3.58.  A significant amount of harmonization of SPS matters has been undertaken at the EAC level since the last Review (see main report). Tanzania has harmonized its SPS rules, based on a number of EAC instruments, including Articles 105 to 110 of the Treaty. The EAC SPS Protocol covers phytosanitary measures for fish and fishery products, food and feed safety measures, and sanitary measures for mammals, birds and bees. The process of ratification of the EAC Sanitary and Phytosanitary Protocol (2013) by the Tanzanian Parliament is still in progress. However, Tanzania has taken steps to implement it by establishing a technical working group and thoroughly reviewing the Protocol. As an SADC member, Tanzania subscribes to the SADC Protocol on Trade and its SPS Annex

3.59.  At the domestic level, the same laws and regulations remain in place. However, Tanzania has been taking many steps to move forward, especially to prepare for the EAC Phytosanitary Protocol. As such, it has been reviewing the Plant Protection Act, with a view to making amendments and taking steps to establish the necessary infrastructure

3.60.  The Ministry of Agriculture and the Ministry of Livestock and Fisheries of the Mainland are the main ministries involved in SPS measures, and oversee a number of acts and regulations concerning SPS matters, in particular the Plant Protection Act (1997) and the Plant Regulation Act, 1999, which provide the rules for the import and export of plants, and procedures and conditions to be met before importation. Conditions for biological control agents are outlined in the Plant Regulation Act. In addition, all pesticides to be imported and used in Tanzania must be registered by the Registrar of the Tropical Pesticides Research Institute

3.61.  The Plant Quarantine and Phytosanitary Services of the Ministry of Agriculture are responsible for SPS matters, including quarantine. For the period 2015/16, they inspected a total of 175,289.5 tonnes of imported crops and 714,372.4 tonnes of exported crops. Also, 5,516 phytosanitary certificates and 635 import permits were issued.[102]

3.62.  In the case of Zanzibar, SPS measures for exported agriculture products are pursuant to the Zanzibar Plant Protection Act No. 9 0f 1997. Under this Act, the products are inspected or tested by the Plant Protection Division of the Ministry of Agriculture, according to appropriate official procedures, before an export permit is granted, to ensure that the products are free from the quarantine pest specified by the importing country and that they conform with the current phytosanitary requirements of the importing country

3.63.  SPS measures on food safety are implemented under the Tanzania Food, Drugs and Cosmetics Act, and are guided by the National Health Policy under the ministry responsible for health, in collaboration with other ministries and stakeholders. The government policy stipulated the establishment of a law for food safety, and the Tanzanian Food, Drugs and Cosmetics Act, 2003 was enacted; subsequently, the Public Health Act was enacted in 2009 to regulate all issues related to environmental health. In line with food security, this is regulated by the Ministry of Agriculture. To ensure the effective enforcement of the law, food safety control in Tanzania is carried out on a number of levels

In 2013, Burundi adopted Decree No. 100/99 of 31 March 2013 on the creation, organization, role and operation of the National Committee for the Coordination and Monitoring of Sanitary and Phytosanitary Measures. The Committee reports to the national focal points for the CODEX (BBN), the OIE (Animal Health Department) and the IPPC (Plant Protection Department)[19], which are the main agencies in Burundi's SPS institutional framework

3.64.  At the national level, policies related to food safety are formulated by the national regulatory authority, the Tanzania Food and Drugs Authority (TFDA). It has overall responsibility for all matters related to food safety, i.e. regulating manufacturing, import and export control, distribution of food products, monitoring of food contaminants, and conducting analyses of food products. The government Chemist Laboratory Agency is also involved as a referral body in food safety analyses

According to the Decree, the Committee's objectives are to: coordinate activities related to sanitary and phytosanitary measures concerning animal health, food safety and plant protection at the national level; advise on policies relating to sanitary and phytosanitary measures and supervise their implementation at the national level; facilitate the dissemination of relevant information among all parties involved with sanitary and phytosanitary measures; coordinate prior consultations with all stakeholders in the preparation of country positions in respect of the international forums that address sanitary and phytosanitary matters; prepare and coordinate SPS training programmes at the national level; provide a forum for information exchange among focal points (CODEX, OIE and IPPC), and cooperation on SPS notifications; help raise awareness on issues relating to sanitary and phytosanitary measures among all public- and private-sector stakeholders throughout the country; and strengthen the partnership between the public and private sectors

3.65.  The local government authorities are responsible for routine enforcement of laws related to food safety control and environmental issues. The TFDA works with the TRA, health officers for plants and plant products, and zoo sanitary inspectors for livestock and fisheries, to control imports and exports of food and related products

