3.100.  In 2016, Law No. 941 created the National Commission for the Registration and Control of Toxic Substances (CNRCST).[136] The CNRCST is responsible for "regulating, implementing, facilitating, developing and coordinating policies, actions and activities related to the import, export, production, marketing, distribution, use and consumption of everything relating to toxic substances".[137]

3.101.  MIFIC is the authority responsible for submitting notifications to the WTO Committee on Sanitary and Phytosanitary Measures (SPS) through the Directorate of Standardization and Metrology's Information and Notification Office. The Ministry of Health (MINSA) is responsible for sanitary measures applied to imports of processed foods. MARENA, through its Directorate‑General of Natural Heritage and Biodiversity, is the competent authority for biodiversity conservation

3.102.  The purpose of the Basic Law on Animal Health and Plant Health (Law No. 291 of 1998) is to establish key provisions to protect the health and conservation of animals, plants and animal and plant products and by‑products from the harmful effects of pests and diseases with a strong economic, quarantine and social impact, while protecting sustainable agricultural activity, human health, natural resources, biodiversity and the environment

3.103.  In 2012, the Law on the Conservation and the Sustainable Use of Biodiversity (Law No. 807) was adopted to "regulate the conservation and sustainable use of biodiversity in Nicaragua, ensuring equitable participation in and sharing of the benefits of biodiversity, with special emphasis on indigenous communities and communities of African descent, and upholding and recognizing the local communities' intellectual property rights and traditional and customary forms of use".[138]

3.104.  Nicaragua also applies the Central American Regulations on Sanitary and Phytosanitary Measures and Procedures as part of the trade facilitation process in the region. COMIECO's resolutions include: COMIECO Resolution No. 175‑2006, which contains a list of products and by‑products of plant origin which, by their very nature, are exempt from import authorization and phytosanitary export certificates and may be inspected within the territory of the member countries of the customs union; Resolution No. 219‑2007 (COMIECO‑XLVII), which sets out the procedure for authorizing the international and regional transit of consignments of agricultural goods; Resolution No. 338‑2014 (COMIECO‑EX), which is the sanitary and phytosanitary directive for the facilitation of trade in Central American consignments and goods, listing products and by‑products of plant and animal origin. These products may be subjected to random inspection at the point of entry into CACM territory only if their nature needs to be verified physically. The CACM member countries mutually recognize each other's sanitary registers of food for human consumption

3.105.  During the period under review, Nicaragua harmonized sanitary export certificates for goods of animal origin with Mexico, Chile and Central America. Currently, the requirements for importing live bovine animals for reproduction, as well as some sanitary requirements for importing live animals and aquaculture‑sourced products, are aligned with those of Panama, Honduras, Mexico, Ecuador, El Salvador, Costa Rica and Guatemala. Certain requirements, mainly for products of animal origin, may change on account of some countries having a different health status

3.106.  Nicaragua is a member of the Codex Alimentarius and the World Organisation for Animal Health (OIE) and a contracting party to the International Plant Protection Convention (IPPC). Nicaragua took over the General Secretariat of the OIE Regional Commission for the Americas in 2019. On 22 May 2018, Nicaragua was certified as having a negligible risk for bovine spongiform encephalopathy (BSE).[139] According to the authorities, in determining sanitary or phytosanitary requirements as a condition for permitting imports, risks are assessed on the basis of the health status of the exporting country and the goods to be imported, in accordance with OIE, Codex Alimentarius and IPPC recommendations

3.107.  Between 2012 and 2019, Nicaragua notified the WTO of 67 sanitary and phytosanitary measures and draft measures, of which around 20% relate to standards issued by one of the three standardization organizations explicitly mentioned in the SPS Agreement. The great majority of notifications allow a period of 60 days for making comments. In general, the drafting and review of SPS measures follow a procedure similar to that used for NTONs (Section 3.3.2). However, SPS measures may also be issued as Ministerial Decisions drawn up by the competent authorities, in which case the measures are not subject to a centralized review procedure

3.108.  Importers of agricultural inputs (veterinary drugs and related products, products used in animal feed and agricultural products and inputs, botanical and microbiological pesticides, bioinputs, biosolids and related substances) are subject to registration requirements with IPSA. Registration for agricultural establishments is possible online and is issued once the requirements have been met

3.109.  Moreover, Nicaragua does not permit imports of food, plants, animals or derived products unless IPSA or MINSA, whichever is competent, has issued a sanitary/phytosanitary import permit or, in the case of food, a free sale certificate. To obtain those documents, it is necessary to submit a phytosanitary and health certificate and a certificate of origin, based on the risk associated with the products and the origin of the products. IPSA maintains a database which can be used to make searches for the sanitary and phytosanitary requirements with which products and by‑products of animal or plant origin must comply. Pharmaceutical products, medical devices, machinery, equipment, spare parts, inputs and raw materials used in the preparation of pharmaceutical products are subject to registration requirements and to import authorization by MINSA. Importers must also comply with registration and sanitary licensing requirements

