EPA
    United States
    Environmental Protection
    Agency
Final Contaminant Candidate List 3
Microbes:  PCCL to CCL Process

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Office of Water (4607M)
EPA815-R-09-009
August 2009
www. epa. gov/safewater

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EPA OGWDW                      Final CCL 3 Microbes.                      EPA 815-R-09-009
                                 PCCL to CCL Process                          August 2009
                                       Contents
Abbreviations and Acronyms	ii
1.0 Final CCL 3	1
2.0 Background and Scope	2
3.0 Rationale Used to Develop Scoring Protocols	3
4.0 Selecting the CCL from the Ranked PCCL	13
5.0 Scoring Data Sheets	13
                                       Exhibits
Exhibit 1.  Draft CCL 3 Microbes	2
Exhibit 2.  Waterborne Disease Outbreak Scoring Protocol	5
Exhibits.  CDC Reported WBDOs (1990 - 2004)	6
Exhibit 4.  Occurrence Scoring Protocol for Pathogens	8
Exhibit 5.  Health Effects Scoring Protocol for Pathogens	10
Exhibit 6.  WBDO, Occurrence and Health Effects Scores for PCCL	12

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EPA OGWDW                      Final CCL 3 Microbes.                     EPA 815-R-09-009
                                 PCCL to CCL Process                          August 2009
                             Abbreviations and Acronyms

CCL - Contaminant Candidate List
CCL 3 - EPA's Third Contaminant Candidate List
CDC - Centers for Disease Control and Prevention
CSTE - Council of State and Territorial Epidemiologists
EPA - United States Environmental Protection Agency
MMWR - Morbidity and Mortality Weekly Report
NPDWR - National Primary Drinking Water Regulation
NRC - National Research Council
PWS - Public Water  System
PCCL - Preliminary Candidate Contaminant List
SDWA - Safe Drinking Water Agency
USEPA - United States Environmental Protection Agency
WBDO - Waterborne Disease Outbreak
U.S. - United States of America (includes territories)

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EPA OGWDW                      Final CCL 3 Microbes.                     EPA 815-R-09-009
                                 PCCL to CCL Process                          August 2009

CCL 3 Microbes: PCCL to CCL Process

1.0    Final CCL 3

       EPA is including twelve pathogens on the final Candidate Contaminant List 3 (CCL 3),
one more than the eleven pathogens on the draft CCL 3. The Agency is adding Adenovirus,
Enterovirus, and Mycobacterium avium, and is removing Vibrio cholerae andEntamoeba
histolytica from the final CCL 3 (see Exhibit 1).

       The scoring process described in this document remained the same as the Draft CCL 3
(73 FR 9645, February 21, 2008) with two exceptions: dropping the early Center for Disease
Control and Prevention (CDC)-Waterborne Disease Outbreaks (WBDO) (before 1990) and the
health effects of Mycobacterium avium (both discussed in detail later).

        Most of the pathogens currently listed on the Final CCL 3 were also included on the
preceding CCLs (1 and 2) with the exception of four pathogens. The four pathogens on the
previous CCLs that are not included on the Final CCL 3 are: Acanthamoeba, which was on CCL
1 (63 FR 10275; March 2, 1998), and cyanobacteria, Aeromonas hydrophila and Microsporidia,
which were included in both CCL 1 and CCL 2 (63 FR 10275; March 2, 1998 and  70 FR 9072;
February 24, 2005).

        Acanthamoeba was not included on the final CCL 3 because EPA made the
determination not to regulate Acanthamoeba. EPA made this determination because regulation
did not present a meaningful opportunity for health risk reduction for the people served by public
drinking water systems (PWSs) (68 FR 42903; July 18, 2003). Furthermore, EPA in
collaboration with CDC developed a guidance document for Acanthamoeba directed mainly to
contact lens wearers and addresses the risks of Acanthamoeba eye infection associated with
improper care of contact lenses (http://www.epa.gov/waterscience/health/acanthamoeba/
#canprevent).

        EPA also decided to include the cyanotoxins produced by cyanobacteria on the Final
CCL 3 chemicals list rather than the cyanobacteria which were listed on CCL 1 and 2 microbial
contaminants. Cyanobacteria are not considered pathogens themselves and the production of
their cyanotoxins is determined by specific environmental conditions. Thus, they were not
included on the microbes list but the toxins they produce were listed on the chemicals CCL 3.
Both Aeromonas hydrophila and Microsporidia were included on the Preliminary Candidate
Contaminant List (PCCL); however, because of their low health effects scores (general
population score of 2 and sensitive subpopulation scores of 3 and 2, respectively) and low
WBDOs score (score of 1) their total scores were not high enough to place them on the CCL 3.
For detailed information see Exhibit 6 and each pathogen's Scoring Data Sheet.

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EPA OGWDW                      Final CCL 3 Microbes.                      EPA 815-R-09-009
                                 PCCL to CCL Process                           August 2009

Exhibit 1. Draft CCL 3 Microbes
   •  Adenovirus
   •  Caliciviruses
   •  Campylobacter jejuni
   •  Enterovirus
   •  Escherichia coli (015 7)
   •  Helicobacter pylori
   •  Hepatitis A virus
   •  Legionella pneumophila
   •  Mycobacterium avium
   •  Naegleria fowleri
   •  Salmonella enterica
   •  Shigella sonnet
2.0    Background and Scope

       The scoring process discussed in this document is the last step in a three-step process
designed to select microbial contaminants for the CCL.  The first step of the process is
identification of a universe of potential drinking water contaminants. The document titled Final
CCL 3 Microbes: Identifying the Universe provides a summary of the statutory and regulatory
background leading to development of a microbial CCL and describes the activities required to
develop a microbial CCL universe as the initial step in a transparent and scientifically sound
CCL process. No changes were made to the universe for the final CCL 3.

       A second document, titled CCL 3 Microbes: Screening to the PCCL, describes a process
to screen human pathogens from a universe of microbiological contaminants for placement on
the Preliminary Contaminant Candidate List (PCCL) as the second step in the CCL process. The
Universe of microbes is screened based on the likelihood to be present in drinking water and that
are associated with illness attributable to drinking water exposure. No changes were made to the
screening document for the final CCL 3.

       In this third step of the CCL process the PCCL, microbes are evaluated for their
occurrence in drinking water and their ability to produce adverse health effects in humans.
Pathogens on the PCCL were scored for placement on the CCL. EPA devised a scoring system
to assign a numerical value to each pathogen on the PCCL.  Pathogens receiving high scores are
considered for placement on the CCL.

       This document describes the set of scoring protocols used to relatively rank pathogens on
the PCCL to produce a CCL. EPA derived this scoring process in part from recommendations of
the National Research Council (NRC) and an expert workgroup  established by the National
Drinking Water Advisory  Council,  and two external workshops  (June 2006 and March 2007).
This document describes the rationale for using scoring protocols to rank pathogens based upon
their occurrence, health effects, and waterborne disease outbreaks.

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EPA OGWDW                       Final CCL 3 Microbes.                       EPA 815-R-09-009
                                  PCCL to CCL Process                            August 2009
3.0    Rationale Used to Develop Scoring Protocols

       Section 1412(b) (1) of SDWA, as amended in 1996, specifies that the list must include
contaminants that are not subject to any proposed or promulgated NPDWRs, are known or
anticipated to occur in PWSs, and may require regulation under SDWA (adverse health effects).
The objective is to target microorganisms with the highest potential for exposure and the most
serious adverse health effects.

       Each of the pathogens on the PCCL was scored using three scoring protocols, one
protocol each for waterborne disease outbreaks (WBDO), occurrence in drinking water, and
health effects. The higher of the WBDO score or the occurrence score is added to the normalized
health effects score to produce a composite pathogen score. Pathogens receiving high scores
were considered for placement on the CCL.

       Occurrence data are based on analytical methods to determine presence and
concentrations of drinking water contaminants. Occurrence data can be collected as part of
public health surveillance or in connection with research efforts and can include data based on
molecular techniques, culture-based methods and response to a disease outbreak. Evaluating
these many types of information is a major challenge in developing the CCL selection process.

       Public health surveillance programs and the scientific literature provided a range of
exposure information from documented microbial outbreaks for microbes with limited
associations to these outbreaks. The sources of information ranged from Centers for Disease
Control and Prevention (CDC) (i.e., Morbidity and Mortality Weekly Reports (MMWR)) to
studies identified from the scientific literature.

       The CCL selection process considered pathogens causing recent waterborne  outbreaks
more important than pathogens detected in drinking water without documented disease. Direct
detection of pathogens indicates the potential for waterborne transmission of disease.
Documented waterborne disease outbreaks provide an additional weight of evidence that illness
was transmitted and that there was a waterborne route  of exposure. EPA developed protocols to
define a hierarchy of the relevance that each of these types of data provide in evaluating
microbes for the CCL. Combining these two sources of occurrence information enabled EPA to
consider both emerging pathogens that should be considered and are not yet tracked by public
health surveillance programs and WBDO data. This hierarchy also acknowledges that organisms
identified as agents in WBDO are a higher priority for the CCL.

       The combination of documented WBDO data and direct detection data identifies and
compares organisms that should be considered for the  CCL based on occurrence. Pathogens
causing outbreaks of moderate illness (i.e., self-limiting gastrointestinal illness) as well as
pathogens that could cause debilitating disease (i.e., hepatitis) or death from  drinking water
exposure are considered for the CCL.

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EPA OGWDW                       Final CCL 3 Microbes.                      EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009

The assumptions used to develop the CCL scoring process were:
   •   Waterborne disease outbreak data and direct detection of microbes provides occurrence
       data that can and should be organized into a hierarchy to evaluate microbes, and
   •   Combining health effects data with the WBDO/occurrence data provides a system that
       evaluates both the severity of potential disease and the potential magnitude of exposure
       through drinking water.

3.1    Waterborne Disease Outbreaks

       Waterborne disease outbreaks (WBDOs) are the documentation of occurrence of
pathogens in drinking water by public health officials through adverse health effects in a
population and are direct evidence of exposure. For a WBDO to occur pathogens must be present
in water and a person must be exposed resulting in clinical manifestations of disease.
Recognition of pathogens causing WBDOs is important to the CCL selection process. This
criterion was used if the source of a pathogen was traced to a public drinking water system and
an epidemiological investigation implicated a drinking water source as the probable cause of the
outbreak. Recreational water settings were included if they were filled with drinking water from
a community water system. EPA excluded non-drinking water sources such as marine and
estuarine water bodies from consideration under the CCL.

       Since 1971, CDC, EPA and the Council of State and Territorial Epidemiologists (CSTE)
maintain a collaborative surveillance system for collecting and periodically reporting data related
to occurrences and causes of WBDOs. These reports from the CDC system are published
periodically in the MMWR. For the draft CCL 3 EPA used CDC's MMWR summaries as the
source for the WBDO scoring protocol.

       EPA requested comments from the public on the Draft CCL 3. Two commenters
recommended using only the more recent WBDOs based on the implementation of the SDWA.
EPA decided for the Final CCL 3, to use only the CDC surveillance data within the period of
1990 through 2004, as the source of data for the waterborne disease outbreaks  protocol.

       For the revised WBDO protocol, a pathogen is scored as having a WBDO(s) in the U.S.
only if that pathogen is listed in a CDC waterborne disease drinking water surveillance summary
(i.e., in the MMWR) during 1990 and 2004. A pathogen with multiple WBDOs (i.e. 2 or more),
within 1990 and 2004, listed by CDC is given the highest score under this protocol (see Exhibit 2
and 3  for more detailed information).

EPA used the following assumptions for the WBDO  scoring protocol:

   •   Used only WBDOs reported in CDC's MMWR from 1990 through 2004;
   •   Only etiologic agents reported on CDC's MMWR under the table "Waterborne-disease
       outbreaks associated with drinking water" in the column labeled "Etiologic Agent" were
       used. Pathogens associated with any given outbreak which were listed on the footnotes of
       the tables and not on the "Etiologic Agent" column were not considered in EPA's WBDO
       scoring protocol (e.g., Blastocystis hominis, CDC, 2002; p. 17);
                                           4

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EPA OGWDW                      Final CCL 3 Microbes.                      EPA 815-R-09-009
                                 PCCL to CCL Process                           August 2009

   •   Only used drinking water related outbreaks in community and non-community systems as
       reported in the MMWR. MMWR outbreaks reported as "individual" (Ind) were not used
       for WBDO scoring;
   •   Only used pathogens reported at the species level.  Outbreaks for which the etiologic
       agent was reported at the genus level or species that were not the one considered for
       CCL 3 (e.g., Entamoeba spp. (CDC, 2006; p. 42), Helicobacter canadensis (CDC, 2006;
       p. 40)) were not counted for Helicobacter pylori in the WBDO protocol; and
   •   Each outbreak is counted on the year the outbreak occurred and not the year of the
       MMWR where the outbreak was reported (i.e., previously unreported outbreaks). EPA
       scored WBDOs outside the U.S. (non-U.S. territories) as well; however these were given
       lower scores than CDC-WBDOs. WBDOs outside the U.S. were scored when
       information was available from other peer-reviewed publications.

       CDC and EPA acknowledge that the WBDOs reported in the surveillance system
represent only a portion of the burden of illness associated with drinking water exposure (CDC,
2004). The surveillance information does not include endemic waterborne disease risks, nor are
reliable estimates available of the number of unrecognized WBDOs and associated cases of
illness.

       EPA also considered data as indicating a WBDO (even though CDC does not list a
WBDO in their MMWR) if the non-CDC data showed a link between human illness defined by a
common water source, a common time period of exposure and/or similar symptoms. EPA also
considered the use of molecular typing methods to link patients and environmental isolates. Only
Mycobacterium avium and Arcobacter butzlerei were given a WBDO score based on data not
listed in CDC's MMWR.

       The WBDO scoring protocol also uses the CDC definition for outbreak as two or more
persons epidemiologically linked by location of exposure to water, time, and illness (CDC,
2006). CDC excludes  single cases of illness from the definition of WBDO except for single cases
of Naegleria fowleri and Vibrio cholerae.
Exhibit 2. Waterborne Disease Outbreak Scoring Protocol
Category
Has caused multiple (2 or more) documented WBDOs in the U.S. as reported by CDC
surveillance between 1990 and 2004
Has caused at least one documented WBDOs in the U.S. as reported by CDC surveillance
between 1990 and 2004
Has caused documented WBDOs at any time in the U.S.
Has caused documented WBDO in countries other than the U.S.
Has never caused WBDOs in any country, but has been epidemiologically associated with
water related disease
Score
5
4
3
2
1

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
 EPA815-R-09-009
	August 2009
Exhibit 3. CDC Reported WBDOs (1990 - 2004)

1990"
1991*
1992* c
1993C
1994C d
1995d
19964 e
1997e/
1998e
1999^
2000**
2001*
2002* h
2003*
2004*
PCCL Pathogen (Etiologic Agent)
Adenovirus
Aeromonas hydrophila
Arcobacter butzleri
Aspergillus fumigatus
Astrovirus
Blastocystis hominis
Caliciviruses7
Campylobacterjejuni
Cyclospora
Entamoeba histolytica
Enterovirus
Escherichia coli (O157)
Exophialajeanselmei
Fusarium solani
Helicobacter pylori
Hepatitis A vims
Hepatitis E vims
Isospora belli
Legionella pneumophila
Microsporidia
Mycobacterium avium
Naegleria fow leri
Plesiomonas shigelloides
Rotaviras
Salmonella enterica2
Shigella sonnei
Toxoplasma gondii















1





















































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3










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1


Total

0
0
0
0
0
0
13
10
0
1
0
7
0
0
0
2
0
0
11
0
0
1
1
0
3
6
0

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
 EPA815-R-09-009
	August 2009

1990"
1991*
1992* c
1993C
1994C d
1995*
1996* e
199Tf
1998e
1999^
2000**
2001*
2002*' A
2003*
2004*
Total
PCCL Pathogen (Etiologic Agent)
Vibrio cholerae
Yersinia enterocolitica








1














1






1
1
 Caliciviruses include Norwalk-like virases and Noroviruses.
2 Salmonella enterica includes Salmonella typhimurium.

References
"CDC. 1991. Wateiborne Disease Outbreaks, 1989-1990. MMWR40(SS-3): 1-42 (Table 1, p. 14; Table 2, p. 15).
* CDC. 1993. Surveillance for Waterborne Disease Outbreaks - United States, 1991-1992. MMWR 42(SS-05):l-22 (Table 2, p. 6; Table 3, p. 7; Table 8, p.  15).
c CDC. 1996. Surveillance for Waterborne Disease Outbreaks - United States, 1993-1994. MMWR 45(SS-1): 1-33 (Table 2, p. 7; Table 3. p. 8; Table 8, p. 19).
d CDC. 1998. Surveillance for Waterborne Disease Outbreaks - United States, 1995-1996. MMWR 47(SS-5):l-33 (Table 2, p. 27; Table 3, p. 28; Table 9, p. 33).
e CDC. 2000. Surveillance for Waterborne Disease Outbreaks - United States, 1997-1998. MMWR 49(SS-4): 1-35 (Table 2, p. 23; Table 3, p. 24; Table 10, p.
28).
7 CDC. 2002. Surveillance for Waterborne Disease Outbreaks - United States, 1999-2000. MMWR 51(SS-8):l-48 (Table 2, p. 8; Table 3, p. 9; Table 11, p. 17).
g CDC. 2004. Surveillance for Waterborne Disease Outbreaks Associated with recreational Water -United States, 2001-2002 and Surveillance for Waterborne
Disease Outbreaks Associated with Drinking Water - United States, 2001-2002. MMWR 53(SS-8): 1-46 (Table 3, p. 29; Table 4, p. 30;  Table 5, p.  30; Table 9, p.
34).
h CDC. 2006.Surveillance for Waterborne Disease Outbreaks Associated with recreational Water -United States, 2003-2004 and Surveillance for Waterborne
Disease Outbreaks Associated with Drinking Water - United States, 2003-2004. MMWR 55(SS-12): 1-66 (Table 4, p. 39; Table 5, p. 40; Table 7, p. 42).

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EPA OGWDW                       Final CCL 3 Microbes.                       EPA 815-R-09-009
                                   PCCL to CCL Process                            August 2009


3.2    Occurrence

       The occurrence attribute is the direct detection of microbes using cultural,
immunochemical, or molecular detection of pathogens in water. It characterizes pathogen
introduction, survival, and distribution in the environment. Occurrence implies that pathogens
are present in water and that they may be capable of surviving and moving through water to
produce illness in persons exposed to water by ingestion, inhalation, or dermal contact.

       Pathogen occurrence is considered broadly to include public drinking water, and all
waters (e.g., recreational, ground water, surface  water) used as drinking water. This attribute
does not characterize the extent to which pathogen's occurrence poses a public health threat from
drinking water exposure. Because viability and infectivity cannot be determined by non-cultural
methods, the public health significance of non-cultural detections is unknown.
Exhibit 4. Occurrence Scoring Protocol for Pathogens
Category
Detected in drinking water in the U.S.
Detected in source water in the U.S.
Not detected in the U.S.
Score
3
2
1
3.3    Health Effects

       The health effects scores (i.e., 5) and the protocol remains the same in the Final CCL 3 as
in the Draft CCL3 with one exception. Based on public comment, EPA re-evaluated
Mycobacterium avium 's health effects information and increased the health effects score for one
of the sensitive subpopulations, specifically, the elderly. The health effects score was increased
based on the severity and treatment duration on the elderly as described in Murray, 2005 (see
Exhibit 5 and Scoring Sheet for more detailed information).

       The health effects protocol evaluates the extent of illness produced in humans from
drinking water. The severity of disease manifestations produced by a pathogen is evaluated
across a range of potential endpoints. The seven level hierarchy developed for this protocol
begins with mild, self-limiting illness (Score of  1) and progresses to death (Score of 7). These
scores reflect the most common clinical presentation and are based on data from recent clinical
microbiology manuals.

       The agency tried to evaluate the potency of an organism, i.e., the concentration of a
pathogen during exposure that is necessary to cause illness in a susceptible host (infectious
dose). Because infectious doses are not available for most pathogens, the Agency uses this health
effect protocol to score both the severity of disease and the organisms' potency with the best
available data.

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EPA OGWDW                      Final CCL 3 Microbes.                      EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009


       The final outcome of a host-pathogen relationship resulting from drinking water exposure
is a function of viability, infectivity, and pathogenicity of the microbe to which the host is
exposed and the host's susceptibility and immune response. SDWA directs EPA to consider
subgroups of the population at greater risk of adverse health effects (sensitive populations) in the
selection of the CCL. Sensitive populations may have increased susceptibility and may
experience increased severity of symptoms, compared to the general population. SDWA refers to
several categories of sensitive populations including the following: children and infants, elderly,
pregnant women, and persons with a history of serious illness.

       Health effects for individuals with marked immunosuppression (primary or acquired
severe immunodeficiency, transplant recipients, individuals undergoing potent cytoreductive
treatments) are not included in this health effects scoring. While such populations are considered
sensitive subpopulations, severely immunosuppressed individuals often have a higher standard of
ongoing health care and protection required than the other sensitive populations under medical
care. More importantly, nearly all pathogens have very high health effect scores for the markedly
immunosuppressed individuals; therefore there is little differentiation between pathogens based
on health effects for the immunosuppressed subpopulation. However, EPA tried to rescore the
PCCL organisms for their health effects in the markedly immunosuppressed in response to
public comments received. EPA found that health effects information on the severely
immunosuppressed was not available for many (11 of 29) of the PCCL microorganisms which
did not allowed for a uniform comparison among the PCCL pathogens.

       This protocol scores the  representative or common clinical presentation for the specific
pathogen for the population category under consideration.  Pathogens may produce a range of
illness from asymptomatic infection to fulminate illness  progressing rapidly to death. Scoring
decisions are based upon the more common clinical presentation and clinical course for the
population under consideration, rather than the extremes. EPA used recently published clinical
microbiology manuals as the data source for the common clinical presentation. These manuals
take a broad epidemiological view of health effects rather than focusing on narrow research
investigations  or single cases. The one exception to this  approach was EPA's scoring of the
health effects for Helicobacter pylori.

       Helicobacter pylori is a pathogen that causes gastric cancer in addition to acute gastric
ulcers. EPA placed this pathogen on the draft CCL. However, the analysis for//, pylori differs
from the other pathogens due to the long term and/or chronic nature of its health effects rather
than the more common acute  effects of most waterborne pathogens. This organism is an
emerging pathogen whose impact has only recently begun to be understood. Given the  slow
development of adverse health effects due to infection by H. pylori, it is more difficult to link
contamination of drinking water and show a waterborne disease outbreak.  Therefore, given the
long timeframe of cancer and ulcer development (as opposed to the commonly acute
gastrointestinal illness of nearly all the other pathogens on the PCCL) as well as the ongoing
nature of the research, EPA used peer-reviewed scientific papers to score the health effects of H.
pylori. The data used to score H. pylori is discussed in more detail in the appendix.

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
       To obtain a representative characterization of health effects in all populations, EPA
evaluated separately the general population and four sensitive populations (children, elderly,
pregnant woman and persons with chronic diseases) as to the common clinical presentation of
illness for that population. EPA added the general population score to the highest score among
the four sensitive subpopulations for an overall health effects score. The resulting score
acknowledges that sensitive populations have increased risk for waterborne diseases.
Exhibit 5.  Health Effects Scoring Protocol for Pathogens
Outcome Category
Does the organism cause
significant mortality (> 1/1,000
cases)?
Does the organism cause pneumonia,
meningitis, hepatitis, encephalitis,
endocarditis, cancer, or other severe
manifestations of illness necessitating
long term hospitalization
(> week)?
Does the illness result in long term
or permanent dysfunction or
disability (i.e., sequelae)?
Does the illness require short term
hospitalization
(
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EPA OGWDW                      Final CCL 3 Microbes.                       EPA 815-R-09-009
                                  PCCL to CCL Process                            August 2009


varies from high significance to low significance. The three attribute scores are then combined
into a total score (see formula and example calculation below).

       Pathogens are first scored using the WBDO and occurrence protocols, and then the
highest score is selected. Selection of the higher score from the WBDO or occurrence protocol
elevates pathogens that have been detected in drinking water or source water in the U.S.
(occurrence  score of 2 or 3) above pathogens that have caused WBDOs in other countries but not
in the U.S. (WBDO score of 2) or pathogens that have not caused WBDOs in any country but
have been epidemiologically associated with water-related disease (WBDO score of 1). This
scoring protocol recognizes the importance of WBDO data in evaluating the public health risk
posed by pathogens in drinking water, while ensuring that pathogens that have been detected in
public water systems and have not been identified as causative agents WBDOs remain in the
CCL process.

       Next, pathogens are scored using the health effects protocol. This protocol scores the
representative health effect characteristic of each pathogen for the general population,  e.g.,
noroviruses  characteristically cause gastrointestinal symptoms that are self-limiting within two
days in otherwise healthy adults. All five population categories are scored for each pathogen
using the most common clinical presentation for the specific pathogen for the population
category under consideration. The pathogen's score for the general population is added to the
highest score among the four sensitive populations to produce a sum score between 2 and 14.

       Finally, EPA normalizes the Health Effects  and WBDO/Occurrence score because the
Agency believes they are of equal importance. The highest possible score for
WBDO/Occurrence is 5 and the highest possible Health Effect score is 14. To equalize this
imbalance, the Agency multiplies the combined health effects score by 5/14.
   r, .,        Highest Score       _     ._    . ,,      Highest Sensitive
   Pathogen     °               General Population      °                _,..
  T .  ,,    = between WBDO            .           -   Subpopulation    x  5/14
  Total Score                           Score               '
             and Occurrence                             Score

Example: Calculation of Adenovirus Total Score

Adenovirus Total Score = 3 (Occurrence Score) + ((6 (General Population Score) + 4 (Children/CD)) x 5/14);
Adenovirus Total Score = 3 + 3.6;
Adenovirus Total Score = 6.6
                                            11

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Exhibit 6. WBDO, Occurrence and Health Effects Scores for PCCL pathogens

Pathogen
Naegleria fow leri
Legionella
pneumophila
Escherichia coli
(0157)
Shigella sonnei
Hepatitis A vims
Helicobacter pylori
Campylobacterjejuni
Salmonella enterica
Caliciviruses
Mycobacterium
avium
Adenovirus
Enteroviras
Arcobacter butzleri
Entamoeba
histolytica
Vibrio cholerae
Fusarium solani
Plesiomonas
shigelloides
Hepatitis E vims
Rotavirus
Yersinia
enterocolitica
Toxoplasma gondii
Aspergillus fumigatus
group
Exophialajeanselmei
Aeromonas
hydrophila
Cyclospora
Astrovirus
Microsporidia
Isospora belli
Blastocystis hominis
WBDO
4
5
5
5
5
1
5
5
5
4
2
2
4
4
4
1
4
2
2
4
2
1
1
1
1
2
1
2
1
Occur.
3
3
3
3
2
3
3
3
o
5
3
o
J
o
J
3
3
3
3
3
1
3
3
1
3
o
5
3
1
2
2
0
1
Health Effects
General
1
4
o
J
3
3
7
3
3
2
3
6
4
o
J
3
o
3
4
2
3
1
2
2
o
3
o
3
2
o
J
2
2
1
1
Child
1
4
6
6
3
3
4
4
4
3
4
6
3
3
3
4
3
3
6
2
2
3
3
3
4
2
2
2
1
Elderly
1
6
6
6
6
7
4
4
4
5
2
2
3
3
3
4
3
6
1
2
2
3
o
3
2
o
J
2
2
1
1
Pregnant
Women
7
4
o
J
3
3
3
3
3
2
3
2
2
o
J
3
o
3
4
2
7
1
2
7
o
3
o
3
2
o
J
2
2
1
1
Chronic
Disease
7
6
3
3
3
3
3
3
4
4
4
2
3
3
3
4
2
3
1
2
2
3
o
3
2
o
J
2
2
1
1
Normalized
Health
5.0
3.6
3.2
3.2
3.2
5.0
2.5
2.5
2.1
2.9
3.6
3.6
2.1
2.1
2.1
2.9
1.8
3.6
2.5
1.4
3.2
2.1
2.1
1.8
2.5
1.4
1.4
1.1
0.7

Total
Score
9.0
8.6
8.2
8.2
8.2
8.0
7.5
7.5
7.1
6.9
6.6
6.6
6.1
6.1
6.1
5.9
5.8
5.6
5.5
5.4
5.2
5.1
5.1
4.8
3.5
3.4
3.4
3.1
1.7
                                          12

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EPA OGWDW                       Final CCL 3 Microbes.                      EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009


4.0    Selecting the CCL from the Ranked PCCL

       The scoring system involves selecting a pathogen and completing three scoring protocols,
one protocol each for WBDOs and Occurrence, and one protocol for normal populations and
four sensitive populations (children, elderly, pregnant women, and persons with chronic
diseases). The higher of the WBDO score or the occurrence score is added to the normalized
health effects score to produce a composite pathogen score. This process results in a ranked list
of pathogens from which the Agency may select for placement on a CCL (see Exhibit 6).

       The scoring process developed by EPA discriminates between microbial drinking water
contaminants in a transparent and scientifically sound manner. The  weighing of occurrence and
health effects information closely mirrors the risk estimate methods used by EPA during
drinking water regulation development. This  scoring system will prioritize and restrict the
number of pathogens on a CCL to only those that have been strongly associated with water-
related diseases. Pathogens failing to meet these criteria will remain on the PCCL until additional
occurrence data, epidemiological  surveillance data, or health effects data support their
reevaluation.

        The 29 PCCL pathogens are ranked according to an equal weighting of their summed
scores for normalized health effects and the higher of the individual scores for WBDO and
occurrence in drinking water. EPA believes this ranking indicates the most important pathogens
to consider for the CCL 3. To determine which of the 29 PCCL pathogens should be the  highest
priority for EPA's drinking water program and included on the CCL 3, the Agency considered
both scientific and policy factors.  The factors included the PCCL scores for WBDO, occurrence,
and health effects; comments and recommendations from the various expert panels; the specific
intent of SOW A; and the need to focus Agency resources on pathogens to provide the most
effective opportunities to advance public health protection. After consideration of these factors,
EPA has determined that the CCL 3 will include the 12 highest ranked pathogens.

        Additionally, there are a few "natural" break points in the ranked scores for the 29
pathogens, with the top 12 forming the highest ranked group of pathogens. EPA believes that the
overall rankings strongly reflect the best available scientific data and high quality expert input
employed in the CCL selection process, and therefore should be important factors in helping to
identify the top priority pathogens for the draft CCL 3.
5.0    Scoring Data Sheets

       This section contains a scoring sheet for each of the pathogens on the PCCL. The scoring
sheets are arranged alphabetically by pathogen.

       A score for each protocol (WBDOs and occurrence, and health effects) is determined.
Bolded text in each protocol box indicates that is the protocol level that was scored for that
pathogen. For example, if the question "Detected in drinking water in the U.S.?" under the

                                           13

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EPA OGWDW                       Final CCL 3 Microbes.                       EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009


occurrence protocol is bolded then that organism received the associated occurrence score (i.e.,
3). The higher of the WBDO score or the occurrence score is added to the normalized health
effects score to produce a composite pathogen score. References for each scoring discussion are
provided. Health effects scoring involved scoring for each of the 5 populations: General (G),
Child/infants (C), Elderly (E), Pregnant Women (PW), and persons with Chronic Disease (CD).
                                            14

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                                Adenovirus Scoring Data
Scoring Summary
Occurrence
3
Health Effects
General population
Sensitive subpopulation(s) [CD, C]
6
4
Score2

5
4
3
2
1

3
2
Data Element
Scoring Data
Reference3
Waterborne Disease Outbreaks
Has caused multiple (2 or
more) documented WBDOs
in the U.S. as reported by
CDC surveillance between
1990 and 2004
Has caused at least one
documented WBDOs in the
U.S. as reported by CDC
surveillance between 1990
and 2004
Has caused documented
WBDOs at any time in the
U.S.?
Has caused WBDOs in
countries other than the
U.S.?
Has never caused WBDOs in
any country, but has been
epidemiologically associated
with water related disease?
No
No
No
Yes
Europe
N/A
CDC, 1991 -CDC,
2006
CDC, 1991 -CDC,
2006

Kukkula et al., 1997

Occurrence
Detected in drinking water
in the U.S.?
Detected in source water in
the U.S.?
Yes
PCR in connection with
an outbreak.
Yes
38% of surface water
samples collected as part
of the Information
Collection Rule contained
Adenovirus 40/41.
O'Reilly et al., 2007
Fong et al., 2007
USEPA, 2007
                                           15

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EPA OGWDW
                       Final CCL 3 Microbes.
                       PCCL to CCL Process
                                  EPA815-R-09-009
                                       August 2009
 Score
       Data Element
      Scoring Data
Reference
   1
Not detected in the U.S.?
N/A
                                         Health Effects
          Does the organism cause
          significant mortality (>
          1/1,000 cases)?
 6[G]
Does the organism cause
pneumonia, meningitis,
hepatitis, encephalitis,
endocarditis, cancer, or
other severe manifestations
of illness necessitating long
term hospitalization (>
week)?
[G] A frequent cause of
pneumonia among
(unvaccinated) military
recruits. Two deaths in
previously-healthy
adults.

ARD is still a significant
problem in military. Less
common manifestations
include fatal  neonatal
disease,
meningoencephalitis and
myocarditis.
                                                                 Gray et al., 2001
                                                                 Robinson in
                                                                 Murray, 2007
          Does the illness result in
          long term or permanent
          dysfunction or disability, i.e.
          sequelae?
                            None reported
 4[C,
 CD]
          Does the illness require
          short term hospitalization
          (< week)?
                             [CD] Children with
                             chronic disease required
                             respiratory ventilation.
                             [C] Young adults may
                             contract acute
                             respiratory disease.
                           CDC, 1983
                           CDC, 1998
          Does the illness require
          physician intervention?
                            Physician office visits are
                            indicated for ocular
                            infections.
                           Robinson in Murray,
                           2007
2 [E, P]
Is the illness self-limiting
within 72 hours (without
requiring medical
intervention)?
[E, P] Approximately 50%
of cases are asymptomatic,
symptomatic cases usually
present as upper
respiratory infections
similar to the common
cold.
    16
                                                                 Robinson in Murray,
                                                                 2007

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2
1
Data Element
Does the illness result in
mild symptoms with minimal
or no impact on daily
activities?
Scoring Data

Reference3

 See section 3.4 for a detailed description on how to calculate the total pathogen score.
2 Bolded Text indicates the highest score for that particular protocol. For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score. The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol: G-
General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
3EPA based the WBDO scores on the CDC MMWR reports from 1991 - 2006 and then
collected occurrence citations if there were no CDC WBDOs.  Two exceptions to this
WBDO scoring criteria are Arcobocter butzleri and Mycobacterium avium.
References
CDC, 1983.  Adenovirus type 7 outbreak in a pediatric chronic-care facility - Pennsylvania.
1972. MMWR, 1983:32;258-60.

CDC, 1998.  Civilian Outbreak of Adenovirus Acute Respiratory Disease - South Dakota, 1997.
MMWR 1998: 47(27);567-570.

CDC, 1991. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3); 1-21.

CDC, 1993. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1991—1992. MMWR Surveillance Summaries, 42(SS-5); 1-22.

CDC, 1996. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1993—1994. MMWR Surveillance Summaries, 45(SS-1); 1-33.

CDC, 1998. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5); 1-33.

CDC, 2000. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4); 1-35.

CDC, 2002. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1999—2000. MMWR Surveillance Summaries, 51(SS-8); 1-36.

CDC, 2004. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001—2002. MMWR Surveillance Summaries, 53(SS08); 23-45.

                                           17

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EPA OGWDW                      Final CCL 3 Microbes.                       EPA 815-R-09-009
                                  PCCL to CCL Process                            August 2009


CDC, 2006. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2003—2004. MMWR Surveillance Summaries, 55(SS12); 31-58.

Fong, T., L. Mansfield, D. Wilson, D. Schwab, S Molloy and J Rose. 2007. Massive
Microbiological Groundwater Contamination Associated with a Waterborne Outbreak in Lake
Erie, South Bass Island, OH. Environmental Health Perspectives.

Gray, G C, P R Goswami, M D Malasig, A W Hawksworth, D H Trump, M A Ryan and D P
Schnurr.  2001. Adult Adenovirus Infections: Loss of Orphaned Vaccines Precipitates Military
Respiratory Disease Epidemics. Clinical Infectious Diseases, 31: 663-70.
Kukkula, M., Arstila P., Klossner M.L., Maunula L., Bonsdorff C.H., and P. Jaatinen.  1997.
Scandinavian Journal of Infectious Disease, 29(4): 415-8.
O'Reilly, C.E.,  A.B. Bowen, E.P. Nytzia,  J.P. Sarisky, C.A. Shepherd, M.D. Miller,
B.C. Hubbard, M. Herring, S.D. Buchanan, C.C. Fitzgerald, V. Hill, M.J. Arrowood, L.X. Xiao,
R.M. Hoekstra, E.D. Mintz, M.F. Lynch, and the Outbreak Working Group. 2007. A
Waterborne Outbreak of Gastroenteritis with Multiple Etiologies among Resort Island Visitors
and Residents: Ohio, 2004. Clinical Infectious Diseases, 44:506-512.
http://www.journals.uchicago.edu/CID/journal/issues/v44n4/40825/40825.text.html -
fnl#fnlhttp://www.journals.uchicago.edu/CID/iournal/issues/v44n4/40825/40825.text.html-fn2#fn2
Robinson, C. and M. Echavarria. 2007. Adenoviruses. In Murray, P. R., E. J. Baron, J. H.
Jorgensen, M.L. Landry, and M. A. Pfaller (ed.) The Manual of Clinical Microbiology, 9th.
edition, American Society for Microbiology, Washington, DC. Vol. 2: p. 1592.
USEPA.  2007. Adenovirus Health and Criteria Document (Draft).
                                            18

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                          Aeromonas hydrophila Scoring Data
Scoring Summary
Occurrence
3
Health Effects
General population
Sensitive subpopulation(s) [C]
2
3
Score2

5
4
O
2
1

3
2
Data Element
Scoring Data
Reference3
Waterborne Disease Outbreaks
Has caused multiple (2 or more)
documented WBDOs in the
U.S. as reported by CDC
surveillance between 1990 and
2004?
Has caused at least one
documented WBDOs in the
U.S. as reported by CDC
surveillance between 1990 and
2004?
Has caused documented
WBDOs at any time in the
U.S.?
Has caused WBDOs in
countries other than the U.S.?
Has never caused WBDOs in
any country, but has been
epidemiologically associated
with water related disease?
No
No
No
No
Yes
CDC, 1991 -CDC, 2006
CDC, 1991 -CDC, 2006


Gavriel et al., 1998
Occurrence
Detected in drinking water in
the U.S.?
Detected in source water in the
U.S.?
Yes
EPA found A
hydrophila in the
distribution systems
of 42 Public Water
systems out of 293
systems tested.
Yes
EPA, 2006 and EPA,
2003
Holmes etal., 1996
EPA, 2006
                                          19

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 EPA OGWDW
                       Final CCL 3 Microbes.
                       PCCL to CCL Process
                               EPA815-R-09-009
                                    August 2009
  Score
        Data Element
    Scoring Data
Reference
     1
Not detected in the U.S.?
N/A
                                           Health Effects
            Does the organism cause
            significant mortality (> 1/1,000
            cases)?
                               Wound infections are
                               usually preceded by
                               injury that occurs in
                               contact with water.
                               These infections
                               range from cellulitis
                               to myronecrotic
                               infections with a poor
                               prognosis.
                      Horneman et al. in
                      Murray, 2007
            Does the organism cause
            pneumonia, meningitis,
            hepatitis, encephalitis,
            endocarditis, cancer, or other
            severe manifestations of illness
            necessitating long term
            hospitalization (> week)?
                               Septicemia occurs
                               rarely in
                               immunocompetent
                               hosts. Can cause
                               HUS.
                      Horneman et al. in
                      Murray, 2007
            Does the illness result in long
            term or permanent dysfunction
            or disability, i.e. sequelae?
            Does the illness require short
            term hospitalization (< week)?
  3[C]
            Does the illness require
            physician intervention?
                               [C] Children may
                               require
                               hopitalization due to
                               dehydration.
                      Horneman et al. in
                      Murray, 2007
2 [G, P, E,
   CD]
Is the illness self-limiting
within 72 hours (without
requiring medical
intervention)?
[G, P, E, CD] Acute
watery disease is the
most common form
as well as
abdominal pain,
vomiting, fever.
                                                                Horneman et al. in
                                                                Murray, 2007
            Does the illness result in mild
            symptoms with minimal or no
            impact on daily activities?
  See section 3.4 for a detailed description on how to calculate the total pathogen score.
                                           20

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EPA OGWDW                      Final CCL 3 Microbes.                      EPA 815-R-09-009
                                 PCCL to CCL Process                           August 2009


2 Bolded Text indicates the highest score for that particular protocol. For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score. The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol: G-
General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
3EPA based the WBDO scores on the CDC MMWR reports from 1991 - 2006 and then
collected occurrence citations if there were no CDC WBDOs.  Two exceptions to this
WBDO scoring criteria are Arcobacter butzleri and Mycobacterium avium.
References
CDC, 1991. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3); 1-21.

CDC, 1993. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1991—1992. MMWR Surveillance Summaries, 42(SS-5); 1-22.

CDC, 1996. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1993—1994. MMWR Surveillance Summaries, 45(SS-1); 1-33.

CDC, 1998. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5); 1-33.

CDC, 2000. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4); 1-35.

CDC, 2002. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1999—2000. MMWR Surveillance Summaries, 51(SS-8); 1-36.

CDC, 2004. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001—2002. MMWR Surveillance Summaries, 53(SS08); 23-45.

CDC, 2006. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2003— 2004. MMWR Surveillance Summaries, 55(SS12); 31-58.

EPA, 2003. Unpublished data on occurrence results from the Unregulated Contaminant
Monitoring Rule,  http://www.epa.gov/safewater/ucmr/data.html. See 70 FR 49094, August 22,
2005 for more information.

EPA. 2006.  Aeromonas: Human Health Criteria Document. Page 136.
http://www.epa.gov/waterscience/criteria/humanhealth/microbial/aeromonas-200603.pdf
Gavriel, A.A., J. P.B. Landre, and AJ. Lamb. 1998. Incidence of mesophilic Aeromonas within a
public drinking water supply in northeast Scotland. Journal of Applied Bacteriology 84: 383-
392.
                                          21

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EPA OGWDW                       Final CCL 3 Microbes.                      EPA 815-R-09-009
                                  PCCL to CCL Process                          August 2009


Holmes, P., L.M. Niccolls, and D.P. Sartory. 1996. The ecology of mesophilic Aeromonas in the
aquatic environment. In Austin, B., M. Altwegg, P. J. Gosling, and S. Joseph, ed. The Genus
Aeromonas. John Wiley & Sons, Chichester, UK.
Horneman, A., A. Ali and S. Abbott. 2007.  Aeromonas. In Murray, P. R., E. J. Baron, J. H.
Jorgensen, M.L. Landry, and M. A. Pfaller (ed.) The Manual of Clinical Microbiology, 9th.
edition, American Society for Microbiology, Washington, DC. Vol. 1: p. 717.
                                           22

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                             Arcobacter butzleri Scoring Data
Scoring Summary
Waterborne Disease Outbreak
4
Health Effects
General population
Sensitive subpopulation(s) [CD, C]
3
3
Score2

5
4
O
2
1

3
2
Data Element
Scoring Data
Reference3
Waterborne Disease Outbreaks
Has caused multiple (2 or
more) documented WBDOs
in the U.S. as reported by
CDC surveillance between
1990 and 2004?
Has caused at least one
documented WBDOs in
the U.S. as reported by
CDC surveillance between
1990 and 2004?
Has caused documented
WBDOs at any time in the
U.S.?
Has caused WBDOs in
countries other than the
U.S.?
Has never caused WBDOs
in any country, but has been
epidemiologically associated
with water related disease?
No
Yes
Not listed in CDC's
MMWR, however,
linked to outbreak
and drinking water.
Symptom severity also
suggests Arcobacter.
N/A
N/A
N/A
CDC, 1991 -CDC,
2006
Fong et al., 2007



Occurrence
Detected in drinking water
in the U.S.?
Detected in source water in
the U.S.?
Yes
Yes
Arcobacter butzleri was
isolated from ground
water in Idaho after a
WBDO.
Fong et al., 2007
Riceetal., 1999
                                           23

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2
1


7







6







5



4






3 [G, C, P, E,
CD]
v^l^J






2


Data Element
Not detected in the U.S.?
Scoring Data
N/A
Reference3

Health Effects
Does the organism cause
significant mortality (>
1/1,000 cases)?
Does the organism cause
pneumonia, meningitis,
hepatitis, encephalitis,
endocarditis, cancer, or other
severe manifestations of
illness necessitating long
term hospitalization (>
week)?





Does the illness result in
long term or permanent
dysfunction or disability, i.e.
sequelae?
Does the illness require short
term hospitalization (<
week)?
Does the illness require
physician intervention?









Is the illness self-limiting
within 72 hours (without
requiring medical
intervention)?

Unknown


Persons with
underlying disease such
as liver disease,
cirrhosis, or alcoholism
may be at increased
risk of complications.

Has been isolated from
patients with
bacteremia,
endocarditis, peritonitis
and diarrhea. Clinical
significance unknown.







[All populations]
Displays clinical
features similar to
Campylobacter jejuni,
however is more
frequently associated
with a persistent
diarrhea. Twenty six
percent of Belgian
patients required
antibiotics.
Usual symptoms are
diarrhea, abdominal
pain, vomiting, and
nausea resolving in < 3
days.



Hsuehetal., 1997
Lerneretal., 1994
Yan et al., 2000




Fitzgerald in Murray,
2007











Vandenberg et al.,
2004









Wybo et al., 2004
Riceetal., 1999



                                             24

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2
1
Data Element
Does the illness result in
mild symptoms with
minimal or no impact on
daily activities?
Scoring Data

Reference3

 See section 3.4 for a detailed description on how to calculate the total pathogen score.
2 Bolded Text indicates the highest score for that particular protocol. For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score. The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol: G-
General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
3EPA based the WBDO scores on the CDC MMWR reports from 1991 - 2006 and then
collected occurrence citations if there were no CDC WBDOs.  Two exceptions to this
WBDO scoring criteria are Arcobocter butzleri and Mycobacterium avium.
References
CDC, 1991. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3); 1-21.

CDC, 1993. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1991—1992. MMWR Surveillance Summaries, 42(SS-5); 1-22.

CDC, 1996. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1993—1994. MMWR Surveillance Summaries, 45(SS-1); 1-33.

CDC, 1998. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5); 1-33.

CDC, 2000. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4); 1-35.

CDC, 2002. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1999—2000. MMWR Surveillance Summaries, 51(SS-8); 1-36.

CDC, 2004. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001—2002. MMWR Surveillance Summaries, 53(SS08); 23-45.

CDC, 2006. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2003—2004. MMWR Surveillance Summaries, 55(SS12); 31-58.
Fitzgerald, C. and I. Nachamkin. 2007.  Campylobacter and Arcobacter. In Murray, P. R., E. J.
                                          25

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EPA  OGWDW                      Final CCL 3 Microbes.                       EPA 815-R-09-009
                                  PCCL to CCL Process                            August 2009


Baron, J. H. Jorgensen, M.L. Landry, and M. A. Pfaller (ed.) The Manual of Clinical
Microbiology, 9th. edition, American Society for Microbiology, Washington, DC. Vol. 1: pp.
933 -935.
Fong, T., L. Mansfield, D. Wilson, D. Schwab, S Molloy and J Rose. 2007. Massive
Microbiological Groundwater Contamination Associated with a Waterborne Outbreak in Lake
Erie, South Bass Island, OH. Environmental Health Perspectives.
Houf, K., L. A. Devriese, et al. 2001. Susceptibility ofArcobacter butzleri, Arcobacter
cryaerophilus, and Arcobacter skirrowii to antimicrobial agents used in selective media. Journal
of Clinical Microbiology 39(4): 1654-1656.
Hsueh, P.R., LJ. Teng, et al.. 1997. Bacteremia caused by Arcobacter cryaerophilus IB. Journal
of Clinical Microbiology 35(2): 489-491.
Lerner, J., V. Brumberger, et al.. 1994. Severe diarrhea associated with Arcobacter butzleri.
European Journal of Clinical Microbiology & Infectious Diseases 13(8): 660-662.
Rice, E.W.,  M.R. Rodgers, IV. Wesley, C.H. Johnson, and S.A. Tanner. 1999. Isolaton of
Arcobacter butzleri from ground water. Lett. Appl. Microbiol. 28: 31-35.
Vandenberg, O., A. Dediste, K. Houg,  S. Ibekwen, H. Souayah, S. Cadranel, N. Douat, G. Zissis,
J. Butzler and P. Vandamme.  2004.  Arcobacter Species in Humans. Emerging Infectious
Diseases. Vol.  10, No. 10, page 1863,  October 2004.
Wybo, I, J.  Breynaert, et al.. (2004). Isolation of Arcobacter skirrowii from a patient with
chronic diarrhea. Journal of Clinical Microbiology 42(4): 1851-1852.
Yan, J.J., W.C. Ko, et al.. (2000). Arcobacter butzleri bacteremia in a patient with liver cirrhosis.
Journal of the Formosan Medical Association 99(2): 166-169.
                                           26

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                           Aspergillus fumigatus Scoring Data
Scoring Summary
Occurrence
3
Health Effects
General population
Sensitive subpopulation(s) [C, P, E, CD]
3
3
Score2

5
4
3
2
1

3
Data Element
Scoring Data
Reference3
Waterborne Disease Outbreaks
Has caused multiple (2 or
more) documented
WBDOsintheU.S. as
reported by CDC
surveillance between 1990
and 2004?
Has caused at least one
documented WBDOs in
the U.S. as reported by
CDC surveillance between
1990 and 2004?
Has caused documented
WBDOs at any time in the
U.S.?
Has caused WBDOs in
countries other than the
U.S.?
Has never caused
WBDOs in any country,
but has been
epidemiologically
associated with water
related disease?
No
No
No
No
Yes
Study on two bone
marrow transplantation
units at a Little Rock,
AR hospital.
CDC, 1991 -CDC,
2006



Anaissie et al., 2002
Anaissie et al., 2003
Warris et al., 2003
Occurrence
Detected in drinking
water in the U.S.?
Yes
Anaissie et al., 2002
Anaissie et al., 2003
Nagy and Olson,
1982
Rosenzweig et al.,
1986
                                            27

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2


7
^
1





7













6









5
^}

Data Element


Detected in source water in
the U.S.?
Not detected in the U.S.?
Scoring Data


Yes

N/A
Reference3
Doggett, 2000
Vesper et al., 2007
Nagy and Olson, 1982


Health Effects
Does the organism cause
significant mortality (>
1/1,000 cases)?





Does the organism cause
pneumonia, meningitis,
hepatitis, encephalitis,
endocarditis, cancer, or
other severe manifestations
of illness necessitating
long term hospitalization
(> week)?











Does the illness result in
long term or permanent
dysfunction or disability,
i.e. sequelae?
Invasive infections
caused by Aspergillus
species are associated
with high rates of
morbidity and mortality,
especially in
immunosuppressed
patients.
Sporadic cases of
invasive aspergillosis
have been reported in
immunocompetent hosts
(chronic meningitis,
endocarditis, pericarditis,
osteomyelitys).

Invasive aspergillosis is
primarily an infection of
severely
immunocompromi sed
patients.
Serious infection can also
occur in patients with
more modest
impairments of host
immune system such as
diabetics.
None reported.



Verweij and Brandt in
Murray, 2007






Bodey and
Vartivarian, 1989











Nagy and Olson, 1982









                                             28

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2
4
3 [G, C, P, E,
CD]
2
1
Data Element
Does the illness require
short term hospitalization
(< week)?
Does the illness require
physician intervention?
Is the illness self-limiting
within 72 hours (without
requiring medical
intervention)?
Does the illness result in
mild symptoms with
minimal or no impact on
daily activities?
Scoring Data
Requirement for
hospitalization depends
upon the manifestation of
disease (e.g., superficial
skin and ear infections do
not require
hospitalization).
[All populations] Most
infections and allergies
caused by this organism
require physician
intervention.

Aspergillus spores are
allergens and persons
who become sensitized
experience symptoms of
allergy and asthma.
Reference3
Bodey and
Vartivarian, 1989
Bodey and
Vartivarian, 1989

Horneretal., 1995
 See section 3.4 for a detailed description on how to calculate the total pathogen score.
2 Bolded Text indicates the highest score for that particular protocol. For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score. The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol: G-
General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
3EPA based the WBDO scores on the CDC MMWR reports from 1991 - 2006 and then
collected occurrence citations if there were no CDC WBDOs. Two exceptions to this
WBDO scoring criteria are Arcobacter butzleri and Mycobacterium avium.
References
Anaissie, E. J., S.L. Stratton, M.C. Dignani, R.C. Summerbell, J.H. Rex, T.P. Monson, T.
Spencer, M, Kasai, A. Francesconi, and TJ. Walsh. 2002. Pathogenic Aspergillus species
recovered from a hospital water system: a 3-year prospectie study. Clin. Infect. Dis. 34: 780-789.
                                          29

-------
EPA OGWDW                      Final CCL 3 Microbes.                      EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009


Anaissie, E.J., S.L. Stratton, M.C. Dignani, C. Lee, R.C. Summerbell, J.H. Rex, T.P. Monson,
and TJ. Walsh. 2003.  Pathogenic molds (including Aspergillus species) in hospital water
distribution systems: a 3-year prospective study and clinical implications for patients with
hematologic malignancies. Blood, 101(7): 2542-2546.
Bodey, G. P. and S. Vartivarian. 1989. Aspergillosis. Eur. J. Clin. Microbiol. Infect. Dis. 8(5):
413-437.
CDC, 1991. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3); 1-21.

CDC, 1993. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1991—1992. MMWR Surveillance Summaries, 42(SS-5); 1-22.

CDC, 1996. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1993—1994. MMWR Surveillance Summaries, 45(SS-1); 1-33.

CDC, 1998. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5); 1-33.

CDC, 2000. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4); 1-35.

CDC, 2002. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1999—2000. MMWR Surveillance Summaries, 51(SS-8); 1-36.

CDC, 2004. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001—2002. MMWR Surveillance Summaries, 53(SS08); 23-45.

CDC, 2006. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2003—2004. MMWR Surveillance Summaries, 55(SS12); 31-58.
Doggett, M.S. 2000. Characterization of fungal biofilms within a municipal water distribution
system. Appl. Environ. Microbiol. 66(3): 1249-1251.
Horner, W.E., A. Helbling, I.E. Salvaggio, and S.B. Lehrer. 1995. Fungal allergens. Clin.
Microbiol. Rev. 8(2): 161-179.
Nagy, L.A. and B.H. Olson. 1982. The occurrence of filamentous fungi in drinking water
distribution systems. Can. J. Microbiol. 28: 667-671.
Rosenzweig W.D., H . Minnigh, and W.O. Pipes. 1986. Fungi in potable water distribution
systems. JAWWA 78(1): 53-55.
Verweij, P.E. and M.E. Brandt. 2007. Aspergillus, Fusarium, and Other Opportunistic
Moniliaceous Fungi. In Murray,  P. R., E. J. Baron, J. H. Jorgensen, M. L. Landry and M. A.
Pfaller (ed.) Manual of Clinical Microbiology, 9th. edition, American  Society for Microbiology,
Washington, DC (Vol. 2). pp. 1804-1818.
Vesper, S.J., M.E. Rogers, A.N. Neely and R.A. Haugland.  2007.  Opportunistic Aspergillus
                                           30

-------
EPA OGWDW                       Final CCL 3 Microbes.                      EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009


pathogens measured in homeand hospital tap water by quantitative PCR (QPCR). Journal of
Water and Health 5(3): 427-431.

Warris, A., C.H. W. Klassen, J.F.G.M. Meis, M.T. de Ruiter, H.A. de Valk, T.G. Abrahamsen, P.
Gaustaad, and P.E. Verweij. 2003. Molecular epidemiology of Aspergillus fumigatus isolates
recovered from  water, air, and patients shows two clusters of genetically distinct strains. J. Clin.
Microbiol. 41(9): 4101-4106.
                                           31

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                                 Astrovirus Scoring Data
Scoring Summary
Waterborne Disease Outbreak
2
Health Effects
General population
Sensitive subpopulation(s) [C, P, E, CD]
2
2
Score2

5
4
3
2
1

3
2
1
Data Element
Scoring Data
Reference3
Waterborne Disease Outbreaks
Has caused multiple (2 or
more) documented WBDOs
in the U.S. as reported by
CDC surveillance between
1990 and 2004?
Has caused at least one
documented WBDOs in the
U.S. as reported by CDC
surveillance between 1990
and 2004?
Has caused documented
WBDOs at any time in the
U.S.?
Has caused WBDOs in
countries other than the
U.S.?
Has never caused WBDOs in
any country, but has been
epidemiologically associated
with water related disease?
No
No
No
Yes
England and Wales
Yes
CDC, 1991 -CDC,
2006
CDC, 1991 -CDC,
2006

Smith et al., 2006
Gofti-Laroche et al.,
2003
Occurrence
Detected in drinking water in
the U.S.?
Detected in source water in
the U.S.?
Not detected in the U.S.?
No
Yes
Astrovirus was
detected in 15 of 29
samples collected
under the
Information
Collection Rule.


Chapron et al., 2000

                                            32

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2

7
6
5
4
O
2[G,C,P,E,
CD]
1
Data Element
Scoring Data
Reference3
Health Effects
Does the organism cause
significant mortality (>
1/1,000 cases)?
Does the organism cause
pneumonia, meningitis,
hepatitis, encephalitis,
endocarditis, cancer, or other
severe manifestations of
illness necessitating long
term hospitalization (>
week)?
Does the illness result in long
term or permanent
dysfunction or disability, i.e.
sequelae?
Does the illness require short
term hospitalization (<
week)?
Does the illness require
physician intervention?
Is the illness self-limiting
within 72 hours (without
requiring medical
intervention)?
Does the illness result in mild
symptoms with minimal or
no impact on daily activities?
No
No
No
No
No
[All populations]
Asymptomatic
infections common.
Moderate self-
limiting
gastroenteritis
(vomiting and
diarrhea).






Farkas in Murray,
2007

 See section 3.4 for a detailed description on how to calculate the total pathogen score.
2 Bolded Text indicates the highest score for that particular protocol. For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score.  The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol: G-
General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
3EPA based the WBDO scores  on the CDC MMWR reports from 1991 - 2006 and then
collected occurrence citations if there were no CDC WBDOs.  Two exceptions to this
                                         33

-------
EPA OGWDW                       Final CCL 3 Microbes.                       EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009


WBDO scoring criteria are Arcobacter butzleri and Mycobacterium avium.
References
CDC, 1991.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3); 1-21.

CDC, 1993.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1991—1992. MMWR Surveillance Summaries, 42(SS-5); 1-22.

CDC, 1996.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1993—1994. MMWR Surveillance Summaries, 45(SS-1); 1-33.

CDC, 1998.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5); 1-33.

CDC, 2000.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4); 1-35.

CDC, 2002.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1999—2000. MMWR Surveillance Summaries, 51(SS-8); 1-36.

CDC, 2004.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001—2002. MMWR Surveillance Summaries, 53(SS08); 23-45.

CDC, 2006.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2003—2004. MMWR Surveillance Summaries, 55(SS12); 31-58.

Chapron, C.D., N.A. Ballester, J.H. Fontaine, C.N. Frades, and A.B. Margolin. 2000. Detection
of astroviruses, enteroviruses, and adnovirus types 40 and 41 in surface waters collected and
evaluated by the information collection rule and an integrated cell culture-nested PCR procedure.
Appl. Environ. Microbiol. 66(6): 2520-2525.


Farkas, T. and X. Jiang.  2007. Rotaviruses, Caliciviruses, Astroviruses, Enteric Adenoviruses,
and Other Diarrheic Viruses. In Murray, P. R., E. J. Baron, J. H. Jorgensen, M. A. Pfaller, and
R. H Yolken (ed.) The Manual of Clinical Microbiology, 9th edition, American Society for
Microbiology, Washington, DC Vol. 2; pp.  1454-1457.
Gofti-Laroche, L., B. Gratacap-Cavallier, D. Demanse, O. Genoulaz, J-M. Segneurin, and d.
Zmirou. 2003. Are waterborne astrovirus implicated in acute digestive morbidity (E.M.I.R. A.
study)? J. Clin. Virol. 27: 74-82.
Smith, A., M. Reacher, W. Smerdon, G.K. Adak, G. Nichols and R.M. Chalmers.  2006.
Oubreaks of waterborne  infectious intestinal disease in England and Wales, 1992-2003.
Epidemiol. Infect. 134(6): 1141-1149.
                                           34

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                            Blastocystis hominis Scoring Data
Scoring Summary
Waterborne Disease Outbreak
1
Health Effects
General population
Sensitive subpopulation(s) [C, P, E, CD]
1
1
Score2

5
4
3
2
1

3
2
1

7
Data Element
Scoring Data
Reference3
Waterborne Disease Outbreaks
Has caused multiple (2 or
more) documented
WBDOsintheU.S. as
reported by CDC
surveillance between 1990
and 2004?
Has caused at least one
documented WBDOs in
the U.S. as reported by
CDC surveillance between
1990 and 2004?
Has caused documented
WBDOs at any time in the
U.S.?
Has caused WBDOs in
countries other than the
U.S.?
Has never caused
WBDOs in any country,
but has been
epidemiologically
associated with water
related disease?
No
No
No
No
Yes
Drinking untreated water
has been associated with
infection.
CDC, 1991 -CDC,
2006
CDC, 1991 -CDC,
2006


Leelayoova et al.,
2004
Stenzel and Boreham,
1996
Taamasri et al., 2000
Occurrence
Detected in drinking water
in the U.S.?
Detected in source water
in the U.S.?
Not detected in the U.S.?
No
No
Yes


Karanis, 2006
Health Effects
Does the organism cause
No

                                           35

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
    August 2009
Score2

6
5
4
3
2
1 [G, C, P,
E,CD]
Data Element
significant mortality (>
1/1,000 cases)?
Does the organism cause
pneumonia, meningitis,
hepatitis, encephalitis,
endocarditis, cancer, or
other severe
manifestations of illness
necessitating long term
hospitalization (> week)?
Does the illness result in
long term or permanent
dysfunction or disability,
i.e. sequelae?
Does the illness require
short term hospitalization
(< week)?
Does the illness require
physician intervention?
Is the illness self-limiting
within 72 hours (without
requiring medical
intervention)?
Does the illness result in
mild symptoms with
minimal or no impact on
daily activities?
Scoring Data

No
No
No
No
Symptoms may be more
pronounced and prolonged
in immunocompromised;
neoplasia and abnormal
intestinal tract function.
[All populations]
Pathogenicity of B.
hominis is controversial.
Symptoms may include
diarrhea, vomiting and
abdominal pain.
Reference3





Leber in Murray, 2007
Leber in Murray,
2007
 See section 3.4 for a detailed description on how to calculate the total pathogen score.
2 Bolded Text indicates the highest score for that particular protocol. For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score.  The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol: G-
General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
3EPA based the WBDO scores  on the CDC MMWR reports from 1991 - 2006 and then
collected occurrence citations if there were no CDC WBDOs. Two exceptions to this
WBDO scoring criteria are Arcobocter butzleri and Mycobacterium avium.
                                         36

-------
EPA OGWDW                       Final CCL 3 Microbes.                       EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009
References
CDC, 1991.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3); 1-21.

CDC, 1993.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1991—1992. MMWR Surveillance Summaries, 42(SS-5); 1-22.

CDC, 1996.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1993—1994. MMWR Surveillance Summaries, 45(SS-1); 1-33.

CDC, 1998.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5); 1-33.

CDC, 2000.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4); 1-35.

CDC, 2002.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1999—2000. MMWR Surveillance Summaries, 51(SS-8); 1-36.

CDC, 2004.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001—2002. MMWR Surveillance Summaries, 53(SS08); 23-45.

CDC, 2006.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2003—2004. MMWR Surveillance Summaries, 55(SS12); 31-58.
Karanis P. 2006 A review of an emerging waterborne medical important parasitic protozoan.
Jpn. J Protozool. Vol 39(1).
Leber, A. and S. Novak-weekley. 2007 Intestinal and Urogenital Amebae, Flagellates, and
Ciliates. In Murray, P. R., E. J. Baron, J. H. Jorgensen, M.L. Landry, and M. A. Pfaller (ed.) The
Manual of Clinical Microbiology, 9th. edition, American Society for Microbiology, Washington,
DC. Vol. 2: pp.  2097-2099.
Leelayoova, S.,  R. Rangsin, P. Taamasri, T. Naaglor, U. Thathaisong, and M. Mungthin. 2004.
Evidence of waterborne transmission of Blastocystis hominis. American Journal of Tropical
Medicine & Hygiene 70(6): 658-662.
Stenzel, D.J., and P.P. Boreham. 1996. Blastocystis hominis revisited. Clinical Microbiology
Reviews 9(4): 563-584.
Taamasri, P., M. Mungthin, R. Rangsin, B. Tongupprakarn, W. Areekul, and S. Leelayoova.
2000. Transmission of intestinal blastocystosis related to the quality of drinking water. Southeast
Asian Journal of Tropical Medicine & Public Health 31(1):  112-117.
                                           37

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                                 Calicivirus Scoring Data
Scoring Summary
Waterborne Disease Outbreak
5
Health Effects
General population
Sensitive subpopulation(s) [C, E, CD]
2
4
Score2


5




4


3

2


1

Data Element
Scoring Data
Reference3
Waterborne Disease Outbreaks
Has caused multiple (2
or more) documented
WBDOs in the U.S. as
reported by CDC
surveillance between
1990 and 2004


Has caused at least one
documented WBDOs in
the U.S. as reported by
CDC surveillance
between 1990 and 2004
Has caused documented
WBDOs at any time in
the U.S.?
Has caused WBDOs in
countries other than the
U.S.?
Has never caused
WBDOs in any country,
but has been
epidemiologically
associated with water
Yes
1 (Norwalk) Community
outbreak (Previously
unreported)
4 (Norwalk)
Noncommunity (1
Previously unreported)
5 (Norovirus)
Noncommunity
1 (Norovirus) Community
(1 Previously unreported)
2 (Norovirus)
Noncommunity
N/A



N/A

N/A


N/A


CDC, 2000
CDC, 2002
CDC, 2004
CDC, 2006












                                            38

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2


3
2
1

7
6
5
4 [C, E, CD]
Data Element
related disease?
Scoring Data

Reference3

Occurrence
Detected in drinking
water in the U.S.?
Detected in source
water in the U.S.?
Not detected in the
U.S.?
Yes
Detection by PCR.
Yes
Detected in ground water by
PCR.
N/A
Huffman et al., 2003
Borchardt et al., 2003
Fout et al., 2003

Health Effects
Does the organism
cause significant
mortality (> 1/1,000
cases)?
Does the organism
cause pneumonia,
meningitis, hepatitis,
encephalitis,
endocarditis, cancer, or
other severe
manifestations of illness
necessitating long term
hospitalization (>
week)?
Does the illness result
in long term or
permanent dysfunction
or disability, i.e.
sequelae?
Does the illness
require short term
hospitalization (<
week)?

No long term sequelae have
been reported.
No
[E, CD] (Norwalk)
Although rare, severe
dehydration can be fatal,
with this outcome
occurring among
susceptible persons (e.g.,
older persons with
debilitating health
conditions).
[C] Sappoviruses cause
disease mainly in children.

CDC, 2001
CDC, 2001
CDC, 2001
Farkas in Murray,
2007
                                             39

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2
O
2 [G, P]
1
Data Element
Does the illness require
physician intervention?
Is the illness self-
limiting within 72
hours (without
requiring medical
intervention)?
Does the illness result
in mild symptoms with
minimal or no impact
on daily activities?
Scoring Data

[G, P] Acute
gastroenteritis. Highly
contagious, able to cause
large outbreaks and
environmentally stable.

Reference3

Farkas in Murray,
2007

 See section 3.4 for a detailed description on how to calculate the total pathogen score.
2 Bolded Text indicates the highest score for that particular protocol.  For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score. The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol: G-
General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
3EPA based the WBDO scores on the CDC MMWR reports from 1991 - 2006 and then
collected occurrence citations if there were no CDC WBDOs.  Two exceptions to this
WBDO scoring criteria are Arcobacter butzleri and Mycobacterium avium.
References
Borchardt, M.A., P.O. Bertz, S.K. Spencer, andD.A. Battigelli. 2003. Incidence of enteric
viruses in groundwater from household wells in Wisconsin. Appl. Environ. Micro 69: 1172-
1180.

CDC, 1991. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water •
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3); 1-21.

CDC, 1993. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water •
United States, 1991—1992. MMWR Surveillance Summaries, 42(SS-5); 1-22.

CDC, 1996. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water •
United States, 1993—1994. MMWR Surveillance Summaries, 45(SS-1); 1-33.

CDC, 1998. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water •
United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5); 1-33.

CDC, 2000. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water •
United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4); 1-35.
                                          40

-------
EPA OGWDW                       Final CCL 3 Microbes.                       EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009


CDC. 2001 Norwalk-like viruses: Public health consequences and outbreak management.
MMWR50(RR-9):1-18.

CDC, 2002. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1999—2000. MMWR Surveillance Summaries, 51(SS-8); 1-36.

CDC. 2003. Managing acute gastroenteritis among children. MMWR 52(RR-16):1-16.

CDC, 2004. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001—2002. MMWR Surveillance Summaries, 53(SS08); 23-45.

CDC, 2006. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2003—2004. MMWR Surveillance Summaries, 55(SS12); 31-58.

Farkas, T. and X. Jiang.  2007. Rotaviruses, Caliciviruses, Astroviruses, Enteric Adenoviruses,
and Other Diarrheic Viruses. In Murray, P. R., E. J. Baron, J. H. Jorgensen, M. A. Pfaller, and
R. H Yolken (ed.) The Manual of Clinical Microbiology, 9* edition, American Society for
Microbiology, Washington, DC Vol. 2; pp.  1454-1457.

Fout, G.S., B.C. Martinson, M.W. Moyer, and D.R. Dahling. 2003. A multiplex reverse
transcription-PCR method for detection of human enteric viruses in groundwater. Appl. Environ.
Microbiol. 69: 3158-3164.

Huffman, D.E., K.L. Nelson, and J.B. Rose. 2003. Calicivirus - an emerging contaminant in
water: state of the art. Environ. Engr. Sci. 20:  503-515.
                                           41

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                           Campylobacter jejuni Scoring Data
Scoring Summary
Waterborne Disease Outbreak
5
Health Effects
General population
Sensitive subpopulation(s) [C, E]
3
4
Score2

5




4



3

2



1


3
Data Element
Scoring Data
Reference3
Waterborne Disease Outbreaks
Has caused multiple (2
or more) documented
WBDOs in the U.S. as
reported by CDC
surveillance between
1990 and 2004?


Has caused at least one
documented WBDOs in
the U.S. as reported by
CDC surveillance
between 1990 and
2004?
Has caused documented
WBDOs at any time in
the U.S.?
Has caused WBDOs in
countries other than the
U.S.?
Has never caused
WBDOs in any country,
but has been
epidemiologically
associated with water
related disease?
Yes
2 Noncommunity
1 Community
2 Noncommunity
1 Noncommunity
2 Noncommunity
2 Community (1
Previously unreported)
N/A




N/A

Yes
Finland

N/A



CDC, 1996
CDC, 2002
CDC, 2004
CDC, 2006








Kuusi, 2005





Occurrence
Detected in drinking
Yes
Sacks et al., 1986
                                           42

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2

2
1

7
6
5
Data Element
water in the U.S.?
Detected in source water
in the U.S.?
Not detected in the
U.S.?
Scoring Data

Yes
N/A
Reference3
O'Reilly, 2007
Carter etal., 1987

Health Effects
Does the organism
cause significant
mortality (> 1/1,000
cases)?
Does the organism
cause pneumonia,
meningitis, hepatitis,
encephalitis,
endocarditis, cancer, or
other severe
manifestations of illness
necessitating long term
hospitalization (>
week)?
Does the illness result in
long term or permanent
dysfunction or
disability, i.e. sequelae?
Death is uncommon.
Complications include
hepatitis, bacteremia
cholecystitis, pancreatitis,
nephritis, abortion and
neonatal sepsis, urinary tract
infection, meningitis and
septic arthritis. Bacteremia
occurs in 0.15% of
intestinal infections with
elderly mostly affected.
N/A
Fitzgerald in Murray,
2007
Fitzgerald in Murray,
2007

                                             43

-------
 EPA OGWDW
               Final CCL 3 Microbes.
               PCCL to CCL Process
                            EPA815-R-09-009
                                 August 2009
   Score
Data Element
Scoring Data
Reference
              Does the illness require
              short term
              hospitalization (<
              week)?
  4 [C, E]
                    [C,E] Most cases do not
                    require hospitalization,
                    pediatric cases and elderly
                    are more likely to require
                    hospitalization than
                    normal adult cases.

                    The highest incidence is in
                    children and infants.

                    Bacteremia occurs at 1.5
                    per 1,000 cases with the
                    highest rate occurring in
                    the elderly.
                     Fitzgerald in
                     Murray, 2007
              Does the illness require
              physician
              intervention?
3 [G, P, CD]
                    [G, P, CD] Guillain-Barre
                    syndrome, reactive
                    arthritis.
                    Guillain-Barre 1/1000
                    cases.
                    Reactive arthritis 1/100
                    cases.
                     Fitzgerald in
                     Murray, 2007

                     Altekruse et al., 1999
              Is the illness self-
              limiting within 72 hours
              (without requiring
              medical intervention)?
                   Duration 2-5 days, usually
                   self-limiting.
                   Several days to more than 1
                   week, self-limiting, relapse
                   in 5-10% cases.
                     Heymann, 2005

                     Fitzgerald in Murray,
                     2007
              Does the illness result in
              mild symptoms with
              minimal or no impact on
              daily activities?
                   Asymptomatic to acute
                   diarrhea, abdominal pain,
                   malaise, and fever.
                     Fitzgerald in Murray,
                     2007
 See section 3.4 for a detailed description on how to calculate the total pathogen score.
 2 Bolded Text indicates the highest score for that particular protocol.  For the health effects
 protocol two scores were selected: the general population [G] and the highest score for a
 sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
 for a final health effects  score.  The higher score between the WBDO and Occurrence
 protocols was used for total pathogen score calculation. Health Effects protocol: G-
 General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
 3EPA based the WBDO scores  on the CDC MMWR reports from 1991 - 2006 and then
 collected occurrence citations if there were no CDC WBDOs.  Two exceptions to this
 WBDO scoring criteria are Arcobocter butzleri and Mycobacterium avium.
                                          44

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EPA OGWDW                       Final CCL 3 Microbes.                       EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009


References
Altekruse, S.F., NJ. Stern, P.I. Fields, and D.L. Swerdlow.  1999.  Campylobacter jejuni - An
Emerging Foodborne Pathogen.  Emerging Infectious Diseases 5(1).
Carter, A. M., R. E. Pacha, G. W. Colark, and E. A. Williams. 1987. Seasonal occurrence of
Campylobacter spp. in surface waters and thieir correlation with standard indicator bacteria.
Appl. Environ. Microbiol. 53(3): 523-526.
CDC, 1991. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3); 1-21.

CDC, 1993. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1991—1992. MMWR Surveillance Summaries, 42(SS-5); 1-22.

CDC, 1996. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1993—1994. MMWR Surveillance Summaries, 45(SS-1); 1-33.

CDC, 1998. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5); 1-33.

CDC, 2000. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4); 1-35.


CDC, 2002. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1999—2000. MMWR Surveillance Summaries, 51(SS-8); 1-36.
CDC, 2004. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001— 2002. MMWR Surveillance Summaries, 53(SS08); 23-45.

CDC, 2006. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2003—2004. MMWR Surveillance Summaries, 55(SS12); 31-58.
Heymann, D. (ed.). 2005. Control of Communicable Diseases Manual,  18* ed. American Public
Health Association, Washington, DC.
Kuusi, M., J.P. Nuorti, M.L. Hanninen, M. Koskela, V. Jussila, E. Kela, I. Miettinen, P. Ruutu.
A large outbreak of campylobacteriosis associated with a municipal water supply in Finland.
Epidemiol Infect. 2005 Aug; 133(4): 593-601
Fitzgerald, C. and I. Nachamkin. 2007. Campylobacter and Arcobacter. In Murray, P. R., E. J.
Baron, J. H. Jorgensen, M.L. Landry, and M. A. Pfaller (ed.) The Manual of Clinical
Microbiology, 9th. edition, American Society for Microbiology,  Washington, DC. Vol.  1: pp.
933 -935.
O'Reilly, C.E., A.B. Bowen, N.E. Perez, J.P. Sarisky, C.A. Shepherd, M.D. Miller, B.C.
Hubbard, M. Herring, S.D. Buchanan, C.C. Fitzgerald, V. Hill, M.J. Arrowood, L.X. Xiao, R.M.
Hoekstra, E.D. Mintz, F. Lynch, and Outbreak Working Group.  2007.  A Waterborne Outbreak

                                           45

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EPA OGWDW                      Final CCL 3 Microbes.                       EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009


of Gastroenteritis with Multiple Etiologies among Resort Island Visitors and Residents: Ohio,
2004. Clinical Infectious Diseases. 44(4): 506-512.
Sacks, J.J., S. Lieb, L. M. Baldy, S. Berta, C.M. Patton, M.C. White, WJ. Bigler, and JJ. Witte.
1986. Epidemic campylobacteriosis associated with a community water supply. Am. J. Public
Health 76(4): 424-429.
                                            46

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                          Cyclospora cayetanensis Scoring Data
Scoring Summary
Waterborne Disease Outbreak
1
Health Effects
General population
Sensitive subpopulation(s) [C]
3
4
Score2

5
4
3
2
1

O
2
1

7
Data Element
Scoring Data
Reference3
Waterborne Disease Outbreaks
Has caused multiple (2 or
more) documented WBDOs
in the U.S. as reported by
CDC surveillance between
1990 and 2004
Has caused at least one
documented WBDOs in the
U.S. as reported by CDC
surveillance between 1990
and 2004
Has caused documented
WBDOs at any time in the
U.S.?
Has caused WBDOs in
countries other than the
U.S.?
Has never caused WBDOs
in any country, but has
been epidemiologically
associated with water
related disease?
No
No
N/A
N/A
Yes
CDC, 1991 -CDC,
2006
CDC, 1991 -CDC,
2006


Huang et al., 1995
Occurrence
Detected in drinking water in
the U.S.?
Detected in source water in
the U.S.?
Not detected in the U.S.?
No
No
Detected in drinking
water in Guatemala.


Dowd et al., 2003
Health Effects
Does the organism cause
No

                                            47

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2

6
5
4[C]
3[G,P,E,
CD]
2
1
Data Element
significant mortality (>
1/1,000 cases)?
Does the organism cause
pneumonia, meningitis,
hepatitis, encephalitis,
endocarditis, cancer, or other
severe manifestations of
illness necessitating long
term hospitalization (>
week)?
Does the illness result in
long term or permanent
dysfunction or disability, i.e.
sequelae?
Does the illness require
short term hospitalization
(< week)?
Does the illness require
physician intervention?
Is the illness self-limiting
within 72 hours (without
requiring medical
intervention)?
Does the illness result in
mild symptoms with minimal
or no impact on daily
activities?
Scoring Data

No
Guillain-Barre and
Reiter's syndromes
have been reported.
[C] Most cases do not
required
hospitalization,
infants may require
hospitalization for
rehydration therapy.
[All populations] Can
cause diarrhea and
biliary disease.
In patients not
treated, illness can be
protracted with
relapsing symptoms.


Reference3


Connor et al., 2001
Fisk et al., 2005
Lindsay in Murray,
2007
Heymann, 2005


 See section 3.4 for a detailed description on how to calculate the total pathogen score.
2 Bolded Text indicates the highest score for that particular protocol. For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score. The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol: G-
                                          48

-------
EPA OGWDW                      Final CCL 3 Microbes.                      EPA 815-R-09-009
                                 PCCL to CCL Process                           August 2009


General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
3EPA based the WBDO scores on the CDC MMWR reports from 1991 - 2006 and then
collected occurrence citations if there were no CDC WBDOs. Two exceptions to this
WBDO scoring criteria are Arcobacter butzleri and Mycobacterium avium.
References
CDC, 1991. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3); 1-21.

CDC, 1993. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1991—1992. MMWR Surveillance Summaries, 42(SS-5); 1-22.

CDC, 1996. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1993—1994. MMWR Surveillance Summaries, 45(SS-1); 1-33.

CDC, 1998. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5); 1-33.

CDC, 2000. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4); 1-35.

CDC, 2002. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1999—2000. MMWR Surveillance Summaries, 51(SS-8); 1-36.

CDC, 2004. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001—2002. MMWR Surveillance Summaries, 53(SS08); 23-45.

CDC, 2006. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2003—2004. MMWR Surveillance Summaries, 55(SS12); 31-58.

Connor, B. A., E. Johnson and R. Soave. 2001. Reiter syndrome following protracted symptoms
of Cyclospora infection. Emerg. Inf. Dis. 7: 453-454.
Dowd, E. S., D. John, J. Eliopolus, C.P. Gerba, J. Naranjo, R. Klein, B. Lopez, M. de Mejia, C.E.
Mndoza and I. Pepper. 2003.  Confirmed detection of Cyclospora cayetanesis, Encepalitozoon
intestinalis and  Cryptosporidium parvum in water used for drinking. Journal of Water and
Health 01 (3): 117-123.
Fisk, T.L., J.S. Keystone, and P. Kozarsky. 2005. In Mandel, G. L., J. E. Bennett, and R. Dolin
Ed. Mandel, Douglas and Bennett's Principles and Practice of Infectious Diseases, 6th Ed.,
Elsevier, Philadelphia.
Heymann, D.(ed.). 2005. Control of Communicable Diseases Manual, 18th ed. American Public
Health Association, Washington, DC.

                                           49

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EPA OGWDW                      Final CCL 3 Microbes.                       EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009


Huang, P. J. T. Weber, D.M. Sosin, P.M. Griffin, E.G. Long, JJ. Murphy, F. Kocka, C. Peters,
C. Kallick. 1995. The first reported outbreak of diarrheal illness associated with Cyclospom in
the United States. Ann. Intern. Med. 123: 409-414.
Lindsay, D., S. Upton and L. Weiss. 2007.  Isospora, Cyclospora and Sarcocystis. In Murray, P.
R., E. J. Baron, J. H. Jorgensen, M. A. Pfaller, and R. H Yolken (ed.) The Manual of Clinical
Microbiology, 9*  edition, American Society for Microbiology, Washington, DC Vol. 2; pp.
2113-2117.
                                            50

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                           Entamoeba histolytica Scoring Data
Scoring Summary
Waterborne Disease Outbreak
4
Health Effects
General population
Sensitive subpopulation(s) [C, P, E, CD]
3
3
Score2

5
4
O
2
1

3
2
1

Data Element
Scoring Data
Reference3
Waterborne Disease Outbreaks
Has caused multiple (2 or
more) documented WBDOs
in the U.S. as reported by
CDC surveillance between
1990 and 2004?
Has caused at least one
documented WBDOs in the
U.S. as reported by CDC
surveillance between 1990
and 2004?
Has caused documented
WBDOs at any time in the
U.S.?
Has caused WBDOs in
countries other than the U.S.?
Has never caused WBDOs in
any country, but has been
epidemiologically associated
with water related disease?
No
Yes
1 Noncommunity
(Previously
unreported)
N/A
N/A
N/A
CDC, 1991 -CDC,
2006
CDC, 2006



Occurrence
Detected in drinking water
in the U.S.?
Detected in source water in
the U.S.?
Not detected in the U.S.?
Found during WBDO.
N/A
N/A
CDC, 2006


Health Effects
                                           51

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2




7









6








5



4





3[G,C,P,E,
CD]




7
^
Data Element
Does the organism cause
significant mortality (>
1/1,000 cases)?





Does the organism cause
pneumonia, meningitis,
hepatitis, encephalitis,
endocarditis, cancer, or other
severe manifestations of
illness necessitating long term
hospitalization (> week)?






Does the illness result in long
term or permanent
dysfunction or disability, i.e.
sequelae?

Does the illness require short
term hospitalization (<
week)?
Does the illness require
physician intervention?








Is the illness self-limiting
within 72 hours (without
Scoring Data
500 million infected (E.
dispar and E.
histolyticd) each year
with approximately 50
million cases of colitis
and liver abscess and
100,000 deaths
worldwide.
Infections in the U.S.
rarely progress to
complications, amoebic
colitis may result in
perforation of the
intestinal wall, resulting
in peritonitis;
dissemination to
extraintestinal sites may
involve the liver, lungs,
or brain. Liver abscess
is the most common
complication.
Abdominal perforations
and peritonitis are rare
complications. Up to
5% develop liver
abscess.
Intestinal invasion can
lead to lesions, ulcers.

[All populations]
Clinical symptoms are
dysentery, colitis or
rarely amoeboma).
Fulminant colitis
occurs most often in
children who present
with diffuse abdominal
pain, profuse bloody
diarrhea and fever.
Most human infections
(90%) are
Reference3
Leber in Murray,
2007






Heymann, 2005












Leber in Murray,
2007



Leber in Murray,
2007

Leber in Murray,
2007


Marshall, 1997





Heymann, 2005

                                             52

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2














1

Data Element
requiring medical
intervention)?











Does the illness result in mild
symptoms with minimal or no
impact on daily activities?
Scoring Data
asymptomatic,
symptomatic non-
invasive strains cause
gastrointestinal
symptoms such as
cramping and increased
frequency of bowel
movements,
constipation may
alternate with diarrhea,
invasive strains may
cause amoebic
dysentery.



Reference3
















 See section 3.4 for a detailed description on how to calculate the total pathogen score.
2 Bolded Text indicates the highest score for that particular protocol. For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score. The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol: G-
General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
3EPA based the WBDO scores on the CDC MMWR reports from 1991 - 2006 and then
collected occurrence citations if there were no CDC WBDOs. Two exceptions to this
WBDO scoring criteria are Arcobocter butzleri and Mycobacterium avium.
References
CDC, 1991. Surveillance for Waterborne-Disease Outbreaks Associated
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3);

CDC, 1993. Surveillance for Waterborne-Disease Outbreaks Associated
United States, 1991—1992. MMWR Surveillance Summaries, 42(SS-5);

CDC, 1996. Surveillance for Waterborne-Disease Outbreaks Associated
United States, 1993—1994. MMWR Surveillance Summaries, 45(SS-1);

CDC, 1998. Surveillance for Waterborne-Disease Outbreaks Associated
United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5);
CDC, 2000. Surveillance for Waterborne-Disease Outbreaks Associated
United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4);
                               with Drinking Water •
                               1-21.

                               with Drinking Water •
                               1-22.

                               with Drinking Water •
                               1-33.

                               with Drinking Water •
                               1-33.
                               with Drinking Water •
                               1-35.
                                          53

-------
EPA OGWDW                       Final CCL 3 Microbes.                      EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009


CDC, 2002. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1999—2000. MMWR Surveillance Summaries,  51(SS-8); 1-36.
CDC, 2004. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001— 2002. MMWR Surveillance Summaries,  53(SS08); 23-45.

CDC, 2006. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2003—2004. MMWR Surveillance Summaries,  55(SS12); 31-58.
Heymann, D. (ed.). 2005. Control of Communicable Diseases Manual, 18th ed. American Public
Health Association, Washington, DC.
Leber, A. and S. Novak-weekley. 2007 Intestinal and Urogenital Amebae, Flagellates,  and
Ciliates. In Murray, P. R., E. J. Baron, J. H. Jorgensen, M.L. Landry, and M. A. Pfaller (ed.) The
Manual of Clinical Microbiology, 9th. edition, American Society for Microbiology, Washington,
DC. Vol. 2: pp. 2097-2099.
Marshall, M., D. Naumovitz, Y. Ortega and C. Sterling.  1997. Clinial Microbiology Reviews,
Jan. 1997, p. 73.
                                           54

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                                Enterovirus Scoring Data
Scoring Summary
Occurrence
3
Health Effects
General population
Sensitive subpopulation(s) [C]
4
6
Score2

5
4
O
2
1

3
2
1

Data Element
Scoring Data
Reference3
Waterborne Disease Outbreaks
Has caused multiple (2 or
more) documented
WBDOsintheU.S. as
reported by CDC
surveillance between 1990
and 2004?
Has caused at least one
documented WBDOs in
the U.S. as reported by
CDC surveillance between
1990 and 2004?
Has caused documented
WBDOs at any time in the
U.S.?
Has caused WBDOs in
countries other than the
U.S.?
Has never caused WBDOs
in any country, but has
been epidemiologically
associated with water
related disease?
No
No
No
Yes
Switzerland and others.
N/A
CDC, 1991 -CDC,
2006
CDC, 1991 -CDC,
2006

Hafliger et al., 2000

Occurrence
Detected in drinking
water in the U.S.?
Detected in source water
in the U.S.?
Not detected in the U.S.?
Yes
Yes
N/A
Mack et al., 1972
Lieberman et al.,
2003
Keswick et al., 1984
Borchardt et al., 2003

Health Effects
                                           55

-------
EPA OGWDW
              Final CCL 3 Microbes.
              PCCL to CCL Process
                           EPA815-R-09-009
                                August 2009
  Score
Data Element
Scoring Data
Reference
             Does the organism cause
             significant mortality (>
             1/1,000 cases)?
   6[C]
             Does the organism cause
             pneumonia, meningitis,
             hepatitis, encephalitis,
             endocarditis, cancer, or
             other severe
             manifestations of illness
             necessitating long term
             hospitalization (> week)?
                    [C] Aseptic meningitis
                    and neonatal sepsis are
                    the most common
                    complications.

                    EVs are the most
                    common cause of
                    meningitis in the U.S.,
                    over 80% of all viral
                    meningitides (estimated
                    30,000 to 50,000
                    hospitalizations for non-
                    polio EV each year
                    (principally echo and
                    coxsackie)).

                    Enterovirus causes
                    myocarditis, viral
                    meningitis, encephalitis
                    and
                    meningioencephalitis.
                    Heymann, 2005
                    Romero in Murray,
                    2007
                                                                Khetsuriani et al.,
                                                                2002
                                                                Kim et al., 2001
                                                                Khetsuriani, 2003
             Does the illness result in
             long term or permanent
             dysfunction or disability,
             i.e. sequelae?
                    Diabetes has been
                    associated with
                    enterovirus infection.
                    Heymann, 2005
   4[G]
             Does the illness require
             short term
             hospitalization (< week)?
                    [G] Hospitalization may
                    be required for severe
                    manifestations of
                    disease. Approximately
                    20-30% of meningitis
                    outbreak cases in young
                    adults require
                    hospitalization.

                    During the summer and
                    fall, responsible for 50 -
                    60% of hospital
                    admissions for
                    evaluation of febrile
                       56
                    Sawyer, 2002
                                                                Romero in Murray,
                                                                2007

-------
EPA OGWDW
                    Final CCL 3 Microbes.
                    PCCL to CCL Process
                                 EPA815-R-09-009
                                     August 2009
   Score
     Data Element
      Scoring Data
Reference
                                       illnesses for infants and
                                       children.
              Does the illness require
              physician intervention?
                          Children with acute
                          pharyngitis may be taken
                          to a physician to
                          differentiate between
                          streptococcal and viral
                          sore throat. Upper
                          respiratory illness lasts 4-
                          6 days, lower respiratory
                          illness lasts 5-7 days, and
                          meningitis lasts 7-10
                          days.
                          Romero in Murray,
                          2007
                                                                 Heymann, 2005
2 [E, P, CD]
Is the illness self-limiting
within 72 hours (without
requiring medical
intervention)?
[E, P, CD] Most cases are
asymptomatic. Most
common symptoms are
acute nonspecific febrile
illness.
                                                                 Romero in Murray,
                                                                 2007
              Does the illness result in
              mild symptoms with
              minimal or no impact on
              daily activities?
 See section 3.4 for a detailed description on how to calculate the total pathogen score.
2 Bolded Text indicates the highest score for that particular protocol.  For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score. The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol: G-
General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
3EPA based the WBDO scores on the CDC MMWR reports from 1991 - 2006 and then
collected occurrence citations if there were no CDC WBDOs.  Two exceptions to this
WBDO scoring criteria are Arcobocter butzleri and Mycobacterium avium.
References
Borchardt, M.A., P.O. Bertz, S.K. Spencer, andD.A. Battigelli. 2003. Incidence of enteric
viruses in groundwater from household wells in Wisconsin. App. Environ. Microbiol. 69(2):
1172-1180.

CDC, 1991.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water •
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3); 1-21.
                                          57

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EPA OGWDW                       Final CCL 3 Microbes.                      EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009
CDC, 1993. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1991—1992. MMWR Surveillance Summaries, 42(SS-5); 1-22.

CDC, 1996. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1993—1994. MMWR Surveillance Summaries, 45(SS-1); 1-33.

CDC, 1998. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5); 1-33.

CDC, 2000. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4); 1-35.


CDC, 2002. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1999—2000. MMWR Surveillance Summaries, 51(SS-8); 1-36.
CDC, 2004. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001—2002. MMWR Surveillance Summaries, 53(SS08); 23-45.

CDC, 2006. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1997-1998. MMWR Surveillance Summaries, 55(SS12); 31-65.

Hafliger D., P.Hubner and J. Luthy. 2000.  Outbreak of viral gastroenteritis due to sewage-
contaminated drinking water, Int. J. FoodMicrobiol., 54(1-2): 123 - 126.
Heymann, D. (ed.). 2005.  Control of Communicable Diseases Manual, 18* ed. American Public
Health Association, Washington, DC.

Keswick, B, C. Gerba, H.  DuPont, and J. Rose.  1984.  Detection of Enteric Viruses in Treated
Drinking Water.  App. and Env. Microbiology, June 1984, pp. 1290 - 1294.

Khetsuriani N., R. Holman, and L. Anderson. 2002. Burden of Encephalitis-Associated
Hospitalizations in the United States, 1988-1997.  Clin. Infect. Dis.  35(2): 175-82.

Khetsuriani, N. E.S. Quiroz, R.C. Holman and LJ. Anderson. 2003. Viral meningitis-associated
hospitalizations in the United States, 1988-1999. Neuroepidemiology, 22(6): 345-352.

Kim, K-S., G. Hufnagel, N.M. Chapman, S. Tracy. 2001. The group B coxsackieviruses and
myocarditis. Reviews in Medical Virology,  11(6): 355-368.

Lieberman, R.J., L.C. Shadix, B.S. Newport, C.P. Frebis, M.W.N. Moyer, R.S. Safferman, R.E.
Stetler, D. Lye, G.S. Fout and D. Dahling. 2002 "Microbial monitoring of vulnerable public
ground water supplies." AWWA Research Foundation and AWWA,  142.

Mack, W.N., L. Yue-Shoung, and D.B. Coohon. 1972 "Isolation of poliomyelitis virus from a
contaminated well." Health Services Report, 87(3): 271-274.
                                           58

-------
EPA OGWDW                      Final CCL 3 Microbes.                       EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009


Romero, J. 2007.  Enteroviruses and Parechoviruses. In Murray, P. R., E. J. Baron, J. H.
Jorgensen, M.L. Landry, and M. A. Pfaller (ed.) The Manual of Clinical Microbiology, 9th.
edition, American Society for Microbiology, Washington, DC. Vol. 2: p. 1394.
Sawyer, M.H. 2002. Enterovirus infections:  diagnosis and treatment. Seminars in Pediatric
Infectious Diseases 13(1): 40-47.
                                            59

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                          Escherichia coli (O157)^ Scoring Data
Scoring Summary
Waterborne Disease Outbreak
5
Health Effects
General population
Sensitive subpopulation(s) [C, E]
3
6
Score2

5
4
O
2
1

3
2
Data Element
Scoring Data
Reference3
Waterborne Disease Outbreaks
Has caused multiple (2 or
more) documented
WBDOs in the U.S. as
reported by CDC
surveillance between
1990 and 2004?
Has caused at least one
documented WBDOs in
the U.S. as reported by
CDC surveillance between
1990 and 2004?
Has caused documented
WBDOs at any time in the
U.S.?
Has caused WBDOs in
countries other than the
U.S.?
Has never caused WBDOs
in any country, but has
been epidemiologically
associated with water
related disease?
Yes
2 Noncommunity (1
Previously unreported)
1 Noncommunity
1 Community
1 Noncommunity
2 Community
N/A
N/A
N/A
N/A
CDC, 1998
CDC, 2000
CDC, 2002




Occurrence
Detected in drinking
water in the U.S.?
Detected in source water
in the U.S.?
Yes
Yes
As a result of animal
fecal contamination.
Bopp et al., 2003
Kramer et al., 1996
                                           60

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EPA OGWDW
                    Final CCL 3 Microbes.
                    PCCL to CCL Process
                                 EPA815-R-09-009
                                     August 2009
  Score
      Data Element
     Scoring Data
Reference
     1
Not detected in the U.S.?
N/A
                                           Health Effects
             Does the organism cause
             significant mortality (>
             1/1,000 cases)?
                          No
                          Approximately 60 deaths
                          per 73,000 cases per
                          year (nearly > 1/1,000)
                          are reported due to E.
                          co//(0157). A case
                          fatality rate of 0.5 has
                          been reported for
                          outbreak-related  cases
                          caused by E. coli
                          O157:H7
                         Nataro in Murray, 2007
                                                                Rangel et al., 2005
  6 [C, E]
             Does the organism cause
             pneumonia, meningitis,
             hepatitis, encephalitis,
             endocarditis, cancer, or
             other severe
             manifestations of illness
             necessitating long term
             hospitalization (> week)?
                           [C, E] Patients at
                           extremes of age have
                           an increased risk for
                           infection and
                           associated
                           complications.
                           Children under 5 are
                           most frequently
                           diagnosed with
                           infection and are at
                           greatest risk of
                           developing HUS. The
                           elderly also appear to
                           be a increased risk of
                           complications.

                           HUS develops in 10%
                           of patients under the
                           age of 10.
                         Chinyu, 1995
                         Heymann, 2005
                                                                Nataro and Kaper,
                                                                1998
             Does the illness result in
             long term or permanent
             dysfunction or disability,
             i.e. sequelae?
                          25% of HUS survivors
                          develop long term renal
                          sequelae.

                          3.2% of children with
                          diarrhea plus HUS
                          develop diabetes.

                          Adults have a greater
                          likelihood of
                             61
                         Garg et al., 2003
                                                                Suri et al., 2005
                                                                Garg et al, 2005

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2

4
3[G,P,CD]
2
1
Data Element

Does the illness require
short term hospitalization
(< week)?
Does the illness require
physician intervention?
Is the illness self-limiting
within 72 hours (without
requiring medical
intervention)?
Does the illness result in
mild symptoms with
minimal or no impact on
daily activities?
Scoring Data
hypertension and
reduced renal function.

[G, P, CD] Fluid
replacement is the
cornerstone of
treatment for EHEC
diarrhea; some
clinicians choose to
hospitalize all patients
with E. coli O157:H7
for hydration to
prevent HUS.

Can present as mild
nonbloody diarrhea.
Reference3


Heymann, 2005

Nataro in Murray, 2007
'The names E. coli O157 and E. coli O157:H7 are used interchangeably for CCL 3 due to
ongoing taxonomical debate in the scientific literature.
JSee section 3.4 for a detailed description on how to calculate the total pathogen score.
2 Bolded Text indicates the highest score for that particular protocol. For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score.  The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol: G-
General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
3EPA based the WBDO scores  on the CDC MMWR reports from 1991 - 2006 and then
collected occurrence citations if there were no CDC WBDOs.  Two exceptions to this
WBDO scoring criteria are Arcobacter butzleri and Mycobacterium avium.
References
Bopp, D.J., B.D. Sauders, A.L. Waring, J. Ackelsberg, N. Dumas, E. Braun-Howland, D.
Dziewulski, BJ. Wallace, M. Kelly, T. Halse, K. Aruda Musser, P.P. Smith, D.L. Morse, and
RJ. Limberger.  2003.  Detection, Isolation, and Molecular Subtyping of Escherichia coli
O157:H7 and Campylobacter jejuni Associated with a Large Waterborne Outbreak. Journal of
                                         62

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EPA OGWDW                       Final CCL 3 Microbes.                       EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009


Clinical Microbiology.  41(1): 174-180.

Chinyu S, and L J Brandt. Escherichia coir. H7 Infection in Humans.  1995.  Annals of Internal
Medicine. 123 (9): 698-707.

CDC, 1991. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3); 1-21.

CDC, 1993. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1991—1992. MMWR Surveillance Summaries, 42(SS-5); 1-22.

CDC, 1996. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1993—1994. MMWR Surveillance Summaries, 45(SS-1); 1-33.

CDC, 1998. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5); 1-33.

CDC, 2000. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4); 1-35.
CDC, 2002. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1999—2000. MMWR Surveillance Summaries, 51(SS-8); 1-36.
CDC, 2004. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001—2002. MMWR Surveillance Summaries, 53(SS08); 23-45.
CDC, 2006. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1997-1998. MMWR Surveillance Summaries, 55(SS12);  31-65.
Garg, A.X., L. Moist, D. Matsel, H.R. Thiessen-Philbrook, R.B. Haynes, R.S. Suri, M.  Salvador!,
J. Ray, and W.F. Clark.  2005. Risk of hypertension and reduced kidney function after acute
gastroenteritis from bacteria-contaminated drinking water.  CMAJ August 2, 2005: 173 (3).
Garg, A.X., R.S. Suri, N. Barrowman, F. Rehman, D. Matsell, M.P. Rosas-Arellano, M.
Salvador!, R.B.  Haynes, and W.F. Clark. 2003. Long-term Renal Prognosis of Diarrhea-
Associated Hemolytic Uremic Syndrome.  JAMA; 290 (10): 1360 -1370.
Heymann, D. (ed.). 2005. Control of Communicable Diseases Manual,  18* ed. American Public
Health Association, Washington, DC.
Karch, H, P.I. Tarr and M. Bielaszewska. 2005.  Enterohaemorrhagic Eschericia coli in human
medicine. International Journal of Medical Microbiology 295: 405-418.
Kramer, M.H., B.L. Herwaldt, G.F. Craun, R.L. Calderon, andD.D. Juranek. 1996. Surveillance
for waterborne-disease outbreaks - United States, 1993-1994. MMWR45(SS-): 1-33.
Nataro, J., C.  Bopp, P. Fields, J. Kaper andN. Strockbine.  2007. Escherichia, Shigella and
Salmonella. In  Murray, P. R., E. J. Baron, J. H. Jorgensen, M.L. Landry, and M. A. Pfaller (ed.)
The Manual of Clinical Microbiology, 9th. edition, American Society for Microbiology,
                                           63

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EPA OGWDW                       Final CCL 3 Microbes.                      EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009


Washington, DC. Vol. 1: pp. 670 - 672.
Nataro, J.P. and J.B. Kaper. 1998. Diarrheagenic Escherichict coli. Clin. Microbiol. Rev. 11(1):
142-201.
Rangel, J.M., P.H. Sparling, C. Crowe, P.M. Griffin, and D.L. Swerdlow. 2005. Epidemiology of
Escherichia coli O157:H7 outbreaks, United States, 1982-2002. Emerg. Infect. Dis. 11(4): 603-
609.
Suri, R.S., W.F. Clark, N. Barrowman, J.L. Mahon, H.R. Thiessen-Philbrook, M.P. Rosas-
Arellano, K. Zarnke, J.S. Garland,  and A.X. Garg. 2005. Diabetes during diarrhea-associated
hemolytic uremic syndrome: a systematic review and meta-analysis. Diabetes Care, 2005
October, 28(10): 2556-62.
                                           64

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                           Exophialajeanselmei Scoring Data
Scoring Summary
Occurrence
3
Health Effects
General population
Sensitive subpopulation(s) [C, P, E, CD]
3
3
Score2

5
4
O
2
1

3
2
1

7
Data Element
Scoring Data
Reference3
Waterborne Disease Outbreaks
Has caused multiple (2 or
more) documented WBDOs
in the U.S. as reported by
CDC surveillance between
1990 and 2004?
Has caused at least one
documented WBDOs in the
U.S. as reported by CDC
surveillance between 1990
and 2004?
Has caused documented
WBDOs at any time in the
U.S.?
Has caused WBDOs in
countries other than the U.S.?
Has never caused WBDOs
in any country, but has been
epidemiologically associated
with water related disease?
No
No
No
No
Yes
CDC, 1991 -CDC,
2006
CDC, 1991 -CDC,
2006


Nucci et al., 2002
Occurrence
Detected in drinking water
in the U.S.?
Detected in source water in
the U.S.?
Not detected in the U.S.?
Yes
Yes
N/A
West, 1986
Nucci etal., 2001

Health Effects
Does the organism cause
significant mortality (>
1/1,000 cases)?
No

                                           65

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2
6
5
4
3[G,C,P,E,
CD]
2
1
Data Element
Does the organism cause
pneumonia, meningitis,
hepatitis, encephalitis,
endocarditis, cancer, or other
severe manifestations of
illness necessitating long term
hospitalization (> week)?
Does the illness result in long
term or permanent
dysfunction or disability, i.e.
sequelae?
Does the illness require short
term hospitalization (<
week)?
Does the illness require
physician intervention?
Is the illness self-limiting
within 72 hours (without
requiring medical
intervention)?
Does the illness result in mild
symptoms with minimal or no
impact on daily activities?
Scoring Data
Infections increase in
severity in patients
with impaired
immunity and
metabolic diseases
such as diabetes.
No
No
[All populations] A
chronic spreading
mycosis.
The frequency of
infection is low, yet
potential severe
outcome and high
degrees of resistance
to antifungal drugs
requires medical
attention.


Reference3
De Hoog in Murray,
2007


Heymann, 2005
De Hoog in Murray,
2007


 See section 3.4 for a detailed description on how to calculate the total pathogen score.
2 Bolded Text indicates the highest score for that particular protocol. For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score.  The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol: G-
General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
3EPA based the WBDO scores  on the CDC MMWR reports from 1991 - 2006 and then
collected occurrence citations if there were no CDC WBDOs.  Two exceptions to this
                                         66

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EPA OGWDW                       Final CCL 3 Microbes.                       EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009


WBDO scoring criteria are Arcobacter butzleri and Mycobacterium avium.
References
CDC, 1991.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3); 1-21.

CDC, 1993.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1991—1992. MMWR Surveillance Summaries, 42(SS-5); 1-22.

CDC, 1996.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1993—1994. MMWR Surveillance Summaries, 45(SS-1); 1-33.

CDC, 1998.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5); 1-33.

CDC, 2000.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4); 1-35.

CDC, 2002.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1999—2000. MMWR Surveillance Summaries, 51(SS-8); 1-36.

CDC, 2004.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001—2002. MMWR Surveillance Summaries, 53(SS08); 23-45.

CDC, 2006.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2003— 2004. MMWR Surveillance Summaries, 55(SS12); 31-58.

Heymann, D. (ed.). 2005. Control of Communicable Diseases Manual, 18th ed. American Public
Health Association, Washington, DC.
Nucci, M.T. Akiti, G. Barreiros, F. Silveira, S.G. Revankar, D.A. Sutton, and T.F. Patterson.
2001. Nosocomial fungemia due to Exophiala jeanselmei \^. jeanselmei and a Rhinocladiella
species: newly described causes of bloodstream infection. J. Clin. Microbiol. 39(2): 514-518.
Nucci, M. T., T. Akiti, G. Barreiros, F. Silveira, S. G. Revankar, B. L. Wickes, D. A. Sutton, and
T. F. Patterson. 2002. Nosocomial outbreak of Exophiala jeanselmei fungemia associated with
contamination of hospital water. Clin. Infect. Dis. 34: 1475-1480.

De Hoog, G. and R. Vitale.  2007.  Bipolaris, Exophiala, Scedosporium, Sporothrix, and Other
Dematiaceous Fungi. In Murray, P. R., E. J. Baron, J. H. Jorgensen, M.L. Landry, and M. A.
Pfaller (ed.)  The Manual of Clinical Microbiology, 9th. edition, American  Society for
Microbiology, Washington, DC. Vol. 2: pp. 1908 and 1918.
West, P.R. 1986. Isolation rates and characterization of fungi in drinking water distribution
systems. Proceedings of the Water Quality Technology Conference, American Water Works
Association, Denver, CO.

                                           67

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                           Fumrium solani Scoring Data
Scoring Summary
Occurrence
3
Health Effects
General population
Sensitive subpopulation(s) [C, P, E, CD]
4
4
Score2

5
4
O
2
1

3
2
1

7
Data Element
Scoring Data
Reference3
Waterborne Disease Outbreaks
Has caused multiple (2 or
more) documented WBDOs
in the U.S. as reported by
CDC surveillance between
1990 and 2004?
Has caused at least one
documented WBDOs in the
U.S. as reported by CDC
surveillance between 1990
and 2004?
Has caused documented
WBDOs at any time in the
U.S.?
Has caused WBDOs in
countries other than the U.S.?
Has never caused WBDOs
in any country, but has been
epidemiologically associated
with water related disease?
No
No
No
No
Yes
Houston TX
CDC, 1991 -CDC,
2006
CDC, 1991 -CDC,
2006


Annaissie et al., 2001
Occurrence
Detected in drinking water
in the U.S.?
Detected in source water in
the U.S.?
Not detected in the U.S.?
Yes
Yes
N/A
Nagy and Olson,
1982
Annaissie et al., 2001


Health Effects
Does the organism cause
significant mortality (>
Mortality associated
with cutaneous
Nucci and Annaissie,
2002
                                           68

-------
 EPA OGWDW
             Final CCL 3 Microbes.
             PCCL to CCL Process
                          EPA815-R-09-009
                              August 2009
   Score
Data Element
Scoring Data
Reference3
              1/1,000 cases)?
                      Fusarium infection is
                      high in
                      immunocompromi sed
                      patients but low for
                      immunocompetent
                      hosts.
              Does the organism cause
              pneumonia, meningitis,
              hepatitis, encephalitis,
              endocarditis, cancer, or other
              severe manifestations of
              illness necessitating long term
              hospitalization (> week)?
                      Most severe disease
                      occurs in severely
                      immunocompromi sed.

                      Fusarium has been
                      associated with
                      pneumonia and
                      disseminated
                      infections
                   Fridkin and Jarvis,
                   1996; Annaissie et al.,
                   2001

                   Verweij and Brandt, in
                   Murray 2007
              Does the illness result in long
              term or permanent
              dysfunction or disability, i.e.
              sequelae?
              Does the illness require short
              term hospitalization (<
              week)?
4[G,C,P,E,
    CD]
                      [G, C, P, E, CD] Can
                      cause infections that
                      may require
                      hospitalization,
                      particularly in
                      immunocompromised
                      patients
                      (endophtalmitis,
                      central nervous
                      system infections,
                      endocarditis)
                   Dignani and
                   Anaissie, 2004
              Does the illness require
              physician intervention?
                      Treatment and/or
                      removal of the foreign
                      body is usually
                      required as well as
                      antifungal therapy.

                      In inmunocompentent
                      patients manifestations
                      include keratitis,
                      localized skin lesions,
                      onychomycosis, and
                      occasionally cellulitis
                      69
                   Dignani and Anaissie,
                   2004

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2

2
1
Data Element

Is the illness self-limiting
within 72 hours (without
requiring medical
intervention)?
Does the illness result in mild
symptoms with minimal or no
impact on daily activities?
Scoring Data
and peritonitis.


Reference3



 See section 3.4 for a detailed description on how to calculate the total pathogen score.
2 Bolded Text indicates the highest score for that particular protocol. For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score. The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol: G-
General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
3EPA based the WBDO scores on the CDC MMWR reports from 1991 - 2006 and then
collected occurrence citations if there were no CDC WBDOs.  Two exceptions to this
WBDO scoring criteria are Arcobocter butzleri and Mycobacterium avium.
References
Anaissie, E.J., R.T. Kuchar, J.H. Rex, A. Francesconi, M. Kasai, F-M.C. Muller, M. Lozano-
Chiu, R.C. Summerbell, M.C. Dignani, SJ. Chanock, and TJ. Walsh.  2001.  Fusariosis
Associated with Pathogenic Fusarium Species Colonization of a Hospital Water System: A New
Paradigm for the Epidemiology of Opportunistic Mold Infections. Clin. Infect. Dis., 33: 1871-
1878.
CDC, 1991. Surveillance for Waterborne-Disease Outbreaks Associated
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3);

CDC, 1993. Surveillance for Waterborne-Disease Outbreaks Associated
United States, 1991—\992.MMWRSurveillance Summaries, 42(SS-5);

CDC, 1996. Surveillance for Waterborne-Disease Outbreaks Associated
United States, 1993—1994. MMWR Surveillance Summaries, 45(SS-1);

CDC, 1998. Surveillance for Waterborne-Disease Outbreaks Associated
United States, 1995—\996.MMWRSurveillance Summaries, 47(SS-5);

CDC, 2000. Surveillance for Waterborne-Disease Outbreaks Associated
United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4);
                               with Drinking Water •
                               1-21.

                               with Drinking Water •
                               1-22.

                               with Drinking Water •
                               1-33.

                               with Drinking Water •
                               1-33.

                               with Drinking Water •
                               1-35.
CDC, 2002. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
                                          70

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EPA OGWDW                       Final CCL 3 Microbes.                      EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009


United States, 1999—2000. MMWR Surveillance Summaries, 51(SS-8);  1-36.

CDC, 2004. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001—2002. MMWR Surveillance Summaries, 53(SS08); 23-45.

CDC, 2006. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2003—2004. MMWR Surveillance Summaries, 55(SS12); 31-58.

Dignani, M. andE. Anaissie. 2004. Human Fusariosis.  Clin. Microbiol. Infect. Suppl. 1: 67-75.

Fridkin, S. and W. Jarvis. 1996. Epidemiology of Nosocomial Fungal Infections. Clin.
Microbiol. Rev.  9(4): 499-511.

Nagy L., and Olson B.  1982.  The occurrence of filamentous fungi in drinking water distribution
systems. Can J Microbiol. 1982 Jun;  28(6):667-71
Nucci, M. and E. Anaissie. 2002. Cutaneous infection by Fusarium species in health and
immunocompromised hosts: implications for diagnosis and management. Clin. Infect. Dis.
35:909-920.
Verweij, P. and M. Brandt. 2007. Aspergillus, Fusarium, and Other Opportunistic Moniliaceous
Fungi. In Murray, P. R., E. J. Baron, J. H. Jorgensen, M. L. Landry and M. A. Pfaller (ed.)
Manual of Clinical Microbiology, 9th. Edition, American Society for Microbiology, Washington,
DC (Vol. 2). pp: 1818-1821.
                                           71

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                             Helicobacter pylori Scoring Data
Scoring Summary
Occurrence
3
Health Effects
General population
Sensitive subpopulation(s) [E]
7
7
Score2

5
4
3
2
1

3
2
1

7[G,E]
Data Element
Scoring Data
Reference3
Waterborne Disease Outbreaks
Has caused multiple (2 or
more) documented WBDOs
in the U.S. as reported by
CDC surveillance between
1990 and 2004?
Has caused at least one
documented WBDOs in the
U.S. as reported by CDC
surveillance between 1990
and 2004?
Has caused documented
WBDOs at any time in the
U.S.?
Has caused WBDOs in
countries other than the
U.S.?
Has never caused WBDOs
in any country, but has
been epidemiologically
associated with water
related disease?
No
No
No
No
Yes
CDC, 1991 -CDC,
2006
CDC, 1991 -CDC,
2006


Klein and Graham,
1991
Hulten et al., 1996
Rolle-Kampczyk,
2004.
Occurrence
Detected in drinking water
in the U.S.?
Detected in source water in
the U.S.?
Not detected in the U.S.?
Yes
N/A
N/A
Hegarty and Baker,
1999


Health Effects
Does the organism cause
[G, E] 6500 deaths per
CDC, 1997
                                            72

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2

6
5
4
3 [C, P, CD]
2
1
Data Element
significant mortality (>
1/1,000 cases)?
Does the organism cause
pneumonia, meningitis,
hepatitis, encephalitis,
endocarditis, cancer, or
other severe manifestations
of illness necessitating long
term hospitalization (>
week)?
Does the illness result in
long term or permanent
dysfunction or disability, i.e.
sequelae?
Does the illness require
short term hospitalization (<
week)?
Does the illness require
physician intervention?
Is the illness self-limiting
within 72 hours (without
requiring medical
intervention)?
Does the illness result in
mild symptoms with
minimal or no impact on
daily activities?
Scoring Data
year.
1.2 Million acute cases
per year (>1/1,000
deaths).
46% of deaths occur
before age of 64.
40 - 50% infection
rates in the elderly.
More likely to suffer
from gastric ulcer,
gastric adenocarcinomas
and MALT.
Main cause for peptic
ulcers and a major risk
factor for gastric cancer.

[C, P, CD] Many
patients have recurrent
abdominal symptoms;
16% develop duodenal
ulcers. Nffl(1994)
recommends diagnosis
and antimicrobial
treatment for anyone
with peptic ulcers.
No
Infection persists
lifelong without
treatment.

Reference3
Stratton et al, 2000
Fox in Murray, 2007
Fox in Murray, 2007

Fox in Murray, 2007
Fox in Murray, 2007

 See section 3.4 for a detailed description on how to calculate the total pathogen score.
2 Bolded Text indicates the highest score for that particular protocol.  For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
                                           73

-------
EPA OGWDW                      Final CCL 3 Microbes.                      EPA 815-R-09-009
                                 PCCL to CCL Process                          August 2009


sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score. The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol:  G-
General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
3EPA based the WBDO scores on the CDC MMWR reports from 1991 - 2006 and then
collected occurrence citations if there were no CDC WBDOs.  Two exceptions to this
WBDO scoring criteria are Arcobocter butzleri and Mycobacterium avium.
References
CDC, 1991. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3); 1-21.

CDC, 1993. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1991—1992. MMWR Surveillance Summaries, 42(SS-5); 1-22.

CDC, 1996. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1993—1994. MMWR Surveillance Summaries, 45(SS-1); 1-33.

CDC, 1997. Knowledge About Causes of Peptic Ulcer Disease — United States, March-April
1997, October 24, 1997 / 46(42);985-987

CDC, 1998. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5); 1-33.

CDC, 2000. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4); 1-35.

CDC, 2002. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1999—2000. MMWR Surveillance Summaries, 51(SS-8); 1-36.

CDC, 2004. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001—2002. MMWR Surveillance Summaries, 53(SS08); 23-45.

CDC, 2006. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2003— 2004. MMWR Surveillance Summaries, 55(SS12); 31-58.
Fox, G. and F. Megraud.  2007. Helicobacter. In Murray, P. R., E. J. Baron, J. H. Jorgensen,
M.L. Landry, and M. A. Pfaller (ed.) The Manual of Clinical Microbiology, 9th. edition,
American Society for Microbiology, Washington, DC. Vol. 1: p. 950.
Hegarty, J. P. and K. H. Baker. 1999. Occcurrence of Helicobacter pylori in surface water in the
United States. J. Appl Microbiol. 87: 697-701.
Hulten, K., S. W. Han, H. Enroth, P. D. Klein, A. R. Opekun, R. H. Oilman D. G. Evans, L.
Engstrand, D. Y. Graham, and F. A. K. El-Zaatari.  1996. Helicobacter pylori in the drinking
                                          74

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EPA OGWDW                       Final CCL 3 Microbes.                      EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009


water in Peru. Gastroenterology 110: 1031-1035.
Klein, P. D, D. Y. Graham, Gaillour, A, Opekun, A.R and Smith, E.G. 1991. Water source as risk
factor for Helicobacterpylori infection in Peruvian children. Lancet 337(8756): 1503-1506.
Rolle-Kampczyk, U.E., GJ. Fritz, U. Diez, I. Lehman, M. Richter, and O. Herbarth. 2004. Well
water - one source for Helicobacter pylori colonization. . International Journal of Hygiene and
Environmental Health. 207: 363-368.

Stratton, K., J. Durch, and R. Lawrence (Editors).  2000. Vaccines for the 21st Century.
National Academy of Sciences, National Academy of Press: pp. 181-187.
                                           75

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                             Hepatitis A Virus Scoring Data
Scoring Summary
Waterborne Disease Outbreak
5
Health Effects
General population
Sensitive subpopulation(s) [E]
3
6
Score2

5
4
O
2
1

3
2
1
Data Element
Scoring Data
Reference3
Waterborne Disease Outbreaks
Has caused multiple (2
or more) documented
WBDOs in the U.S. as
reported by CDC
surveillance between
1990 and 2004?
Has caused at least one
documented WBDOs in
the U.S. as reported by
CDC surveillance
between 1990 and 2004?
Has caused documented
WBDOs at any time in
the U.S.?
Has caused WBDOs in
countries other than the
U.S.?
Has never caused
WBDOs in any country,
but has been
epidemiologically
associated with water
related disease?
Yes
1 Community
1 Noncommunity
(Previously unreported)
N/A
N/A
N/A
N/A
CDC, 1991
CDC, 1996




Occurrence
Detected in drinking
water in the U.S.?
Detected in source
water in the U.S.?
Not detected in the
U.S.?

Yes
N/A

Abbaszadegan et al.,
2003
Borchardt et al., 2004

                                            76

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2

7
6[E]
5
4
3 [G, C, P,
CD]
2
1
Data Element
Scoring Data
Reference3
Health Effects
Does the organism cause
significant mortality (>
1/1,000 cases)?
Does the organism
cause pneumonia,
meningitis, hepatitis,
encephalitis,
endocarditis, cancer,
or other severe
manifestations of
illness necessitating
long term
hospitalization (>
week)?
Does the illness result in
long term or permanent
dysfunction or
disability, i.e. sequelae?
Does the illness require
short term
hospitalization (<
week)?
Does the illness require
physician
intervention?
Is the illness self-
limiting within 72 hours
(without requiring
medical intervention)?
Does the illness result in
mild symptoms with
minimal or no impact on
daily activities?
Reported case fatality is
normally low, 0. 1% -
0.3%; it can reach 1.8%
for adults over 50.
[E] Fulminant hepatitis
may develop. Disease
severity shows a
general increase with
age.


[G,C,P,CD]
Commonly begins with
"flu-like" symptoms.
May develop jaundice.
Physician office visit is
common for diagnosis
and/or vaccination.


Heymann, 2005
Anderson in Murray,
2007


Anderson in Murray,
2007


                                             77

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EPA OGWDW                      Final CCL 3 Microbes.                      EPA 815-R-09-009
                                 PCCL to CCL Process                          August 2009


JSee section 3.4 for a detailed description on how to calculate the total pathogen score.
2 Bolded Text indicates the highest score for that particular protocol. For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score. The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol:  G-
General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
3EPA based the WBDO scores on the CDC MMWR reports from 1991 - 2006 and then
collected occurrence citations if there were no CDC WBDOs.  Two exceptions to this
WBDO scoring criteria are Arcobocter butzleri and Mycobacterium avium.
References
Abbaszadegan, M., M. LeChevallier, and C. P. Gerba, 2003. Occurrence of viruses in U. S.
groundwaters. JAWWA95: 107-120.
Anderson, D. 2007 .  Hepatitis A and E Viruses. In Murray, P. R., E. J. Baron, J. H. Jorgensen,
M.L. Landry, and M.  A. Pfaller (ed.) The Manual of Clinical Microbiology, 9th. edition,
American Society for Microbiology, Washington, DC. Vol. 2: pp.  1428 - 1429.

Borchardt, M. A., N.L. Haas and R.L. Hunt. 2004. Vulnerability of drinking-water wells in La
Crosse, Wisconsin to  enteric-virus contamination from surface water contributions. Appl.
Environ. Microbiol. 10: 5937-5946.
CDC, 1991.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1989—1990. MMWR Surveillance Summaries,  40(SS-3); 1-21.

CDC, 1993.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1991—1992. MMWR Surveillance Summaries,  42(SS-5); 1-22.

CDC, 1996.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1993—1994. MMWR Surveillance Summaries,  45(SS-1); 1-33.

CDC, 1998.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1995—1996. MMWR Surveillance Summaries,  47(SS-5); 1-33.

CDC, 2000.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1997—1998. MMWR Surveillance Summaries,  49(SS-4); 1-35.

CDC, 2002.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1999—2000. MMWR Surveillance Summaries,  51(SS-8); 1-36.

CDC, 2004.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001—2002. MMWR Surveillance Summaries,  53(SS08); 23-45.
                                          78

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EPA OGWDW                       Final CCL 3 Microbes.                       EPA 815-R-09-009
                                  PCCL to CCL Process                            August 2009


CDC, 2006. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2003—2004. MMWR Surveillance Summaries, 55(SS12); 31-58.

Heymann, D. (ed.). 2005. Control of Communicable Diseases Manual, 18* ed. American Public
Health Association, Washington, DC.
                                           79

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                             Hepatitis E Virus Scoring Data
Scoring Summary
Waterborne Disease Outbreak
2
Health Effects
General population
Sensitive subpopulation(s) [P]
3
7
Score2

5
4
3
2
1

O
2
1

7[P]
Data Element
Scoring Data
Reference3
Waterborne Disease Outbreaks
Has caused multiple (2 or
more) documented WBDOs
in the U.S. as reported by
CDC surveillance between
1990 and 2004?
Has caused at least one
documented WBDOs in the
U.S. as reported by CDC
surveillance between 1990
and 2004?
Has caused documented
WBDOs at any time in the
U.S.?
Has caused WBDOs in
countries other than the
U.S.?
Has never caused WBDOs in
any country, but has been
epidemiologically associated
with water related disease?
No
No
No
Yes
Waterborne
outbreaks have
occurred in Asia and
Africa.
Yes
California camping.
CDC, 1991 -CDC,
2006
CDC, 1991 -CDC,
2006

Guthmann et al.,
2006
Panda et al., 2006
Tsang et al., 2000
Occurrence
Detected in drinking water in
the U.S.?
Detected in source water in
the U.S.?
Not detected in the U.S.?
No
No
Yes
India


Jothikumar et al.,
2000
Health Effects
Does the organism cause
[P] May progress to
Anderson in Murray,
                                            80

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EPA OGWDW
                    Final CCL 3 Microbes.
                    PCCL to CCL Process
                              EPA815-R-09-009
                                   August 2009
  Score
       Data Element
    Scoring Data
Reference
             significant mortality (>
             1/1,000 cases)?
                            fulminant disease in
                            pregnant women
                            when infection occurs
                            during the third
                            trimester. High
                            mortality (for fetus)
                            when infection occurs
                            during pregnancy.
                            The case-fatality rate
                            is similar to that of
                            hepatitis A except in
                            pregnant women,
                            where it may reach
                            20% among those
                            infected during the
                            third trimester of
                            pregnancy.
                       2007
                                                                Heymann, 2005
   6[E]
Does the organism cause
pneumonia, meningitis,
hepatitis, encephalitis,
endocarditis, cancer, or other
severe manifestations of
illness necessitating long
term hospitalization (>
week)?
[E] Fulminant hepatitis
may develop. Disease
severity shows a
general increase with
age.
                                                                Anderson in Murray,
                                                                2007
             Does the illness result in
             long term or permanent
             dysfunction or disability, i.e.
             sequelae?
             Does the illness require short
             term hospitalization (<
             week)?
 3 [G, C]
             Does the illness require
             physician intervention?
                            [G, C] Commonly
                            begins with "flu-like"
                            symptoms. May
                            develop jaundice.
                            Physician office visit
                            is common for
                            diagnosis and/or
                            vaccination.
                       Anderson in Murray,
                       2007
                                          81

-------
EPA OGWDW
             Final CCL 3 Microbes.
             PCCL to CCL Process
                          EPA815-R-09-009
                               August 2009
  Score
Data Element
Scoring Data
Reference
             Is the illness self-limiting
             within 72 hours (without
             requiring medical
             intervention)?
             Does the illness result in
             mild symptoms with minimal
             or no impact on daily
             activities?
 See section 3.4 for a detailed description on how to calculate the total pathogen score.
2 Bolded Text indicates the highest score for that particular protocol.  For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score. The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol: G-
General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
3EPA based the WBDO scores on the CDC MMWR reports from 1991 - 2006 and then
collected occurrence citations if there were no CDC WBDOs.  Two exceptions to this
WBDO scoring criteria are Arcobocter butzleri and Mycobacterium avium.
References
Anderson, D. 2007 .  Hepatitis A and E Viruses. In Murray, P. R., E. J. Baron, J. H. Jorgensen,
M.L. Landry, and M.  A. Pfaller (ed.) The Manual of Clinical Microbiology, 9th. edition,
American Society for Microbiology, Washington, DC. Vol. 2: pp. 1428 - 1429.
CDC, 1991.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3); 1-21.
CDC, 1993. Surveillance for Waterborne-Disease Outbreaks Associated
United States, 1991—1992. MMWR Surveillance Summaries, 42(SS-5);

CDC, 1996. Surveillance for Waterborne-Disease Outbreaks Associated
United States, 1993—\994.MMWRSurveillance Summaries, 45(SS-1);

CDC, 1998. Surveillance for Waterborne-Disease Outbreaks Associated
United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5);

CDC, 2000. Surveillance for Waterborne-Disease Outbreaks Associated
United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4);

CDC, 2002. Surveillance for Waterborne-Disease Outbreaks Associated
United States, 1999—2000. MMWR Surveillance Summaries, 51(SS-8);
                                            with Drinking Water •
                                            1-22.

                                            with Drinking Water •
                                            1-33.

                                            with Drinking Water •
                                            1-33.

                                            with Drinking Water •
                                            1-35.

                                            with Drinking Water •
                                            1-36.
                                          82

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EPA OGWDW                       Final CCL 3 Microbes.                      EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009


CDC, 2004. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001—2002. MMWR Surveillance Summaries, 53(SS08); 23-45.

CDC, 2006. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2003—2004. MMWR Surveillance Summaries, 55(SS12); 31-58.
Guthmann, J-P., H. Klovstad, D. Boccia, N. Hamid, L. Pinoges, J-Y. Nizou, M. Tatay, F. Diaz,
A. Moren, R. F. Grais, I. Ciglenecki, E. Nicand, and P. J. Guerin. 2006. A large outbreak of
hepatitis E among a displaced population in Darfur, Sudan, 2004: the role of water treatment
methods. Clin. Infect. Dis. 42: 1685-1691.
Heymann, D. (ed.). 2005. Control of Communicable Diseases Manual, 18* ed. American Public
Health Association, Washington, DC.
JothikumarN., R. Paulmurugan, P. Padmanabhan, R.B. Sundari, S. Kamatchiammal, andK.S.
Rao. 2000. Duplex RT-PCR for simultaneous detection of hepatitis A and hepatitis E virus
isolated from drinking water samples.  J Environ Monit. 2(6): 587-90.
Panda, S.K., D. Thakral, and S. Rehman.  2007. Hepatitis E virus. Rev. Med. Virol. 17(3):  151-
180.
Tsang, T.H, E.K. Denison, H.V. Williams, L.V. Venczel, M.M. Ginsberg, and DJ. Vugia.
Acute Hepatitis E Infection Acquired in California. Clinical Infectious Diseases 30: 618-9.
                                           83

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                                Isospora belli Scoring Data
Scoring Summary
Waterborne Disease Outbreak
2
Health Effects
General population
Sensitive subpopulation(s) [C]
1
2
Score2

5
4
O
2
1

O
2
1

7
Data Element
Scoring Data
Reference3
Waterborne Disease Outbreaks
Has caused multiple (2 or
more) documented
WBDOsintheU.S. as
reported by CDC
surveillance between 1990
and 2004?
Has caused at least one
documented WBDOs in the
U.S. as reported by CDC
surveillance between 1990
and 2004?
Has caused documented
WBDOs at any time in the
U.S.?
Has caused WBDOs in
countries other than the
U.S.?
Has never caused WBDOs
in any country, but has
been epidemiologically
associated with water
related disease?
No
No
No
Yes
Yes
CDC, 1991 -CDC,
2006
CDC, 1991 -CDC,
2006

Karanis, 2006

Occurrence
Detected in drinking water
in the U.S.?
Detected in source water in
the U.S.?
Not detected in the U.S.?
No
No
No



Health Effects
Does the organism cause


                                            84

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EPA OGWDW
                    Final CCL 3 Microbes.
                    PCCL to CCL Process
                                EPA815-R-09-009
                                     August 2009
  Score
      Data Element
     Scoring Data
Reference
             significant mortality (>
             1/1,000 cases)?
             Does the organism cause
             pneumonia, meningitis,
             hepatitis, encephalitis,
             endocarditis, cancer, or
             other severe manifestations
             of illness necessitating long
             term hospitalization (>
             week)?
             Does the illness result in
             long term or permanent
             dysfunction or disability,
             i.e. sequelae?
             Does the illness require
             short term hospitalization
             (< week)?
             Does the illness require
             physician intervention?
                           Can cause serious and
                           sometimes fatal disease
                           in immunocompetent
                           humans, more severe in
                           immunocompromi sed
                           patients.
                         Lindsay in Murray,
                         2007
   2[C]
Is the illness self-limiting
within 72 hours (without
requiring medical
intervention)?
[C] Symptoms are more
severe in infants and
children.
                                                                 Lindsay in Murray,
                                                                 2007
             Does the illness result in
             mild symptoms with
             minimal or no impact on
             daily activities?
                           [G] Symptoms include
                           diarrhea, steatorrhea,
                           headache, fever,
                           malaise, abdominal
                           pain, vomiting,
                           dehydration, and
                           weight loss.
                         Lindsay in Murray,
                         2007
 See section 3.4 for a detailed description on how to calculate the total pathogen score.
2 Bolded Text indicates the highest score for that particular protocol. For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score. The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol: G-
General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
                                          85

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EPA OGWDW                       Final CCL 3 Microbes.                      EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009


3EPA based the WBDO scores on the CDC MMWR reports from 1991 - 2006 and then
collected occurrence citations if there were no CDC WBDOs. Two exceptions to this
WBDO scoring criteria are Arcobocter butzleri and Mycobacterium avium.
References
CDC, 1991.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3); 1-21.

CDC, 1993.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1991—1992. MMWR Surveillance Summaries, 42(SS-5); 1-22.

CDC, 1996.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1993—1994. MMWR Surveillance Summaries, 45(SS-1); 1-33.

CDC, 1998.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5); 1-33.

CDC, 2000.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4); 1-35.

CDC, 2002.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1999—2000. MMWR Surveillance Summaries, 51(SS-8); 1-36.

CDC, 2004.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001—2002. MMWR Surveillance Summaries, 53(SS08); 23-45.

CDC, 2006.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2003— 2004. MMWR Surveillance Summaries, 55(SS12); 31-58.
Karanis P. 2006 A review of an emerging waterborne medical important parasitic protozoan.
Jpn. JProtozool. 39(1): 5-19.
Lindsay, D., S. Upton, and L. Weiss. 2007. Isospora, Cyclospora, and Sarcocystis. In Murray,
P(ed.) The Manual of Clinical Microbio
Washington, DC Vol. 2: pp. 2113-2121.
P(ed.) The Manual of Clinical Microbiology, 9* . edition, American Society for Microbiology,
                                           86

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                          Legionella pneumophila Scoring Data
Scoring Summary
Waterborne Disease Outbreak
5
Health Effects
General population
Sensitive subpopulation(s) [E, CD]
4
6
Score2

5
4
O
2
1

3
2
Data Element
Scoring Data
Reference3
Waterborne Disease Outbreaks
Has caused multiple (2 or
more) documented
WBDOs in the U.S. as
reported by CDC
surveillance between 1990
and 2004?
Has caused at least one
documented WBDOs in the
U.S. as reported by CDC
surveillance between 1990
and 2004?
Has caused documented
WBDOs at any time in the
U.S.?
Has caused WBDOs in
countries other than the
U.S.?
Has never caused WBDOs
in any country, but has been
epidemiologically
associated with water
related disease?
Yes
1 Community
1 Noncommunity
7 Community
1 Community (Previously
unreported)
1 Noncommunity (Previously
unreported)
N/A
N/A
N/A
N/A
CDC, 2004
CDC, 2006




Occurrence
Detected in drinking water
in the U.S.?
Detected in source water in
Yes
Yes
AwwaRF, 2004
Lin et al., 1998
Maier et al.,
2000
Maier et al., 2000
                                           87

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2

1

7
6 [E, CD]
5
4 [G, C, P]
O
2
Data Element
the U.S.?
Not detected in the U.S.?
Scoring Data

N/A
Reference3


Health Effects
Does the organism cause
significant mortality (>
1/1,000 cases)?
Does the organism cause
pneumonia, meningitis,
hepatitis, encephalitis,
endocarditis, cancer, or
other severe
manifestations of illness
necessitating long term
hospitalization (> week)?
Does the illness result in
long term or permanent
dysfunction or disability,
i.e. sequelae?
Does the illness require
short term hospitalization
(< week)?
Does the illness require
physician intervention?
Is the illness self-limiting
within 72 hours (without
requiring medical
intervention)?
Avg. 12% fatality rate; death
rates of 15% (general pop.) up
to 75%
(immunocompromised) if
untreated.
Avg. 25% death rate (between
20-40% during an outbreak.
10- 15% death rate.
Fatality rate has been as high
as 39% in hospitalized cases; it
is generally higher in those
with compromised immunity.
[E, CD] Acute pneumonia
may progress to respiratory
collapse and death if
diagnosis and effective
antibiotic therapy are
delayed. The elderly and
individuals with chronic
diseases are at higher risk.
No
[G, C, P] Hospitalization is
required for treatment of
acute pneumonia.

Pontiac fever resolves without
treatment and has flu-like
symptoms.
Edel stein in
Murray, 2007
AwwaRF, 2004
CDC, 2005
Heymann, 2005
Edelstein in
Murray, 2007
CDC, 2005

Edelstein in
Murray, 2007

Edelstein in
Murray, 2007
Heymann, 2005

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2
1
Data Element
Does the illness result in
mild symptoms with
minimal or no impact on
daily activities?
Scoring Data

Reference3

 See section 3.4 for a detailed description on how to calculate the total pathogen score.
2 Bolded Text indicates the highest score for that particular protocol. For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score. The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol: G-
General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
3EPA based the WBDO scores on the CDC MMWR reports from 1991 - 2006 and then
collected occurrence citations if there were no CDC WBDOs.  Two exceptions to this
WBDO scoring criteria are Arcobocter butzleri and Mycobacterium avium.
References
AwwaRF, 2004. Occurrence of Legionella in Groundwater.

CDC, 1991. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3); 1-21.

CDC, 1993. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1991—1992. MMWR Surveillance Summaries, 42(SS-5); 1-22.

CDC, 1996. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1993—1994. MMWR Surveillance Summaries, 45(SS-1); 1-33.

CDC, 1998. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5); 1-33.

CDC, 2000. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4); 1-35.

CDC, 2002. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1999—2000. MMWR Surveillance Summaries, 51(SS-8); 1-36.

CDC, 2004. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001—2002. MMWR Surveillance Summaries, 53(SS08); 23-45.

CDC, 2005.  Legionellosis: Legionnaires' Disease (LD) and Pontiac Fever.  Disease Listing.
October 12, 2005. http://www.cdc.gov/ncidod/dbmd/diseaseinfo/legionellosis_t.htm

                                          89

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EPA OGWDW                       Final CCL 3 Microbes.                      EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009


CDC, 2006. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2003—2004. MMWR Surveillance Summaries, 55(SS12); 31-58.
Edelstein, P.  2007.  Legionella. In Murray, P.  R., E. J. Baron, J. H. Jorgensen, M.L. Landry, and
M.A. Pfaller (ed.) The Manual of Clinical Microbiology, 9th. edition, American Society for
Microbiology, Washington, DC. Vol. 1: p. 837.
Heymann, D. (ed.). 2005. Control of Communicable Diseases Manual, 18th ed. American Public
Health Association, Washington, DC.
Lin, Y.S., I.E. Stout, V.L. Yu, and R.D. Vidic. 1998. Disinfection of water distribution systems
for Legionella. Semin. Respir. Infect. 13: 147-159.
Maier, R.M.,  I.L. Pepper, C.P. Gerba. 2000. Environmental Microbiology.  Academic Press.
pp.: 454-455, 539.
                                           90

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                               Microsporidia Scoring Data
Scoring Summary
Occurrence 2
Health Effects
General population 2
Sensitive subpopulation(s) [CD, C] 2
Score2

5
4
3
2
1

3
2
1

7
Data Element
Scoring Data

Reference3
Waterborne Disease Outbreaks
Has caused multiple (2 or
more) documented
WBDOsintheU.S. as
reported by CDC
surveillance between 1990
and 2004?
Has caused at least one
documented WBDOs in
the U.S. as reported by
CDC surveillance between
1990 and 2004?
Has caused documented
WBDOs at any time in the
U.S.?
Has caused WBDOs in
countries other than the
U.S.?
Has never caused
WBDOs in any country,
but has been
epidemiologically
associated with water
related disease?
No
No
No
No
Yes
CDC, 1991 -CDC,
2006
CDC, 1991 -CDC,
2006


Cotte, et al., 1999
Enriquez et al., 1998
Hutin et al., 1998
Occurrence
Detected in drinking water
in the U.S.?
Detected in source water
in the U.S.?
Not detected in the U.S.?
No
Yes
N/A

Didier et al., 2004
Dowd et al., 1998

Health Effects
Does the organism cause


                                           91

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2

6
5
4
3
2[G,C,P,E,
CD]
1
Data Element
significant mortality (>
1/1,000 cases)?
Does the organism cause
pneumonia, meningitis,
hepatitis, encephalitis,
endocarditis, cancer, or
other severe
manifestations of illness
necessitating long term
hospitalization (> week)?
Does the illness result in
long term or permanent
dysfunction or disability,
i.e. sequelae?
Does the illness require
short term hospitalization
(< week)?
Does the illness require
physician intervention?
Is the illness self-limiting
within 72 hours (without
requiring medical
intervention)?
Does the illness result in
mild symptoms with
minimal or no impact on
daily activities?
Scoring Data




Antimicrobial therapy
available for
immunodeficient patients.
[All populations]
Diarrhea and weight
loss lasting in up to 2 - 3
weeks in
immunocompetent
hosts. Has been
identified among elderly
persons with acute or
chronic diarrhea.

Reference3




Weber in Murray,
2007
Weber in Murray,
2007

 See section 3.4 for a detailed description on how to calculate the total pathogen score.
2 Bolded Text indicates the highest score for that particular protocol. For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score. The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol: G-
General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
3EPA based the WBDO scores on the CDC MMWR reports from 1991 - 2006 and then
                                          92

-------
EPA  OGWDW                      Final CCL 3 Microbes.                      EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009


collected occurrence citations if there were no CDC WBDOs. Two exceptions to this
WBDO scoring criteria are Arcobocter butzleri and Mycobacterium avium.
References
CDC, 1991. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3); 1-21.

CDC, 1993. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1991—1992. MMWR Surveillance Summaries, 42(SS-5); 1-22.

CDC, 1996. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1993—1994. MMWR Surveillance Summaries, 45(SS-1); 1-33.

CDC, 1998. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5); 1-33.

CDC, 2000. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4); 1-35.

CDC, 2002. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1999—2000. MMWR Surveillance Summaries, 51(SS-8); 1-36.

CDC, 2004. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001—2002. MMWR Surveillance Summaries, 53(SS08); 23-45.

CDC, 2006. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2003— 2004. MMWR Surveillance Summaries, 55(SS12); 31-58.

Cotte, L., M. Rabondonira, F. Chapuis, F. Bailly, F. Bissuel. C. Raynal. 1999. Waterborne
outbreak of intestinal microsporidiosis in persons with and without human immunodeficiency
virus infection. J. Infect. Dis. 180: 2003-2008.
Didier, E.S., M.E. Stovall, L.C. Green, P.J. Brindley, K. Sestak, and P.J. Didier. 2004. Vet.
Parasitol. 126: 145-166.
Dowd, S.E., C.P. Gerba, I.L. Pepper. 1998. Confirmation of the human-pathogenic microsporidia
Enterocytozoon bieneusi, Encephalitozoon  intestinalis, and Vittaforma corneae in water. Appl.
Environ. Microbiol. 64(9): 3332-3335.
Enriquez, F.J., D. Taren, A. Cruz-Lopez, M. Muramoto, J.D. Falling, P. Cruz. 1998. Prevalence
of intestinal encephalitozoonosis in Mexico. Clin. Infect. Dis. 26: 1227-1229.
Hutin, Y.J.F., M.N. Sombardier, O. Ligoury, C. Sarfati, F. Derouin, J. Modai, J.M. Molina. 1998.
Risk factors for intestinal micorspooridiosis in patients with human immunodeficiency virus
infection.: a case control study. J. Infect. Dis. 178: 904-907.

                                           93

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EPA OGWDW                      Final CCL 3 Microbes.                       EPA 815-R-09-009
                                  PCCL to CCL Process                            August 2009


Weber R., A. Mathis and P. Deplazes.  2007. Microsporidia.  In Murray, P. R., E. J. Baron, J.
H. Jorgensen, M. A. Pfaller, and R. H Yolken (ed.) The Manual of Clinical Microbiology, 9th
edition, American Society for Microbiology, Washington, DC Vol. 2; pp. 2133-2135.
                                            94

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                           Mycobacterium avium Scoring Data
Scoring Summary1
Waterborne Disease Outbreak
4
Health Effects
General population
Sensitive subpopulation(s) [E]
3
5
Score2

5
4
O
2
1

3
2
1

7
Data Element
Scoring Data
Reference3
Waterborne Disease Outbreaks
Has caused multiple (2 or
more) documented WBDOs
in the U.S. as reported by
CDC surveillance between
1990 and 2004?
Has caused at least one
documented WBDOs in the
U.S. as reported by CDC
surveillance between 1990
and 2004?
Has caused documented
WBDOs at any time in the
U.S.?
Has caused WBDOs in
countries other than the U.S.?
Has never caused WBDOs in
any country, but has been
epidemiologically associated
with water related disease?
No
Yes
Not listed in CDC's
MMWR however,
data linking patient,
outbreak and
drinking water.
No
No
Yes
CDC, 1991 -CDC,
2006
Tobin-D'Angelo et
al., 2004


Gloveretal., 1994
Aronson et al., 1999
vonReyn et al., 1994
Occurrence
Detected in drinking water
in the U.S.?
Detected in source water in
the U.S.?
Not detected in the U.S.?
Yes
Yes
N/A
Glover et al., 1994
Covert et al., 1999
Falkinham et al.,
2001
Covert etal., 1999
Falkinham et al., 2004

Health Effects
Does the organism cause
significant mortality (>


                                           95

-------
EPA OGWDW
             Final CCL 3 Microbes.
             PCCL to CCL Process
                          EPA815-R-09-009
                               August 2009
  Score
Data Element
Scoring Data
Reference
              1/1,000 cases)?
             Does the organism cause
             pneumonia, meningitis,
             hepatitis, encephalitis,
             endocarditis, cancer, or other
             severe manifestations of
             illness necessitating long
             term hospitalization (>
             week)?
                      Disseminated MAC
                      infections are a major
                      problem in HIV-
                      Infected individuals.
                   Heymann, 2005
   5[E]
             Does the illness result in
             long term or permanent
             dysfunction or disability,
             i.e. sequelae?
                      [E] Most commonly
                      immunocompetent
                      patients develop a
                      slowly evolving
                      cavitary disease that
                      resembles
                      tuberculosis. Elderly
                      non-smoking females,
                      can develop "Lady
                      Windermere's
                      syndrome" which has
                      been associated with
                      significant morbidity
                      and mortality.
                   Murray et al., 2005
  4 [CD]
             Does the illness require short
             term hospitalization (<
             week)?
                      [CD] Tuberculosis-like
                      upper lobe
                      fibrocavitary disease
                      occurs typically in men
                      45 - 60 who have
                      preexisiting lung
                      disease.
                   Pfyffer in Murray,
                   2007
                                          96

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2

3[G]

2

1
Data Element
Does the illness require
physician intervention?


Is the illness self-limiting
within 72 hours (without
requiring medical
intervention)?
Does the illness result in mild
symptoms with minimal or
no impact on daily activities?
Scoring Data
[G] Symptoms of
infection include
pulmonary disease,
lymphadenitis, post-
traumatic wound
infection. Diagnosis
of disease and
treatment requires
physician
intervention.



Reference3
Pfyffer in Murray,
2007
Heymann, 2005




 See section 3.4 for a detailed description on how to calculate the total pathogen score.
2 Bolded Text indicates the highest score for that particular protocol. For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score. The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol: G-
General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
3EPA based the WBDO scores on the CDC MMWR reports from 1991 - 2006 and then
collected occurrence citations if there were no CDC WBDOs. Two exceptions to this
WBDO scoring criteria are Arcobacter butzleri and Mycobacterium avium.
References
Aronson, T., A. Holtzman, N. Glover, M. Boian, S. Froman, O. G. W. Berlin, H. Hill, and G.
Stelma, Jr. 1999. Comparison of large restriction fragments of Mycobacterium avium isolates
recovered from ADDS and non-AIDS patients with those of isolates from potable water. J. Clin.
Microbiol. 37:  1008-1012.
CDC, 1991. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3); 1-21.

CDC, 1993. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1991—1992. MMWR Surveillance Summaries, 42(SS-5); 1-22.
                                          97

-------
EPA OGWDW                      Final CCL 3 Microbes.                       EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009


CDC, 1996. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1993—1994. MMWR Surveillance Summaries, 45(SS-1); 1-33.

CDC, 1998. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5); 1-33.

CDC, 2000. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4); 1-35.

CDC, 2002. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1999—2000. MMWR Surveillance Summaries, 51(SS-8); 1-36.

CDC, 2004. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001—2002. MMWR Surveillance Summaries, 53(SS08); 23-45.

CDC, 2006. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2003—2004. MMWR Surveillance Summaries, 55(SS12); 31-58.
Covert, T.C., M.R. Rodgers, A.L. Reyes, and G.N. Stelma, Jr.  1999. Occurrence of
nontuberculous mycobacteria in environmental samples. Appl. Environ. Microbiol. 65: 2492-
2496.
Falkinham, J.O., III, C.D. Norton, and M.W. LeChevallier. 2001. Factors influencing numbers of
Mycobacterium avium, Mycobacterium intracellulare, and other mycobacteria in drinking water
distribution systems. Appl. Environ. Microbiol.  67: 1225-1231.
Falkinham, J.O., G. Nichols, J. Bartram, A. Dufour, and F. Portaels. 2004. Natural ecology and
survival in water of mycobacteria of potential public health importance. . In Pedley, S., J.
Bartram, G. Rees, A. Dufour, and J. A. Cotruvo (Eds.) Pathogenic mycobacteria in water:  a
guide to public health consequences, monitoring and management. IWA Publishing, London,
UK.
Glover, N. , A. Holtzman, T. Aronson, S. Froman, O. G. W. Berlin, P. Dominguez, K. A.
Kunkel, G. Overturf, G.  Stelma, Jr., C. Smith, and M. Yakrus.  The isolation and identification of
Mycobacterium avium complex (MAC) recovered from Los Angeles potable water, a possible
source of infection in AIDS patients. Int.  J. Environ. Health Res. 4: 63-72.
Heymann, D. (ed.). 2005. Control of Communicable Diseases Manual, 18th ed. American Public
Health Association, Washington, DC.
Murray, P.R., K.S. Rosenthal and M.A. Pfaller.  2005.  Medical Microbiology, 5th edition.
Elsevier Mosby. p. 304.
Pfyffer, G. 2007. Mycobacterium: General Character!sitis, Laboratory Detection, and Staining
Procedures. In Murray, P. R., E. J. Baron, J. H. Jorgensen, M.L. Landry, and M. A. Pfaller (ed.)
The Manual of Clinical Microbiology, 9th. edition, American Society  for Microbiology,
Washington, DC. Vol. 1: pp. 547- 548.
Tobin-D'Angelo, M. J., M. A. Blass, C. del Rio, J. S. Halvosa, H. M. Blumberg, and C. R.
                                           98

-------
EPA OGWDW                       Final CCL 3 Microbes.                       EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009


Horsburgh, Jr. 2004. Hospital water as a source of Mycobacterium avium complex isolates in
respiratory specimens. J. Infect. Dis. 189: 98-104.0
von Reyn, C.  F., J. N. Maslow, T. W. Barber, J. O. Falkinham, III, and R. D. Arbeit. 1994.
Persistent colonization of potable water as a source of Mycobacterium avium infection in ADDS.
Lancet. 343: 1137-1141.
                                           99

-------
EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                             Naegleriafowleri Scoring Data
Scoring Summary
Waterborne Disease Outbreak
4
Health Effects
General population
Sensitive subpopulation(s) [C, P, E, CD]
7
7
Score2

5
4
O
2
1

3
2
1

Data Element
Scoring Data
Reference3
Waterborne Disease Outbreaks
Has caused multiple (2 or
more) documented WBDOs
in the U.S. as reported by
CDC surveillance between
1990 and 2004?
Has caused at least one
documented WBDOs in the
U.S. as reported by CDC
surveillance between 1990
and 2004?
Has caused documented
WBDOs at any time in the
U.S.?
Has caused WBDOs in
countries other than the U.S.?
Has never caused WBDOs in
any country, but has been
epidemiologically associated
with water related disease?
No
Yes
1 Community
N/A
N/A
N/A
CDC, 1991 -CDC,
2006
CDC, 2004
Marciano-Cabral et
al., 2003



Occurrence
Detected in drinking water
in the U.S.?
Detected in source water in
the U.S.?
Not detected in the U.S.?
Yes
Arizona storage -
Sampled pre-treatment
multiple-well study in
Arizona.
Yes
N/A
Gerba et al., 2007
Schuster and
Visvesvara, 2004

Health Effects
                                           100

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2
7 [G, C, P,
E,CD]
6
5
4
O
2
1
Data Element
Does the organism cause
significant mortality (>
1/1,000 cases)?
Does the organism cause
pneumonia, meningitis,
hepatitis, encephalitis,
endocarditis, cancer, or other
severe manifestations of
illness necessitating long
term hospitalization (>
week)?
Does the illness result in long
term or permanent
dysfunction or disability, i.e.
sequelae?
Does the illness require short
term hospitalization (<
week)?
Does the illness require
physician intervention?
Is the illness self-limiting
within 72 hours (without
requiring medical
intervention)?
Does the illness result in mild
symptoms with minimal or
no impact on daily activities?
Scoring Data
[All populations]
Recovery from primary
amoebic
meningoencephalitis is
rare.
Acute fulminating
disease. Only a few
patients have survived.
No
All cases are hospitalized
for diagnosis and
treatment.



Reference3
Heymann, 2005
Visvesvara in
Murray, 2007

Visvesvara in
Murray, 2007



JSee section 3.4 for a detailed description on how to calculate the total pathogen score.
2 Bolded Text indicates the highest score for that particular protocol. For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score. The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol: G-
General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
3EPA based the WBDO scores on the CDC MMWR reports from 1991 - 2006 and then
collected occurrence citations if there were no CDC WBDOs. Two exceptions to this
WBDO scoring criteria are Arcobocter butzleri and Mycobacterium avium.
                                             101

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EPA OGWDW                       Final CCL 3 Microbes.                       EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009
References
CDC, 1991.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3); 1-21.

CDC, 1993.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1991—1992. MMWR Surveillance Summaries, 42(SS-5); 1-22.

CDC, 1996.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1993—1994. MMWR Surveillance Summaries, 45(SS-1); 1-33.

CDC, 1998.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5); 1-33.

CDC, 2000.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4); 1-35.

CDC, 2002.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1999—2000. MMWR Surveillance Summaries, 51(SS-8); 1-36.

CDC, 2004.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001—2002. MMWR Surveillance Summaries, 53(SS08); 23-45.

CDC, 2006.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2003—2004. MMWR Surveillance Summaries, 55(SS12); 31-58.

Gerba, C., B. Blair, P.  Sarkar, and K. Bright.  2007.  Occurrence and Control of Naegleria
fowled  in Well Water and  Chlorine Resistance.   Proceedings, Water Quality Technology
Conference,  American Water Works Association, November 5-8, 2007.
Heymann, D. (ed.). 2005. Control of Communicable Diseases Manual, 18* ed. American Public
Health Association, Washington, DC. pp. 417-419.
Marciano-Cabral, F., R. MacLean, A. Mensah, and L. LaPat-Polasko. 2003. Identification of
Naegleria fowleri in domestic water source by nested PCR. Appl. Environ. Microbiol. 69 (10):
5864-5869.

Schuster, F.L. and G.S. Visvesvara. 2004. Free-living amoebae as opportunistic and non-
opportunistic pathogens of humans and animals. Int. J. Parasitol. 34: 1001-1027.
Visvesvara, G. 2007. Pathogenic and Opportunistic Free-Living Amebae. In Murray, P. R., E.
J. Baron, J. H. Jorgensen, M. A. Pfaller, and R. H Yolken (ed.) The Manual of Clinical
Microbiology, 9th edition, American Society for Microbiology, Washington, DC Vol. 2; pp.
2082-2086.
                                           102

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                          Plesiomonas shigelloides Scoring Data
Scoring Summary
Waterborne Disease Outbreak
4
Health Effects
General population
Sensitive subpopulation(s) [C, E]
2
3
Score2

5
4
3
2
1

3
2
Data Element
Scoring Data
Reference3
Waterborne Disease Outbreaks
Has caused multiple (2 or
more) documented
WBDOsintheU.S. as
reported by CDC
surveillance between
1990 and 2004?
Has caused at least one
documented WBDOs in
the U.S. as reported by
CDC surveillance
between 1990 and 2004?
Has caused documented
WBDOs at any time in
the U.S.?
Has caused WBDOs in
countries other than the
U.S.?
Has never caused
WBDOs in any country,
but has been
epidemiologically
associated with water
related disease?
No
Yes
1 Noncommunity
N/A
N/A
N/A
CDC, 1991 -CDC,
2006
CDC, 1998(b)



Occurrence
Detected in drinking
water in the U.S.?
Detected in source water
in the U.S.?
Yes
Yes
CDC, 1998(a)
Abbott in Murray,
2007
Holmberg and
Farmer, 1984
Holmberg et al., 1986
                                           103

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2
1

7
6
5
4
3 [C, E]
2[G]
1
Data Element
Not detected in the U.S.?
Scoring Data
N/A
Reference3

Health Effects
Does the organism cause
significant mortality (>
1/1,000 cases)?
Does the organism cause
pneumonia, meningitis,
hepatitis, encephalitis,
endocarditis, cancer, or
other severe
manifestations of illness
necessitating long term
hospitalization (> week)?
Does the illness result in
long term or permanent
dysfunction or disability,
i.e. sequelae?
Does the illness require
short term hospitalization
(< week)?
Does the illness require
physician intervention?
Is the illness self-limiting
within 72 hours (without
requiring medical
intervention)?
Does the illness result in
mild symptoms with
minimal or no impact on
daily activities?
No
No
No
Hospitalization may be
required for severe
infections and/or
underlying diseases.
[C,E]
Physician office visit
may be required for
diagnosis and
treatment of
dysenteric form of the
disease in children or
the elderly.
Bacteremia more
common with
advanced age.
[G] Diarrhea may
persist up to two
weeks.
Plesiomonas is
associated with
travelers' diarrhea or a
history of seafood
consumption, most



Abbott in Murray,
2007
Abbott in Murray,
2007
Abbott in Murray,
2007
Abbott in Murray,
2007
                                             104

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EPA OGWDW                      Final CCL 3 Microbes.                      EPA 815-R-09-009
                                 PCCL to CCL Process                          August 2009
Score2

Data Element

Scoring Data
infections are self-
limiting.
Reference3

 See section 3.4 for a detailed description on how to calculate the total pathogen score.
2 Bolded Text indicates the highest score for that particular protocol. For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score.  The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol: G-
General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
3EPA based the WBDO scores  on the CDC MMWR reports from 1991 - 2006 and then
collected occurrence citations if there were no CDC WBDOs. Two exceptions to this
WBDO scoring criteria are Arcobacter butzleri and Mycobacterium avium.
References
Abbott, S.L. 2007. Klebsiella, Enterobacter, Citrobacter, Serratia, Plesiomonas, and other
Enterobacteriaceae. In Murray, P. R., E. J. Baron, J. H. Jorgensen, M. A. Pfaller, and R. H
Yolken (ed.) The Manual of Clinical Microbiology, 9* edition, American Society for
Microbiology, Washington, DC Vol. 1; pp. 700-704.
CDC, 1991.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3); 1-21.

CDC, 1993.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1991—1992. MMWR Surveillance Summaries, 42(SS-5); 1-22.

CDC, 1996.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1993—1994. MMWR Surveillance Summaries, 45(SS-1); 1-33.

CDC. 1998(a). Plesiomonas shigelloides and Salmonella serotype Hartford infections associated
with a contaminated water supply - Livingston County, New York, 1996. MMWR 47(19):394-
396.

CDC, 1998(b). Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water
— United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5); 1-33.

CDC, 2000.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4); 1-35.
CDC, 2002.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1999—2000. MMWR Surveillance Summaries, 51(SS-8); 1-36.
CDC, 2004.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001—2002. MMWR Surveillance Summaries, 53(SS08); 23-45.
                                          105

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EPA OGWDW                       Final CCL 3 Microbes.                      EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009
CDC, 2006. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2003—2004. MMWR Surveillance Summaries, 55(SS12); 31-58.
Holmberg, S.D. and JJ. Farmer. 1984. Aeromonas hydrophila and Plesiomonas shigelloides as
causes of intestinal infections. Rev. Infect. Dis. 6: 633-639.
Holmberg, S.D., K. Wachsmith, F.W. Hickman-Brenner, P.A. Blake, and JJ. Farmer. 1986.
Plesiomonas enteric infections in the United States. Ann. Intern. Med. 105(5):  690-694.
                                          106

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                                 Rotavirus Scoring Data
Scoring Summary
Occurrence
3
Health Effects
General population
Sensitive subpopulation(s) [C]
1
6
Score2

5
4
3
2
1

3
2
1

7
Data Element
Scoring Data
Reference3
Waterborne Disease Outbreaks
Has caused multiple (2 or more)
documented WBDOs in the U.S.
as reported by CDC surveillance
between 1990 and 2004?
Has caused at least one
documented WBDOs in the U.S.
as reported by CDC surveillance
between 1990 and 2004?
Has caused documented WBDOs
at any time in the U.S.?
Has caused WBDOs in
countries other than the U.S.?
Has never caused WBDOs in any
country, but has been
epidemiologically associated with
water related disease?
No
No
N/A
Yes
China and Sweden.
N/A
CDC, 1991 -CDC, 2006
CDC, 1991 -CDC, 2006

Hrdy, 1987
Gerba et al., 1996

Occurrence
Detected in drinking water in
the U.S.?
Detected in source water in the
U.S.?
Not detected in the U.S.?
Yes
Yes
N/A
USGS, 2001
Gerba et al., 1996
Abbaszadegan et al., 2003
Gerba etal., 1996

Health Effects
Does the organism cause
significant mortality (> 1/1,000
cases)?
No
For children under 5
years of age:
Estimated 37 deaths
in 60,000
hospitalized cases per
year in U.S. (1/1621
Fischer et al., 2007
                                           107

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2
















6[C]















5

4

o
j
Data Element

Does the organism cause
pneumonia, meningitis,
hepatitis, encephalitis,
endocarditis, cancer, or other
severe manifestations of illness
necessitating long term
hospitalization (> week)?























Does the illness result in long
term or permanent dysfunction or
disability, i.e. sequelae?
Does the illness require short
term hospitalization (< week)?
Does the illness require physician
intervention?
Scoring Data
hospitalizations).
[C] Rotavirus
infects all children;
causes severe
gastroenteritis in
infants. Significant
numbers of
physician visits and
hospitalizations and
high medical and
societal costs.
A sporadic,
seasonal, often
severe
gastroenteritis of
infants and young
children,
characterized by
vomiting, fever and
watery diarrhea.
Rotaviral enteritis is
occasionally
associated with
severe dehydration
and death in young
children. In
developing
countries, an
estimated 600,000-
870,000 diarrheal
deaths each year.







Reference3

Farkas in Murray, 2007


















Heymann, 2005

















                                             108

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2
2
1 [G, P,
E, CD]
Data Element
Is the illness self-limiting within
72 hours (without requiring
medical intervention)?
Does the illness result in mild
symptoms with minimal or no
impact on daily activities?
Scoring Data

[G,E,P,CD]
Self-limiting acute
watery diarrhea,
vomiting, fever.
Reference3

Heymann, 2005
 See section 3.4 for a detailed description on how to calculate the total pathogen score.
2 Bolded Text indicates the highest score for that particular protocol. For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score. The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol: G-
General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
3EPA based the WBDO scores on the CDC MMWR reports from 1991 - 2006 and then
collected occurrence citations if there were no CDC WBDOs. Two exceptions to this
WBDO scoring criteria are Arcobacter butzleri and Mycobacterium avium.
References
Abbaszadegan, M., M. LeChevallier, and C.P. Gerba. 2003. Occurrence of viruses in U. S.
groundwatersJAWWA95: 107-120.
CDC, 1991. Surveillance for Waterborne-Disease Outbreaks Associated
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3);

CDC, 1993. Surveillance for Waterborne-Disease Outbreaks Associated
United States, 1991—1992. MMWR Surveillance Summaries, 42(SS-5);

CDC, 1996. Surveillance for Waterborne-Disease Outbreaks Associated
United States, 1993—1994. MMWR Surveillance Summaries, 45(SS-1);

CDC, 1998. Surveillance for Waterborne-Disease Outbreaks Associated
United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5);

CDC, 2000. Surveillance for Waterborne-Disease Outbreaks Associated
United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4);

CDC, 2002. Surveillance for Waterborne-Disease Outbreaks Associated
United States, 1999—2000. MMWR Surveillance Summaries, 51(SS-8);
CDC, 2004. Surveillance for Waterborne-Disease Outbreaks Associated
United States, 2001— 2002. MMWR Surveillance Summaries, 53(SS08);
                               with Drinking Water •
                               1-21.

                               with Drinking Water •
                               1-22.

                               with Drinking Water •
                               1-33.

                               with Drinking Water •
                               1-33.

                               with Drinking Water •
                               1-35.
                               with Drinking Water •
                               1-36.
                               with Drinking Water •
                               23-45.
                                          109

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EPA OGWDW                       Final CCL 3 Microbes.                      EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009


CDC, 2006. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2003—2004. MMWR Surveillance Summaries,  55(SS12); 31-58.
Farkas, T. and X. Jiang.  2007. Rotaviruses, Caliciviruses, Astroviruses, Enteric Adenoviruses,
and Other Diarrheic Viruses. In Murray, P. R., E. J. Baron, J.  H. Jorgensen, M. A. Pfaller, and
R. H Yolken (ed.) The Manual of Clinical Microbiology, 9th edition, American Society for
Microbiology, Washington, DC Vol. 2; pp. 1454-1457.
Fischer, T.K., C. Viboud, U. Parashar, M. Malek, C. Steiner, R.  Glass, and L. Simonsen. 2007.
Hospitalizations and deaths from diarrhea and rotavirus among children < 5 years of age in the
United States, 1993-2003. Journal of Infectious Diseases 195:  1117.
Gerba, C.P., J.B. Rose, C.N. Haas, and K.D. Crabtree. 1996. Waterborne rotavirus: a risk
assessment. Wat. Res. 30: 2929
Heymann, D. (ed.). 2005. Control of Communicable Diseases  Manual, 18* ed. American Public
Health Association, Washington, DC.
Hrdy, D.B., 1987. Epidemiology of Rotaviral Infection in Adults. Reviews of Infectious
Diseases. 195(3): 463.
USGS, 2001.  W.S.L. Banks, C.A. Klohe and D.A. Battigelli.  Occurrence and Distribution of
Enteric Viruses in Shallow Ground Water and Factors Affecting Well Vulnerability to
Microbiological Contamination in Worcester and Wicomico Counties, Maryland. Water-
Resources Investigations Report 01-4147: pp. 14, 21.
                                           110

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                            Salmonella enterica Scoring Data
Scoring Summary
Waterborne Disease Outbreak
5
Health Effects
General population
Sensitive subpopulation(s) [C, E]
3
4
Score2

5
4
O
2
1

3
2
1

7
Data Element
Scoring Data
Reference3
Waterborne Disease Outbreaks
Has caused multiple (2
or more) documented
WBDOs in the U.S. as
reported by CDC
surveillance between
1990 and 2004?
Has caused at least one
documented WBDOs in
the U.S. as reported by
CDC surveillance between
1990 and 2004?
Has caused documented
WBDOs at any time in the
U.S.?
Has caused WBDOs in
countries other than the
U.S.?
Has never caused WBDOs
in any country, but has
been epidemiologically
associated with water
related disease?
Yes
1 Community
1 Community
1 Noncommunity
N/A
N/A
N/A
N/A
CDC, 1996
CDC, 2002
CDC, 2006




Occurrence
Detected in drinking
water in the U.S.?
Detected in source water
in the U.S.?
Not detected in the U.S.?
Yes
N/A
N/A
Angulo et al., 1997
CDC, 1998(a).


Health Effects
Does the organism cause
significant mortality (>
Each year, 1 .4 M cases
of illness and 600 deaths
Nataro et al. in Murray,
2007
                                           111

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EPA OGWDW
                     Final CCL 3 Microbes.
                     PCCL to CCL Process
                                  EPA815-R-09-009
                                       August 2009
  Score
     Data Element
     Scoring Data
Reference3
             1/1,000 cases)?
                          are caused by non-
                          typhoidal salmonellosis
                          in the U.S.
                          Estimated 800 cases per
                          year of typhoid fever in
                          the U.S., with fewer than
                          5 deaths/yr.; >70% of
                          U.S. cases related to
                          foreign travel.
            Does the organism cause
            pneumonia, meningitis,
            hepatitis, encephalitis,
            endocarditis,  cancer, or
            other severe
            manifestations of illness
            necessitating long term
            hospitalization (> week)?
                          Nontyphoidal
                          salmonellosis usually
                          causes intestinal
                          infection; can cause
                          extraintestinal infections
                          in rare cases (bacteremia,
                          urinary tract infection,
                          osteomyelitis), especially
                          in immunocompromised
                          persons.
                         Nataro et al. in Murray,
                         2007
            Does the illness result in
            long term or permanent
            dysfunction or disability,
            i.e. sequelae?
                          None reported.
 4[C,E]
            Does the illness require
            short term
            hospitalization (< week)?
                          [C] Extra-intestinal
                          infections highest in
                          infants and young
                          children.

                          [E] Dehydration,
                          especially among
                          infants or in the elderly,
                          may be severe. Deaths
                          are uncommon, except
                          in the young and old,
                          the debilitated and
                          immunosuppressed.
                         Nataro et al. in Murray,
                         2007
                                                                Heymann, 2005
 3 [G, P,
   CD]
Does the illness require
physician intervention?
[G,P,CD] Antibiotic
and rehydration may
be necessary.
                                                                Heymann, 2005
                                          112

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2
2
1
Data Element
Is the illness self-limiting
within 72 hours (without
requiring medical
intervention)?
Does the illness result in
mild symptoms with
minimal or no impact on
daily activities?
Scoring Data
Non-typhoidal
Salmonella usually cause
intestinal infection that
often lasts 1 week or
longer.

Reference3
Nataro et al. in Murray,
2007

 See section 3.4 for a detailed description on how to calculate the total pathogen score.
2 Bolded Text indicates the highest score for that particular protocol. For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score. The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol: G-
General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
3EPA based the WBDO scores on the CDC MMWR reports from 1991 - 2006 and then
collected occurrence citations if there were no CDC WBDOs.  Two exceptions to this
WBDO scoring criteria are Arcobocter butzleri and Mycobacterium avium.

References
Angulo, F. I, S. Tippen, D. J. Sharp, B. J. Payne, C. Collier, J. E. Hill, T. J. Barrett, R. H.  Clark,
E. E. Geldreich, H.  D. Donnell, Jr., D. L Swerdlow. 1997. A community waterborne outbreak of
salmonellosis and the effectiveness of a boil water  order. Am. J. Public Health 87(4): 580-584.
CDC, 1991.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3);  1-21.

CDC, 1993.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1991—1992. MMWR Surveillance Summaries, 42(SS-5);  1-22.

CDC, 1996.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1993—1994. MMWR Surveillance Summaries, 45(SS-1);  1-33.

CDC, 1998(a). Plesiomonas shigelloides and Salmonella serotype Hartford infections associated
with a contaminated water supply - Livingston County, New York, 1996. MMWR 47(19):394-
396.

CDC, 1998(b). Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water
— United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5); 1-33.

CDC, 2000.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —

                                          113

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EPA OGWDW                       Final CCL 3 Microbes.                      EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009


United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4); 1-35.
CDC, 2002. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1999—2000. MMWR Surveillance Summaries, 51(SS-8); 1-36.
CDC, 2004. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001— 2002. MMWR Surveillance Summaries, 53(SS08); 23-45.
CDC, 2006. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1997-1998. MMWR Surveillance Summaries, 55(SS12); 31-65.
Heyman, D. (ed.). 2005. Control of Communicable Diseases Manual, 18ed. American Public
Health Association, Washington, DC.
Nataro, J.P., C.A. Bopp, P.I. Fields, J.B. Kaper, andN.A. Strockbine. 2007. Escherichia,
Shigella, and Salmonella. In Murray, P. R., E. J. Baron, J. H. Jorgensen, M.L. Landry, and M. A.
Pfaller (ed.) The Manual of Clinical Microbiology, 9th. edition, American Society for
Microbiology, Washington, DC. Vol. 1: pp.  680-687.
                                           114

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                              Shigella sonnei Scoring Data
Scoring Summary
Waterborne Disease Outbreak
5
Health Effects
General population
Sensitive subpopulation(s) [C, E]
3
6
Score2

5
4
3
2
1

3
2
1

7
Data Element
Scoring Data
Reference3
Waterborne Disease Outbreaks
Has caused multiple (2 or
more) documented WBDOs in
the U.S. as reported by CDC
surveillance between 1990
and 2004?
Has caused at least one
documented WBDOs in the
U.S. as reported by CDC
surveillance between 1990 and
2004?
Has caused documented
WBDOs at any time in the
U.S.?
Has caused WBDOs in
countries other than the U.S.?
Has never caused WBDOs in
any country, but has been
epidemiologically associated
with water related disease?
Yes
1 Noncommunity
2 Noncommunity (1
Previously unreported)
2 Noncommunity
1 Community
N/A
N/A
N/A
N/A
CDC, 1993
CDC, 1996
CDC, 1998
CDC, 2000




Occurrence
Detected in drinking water in
the U.S.?
Detected in source water in the
U.S.?
Not detected in the U.S.?
Yes
Yes
N/A
Craun, 2003
Black etal., 1978

Health Effects
Does the organism cause
In U.S. approximately
Nataro in Murray,
                                           115

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EPA OGWDW
                      Final CCL 3 Microbes.
                      PCCL to CCL Process
                              EPA815-R-09-009
                                   August 2009
 Score2
        Data Element
     Scoring Data
Reference3
           significant mortality (> 1/1,000
           cases)?
                              450,000 cases occur
                              each year with 70 deaths.
                         2007.
6 [C, E]
Does the organism cause
pneumonia, meningitis,
hepatitis, encephalitis,
endocarditis, cancer, or other
severe manifestations of
illness necessitating long term
hospitalization (> week)?
[C, E] S. dysentariae is
associated with more
serious symptoms than
other species with
complications such as
toxic megacolon,
hemolytic uremic
syndrome and intestinal
perforation. Cases may
be severe in infants  and
the elderly and
convulsions may occur
in young children.
                                                                 Heymann, 2005
           Does the illness result in long
           term or permanent dysfunction
           or disability, i.e. sequelae?
                              Reiter's syndrome.
                         Heymann, 2005
           Does the illness require short
           term hospitalization (< week)?
                              Hospitalization is usually
                              required for intravenous
                              antibiotic therapy due to
                              bacteremia, which is
                         Heymann, 2005
                                         uncommon.
 3[G]
           Does the illness require
           physician intervention?
                              [G] Most cases occur in
                              children under 10
                              years, infants under 6
                              months rarely infected,
                              increased severity in
                              children and elderly,
                              high secondary case
                              rate in outbreaks,
                              outbreaks occur in
                              daycare centers,
                              institutions, refugee
                              camps, among
                              homosexual men, 20%
                              of U.S. cases result from
                              international travel,
                              specific antibiotic
                              therapy available for
                              prolonged or severe
                              ~L16
                         Heymann, 2005

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2

2
1
Data Element

Is the illness self-limiting
within 72 hours (without
requiring medical
intervention)?
Does the illness result in mild
symptoms with minimal or no
impact on daily activities?
Scoring Data
cases, multi-antibiotic
resistance occurs.
Acute diarrhea, fever,
nausea, vomiting, cramps
and tenesmus, stools
contain blood and mucus
(dysentery), usually self-
limiting in 4-7 days
without treatment.
S. sonnet causes most of
the shigellosis cases in
the U.S., cases may be
asymptomatic or mildly
symptomatic, but they
are frequently acute.
Reference3

Heymann, 2005
Heymann, 2005
 See section 3.4 for a detailed description on how to calculate the total pathogen score.
2 Bolded Text indicates the highest score for that particular protocol. For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score. The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol:  G-
General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
3EPA based the WBDO scores on the CDC MMWR reports from 1991 - 2006 and then
collected occurrence citations if there were no CDC WBDOs. Two exceptions to this
WBDO scoring criteria are Arcobacter butzleri and Mycobacterium avium.
References
Black, R.E., G.F. Craun, and P. A. Blake. 1978. Epidemiology of common-source outbreaks of
shigellosis in the United States, 1961-1975. Am. J. Epidemiol. 108: 47-52.
CDC, 1991. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3); 1-21.

CDC, 1993. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1991—1992. MMWR Surveillance Summaries, 42(SS-5); 1-22.

CDC, 1996. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1993—1994. MMWR Surveillance Summaries, 45(SS-1); 1-33.

CDC, 1998. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5); 1-33.
                                          117

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EPA OGWDW                       Final CCL 3 Microbes.                      EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009


CDC, 2000. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4); 1-35.

CDC, 2002. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1999—2000. MMWR Surveillance Summaries, 51(SS-8); 1-36.

CDC, 2004. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001—2002. MMWR Surveillance Summaries, 53(SS08); 23-45.

CDC, 2006. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2003—2004. MMWR Surveillance Summaries, 55(SS12); 31-58.

Craun, G., R. Calderon, and M. Craun. 2003. Waterborne Outbreaks in the United States, 1971-
2000, in Drinking Water Regulation and Health. F. Pontius (ed.): pp. 45 - 60.
Heymann, D. (ed.). 2005. Control of communicable diseases manual.  18th edition. American
Public Health Association, Washington, DC.
Nataro, J. C Bopp, P Fields, J. Kaper and N. Strockbine. 2007. Escherichia,  Shigella, and
Salmonella.  In Murray, P. R., E. J. Baron, J. H. Jorgensen, M. A. Pfaller, and R. H Yolken (ed.)
The Manual of Clinical Microbiology, 9*  edition, American Society for Microbiology,
Washington, DC. Vol. 1: pp. 670, 677 - 678.
                                           118

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                           Toxoplasma gondii Scoring Data
Scoring Summary
Waterborne Disease Outbreak
2
Health Effects
General population
Sensitive subpopulation(s) [P]
2
7
Score2

5
4
3
2
1

3
2
1
Data Element
Scoring Data
Reference3
Waterborne Disease Outbreaks
Has caused multiple (2
or more) documented
WBDOsintheU.S. as
reported by CDC
surveillance between
1990 and 2004?
Has caused at least one
documented WBDOs
in the U.S. as reported
by CDC surveillance
between 1990 and
2004?
Has caused
documented WBDOs
at any time in the U.S.?
Has caused WBDOs
in countries other
than the U.S.?
Has never caused
WBDOs in any
country, but has been
epidemiologically
associated with water
related disease?
No
No
No
Yes
Canada and Brazil.
N/A
CDC, 1991 -CDC,
2006
CDC, 1991 -CDC,
2006

Bowie et al., 1997
de Moura, 2006

Occurrence
Detected in drinking
water in the U.S.?
Detected in source
water in the U.S.?
Not detected in the
U.S.?
No
No
Yes
Groundwater in Poland


Sroka et al., 2006
                                          119

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EPA OGWDW
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PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2


7[P]
6
5
4
3
2 [G, C,
Data Element

Scoring Data
and Canada.
Reference3
Isaac-Renton et al.,
1998
Health Effects
Does the organism
cause significant
mortality (> 1/1,000
cases)?
Does the organism
cause pneumonia,
meningitis, hepatitis,
encephalitis,
endocarditis, cancer, or
other severe
manifestations of
illness necessitating
long term
hospitalization (>
week)?
Does the illness result
in long term or
permanent dysfunction
or disability, i.e.
sequelae?
Does the illness require
short term
hospitalization (<
week)?
Does the illness require
physician intervention?
Is the illness self-
[P] Congenital infection
of neonates severe.
Infection during early
pregnancy may lead to
fetal infection with death
of the fetus or other
severe manifestations.
Later in pregnancy,
maternal infection
results in mild or
subclinical fetal disease.
Immunocompromi sed
hosts may experience
CNS, pneumonitis, and
myocarditis.


Treatment is indicated
only for pregnant women,
infants and
immunocompromi sed
hosts.
[G, C, E, CD] Infection
Wilson in Murray,
2007
Heymann, 2005
Wilson in Murray,
2007


Wilson in Murray,
2007
Wilson in Murray,
                                             120

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EPA OGWDW
Final CCL 3 Microbes.
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EPA815-R-09-009
     August 2009
Score2
E,CD]
1
Data Element
limiting within 72
hours (without
requiring medical
intervention)?
Does the illness result
in mild symptoms with
minimal or no impact
on daily activities?
Scoring Data
is generally
asymptomatic; however
10 - 20% of patients
with acute infection may
develop cervical
lymphadenopathy
and/or flu-like
symptoms.

Reference3
2007

 See section 3.4 for a detailed description on how to calculate the total pathogen score.
2 Bolded Text indicates the highest score for that particular protocol.  For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score. The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol: G-
General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
3EPA based the WBDO scores on the CDC MMWR reports from 1991 - 2006 and then
collected occurrence citations if there were no CDC WBDOs.  Two exceptions to this
WBDO scoring criteria are Arcobocter butzleri and Mycobacterium avium.
References
Bowie, W. R., S. A. King, D. H. Werker, J. L. Isaac-Renton, A. Bell, S. B. Eng, and S. A.
Marion. 1997. Outbreak of toxoplasmosis associated with municipal drinking water. Lancet 350:
173-177.

CDC, 1991. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3); 1-21.

CDC, 1993. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1991—1992. MMWR Surveillance Summaries, 42(SS-5); 1-22.

CDC, 1996. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1993—1994. MMWR Surveillance Summaries, 45(SS-1); 1-33.

CDC, 1998. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5); 1-33.

CDC, 2000. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
                                          121

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EPA OGWDW                      Final CCL 3 Microbes.                      EPA 815-R-09-009
                                 PCCL to CCL Process                           August 2009


United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4); 1-35.

CDC, 2002. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1999—2000. MMWR Surveillance Summaries, 51(SS-8); 1-36.

CDC, 2004. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001— 2002. MMWR Surveillance Summaries, 53(SS08); 23-45.

CDC, 2006. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2003— 2004. MMWR Surveillance Summaries, 55(SS12); 31-58.

Heymann, D. (ed.). 2005. Control of Communicable Diseases Manual, 18*  ed. American Public
Health Association, Washington, DC.

Isaac-Renton, J, W.R. Bowie, A. King, G.S. Irwin, C.S. Ong, C.P. Fung, M.O. Shokeir and J.P.
Dubey.  1998.  Detection of Toxoplasma gondii Oocysts in Drinking Water. Appl. Environ.
Microbiol. 64(6): 2278-2280.

de Moura L., L.M. Bahia-Oliveira, M.Y. Wada, J.L. Jones, S.H. Tuboi, E.H. Carmo, W.M.
Ramalho, N.J. Camargo, R. Trevisan, R.M. Graca, AJ. da Silva, I. Moura, J.P. Dubey, and D.O.
Garrett. 2006. Waterborne toxoplasmosis, Brazil, from field to gene. Emerging Infectious
Diseases, 12(2): 326-9.

Sroka J., A. Wojcik-Fatla, J. Dutkiewicz. 2006. Occurrence of Toxoplasma Gondii in Water
from Wells Locatedon Farms.  Ann Agric Environm Med. 13: 169-175.

Wilson, M., J. Jones and J. McAuley.  2007.  Toxoplasma. In Murray, P. R., E. J. Baron, J. H.
Jorgensen, M.L. Landry, and M. A. Pfaller (ed.) The Manual of Clinical Microbiology, 9th.
edition, American Society for Microbiology, Washington, DC. Vol. 2: p. 2070.
                                          122

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                              Vibrio choleme Scoring Data
Scoring Summary
Waterborne Disease Outbreak 4
Health Effects
General population 3
Sensitive subpopulation(s) [C, E, P, CD] 3
Score2

5
4
3
2
1

3
2
1

7
Data Element
Scoring Data

Reference3
Waterborne Disease Outbreaks
Has caused multiple (2 or
more) documented WBDOs
in the U.S. as reported by
CDC surveillance between
1990 and 2004?
Has caused at least one
documented WBDOs in the
U.S. as reported by CDC
surveillance between 1990
and 2004?
Has caused documented
WBDOs at any time in the
U.S.?
Has caused WBDOs in
countries other than the U.S.?
Has never caused WBDOs in
any country, but has been
epidemiologically associated
with water related disease?
No
1 Community
N/A
N/A
N/A
CDC, 1991 -CDC,
2006
CDC, 1996



Occurrence
Detected in drinking water
in the U.S.?
Detected in source water in
the U.S.?
Not detected in the U.S.?
Yes (outbreak data)
Yes
N/A
CDC, 1996
Rhodes et al., 1986
Kaperetal., 1982

Health Effects
Does the organism cause
significant mortality (>
1/1,000 cases)?
V. choleraeNon-Ol: third
most commonly isolated
in U.S. - Septicemia case
fatality rate from 47-65%.
Abbott in Murray,
2007
                                           123

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 EPA OGWDW
                Final CCL 3 Microbes.
                PCCL to CCL Process
                           EPA815-R-09-009
                                August 2009
  Score2
Data Element
Scoring Data
Reference3
            Does the organism cause
            pneumonia, meningitis,
            hepatitis, encephalitis,
            endocarditis, cancer, or other
            severe manifestations of
            illness necessitating long term
            hospitalization (> week)?
                       V. choleras Ol:
                       Extremely rare cases
                       causes severe
                       extraintestinal infection.
                       If untreated, V. cholerae
                       Ol infection causes
                       severe dehydration which
                       leads to hypovolemic
                       shock, acidosis,
                       circulatory collapse, and
                       death. Unlike Ol strains,
                       non-Ol isolates are
                       commonly associated
                       with extrainstestinal
                       infections such as
                       septicemia.
                    Abbott in Murray,
                    2007
            Does the illness result in long
            term or permanent
            dysfunction or disability, i.e.
            sequelae?
            Does the illness require short
            term hospitalization (<
            week)?
                       In severely dehydrated
                       cases (cholera gravis),
                       death may occur within a
                       few hours, and the case-
                       fatality rate may exceed
                       50%. With proper and
                       timely rehydration, this
                       can be less than 1%.
                    Heymann, 2005
            Does the illness require
            physician intervention?
3 [G, C, P,
  E,CD]
                       [All populations] In
                       most cases infection is
                       asymptomatic or causes
                       self-limiting diarrhea.
                       Treatment consists of
                       fluid replacement by
                       oral rehydration
                       therapy and/or
                       intravenous fluids.
                    Abbott in Murray,
                    2007
                                            124

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2
2
1
Data Element
Is the illness self-limiting
within 72 hours (without
requiring medical
intervention)?
Does the illness result in mild
symptoms with minimal or no
impact on daily activities?
Scoring Data


Reference3


 See section 3.4 for a detailed description on how to calculate the total pathogen score.
2 Bolded Text indicates the highest score for that particular protocol. For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score. The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol: G-
General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
3EPA based the WBDO scores on the CDC MMWR reports from 1991 - 2006 and then
collected occurrence citations if there were no CDC WBDOs.  Two exceptions to this
WBDO scoring criteria are Arcobacter butzleri and Mycobacterium avium.
References
Abbott, S. L., J. M. Janda, J. A. Johnson, and J. J. Farmer.  2007. Vibrio and Related Organisms.
In Murray, P. R., E. J. Baron, J. H. Jorgensen, M. A. Pfaller, and R. H Yolken (ed.) The Manual
of Clinical Microbiology, 8th. edition, American Society for Microbiology, Washington, DC.
Vol. 1: pp. 723-733.

CDC, 1991.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3); 1-21.

CDC, 1993.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1991—1992. MMWR Surveillance Summaries, 42(SS-5); 1-22.

CDC, 1996.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1993—1994. MMWR Surveillance Summaries, 45(SS-1); 1-33.

CDC, 1998.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5); 1-33.

CDC, 2000.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4); 1-35.

CDC, 2002.  Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1999—2000. MMWR Surveillance Summaries, 51(SS-8); 1-36.
                                          125

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EPA OGWDW                       Final CCL 3 Microbes.                       EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009
CDC, 2004. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001—2002. MMWR Surveillance Summaries, 53(SS08); 23-45.

CDC, 2006. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2003—2004. MMWR Surveillance Summaries, 55(SS12); 31-58.

Heymann, D. (ed.). 2005. Control of Communicable Diseases Manual, 18* ed. American Public
Health Association, Washington, DC. pp. 113-127.

Kaper, J. B., H. B. Bradford, N.  C. Roberts, and S. Falkow.  1982. Molecular epidemiology of
Vibrio cholerae in the U.S. Gulf Coast. J. Clin. Microbiol. 16(1): 129-134.

Rhodes, J.B., H.L. Smith Jr., and I.E.  Ogg.  1986. Isolation of Non-Ol Vibrio cholerae Serovars
from Surface Waters in Western Colorado.  Appl. Environ. Microbiol. 51(6): 1216-1219.
                                           126

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
                            Yersinia enterocolitica Scoring Data
Scoring Summary
Waterborne Disease Outbreak
4
Health Effects
General population
Sensitive subpopulation(s) [C]
2
2
Score2

5
4
3
2
1

3
2
1
Data Element
Scoring Data
Reference3
Waterborne Disease Outbreaks
Has caused multiple (2
or more) documented
WBDOsintheU.S. as
reported by CDC
surveillance between
1990 and 2004?
Has caused at least one
documented WBDOs
in the U.S. as reported
by CDC surveillance
between 1990 and
2004?
Has caused documented
WBDOs at any time in
the U.S.?
Has caused WBDOs in
countries other than the
U.S.?
Has never caused
WBDOs in any country,
but has been
epidemiologically
associated with water
related disease?
No
Yes
1 Noncommunity
N/A
N/A
N/A
CDC, 1991 -CDC,
2006
CDC, 2004



Occurrence
Detected in drinking
water in the U.S.?
Detected in source
water in the U.S.?
Not detected in the
Yes
Yes
N/A
Highsmith et al.,
1977
Eden et al., 1977
Meadows and
Snudden, 1982

                                            127

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PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2



7








6








5




4

3






2 [G, C]





Data Element
U.S.?
Scoring Data

Reference3

Health Effects
Does the organism
cause significant
mortality (> 1/1,000
cases)?
Does the organism
cause pneumonia,
meningitis, hepatitis,
encephalitis,
endocarditis, cancer, or
other severe
manifestations of illness
necessitating long term
hospitalization (>
week)?



Does the illness result in
long term or permanent
dysfunction or
disability, i.e. sequelae?

Does the illness require
short term
hospitalization (<
week)?
Does the illness require
physician intervention?
Is the illness self-
limiting within 72
hours (without
requiring medical
intervention)?






No



An uncommon
complication of
gastroenteritis is
septicemia for which the
elderly and
immunocompromised are
at higher risk, particularly
those with metabolic
diseases associated with
iron overload
(hemochromatosis),
cancer, liver disease and
steroid therapy.
Uncommon sequelae
include: reactive arthritis,
inflammatory bowel
disease, autoimmune
thyroid disorders.




The elderly are at greater
risk for septicemia.
[G, C] (No information
available for other
populations) Young
children most
commonly develop
gastroenteritis and
present with fever,
diarrhea, and
abdominal pain.
Symptoms typically
resolve within 7 days.




Wanger in Murray,
2007











Wanger in Murray,
2007







Wanger in Murray,
2007
Wanger in Murray,
2007









                                             128

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EPA OGWDW
Final CCL 3 Microbes.
PCCL to CCL Process
EPA815-R-09-009
     August 2009
Score2

1
Data Element

Does the illness result in
mild symptoms with
minimal or no impact
on daily activities?
Scoring Data
Infection typically
manifested by acute
febrile diarrhea with
abdominal pain
(especially in young
children). Diarrhea
may be absent in up to a
third of Y. enterocolitica
infections.

Reference3
Heymann, 2005

 See section 3.4 for a detailed description on how to calculate the total pathogen score.
2 Bolded Text indicates the highest score for that particular protocol. For the health effects
protocol two scores were selected: the general population [G] and the highest score for a
sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14
for a final health effects score. The higher score between the WBDO and Occurrence
protocols was used for total pathogen score calculation. Health Effects protocol: G-
General, C - Child, E-Elderly, P - Pregnant Women, CD -Chronic Disease.
3EPA based the WBDO scores on the CDC MMWR reports from 1991 - 2006 and then
collected occurrence citations if there were no CDC WBDOs.  Two exceptions to this
WBDO scoring criteria are Arcobacter butzleri and Mycobacterium avium.
References
CDC, 1991. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1989—1990. MMWR Surveillance Summaries, 40(SS-3); 1-21.

CDC, 1993. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1991—1992. MMWR Surveillance Summaries, 42(SS-5); 1-22.

CDC, 1996. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1993—1994. MMWR Surveillance Summaries, 45(SS-1); 1-33.

CDC, 1998. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5); 1-33.

CDC, 2000. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 1997—1998. MMWR Surveillance Summaries, 49(SS-4); 1-35.

CDC, 2002. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —

                                          129

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EPA OGWDW                       Final CCL 3 Microbes.                      EPA 815-R-09-009
                                  PCCL to CCL Process                           August 2009


United States, 1999—2000. MMWR Surveillance Summaries, 51(SS-8); 1-36.

CDC, 2004. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2001— 2002. MMWR Surveillance Summaries, 53(SS08); 23-45.

CDC, 2006. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water —
United States, 2003—2004. MMWR Surveillance Summaries, 55(SS12); 31-58.

Eden, KV, ML Rosenberg, M Stoopler, BT Wood, AK Highsmith, P Skaliy, JG Wells, JC
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