Interpretive Summary:

Quantitative Risk Assessment on the

Public Health Impact of Pathogenic
Vibrio parahaemolyticus
In Raw Oysters
Center for Food Safety and Applied Nutrition
Food and Drug Administration
U.S. Department of Health and Human Services
July 2!
"N#$%&%$#"'$ SU((A%)
Quantitative Risk Assessment on the Public Health Impact of Pathogenic
Vibrio parahaemolyticus in Raw Oysters
PR!A"
#his "nterpretive Summary provides an overvie* of the 2+ Food and Drug
Administration ,FDA- Vibrio parahaemolyticus ris. assessment. "ts purpose is to /riefly
descri/e0 in non1technical language0 the material covered in the complete ris. assessment.
#his includes /ac.ground information on Vibrio parahaemolyticus0 the techni2ues and
data used to develop the ris. assessment0 the results of the ris. assessment0 and the
interpretation0 implications and limitations of those findings. A full understanding of the
ris. assessment re2uires the reader to consider the complete ris. assessment. #he
complete ris. assessment may /e o/tained on the "nternet at TU ***.cfsan.fda.govUT. A
printed copy *ill /e provided upon re2uest. %e2uests may /e fa3ed to the CFSAN
4utreach and "nformation Center at 51677189918822.
I#$RO%&"$IO#
Vibrio parahaemolyticus is a /acterium that occurs naturally in coastal marine *aters and
estuaries ,*here rivers flo* into the sea-. "t is recogni:ed *orld1*ide as a significant
cause of /acterial seafood1/orne illness. #he United States Centers for Disease Control
and &revention ,CDC- estimates that of the appro3imately 7066 Vibrio illnesses each year
in the United States0 appro3imately 206 are estimated to /e associated *ith Vibrio
parahaemolyticus and ra* oyster consumption. Vibrio parahaemolyticus is normally
present in many types of ra* seafood0 including fish0 crustaceans0 and molluscan shellfish.
"t multiplies and coloni:es in the gut of filter1feeding shellfish such as oysters0 clams0 and
mussels. Not all strains of Vibrio parahaemolyticus cause illness; on the contrary0
pathogenic strains represent a small percentage of the total Vibrio parahaemolyticus
present in the environment or seafood.
FDA conducted this <product path*ay= ris. assessment to characteri:e the factors
influencing the pu/lic health impact associated *ith the consumption of ra* oysters
containing pathogenic Vibrio parahaemolyticus. #his is referred to as a <product
path*ay= ris. assessment /ecause the factors that influence the ris. associated *ith Vibrio
parahaemolyticus in oysters are e3amined from harvest through post1harvest handling to
consumption. #he ris. assessment *as conducted in response to out/rea.s in 5>>7 and
5>>6 in the United States involving more than 7 cases of Vibrio parahaemolyticus
illness. #hese out/rea.s rene*ed concern for this pathogen as a serious food/orne threat
to pu/lic health and raised concerns a/out the effectiveness of the ris. management
guidance availa/le at that time.
2
Vibrio parahaemolyticus %is. Assessment
"N#$%&%$#"'$ SU((A%)
S"OP A#% '#RA( APPROA"H
#his ris. assessment *as initiated in January 5>>> and a draft ris. assessment *as made
availa/le for pu/lic comment in 25. #he draft ris. assessment has /een modified to ta.e
into account pu/lic comments0 to incorporate additional scientific data and .no*ledge that
has /ecome availa/le since 250 and to ta.e advantage of improvements in modeling
techni2ues. (odifications made to the draft ris. assessment are provided in Summary
#a/le 5.
Summary $able )* +o,ifications +a,e to the -..) %raft Vibrio parahaemolyticus
Risk Assessment
$opic +o,ifications
Assumptions Additional information *as o/tained that further support the
follo*ing assumptions?
@ro*th rates for pathogenic and non1pathogenic Vibrio
parahaemolyticus are similar;
#ime re2uired for refrigerated oysters to cool do*n to
temperatures that do not support the gro*th of Vibrio
parahaemolyticus is varia/le and may range from 5 to 5 hours.
Additional DataA
"nformation
&revalence of total and pathogenic Vibrio parahaemolyticus at
harvest for &acific North*est ,&NB- and @ulf Coast regions;
%elationship /et*een *ater temperature and Vibrio
parahaemolyticus levels in oysters;
#ime1to1refrigeration after harvest for the &NB region.
(odelA
(odeling #echni2ues
"ncluded intertidal harvesting in the &NB as an additional harvest
region;
$valuated mitigation effect of specific reduction levels of Vibrio
parahaemolyticus in addition to types of interventions;
"ncluded regression1/ased sensitivity analysis;
Added t*o additional uncertainty parameters ,total Vibrio
parahaemolyticus in oysters /ased on *ater temperature and
dose1response relationship- to the e3amination of factors that
influence ris. predictions;
4yster meat *eights at retail *ere used rather than those at
harvest;
Comparison of the model1predicted num/er of illnesses using /oth
retail survey and epidemiological data.
8
Vibrio parahaemolyticus %is. Assessment
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#his ris. assessment is /ased on a 2uantitative simulation model. #he focus is on ra*
oysters0 /ecause that is the food in the United States predominately lin.ed to out/rea.s of
illness associated *ith this pathogen since 5>>7. #he ris. assessment e3amines events
occurring from oyster harvest to consumption that influence the levels of Vibrio
parahaemolyticus li.ely to /e present in ra* oysters at the time of consumption. #he
levels of Vibrio parahaemolyticus in oysters at the time of consumption are influenced /y
the harvest methods and environmental conditions0 as *ell as the handling of oysters after
harvest. #hese practices and conditions vary considera/ly among different geographic
areas and at different times of the year. #herefore0 the model *as constructed to predict
illnesses for each harvest region and season in the United States. #he li.elihood and
severity of illness follo*ing e3posure to pathogenic Vibrio parahaemolyticus from
consumption of ra* oysters *as estimated. 4nce developed0 the /aseline model *as used
to develop <*hat1if= scenarios to evaluate the li.ely impact of potential intervention
strategies on the e3posure to pathogenic Vibrio parahaemolyticus from consumption of
ra* oysters.
#he ris. assessment had t*o main o/Cectives?
determine the factors that contri/ute to the ris. of /ecoming ill from the
consumption of pathogenic Vibrio parahaemolyticus in ra* oysters
evaluate the li.ely pu/lic health impact of different control measures0 including the
effectiveness of current and alternative micro/iological standards
RIS/ ASSSS+#$ !RA+0OR/
(icro/ial ris. assessments generally include four components? Ha:ard "dentification0
Ha:ard Characteri:ation0 $3posure Assessment0 and %is. Characteri:ation. #hese
components are defined and discussed in detail /elo*.
UHa:ard "dentification? "dentifies the pathogenic microorganism ,i.e.0 the ha:ard- that
may /e present in a particular food or group of foods that is capa/le of causing
