March 2014 INVESTMENT CLIMATE Food Safety Toolkit Risk Assessment, Enforcement and Inspections 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. Risk responsibilities at national and international levels 5 The findings and views published are those of the authors and should not be attributed to IFC, the World Bank, the Multilateral Risk assessment 6 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. Risk management 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 Enforcement and Inspections Approach – Risk Focus 10 country, territory, city, area, or its authorities, or concerning the delimitation of its boundaries or national affiliation. Prior registration and approval 14 Rights and Permissions The material in this work is subject to copyright. Because the World Bank Group encourages dissemination of its knowledge, this work Training and education 17 may be reproduced, in whole or in part, for noncommercial purposes as long as full attribution of this work is given. Key messages 22 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. Dairy sector example 24 About the Investment Climate Department of the World Bank Group Acronyms 26 The Investment Climate Department of the World Bank Group helps governments implement reforms to improve their business List of figures, snapshots, boxes, and tables 26 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. Risk responsibilities at national and international levels As previously discussed in the Module entitled “Leg- islative Reform,” the architecture of the food safety regulatory system needs to be built upon several key elements, three of which are risk focused. A food safety regulatory system needs to provide for the following: • Risk assessment. This is the process of identifying food safety hazards, assessing likelihood of occur- rence and severity, and evaluating the significance. • Risk management. This is the coordinated and economical application of resources to minimize, monitor, and control the probability and/or impact of food-borne incidents and to maximize the real- ization of opportunities to prosper throughout the food sector. • Risk communication. This is the process of ensur- ing that the logic, outcomes, significance, and limi- tations of the risk assessment are clearly understood by all stakeholders. Module 5: Risk Assessment, Enforcement and Inspections 5 Risk assessment Risk assessment at international level Results of risk assessment can be used for the develop- ment of new or revision of existing regulations, adop- tion of new measures, and development of policies. The results provide decision makers with advice in the Regulations and inspection should be based on sci- areas of food and feed safety, nutrition, animal health entifically sound estimation of hazard risk and an as- and welfare, plant protection and plant health, and en- At the national level, a food safety agency or a specialized sessment of its management. A risk-based approach vironmental safety. Information on contaminants (bio- scientific panel could: considers hazards and likelihood of compliance. This logical, chemical, physical), but also on food consump- chapter focuses on ensuring a sound underpinning for tion and emerging risks can be analyzed. Correlating • organize expert risk assessment and organize experts in analyzing hazard risk, informed by good scientific data this data estimates the severity and probability of risks scientific groups that will investigate risks associated with and evidence backed up by a risk-based approach to for particular hazards. The EFSA is one example of an groups of commodities (or one sector). Agencies or panels regulatory delivery. international organization that carries out this type of frequently copy the model of the Codex Alimentarius com- risk assessment role. mittees; Risk assessment of hazards consists of: Risk assessment at national level • coordinate and/or manage a network of organizations that Figure 5.1 Process of Risk Assessment assesses health risks (public health services and especially Risk assessment requires specific capacities to be in their epidemiological units); place and can be very expensive. It is, therefore, advis- Snapshot 5.1 Hazard identification able to use scientific information provided by EFSA, European Union Practice • coordinate and/or manage a network of organizations that the FAO, WHO, the OIE, and IPPC and to perform risk the cause of the hazard and its point of entry into the food chain, assesses the impact of risk management, according to ar- In EU countries, national food safety agencies use information the type of contact with humans, animals, plants are investigated assessment only for hazards that are specific for a eas of their competence (in developing countries impact of developed by EFSA and perform their own risk assessment only certain country or in case when special circumstances measures is rarely followed, while in developed countries for some specific contaminants, usually those that are subject Hazard characterization in a country enhance the probability of a hazard. this question is high on the agenda when deciding on new to specific national programs of eradication and monitoring. In the hazard is analyzed in terms of its toxicological properties and In order to help countries perform risk assessment in a regulations or measures); Sweden, for example, the food safety agency conducts inves- assessed both qualitatively and quantitatively standardized and comparable manner, WHO and FAO tigation on Salmonella in food in its own laboratory, which is publish a series of guidelines for risk assessors.1 • communicate risk to the public – scientists should provide also the reference laboratory for the EU, and uses these results Exposure assessment unbiased information and help increase public trust in when assessing the risk and proposing measures. In the United measures taken by government agencies; Kingdom, the Food Standard Agency performs independent the concentration of the substance in food, feed, water, materials in contact with food is linked to consumption data or feeding data research on risks and issues guidance on enforcement of food in order to assess the current exposure • provide government agencies with expertise in scientific safety legislation, as well as overseeing whether