Building a Food Regulatory System using Scientific, Risk-based Approach

1. Building a Food Regulatory System using Scientific, Risk-based Approach Symposium: Building Capacity to Enhance Food Safety in the Middle East, February 25, 2009 4th Dubai International Food Safety Conference February 24-26, 2009 Ewen C. D. Todd Advertising, Public Relations, and Retailing Michigan State University East Lansing Michigan

2. Setting a Risk-based Policy for a Food Safety Agency • What is the mandate of the responsible agency and its main objective? • Is the main aim to satisfy the governmental system (appropriate acts, regulations, guidelines, etc.) or reduce foodborne illness? • is trade more important than domestic products to determine oversight? • how does disease surveillance link to product monitoring to enforcement actions to education of the producers and the consumers? • how much political influence is expected? • are you concerned about counterfeiting/bioterrorism? • How is science defined • what interrelated disciplines, how does science determine policy? • How do you integrate existing research and surveillance data into policy? • Are there clear and achievable short-term and mid-term goals? • Does it report on progress and how it relates to the goals?

3. What Are the Foodborne Illness Risk Factors? • Food from Unsafe Sources • Inadequate Cooking • Improper Hot and Cold Holding • Contaminated Equipment • Poor Personal Hygiene • Increase in illnesses from viruses and parasites • Allergens • Unknown chronic risks from chemicals

4. There are many examples of food safety agencies but we only have time to briefly look at three:The European Union (EFSA)The USA (FDA and USDA)Australia (ANZFA)How do these agencies respond to these risk factors to reduce foodborne illness?

5. European Food Safety Authority (EFSA) • EFSA was set up in 2002, following a series of food crises in the late 1990s, as an independent source of scientific advice and communication on risks associated with the food chain • Risk assessment is done independently to produce scientific opinions and advice for risk management • Collaborates with the European Centre for Disease Prevention and Control (ECDC) to identify, assess and communicate threats to human health posed by zoonotic diseases

6. Examples of EFSA and ECDC Collaboration • Salmonella: Poultry and pig meat were foods most frequently associated with Salmonella, and on average 5.5 % of all fresh poultry meat were contaminated • in 2007, the EU Commission launched a new control program against Salmonella in breeding poultry flocks and at the end of that year 15 Member States had already met the legal target of 1%, which is set for end 2009 • Listeria monocytogenes: cases of listeriosis remained the same as in 2006 but had the highest mortality rate (20%), especially among vulnerable groups • ECDC is working with EFSA to identify the transmission routes of Listeria and what prevention measures can be taken to reduce the number of cases and deaths

7. Salmonellosis per 100,000 in the EU

8. EU Criteria: Absence of Salmonella • Minced meat intended to be eaten raw (25 g) or cooked (10 g) • Mechanically separated meat (10 g) • Gelatin and collagen (25 g) • Ice cream (25 g) • Egg products (25 g) • Live or cooked crustaceans (25 g) • Precut or raw fruit and vegetables (25 g) • Infant formula and dietary foods (25 g)

9. Compliance with EU Criteria for Salmonella

10. VTEC Infections in Europe • Human disease highest in northern countries • Ireland: 2.7 cases per 100,000 in 2008 is exceeded only in Sweden and Denmark, Irish cases have doubled in 3 years • Cattle: VTEC in cattle at slaughterhouse: 0% to 22.1% • Fresh bovine meat: all VTEC - 0.3% (0-2.9%), and VTEC O157 - 0.1% (0-1.6%) positive • serogroups isolated from fresh bovine meat: O157, O26, O103, O111, and O113, all frequently isolated from human patients with VTEC infections • Precut vegetables: 1,852 samples at retail level in Netherlands all negative, as were smaller studies in Italy, Slovenia and Spain

11. Age-specific Distribution of Listeriosis in EU, 2007 – High Risk for Young and Old

12. EU Compliance Criteria for L. monocytogenes • Absence: in RTE products intended for infants and for special medical purposes, L. monocytogenesmust not be present in 25 g • Limit: L. monocytogenesmust not be present in levels >100 cfu/g during the shelf life of the other RTE products • Absence: for RTE food that support the growth of L. monocytogenesit should not be present in 25g at the time of leaving the production plant • however, if the producer is able to demonstrate, to the satisfaction of the competent authority, that the product will not exceed the limit 100 cfu/g throughout shelf life, this criterion does not apply • Non-compliance in 2007: fishery products (4.0%), RTE cheeses (0.7%), deli meats (1.2%), RTE milk (0.1%), other RTE products (4.4%)

13. Problems in Collecting and Interpreting Data for Lm Compliance • Collection methodology: in some cases it was not possible to establish at which stage in the production chain samples were collected • Growth or no growth: not always possible to determine if the RTE food tested is able to support the growth of L. monocytogenes or not • difficult to determine, depending on factors such as the pH, water activity and composition of the specific product • no information by producers on the growth capacity of L. monocytogenes in their products

14. The US Food Safety Oversight System • The US food safety oversight system has been called a patchwork food-safety system, originating from two different legal mandates • FDA:domestic and imported food, except meat and poultry, and egg products, but including shell eggs • USDA (FSIS): meat, poultry, and egg products • EPA: drinking water, new pesticides, toxic substances and wastes • CDC: responsible for human disease prevention and control • CDC: in the US, 76 million people suffer from foodborne illness each year, resulting in 325,000 hospitalizations and 5,000 deaths

15. Food Safety Oversight in China • The Chinese food safety oversight system is multiple and convoluted • Ministry of Agriculture (MOA)- crops/animals to slaughterhouse • Department of Commerce - processing • Transportation - products in transit • AQSIQ - import and export of all products • Ministry of Health (MOH) and State FDA - foodservice operations, wet markets • State Administration for Industry and Commerce - retail • MOA - sets standards for pesticides • MOH - sets standards for foodborne pathogens

16. US Multi-Agency Initiative:Healthy People 2010Food Safety Key Areas • Emerging pathogens • Food preparation and storage practices • Training of retail food employees • Allergens/anaphylactic shock • Global food supply • One goal: 50% reduction in infections caused by pathogens from 1996-98 to 2010

17. 2007 Incidence per 100,000 Compared with 2010 US Objective

18. Salmonella in the US • The incidence of Salmonella infections in 2007 (14.92 cases per 100,000) was the furthest from the national target for 2010 (6.80 cases), and only infections caused by Salmonella Typhimurium and Heidelberg declined significantly • To reduce the incidence of Salmonella infections, concerted efforts are needed throughout the food supply chain, the U.S. FSIS launched a Salmonella initiative in 2006, with enhancements in 2008 • FSIS testing of broiler chicken carcasses showed Salmonella decreases (16.3% in 2005; 11.4% in 2006; 8.5% in 2007)

19. Two Large US Salmonella Outbreaks in 2008-2009 Maki D. N Engl J Med 2009;10.1056/NEJMp0806575 Maki D. N Engl J Med 2009

20. Cases of Infection with the Outbreak Strain of SalmonellaTyphimurium in the United States, September 1, 2008, through February 8, 2009 Maki D. N Engl J Med 2009

21. Control of Listeriosis in the US • CDC data on foodborne illnesses has indicated that the incidence of infection from Lm decreased between 1996 and 2001, then reached a plateau • A major listeriosis outbreak occurs in the US or Canada every two to four years so it became evident that additional targeted measures were needed • Two peer-reviewed risk rankings of products by FSIS and FDA to estimate the potential level of exposure of three age-based U.S. population groups to Lm in 20 food categories were related to public health consequences • deli meats highest risk product for listeriosis • retail sliced deli meats higher risk than packaged retail products

22. Control of Listeriosis in the US • Policy: all RTE foods need to have <1 cfu/25g • Surveys/QRAs provided important data for designing a final Lm Rule which had three strategies that an establishment could choose from to control the pathogen depending on its product(s) and the environment in which it operates • 1. Post-lethality treatment of product • 2. Anti-microbial agent/process that suppresses or limits growth • 3. Sanitation program within HACCP and testing • > 87% of the plants changed their operations to more effectively control L. monocytogenesby one of the above in 2004 • 25% drop of positive Lm regulatory samples in 2004 from 2003, and a 70% decline compared with years prior to the implementation of HACCP • Large deli meat outbreak in Canada in 2008 with many deaths, processor not following the Rule recommendations

