Food Safety Regulatory Enforcement and Inspections – an overview of key features and issues

1. Food Safety Regulatory Enforcement and Inspections – an overview of key features and issues Donald Macrae, Florentin Blanc Amman, 3 June 2014

2. Overview: the Food Safety System

3. World Bank GroupMultilateral Investment Guarantee Agency THE WORLD BANK What is “Food Safety”? • Availability of food for consumers that is safe to eat – chemically, bacteriologically • Requires food business operators to follow best practices – but also consumers to do so (and to be aware of what to avoid) • Regulation has a role to play – but it cannot ensure safety by itself

4. World Bank GroupMultilateral Investment Guarantee Agency THE WORLD BANK The “Food Safety system” • The Food Safety system includes most importantly producers, regulatorsand consumers • It aims at: • Preventing or minimizing contamination of food • Identify any problems in the food chain quickly • Mechanism to address hazards, outbreaks etc. when they occur, including by recalling food • Minimize costs(for business and government) and ensure trust(for consumers and trading partners) • Integration in international tradeis also an essential goal of the system

5. World Bank GroupMultilateral Investment Guarantee Agency THE WORLD BANK

6. World Bank GroupMultilateral Investment Guarantee Agency THE WORLD BANK Food Safety regulation and inspections – what can be achieved? • Regulation cannot provide safe food by itself: • Regulators do not produce the food • They cannot inspect everywhere, all the time • Also cannot replace consumers and cook for them… • Limits on operational capacity (budgets, staff) mean that: • Only limited controls can be implemented • Priorities have to be established • Problems will always (so much food, every day…) so: • Risk focus is essential (minimize harm) • Rapid information flow is vital –with effective mechanisms to react to outbreaks

7. World Bank GroupMultilateral Investment Guarantee Agency THE WORLD BANK Key principles for effective and efficient food safety regulation • Effective: • Requirements =best practice and latest science • Strong, transparent, predictable enforcement • Intense information efforts • Low-burden: • Clear rules, guidance, advice • Simple procedures, minimal paperwork • Differentiation of operators = risk level, and history • Enabling: • Sufficient flexibility for innovation, growth • Affordable food for consumers • Foreign trade

8. World Bank GroupMultilateral Investment Guarantee Agency THE WORLD BANK Instruments of modern food safety regulation • Risk focus: • Focus on critical stages and « control points » of the process • Inspections based on probability and magnitude of harm • Producer/operator liability: • Regulators have a role, but operators are responsible for safety • Can mean less bureaucracy (permits and certification reduced) but also considerable financial and penal liability • Traceability • At all stages, every product and its components • Foundation for rapid response, recalls • Early warning system and recalls: • Accidents, contaminations, mistakes etc. will happen, • Identify origin of contaminations, withdraw/eliminate products

9. World Bank GroupMultilateral Investment Guarantee Agency THE WORLD BANK Conditions for modern food safety regulation to work effectively • Information flow and information technology • Between all regulators and state institutions (health care…) • Between regulators and businesses – guidance • Between regulators and the public – awareness, recalls… • Clear and appropriate rules and requirements • Qualified personnel – both in regulators, and in businesses • Most importantly: change in attitudes • Understanding of what are critical parameters for safety • Regulators to understand their role, and their limits • Businesses and consumers to understand their responsibility in ensuring safety

10. World Bank GroupMultilateral Investment Guarantee Agency THE WORLD BANK Reform of Food Safety regulations – changing attitudes of regulators • Risk focus vs. « total control » • « Total control » is impossible – regulators have to be selective • Risk analysis should be the basis for targeting • Producer liability vs. prior approval by regulator • Less bureaucracy to start new factory, product etc. • Regulators are not responsible for safety – businesses are • Control is needed – but also advice and support to businesses • Strict focus on safety vs. old « standards » • More flexibility to differentiate products, introduce novelties, adapt… • Safety requirements often stricter but more focused on process

11. World Bank GroupMultilateral Investment Guarantee Agency THE WORLD BANK Reform of Food Safety regulations – changing attitudes of businesses, and consumers • Businesses: ensuring safety through process management • Understanding their own responsibility and liability • Learning about key parameters, analyzing their practices • Changing production processes to ensure safety • Process and behaviours often more important than equipment • Consumers: taking safety into their own hands • « Traditional » is not always « safe » • Check where you shop/eat, what you buy • Follow good practices for conservation, cooking • Be ready to pay more if you want safer food

