United States
Environmental
Protection Agency
EPA Science Advisory
Board (1400F)
Washington, DC
EPA-SAB-05-008
June 2005
www.epa.gov/sab
EPA's Draft 2003 Drinkin:
Water Research Multi-Year
Plan
A Review by the Drinking Water Committee
of the EPA Science Advisory Board
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON D.C. 20460
OFFICE OF THE ADMINISTRATOR
SCIENCE ADVISORY BOAR
June 8, 2005
The Honorable Stephen L. Johnson
Administrator
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, N.W.
Washington, DC 20460
Subj ect: Review of EPA's 2003 Draft Drinking Water Research Program Multi-Year Plan
Dear Administrator Johnson:
The U.S. EPA Science Advisory Board's (SAB) Drinking Water Committee (DWC) met
on May 24-25, 2004 to review the Agency's draft "Drinking Water Research Program Multi-Year
Plan 2003" (MYP). According to EPA's Office of Research and Development (ORD), this multi-
year plan presents its strategy for addressing the highest priority areas of research to support EPA's
risk management programs for the next 5-10 years.
The Agency has clearly invested a substantial amount of expertise, time, and energy into
developing the MYP. The Drinking Water Research Program logic model and subsequent key
scientific questions presented in the MYP should lead to more effective planning and more
effective management of scientific programs, with goals, timelines and deliverables. The research
products or Annual Performance Measures identified in the MYP address high priority research for
each major topic area intended to accomplish ORD's Drinking Water research goals. While
establishing the Annual Performance Measures appears to be both a useful and an appropriate
approach, there are some areas that the Agency will need to further explore and define. The MYP
does not, for example, include the research required to conduct a cost benefit analysis which must
consider a variety of health benefits, ranging from lives saved to minor illnesses avoided. Also,
more effort is needed to identify human subpopulations that may be more sensitive to non-cancer
effects following exposure to drinking water contaminants such as arsenic or microbials.
Exploratory and open-ended research has special value to EPA's mission, especially with
respect to emerging issues and new technologies. The SAB believes that this research is
significant because it provides support for drinking water issues of interest to EPA that is not
always available elsewhere. This research also stimulates activities within the agency, transfers
technology and brings new expertise to EPA through EPA conferences and workshops.
Drinking water issues progress from discovery to data collection and regulation followed
by monitoring of the effectiveness of the rule. The SAB believes that research resources dedicated
to a specific issue should evolve in accordance with this progression. In the early stages, modest
research allocation should be dedicated to innovative and forward thinking research. As the
agency approaches rulemaking, more resources should be allocated. After the rulemaking is
established, the budget should be decreased and focused on assessing the effect of the rulemaking
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and the potential for future changes. Examples of mature topics where research may need to be
modified are disinfection by-products and the effects of high levels of Arsenic. Examples of issues
in their early stages are the contaminant candidate list (CCL), watershed protection and the
distribution system.
This leads to one of the SAB's most important comments that elements of the Drinking
Water research program may be continuing with diminishing returns. The DWC recommends that
Annual Performance Measures be framed in the context of the relative risk posed by target
drinking water contaminants. This approach would probably lead to an emphasis in microbials and
chemical mixtures, and further de-emphasis of Disinfection By-Products (DBFs), particularly
single compound research. The SAB does not believe that DBF research should be discontinued,
but encourages a strategic review. The DWC suggests that EPA lead a healthy debate on defining
the highest priorities for drinking water contaminants.
Additionally, the SAB believes that a level budget for drinking water research is not
sufficient to support ORD's research needs. More resources are required to support the growing
research needs of the CCL, the movement toward alternative disinfectants, competing drinking
water regulations, increasing concern with respect to source water protection and distribution
systems and water reuse and desalination. While the relative allocation of resources across the
major components of the drinking water research program may be appropriate based on a
consideration of scientific and programmatic needs, the overall resource level is insufficient to
address the most important research questions and achieve the intended outcomes of the research
program.
Finally, the SAB wishes to strongly encourage ORD to continue to strengthen its multi-
year planning activities by increasing the collaboration within ORD, between ORD and other parts
of the Agency, and with parties outside the Agency in order to prioritize and communicate
research needs. EPA is to be complimented for including organizations, such as, the Global Water
Research Coalition in planning efforts and yet resources could also be better leveraged by
strengthening formal research relationships with other federal agencies, state agencies, etc. The
SAB also wishes to compliment the Agency for its use of the MYP effort to communicate within
EPA, as well as, with organizations outside EPA concerning ORD research plans.
We look forward to working with ORD to improve these efforts in the future.
Sincerely,
/signed/ /signed/
Dr. Granger Morgan, Chair Dr. Rhodes Trussell, Chair
EPA Science Advisory Board Drinking Water Committee
EPA Science Advisory Board
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NOTICE
This report has been written as part of the activities of the EPA Science Advisory Board, a
public advisory committee providing extramural scientific information and advice to the
Administrator and other officials of the Environmental Protection Agency. The Board is structured to
provide balanced, expert assessment of scientific matters related to problems facing the Agency. This
report has not been reviewed for approval by the Agency and, hence, the contents of this report do not
necessarily represent the views and policies of the Environmental Protection Agency, nor of other
agencies in the Executive Branch of the Federal government, nor does mention of trade names or
commercial products constitute a recommendation for use. Reports of the EPA Science Advisory
Board are posted on the EPA Web site at: http://www.epa.gov/sab.
in
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U.S. Environmental Protection Agency
Science Advisory Board
Drinking Water Committee
Drinking Water Research Program Multi-Year Plan Review Panel
CHAIR
Dr. R. Rhodes Trussell, Trussell Technologies, Inc., Pasadena, CA
MEMBERS
Dr. Mary Davis, Department of Physiology & Pharmacology, West Virginia University Health
Sciences Center, Morgantown, WV
Dr. Ricardo DeLeon, Water Quality Laboratory, Metropolitan Water District of Southern California,
La Verne, CA
Dr. Penelope Fenner-Crisp, ILSI Risk Science Institute, International Life Sciences Institute,
Washington, DC
Dr. Stanley B. Grant, Department of Chemical Engineering, School of Engineering, University of
California, Irvine, Irvine, CA
Dr. Barbara Harper, AESE, Inc., West Richland, WA
Dr. Joseph Landolph, Pathology, and Molecular Pharmacology & Toxicology, Cancer Research
Laboratory, Keck School of Medicine, University of Southern California, Los Angeles, CA
Dr. Christine Owen, Tampa Bay Water, Clearwater, FL
Dr. Joan B. Rose, Department of Fisheries and Wildlife, Michigan State University, E. Lansing, MI
Dr. Gary Sayler, The Center for Environmental Biotechnology, University of Tennessee, Knoxville,
Knoxville, TN
Dr. Philip Singer, Department of Environmental Sciences and Engineering, School of Public Health,
University of North Carolina, Chapel Hill, NC
Ms. Susan Teefy, Water Quality and Treatment Solutions, Inc., Castro Valley, CA
SCIENCE ADVISORY BOARD STAFF
Dr. Suhair Shallal, Designated Federal Officer, Washington, DC
IV
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U.S. Environmental Protection Agency
Science Advisory Board
CHAIR
Dr. M. Granger Morgan, Carnegie Mellon University, Pittsburgh, PA
