Microbiology Risk Assessment in China: Current Situation & Challenges Xiumei Liu Institute of Nutrition and Food Safety China CDC July 25,2002

Risk Analysis July 25,2002

RA A scientifically based process RM The process of weighing policy alternatives, distinct from risk assessment July 25,2002

MRA in the Word Foodborne bacteria Risk Assessment FAO/WHO （JEMRA） Risk Management Codex （CCFH） Mycotoxins, metabolites of fungi Risk Assessment FAO/WHO （JECFA） Risk Management Codex （CCFAC） July 25,2002

China Activities in MRA CCFH Since 32nd 1999 JEMRA Since 2000, Food hazard, EA, QMRA CCFAC Over 10 years, 32nd 2000 in Beijing JECFA Expert and data contribution (AF, Fumonisin, DSP) July 25,2002

Why MRA is needed in China？ WTO CODEX / GB FOOD INDUSTRY FOOD SAFETY CONTROL Government Consumers HEALTH PROTECTION Life quality knowledge July 25,2002

Hazard Characterization Risk Characterization Risk Assessment Hazard Identification Hazard Characterization Exposure Assessment Risk Characterization July 25,2002

Toxic plants and animals Potential environmental toxicants Hazards in Food Foodborne bacteria Fungi and mycotoxins Viruses and parasites Toxic plants and animals Potential environmental toxicants July 25,2002

Foodborne bacteria in China Pathogens Mortality (%) Salmonella 0.1 Bacillus cereus 0.037 Burkholderia cocovenenans 40 Proteus 0.03 Staphylococcus aureus 0.045 Clostridium botulinum 7.3 Escherichia coli 0.1 Vibrio parahaemolyticus 0.01 (1990-1996) July 25,2002

Case 1 BA Food Poisoning Control 1933. Indonesia: Case 1 BA Food Poisoning Control 1933 Indonesia: Fermented coconut food poisoning 1960 Pseudomonas cocovenenans Bongkrekic acid 1950’s China: Unknown causes fermented corn flour poisoning 1979 Flavobacterium farinofermentans nov. sp 1984 China: Deteriorated tremella poisoning, 1987 P. cocovenenans subsp. farinofermentans 1995 Burkholderia cocovenenans (B. gladiali) July 25,2002 8

Bongkrekic acid Food Poisoning Caused. by Various Food in China. Food Bongkrekic acid Food Poisoning Caused by Various Food in China Food Provinces Outbreaks Patients Fatal Mortality cases (%) _______________________________________________________________ Cereal products 12 78 499 238 62.12 Deteriorated tremella 5 22 148 54 36.49 Potato product 3 3 20 9 45.00 Total 16 103 667 301 45.13 _______________________________________________________________ (1985-1994) July 25,2002 19

Hazard identification: Bongkrekic acid, BA Target Organs Liver Brain Kidney Molecular formula C28H38O7 LD50 3.16mg/kg July 25,2002

Studies on the last 15 years l        Identification and examination of the foodnorne pathogen   l        Identification analysis and detoxication of BA   l        Diagnosis, monitor and prevention of food poisoning July 25,2002 21

Risk Manegement in China. GB/T 4789. 29-94. Examination of P Risk Manegement in China GB/T 4789.29-94 Examination of P. cocovenenans subsp. Farinofermentans GB 11675-89 Hygienic Standard of Tremella (BA Detection method) GB WT/12-96 Diagnostic Criteria and Principle of Management for P. Cocovenenans subsp. farinofermentans Food Poisoning July 25,2002 3

Outbreaks of BA reduced about 80% BA poisoning control Outbreaks of BA reduced about 80% in 1990’s. July 25,2002

Prevalence in fly feces Mean: 11.9% 5th-95th: 10.7%-13.1% Prevalence Fig Distribution for E.coli prevalence in fly feces ——Beta(235,1988-235+1) July 25,2002

Mar 21 Number of houseflies Month Average flies density （no. of flies/cage·day） Mar 21 Apr 63 May 125 June 221 July 314 Aug 341 Sep 257 July 25,2002

No. of ingested bacteria Mean: 310 cfu/meal 5th-95th: 23～875cfu/meal July 25,2002