local authori- Risk characterization and technical support for policy and decision making; ties perform enforcement according to the guidance. In Croatia, the food safety agency performs risk assessment mainly accord- statements are issued on the probability, frequency, and severity of • collaborate with other national and supranational food ing to data gathered from the national food safety system and known or potentially negative effects on human or animal health or on plants safety agencies (like EFSA) in research and shaping of na- only compares that data with the existing ones published in the tional policies; and international scientific literature and EFSA. Risk assessment is done according to a defined meth- • perform nutritional studies (on nutritional status of the odology in an open and transparent manner. In order population, nutritional toxicity) in order to have the nec- to secure the independence of the scientific work, a essary information for risk assessment of hazards at the body in charge of risk management should be sepa- national level. rated from that performing risk assessment. Hazard Characterization for Pathogens in Food and Water 1 Microbiological Risk Assessment Series 3, WHO/FAO 2003; Exposure Assessment of Microbiological Hazards in Food, Microbiological Risk Assessment Series 7, WHO/FAO 2008; Risk characterization of Microbiological Hazards in Food, Microbiological Risk Assessment Series 17, WHO/FAO 2009 6 Investment Climate Food Safety Toolkit Module 5: Risk Assessment, Enforcement and Inspections 7 Risk Risk management at national level In order to increase the capacity of the national man- agement bodies, international standard setting bodies Risk Management at International Level management National risk management bodies, which are official regulatory and control bodies (inspections and testing organize training for officials worldwide. Also, a prac- tice of setting up contact points for such organizations The EU Directorate General on Health and Consumers (also known as DG SANCO) monitors how risk manage- laboratories), exist in most countries. While in some within the structure of national agencies is facilitated ment is being performed by individual member states. countries a risk-based approach is taken, in others the by the CAC, OIE, and IPPC. Through contact points One of the ways in which it does this is by overseeing approach can have no basis in hazard identification and information can be exchanged on best international how rules and measures are applied, and inspecting risk. If this is the case, it is recommended that reforms knowledge and on national results of implementation how these measures function in EU member states as “Risk management is the process of weighing policy of the national food safety management system should of measures based on risk management. If this “two well as third countries. It organizes inspection visits to alternatives in the light of results of a risk assessment be prioritized. Examples from EU member states, Cana- way communication” exists, it will increase the local countries, provides reports with recommendations for and, if required, selecting the appropriate actions nec- da, or some fast developing countries where functional capacity, secure understanding of international stan- improvement and according to data from its own in- essary to prevent, reduce or eliminate the risk in order management system exist may be used as models. dards, and prevent requirements from being issued on spections keeps an updated list of facilities permitted to ensure the high level of health protection deter- the basis of unnecessary protectionism. to place products on the EU market. It also supports mined as appropriate.”2 It is important to emphasize that when there is no re- national and regional authorities when preparing par- liable information available from recognized interna- On the other hand, if such contact points are placed ticular risk management measures. In the risk management phase, the decision makers tional sources on specific hazards, national bodies are within bodies that have no responsibility for implement- need to consider a range of information in addition allowed to implement their own standards. This imple- ing measures aimed to reduce or eliminate potential According to DG SANCO and EFSA findings and rec- to the scientific risk assessment. These include, for ex- mentation may also be accompanied by precautionary hazards (for example, a case when contact points are ommendations, the European Commission, European ample: the feasibility of controlling a risk; the most ef- measures on imported goods, and these measures can placed in the standardization offices), then the informa- Parliament, and member states issue policy, legislative fective risk reduction actions depending on the part of require meeting higher standards than may be in place tion flow might be jeopardized and the body respon- documents, and relevant measures. the food supply chain where the problem occurs; the within the importing or exporting country. The bur- sible for issuing regulations and measures in the food practical arrangements needed; the socio-economic ef- den of proof will be on countries implementing these safety area could be deprived from access to the in- Risk communication fects; and the environmental impact. It is important to new higher standards. The standards should not be ternational knowledge. Also, in case when the contact stress that all these issues need to be taken into consid- implemented to limit trade and should only be rigorous point for one international organization (or sometimes Both national and international bodies should be eration when assessing the risk of a particular hazard. enough to prevent the hazard.3 even for several of them) is only one person – usually a involved in the process of risk communication to Both national and international bodies are involved in director (general manager) of one governmental body, ensure that all stakeholders (regulators, businesses, and risk management. the information flow to all participants in the national citizens) are fully aware of outcomes, limitations, and risk assessment/management area is often obstructed implications of the risk assessment process. Article 3, point 12, Reg Ec 178/2002. 