the Constitution, in addition to morality, bureaucratic speed, efficiency, and legal certainty, cannot be violated. Therefore, the understanding that has prevailed is that the delay for pesticide registration analysis is abusive and unjustified.
AgriBrasilis – Even so, why are there several injunctions granted before the deadline?
Luciana Mazza – This is based on the understanding, which finds precedent in the Federal Supreme Court, that the pesticide registration applicant has the right to have its process analyzed within an acceptable period of time, in compliance with the principle of reasonable process duration, in addition to being able to trust that, when the request protocol was carried out, the law in force ensured that the 120-day period proposed by Decree No. 4074/2002, article 15 would be applied, and this legal certainty must be respected.
AgriBrasilis – How long does this type of lawsuit take and what are the procedural costs?
Luciana Mazza – In this type of lawsuit, a measure is requested at the beginning of the process, which is an urgent injunction, for example, so that the judge determines that the regulatory agencies must carry out the pesticide evaluation within a certain period (of 30 to 90 days, usually).
Theoretically, the decision about the lawsuit should only be given at the end of the process, however, as these cases already deal with the delay of federal regulatory agencies in analyzing the registration requests, it would not make sense to still wait for the entire judicial process to obtain a decision.
Once the injunction has been granted by the Judiciary, it must be complied with during the specified period, and there is also the possibility of establishing a fine in the event of non-compliance.
The value of procedural costs corresponds, in this case, to 0.5% to 1% of the value of the case, and the value of the case is estimated (a value is assigned to the action).
AgriBrasilis – Why are there differences in decisions from different Courts regarding the granting of injunctions?
Luciana Mazza – Judicial decisions depend on the interpretation made by the judge in each case and there is no settled case law on the subject yet, which is to say that there is not an already consolidated position of the Courts.
What we have observed, however, is that there is a high probability of the injunctions being granted, and there are cases in which judges postpone the analysis of the request, so the injunction is not rejected, but the regulatory agencies are allowed to present a defense before the decision on the injunction.
We have performed a study regarding the registration requests approved through legal action in 2022 and the monitoring of injunctions granted later, together with AllierBrasil Consulting, and we verified that at least five Courts were responsible for 50% of injunction approvals. Thus, we were able to have a good perspective about the Judiciary’s position on this topic.
AgriBrasilis – With the Pesticide Bill close to being sanctioned, which contains deadlines for completing the evaluation of pesticide registrations of 60 days to 24 months, do you believe that this type of lawsuit will happen less?
Luciana Mazza – According to the text of the Pesticide Bill No. 1459/2022, the deadlines established are:
– New product – formulated, new product – technical: 24 (twenty-four) months
– Formulated product, generic product, equivalent technical product: 12 (twelve) months
– Identical formulated product: 60 (sixty) days
Considering the recurring allegations from the federal regulatory agencies, we conclude that the proposed deadline above, which are even shorter than those established in the current legislation (Decree No. 10833/2021), will probably not be met. Therefore, lawsuits may become more frequent. Once the deadlines of 60 days, 12 or 24 months have expired, depending on the type of registration, the applicants will be able to initiate lawsuits.