3.110.  The regulatory framework for formulating and implementing sanitary and phytosanitary measures has not changed significantly since the previous review in 2015. A vast number of laws, decrees, regulations and resolutions continues to regulate plant and animal health and food safety, despite attempts by the Dominican Republic to update the statute book, as notified to the WTO (Table A3.6).[220]

3.111.  The main institution responsible for developing and implementing sanitary and phytosanitary (SPS) measures is the Ministry of Agriculture, through the Department of Plant Health (DSV) and the Department of Animal Health, which is attached to the Directorate‑General of Livestock (DIGEGA).[221] To prevent the introduction and spread of pests and diseases the Departments of Plant Health and Animal Health are responsible for conducting risk analyses on imports of products and by‑products of plant or animal origin to use as the basis for plant and animal health import requirements.[222] All agricultural products require a sanitary or no‑objection phytosanitary certificate (health permit). The Department of Animal Health operates specific programmes to control and eradicate animal diseases that are classed as priorities, due to their nature and the potential economic losses they could cause

3.112.  The Ministry of Public Health and Social Assistance has responsibility for the safety of processed foods. The Food and Beverage Risk Control Department of the Directorate‑General of Medicines, Food and Health Products (DIGEMAPS) is the national technical and regulatory body with responsibility for conducting health controls on all foods and beverages – during production, transportation, storage, preparation, sale and consumption – in order to reduce the incidence of food‑borne diseases, including imported diseases. The Ministry of Agriculture also has a Department of Food Safety (DIA) (Resolution No. 18/2005, amended by Resolution No. 27/2006). This Department promotes agrifood safety at primary level through training and the implementation of the food risk management system in order to promote the supply of agricultural foods of a high sanitary quality for domestic consumption and export

3.113.  The National Committee for the Application of Sanitary and Phytosanitary Measures (CNMSF) brings together various public and private sector entities to manage the implementation of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures and the commitments undertaken by the Dominican State as part of other regional and bilateral agreements entered into on sanitary and phytosanitary matters and food safety.[223] The Committee also acts as a consultation body when emergencies arise in agricultural health and food safety, and recommends the most appropriate measures and mechanisms that the designated national authorities should introduce to mitigate the emergency's impact.[224] Additionally, the Office of Agricultural Trade Agreements (OTCA) at the Ministry of Agriculture is the body that negotiates and administers international arrangements on agricultural matters.[225] The Dominican Republic notified OTCA at the Ministry of Agriculture and the Executive Secretariat for the CNMSF as national enquiry points and notification authorities.[226]

3.114.  The aim of the sanitary and phytosanitary system of the Dominican Republic is to prevent, by means of three systems, the introduction into the national territory of pests or diseases. Those systems are sanitary and phytosanitary protection at the national borders, surveillance and diagnostic capacity to detect pests, diseases and sanitary issues, and the capacity to respond in agile fashion to emergencies. The Dominican Republic places special emphasis on enhanced border protection through the installation of inspection infrastructure.[227] Thus the aim of the bulk of the import restrictions applied by the Dominican Republic currently is to prevent the entry of pests or diseases into the national territory (Section 3.1.6). Moreover, exporting establishments are inspected and agricultural products for export are certified to ensure the health of Dominican products on international markets

3.115.  The drafting of SPS measures is governed by the regulations of the relevant ministries. There is still no single centralized mechanism for their preparation. However, they are drafted largely along the same lines as those used for technical regulations (Section 3.3.2). According to the authorities, technical working groups are being set up to assess the risks to plant and animal health and their economic impact, as well as how to mitigate them. An action plan is then drawn up to minimize those risks, based on scientific analysis, and is presented to the most senior authorities (the Ministries of Agriculture and Public Health) so that a resolution can be issued and the measure implemented. Generally, sanitary and phytosanitary measures are based on scientific principles, risk criteria and parameters laid down by international organizations such as CODEX, the International Plant Protection Convention (IPPC) and the World Organisation for Animal Health (WOAH). The aim of the measures is to protect the lives and health of people, animals and plants and to preserve the environment while facilitating national and international trade in goods

3.116.  Where the Ministry of Agriculture is concerned, the responsibility for coordinating the formulation, implementation and monitoring of technical regulations lies with each designated national authority (departments of animal health, plant health and food safety)

3.117.  In order to amend or update an obsolete regulation, a multidisciplinary team instructed by the Ministry of Agriculture conducts a study to ascertain whether the regulation is in line with other national regulations and international standards. As a result of their assessment, a draft regulation is drawn up and circulated to domestic authorities and legal advisors in order to obtain preliminary approval. The multidisciplinary team reviews the legal advisors' comments and adjusts the proposal before notifying it to the WTO

3.118.  Imported products that present a risk to human, animal, plant, aquacultural or forest health must comply with the sanitary, phytosanitary, and animal health measures specified in the technical regulations and must have a no‑objection permit

3.119.  Phytosanitary inspections are governed by the Law on Plant Health (Law No. 4990‑58) determining crop zoning and the techniques approved for the production of plant products in order to prevent pests and disease. Inspections are performed when an agricultural operation begins, and are repeated at regular intervals that vary according to the product concerned.[228] Inspections are also carried out in the event of a report of non‑compliance or when requests are made for letters of compliance or export certificates.[229]