In February 2014, under the SPS Agreement, Burundi notified the WTO of Decision No. 750/1103/2013 banning the importation, manufacture and marketing of liquor in plastic sachets and bottles.[20]

3.66.  During the review period, Tanzania has made one notification to the WTO SPS Committee. In 2017, it notified its Seeds (Amendment) Regulations, that impose certain rules on the trade of seeds. Importation or exportation of seeds requires a licence or other permit from the Ministry of Agriculture (Sections 3.1.5 and 3.2.3)

Law No. 1/123 of 23 November 2017 on plant protection in Burundi (replacing Decree‑Law No. 1/033 of 30 June 1993) regulates border control of plant imports and exports and the issuance of phytosanitary certificates to exporters. The resulting controls and inspections are performed by the Plant Protection Department of the Ministry of Agriculture and Livestock. Fees are charged for these services: the phytosanitary certificate costs BIF 5,000 (less than USD 4), while phytosanitary inspection fees are not yet being collected pending the adoption of implementation instruments for the 2017 Law

3.67.  Ordinances No. 710/837 and No. 710/838 of 29 October 2001 set the status, respectively, of pesticides approved for agricultural use and pesticides prohibited for agricultural use in Burundi. Ordinance No. 770/406 of 24 March 2003 establishes a National Code of Conduct for Pesticide Management; and several ordinances authorize or prohibit the use of specific pesticides, based on information held by the National Committee responsible for the approval and control of pesticides (177 pesticides are approved, and 37 are banned from manufacture, marketing or importation in Burundi)

3.68.  Law No. 1/28 of 24 December 2009 on health policy in respect of domestic animals, wild animals, aquaculture and bees covers health control at the border, among other issues. It places special emphasis on export and import controls, the establishment of a fund to combat epizootic diseases and measures to prevent communicable diseases. In general, imports and exports of animals and animal products require a health certificate, and they are subject to inspection by the Burundi Animal Protection Service. Imports of animals listed in Article 85 of the Animal Health Law require a health certificate issued by the country of origin. This must state that the animals do not come from an area in which infection by one of the communicable diseases listed in Burundian legislation has been notified in the last 42 days or more

3.69.  In June 2017, Burundi ratified the EAC Protocol on SPS Measures, which was adopted by the Council of Ministers of the Member States and signed in July 2013. The protocol aims to harmonize sanitary and phytosanitary protection measures and to facilitate the circulation of plants, phytosanitary products, food and animals within the subregion

3.70.  On 1 August 2008, Burundi ratified the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. The country currently has a biosafety policy, a national biosafety committee, and a clearing house for information on the subject. A draft biotechnology safety law sets out basic rules to protect the population and the environment against the risks of genetically modified organisms (GMOs) and products derived therefrom through modern biotechnology. Once adopted, the law will apply to the import, export, transit, contained use, release or placing on the market of any GMO, whether intended for dissemination in the environment, or as a food, livestock feed, or processed product, or one derived from a GMO

3.72.  The EAC Treaty requires the countries to harmonize sanitary and phytosanitary (SPS) measures for pest and disease control. Under the Customs Union Protocol, the EAC countries are to cooperate in several areas, including SPS measures. In this context, an SPS Protocol was developed in 2013, based on the provisions of the WTO SPS Agreement. As of December 2017, harmonized measures and procedures have been developed for plants; mammals, birds and bees; fish and fishery products; and food safety (see Table 3.8)

3.73.  To date, the SPS Protocol has been ratified by Rwanda, Burundi, Kenya and Uganda. The Phytosanitary (Plant Health) Measures Act was adopted in 2016. It aims at minimizing phytosanitary risk, and facilitating the implementation of common and harmonized procedures in the areas of inspection and certification, movements of plants and plant products, and import and export requirements. The related SPS Bill was adopted by the Sectoral Council on Agriculture and Food Security in June 2017. Approval of the Bill by the Council of Ministers and its enactment into law by EALA are awaiting full ratification by all EAC member States

3.74.  A mutual recognition procedure for veterinary vaccines and pharmaceuticals was adopted in 2015, together with a harmonized registration system

3.75.  During the period under review, Uganda's framework for sanitary and phytosanitary (SPS) requirements appears largely unchanged. The main SPS-related legislation includes the Food and Drugs Act, 1964, the Public Health Act, 1964, the Plant Protection Act, 1964, the Drugs Act, 1993, the Seeds and Plant Act No. 3, 2007, and the Agricultural Chemicals (Control) Act No. 1, 2007. The authorities are revising or preparing laws and regulations in the SPS area, e.g. regulations for the Agricultural Chemicals (Control) Act, the draft Biosafety Act and Regulations, the Plant Protection and Health Act, and the Food and Nutrition Bill

