stra<strong>in</strong>s have been identified as a predom<strong>in</strong>ant cause of <strong>Vibrio</strong>-associated gastroenteritis on the West Coastof the United States and <strong>in</strong> Mexico (Abbott et al., 1989). The presence of a pathogenicity island (aphysical group<strong>in</strong>g of virulence-related genes) <strong>in</strong> V. parahaemolyticus may foster rapid microevolution,promote growth and survival and result <strong>in</strong> transmission of factors (<strong>in</strong>clud<strong>in</strong>g virulence) to other stra<strong>in</strong>s(horizontal gene transfer) (Frischer et al., 1990; Ichige et al., 1989; Iida et al., 1998). Bacteriophages mayalso genetically alter vibrios (Baross et al., 1978; Ichige et al., 1989).The distribution and variation <strong>in</strong> numbers of virulent V. parahaemolyticus <strong>in</strong> oysters and amongoyster grow<strong>in</strong>g areas may need to be determ<strong>in</strong>ed before harvest because many of the described factors mayhave contributed to higher concentrations of virulent stra<strong>in</strong>s <strong>in</strong> certa<strong>in</strong> areas. Dur<strong>in</strong>g the 1998 outbreaks <strong>in</strong>the United States, shellfish harvested from the Hood Canal area of Wash<strong>in</strong>gton State <strong>in</strong> the PacificNorthwest were responsible for 67% (32/48) of the illnesses <strong>in</strong> that state (Thieren, 1999). In the GulfCoast area of the United States two thirds (20/30) of the harvest sites were implicated while <strong>in</strong> the AtlanticNortheast, only one harvest area, Oyster Bay Harbour, was implicated <strong>in</strong> the outbreak <strong>in</strong> that region (CDC,1999).2.2.4 Consumption of oystersAnyone who consumes shellfish raw is “at risk” for <strong>in</strong>fection by V. parahaemolyticus and thecharacteristics of the host are addressed <strong>in</strong> more detail <strong>in</strong> section 2.3.1.2. Intake data for molluscanshellfish are available from a number of governmental and non-governmental sources, however, there is ascarcity of such consumption data as noted recently <strong>in</strong> the European Union (European Commission, 2001).Also, because raw shellfish is not a commonly consumed food <strong>in</strong> many countries, for example <strong>in</strong> theUnited States approximately 10- 20% of the population will consume shellfish raw at least once dur<strong>in</strong>g ayear, some of the data are available are typically based on very few eaters report<strong>in</strong>g consumption. TheUnited States Department of Agriculture (USDA) Cont<strong>in</strong>u<strong>in</strong>g Survey of Food Intake by Individuals(CFSII) (USDA, 1989-1992) and the food frequency survey conducted by the Market ResearchCorporation of America (MRCA) (Degner, 1998) suggest that <strong>in</strong> the United States raw oysters areconsumed on average approximately once every 6 weeks. The mean amount of raw oysters consumed at as<strong>in</strong>gle serv<strong>in</strong>g is 110g, approximately one-half dozen raw large oysters (TAS, 1995). The distribution ofshellfish <strong>in</strong>take will be derived from food <strong>in</strong>take surveys, food frequency surveys, and from reportedland<strong>in</strong>gs of shellfish and <strong>in</strong>dustry estimates of the percentage of shellfish consumed raw. In Asiancountries, for example Japan, consumption of raw <strong>seafood</strong> can be more frequent as reported <strong>in</strong> section3.2.4.3.2.2.5 Modell<strong>in</strong>g exposure to V. parahaemolyticus2.2.5.1 ApproachesThe solicitation and assembly of <strong>in</strong>formation and scientific data on V. parahaemolyticus frommany sources is be<strong>in</strong>g undertaken to produce a thorough, up-to-date compilation of data from around theworld. This process is ongo<strong>in</strong>g therefore the follow<strong>in</strong>g section is currently based primarily on data fromthe United States and the FDA-VPRA (Anonymous, 2001). Various gaps <strong>in</strong> the data and currentknowledge have been identified (section 2.5) and some of these have to be filled before the model can beextended to meet the needs of a variety of countries.This <strong>in</strong>formation available was used <strong>in</strong> the construction of a mathematical model to produceresults on the risk of illness <strong>in</strong>curred by eat<strong>in</strong>g raw oysters conta<strong>in</strong><strong>in</strong>g pathogenic V. parahaemolyticus.Three factors were proposed to model exposure:• Level of pathogenic V. parahaemolyticus <strong>in</strong> <strong>seafood</strong> at harvest12