PAST CHAIR
Dr. William H. Glaze, Oregon Health & Science University, Beaverton, OR
VICE CHAIR
Dr. Domenico Grasso, Smith College, Northampton, MA
MEMBERS
Dr. Gregory Biddinger, Exxon Mobil Refining and Supply Company, Fairfax, VA
Dr. James Bus, The Dow Chemical Company, Midland, MI
Dr. Trudy Ann Cameron, University of Oregon, Eugene, OR
Also Member: COUNCIL
Dr. Deborah Cory-Slechta, Rutgers University, Piscataway, NJ
Dr. Maureen L. Cropper, The World Bank, Washington, DC
Dr. Kenneth Cummins, Humboldt State University, Arcata, CA
Dr. Virginia Dale, Oak Ridge National Laboratory, Oak Ridge, TN
Dr. Baruch Fischhoff, Carnegie Mellon University, Pittsburgh, PA
Dr. A. Myrick Freeman, Bowdoin College, Brunswick, ME
Dr. James Galloway, University of Virginia, Charlottesville, VA
Dr. Linda Greer, Natural Resources Defense Council, Washington, DC
Dr. Philip Hopke, Clarkson University, Potsdam, NY
Also Member: CASAC
Dr. James H. Johnson, Howard University, Washington, DC
Dr. Meryl Karol, University of Pittsburgh, Pittsburgh, PA
Dr. Roger E. Kasperson, Stockholm Environment Institute, Stockholm,
Dr. Catherine Kling, Iowa State University, Ames, IA
Dr. George Lambert, Robert Wood Johnson Medical School/ University of Medicine and Dentistry
of New Jersey, Piscataway, NJ
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Dr. Jill Lipoti, New Jersey Department of Environmental Protection, Trenton, NJ
Dr. Genevieve Matanoski, Johns Hopkins University, Baltimore, MD
Dr. Michael J. McFarland, Utah State University, River Heights, UT
Dr. Rebecca Parkin, The George Washington University, Washington, DC
Dr. David Rejeski, Woodrow Wilson International Center for Scholars, Washington, DC
Dr. Kristin Shrader-Frechette, University of Notre Dame, Notre Dame, IN
Dr. Deborah Swackhamer, University of Minnesota, Minneapolis, MN
Dr. Thomas Theis, University of Illinois at Chicago, Chicago, IL
Dr. R. Rhodes Trussell, Trussell Technologies, Inc., Pasadena, CA
Dr. Robert Twiss, University of California-Berkeley, Ross, CA
Dr. Lauren Zeise, California Environmental Protection Agency, Oakland, CA
SCIENCE ADVISORY BOARD STAFF
Mr. Thomas Miller, Designated Federal Officer, Washington, DC
VI
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TABLE OF CONTENTS
EXECUTIVE SUMMARY 1
INTRODUCTION 4
GENERAL RESPONSE AND RECOMMENDATIONS 5
SPECIFIC RESPONSES AND RECOMMENDATIONS 5
CHARGE QUESTION 1 5
COMMITTEE RESPONSE TO THE FIRST QUESTION IN
CHARGE QUESTION 1 6
COMMITTEE RESPONSE TO THE SECOND QUESTION IN
CHARGE QUESTION 1 7
Arsenic Rule 8
Disinfection By-Products 8
CCL Pathogens 8
Six Year Review of Regulated Contaminants 9
Source Water Protection and Distribution Systems 9
CHARGE QUESTION 2 10
COMMITTEE RESPONSE TO CHARGE QUESTION 2 10
General Comments on Charge Question 2 10
Specific Comments on Charge Question 2 11
CHARGE QUESTION 3 18
COMMITTEE RESPONSE TO CHARGE QUESTION 3 18
Arsenic Rule 19
Disinfection Byproducts 19
Unregulated Contaminants (CCL)-Chemicals 19
Unregulated Contaminants (CCL)-Pathogens 19
Six-Year Review 20
Innovative Approaches 20
CHARGE QUESTION 4 21
COMMITTEE RESPONSE TO CHARGE QUESTION 4 21
REFERENCES 3
Vll
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EXECUTIVE SUMMARY
On May 24-25, the Science Advisory Board (SAB) Drinking Water Committee (DWC)
met to review the "Drinking Water Research Program Multi-Year Plan 2003" (MYP) developed
by the U.S. Environmental Protection Agency's (EPA) Office of Research and Development
(ORD). The MYP describes the drinking water research activities and plans for fiscal years 2003
- 2010. It focuses on four major drinking water research areas: 1) Regulated and Unregulated
Pathogens, 2) Regulated and Unregulated Chemicals, 3) Source Water Protection and
Distribution Systems, and 4) Innovative Approaches and the Six-Year Review. The DWC has
therefore provided comments and recommendations based on these four areas of research to
address the charge questions.
ORD requested that the DWC review and provide advice on the Drinking Water MYP
with respect to its overall organization, rationale and content. The specific charge, as created by
ORD, to the DWC was as follows:
• Does the MYP provide a logical framework for organizing the drinking water program to
best meet EPA 's needs? For each major topic area addressed by the research program (e.g.,
Disinfection Byproducts, CCL Pathogens, Distribution Systems), do the research goals (APGs)
represent logical progressions of activities and intended outcomes?
• Do the science questions identified in the MYP address the most important research issues
for each of the major research topic areas?
• Do the research products identified in the MYP focus on the highest priority research for
each major topic area? Do the sets ofAPMs under the APGs appear both necessary and
sufficient for accomplishing the intended goals?
• Is the relative allocation of resources across the major components of the drinking water
research program appropriate, based on a consideration of scientific and programmatic needs?
Is the overall resource level generally sufficient to address the most important research
questions and achieve the intended outcomes of the research program?
The Agency has clearly invested a substantial amount of expertise, time, and energy into
developing the MYP. The Drinking Water Research Program logic model and subsequent key
scientific questions presented in the MYP will lead to more effective planning and more effective
management of scientific programs, with goals, timelines and deliverables.
Overall the DWC agrees that the MYP provides a logical framework for organizing the
drinking water program to meet EPA's Drinking Water research goals. The use of Annual
Performance Goals as milestone markers en route to achieving Long-Term Goals is a valuable
approach and the entire process is beneficial as it increases the transparency of EPA decision-
making. The rationale for where the Annual Performance Goals appear in the timeline in Figures
1 through 3 is, however, not well articulated. Additionally, the origins of the process that led to
the logic model were also not clear. The DWC does not challenge the logic model, rather the
way it is presented in the MYP.
The DWC suggests that the MYP be presented as a stand-alone document. The MYP
primarily focuses on the research activities in ORD and does not provide a full account of other
research activities in other parts of the Agency. While this is reasonable for an ORD research
review, it does not provide the reviewer with a complete view of all the research. A more
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transparent and comprehensive representation of the research program would provide a
significant improvement.
The DWC supports and encourages the continued development of the Environmental
Information Management System (EIMS) as it represents an important contribution to
transparency. The EIMS stores, manages, and delivers descriptive information for scientific
documentation that can be easily accessed with standard Web browsers. Having direct access to
descriptions of ongoing or planned research activities, through EIMS links, was extremely
helpful.
In general, the science questions identified in the MYP do address important research
issues for each of the major research topic areas. However, some of the questions are not clearly
articulated and recommendations for revisions can be found in the body of the report. The DWC
recommends that the contextual background be provided for each key question so that they can
be more easily understood and the relationship between Long-term Goals, Annual Performance
Goals, and Annual Performance Measures can be readily discerned. Finally, with regard to the
key scientific questions, the MYP should provide a distinction between natural or accidental
contamination and intentional contamination, for example, storm events or wastewater spills
versus bioterrorism events.
The research products (i.e., Annual Performance Measures) in the MYP focus on EPA's
identified high priority research for each major topic area and provide a useful and appropriate
approach for addressing accomplishments toward meeting the intended goals. The MYP does
not, however, include the research required to conduct a cost-benefit analysis which must
consider a variety of health benefits, ranging from lives saved to minor illnesses avoided. Also,
more effort is needed to identify human subpopulations that may be more sensitive to the non-
cancer effects following exposure to drinking water contaminants such as arsenic or microbes.