12. World Bank GroupMultilateral Investment Guarantee Agency THE WORLD BANK How to make attitudes change? • Regulators: • Clear guidelines (in Laws and Gov’t instructions) • Right incentives (funding, salaries, careers…) • Businesses: • Requirements in law – liability, control of production process… • Awareness campaign, targeted training • Consumers: • Awareness raising, starting in schools, using media… • State institutions (schools, hospitals) to lead the way

13. Food safety inspections and control – a « piece of the puzzle » • Food Safety inspections have an important role to play in the overall food safety system – but they are just a piece of the whole • They cannot deliver expected results if other elements are not there, in particular: • Appropriate norms and requirements • Clear responsibility and liability of operators • Education and knowledge on all sides • Adequate technical capacity • Without these, adding inspections will have no positive impact…

14. Food Safety Inspections and Control in Focus

15. Reform of Food Safety regulations – changing the approach to inspections and control • Risk focus vs. « total control » • « Total control » is impossible – regulators/inspectors have to be selective • Risk analysis should be the basis for targeting inspections • Producer liability vs. prior approval by regulator • Less bureaucracy to start new factory, product etc. • Regulators are not responsible for safety – businesses are • Control is needed – but also advice and support to businesses • Strict focus on safety only vs. old « standards » that regulate « quality » • More flexibility to differentiate products, introduce novelties, adapt… • Safety requirements often stricter but more focused on process

16. Some key principles – what inspections can achieve, and what they cannot… • Goal of inspections? Too often defined as “identifying and eliminating violations of regulations” – in fact goal should be outcomes such as reducing contaminations and spread of diseases, etc. • Inspections cannot achieve these goals alone, but they can contribute to them – if they are properly targeted and implemented • State resources should not be spent, and burden created, to enforce regulations that have no relation to real risks (e.g. “quality”) • Risk analysis, risk focus are essential – checking everything, all the time, everywhere is not possible – and trying to check everything means in practice not inspecting anything properly • Inspections are not alone – for serious crimes, there are law enforcement bodies! this is not inspectors’ job

17. …which means in practice… • If requirements and regulations are unrealistic (too costly, complex etc.) more inspections will not make them complied with – it will just create more corruption • Controlling every establishment regularly is not a rational use of resources – education and prevention are essential – and only objects with a significant level of risk should be checked regularly • Risk analysis should be based on possible outcomes: likelihood and potential magnitude of real harm – not possibility of “violations” • Inspections and enforcement that are burdensome, excessive, “bureaucratic” and seen as unfair have been shown to decrease compliance with regulations instead of increasing it

18. What and how to control during an inspection – concentrating on essential issues, educating (1) • Helpful approach for both inspectors and FBOs: use “check lists” which summarize all the points to be controlled • “Check lists” should be instruments of risk focus and education – so they should be developed from practice – “critical control points” • Example from the UK – “Safer Food Better Business” toolkit: • Guides small businesses step by step, explaining not just “how” but “why” this is important • Includes all points checked by regulators – no “surprise”, inspectors will not suddenly penalize due to requirements not covered in the toolkit • Goal: safer businesses – less hazards for consumers – better business (no bureaucracy, no loss of consumers because of contaminations etc.) • Same approach as HACCP – but simple and for MSMEs

19. What and how to control during an inspection – concentrating on essential issues, educating (2)

20. What and how to control during an inspection – concentrating on essential issues, educating (3)

21. What and how to control during an inspection – concentrating on essential issues, educating (4) Source: Ayres and Braithwaite, Responsive Regulation, 1992

22. Some country examples

23. United Kingdom – emphasis on guidance and risk-management • Single agency (Food Standards Agency) for guidelines and for meat hygiene – but local authorities inspect all other issues • Key element of approach is guidance – let business know clearly what they should do, and why – through: • Detailed, in-depth agreed guidelines for larger businesses (those with several premises/locations in particular) • Simple “toolkits” covering all critical control points for small and micro businesses (“Safer Food, Better Business”) • Use of check-lists for most inspections (designed mostly by the Food Standards Agency) • Risk management in planning – applied by each local authority and by the Food Standards Agency (for meat hygiene) – some general recommended guidelines in next slide

