Anvisa toxicological report recommends banning carbendazim: Brazil

A request for a joint review interrupted the voting on March 23, by the collegiate directorate of the Brazilian National Health Surveillance Agency (Anvisa), of a report in which technicians from the agency itself recommended a ban on the sale and use of pesticides based on carbendazim, one of the fungicides most used by Brazilian farmers to combat fungi that attack crops of beans, rice, soybeans and other important agricultural products.

Director Cristiane Rose Jourdan presented the document proposing the banning of carbendazim during the 3rd Ordinary Public Meeting of the agency's board. Cristiane is the rapporteur of the regulatory impact analysis process started in December 2019 to reassess safety aspects of the fungicide. Technicians from the general management of toxicology formulated the document.

According to the report, carbendazim “has toxicological aspects that are prohibitive to record, and it is not possible to establish a safe dose threshold for human exposure.” Among the aspects listed by Anvisa technicians and emphasized by Cristiane is the potential of pesticides to cause cancer, harm human reproductive capacity and affect development.

“It is important to point out that the analyses carried out [by the general management] were based on technical and scientific evidence, including studies and reports from companies [manufacturers of products registered in Brazil] and the main international regulatory agencies, in addition to scientific literature and other references necessary,” Cristiane pointed out.

Revaluation

Carbendazin tops the list of seven active ingredients of pesticides that Anvisa intends to submit for toxicological reassessment.

According to Cristiane, this is because, in addition to being “fitted into potentially prohibitive criteria” for obtaining the registration of pesticides, the product “presents significant commercialization in the country, being the most detected active ingredient in foods, in addition to representing a dietary risk to the population.” According to the director, 24 companies currently hold 67 different carbendazim-based products registered in Brazil.

“Carbendazim is among the 20 most traded pesticides in the country and has agricultural use as an approved pesticide for the foliar modality in cotton, barley, citrus, beans, apples, corn, soybeans and wheat. It is also used for application in cotton, rice, beans, corn and soybean seeds,” the director explained while reading the report.

In the document, the agency's technicians maintain, "If Anvisa's board of directors chooses not to act, the population will be at risk due to exposure to a substance that, due to its properties, should be prohibited according to current legislation."

During the public meeting, the board would only vote on the report’s content and then proceed with the toxicological reassessment process, which may or may not result in a ban on the production, import, export, sale and use of the pesticide. One of the steps in the process, if it goes ahead, will be the holding of a public hearing to discuss with interested sectors the impacts of a possible ban.

“Companies holding pesticide registrations may have immediate economic impacts on the sale of products since the active ingredient is among the 20 most commercialized pesticides in Brazil. On the other hand, the use of carbendazim as a fungicide will be replaced by one or more active ingredients. In the short or medium term, companies will eventually be able to replace immediate losses with the sale of substitute products,” pondered Cristiane, admitting that initially, there may be a rise in the prices of the main foods.

“Farmers and industrial seed treatment companies will suffer the impacts of the decrease in the supply of fungicide products, having to adapt their agricultural or industrial practices to new products, which can increase production costs in the short term. On the one hand, with the approval of other active ingredients, the behavior of the pesticide market may normalize and return to previous levels. On the other hand, depending on the amount of these substitutes, workers may be exposed to a greater diversity of active ingredients. However, [it is certain that] they will benefit from reduced occupational exposure to carbendazim, a relevant risk factor to human health,” he added.

Postponement

The deliberation of the collegiate board on the content of the Regulatory Impact Analysis report in which the General Management of Toxicology of Anvisa manifests itself for the banning of carbendazim and, consequently, for the continuity of the toxicological reassessment process of the product, was postponed due to requests from the Deputy Director-President, Meiruze Sousa Freitas, and Director Alex Machado Campos. The two praised the report and defended that some pesticides consumed in the country undergo a reanalysis process but highlighted the importance of clarifying all doubts on the subject.

“From the material point of view, from the merit point of view, the work and the vote that Dr. Cristiane brought is impeccable. In addition to this […], I have some doubts about how we will deal with the regulatory impact [of toxicological reassessment] after a year in which Anvisa, due to the pandemic, stopped doing this. Mainly because, in this matter, there can be no doubt or shadow, since we are protecting people's health,” said Campos, assuring that, “soon”, the matter will be taken to the public hearing.

“The report is very impactful and very robust from the point of view of the impacts on human health […] However, in this context, I also think that the collegiate board needs to improve its knowledge,” Meiruze added.