United States
Environmental Prdieeyon Ae
Drinking Water Research Program
Multi-Year Plan
2003
Office of Research and Development
U.S. Environmental Protection Agency
Not Yet Externally Peer Reviewed
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The Office of Research and Development's (ORD) multi-year plans (MYPs) present ORD's
proposed research (assuming constant funding) in a variety of areas over the next 5-8 years. The
MYPs serve three principal purposes: to describe where our research programs are going, to
present the significant outputs of the research, and to communicate our research plans within
ORD and with others. Multi-year planning permits ORD to consider the strategic directions of
the Agency and how research can evolve to best contribute to the Agency's mission of protecting
human health and the environment.
MYPs are considered to be "living documents." ORD intends to update the MYPs on a regular
basis to reflect the current state of the science, resource availability, and Agency priorities. ORD
will update or modify future performance information contained within this planning document
as needed. These documents will also be submitted for external peer review.
n
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DRINKING WATER MULTI-YEAR PLAN
WRITING TEAM
Office of Research and Development1
Fred Hauchman (NHEERL) - Lead Author
BenBlaney(NRMRL)
Mimi Dannel (OSP)
Cynthia Nolt-Helms (NCER)
Bruce Mintz (NERL)
Lynn Papa (NCEA)
John Reyna (ORMA)
Barbara Walton (NHEERL)
Molly Whitworth (OSP)
Office of Water2
Lisa Almodovar (OST)
Ann Codrington (OGWDW)
Joyce Donohue (OST)
Jennifer McLain (OGWDW)
Renee Morris (OGWDW)
Rita Schoeny (OST)
Roy Simon (OGWDW)
Kristy Stevenson (OGWDW)
'ORD Laboratories, Centers and Offices: NHEERL - National Health and Environmental Effects Research
Laboratory; NRMRL - National Risk Management Research Laboratory; NERL - National Exposure Research
Laboratory; NCEA - National Center for Environmental Assessment; NCER - National Center for Environmental
Research; OSP - Office of Science Policy; ORMA - Office of Resources Management and Administration.
OW Offices: OGWDW - Office of Ground Water and Drinking Water; OST - Office of Science and
Technology
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TABLE OF CONTENTS
I. INTRODUCTION 1
I.I Overview of the Multi-Year Plan 1
1.2 Drinking Water Concerns and the Safe Drinking Water Act 1
2. EPA's DRINKING WATER RESEARCH PROGRAM 2
2.1 Scope, Organization and Budget 2
2.2 Drinking Water Research Program Logic Model 3
2.3 Relationship to Other EPA Plans and Programs 4
2.4 ORD's Position in the Research Community 5
2.5 Progress to Date 5
3. IDENTIFICATION OF KEY SCIENCE QUESTIONS 6
3.1 Arsenic Rule 7
3.2 M/DBP Rules 7
3.3 Six-Year Review of NPDWRs 8
3.4 Unregulated Contaminants (CCL) and Future Rules 8
3.5 Source Water Protection 9
3.6 Distribution Systems 10
4. LONG-TERM GOALS 10
4.1 Overview 10
4.2 Changes in Emphasis of the LTGs 11
4.3 Description of the Flow Diagrams and Tables • 12
4.3.1 APGs and APMs in LTG 1 '. 12
4.3.2 APGs and APMs in LTG 2 14
4.3.3, APGs and APMs in LTG 3 15
4.4 Potential Additional Work 15
5. CHANGES FROM PREVIOUS MYPs 16
6. COMMUNICATION 18
7. REFERENCES 18
FIGURES
Figure 1. Flow diagram for LTG 1 and associated APGs 19
Figure 2. Flow diagram for LTG 2 and associated APGs 20
Figure 3. Flow diagram for LTG 3 and associated APGs 21
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TABLES
Table 1. LTG 1 APGs and APMs T-l.l
Table 2. LTG 2 APGs and APMs T-2.1
Table 3. LTG 3 APGs and APMs T-3.1
APPENDIX A
Overview of Rules and Statutory Provisions A-l
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DRINKING WATER RESEARCH PROGRAM
MULTI-YEAR PLAN
1.
INTRODUCTION
1.1 Overview of the Multi-Year Plan
This Multi-Year Plan (MYP) describes the U.S. Environmental Protection Agency's (EPA)
drinking water research program activities and plans for fiscal years 2003 - 2010. Developed by
the EPA Office of Research and Development (ORD) in partnership with the Office of Water
(OW), the MYP provides a link between the annual plans that support EPA's budget request and
the strategic plans developed by the Agency and ORD. As a tool for planning and
communication, the MYP provides: (1) a context for annual planning decisions and a basis for
describing the impacts of these decisions; (2) a framework for integrating research on common
issues across the ORD laboratories and centers, as well as across the various Agency Goals
established under the Government Performance and Results Act (GPRA); and (3) a resource for
communicating research plans and products within ORD and with EPA programs, the regions
and interested parties outside of EPA.
It is recognized that research is an iterative process for which the results are not certain until the
work is completed. Research findings may identify additional needs or provide new tools that
can be used to pursue other lines of inquiry that may not have been anticipated or possible when
the original research was planned, hi addition, unexpected changes may occur in available
resources or strategic priorities. For these reasons, MYPs are updated on a biennial basis to
provide opportunities for making the necessary adjustments to the research program.
1.2 Drinking Water Concerns and the Safe Drinking Water Act
The provision of safe drinking water is based upon the multi-barrier concept; that is, selecting the
best available source and protecting it from contamination, using water treatment to control
contaminants, and preventing water quality deterioration in the distribution system. Although
such practices in the U.S. have resulted in the virtual elimination of waterborne threats such as
typhoid and cholera, some public health concerns remain. The continued occurrence of
waterborne disease outbreaks demonstrates that the safety of drinking water may be threatened
by pathogenic microorganisms if treatment is inadequate or if the quality of water in the
distribution system is compromised.
Concerns have also been raised about chemical contaminants in our drinking water supply.
Surface water and ground water sources may be contaminated with many different natural (e.g.,
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arsenic) and man-made (e.g., pesticides) substances that could pose a risk. The disinfection
process itself leads to the formation of a number of potentially toxic organic and inorganic
chemical by-products. Some subpopulations, such as infants and children or those with
weakened immune systems, are known to be particularly sensitive to the effects of certain
waterborne pathogens and chemicals. Finally, there is a heightened awareness that water supply
systems may be vulnerable to deliberate threats that could damage water supply infrastructure, or
lead to contamination of source or treated water with biological or chemical agents.3
The Safe Drinking Water Act (SDWA) requires EPA to set national drinking water standards to
ensure the safety of water consumed by the millions of people in the U.S. who receive their water
from public water systems. Under the 1996 Amendments to SDWA, EPA is directed to use a
risk-based standard-setting process and sound science in fulfilling the requirements of the Act.
In addition to establishing timelines for regulatory actions, the Amendments include important
provisions on such issues as support for small water supply systems, source water protection,
public right-to-know, health risk reduction benefit analyses and water system infrastructure
assistance. The Amendments contain specific requirements for research on waterborne
pathogens (e.g., Cryptosporidium and Norwalk virus), disinfection byproducts (DBFs), arsenic,
and other harmful substances in drinking water. EPA is also directed to conduct studies to
identify and characterize groups that may be at greater risk than the general population following
exposure to contaminants in drinking water.
The SDWA regulatory requirements with the most significant implications for drinking water
research include the Microbial/Disinfection Byproduct (M/DBP) set of rules, the arsenic rule, and
future decisions on unregulated waterborne pathogens and chemicals on the Contaminant
Candidate List (CCL). Source water protection is a SDWA priority for which important research
needs exist, and concerns about the quality of water in the distribution system raise another high
priority set of needs. There are also research needs associated with a subset of the contaminants
subject to the Six-Year Review requirement for all established National Primary Drinking Water
Regulations. A brief description of these rules and statutory provisions is found in Appendix A.
2. EPA's DRINKING WATER RESEARCH PROGRAM
2.1 Scope, Organization, and Budget
In response to the SDWA requirements, ORD has established an integrated, multidisciplinary
research program that is closely linked to OW's regulatory activities and timelines. The broad
scope of ORD's research includes the development of new scientific data, innovative methods
3Water security research is described in a separate planning document that is being developed jointly by
OW's Water Protection Task Force and ORD's National Homeland Security Center.
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and cost-effective technologies for improving the assessment and control of drinking water risks.
The research products and technical assistance provided by ORD scientists support both OW
decision making and the implementation of EPA rules and guidance by the states, local
authorities and water utilities. Within ORD, this research is the responsibility of five national
laboratories and centers: the National Exposure Research Laboratory (NERL), the National
Health and Environmental Effects Research Laboratory (NHEERL), the National Risk
Management Research Laboratory (NRMRL), the National Center for Environmental
Assessment (NCEA), and the National Center for Environmental Research (NCER).
The level of resources for drinking water research in FY03 is approximately $50M and 232 full-
time equivalent (FTE) personnel. The research program described in this MYP has been
developed with the assumption that the resources available for drinking water research over the
period covered by the MYP will remain constant.
2.2 Drinking Water Research Program Logic Model
The design of the drinking water research program is based on the application of the research
program logic model, shown below. This model describes the components of the drinking water
Program Planning
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program and the sequence of activities that lead to the accomplishment of desired outcomes. The
process of designing the research program begins at the right side of the figure and moves toward
the left (in the "Program Planning" direction); The first steps involve a consideration of the
Agency's long-term, intermediate and short-term outcomes for drinking water, which are derived
from Goal 2 of EPA's Strategic Plan. These outcomes and the key science questions relating to
the assessment and control of waterborne contaminants then provide a context for ORD's Long-
Term Goals (short-term outcomes), Annual Performance Goals (outputs of the research program,
defined in the context of the desired outcomes), and Annual Performance Measures (scientific
outputs that contribute to the accomplishment of the annual goals). Moving in the figure from
left to right (in the "Program Evaluation" direction) illustrates the linkages between resources,
research activities and outputs, clients and outcomes. The logic model highlights the importance
of effective outreach and transfer of scientific and technical products to clients. Another
important feature is the use of environmental indicators, also from the EPA Strategic Plan, to
measure the success in achieving the intended outcomes.
2.3 Relationship to Other EPA Plans and Programs
ORD's drinking water research program supports
GPRA Goal 2, "Clean and Safe Water," of the
Agency's new draft Strategic Plan. As shown in Box
1, EPA's strategy for assuring safe drinking water
includes four key elements. ORD is directly aligned
with this strategy through its program of leading-edge,
problem-driven research that supports the development
or revision of standards for contaminants of concern,
the effective implementation of these standards, and
the protection of drinking water sources.
Boxl
EPA Strategy for Assuring Safe
Drinking Water
• Develop or revise drinking water
standards to assure safe drinking
water
• Support states and water systems
in effective implementation of
standards
• Protect sources of drinking water
from contamination
• Develop sustainable management
of drinking water infrastructure
The drinking water research program is guided by the
ORD Strategic Plan (EPA, 2001), this MYP, and the
Agency's drinking water research plans for arsenic
(EPA, 1998a) and Microbes/Disinfection Byproducts
(EPA, 1997). Additional guidance is obtained through
internal program reviews, expert workshops on special
topics, and consultations with advisory groups,
research organizations and other federal agencies.
Research being conducted under other ORD research programs is helping to address some
important drinking water concerns. The Human Health MYP includes research relating to
sensitive subpopulations and improving the scientific basis for risk assessments. Research on
source water protection issues, such as best management practices, the development of diagnostic
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tools and studies of pharmaceuticals/personal care products, is part of the Water Quality MYP.
Related water quality research is also described in the Ecological Research MYP. The Endocrine
Disrupters MYP describes ORD's program to provide new data and methods to help assess and
manage these types of chemicals in the environment. Finally, an important component of ORD's
research in the Pollution Prevention MYP is the Environmental Technology Verification (ETV)
Program, which is designed to verify the performance of improved treatment technologies
developed by the private sector. The ETV's Drinking Water Systems Center was established in
2000 to provide independent verifications of drinking water technologies.
2.4 ORD's Position in the Research Community
ORD has long been a leader in the field of drinking water research, with unique capabilities for
solving the broad range of scientific and technical issues faced by OW. No other organization's
overall mission and drinking water research plans so directly support the Agency's regulatory
needs. Several public and private organizations, most notably the American Water Works
Association Research Foundation, the Centers for Disease Control and Prevention, the National
Institute for Environmental Health Sciences, and the U.S. Geological Survey, collectively
conduct or support millions of dollars of drinking water research annually. Partnerships with
these organizations provide a means of leveraging resources and ensuring the coordination of
research. EPA recently established a cooperative agreement with the Global Water Research
Coalition (GWRC), which is comprised of 12 of the most prominent national water and
wastewater research groups in the world. The principal purpose of the GWRC is to provide a
forum for leveraging funding and expertise among the participating organizations, and fostering a
coordinated approach to water research on common issues of concern.
In addition to its interactions with the research community, ORD plays an active role in
providing technical assistance to states, local authorities, utilities and others in the drinking water
community. For example, simplified technology resource guides are routinely developed and
shared with the National Rural Water Association to help small utilities. ORD scientists work
with the Association of State Drinking Water Administrators on a variety of issues, such as the
identification of host sites for arsenic treatment technology demonstration projects.
2.5 Progress to Date
In FY 2001 and 2002, considerable progress was made toward meeting some of the major goals
of the drinking water research program. Accomplishments include:
Arsenic
- A guidance document on small system arsenic removal is assisting communities in the
implementation of the new drinking water standard for arsenic.
- Research findings from laboratory and field studies have provided new data on the health
effects of arsenic.
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Disinfection Byproducts
- New information was developed to assess exposures and health risks for several well
known DBFs of potential concern.
-. A report was produced on approaches for designing DBF mixture studies and assessing
risks.
, - Methods were developed for integrating multi-route exposures and dose-response data to
evaluate the risk of complex mixtures of drinking water contaminants.
- Some of the remaining implementation issues for DBFs were addressed in studies of
technologies for reducing levels of byproducts in finished water. Approaches
investigated included enhanced softening to remove DBF precursors and enhanced
coagulation to control DBFs in the treatment plant
Cryptosporidium and Waterborne Disease Outbreaks
- Improved methods were developed for detecting Cryptosporidium and for optimizing the
control of this pathogen through treatment.
- Scientists from EPA and CDC collaborated to produce the biennial report on the
occurrence of waterborne disease in the U.S.
Chemicals and Pathogens on the Contaminant Candidate List
Formal risk assessments were completed for several CCL chemicals
Improved analytical methods were developed for detecting various CCL chemicals and
pathogens
3. IDENTIFICATION OF KEY SCIENCE QUESTIONS
The key science questions for drinking water correspond to the areas of greatest uncertainty in
the assessment and control of drinking water risks. The research that is needed to address these
questions depends upon the type of contaminant, the strength of the underlying data base, and the
ultimate use of the new information by a decision maker. For certain waterborne pathogens or
chemicals, basic analytical detection methods may be inadequate for conducting national
occurrence studies, and the health effects data base may be insufficient for characterizing the
potential hazard. The ability of conventional treatment technologies to remove or inactivate the
contaminant may be unknown. More specialized research studies of individual contaminants or
,mixtures may be necessary to better evaluate the mode of action, the risk posed by drinking water
exposures versus other exposure routes, or the effectiveness of advanced treatment technologies.
New data, improved methods and technologies are often needed to support the establishment of
Maximum Contaminant Level Goals (MCLGs), Maximum Contaminant Levels (MCLs), and
treatment technique requirements for contaminants of concern. Research findings can also play
an important role in evaluating the benefits of various regulatory options.
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In general, the research needs for contaminants that are already regulated are highly focused on
the remaining critical uncertainties in the assessment or management of the risks. For
unregulated contaminants, the needs may initially be more broad if the underlying scientific data
base is less developed. Chemicals or pathogens on a track toward regulation typically require a
more robust scientific data base than those for which a decision to not regulate will be made.
The important scientific questions for each of the major components of the drinking water
research program are identified in the following sections.
3.1 Arsenic Rule
New scientific data and assessments by EPA and outside scientists in recent years provided a
basis for lowering of the drinking water standard for arsenic from 50 to 10 fig/liter in 2001. The
most important remaining scientific issues relate to aspects of the implementation of this new
rule and the required regulatory review that occurs in six-year cycles. The key scientific
questions for arsenic are:
(I) What are the most cost-effective technologies for removing arsenic from drinking
water and managing residual wastes, particularly for small systems? What is the
significance of arsenic accumulation in the distribution system?
(2) How can the quantitative assessment of the relationship between exposure at low
doses (in the 10 ug/liter range) and the risk of cancer or noncancer effects in susceptible
populations be strengthened?
3.2 M/DBP Rules
The M/DBP rules are an interrelated set of regulations designed to provide public health
protection against waterborne pathogens (Surface Water and Ground Water rules) while
minimizing the risks posed by exposure to DBFs (Stage 1 and 2 DBF rules). Scientists from
EPA and other research groups have made important contributions to the establishment of the
M/DBP rules. A number of research issues still need to be addressed to support the
implementation of the rules and to improve the scientific basis for future regulatory reviews as
required by SDWA. The most important outstanding scientific questions for these rules include:
Waterborne Pathogens
(1) How can analytical methods to detect Cryptosporidium in water matrices be
improved?
(2) What data and methods are needed for assessing the risks associated with exposure to
protozoa and viruses in source water and ground water?
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(3) How can treatment be optimized to remove/inactivate Cryptosporidium, particularly
for small systems? How can these approaches be balanced to also control DBFs?
Disinfection Byproducts
(1) How can the health effects (especially adverse reproductive outcomes) of the highest
priority byproducts and DBF mixtures be better characterized?
(2) What is the risk posed by exposure to the byproducts that are formed: (a) from the use
of alternative disinfectants (i.e., other than chlorine alone), and (b) as a consequence of
differences in source water quality (e.g., sources with high versus low bromide
concentrations) ?
(3) What analytical methods, occurrence data and methods for estimating DBF formation
are needed for determining exposures to byproducts of concern?
3.3 Six-Year Review of NPDWRs (1996-2002 Review Cycle)
The outstanding scientific questions associated with this part of the research program are
contaminant-specific. EPA conducted a research needs analysis as part of the systematic review
of most of the National Primary Drinking Water Regulations (NPDWRs) that were published
prior to the 1996 SDWA Amendments. This analysis led to the identification of data gaps or
assessment needs for chromium, fluoride and lead/copper. To address these needs, the National
Toxicology Program is performing research on the health effects of chromium, and the National
Academy of Sciences is conducting an assessment of recently published health effects data on
fluoride. EPA is farther evaluating the treatment and monitoring issues identified for
lead/copper. The Agency is also considering comments from some stakeholders concerning the
need for health effects and treatment research on antimony. Additional needs in the areas of
health effects, treatment, analytical methods, occurrence and/or exposure may be identified in
future reviews of NPDWRs.
3.4 Unregulated Contaminants (CCL) and Future Rules
The research issues for the unregulated contaminants presents some of the biggest challenges to
the drinking water research program, along with perhaps the greatest opportunities for advancing
the science. The existence of many thousands of unregulated chemicals and microbes that may
contaminate water at the source highlights the need to focus scientific efforts on those that may
pose the greatest public health risk. The large number of substances with a highly variable
underlying scientific data base also necessitates the development of new approaches for
prioritizing, assessing and managing these contaminants. There are two general scientific
questions relating to the CCL unregulated contaminant program:
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(1) What contaminant-specific research is needed to address key data gaps for high
priority waterbornepathogens and chemicals that are or could be listed on the CCL?
The process of identifying and prioritizing contaminant-specific research involves a two-
phased approach that considers the needs for screening level and more detailed risk
assessment/risk management analyses. Research needs may relate to analytical methods
or exposure issues, health effects data for endpoints of concern, risk assessments and/or
treatment technologies. The specific scientific questions, therefore, will vary depending
• upon the particular contaminant of interest and the phase of the risk assessment/risk
management process.
(2) What innovative approaches can be developed for identifying and prioritizing
contaminants for listing on the CCL, as well as for assessing and managing risks?
Research needs in this area stem in part from the issues raised by the National Research
Council in their report entitled "Classifying Drinking Water Contaminants for Regulatory
Consideration " (NRC, 2001). The primary focus of this report was on approaches for
narrowing the broad universe of potential waterborne pathogens and chemicals into a
smaller, more focused list of contaminants that should be included on future CCLs.
3.5 Source Water Protection
The key scientific questions for source water protection fall into the following categories: (a)
water quality criteria; (b) source water assessments; (c) preventative measures to address sources
of contamination; and (d) contingency planning. A range of scientific issues exists within each
of these categories. Some of the most important questions include:
(j) How adequately do the Ambient Water Quality Criteria (AWQC) that address the
major drinking water contaminants protect public health?
(2) What improved techniques are needed to better define source water characteristics
and sources of contamination?
(3) What are the fate and transport characteristics of certain types of contaminants in
surface water and ground water?
(4) How effective are candidate protection measures (i.e., Best Management Practices)
on improving the quality of the source water?
(5) What is the impact of sudden increases in source water contaminant concentrations
on drinking water treatment performance?
(6) What early warning and monitoring systems should be developed to alert utility
operators of contaminant excursions at the source so that corrective actions might be
employed?
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Efforts are currently underway within EPA to further identify and prioritize the research needs as
they relate to these questions. This will help to further strengthen linkages between the SDWA-
oriented drinking water research program and the Clean Water Act-based water quality research
program within ORD,
3.6 Distribution Systems
Deterioration of the quality of water in the distribution system is increasingly being recognized as
a potentially important public health concern, Some of the factors that can affect water quality in
distribution systems include the intrusion of contamination due to pressure transients, cross-
connections, growth and survival of pathogens in biofiltns, and deterioration of the structural
integrity of aging systems across the country. Contamination entering the distribution system has
been responsible for a significant percentage of the waterbome disease outbreaks reported in
recent years. These problems raise a number of important scientific questions, as identified
below:
(1) What are the public health risks associated with contamination of the distribution
system?
(2) How can the structural and operational failure modes that reduce water quality in the
distribution system be characterized?
(3) What new or improved methods are needed to prevent, detect, locate, repair, and
rehabilitate contaminant intrusion points in water distribution systems?
(4) What new or improved methods are needed to monitor and control internal
distribution system conditions that may result in the deterioration of water quality?
4. LONG-TERM GOALS
4.1 Overview
The MYP has three Long-Term Goals (LTGs), as shown in Box 2. The LTGs address the need
for new scientific knowledge, tools and technologies to support more sound decision making in
three distinct areas of the drinking water regulatory program:
- Regulated contaminants (LTG 1)
- Unregulated contaminants, as well as innovative approaches and new data to support
future decision making (LTG 2)
- Source water protection and distribution systems (LTG 3)
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Research to accomplish the LTGs seeks to improve the scientific foundation for identifying and
assessing the risk associated with exposure to contaminants of potential concern. The research is
also intended to help states, local authorities and utilities to implement EPA rules in the coming
I
Box 2
Long-Term Goals
*
LTG 1. By 2010, develop scientifically sound data and approaches to assess and manage risks to
human health posed by exposure to regulated waterborne pathogens and chemicals,
including those addressed by the Arsenic, M/DBP, and Six-Year Review Rules.
LTG 2. By 2010, develop new data, innovative tools and improved technologies to support
decision making by the Office of Water on the Contaminant Candidate List and other
regulatory issues, and implementation of rules by states, local authorities and water
utilities.
LTG 3. By 2009, provide data, tools and technologies to support management decisions by the
Office of Water, state, local authorities and utilities to protect source water and the quality
of water in the distribution system.
years by providing new information on how to better protect source waters, optimize treatments
for the control of targeted contaminants, and improve the quality of water in the distribution
system. Accomplishing these LTGs will play a vital role in helping the Agency meet its strategic
goal of ensuring the safety of the nation's public drinking water supply.
4.2 Changes in Emphasis of the LTGs
The relative level of scientific effort and corresponding
resources for each of the LTGs is expected to change
according to the trends shown in Box 3. As a general
trend, the level of effort devoted to further refining the
underlying science supporting the existing rules
covered by LTG 1 (e.g., arsenic treatment technology
research) will be reduced as progress is made in the
coming years. Continued efforts will be needed for the
existing rules in some areas to address the outstanding
scientific issues that will be the focus of future
regulatory reviews. LTG 2 represents an increasingly
important part of the drinking water research program,
Change
LTG
1
2
3
Box 3
s in Emphasis of the LTGs
(FY 2003 - 2010)
Emphasis
Decreasing
Level, then possibly
increasing
Level, then possibly
increasing
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as it includes research on unregulated contaminants that may be candidates for future regulatory
decisions. It also includes the development of new data and innovative approaches for other
decision making activities. Finally, as new focus areas in LTG 3 of the MYP, source water
protection and distribution system research will stay level in the near-term. The level of effort
may increase in the future because of the many scientific challenges in these areas,
4.3 Description of the Flow Diagrams and Tables
Accomplishment of the LTGs is dependent upon the successful completion of a series of
associated Annual Performance Goals (APGs). APGs are major research outputs that are
described in the context of the outcome to which they contribute. They represent significant
milestones along a critical path toward accomplishment of the LTG. The APGs are in turn
achieved through the completion of a set of Annual Performance Measures (APMs). APMs are
defined as ORD research outputs that contribute to the accomplishment of an APG by addressing
the most important scientific issues for that particular performance goal.
Figures 1-3 show the relationships between the APGs for each of the drinking water research
program's LTGs. The APGs address the scientific questions described in Section 3, and have a
distinct programmatic orientation in terms of timing over the period of FY 2003 - 2010. The
designation of a fiscal year for a particular APG is based on a projection of critical points in the
development of the science, plus a consideration of when scientific information is needed to
support important regulatory milestones relating to the development, review or implementation
of the rules. It is acknowledged that scientific discovery cannot always be timed to produce
information by designated dates. Nevertheless, the planning of the drinking water research
program in this manner serves to focus the research and enhance ORD's responsiveness to the
needs of OW and to outside clients.
Tables 1-3 show the APGs and APMs for each LTG. As indicated in the tables, a number of the
APMs address more than one APG. The following discussion provides an overview of the
performance goals and measures, with highlights of some of the important ORD products that
will be produced.
4.3.1 APGs and APMs in LTG 1 (Figure 1, Table 1). The APGs and APMs for arsenic
address the scientific questions pertaining to the implementation of the current rule and the
reviews of the rule in 2006 and 2012 (see Section 3.1). The implementation-related APGs in FY
2004 and 2006 are along a critical path that will provide information and technologies to help
states, local authorities and water utilities meet the 2006 deadline for complying with the new
rule. The two remaining arsenic APGs in FY 2006 and 2010 support the SDWA-required review
of the rule by focusing on research to improve the arsenic risk assessment. APMs under these
APGs represent a progression of studies in animals and in human populations, providing OW
with new information on exposure to arsenic and on its metabolism, mode of action and health
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effects. Achievement of the FY 2006 APG will involve the preparation of a synthesis document
that summarizes these new findings and identifies research that may further strengthen the
arsenic risk assessment that will support the next six-year review of the rule.
DBF research to address the scientific questions in Section 3.2 is represented by APGs in FY
2004, 2007, and 2010. The primary emphasis of these APGs and supporting APMs is to provide
data on the most important unresolved issues in the DBP risk assessment, in anticipation of the
review of the Stage 2 DBP rule in 2011. APMs include research to better characterize the
reproductive toxicity and carcinogenicity of individual DBFs and mixtures of byproducts
(including an innovative cross-ORD complex mixture study), epidemiology studies to evaluate
DBP reproductive risks, and analytical chemistry studies to identify previously uncharacterized
byproducts associated with the use of alternative disinfectants. The FY 2007 APG, which
includes the delivery of a synthesis document on reproductive outcomes and DBFs, represents a
particularly important milestone along the path of understanding the potential risks associated
with exposure to DBFs. Many of the health effects, exposure and risk assessment studies that are
being conducted or planned in support of the APGs in FY 2004,2007 and 2010 represent a
progression of research that builds upon the earlier accomplishments to further the science.
The FY 2004 APG also has a relatively small emphasis on research to support the
implementation of the current Stage 1 DBP rule and the new Stage 2 rule proposed in 2003. This
APG includes APMs on the formation, occurrence and detection of DBFs of particular concern.
Microbial research addressing the key scientific questions relating to the Surface Water and
Ground Water Rules (see Section 3.2) is covered by APGs in FY 2004, 2006, and 2009. APMs
supporting the implementation of these rules include the development of improved analytical
detection methods for Cryptosporidium and viruses, and the evaluation of various water
treatment technologies for removing Cryptosporidium from water (particularly for small
systems). Other APMs describe efforts mat will contribute to future reviews of the rules to
determine if additional requirements may be necessary to afford greater protection against
microbial risks. This research includes studies of human exposure to waterborne pathogens and
the development of improved methods to assess microbial risks. Data on the infectious dose and
other properties of Cryptosporidium, along with new information on waterborne disease in the
U.S., will provide a better understanding of the risks posed by pathogens in drinking water as a
function of water source, type of treatment and etiologic agent.
Finally, there are two APGs in LTG 1 that pertain to the Six-Year Review of the National
Primary Drinking Water Regulations. These APGs are not arrayed along a critical path at this
time, as they represent distinct sets of research projects to address specific needs for a few
contaminants. The overall level of effort devoted to these studies is relatively small, and
planning decisions involve a careful consideration of the needs and benefits of investing ORD
resources on these issues. The APMs under the FY 2005 and 2008 APGs are comprised of
13
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studies in the areas of chemistry, treatment or risk assessment to address high priority needs for
chromium, lead/copper, fluoride, nitrate, antimony, and other contaminants to be determined
(Section 3.3).
4.3.2 APGs andAPMs in LTG 2 (Figure 2, Table 2). The CCL-related APGs in FY 2003,
2005,2007, and 2010 support OW's listing decisions and regulatory determinations on specific
unregulated waterborne contaminants. The APGs represent a progression of outcomes supported
by research activities that provide the necessary scientific information and tools for moving listed
contaminants in the direction toward a regulatory determination and to support promulgation of
the regulations. To accomplish these goals, ORD has placed a major emphasis on the
development of new data and methods for selected high priority pathogens and chemicals on the
CCL. As noted in Section 3.4, the research needs are contaminant-specific and are addressed
using a phased approach, hi this manner, ORD will provide OW with the type of information
needed to support decision making at various steps in the CCL process.
Research in the areas of exposure, health effects, risk assessment and risk management is being
conducted on many of the same CCL contaminants. APMs for pathogens in LTG 2 include
reports on improved analytical methods and occurrence data for priority agents such as
Mycobacterium, Helicobacter and microsporidia. Health effects research includes studies on
Mycobacterium, microsporidia and cyanobacterial toxins, and risk assessments for some of these
and other CCL pathogens are being conducted or planned. Risk management research includes
studies to evaluate the ability of conventional and alternative treatment technologies to inactivate
or remove many of the listed pathogens. CCL chemical research emphasizes the development of
improved analytical methods and occurrence data, along with treatability and distribution system
studies. Health effects and risk assessment research includes toxicity, mode of action and
pharmaeokinetic studies to improve the risk assessments for chemicals such as MTBE and
organotins.
"Innovative methods" APGs in FY 2005,2007, and 2010 address the need for new data, tools
and technologies that will significantly advance the science of assessing and controlling drinking
water risks (see Section 3.4). This research is designed to support the CCL program, as well as
other areas where innovative approaches are needed to support decision making at the national,
state and local level. A focused effort will be made in the next two years to further refine this
part of the MYP, as the process for using these new tools and information has not yet been fully
determined.
Research products supporting the FY 2005 and 2007 APGs explore the use of a number of
different approaches for identifying, characterizing, and prioritizing contaminants for further
analysis or listing on the CCL. Examples include APMs that describe the use of quantitative
structure-activity relationships (QSARs) for predicting health effects, and the use of
computational and genomic/proteomic approaches to better understand the mode of action of
14
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contaminants of potential concern. DNA microarrays are being developed for detecting multiple
pathogens in water, and virulence activity factors are being evaluated for their usefulness in
characterizing CCL pathogens. Risk management research includes studies to evaluate
alternative strategies for compliance with drinking water regulations, and studies of approaches
for dealing with the emerging issue of indirect drinking water reuse. The FY 2010 APG includes
research that builds upon the accomplishments of the prior-year APGs. This goal has a particular
focus on the development of new data for more robust risk assessments, considering cumulative
risks and aggregate exposures. A synthesis report will be produced on the use of mixtures risk
assessment approaches to inform drinking water regulatory decisions. The APG also includes
research to evaluate the benefits of risk management decisions for drinking water.
4,3.3 APGs and APMs in LTG 3 (Figure 3, Table 3). The scientific questions associated with
source water protection and distribution systems (see Sections 3.5 and 3.6) encompass abroad
range of issues. As mentioned in Section 2.2, source water protection is also a component of
other ORD research programs, although the protection of drinking water quality may not be their
primary goal. The water industry has an active research program in source water protection and
distribution systems. ORD's drinking water research program is therefore focused on areas that
are not being fully addressed by other means and that match ORD's technical capabilities.
APGs for source water protection in FY 2006 and 2009 are designed to assist decision makers at
the national, state and local level by providing tools and information that contribute to more
effective management practices. Research supporting these APGs is distinguished from related
research in the Water Quality MYP by virtue of its focus on protecting the quality of water used
as a drinking water source. APMs include reports that describe how to better assess the
vulnerability of watersheds, how to detect specific contaminants and other changes in water
quality using improved diagnostic tools, and how to more effectively manage different types of
contamination problems. The APGs for distribution systems in FY 2006 and 2008 will be
accomplished by providing new information and tools for characterizing and managing
distribution contamination problems. Examples of the types of issues being investigated by ORD
include biofilm formation and control, detection methods for monitoring selected water quality
parameters and system structural integrity, and the contamination of distribution systems with
organotins and opportunistic pathogens on the CCL.
4.4 Potential Additional Work
The topic areas listed below have been identified as possible candidates for funding if additional
resources above the base become available. These areas represent logical extensions of activities
that are being conducted or planned in the base program. The enhanced level of research in these
areas would, in general, further strengthen ORD's ability to address the existing LTGs in this
plan. The priority and resource requirements for these topics have not been determined.
15
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- Source water assessment and protection, with a focus on such areas as reducing impacts
of septic systems and other non-point sources, wet weather flow and the development of
real-time monitoring systems.
- Expansion of the new program on molecular technologies for screening, prioritizing and
monitoring contaminants of concern. This would have applications for risk assessment
(e.g., to support hazard evaluations), risk management (e.g., to monitor water sources,
treatment plants and distribution systems), and research planning in general.
- Contaminant mixtures research in the areas of health effects, exposure/methods, risk *•
assessment and prevention/treatment to support,risk management decisions. This could
include, for example, studies of mixtures of DBFs, endocrine disrupters or CCL
chemicals that occur together in drinking water.
- Research to support assessments of aggregate exposures and cumulative risks for specific
drinking water contaminants to determine relative source contributions and to support
health risk reduction/risk benefit analyses. This research would address exposure and risk
issues associated with oral, inhalation (e.g., from showering, cooking) and dermal (e.g.,
from showering, swimming) exposures to chemicals in drinking water. The impact of
episodic vs. chronic exposures on risk would also be addressed.
- Assessment of human exposure and health impacts of distribution systems. This includes
an evaluation of the prime causes of health risks (e.g., structural failures, cross-
connections, biofilms)
- Social science research on drinking water issues (e.g., to support cost/benefit analyses).
This would be a new line of research in ORD's drinking water program.
5. CHANGES FROM PREVIOUS MYPs
Several major changes were made to the MYP this year. The drinking water research program is
now described in terms of three LTGs instead-of one, which better represents both the scientific
and programmatic dimensions of the research program. Of particular note is the introduction of a
new area of emphasis in one of the LTGs: innovative approaches for identifying, prioritizing and
managing contaminants of concern. In addition, research on source water protection and
distribution systems is described in a separate LTG, which places a greater focus on these
important issues in the plan. In general, the relative level of research activity and resources in the
various areas across the program are approximately the same as what was described in the
previous MYP, although the new plan reflects an enhanced effort on arsenic implementation
issues through 2006.
16
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A new feature of this MYP is that it identifies several "synthesis documents" (Box 4) that
provide a means of more effectively communicating the results of certain research activities to
clients. These documents summarize the results of a body of ORD research on a particular topic,
highlighting the importance of this research in advancing the science and meeting performance
goals. The synthesis document may also provide an analysis of research needs and priorities to
support outyear goals.
Box 4
Synthesis Documents in the MYP
- Synthesis document on small drinking water systems: State of the industry and treatment
technologies to meet Safe Drinking Water Act requirements (FY 2005)
- Synthesis document on the health effects of arsenic and research needs to improve human
Health risk assessment in U.S. populations (FY 2006)
- Synthesis document on reproductive outcomes and exposure to disinfection byproducts (FY
2007)
- Integrated disinfection byproduct mixtures research - Synthesis of toxicological data
(cancer, reproductive/ developmental, other noncancer effects) from the Four-Lab Study
(FY 2007)
- Summary document on the utility of computational modeling (QSARs), genetox assays
(microcomet), toxicokinetics, and alternative animal models to predict health outcomes (FY
2007)
- Synthesis document on the management and control of water quality in distribution systems
(FY 2008)
- Synthesis document on the use of mixtures risk assessment approaches to inform drinking
water regulatory decisions (FY 2009)
17
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6. COMMUNICATION
Effective communication of ORD research plans and products with clients is essential for
ensuring that the research program is responsive to client needs and effective in achieving the
intended outcomes of the research. ORD and OW have an exceptionally close working
relationship, characterized by frequent consultations, briefings and joint planning meetings. A
series of APG-oriented topic area discussions involving ORD and OW scientists and managers
has been initiated. The goal of these meetings is to review the underlying science for a
particular topic area in the MYP, discuss research priorities, and examine ORD research outputs
in the MYP to see how well the research matches the needs.
As described in the previous chapter, the MYP identifies several synthesis products that are
intended to provide an effective means of transferring ORD's scientific products to OW and
other clients. In addition, an internet-based drinking water research tracking system is being
developed as a tool to be used by internal management and staff, as well as by external clients,
for reviewing the status of current projects supporting APMs in the MYP. Many of the near-
term APMs (generally FY2003 - 2006) in Tables 1-3 of the MYP have hotlinks to project
descriptions that reside within this data base. A fully operational tracking system will be
available to the public in 2004.
7. REFERENCES
EPA, 1997. Research Plan for Microbial Pathogens and Disinfection By-Products in Drinking
Water. EPA 600-R-97-122, Office of Research and Development, U.S. EPA, Washington, D.C.
EPA, 1998a. Research Plan for Arsenic in Drinking Water. EPA 600-R-98-042, Office of
Research and Development, U.S. EPA, Washington, D.C.
EPA, 1998b. 63 Federal Register 10274, March 2, 1998.
EPA, 2001. Office of Research and Development Strategic Plan. U.S. EPA, Washington, D.C.
(EPA/600/R-01/003)
NRC.2001. Classifying Drinking Water Contaminants for Regulatory Consideration. National
Research Council Committee on Drinking Water Contaminants, National Academy Press,
Washington, D.C.
is
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LTG I (Arsenic)
TABLE 1. LONG-TERM GOAL 1 - ANNUAL PERFORMANCE GOALS AND MEASURES
LTG 1. REGULATED CONTAMINANTS
By FY 2010, develop scientifically sound data and approaches to assess and manage
risks to human health posed by exposure to regulated waterborne pathogens and
chemicals, including those addressed by the Arsenic, M/DBP and Six-Year Review Rules
ARSENIC
APG 137' - Provide interim reports on the performance of arsenic
treatment technologies and/or engineering approaches to the Office of
Water and water supply utilities to aid in the implementation of the
arsenic rule and the protection of human health {External APG1
APM3
APM
APM
APM
173
APM
APM
Design manual for arsenic removal via iron removal processes, summary
reports on solid oxidizing media and evaluation of adsorptive media
processes fEIMS #256371
Technical manual and computer program to determine cost estimates for
use of adsorption media and ion exchange FB1MS #184811
Report on arsenic iron removal/adsorption optimization FE1MS #184771
Final reports of full-scale demonstrations of arsenic treatment technologies
[External APM] FBI MS #519961
Environmental Technology Verification (ETV) of two arsenic adsorptive
media technologies (from Pollution Prevention and New Technologies
MYP) fEIMS if 182821
Two Environmental Technology Verification (ETV) reports for arsenic
treatment technologies (from Pollution Prevention and New Technologies
MYP) fEIMS #18282}
20B4
2003
2003
2003
2004
2004
2004
ORD*
NRMRt
MRMRL
NRMRI,
NRMR),
MtMRL
NRMRL
Numbers are assigned to selected APGs and APMs for internal and GPRA (Government Performance and
Results Act) tracking purposes. APG 137 and APM 173 are designated as "external" for the purpose of
reporting requirements under GPRA
ORD Laboratories and Centers:
NERL - National Exposure Research Laboratory
NHEERL - National Health and Environmental Effects Research Laboratory
NCEA - National Center for Environmental Assessment
NRMRL - National Risk Management Research Laboratory
NCER1- National Center for Environmental Research
Many near-term APMs have hotlinks to project descriptions that reside within EPA's Environmental
Information Management System (E1MS), Project descriptions may be accessed using the electronic
version of this MYP by clicking the [E1MS #xxxxx] that is associated with the APM,
T-l.l
-------
LTG 1 (Arsenic)
APG 242 - Provide the Office of Water, states, local authorities and
utilities with the results of fall-scale treatment demonstration projects
and evaluations of other approaches for managing arsenic in drinking
water, to support implementation of the current Arsenic Rule
APM
APM
435
APM
436
APM
437
APM
438
APM
439
APM
433
APM
334
Data to assess the stability of arsenic in water distribution systems (Also
applies to LTG 3. 2006 APG on distribution systems) FE1MS #5J0821
Data on the treatment conditions which may enhance the solubilization of
arsenic containing iron oxides within the distribution system (Also applies
to LTG 3, 2006 APG on distribution systems) [E1MS #560821
Report on siting of wells and operation to control arsenic
Final reports of full-scale demonstrations of arsenic treatment technologies
FEIMS #519961
Updated technology selection/design manuals (including results of
demonstration projects)
[E1MS #256371
Provide report on use of geochemical data to manage risks to public water
supply wells from arsenic contamination FE1MS #295711
Data on solubilization and mobility of arsenicals from iron oxide residuals
produced by drinking water treatment FEIMS #560821
Report on the association of arsenic with iron particles, corrosion
byproducts and sediment in drinking water distribution systems (Also
applies to LTG 3, 2006 APG on distribution systems)
FE1MS #290981
2W6
2003
2005
2005
2005
2005
2005
2006
2006
0RD
NERL
NERL
NKMRL
NRMRi.,
NftMRL
NRMRL
NERL
INRJV1RI,
APG 243 - Provide a summary of EPA health effects, exposure and
assessment research on arsenic, and of research needs to improve the
arsenic risk assessment, in support of the Office of Water's Six-Year
Review of the Arsenic Rule
APM
APM
APM
APM
APM
205
Data on arsenic species in target foods/groups or composite diets [E1MS
#183261
Identify biomarkers of effect from a population exposed to arsenic in China
[E1MS #185991
Report on reproductive effects of arsenic in a Chinese population fElMS
#18599]
Report on neurosensory effects of arsenic in a Chinese population [B1MS
#185991
Preliminary database on arsenic species in target foods/groups to improve
arsenic risk characterization FE1MS #183291
2«06
2003
2003
2003
2003
2004
ORB
NERL
NMEERL
.NHEERL
NHEERL
NERL
T-1.2
-------
LTG 1 (Arsenic)
APM
68
APM
APM
69
APM
260
APM
235
APM
442
APM
443
APM
432
APM
335
APM
336
APM
337
APM
338
Evaluation of urinary arsenic profiles in a second U.S. population (Fallon,
NV) to establish human metabolic profiles and urinary bioraarkers of
exposure
Report on cardiovascular effects of arsenic in a Chinese population [EJMS.
#185991
Development of animal models for mechanistic studies of arsenic
carcinogenesis
Peer-reviewed journal article on noncancer risks of arsenic FBI MS
8,1131.3]
Genetic and environmental determinants of interindividual variation in
arsenic metabolism: Mode of action of arsenic as a carcinogen and
toxicant, its relation to risk of chronic exposure, and identification of
susceptible subpopulations [EIMS #593041
Application of biomarkers in a Chinese population to assess cancer and
noncancer effects of arsenic [EIMS #185991
Transplacental exposure of rodents to inorganic and methylated arsenicals
to assess the carcinogenic response to arsenic in mice
Characterization of bioavailability of arsenic species from target
foods/groups FElMStf 183251
SYNTHESIS DOCUMENT on the health effects of arsenic and research
needs to improve human health risk assessment in U.S. populations
Assessment of exposure to arsenic in humans in utero and in early postnatal
life
Mortality studies of arsenic exposure in a Chinese population [E1MS
#18599]
Development and refinement of a physiologically based pharmacokinetic
model for arsenic in humans: Use in tissue dosimetry and risk assessment
fElMS #186021
2004
2004
2004
2004
2005
2005
2005
2006
2006
2006
2006
2006
NHEERL
NHEERL
•NHEERL
NCEA
NHEERL
NHEERL
NHEERL
NERL
NHEERL
wiCh NCEA and
NEHL
NHEERL
NHEERL
NHEERL
T-1.3
-------
LTG i (Arsenic)
APG 77 - Provide the results of health effects and dietary exposure
studies to improve the quantitative assessment of health risks at tow
levels of exposure to arsenic., in support of tike Office of Water's Six-
Year Review of the Arsenic Rttle
APM
215
APM
216
APM
217
APM
218
APM
219
APM
220
Evaluation of regional target food composites to estimate arsenic exposure
en a regional/national population basis
Case-control studies of arsenic health effects in a Chinese population
Assessment of the contribution of the metabolism of arsenicals by the
gastrointestinal flora to overall arsenic exposure
Age-dependent kinetics in metabolism of inorganic arsenic to evaluate the
risk of chronic health effects due to pre-adult exposure
Modification of arsenic toxicity and carcinogenicity by selenium-arsenic
interactions
Genotype-phenotype correlations and susceptibility to (he toxic and
carcinogenic effects of arsenic
2«10
2007
2007
2007
2007
2007
2007
GR0
NERL
iNHEERL
NHEERL
NHF.ERJL
NHEERL
1SHEERL
T-1.4
-------
DISINFECTION BYPRODUCTS
LTG I (DBFs)
APG 12 - QRD will deliver new data and approaches for assessing a»4
managing the potential public health risks associated with exposure to
disinfection byproducts (DBFs) to assist the Office of Water in
determining the need for revising the Stage 2 DBF rule.
APM
APM
APM
APM
APM
APM
APM
APM
APM
APM
APM
APM
APM
Occurrence data for newly identified disinfection byproducts [E1MS
#182911
Improved method for total organic carbon in drinking water [E1MS
#18287]
Hazard identification, biomarker and mode of action information to
improve risk assessments for selected disinfection byproducts, potassium
bromate, dibromoacetonitrile and haloacids [ElMS #18300, 549431
Evaluation of disinfection byproducts and semen quality in men: pilot study
(Also applies to LTG 1, 2007 APG on DBF reproductive effects) fBlMS
#580911
Improve predictive models for identification of carcinogens (Also applies to
LTG 2, 2005 APG on innovative methods) 1E1MS #184681
Report on proteomic and steroidogenic markers that may define mode of
action following disinfection byproduct-induced alterations in reproduction
and fetal development (Also applies to LTG 1, 2007 APG on DBF
reproductive effects)
Report on an animal model to identify low-dose effects of dibromoacetic
acid on reproductive development (Also applies to LTG I, 2007 APG on
DSP reproductive effects)
Report on disinfection byproducts and adverse reproductive outcomes in
California (Also applies to LTG I, 2007 APG on DBP reproductive
effects) [EIMS #182951
Report on behavioral and neuropatho logical studies of dibromoacetic acid
[EIMS #183031
Report on the potential colon carcinogenicity of individual and a mixture of
trihalomethanes and other disinfection byproducts
Report on studies to evaluate if defined mixtures of trihalomethanes are
dose-additive [EIMS #183181
Estimate of internal dose for selected disinfection byproducts (chloroform,
bromoform, bromodichloromethane, chlorobromomethane) [EIMS
S5209.7]
Evaluation of organic contaminant (haloacetic acids) using quantitative
structure-activity relationships (Topkat) fEIMS #184901
2004
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
2003
ORD
NERL
NERL
NHEERL
NHEERL
NHEERL
NHEERL
NHEERL
NHEERL
NHEERL
NHEERL
NHEERL
NCEA
NCKA
T-1.5
-------
LTG 1 (DBFs)
APM
APM
APM
APM
APM
61
APM
62
APM
APM
63
APM
118
APM
APM
323
APM
Develop a simple procedure for analysis of broraate at occurrence levels in
the range of 0.05-2 (Jig/1, where the cancer risk level is estimated to be 10"6
(H, Weinberg) [E1MS #18652]
Provide a kinetic-based model to predict bromate formation during
ozonation of natural waters in the presence of natural organic matter (P.
Westerhoff) FE1MS #186581
Characterize previously unidentified disinfection byproducts from different
disinfection processes by using new tandem mass spectrometry techniques
(R. Minear) [ElMS #186361
Report on the mechanisms and kinetics of chloramine loss and disinfection
byproduct formation in distribution systems. This work includes modeling
the formation of NDMA (n-nitrosodimethylamine) (Also applies to LTG 3,
2006 APG on distribution systems) (R. Valentine) [E1MS #522871
Human pharmacokinetics of bromodichloromethane: development of data
and models for use in rodent-to-human, high-to-low dose, and route-to-
route extrapolations to improve risk assessment (Also applies to LTG 1,
2007 APG on DSP reproductive effects) [E1MS #200691
Multigenerational effects of exposure to bromochloroacetic acid in the
drinking water (Also applies to LTG 1, 2007 APG on DBF reproductive
effects)
Examination of the role of glutathione transferase-mediated metabolism in
the carcinogenicity of brominated trihalomelhanes: an issue of human
susceptibility [B1MS #200691
Integrated disinfection byproduct mixtures research: Summary of methods
development and preliminary lexicological data (Four Lab Study) [E1MS
#18314]
Report on proposed chemical mixtures risk assessment methods and data
analysis techniques for application to Four Lab Study results FE1MS
#184951
Report on the analysis of Information Collection Rule water quality to
predict disinfection byproduct formation and associated changes [El MS
#256451
Report on how the distribution of specific ultraviolet absorbance (SUVA) in
source waters influences the formation and speciation of brominated
disinfection byproducts. Will help optimize treatment goals and devise
strategies to comply with the D/DBP rule (J. Kilduff) [E1MS #52901]
Report on the formation and stability of disinfection byproducts from the
combined use of ozone as a pre-oxidative treatment with terminal
disinfectants chlorine and chloramine (H. Weinberg) [E1MS #186541
2003
2003
2003
2003
2004
2004
2004
2004
2004
2004
2004
2004
.NCKK.
NCER
NCER
.NCER
NHEERL
MHEERL
NHEERL
NHEERL
wilh NERL,
NCSA and
NRMRL
NCEA
with NERL,
NHEERL and
NRMRL
NRMRL
MC£.«
NCER
T-1.6
-------
LTG I (DBFs)
APM
APM
239
Report of a model for formation of halo substituted nitrites and cyanogen
halides in the Colorado River. Includes determining amino acid precursors
and characterizing kinetics and formation mechanisms (T. Olson) FB1MS
#18639]
Report characterizing the absorption, disposition and oral bioavailability of
chlorinated and brominated haloacetates in humans after drinking water
containing a naturally occurring mixture of these compounds (1. Schultz)
[E1MS #186441
2004
2004
NCER
NCSR
APG 17? - Support the Office of Water's evaluation of tlje potential
adverse reproductive effects associated with exposure to disinfection
byproducts (DBPs) by providing the results of epidemiology studies of
male and female reproductive risks, and of research on the mode of
action of priority DBFs
APM
APM
APM
APM
APM
61
APM
6.2
APM
449
APM
441
APM
442
APM
339
Evaluation of disinfection byproducts and semen quality in men: pilot study
(Also applies to LTG 1, 2004 APG on DBPs) FE1MS # 5809J1
Report on proteomic and steroidogenic markers that may define mode of
action following disinfection byproduct-induced alterations in reproduction
and fetal development (Also applies to LTG 1, 2004 APG on DBPs)
Report on an animal model to identify low-dose effects of dibromoacetic
acid on reproductive development (Also applies to LTG 1, 2004 APG on
DBPs)
Report on disinfection byproducts and adverse reproductive outcomes in
California (Also applies to LTG 1, 2004 APG on DBPs) [B1MS # 182951
Human pharmacokinetics of bromodichloromethane: development of data
and models for use in rodent-to-human, high-to-low dose, and route-to-
route extrapolations to improve risk assessment (Also applies to LTG 1,
2004 APG on DBPs) [ElMS #200691
Multigenerational effects of exposure to bromochloroacetic acid in the
drinking water (Also applies to LTG 1, 2004 APG on DBPs)
Results of study of disinfection byproduct exposures in men and resultant
semen quality [E1MS #580911
Results of a second major national study of disinfection byproduct
exposures and spontaneous abortions FB1MS #182991
Results of study of disinfection byproduct exposures and birth defects in
U.S. populations fEIMS #182971
Information on the mechanisms of action of priority disinfection byproducts
that produce adverse reproductive effects
2W
2003
2003
2003
2003
2004
2004
2005
2006
2006
2006
ORD
NHEERL
NHEERL
NHEERL
NHEERL
NHEERL
NHEERL
NHEERL
NHEERL
NHEERL
NHEERL
T-1.7
-------
LTG 1 (DBFs)
APM
221
APM
222
APM
223
Report(s) identifying latent reproductive, developmental and cancer
consequences of gestational exposure to disinfection byproducts (Also
applies to LTG L 2010 APG on DSPs)
integrated disinfection byproduct mixtures research - Synthesis of
toxicological data (cancer, reproductive/developmental, other noncancer
effects) from the Four-Lab Study (Also applies to LTG 1. 2010 APG on
DSPs) {EIMS #183141
SYNTHESIS DOCUMENT on reproductive outcomes and exposure to
disinfection byproducts FE1MS# 56974]
2007
2007
2007
NHEERL
NHEERL
wild NEW.,
NCEA and
NRMRL
.NCEA
with NERL and
NIIEERL
APG (55 - Provide key health, exposure, treatment, and assessment
studies to characterize (he potential cancer and noncancer risks
associated with disinfection byproducts, in support of the Office of
Waters review of the Stage 2 Disinfection Byproduct Rule
APM
447
APM
448
APM
340
APM
341
APM
224
APM
225
APM
226
APM
227
Publication on behavioral and neuropathological studies of dibromo-
acetonitrile and bromodichloromethane
Report on the development of models to combine doses of simple, defined
mixtures across pathways of exposure for risk characterization of drinking
water contaminant mixtures, to support the review of the Stage 2
Disinfection Byproduct Rule (Also applies to LTG 2, 2010 APG on
innovative approaches) FBIMS #544701
Information on the carcinogenic mechanisms of action of haloacetonitriles,
halonitromethanes and structurally related disinfection byproducts [B1MS
#54943]
Improved epidemiological methods to identify adverse human health
outcomes associated with exposure to disinfection byproducts fElMS
£18295]
Data on the occurrence of byproducts from alternative disinfection
processes
Report(s) identifying latent reproductive, developmental and cancer
consequences of gestational exposure to disinfection byproducts (Alxo
applies to LTG I, 2007 APG on DBPx)
Develop rapid micro- and macro- methods for screening large numbers of
disinfection byproducts. (Also applies to LTG 2, 2007 APM on innovative
approaches)
Integrated disinfection byproduct mixtures research - Synthesis of
toxicological data (cancer, reproductive/developmental, other noncancer
effects) from the Four-Lab Study (Also applies to LTG 1, 2007 APG on
DBFs) [EIMS #183 141
2010
2005
2005
2006
2006
2007
2007
2007
2007
ORD
NHEERL
NCEA
MH££RL
NHEERL
NERL
NHEERL
NHEERL
NHEERL
with NERL,
NCEA and
NRMRL
T-1.8
-------
LTG 1 (DBPs)
APM
228
APM
229
APM
187
APM
188
APM
189
APM
190
APM
191
APM
192
APM
40
Metabolism and dosimetry studies of halonitromethanes and iodonated
disinfection byproducts
Report on the characterization and prediction of disinfection byproducts in
distribution systems (Also applies to LTG 3, 200& APM on distribution
systems) [ElMS #519731
Report(s) on the toxicity and potential care in o genie ity of disinfection
byproducts from waters with different levels of bromide and iodide
Integrated disinfection byproduct mixtures research - Synthesis of
quantitative and qualitative chemical analysis of disinfection byproducts
from the Four-Lab Study [E1MS #183141
Pharmacokinetics and pharmacodynamics of halonitromethanes and
iodinated disinfection byproducts to address extrapolation and mode of
action issues for risk assessments
Report(s) on disinfection byproducts that potentially enhance the
development of epidemiologically relevant cancer outcomes (colon and
urinary bladders)
Epidemiologic studies on reproductive effects associated with haloacetic
acids
Epidemiology studies on alternative disinfectant processes and their
byproducts
Provide data and reports on the toxicity and potential carcinogenicity of
disinfection byproducts (e.g., nitrohalomethanes) generated from
disinfection processes other than chlorine
2007
2007
2008
2008
2008
2008
2008
2008
2010
NHEERL
NRMRL
NHEERL
NHEERL
with NERL,
NCEA and
NRMRL
NHEERL
NHEERL
NHEERL
NHEERL
NHEERL
T-1.9
-------
LTG 1 (SW/GW)
SURFACE WATER/GROUND WATER RULES
APG 13 - ORD will provide new scientific data, analytical methods and
treatment technologies for waterborne pathogens to support the cost-
effective implementation of th4 Long-Term 2 Enhanced Surface Water
Treatment Rule (LT2ESWTR) by local communities, and to support the
potential future revision of the rule by the Office of Water
APM
APM
APM
APM
204
APM
206
APM
APM
64
APM
125
APM
240
APM
287
Report on waterborne disease in the young and elderly in Washington State
community intervention study (Also applies to LTG 2, 201 0 APG on
innovative approaches) [E1MS #185931
Microbial dynamic transmission modeling - Final Report (Also applies to
LTG 2, 2007 APG on innovative approaches) FE1MS #1 84731
An evaluation of the presence and distribution of genotypes of
Cryptosporidium in feedlot cattle in Western U.S. to determine the potential
human health risk from feedlot run-off (E. Atwill) fEIMS #529031
Improved methods to measure levels of Cryptosporidium spp. and Giardia
spp. in U.S. waters PE1MS #560851
Improved method(s) for CCL-related microbes for use in the Unregulated
Contaminant Monitoring Rule (UCMR) [e.g., entero viruses, caliciviruses,
rotaviruses] (Also applies to LTG 2, 2005 APG on CCL pathogens)
PE1MS #18289, 560941
Infectious dose of protozoan pathogens and their occurrence in water
matrices [EIMS #56085]
Waterborne disease: Results of community intervention study #3 (Also
applies to LTG 3, 2010 APG on innovative approaches) [E1MS. #1.8593]
Report on the development of improved dose-response models for
pathogens: Cryptosporidium parvum case study [E1MS #544681
Report evaluating the infectivity and virulence of the Cryptosporidium
oocyst that is transferred human-to-human and is responsible for many
outbreaks of gastroenteritis (C. Chappell) FE1MS #186301
Development of methods to concentrate, separate and determine viability
and infectivity of Cryptosporidium and Giardia. Proposed method would
allow continuous monitoring (S. Tzipori) [E1MS #186471
2904
2003
2003
2003
2004
2004
2004
2004
2004
2004
2004
ORD
NHEERL
NCEA
NCE8
NERL
NERL
NERL
NHEERL
fcCEA
KCJGR
NCER
T-1.10
-------
LTG I (SW/GW)
APG -244 - Provide the Office of Water with a synthesis report on
package treatment technologies for small systems and on improved
analytical methods for the detection of waterborne pathogens, to support
implementation of the Ground Water and Surface Water Rules
APM
449
APM
450
APM
451
APM
342
APM
343
Evaluate various combinations of micro filtration and ultrafiltration systems,
in series and in parallel, to develop filtration credits for protozoan removal
following conventional package plant systems (Small systems) [E1MS
#18551, 185611 .
Summary report of Environmental Technology Verifications for package
drinking water treatment technologies for small systems (Small Systems)
[E1MS #182821
SYNTHESIS DOCUMENT on small drinking water systems: State of the
industry and treatment technologies to meet Safe Drinking Water Act
requirements
Improved methods for drinking and recreational water microbes; Detection
of bacteriophage in water matrices fElMS #560801
Improved methods for drinking water microbes (Report on advances in
protozoan detection procedures) [E1MS #560831
2006
2005
2005
2005
2006
2006 '
om
NRMKL
NRMR1,
N8MRL
NERL
NERL
APG 144 - Provide key health, exposure, treatment and assessment
studies to address the risks of viruses and Ctyptosporiititim, in support of
the Office of Water's Six-Year Review of the Ground Water and Surface
Water Rules
APM
452
APM
527
APM
453
APM
454
APM
344
APM
345
Report on the use of FoodNet for estimating waterborne disease
Report on waterborne disease outbreaks in the U.S. in 2001-2002
Summary report on surrogates for the control of Cryptosporidium
At least three publications evaluating the infectivity, illness and immune
response to three noh-parvum species of Cyptosporidium in healthy human
volunteers. This will enable development of improved risk assessment
models (C. Chappell) FEIMS #532031
Final report on the application of transmission models for use in pathogen
risk assessment to support risk management decisions (case studies include
Cryptosporidium, coxsackievirus and calicivirus) PE1MS #18473. 22389.
5J468, 544161
Characterization of human exposure to viruses from groundwater
2009
2005
2005
2005
2005
2006
2006
ORD
NHEERL
NHEERL
NRMJU;
NCER
NCEA
NERL
T-l.ll
-------
LTG 2 (CCL Pathogens)
TABLE 2. LONG-TERM GOAL 2 - ANNUAL PERFORMANCE GOALS AND MEASURES
LTG 2. UNREGULATED CONTAMINANTS AND INNOVATIVE APPROACHES
By FY 2010, develop new data, innovative tools and improved technologies to support
decision making by the Office of Water on the Contaminant Candidate List and other
regulatory issues, and implementation of rules by states, local authorities and water
utilities
CCL PATHOGENS
APG1 -The Office of Water will have data, methods, assessments and
technology evaluations necessary to support scientifically sound risk
assessment and risk management decisions on unregulated contaminants
of potential public health concern
APM3
101
APM
APM
APM
38
APM
APM'
APM
Develop methodology to identify and characterize H. pylori, caliciviruses
and sources of human pathogens in water [E1MS #15806, 56080]
f
Occurrence data and/or method performance results for selected CCL
pathogens [Mycobacterium avium, Helicobacter pylori, caliciviruses]
FEIMS# 182891
Data on the reproductive toxicity of microcystin
Report on the potential health risks associated with three CCL pathogens
[coxsackievirus, calicivirus, Mycobacterium] fElMS #223891
Report on optimized and validated methods to detect and determine the
prevalence of infectious microsporidia in environmental waters (P .
Rochelle) rEIMS'tf 186421
Publication of improved methods for detecting variants of Mycobacterium
avium complex, determining infectivity, evaluating susceptibility to
disinfection, and determining factors influencing distribution in municipal
water systems (G. Cangelosi, T. Ford) [E1MS #19589, 186311
Development of an improved method for quantitative detection of infectious
coxsackieviruses and echoviruses (M. Yates) [E1MS #186591
2003
2003
2003
2003
2003
2003
2003
2003
ORD3
NERL
NERL
NHEF.R1,
NCSA
NCKR
NC.K8L
MCKR
Numbers are assigned to selected APGs and APMs for internal and GPRA (Government Performance and
Results Act) tracking purposes
ORD Laboratories and Centers:
NERL - National Exposure Research Laboratory
NHEERL - National Health and Environmental Effects Research Laboratory
NCEA - National Center for Environmental Assessment
NRMRL - National Risk Management Research Laboratory
NCER - National Center for Environmental Research
Many near-term APMs have hotlinks to project descriptions that reside within EPA's Environmental
Information Management System (E1MS). Project descriptions may be accessed using the electronic
version of this MYP by clicking the [E1MS #xxxxx] that is associated with the APM.
T-2.1
-------
LTG2 (CCL Pathogens)
APG 122 -Provide the Office of Water with the results of health effects,
exposure/methods and treatment studies, in support of decisions to
regulate or not regulate at least five pathogens and toxins on the
Contaminant Candidate List
APM
206
APM
175
APM
176
APM
APM
APM
285
APM
286
APM
457
APM
458
APM
459
APM
460
APM
461
APM
462
APM
463
Improved method(s) for CCL-related microbes for use in the Unregulated
Contaminant Monitoring Rule (UCMR) [e.g., enteroviruses, caliciviruses,
rotaviruses] (Also applies to LTG 1, 2004 APG on Surface Water/Ground
Water) [E1MS #18289. 560941
Report on screening studies to determine inactivation of//, pylori by
chloramine and UV [E1MS #185741
Project report on effectiveness of conventional treatment and filtration for
cyanobacteria (blue-green algae) FE1MS #256361
Screening studies to determine the effectiveness of chloramine to inactivate
microsporidia spores [E1MS #185731
Report on the detection of opportunistic pathogens (E. coli, Aeromonas,
Mycokacterium) in biofilms using molecular detection techniques (Also
applies to LTG 3, 2006 APG on distribution systems) fEIMS #185701
Reports from two studies of microsporidia attempting to develop methods to
detect, determine viability and infectivity, and determine the prevalence in
environmental waters to improve risk assessment (W. Sonzogni and P.
Rochelle) [El MS #52906. j_g 6421
Report on the development and validation of new techniques for rapid
detection of Helicobacter pylori from environmental samples {M.
Shahamat) [E1MS #186451
Occurrence data for CCL-related cyanobacterial toxins [E1MS #560941
Evaluation of potential detection method for Helicobacter pylori occurrence
studies rglMS #158061
Report on the link between the distribution system and Mycohacterium
avium complex (MAC) found in clinical cases (Also applies to LTG 3,
2006 APG on distribution systems)
Development of a sero logical method for microsporidia FE1MS #546171
Cyanotoxins: Data on anatoxin-a mechanism of cholinergic neurotoxicity
using neurobehavioral tests
Report on disinfection efficacy of adenovirus and bacteriophage in drinking
water FE1MS #185761
Report on survival of calicivirus in surface and subsurface water and its
impact on drinking water treatment FE1MS #206531
2005
-
2004
2004
2004
2004
2004
2004
2004
2005
2005
2005
2005
2005
2005
2005
ORD
•"
NERL
NKMRi*
NRMKL
NRMRL
NKM.KL
NCER
NCKR
NERL
NERL
NHEERL
NHEERL
NHEERL
NRMRL
NKMKL
T-2.2
-------
LTG 2 (CCL Pathogens)
APM
464
APM
465
APM
466
APM
467
Report on oxidation of cyanobacteria (algal) toxins in drinking water
treatment [EIMS #20655]
Report on characterization of drinking water distribution system biofilm
microbial' populations using molecular detection methods (Also applies to
LTG 3, 2006 APG on distribution systems) [E1MS #20654. 5L7011
Report on the development of DNA microarrays to detect multiple
pathogens (including H. pylori) in a single water sample and using mRN A
analysis to determine viability. (Also applies to LTG 2, 2005 APG on
innovative approaches) (D. Chandler) FE1MS #186291
Publications evaluating the effectiveness of UV disinfection at inactivating
drinking water pathogens and the influence of water quality parameters on
effectiveness, to assist in the use and design of UV disinfection systems {K.
Linden) [ElMS #53204]
2005
2005
2005
2005
NKMKL
WRM8.L
NCER
MCE 8
APG 1$P -Provide health effects, occurrence, exposure, risk
characterization and treatment studies on at least five unregulated
pathogens and toxins, to support Office of Water decision making on the
Contaminant Candidate List _
APM
124
APM
339
APM
468
APM
351
APM
352
APM
353
APM
354
APM
355
Provide risk characterization and related support materials that provide
scientific rationale for CCL decision making fElMS #544691
Report on the role of municipal sewage effluents in contributing to the
occurrence of enterohemorrhagic Escherichia colt (BHEC) in watersheds
(Also applies to LTG 3, 2006 APG on source water protection) fElMS
#206451
Report on approaches for assessing the disease burden associated with
waterborne disease outbreaks [EIMS #184961
Improved method(s) for CCL related microbes (Mycobacterium
paratuberculosis, rotavirus, hepatitis E virus, pathogenic fungal species)
Characterization of the virulence of potential CCL pathogens (bacteria in
biofilms and/or cooling towers; Includes methods to distinguish virulent and
avirulent isolates)
Characterization of human exposure to mycobacteria
Evaluation of potential biomarkers of exposure and effects for selected
cyanobacterial toxins in rodent studies
Metabolism and dosimetry studies of cyanobacteria toxins to evaluate
intoxication and detoxication pathways and determine appropriate dose
metrics
2007
2004
2004
2005
2006
2006
2006
2006
2006
o*m
NCEA
NKMRL
NCEA
NERL
NERL
NERL
NHEERL
NHEERL
T-2.3
-------
LTG 2 (CCL Pathogens)
APM
356
APM
357
APM
358
APM
359
APM
360
APM
234
APM
235
APM
236
APM
237
APM
238
APM
239
APM
240
APM
241
APM
242
APM
243
Assessments of CCL pathogens for use in making regulatory determinations
and CCL listing decisions (cyanobacteria and others to be determined)
[E1MS #581621
Final report on pathogen dose-response for use in characterizing risks
associated with pathogens in drinking water and the development of
effective treatment options [E1MS #544681
Conduct pilot/full scale evaluations (cost and performance) of the most
promising treatment processes to control selected CCL pathogens
Conduct cost and performance evaluations for advanced oxidation processes
(e.g., ozone/UV/hydrogen peroxide combinations) to control selected CCL
microbial contaminants in small drinking water systems (Small Systems)
Evaluate control of Aeromonas in distribution systems using chlorine and
chloramine (Also applies to LTG 3, 2006 APG on distribution systems)
FE1MS #185751
Determine the validity of, and methods for, extrapolating animal data to
humans for the assessment of the health effects of cyanobacterial toxins
Develop standardized, validated assays and rapid analytical methods to
detect selected cyanobacterial toxins in water
Population-based studies on the health effects associated with microcystins
Comparison ofMycobacterium disease isolates and distribution system
isolates (Also applies to LTG 3, 2008 APG on distribution systems)
Characterization of human exposure to Legionella
Report on bio film and regrowth issues associated with non-tuberculous
mycobacteria (Also applies to LTG 3, 2008 APG on distribution systems)
Conduct pilot/full scale evaluations (cost and performance) of the most
promising treatment processes to control selected CCL pathogens
Evaluate ultraviolet irradiation for inactivation ofMycobacterium spp. and
cyanobacteria
Evaluate inactivation of human calicivirus by chemical disinfectants
(chlorine, chloramine, chlorine dioxide, ozone)
Evaluate inactivation of human calicivirus by ultraviolet irradiation
2006
2006
2006
2006
2006
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
NCEA
NCKA
NRMRL
NMtRL
NRMRL
NHF.ERL
NHEERL
NHEERL
NHEERL
NERL
NRMRL
NRMKL
NRMKL
NRMRL
NRMRJL
T-2.4
-------
LTG 2 (CCL Pathogens)
AFG 66 -JProvWte health effects, exposure, risk characterization and/or
treatment studies on at feast five unregulated pathogens and toxins on the
Contaminant Candidate List, to support the Office of Water's regulatory
determination process
APM
199
APM
45
APM
46
APM
41
APM
42
Pharmacokinetics and pharmacodynamics of cyanobacterial toxins to
address extrapolation and mode of action issues for risk assessment of CCL
contaminants
Treatment screening studies for newly identified CCL microbial pathogens
Screening studies to evaluate sensitivity of coxsackievirus and echovinis to
disinfection treatment (chlorine, chlorine dioxide, ozone and U V)
Evaluate ultraviolet irradiation for inactivation of Mycobacterium spp. and
cyanobacteria
Evaluate inactivation of human calicivirus by chemical disinfectants
(chlorine, chloramine, chlorine dioxide, ozone)
2019
2008
2009
2009
2010
2010
om>
NHEERL
NRMRi,
NRMRL
NRMIU.
NK.-V1RL
T-2.5
-------
CJCL CHEMICALS
LTG 2 (CCL Chemicals)
APG -The Office of Water will have data, methods, assessments anil
technology evaluations necessary to support scientifically sound risk
assessment and risk management decisions on unregulated contaminants
of potential public health concern
APM
66
APM
APM
APM
APM
56
APM
72
APM
171
Pharmacokinetics of dichloropropanes and dichloropropenes FBI MS
#18588]
Evaluate in vitro technologies to study metabolism of dichloropropanes
FEIMS #18588]
Report on the in vitro genetic toxicity of 1 ,3-dichloropropane and 1,1-
dichloropropene [ElMS #185871
Data on mode of action and potential carcinogenicity of 1,3-dichloropropane
and 1,1-dichloropropene FE1MS #185871
Complete a report for external peer review on the available information and
approaches to assess developmental effects in children from exposure to
chemicals on the drinking water CCL FE1MS #545351
Report on identifying CCL pesticides for cumulative risk assessment
FE1MS #22448]
Publish an interim report on the treatability of selected endocrine disrupting
chemicals [estradiol, estriol, ethynylestradiol, progesterone, testosterone,
and dihydrotestosteronel fEIMS #185641
2003
2003
2003
2003
2003
2003
2003
2003
OK0
NHEERL
NHEERL
NHEERL
NHEERL
NCEA
NCE.-x
NRMSf,
APG 123 - Provide the Office of Water with the results of health effects,
exposure/methods, risk characterization and treatment studies, in
support of decisions to regulate or not regulate at least five unregulated
chemicals on the Contaminant Candidate List
APM
202
APM
APM
APM
Improved method(s) for CCL-related chemicals for use in the Unregulated
Contaminant Monitoring Rule (UCMR) [e.g., alachlor ESA and other
acetanilide pesticide degradation products, organotins] FEIMS #18290.
18311, 18406. 56081. 56097]
Immunotoxicity of dibutyltin dichloride, an organotin used to stabilize PVC
pipes, on the developing and mature immune system fEIMS #545241
Publications describing the effects and molecular mode of action of
organotins on an in vitro model of neuronal development to use as a
biomarker of developmental neurotoxicity FEIMS #185891
Publications describing the characterization of learning impairments and
structural correlates in the Hmbic system resulting from developmental
exposure to methytins in drinking water FEIMS #185891
2005
2004
2004
2004
2004
ORO
NERL
NHEERL
NHEERL
NHEERL
T-2.6
-------
LTG 2 (CCL Chemicals)
APM
170
APM
APM
APM
APM
APM
APM
APM
APM
20
APM
21
APM
23
APM
24
APM
489
APM
471
APM
472
APM
473
Publish a technical report on treatability of three chemicals on the 1998 CCL
to provide information to the program offices for use in the regulatory
determination process [MTBE, perchlorate and several organics] FEIMS
#18471,18474, 184751
Initia] development of the treatability database for drinking water chemicals
[E1MS #256541
Results of membrane treatment of semi-volatile CCL chemicals fElMS
#51960]
Handbook of reverse osmosis (RO) treatment for CCL and other chemicals
[EIMS #185621
Results of lime softening for soluble CCL chemicals FEIMS #519671
Evaluate conventional and innovative treatment options for controlling
perchlorate in drinking water [E1MS #18475]
Results of oxidation screening studies for CCL organic chemicals fElMg
#519641
Initial development of the treatability data base for drinking water microbials
Polar organic chemical inlegrative sampling (POCIS) and LC-ES/ITMS for
assessing selected prescription and illicit drugs in treated sewage effluents
(from Water Quality MYP)
Levels of synthetic musks in municipal wastewater for estimating biota
exposure in receiving waters (from Water Quality MYP)
"Virtual" Symposium: State of the Science - Pharmaceuticals/Personal
Care Products (P/PCPs) as environmental pollutants (from Water Quality
MYP)
Review of environmental forensic techniques (e.g.. high resolution MS and
ICE software) over the last decade (from Water Quality MYP)
Describe the pharmacokinetics of oxygenate mixes in young and elderly
populations FE1MS #18591]
Data on the developmental neurotoxicity of butyltins FEIMS #185891
Data on the immunotoxicity of selected CCL contaminants: organotin
leachates. Do organotin stabilizers used in PVC pipe affect the developing
or mature immune system? [E1MS #185891
Provide risk characterization and related support materials that provide
scientific rationale for CCL decisions (including bromobenzene, RDX,
chlorophenol, and others to be determined) fElMS #18709, 54469, 54474,
566501
2004
2004
2004
2004
2004
2004
2004
2004
2005
2005
2005
2005
2005
2005
2005
2005
NKMRL
MKMKL
iNRMSf,
NKMRL
NRMKL
NRMKi,
NKMftL
NJRMRl.
NERL
NERL
NERL
NERL
NHEERL
NHEERL
NHEER1.
NCEA
T-2.7
-------
LTG 2 (CCL Chemicals)
APM
474
APM
475
APM
476
Develop and test innovative advanced oxidation process technologies for
destruction of MTBE in small drinking water systems (Small Systems)
FELMS #185541
Conduct performance evaluations for utilizing advanced oxidation processes
for treating emerging CCL contaminants [E1MS #256391
Evaluate small system innovative treatment options for controlling
perchlorate in drinking water (Small Systems)
2005
2005
2005
NKMKi,
NRMRL
NRMRL
APG ISt - Provide health effects, exposure, risk characterization and
treatment studies on at least five unregulated chemicals, to s&pport
Office of Water regulatory decision making on the Contaminant
Candidate List
APM
477
APM
361
APM
362
APM
363
APM
364
APM
365
APM
366
APM
367
APM
368
APM
16
Final report on the treatability of selected endocrine disrupting chemicals
(EDCs) fElMS #185641
Improved method for CCL-related chemicals (e.g., NDMA) FE1MS
#183391
Report on the identification of CCL chemicals with common metabolism-
pharmacokinetic models
Report on the identification of CCL chemicals with common modes of
action
Metabolism and dosimetry studies of CCL toxicants to evaluate intoxication
and detoxication pathways and to determine appropriate dose metrics
Comparative risk assessment of life-cycle environmental impacts of
alternative fuels, to support UCMR and CCL determinations
Leaching studies to characterize organotin concentrations in distribution
systems (Also applies to LTG 3. 2006 APG on distribution systems)
Determine what the bank filtration removal efficiency is for pesticides,
endocrine disrupters and other organic contaminants [B1MS #256531
Conduct pilot/full scale evaluations (cost and performance) of the most
promising treatment processes to control selected CCL chemicals
improved detection methods for, and occurrence levels of, Pharmaceuticals
and personal care products in effluents, surface waters, treated drinking
water and ground water (from Water Quality M-YP) (B. Brownawell, D.
Graham, H. Weinberz and L. Roberts) FE1MS #53139, 53140,53142,
531371
200?
2005
2006
2006
2006
2006
2006
2006
2006
2006
2006
O»D
NRMRL
NERL
NH'EEKL
NHEERJL
NHEERL
ISCEA
NKMR.L
NKMKL
NRMRi,
NCEtt
T-2.8
-------
LTG 2 (CCL Chemicals)
APM
17
APM
IS
APM
19
APM
244
APM
245
APM
246
APM
247
APM
248
APM
249
APM
250
APM
251
APM
252
APM
253
An evaluation of how effective wastewater treatment practices are at
decreasing levels of Pharmaceuticals and antiseptics in drinking water
(from Water Quality MYP) (B. Brownawell, D. Graham and L. Roberts)
TRIMS #53139, 53140, 531371
An evaluation of conferred antibiotic resistance in microbial communities
resulting from pharmaceuticals and personal care products in the water
(from Water Quality MVP) (D. Graham and H. Weinberg) FB1MS
#53140,531421
An evaluation of the influence ofamphiphiles on the fate and transport of
Pharmaceuticals in the environment (from Water Quality MYP) (G,
Kibbey and D. Sabatini) [E1MS #531381
Data on the reproductive toxicity of selected CCL contaminants
Data on the mode of action and carcinogenicity of selected CCL
contaminants
Pharmacokinetics and pharmacodynamics of CCL chemicals to address
extrapolation and mode of action issues far risk assessments
Develop animal models of human genetic polymorphisms to assess potential
susceptibility to CCL chemicals (Also applies to LTG 2, 2007 APG on
innovative approaches)
Determine treatability of endocrine disrupting chemicals (e.g., surfactant
degradation products) fElMS #185641
Conduct pilot/full scale evaluations (cost and performance) of the most
promising treatment processes to control selected CCL chemicals
Assessment and management of organotins in source waters (Also applies
to LTG 3, 2009 APG on source water protection)
Small system treatment options for CCL chemicals (Small Systems)
Research results to indicate whether oral aluminum (Al) bioavailability is
independent of the Al species consumed in water, to support the risk
assessment for Al in drinking water (R. Yokel) [E1MS #574911
An evaluation of whether aluminum in drinking water can induce neuronal
injury and whether aging increases susceptibility (J. Savory) FE1MS
#574891
2006
2006
2006
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
NCE8
NCER
NCER
NHEERL
NHEERL
NHEERL
NHEERL
•NSMKL
NRMRL
NRMRL
NKMRL
.NCER
NCER
T-2.9
-------
LTG 2 (CCL Chemicals)
APG 67 - Provide health effects, exposure, risk characterization and/or
treatment studies on at least live unregulated chemicals oft the
Contaminant Candidate List, to support the Office of Water's regulatory
determination process
APM
200
APM
201
APM
202
APM
47
APM
48
APM
49
APM
43
Improved method(s) for CCL-related chemicals for use in Unregulated
Contaminant Monitoring Regulations
Immunotoxicity assessment of priority CCL toxicants
Report on applications of computational toxicology to the development of
prototype-based approaches for the CCL
Pharmacokinetics and pharmacodynamics of CCL toxicants to address
extrapolation and mode of action issues for risk assessments
Determine treatability of pharmaceutically active compounds and
degradation products [E1MS #185641
Treatment options for selected CCL chemicals
Screening studies (bench scale) for newly identified CCL #3 chemicals
2010
2008
2008
2008
2009
2009
2009
2010
ORD
NERL
NHEERL
NHEERL
NHEERL
NS.MRL
NRM Ri,
NKMRL
T-2.10
-------
LTG 2 (Innovative Approaches)
INNOVATIVE APPROACHES
APG 124 - Provide the Office of Water with new predictive models and
innovative methods to assist in classifying and prioritizing unregulated
chemicals and pathogens for possible listing on the next Contaminant
Candidate List
APM
APM
APM
478
APM
479
APM
535
APM
466
Computational chemistry and Structure-Activity Relationship (SAR)
modeling of chemical contaminants in drinking water FE1MS #184681
Improve predictive models for identification of carcinogens (Also applies
to LTG 1, 2004 APG on DBPx) FE1MS #18468]
Report(s) detailing merged computational and genomic/proteomic
approaches to relate mode of action studies in laboratory animals to human
outcomes
Implementation of novel proteomic approaches to identify and characterize
biomarkers of effect and elucidate mode of action following exposure to
drinking water contaminants
Quantitative Structure-Activity Relationship (QSAR) models to predict
cancer potency for CCL chemicals [E1MS #22490]
Report on the development of DN A microarrays to detect multiple
pathogens (including H, pylori) in a single water sample and using mRNA
analysis to determine viability (Also applies to LTG 2, 2005 APG on CCL
pathogens) (D. Chandler) [E1MS #186291
2005
2003
2003
2005
2005
2005
2005
ORB
NHEERL
NHEERL
NHEERL
NHEERL
NOEA
NCEtt
APG 189 - Develop new data and tools for determining the cost,
feasibility and performance of technologies, to support management
decisions by the Office of Water, states, local authorities and water
utilities
APM
APM
482
APM
369
APM
370
Develop cost models for selected separation and disinfection technologies
FE1MS #185651
Maintenance/update of the treatability data base (drinking water chemicals
and microbials, with initial focus on CCL contaminants) [EIMS #256541
Evaluation of cost and feasibility of small slow sand filtration technology for
indirect drinking water reuse
Evaluation of cost and performance of new filtration and destruction
technologies for indirect drinking water reuse
2007
2004
2005
2006
2006
ORI>
NB.MRL
NRMRL
NRMRL
NRM.K1,
T-2.11
-------
LTG 2 (Innovative Approaches)
APG 182 - Develop new approaches for estimating risks and prioritizing
contaminants of potential concern, for use by the Office of Water in
developing future Contaminant Candidate Lists and making other
management decisions .
APM
APM
128
APM
536
APM
371
APM
372
APM
254
APM
255
APM
256
APM
257
APM
258
APM
259
APM
260
APM
261
Microbial dynamic transmission modeling - Final Report (Also applies to
LTG 1, 2004 APG on Surface Water/Ground Water) [E1MS #184731
Report on the application of physiologically based pharmacokinetic
modeling to assess the impacts of changes in health status due to variance in
susceptibility associated with exposure to CCL chemicals [ElMS #184801
Report on statistical models/approaches for assessing cancer risk to children,
for refining risk assessments used by the Office of Water in establishing and
reviewing Maximum Contaminant Levels FE1MS #519241
Data on drinking water pathogens using a proteomics based approach
[EIMS #183381
Review of selected approaches for application of Quantitative Structure-
Activity Relationships (QSAR) for extrapolation of data for CCL
development
Report on an approach of using micro arrays in conjunction with human
tissue cultures for identifying virulence factors of waterborne pathogens
Evaluation of the usefulness of virulence factor activity relationships
(VFARs) in characterizing CCL pathogens
Development of rapid micro- and macro-methods for screening large
numbers of contaminants (Also applies to LTG 1, 2010 APG on DBFs)
Identification of potential biomarkers of exposure and effect for use in
activity-based assays applicable to unregulated drinking water contaminants
Report on potential applications of computational toxicology to the
development of prototype-based approaches for CCL development
Summary document on the utility of computational modeling (QSARs),
genetox assays (microcomet), toxicokinetics, and alternative animal models
to predict health outcomes
Develop animal models of human genetic polymorphisms to assess potential
susceptibility to CCL chemicals (Also applies to LTG 2, 2007 APG on CCL
chemicals)
Web-enabled, secure treatability data base for chemicals and microbes
2007
2003
2004
2005
2006
2006
2007
2007
2007
2007
2007
2007
2007
2007
ORI>
MCE A
1NCEA
NCiSA
NERL
NHEERJL
NERL
NERL
NHEERL
NHEERL
NHEERL
NHEERL
NHEF.8L
NEiVUU.
T-2.12
-------
LTG 2 (Innovative Approaches)
APG 68 - Provide reports with new data, tools, and approaches for
determining cumulative risks, aggregate exposures, treatment, and the
benefits of risk management decisions tor drinking water contaminants
APM
APM
APM
64
APM
484
APM
448
APM
373
APM
262
APM
203
APM
196
APM
205
APM
50
APM
51
APM
44
Report on waterborne disease in the young and elderly in Washington State
community intervention study (Alto applies to LTG 1, 2004 APG on
Surface Water/Ground Water) [E1MS #185931
Report on approaches for assessing the cumulative risk of drinking water
mixtures [E1MS #18494]
Waterborne disease: Results of community intervention study #3 (Also
applies to LTG 1, 2004 APG on Surface Water/Ground Water) [El MS
#18593J
Report on the use of epidemiologic data as a tool for estimating the health
benefits of water filtration
Report on the development of models to combine doses of simple, defined
mixtures across pathways of exposure for risk characterization of drinking
water contaminant mixtures, to support the review of the Stage 2
Disinfection Byproduct Rule (Also applies to LTG 1,2010 APG on DBPs)
[E1MS #54470]
Conduct health benefit studies evaluating the reduction in exposure to
microorganisms in bank filtration versus conventional treatment
Report on the development of risk assessment methods to characterize health
risks from exposure to complex mixtures including consideration of
potential risk from unidentified components using data from Four Lab study
fElMS #18495]
Development of technical guidance on microbial dose-response modeling
and population dynamic transmission modeling for microbial risk assessment
guidelines
Publish results from a prospective epidemiological study of the
gastrointestinal health effects associated with conventionally treated ground
water (Alia applies to LTG 1, 2009 APG on Surface Water/Ground Water)
(C. Moe) [E1MS #574851
Report on molecular microarrays for detection of non-pathogenic bacteria
and bacterial pathogens in drinking water source waters (Also applies to
LTG 3, 2009 APG on source water protection)
SYNTHESIS DOCUMENT on the use of mixtures risk assessment
approaches to inform drinking water regulatory decisions
Development of at least one new approach to determine the relative risks
posed by pathogens in drinking waters, the passage of pathogens through
treatment barriers, or the vulnerability of distribution systems to pathogen
intrusion or growth [Placeholder for Jan 03 solicitation (RFA)J
Utilization of treatability data base to improve modeling of drinking water
treatment for selected chemical and microbial contaminants
2010
2003
2003
2004
2005
2005
2006
2007
2008
2008
2008
2009
2009
2010
ORD
NHEERL
NCEA
NHEERL
NHEERL
MCE A
NHEERL
NCI; A
2SCEA
NCER
NRMRL
NCEA
NCER
NRMfti,
T-2.13
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LTG 2 (Source Water Protection)
TABLE 3. LONG-TERM GOAL 3 - ANNUAL PERFORMANCE GOALS AND MEASURES
LTG 3. SOURCE WATER PROTECTION AND DISTRIBUTION SYSTEMS
By 2009, provide data, tools and technologies to support management decisions by the
Office of Water, state and local authorities to protect source waters and the quality of
water in the distribution system
SOURCE WATER PROTECTION
APG 248* - Develop assessments^ approaches and early warning;
technologies for managing key contaminants of concern, to assist
drinking water utilities in protecting source waters
APM3
APM
APM
APM
339
APM
4S6
APM
487
APM
374
Interim report on characterization of Cryptosporidium and Giardia in
combined sewer overflows {CSOs) [E1MS #20670]
Toward a green pharmacy - Cradle to cradle stewardship of drugs for
minimizing their environmental disposition while promoting human health
(from Water Quality MYP)
Report on early warning upstream monitoring network to protect source
waters [E1MS #185601
Report on the role of municipal sewage effluents in contributing to the
occurrence of enterohemorrhagic Escherichia call (EHEC) in watersheds
(Also applies to LTG 2, 2007 APG on CCL pathogens) FBI MS #20645]
Assessment of Best Management Practices (BMP) for atrazine in rural
watersheds [EIMSJ51704]
Final report on characterization of Cryptosporidium and Giardia in
combined sewer overflows (CSOs) [EIMSJ20670]
Improved method for rapid detection of water quality changes (Also applies
to LTG 3, 2006 APG on distribution systems)
2006
2003
2004
2004
2004
2005
2005
2006
ORB*
NRMKL
NERL
NRMKI,
NRMKL
NRMR1.
MB. MR!;
NERL
Numbers are assigned to selected APGs and APMs for internal and GPRA (Government Performance and
Results Act) tracking purposes
ORD Laboratories and Centers:
NERL - National Exposure Research Laboratory
NHEERL - National Health and Environmental Effects Research Laboratory
NCEA - National Center for Environmental Assessment
NRMRL - National Risk Management Research Laboratory
NCER - National Center for Environmental Research
Many near-term APMs have hotlinks to project descriptions that reside within EPA's Environmental
Information Management System (E1MS). Project descriptions may be accessed using the electronic
version of this MYP by clicking the [E1MS #xxxxx] that is associated with the APM.
T-3.1
-------
LTG 2 (Source Water Protection)
APM
375
APM
376
APM
377
APM
378
APM
Data on the utility of chemical indicators of human fecal contamination and
their correlation to health effects
Biosensor evaluation and demonstration as a tool to protect source waters
rEtMS#18S631
State-of-the-science report for on-site sewage management and septic
systems technology
Placement of Best Management Practices (BMPs) in urban watersheds to
meet water quality goals
Watershed boundary condition identification (from Global Change MYP)
fEIMS#517001
2006
2006
2006
2006
2006
NERL
NJR.MRL
NK&iRL
NKItfKi,
JV&.MXI.
APG 145 -* Provide the Office of Water, states and other stakeholders
with toots, methods, models and data for improving source water
protection
APM
250
APM
264
APM
265
APM
266
APM
205
APM
207
APM
208
APM
209
Assessment and management of organotins in source waters (Also applies
to LTG 2, 2007 APG on CCL chemicals)
Optimization of Best Management Practice (BMP) design/location for
atrazine
Report on modeling and placement of structural Best Management Practices
(BMPs) as a source water protection approach
Develop neural network model for Kentucky River to indicate presence,
concentration, age and source of microbial pathogens. Can be used for
qualitative risk assessments of pathogen inputs into identified water source
(G. Brion) [E1MSJ57486]
Report on molecular microarrays for detection of non-pathogenic bacteria
and bacterial pathogens in drinking water source waters (Also applies to
LTG 2, 2010 APG on innovative approaches)
State-of-the-science report on real time early warning systems for source
water protection [E1MS #18560, 185631
Determine the fate and transport of NDMA and other disinfection
byproducts in aquifer and large multiple-use source waters
Evaluate the effectiveness of selected structural Best Management Practices
(BMPs) to help macro nutrient balances and sediments in source water
turbidity, algae, taste and odor (from Water Quality MYP)
20&9
2007
2007
2007
2007
2008
2008
2008
2008
ORD
NRMRL
NKMKL
NttMRL
NCER
NKMKL
NRMRL
iNRMRL
NRMKL
T-3.2
-------
LTG 3 (Distribution Systems)
DISTRIBUTION SYSTEMS
APG 347 - Provide the Office of Water, states, local authorities and
utilities with data and tools for characterizing and Managing chemical
and roicrobial contaminants in distribution systems
APM
APM
APM
APM
APM
APM
APM
APM
435
APM
459
APM
465
APM
456
APM
492
APM
374
APM
366
Data to assess the stability of arsenic in water distribution systems (Also
applies to LTG I, 2006 APG on arsenic implementation) FE1MS #560821
Report on chlorine and chloramine to control bio films in model distribution
systems [El MS #185721
Report on the mechanisms and kinetics of chloramine loss and DBP
formation in distribution systems. This work includes modeling the
formation of NDMA (n-nitrosodimethylamine) (Also applies to LTG 1.
2004 APG on DSPs) (R. Valentine) [E1MS #522871
Report on the effect of oxidizing conditions on metal releases, corrosion rate
and scale properties of distribution system materials FE1MS #290991
Report on studies of bio film formation rates in pilot scale distribution
systems [E1MS _#181391
Report on the characterization and prediction of scale formation (including
aluminum) in distribution system [E1MS #185001
Report on the detection of opportunistic pathogens (E. colt, Aeromonas,
Mycabacterium) in biofilms using molecular detection techniques (Also
applies to LTG 2. 2005 APG on CCL pathogens) FBIMS #185701
Data on the treatment conditions which may enhance the solubilization of
arsenic containing iron oxides within the distribution system (Also applies
to LTG 1, 2006 APG on arsenic implementation) [E1MSJ5_60821
Report on the link between the distribution system and Mycobacterium
avium complex (MAC) found in clinical cases (Also applies to LTG 2.
2005 APG on CCL pathogens)
Report on characterization of drinking water distribution system biofilm
microbial populations using molecular detection methods (Also applies to
LTG 2, 2005 APG on CCL pathogens) fEIMS #20654, 517011
Report on corrosion chemistry relationships and treatment approaches (Also
applies to LTG 1. 2005 APG on Six-Year Review) [B1MS #185011
Report on the impact of change from conventional treatment of surface water
to alternative treatment (membrane) on biofilm growth in water distribution
systems in support of regulation development FE1MS #185721
Improved method for rapid detection of,water quality changes (Also applies
to LTG 3, 2006 APG on source water protection)
Leaching studies to characterize organotin concentrations in distribution
systems (Also applies totLTG 2. 2007 APG on CCL chemicals)
2066
2003
2003
2003
2004
2004
2004
2004
2005
2005
2005
2005
2005
2006
2006
ORD
NERL
NKM81,
NCE8
NKMRL
NRMRL
NRMHt
NRMRL
NERL
NHEERL
NRMRL
N8.&1RL
NJiMRI.
NERL
NRMRL
T-3.3
-------
LTG 3 (Distribution Systems)
APM
381
APM
334
APM
360
APM
384
Update of the EPANET distribution system model
Report an the association of arsenic with iron particles, corrosion byproducts
and sediment in drinking water distribution systems (Also applies to LTG 1,
2006 APG on arsenic) FE1MS #290981
Evaluate control ofAeromonas in distribution systems using chlorine and
chloramine (Also applies to LTG 2. 2007 APG on CCL pathogens)
[E1MS #185751
Interim report on management and control of water quality in distribution
systems [E1MS #18555, 18556, 18560, 185631
2006
2006
2006
2006
NR&1RJL
NR.MRJ:
NKMK1,
NRMRL
APO 319 - Provide the Office of Water and other stakeholders with Dew
data and tools for monitoring, designing, managing and understanding
the risks associated with contamination of distribution systems
APM
' 459
APM
267
APM
237
APM
239
APM
229
APM
271
APM
210
Report on the link between the distribution system and Mycohacterium
avium complex (MAC) found in clinical cases (Also applies to LTG 2,
2005 APG on CCL pathogens)
Report on studies evaluating distribution system variables associated with
microbial health effects
Comparison of Mycobacterium disease isolates and distribution system
isolates (Also applies to LTG 2, 2007 APG on CCL pathogens)
Report on bio film and regrowth issues associated with non-tuberculous
mycobacteria (Also applies to LTG 2, 2007 APG on CCL pathogens)
[E1MS #185771
Report on the characterization and prediction of disinfection byproducts in
distribution systems (Also applies to LTG I, 20 JO APG on DBPs) fElMS
#51973J
Report on the performance and net cost targets for remote, on-line structural
integrity monitoring for drinking water distribution systems fElMS
#206721
SYNTHESIS DOCUMENT: State-of-the-science report on management
and control of water quality in distribution systems
2008
2005
2007
2007
2007
2007
2007
2008
ORD
NHEERL
NHEERL
NHEERL
NRMRL
WKftlKL
NKMRL
NRMKJL
T-3.4
-------
APPENDIX A
Overview of Rules and Statutory Provisions
Arsenic Rule
Arsenic occurs widely in the earth's crust and is a natural contaminant of water. Elevated levels
of arsenic in water and soil can be found in certain areas of the U.S. as a result of leaching from
rock into ground water and possible geothermal activity. Human health effects associated with
exposure to ingested arsenic include skin and internal cancers, cardiovascular disease,
cerebrovascular disease, diabetes, and developmental toxicity. In 1975, EPA established an
MCL for arsenic of 50 ng/liter under the statutory authority of the 1974 SDWA. As required by
the 1996 SDWA Amendments, EPA conducted a reevaluation of this standard and established a
new MCL of 10 jjg/liter in 2001. The new standard will be subjected to review and possible
revision, as necessary, as part of the Six-Year Review process.
The compliance dates for water systems to meet the revised MCL are 2006 for surface water
systems and the end of 2007 for ground water systems. Some systems that are unable to meet
these deadlines may be eligible for an exemption under § 1416 of SDWA, which provides
additional time to obtain the resources or take the steps needed to comply with the rule in an
appropriate period of time. All public water systems that meet the minimum criteria outlined in
SDWA are eligible for an exemption of up to three years. For smaller water systems, exemptions
can provide up to nine additional years beyond the compliance date of the MCL to achieve
compliance.
(http://www.epa.gov/safewater/arsenic.html)
M/DBP Rules
A major challenge for drinking water providers is to ensure protection against waterborne
pathogens while minimizing the potential risks associated with exposure to disinfection
byproducts (DBPs). The 1996 Safe Drinking Water Act (SDWA) Amendments established
deadlines for a set of interrelated regulations that are intended to address this complex risk trade-
off issue, hi keeping with a phased M/DBP strategy agreed to by stakeholders and affirmed by
the 1996 SDWA Amendments, EPA finalized the Stage 1 DBF Rule in November 1998. The
Stage 1 DBF Rule established Maximum Contaminant Levels Goals (MCLGs) and Maximum
Contaminant Levels (MCLs) for trihalomethanes, haloacetic acids, chlorite and bromate.
Maximum Residual Disinfectant Levels Goals (MRDLGs) and Maximum Residual Disinfectant
Levels (MRDLs) were established for three chemical disinfectants: chlorine, chloramine and
chlorine dioxide. The rule also required certain types of water systems to remove specified
percentages of organic materials, measured as total organic carbon (TOC), that may react with
disinfectants to form DBPs.
The Stage 2 DBF Rule, which was proposed in 2003, is intended to provide additional public
health protection from the potentially harmful effects of DBPs. The proposed Stage 2 Rule will
retain the Stage 1 MCLs but will include revised requirements for collecting compliance
monitoring data and calculating compliance. The proposed rule also requires an initial
distribution system evaluation to identify compliance sites that reflect locations with the highest
A-l
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DBF occurrence levels in the distribution system.
A series of microbial rules is being developed and implemented concurrently with the DBF rules.
The first of these rules, the Interim Enhanced Surface Water Treatment Rule (IESWTR), was
finalized in December 1998. The IESWTR amends the 1989 Surface Water Treatment Rule to
strengthen microbial protection and to address risk trade-offs with DBFs. Key provisions include
treatment requirements for Cryptosporidium for filtered water systems, tightened turbidity
standards, and inclusion of Cryptosporidium in the watershed control requirements for unfiltered
public water systems. In January 2002, EPA finalized the Long-Term 1 Enhanced Surf ace Water
Treatment Rule (LT1ESWTR). This rule extends the provisions of the IESWTR to cover all
system sizes, particularly those serving <10,000 individuals. The LTIESWTR improves control
of Cryptosporidium in drinking water and addresses risk trade-offs with DBFs. The next
generation of surface water treatment rule, the LT2ESWTR, is scheduled to coincide with the
proposal and promulgation of the Stage 2 DBF Rule.
(http://www.epa.goy/safewater/mdbp.html)
The Ground Water Rule (GWR) is a targeted strategy to identify ground water systems at high
risk for fecal contamination. The GWR establishes a multiple barrier approach to identify and
provide corrective measures for public ground water systems at risk of fecal contamination. The
GWR is scheduled to be issued as a final regulation in 2003.
(http://www.epa.gov/safewater/gwr.html)
Six Year Review
The 1996 SDWA Amendments require EPA to review each National Primary Drinking Water
Regulation (NPDWR) at least once every six years and revise them, if appropriate. SDWA
specifies that any revision must maintain or increase public health protection. In consultation
with stakeholders, EPA developed a systematic approach for the review of the NPDWRs. This
protocol was applied to the Agency's initial Six-Year Review of most of the NPDWRs published
prior to the 1996 SDWA Amendments (i.e., pre-1997 NPDWRs). In 2002, EPA announced
preliminary revise/not revise decisions for 68 chemical NPDWRs and the Total Coliform Rule
(see a description of this rule as it relates to distributions systems at the end of this section). EPA
requested public comment on these preliminary determinations and on the protocol used to
conduct the review. Final revise/not revise decisions were published in 2003. The Six-Year
Review requirements also apply to the other EPA regulations discussed in this Appendix, The
timing of these reviews will be determined based on their respective promulgation dates.
(http://www.epa.gov/safewater/review.htm)
Unregulated Contaminants - The Contaminant Candidate List (CCL)
The 1996 SDWA Amendments require the EPA to establish a list of unregulated microbiological
and chemical contaminants that may be regulated by EPA at some future date. Regulatory
determinations must be made on at least five contaminants on the list every five years. The list,
referred to as the Contaminant Candidate List (CCL), was first published by EPA in 1997 and
finalized in 1998 (EPA, 1998b) after extensive consultation with stakeholders. In establishing
A-2
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the CCL, EPA divided the contaminants into three major categories: 1) a Regulatory
Determination Priorities Category, with contaminants that have enough data to determine
whether a regulation is necessary; 2) a Research Priorities Category, which contains
contaminants with additional research needs in the areas of health effects, treatment, and/or
analytical methods; and 3) an Occurrence Priorities Category, with contaminants for which
additional occurrence data are needed. The 1998 CCL includes 50 chemicals and 10 microbia!
pathogens, most of which are in the Research and Occurrence Priorities Categories. For each
contaminant on the CCL, the Agency will need to obtain sufficient data to conduct analyses on
the extent of occurrence and the risk posed to populations via drinking water. This will
ultimately lead to an appropriate Agency action for that contaminant — regulation, guidance, or a
decision not to regulate.
In 2002, EPA announced a preliminary regulatory determination that no regulatory action is
appropriate or necessary for nine contaminants on the first CCL. These contaminants include:
Acanthamoeba, aldrin, dieldrin, hexachlorobutadiene, manganese, metribuzin, naphthalene,
sodium, and sulfate. A final CCL regulatory determination was published in 2003.
The next CCL will be published in 2003, and a new CCL list will be published every five years
thereafter. For the 2003 CCL, the starting point will be the list of contaminants from the
previous CCL where a regulatory determination has not been made. EPA, with guidance from
the National Academy of Sciences and the National Drinking Water Advisory Council, is
developing a more rigorous process for selecting contaminants for future CCLs.
(http://www.epa.aov/safewater/ccVcclfs.html)
Source Water Protection
Protecting sources of drinking water before contamination occurs offers a common sense
approach to maintaining the quality of drinking water and safeguarding public health. Source
water protection is an ongoing process that includes conducting assessments to understand the
vulnerabilities of the source to contaminants, monitoring to detect contamination as early as
possible, protecting and treating sources using Best Management Practices (BMPs), and planning
for quick response when contamination occurs.
SDWA includes important provisions that require or otherwise promote actions at the national,
state and local levels to protect source waters from contamination. The 1996 SDWA
Amendments require states to develop and implement Source Water Assessment Programs
(SWAPs) to analyze existing and potential threats to the quality of the public drinking water
throughout the state. The national Wellhead Protection (WHP) Program, established under the
1986 SDWA Amendments, is a pollution prevention and management program used to protect
underground sources of drinking water. States may use the funds from the SDWA-authorized
Drinking Water State Revolving Fund (DWSRF) set-asides to support a mixture of source water-
A-3
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related local assistance activities. Other statutory authorities, particularly the Clean Water Act
(CWA), the Resource Conservation and Recovery Act (RCRA), the Comprehensive
Environmental Response, Compensation and Liability Act (CERCLA) and the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA) support source water protection activities.
For example, the Clean Water Action Plan is a CWA program that represents an effort by nine
federal agencies to develop and implement a comprehensive plan to protect water resources by
targeting watershed protection efforts in high priority areas. The Action Plan also provides
communities with new resources to control polluted runoff and enhance natural resource
stewardship. The CWA also authorizes the Clean Water State Revolving Fund, which provides
resources for communities, water systems, and other organizations (including land conservation
associations), for projects that protect source water and enhance water quality.
(http://www.epa.gov/safewater/protect.html)
Distribution Systems and the Total Coliform Rule
Post-treatment water quality degradation in aging water distribution systems is already a
significant problem that is likely to get worse over time, hi the U.S., 24% of the waterborne
disease outbreaks reported in community water systems over the past decade were caused by
contamination of the water distribution system. This estimate provides only a limited basis for
assessing the potential public health risk posed by contamination of the distribution system due
to such causes as cross-connections and backflow, intrusion, and biofilms. Based on data from
1993 to 1996, the American Water Works Association estimated that water main breaks occur at
a rate of approximately 75,000/year. Approximately 26% (about 220,000 miles) of distribution
system pipe is unlined cast iron and steel and is in poor condition. Even in a distribution system
with good structural integrity, water quality degradation may occur if the distribution system is
designed, constructed, operated, or maintained in a manner that promotes excessive microbial
growth or chemical formation and migration.
These concerns have been raised in the context of the SDWA-required Six-Year Review of the
Total Coliform Rule (TCR), which was promulgated on June 29, 1989. The TCR requires all
public water systems (PWSs) to monitor for the presence of coliforms in their distribution
systems, as measured by "total coliforms."
The Microbial and Disinfection Byproducts (M/DBP) Federal Advisory Committee (FACA)
agreed in principle that valid health concerns from distribution systems exist. The committee
recommended that EPA should review available data and research on distribution system risks,
and work further with stakeholders. These efforts will result in the review and possible revision
of the TCR, as well as the potential for requirements to address finished water quality in the
distribution system.
EPA, in association with distribution system experts, has developed a series of "white papers"
that provide background information on nine distribution system issues. These papers and
additional information on the Six-Year Review of the TCR can be found at the URL below.
(http://www.epa.gov/safewater/tcr/tcr.html')
A-4
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