Management of food safety crisis case study EHEC in Japan Regional Seminar for OIE National Focal Points on Animal Production Food Safety Tokyo, Japan, 31 October 2 November 2012 Hajime TOYOFUKU, DVM., PhD Department of International Health and Collaboration National Institute of Public Health, Ministry of Health, Labour and Welfare, Japan Microorganisms/viruses panel member of the Food Safety Commission, Japan
Contents Outbreak overview Risk management Risk assessment Concusion
Locations of the restaurants and cases Number of patients: 181, Number of HUS cases: 34, fatalities: 5 Places where cases were lived Restaurants located, but no cases reported
Toyama prefecture, 1.09 million population Takaoka Station South Tonami
Detection 1 26 th April (Tue) A potential VTEC infection, a hospital asked Takaoka Health Center to perform VT test 6years old boy, onset on 24 th, vomiting and bloody diarrhea
Detection 2 27 th April (Wed) Toyama Prefecture identified an Outbreak, Common eating place; Ebisu Tonami restaurant Agents: VTEC O157 was isolated from a case Cases: 3 groups A group ate on 23 rd (2 /5), B group ate on 22nd (2/4), C group ate on 23 rd (1/3). total 5 cases, 3 hospitalizations Enforcement: the restaurant was ordered to stop business for 3 days All the restaurants in the F chain voluntary stop serving Yukee (raw beef) Fukui Pref. identified a boy case infected with VTEC O111 on 28th, he died Asked Tokyo pref. to investigate a meat processing est. where the raw material beef was processed.
Detection 3 28th Apr(Thur) The Ministry of Health, Labour and Welfare (MHLW) searched for other cases associated with F chain restaurants outside of Toyama and Fukui pref. The MHLW asked Toyama and Fukui Public Health Institute to perform PFGE pattern analysis. Toyama pref. opened 4 consumer consulting counters. 2 hospitalization cases who had eaten at Ebisu Takaoka Station South Restaurant were reported.
National holiday Detection 4 29 th April (Fri) A Case ate at Tonami Res died (<10 Yrs boy) All 20 restaurants in the Chain F voluntarily stopped business. Cases finding was carried out from other restaurants in the chain F. Toyama pref. began inspections for all raw beef serving restaurants. VTECO157&O111 were isolated from cases.
1 st of May (Sun) Detection 5 2nd of May(Mon) A HUS case who ate at Toyama Yamazato restaurant was reported.(1 st May) Another HUS case who ate at Yokohama Kamishirane restaurant was reported (2 nd May). O111PFGE patterns isolated from cases in Fukui and Toyama were indistinguishable. A FETP team in the National Institute of Infectious Diseases (NIID) was sent to Toyama Pref. to help the outbreak investigation.
Detection 6 3 rd May(Tue) A potential case who ate at Fujisawa Shonandai branch was reported. 4th May(Wed) A case who ate at Tonami restaurant died (female. 40s) 5th May (Thu) A case who ate at Tonami restaurant died (female. 70s) The MHLW asked all local gov. to perform restaurant inspections (in which potentially serving raw beef) 6th May (Fri) Tonami, Takaoka Station South, and Fukuii restaurants banned
Detection 7 24th May PFGE patterns of VTEC isolated from unopened beef and VTEC isolated from a case who ate at Tonami restaurant were indistinguishable.
consequence The Governor of the Toyama prefcture requested the Health, Labour and Welfare Minister to develop a regulatory standard and Microbiological criteria for raw beef. Health Minister promised to develop a regulatory requirement by 1 st of October.