2 and when such a person leaves the service, no histori- Section 2, Article 7, Reg EC 178/2002, Articles 5, points 6,7,8 of 3 cal memory remains on how to use the international Mechanisms for doing this may vary depending on the WTO-SPS Agreement standards and why they are recommended. This sets the nature of the risk and the threat to public health. a ground for risk management based only on nation- Newspapers, television, and the Internet – websites ally available data and limits the quantity and quality and social media – are the most common vehicles used of information used when assessing risks and planning to facilitate communication. Strategic formulation regulations and measures. of risk communication mechanisms should form an integral part of risk management for both national and international bodies. Information on risk should be provided by credible sources and based on real hazards. Both level of risk and outcome of risk management have to be communicated. 8 Investment Climate Food Safety Toolkit Module 5: Risk Assessment, Enforcement and Inspections 9 Enforcement Inspections should never be designed to cover all es- tablishments because this is not an effective use of Risk-focused approach Risk-based enforcement requires a methodology and set of criteria to assess businesses. The level of risk posed by and inspections public money. Experience shows that agencies that try to inspect all food business operators are not effective So what is meant by a risk-focused approach? The term “risk assessment” can mean many different things according to a particular business can be calculated using the simple formula: approach – risk in controlling risk or improving food safety and incur high costs. Agencies have a choice between a “ran- the different contexts within which it is used. Here a risk- focused approach means thinking about: hazard x likelihood of non compliance focus dom focus” (by trying to check all premises and failing) and “risk-based focus” (choosing to focus efforts on • the key regulatory risks that the legislation and food safety The accuracy of this formula is dependent on the availability those businesses that present a higher risk, the better authority is designed to control, and definition of objec- of information on hazards (which is a fact-based assessment) choice). tives to address those risks; and the ability of inspectors to assess the likelihood of non-compliance in a business (which is a judgment-based • the design of risk-based interventions by deciding the best assessment). The first principle of an effective approach to enforce- type of intervention to achieve the outcome, taking into ment of food safety is that regulatory interventions, account the business environment and wider market con- In assessing hazards, most criteria involve consideration of: such as inspections, cannot ensure food safety. The ditions; (the intervention may be education, provision of responsibility for ensuring food safety belongs to the information, inspection); • the sector of activity; business. This is also central to the introduction of a • specific processes used; risk-based approach to inspections and enforcement, • risk assessment of individual businesses and premises; • scope of operations; as it is not possible to control or eradicate all risk. and • the number of people affected (or potentially affected) by its operations; and • sanctioning according to risk, taking a proportionate re- • where relevant, geographical locations (for example, close It is often through enforcement that businesses experi- sponse to non-compliance. to sources of pollution, or likely to cause pollution to other ence regulation on a day-to- day basis and this is where critical sources such as drinking water). burdens can be most acutely felt. Even well designed Risk assessment involves a number of commonly used terms. food safety regulations cannot address food safety if However, it is important that these terms are correctly under- In assessing the likelihood of non-compliance, relevant factors enforcement is not targeted, risk based and focused stood by inspectors in order to adopt a risk-based approach. include: on the outcomes of protecting safety. Food safety in- The key terms are given alongside definitions in Box 5.1 spections can be some of the most burdensome state • assessing the attitude of the management; interventions in many developing countries, affecting a Box 5.1 Glossary of Key Terms in Risk Assessment4 • implementation of compliance systems; and huge number of businesses, and in many cases carried • data from previous inspections and responses to previous Glossary of Key Terms in Risk Assessment4 out with a strong “rent seeking” bias. advice given. Hazard This is anything with the potential to cause harm. This includes objects, While enforcement of food safety regulations is usually substances, conditions, processes, premises, and activities. The level of Scores for hazard and scores for likelihood of non-compliance a hazard will be determined by the potential severity of the harm it can carried out using an inspections based approach, it is cause. can be given and then translated into a risk-assessment crucial that regulators understand the importance of Harm matrix, such as the one shown at Table 5.1. This allows the selecting the right type of intervention to control the Adverse impact on individuals, the environment, or on other businesses. categorization of businesses into high, medium, and low-risk This is a wide definition that includes physical, mental, social, and risk and meet the needs of the business in achieving economic adverse impacts. categories. compliance. This could mean taking samples, providing Risk A function of the level of a hazard and the likelihood that the hazard will information to consumers, delivering advice or carry- cause harm. The likelihood of a hazard causing harm is represented by the ing out an inspection. Selecting the right intervention likelihood of compliance. should be guided by a clear sense of the purpose of Likelihood of compliance The likelihood that a business will achieve compliance. Assessing the regulation and the outcome to be achieved – namely likelihood of compliance involves consideration of a range of factors protecting public safety rather than simply checking that allow a business to be compared with others for the purpose of conducting a risk assessment. It is largely a reflection of the inspector’s compliance with a technical set of standards. confidence in management’s ability to achieve compliance and so control the risks presented by the hazard in the foreseeable future. Risk assessment The process by which the risk associated with a particular hazard is identified and categorized. The categorization process normally allows comparisons to be made between businesses. 