3.76.  The MAAIF is the national enquiry point for all SPS-related issues (including for the issuance of permits and certificates), while the MITC is responsible for notifications to the WTO. During the period between 1 January 2012 and 31 July 2018, Uganda submitted 35 regular notifications to the WTO under the Agreement on the Application of Sanitary and Phytosanitary Measures, covering food safety, and animal health issues

3.77.  Various institutions share responsibility for the implementation of food safety controls. At the time of the previous Review, Uganda developed a National Food Safety Strategic Plan (2007-16), aiming at, inter alia, guiding the implementation of food safety laws, programmes, activities, and other food safety control systems.[42] The Ministry of Health is responsible for issues related to drugs and food safety. Imports of drugs require a valid import permit issued by the NDA.[43] The drugs are inspected by an NDA inspector at the port of entry, to ensure that they comply with the approved specifications and regulations. Each batch must be accompanied by a relevant certificate of analysis. The inspector may carry out sampling or pick samples for further investigation

3.78.  The MAAIF is responsible for initiating the formulation and review of laws, regulations, standards, strategies, and plans related to SPS measures and for the regulation of animal and animal products (including fish and fish products). A phytosanitary certificate is required from the exporting country for flowers, fruits, vegetables, and plants, and related products; and a health certificate is required for animals and animal products, certifying that they are free from infectious or contagious diseases. A permit from the relevant department under the MAAIF is required prior to the importation of these products

3.79.  The Department of Fisheries Resources is responsible for the certification of fish and fish products intended for export. It enforces fisheries regulations, including the inspection of factory premises, processing lines, landing sites, fish transport, and export points for adherence to safety and quality requirements, as well as maintaining a national fish inspection and quality control system

3.80.  The Crop Protection Department of the MAAIF is responsible for all matters related to plant health, including the control of SPS permits on imports, the issuance of export phytosanitary certificates for live plant material and horticultural crops, and the deployment of staff at all border posts to enforce agricultural import and export regulations and certification against crop pests and diseases. The Department is also responsible for enforcing regulations on the registration and use of pesticides and other agri-chemicals. Imports of flowers, fruits, vegetables, plants, and seeds require a phytosanitary certificate. Seed importers are subject to licensing requirements. Soil imports are prohibited

There has been no major change to Kenya's sanitary and phytosanitary (SPS) legal and institutional framework since the last Review in 2012 (Table 3.8). National enquiry points under the WTO SPS Agreement are: the Kenya Plant Health Inspectorate Service, for plant health issues; the Department of Veterinary Services for animal health; and the Department of Public Health for food safety issues. Veterinary medicines and poisons are regulated by the Veterinary Medicine Directorate, established in 2016.[66]

3.81.  During the review period, Kenya submitted five notifications to the WTO Committee on SPS Measures.[67] Kenya did not raise any specific trade concern (STC). However, it supported two concerns: European Union revised proposal for categorization of compounds as endocrine disruptors (STC N382); and India's fumigation requirements for cashew nuts (STC N427). Kenya is a member of Codex Alimentarius, the World Organization for Animal Health, and the International Plant Protection Convention. Kenya is party to the Cartagena Protocol on Biosafety, and the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES)

3.82.  Kenya ratified the EAC Protocol on SPS measures in July 2016

3.83.  Plant health is governed mainly by the Plant Protection Act. The importation of any plant product is subject to an import permit from the Kenya Plant Health Inspectorate Service (KEPHIS), and a phytosanitary certificate from the relevant authority in the exporting country.[68] Plants are inspected upon arrival at the port of entry, and laboratory tests may be carried out

3.84.  Live animals and other veterinary goods are subject to an import permit by the Directorate of Veterinary Services (DVS).[69] The permit is issued electronically through the single window system (Section 3.1.1). The Directorate also issues the international veterinary certificate for exports. In some cases, the application must be lodged with the relevant institutions such as: the Kenya Dairy Board, for milk and milk products; the Pharmacy and Poison Board for veterinary drugs and vaccines; the Fisheries Department for fish and other aquatic products; and the Kenya Wildlife Service, for game animals and their products. For genetically modified animals and feedstuffs, the importer must obtain the approval from the National Biosafety Council before applying for the import permit. Consignments are inspected at the port of entry by relevant institutions

3.85.  Between 2014 and 2017, KEPHIS received technical assistance under the Standards and Market Access Programme (SMAP) to enhance market access and the competitiveness of the country's animal and plant-based products

3.86.  Drugs and medical supplies are under the purview of the Kenya Medical Supplies Agency. It is responsible for procuring, warehousing and distributing drugs and medical supplies to health institutions.[70] It is also responsible for maintaining the national strategic reserve stock defined as equivalent to six months stocks of a list of prescribed medical supplies