3.131.  Since 2014, there have been no structural changes to the main legal instruments that regulate the phytosanitary system in Panama.[279] However, since the animal and health situation at the global, regional and local levels is constantly evolving, new regulations are issued as required by circumstances.[280] Furthermore, a law passed in 2021 modified the powers of the institutions that develop and implement sanitary and phytosanitary measures.[281]

3.132.  When Panama's Protocol of Incorporation into SICA entered into force in 2013, the country adopted the Central American Regulations on Sanitary and Phytosanitary Measures and Procedures (COMIECO Resolution No. 271-2011).[282] As a result, it had to adopt certain changes to its SPS system to bring its measures into line with the measures in place in the rest of the region. The changes included those related to requirements for producing and marketing certified seeds of staple grains and soya and requirements for developing labels and pamphlets.[283]

3.133.  The Panamanian Food Safety Authority (AUPSA), which used to issue safety standards for imported foods, including those in transit and transhipment, was dissolved in 2021 and replaced by the Panamanian Food Agency.[284] MIDA is responsible for plant and animal health measures; the Ministry of Health is responsible for measures related to food safety, animal disease control and food-borne diseases; and MICI is responsible for measures related to technical standards and management of the implementation of international trade agreements (Box 3.8)

3.134.  APA is an autonomous state body subject to the policies and guidelines of the three ministries mentioned above. Through the Integrated Procedures Scheme,[285] APA ensures that food production, import, export, transit and transhipment requirements are met, in accordance with animal health, plant health, quarantine and safety regulations and international trade rules. Source: Information provided by the authorities

3.135.  The National Directorate for the Administration of International Trade Agreements and Trade Protection is responsible for notifications to the WTO. MIDA, through the DNSV, is the national enquiry point that was notified to the WTO.[286]

3.136.  Between 2014 and 2021 (September), Panama submitted 18 regular SPS notifications to the WTO, none of which was an emergency measure. The SPS measures that Panama has notified to the WTO are based on the recommendations of international organizations. The affected products include flours, meals and pallets of fish; molluscs; aquaculture fish, freshwater and saltwater fish, shrimps and prawns, lobsters, crabs and dairy produce. Panama also notified the WTO that it had abolished AUPSA and replaced it with APA. During the period under review, WTO Members raised five concerns regarding Panama's sanitary and phytosanitary measures. These concerns related to restrictions imposed on imports of animal and plant products in general, imports of specific products (beef and poultry meat, potatoes and onions) and delays in the renewal of authorizations for plants of fishery and livestock enterprises.[287] In this context, Costa Rica requested WTO consultations regarding measures related to imports of certain products (DS599).[288]

3.137.  All imports of live animals and plants, fresh fruit and vegetables, and grain are tested in the laboratory at the point of entry into the country to verify that they meet sanitary and phytosanitary requirements. For all other products, random tests may be carried out at the border based on the product's risk and origin and the importer's background. Such tests take into account international sanitary or phytosanitary warnings and any cases of non-conformity detected in previous imports

3.138.  When products subject to a phytosanitary requirement established by the DNSV enter Panamanian territory, they must be accompanied by an import permit (plant and animal health import permit) issued by the Executive Directorate of Agricultural Quarantine (DECA). In accordance with phytosanitary standards, if a pest risk analysis (PRA) is required, DECA must inspect the imported plants, plant products and phytosanitary inputs imported before the shipment is released.[289] Sometimes, samples are sent to official DNSV laboratories for analysis. Panama accepts laboratory analyses conducted in other countries if the laboratories are accredited, but reserves the right to carry out its own tests once the product reaches Panamanian territory. Upon inspection and review of the import documents, the phytosanitary authority may require that the goods be processed, isolated, re-exported or destroyed at the cost of the importer. Inspections may be carried out at any time. DECA carries out inspections and technical measures.[290]

3.139.  If there is no phytosanitary import requirement, the DNSV shall establish one at the request of the user and/or importer. Once the DNSV's Section for Pest Risk Analysis and Phytosanitary Requirements has analysed the information provided by the importer (type of product being imported (seeds, grain, plants, seedlings, rooted cuttings, slips, rhizomes or tubers), the scientific and common name, the country of origin and provenance, and the supplier's details), determines whether or not to conduct a PRA study. If a PRA study is required, the DNSV will ask the National Plant Protection Organization for the information needed to certify the origin of the product or by-product being imported and to develop the PRA study.[291]

3.140.  Based on a risk assessment study, the National Animal Health Directorate (DINASA) establishes the animal health requirements for introducing into Panama animals, animal products and by-products, medicines exclusive for veterinary use, and biological, biotech, chemical and food products used for and consumed by animals. Likewise, it authorizes certain areas, countries and regions to export to Panama live animals and animal products other than those for human and animal consumption. When an importer first imports live animals, products of animal origin or plants or products of plant origin, pre-inspection at origin of the processing facilities or processing plants is required. This is done by through a risk analysis by DINASA that follows the recommendations of the relevant international organizations (such as the World Organisation for Animal Health). Based on the analysis, DINASA proposes animal health standards for the import, export, transit and movement of live animals and supervises and monitors compliance with the standards. Sanitary measures may be imposed through a law, executive decree, ministerial decision (resuelto) or resolution.[292]

3.141.  A plant and animal health import permit is required to import live animals and animal products. The competent authority in the country of origin must certify that the product to be exported meets the corresponding animal health requirements. These permits are issued by DECA before the goods reach Panamanian territory. If all the correct information is provided, approval of the permits normally takes 24-48 hours. DECA reserves the right to assess, approve or reject an application. Once the goods reach Panamanian territory, DECA may decide to quarantine animals, as well as any animal products or by-products if it is suspected or it is clear that they cause damage to the health of animals. When it is confirmed that the goods are dangerous, DECA may determine their destination. Goods or products that are considered dangerous may be returned or destroyed, with the applicant or importer responsible for all costs. When the licence application is for live animals, a spot must be requested at the quarantine stations before the permit is authorized. The live animals must then be quarantined at one of Panama's two stations, which are in Tocumen and Paso Canoa.[293] Animals in transit must also be quarantined at one of the stations