Responses for preventing EHEC outbreaks VTEC 0 157 outbreaks associated with raw beef liver in 1996 Asked consumers to avoid raw liver In response to consumer demands for raw beef meat and liver The Minister asked the Food Sanitation Commission of the Pharmaceutical Affairs June 1997 Pose questions on establishment of standards for raw beef Guidelines for meat for raw consumption The FSC replied to the Health Minister in Sep 1998 A voluntary based guideline was published in 1998
Three Elements of the Risk Analysis Risk Assessment (FSC) Food Safety Hazards in food Risk Management (Ministry of Health, Labour and Welfare & Ministry of Agriculture, Forestry and Fisheries) Based on assessment results Scientific knowledge Public sentiment Cost effectiveness Technical feasibility Implements risk assessment of the adverse health effects resulting from consumption Determine maximum use levels, residue limits, etc. Risk Communication 2
Risk assessment and management for raw beef 24 June 2011: The MHLW asked scientific opinions to the Pharmaceutical Affairs and Food Sanitation Council July 8 2011: The MHLW asked the Food Safety Commission to perform a risk assessment in order to develop Microbiological Criteria and processing criteria. July 26 2011: The MHLW notified to WTO Committee on Sanitary and Phytosanitary Measures of the introduction of MC and processing standards for meat intended to be eaten raw for raw beef (G/SPS/N/JPN/280) 25 August 2011: The Food Safety Commission sent back the result of the risk assessment to the MHLW. Risk Based, ALOP FSO, PO based MC 1 of October; MC and standards for meat intended to be eaten raw were published and enforced.
ALOP New metrics for microbiological risk management the level of protection deemed appropriate by the Member establishing a sanitary measure to protect human life or health within its territory. This concept is also referred to as the acceptable level of risk. Food Safety Objective The maximum frequency and/or concentration of a hazard in a food at the time of consumption that provides or contributes to the appropriate level of protection (ALOP). Performance Objective The maximum frequency and/or concentration of a hazard in a food at a specified step in the food chain before the time of consumption that provides or contributes to an FSO or ALOP, as applicable. Performance Criteria Microbiological Criteria
Food Safety Objective (FSO) A level of hazard or prevalence at point of consumption A basis for discussing food control measures with stakeholders and ensuring feasibility A link to ALOP A clear goal for food control measures Determine the degree of stringency of your control measures 17
FSOs and Pos are means of commutating public health goals o be met by food processors by GMP and HACCP. Industry and Government can set PO to ensure that FSOs are met. ICMSF and Mr Minamoto
FSO/PO/MC Establishing a FSO or a PO is both a scientific and a societal decision FSO is means of relating stringency of the entire food safety control system to public health outcomes PO is the primary means of articulating the level of stringency to level of performance at a specified step in the food chain MC is a means of verifying that a PO is being achieved
Beef distribution farm Risk assessment of raw beef Approach To verify PO, MC is implemented slaughterhouses Determine PO Cut meat Processing plants restaurants consumption Food poisoning 1/10 of FSO Determine FSO ALOP:foodborne disease patients associated with raw beef should be reduced from 190 to zero, death : from 10 /y to <1/100 yrs To achieve FSO To achieve ALOP 20
Converting an ALOP (expressed as number of cases/year) into an FSO Probability of illness Pi 1-2 - 4-6 Doserespons e curve No of m/o ingested Number of cases / 10M people / year Pi x population 20 ALOP Acceptabl e level of hazard Level of hazard per serving converted in FSO in cfu/gram Note: this is a simplification for illustrative purposes only Level of hazard/serving at point of consumption