Exploratory and open-ended research also has special value to EPA's mission, especially with
respect to new issues and new technologies. The DWC believes that this research is significant
because it provides support for drinking water issues of interest to EPA that is not available
elsewhere. In addition, this research stimulates activities within the agency, transfers technology
and brings new expertise to EPA through EPA conferences and workshops. EPA is to be
complimented for its cooperation in the Global Water Research Coalition and yet resources
could also be better leveraged by strengthening formal research relationships with other
governmental agencies (e.g. NIEHS, NSF, USGS, CDC, NCBI (bioinformatics), state agencies,
etc.)
One of the DWC's most important comments is that elements of the Drinking Water
research program may be continuing with diminishing returns. The DWC recommends that
Annual Performance Measures be framed in the context of the relative risk posed by target
drinking water contaminants. This approach would probably lead to an emphasis on microbials
and chemical mixtures, and de-emphasis of Disinfection By-Products (DBFs), particularly single
compound research. EPA should lead a healthy debate on defining the highest priorities for
drinking water contaminants. The DWC does not believe that DBF research should be
discontinued, but encourages a strategic review.
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Finally, in view of the growing research needs to support the CCL, the movement toward
alternative disinfectants, competing drinking water regulations, increasing concern with respect
to source water protection and distribution systems and water reuse and desalination, the DWC
believes that a level budget for drinking water research is not sufficient. While the relative
allocation of resources across most of the major components of the drinking water research
program may be appropriate based on a consideration of scientific and programmatic needs, the
overall resource level is insufficient to address all the important research questions and achieve
the intended outcomes of the research program. One area where a shift of funds may be needed,
as new issues arise, is for Distribution Systems. For Distribution Systems, the overall allocation
of resources and timing appear to be insufficient and lag behind the drinking water program
timeline. The DWC believes that research resources dedicated to a specific issue should evolve
in accordance with their progression. In early stages, modest research allocations should be
dedicated to reconnaissance and forward thinking research. As the agency approaches
rulemaking, more resources should be allocated. After rulemaking, the budget should be
decreased and focused on assessing the effect of the rule and the potential for future changes.
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INTRODUCTION
This report was prepared by the Science Advisory Board (SAB) Drinking Water
Committee (DWC) in response to a request by EPA's Office for Research and Development
(ORD) to review the Drinking Water Research Program Multi-Year Plan 2003 (MYP)1. ORD
describes the MYP as EPA's drinking water research activities and plans for 2003 - 2010. In
partnership with the Office of Water (OW), ORD developed this MYP which will link research
plans that support EPA's annual budget request with EPA's strategic plan. The MYP was
developed as a tool for planning and communication; it 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 ORD research plans and products within ORD,
with EPA programs, with the Regions and with interested parties outside of EPA.
As stated in the MYP, the overall organization of the drinking water research program is
represented in the context of EPA's Strategic Goals and Objectives, and ORD's Long-Term
Goals (LTGs), Annual Performance Goals (APGs) and Annual Performance Measures (APMs).
The MYP establishes three Long-Term Goals in the following areas: (1) regulated contaminants;
(2) unregulated contaminants and innovative methods; and (3) source water protection and
distribution systems. Annual Performance Goals within each of these Long-Term Goals is
represent as milestones along the path toward attaining the long-term outcome.
Accordingly ORD identified key scientific questions for each of the major components of
the research program discussed in the MYP to focus research on their highest priority issues.
Annual Performance Measures in the MYP are presented in the form of research outputs, such
as, new data, tools, technologies, databases, models, or assessments that are considered necessary
for accomplishing a particular goal (APG). The MYP also identifies several synthesis
documents, which integrate and summarize new research findings on a particular topic. The
MYP does not, by design, provide detailed information on specific research activities and
products represented by Annual Performance Measures. Nevertheless, a general evaluation of
the research program outputs was made via the Annual Performance Measures titles and the
supplementary information on near-term Annual Performance Measures through linkages to the
drinking water research tracking system. Some budgetary information was provided to the DWC
for their consideration of resource allocations within the drinking water research program. The
development of the MYP was based on an assumption of level resources over the period covered
by the plan.
In the MYP, ORD has stated 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 which can be used to pursue other lines of inquiry that may not have been
anticipated or possible when the original research was planned. In addition, unexpected
changes may occur in available resources or strategic priorities. For these reasons, ORD
intends to update the MYP on a biennial basis (NEXT UPDATE TO OCCUR IN 2005) to
provide opportunities for making the necessary adjustments to the research program.
1 The MYP document can be found at the following URL: http://www.epa.gov/osp/myp/dw.pdf
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GENERAL RESPONSE AND RECOMMENDATIONS
The DWC wishes to compliment ORD on the quality of the MYP and on the serious
investments ORD is making in the multi-year research planning process. The identification of
EPA's key scientific questions should lead to more effective planning and management of
scientific programs, with goals, timelines and deliverables. Such efforts help ORD staff to focus
on their highest priority areas of research and to understand management decisions that influence
their activities. Documents of this kind also help both internal and external organizations
understand where ORD intends to focus its research effort. The DWC supports and encourages
the continued development of the Environmental Information Management System (EIMS) as an
important contribution to transparency. Direct on-line access, through the EIMS links to
descriptions of the ongoing research activities in ORD, was extremely helpful. The DWC also
strongly encourages ORD to continue to strengthen its multi-year planning activities. Better
coordination between ORD and other parts of the Agency will produce a MYP that is more
useful in identifying the Agency's most urgent research needs and setting research priorities.
The current MYP does not include all the drinking water-related research and data-
gathering activities supported by EPA or its partners. Using the available information, the DWC
has reviewed and addressed the approach of the program overall in meeting EPA's general needs
and has offered recommendations and suggestions to improve future iterations of the MYP.
Perhaps one of the DWC's most important criticisms is that elements of the Drinking Water
research program may be continuing without clear benefit. This comment is explained in greater
detail under Charge Question 2 later in the report. As ORD intends to update the MYP on a
biennial basis (NEXT UPDATE TO OCCUR IN 2005), the opportunities for making the
necessary adjustments to the research program can now occur in a more timely fashion.
Charge questions, as created by ORD, are provided below and are followed by the
DWC's specific responses and recommendations for each charge questions. The responses focus
on the four key research topic areas addressed in the MYP. These include: 1) Regulated and
Unregulated Pathogens; 2) Regulated and Unregulated Chemicals; 3) Source Water Protection
and Distribution Systems; and 4) Innovative Approaches and the Six-Year Review.
SPECIFIC RESPONSES AND RECOMMENDATIONS
CHARGE QUESTION 1
The Research Program Design Logic Model on page 3 of the MYP presents the overall
organization of the drinking water research program in the context of EPA's Strategic Goal and
Objective, and ORD's Long-Term Goals (LTGs), Annual Performance Goals (APGs) and
Annual Performance Measures (APMs). The MYP establishes three Long-Term Goals in the
following areas: (1) regulated contaminants; (2) unregulated contaminants and innovative
methods; and (3) source water protection and distribution systems. Annual Performance Goals
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within each of these Long-Term Goals are represented as important milestones along the path
toward accomplishment of the Long-Term Goals and long-term outcomes.
• Does the MYP provide a logical framework for organizing the drinking water
program to best meet EPA 's needs?
• For each major topic area addressed by the research program (e.g., Disinfection
Byproducts, Contaminant Candidate List (CCL) Pathogens, Distribution Systems), do
the research goals (APGs) represent logical progressions of activities and intended
outcomes?
COMMITTEE RESPONSE TO THE FIRST QUESTION IN CHARGE QUESTION 1
• Does the MYP provide a logical framework for organizing the drinking water
program to best meet EPA's needs?
The MYP does provide a logical framework for organizing the research intended to
support the drinking water program. The delineation of three areas of Long-Term Goals (as
opposed to one), better reflects research needs and allows better coordination with rule
development, implementation and review. Further delineation would be helpful in the future.
For example, the DWC recommends that distribution systems and source water protection not be
combined as they deal with different aspects of water research.