3.142.  Since 2021, food safety has been the responsibility of the Ministry of Health after the Government abolished AUPSA, the organization previously responsible for issuing manuals containing the procedures and instructions for importing food.[294] [295] The National Food Inspection and Veterinary Supervision Directorate is responsible for monitoring, prevention and control in terms of the quality and hygiene of food for human consumption and in terms of foodborne illnesses.[296] MICI is responsible for the purely commercial formalities required for food imports

3.143.  Panama allows the import of genetically modified products. The National Biosafety Commission for genetically modified organisms issues decisions (resueltos) approving and refusing entry to imports based on a risk analysis conducted by the corresponding Sectoral Biosafety Committee (agricultural, environmental and public health). Depending on the outcome of the risk analysis and the use of the genetically modified organisms (import, export, production or consumption), the Committee approves or rejects the import and issues a recommendation to the Commission

3.122.  The provisions related to technical standardization, conformity assessment, accreditation and quality certification are set out in the same laws that were in force in 2014. According to information provided by the authorities, no substantial changes have been made to those laws (Table 3.15). Source: WTO Secretariat

3.123.  MICI's Directorate-General of Standards and Industrial Technology (DGNTI) remains the only body authorized to develop standards and technical regulations in Panama. The DGNTI is also the national standardization body and the WTO enquiry point.[272] The roles of the DGNTI have not changed substantially since 2014. As the national standardization body, it develops, adopts or adapts standards for industry, trade and services. It is also authorized to establish agreements with national and international institutions and to conclude mutual recognition agreements with the bodies responsible for certifying and inspecting testing and metrology laboratories. Moreover, it is responsible for monitoring and verifying compliance with technical standards and technical regulations and it penalizes manufacturers and importers

3.124.  Several institutions support the DGNTI with its work. One such institution is the Panamanian Industrial and Technical Standards Commission (COPANIT), which is composed of representatives from the public and private sectors. The Commission reviews draft standards prepared by the technical committees and submits recommendations to the DGNTI during the period of public discussion. The DGNTI is also supported by the National Accreditation Council (CNA), which is responsible for accreditation, and the National Metrology Council (CNM), which develops metrology‑related regulations

3.125.  The goal of the standardization policy is to develop voluntary technical specifications to be used as a benchmark for improving the quality and safety of technological, scientific and industrial activities as well as services. Technical regulations are developed based on objectives that include national security requirements, the prevention of deceptive practices, the protection of human health or safety, the protection of animal or plant life or health, and the protection of the environment. Before a procedure to draft a technical regulation is initiated, the DGNTI evaluates whether the application reflects these objectives

3.126.  The procedures for developing national technical regulations have not changed substantially during the period under review (Chart 3.3). The procedure for preparing, updating and revising standards is the same, unless the public consultation process is conducted only at the national level. To make the technical standards and regulations official, the corresponding Ministerial Resolution is drawn up without the technical content and is published in the Official Journal. Technical regulations are usually revised every five years, or when there is a request to revise, update or adapt them. Source: WTO Secretariat, based on information provided by the authorities

3.127.  The DGNTI is also responsible for conformity assessment procedures, with the support of other public institutions. It accepts foreign technical regulations that differ as equivalent, provided that they meet the objectives of the Panamanian regulations. It also establishes mutual recognition agreements for conformity assessment procedures. Before they place a product on the market, manufacturers and importers must prove that the product complies with relevant technical regulations by presenting a certificate of conformity issued by a certifying body. Panama recognizes certificates issued abroad. The sampling, testing and analysis required to obtain a certificate of conformity must be carried out by laboratories and inspection agencies that are duly accredited by the accreditation body

3.128.  The CNA is responsible for accrediting Panamanian or foreign public and private conformity assessment bodies (OECs).[273] Its quality system and its accreditation processes are based on international accreditation standards (International Organization for Standardization (ISO) and ISO/International Electrical Commission (IEC)) and follow the guidelines of International Laboratory Accreditation Cooperation (ILAC), the International Accreditation Forum (IAF) and Inter-American Accreditation Cooperation (IAAC).[274] The CNA currently offers accreditation services to testing laboratories, calibration laboratories and inspection bodies.[275]

3.129.  The CNA notifies OECs of any changes in the accreditation requirements. OECs that are recognized, accredited or in the process of becoming accredited may use the accreditation symbol. The CNA may fully or partially suspend accreditation for up to six months. During their suspension, OECs may not issue or use documents that mention accreditation or recognition. During the period under review, 19 OECs lost their accreditation. There were 58 accredited national bodies in 2021: 31 testing laboratories (of which four are public), 3 calibration laboratories and 24 inspection bodies

3.130.  Between 2014 and 2021 (September), Panama notified the WTO of 74 new technical regulations on quality requirements; the protection of human, animal and plant health; protection of the environment; and consumer protection and information (labelling). Most are based on Central American Technical Regulations (RTCAs).[276] Panama also notified the WTO of amendments to 19 technical regulations that had already been notified. Between 2013 and 2021 (September), Panama's technical regulations were the subject of a specific trade concern raised before the WTO Committee on Technical Barriers related to the harvest life and sprouting requirements of onions and potatoes.[277] Panama has catalogues containing technical standards, technical guides and technical regulations. Panamanian technical standards and technical guides are sold at the DGNTI's Regulatory Information Centre.[278]