“…it takes an average of 4 – 4,5 years for the approval of a registration…”
Jorge Armando Aranibar Monrroy is the president of the Association of Suppliers of Agricultural and Livestock Inputs, Goods and Services from Bolivia – Aprisa, manager of Crystal Chemical Industries, with a degree in agronomy from EAP Zamorano, and MBA from the Bolivian Catholic University.
Jorge Aranibar, president of Aprisa
AgriBrasilis – How long does it take to register pesticides in Bolivia? Why?
Jorge Aranibar – Currently, with the application of the Andean legislation (Decision No. 804 and Resolution No. 2075), it takes an average of 4 – 4,5 years for the approval of a registration from the filing of the request before Senasag (National Agricultural Health and Food Safety Service) and then before the Ministries of Environment and Health.
Due to non-compliance with the provisions of the Andean legislation, which indicates that the request must be submitted to Senasag and that it must coordinate the toxicological and ecotoxicological evaluations with the Ministries of Health and Environment, centralizing the evaluations, the request is currently submitted to Senasag together with the corresponding dossier to the Ministry of the Environment, but the dossier for toxicological evaluation is submitted independently to the Ministry of Health.
On the other hand, evaluation deadlines are not being respected: Administrative Resolution No. 03/2022 establishes that evaluations must be carried out within 180 days and are currently being carried out after one year.
A suggestion to try and remedy this is, when hiring new professions for the evaluation of pesticide registration requests, consideration should be given to hiring personnel with the necessary knowledge of the issues, as well as avoiding continuous changes or job rotation.
“…when hiring new professionals for the evaluation of applications, consideration should be given to hiring personnel with the necessary knowledge of the issues…”
AgriBrasilis – What changed with the inclusion of the Ministries of Health and the Environment in the registration process?
Jorge Aranibar – The creation of three pesticide registration authorities instead of one, new evaluation criteria, more bureaucracy and delays in evaluations.
AgriBrasilis – What is the cost to register a pesticide product in Bolivia? And what are the steps?
Jorge Aranibar – Currently it costs between US$ 8 thousand and US$ 10 thousand to register a pesticide in Bolivia. The steps are as follows:
- Hiring a professional accredited as a field effectiveness analyst, who prepares the Field Effectiveness Protocol to be presented to Senasag and proceeds with its analysis and approval;
- Preparation of the Import License for the commercial sample for the field effectiveness test and the Import License for the commercial and standard sample to carry out the quality control analysis in a laboratory accredited by Senasag;
- Nationalization of samples;
- Sealing the samples for field effectiveness tests and quality control analysis;
- The effectiveness test is carried out in two locations by the accredited tester and the sample is analyzed in the accredited laboratory;
- Once the test has been completed, the test and quality control analysis have been carried out, the technical dossier is prepared;
- Submission of the request with the technical dossier accompanied by the requirements to Senasag and the Ministries of Health and the Environment for the agronomic, toxicological and ecotoxicological evaluation;
- Approval or not of agronomic, toxicological and ecotoxicological technical reports and their submission to Senasag;
- If three favorable opinions are issued, the Risk/Benefit analysis (Senasag) is initiated;
- Once the Risk/Benefit is completed, the pesticide registration is issued.
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