823-R-08-002
CRITICAL PATH SCIENCE PLAN
FOR THE DEVELOPMENT OF NEW OR REVISED
RECREATIONAL WATER QUALITY CRITERIA
Itottcy
Office of Water
Office of Research and Development
AUGUST 31, 2007
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Critical Path Science Plan for the Development of New or Revised Recreational Water Quality Criteria
TABLE OF CONTENTS
ACRONYMS AND ABBREVIATIONS iv
CHAPTER 1 INTRODUCTION 1-1
1.0 Purpose and Scope 1-1
1.1 Statutory Background and Purpose of EPA's Recommended Water Quality
Criteria 1-2
1.2 Purpose of Water Quality Criteria Components of State Water Quality
Standards 1-3
1.3 Goals of EPA's Scientific Research 1-4
CHAPTER 2 DEVELOPMENT OF THE CRITICAL PATH SCIENCE PLAN 2-1
2.0 Summary of EPA Research Already Completed 2-1
2.0.1 Early Studies 2-1
2.0.2 National Epidemiology and Environmental Assessment of Recreational
Water Study 2-1
2.0.3 Environmental Monitoring for Public Access and Community Tracking
Study 2-2
2.0.4 Other Completed Studies 2-2
2.1 Consideration of Stakeholder Input on the 1986 Bacteria Criteria 2-3
2.2 Experts Scientific Workshop and Report 2-4
CHAPTER 3 KEY SCIENCE QUESTIONS EPA WILL ADDRESS UNDER THE CRITICAL
PATH SCIENCE PLAN 3-1
3.0 Peer-Review of Draft Critical Path Science Plan 3-1
3.1 Assessment of Human Health Risks (Goal 1) 3-2
3.1.1 Description of the Key Science Question 3-3
3.1.2 Risks from Human Sources of Fecal Contamination 3-3
3.1.3 Risks from Non-Human Sources of Fecal Contamination 3-5
3.2 Development of Indicators and Methods (Goals 2 and 3) 3-7
3.2.1 Description of the Key Science Question 3-8
3.2.2 Develop, Evaluate and Validate Indicators and Methods 3-9
3.2.3 Assess Linkages Between Indicators and Methods 3-9
3.2.4 Characterize Temporal and Spatial Variability in Measurements 3-10
3.3 Extrapolation of Research Results for Developing New and Revised
Criteria (Goal 4) 3-10
3.3.1 Description of the Key Science Question 3-11
3.3.2 Assess Variability in Diverse Geographic and Aquatic Conditions 3-11
3.3.3 Assess Methods Suitability to Different CWA Purposes 3-13
3.3.4 Develop, Evaluate and Validate Predictive Models and Tools 3-13
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CHAPTER 4 FUTURE RESEARCH 4-1
4.0 Science Issues EPA Deferred for Future Research 4-1
CHAPTERS REFERENECES 5-1
LIST OF TABLES
Table 3-1 Science Plan Research Activities and Projects 3-16
Table 3-2 Overview of Proposed Near-term Research Activities to Support Development of
New or Revised Recreational Criteria 3-26
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Critical Path Science Plan for the Development of New or Revised Recreational Water Quality Criteria
ACRONYMS AND ABBREVIATIONS
AL
ATP
AWQC
BEACH Act
BMP
CA
CFR
CPSP
CWA
DNA
EMPACT
EPA
GI
CIS
MS
NEEAR
NOAA
NPDES
PCR
Alabama
Alternate Test Procedure
ambient water quality criteria
Beaches Environmental Assessment and Coastal Health Act
Best Management Practices
California
Code of Federal Regulations
Critical Path Science Plan
Clean Water Act
deoxyribonucleic acid
Environmental Monitoring for Public Access and Community Tracking
Study
U.S. Environmental Protection Agency
gastrointestinal
Geographic Information System
Mississippi
National Epidemiological and Environmental Assessment of Recreational
Water Study
National Oceanic and Atmospheric Administration
National Pollutant Discharge Elimination System
polymerase chain reaction
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POTW
QMRA
qPCR
RI
SCCWRP
TMDL
URI
U.S.
uses
UV
WQS
WWTP
publicly-owned treatment works
Quantitative Microbial Risk Assessment
quantitative polymerase chain reaction
Rhode Island
Southern California Coastal Water Research Project
Total Maximum Daily Load
upper respiratory illness
United States
United States Geological Survey
ultraviolet
water quality standard
Wastewater Treatment Plant
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Critical Path Science Plan for the Development of New or Revised Recreational Water Quality Criteria
CHAPTER 1 INTRODUCTION
On October 10, 2000, the Beaches Environmental Assessment and Coastal Health Act (BEACH
Act) was signed into law, amending the Clean Water Act (CWA). Two of the major provisions
of the BEACH Act are CWA sections 104(v) and 304(a)(9), which together require the U.S.
Environmental Protection Agency (EPA) to conduct studies associated with pathogens and
human health and to publish new or revised recreational water quality criteria for pathogens
and pathogen indicators based on those studies. These criteria will be used by States,
Territories, and Tribes to develop their water quality standards (WQS). EPA has conducted a
significant amount of research since the BEACH Act was enacted and is now in the process of
defining what additional studies EPA will conduct in order to issue new or revised CWA
criteria by 2012.
1.0 PURPOSE AND SCOPE
Since EPA issued its current recreational water quality criteria over 20 years ago, there have
been significant scientific advances, particularly in the areas of molecular biology, virology and
analytical chemistry. EPA believes these new scientific and technological advances need to be
considered and evaluated for feasibility and applicability in the development of new or revised
criteria for pathogens and pathogen indicators. To this end, EPA has conducted a significant
amount of research including developing new methods for measuring microbiological
organisms in water and conducting epidemiologic studies to provide the scientific foundation
for new or revised criteria. However, these studies are only a part of what is needed. EPA's
review of existing research and science has raised a series of significant questions that need to
be answered in order for EPA to move forward with criteria development. These questions are
presented and discussed in Chapter 3.
To address these questions, EPA has engaged a range of stakeholders representing the general
public, public interest groups, State and local government, industry, and municipal wastewater
treatment professionals. Based on their feedback as well as detailed input and
recommendations from the scientific community, the Agency has developed a Critical Path
Science Plan for Development of New or Revised Recreational Water Quality Criteria (CPSP or Science
Plan). The purpose of the CPSP is to articulate the essential research and science that EPA will
conduct between 2007 and the end of 2010 to establish the scientific foundation for new or
revised recreational water quality criteria to protect swimming in waters designated by a State
for that use (referred to in this document as "recreational water quality criteria" or "recreational
criteria"). The CPSP also describes studies for which EPA is providing financial and/or
technical support. The specific near-term critical research and science needs described in the
Science Plan were informed by the individual input of the 43 international and U.S. experts who
attended a scientific workshop held by EPA in March 2007 at the Airlie Center in Warrenton,
Virginia. Near-term needs were defined as specific research and science activities that could be
accomplished in 2 to 3 years to support development of new or revised criteria by 2012. The
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Report of the Experts Scientific Workshop on Critical Research Needs for the Development of New or
Revised Recreational Water Quality Criteria is available online at www.epa. gov/waterscience.
The CPSP represents an integrated approach to answering the key questions that EPA believes
need to be addressed to ensure that the new or revised criteria are scientifically sound. EPA
recognizes, however, that the outcome of one study may affect the design and implementation
of those that follow. Therefore, some contingencies have been identified in this Science Plan to
accommodate unexpected outcomes, and it is acknowledged that others may arise that have not
been foreseen.
1.1 STATUTORY BACKGROUND AND PURPOSE OF EPA's RECOMMENDED WATER
QUALITY CRITERIA
Section 304(a)(l) of the CWA directs EPA to publish recommended water quality criteria
reflecting the latest scientific knowledge on the effects of the presence of pollutants in water on
health and welfare. The criteria published by EPA under section 304(a) are intended to provide
guidance to States in setting WQS to protect public health as well as to maintain and restore
water quality and ecosystem integrity.
CWA section 303 requires each State to adopt WQS for all waters of the State and to review, and
revise them as necessary, every 3 years. A WQS is a method of expressing the desired condition
of a water body. Such standards consist of three main elements: (1) one or more designated
"uses" of each of the State's waters, such as recreation or propagation of fish; (2) "criteria"
expressed as pollutant concentration levels or narrative statements representing a quality of
water that supports a designated use; and (3) an anti-degradation policy to protect existing uses
and high quality waters. WQS serve the dual purposes of establishing the water quality goals
for a specific water body and serve as the regulatory basis for the establishment of water-
quality-based treatment controls and strategies beyond the technology-based levels of treatment
required by sections 301 (b) and 306 of the CWA. In the case of WQS for pathogens or pathogen
indicators to protect the swimming use of waters, States also use WQS in their beach monitoring
and notification programs.
The BEACH Act was enacted on October 10, 2000. It amended the CWA in part by adding
Section 304(a)(9)(A), which provides:
"Not later than 5 years after the date of the enactment of this paragraph, after
consultation and in cooperation with appropriate Federal, State, tribal, and local officials
(including local health officials), the Administrator shall publish new or revised water
quality criteria for pathogens and pathogen indicators (including a revised list of testing
methods, as appropriate), based on the results of the studies conducted under section
104(v), for the purpose of protecting human health in coastal recreation waters."
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Section 104(v) of the CWA was also enacted as part of the BEACH Act. It provides that EPA
"shall initiate, and not later than 3 years after the date of enactment" of the BEACH Act,
"complete . . . studies to provide additional information for use in developing
(1) an assessment of potential human health risks, resulting from exposure to pathogens
in coastal recreation waters, including non-gastrointestinal effects;
(2) appropriate and effective indicators for improving detection in a timely manner in
coastal recreation waters of the presence of pathogens harmful to human health;
(3) appropriate, accurate, expeditious, and cost-effective methods (including predictive
models) for detecting in a timely manner in coastal recreation waters the presence of
pathogens that are harmful to human health; and
(4) guidance for State application of the criteria for pathogens and pathogen indicators
to be published under section 304(a)(9) to account for the diversity of geographic and
aquatic conditions."
1.2 PURPOSE OF WATER QUALITY CRITERIA COMPONENTS OF STATE WATER QUALITY
STANDARDS
Water quality criteria when adopted into State WQSs play a critical role in implementing a
range of essential purposes and functions under the CWA.
Water Quality Sections 303(d) and 305(b) provide that States are required
to assess their waters on a regular basis to determine if they are meeting WQS. The
States' water quality criteria are an essential baseline against which States determine
whether particular waters are "impaired."
Total Daily Loads. Total maximum daily load (TMDL) calculations are
required for all waters that have been listed as "impaired" under section 303(d). A
TMDL specifies the maximum amount of a pollutant that a waterbody can receive and
still meet WQS, and "allocates" pollutant loadings among point and non-point pollutant
sources. TMDL calculations for impaired waters must be written to implement the
applicable State WQS.
National Pollutant Elimination (NPDES). NPDES permits are
required under section 402 for point source discharges of pollutants to waters of the
United States. NPDES permits must include effluent limitations more stringent than
required by technology regulations if necessary to meet water quality standards, which
include State water quality criteria.
