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1、FSIS Risk Assessment forListeria monocytogenes,in Deli Meats,Prepared by:,Daniel L.GallagherDept.of Civil and Environmental EngineeringVirginia Polytechnic Institute and State University,Eric D.Ebel and Janell R.Kause,Risk Assessment DivisionFood Safety and Inspection Service,USDA,May 2003,DRAFT FSI
2、S Listeria Risk Assessment,May 26,2003,FSIS LISTERIA RISK ASSESSMENT REPORTSCOPE AND MANDATEThis risk assessment was initiated in February 2002 in response to public comments on the FoodSafety and Inspection Service(FSIS)proposed rule:Performance Standards for the Productionof Processed Meat and Pou
3、ltry Products 66 FR 12589,February 27,2001.Several commentsindicated a need for a stronger scientific basis for the proposal to require testing and sanitation offood contact surfaces for Listeria species.1 In general,the scientific literature indicated that therelationship between the prevalence and
4、 level of Listeria species in the plant environment(e.g.,food contact and non-food contact surfaces)to the prevalence and level of Listeriamonocytogenes(L.monocytogenes)in ready-to-eat(RTE)meat and poultry products is not wellunderstood.To better understand this relationship,FSIS requested public in
5、put as part of theproposed rule for RTE meat and poultry products(66 FR 12609).In addition to the publicrequest for data,FSIS initiated the planning and development of this risk assessment to:1)provide insight into the relationship between Listeria species on food contact surface(s)and L.monocytogen
6、es in RTE meat and poultry products;and 2)to evaluate the effectiveness of foodcontact surface testing and sanitation regimes,pre-and post-packaging interventions,use ofgrowth inhibitors,and combinations of these interventions to mitigate contamination on RTEmeat and poultry products and reduce the
7、subsequent risk of illness or death from L.monocytogenes.This report provides information on the risk assessment model developed,including the sourcesof data used,underlying assumptions,model equations,and techniques applied,to provideestimates of the number of deaths from L.monocytogenes in deli me
8、ats in response to specificrisk management questions.This report is organized into the following sections:1.Public Health Regulatory Context2.Risk Management Questions3.FSIS Listeria Risk Assessmenta.Model Overviewb.Model Parametersc.Conceptual Modeld.FDA/FSIS Risk Ranking Modele.In-Plant Dynamic Mo
9、delf.Model Implementation and User Interfaceg.Calibration of the In-Plant Dynamic Model4.Listeria Risk Assessment Outputs5.Sensitivity Analysis1 The purpose of risk assessment as a public health tool is to use available data and information in a model to predictoutcomes(i.e.,effectiveness of an inte
10、rvention in reducing illnesses)to inform decision-making.Without riskassessment,the public health benefit of selecting one policy intervention over another would be unknown.Onthe other hand,waiting to have all the data would prevent public health measures from being implemented in atimely manner.The
11、 risk assessment methodology is a tool designed to inform decision-makers when all of thedata or information are not known.Risk assessment allows there to be scientifically-based informed decision-making.3,DRAFT FSIS Listeria Risk Assessment,May 26,2003,6.References7.Appendix A:Revisions to the 2001
12、 FDA/FSIS Risk Ranking Model8.Appendix B:Predicted Growth Between Processing and Retail9.Appendix C:Evaluation of FSIS RTE Survey Data for Volume of Productionfor Establishments Producing Deli Meats10.Appendix D:Risk Assessment Model Outputs Stratified by High,Medium andLow Production Volume Establi
13、shments&Consecutive Positive FCS Samples.PUBLIC HEALTH REGULATORY CONTEXTThis section provides background information on the health risks posed by L.monocytogenesand the regulatory context for this pathogen in FSIS-regulated RTE meat and poultry products.Public Health BackgroundL.monocytogenes is a
14、pathogen that occurs widely in both agricultural(e.g.,soil,water,andplants)and food processing environments(e.g.,air,drains,floors,machinery)(Ryser 1999).L.monocytogenes grows at low oxygenconditions and refrigeration temperatures,and Definition:Ready-to-Eat(RTE)therefore survives for long periods o
15、f time inthe environment,on foods,in processing plants,RTE meat and poultry products areand in household refrigerators.Although products that are in a form that is ediblefrequently present in raw foods(dairy,meat,without additional preparation to achievepoultry,fruits,and vegetables),it can also be
16、food safety and may receive additionalpresent in RTE foods due to post-processing preparation for palatability or aesthetic,contamination(Mead 1999a,CDC 2000).2 In gastronomic,or culinary purposes(92001,the Food and Drug Administration and CFR Part 430).the Food Safety and Inspection Servicecomplete
17、d a draft risk ranking of RTE foods for L.monocytogenes(FDA/FSIS,2001).Ofthe 20 RTE food categories evaluated,deli meats posed the highest per annum risk of illnessand death from L.monocytogenes,while hot dogs(i.e.,frankfurters,wieners,etc.)posed amoderate public health risk.Since the release of the