3.120.  The Quarantine Division of the Plant Health Department is responsible for phytosanitary inspections that are carried out to identify the presence of pests, disease or other pathogenic agents on products of plant origin. Inspections are conducted of plants, fruits, vegetables and other products and by‑products of plant origin intended for export, transit or domestic consumption. The Plant Health Department issues a Phytosanitary Export Certificate after performing the relevant inspection and ascertaining compliance with the requirements in place at the product's place of destination.[230]

3.121.  The Ministry of Agriculture's Department of Food Safety inspects production units to assess whether they comply with good agricultural practices (GAP), good animal husbandry practices (GAHP), good management practices (GMP) and preventive measures to ensure agricultural food safety.[231] The Quality Management Division of the Ministry's Department of Food Safety issues certificates and letters of compliance for GAP, GAHP and GMP. The certificates are issued at the request of a farming concern, provided that the business complies with 90% of the basic requirements of GAP, GAHP or GMP laid down in Decree No. 52‑08. Letters of compliance are issued to concerns that comply with 80% of basic requirements. Certification is retained on the basis of on‑site inspections that are conducted to ascertain compliance with the requirements

3.122.  Currently (2022) there are three state test laboratories in the Dominican Republic that assess sanitary and phytosanitary compliance. The Central Veterinary Laboratory (LAVECEN), a DIGEGA agency, is the national reference laboratory for the study of animal health and zoonotic diseases, as well as for quality control on food, animal feed, chemical residues in meat, fruit, plants, the quality of agrichemical products, and the production of biological agents and antigens for the veterinary industry.[232] The laboratory of the Dominican Agricultural and Forestry Research Institute (IDIAF) has responsibility for plant protection (bacteriology, mycology, virology and entomology), post‑harvest management, soils and water, plant biotechnology and molecular biology. In addition to the Biotechnological and Industrial Innovation Institute (IIBI), which provides analytical services in respect of microbiology, pesticides, agricultural consultancy, plant biotechnology and safe food practices, there are other accredited laboratories in the Dominican Republic, one of them a private facility

3.123.  During the period 2015‑22, the Dominican Republic made 25 notifications (including addendums and revisions) to the WTO SPS Committee. Twelve were related to food safety or the protection of human health, seven to animal health, four to plant health, and two to both plant and animal health. No emergency measures were issued. During the review period no trade concerns were raised in relation to the measures adopted by the Dominican Republic in this regard.[233]

3.100.  In 2021 the Dominican Republic adopted the Handbook of Good Technical Regulation Practices (GBPRT) based, as the name indicates, on the WTO TBT Code of Good Practice.[199] The Handbook sets out the steps involved in drafting a technical regulation (Chart 3.5). INDOCAL assists ministries as part of the drafting process, providing them with the scientific and technical information that must be taken into account when drafting technical regulations and noting the points where the regulation must be based, whether wholly or in part, on Dominican standards (NORDOM), or on regional or international standards.[200] The draft is assessed by the Technical Committee on Technical Regulations (CTRT) established under the Ministry, in which INDOCAL and Pro Consumidor are represented. The draft is assessed using a regulatory impact analysis (RIA) (Section 2.2). One of the steps is an international public consultation, conducted by INDOCAL (the national authority for TBT notifications to the WTO) and the Directorate of Trade Integration (DIC) of the Vice‑Ministry of Foreign Trade, within the MICM (the WTO enquiry point).[201] Technical regulations must comply with all steps in the procedure, except where emergency technical regulations are concerned: emergency technical regulations are not subject to international public consultation and may be issued only where a product presents risks to health or national security. They must nonetheless be notified to the WTO as soon as they are implemented.[202]

3.101.  Once approved by the CTRT, the Ministry issues a resolution to make the draft an official technical regulation (RT). The Ministry may present the RT to CODOCA's Technical Commission of Experts (CTE) for it to confirm that the RT was drafted in conformity with the GBPRT. Following confirmation, the RT becomes a Dominican Technical Regulation (RTD) and is published in a CODOCA resolution.[203] Currently there is no digital catalogue of technical regulations; according to the authorities, metrological technical regulations (RTMs) and RTDs can be viewed on the INDOCAL and CODOCA websites respectively

3.102.  Technical regulations (RT/RTD/RTM) must be reviewed every five years or, because of the demands of technological or scientific developments, following a request to that end. Nonetheless, the authorities indicated that the bulk of RTs has been subject to this process and that during the review period (2015‑22) only RTMs were reviewed

3.103.  Between 2015 and 2022 (August), the Dominican Republic notified 12 new technical regulations to the WTO and the revision of or addenda to four previously notified technical regulations. The 12 technical regulations notified relate to products such as alcohol, tobacco, LPG, tyres, and metrological and measuring instruments. Two specific trade concerns were raised at the WTO TBT Committee about Dominican technical regulations; they related to cosmetic and hygiene products and steel rebar. Since 2015, only one emergency technical regulation has been notified, relating to alcohol and tobacco.[204]