adverse health effects. #he ha:ard on *hich this ris. assessment is focused is
pathogenic Vibrio parahaemolyticus in ra* oysters. #he adverse health effects are the
primary illnesses caused /y oral ingestion of Vibrio parahaemolyticus? gastroenteritis
alone or gastroenteritis follo*ed /y septicemia.
UHa:ard Characteri:ationADose1%esponseASeverity Assessment? Characteri:es the
relationship /et*een the level of e3posure to a pathogen ,dose- and the li.elihood of
an adverse health effect for individuals *ithin a population ,response-. For this ris.
assessment0 a 2uantitative relationship *as developed to predict the num/er and
severity of illnesses resulting from ingestion of different amounts of pathogenic Vibrio
parahaemolyticus. #he ris. assessment considered t*o su/populations0 <healthy=
individuals0 and individuals *ith impaired immune systems0 in evaluating the li.elihood
of septicemia.
U$3posure Assessment? Defines the fre2uency and li.ely level of e3posure to Vibrio
parahaemolyticus from consumption of ra* oysters containing these microorganisms.
U%is. Characteri:ation? "ntegrates Dose1%esponse and $3posure Assessment to predict
the pro/a/ility of potential adverse outcomes for individuals *ithin a population or a
+
Vibrio parahaemolyticus %is. Assessment
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specified su/population. For this ris. assessment the li.elihood and severity of illness
from the consumption of ra* oysters containing pathogenic Vibrio parahaemolyticus
*ere predicted. An important part of this step is determining the uncertainties
associated *ith these predicted ris. estimates distinguishing0 to the e3tent possi/le0
uncertainty from the inherent variation that occurs in any /iological and environmental
system.
Summary Figure 5 depicts a schematic representation of the components of the Vibrio
parahaemolyticus ris. assessment model. #he $3posure Assessment model *as separated
into three modules? harvest0 post1harvest0 and consumption. #he model outputs from the
$3posure Assessment *ere then com/ined *ith the Dose1%esponse model to relate these
e3posures to pu/lic health outcomes. #he model inputs are e3pressed as distri/utions
instead of single point estimates ,such as a mean-. Using a distri/ution allo*s a range of
values0 each *ith a specific fre2uency of occurrence0 to /e included in the model.
Distri/utions are commonly used in simulation modeling to account for the inherent
/iological varia/ility in nature and our uncertainty of the <true= values0 resulting in a more
accurate prediction of the ris..
Data for this ris. assessment *ere o/tained from many sources including pu/lished and
unpu/lished scientific literature and reports produced /y various organi:ations such as
State shellfish control authorities0 the CDC0 the shellfish industry0 the "nterstate Shellfish
Sanitation Conference ,"SSC-0 and state health departments. "n some instances0 the
conduct of the ris. assessment re2uired that assumptions /e made *hen data *ere
incomplete for the purposes of modeling. #o the e3tent possi/le0 research underta.en to
address the data gaps identified in the 25 draft ris. assessment have /een incorporated
into the model. #he criteria used to select data for the ris. assessment modeling are
descri/ed in detail in the complete ris. assessment.
For the ris. assessment0 9 harvest regions and + seasons ,*inter0 spring0 summer0 and fall-
*ere considered separately in the model for a total of 2+ regionAseason com/inations ,i.e.0
there *ere predictions of illnesses for 2+ regionsAseasons-. #he oyster harvest regions
included? @ulf Coast ,Douisiana-0 @ulf Coast ,non1Douisiana-0 (id1Atlantic0 Northeast
Atlantic0 &acific North*est ,Dredged-0 and &acific North*est ,"ntertidal-. "n the @ulf
Coast0 the harvest duration ,i.e.0 time /et*een removal of the oysters from the *ater to
unloading them at the doc.- for Douisiana is longer than for other states in that region
,Florida0 (ississippi0 #e3as0 and Ala/ama-. Since harvest duration can affect the levels of
Vibrio parahaemolyticus in ra* oysters0 the @ulf Coast *as divided into these t*o distinct
regions. #he &acific North*est *as also divided into t*o regions0 /ut in this case it *as
/ased on harvest methods0 intertidal versus dredged. 4ysters harvested in intertidal areas
are typically e3posed to higher temperatures /efore refrigeration than those harvested
using dredging0 leading to the need to define t*o harvest practice1/ased regions *ithin the
&acific North*est.
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Vibrio parahaemolyticus %is. Assessment
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Summary !igure )* Schematic Representation of the 1ibrio parahaemolyticus Risk
Assessment +o,el E#he light grey /o3es *ith /lac. lettering sho* the Harvest (odule0 the gray
/o3es *ith /lac. lettering sho* the &ost1Harvest (odule0 the dar. grey /o3es *ith *hite lettering sho*
the Consumption (odule0 the *hite /o3es *ith /lac. lettering sho* the Dose1%esponse model0 and the
*hite /o3es *ith dar. /lac. outline sho* the %is. Characteri:ation. 'pF Vibrio parahaemolyticusG
9
Vibrio parahaemolyticus %is. Assessment
Cold Storage Time
Die-off Rate
Relationship between Total
Vp in Oysters and Water
Temperature
Total Vp/g Oyster
at Harvest
Water Temperature
[regional/seasonal
variation]
Ratio of athogeni! to Total Vp/g
in Oysters
Duration of Harvest
Time-to-Refrigeration
"ir Temperature
#rowth Rate
Cooldown Time
#rowth Rate
Cooldown Time
#rams per Oyster
$umber of Oysters
per Serving
athogeni!
Vp/g in Oysters
at Harvest
athogeni! Vp/g
Oysters at Time of
%nitial Refrigeration
athogeni! Vp/g
Oysters at Retail
Ris& of %llness
'per year(
Dose-Response
Relationship
Ris& of %llness
'per serving(
athogeni!
Vp/g Oysters at
Refrigeration
athogeni! Vp per
serving at Consumption
Human Clini!al
Studies
Surveillan!e Data
)re*uen!y of
Servings
"N#$%&%$#"'$ SU((A%)
HA2AR% I%#$I!I"A$IO#
Vibrio parahaemolyticus is a salt tolerant /acterium and a normal inha/itant of the marine
environment. #his /acterium is found in many types of seafood0 including fish0
crustaceans0 and molluscan shellfish. "t *as first isolated in 5>! and implicated in an
out/rea. of food poisoning in Japan. "n the United States0 the first confirmed out/rea. of
Vibrio parahaemolyticus illness occurred in (aryland in 5>75. Since 5>>70 several large
out/rea.s0 associated *ith the consumption of ra* oysters0 have /een reported in the
United States. #hese out/rea.s are sho*n in Summary #a/le 2.
Summary $able -* Outbreaks of Illnesses from Vibrio parahaemolyticus
Associate, with "onsumption of Raw Oysters in the &nite, States
3ear (ocation #umber of "ases
5>>7 &acific North*est
a
2>
5>>6
5>>6
5>>6
&acific North*est
a
#e3as
Northeast Atlantic
+6
+59
/
5
22 Ne* )or. 7
22 Ne* Jersey 55
2+ Alas.a +9
a
#he &acific North*est includes California0 4regon0 Bashington State0 and Hritish Colum/ia.
/
2>9 cases in #e3as and

