Aug. 9, 2019
Usted puede encontrar la versión en español de este artículo aquí. 'América Latina: mejoras en el entorno regulatorio de pesticidas'
Latin America, an important pesticide market in the world, has not fully recovered from the downturn in past years, but the regulatory environment, policies and regulations for pesticides are undergoing significant changes, especially in Brazil.
For many years, Brazil has been a battlefield for agrochemical companies, though it is not easy for them to register pesticides in the country. Brazil has three regulatory agencies jointly responsible for the registration and approval of pesticides, and the long wait required for product registration has been criticized, as it may hinder the launch of new products and further affect the development of agriculture. However, with the new government taking office and the upcoming introduction of a new pesticide law, Brazil's pesticide industry is expected to usher in a new development stage under the influence of a series of favorable policies.
This article reviews the product regulatory events and policy trends in several important pesticide markets in Latin America last year, and invites the Brazilian crop protection industry trade association, the Sindiveg, to comment on the new pesticide law in Brazil. Other viewpoints are also voiced, including from the Argentine National Food Safety and Quality Service, the Senasa.
Controversies around Popular Product
Glyphosate, as a world's best-selling herbicide, has been beset by negative news over the years. The prominent points are the issue of weed resistance and whether its use can cause cancer. And following Bayer’s acquisition of Monsanto, thousands of lawsuits related to glyphosate
causing cancer were filed in the United States, raising concerns in many countries, which sought research or are considering banning the product.
Last August, federal judge Luciana Raquel Tolentino de Moura of the seventh regional federal court in the capital city of Brasilia (Brazil) suspended the use of products containing glyphosate until the government reevaluates its toxicology. The ruling caused a stir in the sector, and then agriculture-related practitioners called for the decision to be rescinded. One month after the ruling, the Federal Court of the 1st Region in Brasília (TRF1) overturned the suspension of glyphosate. According to the decision of Federal Judge Kássio Marques, vice-president (holding the interim presidency of TRF1), "there is no justification for suspending registrations of glyphosate [...] so abruptly, without analyzing the serious impacts that such a measure will bring to the country's economy and the population, in general."
This past February, further progress was made in this case as the National Health Surveillance Agency (Anvisa) concluded that there is no scientific evidence to indicate that glyphosate is carcinogenic, or to support prohibition of glyphosate in Brazil. That's definitely good news for the agricultural community. However, Anvisa proposed some restrictions on glyphosate use to increase the safety of operators.
The storm over glyphosate in Brazil has temporarily subsided, but the opposition to glyphosate in Costa Rica, another country in Latin America, is still fermenting. Glyphosate has been banned by 21 municipalities, along with the National Technical University, since a US court ruled that there was a link between the herbicide and a terminal cancer inflicting California gardeners. Three ministries, including the Health Ministry, are reviewing whether to continue allowing the use of glyphosate.
Another herbicide that has been controversial in Brazil is 2,4-D. Rio Grande do Sul, the largest grape growing region in Brazil, has been investigating 2,4-D since 2015 to research the effects of product drift. This investigation puts 2,4-D at risk of being banned.
According to official government data, 2,4-D drift has damaged 68 properties in 19 municipalities in the region. Until this January, no consensus was reached between the government and interested parties of 2,4-D on whether to ban the product. Then, the Secretary of Agriculture, Livestock and Rural Development, Covatti Filho, requested the formation of a working group to the governor of Rio Grande do Sul, Eduardo Leite. Filho said that the intention of creating this group is to share ideas for a series of actions that can solve the problem of 2,4-D drift.
In this May, Anvisa concluded the re-evaluation of 2,4-D and decided to maintain the approvals of 2,4-D. Anvisa said that the analysis of the scientific studies and data indicated that 2,4-D is not harmful to consumers. However, the government regulatory body will impose restrictive measures in its application to crops, such as revising all existing residue limits; defined an exposure limit for the rural worker; compulsory use of equipment or alteration in the formulation that minimizes the risk of dispersion of the product outside the crop.
Regulatory Environment Improved
Scenario in Brazil
The pesticide registration process in Brazil is complicated and always requires a long wait, which has been criticized by the industry. However, recently Brazil's agrochemical market environment seems to have improved somewhat. In 2018, 450 pesticide product registrations were approved, a record high in the past 13 years, wherein at least 52 are biopesticides, an increase of 30% compared to 2017. According to Bruno Gentleman Breitenbach, the head of the Registration Division of Formulated Products of the Secretariat of Agricultural Defense, "The record of less toxic products is a result of the federal government's policy of prioritizing the analysis of registration processes for these products." He also said that there is a greater demand from Brazilian farmers for alternatives that are less aggressive to the environment and the consumer.
Three agencies in Brazil are responsible for the registration of agrochemical products, the Ministry of Agriculture, Livestock and Supply (Mapa), the Brazilian Institute of Environment and Renewable Resources (Ibama), and the National Health Surveillance Agency (Anvisa), signed a technical cooperation agreement for the development of the Integrated System of Agrochemicals (SIA). The goal of this unification is to shorten the registration deadlines for new active ingredients or post-patent generic products.