Non-point Program. Water quality standards (including criteria) play a similarly
important role under the CWA section 319 non-point source program as part of the
listing and TMDL processes outlined above to determine whether best management
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practices (BMPs) or other risk management control strategies are needed to address non-
point source pollution.
Recreational Water Monitoring and Notification, A State's recreational water quality
criteria are used in beach monitoring and notification programs. States and beach
managers typically make decisions about whether to issue advisories or closure notices
by measuring the results of their monitoring against their WQS.
1.3 GOALS OF EPA's SCIENTIFIC RESEARCH
The studies that EPA is to conduct under CWA section 104(v) are to provide additional
information for developing (1) an assessment of potential health risks resulting from exposure
to pathogens; (2) appropriate and effective indicators of the presence of pathogens; (3)
appropriate, accurate, expeditious, and cost-effective methods for detecting the presence of
pathogens; and (4) guidance for State application of any new or revised criteria to account for
diversity of geographic and aquatic conditions. The results of these studies will support EPA's
development of new or revised water quality criteria under CWA 304(a) to protect public health
in waters designated by States for swimming (i.e., recreational waters). Below is a general
summary of the goals of EPA's scientific research which are consistent with the requirements of
section 104(v).
1. Assessment of Human Health Risk. Conduct research (e.g., epidemiologic studies and
quantitative microbial risk assessment [QMRA]) to allow for an assessment of potential
human health risks (including non-gastrointestinal effects) in the general population,
including children, from swimming-related exposure to different sources of fecal
contamination (human versus non-human).
2. Development of Indicators.1 Conduct research to identify appropriate indicators of
fecal contamination to allow for a reliable correlation between indicator concentrations
and health effects. Develop studies to evaluate temporal and spatial variability in
indicator concentrations to appropriately characterize water quality and inform
recreational water quality management decisions.
3. Development of Methods.2 Conduct research to develop, evaluate and validate
appropriate methods to measure indicators of fecal contamination to allow for a reliable
correlation between indicator concentrations and health effects. Assess linkages between
indicators and methods to ensure that they will be protective of the swimming use when
implemented singly or in combination.
4. Extrapolation of Research Results for Developing New or Revised Criteria. Conduct
appropriate studies to assess the influence of variability in geographic and aquatic
1 Research on indicators and methods are discussed together in Chapter 3 (Section 3.2).
2 Research on methods (including models) is discussed in Chapter 3 (Sections 3.2 and 3.3).
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conditions on indicator and method performance, and assess the suitability of indicators
and methods for various CWA purposes (e.g., beach monitoring, assessments, TMDLs,
and permitting). Develop, evaluate and validate predictive models and tools to
understand the extent to which data from epidemiologic study sites can be extrapolated
to other geographic locations and aquatic conditions; and examine the role of models as
a tool in predicting water quality problems to assist in new or revised criteria
implementation.
The requirements in CWA sections 104(v) and 304(a)(9)(A) are for studies and water quality
criteria related to "coastal recreation waters" as defined in section 502(23) of the CWA (i.e.,
marine coastal waters, coastal estuaries, and Great Lakes waters). However, some of the studies
included in this Science Plan would be used to support the development of recommended
water quality criteria that applies to both coastal recreational waters and inland waters
designated for swimming.
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CHAPTER 2 DEVELOPMENT OF THE CRITICAL PATH SCIENCE PLAN
2.0 SUMMARY OF EPA RESEARCH ALREADY COMPLETED
2.0.1 Early Studies
Current 304(a) recreational water quality criteria are based on epidemiologic studies conducted
by EPA in the 1970s and 1980s. The currently recommended indicators are based on methods
that involve culturing and enumerating fecal indicator bacteria (Enterococcus spp. or E. coll). One
shortcoming of these methods is that the bacteria require at least 18 to 24 hours to grow visible
colonies for subsequent enumeration. Recent research indicates that the quality of water that is
impacted by fecal contamination can change rapidly, and thus, criteria based on indicator
organisms and associated methods that require 18 hours or more to produce results can lead to
either unnecessary beach closings or the exposure of swimmers to water of poor quality.
Since the enactment of the BEACH Act, EPA has undertaken several significant studies
designed to improve the scientific basis for recreational water quality criteria. Each study is
discussed below.
2.0.2 National Epidemiological and Environmental Assessment of Recreational Water
Study
EPA's National Epidemiological and Environmental Assessment of Recreation (NEEAR) Water
Study is a collaborative research study between EPA and the Centers for Disease Control and
Prevention (CDC). EPA also coordinated this study with the U.S. Geological Survey (USGS) and
other interested agencies. A primary goal of this study is to establish a health-based relationship
between indicators of fecal contamination and swimming-associated illness as measured by a
variety of methods, including timely molecular methods. To date, four Great Lakes freshwater
epidemiologic studies have been completed, one marine study3 was started but halted due to
hurricane conditions and two EPA-conducted marine epidemiologic studies (described in
Chapter 3) are currently underway. The Great Lakes freshwater studies were the first to
establish a relationship between the levels of fecal contamination in recreational waters
(referred to in this document as "microbial water quality"), as measured by timely methods,
and swimming-associated health effects occurring within 10 to 12 days after a beach visit. In
these studies, molecular methods showed great promise for allowing beach managers to
potentially make more timely decisions regarding the safety of beach waters on any given day.
3Marine study in Biloxi, Mississippi was halted because the beach study site was destroyed by Hurricane Katrina in
2005.
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2.0.3 Environmental Monitoring for Public Access and Community Tracking Beaches
Project
The Environmental Monitoring for Public Access and Community Tracking (EMPACT) Beaches
Project (EPA, 2005) was designed to identify the characteristics of a beach environment that
have a significant impact on microbial water quality monitoring results. Five beach
environments were examined to determine the factors that most influence the measurement of
microbial water quality at beaches. Two ocean beaches, an estuarine beach, a Great Lakes
beach, and a riverine beach were selected to provide as broad a representation of beach
environments as possible. The results indicated the following:
The greatest single determinant of fecal indicator level was found to be the depth
zone, or distance from the shoreline at which the sample was collectedfecal
indicator concentrations were substantially lower as one moved from ankle-deep
to knee-deep to chest-deep water;
Significant declines in indicator densities from the morning to the afternoon were
observed at four of the five study beaches; and
There was significant variability over time so that measurements of indicators on
any given day did not correlated to indicator levels on subsequent days.
2.0.4 Other Completed Studies
The following additional studies were critical to determining which indicators and methods
were available for inclusion in the NEEAR study in the Great Lakes to provide timely
quantification of fecal contamination.
Method evaluation of off-the-shelf technologies for rapid methods for indicators of fecal
contamination;
Method development study of quantitative polymerase chain reaction (qPCR) methods
for Enterococcus and ftacteroides; and
Completion of a chemical indicator study evaluating other chemical substances,
including coprostanol, urobilin, caffeine, acetaminophen, cotinine and codeine as
possible indicators of human fecal contamination (from wastewater).
EPA also completed related studies to allow for the use of the epidemiologic study results to:
(1) develop a predictive modeling tool, and (2) understand whether the Great Lakes study
results could be applied beyond the study locations to other freshwaters. These studies
included:
A study to develop a virtual beaches model intended to allow beach managers to collect
and analyze explanatory variables and develop a beach prediction tool; and
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An evaluation of the aquatic matrix effects on the performance of the qPCR method in
order to determine the method's applicability in freshwaters beyond the four Great
Lakes test sites.
Additional information is needed to fulfill several important goals and objectives for new or
revised criteria. For example, the relative health effects and associated risk levels from different
sources of fecal contamination (e.g., human versus non-human sources of fecal contamination,
and treated versus untreated or poorly treated human sewage) are not well understood and
may vary significantly; the relationship between indicator organism concentrations and adverse
health effects in different waterbody types are not well understood; the compatibility of existing
culture methods with the newly developed rapid methods for indicator organisms is not
sufficiently understood; and the optimization of sampling, recovery, and processing of samples
using rapid methods is still under development.
2.1 CONSIDERATION OF STAKEHOLDER INPUT ON THE 1986 BACTERIA CRITERIA
Although EPA considers the science underlying the 1986 bacteria criteria to be superior to the
science underlying the previously recommended criteria for fecal coliforms, some States have
yet to adopt new or revised standards for inland waters based on the 1986 bacteria criteria.
States and other stakeholders, including experts from the Experts Scientific Workshop have
suggested that EPA consider the following recommendations in conducting studies and
developing the new or revised criteria, based on their experience implementing the 1986
bacteria criteria.
Provide clear, science-based guidance and flexibility regarding use of the single-sample
maximum values (a feature of the 1986 criteria) and differing risk levels, or change the
approach to include specific measures to assess water quality for both the short-term
(beach closure/advisory decisions) and the long-term (attainment of the designated
swimming use over a length of time).
Consider the impact on transition from current criteria (e.g., fecal coliforms-based
criteria or the 1986 bacteria criteria) to new criteria on impaired waters listings, existing
bacteria TMDLs, and associated discharge permits; and develop tools, strategies, and
policies to ease the transition.
Develop EPA-approved analytical methods for use in both ambient and wastewater for
the new indicator bacteria.
Collect data or perform analysis to assess the applicability of the new bacteria criteria to
flowing streams.
Conduct research to quantify the risk associated with contributions from the range of
non-human sources of fecal contamination, and incorporate flexibility to adjust the new
criteria for water bodies that do not receive human sources of fecal contamination.
Continue dialogue with States and other stakeholders during the development of the
new bacteria criteria to keep them informed regarding the outcomes of the research and
the effect on the criteria development approach.
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2.2 EXPERTS SCIENTIFIC WORKSHOP AND REPORT
The Experts Scientific Workshop on Critical Research and Science Needs for the Development of New or
Revised Recreational Water Quality Criteria took place at the Airlie Center in Warrenton, Virginia,
from March 26 to March 30, 2007. Forty-three U.S. and international experts from academia,
States, public interest groups, EPA, and other federal agencies, met to discuss the state-of-the-
science on recreational water quality research and implementation issues.
The purpose of the workshop was for EPA to obtain input from individual members of the
broad scientific and technical community on the "critical path" research and related science
needs for developing scientifically defensible new or revised CWA Section 304(a)(9) recreational
ambient water quality criteria in the near-term. Near-term needs were defined as those specific
research and science activities that could be accomplished in the next 2 to 3 years so that results
would be available to EPA in time to support development of new or revised criteria by 2012.
For additional information on the Experts Workshop Report and research identified by the
experts, go to www.epa.gov/waterscience.
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CHAPTER 3 KEY SCIENCE QUESTIONS EPA WILL RESEARCH UNDER THE
CRITICAL PATH SCIENCE PLAN
3.0 PEER-REVIEW OF DRAFT CRITICAL PATH SCIENCE PLAN
In developing the Science Plan, EPA considered the research needs identified by the experts
participating in the Experts Scientific Workshop. EPA then established its research priorities
based on the most significant science questions, which EPA believes it can make significant
progress toward answering in the next 2 to 3 years to support development of new or revised
recreational criteria.