3.110.  At present, IPSA and the CNRCST regulate and control agricultural and livestock inputs, as well as the entire input marketing chain at the domestic level, including importers, distributors, marketers and formulators. Various software applications exist for monitoring IPSA‑regulated products, which is done by a group of specialists trained for that purpose. Foreign establishments that manufacture medicines and feed for animals are regulated and monitored

3.111.  No Member has turned to the WTO's formal dispute settlement procedure in relation to matters concerning the SPS measures applied by Nicaragua

3.98.  Major changes have been made to sanitary and phytosanitary requirements since the previous Review. In 2014, the Institute for Agricultural and Livestock Protection and Health (IPSA) was established by Law No. 862.[133] IPSA replaced the Directorate‑General of Agricultural and Livestock Protection and Health (DGPSA) of the Ministry of Agriculture and Forestry as the institution responsible for implementing sanitary and phytosanitary measures related to the production, import and export of plant material, plants, and agricultural, aquaculture and fisheries products and by‑products.[134]

3.99.  IPSA is responsible for strengthening prevention, diagnosis, research and epidemiological surveillance; agricultural quarantine; the registration and control of agricultural, aquaculture, fisheries, forestry and agro‑forestry inputs; the registration of importers of consignments and goods of animal origin; and sanitary inspections in establishments processing agricultural, aquaculture and fisheries products and by‑products of animal and plant origin. IPSA is also responsible for promoting pest and disease management, control and eradication programmes and campaigns; emergency agricultural health arrangements; the accreditation of professionals and businesses for sanitary and phytosanitary programmes and other domestic and international harmonization and coordination mechanisms. IPSA will create the register for radioactive veterinary products of biochemical origin and animal feed, as well as agricultural inputs not listed in the National Register of Pesticides, Toxic Substances, Hazardous Substances and Other Similar Substances.[135]

3.82.  The institutional and legal framework for standards and other technical requirements has changed little since the previous Review. MIFIC coordinates the National Quality Assurance System (SNC) and chairs the National Commission on Technical Standardization and Quality (CNNC), which is the coordinating body and the highest national authority for voluntary and mandatory standardization. The Commission has 17 members who represent the private sector, the scientific and technical sector, consumers and public institutions

3.83.  The Information and Notification Office (OIN), under MIFIC's Directorate of Standardization and Metrology (DNM), is the enquiry point provided for in the Agreement on Technical Barriers to Trade (TBT Agreement) and is also responsible for implementing the provisions of that Agreement related to notification procedures.[121]

3.84.  The National Accreditation Office (ONA), attached to MIFIC, is a non‑profit public entity that administers the National Accreditation System for conformity assessment bodies. Currently, the accredited bodies in Nicaragua comprise 14 testing laboratories, four calibration laboratories and one inspection body. ONA has also signed three mutual recognition agreements with the Inter‑American Accreditation Cooperation (IAAC) and the International Laboratory Accreditation Cooperation (ILAC), which cover test laboratories, calibration laboratories and inspection bodies

3.85.  In 2015, Nicaragua opened the new physical facilities of the National Metrology Laboratory (LANAMET) and the Food Technology Laboratory (LABAL).[122] LANAMET is responsible for ensuring and maintaining the traceability of national measurement standards and acts as a reference laboratory for industrial and legal metrology and for test laboratories and calibration laboratories. LANAMET protects national standards for physical quantities of mass, volume, pressure, temperature, force, power and length. LABAL provides food‑analysis services.[123] Controls on conformity with technical regulations are carried out by the respective competent authority at the point of entry into Nicaragua or at points of sale, as appropriate, through on‑site inspections and sampling

3.86.  The DNM coordinates the development of Nicaraguan technical standards (NTN), which are voluntary, and Nicaraguan Mandatory Technical Standards (NTONs, referred to as technical regulations by the WTO) through various technical committees, the most significant of which are for veterinary medicines, milk and dairy products, meat and meat products, fish and fisheries products, conformity assessment, food additives, building material and microbiological criteria. The technical committees work in the different areas of standardization (NTN and NTON), according to their sphere of competence. They are made up of professional and technical staff from the public and private bodies and entities in the sectors with an interest in standardization/regulations and are entrusted with the drafting and review of proposals for both mandatory and voluntary technical standards.[124]