52 cases in other states that *ere traced /ac. to oysters harvested from #e3as.
Human illnesses from ingestion of Vibrio parahaemolyticus have /een *ell documented.
Any e3posed individual can /ecome infected *ith Vibrio parahaemolyticus and develop
illness. #he most common clinical manifestation of Vibrio parahaemolyticus infection is
gastroenteritis0 an inflammation of the gastrointestinal tract. @astroenteritis is usually an
illness of short duration and moderate severity that is characteri:ed /y diarrhea0 vomiting0
and a/dominal cramps. Vibrio parahaemolyticus infections can also lead to septicemia0 a
severe0 life1threatening disease caused /y the multiplication of pathogenic microorganisms
andAor the presence and persistence of their to3ins in circulating /lood. "ndividuals *ith
underlying chronic medical conditions ,such as dia/etes0 alcoholic liver disease0 hepatitis0
and those receiving immunosuppressive treatments for cancer or A"DS- do not appear to
/e at a higher ris. of ac2uiring the initial infection than other*ise healthy people.
Ho*ever0 individuals *ith underlying chronic conditions do appear to have a higher ris. of
the initial infection developing into septicemia.
#he CDC estimates that of the total Vibrio illnesses in the United States ,average 7066
per year-0 there are appro3imately +0! Vibrio parahaemolyticus illnesses and of those
appro3imately 206 are estimated to /e associated *ith ra* oyster consumption. #here
have /een reports of Vibrio parahaemolyticus illness associated *ith various types of
coo.ed and ra* seafood including crayfish0 lo/ster0 shrimp0 cra/0 oysters0 and clams.
Vibrio illnesses associated *ith coo.ed seafood are li.ely due to inade2uate heating or
recontamination after coo.ing. Although thorough coo.ing destroys Vibrio0 oysters are
often eaten ra*0 *hich may e3plain *hy it is the most common seafood associated *ith
Vibrio infection in the United States. $pidemiological data indicate that consumers of ra*
oysters are 2.6 times more li.ely to e3perience Vibrio parahaemolyticus illness compared
7
Vibrio parahaemolyticus %is. Assessment
"N#$%&%$#"'$ SU((A%)
to non1ra* oyster eaters. Food inta.e surveys indicate that ra* shellfish is not a
commonly consumed food in the United States? only 5 to 2I of the population
consumes ra* shellfish at least once a year. Among oyster consumers0 ra* oysters are
typically eaten appro3imately once every 9 *ee.s and the typical serving si:e ranges from
9 to 2+ oysters0 *ith 52 /eing the most fre2uent.
Not all strains of Vibrio parahaemolyticus cause illness; on the contrary0 pathogenic
strains generally represent a small percentage of the total Vibrio parahaemolyticus present
in the environment or seafood. &athogenic Vibrio parahaemolyticus strains are more
li.ely to produce symptomatic infections and have one or more distinctive traits that are
generally a/sent in non1pathogenic strains. #*o important virulence indicators are the
a/ility to produce thermosta/le direct hemolysin ,#DH- and the a/ility to produce a
related to3in0 thermosta/le related hemolysin ,#%H-. Hemolysin is an en:yme that /rea.s
do*n red /lood cells on a /lood agar plate0 *hich is referred to as the Janaga*a
phenomenon. #he vast maCority of Vibrio parahaemolyticus strains isolated from the
stools of patients *ith Vibrio parahaemolyticus gastroenteritis are #DH1positive ,#DH
K
-.
#he role of traits other than #DH has not yet /een determined. #herefore0 for the
purposes of this ris. assessment0 pathogenic Vibrio parahaemolyticus is defined as strains
that are #DH
K
.
Vibrio parahaemolyticus infections occur throughout the year0 pea.ing in spring and
summer. Cases are most often associated *ith the regions of the country *ithin close
pro3imity to marine environments. #he geographical distri/ution of cases attri/uted to
oysters from specific harvest areas li.ely reflects the propensity for individuals in close
pro3imity to coastal areas to consume ra* shellfish. Di.e*ise0 the volume of oysters
harvested in the U.S. each year varies /y season. Appro3imately 99I of the annual oyster
harvest occurs in the *inter and fall *ith the remainder in spring and summer. #here are
also regional differences in the oyster harvest volume; the @ulf Coast accounts for
appro3imately one1half of the oyster harvest0 the &acific North*est a/out a fourth0 and
less than a tenth from the (id1Altantic region. "n addition0 regional climatic differences
,e.g.0 *ater temperatures- and post1harvest handling practices influence the levels of
Vibrio parahaemolyticus in shellfish and conse2uently the potential for illness.
HA2AR% "HARA"$RI2A$IO#
"n a 2uantitative ris. assessment0 the Ha:ard Characteri:ation typically entails the
determination of a dose1response relationship for a specified population0 relating the
incidence of an identified adverse effect *ith the level of e3posure to a particular
microorganism ,or su/stance-. #his dose1response relationship is often e3pressed as a
relation /et*een different levels of e3posure and the li.elihood ,or pro/a/ilities- that such
e3posures *ill result in illness. For this ris. assessment0 a 2uantitative relationship *as
developed to predict the num/er and severity of illnesses resulting from ingestion of
pathogenic Vibrio parahaemolyticus.
A 2uantitative dose1response model for Vibrio parahaemolyticus *as developed /ased on
human clinical feeding studies. #he model e3trapolates the o/served illness rates from the
studies to doses and illness rates that are more li.ely to /e encountered *ith contaminated
6
Vibrio parahaemolyticus %is. Assessment
"N#$%&%$#"'$ SU((A%)
oysters. Ne3t0 the dose1response curve *as adCusted to account for the estimates of the
annual illness /urden ,206 cases per year- as determined /y CDC. #his approach is
typically referred to as <anchoring= to epidemiological data. #here is uncertainty in the
dose1response relationship /ecause of the limited data from the clinical studies. #his
uncertainty *as accounted for in the model /y multiple curve1fitting of the data.
Summary Figure 2 sho*s the dose1response model. Using the most li.ely estimate of the
dose1response curve ,i.e.0 the dashed line-0 the pro/a/ility of illness is appro3imately .!
,!I- for a dose of appro3imately 5 million ,i.e.0 535
6
- Vibrio parahaemolyticus
cellsAserving. #his means for every 5 individuals eating a serving of oysters that
contains 535
6
cells of pathogenic Vibrio parahaemolyticus0 appro3imately ! individuals
*ill /ecome ill. At lo*er e3posure levels ,535
8
or 535
+
-0 the pro/a/ility of illness is
much lo*er ,L.5-. Using the ris. assessment results and availa/le epidemiological
data0 the li.elihood that a Vibrio parahaemolyticus illness ,gastroenteritis- *ill lead to
septicemia *as determined for healthy and immunocompromised individuals. ,See section
entitled0 %is. Characteri:ation0 for the results of the assessment.-
>
Vibrio parahaemolyticus %is. Assessment
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Summary !igure -. $he %ose4Response +o,el for Vibrio parahaemolyticus (Vp)
E#he solid line is the /est estimate of the model fit to pooled human feeding studies. #he dashed line
sho*s the shift adCustment so that the model predictions agree *ith epidemiological surveillance data.
(D$ denotes the ma3imum li.elihood estimate. "D! is the dose corresponding to a !I pro/a/ility of
gastroenteritis.G
5POS&R ASSSS+#$
#he purpose of the $3posure Assessment is to determine the li.elihood of ingesting
pathogenic Vibrio parahaemolyticus from consumption of ra* oysters0 and the li.ely level
of e3posure. "nsufficient data are availa/le on the levels of pathogenic Vibrio
parahaemolyticus in ra* oysters at the moment of consumption. #herefore0 the model
predicts these levels using availa/le data on the factors that influence the levels of the
pathogen present in oysters at harvest. #hese factors include the environmental conditions
that contri/ute to the li.ely presence of Vibrio parahaemolyticus in oysters at harvest and
the impact of post1harvest handling and processing practices on the gro*th or decline of
Vibrio parahaemolyticus in oysters prior to consumption. "n addition0 the fre2uency of
oyster meals and the amount of oysters consumed per serving *ere considered.
#he $3posure Assessment *as divided into three modules that reflect the chain of events
from oyster harvest to consumption? Harvest0 &ost1Harvest0 and Consumption. #he levels
of total and pathogenic Vibrio parahaemolyticus in oysters *ere estimated for each
handling or processing event. #he predicted levels of Vibrio parahaemolyticus from each
module *ere used as inputs for the su/se2uent module ,e.g.0 results from the Harvest
5
Vibrio parahaemolyticus %is. Assessment
0%
25%
50%
75%
100%
100,00
0
1,000,00
0
10,000,00
0
100,000,00
0
1,000,000,00
0
+ean Dose ',p !ells per serving(
R i
s &
o f
% l l
n e
s s
%nferre
d
Dose-
Response
with
Oyster
)ood
+atri-
+./ of Dose-
Response
Observed in
,olunteer
)eeding Trials
with
0i!arbonate
%nferred %D12
with
Oyster )ood
+atri-
/stimated
%D12
in )eeding
Trials
"N#$%&%$#"'$ SU((A%)
module served as the input to the &ost1Harvest module-. Hecause Vibrio
parahaemolyticus levels may /e affected /y climate and region1specific oyster harvesting
practices0 modeling *as conducted separately for each of the 2+ harvest regionAseason
com/inations descri/ed in the <%is. Assessment Frame*or.= section a/ove.
Harvest +o,ule* "n the Harvest (odule of the $3posure Assessment model0 factors
identified as potentially influencing the variation of levels of Vibrio parahaemolyticus at
