Overview of Technical Support Materials:
A Guide to the Site-Specific Alternative Recreational
Criteria TSM Documents
EPA-820-R-14-010
U.S. Environmental Protection Agency
Office of Water
Office of Science and Technology
Health and Ecological Criteria Division
December 2014
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Table of Contents
Table of Contents i
Acronyms ii
About EPA's Technical Support Materials 1
Alternative Health Relationships 4
Non-Human Fecal Sources 5
Alternative Indicators and Methods 7
Questions and Answers 8
Why would I want to usetheseTSM documents? 8
Who can use these Technical Support Materials? 9
Is my site a candidate for site-specific alternative water quality criteria? 9
How do I decide which TSM to use? 9
Can I use these TSMs to develop site-specific alternative criteria for other designated uses? 10
What kind of information is useful in the sanitary characterization? 11
Conclusion 12
References 13
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Acronyms
ATP Alternate Test Procedure
CPU colony forming units
CFR Code of Federal Regulations
CWA Clean Water Act
E. coli Escherichia coli
EPA Environmental Protection Agency
FIB fecal indicator bacteria, (e.g. fecal coliforms, E. coli, enterococci, Enterococcus
spp.)
Gl gastrointestinal
CIS geographic information system
GM geometric mean
ml milliliters
MPN most probable number
MTF multiple tube fermentation
MST microbial source tracking
NEEAR National Epidemiological and Environmental Assessment of Recreational Water
NGI NEEAR-GI illness
NRC National Research Council
QMRA quantitative microbial risk assessment
qPCR quantitative polymerase chain reaction
RWQC recreational water quality criteria
TSM technical support materials
U.S. United States
WQ water quality
WQC water quality criteria
WQS water quality standard(s)
WWTP wastewater treatment plant
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About EPA's Technical Support Materials
This Guide to the Technical Support Materials (TSM) documents is designed to help users
evaluate site information and decide which tools would best support the development of site-
specific alternative water quality criteria (WQC) that are scientifically defensible and protective
of the recreational designated use. The Environmental Protection Agency's (EPA) nationally
recommended recreational water quality criteria (RWQC) are broadly applicable for ambient
waters designated for primary contact recreation. However, there are waterbodies with
conditions that differ from those studied and used to inform EPA's 2012 RWQC. Water quality
managers may want to consider WQC reflective of specific conditions or may want to use a
different indicator of fecal contamination and/or enumeration method.
Text Box 1: Clean Water Act and Establishing WQC
EPA's implementing regulations for §303 of the CWA provide that "states must adopt those WQC [water
quality criteria] that protect the designated use. Such criteria must be based on sound scientific rationale and
must contain sufficient parameters or constituents to protect the designated use." (40 CFR §131.11(a)). EPA's
regulations stated in 40 CFR §131.11(b)(l) provide that "In establishing criteria, States should (1) Establish
numerical values based on (i) 304(a) Guidance; or (ii) 304(a) Guidance modified to reflect site-specific
conditions; or (iii) Other scientifically defensible methods." WQS can be established for waterbodies or a
portion of a water body and therefore they could be established for a specific site, such as a waterbody
adjacent to a beach or the entire water body that is anticipated to have uniform qualities throughout. When
EPA reviews adopted state WQS for approval or disapproval under the CWA, EPA must ensure that the WQC in
the standard (regardless of whether they are "site-specific") are scientifically defensible and protective of the
designated use.