The MYP identifies critical issues and provides a roadmap which describes the path that
ORD is following to achieve its research goals. ORD has taken great effort to organize the plan
and its work products. This is significant because of the breadth of the research needed to
support the goals. The changes that have been made from previous plans are excellent
improvements.
The MYP was developed, in part, as a vehicle "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 a resource for
communicating ORD research plans and products within ORD, with EPA programs, with the
Regions and with interested parties outside of EPA " and as such presents research that supports
regulatory activities of the Office of Water (OW) and addresses EPA's and ORD's strategic
plans. It reports ORD activities and the interaction between the five ORD laboratories (National
Exposure Research Laboratory, National Health and Ecological Effects Laboratory, National
Risk Management, National Center for Environmental Assessment Laboratory, and the National
Center for Environmental Research) involved with various goals. However, the MYP did not
include all of the water-related research projects. Additional ORD water-related research
programs are reported under different MYPs. The MYP does not capture all the research
activities under OW or those of non-Agency partners such as the American Water Works
Association Research Foundation (AwwaRF). Any other water-related research and data
gathering activities which supplement ORD research should be explicitly recognized in the
MYP, with links whenever possible. The framework should explicitly address the Drinking
Water Program's response and approach to incorporating the needs of stakeholders and refer to
the Global Water Research Network and interactions with other programs to leverage resources.
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The DWC recommends that future versions be a self-contained document; (i.e., it should
include all the information a reviewer would need to be able to fully assess if the research
program meets EPA's needs). Specific suggestions are given below.
EPA research provides the scientific underpinning for regulation. For the water research
program, there are numerous regulations, each including multiple deadlines. These have been
incorporated into the three Long Term Goals and their Annual Performance Goals and Measures.
The reader needs a deep understanding of OW's various and vast regulatory deadlines, more than
that which is included in the MYP, to comprehend the nuances of the different milestones
captured as Annual Performance Goals. The logic model presented in figure 1 could be
improved by showing the linkages either graphically or through narrative, without going to
Appendix A, between the Long-Term Goals and the following items:
o Statutory drivers (i.e., which statutes and time frames are each of the Long-Term
Goals designed to respond to?);
o Long-Term Goals in other MYPs.
There should be more discussion about the relationship between the Annual Performance
Goals, the Annual Performance Measures and the scientific questions, including: a brief
discussion of the issue; the current state of knowledge; and an indication of knowledge gaps.
The key questions can then be derived from those gaps, ordered by regulatory priority or by
scientific need. This discussion should include an assessment of the likelihood that the goals set
forth in each APG will be met.
The tables are an integral component of the MYP and list the Annual Performance Goals
and their associated Annual Performance Measures. The figures provide the broad context. The
rationale for placement of the Annual Performance Goals in the timeline in Figures 1 through 3
is not well articulated. Annual Performance Goals in the figures should also be numbered and
more specifically and succinctly labeled. The tables should provide sufficient information for the
reader to grasp the context of the Annual Performance Goals and the content of the Annual
Performance Measures. As an example, for Annual Performance Goals addressing a Six-Year
Review, the scheduled completion date for the review should be given. For Annual Performance
Goals addressing a rule revision or implementation, further details (e.g., "possible revision to the
[add specific name] final rule to be issued on...") should be provided. The Committee found the
Environmental Information Management System (ELMS) links to be very useful and encourages
ORD to include them for all the Annual Performance Measures.
COMMITTEE RESPONSE TO THE SECOND QUESTION IN CHARGE QUESTION 1
• For each major topic area addressed by the research program (e.g., Disinfection
Byproducts, CCL Pathogens, Distribution Systems), do the research goals (APGs)
represent logical progressions of activities and intended outcomes?
The MYP presents three Long-Term Goals that address regulated contaminants, new
(unregulated) contaminants, and protection of source water and distribution systems. They were
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developed with Annual Performance Goals and Annual Performance Measures, which are
intended to measure the outcomes. We noted that arsenic and DBF research priorities have
changed from those given in previous research plans. It would be useful to elaborate on such
changes.
Arsenic Rule:
As envisioned a priori, the Annual Performance Goals for the arsenic rule represent a logical
progression. First, research is conducted to develop and evaluate treatment technologies to aid in
implementation of, and compliance with the current MCL. Then risk-related research to support
OW's initial six-year review of the current MCL and its second six-year review of that, or a
different MCL (pending the outcome of the initial six-year review).
There is a significant concern about the numbers of projects or Annual Performance
Measures that are behind schedule and whether there will be a sufficiently robust body of new
health effects and exposure data available by 2006 for OW to perform its first six-year review of
the current MCL in a credible way.
Disinfection By-Products:
These Annual Performance Goals are reasonable for supporting future regulatory review,
although they are not necessarily sequential, nor do they appear to be progressing towards the
regulatory review or action. It is not obvious that the earlier Annual Performance Goals are
setting the groundwork for remaining Annual Performance Goals or providing specific
information that is needed for intermediate decision points. The MYP would benefit from
including a decision analysis approach wherein the data gaps are clearly laid out and prioritized.
CCL Pathogens:
The Regulated Pathogens include: Cryptosporidium; Giardia; Legionella; viruses in
surface water and groundwater; and pathogens on the CCL. Microorganisms should be viewed
as a high health risk priority, due to the acute nature of the impacts. Deaths are often associated
with microbial contamination events. Among health risks the high priority of microbial
contaminants should be clearly stated in the MYP. Microbial issues focus on microbial
contamination of source water, treatment to remove microbes, and the distribution system, both
as a protector of the water's integrity and as a potential habitat for opportunistic pathogens. The
MYP should include efforts to develop techniques for measuring pollution sources and the
efficacy of prevention measures for watershed protection; verifying small treatment system
performance; and examining health risks. Where pathogens are concerned, the focus on the
small systems is especially important given the high number of outbreaks that occur in small
communities where they are more likely to be recognized than in more diffusely spread
populations.
For microorganisms, data, tools and techniques as well as assessment are the key
descriptors in each of the goals (APG) and final management strategies (LTG). These
descriptors in each of the goals and final management strategies may be seen as occurrence
(data), methods (tools), environmental assessment (survival & transport), health assessment
(risk), and water treatment (management), which should be explicitly addressed in more detail in
each long-term goal.
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The Annual Performance Goals for Long-Term Goal 1 include: implementation of the
rules; implementation for small systems; and a general category on health, exposure, treatment
and assessment. Long-Term Goal 2 begins with an assessment of unregulated pathogens, and
then moves to methods, exposure, treatment, health risks, occurrence and risk characterization
for five organisms (methods, occurrence and exposure must be better linked in the APG, prior to
health risks) In Long-Term Goal 3, better monitoring of sources and distribution systems is
needed as part of the Annual Performance Goals to meet the model development needs. The
flow from one Annual Performance Goal to the next is not well described. The DWC believes
that innovative tools, methods and techniques, and treatments are critical. An approach to verify
the performance of watershed protection best management practices (BMPs), and treatment and
protection of distribution systems is also needed in the LTG.
Six Year Review of Regulated Contaminants
The Six Year Review concerns specific contaminants, lead/copper, fluoride, and
chromium, with some specific requirements for distribution systems, particularly with the total
coliform (TC) monitoring requirement. Overall, the research goals do represent logical
progression of activities and intended outcomes. They should also provide useful information
that can be used to aid the Six Year Review. However, the Annual Performance Goals for
Distribution Systems and the associated Annual Performance Measures do not have the
provisions necessary to re-evaluate the TC monitoring requirements. While a number of Annual
Performance Measures for Distribution Systems are referred back to Annual Performance Goals
for Long-Term Goal 1 and Long-Term Goal 2, it does not appear that any are related specifically
to the Six Year Review in Long-Term Goal 1.
