Sep. 13, 2018
Latin America (LATAM) is a growing and increasingly attractive region for biocontrol products. From an European perspective, it is interesting to see what those countries that are exporting food and animal feed to Europe have set as a national regulatory framework for biocontrol products.
In countries like Costa Rica, the influence of the US Environmental Protection Agency plays an important role when defining the national data requirements and procedures to registration. Costa Rica is here used as an example and its data requirements for microbial and botanical pesticides will be briefly presented.
The national regulations in Costa Rica define “Biopesticide” as “natural pesticides derivate from: plant extracts, microorganisms or substances released by them”. In this context, bioactive substances produced by microorganisms are included in the definition.
While the National Law 7664 of 1997 and the Decree N° 33495 of 2007 covers the conventional pesticides in Costa Rica, the microbial and botanical pesticides have been considered to be an individual type of pesticide in Costa Rica, and have their own regulation. Invertebrates and nematodes also represent a separate category of biopesticides in the country. Beneficial arthropods and nematodes for agricultural use as plant protection products are regulated by the National Technical regulation N° 33103, which exists since 2006.
Biopesticides registered in Costa Rica
In 2018, around 137 “bioactive substances” have been registered in Costa Rica. From the biopesticides registered for crop protection purposes: 56 are microbial pesticides, 36 are botanical products, and 45 are invertebrates. USA is the main provider for microbial and botanical pesticides in Costa Rica. Bacillus species are the most commonly registered in the country.
The biodiversity law, the phytosanitary law, the conservation and wildlife law, and related legislation are part of the regulatory framework for biopesticides in Costa Rica. The registration of a biopesticide product is valid for 10 years in the country and needs to be renewed after that period.
The regulations for biopesticides in Costa Rica have set up the data requirements for the different biopesticides. Some requirements (studies) are clearly difficult to present and, as in Europe, technical-scientific justifications should be submitted to the authorities. Costa Rica has recognized the lack of international guidelines for these “kinds” of pesticides and encourages the applicants to use a case-by-case approach in such situations.
The registration process for biopesticide products was established based on the assumption that less data is requirered when compared to a conventional pesticide, while keeping the risk assessment approach. The dossier is to be submitted in Spanish, along with national efficacy data and other national regulatory forms, and is comparable to any other registration of a Plant Protection Product.
The regulation for botanical pesticides is the Regulation N° 346-2014 which entered into force in December 2014. This Regional Regulation[ Reglamento Técnico Centroamericano (RTCA) 65.05.62.11 Plaguicidas Botánicos de uso Agrícola. Requisitos para el registro], and its annexes, is a joint effort of the Central Latin-American countries – Guatemala, Honduras, El Salvador, Costa Rica, Nicaragua, and Panama – to established more harmonized data requirements for botanical pesticides in the region.
This regulation has been applicable for all dossiers submitted since December 2014.
The identity of the botanical active (Point 5.2.1 of the regulation) request:
5.2.2 (a) common name and synonym of the plant used for “extraction”
5.2.2 (b) scientific name and variety of the plant used for “extraction”
One particularity for botanicals in the country is that the botanical extract used to formulate the plant protection product should be first registered by the national competent authority in Costa Rica (SFE, Servicio Fitosanitario del Estado), as established under point 4.20 of the regulation N° 346-2014. This should be done prior to importing the active substance.
In 2017, also in the framework of Guatemala´s Protocol, the Regulation 383-2017 was signed by the same central Latin-American countries which signed the Botanical Regional Regulation (Regulation N° 346-2014). The new law sets up the registration requirements for microbial pesticides for agricultural use, but only for the active ingredients. The Regulation 383-2017 repealed the Regulation N° 297-2012 (COMIECO-LXIV) from 11 of December 2012 (Decree N° 37561-MAG-MEIC-COMEX (in force since 2013).
All technical sections are addressed, studies at the strain level are requested, and there is only a reference to the American guidelines (OCSPP). This new law entered into force from 28th July 2017 onwards.
For the identity of the microorganism, among others, the life cycle, the history of the microbial agent, and information of the presence of the microorganisms in Costa Rica should be addressed.
The toxicological section is comprised of mainly acute routes of exposure and data on the acute pathogenicity properties of the strain in non-target organisms (OPPTS 885.4000).
Examples of some of the data requirements requested for biopesticide registration in Costa Rica are summarized in the table. OECD requirements are listed as a reference for comparison purposes: