March 2014 INVESTMENT CLIMATE Food Safety Toolkit Institutional Structure Investment Climate l World Bank Group ©2014 The World Bank Group Table of Contents 1818 H Street N.W., Washington D.C., 20433 All rights reserved. March 2014 Available online at www.wbginvestmentclimate.org This work is a product of the staff of the World Bank Group with external contributions. The information included in this work, while based on sources that the World Bank Group considers to be reliable, is not guaranteed as to accuracy and does not purport to be complete. The World Bank Group accepts no responsibility for any consequences of the use of such data. The information in this work is not intended to serve as legal advice. Introduction 5 The findings and views published are those of the authors and should not be attributed to IFC, the World Bank, the Multilateral Responsibilities of government agencies 7 Investment Guarantee Agency (MIGA), or any other affiliated organizations. Nor do any of the conclusions represent official policy of the World Bank or of its Executive Directors or the countries they represent. Chain of command 8 The denominations and geographic names in this publication are used solely for the convenience of the reader and do not imply the expression of any opinion whatsoever on the part of IFC, the World Bank, MIGA or other affiliates concerning the legal status of any Single agency vs. multiple agencies 9 country, territory, city, area, or its authorities, or concerning the delimitation of its boundaries or national affiliation. Accountability of regulators 10 Rights and Permissions The material in this work is subject to copyright. Because the World Bank Group encourages dissemination of its knowledge, this work Dairy sector example 12 may be reproduced, in whole or in part, for noncommercial purposes as long as full attribution of this work is given. Acronyms 14 Any queries on rights and licenses, including subsidiary rights, should be addressed to the Office of the Publisher, the World Bank, 1818 H Street NW, Washington, DC 20433, USA; telephone: 202-522-2422; email: pubrights@worldbank.org. List of figures, snapshots, boxes, and tables 14 About the Investment Climate Department of the World Bank Group The Investment Climate Department of the World Bank Group helps governments implement reforms to improve their business environments and encourage and retain investment, thus fostering competitive markets, growth, and job creation. Funding is provided by the World Bank Group (IFC, the World Bank, and MIGA) and over 15 donor partners working through the multidonor FIAS platform. Introduction In developing countries the capacity of the state to regulate and control food safety in a risk-based approach will usually need to be strengthened. Reforming the institutions with responsibilities for regulating and controlling food safety may be a necessary step. The role of governmental institutions that are responsible for controls on food safety (sometimes called “competent authorities”) will include making food safety policy and regulations, analysing evidence to implement a risk-based approach as well as carrying out the checks that the regulations are being implemented. Often the policy and rule making is carried out in one government institution (such as a ministry) and the checks on implementation of the rules are made by other institutions, such as inspectorates and laboratories. Module 4: Institutional Structure 5 Responsibilities Control is performed across the food chain, for exam- ple animal health and welfare, feed safety, plant health of government and food safety in food handlers. Control is exhibited through: agencies • single or multiple inspection agencies – governmen- tal, private or both; and • laboratories where samples taken during inspection or those taken during “self inspection”1 are tested. For the government to have an effective role in food The FAO guidelines on strengthening national food safety requires one or more ministries or regulatory control systems should be considered when looking at agencies to have the following responsibilities: institutional reforms relating to food.2 • Food policy – developing food policy based on inter- national standards and available evidence. • Food legislation – drafting, updating, and owning Self inspection is performed by food handlers themselves as 1 the regulations, acts, and measures in the food safe- a way of continuous assessment of efficacy of food safety practices applied. For example: periodical review of GHP and ty area. GMP or HACCP systems in place, by producers (performed by a • Food safety controls – assessing and encouraging quality manager, or HACCP team, or internal auditors-employees trained how to audit system in place, or all of them). business compliance with the law, and enforcing the Assuring Food Safety and Quality: Guidelines for strengthening 2 law. national food control systems, FAO http://www.fao.org/ • Collecting and analyzing data for monitoring and docrep/006/y8705e/y8705e05.htm  risk analysis on a national basis. Regulatory agencies are usually linked with either the ministry in charge of health or the ministry in charge of agriculture, but in many countries both ministries share responsibilities in this area. Sometimes, ministries in charge of consumer affairs, or even economy or trade, participate in regulating and control of the food area, mostly dealing with food quality issues and prevention of fraud. Since agriculture and food production have an impact on the environ- ment, the ministry of the environment is often included in regulation of certain issues in connection with food safety (mostly in disposition of solid and liquid waste, but there are cases when this ministry regulates water to be processed into drinking water as well). Regulatory agencies should divide responsibilities for regulating certain areas. Issues that are of the common interest for various agencies should be regulated with the collaboration of all agencies concerned. Module 4: Institutional Structure 7 Chain of Single agency vs. Policy spheres command multiple agencies • These should be clearly defined so that there is no overlap in applicable regulations. If several ministries are involved in food-safety related regulations, their spheres of competence should be strictly defined. • Where possible, having a single structure in charge Different countries have different arrangements for chain of command for the institutions that enforce the regulatory Depending on capacities of agencies (level of expertise, of science and risk assessment (whether or not com- requirements. There are two models: number of staff, equipment), constitutional organiza- bined with inspection/control functions, and/or with tion of the country, level of decentralization, number policy) is a good step. • A centralized inspection structure where a cen- • A decentralized inspection structure where lo- of premises to be inspected and the level of develop- tral government agency carries out inspections and cal government agencies are given the responsibil- ment of the food safety system in a particular country, • Having a single agency doing both science/risk as- enforcement activity such as planning frequency and ity of enforcing food safety law. The local govern- it should be decided which system should be optimal. sessment and regulations can also be a good ap- type of inspections. In this structure there will often ment agencies will have autonomy in deciding how Nevertheless, control of food safety should be per- proach (for example, the U.S. FDA). be local or regional offices to facilitate enforcement requirements of framework laws will be enforced, formed by professional bodies (governmental or pri- activity, but as these are all parts of the same agency have a separate budget, plan frequency of inspection vate) trained in import or export and inland inspection Control functions the strategic planning, budget, reporting, activity by themselves and usually only inform the central that perform duties in line with ISO/IEC 17020: 2012 monitoring and complaints/appeals system will all be level about the number of inspections, on an annual standard.3 Level of overlapping of different inspection • Full integration of food safety inspections in one in- carried out by the central government agency. basis. Monitoring plans are prepared, financed and bodies should be decreased to least possible/optimal spection agency can be a good model as long as effects analyzed on the central level. level and that can be done only if clear division of re- it is not seen as the panacea to all ills in itself. The sponsibilities is made. existing political and institutional structure should be taken into consideration in this respect. The final legal decision, both in centralized and in decentralized systems, lies within the courts. As noted, food safety-related regulation is vast, and covers a lot of issues and steps, including (and not lim- • A “single inspectorate” could also comprise extend- ited to): ing a “single department” into a broader “unified • risk assessment and science; inspectorate. • policy making, issuing regulations; • inspections or control of primary production includ- • A potential variation on the models outlined above, ing animal health, processing, transportation, stor- would involve one inspectorate which controlled age, marketing, catering; either primary production/phytosanitary measures/ • health care and the feedback from health services to animal health or as a minimum unified control from the rest of the chain to identify outbreaks; and slaughter onwards. • information, outreach. • In the absence of an institutional structure that lends TThere isn’t a specific model of a single food safety itself to the establishment of any of the above mod- agency that would cover absolutely all of these func- els, then it is essential that each agency involved in tions and very few countries where even most of these food safety control intervenes at a given stage and functions would be integrated. The challenges in re- that there is a robust mechanism in place for multi spect of local specifics prevent