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DR/FT SABREPORT- BOARD REVIEW DRAFT; DO NOT QUOTE OR CITE. 1/14/2005
United States EPA Science Advisory EPA-SAB-EC-04- XXX
Envtrontnental Board (1400F) November 1004
Protection Agency Washington DC OTVjV.epa.goy/33t)
Review of EPA's Drinking
Water Research Program
Multi-Year Plan 2003
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A REPORT BY THE DRINKING
WATER COMMITTEE OF THE
EPA SCIENCE ADVISORY BOARD
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DRAFT SABREPORT- BOARD REVIEW DRAFT; DO NOT QUOTE OR CITE. 1/14/2005
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON D.C. 20460
OFFICE OF
THE ADMINISTRATOR
EPA SCIENCE ADVISORY BOARD
November 16, 2004
The Honorable Michael Leavitt
Administrator
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Subject: SAB Review of EPA's Drinking Water Research Program Multi-Year 2003
Dear Administrator Leavitt:
The U.S. EPA Science Advisory Board's Drinking Water Committee met on May 24-25,
2004 to review the Agency's draft "Drinking Water Research Program Multi-Year Plan 2003"
(MYP). This multi-year plan presents EPA's Office of Research and Development (ORD)
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 will 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 focus on the highest priority
research for each major topic area and appear both necessary and sufficient for accomplishing
the intended goals.
Exploratory and open-ended research has special value to EPA's mission, especially with
respect to new 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. 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, state agencies, etc.
The SAB wishes to compliment the Agency for its effort in communicating within EPA,
as well as, with organizations outside EPA concerning ORD's research efforts. Perhaps the
SAB's most significant comment is that elements of the Drinking Water research program may
be locked into institutional momentum. In other words, research on some long-standing issues
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DRAFT SAB REPORT- BOARD REVIEW DRAFT; DO NOT QUOTE OR CITE. 1/14/2005
may be continuing with diminishing returns. The DWC recommends that Annual Performance
Measures be framed in the context of epidemiological prioritization of the relative risk posed by
target drinking water contaminants. This approach would probably lead to an emphasis in
microbial contaminants and chemical mixtures, and de-emphasis of Disinfection By-Products
(DBPs), particularly single compound driven research. EPA should lead a healthy debate on
defining the highest priorities for drinking water contaminants.
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
stage, 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 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.
Additionally, 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 is 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. The. SAB
believes that a level budget for drinking water research is not sufficient to support these needs.
Finally, the SAB wishes to strongly encourage ORD to continue to strengthen its multi-
year planning activities. We look forward to working with ORD to improve these efforts in the
future.
Sincerely,
Dr. Granger Morgan, Chair Dr. Rhodes Trussell, Chair
EPA Science Advisory Board Drinking Water Committee
v' EPA Science Advisory Board
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NOTICE
This report has been written as part of the activities of the Science Advisory Board, a public advisory
group 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.
Distribution and Availability: This EPA Science Advisory Board report is provided to the EPA
Administrator, senior Agency management, appropriate program staff, interested members of the
public, and is posted on the SAB website (www.epa.gov/sab). Additional copies and further
information are available from the SAB Staff [US EPA Science Advisory Board (1400A), 1200
Pennsylvania Avenue, NW, Washington, DC 20460-0001; (202) 343-9999)].
IV
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Drinking Water Committee
Drinking Water Research Program Multi-Year Plan Review
CHAIR
Dr. R. Rhodes Trussell, Trussell Technologies, Inc., 939 E Walnut St., Suite 300, Pasadena, CA,
91106-1775
OTHER SAB MEMBERS
'Dr. Mary Davis, Professor, Department of Physiology & Pharmacology, West Virginia University •
Health Sciences Center, P.O. Box 9229, Morgantown, WV, 26506-9223
Dr. Ricardo DeLeon^Microbiology Unit Manager, Water Quality Laboratory, Metropolitan Water
District of Southern California, 700 Moreno Avenue, La Verne, CA, 91750
Dr. Penelope Fenner-Crisp, Executive Director, ILSI Risk Science Institute, International Life
Sciences Institute, One Thomas Circle, N.W., Suite 900, Washington, DC, 20005
Dr. Stanley B. Grant, Professor, Department of Chemical Engineering, School of Engineering,
University of California, Irvine,, Irvine, CA, 92697
Dr. Barbara Harper, Toxicologist, AESE, Inc., 44803 E. Alderbrook Court, West Richland, WA,
99353
Dr. Joseph Landolph, Associate Professor of Molecular Microbiology & Immunology, Pathology,
and Molecular Pharmacology & Toxicology, Cancer Research Laboratory, Keck School of
Medicine, University of Southern California, 1303 North Mission Road, Los Angeles, CA, 90031
Dr. Christine Owen, Water Quality Assurance Officer, Tampa Bay Water, 2535 Landmark Drive
Suite 211, Clearwater, FL, 33761
Dr. Joan B. Rose, Professor, Homer Nowlin Chair in Water Research, Department of Fisheries and
Wildlife, Michigan State University, 13 Natural Resources, E. Lansing, MI, 48824
Dr. Gary Sayler, Distinguished Research Professor, The Center for Environmental Biotechnology,
University of Tennessee, Knoxville, 676 Dabney Hall, KnoxviUe, TN, 37996
Dr. Philip Singer, Professor, Department of Environmental Sciences and Engineering, School of
Public Health, University of North Carolina, CB 7431, Chapel Hill, NC, 27599-7431
Ms. Susan Teefy, Operations Engineer, Water Quality and Treatment Solutions, Inc., 18914 Walnut
Road., Castro Valley, CA, 94546
SCIENCE ADVISORY BOARD STAFF
Dr. Suhair Shallal, Designated Federal Officer, US EPA Science Advisory Board (WOOF), 1200
Pennsylvania Avenue, NW, Washington, DC, 20460, Phone: 202-343-9977, Fax: 233-0643/0645,
(shailal.suhair@epagov ).