The Six-Year Review has variable target dates, based on the actual promulgation dates of
the individual National Primary Drinking Water Regulations (NPDWRs; the last major review
was completed in 2002). Data on the effects, occurrence, treatability, and risks of regulated
chemicals specific to the Six Year Review are anticipated outcomes sufficiently in advance to be
of use in the review process. The Six-Year Review under Long-Term Goal 1 (T-l. 13) is
somewhat limited in scope, with rather specific and attainable Annual Performance Measures for
the 2005 Annual Performance Goals. However, it is less well-defined for the 2008 Annual
Performance Goals. The progress!onal logic of the research plan is appropriately driven by
statutory requirements of the rules.
Source Water Protection and Distribution Systems
For Source Water Protection and Distribution Systems, the research goals do present
logical progressions of activities and intended outcomes. They are rather broad, but this may be
the best that can be done at this time in capturing the over-arching goals of this new program. As
the Long-Term Goal 3 timeline continues into the future (in coordination with the rule
schedules), it is expected that the next cycle of the DWMYP will identify more specific targets
for this effort. Since specificity is achieved through the Annual Performance Measures, it is
expected that the number of Annual Performance Measures will increase in these two areas in
the future.
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Some attention should be placed on the timing of ORD research efforts. EPA is currently
engaged in discussions on distribution systems and water quality, and it may be appropriate to
bring many of these work products up in the timeline. EPA has been working with stakeholders
to develop rule options for the Stage 2 DBPR and the Long Term 2 Enhanced Surface Water
Treatment Rule (LT2ESWTR), both of which have distribution system components. As the
Long-Term Goal 3 timeline extends out further into the future (i.e., 2008), it would be beneficial
to move work efforts forward to accommodate the rule schedule.
Given the importance of Source Water Protection, it is not clear why the first Annual
Performance Goal is delayed until FY06. For example, earlier Annual Performance Goals might
involve the development of linkages with the Clean Water Act activities of ORD to facilitate
integration of those activities with long-term drinking water goals. Another earlier Annual
Performance Goal might be the identification of key contaminants of concern that need to be
managed for the FY06 Annual Performance Goal. Another Annual Performance Goal for FY10
could be added to address performance of those tools, methods, models and data for improving
source water protection developed in the FY09 Annual Performance Goal.
A similar comment applies to Distribution Systems regarding the delay of the first
Annual Performance Goal until FY06 and the importance of this subject. Contaminants of
concern need to be identified before they are characterized and managed in the FY06 Annual
Performance Goal. Additionally, the hydraulic behavior of water and contaminants in
Distribution Systems is a key component of public exposure to contaminants in tap water.
Accordingly, an important Annual Performance Goal that could be added for FY05 or FY06 is
the development and demonstration of network models for water quality in distribution systems.
Such models would address the spatial and temporal variability of water in distribution systems.
CHARGE QUESTION 2
On pages 6-10, the MYP identifies key scientific questions for each of the major components of
the research program. These questions are intended to focus research on the highest priority
issues (i.e., the areas of greatest scientific uncertainty and programmatic impact).
• Do the science questions identified in the MYP address the most important research
issues for each of the major research topic areas
COMMITTEE RESPONSE TO CHARGE QUESTION 2
General comments on Charge Question 2
ORD has, for the most part, framed appropriate questions for targeting the important
research efforts. We expect that questions will evolve (as will the APGs) with progress and rule
development. The DWC has some concerns with research priorities. Elements of the research
program may be continuing without any clear benefit. Drinking water issues progress from
discovery, to data collection and regulation, followed by monitoring the effectiveness of the rule.
The DWC believes that research resources dedicated to a specific issue should evolve in
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accordance with this progression. In early stages, modest research allocations should be
dedicated to reconnaissance and forward thinking research. As the agency approaches
rulemaking, more resources should be allocated. After rulemaking, the budget should be
decreased and focused on assessing the effect of the rule and the potential for future changes.
Mature topics where research may need to be refocused include disinfection by-products and the
effects of high levels of arsenic. Issues in early stages include CCLs, watershed protection and
distribution systems.
Third party input to the development of the Long-Term Goals should be clearly stated,
and a process should be articulated regarding how third party recommendations were handled.
For example, were the recommendations adopted, not adopted, or are they under consideration
(e.g., why were the Classification Methods described in the NAS report2 not included in the
Annual Performance Measures under Innovative Methods)?
The DWC recommends that the text and logical development of the Annual Performance
Goals which form the Long-Term Goals should be reorganized with headings which include: a
brief discussion of the issue; the current state of knowledge; and an indication of knowledge
gaps. The key questions can then be derived from those gaps and ordered by regulatory priority
or scientific need.
The MYP should distinguish between natural, accidental and intentional contamination
(e.g., storm events or wastewater spills versus bioterrorism events). A context is also needed for
each key question, so they can be more easily understood and relationships between Long-Term
Goals, Annual Performance Goals, and Annual Performance Measures can be readily discerned.
Further clarification was needed for some of the key scientific questions (section numbers in the
pages that follow refer to those found in the MYP on pgs. 7-10).
Specific comments on Charge Question 2
Section 3.1 Arsenic Rule
(1) 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 fig/liter range) and the risk of cancer or noncancer effects in susceptible
populations be strengthened?
These science questions are short, yet capture the debate over the treatment technology
issues and health effects in the arsenic rule.
Section 3.2 M/DBP Rules—Water borne Pathogens:
2 National Academy Press, (2001) Classifying Drinking Water Contaminants: for regulatory consideration,
National Research Council, Washington DCError! Main Document Only-
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(1) How can analytical methods to detect Cryptosporidium in water matrices be improved?
Before asking how to improve methods, ORD should define why they need to be
improved (i.e., the rationale behind the question). Is the objective to improve Method 1623 so
that it can be effective with a broader range of water matrices? Perhaps a bigger issue with the
current detection method is the sample volume (10 liters) and its relationship with protozoa
isolation in source waters. Reported results from Method 1623 are much lower than from the old
Information Collection Rule (ICR) method and the reasons for this discrepancy should be
determined. Is it due to misidentification by the old ICR method or is the sample volume the
problem? or was the 18 month assessment a better representation of concentrations? The DWC
suggests that new methods and monitoring schemes should focus on the infectivity and viability
of pathogens.
(2) What data and methods are needed for assessing the risks associated with exposure to
protozoa and viruses in source water and ground water?
It is difficult to understand what this question refers to. Is it a general risk question (i.e.,
are the current risk assessment tools the appropriate ones)? Or is it referring to new approaches
to risk assessment or a question of whether there is a possible reduction in efficacy of
disinfection from complying with the Stage 1 and 2 Disinfection By-Products (DBF) rules? The
question that should be asked is: Has implementation of Stage 1 and 2 DBF rules at treatment
plants effectively reduced or increased protection against pathogens, and what is a reasonable
approach to determine the level of protection?
Better methods to detect and eliminate viruses are needed, given that groundwater and
small systems are at risk. The second science question should be refrained. The data and
methods needed to assess risk are known. The real question is how to more effectively monitor
source waters given limited funding and laboratory capacity. The contamination is tied to land
use and transport during environmental conditions (i.e., rain events) so spatial and temporal
assessment is a challenge. The DWC recommends a greater emphasis be placed on viruses and
groundwater, and measuring the effect of compliance with Stage 1 and Stage 2 DBF rules on
pathogen inactivation.
(3) How can treatment be optimized to remove/inactivate Cryptosporidium, particularly for
small systems? How can these approaches be balanced to also control DBFs?
Is this question about optimization of conventional treatment, or is it more general? The last
question on small systems is particularly important. Monitoring small systems will be a
challenge. There are issues associated with small systems that need to be considered:
• Small systems are more likely to be located in rural, agricultural environments;
• Small systems often rely on groundwater with an assumption that groundwater is safer
without proper assessment; and
• Water supply degradation may go unnoticed due to inadequate microbial monitoring.
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The DWC recommends including small systems using groundwater in research projects.
Questions should be framed as follows: what conventional optimization procedures and
alternative treatment technologies may be most effective for the reduction and inactivation of
Cryptosporidium in small systems? How can treatment approaches for Cryptosporidium in
(medium and) small systems be optimized in light of the new DBF rules?
Section 3.2 M/DBP Rules—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?
For Disinfection By-Products, the DWC concurs that the three questions posed are
important. The question regarding how health effects can be better characterized is too
qualitative. There are many ways to define "better" and each would lead to different research
programs. Better can mean less expensive, more rapid, or in a system that extrapolates to
humans, more reliable or more detailed versions of the characterizations that have already been
done (e.g., more doses to better define the shape of the dose-response curve in the region of
likely human exposure or where there is concern for non-linearity). Therefore, the DWC
recommends that the phrase "better characterized" be more clearly defined.
The MYP needs to address the future of disinfection, chlorination, ozonation, UV
disinfection, plasma disinfection, etc. EPA should take a leadership role in defining the future of
disinfection (and its by-products). For example, EPA could commission the NRC to analyze the
future of disinfection. Such an analysis would include the costs and benefit to society vs. cost of
research. The DBF research program may be locked into institutional momentum. In other
words, is research continuing without clear benefit?
Section 3.3 Six-Year Review ofNPDWRs
The science questions identified in the MYP do address important research issues for
each of the major research topic areas identified in the Six-Year Review. However, specific
science/research questions for this topical area of the MYP are not developed. Future National
Primary Drinking Water Regulation (NPDWR) reviews may identify heretofore unrecognized
data requirements and issues. Therefore, a matrix ofNPDWRs, review cycles, and current data
requirements may help to guide the development of additional science issues. A matrix of
priorities for the DW Research Program would be useful.
Section 3.4 Unregulated Contaminants (CCL) and Future Rules
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(1) What contaminant-specific research is needed to address key data gaps for high
priority waterborne pathogens and chemicals that are or could be listed on the CCL?
For unregulated contaminants (CCL), EPA needs to develop research programs for
understanding and mitigating predictable hazards that will affect drinking water. These arise
from changes in agricultural practices that will impact drinking water, by affecting source water
quality (both pathogens and the types of agricultural chemicals that enter water) and seawater
desalination and potable water reuse.
For CCL pathogens on page 9, the DWC supports the broad scientific question as stated.
For pathogens that might be added to the CCL in the future, new approaches are needed. For
current CCL pathogens, the questions should focus on developing a risk assessment that
addresses:
• Where do microbes of most serious concern enter the system (at the source or in the
distribution system)?
• What new methods can be used to address potential for exposure (occurrence, survival
and transport)?
• How can gaps in treatment be filled (conventional vs. future technology)?
• Where is the uncertainty in the health risk (dose, health outcomes, sensitive populations)?
It should be noted that there is a separate research plan for Homeland Security and there
should be exchange between the EPA Drinking Water MYP and the Water Protection Division's
research plan. Separate research for intentional and natural/accidental contamination events
should be developed with a different set of key questions for each.
(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?
This question is an example of water-related research activity that is outside of ORD and
therefore not included in the MYP. This question is addressed in the 2001 NRC report
Classifying Drinking Water Contaminants for Regulatory Consideration with modified
recommendations adopted by the National Drinking Water Advisory Committee (NDWAC) in
May, 2004. This is a broad science question; it includes innovative models, predictive tools,
methods, and exemplary experimental approaches, such as assay systems and microarray
technology. In terms of innovative approaches, the Annual Performance Goals and Annual
Performance Measures under Innovative Approaches address this science question well for the
CCL list.
The DWC recommends expanding the scientific questions to include the following:
• Where innovative technology exists in allied science and engineering fields, what
environmentally unique drinking water and source water issues exist that inhibit
exploitation of these technologies for ORD problem solving?
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• What is the most effective way to integrate across ORD's pre-existing development or
use of innovative technology to achieve the greatest benefits for GW/DW, Source, and
Distribution in meeting the SDWA requirements?
• Can innovative approaches be effectively transmitted to State and municipal governments
to avoid basing future rules on outdated technology, such as total coliform analysis?
If ORD is seeking a compilation of the development, use and implementation of
innovative technology, this could be accomplished by an internal Annual Performance Measure,
a cooperative agreement, or an international workshop.
Section 3.5 Source Water Protection
The Agency has, for the most part, framed appropriate questions for targeting the
important research efforts. However it is not clear how each Annual Performance Measure
specifically addresses the science needed to answer these questions. The Annual Performance
Goals do not seem to address each of the science questions in Table 3, particularly the first
question about the adequacy of Ambient Water Quality Criteria in protecting public health.
(1) How adequately do the Ambient Water Quality Criteria (A WQC) that address the
major drinking water contaminants protect public health?
It does not appear that significant effort is directed at answering this question based on
the work products which are associated with Long-Term Goal 3. It is an important question
which will frame how the CWA and the SDWA efforts can be coordinated. Coordination of
these two programs is critical to appropriately directing EPA's resources and efforts. It might be
helpful to develop a series of white papers that review AWQC parameters, SDWA expectations
and treatment. This would provide a framework for developing targeted research projects.
(2) What improved techniques are needed to better define source water characteristics
and sources of contamination?
A significant effort is aimed towards developing methods for assessing microbial
contamination and new emerging chemical contaminants. Defining source water characteristics
is addressed to a lesser extent. It will be important to not only identify what contaminants are in
source waters but also the variability in space and time of these constituents. This will be critical
information needed to answer Question #5 below.
(3) What are the fate and transport characteristics of certain types of contaminants in
surface water and ground water?
Based on the work products identified for Long-Term Goal 3, it appears that limited
effort is targeted at this issue. Fate and transport is an important consideration for both the
CWA and the SDWA. The occurrence and persistence of known and emerging chemical and
microbial contaminants will drive treatment for both wastewater and drinking water utilities.
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(4) How effective are candidate protection measures (i.e., Best Management Practices)
on improving the quality of the source water?
This is an important area of research because pollution prevention is one of the most
important things that can be done to ensure public health and safety. For the most part, however,
BMP's are not inexpensive and historically, regulatory agencies have been reluctant to identify
reliable benefits to a utility. This is understandable because of the paucity of demonstrations. To
encourage utilities to participate, clear, measurable benefits need to be demonstrated. A small
number of work products address this question for specific contaminants. More effort could be
directed towards this question as it is another important link between the CWA and the SDWA.
BMP's also are a critical element of the proposed LT2 "Toolbox" which currently has too few
viable tools in it. These BMP's (their characterization and value to avoiding treatment at a plant)
are necessary for inclusion in the rule to meet the stated expectations of the FACA agreement for
that negotiated rule package.
(5) What is the impact of sudden increases in source water contaminant concentrations
on drinking water treatment performance?
It is not clear that this question is appropriate as a part of Long-Term Goal 3 and source
water protection. This question speaks to water treatment plant operations, performance and
reliability. It also may be geared towards security considerations. As stated, this question
would be best evaluated through pilot plant work and assessment of full scale plants under stress
conditions. This question can be re-worded to ask how robust are treatment facilities in their
ability to respond to sudden increases in source water contaminant concentrations and to
changes in the source water contaminants themselves in the event of an intentional or
unintentional spill/challenge ?
A more logical connection to source water protection would be to characterize variability
(space, time and concentration) of various contaminants across water sources and then using
those levels challenge a pilot plant or document full scale plant performance. No Long-Term
Goal 3 work products are clearly related to this aspect of the question.
(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?
Coordination with security efforts will enhance the resources which can be allocated to
this important issue. The type of contaminant, the extent of the excursion and the frequency of
events all must be identified a priori to the selection of "sensors". The nature of the excursion
(intentional or natural) will also be a determining factor. Once these factors are established, then
warning systems can be logically developed. A key item not identified in the question (or any
work products associated with this Long-Term Goal) is characterization of the appropriate
corrective actions that utility operators could employ once "warned". If the excursion is
"natural" then it would be logical to follow "good operating practices" at the Water Treatment
Plant; if the event is an intentional contamination, then security Standard Operating Procedures
should be employed. These security Standard Operating Procedures are yet rather ill-defined for
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the drinking water industry. The question should be expanded to address corrective actions
utilities might take when they are alerted to contaminant excursions at the source, and to identify
when an excursion is significant enough to require corrective action.
An additional science question that should be added to this section is, what new
developments in the arena of cyber-infrastructure and information technology are appropriate
for incorporation and use in source water protection monitoring programs? Lastly, the subject
of water reuse is not mentioned at all in any of these questions, yet it is a growing practice, and
its potential impact on health is of considerable concern to the public.
Section 3.6 Distribution Systems
(1) What are the public health risks associated with contamination of the distribution
system?
This is the most important question to ask regarding distribution systems. It frames the
entire cost benefit discussion inherent in rule-making. In order to address this extremely
important question we need to improve our understanding of what diseases are related to
distribution systems. The synthesis documents should provide some of this information, but the
timing of their completion does not appear to be well coordinated with other research efforts. It
may be useful to identify coordination with other agencies such as the CDC so that all the work
underway or planned is identified. As reported in the MYP, however, that effort is not sufficient.
(2) How can the structural and operational failure modes that reduce water quality in the
distribution system be characterized?
This question is not worded very clearly. Does "failure mode" refer to infrastructure
failure, or to degradation in distribution system water quality? Further, questions should not be
restricted to failure modes. An additional question would be, what operational practices help
avoid degradation of distribution system water quality?
The work products which focus on the formation and behavior of biofilms and scales, and
the impact of treatment changes on the same appear to be the major work efforts designed to
address the distribution system-water quality issue. Beyond that there is a need to understand the
integrity of our distribution systems, opportunities for backflow and cross connections, the
significance of transient pressure changes and how water ages in a distribution system. The
latter (water age) is addressed in some of the work products, but should be more thoroughly
investigated. Coordinating microbial methods development and ensuring that occurrence data
from distribution systems is collected will also provide valuable information.
(3) What new or improved methods are needed to prevent, detect, locate, repair, and
rehabilitate contaminant intrusion points in water distribution systems?
Enhancement of hydraulic models coupled with water quality layers would be a valuable
tool for locating intrusion points. Improvements in construction and repair guidance and
strengthening backflow prevention and cross connection control programs are also necessary.
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Some work products are designed to address hydraulic modeling but do not appear to be
sufficient to address this significant need.
(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?
First it is necessary to understand the changes in water quality that occur in distribution
systems. Some work is designed to address this portion of the question. In order to control
distribution conditions, the processes in the system which affect water quality need to be
adequately assessed. The work products identified to do this are a good beginning but do not
adequately address the breadth or immediacy of the needs. The word "model" might be added to
Question #4 (i.e. . ..needed to monitor, model, and control...). Perhaps another related question
here deals with a better understanding of the dynamic nature of the distribution system as it
influences spatial and temporal variations in water quality, which directly affects exposure of the
consumers to these contaminants.
CHARGE QUESTION 3
Research outputs (APMs) in the MYP represent new data, tools, technologies, databases, models,
or assessments that are considered necessary for accomplishing a particular goal (APGs).
Outputs listed under an APG are either interim or final products that are typically specific to one
ORD Laboratory or Center. The MYP also identifies several synthesis documents, which
integrate and summarize new research findings on a particular topic.
The MYP does not, by design, provide detailed information on specific research activities and
products represented by Annual Performance Measures. Nevertheless, a general evaluation of
the research program outputs can be based on a review of the Annual Performance Measures
titles and the supplementary information on near-term Annual Performance Measures provided
through linkages to the drinking water research tracking system.
• Do the research products identified in the MYP focus on the highest priority research
for each major topic area?
• Do the sets of Annual Performance Measures (APM) under the Annual Performance
Goals appear both necessary and sufficient for accomplishing the intended goals?
COMMITTEE RESPONSE TO CHARGE QUESTION 3
The research products, also referred to as Annual Performance Measures (APMs), under
each Annual Performance Goal identified in the MYP do focus on high priority research for each
major topic area. The MYP does not, however, include the research required to support the
conduct of a cost benefit analysis which must consider a variety of health benefits, ranging from
lives saved to minor illnesses avoided. Annual Performance Measures should be framed in the
context of the relative risk posed by target drinking water contaminants. This approach would
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probably lead to an emphasis in microbial contaminants and chemical mixtures, and de-emphasis
of individual trihalomethanes (THMs) and haloacetic acids (HAAs). For Distribution Systems,
the opening paragraph in Section 3.6 (page 10) makes no mention of corrosion or formation of
new DBFs (e.g. NDMA) in distribution systems. These items are important and should be
added.
Arsenic Rule:
The Committee considers this to be another area where some research is driven more by
institutional momentum rather than by need to support regulation. The information available to
the Committee indicates that the studies in the Chinese population address high-dose exposure
and actually classifies exposure of 10 ug/L or less as control. Because the low-dose exposure of
interest is put in the control group, it is hard to envision how this study could strengthen the
quantitative dose-response assessment in the low dose range. The Annual Performance Measures
appear to be weighted towards cancer rather than non-cancer effects. There also appears to be a
lack of effort in identifying human subpopulations that may be more sensitive to the non-cancer
effects following exposure to arsenic. The 2000 Arsenic Rule included a discussion of important
non-cancer health effects; however these could not be included in the cost-benefit analysis
because the value of these benefits could not be estimated. This research need is not addressed in
the MYP. If such research is being conducted as part of another MYP, then cross-references
may be appropriate.
Disinfection Byproducts
The research emphasis given to THMs and HAAs should reflect the balance of evidence
of their health effects. This committee has previously expressed the concern that the practice of
using the THMs and HAAs as surrogates for whatever DBF causes cancer may lead to treatment
strategies that increase exposure to the actual carcinogen while decreasing exposure to the
surrogates.
The committee is uncertain as to whether or not there is enough effort on analytical
methods, on occurrence and on methods for estimating formation of other potentially harmful
DBFs. Are the data obtained from the Information Collection Rule sufficient for determining the
nature and magnitude of exposures?
Unregulated Contaminants (CCL)- Chemicals
The list of substances making up CCL2 seems to consist largely of those agents retained
from CCL1. It would be appropriate to revisit previously identified research needs for them, and
verify that the research needs are covered in the 2005 and 2010 Annual Performance Goals; or
that there is scientific justification for not filling them. The four Annual Performance Goals and
their Annual Performance Measures collectively do cover all four categories of the risk
assessment/risk management spectrum3.
Unregulated Contaminants (CCL)- Pathogens
Research projects on pathogens are divided into several categories. Twenty three (23)
projects focus on new methods (including modeling), 18 on survival (mostly surrogates and
3 National Academy Press, (1983). Risk Assessment in the Federal Government: Managing the Process. National
Research Council, Washington DCErrorl Main Document Only.
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models), 17 on control treatment (bank filtration, UV) and 24 on health risks (primarily
epidemiological data). The epidemiological data does not provide new tools; however, there are
some new data (spatially and temporally limited) and new controls (there are a few intervention
type studies). With respect to defining health risks, the broad outcomes are not often assessed
very specifically to dose-response or defining toxic algal outcomes. There are 13 projects
focused on Cryptosporidium, 10 on Cyanobacteria, 15 on other CCL microbes, 6 on biofilms
and approximately 24 on generic topics related to health and new methods. The generic projects
may not provide as much information as needed. In the Source Water section, the combined
sewer overflows (CSO) assessment will be of great interest. It seems there should be more on
"Source Tracking," parasites and other pathogens in sewage discharges besides the Method^br
E.co/70157.