Concentrations of EHEC in beef at retail No report on concentrations of EHEC in retail beef in Japan. Only available published data: beef trim at retail in Ireland, enumerated by direct count of E. coli O157, Direct plating detected the pathogen at concentrations ranging from 0.70 to 1.61 log10 cfu/g=5.0~40.7 cfu/g( arithmetic mean 14cfu/g) If the concentrations of EHEC in retail beef in Ireland and Japan are assumed to be similar, the concentration shall be reduced from 40.7 cfu/g to <0.04 cfu/g (<1/1,018). 22
Considerations on FSO ALOP Death based (from 10/year to,1/100y) Cases based (from 190/y to <1/y. Current level Safety factor FSO (cfu/g) 14 cfu/g 10 100 =0.014 14 cfu/g 190 =0.07 Same as above with Safety Factor Minimum dose reported in a foodborne outbreak investigation report Same as above with safety factor 14 cfu/g 200 5 =0.014 2cfu/50g =0.04 2cfu/50g 3 =0.013 23
Distribution of beef farm slaughterhouses Cut meat Processing plants Risk assessment of raw beef approach Establish PO PO is 1/10 of FSO Verifying PO by implemen ting MC To achieve FSO restaurants consumed 食中毒 Establish FSO ALOP: cases from 190 to <1 or Death 10/y to <1/100 yr 食安委提供 To achieve ALOP 24
From FSO to PO Cross contamination: The percentage of EHEC which is transferred from meat to equipment is assumed to be 2% Growth EHEC O157 in beef at 10, to grow 1 log, it is assumed to take 14~18 hrs At 20, for 7hrs, growth 3.11 log 3.71 log cfu, 3.2 log cfu 3.72 log cfu, 3.14 log cfu 3.69 log cfu PO was established as 1/10 of FSO. Under appropriate food safety control system, this is considered to include certain safety margins.
Processing criteria and Microbiological criteria target : beef Processing standard (Cooking requirement) at 1cm from the surface of meat, cook at >60, >2 minutes consumption farm slaughterh ouse Processing plants restaurants 食中毒 (PO) FSO Enterobacteriacea testing Enterobacteriaceae They are distributed worldwide and may be found in soil, water, plants and animals. Esherichia coli, Klebsiella pneumoniae and Proteus mirabilis comprise 80 to 95% of all isolates in the clinical setting. Salmonella, Shigella, Yersinia are also included. The isolation of Enterobacteriaceae in a food indicated that the food was contaminated by feces of human or animals. 26
Distribution of beef farm slaughterhouse Cutting plants Risk assessment of raw beef Approach Establish PO PO is 1/10 of FSO Conversion factor between Enterobacteriaceae &EGEC:100:1 PO in Enterobacteriaceae PO =-0.85 log cfu/g 0.014cfu/g 10= 0.0014cfu/g= 2.85log cfu/g restaurants consumption FBO Establish FSO ALOP: cases from 190 to <1 or Death 10/y to <1/100 yr 食安委提供 14cfu/g 1000 =0.014 cfu/g (as Sal&VTEC) 27
Sampling plan to confirm the PO is achieved Interpretation 3. The sample number is assumed to be 25. By applying a sampling plan (n=25, Enterobacteriaceae non detectable in 25g of all 25 samples, the average concentrations of Enterobacteriaceae in rejected lot (with >95% probability) was 3.25 log cfu/g. 97.7%(=2SD) of this lot were below the PO expressed in Enterobacteriaceae ( 0.85 log cfu/g) 3.25 + 1.2 x2 log cfu/g= 0.85 log cfu/g The distance from the average of the lot to the PO was ensured to be 2SD. 0.35 0.30 0.25 0.20 0.15 0.10 0.05 0.00-7 Normal(-3.25, 1.2) -6-5 -4-3 -2-1 0 < 97.7% > -Infinity -0.850 Distribution of the concentration of the lot which is rejected with 95%probability(n=25 (25g), all negative)
1 Cooked part: More than 10 mm from the surface 1 sample(25 g) 7 1 3 5 6 8 9 More than 25 5 2 10 11 13 12 samples
Microbiological criteria Target microorganism Enterobacteriac e n C Sample size class 25 Non detected 25g 2 class
Characteristics of this risk assessment The stringency of food control system was established by FSO,PO, and then confirmed by the MC. Processing standard was established, however, the edible part is not cooked. The pathogen reduction effects derived from cooking process only could not estimate the direct risk reduction effects. It is very difficult to confirm this level of stringency by microbiological sampling and testing By combining with microbiological sampling and testing, it is confirmed if PO is met Control by both Microbiological criteria and processing standard