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TABLE OF CONTENTS
EXECUTIVE SUMMARY 1
INTRODUCTION 3
GENERAL RESPONSE AND RECOMMENDATIONS 4
SPECIFIC RESPONSES AND RECOMMENDATIONS 4
CHARGE QUESTION 1 4
COMMITTEE RESPONSE TO THE FIRST QUESTION IN
CHARGE QUESTION 1 5
COMMITTEE RESPONSE TO THE SECOND QUESTION IN
CHARGE QUESTION 1 .6
Arsenic Rule. 6
Disinfection By-Products . 7
CCL Pathogens 7
Six Year Review of Regulated Contaminants 7
Source Water Protection and Distribution Systems— 8
CHARGE QUESTION 2 9
COMMITTEE RESPONSE TO CHARGE QUESTION 2 9
General Comments on Charge Question 2 .9
Specific Comments on Charge Question 2 10
CHARGE QUESTION 3 16
COMMITTEE RESPONSE TO CHARGE QUESTION 3. ...16
Arsenic Rule 16
Disinfection Byproducts ................17
Unregulated Contaminants (CCL)-Chemicals ..17
Unregulated Contaminants (CCL)-Pathogens .17
Six-Year Review 17
Innovative Approaches ...18
CHARGE QUESTION 4 19
COMMITTEE RESPONSE TO CHARGE QUESTION 4 19
REFERENCES 21
VI
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EXECUTIVE SUMMARY
On May 24-25, the Science Advisory Board (SAB) Drinking Water Committee (DWC) met to
provide advice on questions relating to 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 to the DWC is 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 best meet EPA's 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 only
captures the activities in ORD, not other research activities in other parts of the Agency (e.g. OW).
While this is reasonable for an ORD research review, it does not provide the reviewer with an
accurate or complete view of the research. The reviewer is, therefore, unable to evaluate if the total
drinking water research program meets the Agency's needs. A more transparent and comprehensive
representation of the research program would provide a significant improvement.
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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.
In general, the science questions identified in the MYP do address the most important research
issues for each of the major research topic areas. However, some of the questions are not clearly
articulated and recommendations for revisions only 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 regards 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 or Annual Performance Measures identified in the MYP focus on the
highest priority research for each major topic area and appear both necessary and sufficient for
accomplishing the intended goals. 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 is significant 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 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.)
Perhaps the DWC's most significant comment is that elements of the Drinking Water research
program may be locked into institutional momentum. In other words, research on long-standing
issues may be continuing with diminishing returns. Annual Performance Measures should be framed
in the context of epidemiological prioritization of the relative risk posed by target drinking water
contaminants. This approach would probably lead to an emphasis on microbial contaminants and
chemical mixtures, and de-emphasis of Disinfection By-Products (DBPs), particularly single
compound driven research.. EPA should lead a healthy debate on defining the highest priorities for
drinking water contaminants.
Finally, the relative allocation of resources across the major components of the drinking water
research program is appropriate based on a consideration of scientific and programmatic needs. The
overall resource level is, however, insufficient to address the most important research questions and
achieve the intended outcomes of the research program. 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.
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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. The MYP describes EPA's
drinking water research activities and plans for 2003 - 2010. Developed by ORD in partnership with
tiie Office of Water (OW), the MYP links research plans that support EPA's annual budget request
with EPA's-strategic plan.. 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 ORD research plans and products within ORD,
with EPA programs, with the Regions and with interested parties outside of EPA.
The MYP presents the overall organization of the drinking water research program 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 represent important milestones along the
path toward attaining those goals.