4 http://www.bis.gov.uk/assets/brdo/docs/resources/risk- assessment-paper.pdf 10 Investment Climate Food Safety Toolkit Module 5: Risk Assessment, Enforcement and Inspections 11 Table 5.1 Example of Risk Assessment Categorization from the United Kingdom5 Planning and data Effective sharing of data between agencies is central to the success of the “farm to table” approach to food safety. If Risk categories Likelihood of non-compiance Risk-based inspections can only be achieved if time and re- electronic databases are interconnected, or allow easy data sources are spent on strategic planning and analyzing. Stra- sharing with other agencies, all potential sources of hazards VERY LOW LOW MEDIUM HIGH VERY HIGH tegic planning includes collating information, identifying can be better identified and results of their control visibly HIGH LOWER MEDIUM UPPER MEDIUM UPPER MEDIUM HIGH HIGH trends, and making evidence-based decisions on where to displayed. It also helps, for auditors coming from the side focus resources and the efforts of inspectors. It is desirable to of buyers (EU, United States) to perform inspection of one Level of hazard UPPER MEDIUM LOWER MEDIUM LOWER MEDIUM UPPER MEDIUM UPPER MEDIUM HIGH have dedicated planning and analytical teams based in food particular segment or the whole food safety system, since it safety organizations. The key functions of these teams should displays effects of measures undertaken and provides insight LOWER MEDIUM LOW LOWER MEDIUM LOWER MEDIUM UPPER MEDIUM UPPER MEDIUM be prioritization, risk planning, and evaluation. This includes into functioning of the food safety system in whole. LOW LOW LOW LOWER MEDIUM LOWER MEDIUM UPPER MEDIUM identifying what type of food safety issues agencies should focus on, categorizing businesses according to risk levels, Where possible, a common food safety database is desirable. and monitoring improvements in rates of business compli- This database should cover all steps in food production, ance and public safety. transportation, sale, services, and results of all laboratory analysis of samples taken at all steps, kept and updated by Table 5.2 Estimation of Risk Associated With Individual Figure 5.2 Business Profiling Following Risk Assessment Risk-based planning requires data in order to identify pri- the central national responsible agency for food safety. If a Food Business Operator6 orities and categorize businesses according to risk. Types of central database is not possible, different databases should be Product data required include complaints about products, complaints either interconnected or allow easy exchange of information. SK risk profile RI about food businesses, records of previous inspections, sam- The introduction on electronic databases and effective system ER Compliance Inspection GH Establishment profile priority pling and testing, and data on major incidents and outbreaks design can be a major undertaking, and our assistance on HI Low High 1 of foodborne disease. This data needs to be held on a data- this point often focuses only on “how” and “what” rather SK base to allow information on businesses to be collected and than on supporting the setup of the whole system. RI Low Low 2 M IU stored for future risk profiling and evaluation. ID M High High 2 SK The FAO Risk Based Food Inspection Manual7 recommends RI High Low 3 ER the following necessary data to inform risk assessment: W LO *1 1= top priority; 2 = medium priority; 3 = low priority • Information on existing food operators (updated Register of Facilities). Robust risk assessment should lead to the following type of Risk assessments (or risk “ratings”) of businesses should be business profile (Figure 5.2), where there are few high-risk based not only on what is found at the time of an inspection • Categorization of food operators (according to the type of businesses premises. When implementing a risk-based ap- or other intervention, but should also take account of other food they produce, process, number of expected consum- proach, care should be taken to avoid an overly cautious ap- relevant available information, to inform the decision. Risk ers). proach where low risk becomes medium risk and many busi- assessment plays a crucial part in improving targeting of nesses are rated as high risk. This is a significant problem if resources, consistency for business, and transparency to • Prioritization of inspection based on high- or low-risk food inspectors are not rigorous in applying risk assessment, based business. Risk assessments based on good intelligence (for operator’s profiles- occurrence of foodborne diseases and on available data. example, information shared with other regulators) support type of safety and quality management system they have. effective risk-based targeting, which reduces duplication Priorities are reviewed after each inspection according to of regulatory activity and reduces burdens on compliant new data (changes in establishments, type of products, businesses. market). It is important for businesses to receive meaningful feedback from regulators on their compliance performance and how to improve it. A business should be able to understand the risk assessment systems they are subject to, and particularly, what criteria is used to assess their performance, what the trigger 5 Proposals for Developing a common approach to risk points are for changes in assessment ratings, how easy is 7 FAO Food and Nutrition Paper 89, ISSN 0254-4725 ftp://ftp.fao. assessment, BRDO http://www.bis.gov.uk/assets/brdo/docs/ org/docrep/fao/010/i0096e/i0096e00.pdf resources/risk-assessment-paper.pdf it to move between ratings, and what that means for the 6 FAO Food and Nutrition Paper 89 frequency and nature of the response from inspectors. 12 Investment Climate Food Safety Toolkit Module 5: Risk Assessment, Enforcement and Inspections 13 Prior registration The principles of FBO registration and approval are sound and sit favorably alongside the wider objectives Choosing appropriate risk-based interventions • Advice is an informal action through which inspectors as- sist food handlers in achieving compliance to safety prac- and approval and guiding principles of regulatory delivery. However, in many intervention countries the notion of FBO ap- Currently, much of enforcement activity is focused on inspec- tions. One way of thinking about inspections and enforce- tices and rules. proval and/or registration can pave the way for onerous ment is that they provide information and reassurance to the • Written notice – This is a formal letter usually containing and complex requirements for permits and certifications majority of businesses that want to comply. If provided with a list of non-conformities and detailed instructions how that may or may not be risk based and proportionate. the information on “how to,” inspection can also be an ef- these should be corrected and a time given for improve- fective means to encourage more businesses to improve, but ments. Prior registration of food businesses helps to support Reform in this area should follow the guiding principles cannot eradicate deliberate non-compliance or criminality. A decision making on risk-based interventions by provid- that premises registration should be simple and inclu- well-targeted inspection system can, however, help to reduce • Official recall of food – This occurs when food contains ing enforcing authorities with information they can re- sive, and designed to ensure that FBOs are known to the numbers of businesses that are deliberately non-compli- hazards that can endanger public health. tain on a database that can be used to assess frequency enforcing authorities for the purposes of inspection, ant, and to limit their negative impact. of inspection and interventions. In many intervention guidance, and advice. Any wider requirements for • Warnings – These are issued when a violation of a legal countries the requirement for food business operators premises registration and approval should be based on However, in addition to using inspection, it is important that provision has been determined and the food handler has to be subject to wide range of prior permits, licenses, risk, proportionate and linked to measurable param- regulators develop an approach that delivers the best interven- admitted to breaching the law. approvals, certifications, and examinations for staff, is eters, such as: tion for the circumstances, and here agencies should develop very common. an approach inspired by the “enforcement pyramid,” shown • (Administrative) court procedure – When food business • products of animal origin – meat, fish and dairy in Figure 5.3. Effective approaches to securing compliance operator does not comply with a written letter or when This requirement is reflected in the food safety legisla- products; require inspectors with a range of softer skills, in addition to after a warning was issued, fails to correct the problem in tion of many developed as well as developing countries. technical knowledge, including understanding business, as- question. For example, the U.K. Food Safety Act 1990 required • high-volume operations implicating the above prod- sessing risks, investigation, and effective communication. that all food businesses underwent formal registration uct groups; and • Closing down facilities – This action should be ordered not less than 28 days prior to commencing trade. This As shown in the pyramid, the main response to non-compli- when there is a reasonable doubt that an outbreak is asso- allowed for enforcement agencies to create a database • high-risk process sectors such as canning. ance should normally be explanation and information, com- ciated with food produced in a particular facility, or when of existing and emerging food businesses that required bined with an enforcement notice (particularly for first rela- a facility fails to comply with hygiene and safety require- inspection prior to them being allowed to trade. In the EU, additional approval is sought by enforcing tively minor issues), with sanctions being used with graded ments in such a manner that food produced may pose an authorities for food handlers dealing with high risk severity. Inspectors have different mechanisms of warning or immediate threat to health. The usual position is that registration of food business- products (products of animal origin). Further informa- penalizing food business operators, depending on the level es is undertaken once the business has begun trading tion on the EU regulations for products of animal origin of food safety risk caused, or potentially caused: for the purpose of ensuring that the necessary enforce- can be found in Annex 1. ment interventions are undertaken at the appropriate intervals determined by risk. The process of food busi- ness registration provides a framework for regulators to use so that they can identify the FBOs that require inspection as well as creating a database of FBOs for the purposes of communication, advice, and guidance. Figure 5.3 Enforcement Pyramid This serves the additional purpose of giving regulatory TERMINAL SANCTION agencies an understanding of the complexity and diver- Emergency Closure Denial or Revocation sity of FBO activity is useful in informing the regulatory of a licence Petit for Court intervention delivery resource agenda in terms of understanding the INTERMEDIATE SANCTIONS numbers of enforcement and inspection personnel that Fines Reduce Capacity or Reduce Admissions for Cause may be required as well as establishing any specialist Probationary Status Stipulated Consent Agreements sectors which may need additional enforcement exper- tise. PREVENTIVE AND CORRECTIVE STRATEGIES Compliance Monitoring Technical Assistance, Training, Consulting Violation w/ Corrective Action Plan 14 Investment Climate Food Safety Toolkit Module 5: Risk Assessment, Enforcement and Inspections 15 Training and Even though this toolkit covers the legal and institution- al aspects in detail, often the most important challenge education to the success of food safety reform is the change in at- titudes in relation to food safety needed by regulators, food business operators, and citizens. Competency of inspectors Inspectors should look at how food handlers have secured Regarding the nature of the inspection, developing checklists Moving to a risk-based approach to enforcement and Regulators and particularly enforcement staff very food safety, whether their systems provide enough protection (and guidelines for implementation and control of preventive inspections is usually a considerable change compared often will need thorough retraining in a number of and whether they are satisfied that procedures are in place to programs) that lay out clearly the main requirements can sup- with the existing situation in many developing coun- areas. The three aspects that make up a competent correct hazards if they remained in products. port greater transparency. Checklists should be based on risk tries “prior situations,” so, risk-based planning requires inspector are shown in Figure 5.4. criteria, focusing on the highest hazards. Checklists should considerable retraining of inspections staff. In the past, If inspection is identified as the most effective tool, a number follow the natural course of operations starting from pur- inspection was mainly product-based, relying on visual Figure 5.4 Elements of Inspector Competency of different types of inspection visits may be used: chase of inputs, production and ending with the release of inspection and sampling of final products. Safety and final products. To provide transparency to businesses, check- quality parameters of food were equally important. • Scheduled visit (according to the annual plan and based on lists should be publically available and easily accessible, for ex- While food safety problems endanger health, lower risk). ample, through publication on inspection agencies’ websites. quality products need not to be unsafe. Visual inspec- KNOWLEDGE This enables food operators to use them when performing tion and sampling of final products, without a clear • Follow-up visit (in case when non-conformities were iden- self-inspection, prepare for the official inspection, and follow plan, didn’t improve the food safety situation and re- tified at the scheduled visit and in order to check how rec- on a continuous basis the recommendations for their type of peatedly, year after year, the huge numbers of samples ommendations given by inspector were followed). operation. were tested, without reducing the number of food- COMPETENCE borne diseases. Scientific knowledge gathered in the • Surveillance visit – inspection of one homogenous group meantime indicated that, control of hazards (biological, SKILL ATTITUDE of food operators (control of hazards in production of one chemical, physical) at the place they emerged or at the type of commodity, for example: ice cream producers; egg place where a specific technological operation is con- farms; green houses). ducted, dramatically improve safety of food. • Monitoring of contaminants/pests/animal or plant health according to the national monitoring plan (for example: the monitoring plan on eradication of Trichinella, Brucel- losis, Tuberculosis, certain plant pests, or pesticide residues in certain food). • Audit of food safety systems in place (are all necessary elements of a mandatory system in place, for example, HACCP). 16 Investment Climate Food Safety Toolkit Module 5: Risk Assessment, Enforcement and Inspections 17 Knowledge – technical scientific knowledge of food safety Food business operators9 Educated citizens issues needs to be up to date and in line with the reformed food safety system. For example inspectors will often need Outreach to food business operators is essential to ensure Education and information for citizens is a key way to to move from checking purely formal requirements (“is the that they understand their role and responsibilities in relation influence attitudes about food safety, which in turn can drive floor in the prescribed material?”) and look at the production to food safety. The focus of education or information for food businesses to produce and sell safe food. Citizens should process as a whole, and at its critical aspects (the HACCP food business operators will depend on the types of changes understand that food safety regulations are there to ensure approach in practice, regardless of the presence or absence implemented as part of the reform project but could include that the food they buy is safe to eat and should be able to of a formal “HACCP certification requirement”). the way modern requirements work (in particular the focus on quickly report any deficiencies to food business operators or process), what liability entails for them, and advice on how to regulators. Skills – generic skills needed to be an effective inspector comply with the law. include the ability to assess risk in terms of hazard and In countries where there is a market economy or a developing likeliness; planning/prioritization skills; ability to advise and Part of the inspectors’ role should be to provide the food market, making information publicly available about the Snapshot 5.2 Using Consumer Information to influence businesses as part of securing compliance; ability business operator with information and advice to help them safety of food sold to consumers can act as a mechanism to Improve Food Safety10 to communicate with food business operators and other to comply with the law. Regulatory agencies will often design drive food businesses to comply with food safety regulations. stakeholders as well as the ability to conduct inspections, campaigns and literature designed to support businesses by For an example see Snapshot 5.2 below. Inspection of retail food premises is a key component of efforts interviews, and other interventions appropriately.8 providing information about new requirements. to prevent food-borne illness and improve food safety. Figure 5.5 Relationship Between Business, Regulators, In 1998, Los Angeles County Department of Health Services Attitude – the attitude and culture of inspectors needs to As part of the reform process, it is important to gather the and Citizens in the Regulatory System implemented a new inspection program that required inspection be appropriate to the aims of the regulator. “Rent-seeking” views of businesses on the current situation, and consult on scores of restaurants and commercial food establishments to behaviors often need to be eliminated and inspectors need to proposed changes to food safety rules. It can be difficult for Signal their needs be publicly displayed. To further increase transparency and understand better how to promote compliance rather than policy makers or regulators to see how particular changes will BUSINESS REGULATORS availability of this data, a searchable internet-based database just punish infringements. Inspectors need to be able to take affect businesses without asking them. Regulation & Advice was established providing information on inspection scores, on more “integrated” roles, with fewer specific inspectors non-compliances found, and restaurant closures. The program focusing only on small parts of the food chain, and more Businesses should be able to understand what regulatory Re was also accompanied by improved inspection targeting of gu la n “multi-purpose” ones that can handle different types of requirements apply to them, and how they should act in io te at d high-risk premises, additional training of inspection staff, and rm In Ch ns fo fo er order to comply with food safety law. Businesses should oo establishments, depending on changing priorities based on rm in nc se increased efforts in providing education and training materials at e co id to io ov s& risk analysis. Changing the culture of regulators is difficult also understand how inspectors will behave and should feel n bu Pr ie for restaurant owners and staff. y rit or io and needs strong leadership. able to complain about the behavior of inspectors if they are no pr t al gn unhappy. Results show that this new approach was associated with a Si CITIZEN 13.1 percent decrease in the number of foodborne disease hospitalizations in Los Angeles County in the year after introduction, a decrease that was sustained in following years. Data also suggests that the program increased compliance, improved inspection scores, and influenced consumers’ choices. Published inspection scores allow consumers to include information on food safety practices when they choose where to eat, therefore creating an economic incentive for restaurants to maintain good hygiene, which should ultimately lead to fewer foodborne illnesses. The concept of decreasing the number of outbreaks of food- related illness through improved information to consumers is an increasingly popular one, with similar schemes in operation For an example of UK competency framework for regulators 8 10 Information taken from Impact of Restaurant Hygiene Grade see http://www.bis.gov.uk/assets/brdo/docs/competency/sms- in the United Kingdom and Denmark. By introducing economic Cards on Foodborne-Disease Hospitalizations in Los Angeles core-regulatory.pdf and http://www.bis.gov.uk/brdo/resources/ incentives to businesses, regulators can drive business County, Journal Of Environmental Health, March 2005, Volume competency 67, Number 7 and Effectiveness of Altered Incentives in a Food compliance and improve food safety outcomes. There is considerable detail in this area contained in the already 9 Safety Inspection Program, Preventative Medicine 32, 239-244 existing firm specific Food Safety Toolkit designed by IFC (2001) Sustainable Business Advisory. see https://spark.worldbank.org/docs/DOC-36707 18 Investment Climate Food Safety Toolkit Module 5: Risk Assessment, Enforcement and Inspections 19 Snapshot 5.3 As an added means to give business confidence, the Snapshot 5.4 U.K. Primary Authority Scheme: scheme contains protections for businesses that if they have Use of Private Veterinarians in Croatia Providing Reliable Advice to Business followed the advice given by the primary authority, their In Croatia, the number of veterinary inspectors at the local level actions cannot be challenged by another local regulator The United Kingdom is widely recognized for its innovative employed by the government is not sufficient to cover all food and enforcement action cannot be taken against them. work on inspection reform, including the development of business operators dealing with food of animal origin. According This assurance gives businesses confidence to invest in their the Primary Authority scheme which was launched by the to the Croatia Law on Veterinary, licensed veterinarians compliance with the knowledge that another inspector will government in April 2009. Primary Authority was originally perform control over animal health, transportation of animals, not impose a different set of requirements, which often established to address a historical problem of inconsistency slaughtering, milking, production of dairy products, fishing and results in both unnecessary time and cost burdens. of enforcement among regulators. It has since grown to fish farming, processing of fish, and production of honey, eggs, become a highly successful scheme that enables businesses In the United Kingdom, the scheme has proved successful, poultry. Therefore, due to lack of state-employed veterinary to receive professional, tailored compliance advice that with over 700 businesses participating, including many large, inspectors, the State Veterinary Inspection Directorate hires is respected by all other inspection agencies, providing multi-national companies and with strong representation private veterinarians to perform veterinary inspection. businesses with confidence to invest and grow. from businesses within the food sector. The U.K. government In order to do that, they must have a certificate that they have intends to extend the scheme to enable more businesses to Primary Authority is based on the concept of a new, more passed the Veterinary Board exam and have at least three participate and allow trade associations to gain assurance positive relationship between regulators and business years of work experience after the exam. They must be trained from primary authorities for the compliance advice they that delivers benefits for business and is more efficient for in principles of inspection and administrative rules. They are produce for member businesses. regulators. appointed and deployed by the head of the State Veterinary For more information on Primary Authority, see http://www. Inspection Directorate, have a badge verifying their status and As part of the scheme, a regulator acts as a “primary bis.gov.uk/brdo/primary-authority their official number, and when performing official inspection, authority” for a named business, and is responsible for are paid according to the number of work hours from the providing the business with detailed compliance advice and Veterinary Inspection budget. All decisions they make have the support. This advice should be specific to the business needs same power as decisions made by state-employed inspectors. and mode of operation, and based on high levels of technical knowledge and understanding of the business environment. In case of appeal to their decisions, regional state-employed By forming a good relationship, the regulator is more able inspectors issue decisions. The third and final level of decision is to influence compliance and improve performance, and the made by the State Veterinary Inspection Directorate. business is able to get the advice it needs to get things right FBOs can appeal to the court on decisions of the third level. first time. 20 Investment Climate Food Safety Toolkit Module 5: Risk Assessment, Enforcement and Inspections 21 Key messages • In deciding which measure to apply, inspectors should take into consideration: • the risk to public health; • the past record of cooperation of the food busi- ness operator; and • the level of non-conformities found. • Primary responsibility for food safety lies with food business operators. • Measures imposed by inspectors have to be propor- tionate to the level of health risk, not unnecessarily • Inspectors control how food safety is secured by strict, and should in no way be proposed for reasons food handlers and whether regulatory requirements of securing monopoly to some producers on the are met. market or due to conflict of interest. • Inspectors advise food business operators how to • The goal of inspection should be to support food meet regulatory requirements. business operators and enable them to improve safety of their products and at the same time to • Inspectors must be well trained in order to recognize prevent food that was proved to be unsafe to reach which non-conformities may pose health risks. consumers. • Inspectors must identify the level of risk associated with certain non-conformities and impose measures accordingly. Further details can be found in specific World Bank Group and OECD publications: • World Bank Group, Study of Food Safety Inspections 2009  https://www.wbginvestmentclimate.org/uploads/Study%20of%20Food%20Safety%20Inspections%202009.pdf • World Bank Group, How to Reform Business Inspections 2011 https://www.wbginvestmentclimate.org/uploads/How%20to%20Reform%20Business%20Inspections%20WEB.pdf • OECD Inspections Reforms - Why, How and with What Results? 2013 http://www.oecd.org/gov/regulatory-policy/Inspection%20reforms%20-%20web%20-F.%20Blanc.pdf 22 Investment Climate Food Safety Toolkit Q1. Is a risk based approach currently NO Identify gaps OR STOP Dairy sector example taken to regulation/ enforcement? YES Consider risk planning Q1. Regulation must be risk based if food safety is to be controlled adequately in this sec- requirements tor. Too much emphasis on issues not related to food safety and more about quality NO Q2. Is risk managed at or standards can result in risks being ill-considered. Critical issues in food safety in this national level? sector are well documented in many guidance and standards documents (for example, time and temperature controls for processing). This should be used as a basis to sup- port risk- based regulations and enforcement, and dairy sector-specific, risk- based regulations and enforcement in this area. YES Consider risk based approaches to enforcement Q2. Risk responsibility will need to be established for the dairy sector. Which ministries, individuals or organizations are involved? How much expertise do they have ?. What is the relationship between national and local risk management and are international Q3. Is risk communicated at National level? agencies involved? Who? When? Where? What? How? Are the questions that need to be asked in the context of this sector? NO Consider risk Q3. If risk is communicated at national level what role do businesses and citizens play in communication strategy YES this and how is the information circulated? Is communication strategic? What does the process of communication of risk look like? Are there any gaps? Q4. Competency of officers in this sector is paramount to good regulatory delivery and Q4. Are enforcing supporting the risk framework. Expertise needs to be at the technical level with respect officers/inspectors NO to dairy sector specificity- an understanding of the hazards associated with this sector competent? Identify gaps in training and how they need to be managed. What prerequisite requirements need to be in and competency issues place and what constitutes effective implementation of food safety controls? YES Develop risk based approach to Train officers regulation and enforcement Module 5: Risk Assessment, Enforcement and Inspections 25 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 Figure 5.1 Process of Risk Assessment 06 Snapshot 5.1 European Union Practice 07 Box 5.1 Glossary of Key Terms in Risk Assessment 11 Table 5.1 Example of Risk Assessment Categorization from the United Kingdom 12 Table 5.2 Estimation of Risk Associated With Individual Food Business Operator 12 Figure 5.2 Business Profiling Following Risk Assessment 12 Figure 5.3 Enforcement Pyramid 15 Figure 5.4 Elements of Inspector Competency 17 Figure 5.5 Relationship Between Business, Regulators, and Citizens in the Regulatory System 19 Snapshot 5.2 Using Consumer Information to Improve Food Safety 19 Snapshot 5.3 U.K. Primary Authority Scheme: Providing Reliable Advice to Business 20 Snapshot 5.4 Use of Private Veterinarians in Croatia 21 Credits Photography: BigStockPhoto, Robert Gerhardt (cover page, page 17), Richard Thornton (page 5), Hywit Dimyadi (page 6), Sebastian Duda (page 7), Nasaruddin Bin Abdul Muttalib (page 8), Laurentiu Iordache (page 10), Pam Burley (page 14), David Snyder (page 16), Pedro Salaverría Calahorra (page 18), Erwin Wodicka (page 19), Lucian Milasan (page 20), Sinisa Botas (page 21) in partnership with: