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

based Approachbased Approach

Ewen C. D. ToddEwen C. D. ToddAdvertising, Public Relations, and RetailingAdvertising, Public Relations, and Retailing

Michigan State UniversityMichigan State UniversityEast LansingEast Lansing

MichiganMichigan

Symposium: Building Capacity to Enhance Food Safety in the Middle East, February 25, 2009

4th Dubai International Food Safety ConferenceFebruary 24-26, 2009

Setting a Risk-based Policy for a Food Setting a Risk-based Policy for a Food Safety AgencySafety 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?

What Are the Foodborne Illness Risk What Are the Foodborne Illness Risk Factors?Factors?

Food from Unsafe Sources Inadequate Cooking Improper Hot and Cold Holding Contaminated Equipment Poor Personal Hygiene

Allergens Unknown chronic risks from chemicals

Increase in illnesses from viruses and parasites

There are many examples of food There are many examples of food safety agencies but we only have time safety agencies but we only have time

to briefly look at three:to briefly look at three:The European Union (EFSA)

The USA (FDA and USDA)Australia (ANZFA)

How do these agencies respond to How do these agencies respond to these risk factors to reduce these risk factors to reduce

foodborne illness?foodborne illness?

European Food Safety Authority (EFSA)European Food Safety Authority (EFSA)

• EFSAEFSA 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 European Centre for Disease Prevention and ControlPrevention and Control (ECDC) to identify, assess and communicate threats to human health posed by zoonotic diseases

Examples of EFSA and ECDC CollaborationExamples 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

Salmonellosis per 100,000 in the EU Salmonellosis per 100,000 in the EU

EU Criteria: Absence of EU Criteria: Absence of SalmonellaSalmonella• 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)

Compliance with EU Criteria for Compliance with EU Criteria for SalmonellaSalmonella

VTEC Infections in EuropeVTEC 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

Age-specific Distribution of Listeriosis in EU, Age-specific Distribution of Listeriosis in EU, 2007 – High Risk for Young and Old2007 – High Risk for Young and Old

EU Compliance Criteria for EU Compliance Criteria for L. monocytogenesL. monocytogenes

• Absence: in RTE products intended for infants and for special medical purposes, L. monocytogenes must not be present in 25 g

• Limit: L. monocytogenes must 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. monocytogenes it 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%)

Problems in Collecting and Problems in Collecting and Interpreting Data for Interpreting Data for LmLm Compliance 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

The US Food Safety Oversight SystemThe 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

Food Safety Oversight in ChinaFood 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

US Multi-Agency Initiative:US Multi-Agency Initiative:Healthy People 2010Healthy People 2010 Food Safety Key AreasFood Safety Key Areas

• Emerging pathogens• Food preparation and storage practices• Training of retail food employees• Allergens/anaphylactic shock• Global food supply

• One goal: 50% One goal: 50% reduction in infections caused reduction in infections caused by pathogens from 1996-98 to 2010by pathogens from 1996-98 to 2010

2007 Incidence per 100,000 2007 Incidence per 100,000 Compared with 2010 US ObjectiveCompared with 2010 US Objective

Agent 1997

2001

2004

2005 2007

2010

SalmonellaSalmonella 13.713.700

15.115.1 14.714.7 14.6 14.6 14.914.9 6.86.8

Campylobacter

24.60

13.8 12.9 12.7 12.8 12.3

Shigella NA 6.4 5.1 4.7 6.6 NA

E. coli E. coli O157O157 2.102.10 1.61.6 0.90.9 1.11.1 1.21.2 1.01.0

Cryptosporidium

NA 1.5 1.32 3.0 2.7 NA

ListeriaListeria 0.50.5 0.30.3 0.270.27 0.3 0.3 0.270.27 0.250.25

Vibrio NA 0.2 0.28 0.3 0.24 NA

Cyclospora NA 0.1 0.03 0.02 0.03 NA

SalmonellaSalmonella in the US 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)

Maki D. N Engl J Med 2009;10.1056/NEJMp0806575

Two Large US Two Large US SalmonellaSalmonella Outbreaks in 2008-2009 Outbreaks in 2008-2009

Maki D. N Engl J Med 2009

Maki D. N Engl J Med 2009

Cases of Infection with the Outbreak Strain of Cases of Infection with the Outbreak Strain of SalmonellaSalmonella Typhimurium in the United States, September 1, 2008, through Typhimurium in the United States, September 1, 2008, through

February 8, 2009February 8, 2009

Control of Listeriosis in the USControl 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

Control of Listeriosis in the USControl 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. monocytogenes by 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 Large deli meat outbreak in Canada in 2008 with many deaths, processor not

following the Rule recommendationsfollowing the Rule recommendations

Australia New Zealand Food Australia New Zealand Food Authority (ANZFA)Authority (ANZFA)

• Within Imported Foods Program, foods are classified as RiskRisk or SurveillanceSurveillance 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) system to recognize compliant producers and penalize those that have failures

Risk Ranking of Australian SeafoodRisk Ranking of Australian SeafoodHazard Selected population Risk ranking

Ciguatera in reef fish General population 45Ciguatera in reef fish Recreational fishers 60Histamine in fish General population 40Algal biotoxin in shellfish-controlled waters

General population 31

Mercury in predaceous fish General population 24Viruses in oysters – uncontam. waters General population 31V. parahaemolyticus in cooked prawns

General population 37

V. vulnificus in oysters General population 41L m in cold smoked seafoods General population 39L m in cold smoked seafoods Susceptible population 45L m in cold smoked seafoods Extremely susceptible(eg., AIDS) 47C. bot in vacuum packed smoked fish General population 28Parasites in sushi/sashimi General Australian population 31Enteric bacteria in imported cooked shrimp

Susceptible (e.g., aged, hospitalized, pregnant)

48

How Changes Are Made to Australia How Changes Are Made to Australia New Zealand Food Standards 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

Public Attitudes to Food and Its SafetyPublic 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

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?

February 2/3, 2009

Gulf Cooperation Council (GCC) Gulf Cooperation Council (GCC) Common MarketCommon 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

Components of an Effective Components of an Effective Food Safety ProgramFood 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

Components of an Effective Components of an Effective Food Safety ProgramFood 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

Components of an Effective Components of an Effective Food Safety ProgramFood Safety Program

• Establish adequate, consistent and long-term funding

• Create means to share data with other jurisdictions to avoid overlaps in surveillance and monitoring and to reduce inspection costs

• Incorporate all stakeholders as a part of the program with 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

Thank you for your attention