18、 FDA/FSIS risk ranking of RTE foods,public comments and additional data have been made available to update the exposureassessment for deli meats3 and the L.monocytogenes dose-response relationship(seeAppendix A).In general,consumption of food contaminated with L.monocytogenes may cause listeriosis,w
19、hich can result in serious human illness(Ryser 1999).In 1999,the Centers for Disease2 In 1991,after a series of outbreaks of human illness associated with the consumption of a variety of foods(e.g.,meats,coleslaw,pasteurized milk,soft cheese),the National Advisory Committee for Microbiological Crite
20、ria inFoods(NACMCF)recommended control strategies to minimize the presence,survival,and multiplication of L.monocytogenes in foods(NACMCF 1991).These control strategies included the development of an effectivenational surveillance system for listeriosis and inclusion of this pathogen in industry HAC
21、CP systems to ensurethe safety of foods from production to consumption.3 The exposure assessment for hot dogs was also updated based on public comments and additional data since therelease of the FDA/FSIS risk ranking of RTE foods.4,DRAFT FSIS Listeria Risk Assessment,May 26,2003,Control and Prevent
22、ion(CDC)reported that of all the foodborne pathogens undersurveillance in the United States,L.monocytogenes had the second highest fatality rate(20%)and the highest hospitalization rate(90%).Those at greatest risk of illness were theelderly(i.e.,those 60 years and older),those with suppressed or com
23、promised immunesystems(e.g.,those who have received a bone marrow transplant,cancer treatment,etc.),andfetuses or newborns(Slutsker and Schuchat 1999).4 Each year,L.monocytogenes causes anestimated 2,500 cases of foodborne listeriosis,including approximately 500 fatalities(Mead1999a,b).Policy Contex
24、tPrior to initiating this risk assessment,FSIS has taken a number of regulatory steps to protectthe publics health,including the following:Microbiological Testing for L.monocytogenes in RTE Meat and Poultry Products.Since1987,FSIS has randomly sampled and tested RTE meat and poultry products5 produc
25、ed infederally inspected establishments for L.monocytogenes.During the 1980s,when L.monocytogenes emerged as a public health problem associated with deli meats and otherprocessed foods,FSIS established a“zero tolerance”(e.g.,no detectable level of viablepathogens permitted)for L.monocytogenes in RTE
26、 meat and poultry products.Suchproducts testing positive for L.monocytogenes are considered“adulterated”under theFederal Meat Inspection Act(FMIA)or the Poultry Products Inspection Act(PPIA)(21 USC453(g)or 601(m).6 The combination of declaring L.monocytogenes in RTE meat andpoultry products an adult
27、erant and continued microbiological sampling of these products forL.monocytogenes may have contributed to the 44 percent decline from 1989 to 1993 in therate of illness from L.monocytogenes.7PR/HACCP.On July 25,1996,FSIS published its final rule on Pathogen Reduction andHACCP(PR/HACCP)Systems(61 FR
28、38806),which established new requirements forestablishments producing meat and poultry products to improve food safety.Under HACCP,establishments must analyze their production systems,identify where hazards such asmicrobial contamination(e.g.,L.monocytogenes)can occur,and establish controls to preve
29、ntor reduce those hazards.For hazards that are considered an adulterant in certain products,a”zero tolerance”is followed,and if the pathogen is detected in product,a recall of productmay ensue if the product is in the market place.FSIS also requires establishments to adoptand follow written Sanitati
30、on Standard Operating Procedures(Sanitation SOPs)to reduce thelikelihood that harmful bacteria will contaminate finished products(e.g.,RTE meat andpoultry products)that are exposed to the environment post-lethality treatment,particularlythose products that support the growth of this pathogen.4 Perin
31、atal listeriosis results from in utero exposure of the pregnant mother,causing fetal infection that leads to fetaldeath,premature birth,or neonatal illness,or death(Lennon 1984,Souef 1981).5 These products include cooked and fermented sausages,cooked corned beef,sliced ham and luncheon meats,beefjer
32、ky,cooked uncured poultry,and meat salads and spreads.6 Adulterated products are usually recalled voluntarily by the manufacturer.7 FSIS believes that while testing approximately 7,000 RTE meat and poultry products for L.monocytogenes each year helped to reduce the incidence of listeriosis,improved
33、sampling methods(e.g.,sampling design)are neededto effectively prevent illness from RTE meat and poultry products.See current RTE sampling directive:http:/www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/10240.3.htm.5,DRAFT FSIS Listeria Risk Assessment,May 26,2003,FSIS Notice/L.monocytogenes in HACCP Pl