3.104.  Locally manufactured and imported products must comply with the technical regulations (RT/RTD/RTM) in force in the Dominican Republic.[205] Conformity assessment is performed by ODAC‑accredited conformity assessment bodies (CABs). The bodies may be either Dominican or foreign, provided in the latter case that the Dominican Republic has entered into multilateral recognition arrangements with the CAB's country of origin.[206] The authorities stated that in 2022 there were seven accredited Dominican bodies. ODAC awards foreign CABs a "proof of accreditation" to allow them to operate. During the review period no accreditations were annulled or suspended.[207] In the Dominican Republic, manufacturers may not assess the conformity of their own products. However, consumers are able to assess the conformity of the products they use through Pro Consumidor, which was accredited by ODAC in 2019 as an inspection body.[208]

3.105.  Where imports are concerned, it must be established at the border that the imported product complies with the requirements of the relevant RTD/RTM; accordingly it is recommended that conformity assessment should be performed prior to a good's arrival at its destination in order to expedite customs clearance. The Dominican Republic accepts conformity assessments conducted by foreign bodies that hold "proof of accreditation" issued by ODAC.[209] Equally, importers are able to conduct conformity assessments in accredited laboratories in the Dominican Republic. For example, in order to import measuring instruments, INDOCAL may, after examination of a sample, issue a "type approval certificate" in advance. If the importer fails to present the certificate upon clearance of the goods, the goods will be held for between 5 and 15 business days, which is the period deemed necessary for type‑approval purposes.[210]

3.106.  Original labels must be in Spanish; if not, an additional label must be added in Spanish such that it does not cover the original label.[211] Since 2021, it has been possible to add the label to the product after importation but before being placed on the market; previously products had to be labelled at origin.[212] In accordance with the General Law on Health (Law No. 42‑01), labels on imports of beer, alcoholic beverages and tobacco must include a disclaimer (Articles 123 and 124)

3.107.  As the official body for standardization in the Dominican Republic, INDOCAL is responsible for drafting NORDOMs following a procedure similar to that used for technical regulations, but omitting the international consultation phase (Chart 3.6). NORDOMs must be based on regional or international standards, where they exist.[213] Reviews of standards are held every five years but may be conducted earlier if necessary.[214] A NORDOM is published as an INDOCAL resolution. INDOCAL has a pay‑for‑access electronic catalogue of standards.[215]

3.108.  Use of NORDOMs is voluntary. However the authorities indicated that in conformity with the Health Law (Law No. 42‑01), use of NORDOMs for food and beverages is compulsory

3.109.  Locally produced or imported products that comply with the technical regulations or NORDOMs may be certified by INDOCAL. Certification is voluntary, except for products containing specific types of cement and steel bars.[216] Certification may be compulsory in other cases by default. For example, since 2022, the Tobacco Institute of the Dominican Republic (INTABACO) has allowed the use of the geographical indication (GI) "cigarro dominicano" (Dominican cigar) only when the good manufacturing practice set out in the NORDOM has been complied with.[217] A product certified by INDOCAL may obtain a "quality seal", awarded for three years, subject to regular assessments.[218]

3.96.  The Dominican Quality System (SIDOCAL) is governed by Law No. 166‑12, which was not amended during the review period. The Law has not yet been fully implemented, pending the entry into force of its implementing regulations which, as of 2022, have not yet been drafted. Additionally, there is sectoral legislation in the areas of health, safety, the environment and consumer protection that also govern technical regulations

3.97.  SIDOCAL's composition was not amended between 2015 and 2022 (Chart 3.4). The Dominican Quality Council (CODOCA) is the governing body that coordinates policy on quality with the system's other bodies, namely the ministries and other state institutions, the Dominican Quality Institute (INDOCAL) and the Dominican Accreditation Authority (ODAC). These bodies are attached to the MICM. Pro Consumidor, the state body with responsibility for consumer protection, is also part of SIDOCAL. Source: National Quality Policy (PNC) 2021‑24. Viewed at: https://indocal.gob.do/wp‑content/uploads/2021/08/Politica‑Nacional‑de‑Calidad.pdf

3.98.  INDOCAL has responsibility for drawing up national standardization policy and the national standardization plan, based on national development needs. In 2020, the Dominican Republic adopted its first national quality policy (PNC) 2021‑24; this gave rise to the national standardization policy (PNN), implementation of which began in 2021.[194] The aim of the PNC is to promote quality in order to increase the competitiveness of Dominican goods and services and thereby increase their integration into international markets.[195] According to the PNC, in order to encourage a culture of quality in the country it is necessary to strengthen quality systems, both in production processes and in marketing, adopt good practice to promote sustainable production, encourage the signature of agreements for the mutual recognition of conformity assessment procedures, and promote training.[196]

3.99.  Ministries, assisted by INDOCAL and (where necessary) Pro Consumidor, have responsibility for drafting the technical regulations for the areas within their purview.[197] As the authority with responsibility for metrology, INDOCAL is the only body that can draft technical regulations in that particular field. Technical regulations ensure national security; protect human life, health and safety, animal life and health, and the environment; and prevent misleading business practices that are harmful to consumers.[198]