States establish WQC and water quality standards (WQS) under the Clean Water Act (CWA) (see
Text Box 1). EPA has previously indicated that States and Territories can use scientific
approaches to propose alternative criteria. For example, EPA's 2004 Water Quality Standards
for Coastal and Great Lakes Recreation Waters Rule indicates that States and Territories must
apply the Escherichia coli (E. coli) and enterococci criteria to all coastal recreation waters. If,
however, sanitary surveys and epidemiological studies show the sources of the indicator
bacteria to be non-human and the indicator densities do not indicate a human health risk, then
it is reasonable for the State or Territory not to consider those sources of fecal contamination in
determining whether the standard is being attained (U.S. EPA, 2004). This approach was also
included in the 1986 criteria document (U.S. EPA, 1986). EPA also previously indicated that it
would be reasonable for a State or Territory to use existing epidemiological studies rather than
conduct new or independent epidemiological studies for every waterbody if it is scientifically
appropriate to do so (U.S. EPA, 2004). These flexibilities are included in the Code of Federal
Regulations (CFR).1
1 Footnote "e" to 40 CFR 131.41(c)(l) and footnote "c" to 40 CFR 131.41(c)(2) state: 'These values apply to [f. coli
or enterococci] regardless of origin unless a sanitary survey shows that sources of the indicator bacteria are non-
human and an epidemiological study shows that the indicator densities are not indicative of a human health risk."
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The 2012 RWQC recommends fecal indicator bacteria (FIB) levels (Table 1 in U.S. EPA, 2012a)
that appear similar to the 1986 water quality criteria (U.S. EPA, 1986). However, two
fundamental differences exist between these criteria that contribute to the scientific
foundation of the approaches for derivation of site-specific WQC in Section 6.2 of the 2012
RWQC. These differences were informed by the scientific progress made over the last few
decades that contributed to our understanding of microbiology, water quality, risk
management, and public health protection. Although states have always had the option of
developing WQC tailored to their specific waters, demonstrating the scientific defensibility and
protection of the designated use has, until now, been a difficult and potentially burdensome
task.
First, our understanding of the health effects associated with the historical levels of water
quality recommended for public health protection has substantially progressed since 1986.
Health studies informing the development of the 2012 RWQC and previous recommendations
were conducted at sites predominantly affected by human fecal contamination in the form of
secondary treated and disinfected effluent. There is a body of scientific evidence that indicates
enteric viruses most likely caused the illnesses reported in those studies (Cabelli, 1983; Dufour,
1984; Seller et al., 2010a). The sources of fecal contamination determine the level and diversity
of pathogens, and hence, the potential human health risks, which can be present in water.
Similar health studies conducted at sites affected by non-human sources of fecal contamination
have not provided a clear linkage between water quality measured by FIB and health effects.
Although waters impacted by non-human fecal contamination have long been considered to
confer less potential for health risks compared to human impacted waters, the ambiguous
results of the health studies did not provide risk managers evidence of the potential health
implications of recreational exposure to waters containing animal feces relative to waters
containing human feces. Recent advances in human health risk assessment methodologies,
source identification techniques, and microbiology have now provided the linkages that allow
for the derivation of source- and site-specific WQC (Schoen and Ashbolt, 2010; Seller et al.,
2010b; Wuertzetal., 2011).
Second, the 2012 RWQC rely on a fundamentally different approach to derive the
recommended values. The 1986 criteria recommended values for the culturable fecal indicator
bacteria, enterococci and E. coli, were derived based on a proportional translation from the
previous fecal coliform recommendations of 200 colony forming units (CFU) per 100 milliliters
(ml). The reader is referred to the 2012 RWQC and other references for more discussion on the
mathematics of this translation (Dufour and Schaub, 2007; U.S. EPA, 2012a). The values for
enterococci and E. coli resulting from this translation were not directly linked to a specific
illness rate, nor did they represent a potential risk management target. The 1986 criteria values
simply represented an effort to carry forward historically accepted levels of water quality in
terms of alternative fecal indicator bacteria (i.e., enterococci and E. coli) that the best available
science at the time concluded were more effective at indicating potential fecal contamination.
The health studies conducted by Cabelli (1983) and Dufour (1984) informed risk managers
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about the potential for human illness that might occur following recreational exposure to
waters containing levels of enterococci or E. coli at the recommended levels.
In contrast, the 2012 RWQC recommendations have an underlying health basis. Using the
results of National Epidemiological and Environmental Assessment of Recreational Water
(NEEAR) study, EPA derived the current recommendations based on an adjusted odds ratio of
gastrointestinal (Gl) illness below which there was no observed statistically significant increase
in swimming-associated illness (U.S. EPA, 2012a). This significant increase in illness was first
observed to occur at a geometric mean (GM) of 30 CPU enterococci per 100 ml, corresponding
to 32 NEEAR-GI illness (NGI) per 1000 recreators. There was no significant difference between
the swimming-associated illness rate at a GM of 30 CPU enterococci per 100 ml and a GM of 35
CPU enterococci per 100 ml, corresponding to 36 NGI per 1000 recreators. The 2012 RWQC
recommendations for water quality based on an observed increase in illness provides the risk
'anchor' for evaluating the use protection of the alternative WQC.
The 2012 RWQC document includes tools that can be used by states to develop site-specific
alternative WQC for inclusion into WQS packages to be submitted to and evaluated by EPA.
Site-specific alternative WQC need to be scientifically defensible and protective of the
designated use. Further, it is incumbent upon the state to substantiate those attributes in their
proposed WQS packages. Site-specific alternative WQC should reflect the conditions of the
watershed including current land uses and potential sources of fecal contamination and thus,
should be revisited no less frequently than triennially to ensure the site-specific alternative
WQC remain protective of the designated use. For example, if a substantial source of fecal
pollution [e.g., wastewater treatment plant (WWTP)] is added, drainage is altered, or further
human growth occurs (e.g., new buildings) the site-specific alternative WQC should be
reviewed. This guide will help you decide if your waterbody is a candidate for site-specific
alternative criteria and determine which set of tools would be amenable for you to use in
deriving site-specific WQC.
For over a century, FIB have been used to protect public health (NRC, 2004). FIB have been used
as water quality indicators because, among other things, they tend to be more numerous than
pathogens in human fecal material, thus are a cheaper, safer, and easier target to enumerate
for gauging ambient water quality. However, increasing numbers of scientific studies have
demonstrated the existence of non-fecal sources of FIB in environmental matrices (Fujioka and
Byappanahalli, 2003; Stewart et al., 2008; Byappanahalli et al., 2011; Van et al., 2011). Notable
examples of potential non-fecal sources of FIB include sands and soils (Yamahara et al., 2007;
Van et al., 2011), plant and periphyton-associated species (Ksoll et al., 2007; Badgley et al.,
2010a,b; Ferguson, 2012), and growth in biofilms (Ferguson, 2006; Skinner et al., 2010). The
relationship of the FIB from non-fecal sources to the occurrence and distribution of enteric
pathogens and the potential for those microbes to predict human health effects in these
examples has not been demonstrated (Halliday and Cast 2011; Viau et al., 2011; Shibata and
Solo-Gabriele, 2012). Fecal, but non-human, sources of FIB also exist, but can co-occur with a
different enteric pathogen profile relative to secondary treated and disinfected human
wastewater effluent (i.e., the predominant source of fecal contamination impacting the
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epidemiological studies informing EPA's 2012 RWQC). These profile differences can result in
differences in potential relative health impacts (Schoen and Ashbolt 2010; Sinigalliano et al.,
2010; Seller et al., 2010b; U.S.EPA, 2010a). Traditional culturable FIB have been crucial and
successful in protecting public health and as advancements in science and technology occur,
additional options become possible. The tools mentioned in this guide and discussed in more
detail in the respective TSM documents present scientifically defensible and consistent
approaches for understanding your site-specific information in context with water quality and
human health risks. The TSM documents also discuss how you can use that information in the
development of site-specific alternative water quality criteria.
This guide provides an overview of the set of TSM documents that EPA is providing for
development of site-specific alternative criteria (as discussed in Section 6.2 of EPA's 2012
RWQC document). This set of TSM documents discusses tools related to the following areas:
1. alternative health relationships (Section 6.2.1 in RWQC "Epidemiological Studies")
2. non-human fecal sources (Section 6.2.2 in RWQC "Quantitative Microbial Risk
Assessment")
3. alternative indicators and methods (Section 6.2.3 in RWQC "Alternative Indicators or
Methods")
EPA plans to publish TSM documents corresponding to each set of these tools. The TSM
documents will provide the detailed information that users need to determine which set of
tools may be germane for their needs. They will also provide suggestions for gathering
information and data to support the approach, conducting analyses, deriving site-specific
alternative criteria, and preparing documentation for water quality standards packages. A brief
synopsis of each set of tools follows. More detailed information can be found in each TSM
document. These TSM documents will allow states to take advantage of the rapid and
continuing advancements in the science of microbial water quality for use in their WQS.
Alternative Health Relationships
Recreational water epidemiological studies describe the probability of illnesses associated with
exposure to fecal contamination as measured by FIB. It is important to note that the FIB do not
necessarily cause illness themselves. Instead they are used to gauge the magnitude and extent
of fecal pollution in a waterbody. Epidemiological studies with or without quantitative microbial
risk assessment (QMRA) could be used to develop an alternative health relationship for a water
quality metric. This alternative health relationship could inform the basis of site-specific
alternative criteria.
EPA's NEEAR epidemiological study was conducted in water primarily impacted by human fecal
contamination, with the exception of one site that was impacted by urban runoff (U.S. EPA,
2010b; Wade et al., 2006, 2008, 2010). Statistically significant associations between water
quality, as determined using EPA's Enterococcus spp. quantitative polymerase chain reaction
(qPCR) Method 1611 (U.S. EPA, 2012b), and reported Gl illness were observed in the temperate
marine and fresh water beaches impacted by WWTP. In the United States (U.S.) other agencies
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have also conducted recreational water epidemiological studies. For example, epidemiological
studies of recreational water exposures have been conducted in Southern California (Colford et
al., 2012), Southern Florida (Fleming et al., 2006, 2008; Sinigalliano et al., 2010), and Ohio
(Marion etal., 2010).
Several factors can influence the potential epidemiological relationship between indicator
density and the potential for human illness. Some of the potentially important factors include
the source of fecal contamination, age of the fecal contamination, solar radiation, water
salinity, turbidity, dissolved organic matter, water temperature, and nutrient content.
Additionally, numerous factors also affect the occurrence and distribution of FIB and
pathogens, including but not limited to: predation of bacteria by other organisms; differential
interactions between microbes and sediment, including the release and resuspension of
bacteria from sediments in the water column; and differential environmental effects on
indicator organisms versus pathogens (U.S. EPA, 2010b; WERF, 2009).
States or local agencies may choose to conduct epidemiological studies in their waterbodies
and use the results from those studies to derive site-specific alternative criteria. To derive
scientifically defensible alternative WQC for adoption into state standards, ideally the
epidemiological studies should be rigorous, comparable to those used to support the 2012
RWQC, and peer-reviewed. However, smaller scale epidemiological studies may also provide a
scientifically defensible foundation for alternative criteria. Additionally, QMRA (see section
6.2.2) can enhance the interpretation and application of new or existing epidemiological data
(Boehm et al., 2009; Dorevitch et al., 2011; Seller et al., 2014). QMRA can supplement new or
existing epidemiological results by characterizing various exposure scenarios, interpreting
potential etiological drivers for the observed epidemiological results, and accounting for
differences in risks posed by various types of FIB sources. The additional insights QMRA can
provide in these situations may help inform site-specific alternative WQC development.
The Site-Specific Alternative Recreational Criteria Technical Support Materials for Alternative
Health Relationships document discusses approaches that can be used to document potential
human health effects from exposure to feces-contaminated recreational waters. This TSM could
be used for documenting the health relationship of new or existing indicators of fecal
contamination and their associated enumeration methods to levels of reported illness, or for
determining the site-specific health relationship at any site where site-specific epidemiological
studies and/or QMRA are conducted. The TSM includes examples of how epidemiological data
and QMRA can be used to derive site-specific alternative WQC. Special circumstances related to
the waterbody characteristics (i.e., waterbody biology, chemistry, or physics), the
demographics of bathers, or the nature of the source may lead to exploration of health
relationship based site-specific alternative criteria.
Non-Human Fecal Sources
EPA believes the 2012 RWQC are protective of the primary contact recreational designated use
for waterbodies affected by any source of fecal contamination. The 2012 RWQC was informed
by studies conducted in WWTP effluent-impacted waters. Since all pathogens in human feces
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are potentially infectious to humans, developing criteria recommendations based on these
studies represents a prudent and health protective benchmark. However, there are scenarios of
contamination from non-human sources and non-fecal sources of FIB that potentially present
markedly different probability of illness relative to human sources. QMRA can be used as a
basis to develop site-specific alternative criteria, where sources are characterized
predominantly as non-human or non-fecal (U.S. EPA, 2009). EPA's research indicates that
understanding the predominant source of fecal contamination could help characterize the
human health risks associated with recreational water exposure. QMRA studies have
demonstrated that the potential human health risks from human and non-human fecal sources
could be different due to the nature of the source, the type and number of pathogens from any
given source, as well as variations in the co-occurrence of pathogens and fecal indicators
associated with different sources (Till and McBride, 2004; Roser and Ashbolt, 2006; Schoen and
Ashbolt, 2010; Seller et al., 2010b; Wuertz et al., 2011).
Further, research demonstrates that swimming-associated illnesses can be caused by different
pathogens, which depend on the source of fecal contamination. For example, in human-
impacted recreational waters, human enteric viruses appear to cause a large proportion of
illnesses (Seller et al., 2010a). In recreational waters impacted by gulls and agricultural animals
such as cattle, pigs, and chickens, pathogenic bacteria and protozoa are the likely etiologic
agents of concern (Roser and Ashbolt, 2006; Schoen and Ashbolt, 2010; Seller et al., 2010b).
The relative level of predicted human illness in recreational waters contaminated by non-
human fecal sources can also vary depending on whether the contamination is direct or via
runoff due to a storm event (Seller et al., 2010b; U.S. EPA, 2010a; Seller et al., 2014).
To derive site-specific alternative criteria that are considered scientifically defensible and
protective of the designated use, QMRA studies should be well documented, transparently
presented, follow accepted practices, and rely on scientifically defensible data. A sanitary
characterization can provide detailed information on the source(s) of fecal contamination in a
waterbody to determine whether the predominant source is human or non-human. EPA
developed a QMRA-specific sanitary survey2 application, which could be included in a sanitary
characterization, to capture information directly applicable to a QMRA.
At sites where non-human sources predominate, QMRA can be used to determine a different
enterococci or E. coli criteria value that is equally protective as the recommended 2012 RWQC.
Fundamental to this approach is a thorough understanding of the potential sources of fecal
contamination impacting your waterbody. The TSM, Site-Specific Alternative Recreational
Criteria Technical Support Materials for Predominantly Non-Human Fecal Sources, describes the
process that can be used to document likely sources of fecal contamination impacting a
waterbody. Fecal source tracking and identification methods can be used to substantiate the
findings of the sanitary survey (i.e., human sources do not predominate). As described in the
TSM, a sanitary characterization consists of conducting a sanitary survey and substantiating
water quality data. The results of monitoring for pathogens and indicators can be used to
2 See: Site-Specific Alternative Criteria Technical Support Materials for Predominantly Non-Human Fecal Sources,
Volume A, Appendix A.
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conduct QMRA. EPA provides QMRA results from several conservative (health protective)
scenarios where the predominant sources are from one or more of the following: gulls, pigs,
chickens, and non-pathogenic sources. If users document that their site fits one of EPA's
conservative scenarios, then EPA provides potential criteria values. Users also have the option
of conducting QMRA for other non-human fecal sources and other site-specific parameters
documented at a site.
Alternative Indicators and Methods
EPA anticipates that scientific advancements will provide new technologies for enumerating
fecal pathogens or FIB. New technologies may provide alternative ways to address
methodological considerations, such as rapidity, sensitivity, specificity, and method
performance. As new or alternative indicator and/or enumeration method combinations are
developed, states may want to consider using them to develop site-specific alternative criteria
for adoption in WQS or as the basis for beach notification when a state does not plan to modify
existing WQS. The TSM, Site-Specific Alternative Recreational Criteria Technical Support
Materials for Alternative Indicators and Methods, describes a process for comparing
enumeration methods that may allow users to take advantage of the rapid and continuing
advancements in the science of microbial water quality. Text Box 2 contains examples of
potentially useful newer enumeration methods and indicator organisms.
Text Box 2: Newer Enumeration Methods and Indicators
Some examples of new enumeration methods for FIB include: immunomagnetic separation/adenosine
triphosphate, propidium monoazide qPCR, reverse transcriptase qPCR, covalently linked immunomagnetic
separation/adenosine triphosphate, and transcription mediated amplification. New methods and additional
improvements to currently available methods, platforms, and chemistries may also be developed in the
future.
Examples of possible alternative indicators include, but are not limited to Bacteroidales, Clostridium
perfringens, human enteric viruses, and coliphages. These possible alternative indicator organisms could be
used with new methodologies or methodologies similar to those recommended by the 2012 RWQC. For
example, in one case, Bacteroidales measured by qPCR were highly correlated with Enterococcus spp. and E.
coli when either culture-based methods or qPCR methods were used (Wuertz et al., 2011). The pathogens
norovirus Gl and Gil have also been shown to be predictors of the presence of other pathogens such as
adenovirus measured by qPCR (Wuertz et al., 2011).
The evaluation of multiple FIB and enumeration methods has been used to describe a common
level of water quality. For example, the derivation of EPA's 1986 criteria values was
fundamentally based on the proportional comparison of multiple FIB: fecal coliform,
enterococci, and E. co//. In those specific cases, comparisons were made among membrane
filtration methods specific to each target organism. EPA has also approved other culture-based
methods for the detection of enterococci and E. coli based on how those methods compare to
EPA published methods. In this comparison, results from a membrane-filtration method were
compared to another most probable number (MPN) method that relies on substrate-utilization
and multiple tube fermentation (MTF). Rapid methods, such as E. coli enumerated by qPCR,
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have already been evaluated against cultivable methods and have demonstrated utility on a
site-specific basis (Lavender and Kinzelman, 2009).
If a state adopts WQS using alternative indicator/method combinations, EPA will review those
standards, including any technical information submitted to determine whether such standards
are scientifically defensible and protective of the primary contact recreation use. To facilitate
consideration of such standards, states may gather water quality data over one or more
recreational seasons for the indicator/method recommended in the 2012 RWQC and the
proposed alternative indicator/method combination. A robust relationship need not be
established between EPA's recommendation and alternative indicator(s) for the whole range of
indicator densities (U.S. EPA, 2010c). It is, however, important that a consistent and predictable
relationship exist between the enumeration methods and an established indicator/health
relationship in the range of the recommended criteria. If a state wishes to use an alternative
indicator method without modifying existing WQS, then the alternative method should be a
reliable predictor of the likelihood of an exceedance of the applicable WQS.
As technology advances there may be newer indicators or methods that offer advantages over
the EPA published methods. With this approach, a new indicator-method combination can be
statistically compared to an EPA method recommended in the RWQC (Methods 1600, 1603,
and 1611 or equivalent). This approach uses site-specific water quality data to demonstrate the
statistical correlation and may be useful for new methods that will be developed in the future,
if that method correlates with EPA's methods at the site under consideration. This TSM
approach is different from EPA's Alternate Test Procedure (ATP) program because it is limited
to site-specific use, allows different analytes to be compared, and uses actual environmental
monitoring for comparing methods.
Questions and Answers3
The following questions should help users determine which TSM best fits their needs. For clarity
and ease of use, the format of this section is in a question and answer format.
Why would I want to use these TSM documents?
EPA's recommended RWQC can be applied nationally and are scientifically defensible and
protective of the use. These criteria describe a condition that is protective of human health at a
given level of water quality. The linkage between WQ and health protection in the RWQC was
informed by studies conducted at sites with specific characteristics. EPA recognizes that there
are site-specific characteristics and conditions that differ from those used to support the 2012
RWQC. EPA encourages states to improve and update their WQS to reflect the latest science
and information.
In this format, the question is presumed to be posed by someone who may use the TSMs to develop alternate
site-specific alternative criteria and WQS (the use of "I" in many instances). The answer is a response to the user's
question (the use of "you" refers back to the person who is interested in developing alternate site-specific criteria).
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These TSM documents provide states with approaches to fine-tune EPA's recommendations to
reflect site-specific characteristics and conditions, while maintaining equivalent public health
protection. WQC that reflect site-specific conditions allow states to account for differences in
their waterbodies or preferred enumeration method-indicator, while protecting public health.
WQS reflective of site-specific conditions are better for determining attainment.
Who can use these Technical Support Materials?
These TSMs were created for states4 who are interested in deriving site-specific alternative
water quality criteria for inclusion in their WQS. The TSM also provide a transparent process
that should allow EPA to evaluate and approve these WQS more easily.
7s my site a candidate for site-specific alternative water quality criteria?
The nationally recommended RWQC are designed to be scientifically defensible and protective
of the designated use for all waters, and were informed by epidemiological data from sites
where WWTP effluent impacts the recreational waterbody. You might consider site-specific
alternative criteria if your site is not predominantly impacted by WWTP effluent or if you are
interested in developing criteria using an alternative indicator or newer method. The national
RWQC values are based on the fecal indicator bacteria enterococci and E. coli (Methods 1600,
1603,1611 or equivalent). The TSM approaches can help you develop different enterococci or
E. coli values, or derive criteria based on a different indicator or method.
How do I decide which TSM to use?
A sanitary characterization allow you to gain a better understanding of the potential sources of
contamination impacting your waterbody and decide which TSM approach would be most
useful for your situation. For more information on watersheds and approaches to watershed
management, please see EPA's watershed website (http://water.epa.gov/type/watersheds/).
Table 1 summarizes how the sources of fecal contamination and the type of method influence
which TSM you should consider.
The sanitary characterization is a process that includes 1) compiling information on sources,
water quality, and historical trends within your watershed, 2) evaluating this information
against this guide and the related TSM documents, 3) identifying and addressing important data
gaps relevant for the TSM approach you are considering, 4) collecting information to confirm
the conclusions made in the first step. These steps are iterative and should be revisited by risk
managers throughout the characterization process.
If you do not think that enterococci or E. coli provide the best water quality information and
you are interested in developing a health relationship for a different indicator, refer to Site-
Specific Alternative Recreational Criteria Technical Support Materials for Alternative Health
Relationships.
Anyone can prepare WQS and submit to the state. The state submits to EPA for review and approval.
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Table 1. How do source and indicator method influence which TSM I should choose?
TSM
Sources of fecal
contamination
Enumeration methods
Alternative Health
Relationship
Any
Any
Alternative Fecal
Sources
Predominantly non-
human
EPA Methods 1600,1603 or 1611 (or
equivalent5)
Alternative indicator-
method
Any
New method has predictable consistent
relationship with EPA Methods 1600,1603
or 1611 (or equivalent)
If the sanitary characterization of your waterbody indicates that there are predominantly non-
human fecal sources affecting it, then you may consider using QMRA to determine the potential
probability of illness associated with recreating. Please refer to Site-Specific Alternative
Recreational Criteria Technical Support Materials for Predominantly Non-Human Fecal Sources
for information on what site-specific data is needed, how to conduct QMRA, and how to select
alternative criteria values for enterococci or E. coli.
If you are interested in using an alternative indicator or method, possibly because of cost,
speed, or other methodological advancements, refer to the Site-Specific Alternative
Recreational Criteria Technical Support Materials for Alternative Indicators and Methods. The
TSM for alternative indicators and methods explains how to demonstrate whether a consistent
predictable relationship exists between the new method and one of EPA's methods for
enumerating enterococci or E. coli (EPA methods 1600, 1603, 1611 or equivalent). This
approach differs from EPA's ATP process in the following ways: 1) ATP is for national or limited
use, whereas the TSM is for site-specific use only, 2) ATP is for methods with the same analyte
only, whereas the TSM can be used for different indicators, 3) ATP is for new methods for 40
CFR 136 (for CWA uses) or 40 CFR 141 (for drinking water), whereas the TSM is for new
methods for ambient water monitoring, and 4) ATP determines correlations by utilizing spiked
samples in a laboratory, whereas the TSM determines correlations by environmental
monitoring. The TSM approach is for comparing method performance on a site-specific basis
and does not include the development of a health relationship with the new method.
Can I use these TSMs to develop site-specific alternative criteria for other
designated uses?
The set of tools discussed in the TSM documents is designed to evaluate potential impacts to
human health from exposure to fecal contamination in ambient surface waters designated for
primary recreational contact. Any site-specific alternative WQC derived from using these tools
In this context, "equivalent" refers to methods that are approved under EPA's ATP.
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should be scientifically defensible and protective of the recreational designated use. These TSM
tools are not designed to be used to characterize potential human health risks associated with
other designated uses.
If you are interested in assessing human health risks for other stressors/agents or exposure
scenarios, refer to other frameworks such as EPA's Framework for Human Health Risk
Assessment to Inform Decision Making (U.S. EPA, 2014) and the interagency Microbial Risk
Assessment Guideline Pathogenic Microorganisms with Focus on Food and Water (U.S.
EPA/USDA, 2012).
What kind of information is useful in the sanitary characterization?
Once you decide to explore whether site-specific alternative criteria would be desired, the first
step is to conduct a sanitary characterization. A sanitary characterization for this purpose
includes gathering relevant information about the potential sources of contamination in the
waterbody and other information related to source dynamics. As mentioned above, the
sanitary characterization is a multistep process for understanding your watershed. Depending
on which TSM you choose, the sanitary characterization can include information such as:
• Historical information -This includes information from previous FIB or pathogen
monitoring. The history of best management practices and other mitigation efforts can
be included.
• Sanitary survey information -This can be gathered with the marine and Great Lakes
sanitary guides6 or the QMRA sanitary survey.7
• Microbial source tracking (MST) - If any information is available from MST monitoring,
this information can be very helpful in identifying sources of FIB.
• Wildlife survey - The occurrence of wildlife that could be a source of FIB or pathogens
(e.g., warm-blooded animals) should be discussed. If there are seasonal differences and
other discernible patterns for wildlife, those aspects can be included.
• Geographic information system (CIS) mapping - A map should be included in the
sanitary characterization. If there are outfalls or other features that could contribute to
FIB, those should be included on the map.
• Hydrological data - If information on currents and tidal effects is available, it can help
characterize how the FIB are moving throughout the waterbody. In some cases, this
information may be available in map format.
These components can be prioritized based on available resources and the relative usefulness
of the information. For more information on how to utilize sanitary characterization for the
development of site-specific alternative criteria, see the TSM documents.
6 Visit EPA's Beach Sanitary Surveys website to find FAQs, guides, forms, and examples
(http://water.epa.gov/type/oceb/beaches/sanitarvsurvev index.cfm)
7 See Site-Specific Alternative Recreational Criteria Technical Support Materials for Predominantly Non-Human
Fecal Sources
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Conclusion
The three TSM documents will help users collect data, derive site-specific alternative criteria,
and prepare WQS. EPA considers that the approaches in these documents reflect the state of
the science and provide public health protection in a practical and cost effective manner.
States can adopt site-specific alternative criteria to reflect local environmental conditions and
human exposure patterns. An alternative WQS may involve the adoption of different numerical
value(s) that are based on the approaches described in the set of TSM documents. EPA
recommends that alternative criteria reflect the same risk management decision regarding
illness rate that are the basis of the 2012 RWQC. Such alternative criteria should be scientifically
defensible, protective of the use, and reviewed and approved by EPA under CWA §303(c).
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