Exposure probability Mean: 63.5% 5th-95th: 59.5%～67.4% July 25,2002

Natural toxicants --Actual and potential effects in humans Acute effects liver illness, poisoning, death Aflatoxin, DON, 3-NPA, Ergot Microcystin, Saxitoxins, Domoic acid, Solanine Chronic effects Carcinogenic, genotoxic & endemic illness Aflatoxins, Fumonisins, Deoxynivalenol, Zearalenone, Ochratoxin A, Patulin, T-2 toxin, Moniliformine, Sterigmatocystin Microcystin, Domoic acid, Cyanogenic glycosides July 25,2002

Example: Aflatoxin B1 Animal toxicity data showed: it could cause primary liver cancer in most species studied Epidemiological studies found an association between consumption of food contaminated with aflatoxin B1 and liver cancer Is a genotoxic carcinogen July 25,2002

Quantitative risk assessment at 49th JECFA Meeting HBsAg (＋) :0.3 liver cancer/year/100,000/ ng AF/ kg bw/day HBsAg (－) :0.01 liver cancer /year /100,000 / ng AF/kg bw/day July 25,2002

HBsAg(＋) 1%; European Cont. level & Dietary Pattern AFB1 intake Risk (ng/day) (Cancer/year/100,000) AFB1 limit 20 µg/kg 19 0.0041 (0.0006-0.01) AFB1 limit 10 µg/kg 18 0.0039 (0.0006-0.01) 2 cancers/year/billion July 25,2002

China cont. level and far east dietary pattern AFB1 intake Risk (ng/day) (Cancer/year/100,000) AF limit 20 µg/kg 125 0.17 (0.03-0.3) AF limit 10 µg/kg 103 0.14 (0.02-0.3) 300 cancers/year/billion *The mortality of liver cancer was 20/100,000 in the period of 1990-1992. (20.03/100,000) July 25,2002

Case 2 The Control of the Deteriorated Sugarcane Food Poisoning in China Fresh sugarcane grown in southern area of China Usually shipped to northern parts of China, stored and sold through the winter season Contaminated sugarcane can cause fatal food poisoning when sold in the next spring July 25,2002

Sugarcane poisoning The first outbreak of sugarcane poisoning with unknown causes occurred in Henan Province in 1972 From 1972 to 1989: No. of outbreak: 217 No. of cases: 884 No. of deaths: 88 Average fatality: 10% Identified as a priority to assess and control July 25,2002

Characteristics of 34 MSP Cases Age: Characteristics of 34 MSP Cases   Age: 3 to 27 years old Incubation period: 10 minutes to 8 hours Manifestations: Vomiting Dystonia Stare on one side Convulsion Carpopedal spasm Coma Electroencephalogram Sequelae July 25,2002

Etiology and risk assessment Etiology: the Chinese Academy of Preventive Medicine studied on the etiology of this specific food poisoning since 1984 and found: Arthrinium spp. was the pathogenic fungus; 3-nitropropionic acid (3-NPA) produced by A. spp. was proved to be the causative compound Assessment was made according to case-based studies, epidemiological and laboratory studies July 25,2002

Decision making and management activities Based on discovery and assessment, MOH promulgated: Diagnostic criteria and principles for the management of deteriorated sugarcane poisoning (WS/T10-1996); Methods for the isolation and identification of Arthrinium strains and analyzing 3-nitropropionic acid (GB47689.16) At the same time, MOH issued a notification on the prevention and control of DSP to all provinces of China A national health campaign for prevention and control of the poisoning was launched July 25,2002

Prevention and control measures The main measures adopted by local health inspectors: Fresh sugarcane shipped to northern China should not be stored for more than 3 weeks The deteriorated sugarcane with unpleasant smell and mold growing should not be sold in market When poisoning outbreak occurred, the suspected left-over sugarcane should be immediately sealed and destroyed During the outbreak, food inspectors and clinical doctors should work closely to identify and treat patients July 25,2002

No typical cases were reported in China in the last 10 years! Good results As a result of these efforts, sugarcane poisoning has been satisfactory controlled No typical cases were reported in China in the last 10 years! July 25,2002

Challenges: Areas for Strengthening Knowledge Team （National level） Practice （Data, Modeling） Food consumption / dietary intake Effects of processing QMRA   (Quantitative method) Analytical methods Sampling protocols July 25,2002

FAO/WHO Activates in China Workshop on Microbiological Risk Assessment Sponsored by FAO/ ILSI /WHO/ MOH May 10-11, 2002 Beijing Quantitative Microbiological Risk Assessment Training Course (David Vose) Sponsored by WHO/INFS May 13-24, 2002 Beijing July 25,2002