34、ans.In February 1999,during a large outbreakof listeriosis associated with hot dogs and deli meats,FSIS issued a notice advisingmanufacturers of RTE meat and poultry products of the need to reassess their HACCP plansto ensure that the plans were adequately addressing L.monocytogenes(64 FR 27351).FSI
35、Sbelieves that L.monocytogenes contamination is reasonably likely to occur in the productionof most RTE meat and poultry products.Food Contact Surface Testing for Listeria Species.FSIS acknowledges that there may becertain processing operations in which L.monocytogenes is not a hazard reasonably lik
36、ely tooccur because of control procedures addressed in the Sanitation SOPs and other programs.In these cases,the hazard is,therefore,not addressed in an establishments HACCP system.In such establishments,verification through microbiological testing of food contact surfacesto ensure the establishment
37、s Sanitation SOP in controlling Listeria species may beappropriate.8 Were an establishment to find Listeria species on a food contact surface,thatfinding may be indicative of a sanitation problem that could cause adulteration of the product(e.g.,cross-contamination).9,10 Establishments may need to t
38、ake certain actions after foodcontact surfaces test positive for Listeria species(e.g.,those defined in its Sanitation SOPaccording to 416.15).11Proposed RTE Rule.On February 27,2001 FSIS issued a proposed rule(66 FR 12590)torequire that all establishments that produce RTE meat and poultry products
39、conductenvironmental testing of food contact surfaces for Listeria species after lethality treatmentand before final product packaging.Establishments were given the option to avoid testing ifthey established a critical control point(CCP)addressing possible L.monocytogenesecontamination after lethali
40、ty treatment.The focus on the non-pathogenic indicator was madebecause these organisms would be found more frequently in the environment than L.monocytogenes and because test results would be available more quickly.Finding Listeriaspecies would be indicative of a sanitation problem even though the c
41、ontaminant may not beL.monocytogenes.The establishment and FSIS would use the test results to verify theefficacy of the establishments“Sanitation SOPs”in preventing RTE product contaminationby L.monocytogenes.FSIS also suggested an increased frequency of Listeria species testingon food contact surfa
42、ces for larger establishments.Since neither the suggested frequency oftesting nor the relationship between testing for Listeria species on food contact surfaces andL.monocytogenes on the product was based on either scientific data or a risk assessment,theagency requested comment from the public rega
43、rding this ruling and initiated this riskassessment.8 On January 13,2000,the Center for Science in the Public Interest(CSPI)requested that FSIS require all RTE meatand poultry processing establishments,including those that address L.monocytogenes as part of their HACCPsystem,to conduct environmental
44、 testing for Listeria spp.and product testing for L.monocytogenes.9 Notably,Tompkin et al.(1986)recommended plant-wide environmental testing for a non-pathogenic“indicator”(e.g.,Listeria spp.)instead of testing for L.monocytogenes.An indicator organism is one that occurs frequentlyin the environment
45、 or food and the presence of which is correlated to the pathogen of concern.10 Recurring test positives for Listeria spp.may indicate that the establishment has a serious sanitation problem,even if L.monocytogenes is never found.FSIS enforcement action will vary depending on the establishmentseffort
46、s to correct its sanitation and processing problems and its disposition of affected product.11 Sanitation SOP corrective actions may include“procedures to ensure appropriate disposition of product(s)thatmay be contaminated,restore sanitary conditions,and prevent the recurrence of direct contaminatio
47、n oradulteration of product(s).”(66 FR 12604).6,DRAFT FSIS Listeria Risk Assessment,May 26,2003,Technical Public Meetings.On May 15,2000,FSIS held a public meeting to discuss:currentAgency initiatives to prevent human illness from L.monocytogenes in RTE meat and poultryproducts;the use of Listeria s
48、pecies as an indicator organism for L.monocytogenes;and theefficacy of environmental testing for Listeria species.12 On May 8,2001,FSIS held a publicmeeting to discuss scientific research and new technologies relevant to the L.monocytogenesin RTE meat and poultry products.At this meeting,FSIS reques
49、ted data relevant to theproposed regulation regarding frequencies of testing for environmental Listeria species andthe correlation with volume of production.13Listeria Summit.On November 18,2002,FSIS held a public meeting to provide a forum forexperts from government,academia,industry,and elsewhere
50、to discuss current research andinformation related to improving the safety of RTE products.The topics discussed includedthe role of environmental and product testing,decontamination strategies,and consumerbehaviors related to RTE foods.Risk Assessment Public Meeting.On February 26,2003,FSIS held a p