Key scientific questions are identified for each of the major components of the research
program discussed in the MYP to focus research on the 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 (APGs). 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 is made possible by
providing 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.
The MYP 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. In addition, unexpected changes may occur in available
resources or strategic priorities. For these reasons, the MYP will be updated on a biennial basis to
provide opportunities for making the necessary adjustments to the research program.
The MYP document can be found at the following URL: http://www.epa.gov/osp/myp/dw.pdf
3
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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 key
scientific questions will lead to more effective planning and management of scientific programs, with
goals, timelines and deliverables. Such efforts help ORD staff to focus on the 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 will 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. The DWC
also strongly encourages ORD to continue to strengthen its multi-year planning activities.
The current MYP does not include all the drinking water-related research and data-gathering
activities supported by EPA or its partners. Thus, the DWC can not determine if the program meets
EPA's overall needs. Perhaps the DWC's most significant criticism is that elements of the Drinking
Water research program may be locked into institutional momentum. This comment is explained in
greater detail under Charge Question 2 later in the report.
Specific responses and recommendations for each charge questions are provided below. 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 within each of these
Long-Term Goals represent important milestones along the path toward accomplishment of the Long-
Term Goals.
• 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?
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COMMITTEE RESPONSE TO THE FIRST QUESTION IN CHARGE QUESTION 1
• Does the M YP 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 a significant
improvement.
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 the research activities under OW or those of non-Agency partners such as the
American Water Works Association Research Foundation (AWWARF). All 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.
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 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
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?);
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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 (EIMS) 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
developed with Annual Performance Goals and Annual Performance Measures, which are intended to
measure the outcomes. Data, tools and techniques as well as assessment are the key descriptors in
each of the goals and final management strategies. We noted that, for the arsenic and DBP research,
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
OWs 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 serious 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.
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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:
For microorganisms, 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.
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. 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
contamination events. This should be clearly stated in the MYP. Microbial issues need to be focused
on source water, treatment, and the distribution system. There should be 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 extremely important given the high
number of outbreaks that occur in small communities. The question is: can disease outbreaks like '
that in Walkerton, Ontario in 2002 be prevented?
1 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.
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.
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. An approach to verify the
performance of watershed protection best management practices (BMPs), and treatment and
protection of distribution systems is also needed.
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.
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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
progressional 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. 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.
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.
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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
locked into institutional momentum. In other words, ongoing research on long-term issues 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 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 refer to those
found in the MYP on pgs. 7-10).
2 Classifying Drinking Water Contaminants (NAS, 2001)
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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) Haw 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 3.2M/DBPRules-Waterborne Pathogens:
(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 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? 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 of disinfection from complying with
the Stage 1 and 2 Disinfection By-Products (DBP) rules? The question mat should be asked is: Has
implementation of Stage 1 and 2 DBP 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 reframed. 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 DBP rules on pathogen inactivation.
U
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(3) Haw 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 system 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,
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 3.2M/DBP Rules—Disinfection Byproducts:
(I) 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).
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
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Primary Drinking Water Regulation (NPDWR) reviews may identify heretofore unrecognized data
requirements and issues. Therefore, a matrix of NPDWRs, 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
(I) 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 (source, treatment or distribution
system)?
• What new methods can be used to address potential for exposure (occurrence, survival and
transport)?
• How to fill gaps in treatment (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:
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• 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?
• 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 WTP; if the event is an intentional contamination, then
security SOP's should be employed. These security SOP's are yet rather ill-defined for 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.
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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 impact on health is of
considerable concern to the public.
Section 3.6 Distribution Systems
(I) 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. 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?
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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 mat 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 should be possible 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 decision logic and theory research needed to
determine the cost-benefit analysis of non-cancer endpoints. Annual Performance Measures should be
framed in the context of epidemiological prioritization of the relative risk posed by target drinking
water contaminants. This approach would 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 DBPs (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-
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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 costs of these could not
be estimated. This research need is not addressed in the MYP.
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 ICR 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 spectrum.
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 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 Method 0157.
The Annual Performance Measures as described are necessary. The only deficiency may be
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 both necessary and sufficient 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.
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Innovative Approaches
Under Innovative Approaches, for Annual Performance Goal 1, all the Annual Performance
Measures appear necessary and sufficient 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 sufficient 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 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 waterbome 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 ORD 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. In some cases, a little more
explanation is needed. However, there are certainly areas that need further attention as well. 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. The
integration of results is addressed to some extent.
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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. i
• 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.
Based on the information provided in the MYP, it is very difficult to judge whether the allocation of
resources is appropriate to meet the objectives of the program. Long-Term Goal 2 has been allocated
more than half of the total budget (64%), and the Innovative Approaches catagory (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. 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. Scientifically
credible data is essential.
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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 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
NAS (2001) Classifying Drinking Water Contaminants: for regulatory consideration, NRC,
Washington, D.C.
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