In addition, the new pesticide law is expected to take effect this year. According to Congressman Luiz Hiloshi Nishimori, who is also the new pesticide law rapporteur, the current pesticide law of Brazil was enacted 30 years ago, appears to be rather outdated and needs to be updated to adapt to current developments in the pesticide industry in Brazil. On the other hand, Brazil is a large farm product exporting country where farmers need more novel products and new solutions to safeguard the quality of food. Therefore, the Brazilian government released a new pesticide law, Bill PL 6299/2002, which was approved by a special committee headed by Tereza Cristina. Based on the effective communication between the congressmen and Brazilian President, the new pesticide law has been submitted to Brazil’s congress. After the approval by congress, it will be forwarded to the senate, and will finally become effective after being duly signed by the President. Nishimori is confident in obtaining the approval of the new pesticide law this year. After the new pesticide law comes into force, the time-consuming registration process in Brazil is anticipated to be much improved.
The Brazilian crop protection industry trade association, the Sindiveg, notes that the pesticide sector favors Bill PL 6299 / 2002, which aims to modernize legislation that regulates the production and commercialization of pesticides in Brazil. The Bill does not facilitate the registration of these products, but includes objective criteria in the evaluation, respecting scientific methodologies, which ensure the competitiveness of Brazilian agriculture without dispensing with the safety aspects of the products. In addition, it also reinforces the Government's commitment to transparency and best regulatory practices.
This modernization brings advances to Brazilian agriculture, since the substitutive text predicts two important aspects:
The implementation of the risk assessment, which corresponds to a set of procedures that makes it possible to evaluate in depth and identify the possible effects that the use of pesticides can cause, always with a focus on the safety of those who apply the product, on the health of the consumer of food and the preservation of the environment. It is a scientific tool for systematizing the information available for decision making and directing how to better manage and regulate the product. It is on the basis of this identification that the registering body will be able to determine what is acceptable or not. The risk assessment, in practice, is a complement to the hazard assessment, currently used technique, which evaluates the characteristics of each substance, without taking into account their conditions of use.
Another improvement is the proposed extension of the deadline of up to two years (currently the Law provides 120 days, but takes, on average, 8 years) for the approval of product registration. This is the average that the process usually takes in other countries, such as the United States and Australia, which also have agriculture as one of their nations’ most important economic activities.
It is essential to point out that we support the maintenance of the competencies of the Ministry of Agriculture, Anvisa and Ibama, which remained in the latest version of the bill approved by the Special Committee. In the proposal, the three agencies continue to evaluate agronomic efficiencies and aspects related to health and the environment, according to their specific attributions and capabilities. Without the approval of Anvisa or Ibama, the registration will not be granted.
The law update will bring more technology to the field, allowing more innovation, efficiency, and investment in Brazilian agricultural production and ensuring more quality food at the Brazilian table.
Eliminate Obsolete Pesticides
In April, Anvisa announced that it plans to begin a process to review the list of active ingredients in pesticides authorized throughout the country, and exclude 34 substances already considered obsolete, including azocyclotin, bromopropylate, edifenphos, oxasulfuron and sulfonate, among others. This is the first time, since 2005, that Anvisa plans to revise the list of monographs based on these criteria.
In Argentina, at the end of last year, the president of the National Food Safety and Quality Service (Senasa), Ricardo Negri, signed Resolution 263/2018 which prohibits the processing, import, and fractionation of the active ingredients carbofuran, carbosulfan, diazinon, aldicarb and dicofol, and their formulated products. The purpose of the prohibition is to maximize the precautionary measures to prevent production, use and commercialization of products that could seriously endanger human health and the environment, as well as accompany international standards that regulate plant protection products. In addition, AgroPages learned from Senasa that Argentina will ban the formulation products based on 2,4-D butyl ester and/or isobutyl, in the short term.
Focus on Agrochemical Use on Minor Crops
Brazil and Argentina have made some moves in minor crops. Brazil is a major producer of many cash crops, in addition to corn and other food crops. However, some minor crops are facing difficulties in the use of agrochemicals. Last December, Anvisa announced a technical-scientific cooperation agreement with Canada and the United States to evaluate existing products and stimulate the development of new agrochemicals for use on minor crops - crops of less economic interest, such as fruits and vegetables. The main objective of the partnership is the exchange of experiences among the countries for the development of strategies to resolve problems faced in this sector.
Anvisa explained that the partnership is important, because in Brazil, as well as Canada, the USA and other countries, companies in the industry are reluctant to invest in studies to generate data for the registration of agrochemicals for these crops. This is due to the fact that the registration process for this type of product is extensive and expensive.
In Argentina, Senasa has expanded its list of agrochemicals that can be applied in the management of 'minor crops'. Resolution 829/2018 establishes the extension of the use of products already registered for pest control for crops of lesser economic interest, such as fruits and vegetables.
The objective of this expansion, explains Senasa, is to reduce problems faced by producers, who often cannot find authorized phytosanitary products and must use agrochemicals destined for other crops, or even illegal chemicals.
This story was initially published in AgroPages '2019 Latin America Focus' magazine. Download the PDF version of the magazine to read more stories.