The research projects were described in a draft of the Science Plan which was peer reviewed by
three scientific experts external to EPA.4 The purpose of the peer review was to obtain expert
feedback and comments on the clarity and scientific merit of the proposed research activities,
and on the likelihood they can be completed in a 2- to 3-year period and meet EPA's goals and
objectives for the new or revised criteria. In addition, EPA asked the peer reviewers whether or
not the proposed research activities effectively addressed the science questions and research
needs identified in the document, and to identify the noteworthy strengths and weaknesses of
the proposed research activities. EPA requested that peer reviewers indicate any modifications
that would improve upon any particular research project or upon the science plan in its entirety.
The reviewers provided beneficial and constructive input to EPA on the draft Science Plan. The
reviewers confirmed that the epidemiologic studies, assay methodologies, fecal contamination
source identification studies, QMRA methods, and other studies reflected a generally
reasonable and effective approach to answering the research questions. They supported EPA's
focus on research related to non-human sources of fecal contamination. They also indicated that
the plan as outlined is achievable in the 2- to 3-year timeframe available. However, they
suggested that EPA clarify the key goals and questions articulated in the Science Plan to
increase understanding and transparency in the document (e.g., more clearly articulating the
connection between the research projects and the goals, improving individual project
descriptions and justifications, identifying how research results would be used and how the
project results may interact). EPA concurred with many of these comments and has revised the
Science Plan accordingly. EPA has clarified the key goals and key research questions as
presented in section 1.3 as follows:
Assessment of Human Health Risks (Goal 1, discussed in section 3.1)
o Key Research Question: What is the risk to human health from swimming in water
contaminated with human fecal matter as compared to swimming in water
contaminated with non-human fecal matter?
Development of Indicators (Goal 2) and Methods (Goal 3) (discussed in section 3.2)
4 peer review comments are available upon request.
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o Key Research Question: How well do culture and molecular methods for various
indicators (singly or in combination) correlate with swimming-related illnesses?
Extrapolation of Research Results for Developing New or Revised Criteria (Goal 4,
discussed in section 3.3)
o Key Research Question: Are these indicators, methods and models suitable for use
in different types of waters and for different CWA programs?
3.1 ASSESSMENT OF HUMAN HEALTH RISKS (GOAL 1)
EPA's current CWA 304(a) recommended criteria for bacteria are based on E. coll and
enterococci as indicators of fecal contamination. These criteria were derived largely from the
results of epidemiologic studies at beaches predominantly impacted by publicly-owned
treatment works (POTWs) in the 1970's and 1980's. At that time, human sources of fecal
contamination originating from POTWs were viewed as representing the highest relative risks
to swimmers. While human fecal contamination may pose a higher risk, there are other sources
of fecal contamination for which the risk is not well understood. These other sources include
poorly- treated or untreated human fecal waste, and non-human sources of fecal contamination
(e.g., fecal contamination from agriculturally important animals and wildlife in the watershed).
Also, stormwater runoff in urban areas may represent a mixed source of human and animal
fecal material. Animal sources in an urban setting may include domesticated and other animals
such as geese.
There have been limited studies on poorly-treated or untreated human fecal contamination, and
few studies on waters largely impacted by animal sources of fecal contamination. Many of these
studies used different indicators of fecal contamination, various (qualitative to quantitative)
approaches at differentiating sources of contamination, and different approaches or protocols to
assess health effects in the study population. The lack of studies using similar study design and
protocols focusing on various sources of fecal contamination represents a major data gap. As
such, it is difficult to determine in a quantitative manner the relative risks of swimming-
associated illness from various sources of fecal contamination. Specific uncertainties that EPA
intends to address include:
Understanding what human illnesses are caused by swimming in waters contaminated
with human fecal matter from different sources, the levels of human fecal matter in these
waters that cause human illness, and the relationship between different levels of human
fecal matter in waters and human illness rates.
Understanding what human illnesses are caused by swimming in waters contaminated
with non-human fecal matter, the levels of non-human fecal matter in these waters that
cause human illness, and the relationship between different levels of non-human fecal
matter in waters and human illness rates.
Understanding any differences in risk to children swimming in waters contaminated
with fecal matter versus adults swimming in these waters.
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3.1.1 Description of the Key Science Question
What is the risk to human health from swimming in water contaminated with human fecal
matter as compared to swimming in water contaminated with non-human fecal matter?
The research described in this section addresses Goal 1 as outlined in section 1.3 and focuses on
the following two areas:
Risks from Human Sources of Fecal Contamination (Section 3.1.2)
Risks from Non-Human Sources of Fecal Contamination (Section 3.1.3)
3.1.2 Risks from Human Sources of Fecal Contamination
3.1.2.1 Treated POTW Effluent
EPA conducted prospective cohort epidemiologic studies at four Great Lakes beaches impacted
by treated wastewater discharges as part of the NEEAR studies. EPA included several
indicators and methods of fecal contamination and assessed their relationship to the following
non-enteric and enteric illnesses:
(1) gastrointestinal illness (GI), defined as any of the following:
a) diarrhea (3 or more loose stools in a 24-hour period), or
b) vomiting, nausea and stomachache, or
c) nausea or stomachache and impact on activity;
(2) upper respiratory illness (URI), defined as any two of the following: sore throat, cough,
runny nose, cold, fever;
(3) rash;
(4) eye ailment, defined as either eye infection or watery eye; and
(5) earache.
Furthermore, EPA collected extensive demographic data which will allow for analysis of risk in
various subpopulations, including children, relative to the general population.
Swimming-related GI rates were found to be significantly associated with fecal contamination
(as measured by qPCR enterococci) in the Great Lakes NEEAR studies (Wade et al., 2006). EPA
intends to conduct comparable studies (using the same site selection criteria and protocols and
methods) at POTW-impacted marine beaches to determine if a similar indicator-illness
relationship holds.
EPA initiated a marine epidemiologic study in Biloxi, MS in the summer of 2005 that was
curtailed due to severe weather events caused by Hurricane Katrina. Although the study was
insufficient in terms of sample size, it represents a source of additional data that can be
analyzed along with data from ongoing and future epidemiologic studies. At this time, the lack
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of similar epidemiologic studies in marine waters represents a data gap; EPA needs to
determine whether the relationship between fecal contamination and illness, which was
observed in the Great Lakes, is similarly applicable in marine waters. To address this gap, EPA
intends to conduct the following research activities and projects:
Conduct an epidemiology study at a POTW-impacted marine beach at Goddard, Rhode
Island. (PI)5
Conduct an epidemiology study at a POTW-impacted marine beach at Fairhope,
Alabama. (P2)
Conduct statistical analysis of children data (P29) to determine if there is a significant
difference in risk in all epidemiologic studies.
Compare 1986 to NEEAR data to better understand the relationship between fecal
contamination and illness in these data sets (P27).
If the results of these studies do not yield sufficient statistical power or if the results between
these studies (Alabama, Rhode Island, and Mississippi) are not consistent, then an additional
epidemiologic study on POTW- impacted marine waters (P6) would be conducted.
When completed, these studies will fill a data gap and help EPA determine whether and how
fecal contamination is associated with illness in marine waters. Detailed descriptions of each
research activity can be found in Table 3-1, organized under a broad research category (e.g.,
epidemiology studies). Table 3-2 presents a timeline for these studies indicating when EPA
expects to initiate and complete the studies. The timeline for epidemiology studies includes
study design, study initiation and completion, data analysis, peer review, and publication.
3.1.2.2 Poorly Treated or Untreated Wastewater
Since past research efforts have largely focused on POTW-impacted waters, there have been few
epidemiologic studies which have addressed the relative risks of illness associated with poorly
or untreated human fecal matter. Addressing this gap has been the focus of the Southern
California Coastal Water Research Project (SCCWRP). A prospective cohort epidemiology
study is being conducted by SCCWRP with EPA support to assess health risks and illness-
indicator relationships at a marine beach in California. Avalon beach is affected by a mix of
sources of fecal contamination including bird droppings, urban runoff and leaking sanitary
sewers (including failing infrastructure and leaking collection systems). EPA is interested in this
study as an example of a beach believed to be predominantly impacted by poorly/untreated
human fecal contamination. Water samples are being tested for Enterococcus qPCR, Bacteroides
qPCR, Bacteroides thetaiotamicron qPCR, and coliphage by antibody assay in addition to
5 Codes (P1-P32) refer to an arbitrarily assigned project number.
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traditional culture-based assays. The study design is largely based on EPA's current marine
study design and the data could potentially be combined with EPA conducted studies for future
analysis. Because the focus of this SCCWRP research is expected to help fill this gap, EPA does
not intend to conduct any additional studies in this area.
SCCWRP is expected to ultimately generate data from two, other beaches: a beach that is
predominantly impacted by animal fecal contamination (Doheny, CA), and a beach that is
impacted by a mixture of animal and human fecal contamination (Malibu, CA). This data set
could potentially help EPA understand differences in illness rates under different source
conditions in the same geographic/climatic region. These other SCCWRP studies are receiving
EPA technical input.
Summary of research activities and projects:
Support an epidemiologic study at a beach in Avalon, CA believed to be impacted
primarily by untreated human fecal contamination. (P3)
Conduct statistical analysis of children data (P29) to determine if there is a significant
difference in risk in the Avalon, CA epidemiologic study.
EPA will consider the results of the SCCWRP studies to determine whether risks associated
with poorly treated or untreated human fecal matter differ greatly from risks associated with
swimming in waters in proximity to POTWs and if the risks are different, what the relative
difference is in risk of illness. A detailed description and a timeline for each study are provided
in Tables 3-1 and 3-2, respectively.
3.1.3 Risks from Non-Human Sources of Fecal Contamination
3.1.3.1 Animal Sources and Stormwater
Human and animal feces can both potentially contain pathogens that cause human illness.
Some human pathogens can be shed in feces by both humans and animals, while others such as
viruses are typically host specific. As a result, the relative risks associated with animal fecal
matter are dependent somewhat on the host species. As noted in the Experts Workshop Report
(EPA, 2007), "it is widely believed that human feces pose a larger health risk than animal feces
to swimmers and other primary contact recreational waster users. This belief derives from the
basic concept that virtually all enteric pathogens of humans are infectious to other humans,
while relatively few of the enteric pathogens of animals are infectious to humans.. .The bottom
line is that there are few data to demonstrate whether animal feces pose a lower, greater, or
equivalent heath risk to swimmers than human feces. If there is a difference, it would be
important to know the magnitude of the difference, in order for EPA to make appropriate
criteria recommendations. The only way to get a better sense of the health risk to swimmers
posed by animal feces is to conduct targeted studies."
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EPA plans on conducting several lines of research to support such targeted studies. Initially,
EPA will conduct a state-of-the science review of published studies to identify major data gaps,
outline current thinking on relative risks and target animals/pathogens of concern, and identify
specific data collection needs that may influence the direction and design of field studies that
would be conducted to help answer this question. Then, EPA will:
(1) develop new and/or evaluate previously published genetic biomarker methods (or
assays) for identifying human and a particular source of animal contamination, and
(2) collect data and conduct source and site characterization evaluations at potential study
sites.
Based on the findings from this research, EPA will conduct at least one epidemiologic study
and/or conduct QMRA to characterize the indicator-illness relationship at a freshwater beach
impacted by agricultural animal sources of fecal contamination for comparison to the
relationship(s) obtained at beaches impacted by human fecal contamination.
The genetic biomarker assays will be useful in characterizing the sources of fecal contamination
at recreational water sites, as an initial step prior to conducting epidemiologic or QMRA
studies. Source and site characterization activities will be conducted concurrently with the use
of the genetic biomarker methods to identify likely agricultural sources and site characteristics
that may influence contributions of fecal contamination at the beach. While various assays are
being researched which may in the future allow for differentiation among animal groups, only
those that differentiate human fecal material from the total fecal material, and those that
differentiate bovine fecal material from other animal fecal material, will be available given the
2- to 3-year timeframe for developing the new or revised criteria.
Source and site characterization activities will also be conducted to assess risks posed by urban
stormwater sources of contamination. Based on these activities and an evaluation of the
preliminary results of the proposed Doheny, CA, SCCWRP study, EPA will decide whether the
potential differences in risks can be assessed through QMRA activities or whether an
epidemiologic study is needed. If an additional epidemiologic study is warranted, EPA will use
the site/source characterization study to develop site selection criteria, and/or revise study
design if needed. The site/source characterization study activity will also potentially support
the development of quantitative sanitary investigation tools/protocols.
Summary of research activities and projects:
Conduct several state-of-the-science reviews of published studies focusing on:
o sources of non-human fecal contamination (P30),
o studies on occurrence and cross-infectivity of specific pathogens associated with
animals (P31), and
o components and data requirements for QMRA (P7).
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Develop new and/or evaluate previously published source-identifying assays (P19) or
molecular biomarkers.
Evaluate human assays with water samples with different levels of fecal contamination
from wide geographic range to supplement site characterization and quantitative
sanitary investigation. (P20)
Evaluate genetic markers for cows to supplement the site characterization and
quantitative sanitary investigation. (P21)
Collect data and conduct source and site characterization evaluations at potential study
sites to determine the extent of specific animal sources, and factors influencing the
extent to which they would contribute to fecal contamination at the beach. (P9)
Conduct site and source characterization studies to better understand the factors
influencing the contributions of untreated sources (e.g., urban runoff) to total fecal
contamination to ambient waters. (Pll)
Conduct at least one epidemiologic study and/or QMRA to characterize the indicator-
illness relationship at a freshwater beach impacted by agricultural animal sources of
fecal contamination for comparison to those obtained at POTW-impacted beaches. (P4)
Conduct epidemiologic study in marine or fresh waters impacted by urban runoff
and/or conduct QMRA analysis. (P5)
These targeted studies will address current data gaps and uncertainties in assessing the relative
risks associated with non-human sources of fecal contamination. A detailed description and a
timeline of each study are provided in Tables 3-1 and 3-2, respectively.
3.2 DEVELOPMENT OF INDICATORS AND METHODS (GOALS 2 AND 3)
EPA's current CWA 304(a) recommended criteria for bacteria are based on methods that
involve culturing and enumerating E. coll and enterococci as indicators of fecal contamination.
One shortcoming of these methods is that the bacteria require at least 18 to 24 hours to grow
visible colonies for subsequent enumeration. The need for appropriate and effective indicators
and methods for timely detection of fecal pathogens is reflected in the EPA science Goals 2 and
3 described in section 1.3. As described in Chapter 2, EPA has conducted epidemiologic studies
at four Great Lakes beaches and tested a suite of indicators and methods which were available
at the time the studies were conducted and that met EPA performance criteria. The results of
those studies indicate that Enterococcus qPCR is positively correlated with GI illness. EPA has
also conducted a study evaluating the performance of this method in various settings. At
present, EPA is testing a similar suite of indicators and methods in marine waters impacted by
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human fecal contamination. The analysis of the marine studies will determine whether the same
or a different indicator and method are most appropriate for marine environments.
EPA may identify or recommend more than one indicator or method, recognizing the different
purposes served by criteria in the implementation of CWA programs (e.g., criteria are used to
determine NPDES limits, to trigger beach advisories, and to define impaired waters). If EPA
does recommend more than one indicator or method, EPA must understand the relationship
between any separately recommended indicators and methods (for the various CWA purposes)
and ensure that the recommended combination of indicators and methods will be, when
implemented, protective of the swimming use.
Recent research indicates that indicator organism concentrations can vary at a given beach on
time scales ranging from minutes to decades based on events such as changes in wastewater
treatment, meteorological events (El Nino), strength or magnitude of rainfall events, tidal
cycles, and UV-induced mortality. Of particular concern are the short-term (minute to hour)
variability and heterogeneous mixing which can lead to moving hot spots of microorganisms.
Additional research is needed to understand these processes and develop robust monitoring
protocols that will allow for adequate characterization of microbial water quality.
EPA studies have demonstrated the utility of a new indicator and method (i.e., qPCR for
enterococci) as a predictor of swimming-related illness in the Great Lakes. Whether this
indicator and method is applicable to other settings or appropriate for use across the range of
CWA programs is not fully understood. Data gaps include understanding how well the various
indicators and methods perform in other settings (e.g., marine versus fresh water; human
versus non-human sources of fecal contamination), and how they relate to one another. These
data gaps led EPA to identify the following key science question.
3.2.1 Description of the Key Science Question
How well do and molecular methods for various or in
correlate with illnesses?
The research activities described in section 3.2 aim to identify appropriate indicators of fecal
contamination and related methods for use in new or revised criteria. This research addresses
Goals 2 and 3 as outlined in section 1.3. The research related to indicators is not separate from
the research related to methods. This is because in conducting epidemiologic studies to
determine the relationship between illness and indicators, methods are used to detect and
quantify the indicators. EPA will conduct health-based studies to identify those
indicators/methods that show a positive correlation between indicator concentrations in the
water and health effects. The research in this section focuses on the following three areas:
Develop, Evaluate and Validate Indicators and Methods (Section 3.2.2)
Assess Linkages between Indicators and Methods (Section 3.2.3)
Characterize Temporal and Spatial Variability in Measurements (Section 3.2.4)
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3.2.2 Develop, Evaluate and Validate Indicators and Methods
As discussed in Chapter 2, EPA conducted prospective cohort epidemiologic studies at four
Great Lakes beaches impacted by treated waste water discharges as part of the NEEAR studies.
EPA included several validated methods available at that time and assessed their relationship to
various illness endpoints described in section 3.1.2.1. Water samples were tested for Enterococcus
using qPCR, Enterococcus using standard culture method, E. coll using a standard culture
method, and Bacteroides using qPCR. The samples also were tested for over 30 pharmaceutical
and industrial chemicals. Swimming-related illness rates and qPCR measures of enterococci
were significantly associated in these studies. EPA is conducting comparable studies in marine
waters impacted by POTWs to determine if a similar relationship holds at sites using the same
site-selection criteria and protocols and methods used at the Great Lakes beaches. Additional
indicators and methods included in the marine study sites (section 3.1) are E. coll using qPCR,
Bacteroides using qPCR (not human-specific), Bacteroides using qPCR (human-specific), and
male-specific coliphages antibody assay. EPA will evaluate each of the indicators/methods, and
should any of these prove superior to enterococci qPCR, those methods will be further studied.
Archived samples on frozen filters from the Great Lakes epidemiologic studies will be analyzed
if appropriate for indicators and methods not originally available, but that showed promise in
marine studies, to determine whether a better correlation can be established with swimming-
associated illness. In addition, EPA is refining several indicators/methods (e.g., Bacteroides) and
plans to include improved techniques in any re-analysis. However, prior to analyzing any
archived samples, EPA plans to conduct a study to assess the effects of sample holding time,
sample storage, and preservation on sample integrity for future use (P16).
Summary of research activities and projects:
Study the effects of sample holding time, sample storage, and preservation on sample
integrity for future use. (P16)
Re-analyze archived NEEAR samples for other indicators (depending on the outcome of
MO and the nature of the indicator/method). (P22)
Develop, refine, validate, and publish new ambient and wastewater test methods. (PI7)
3.2.3 Assess Linkages Between Indicators and Methods
Recognizing that any single indicator or method may not be suitable for all CWA purposes,
EPA intends to conduct scientific studies to explore correlations and linkages between available
indicators and methods to ensure that they provide for equivalent or comparable public health
protection. EPA plans to analyze each indicator and method relative to its relationship with
swimming-associated risk of illness. Additionally, EPA plans to use this information to develop
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water quality models that can be extrapolated from one waterbody type to another. (See also
section 3.3).
Summary of research activities and projects:
Study various parameters that affect performance of qPCR signal for enterococci and
compare with other methods and pathogens in treated wastewater mixed with ambient
waters (enterococci, E. coll, Cryptosporidium, and enterovirus). (P8)
Evaluate multiple indicator/method combinations to develop quantifiable relationships.
(P15)
Pilot sanitary survey in Great Lakes. (P14)
3.2.4 Characterize Temporal and Spatial Variability in Measurements
The NEEAR studies used a detailed sampling protocol for collecting data at various locations
and water depths at a beach several times each day. These data were evaluated to determine
their relationship with observed rates of swimming-associated illness. The results of that
evaluation provide insights on the variability that one may expect spatially and temporally at a
beach. Recent research external to EPA supports these findings (EPA, 2007). Additional
research is needed to understand the short-term (minute-to-hour) variability caused by various
processes, such as tidal cycles, as well as the effects of these processes on monitoring data.
Accounting for this variability will lead to more robust monitoring protocols that will allow
beach managers to better characterize the water quality at their beaches.
Summary of research activities and projects:
Design and evaluate a monitoring approach that will characterize the quality of beach
waters that takes into account the spatial and temporal variability associated with water
sampling. (P12)
These studies will address the current data gaps and uncertainties in assessing the performance
of various indicators and methods to detect pathogens in a time manner, and how various
indicators and methods relate to one another in predicting risks. A detailed description and a
timeline of each study are provided in Tables 3-1 and 3-2, respectively.
3.3 EXTRAPOLATION OF RESEARCH RESULTS FOR DEVELOPING NEW OR REVISED
CRITERIA (GOAL 4)
As described in section 3.1, EPA is conducting or supporting epidemiological studies at select
sites. Environmental factors, such as meteorology or the physical and chemical characteristics
of freshwater and marine environments, vary geographically and may influence the presence
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and viability of indicators and pathogens. Consequently, they may also influence any observed
indicator-illness relationship. Therefore, EPA intends to conduct studies to better understand
what differences in geography and climate are significant in the context of development of new
or revised criteria.
As described in section 3.2, EPA may identify or recommend more than one indicator or
method. Individual CWA programs (e.g., beach monitoring, assessments, TMDLs, and
permitting) have specific purposes that may influence the selection of indicators or methods.
For example, timeliness of obtaining test results may be critical for effective beach monitoring
and notification, but may not be essential for NPDES permitting. Understanding the specific
attributes of various indicators and methods as they relate to different CWA programs
represents another data gap.
The research activities described below address the major data gaps in understanding how
variations in diverse geographic and aquatic conditions can influence indicator performance,
and whether and how individual indicators and methods are suitable for various CWA
programs. These data gaps lead EPA to identify the following key science question.
3.3.1 Description of the Key Science Question
Are the use in of waters
CWA programs?
This research addresses Goal 4 as described in section 1.3 and focuses on the following three
areas:
Assess Variability in Diverse Geographic and Aquatic Conditions (Section 3.3.2)
Assess Methods Suitability to Different CWA Purposes (Section 3.3.3)
Develop, Evaluate and Validate Predictive Models and Tools (Section 3.3.4)
3.3.2 Assess Variability in Diverse Geographic and Aquatic Conditions
EPA expects that differences between freshwater and marine environments present the greatest
potential for variation in indicator performance. Other factors that are likely to influence
variability include hydrometeorology, biogeochemistry, and temperature.
3.3.2.1 Fresh and Marine Waters
EPA has or will be conducting or supporting several epidemiologic studies in both fresh and
marine waters. The same protocol is being used across all epidemiologic studies to allow for an
analysis of any differences in indicator performance between waterbody types.
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3.3.2.2 Temperature/Climatic Conditions
Temperature influences the general persistence and survival of indicators and specific
pathogens deposited or discharged into the environment. As described in section 3.1, EPA has
or intends to conduct or support epidemiologic studies at sites representing a range of
temperature and climatic conditions. These include: freshwater temperate (Great Lakes), a
marine subtropical beach (Fairhope, AL), a marine temperate beach on the Atlantic coast
(Goddard, RI), and a marine temperate beach on the Pacific coast (Avalon, CA). The same
protocol is being used across all epidemiologic studies to allow for analysis of any differences
between temperature and climatic conditions and indicator performance as predictors of illness.
In the near term, EPA is not intending to conduct an epidemiology study in tropical waters.
This is because available data indicate that the characterization of indicators and pathogens in
tropical climates and the factors influencing their existence, persistence, and behavior (e.g., re-
growth, naturally occurring sources) are not sufficiently characterized to pursue targeted
research in the near-term. There has been extensive research in recent years in an attempt to
understand the behavior of pathogens and pathogen indicators in tropical waters, but this
research has yielded ambiguous results as to what may actually be influencing the presence and
growth of indicators and pathogens. If EPA were to conduct an epidemiologic study in tropical
waters within 2-3 years, and differences between tropical and temperate waters were observed,
EPA would not be able to use its results in developing new or revised criteria without a better
understanding of the factors influencing the presence and growth of indicators and pathogens.
Additional research is needed to characterize organism ecology and fate before an appropriate
study design can be developed for an epidemiologic study. (Refer to Chapter 4 for further
discussion on deferred research at tropical beaches.)
Instead, EPA will conduct a comprehensive literature review to determine the extent to which
indicators may perform differently in a tropical environment compared to temperate or
subtropical environments, and to better understand the underlying causes for any differences.
EPA is also open to evaluating epidemiologic and other data generated at tropical locations by
other entities to determine if an alternative indicator is appropriate.
Summary of research activities and projects (for tropical waters):
Conduct literature review, and evaluate and interpret available data on indicator
behavior in tropical climates: (e.g., water, sand, and sediments). (P32)
3.3.2.3 Extrapolation to Other Fresh Waters
EPA is interested in evaluating whether it is scientifically valid to extrapolate results from
studies conducted in Great Lakes freshwater environments to other freshwater environments
that may differ from the Great Lakes.
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Sites can vary in the type and magnitude of contamination sources and their relative
contribution to the mix of individual pathogens, and they may differ with respect to site-specific
environmental factors (e.g., hydrology, meteorology). Given the numerous factors to be
considered, it is not feasible to conduct field studies that can adequately control for all
parameters. Collecting weather information along with physical and chemical water
characteristics data during epidemiology studies provides the opportunity to utilize water
quality models to examine any correlation of these data with health effects. Utilizing existing or
developing new predictive water quality models, one can evaluate whether and how the
epidemiologic data can be extrapolated to estimate potential health effects across different
geographic areas. (Refer to section 3.3.4 for research activities related to development,
evaluation and validation of predictive models and tools.)
Summary of research activities and projects:
Evaluate applicability of NEEAR Great Lakes data to inland waters. (P28)
Expand spatial scale of collection of site-specific data at epidemiologic study locations to
characterize watershed and support research into development of predictive models and
QMRA. (P10)
3.3.3 Assess Methods Suitability to Different CWA Purposes
Individual CWA programs (e.g., beach monitoring, assessments, TMDLs, and permitting) have
specific purposes that may influence selection of indicators or methods. For example, timeliness
of obtaining test results may be critical for effective beach monitoring and notification, but may
not be essential for NPDES permitting. Understanding the specific attributes of various
indicators and methods as they relate to different CWA programs represents a data gap.
Summary of research activities and projects:
Evaluate the suitability of individual combinations of indicators and methods for
different CWA programs. (P18)
3.3.4 Develop, Evaluate and Validate Predictive Models and Tools
Statistical models that relate water quality to environmental factors like wind speed, prior
rainfall, and tide level are valuable tools for making beach closure or advisory decisions. Site-
validated models predict water quality problems reliably and in a more timely fashion than
traditional bacterial indicator monitoring alone. Once a model is site-validated, traditional
water monitoring could be reduced and targeted.
As described in Sections 3.2 and 3.3.2, EPA is conducting research to understand those factors
that contribute to variability of indicator and pathogen behavior across diverse aquatic
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conditions including those that influence sources of indicators and pathogens, their persistence,
and their concentrations at beaches. As a result of these studies, EPA intends to refine an
existing predictive model (virtual beach) based largely on the Great Lakes studies for use in
beach monitoring at specific sites. EPA intends to test and validate this model and other
existing models in various freshwater and marine environments in different geographic
conditions, and in waters impacted by a wide range of fecal sources of contamination for site
specific application. A technical protocol for site-specific application of the model(s) would then
be developed to assist States and tribes with implementation of new or revised criteria. In
addition to predictive models, EPA intends to develop tools such as sanitary surveys to
facilitate the collection and evaluation of data for site-specific applications.
The research activities described below provide useful tools for extrapolating data from
epidemiologic study sites to other geographic locations and aquatic conditions, and predicting
water quality problems to assist in beach monitoring and notifications programs. Potentially,
these tools may also prove useful in predicting water quality problems in other CWA programs
for which criteria are intended.
Summary of research activities and projects:
Pilot test Virtual Beach model for beach notification and advisories/closures. (P23)
Refine and validate other existing water quality models for freshwater and marine beach
notification and advisories/closures. (P24, P25)
Develop technical protocol for site-specific application of predictive models to be used in
making beach advisory decisions. (P26)
Develop, refine and evaluate quantitative sanitary investigation method - sanitary
survey protocol for recreational waters. (P13)
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Table 3-1. Science Plan Research Activities and Projects
GOALS
ADDRESSED
BY RESEARCH
PROJECT TITLE
RESEARCH DESCRIPTION
START DATE/
END DATE
Epidemiology Studies/QMRA
1-4
Conduct epidemiologic studies at POTW-impacted
marine beaches in Fairhope, Alabama and Goddard,
Rhode Island (P1.P2)
Prospective cohort epidemiology studies designed to evaluate the ability of rapid and novel
indicators of recreational water quality to predict swimming-associated illness at marine beach
sites impacted by treated wastewater effluent discharge. The study design is nearly identical
to the recently completed Great Lakes studies (Wade et al., 2006), and very similar to studies
recently completed and ongoing in California (Colford, 2007). Water samples are tested for
Enterococcus using qPCR, Enterococcus using standard culture method, E. coll using qPCR,
Bacteroides using qPCR (not human specific), Bacteroides using qPCR (human specific), and
male-specific coliphages by antibody assay. Additional tests include over 30 Pharmaceuticals
and industrial chemicals. Water quality measures will be compared to illness rates to derive
exposure-response relationships between indicator measures and illness reported among
beachgoers. Study will have a multi-station sampling grid with multiple samples taken each
day to capture local temporal and spatial variability.
2007-2009
1-4
Support epidemiologic study at a beach in Avalon, CA
considered to be impacted primarily by untreated human
fecal contamination (P3)
Prospective cohort epidemiology study being conducted by SCCWRP with EPA support to
assess health risks and illness/indicator relationship in marine beach primarily impacted by
untreated human wastewater (as compared to treated human sources from other marine
studies). Avalon beach is affected by a mix of sources of fecal contamination including bird
droppings, urban runoff and leaking sanitary sewers (including failing infrastructure and
leaking collection systems). Water samples are tested for Enterococcus qPCR, Bacteroides
qPCR, Bacteroides thetaiotamicron qPCR, and coliphage by antibody assay. The study design
is based on EPA's current marine study design. The intent is for data to be combined for
future analysis. This study is part of a three beach "suite" in California. SCCWRP will
ultimately have data from a beach that is predominantly impacted by animal fecal
contamination (Doheny) and a beach predominantly impacted by a mixture of animal and
human fecal contamination (Malibu). This data set could help EPA understand differences in
illness rates under different source conditions in the same geographic/climatic region. The
SCCWRP studies are receiving EPA technical input to ensure the usability of the information
developed. Study will have a multi-station sampling grid similar in design to the NEEAR
studies with multiple samples taken each day to capture local temporal and spatial variability.
2007-2009
1-4
Conduct epidemiologic study (ies) and/or QMRA to
characterize the indicator-illness relationship at a
freshwater beach impacted by agricultural animal
sources of fecal contamination for comparison to those
obtained at POTW-impacted beaches (location to be
determined) (P4)
Evaluate the ability of indicators to predict swimming-associated illness and compare the
results with those at POTW-impacted beaches. Use a prospective cohort approach where
feasible. Collect information to support predictive modeling. Study will have a multi-station
sampling grid with multiple samples taken daily to capture local temporal and spatial
variability.
2009-2010
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GOALS
ADDRESSED
BY RESEARCH
PROJECT TITLE
RESEARCH DESCRIPTION
START DATE/
END DATE
1-4
Conduct epidemiologic study in fresh or marine waters
impacted by urban runoff and/or conduct QMRA
analysis (P5)
Evaluate the ability of indicators to predict swimming-associated illness and compare the
results with those at POTW-impacted beaches. Use a prospective cohort approach where
feasible. Collect information to support predictive modeling. Study will have a multi-station
sampling grid with multiple samples taken daily to capture local temporal and spatial
variability.
2009-2010
1-4
Conduct epidemiology study on POTW-impacted marine
waters (location to be determined) (P6)
Conduct epidemiologic study at a POTW-impacted beach to increase statistical power, and/or
at a location similar to one of the previous marine studies or at a location in -between to
account for geographic differences to assess indicator illness. Utilize the same prospective
cohort approach and same study design. Study will have a multi-station sampling grid with
multiple samples taken daily to capture local temporal and spatial variability.
2008-2010
1,4
Determine data/components needed (e.g., monitoring
and exposure) for QMRA applications (P7)
The overall objective of this project is to identify the data and information that will be needed to
use QMRA techniques to interpret and interpolate the epidemiologic data that EPA expects to
have available by 2011, and if necessary extrapolate to conditions for which specific
epidemiologic data have not been collected or are not planned. A research team experienced
with QMRA and recreational water will collaborate with EPA scientists and epidemiologists to
identify critical data and information to support QMRA, evaluating how data from epidemiologic
studies can be utilized, and identify additional data could be collected in concert with the
planned epidemiologic studies to leverage the interpretation of those studies via QMRA for
interpolation and/or extrapolations. For example, epidemiologic studies of recreational waters
typically relate water quality characteristics (density of indicator organisms) to the probability of
illness among recreators, and to interpret these studies via QMRA, additional data (such as
the volume of water ingested during recreational activities and the critical etiologic agents)
may need to be collected as part of and/or in parallel with the planned epidemiologic studies.
Study will consider site-specific spatial and temporal sampling conditions that will be required
in QMRA to assess swimmer exposure to indicators/pathogens.
2007-2008
Site Characterization Studies
2-4
Study various parameters that affect performance of
qPCR signal for enterococci and compare with other
methods and pathogens in treated wastewater mixed
with ambient waters (enterococci, E, coll,
Cryptosporidium, and enterovirus) (P8)
The objective of this project is to understand what happens to the EnterococcusqPCR signal
during wastewater treatment, after release into the environment and relationship of the
Enterococcus qPCR signal to other indicators and pathogens. This project is important
because it will establish whether and under what conditions EPA could recommend that States
use Enterococcus qPCR as an indicator/method in new or revised criteria that is scientifically
defensible for the broad CWA uses of criteria, including NPDES permitting of wastewater
treatment plans. Understanding if and how the qPCR signal changes as a result of different
kinds of wastewater treatment, and the relationship between treatment and what is found in
the water at end-of-pipe, will allow EPA to understand the controls that would need to be in
place during treatment to meet the criteria at the beach. This study will evaluate the fate of
2008-2009
3-16
August 2007
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Critical Path Science Plan for the Development of New or Revised Recreational Water Quality Criteria
GOALS
ADDRESSED
BY RESEARCH
PROJECT TITLE
RESEARCH DESCRIPTION
START DATE/
END DATE
enterococci, E. coll, and F-specific (F+) coliphage as well as specific pathogens (enterovirus
and Cryptosporidium] through wastewater treatment. In addition, the decay of the indicators
will after treatment be examined after mixing with surface water under laboratory conditions.
1 3 Collect data and conduct source and site
characterization evaluations at potential study sites to
determine the extent of specific animal sources, and
factors influencing the extent to which they would
contribute to fecal contamination at the beach (P9)
This project will generally address the need to characterize non-human sources, e.g. animals,
and conditions in watersheds that can result in pathogen contamination of recreational waters.
This activity would contribute to the hazard identification and exposure assessment steps of a
QMRA. Simple models that correlate watershed activities (presence of treatment plant
effluents, types of agricultural activities, and domesticated animals) and attributes (slope, soil
type, vegetation cover climate, soil moisture) will be used to determine the susceptibility of a
watershed to pathogen impairment. Geographic Information System (GlS)-based software
such as Digital Watershed and available beach survey data will be used to examine land use
patterns in a watershed and help evaluate, for example, whether animal sources are present.
Factors that modulate contributions of animal wastes to pathogen loads in watersheds and
adjacent recreational waters coupled with meteorological factors (e.g., rainfall, wind
speed/direction, etc.) will also be investigated. Source differentiation assays for human and
bovine fecal matter being developed and evaluated as a part of this Science Plan, as well as
other assays (e.g., avium) available in the published literature or being independently
developed externally, could be used along with traditional fecal indicator measures, to
characterize the potential fecal input from animal feeding operations and pastures. Short-term
spatial and temporal variability will be captured by multi-sample station grids and multiple
samples taken during the day that would impact on assessing exposure risks.
2008-2009
2 4 Expand spatial scale of collection of site-specific data at
epidemiology study locations to characterize watershed
and support research into development of predictive
models and QMRA(P10)
This project will build on the base studies to provide more extensive fecal indicator and
hydrometeorological and biogeochemical data to develop predictive models that can be used
to predict fecal indicator levels based on weather and physical/chemical water characteristics
and provide the opportunity to assess any potential direct correlation between
weather/physical water characteristics data and health effects being documented in the
epidemiologic studies. This project will also allow for development of models which
extrapolate potential for health effects in geographic areas which possess some common
characteristics of the settings of epidemiologic study locations, based on correlations between
weather and other data with health effects at epidemiology study sites. GIS-based software
such as Digital Watershed and available beach survey data will be used to identify the sites for
the expanded studies. Where possible, measurement of the hydrometeorological data will be
automated with equipment that is compatible with data loggers to increase frequency and
reduce man-hours required for data collection Parameters such as current velocity and
direction, water temperature, wave height, tides, irradiance, turbidity, salinity, carbonaceous
dissolved organic matter, and chlorophyll all can be logged automatically. The project also will
use data from nearby National Oceanic and Atmospheric Administration (NOAA) National
2007-2009
3-17
August 2007
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Critical Path Science Plan for the Development of New or Revised Recreational Water Quality Criteria
GOALS
ADDRESSED
BY RESEARCH
PROJECT TITLE
RESEARCH DESCRIPTION
START DATE/
END DATE
Data Buoy Center observation stations and the Weather Service to help develop models that
nowcast and forecast fecal indicator levels at the epidemiologic sites. Data will help inform the
spatial and temporal variables impact beaches. These variables will be used to determine
sampling locations and sampling times/frequencies for QMRA and new or revised criteria.
1 3 Conduct site and source characterization studies to
better understand the factors influencing the
contribution of untreated sources (e.g., urban runoff) to
total fecal contamination to ambient waters (P11)
If an additional epidemiologic study is necessary EPA will use the site/source characterization
study to select the study location based upon the site selection criteria, and/or revise study
design. Data will inform sampling requirements to capture spatial and temporal variability
based on upstream fecal contamination.
2008-2009
3,4
Design and evaluate a monitoring approach that will
characterize the quality of beach waters that takes into
account the spatial and temporal variability associated
with water sampling (P12)
Utilize data from the literature, e.g., the EMPACT study, or develop new data, as needed for
molecular methods, to provide sufficient information for use by a limited number of experts to
design a sampling plan or plans at a focused workshop. Future EPA epidemiology studies and
other related studies will incorporate mutli-site grids with multiple samples taken each day in
epidemiology studies. These will be used to determine how temporal and spatial sampling will
be used for future ambient recreational water quality criteria.
2008-2009
3,4
Develop, refine and evaluate quantitative sanitary
investigation method - sanitary survey protocol for
recreational waters (P13)
The sanitary survey protocol should provide users with a set of tools to help them determine
sources of bacterial contamination. This information can be used to make better informed
decisions on remediation. The protocol and set of tools should be broad enough and in
modular form so that it can be applied to all geographies and beach environments, and flexible
enough to provide a variety of tools to be used if resources are limited. Sanitary inspections
will consider sampling of upstream waters to quantify the contribution of fecal contamination
that will impact beaches and the spatial and temporal factors that will need to be considered in
criteria informed by the sanitary inspections.
The approach to develop these tools is:
1) Analyze results of Great Lakes Beach Sanitary Survey Pilot Project with some of the
following questions in mind:
-identification of specific avenues of investigation that produce results in the most cases, if
there are any,
-identification of structure of survey forms and database that is easiest to use and understand,
2) Assess on-going beach sanitary survey activities non Great Lakes waters, (two inland
water beach sanitary surveys, three west coast marine, three east coast marine, and four
tropical marine).
-identify approaches in a variety of geographies and climates,
-identify approaches with a spectrum of resource availability (national data coverage may or
may not be available, local information on septic tanks or storm water infrastructure may or
may not be available, manpower for field investigations may or may not be available). (In other
words, does the simple stuff work as well as the high tech stuff?)
2009/2009
3-18
August 2007
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Critical Path Science Plan for the Development of New or Revised Recreational Water Quality Criteria
GOALS
ADDRESSED
BY RESEARCH
2-4
PROJECT TITLE
Pilot sanitary survey in Great Lakes (P14)
RESEARCH DESCRIPTION
3) Combine results of above assessments into a nationwide protocol and set of tools.
This project is a 3-year effort to design and implement beach sanitary surveys in Great Lakes
recreational waters. Major milestones include:
(1) developing a draft sanitary survey form and receiving comments from Great Lakes Beach
Managers and public health officials; (2) developing grant criteria and award grants to States
to pilot and implementing sanitary surveys; (3) pilot testing Beach Sanitary Survey Tool; (4)
piloting the use of a data entry template to ensure consistent data entry for ease of data
analysis; and (5) evaluating pilot studies and publishing a final beach sanitary survey tool for
use by beach managers. Studies will consider spatial and temporal factors from fecal
contamination events that will contribute to similar spatial and temporal variability at impacted
beaches as reflected in criteria.
START DATE/
END DATE
2006-2008
Indicators/Methods Development and Validation Studies
2-3
2,3
2-4
Evaluate multiple indicator/method combinations to
develop quantifiable relationships (P15)
Study the effects of sample holding time, sample
storage, and preservation on sample integrity for future
use(P16)
Develop, refine, validate, and publish new ambient and
wastewater test methods (P17)
Multiple indicator/method combinations are being or will be tested in the marine epidemiology
studies. The illness response to exposure relationship for each method will be compared to
develop a quantifiable relationship among the results derived using the various
indicator/method combinations. The relationships derived will serve as a basis for ensuring
that results using the differing approaches can be compared to determine that similar risk
levels are being attained.
The objective of the study is to determine feasibility of using freezer-archived samples for
determining quantitative relationships between levels of target deoxyribonucleic acid (DMA)
sequences from new and/or improved water quality indicators and health data from the
NEEAR epidemiologic studies. The effect of holding time of fresh samples on detection
efficiency by qPCR will also be investigated. Analyses will be performed on freezer-archived
water sample filter retentates and DMA extracts of water sample filter retentates from NEEAR
epidemiologic studies using previously employed assays for target DMA sequences.
Additional analyses will be performed on replicate freezer-archived sample filter retentates
from common water samples after storage for incremental time periods. The results will be
used to assess comparability of performance levels of the initial and subsequent analyses.
Time point analysis (up to overnight) to investigate the effect of holding fresh samples on the
qPCR signal will also studied.
Once the epidemiologic studies identify those indicator/methods that are better at predicting
swimming-related illness, those methods will be further developed and validated through
single- and/or multi-lab validation studies for monitoring in ambient water and wastewater.
This activity involves considering those methods for promulgation in 40 Code of Federal
Regulations (CFR) Part 136. Additionally, this activity involves developing an Alternate Test
Procedure (ATP) protocol to facilitate addition of new molecular methods to Part 136 as
2008-2009
2007-2008
2008-2011
3-19
August 2007
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Critical Path Science Plan for the Development of New or Revised Recreational Water Quality Criteria
GOALS
ADDRESSED
BY RESEARCH
PROJECT TITLE
RESEARCH DESCRIPTION
START DATE/
END DATE
methods mature. Included in this approach will be elements of training of the participant labs
to ensure proper levels of understanding of the validation plan and protocols.
2 4 Evaluate the suitability of individual combinations of
indicators and methods for different CWA programs
(P18)
The overall objective of this project is to identify and evaluate indicator/method combinations
for their strengths and limitations with respect to fecal source identification (human, animal);
performance in different waterbody types. The important features of each indicator/method
will be described and the strengths and weaknesses of those features will be explained and
evaluated. The ideal set of features will be proposed so that the indicator/methods can be
compared to a hypothetical ideal indicator/method. The indicators/methods under
consideration will be ranked for each feature with respect to ability to differentiate fecal
sources, performance in different waterbody types, and appropriateness for different CWA
purposes. EPA plans to use the results of this evaluation to inform the decisions regarding
which indicator/methods will be included in the new or revised criteria and under what
conditions those indicators/methods will be recommended.
2007-2008
1 3 Develop new and/or evaluate previously published
source-identifying assays (P19)
This project will develop human-specific qPCR assays and evaluate the performance of these
assays and other currently available qualitative and quantitative PCR-based methods
designed to discriminate between human and non-human sources of fecal pollution.
Performance measures will include specificity, sensitivity, precision and range of
quantification, as well as genetic marker geographic continuity and abundance within and
between human populations. Top performing qualitative PCR assays, providing evidence of
human fecal pollution, will be recommended for use in epidemiology study site
characterizations. If possible, qPCR assays will be recommended that prove useful in
calculating a meaningful ratio of human to non-human fecal load in environmental samples.
2007-2008
1 4 Evaluate human assays with water samples with
different levels of fecal contamination from wide
geographic range to supplement site characterization
and quantitative sanitary investigation (P20)
This project will assemble a collection of human fecal impacted water samples from across a
wide geographic range and compare detection levels between select human-specific PCR
assays and currently recommended water quality fecal indicators. Water samples will be
collected from both fresh and marine sites where applicable with the goal of analyzing
samples from each EPA region. Parallel tests will also be completed to measure E, co/iand
enterococci cell densities. Results from PCR studies will be compared to bacterial cell counts
to characterize any relationships between human-specific genetic methods and culture-based
fecal indicator approaches.
2008-2009
1 3 Evaluate genetic markers for cows to supplement the
site characterization and quantitative sanitary
investigation (P21)
This project will evaluate the performance of currently available ruminant- and cow-specific
qualitative and quantitative PCR assays. Top performing qualitative PCR assays and if
possible qPCR assays will be recommended for use in epidemiology study site
characterizations. Select host-specific qualitative and quantitative PCR assays (maximum of 8
methods) will be evaluated in regards to specificity, sensitivity, precision and range of
quantification, as well as genetic marker geographic continuity and abundance within and
2008-2009
3-20
August 2007
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Critical Path Science Plan for the Development of New or Revised Recreational Water Quality Criteria
GOALS
ADDRESSED
BY RESEARCH
PROJECT TITLE
RESEARCH DESCRIPTION
START DATE/
END DATE
between host populations.
1 4 Re-analyze archived NEEAR samples for other
indicators (depending upon the outcome of P16 and the
nature of the indicator/method) (P22)
Determine quantitative relationships between absolute and/or relative levels of target DMA
sequences from new water quality indicators and health data from previous epidemiologic
studies based on analyses of freezer-archived samples. As many as eight new indicators,
including presumptive human-specific indicators, several new Bacteroidesspecies, C,
perfringens and E, co//'may be analyzed for in frozen archived samples from 2003, 2004,2005
and 2007 NEEAR epidemiologic studies.
2008-2009
Modeling
2 4 Pilot test Virtual Beach model for beach notification and
advisories/closures (P23)
This project is pilot testing models in current use in the Great Lakes, including the Virtual
Beach model, to provide early warnings about fecal indicator levels that pose health risks to
beach communities. The synthesized system will forecast fecal indicator levels as a function of
time and location. The project is limited to two beaches in Lake Erie and Lake Michigan where
the models will be validated for predicting culturable E, co/ior fecal enterococci. Statistical
models for static and dynamic nowcasting of indicator bacteria at beaches will be refined using
observations of variables by buoy/sonde, current instrumentation and optical systems and
meteorological data. These observations include water quality and dynamic variables
(temperature, turbidity, currents, density stratification), optical (UV and visible irradiance, light
scattering) and meteorological (wave height, wind speed, rainfall) parameters. Other studies
will be pursued in conjunction with NOAA forecasts of the environmental and meteorological
variables that are used as model inputs, to forecast exceedance of recreational water
standards a day in advance.
2007-2008
2 4 Refine and validate existing water quality models for
freshwater beach notification and advisories/closures
(P24)
This project will validate the ability of Virtual Beach and other selected statistically-based
predictive models in current use from our base studies to provide early warnings about fecal
indicator levels that pose health risks to a wider range of beach communities that are affected
by POTWs around the Great Lakes. Five beaches in the Great Lakes will be selected for
modeling in collaboration with Region 5 and local State and municipal beach managers. GIS-
based software such as Digital Watershed and available beach survey data will be used to
identify the POTW-impacted beaches. In all beaches, models will be developed for predicting
either culturable E. coll, or fecal enterococci. One beach will be used for predicting culturable
E, coll, fecal enterococci and EnterococcusqPCR detection methods. Models including the
Virtual Beach model for static and dynamic nowcasting and forecasting of indicator bacteria at
beaches, along with other modeling configurations being successfully used in the Great Lakes
will be integrated to include observations of variables by buoy/sonde, current instrumentation,
optical systems and meteorological data that will be automated where possible. Predictive
models will be developed to evaluate concentrations of fecal indicator bacteria measured by
culturable and qPCR methods at several points in a POTW-contaminated stream (Salt Creek)
2007-2008
3-21
August 2007
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Critical Path Science Plan for the Development of New or Revised Recreational Water Quality Criteria
GOALS
ADDRESSED
BY RESEARCH
2-4
4
PROJECT TITLE
Refine and validate other existing water quality models
for marine beach notification and advisories/closures
(P25)
Develop technical protocol for site-specific application of
predictive models to be used in making beach advisory
decisions (P26)
RESEARCH DESCRIPTION
in a small catchment that runs into beach areas along southern Lake Michigan.
This project will evaluate the ability of Virtual Beach and other selected predictive models from
our base studies to provide warnings with an acceptable level of statistical reliability about
fecal indicator levels that pose health risks to coastal marine beach communities that are
affected by POTWs and other sources. The project will be applied to at least two marine
beaches to be selected in collaboration with Region 4, Region 9, and Region 10 (or others)
and local State and municipal beach managers. GIS-based software such as Digital
Watershed and available beach survey data will be used to identify the POTW-impacted
beaches. Models will be developed at all study beaches for predicting (nowcasting and
forecasting) culturable E, coll, fecal enterococci and one beach for predicting culturable E. coli
or fecal enterococci and Enterococcus qPCR detection methods. The predictive models for
static and dynamic nowcasting and forecasting of indicator bacteria at beaches will include in
their statistic bases observations of variables by buoy/sonde, current instrumentation, optical
systems and meteorological data that will be automated where possible. Observations to be
made in the project include water quality and oceanographic variables (tides, salinity,
temperature, turbidity, currents, density stratification, wave height), optical (UV and visible
irradiance, light scattering) and meteorological (humidity, clouds, temperature, wind, rainfall)
parameters. EPA will pursue other studies regarding the ability of NOAA forecasts of the
environmental and meteorological variables that are used as model inputs to forecast
exceedance of recreational water standards a day in advance. These studies will include
evaluation of the accuracy of the forecasts as a function of distance of the weather station
from the beach of interest relative to the parameters measured in situ during sampling events.
Develop a guide to assist States and localities in using Virtual Beach and other predictive
models in their beach advisory programs to support criteria implementation.
START DATE/
END DATE
2008-2009
2009/2009
Appropriate Level of Public Health Protection
1-4
3,4
Compare 1986 to NEEAR to better understand the
relationship between fecal contamination and illness in
these data sets (P27)
Evaluate applicability of NEEAR Great Lakes data to
inland waters (P28)
Obtain raw data from the 1986 studies (if available). Conduct statistical analysis to control for
known differences in the two studies such as recall period, age distribution background illness
rates, and illness definition to attempt to create comparable definitions. Once comparable
illness definitions are created, it may be possible to use this information to determine adjusted
"new" acceptable risk levels that do not exceed those from 1986, accounting for differences in
the studies.
Assess the similarities and differences between coastal freshwaters and inland freshwaters to
establish whether there are or not significant differences to justify additional studies to support
applicability of criteria to inland waters. Additional studies could include an epidemiology
2009-2010
2008-2009
3-22
August 2007
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Critical Path Science Plan for the Development of New or Revised Recreational Water Quality Criteria
GOALS
ADDRESSED
BY RESEARCH
PROJECT TITLE
RESEARCH DESCRIPTION
START DATE/
END DATE
study or QMRA application in flowing inland water.
1
Conduct statistical analysis of children data from
epidemiologic studies (P29)
Conduct statistical analyses of data collected for children during epidemiologic studies to
determine if there is a significant difference in risk to children.
2007-2010
Literature Reviews
1
Conduct state-of-the-science reviews of published
studies to characterize relative risks from different
sources (P30)
Search the epidemiologic literature (international and domestic journals and government
reports) for references to illness resulting from exposure to fecal materials from a variety of
sources. Particular emphasis will be placed on animal-derived waste. The literature
information will be evaluated to determine the extent to which it supports characterization of
differences in illness resulting from exposure to waters contaminated with fecal material from
different sources. While recreational exposures are the primary focus, attention should also
be paid to contaminated drinking water and reported illness. Report detailing the studies
identified and an evaluation of what they indicate relative to illness resulting from exposure to
different sources of fecal contamination.
2007/2007
Conduct state-of-the-science review on occurrence and
cross-infectivity of specific pathogens associated with
animals (P31)
Search available literature (international and domestic journals, waterborne disease outbreak
surveillance reports, and other government reports) on organisms that occur in ambient waters
that are pathogenic to humans, which of these organisms are also present in animal
populations, and the extent to which strains found in animals can be transmitted to humans.
The product will be a report discussing the issues above with an evaluation of the extent to
which the information identified can be used to support the differentiation of risk from animal
and human sources of fecal contamination.
2007/2007
Conduct literature review, and evaluate and interpret
available data on indicator behavior in tropical climates
(e.g., water, sand and sediments) (P32)
Determine the extent to which indicators perform differently in a tropical environment
compared to a temperate environment, investigate the underlying cause if a difference is
identified, and consider possible alternative indicators for future development as deemed
appropriate. The domestic and international literature will be searched to identify relevant
articles and reports that discuss and evaluate the extent to which indicator organisms and
other accompanying organisms derived from fecal sources are impacted by temperature
regime (e.g., temperate vs. tropical). In addition, the literature will also be queried for
information on what other parameters, such as resuspension or regrowth, may impact the
amount of indicators measured in compliance monitoring. Finally, the review will consider
potential alternative indicators that may provide more meaningful results in tropical
environments if the current indicators are determined to be limited in application in a tropical
environment.