the time of harvest *ere evaluated and the effects of those factors that could /e suita/ly
2uantified *ere incorporated into the 2uantitative simulation model.
#he availa/le data suggest that a num/er of factors can affect the presence and gro*th of
Vibrio parahaemolyticus in oysters at the time of harvest. 4nce present in the
environment0 Vibrio parahaemolyticus levels are affected primarily /y *ater temperatures
and to a lesser e3tent /y salinity levels. Such factors as the amount of :ooplan.ton in the
shellfish gro*ing area0 the rate of tidal flushing0 levels of dissolved o3ygen in the *ater0
and the presence of pollutants have less certain effects on Vibrio parahaemolyticus levels.
4yster1specific factors0 such as the physiology and health of the oyster also contri/ute to
the a/ility of Vibrio parahaemolyticus to coloni:e and gro* in the oysters.
Hacteriophages0 to3ins0 or other proteins produced /y /acterial strains that infect or
coloni:e oysters at the same time as Vibrio parahaemolyticus may affect the survival of
the Vibrio parahaemolyticus. "n addition0 the percentage of the total Vibrio
parahaemolyticus that is pathogenic may vary. Several studies suggest that the average
percentage of pathogenic Vibrio parahaemolyticus is higher on the Best Coast than in
other areas of the country.
Although a num/er of potential factors affecting Vibrio parahaemolyticus levels at the
time of harvest *ere identified0 there *ere little data availa/le to 2uantify the effects of
most of these factors. Furthermore0 accompanying analyses indicated that in most
instances *ater temperature is over*helmingly the primary determinant that controls
Vibrio parahaemolyticus levels in oysters. Bater salinity *as not included as a varia/le in
the model /ecause preliminary modeling indicated that the small varia/ility in *ater
salinity in the maCor commercial harvest regions *as not a strong determinant of Vibrio
parahaemolyticus prevalence and gro*th in oysters. Additionally0 the impact on the
model of varying *ater salinity *as overshado*ed /y the impact of varying *ater
temperatures. Devels of pathogenic Vibrio parahaemolyticus in oysters at1harvest *ere
predicted using data on? 5- the relationship /et*een total Vibrio parahaemolyticus in
oysters and *ater temperature0 2- *ater temperature distri/utions0 and 8- the ratio of
pathogenic to total Vibrio parahaemolyticus in oysters.
#he relationship /et*een total Vibrio parahaemolyticus levels in oysters and *ater
temperature *as modeled /ased on the assumption that Vibrio parahaemolyticus may /e
present at levels /elo* the sensitivity of the analytical method ,e.g.0 less than the limit of
detection- /ut not actually :ero0 even at lo* temperatures. #he distri/ution of pathogenic
Vibrio parahaemolyticus in oysters at harvest *as determined using the distri/ution of
total Vibrio parahaemolyticus in oysters at harvest and the appropriate pathogenic
percentage for each region ,i.e.0 2.8I for the &acific North*est and .56 I for the @ulf
Coast0 (id1Atlantic0 and Northeast Atlantic regions-.
55
Vibrio parahaemolyticus %is. Assessment
"N#$%&%$#"'$ SU((A%)
Summary #a/le 8 provides the predicted mean levels of Vibrio parahaemolyticus at
harvest for each of the 2+ regionAseason com/inations. Across all regions0 the predicted
levels are much higher in the *armer months compared to the cooler months. #he
predicted levels for the @ulf Coast region are considera/ly higher than the other regions
due to the *armer *ater temperatures. During the summer0 the levels of Vibrio
parahaemolyticus in the mid1Atlantic and Northeast Atlantic are higher than those of the
&acific North*est ,*hen harvest occurs /y dredging-. $ven during the summer0 air
temperatures in the &acific North*est are cooler0 on average0 than in the @ulf and Atlantic
regions. Ho*ever0 e3posure to higher temperatures for longer time periods0 such as
occurs during intertidal harvest in some &acific North*est areas0 allo*s for additional
gro*th0 resulting in an increase of total and pathogenic Vibrio parahaemolyticus to levels
higher than that of the Northeast Atlantic region.
Summary $able 6* Pre,icte, +ean (evels of Vibrio parahaemolyticus per gram in
Oysters At4Harvest
Region (evel Summer
a
!all
a
0inter
a
Spring
a
@ulf Coast #otal 205 22 !2 >+
,Douisiana-
/
&athogenic + L5 L5 2
@ulf Coast
,Non1Douisiana-
/
#otal 205 22 !2 >+
&athogenic + L5 L5 2
(id1Atlantic #otal 76 !5 8 2
&athogenic 5 L5 L5 L5
Northeast Atlantic #otal 28 88 + +2
&athogenic L5 L5 L5 L5
&acific North*est
,Dredged-
c
#otal ! L5 L5 L5
&athogenic L5 L5 L5 L5
&acific North*est
,"ntertidal-
d
#otal 9! 2 L5 95
&athogenic 5! L5 L5 5
a
&redicted mean levels of total and pathogenic Vibrio parahaemolyticus per gram of ra* oysters. 'alues
rounded to 2 significant digits.
/
Note? the values for Douisiana and non1Douisiana areas are the same
/ecause the *ater temperature is similar for these regions. Differences in the @ulf Coast states occur in
the post1harvest portion of the model ,See Summary #a/le +-.
c
&redicted mean levels *hen oyster reefs
are su/merged.
d
&redicted mean levels after intertidal e3posure.
Post4Harvest +o,ule* #he &ost1Harvest (odule of the $3posure Assessment model
predicts the effects of typical industry practices on Vibrio parahaemolyticus densities in
oysters during transportation0 distri/ution0 and storage from harvest through retail. After
oysters are harvested0 levels of Vibrio parahaemolyticus can increase or decline in oysters
during handling and storage /efore consumption. After harvesting0 oysters are typically
stored unrefrigerated on the oyster /oat for a period of time ranging from a fe* hours to
more than half a day. #he potential gro*th of Vibrio parahaemolyticus in the oysters
during this period of unrefrigerated holding is a function of the air temperature at the time
of harvest and the length of time oysters are unrefrigerated. 4nce the oysters are placed
under refrigeration ,e.g.0 during transport or after arrival at *holesalers-0 the rate of
gro*th slo*s until oysters reach a <no1gro*th= temperature ,i.e.0 /elo* 5C- for Vibrio
parahaemolyticus. #he length of time during *hich Vibrio parahaemolyticus gro*th
occurs after the start of refrigeration and the ,reduced- rate of gro*th during this period
of time *ere estimated. Bhen held at a refrigeration temperature of +!F ,7.2C-0 levels
52
Vibrio parahaemolyticus %is. Assessment
"N#$%&%$#"'$ SU((A%)
of Vibrio parahaemolyticus decrease slo*ly as cells die under this storage condition; this
effect *as included in the &ost1Harvest model. #he post1harvest levels are carried
for*ard to the Consumption (odule *here the dose levels of Vibrio parahaemolyticus
consumed are modeled.
Summary #a/le + provides the predicted mean levels for total and pathogenic Vibrio
parahaemolyticus in oysters post1harvest. #hese results0 in comparison to those sho*n in
Summary #a/le 80 are indicative of the effects of current post1harvest handling and
processing practices on Vibrio parahaemolyticus levels. #he predicted total and
pathogenic Vibrio parahaemolyticus levels in oysters post1harvest are highest in /oth the
Douisiana and non1Douisiana @ulf Coast regions /ecause the levels at1harvest *ere the
highest and am/ient temperature is much higher in this region than in the other regions0
allo*ing for more gro*th. &redicted levels in the @ulf Coast ,Douisiana- are higher than
those in the @ulf Coast ,non1Douisiana-0 reflecting a longer time from harvest to
refrigeration. #he type of harvesting also has an impact on the levels of Vibrio
parahaemolyticus. "n the &acific North*est0 the typically longer e3posure to *armer air
temperatures during intertidal harvesting can elevate oyster temperatures0 allo*ing for
additional gro*th of Vibrio parahaemolyticus during intertidal harvesting.
Summary $able 7* Pre,icte, +ean (evels of $otal an, Pathogenic Vibrio
parahaemolyticus per gram in Oysters Post4Harvest
Region (evel Summer
a
!all
a
0inter
a
Spring
a
@ulf Coast #otal 90 !07 2> 280
,Douisiana- &athogenic 5 5 L5 8>
@ulf Coast #otal +20 20! 58! 590
,Non1Douisiana- &athogenic 78 + L5 26
(id1Atlantic #otal 520 85 5 +02
&athogenic 25 L5 L5 7
Northeast Atlantic #otal 20! !2 5 !5
&athogenic + L5 L5 L5
&acific North*est
,Dredged-
/
#otal 5 L5 L5 >
&athogenic 2 L5 L5 L5
&acific North*est
,"ntertidal-
c
#otal 507 + L5 5!
&athogenic 86 L5 L5 +
a
&redicted mean levels of total and pathogenic Vibrio parahaemolyticus per gram of ra* oysters. 'alues
rounded to 2 significant digits.
/
&redicted mean levels *hen oyster reefs are su/merged.
c
&redicted mean
levels after intertidal e3posure.
"onsumption +o,ule* #he Consumption (odule of the $3posure Assessment model
estimates the levels of total and pathogenic Vibrio parahaemolyticus in a single serving of
an oyster meal. #he num/er of oyster meals or servings eaten0 the 2uantity of oysters
consumed per serving0 and the pathogenic Vibrio parahaemolyticusAg oyster at
consumption are included in this module. #he num/er of servings eaten refers to the
oysters harvested from a specific region. As such0 the ris. assessment model predicts
illness associated *ith oysters harvested from specific regions /ut does not predict illness
associated *ith the location ,region- *here the oysters *ere consumed or illness reported.
Summary #a/le ! provides the mean predicted levels of total and pathogenic Vibrio
parahaemolyticus at consumption.
58
Vibrio parahaemolyticus %is. Assessment
"N#$%&%$#"'$ SU((A%)
Summary $able 8* Pre,icte, +ean (evels