The Annual Performance Measures as described while necessary, have deficiencies in the
development of a clear application for method and technology transfer, and the development of
occurrence data. Research on new innovative monitoring designs and statistical evaluation
appear to be addressed in much of the modeling projects and efforts.
Six-Year Review
Under the Six-Year Review in general, the Annual Performance Measures within the
Annual Performance Goals are necessary and appropriate for accomplishing the intended goals.
The Annual Performance Measures for chromium, arsenic, lead, copper, and antimony are also
very appropriate and will help provide a basic database on the health effects that these
metals/metalloids exert.
Innovative Approaches
Under Innovative Approaches, for Annual Performance Goal 1, all the Annual
Performance Measures appear necessary and appropriate for accomplishing the intended goals.
When completed, Annual Performance Measures should be reevaluated to determine whether
other research will need to be conducted. The use of QSAR models to predict cancer potency for
CCL chemicals is necessary for determining the carcinogenicity of Drinking Water
Contaminants. The development of DNA micro-arrays to detect multiple pathogens in a single
water sample is a novel and potentially very powerful approach to achieve a practical end in the
Drinking Water Program.
Four Annual Performance Measures are identified under Annual Performance Goal 2
which deals with developing new data and tools to determine cost, feasibility, and performance
of technologies to support management decisions. These Annual Performance Measures will
develop cost models for selected separation and disinfection technologies, maintain and update
the treatability data base, evaluate costs and feasibility of small slow sand filtration technology
for indirect drinking water reuse, and evaluate the cost and performance of new filtration and
destruction technologies for indirect drinking water reuse. The Annual Performance Measures
under Annual Performance Goal 2 all appear practical, and are necessary and appropriate for
accomplishing the intended goals.
Under Annual Performance Goal 3, ORD proposes to develop new approaches for
estimating risks and prioritizing contaminants of potential concern for the development of future
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Contaminant Candidate Lists and making other management decisions. There are thirteen
Annual Performance Measures to support this Annual Performance Goal. All of these Annual
Performance Measures are necessary for accomplishing Annual Performance Goal 3. Microbial
dynamic transmission, physiologically-based pharmaco-kinetic (PBPK) modeling, statistical
models to assess cancer risk for children, proteomics approaches to detect drinking water
pathogens, QSAR approaches to extrapolate data for CCL development, microarray approaches,
methods to screen large numbers of contaminants, biomarkers of exposure to CCL chemicals,
computational toxicology approaches, and animal models of human genetic polymorphisms to
assess potential susceptibility to CCL chemicals, are all useful approaches. Many are novel and
should increase the efficiency of accomplishing Annual Performance Goal 3.
The desired research outcomes under Long-Term Goal 2 are intended to address the issue
related to classification of the waterborne contaminants on the CCL. The Annual Performance
Goals and their associated Annual Performance Measures for Innovative Approaches which are
listed under Long-Term Goal 2 are laudable but not complete. A number of the
recommendations presented in the previously cited NRC report are not addressed in the MYP.
The DWC notes that this is an OW activity not captured in the ORE) MYP, and that
modifications to the NRC report recommendations have been made by NDWAC. It seems likely
that ORD will have research activities in support of innovative approaches for classifying
drinking water contaminants. The DWC recommends that these be included in future plans.
All of the Annual Performance Measures are important. A clarification of the priorities
among Annual Performance Measures and an explanation of the ways in which project results
will contribute to refining and directing future research would be helpful. In some cases, only a
little more explanation is needed; however, there are certainly areas that need further attention as
well. The integration of results is addressed to some extent.
CHARGE QUESTION 4
The total budget for the drinking water research program in FY 2003 was approximately $50 M
and 232 full-time equivalent (FTE) personnel. The MYP was developed based on an assumption
of level resources over the period covered by the plan.
Is the relative allocation of resources across the major components of the drinking
water research program appropriate, based on a consideration of scientific and
programmatic needs?
Is the overall resource level generally sufficient to address the most important
research questions and achieve the intended outcomes of the research program?
COMMITTEE RESPONSE TO CHARGE QUESTION 4
Given the materials provided to the DWC, this question was difficult to answer critically.
Overall, the DWC believes that $44.1 million is too little for the entire Drinking Water Program.
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Long-Term Goal 2 has been allocated more than half of the total budget (64%), and the
Innovative Approaches category (i.e., $15.1 million or 34.2% of the total DWMYP budget for
FY 2004, including 23 FTEs) within Long-Term Goal 2 is twice as large as any other category.
In contrast, Long-Term Goal 3, which covers two very broad topics, is due to be addressed a year
earlier and yet comprises only 5.6% of the total budget.
Innovative approaches will be important for answering many of the important scientific
questions posed in the MYP, both from a scientific and practical point of view. Some of the
scientific questions asked and the goals enumerated cannot be accomplished without use of novel
technologies such as micro-arrays and proteomic approaches. These technologies will be
expensive. After the first round of Annual Performance Measures has been accomplished, this
issue should be revisited.
For Distribution Systems, the overall allocation of resources and timing appear to be
insufficient and lag behind the drinking water program timeline. A shift of funds to Distribution
Systems may be needed given the current issues that have arisen (i.e. use of chloramines,
meeting lead and bacterial concentration limits and goals). The needs of the drinking water
program will certainly increase over time and the MYP timelines will need to evolve.
The effort in the Source Water Protection research is less than needed, especially with
regards to drinking water research. Many of the projects connected to Source Water Protection
are identified with other efforts (i.e., other MYP's). If one includes the work in those research
projects which address Source Water Protection needs, then the relative allocation is improved.
Long-Term Goal 3 is further out on the time line and based on the MYP, it would be expected
that more resources and efforts will shift in the future. The paucity of work aimed at the source
water protection goals identified as part of the proposed Long Term 2 Enhanced Surface Water
Treatment Rule (LT2ESWTR) is of some concern.
In conclusion, the drinking water program in general is under-funded. The safety of
drinking water is still a high priority for the public. The Walkerton tragedy is a reminder of what
happens with complacency, inadequate development of rules and inadequate implementation.
A few general observations and some additional specific recommendations are listed below:
• Exploratory and open-ended research has special value to EPA's mission, especially with
respect to new issues and new technologies. The DWC believes that this research has
significance because it provides support for drinking water issues of interest to EPA that
is not always available elsewhere. In addition, this research stimulates activities within
EPA, brings new expertise to EPA and transfers technology through EPA conferences
and workshops.
• EPA is to be complimented for its cooperation in the Global Water Research Coalition
and yet resources could also be better leveraged by strengthening formal research
relationships with other governmental agencies (e.g. NIEHS, NSF, USGS, CDC, NCBI
(bioinformatics), state agencies, etc.)
• In view of the growing research needs to support the CCL, the movement toward
alternative disinfectants, competing drinking water regulations, increasing concern with
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respect to source water protection and distribution systems, and increasing movement
toward water reuse and desalination, the DWC believes that a level budget for drinking
water research will not be adequate to accomplish what must be done to address these
needs.
The DWC would also like to encourage ORD research staff to take some risks and follow
some research which is not clearly regulation-driven. This will help EPA to further improve its
research reputation and make EPA a more attractive home for top quality research professionals.
With the emergence of new challenges and methodologies, the DWC sees the need for program
staff to engage in professional development, as it is difficult for them to stay abreast with their
scientific disciplines. Perhaps having some Annual Performance Goals and associated Annual
Performance Measures within the program offices might be one way this could be approached.
This would require EPA to invest in its human capital, and explicitly recognize it.
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REFERENCES
National Academy Press, (2001) Classifying Drinking Water Contaminants: for regulatory
consideration, National Research Council, Washington, DC
National Academy Press, (1983). Risk Assessment in the Federal Government: Managing the
Process. National Research Council, Washington, DC
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