Summary of the risk assessment FSO is in a safer side, based on the lowest reported dose in an EHEC outbreak report. PO is 1/10 of FSO. This also include reasonably safe magin under an appropriate food safety control system in place. A part of meat for raw consumption is not directly heat treated. Processing standard only does not nesesalily guarantee the achievement of the PO. Need to combine with Microbiological testing with necessary sampling number and size. To establish a cooking process in food processing plants, the validation of the control system is critical. 32
Safety of raw beef which meet this standard The MHLW indicated that this Microbiological Criteria and Processing Standard does not guarantee 100% of the safety of raw beef consumption. Basically raw beef consumption shall be avoided. High risk population including children, elderly people shall not eat any raw, undercooked meat and internal organs (e.g. liver). 33
Heat Treatment of Beef to Be Eaten Raw To business operators treating beef to be eaten raw From October 1, 2011, standards and criteria, and labeling standards based on the Food Sanitation Act are to be enforced regarding beef (except innards) to be eaten raw. Be careful that foods to be eaten raw cannot be processed or prepared, or served or sold at shops, etc. unless the foods conform to these standards. * Violators of the standards, criteria, or labeling standards will be subject to administrative punishment or penalty based on the Food Sanitation Act. <Standards and criteria set by MHLW> Standards and criteria for processing and preparation (Outline) (1) Enterobacteriaceae must be negative. (2) Processing and preparation shall be conducted in a hygienic place provided with equipment dedicated to raw meat. (3) Processing and preparation shall be conducted by a person with knowledge about the risks of enterohemorrhagic Escherichia coli, etc. (4) A piece of meat shall be sterilized by heat treatment immediately after cut from the carcass. <Labeling standards set by Consumer Affairs Agency (CAA)> Labeling standards for serving and selling foods, not canned or packaged, at shops such as restaurants The following two notices shall be displayed in easily visible locations, such as in store fronts or menus. (1) Generally, eating raw meat brings the risk of food poisoning. (2) Children, elderly people, and people vulnerable to food poisoning should refrain from eating raw meat. Labeling standards for selling canned or packaged foods In addition to the above, the following three notices shall be written in easily visible locations on containers and packaging. (3) This food is to be eaten raw. (4) The prefecture (country of origin in case of imported meat) and name of the slaughterhouse (and information that it is a slaughterhouse) where the slaughtering or dressing of the carcass was carried out (5) The prefecture (country of origin in case of imported meat) and name of the processing facility (and information that it is a processing facility) where the processing was carried out in a method conforming to processing standards for meat to be eaten raw * For details, visit the CAA website at http://www.caa.go.jp/foods/index10.html#m01 1. Refrain from serving raw meat, even if it meets standards and criteria, to people such as children and elderly people with little resistance. Consumer Affairs Agency; Ministry of Health,Labour and Welfare
Raw beef liver June 2011: During the discussion in the MHLW and the FSC, more elevated level of risk associated with raw liver consumption was identified 6 th July 2011: MHLW requested Food Business Operators not serving beef liver for raw consumption June December 2011: The MHLW performed research to identify contamination pathway and potential interventions, as a result, an internal contamination was suggested April 2012: The MHLW asked the FSC to perform risk assessment if heat treatment (63C, 30min) would be required 14 April 2012: FSC replied to MHLW If heat treatment is introduced and implemented, the risk reduction is so obvious, no need to perform any risk assessment. From July 1 st 2012 : Beef liver shall be heat treated before consumption. raw beef liver consumption will be disappeared.
Weekly reports of VTEC O157 & O26 isolation, 2008 2012 (Infectious Agents Surveillance Report: Data based on the reports received before October 19, 2012 from public health institutes)
Thank you for your attention Any questions? toyofuku@niph.go.jp