of $otal an, Pathogenic Vibrio
parahaemolyticus per Serving of Oysters at "onsumption
Region (evel Summer
a
!all
a
0inter
a
Spring
a
@ulf Coast ,Douisiana- #otal 5200 5020 !60 +090
&athogenic 250 20 >6 70>
@ulf Coast ,Non1Douisiana- #otal 60!0 !0 270 8020
&athogenic 5!0 66 +7 !09
(id1Atlantic #otal 20!0 920 26 6!0
&athogenic +08 55 L5 50!
Northeast Atlantic #otal !0 550 8 50
&athogenic 69 57 L5 56
&acific North*est
,Dredged-
/
#otal 250 +9 2 50>
&athogenic +9 5 L5 +8
&acific North*est ,"ntertidal-

c
#otal 880 6 8 80
&athogenic 70! 57 L5 7+
a
&redicted mean levels of total and pathogenic Vibrio parahaemolyticus per serving of ra* oysters.
'alues rounded to 2 significant digits.
/
&redicted mean levels *hen oyster reefs are su/merged.
c

&redicted mean levels after intertidal e3posure.
RIS/ "HARA"$RI2A$IO#
#he %is. Characteri:ation com/ines the results of the $3posure Assessment model *ith
the Dose1%esponse model to predict the num/er of illnesses and the severity of illness
associated *ith different regions and seasons. $stimates of the uncertainty associated *ith
these predictions of ris. and illness /urden ,i.e.0 upper and lo*er /ounds- are also
determined. For simplicity0 the results of these regional and seasonal predictions of illness
are presented /elo* as the mean of the distri/ution ,i.e.0 the mean num/er of predicted
illnesses-. A detailed description of the uncertainty distri/utions can /e found in the
complete ris. assessment. Sensitivity analyses *ere conducted to evaluate the importance
of the various input factors on the model results. #he model *as validated /y comparing
the results to a retail study and epidemiological data.
Pre,icte, Illness 9ur,en
%is. per Serving. #he <ris. per serving= is the ris. of an individual /ecoming ill
,gastroenteritis alone or gastroenteritis follo*ed /y septicemia- *hen he or she consumes
a single serving of oysters. As sho*n in Summary #a/le 90 the predicted ris. per serving is
highest for the @ulf Coast ,Douisiana- region and lo*est for &acific North*est ,Dredged-
region. Bithin a region0 the ris. per serving is highest for the *armer months and lo*est
for the cooler months. For e3ample0 for the Northeast Atlantic0 the ris. per serving in the
*inter is on the order of 535
16
0 meaning only one illness in every 5 million servings.
For this same region0 the ris. per serving in the summer is appro3imately 8 orders of
magnitude higher ,one illness in every 50 servings-. For the &acific North*est
region during the summer and spring0 the ris. per serving is higher for oysters harvested
/y intertidal compared *ith dredged methods.
5+
Vibrio parahaemolyticus %is. Assessment
"N#$%&%$#"'$ SU((A%)
Summary $able :* Pre,icte, +ean Risk per Serving Associate, with the
"onsumption of Pathogenic Vibrio parahaemolyticus in Raw Oysters
Region +ean Risk Per Serving
a
Summer !all 0inter Spring $otal
@ulf Coast ,Douisiana- +.+ 3 5
1+
+.8 3 5
1!
2.5 3 5
19
5.7 3 5
1+
9.9 3 5
1+

@ulf Coast ,Non1Douisiana-
/
8.5 3 5
1+
5.> 3 5
1!
5.5 3 5
19
5.2 3 5
1+
+.! 3 5
1+

(id1Atlantic >.2 3 5
1!
2.2 3 5
19
5.5 3 5
16
8.5 3 5
1!
5.8 3 5
1+

Northeast Atlantic 5.6 3 5
1!
+. 3 5
17
5.5 3 5
16
8.9 3 5
19
2.2 3 5
1!
&acific North*est ,Dredged- 5. 3 5
1!
2.9 3 5
16
6.5 3 5
15
6.7 3 5
17
5.5 3 5
1!

&acific North*est ,"ntertidal-
c
5.+ 3 5
1+
8.> 3 5
17
5.7 3 5
1>
5.8 3 5
1!
5.! 3 5
1+

a
%is. per serving refers to the predicted ris. of an individual /ecoming ill ,gastroenteritis alone or
gastroenteritis follo*ed /y septicemia- *hen he or she consumes a single serving of ra* oysters.
/
"ncludes oysters harvested from Florida0 (ississippi0 #e3as0 and Ala/ama. #he time from harvest to
refrigeration in these states is typically shorter than for Douisiana.
c
4ysters harvested using intertidal methods are typically e3posed to higher temperature for longer times
/efore refrigeration compared *ith dredged methods.
%is. per Annum* #he <ris. per annum= is the predicted num/er of illnesses
,gastroenteritis alone or gastroenteritis follo*ed /y septicemia- in the United States each
year. As sho*n in Summary #a/le 70 for each region0 the highest num/er of predicted
cases of illnesses is associated *ith oysters harvested in the summer and spring and the
lo*est in the *inter and fall. 4f the total annual predicted Vibrio parahaemolyticus
illnesses0 appro3imately >2I are attri/uted to oysters harvested from the @ulf Coast
,Douisiana and non1Douisiana states- region in the spring0 summer and fall and from the
&acific North*est ,intertidal- region in the summer. #he lo*er num/ers of illnesses
predicted for the Northeast Atlantic and (id1Atlantic oyster harvests are attri/uta/le /oth
to the colder *ater temperatures and the smaller harvest from these regions. #he
harvesting practice also has an impact on the illness rate. "ntertidal harvesting in the
&acific North*est poses a much greater ris. than dredging in this region ,5>2 vs. +
illnesses per year-. #his is li.ely attri/uta/le to elevation of oyster temperatures during
intertidal e3posure leading to Vibrio parahaemolyticus gro*th.
Summary $able ;* Pre,icte, +ean Annual #umber of Illnesses Associate, with the
"onsumption of Vibrio parahaemolyticus in Raw Oysters
Region +ean Annual Illnesses
a
Summer !all 0inter Spring $otal
@ulf Coast ,Douisiana- 50+9 582 7 !! 20!
@ulf Coast ,Non1Douisiana-
/
2>> !5 8 5>8 !+9
(id1Atlantic 7 + L5 + 5!
Northeast Atlantic 5+ 2 L5 8 5>
&acific North*est ,Dredged- + L5 L5 L5 +
&acific North*est ,"ntertidal-
c
578 5 L5 56 5>2
$O$A( 50>8 5> 5 728 20629
a
(ean annual illnesses refers to the predicted num/er of illnesses ,gastroenteritis alone or gastroenteritis
follo*ed /y septicemia- in the United States each year.

/
"ncludes oysters harvested from Florida0 (ississippi0 #e3as0 and Ala/ama. #he time from harvest to
refrigeration in these states is typically shorter than for Douisiana.
c
4ysters harvested using intertidal
methods are typically e3posed to higher temperature for longer times /efore refrigeration compared *ith
dredged methods.
5!
Vibrio parahaemolyticus %is. Assessment
"N#$%&%$#"'$ SU((A%)
Severity of "llness. #he predicted num/er of cases of septicemia *as determined for the
total United States population as sho*n in Summary #a/le 6. #he num/er of predicted
cases of septicemia *as calculated /y multiplying the mean num/er of predicted illnesses
,Summary #a/le 7- /y the pro/a/ility of gastroenteritis progressing to septicemia
,.28-. #he calculation of the pro/a/ility of gastroenteritis progressing to septicemia is
descri/ed in the complete ris. assessment. Since most of the cases of illness are predicted
to /e associated *ith the @ulf Coast ,Douisiana- harvest0 this is also the harvest that
*ould /e e3pected to /e associated *ith the highest num/er of cases of septicemia.
Anyone e3posed to Vibrio parahaemolyticus can /ecome infected and develop
gastroenteritis. Ho*ever0 compared to the healthy population0 there is a/out a +1fold
higher pro/a/ility of an infected individual *ith a concurrent underlying chronic medical
condition developing septicemia. #he model predicts a/out 7 cases of septicemia each
year for the total population0 of *hich 2 *ould /e e3pected to occur in healthy individuals
and ! *ould /e e3pected to occur among the immunocompromised population.
59
Vibrio parahaemolyticus %is. Assessment
"N#$%&%$#"'$ SU((A%)
Summary $able <* Pre,icte, +ean #umber of "ases of Vibrio parahaemolyticus
Septicemia Associate, with the "onsumption of Raw Oysters
Region
+ean Annual "ases of Septicemia
a
Summer !all 0inter Spring $otal
@ulf Coast ,Douisiana- 8 L5 L5 5 +
@ulf Coast ,Non1Douisiana-
/
L5 L5 L5 L5 5
(id1Atlantic L5 L5 L5 L5 L5
Northeast Atlantic L5 L5 L5 L5 L5
&acific North*est ,Dredged- L5 L5 L5 L5 L5
&acific North*est ,"ntertidal- L5 L5 L5 L5 L5
$O$A( + L5 L5 2 7
a
Calculated /y multiplying the pro/a/ility of septicemia ,.28- /y the mean predicted num/er of
illnesses ,see Summary #a/le 7-.
/
"ncludes oysters harvested from Florida0 (ississippi0 #e3as0 and
Ala/ama. #he typical time from harvest to refrigeration of oysters for these states is shorter than for
Douisiana.
Sensitivity Analysis
A sensitivity analysis *as conducted to determine *hich model input factors have the
strongest influence on the predicted pro/a/ility of illness. A representative e3ample of this
type of evaluation is sho*n in Summary Figure 8. #he graph ,referred to as a #ornado
&lot- sho*s the ran. and magnitude of influence of factors ,from highest to lo*est- on the
pro/a/ility of illness. For e3ample0 in the @ulf Coast ,Douisiana- Summer harvest0 the
model prediction of ris. is influenced the most /y the level of Vibrio parahaemolyticus in
the environment and secondly /y the percent of pathogenic Vibrio parahaemolyticus in
oysters at the time of harvest. #he length of time oysters are unrefrigerated after harvest
and air temperature are also important factors. #he ran.ing is similar for all regions0
e3cept for intertidal1harvested oysters in the &acific North*est. For the &acific North*est
intertidal harvest0 the second and third most influential factors are air and oyster
temperatures. #hus0 for this region0 higher levels of ris. are associated *ith oysters that
have /een collected on *arm sunny days. Since the levels of Vibrio parahaemolyticus
decrease during cold storage0 the length of time the oysters are refrigerated is negatively
correlated *ith the ris. for all regions and seasons and the factor points to the left rather
than to the right on the #ornado &lot.
57
Vibrio parahaemolyticus %is. Assessment
"N#$%&%$#"'$ SU((A%)
Summary !igure 6* $orna,o Plot of Influential 1ariability !actors of Vibrio
parahaemolyticus =1p> Illness per Serving of Raw Oysters in the 'ulf "oast
=(ouisiana> Summer Harvest
+o,el 1ali,ation
$3posure predictions *ere validated /y comparing predicted Vibrio parahaemolyticus
levels in oysters at the time of consumption to data from a 5>>615>>> survey of Vibrio
parahaemolyticus levels in oysters at retail conducted colla/oratively /y the "nterstate
Shellfish Sanitation Conference ,"SSC- and the FDA ,Summary Figure +-. #hese data
*ere not used in the development of the ris. assessment model. "n general0 the mean
Vibrio parahaemolyticus levels predicted /y the model compared *ell *ith the mean
levels from the "SSCAFDA survey0 particularly for the @ulf and (id1Atlantic summer *hen
the ris. of illness is highest. For the &acific North*est0 the model predictions are higher
than the "SSCAFDA estimates0 /ut there is su/stantial uncertainty associated *ith the
"SSCAFDA data for this region due to the relatively small num/er of samples. Hased on
the generally good agreement /et*een model1predicted V. parahaemolyticus densities and
o/served densities at retail0 the e3posure assessment portion of the model is considered to
/e validated.
56
Vibrio parahaemolyticus %is. Assessment
"N#$%&%$#"'$ SU((A%)
Summary !igure 7* Observe, log). %ensity of $otal Vibrio parahaemolyticus at Retail
"ompare, to +o,el Pre,ictions for the 'ulf "oast =(ouisiana an, non4(ouisiana
states> E#he error /ars indicate one standard deviation a/ove and /elo* either the model predictions
,s2uare /o3- or o/served values ,filled circle-.G
#he corresponding validation of the ris. estimates /ased on a comparison of the ris.
assessment predictions and availa/le epidemiological data sho*ed a higher degree of
uncertainty. #he surveillance data reported to CDC are the only data availa/le to validate
the model predictions of illness for each region and season. #emporally0 the model
predictions and CDC data /oth indicate that the ris. of illness is higher in the spring and
summer than in the *inter and fall. Ho*ever0 agreement /et*een the surveillance data
and the regional predictions of ris. *ere less clear cut0 though /oth sho*ing similar trends
,e.g.0 the highest num/er of illnesses are associated *ith @ulf Coast oysters follo*ed /y
&acific North*est oysters-. "n part0 this uncertainty reflects the fact that the surveillance
data indicate *here ,location- the illness occurred and the model predicts illnesses
attri/uted to *here ,region- oysters *ere harvested. "t is difficult to trace the oysters that
caused an illness /ac. to the harvest region. Hecause of the intrinsic difference in *hat the
t*o systems measure ,location of illness occurrence vs. harvest region of oysters that
cause illness-0 full validation of the regional model predictions of illness /ased on regional
surveillance data *ill re2uire additional research and targeted surveillance initiatives *ith
more thorough trace/ac. data.
0HA$4I! S"#ARIOS
5>
Vibrio parahaemolyticus %is. Assessment
-3
3
4
1
D
e n
s i t
y
' l
o
g
3
2