3.87.  A list of Nicaragua's mandatory technical regulations is available on the DNM's website.[125] In December 2019, there were 289 NTONs in force. Of those, 104 were in the food sector, 31 were related to the environment, 43 to agriculture and health protection, 24 to hydrocarbons, and the rest covered a range of areas such as pesticides, pharmaceutical products and transport

3.88.  Between 2012 and 2019, Nicaragua adopted 153 NTNs and 90 NTONs, including technical regulations harmonized at the CACM level, with some of the measures dealing with conformity assessment procedures. During the same period, Nicaragua notified the WTO Committee on Technical Barriers to Trade of 62 draft technical regulations relating to international trade measures. By December 2019, around 90% of NTNs and 15% of NTONs were based on international standards

3.89.  Standardization, accreditation and metrology activities are governed by the Law on Technical Standardization and Quality (Law No. 219) and its implementing regulations[126], and the Metrology Law (Law No. 225) and its implementing regulations.[127] Nicaragua also applies the provisions laid down by COMIECO within the framework of the CACM for the preparation of Central American Technical Regulations

3.90.  The purpose of Law No. 219 is to order and integrate the activities of the public, private, scientific and technical sectors and consumer activities in order to prepare, adopt, adapt and review technical standards. The Law establishes a uniform procedure for developing technical standards, similar to the procedure used internationally. It also created the CNNC. Under this Law, all products, processes, methods, installations, services and activities for which the use or consumption is affected by NTONs must comply with the relevant standards, and those producing or offering them in the national territory must ensure compliance with those standards by means of the appropriate certification. Where a product subject to compliance with a particular NTON fails to meet all the corresponding specifications, its marketing or supply is prohibited forthwith. The Law allows imported products to comply with a standard in force in the country of origin or an international standard in place of the NTON, provided such compliance is certified before and during marketing

3.91.  The procedure for preparing technical regulations in Nicaragua is laid down in the Regulations for the Preparation and Approval of Nicaraguan Mandatory and Voluntary Technical Standards, which were approved at the Second Regular Meeting (002‑98) of the National Commission for Technical Standardization and Quality (CNNC) and are summarized in Box 3.1

3.92.  In the event of a national emergency, the competent public institution may prepare and issue an emergency NTON jointly with MIFIC and the other ministries involved, without going through the ordinary drafting procedure, and order its publication in the Official Journal, La Gaceta. Emergency NTONs may not remain in force for more than six months after publication. If the emergency continues for more than six months, the NTON may be extended for a further six months, in which case a Regulatory Impact Statement indicating the need for an extension must be submitted. MIFIC must justify the extension in coordination with the government entity that participated in preparing the standard

3.93.  The amendment of an NTON follows the same procedure as that followed during its preparation, unless the specifications are obsolete or inapplicable or the purpose of the NTON is to deregulate provisions contained in the standard, in which case, on its own initiative or at the request of the CNNC, the public institution that issued the standard may amend or cancel it without following the same procedure as that used for its preparation

3.94.  The Code of Good Practice annexed to the TBT Agreement has been accepted by the DNM, the Nicaraguan Institute of Water Supply and Sewage Systems (INAA) and the Nicaraguan Energy Institute (INE).[128] The authorities have pointed out that no mutual recognition agreement concerning technical regulations or analytical procedures has been concluded between the competent entities in Nicaragua and their foreign counterparts. Within the context of Central American integration, mutual recognition exists only in the field of registration. Technical regulations harmonized at the CACM level (foodstuffs, medicines, hygiene products and cosmetics)[129] are applied by the member countries

3.95.  Nicaragua participates in the activities of the International Organization for Standardization, the Pan American Standards Commission, the IAAC, ILAC and the Inter‑American Metrology System

3.96.  Within the context of the CACM, the request for the preparation of new technical regulations and conformity assessment procedures or for the revision of those already in force must be submitted by a member State.[130] Requests accepted by the Directors of Economic Integration are forwarded to working subgroups, composed of technical representatives of the member countries, for examination and the preparation of draft regulations. In principle, the WTO public consultation period is 60 calendar days from publication of the notification by the WTO.[131] The internal consultation must be carried out in accordance with each member's own legislation, but the comments received must be examined before the end of the WTO public consultation period. The draft technical regulation or conformity assessment procedure prepared in the working subgroup is submitted to COMIECO for approval. Each member country must publish and incorporate the approved text in accordance with its national legislation

3.97.  The Law on the Protection of Consumer and User Rights stipulates that goods and services sold in Nicaragua must comply with conditions concerning quantity, quality, security and safety, in accordance with mandatory technical standards concerning products, quality, labels, weights and measures and other requirements within the domestic and international regulatory framework for goods and services sold in Nicaragua.[132]