24. Baltic States – single agency and adoption of the EU legal and regulatory system • Before reform: system similar to other former Soviet Union republics: multiple agencies and layers of regulation, many formal procedures • Requirements for entry into the EU: not only adopt 100% of legislation and regulations but also transform entirely practices • Institutional choice: create a single agency based on Veterinary service, but with incorporation of relevant staff from SES (and some more, e.g. laboratory specialists etc.) • Differences between countries on exact scope of single agency: in Lithuania probably broadest, incorporates risk assessment body, laboratory network, even some regulatory functions (most regulations set by Min.Ag. and Min.Health, but veterinary regulations mostly by State Food and Veterinary Service)

25. Italy and the Netherlands – further simplification inside the EU framework • Requirements themselves (mandatory norms re: hygiene, residues, process control etc. + registration/authorization for different types of premises) are constant throughout EU members – but flexibility in implementation is possible, and can be made good use of • In Lombardy (Italy’s largest region – 9.8 Mln inhabitants) the Regional Gov’t in last 3 years cancelled most permits, approvals, professional certifications etc. that were required in addition to EU law – as they were shown to have little positive impact and add serious costs • In the Netherlands, the national Gov’t reduced costs and burden by: • Consolidating agencies into one single inspectorate • Requiring inspections to focus essentially on very high risk objects • Setting a target of no more than 2 inspections/year (not just food safety, all inspections) per business (as a maximum – the average is less!)

26. Institutional Models

27. Food Safety Agency Models - 1 The idea of a single Food Safety Agency is very popular - but it comes in very different forms. The UK’s FSA is a policy body with (almost) no inspectors. It has the Meat Hygiene Service which deals with slaughterhouses and cutting plants but inspections are done by Local Government inspectors. The UK has 433 local authorities, each with its own inspection services, and they do all the food safety and non-food product safety inspections, plus some occupational safety and some environmental protection. The FSA deals with risk assessment, public advocacy, EU negotiations, regulation and political accountability.

28. Food Safety Agency Models - 2 In contrast, the Canadian Food Inspection Agency has 8,375 inspection staff, but policy for food safety remains with the Ministry of Health. It also combines the whole Veterinary service within the Agency. The State Food and Veterinary Service of Lithuania also combines both food safety and the State Veterinary Service. The Dutch Food and Consumer Product Safety Authority has both a large direct inspectorate and is responsible for advising the Minister on policy.

29. Food Safety Agency Models - 3 It is common to combine Food and Drugs, mainly because of the USA example of the Food and Drugs Administration. However, these two functions are not merged, even in the US model. The FDA does not cover food of animal origin, which is USDA (Agriculture) and much inspection is done at State level. TheChinese have very recently streamlined their Food Safety administration, creating the CFDA. But risk assessment remains with Health and primary production with Agriculture. There are 320,000 inspectors but in local government. (And food exports have their own regulator – AQSIQ)

30. Food Safety Agency Models - 4 • So, there can be Food Safety Agencies that are: • Policy and no direct inspectorate; • Direct inspectorate and no policy; • Both policy and inspectorate. • So, there can also be Food Safety Agencies that are: • Only food safety, with a separate State Vet Service (UK); • Combined food safety and State Vet Service (Canada, Lithuania); • Combined food safety with something else (Netherlands, combined with non-food product safety), (USA / China, combined nominally with Drugs.)

31. Conclusion

32. Some words of conclusion - conditions for modern food safety regulation to work effectively • Information flow and information technology • Between all regulators and state institutions (health care…) • Between regulators and businesses – guidance • Between regulators and the public – awareness, recalls… • Clear and appropriate rules and requirements • Qualified personnel – both in regulators, and in businesses • Most importantly: change in attitudes • Understanding of what are critical parameters for safety • Regulators to understand their role, and their limits • Businesses and consumers to understand their responsibility in ensuring safety

33. Challenges and expected benefits • Challenges: • Significant cost of upgrading equipment and processes • Difficulty of changing attitudes • Need for restructuring of state structures • Considerable training needs • Expected benefits • Safer food for all consumers • Greater public trust in the system and in food safety overall • Greater price-differentiation possible between « good » and « bad » producers • Far greater access to international markets - possibility to move into higher value-added products

34. Thank you for listening. Donald Macrae Florentin Blanc DMacrae@ifc.org Fblanc@ifc.org