2007/2007
Note: Codes (P1-P32) refer to an arbitrarily assigned project number.
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August 2007
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Critical Path Science Plan for the Development of New or Revised Recreational Water Quality Criteria
Table 3-2. Overview of Proposed Near-term Research Activities to Support Development of New or Revised Recreational Criteria6
Broad Research
Category
Epidemiology
Studies/QMRA
Site Characterization
Completed
Great Lakes NEEAR
freshwater studies
Incomplete marine study
in Biloxi, MS
P1 4: Pilot Great Lakes
sanitary survey
2007
2008
2009
P1 : Conduct epidemiologic study on POTW-impacted marine beach in Goddard, Rhode Island.
P2: Conduct epidemiologic study on POTW-impacted marine beach in Fairhope, Alabama.
P3: Support epidemiologic study at a beach in Avalon, CA considered to beprimarily impacted by
untreated human fecal contamination.
2010
P4: Conduct epidemiologic study(ies) and/or QMRA to characterize the
indicator-illness relationship at a freshwater beach impacted by
agricultural animal sources of fecal contamination for comparison to
those obtained at POTW-impacted beaches.
P5: Conduct epidemiologic study in fresh or marine waters impacted by
urban runoff and/or conduct QMRA analysis.
P6: Conduct epidemiology study on POTW-impacted marine waters.
P7: Determine data/components needed (e.g., monitoring and
exposure) for QMRA applications.
P8: Study various parameters that affect performance of qPCR signal
for enterococci and compare with other methods and pathogens in
treated wastewater mixed with ambient waters (enterococci, E . coll,
Ciyptosporidium, and enterovirus).
P9: Collect data and conduct source and site characterization
evaluations at potential study sites to determine the extent of specific
animal sources, and factors influencing the extent to which they would
contribute to fecal contamination at the beach.
P10: Expand spatial scale of collection of site-specific data at epidemiologic study locations to
characterize watershed and support research into development of predictive models and QMRA.
P1 1 : Conduct site and source characterization studies to better
understand the factors influencing the contribution of untreated sources
(e.g., urban runoff) to total fecal contamination to ambient waters.
6 Note: The timeline for epidemiologic studies includes study design, study initiation and completion, data analysis, peer review, and publication.
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August 2007
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Critical Path Science Plan for the Development of New or Revised Recreational Water Quality Criteria
Broad Research
Category
Indicators/Methods
Development and
Validation
Modeling
Completed
Test methods through
epidemiology studies
Conduct lab validation of
enterococci qPCR in
freshwater
Publish wastewater
culture method for
enterococci and E. coli in
40 Code of Federal
Regulations (CFR) Part
136
Virtual Beach model and
other existing models
2007
2008
2009
P12: Design and evaluate design a monitoring approach that will
characterize the quality of beach waters that takes into account
temporal and spatial variability associated with water sampling.
P14: Pilot sanitary survey in Great Lakes.
P13: Develop, refine and
evaluate quantitative sanitary
investigation tools/protocols.
P15: Study equivalency between enterococci qPCR and various
indicators and methods.
P16: Study the effects of sample holding time, sample storage, and
preservation on sample integrity for future use.
2010
P17: Develop, refine, validate, and publish new ambient and wastewater test methods.
P18: Evaluate the suitability of individual combinations of indicators
and methods for different CWA programs.
P19: Develop new and/or evaluate of previously published source-
identifying assays.
P20: Evaluate human assays with water samples with different levels of
fecal contamination from wide geographic range to supplement site
characterization and quantitative sanitary investigation.
P21 : Evaluate genetic markers for cows to supplement site
characterization and quantitative sanitary investigation.
P22: Re-analyze archived NEEAR samples for other indicators
(depending on the outcome of P1 6 and the nature of the
indicator/method)
P23: Pilot test Virtual Beach model for beach notification and
advisories/closures
3-25
August 2007
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Critical Path Science Plan for the Development of New or Revised Recreational Water Quality Criteria
Broad Research
Category
Appropriate Level of
Public Health
Protection
Literature Reviews
Completed
Analysis of Great Lakes
NEEAR freshwater
epidemiology data for
general population and
subgroups (e.g., children
and elderly)
2007
2008
P24: Refine and validate other existing water quality models for
freshwater beach notification and advisories/closures.
2009
P25: Refine and validate other existing water quality models for marine
beach notification and advisories/closures.
P26: Develop technical
protocol for site-specific
application of predictive models
to be used in making beach
advisory decisions.
2010
P27: Compare 1986 to NEEAR data to better understand the relationship
between fecal contamination and illness in these data sets.
P28: Evaluate applicability of NEEAR Great Lakes data to inland
waters.
P29: Conduct statistical analysis of children data from epidemiologic studies.
P30: Conduct state-of-the-
science review of published
studies to characterize
relative risks from different.
P31: Conduct state-of-the -
science review on
occurrence and cross-
infectivity of specific
pathogens associated with
animals.
P32: Conduct literature
review and evaluate and
interpret available data on
indicator behavior in tropical
climates (e.g., water, sand
and sediments).
Note: Codes (P1-P32) refer to an arbitrarily assigned project number.
3-26
August 2007
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Critical Path Science Plan for the Development of New or Revised Recreational Water Quality Criteria
CHAPTER 4 FUTURE RESEARCH
4.0 SCIENCE ISSUES EPA DEFERRED FOR FUTURE RESEARCH
EPA limited the scope of the Science Plan to science and research activities that could be
completed within 2 to 3 years. The completion of research by the end of 2010, which would
include data collection, analysis and reporting, is critical to EPA's goal of publishing new or
revised criteria by the end of 2012. EPA recognizes that a number of science issues will be
deferred for future criteria efforts because the current state-of-the-science does not support their
inclusion in the shorter term effort, or because preliminary research must be completed before
remaining science issues can be addressed. For example, the Science Plan partially addresses
the differentiation of non-human sources, and places emphasis on addressing what is expected
to be the greatest sources of risk first. Additional research to potentially differentiate between
non-human sources of fecal contamination (e.g., wildlife versus agricultural animals such as
cows) cannot be completed in the proposed timeframe. Such longer-term research for
example, developing source identification tools that reflect avian and wildlife sources of fecal
contamination will continue on a separate track. These tools may be useful in revising the
criteria in the future.
Understanding the etiology of illness arising from recreational water exposures was identified
by EPA as a desired outcome of future research. This information would allow EPA to better
evaluate the effectiveness of its current regulatory policies regarding waste treatment, and the
relationship between discharges and beach closures. It would also improve the ability to
extrapolate data from epidemiology studies to locations with different site characteristics. The
tools to permit easier collection of etiology data in conjunction with illness data are not yet
sufficiently developed to permit their inclusion in near term studies. They will not be available
within the 2 to 3 year timeframe for the current criteria development effort.
The concern that different fecal indicators may be more appropriate for use in tropical or
subtropical versus temperate environments was raised during the Experts Scientific Workshop.
EPA is addressing the need for studies to develop guidance to account for the diversity of
geographic conditions of marine waters by conducting epidemiology studies along diverse
locations on the east, west and gulf coasts of the United States. An epidemiologic study at a
tropical site is not specifically included in the Science Plan because (1) indicators of fecal
contamination for temperate and subtropical waters may not be suitable for tropical waters; and
(2) additional preparatory research would need to be completed prior to conducting a tropical
study. The additional research activities EPA would need to complete before conducting a
tropical epidemiology study include: (1) evaluating the results of marine epidemiology studies
to determine if the indicators used would be suitable for tropical sites; (2) identifying and
developing new potential indicators for tropical waters; (3) identifying an appropriate study
site to conduct tropical epidemiology study; and (4) establishing a partnership with the
municipality where the study would be conducted. These research activities are sequential and
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Critical Path Science Plan for the Development of New or Revised Recreational Water Quality Criteria
will require more than 3 years to complete. Therefore, they are being deferred for future
research.
EPA will conduct a comprehensive literature review to determine the extent to which indicators
perform differently in a tropical environment compared to the temperature environment and
the underlying cause if there is a difference. EPA is also open to evaluating epidemiologic and
other data generated at tropical locations by other entities to determine if an alternative
indicator is appropriate.
Scientific uncertainty regarding the re-growth of fecal indicators and the impact of this
phenomenon on water quality as well as beach sand was also identified as having a potential
impact on the utility of indicators as a measure of fecal contamination in recreational water,
especially in tropical climates. EPA has not included any specific research activity in this topic
in the current Science Plan but will conduct a literature review to determine: how significant is
this issue, if regrowth of indicators is just an issue in tropical environments, if regrowth of
indictors is due to nutrient contamination, and the impact of indicator regrowth on human
health risk. EPA will evaluate the results of the literature search to identify any subsequent
steps that may be helpful to address this issue. This research will not be conducted to support
the current criteria development because of the short timeframe available.
4-2 August 2007
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Critical Path Science Plan for the Development of New or Revised Recreational Water Quality Criteria
CHAPTERS REFERENCES
Colford, J.M., Jr., T.J. Wade, K.C. Schiff, C.C. Wright, J.F. Griffith, S.K Sandhu, S. Burns, M.
Sobsey, G. Lovelace, and S.B. Weisberg. 2007. Water quality indicators and the risk of illness at
beaches with nonpoint sources of fecal contamination. Epidemiology 18(l):27-35.
Dick, L.K., and K.G. Field. 2004. Rapid estimation of numbers of fecal Bacteroides by use of a
quantitative PCR assay for 165 rRNA genes. Applied and Environmental Microbiology 70:5695-
5697.
Kim, J.H. and S.B. Grant. 2004. Public mis-notification of coastal water quality: A probabilistic
evaluation of posting errors at Huntington Beach, California. Environmental Science and Technology
38(9):2497-2504.
Layton, A., L. McKay, D. Williams, V. Garrett, R. Gentry, and G. Sayler. 2006. Development of
Bacteroides 165 rRNA Gene TaqMan-based real-time PCR assays for estimation of total, human, and
bovine fecal pollution in water. Applied and Environmental Microbiology 72:4214-4224.
U.S. Environmental Protection Agency. 1999. Review of Potential Modeling Tools and Approaches to
Support the BEACH Program. 823-R-99-002, March 1999.
U.S. Environmental Protection Agency. 2005. The EMPACT Beaches Project Results from a Study on
Microbiological Monitoring in Recreational Waters. EPA 600/R-04/023, August 2005.
U.S. Environmental Protection Agency. 2007 Report of the Experts Scientific Workshop on Critical
Research Needs for the Development of New or Revised Recreational Water Quality Criteria. EPA 823-
R-07-006, June 2007.
Wade, T.J., R.L. Calderon, E. Sams, M. Beach, K.P. Brenner, A.H. Williams, and A.P. Dufour,
2006. Rapidly Measured Indicators of Recreational Water Quality are Predictive of Swimming-
Associated Gastrointestinal Illness. Environmental Health Perspectives, 114(1): 24-28.
5-1
August 2007
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