• Effect of post harvest handl<strong>in</strong>g and process<strong>in</strong>g• Ability of the <strong>org</strong>anism to multiply to an <strong>in</strong>fective doseAs a result, the exposure assessment was divided <strong>in</strong>to separate modules, which corresponded todifferent stages lead<strong>in</strong>g potentially to consumer exposure: the harvest and post harvest, retail andconsumption modules.The Harvest Module estimates the prevalence of pathogenic V. parahaemolyticus at time ofharvest. The Post Harvest Module determ<strong>in</strong>es the role of post harvest process<strong>in</strong>g and handl<strong>in</strong>g on thenumbers of pathogenic V. parahaemolyticus at consumption.As this section is currently based on the model developed <strong>in</strong> the United States FDA-VPRA(Anonymous, 2001) a similar approach and structure is be<strong>in</strong>g used. It also <strong>in</strong>volves the collection of datafrom other countries, if possible on a regional and seasonal basis and then <strong>in</strong>corporat<strong>in</strong>g such data <strong>in</strong>to themodel. In the development of FDA-VPRA model, because of harvest<strong>in</strong>g and temperature differences, theUnited States harvest areas were divided <strong>in</strong>to five regions, and each region was divided <strong>in</strong>to four seasons.Differences exist<strong>in</strong>g <strong>in</strong> oyster harvest<strong>in</strong>g practices and climates <strong>in</strong> the United States were sufficientlysignificant to identify five separate geographic regions (Northeast Atlantic, Mid-Atlantic, PacificNorthwest, Louisiana Gulf Coast and the rema<strong>in</strong>der of the Gulf Coast) for each season, for consideration <strong>in</strong>modell<strong>in</strong>g each of the modules. Factors <strong>in</strong>fluenc<strong>in</strong>g the risk of illness posed by V. parahaemolyticus wereidentified and <strong>in</strong>corporated <strong>in</strong>to each module as appropriate. Integration of the various parameterscompris<strong>in</strong>g these modules <strong>in</strong>to a quantitative risk assessment model will provide a more comprehensiveunderstand<strong>in</strong>g of the relative importance and <strong>in</strong>teractions among the factors <strong>in</strong>fluenc<strong>in</strong>g risk.2.2.5.2 AssumptionsWhile provid<strong>in</strong>g a framework for understand<strong>in</strong>g the relationship of risk to various parameters, thedevelopment of the risk assessment model necessarily requires certa<strong>in</strong> assumptions to fill the data gaps. Inthe development of the United States <strong>Vibrio</strong> risk assessment the assumptions <strong>in</strong>corporated <strong>in</strong> the modelwere reviewed by the National Advisory Committee on Microbiological Criteria for Foods (NACMCF,1998) at a public meet<strong>in</strong>g <strong>in</strong> September 1999. In the current risk assessment the work undertaken to date<strong>in</strong>clud<strong>in</strong>g the assumptions made have been reviewed by a group of experts at a jo<strong>in</strong>t <strong>FAO</strong>/WHO expertconsultation on risk assessment of microbiological hazards <strong>in</strong> foods that was convened <strong>in</strong> July 2001(<strong>FAO</strong>/WHO, 2001). Such a review step ensures that the assumptions are the best that can be made basedon current knowledge and also facilitates transparency of the risk assessment process.Based on the <strong>in</strong>formation currently available, for the Harvest Module, it was assumed that thepresence of the thermostable direct hemolys<strong>in</strong> (TDH) gene be used as the basis for pathogenicity. It is notcurrently known what average numbers of TDH-positive stra<strong>in</strong>s exist <strong>in</strong> shellfish, nationally or regionally(see also section 3.1.3 on TDH). The estimates made <strong>in</strong> the V. parahaemolyticus risk assessment, based onthe observed frequency of TDH-positive isolates, were the best possible from the data currently available.However, s<strong>in</strong>ce it is currently not known how this frequency may vary from one year to the next, a twofoldup or down triangle distribution was assumed. Also, with<strong>in</strong> a given year, there is uncerta<strong>in</strong>ty aboutthe variance of the percentage pathogenic V. parahaemolyticus <strong>in</strong> one composite of oysters to the next.For example, for the United States coastal area, with the exception of the Pacific Coast (where the rangewas 2% to 4%), the percentage pathogenic V. parahaemolyticus <strong>in</strong> a given year ranged from 0.1% to 0.3%.However, these estimates are based on older data and may not be predictive of future years, given that thefrequency of percentage pathogenic V. parahaemolyticus may be chang<strong>in</strong>g as new outbreak stra<strong>in</strong>s emergeor re-emerge, such as the emergence of O3:K6 or recurrence of known outbreak stra<strong>in</strong>s such as O4:K12. Ithas also been noted that the proportion of pathogenic stra<strong>in</strong>s occurr<strong>in</strong>g can vary from region to region, forexample these stra<strong>in</strong>s tend to occur with greater frequency <strong>in</strong> Asia than <strong>in</strong> the United States (<strong>FAO</strong>/WHO,13
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foodborne case has been associated
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1.5Probability Density0.7501 2 3 4
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Dec 15 0.76 0.61 1,841,000 1,025,00
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ICMSF. 1996. Microorganisms in Food
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De Paola, A. 1981. Vibrio cholerae
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Reilly, L.A. and Hackney, C.R. 1985