,
p /
g (
%SSC/)D" retail data
model predi!tions
Summer )all Spring Winter
"N#$%&%$#"'$ SU((A%)
#he ris. assessment model can /e used to estimate the li.ely impact of intervention
strategies on the predicted num/er of illnesses. #he impact of different harvesting
methods0 seasons ,i.e.0 *ater and air temperatures-0 time until refrigeration0 and length of
storage /efore consumption *ere parameters considered in the /aseline model. Hy
changing one or more of the input parameters and measuring the resulting change in the
model outputs0 the li.ely impact of ne* or different processing procedures or regulatory
actions can /e evaluated. #hese changes to the /aseline model are commonly referred to
as <*hat1if= scenarios. #he *hat1if scenarios evaluated include the follo*ing? reducing
levels of Vibrio parahaemolyticus in oysters ,representing various post1harvest mitigation
controls-; reducing time1to1refrigeration; re1su/mersion of intertidally harvested oysters;
and sample1/ased control plans.
Re,ucing (evels of Vibrio parahaemolyticus in Oysters .
&ost1harvest mitigation control scenarios included an evaluation of treatments that reduce
levels of Vibrio parahaemolyticus in oysters. #he reduction levels represent a range of
potential mitigation controls? immediate refrigeration ,i.e.0 cooling immediately after
harvest-; 21log reduction ,e.g.0 free:ing and cold storage-; and +.!1log reduction ,e.g.0
mild heat treatment0 irradiation0 or ultra high hydrostatic pressure-. #he effectiveness of
immediate refrigeration may /e e3pected to vary /oth regionally and seasonally and is
typically appro3imately 51log reduction.
(easures that control or reduce the levels of Vibrio parahaemolyticus in oysters reduced
the predicted ris. of illness associated *ith this pathogen ,Summary #a/le >-. #reatment
such as immediate refrigeration decreased the num/er of predicted illnesses /y
appro3imately 51fold. #he effect of immediate refrigeration is less pronounced in the
cooler regions than in the *armer @ulf Coast. #reatment causing a 21log decrease in the
levels of Vibrio parahaemolyticus in oysters reduces the pro/a/ility of illness /y
appro3imately 51fold. #reatment causing a +.!1log decrease in the num/er of Vibrio
parahaemolyticus /acteria reduces predicted illness to an e3tent that ma.es it unli.ely that
illnesses *ould /e o/served.
2
Vibrio parahaemolyticus %is. Assessment
"N#$%&%$#"'$ SU((A%)
Summary $able ?* Pre,icte, +ean #umber of Illnesses per Annum from Re,uction
of (evels of Pathogenic Vibrio parahaemolyticus in Oysters
Region
Pre,icte, +ean #umber of Illnesses per Annum
9aseline Imme,iate
Refrigeration
a
-4log
Re,uction
b
7*84log
Re,uction
c
@ulf Coast ,Douisiana- 20! 22 22 L5
@ulf Coast ,Non1Douisiana- !+9 6 9 L5
(id1Atlantic 5! 2 L5 L5
Northeast Atlantic 5> 8 L5 L5
&acific North*est ,Dredged- + L5 L5 L5
&acific North*est ,"ntertidal- 5>2 59 2 L5
$O$A( 20629 8>5 8 L5
a
%epresents refrigeration immediately after harvest; the effectiveness of *hich varies /oth regionally and
seasonally and is typically appro3imately 51log reduction.
/
%epresents any process *hich reduces levels of Vibrio parahaemolyticus in oysters 21log0 e.g.0 free:ing.
c
%epresents any process *hich reduces levels of Vibrio parahaemolyticus in oysters +.!1log0 e.g.0 mild
heat treatment0 irradiation0 or ultra high hydrostatic pressure.
Re,ucing the $ime4to4Refrigeration
For this scenario0 the impact of <rapid= cooling ,i.e.0 using ice or an ice slurry after
harvest- such that oysters *ould /e chilled to a <no1gro*th= temperature ,L5C- *ithin
5 hour of harvest *ere compared to <conventional= cooling ,i.e.0 refrigeration after
harvest- such that up to 5 hours *ere presumed for oysters to reach the no1gro*th
temperature. For the @ulf Coast DouisianaA Summer harvest0 the greatest reductions *ere
predicted for shorter times to refrigeration and using cooling *ith ice compared to cooling
under conventional refrigeration ,Summary Figure !-. &redicted reduction in Vibrio
parahaemolyticus illnesses from oysters cooled *ithin 5 hour after harvest ranged from
69I ,conventional refrigeration- to >7I ,cooling *ith ice-. #he lo*er temperatures
associated *ith the other regions result in predicted reductions that are less dramatic.
25
Vibrio parahaemolyticus %is. Assessment
"N#$%&%$#"'$ SU((A%)
Summary !igure 8* Pre,icte, ffectiveness of $wo %ifferent +etho,s of "ooling on
Vibrio parahaemolyticus Risk for the 'ulf "oast Region =(ouisiana an, non4
(ouisiana> Summer Harvest E$rrors /ars denote central >!I of uncertainty distri/ution
a/out the mean I reduction.G
Re4submersion of Interti,ally Harveste, Oysters
22
Vibrio parahaemolyticus %is. Assessment
0%
20%
40%
60%
80%
100%
0 1 2 3 4 5
+a-imum Time to la!ement under Refrigeration 'hours(

r
e
d
i
!
t
e
d

e
r
!
e
n
t
a
g
e

R
e
d
u
!
t
i
o
n

o
f

+
e
a
n

R
i
s
&

o
f

%
l
l
n
e
s
s

0
u
r
d
e
n
Rapid cooling wit ice !1 r to no growt
te"perat#re$
%ooling wit nor"al re&rigeration !#p to 10 rs
to
growt te"perat#re a&ter start o& re&rigeration$
"N#$%&%$#"'$ SU((A%)
As an e3ample of a harvest practice scenario0 the impact of overnight su/mersion of
oysters *as evaluated. #he model predicts the levels of Vibrio parahaemolyticus in
intertidally1harvested oysters0 e.g.0 oysters are placed into /as.ets and removed after the
tide rises0 a typical practice in the &acific North*est. Vibrio parahaemolyticus levels can
increase in oysters during intertidal e3posure /ut overnight su/mersion of the oysters in
*ater has /een sho*n to reduce these levels. Delaying harvest until near the end of the
tidal cycle0 Cust /efore oysters are e3posed again0 *as predicted to reduce the ris. of
illness /y appro3imately >I. %esearch is needed to determine *hether the predicted
level of reduction can /e achieved *hen oysters are stac.ed in /as.ets.
28
Vibrio parahaemolyticus %is. Assessment
"N#$%&%$#"'$ SU((A%)
Sample49ase, "ontrol Plans
#he FDAA"SSC recommends that the levels of Vibrio parahaemolyticus in oysters not
e3ceed 50 cellsAgram and the "SSC interim control plan ,"C&- recommends
monitoring of oyster meats for the presence of Vibrio parahaemolyticus. &rior to 250
"SSC recommended that shellfish harvest *aters /e re1sampled for pathogenic Vibrio
parahaemolyticus if the levels of total Vibrio parahaemolyticus in oyster meats at harvest
e3ceed 50 cellsAgram. "n 250 the "C& *as revised to recommend that shellfish
harvest *aters /e re1sampled for pathogenic Vibrio parahaemolyticus if the levels of total
Vibrio parahaemolyticus in oyster meats at harvest are a/ove !0 cellsAgram.
#he incidence of illness *as evaluated assuming that it *as possi/le to identify and
e3clude oysters from the ra* mar.et *hich contained various specified levels of Vibrio
parahaemolyticus either at harvest or at retail. #he @ulf Coast region ,Douisiana-A
Summer harvest is presented here as an e3ample. As sho*n in Summary Figures 9 and 70
restricting the levels of Vibrio parahaemolyticus in oysters either at1harvest or at1retail
reduces the num/er of predicted illnesses0 /ut re2uires diversion of oysters from the ra*
mar.et ,or modification of handling practices to reduce post1harvest Vibrio
parahaemolyticus gro*th-. For the @ulf Coast region ,Douisiana- summer harvest0 in the
a/sence of su/se2uent post1harvest mitigation0 e3cluding oysters containing M50
Vibrio parahaemolyticusAg at the time of harvest is predicted to prevent appro3imately
59I of illnesses *ith an impact of appro3imately 8I of the oyster harvest,Summary
Figure 9-. Ho*ever0 e3cluding oysters containing M50 Vibrio parahaemolyticus at1
retail reduced predicted illness /y >>I /ut *ould re2uire appro3imately +8I of the oyster
harvest to /e diverted from the ra* mar.et consumption ,or su/Cected to preventive
controls-. #he impact of compliance *ith different <at1harvest= and <at1retail= ,i.e.0 after
refrigeration- control levels *as also evaluated. As might /e e3pected0 the effectiveness of
a specific ,or hypothetical- control level to reduce illnesses depend *as proportional to the
e3tent of compliance *ith that level.
2+
Vibrio parahaemolyticus %is. Assessment

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Summary !igure :* Potential ffect of "ontrol of $otal Vibrio parahaemolyticus
9acterium per gram At4Harvest for the 'ulf "oast Region =(ouisiana> Summer
Harvest
Summary !igure ;* Potential ffect of "ontrol of $otal Vibrio parahaemolyticus per
gram At4Retail for the 'ulf "oast Region =(ouisiana> Summer Harvest
"O#"(&SIO#S
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Vibrio parahaemolyticus %is. Assessment
0
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Total Vibrio parahaemolyticus/g .evel in Oysters
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Total Vibrio parahaemolyticus/g guidan!e level

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"N#$%&%$#"'$ SU((A%)
#his ris. assessment included an analysis of the availa/le scientific information and data in
the development of a model to predict the pu/lic health impact of pathogenic Vibrio
parahaemolyticus in ra* oysters. #he assessment focuses on comparing the relative ris.
among different geographic regions0 seasons0 and harvest practices. #he scientific data
and the mathematical models developed during the ris. assessment facilitate a systematic
evaluation of strategies to reduce the pu/lic health impact of pathogenic Vibrio
parahaemolyticus associated *ith the consumption of ra* oysters.
Although the ris. assessment modeled sporadic Vibrio parahaemolyticus illnesses0 steps
ta.en to reduce sporadic cases *ould /e e3pected to reduce the si:e and fre2uency of
out/rea.s. #he proportional reduction *ould depend on the virulence of the out/rea.
strain and on the surviva/ility and gro*th of the strain follo*ing post1harvest treatments.
(itigation or control measures aimed at decreasing levels of Vibrio parahaemolyticus in
oysters *ill also li.ely decrease levels of other species in the Vibrio genus ,or family-0 such
as Vibrio vulnificus.
Helo* are the responses to the 2uestions that the ris. assessment team *as charged *ith
ans*ering.
0hat is known about the ,ose4response relationship between consumption of Vibrio
parahaemolyticus an, illnesses@
Although an individual may /ecome ill from consumption of lo* levels of Vibrio
parahaemolyticus0 it is much more li.ely that he or she *ill /ecome ill if the level is
high. #he pro/a/ility of illness is relatively lo* ,L.5I- for consumption of 50
Vibrio parahaemolyticus cellsAserving ,e2uivalent to a/out ! cellsAgram oysters-.
Consumption of a/out 5 million Vibrio parahaemolyticus cellsAserving ,!
thousand cellsAgram oysters- increases the pro/a/ility of illness to a/out !I.
Anyone e3posed to Vibrio parahaemolyticus can /ecome infected and develop
gastroenteritis. Ho*ever there is a greater pro/a/ility of gastroenteritis developing
into septicemia ,and possi/ly death- among the su/population *ith concurrent
underlying chronic medical conditions.
#he model predicts a/out 206 Vibrio parahaemolyticus illnesses from oyster
consumption each year. 4f infected individuals0 appro3imately 7 cases of
gastroenteritis *ill progress to septicemia each year for the total population0 of *hich
2 individuals *ould /e from the healthy su/population and ! *ould /e from the
immunocompromised su/population.
#his ris. assessment assumed that pathogenic strains of Vibrio parahaemolyticus are
#DH
K
and that all strains possessing this characteristic are e2ually virulent.
(odifications can /e made to the ris. assessment if data /ecome availa/le for ne*
virulence determinants. For e3ample0 data from out/rea.s suggest that fe*er
microorganisms of Vibrio parahaemolyticus 48?J9 are re2uired to cause illness
compared to other strains.
0hat is the freAuency an, eBtent of pathogenic strains of Vibrio parahaemolyticus in
shellfish waters an, in oysters@
Devels of pathogenic Vibrio parahaemolyticus usually occur at lo* levels in shellfish
*aters.
29
Vibrio parahaemolyticus %is. Assessment
"N#$%&%$#"'$ SU((A%)
Devels of pathogenic Vibrio parahaemolyticus in oysters at the time of harvest are
only a small fraction of the total Vibrio parahaemolyticus levels.
0hat environmental parameters =e*g*C water temperatureC salinity> can be use, to
pre,ict the presence of Vibrio parahaemolyticus in oysters@
#he primary driving factor to predict the presence of Vibrio parahaemolyticus in
oysters is *ater temperature. Salinity *as a factor evaluated /ut not incorporated into
the model. Salinity is not a strong determinant of Vibrio parahaemolyticus levels in
the regions that account for essentially all the commercial harvest. 4ther factors such
as oyster physiology and disease status may also /e important /ut no 2uantifia/le data
*ere availa/le to include these factors in the model.
#here are large differences in the predicted levels of Vibrio parahaemolyticus in
oysters at harvest among regions and seasons. For all regions0 the highest levels of
Vibrio parahaemolyticus *ere predicted in the *armer months of summer and spring
and the lo*est levels in the fall and *inter.
4verall0 the highest levels of total and pathogenic Vibrio parahaemolyticus *ere
predicted for the @ulf Coast ,Douisiana- and the lo*est levels in the &acific North*est
,Dredged- harvested oysters.
After harvest0 air temperature is also an important determinant of the levels of Vibrio
parahaemolyticus in oysters. Vibrio parahaemolyticus can continue to gro* and
multiply in oysters until they are ade2uately chilled.
Devels of Vibrio parahaemolyticus are lo*er in oysters after harvest in the cooler vs.
*armer months. #his means that reducing the time /et*een harvest and cooling *ill
/e more important in the summer and spring than in the fall and *inter.
How ,o levels of Vibrio parahaemolyticus in oysters at harvest compare to levels at
consumption@
Bith no mitigation treatments0 levels of Vibrio parahaemolyticus are higher in oysters
at consumption than at harvest. #he difference /et*een Vibrio parahaemolyticus
densities at1harvest versus at1consumption is largely attri/uta/le to the e3tent of
gro*th that occurs /efore the oysters are cooled to no1gro*th temperatures.
Devels of Vibrio parahaemolyticus in oysters vary /y region and season and are
highest during the summer.
During intertidal harvest0 oysters are e3posed to higher temperatures for longer times0
allo*ing additional gro*th of Vibrio parahaemolyticus in oysters and leading to
higher predicted ris. of illness.
&reventing gro*th of Vibrio parahaemolyticus in oysters after harvest ,particularly in
the summer- *ill lo*er the levels of Vibrio parahaemolyticus in oysters and0 as a
conse2uence0 lo*er the num/er of illnesses associated *ith the consumption of ra*
oysters.
0hat is the role of post4harvest han,ling on the level of Vibrio parahaemolyticus in
oysters@
&ost1harvest measures aimed at reducing the Vibrio parahaemolyticus levels in oysters
reduced the model1predicted ris. of illness associated *ith this pathogen.
27
Vibrio parahaemolyticus %is. Assessment
"N#$%&%$#"'$ SU((A%)
%educing the time /et*een harvest and chilling has a large impact on reducing levels
of Vibrio parahaemolyticus in oysters and the num/er of illnesses. &redicted
reductions *ere greater for shorter times to refrigeration using ice ,oysters reach no1
gro*th temperature in 5 hour- compared to cooling under conventional refrigeration
,*hich may ta.e up to 5 hours until oysters reach a no1gro*th temperature-.
0hat re,uctions in risk can be anticipate, with ,ifferent potential intervention
strategies@
4verall. #he most influential factor affecting predicted ris. of illness is the level of
total Vibrio parahaemolyticus in oysters at the time of harvest. "ntervention strategies
should /e aimed at reducing levels of Vibrio parahaemolyticus andAor preventing its
gro*th in oysters after harvest. #hese strategies0 either at1harvest or post1harvest0
may need to consider regionalAseasonal differences. For e3ample0 the use of ice on
harvest /oats to cool oysters to the no1gro*th temperature of Vibrio
parahaemolyticus *ill have a larger impact on reducing illnesses in the summer than in
the *inter *hen air temperatures are cooler and Vibrio parahaemolyticus levels are
lo*er.
%egionalASeasonal Differences. #he ris. of Vibrio parahaemolyticus illness is
increased during the *armer months of the year0 *ith the magnitude of this increase a
function of the e3tent to *hich the gro*ing *aters ,and air temperature- are at
temperatures that support the gro*th of the pathogen ,e.g.0 temperatures a/ove
5C-. For each region0 the predicted num/ers of illnesses are much higher for the
summer compared to the *inter months. "ntervention measures that depend on
cooling oysters to no1gro*th temperatures for Vibrio parahaemolyticus may /e more
important in *armer seasons and regions.
#he ris. of Vibrio parahaemolyticus illness is su/stantial in the @ulf Coast region
*here *ater temperatures are *arm over a large part of the year as compared to the
Northeast Atlantic region *here *ater temperatures support the gro*th of Vibrio
parahaemolyticus only during a relatively small portion of the year. A difference is
seen among the regions due to different harvesting methods. Bithin the @ulf Coast0
the predicted num/er of illnesses is much higher in Douisiana compared to other states
in this region /ecause the harvest /oats in Douisiana are typically on the *ater longer0
i.e.0 leading to a longer time from harvest to refrigeration. Harvest volume is also a
determining factor; in the summer0 Douisiana accounts for appro3imately 77I of the
@ulf Coast harvest. #his is also seen in the &acific North*est /y comparing intertidal
versus dredged harvesting. "ntertidal harvesting accounts for 7!I of the &acific
North*est harvest and e3poses oysters to higher temperatures longer0 allo*ing greater
gro*th of Vibrio parahaemolyticus. 4vernight su/mersion for a single tidal cycle0
reduces levels of Vibrio parahaemolyticus in oysters and the ris. of illness.
&ost1Harvest #reatments. &ost1harvest treatments that reduce levels of Vibrio
parahaemolyticus /y 2 to +.!1logs *ere found to /e effective for all seasons and
regions0 *ith the most pronounced effects seen for regions and seasons *ith higher
/aseline ris.. #he model sho*s that any treatment that causes at least a +.!1log
decrease in the num/er of Vibrio parahaemolyticus /acteria reduces the pro/a/ility of
26
Vibrio parahaemolyticus %is. Assessment
"N#$%&%$#"'$ SU((A%)
illness to such an e3tent that fe* illnesses *ould /e identified /y epidemiological
surveillance. Ho*ever0 some out/rea. strains ,e.g.0 48?J9- are more resistant to
mitigations than endemic pathogenic Vibrio parahaemolyticus strains0 and the duration
or e3tent of treatment may need to /e more stringent to achieve an e2uivalent degree
of reduction. Studies have sho*n that /oth Vibrio parahaemolyticus and Vibrio
vulnificus respond similarly to control measures such as ultra high pressure0 mild heat
treatment0 and free:ing. #herefore0 mitigations aimed at decreasing levels of Vibrio
parahaemolyticus *ill also li.ely decrease levels of Vibrio vulnificus.
#he model also demonstrated that if oysters are not refrigerated soon after harvest0
Vibrio parahaemolyticus rapidly multiply resulting in higher levels. For e3ample0 the
model indicates that for the @ulf Coast there is a significant reduction ,N51fold- in the
pro/a/ility of illness *hen the oysters are placed in a refrigerator immediately after
harvest. Dess pronounced reductions are predicted for the other regions. &redicted
reduction in illness is less in colder seasons /ecause oysters harvested in cooler
*eather are already at or /elo* the temperature threshold for Vibrio
parahaemolyticus gro*th and as such refrigeration has little additional impact on
levels of Vibrio parahaemolyticus.
At1Harvest and At1%etail Controls. Controlling the levels of Vibrio parahaemolyticus
in oysters at1harvest or at1retail ,after refrigeration and storage- drastically reduces the
num/er of predicted illnesses /ut *ould re2uire diversion of oysters from the ra*
mar.et or modification of handling practices to reduce post1harvest Vibrio
parahaemolyticus gro*th. For the @ulf Coast ,Douisiana- region in the summer0
e3cluding all oysters *ith at least 50 Vibrio parahaemolyticusAg at1harvest *ould
reduce illness /y appro3imately 59I at a loss of appro3imately 8I of the total harvest
from the ra* consumption mar.et; and this same control level at1retail *ould reduce
illness /y a/out >>I *ith a +8I loss from the ra* oyster mar.et ,or su/Cected to
preventive controls-. #he effectiveness of the control level either at1harvest or at1retail
to reduce illnesses depends on the e3tent of compliance *ith that control level.
"n a sample1/ased control strategy0 a reasona/le surrogate for pathogenic Vibrio
parahaemolyticus may /e total levels of this microorganism. Criteria for reCection of
oysters /ased on the levels of this surrogate might have to vary /y region. For
e3ample0 an at1harvest control criterion /ased on total Vibrio parahaemolyticus levels
in the &acific North*est might need to /e more stringent than in the @ulf Coast
/ecause the incidence of pathogenic strains appears to /e higher in the &acific
North*est. Ho*ever0 in an out/rea.0 the ratio of pathogenic to total Vibrio
parahaemolyticus may not /e the same or consistent0 and the model does not evaluate
ho* *ell total Vibrio parahaemolyticus *ould serve as a surrogate for pathogenic
Vibrio parahaemolyticus in an out/rea. situation.
"n conclusion0 the ris. assessment illustrates that the levels of Vibrio parahaemolyticus at
the time of harvest play an important role in causing human illness. Ho*ever0 other
factors that either reduce or allo* gro*th of Vibrio parahaemolyticus in oysters are also
important in determining the num/er of illnesses. For e3ample0 shortening the time1to1
2>
Vibrio parahaemolyticus %is. Assessment
"N#$%&%$#"'$ SU((A%)
refrigeration of oysters in the summer controls gro*th of Vibrio parahaemolyticus in
oysters and su/se2uently reduces illnesses associated *ith this microorganism.
#he results of this ris. assessment are influenced /y the assumptions and data sets that
*ere used to develop the $3posure Assessment and Dose1%esponse models. #he
predicted ris. of illness among consumers of ra* oysters could change as a result of future
data o/tained from continuing surveillance studies. "t is anticipated that periodic updates
to the model *ill continue to reduce the degree of uncertainty associated *ith the factors
that influence the ris.. #his ris. assessment provides an understanding of the relative
importance of and interactions among the factors influencing ris.. "t can /e used to
facilitate the formulation of effective guidance and re2uirements for the industry and in the
evaluations of ris. mitigation strategies. #his "nterpretive Summary provides a /rief0 non1
technical description of the materials covered0 /ut a full understanding re2uires the reader
to consider the complete ris. assessment.
8
Vibrio parahaemolyticus %is. Assessment