23. Australia New Zealand Food Authority (ANZFA) • Within Imported Foods Program, foods are classified as Risk or Surveillance category foods • risk category foods are determined by ANZFA on the basis of scientific risk assessments for contamination likely to be unacceptable from a consumer safety perspective • risk foods are subject to the most intensive inspection frequency • Provisions are built into the Australian Quarantine and Inspection Service (AQIS) systemtorecognize compliant producers and penalize those that have failures

24. Risk Ranking of Australian Seafood

25. How Changes Are Made to Australia New Zealand Food Standards • Written submissions from interested individuals and organizations are an important part of the standards development process • Listing of Applications and Proposals undergoing the assessment process for which public comment is currently sought. • Rationale for standard/risk assessment/cost-benefit • Risk management strategy/impact analysis • Consultation and communication • Preferred option and implementation by which agencies

26. Public Attitudes to Food and Its Safety • Fears impact trade with developing countries • GM foods and GM crops • Food irradiation • Dioxins and other industrial contaminants • Any level of pesticides • New uncertain-risk compounds like heat generated acrylamide • Chemical additives (Sudan dye), chlorine compounds in poultry • Avian Influenza • Bovine spongiform encephalopathy (BSE)  • The EU Commission remedy for these concerns is more scientific evidence and stronger regulations • Consumer demand: local, fresh products, organic food, minimally processed products, raw milk and raw milk cheese

27. February 2/3, 2009 The deadly E.coli virus is just one of many risks facing consumers of meat products stored or transported in unhygienic conditions, "Though we have no clear figures about Bahrain, we are reasonably sure that most of the food poisoning cases that are treated at hospitals here are due to undercooked meat and meat products.“ ..punish traders who illegally transport uncovered meat in open trucks, exposing their customers to health risks including the potentially fatal E.coli virus. ….warned another global meat-related scare centred on the deadly Listeria monocytogenes (listeria)…… weakened immune systems…. So, what do we know officially of E. coli O157/VTEC and Listeria surveillance in Bahrain, Dubai, the UAE, or even in the whole Middle East?

28. Gulf Cooperation Council (GCC) Common Market • Launched on January 1, 2008 this should remove all barriers to cross country investment and services trade • This means that there should be common standards for traded food unless these are still to be agreed upon • GCC Standardization Organization (GSO) taking the lead for the protection of the health and safety of people in GCC through the maintenance of a safe food: • preventing foodborne diseases/hazards in food at any stage of the food chain • providing for more effective and unified GCC food safety regulations • providing transparency

29. Components of an Effective Food Safety Program • One central organization with clear links to the regional levels (local, state, provincial) to avoid overlaps and gaps in deliverable programs and less conflict of interest • National laws that are clear, rational, and scientific based on risk analysis, and no more than necessary to accomplish the program’s goals • have a clear mandate for complete food safety • define the science(s) used for policy • have clear and achievable short-term and mid-term goals and report on progress? • set and revise standards with international input • develop/revise criteria (performance, product criteria) • collaborate to establish ALOPs and FSOs

30. Components of an Effective Food Safety Program • Ensure the epidemiology can identify foodborne illnesses • Ensure lab capacity is sufficient for monitoring including rapid methods • Links with trading partners and contribution to international bodies like the Codex Alimentarius • Comprehensive surveillance (epidemiology and laboratory components) to understand the current situation and used as a basis for any improvements in disease control or prevention through the risk analysis process • Encourage traceability processes by industry for more effective shipments of products and to limit contaminated product reaching the consumer

31. Components of an Effective Food Safety Program • Establish adequate, consistent and long-term funding • Create means to share data with other jurisdictionsto avoid overlaps in surveillance and monitoring and to reduce inspection costs • Incorporate all stakeholders as a part of the programwith industry and consumer input through representation and open forums for both public and private discussion • Partnering with academia/industry consortia to fund applied and basic research, education and outreach programs to understand and reduce foodborne disease

32. Thank you for your attention