Building a Food Regulatory System using Scientific, Riskbased Approach

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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

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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/bioterroris
  m?
• 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?

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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

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

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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

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Salmonellosis per 100,000 in the EU
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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)

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Compliance with EU Criteria for Salmonella
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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

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Age-specific Distribution of Listeriosis in EU,
2007 High Risk for Young and Old
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EU Compliance Criteria for L. 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 gt100 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)

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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

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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

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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

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US Multi-Agency InitiativeHealthy People 2010
Food 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

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

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Two Large US Salmonella Outbreaks in 2008-2009
Maki D. N Engl J Med 200910.1056/NEJMp0806575
Maki D. N Engl J Med 2009
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Cases of Infection with the Outbreak Strain of
Salmonella Typhimurium in the United States,
September 1, 2008, through February 8, 2009
Maki D. N Engl J Med 2009
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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

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Control of Listeriosis in the US

• Policy all RTE foods need to have lt1 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
• gt 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 following the Rule
  recommendations

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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) system
  to recognize compliant producers and penalize
  those that have failures

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Risk Ranking of Australian Seafood
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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-benefi
  t
• Risk management strategy/impact analysis
• Consultation and communication
• Preferred option and implementation by which
  agencies

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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

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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?
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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

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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 programs 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

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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

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Components of an Effective Food 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

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Thank you for your attention