Latin American Regulatory Issues: Interview with Knoell’s Ana Bejarano and Piyatida (Tung) Pukclai
15 July 2022 AgriBusiness Global sat down with Knoell’s Ana Bejarano and Piyatida (Tung) Pukclai to ask about the regulatory changes happening in Latin America. From harmonization to fast-paced changes, Bejarano and Pukclai shared updates and their best advice for product registration in LaTam.
ABG: How would you characterize the regulatory environment for traditional chemicals in Latin America right now?
AB/PP: The regulatory environment for traditional chemicals in Latin America is well defined in each individual country. Several attempts have been made to harmonize the registration of chemical pesticides in some areas, but in general there is a lack of harmonized regulations within the Latin American (LaTam) region.
Chemical pesticides are regulated by the Andean Technical Manual (Manual Técnico Andino) in Bolivia, Colombia, Ecuador, and Perú. Similarly, registration of chemical pesticides is harmonized by the Central American Technical Regulations (Reglamento Técnico Centroamericano) in Costa Rica, Guatemala, Honduras, Panama, and Dominican Republic, where the authorization of a pesticide in one member state can be used for mutual recognition in another member state.
The harmonization of registration processes and mutual acceptance of efficacy and residue data within LatAm countries, as well as simultaneous pesticide registration in multiple countries, and establishment of a regional Technical Working Group to tackle common challenges related to pesticide registration and data sharing would bring benefits to many countries in the region.
ABG: What are the top three countries facing the biggest changes and how are they coping?
AB/PP: Probably Argentina, Brazil, and Mexico. Being the adaptation to biotechnological advances and new policies on environmental risk assessments and the banning of pesticides are the biggest changes manufactures are coping with.
Argentina updated its regulatory policies on the environmental risk assessment (in particular for genetically modified crops), basing the revisions on the current global scientific advances and the experience accumulated in the last decades and lessons learned. The continuous process of updating regulatory policies allows the Argentinian regulators to efficiently address new challenges.
Brazil has published a new decree regulating the registration of agrochemicals with the aim of reformulating the process of analyzing registers, facilitating research, and updating the rules on the use of the import and export of agrochemicals. This new decree aims to enable registration of innovative and less toxic products and to simplify the registration process and reduce the number of applications (e.g., by making deadlines more feasible, simplifying demonstration of efficacy).
Timelines and requirements have been defined according to technical complexity criteria. If an applicant submits several applications of different products with similar specifications, the number of required studies related to the verification of agronomic efficacy will be reduced if these products contain an already registered active ingredient.
A new ordinance has also been published to set out criteria for prioritizing agrochemical registration processes based on pests, weeds, and diseases of most concern. Moreover, new proposals have been approved to develop a new legislative framework regulating the production, commercialization, and use of agricultural biological controls. Brazilian authorities also aligned to many other countries policies and banned and withdrew several product registrations of herbicides and pesticides.
In Mexico, a new decree has been published to phase out the use of glyphosate along with all genetically modified maize by 2024. The Ministry of Agriculture sent a message to the industry to draw the attention to agrobiotechnology and organic agriculture.
ABG: Are there any major differences between how various countries view these products?
AB/PP: Major differences can be found on how countries regulate biological products. Biological products are often regulated under the same regulation than chemicals (this is the case of Brazil), rather than under a dedicated regulation.
ABG: What regulatory changes have occurred in the past year or two that caused manufacturers and distributors to change how they develop, manufacture, and/or distribute products?
AB/PP: In the recent past, some countries in Central and South America adopted new legislative frameworks to move toward the harmonization of the registration process, obliging manufacturers and distributors to meet new and stricter requirements related to the use of chemical pesticides.
ABG: How do you see the regulatory environment changing over the next few years?
AB/PP: In view of stricter environmental laws, regulations are becoming tighter. More requirements will be set out, and more time to develop the product and launch the product to the market will be needed.
ABG: What can manufacturers do to take advantage (or manage) any regulatory changes/trends?
AB/PP: Manufacturers should actively participate in public surveys and commenting on draft regulations to be able to cope with policy changes and be always at the forefront as specialist in agriculture and in sustainability.
ABG: What else do we need to know?
AB/PP: Latin America is an important region for the agricultural sector and it has been long associated with the production and export of food and agricultural commodities. In this context, Latin America is seen as a pivotal supplier of agricultural commodities to a growing world population, and it is not surprising that international trading companies have been investing around this region. Yet, the structure of the region’s agriculture is very diverse, as is the regulatory legislative framework (varying from country to country).
Harmonization of regulatory legislative frameworks, as well as allowing the simultaneous registration in multiple countries and/or the application of mutual recognition of products, would prompt the transition of Latin America agricultural (emerging) market into a developed market. On the other hand, regulatory harmonization comes along with the implementation of stricter requirements. This obligates manufacturers to take necessary measures so that the manufacturing process and its monitoring ensure compliance of the manufactured products. The implementation of tighter regulatory frameworks also entails that authorities, regulators, and subcontractors align with these stricter requirements (e.g., providing in-country infrastructures and services).
How will the regulatory landscape evolve in the near future is unknown. However, if there is something of which we are certain, is that the regulatory gaps will be narrowed via strengthening and harmonization. If Latin American countries start to harmonize their regulatory framework and companies foresee big financial incentives, the market will increase.
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