the development of a agency coordination. universal model which could be applied everywhere. It is essential that any model assures effectiveness, ef- ficiency, coherence, minimizing costs and burdens and minimizing information loss. When deciding to advo- cate an approach consideration should broadly be giv- en to the following; ISO/IEC 17020:2012 Conformity assessment -- Requirements for 3 the operation of various types of bodies performing inspection 8 Investment Climate Food Safety Toolkit Module 4: Institutional Structure 9 Accountability of Inspectors should not be in the position where there is a conflict of interest with their role as an inspector. Snapshot 4.2 Norway: regulators Examples could include being an auditor for a certifica- tion body, receiving money or other types of bribery A Single Agency Approach from food business operators or their associates, hav- In 2004 several agencies (Food Control Authority, Animal Health ing a family member employed by the food business Authority, Agriculture Inspection Service, Directorate of Fisheries, operator he/she inspects. Seafood inspectorate and Municipal Food Control Authorities) merged into one governmental agency called the Norwegian Inspectors should be penalized if their behavior breach- Food Safety Authority, which oversees control of the entire food es agreed codes of inspection practice. There should chain (animal welfare and entire animal health, plant health, both be a system in place to suspend inspectors in situations food and non-food related, drinking and production water), cos- where there is evidence that they have performed their metics, and sales of medicinal products from retailers. The role of work negligently or not at all. the authority is to prepare draft legislation, inform on legislation, scientific opinions, and to institutionalize the reformed regulatory perform risk-based inspections, monitor food safety, plant and and inspection area. Regulators should be accountable to food business animal health, and handle relevant emergency situations. operators and there should be a mechanism whereby Lessons learned in Norway: businesses or citizens can complain about inspectors Laboratory control is outsourced. and a way for complaints to be dealt with. • The system is still developing. It takes time to perform and ac- The authority has three levels: the central level, eight regional cept changes. offices (out of which five have national competence over certain Snapshot 4.1 Sweden: The National Veterinary Institute5 – under Ministry of Rural type of commodities along the whole food chain: terrestrial • Regional and district level agencies proved to be more ready for Multiple Agency Decentralized System Affairs, Food and Fisheries, performs laboratory control of animals, fish and plants/vegetables) and 64 district offices. First changes than the central level – they already collaborated closely samples taken for the purpose of control of animal health instance decisions are mostly delegated to district offices. on different issues. In Sweden, risk assessment is not separated from risk man- and zoonosis. agement. The central agency in charge of food safety policy Risk assessment is separated from risk management and is • After the initial enthusiasm about reforms passed, staff from dif- is the Ministry of Rural Affairs. The structure of the food The Swedish Board of Agriculture6 – an independent, non- performed by an independent scientific committee, which has ferent agencies had to invest lot of energy and goodwill to work safety system is associated with the constitutional type of the ministerial government authority. Prepares drafts of legisla- eight scientific panels (following the pattern of the EFSA) and is in the one single agency (to overcome cultural, professional, and country and high level of independence that counties and tion, inspects feed, residues of plant protection products and funded from the state budget. The participants on the panels are other differences).7 municipalities have. There are three main agencies at the na- GMOs in feed. chosen based on their scientific merits in the appropriate field tional level and numerous at the local level: At the local level, 21 County Administrations are responsible covered by the panel. Along with a reform of risk assessment • Reform of institutions should be followed with a reform in legis- The National Food Agency4 – an independent authority, per- for coordinating food control at the regional level and the and management area, a new food safety law was issued. It was lative area (to set new structures and risk based principle). forms scientific investigations and risk assessment, and pre- municipal Environment and Health Protection Committees used to simplify the legislative environment (provisions of 13 legal pares drafts of legislation on the basis of its own data. NFA have responsibility for food control at the local level. acts were merged into this law), update it in the line with acting inspects slaughterhouses, cutting establishments, dairies, egg product establishments, FBOs