Bill 51.

Summary.

The bill would create a regulatory framework for bioinputs and related substances used in agricultural production in the Republic of Panama. It seeks to promote research, education and new methods of use so that artificially synthesized chemical products are gradually used less. The Executive Branch (Órgano Ejecutivo), through the Ministry of Agricultural Development (Ministerio de Desarrollo Agropecuario) and the Ministry of Economy and Finance (Ministerio de Economía y Finanzas), would promote technical and scientific support programs and financial and tax incentives for the natural biological products industry. The Ministry of Agricultural Development, through the National Plant Health Directorate (Dirección Nacional de Sanidad Vegetal), would administer the framework. The bill defines covered products, agents, operators, tests, controls and procedures, and classifies bioinputs as biofertilizers or biological control agents.

The National Plant Health Directorate would register products, oversee their quality and supervise their handling and application. It would also prepare procedures, set tolerances for impurities and contaminants, and authorize laboratories. Activities involving products that fail to meet statutory or regulatory parameters would be prohibited. Efficacy trials would have to be completed before registration and accompanied by protocols and validation. The bill would allow the recognition of efficacy trials for products with the same guaranteed composition, where the studies were conducted in the Republic of Panama or countries with similar agroecological and climatic conditions and the relevant registration holder had given prior approval.

The bill establishes a technology based traceability system managed by the National Plant Health Directorate to track production, marketing, imports and exports. It distinguishes tracking of incoming raw materials, internal processing and distribution of finished products. Laboratories and production plants would need facilities designed to prevent contamination. Registration of microbiological active ingredients and natural substances would require information on identity, origin, characteristics, manufacture and behavior; mixtures would require information on each active ingredient. Formulated products would require data on composition, stability, application and effects on human health and the environment. Labels for domestic and imported products would state composition, quality, origin, batch, expiry, use and storage information, and would be permanent, visible and in Spanish. Export labels could meet destination country requirements.

Sale, agricultural use and importation would require prior registration. Products imported or marketed domestically would carry the approved label and leaflet on their containers and packaging. The authority could collect samples to verify composition and quality. In certain cases, a certificate issued at origin could replace the initial analysis of an imported product, while the authority would retain its power to verify it. For exports, the authority could issue free sale certificates and permit adjustments to destination market requirements. The State would provide resources for the National Plant Health Directorate’s laboratories, and the Ministry of Agricultural Development could confer official status on other authorized laboratories.

A National Registration System for Bioinputs and Related Substances would cover domestically produced and imported products. Persons engaged in reproduction, formulation, importation, packaging, exportation, storage or marketing would have to register and submit a file with certificates and composition data. Documentation would be in Spanish or accompanied by an official Spanish translation; applicants would pay for analyses and could request confidential treatment of composition information. Registration and renewal would each last ten (10) years. Each application would cover a single product, although it could include several brands. Labels, leaflets and studies supporting product properties, efficacy and toxicological data would be required. The bill governs the use of product names, justification when a technical requirement does not apply, and grounds for refusing, suspending, cancelling, renewing or changing registrations. Suspension would restrict activities involving the product and provide three (3) months to remedy the cause. The authority could also restrict products shown by technical and scientific grounds to be harmful. The Ministry of Agricultural Development would set service fees by resolution published in the Official Gazette.

The National Plant Health Directorate would inspect establishments and set transport conditions. Participants in the supply chain would preserve the integrity of containers, labels and products during storage and distribution. The Directorate would also supervise compliance, inspect and collect samples at any stage. Any citizen or institution could report an offense; where composition or quality differs from registered or supplied information, a user or requesting institution could seek compensation in court. The bill provides for fines, suspension, seizure, destruction and cancellation or nonrenewal of registration for conduct such as marketing without registration, failing to meet product parameters, selling under a suspended registration or obstructing inspections. It sets fine ranges according to the severity of harm and liability for damage to agricultural or livestock production, the environment or food. Sanctioning decisions would be subject to reconsideration and appeal within the prescribed filing and decision periods. The provisions could concern agricultural producers and users, manufacturers, laboratories, importers and distributors, as well as the Executive Branch, the Ministry of Agricultural Development, the Ministry of Economy and Finance and the National Plant Health Directorate.