Ministerial Agreement No. 063-2023: Technical Guidelines for the Use of Seeds or Crops Obtained through Precision Breeding Techniques

Ministerial Agreement No. 063-2023, issued by Ecuador's Ministry of Agriculture and Livestock on September 13, 2023, and published in Official Gazette No. 479 on January 17, 2024, establishes technical guidelines to determine whether seeds or crops obtained through precision breeding or genome-editing techniques may be registered or marketed as conventional, in accordance with the Organic Law on Agrobiodiversity, Seeds and the Promotion of Sustainable Agriculture and its implementing regulations. The agreement applies to public and private individuals and legal entities seeking to research, develop, plant, conduct field evaluations, import, export, transport, store or market seeds and crops obtained through these techniques. It establishes a Preliminary Analysis Request (SAP), under which the Technical Seed Committee (CTS) assesses the scientific and technical information submitted to determine whether the final product contains a novel combination of genetic material or foreign genetic material. Where no such combination is identified, the CTS informs the applicant that the product may be registered as conventional; where foreign genetic material incorporated into the genome is identified, the CTS informs the National Biosafety Commission (CONABIO). The agreement also provides for a voluntary Preliminary Guidance Consultation (COP) for early-stage research projects, technical coordination and regional harmonization of assessment criteria. It establishes an assessment and classification procedure rather than a blanket authorization for all genome-edited organisms or a program for financing research or distributing seeds. For PAESA purposes, it is a national regulatory framework directly related to agricultural biotechnology and the governance of genome editing.