producing for export, and other very large FBOs (about 700 FBOs), novel foods, food supplements, GMOs, foodborne infections, mineral water, Factors to take into consideration when deciding which model is the most suitable for a specific country8 drinking water, residues of plant protection products in fruit, • The historical and constitutional background vegetables and cereals and veterinary medicinal products. It • Capacities in place (staff, equipments, knowledge) controls import of food (at Border Inspection Posts) and per- • Political will forms microbiological analysis of samples of imported food. • Level of corruption-autonomy in decision making • Geographical distribution of food handlers It follows up the results of food control carried out at the • Number of food handlers regional and municipal level. It also performs investigations • Sustainability of the system/agency on nutrition in Sweden. • Accessibility to funds • Regional experiences and good examples 4 http://www.slv.se/en-gb/ 5 http://www.sva.se/en/ 6 http://www.sjv.se/swedishboardofagriculture.4.6621c2fb1231eb917e680002462.html 7 Reforming the Food safety Administration in Norway ftp://ftp.fao.org/es/esn/food/meetings/norway_crd.pdf 8 In line with Joint FAO/WHO PROPOSED DRAFT PRINCIPLES AND GUIDELINES FOR NATIONAL FOOD CONTROL SYSTEMS, July 2011 10 Investment Climate Food Safety Toolkit Module 4: Institutional Structure 11 Q1. Are regulatory responsibilities clearly NO Consider assigning responsibilities OR STOP Dairy sector example assigned? YES Q1. Is there a department that deals with regulation and enforcement in the dairy sector? If so, are responsibilities for animal welfare and feed controls in different settings to Q2. Do existing food safety? Many departments may be involved by identifying who is responsible for regulatory agencies Identify gaps and NO what is important so you can build a picture and identify any responsibility gaps. Re- collaborate? collaboration needs assignment and harmonisation may be required. Q2. If many departments have been identified, do they collaborate and are there any YES overlaps? How do they communicate? In the event of an outbreak, how easy or difficult would it be to investigate, trace, and alert? Q3. If controls are not performed across the dairy sectorfood chain then gaps need to be Q3. Is control performed across the food Identify responsibility identified and control needs to be established. This should be done based on risk, NO options chain? with the focus on ensuring food safety throughout but particularly at the point where a loss of food safety control would have serious consequences (such as raw milk processing). YES Q4. If multiple agencies are involved in the dairy sector, regulatory and enforcement space that may mean an overlap of responsibility. This may be a farm crossing over between feed and animal health or later in the chain between animal health and raw milk Q4. Is there overlap in processing. Overlap should be avoided as it wastes resources, impedes communication, food safety control YES Identify issues and may burden business with too many inspections and inconsistent advice and between different agencies? guidance. NO Devise optimal single or multi agency Module 4: Institutional Structure 13 Acronyms APLAC Asia Pacific Accreditation cooperation HACCP Hazard Analysis Critical Control Point System BAP Best Aquaculture Practice ILAC International Laboratory Accreditation Cooperation BRC British Retail Consortium KDB Kenya Dairy Board CAC Codex Alimentarius Commission KEBS Kenya Bureau of Standards CAS Country Assistance Strategy LIMS Laboratory Integrated Management System CFIA Canadian Food Inspection Agency NGOs Nongovernmental organizations CPS Country Partnership Strategy ILAC International Laboratory Accreditation Cooperation EAL European Cooperation for Accreditation of IPPC International Plant Protection Convention Laboratories OECD Organisation for Economic Co-operation and EC European Commission Development EAC East African Community OIE World Organization for Animal Health EFSA European Food Safety Authority PCB Pest Control Products Board EU European Union PRPs Prerequisite Programs FAO Food and Agricultural Organization RFID Radio frequency identifier FBO Food business operators SBA Sustainable Business Advisory GDP Goss Domestic Product SPS Sanitary and Phytosanitary GAP Good agricultural practices SQF Safe Quality Food GFSI Global Food Safety Initiative USAID U.S. Agency for International Development GHP Good hygiene practices USDA U.S. Department of Agriculture GMO Genetically modified organisms WHO World Health Organization GMP Good management practices WTO World Trade Organization GRMS Global Red Meat Standard List of figures, snapshots, boxes, and tables Snapshot 4.1 Sweden: Multiple Agency Decentralized System 10 Snapshot 4.2 Norway: A Single Agency Approach 11 Credits Photography: BigStockPhoto, Robert Kneschke (cover page), Geoffrey Whiteway (page 5), Hongqi Zhang (page 7), Daniel Hurst (page 8), Oliver Hoffmann (page 10), Maren Wischnewski (page 11) in partnership with: