A Federal Advisory Committee for the U.S. Environmental Protection Agency’s Office of Research and Development 

REVIEW OF THE OFFICE OF

RESEARCH AND DEVELOPMENT’S 

DRINKING WATER RESEARCH PROGRAM 

AT THE 

U.S. ENVIRONMENTAL PROTECTION AGENCY

Final Report 

BOSC SUBCOMMITTEE ON 

DRINKING WATER RESEARCH

Gary S. Sayler (Chair) – University of Tennessee, Knoxville 

James H. Johnson, Jr. (Vice-Chair) – Howard University 

Chi-Hsin Selene Chou – Agency for Toxic Substances and Disease Registry 

James Raymer – RTI International 

David L. Sedlak – University of California, Berkeley 

Mary H. Ward – National Cancer Institute NIH/DHHS (Consultant) 

October 27, 2005 
This report was written by the Drinking Water Research Subcommittee of the Board of 

Scientific Counselors, a public advisory committee chartered under the Federal 

Advisory Committee Act (FACA) that provides external advice, information, and 

recommendations to the Office of Research and Development (ORD). This report has 

not been reviewed for approval by EPA, and therefore, the report’s contents and 

recommendations do not necessarily represent the views and policies of the EPA, or 

other agencies of the federal government. Further, the content of this report does not 

represent information approved or disseminated by EPA, and, consequently, it is not 

subject to EPA’s Data Quality Guidelines. Mention of trade names or commercial

products does not constitute a recommendation for use. Reports of the Board of 

Scientific Counselors are posted on the Internet at http://www.epa.gov/osp/bosc. 
TABLE OF CONTENTS

I. SUMMARY ...............................................................................................................................1

I.1 Introduction .................................................................................................................1

I.2 Review of Objectives and Charge.................................................................................1

I.3 Findings.......................................................................................................................2

I.4 Conclusions and Recommendations .............................................................................4

II. REVIEW OF THE DRINKING WATER RESEARCH PROGRAM.................................................6

II.1 Introduction................................................................................................................6

II.2 Objectives ..................................................................................................................7

II.3 Long Term Goal 1: Regulated Contaminants..............................................................7

II.3.1 Introduction .....................................................................................................8

II.3.2 Surface/Ground Water Rules and Distribution Systems ....................................8

II.3.3 Arsenic ..........................................................................................................11

II.3.4 Disinfection Byproducts (DBPs) ....................................................................12

II.4 Long Term Goal 2: Unregulated Contaminants ........................................................13

II.4.1 Introduction ...................................................................................................13

II.4.2 Contaminant Candidate List ...........................................................................14

II.4.3 Source Water Protection.................................................................................18

III. QUALITY ...........................................................................................................................20

IV. SCIENTIFIC LEADERSHIP ...................................................................................................22

V. COMMUNICATION AND COORDINATION .............................................................................24

VI. APPENDIX A: DRAFT CHARGE QUESTIONS FOR ORD’S DRINKING WATER 

RESEARCH PROGRAM REVIEW .........................................................................................26

VII. APPENDIX B: DRINKING WATER SUBCOMMITTEE MEMBER BIOGRAPHIES...................28

VIII. APPENDIX C: LIST OF ACRONYMS .................................................................................31
BOSC Drinking Water Research Program Review Final Report 

I. SUMMARY

I.1 Introduction 

The U.S. Environmental Protection Agency (EPA) Office of Research and Development (ORD) 

is responsible for the conduct of research to strengthen the Agency’s science base and to provide 

critical data, information, and tools to EPA’s program and regional offices to support the 

development and implementation of environmental policies, regulations and practices. The 

principal statutory authority driving ORD’s Drinking Water (DW) research is the Safe Drinking 

Water Act (SDWA) of 1974, as amended in 1986 and 1996, with a requirement for regulations to 

be based on sound and objective science. 

ORD conducts both problem-driven and core research in drinking water, largely in support of the 

needs of the Office of Water (OW) as its principal DW client. In June 2005, ORD sought an 

independent Board of Scientific Counselors (BOSC) expert review of its Drinking Water 

Research Program (DWRP). This is, in part, driven by the need to prepare for performance and 

accountability reports to Congress under the Government Performance and Results Act (GPRA) 

of 1993. 

The DW research program contributes mainly to EPA’s Strategic Goal 2 for Clean and Safe 

Drinking Water, as described by the Agency’s 2003-2008 Strategic Plan. The DWRP mirrors 

the Agency’s 2003 Draft Multi-Year Plan (MYP) for Drinking Water Research focusing on two 

modified Long Term Goals (LTGs). These LTGs are prescribed by the SDWA. LTG 1 is 

inclusive of the regulated contaminants, the 6-year review cycle for contaminants, and water 

distribution systems. LTG 2 focuses on unregulated contaminants and the Candidate 

Contaminants List (CCL) process and is inclusive of source water protection. 

After consultation with the Agency, the BOSC established the BOSC Drinking Water Research 

Subcommittee to review and evaluate the ORD DWRP. The Subcommittee members 

communicated through an administrative conference call followed by two formal conference 

calls that were open to the public. The Subcommittee met with ORD staff, the Acting National 

Program Director (NPD) for DW, individual researchers, Science To Achieve Results (STAR) 

grantees, program clients and stakeholders, and the public on June 21-23, 2005, in Cincinnati, 

Ohio, to conduct the review and draft a review report for BOSC Executive Committee approval. 

I.2 Review of Objectives and Charge 

The specific objective of this BOSC review was to evaluate the relevance, quality, performance, 

and scientific leadership of ORD’s DWRP. This review was anticipated to assist ORD in 

program enhancement, comparative analysis with other similar programs, intermediate mid-term

investment decisions, GPRA reporting, and response to the Program Assessment Rating Tool 

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(PART) process. The Subcommittee was asked to respond to six multi-component charge 

questions. These charge questions are summarized below and are provided in entirety in VI. 

Appendix A (see page 23). 

1. Program Relevance. Is the DWRP focusing on EPA’s strategic goals, and are potential 

public benefits clearly evident?

2. Program Design. Is the program design logical, with goals and priorities clearly identified 

and with the MYP describing an appropriate flow of work?

3. Progress on Key Scientific Questions and Client Needs. Has progress been made toward 

the LTGs while addressing key science questions in a rational and clearly articulated 

manner? Has the research met the clients’ needs in a timely fashion with outcomes 

identifiable in environmental decisions, regulations, and technical assistance? 

4. Scientific Quality. What is the scientific quality of the research product, and is it ensured 

through competitive merit-based funding? How is quality maintained, and how are funds 

allocated for non-competitively awarded projects?

5. Scientific Leadership. Have the program and/or individual ORD researchers demonstrated 

or played a leadership role in drinking water research, problem-solving, or advancing the 

frontier of science? 

6. Coordination and Communication. Does the program effectively engage scientists and 

managers from both ORD and DW in planning and identifying key gaps? Is the process open 

to all stakeholders and the science community? How effective is interagency interaction in 

advancing EPA’s research agenda, and are there effective mechanisms for research 

communication?

Through the course of this review, the Subcommittee was focused keenly on the issues of 

research “outcomes,” that being the use, impact, or application of the research at a higher level 

than preparation of a report or publication of a scientific article. To assess the translation of 

outputs into outcomes, the Subcommittee conducted its review with careful consideration of 

communication within and among agencies, stakeholders, and the public and how this was used 

to ensure that the ORD DWRP contributed to EPA’s long-term goals. 

I.3 Findings 

The BOSC Subcommittee finds that the DWRP is relevant and critically important to EPA’s 

mission in protecting human health and the environment. The program is focused on high 

quality research of national importance in support of OW, and in particular EPA’s Strategic Goal 

2 for Clean and Safe Water. 

Research projects within the DWRP are timely and consistent with the MYP for Drinking Water 

Research. In particular, research progress for regulated contaminants (LTG 1) has been 

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BOSC Drinking Water Research Program Review Final Report 

excellent. There also has been good progress on the CCL (LTG 2). Innovative research and 

methods development, a second component of LTG 2, has allowed ORD to stay involved in 

rapidly evolving areas, such as genomics and proteomics, bioinformatics, computational science, 

and toxicology, as they relate to DW problems and research needs. The STAR grants program

continues to play an important role in bringing in new and needed expertise and vigor to enhance 

the overall performance of the DWRP. 

Scientific leadership by ORD staff members has been significant in the past; but, both reduced 

funding and data and information mandates imposed by the SDWA threaten ORD’s broader 

leadership role. Research funding, which has decreased in recent years after accounting for 

inflation, is not keeping pace with the challenges associated with protecting public health. The 

diminished resources are likely to limit ORD’s ability to maintain broad scientific leadership in 

the DW field without extensive partnering and leveraging with other agencies and 

nongovernment organizations (NGOs). Individually, some ORD researchers will continue to 

provide strong scientific leadership, but ORD’s leadership may only be sustainable in certain 

pockets if this issue is not addressed soon. 

It is clear that research outputs from the DWRP are leading to important outcomes with respect 

to OW and other clients, including the states, and stakeholders such as the drinking water 

utilities. It often is difficult, however, to quantify specific outcomes within the current structure 

of ORD. There appears to be a need to enhance the accounting metrics, visibility, and 

communication of the DWRP outputs contributing to these outcomes. 

A major departure from the draft MYP for Drinking Water Research has been the consolidation 

of three LTGs into two. LTG 3 in the MYP, which comprised both distribution systems and 

source water protection research, now is nested within LTG 1 (distribution systems) and LTG 2 

(source water protection) in the DWRP. Ultimately, these are both important topics from the 

near- and long-term perspectives of safe drinking water including the homeland security 

perspective. The BOSC Subcommittee was asked to comment on this change of collapsing three 

LTGs into two and whether, within these two goals, sufficient attention was being directed at the 

research priorities of former LTG 3. 

 

High quality research is being conducted in the areas of source water protection and distribution 

systems. Based on reviews of research posters and discussions with researchers, it appears that 

STAR grant recipients are being relied upon for more fundamental work and research that fills 

critical information gaps in a particular project area, while internal ORD work represents 

application of results from other researchers. There is evidence of good collaboration between 

ORD and other agencies and private firms to address homeland security issues of source water 

monitoring and early warning systems. This collaboration is being promoted through ORD’s 

National Homeland Security Research Center and the Testing and Evaluation Facility in 

Cincinnati, Ohio. 

The exact rationale for collapsing three LTGs into two remains somewhat elusive. While the 

placement of the former LTG 3 efforts into LTGs 1 and 2 makes some rational sense (regulated 

versus unregulated contaminants); the fit is not perfect, and it is worrisome to the Subcommittee 

that the two topical areas of research (source water protection and distribution systems) 

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ultimately may be underrepresented in the DWRP research portfolio. It is recognized that 

relatively limited resources are being applied to these areas and, consequently, reorganization of 

the LTGs may not have resulted in a significant decline in the priority of these research topics. 

I.4 Conclusions and Recommendations 

1. The decision to consolidate three LTGs into two is not well justified. Although it may lead 

to a streamlined research plan, it also may result in an unintended de-emphasis of source 

water protection and distribution systems research. Given budget constraints this may be 

unavoidable, but it is likely that these research areas will continue to grow in importance, 

partly as a result of homeland security issues and the further recognition of the impact of 

source water on drinking water quality. 

The ORD/DWRP should continue to evaluate the question of whether the two LTGs can 

accommodate the source water protection and distribution systems research needs 

adequately. 

2. The SDWA and rules drive the MYP for Drinking Water Research; this in turn, guides 

research efforts and investment in the DWRP, which further constrains the scope of research 

and limits the magnitude of “anticipatory” research the program can support. 

ORD should evaluate strategies that could be implemented to encourage more cutting edge 

research to identify and circumscribe issues, problems, and solutions that impact safe 

drinking water. One such strategy could be to invest greater resources in the STAR Program

for an enlarged anticipatory research effort. 

3. EPA’s role as a science leader is multifaceted and is perceived differently by differing 

constituents both within and outside the Agency. In a pure research context, however, 

ORD’s historical leadership role in drinking water research is eroding. While it is expected 

that islands of science and scientific leadership will be maintained, resource availability and 

federal regulatory mandates will define those areas where ORD will have recognizable 

international leadership. 

ORD is strongly encouraged to develop a “Science Leadership” mission statement and to 

identify those areas it believes it is capable of establishing or sustaining international 

leadership over the long term. This will be challenging, given the dynamics of such issues as 

homeland security or global change as they are superimposed on more conventional topics 

and mandates in drinking water research. Without such a vision, however, ORD runs the risk 

of becoming too applications-oriented and implementations-oriented in its DWRP, with little 

direction for individuals to strive for scientific leadership. 

 

4. ORD’s DWRP has had significant outputs that have been translated by its clients into 

outcomes, largely in support of its principal client, OW, but also in support of states and 

industry. Unless the client is active in attributing ORD’s research contributions to outcomes, 

these contributions are difficult to identify and quantify. 

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ORD needs to be proactive in developing metrics to document and support its assertion that 

translation of its research outputs is making significant contributions with respect to 

downstream outcomes as part of the overall logic model. If “outcomes” are indeed an 

important GPRA and PART process metric, then a focused effort is needed to make the 

process of outputs-to-outcomes transparent. 

5. The CCL process is challenging, given the potential for large numbers of contaminants. 

Additional resources ultimately will be needed by ORD to respond adequately to this 

mandate. 

ORD is strongly encouraged to aggressively pursue partnering with other agencies and NGOs 

to ensure that the CCL needs are addressed adequately. 

6. The STAR Program remains critical to EPA’s overall research strategy and capabilities. The 

program lends diversity and vigor to ORD’s research mission. 

To anticipate new problems in drinking water contamination, treatment, distribution, and 

source water protection, the Agency should consider STAR solicitations that are somewhat 

more open ended. In particular, research contributing to the CCL process could benefit from

greater levels of anticipatory/exploratory research. 

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BOSC Drinking Water Research Program Review Final Report 

II. REVIEW OF THE DRINKING WATER RESEARCH PROGRAM

II.1 Introduction 

A BOSC Subcommittee was established to respond to ORD’s request for an independent review 

of the DWRP. This Subcommittee was comprised of Dr. Gary Sayler (Chair), University of 

Tennessee; Dr. James H. Johnson, Jr. (Vice Chair), Howard University; Dr. David Sedlak, 

University of California, Berkeley; Dr. Chi-Hsin Selene Chou, Agency for Toxic Substances and 

Disease Registry (ATSDR); Dr. James Raymer, Research Triangle Institute; and Dr. Mary Ward, 

National Cancer Institute. Dr. Ward’s official capacity was as a consultant to the Subcommittee. 

The Subcommittee was provided with extensive Agency and program documentation and 

background information that included the EPA Strategic Plan (2003-2008) Goal 2; the 2003 

Draft MYP for Drinking Water Research; ORD’s organizational structure, facilities, and prioritysetting strategy; the program logic model and LTGs; and a compilation of references and sources 

useful to responding to specific charge questions. Two pubic teleconferences were held with the 

Subcommittee and ORD administrators and managers to review the documentation and receive 

briefings on the DWRP structure and goals and the PART process. The Subcommittee also was 

able to request and receive supplemental information, such as the Science Advisory Board (SAB) 

Drinking Water Committee 2004 Review Report of the DW MYP. All of this information was 

provided to the Subcommittee prior to the formal onsite review, which was held in Cincinnati, 

Ohio, on June 21-23, 2005. 

The onsite review was a public process, consisting of overview and explanatory presentations 

from the Acting Deputy Assistant Administrator for Science, ORD; various Acting Directors 

from the research laboratories and centers, as well as the Acting NPD, ORD Drinking Water 

Research. The Subcommittee was able to question the presenters fully, and several requests for 

further documentation and clarification were made through the Subcommittee Chair and the 

Designated Federal Officer (DFO) for the Subcommittee. ORD administrators were responsive 

to these requests. 

A significant effort was devoted to the Subcommittee’s review of poster presentations by ORD 

researchers, collaborators, and STAR grantees. The poster presentations were organized around 

LTGs 1 and 2 of the DWRP. There was excellent turnout and ample opportunity for 

Subcommittee discussion of the research goals, outputs, and potential outcomes with ORD 

researchers and poster presenters. Agency program offices as well as state and research partners, 

such as the American Water Works Association Research Foundation (AwwaRF), provided their 

perspectives on the relevance of the DWRP. There also was an opportunity for public comment, 

and, at the conclusion of the meeting, the Subcommittee provided an out-briefing of the general 

findings and impressions gathered during the course of the reviews. 

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During the review, the Subcommittee requested specific documents to clarify the following 

questions: 

1. How do ORD laboratories prioritize and implement their intramural DW research programs? 

2. Following peer review, how are meritorious proposals selected for award, given that 

available funding can only support a very limited number of awards?

3. To what extent does the National Program Director (NPD) have budgetary authority for DW

resource allocation across the ORD program?

4. What is the review and evaluation process to ensure quality science for contractors and 

cooperative agreements? 

The information provided to the Subcommittee and the onsite responses to the first three of these 

questions were adequate to assist the Subcommittee’s review of these issues. An oral response 

was provided for the fourth question, but was left somewhat ambiguous in terms of a concise 

ORD response. 

II.2 Objectives 

The objective of the Subcommittee review of the ORD DWRP was to evaluate of the relevance, 

quality, performance, and scientific leadership of the program. Specific charge questions 

focusing on these issues and to be addressed by the review are listed in VI. Appendix A; 

however, each of these charge questions will be reiterated for LTG 1 and LTG 2 research results 

and outcomes independently. 

The PART review is used by the Office of Management and Budget (OMB) to evaluate program

effectiveness in areas of Purpose/Design, Strategic Planning, Program Management, and 

Program Results. The BOSC Subcommittee review is an external evaluation that contributes to 

the Strategic Planning and Results evaluation section of PART. Results are linked to Annual and 

Long-Term Performance Goals with an emphasis on “outcomes.” Results represent 50 percent 

of the PART score, and the Strategic Planning and Results combined account for 60 percent of 

the score. 

Quality, relevance, and performance are key research and development PART issues used to 

guide OMB/Office of Science and Technology Policy Investment Criteria. Thus, a primary 

output of this BOSC review is not only to assist the Agency in evaluating the DWRP science, but 

also to provide the mandated external independent evaluation for the PART process. 

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II.3 Long Term Goal 1: Regulated Contaminants 

ORD’s stated, outcome-oriented, LTG 1 is “Office of Water and other key clients use ORD’s 

new scientific data and leading-edge approaches in the Agency’s Six-Year Review

decisions.”

II.3.1 Introduction

LTG 1 encompasses research related to future changes in regulations pertaining to drinking 

water contaminants that already are regulated under the SDWA and related regulations. In 

particular, research is being conducted on arsenic, disinfection byproducts (DBPs), and priority 

contaminants undergoing 6-year reviews, such as lead and copper. LTG 1 also includes research 

on drinking water distribution systems, which originally was included under LTG 3. 

The research program has been designed to address the largest uncertainties associated with 

future regulatory decisions. The research provides critical data needed to assess the occurrence 

of contaminants in drinking water, their human health effects, and the efficacy of treatment 

technologies. ORD has a long history of research on these topics and, as a result, there is 

considerable expertise in the various laboratories. The research program timing and focus is 

closely connected to regulatory mandates. ORD staff members have established collaborations 

with federal researchers outside of EPA (e.g., Centers for Disease Control and Prevention 

[CDC]) and with academics through cooperative agreements. These collaborations have 

expanded the expertise of the Agency into new areas. 

II.3.2 Surface/Ground Water Rules and Distribution Systems

Program Relevance 

Surface/Ground Water Rules

Subsequent to an outbreak in Milwaukee, Wisconsin, affecting 400,000 people in 1993, 

considerable attention was focused on the risks posed by Cryptosporidium in surface waters. 

The greatest challenges associated with the development of regulations to protect public water 

supplies from Cryptosporidium were related to the absence of good monitoring techniques, data 

on the infectivity of different strains of the organism, and its fate in different types of treatment 

systems. Much of ORD’s research in support of surface and ground water rules was related to 

addressing these critical issues. 

In addition to Cryptosporidium in surface waters, several other pathogens posed challenges to 

public water supplies. ORD has supported research on other pathogens in ground water and 

drinking water distribution systems by developing improved methods for microbial risk 

assessment and epidemiological studies targeted at determining the frequency and causes of 

outbreaks. 

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BOSC Drinking Water Research Program Review Final Report 

Distribution Systems 

The 6-year review requires an evaluation of regulated contaminants of concern. In particular, 

research has focused on lead and copper. In most cases, lead and copper are derived from the 

water distribution system or plumbing within homes. ORD research is addressing the effect of 

residual disinfectants (e.g., chloramines) on the leaching of lead, copper, and arsenic in 

distribution systems important to safe water. This research is particularly relevant because aging 

infrastructures are more susceptible to leaching of metals. Furthermore, changes in treatment 

processes may mobilize contaminants from within the distribution system. Recent work has 

begun to investigate the release of organotin compounds from polyvinyl chloride (PVC) pipes in 

home plumbing. ORD also conducts research on biofilms in distribution systems because the 

biofilms can contribute to corrosion and can serve as reservoirs for pathogens. These issues will 

become more important as the infrastructure continues to age and as pathogens from the CCL 

become more of a concern in drinking water. Finally, distribution systems are critical to 

homeland security, and ORD’s research on distribution systems has important implications for 

researchers focused on terrorist threats to water distribution systems. 

Program Design

Surface/Ground Water Rules 

Research being conducted on pathogens in support of surface and ground water rules closely 

follows the schedule described in the MYP. The research on Cryptosporidium follows a logical 

progression from detection to infectivity and then to treatment. The research on 

Cryptosporidium inactivation and removal in drinking water treatment processes was not a major 

focus of the MYP. It is a meritorious topic, however, and fits into the overall research

objectives. This research demonstrates that ORD is able to support relevant projects that are not 

articulated fully in the MYP. The Subcommittee believes that the MYP should guide ORD’s 

research program, but the program should retain the flexibility to include different projects as 

opportunities arise or as new research becomes available. 

Distribution Systems 

ORD has developed expertise in the area of corrosion and biofilms. The corrosion research is 

linked to lead, copper, DBPs, and arsenic, while the biofilm research is linked mainly to 

pathogens. The Subcommittee believes that there may be advantages associated with better 

integration of research that is more inclusive of all elements of the distribution system (e.g., 

evaluating how biofilms affect corrosion or how corrosion products affect pathogen populations 

in biofilms). 

The Subcommittee is uncertain of the merits associated with placing distribution systems 

research in LTG 1, an area that ORD has projected to become less important over time. Issues 

related to the management of distribution systems are likely to become more important in the 

near future and may merit more resources. For example, the American Society of Civil 

Engineers (ASCE) has projected that more than $11 billion per year will be needed to maintain 

and rehabilitate aging water distribution systems. It may be possible to extend the lifetime of

aging distribution systems through different management approaches. Research is needed to 

determine the costs and public health implications associated with different options for 

maintaining distribution systems. Grouping distribution systems research with LTG 1 may prove 

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to be counterproductive, especially if it means that research in this area will continue to be 

subject to the current inadequate level of funding. The Subcommittee suggests that ORD 

consider restoring LTG 3 from the MYP and allocating additional resources to distribution 

systems and watershed protection commensurate with the needs in these two critical areas. 

Current research on distribution systems is timed to coincide with 6-year reviews of lead and 

copper rules. Although it is important to coordinate research with rulemaking, the Subcommittee 

also sees merit in research that is not directly tied to the 6-year review. For example, ORD 

research has demonstrated that changing residual disinfectants from free chlorine to chloramines 

may have played a role in recent increases in lead in the water distribution system of 

Washington, DC. It may be appropriate to conduct research after new regulations are 

implemented to assess the impacts of changes in treatment methods on water quality. 

Some of the current research on distribution systems relies upon dedicated facilities or long-term

contracts to conduct field work through contractors. For example, the contract for the Testing 

and Evaluation Facility in Cincinnati, Ohio, has been used to conduct research on chlorine and 

DBPs in distribution systems. Research also is being conducted at a dedicated pipe loop facility. 

The pipe loop research has considerable overlap with research conducted at a similar facility in 

Montana (run by one of the investigators associated with ORD’s facility), and the contributions 

of the EPA facility are incremental at best. Furthermore, biofilm research at actual field sites, 

where pipes have been aged in the presence of biofilms, may have more merit than the controlled 

conditions of a pipe loop. This type of research (i.e., long-term commitments for fixed facilities) 

provides ORD with little benefit compared to the amount of resources allocated. Given the 

limited funding available to ORD’s DWRP, a reallocation of resources to areas with a higher 

return might be appropriate. 

Progress

Surface/Ground Water Rules 

The research program for Cryptosporidium has made significant progress in addressing the water 

quality challenges posed by the presence of the pathogen in water supplies. In particular, the 

research on Cryptosporidium infectivity and removal has provided information that is useful in 

the protection of public health and the design of treatment systems. The new analytical methods 

developed for Cryptosporidium measurement will be crucial to the implementation of the 

Information Collection Rule and will provide numerous future benefits. 

Distribution Systems

The research focused on the fate of metals in distribution systems has been a highlight of ORD’s 

mandate to minimize human exposure to toxic metals. The theoretical studies on the chemistry 

of metals in distribution systems have provided a new understanding that will be useful in 

managing distribution systems. The research in this area also has shown tangible outcomes, such 

as the contribution of ORD’s research team to identifying the causes of elevated lead 

concentrations in Washington, DC’s, water supply. 

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Strengths

The Cryptosporidium research has been highly responsive to the Agency’s objective of ensuring 

safe drinking water. ORD has played a leading role in a comprehensive research program that 

integrates expertise from the National Exposure Research Laboratory (NERL), the National Risk 

Management Research Laboratory (NRMRL), and the STAR Program managed by the National 

Center for Environmental Research (NCER). The progress in this area is particularly noteworthy 

in light of the interdisciplinary nature of the problem. 

In the distribution system area, ORD has made good progress in developing a better 

understanding of corrosion and its role in the release of contaminants. 

Opportunities

Surface/Ground Water Rule 

ORD and the scientific community have identified a need to conduct comprehensive 

epidemiological studies to understand the sources of disease outbreaks and the efficacy of 

different actions that can be taken to prevent outbreaks. The funding levels for ORD projects 

typically are too small and the timeframes too short to complete these studies. ORD may need to 

increase STAR grant funding and the grant performance period and/or partner more effectively 

with other federal agencies or stakeholders to make progress in the area of epidemiology. 

Distribution Systems 

Research on distribution systems has not received the same attention as some of the other areas. 

The issues pertaining to distribution systems need to be better integrated (e.g., chemical and 

biological processes should be considered together). Furthermore, ORD should not restrict 

research on distribution systems to contaminants listed under LTG 1. The distribution system is 

relevant to many of the issues addressed in LTG 2. 

A separate but important issue related to LTG 1 is the question of whether too much focus on 

regulatory determinations can be a handicap. There are real issues related to the Agency’s goal 

of safe drinking water that are not addressed effectively by LTG 1 and LTG 2. For example, 

how are ORD staff members anticipating new problems outside of CCL issues? Where does 

water reuse fit into the research program? Anticipatory research may fit well with the STAR 

Program rather than with proscriptive Requests for Proposals (RFPs). 

II.3.3 Arsenic

Relevance 

Arsenic is an element that is widely distributed in the earth’s crust, and is a natural contaminant 

of water. Humans may be exposed to arsenic in air and from food and water. Arsenic is toxic 

and carcinogenic in humans. Information from recent studies has raised concerns about adverse 

human health effects from chronic exposures. EPA set a new maximum contaminant level 

(MCL) for arsenic of 10 ppb in 2001. The Arsenic Rule is subject to reviews in 6-year cycles. 

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The ORD DWRP for arsenic directly supports the Agency’s strategic goals for Clean and Safe 

Water to protect the public health by ensuring the safety of the nation’s public water supply. The 

research on health effects would strengthen the quantitative assessment of relationships between 

low dose (in the 10 ppb range) exposures and health effects. The research on treatment 

technology provides technical assistance that helps small systems and other stakeholders develop 

cost-effective strategies for implementing the new drinking water rule for arsenic. 

Program Design 

The ORD arsenic research program addresses the scientific questions pertaining to the

implementation of the new rule and supports the 6-year reviews of the rule with a focus on 

research to improve the arsenic risk assessment. 

Progress 

Excellent progress has been made in characterizing arsenic exposures, biomarker development, 

and health effects evaluation in studies in human populations and in laboratory studies of 

toxicity, metabolism, mode of action, and pharmacokinetic modeling to support the new rule. 

Much progress also has been made in conducting full-scale treatment technology/engineering 

demonstrations at 40 sites nationwide, developing guidance documents, and establishing 

outreach programs in support of timely implementation of the new rule. 

Strengths 

The research scientists are well qualified with proper expertise capable of conducting cuttingedge research and applying best available technology. The program includes human studies in 

the United States and in other countries. The program develops sensitive human biomarkers and 

addresses health effects from arsenic exposure in sensitive subpopulations. 

Opportunities 

 

The potential and possible need exist to develop a strategy to manage arsenic in residual wastes 

from treatment on a long-term basis. The magnitude of the problem scope has not been 

delineated fully. Technically, it may represent a significant issue, and there is a mandate to 

manage arsenic in residual wastes. 

II.3.4 Disinfection Byproducts (DBPs) 

Program Relevance 

The DBP rule is designed to provide public health protection against waterborne pathogens while 

minimizing the risks posed by exposure to DBPs. ORD has a long history of conducting 

research on DBP exposure, health effects, and treatment. More recently, the research has 

focused on the remaining critical issues, including reproductive effects of specific DBPs and 

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DBP mixtures, health risk from exposure to byproducts generated from alternative disinfectants, 

and source waters of different quality. 

Program Design 

The research focuses on characterizing health effects of high priority byproducts and DBP 

mixtures and evaluating risk from alternative disinfectants (other than chlorine alone) and 

varying raw water quality in support of the implementation of the rule and to improve the science 

base for future reviews as required by the SDWA. 

Progress 

Excellent progress has been made in: (1) evaluating DBP reproductive/developmental effects, 

(2) developing methods for integrating multi-route exposures and dose-response data to evaluate 

exposure to complex mixtures of drinking water contaminants, (3) developing methods to 

monitor formation and occurrence of DBPs from source water of different quality, 

(4) developing methods to screen and detect DBPs produced from alternate disinfectants, and 

(5) awareness of unintended DBP perturbations from processes tailored to minimize a particular 

class of DBPs. When disinfection processes are changed to minimize one class (e.g., avoiding 

chlorination to minimize trihalomethanes [THMs]) other classes become more significant (e.g., 

brominated compounds as a result of ozone/chloramines). The new compounds could have toxic 

effects that need to be investigated.

Research results from ORD ultimately supported a regulatory outcome for a decrease in the total 

THM standard stage 1 DBP rule from 100 ppb to 80 ppb. ORD research data on the nonlinear 

cancer risk assessment of chloroform was used as basis for support changing the chloroform

MCL goal (MCLG) from 0 ppb to 70 ppb in the proposed stage 2 DBP rule. ORD data on 

chronic effects of bromate were critical to the EPA non-cancer and cancer risk assessments 

presented in the EPA Integrated Risk Information System (IRIS) database.

 

Strengths 

The DWRP is highly responsive to DBP issues. ORD is recognized internationally as a leader in 

DBP research. The DWRP draws expertise from broad areas of discipline inside ORD and has 

achieved successful team efforts as demonstrated by the four laboratory studies of DBP mixtures 

arising from chlorination. The research program also leverages and expands resources and 

expertise through productive collaboration with other agencies and organizations, such as the 

National Toxicology Program, the CDC, and the Department of Homeland Security. 

Opportunities 

Opportunities exist to develop research to fill data gaps in potential health risks and treatment 

technology of newly identified DBPs in drinking water treated with chlorination, such as 

haloacetonitriles, in addition to dibromoacetonitrile. 

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II.4 Long Term Goal 2: Unregulated Contaminants 

ORD’s stated, outcome-oriented LTG 2 is “Office of Water and other key clients use ORD’s 

relevant, timely, and leading-edge data, tools, and technologies in decisions leading to a 

scientifically sound Contaminant Candidate List process.” 

II.4.1 Introduction

LTG 2 encompasses issues related to unregulated contaminants and is focused on the CCL and 

source water protection. Source water protection research formerly was included under LTG 3 

in the MYP. Research on exposure and potential health effects of CCL chemicals and pathogens 

provides the scientific basis to support the 1996 SDWA Amendments, which require EPA to 

establish a list of unregulated contaminants to consider for regulation. The first CCL was 

finalized in 1998, and EPA is required to make regulatory determinations on at least five 

contaminants every 5 years. In 2002, EPA announced a determination not to regulate nine 

contaminants, which included eight chemicals and one pathogen. The second CCL (CCL2) was 

finalized in early 2005, and subsequent CCLs are scheduled every 5 years. The regulatory 

determinations for CCL contaminants can be to develop a drinking water standard, to provide a 

health advisory, or to decide not to regulate. 

With regard to source water protection, the key scientific questions fall into four general areas: 

water quality criteria, source water assessments, prevention measures to address sources of 

contamination, and contingency planning (e.g., early warning systems). Source water protection 

research relates to the CCL research area, in that source water assessments are key to 

understanding the potential for future changes in contaminant occurrence and human exposure. 

II.4.2 Contaminant Candidate List

Relevance 

The CCL research program clearly is responsive to the Agency’s strategic goal of Clean and Safe 

Water. The process of making regulatory decisions about contaminants on the CCL2 and 

evaluating additional contaminants for possible listing is one of the most challenging areas in the 

DWRP. Because this research effort is relatively new and many data gaps still exist, the 

potential public health benefits are not yet evident in some areas. Future outcomes of the CCL 

research program, however, may result in many public health benefits. 

Program Design 

The difficult charge of developing future CCLs drove ORD and OW to seek expert advice from

the National Research Council (NRC) and the National Drinking Water Advisory Council 

(NDWAC). The NRC recommended a two-step approach of developing a CCL from a universe 

of contaminants that have the potential for human exposure, health effects, or both. The 

NDWAC report (May 2004) made specific recommendations for the implementation of the two14 
BOSC Drinking Water Research Program Review Final Report 

step approach. As a result of this input from the NRC and NDWAC, identification of gaps in the 

data required to make CCL regulatory decisions occurs via a two-phase process. In Phase 1, 

analytical methods are developed and used to screen for the chemicals and pathogens on the 

CCL. Additional information is sought through a more detailed risk assessment/risk 

management process. The outcome leads to a regulatory determination or a decision to move a 

contaminant to Phase 2. During Phase 2, a more comprehensive database on analytical methods, 

occurrence, exposure, and treatment is generated. The research needs are specific to a chemical 

or microorganism. 

The program design is logical, and goals and priorities are identified clearly. The research 

appears to follow the MYP closely. The framework for addressing the CCL research includes 

two scientific issues: (1) identifying data gaps on occurrence and health risks of exposure for at 

least five chemicals and pathogens on the CCL, and (2) development of innovative approaches 

for identifying and prioritizing unregulated contaminants for possible listing on the CCL. 

Occurrence data for CCL contaminants are primarily obtained through the Unregulated 

Contaminant Monitoring Rules (UCMR). ORD’s intramural and STAR research support this 

mandatory data collection through the development of measurement methods. Treatment studies 

to evaluate the effectiveness of routine treatment practices for removing CCL chemicals and 

killing pathogens are an important part of the CCL research program. 

 

Progress 

Research on CCL2 contaminants has taken on increasing importance within ORD, as proscribed 

by the mandated regulatory decisions and their associated timeline. The research budget 

allocation shifts from LTG 1 to LTG 2 reflect this change in recent years. 

ORD is developing new analytical methods in support of the UCMR and is making those 

validated and detailed methods available to the research community. Excellent progress has 

been made for high priority pollutants, such as perchlorate. Good to excellent progress also is 

being made on treatment technologies. Laboratories are evaluating current treatment methods to 

determine their effectiveness in removing more than 35 CCL-related contaminants (e.g., 

endocrine disruptors, pharmaceuticals and personal care products [PPCPs], pesticides, and their 

breakdown products). A database that contains the efficacy of current treatment technologies to 

address CCL contaminants is being developed. 

Research on innovative approaches has focused on developing methods for using genomic, 

proteomic, and cell-based assays to classify unregulated contaminants. There is, however, some

disagreement on the most appropriate choices of gene arrays in genomics studies; such choices 

should be considered carefully. The aim of the research is to use these technologies to 

understand biological effects and modes of action by which a contaminant produces an adverse 

health effect. Although progress is being made in gearing up for the “omics” revolution, this 

progress is “catch-up” in nature with respect to ORD’s capability in the drinking water area. 

This approach, which includes the development of biomarkers linked to health outcomes, then 

would be used for risk prioritization and screening of a large number of contaminants. 

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The Computational Toxicology Program of ORD’s National Health and Environmental Effects 

Research Laboratory (NHEERL) is being used to develop models, including quantitative 

structure-activity (QSAR) models, to predict health effects to aid the development of future 

CCLs. To date, much of the research is focused on questions regarding unregulated DBPs and 

endocrine disruptors. The plan is to extend this approach to other CCL contaminants. Research 

using computational toxicology and QSARs for predicting contaminant behavior and health 

effects is ongoing. Several studies also are investigating the biological effects of mixtures. 

New chemicals that can arise from new treatment schemes to address specific contaminant 

reduction problems are being investigated. For example, new DBPs arising from chloramination 

are being characterized. Research in this area follows closely from the experience with the 

regulated DBPs and the experience gained from these efforts should be translatable to other CCL 

contaminants. 

For microbes, the research plan focuses on developing microorganism-specific information on 

serology, infectious dose, and surveillance. Research is focused on priority CCL pathogens 

including Mycobacterium, Helicobacter, and microsporidia. DNA microarrays are being 

developed for detecting multiple pathogens in water, and virulence factors are being evaluated 

for their usefulness in characterizing CCL pathogens. Another major problem area is the 

determination of the nature and magnitude of endemic and epidemic waterborne disease. This 

research involves both surveillance activities and community intervention studies to evaluate the 

risk of disease from waterborne microbes. These efforts involve extensive partnering with CDC 

and the National Center for Infectious Disease. 

Studies are underway to evaluate the risk to susceptible subpopulations (immunocompromised 

individuals) from CCL microbes. To date, research has focused on Mycobacterium avium

intercellulare (MAC) and, in the future, it also will be important to develop research programs 

for other potential pathogens to improve estimates of potential adverse health effects in 

susceptible subpopulations. Well-designed epidemiologic and human biomonitoring studies can 

play an important role in this effort. 

Good to excellent progress is being made on understanding the nature and magnitude of endemic 

and epidemic illness caused by waterborne microbes. Research on endemic illness is focused on 

gastrointestinal illness. Epidemiologic studies to evaluate the risk of disease are key to this 

research area. Progress on assessing waterborne disease outbreaks through collaboration with 

CDC has been good. 

Strengths 

CCL contaminant research represents the most challenging area of ORD’s DW research effort. 

A particular strength of the research program design is the use of experiences in the area of 

byproducts of disinfection to inform the research plan for CCL contaminants. The development 

of innovative methods for identifying, characterizing, and prioritizing contaminants is underway. 

Research is at the early stages and is innovative and showing reasonable progress. The 

development of screening methods is ongoing. 

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ORD has made excellent progress in the development, standardization, and dissemination of 

methods for high priority pollutants. For example, the perchlorate method development and 

standardization was useful in bringing common tools to bear for the affected stakeholders. The 

treatment technology database for CCL contaminants is an important resource for identifying and 

prioritizing CCL research. This area is particularly important because contaminants with 

treatment issues are the focus of additional research into treatment methods and will move into 

the next steps of risk characterization.

Research into the development of innovative methods for identifying, characterizing, and 

prioritizing contaminants is in the early stages. The research appears to be innovative and is 

showing reasonable progress to date. Good research progress is leading to improved methods in 

detecting and describing the spatial and temporal occurrence of cyanotoxins in aquatic 

environments. 

It also appears that important contributions are originating from DWRP research to quantify 

levels of microbial pathogens and relative risks to susceptible subpopulations, such as the 

immune-compromised. 

A major strength of the DWRP is the ongoing collaborative effort with CDC and STAR grantees 

to assess endemic and epidemic disease caused by waterborne microbes in distribution systems. 

Opportunities 

There are many challenges related to the CCL research program. Specifically, the anticipation of 

new CCL issues will require an understanding of likely trends in drinking water source use and 

source water assessments. There will be new chemicals, new endpoints (e.g., reproductive 

effects, endocrine disruption) and new treatment technologies that need to be evaluated. A 

potential mechanism for addressing these challenges could be to have more open-ended calls for 

STAR grants on CCL-related topics. The broad scope of the CCL research program and limited 

funding for this research means that partnering and value-added research will be critical to 

meeting the research aims of LTG 2. Anticipating potential future unregulated contaminants and 

prioritization of research on the current CCL will be aided by good communication and 

responsiveness between OW and ORD and stakeholders (i.e., utilities) and other agencies. 

The use of computational toxicology and QSAR approach for evaluating potential health effects 

of CCL contaminants and screening future chemicals may be useful; however, caution should be 

used to ensure these methods are validated in some way and are not used in isolation. 

In some areas, such as 1, 4-dioxane and in the early stages of perchlorate and methyl tertiarybutyl ether (MTBE) problem definition, one could argue that the ORD DWRP was late-to-thetable. It appears that EPA needs some way to respond quickly to the detection of new 

contaminants. At this time, it is not clear as to the degree that new “omics” will contribute to 

these efforts. Recent experience shows that identification of new contaminants requires 

followup on unusual observations and support for research that is not centrally planned 8 years in 

advance. 

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The problem associated with health effects of mixtures is acknowledged and is deserving of 

additional research. ORD has contributed to understanding the issue of mixture toxicity, and the 

complexity of this issue is far ranging. The issue extends beyond simple acute or chronic 

toxicity to complex synergies and antagonisms to the integrative effects in reproduction and 

developmental biology. This is expected to continue to grow as an area of priority concern and 

could be prime territory for STAR solicitations and multi-agency programmatic thrusts, which 

the ORD could lead. 

Continuing research on waterborne disease requires ongoing surveillance efforts and long-term

epidemiologic studies. Challenges in this area include the limited research budget for conducting 

the longer-term epidemiologic studies required. Additional opportunities should be sought for 

partnering with academic institutions and other government agencies. 

The budget for CCL research has increased and now represents approximately one-half of the 

ORD DW research. The scope of the mandated research effort is considerable, however, and it 

will be important to prioritize research areas carefully and to ensure that maximum efforts at

partnering are made. 

II.4.3 Source Water Protection

Relevance 

The changing geographic distributions of the U.S. population and depletion of ground water is 

leading to increases in surface water use; however, this issue does not appear to be well 

documented. Because surface water is impacted by human activities to a greater extent than 

ground water, source water assessment and protection should play an increasingly important role 

in the future. Research in these areas, as well as contingency planning to prevent terrorist attacks 

on drinking water supplies, is directly relevant to EPA’s goal for clean and safe water. 

Additionally, source water assessment and prevention research is directly relevant to the 

evaluation of additional contaminants for possible listing on the CCL. 

Program Design 

Source water protection research questions address four primary areas: methods development 

for characterizing sources of contamination, fate and transport of contaminants, evaluation of 

best management practices on source water protection, and the development of early warning 

systems for alerting utilities of contaminant incursions in source water. The research program on 

source water protection has relevance to the CCL research program design. The research efforts 

in these areas are relatively modest at this time and do not necessarily represent a coherent vision 

of the areas that pose the greatest potential threats to public health. The area of source water 

protection is interdisciplinary in nature and overlaps with OW research on aquatic ecosystems 

and ORD research on homeland security. 

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Progress 

There is an ongoing effort to develop methods to detect cyanotoxins, which are increasing either 

in incidence or general reporting in source water. Future plans are to generate better information 

on occurrence and spatial and temporal fluctuations in toxin concentrations. Progress in other 

areas includes development of methods to track fecal pollution sources, methods for delineation 

of source water protection zones for public water supplies, and the evaluation of best 

management practices. ORD intramural activities and STAR grants are being used to develop 

research in these areas. 

Improved surveillance methods for detecting epidemics will supplement work within EPA and 

CDC on protecting water systems from terrorist attacks. 

Strengths 

The Agency is moving forward to embrace new molecular methods for source identification of 

fecal organisms. Progress in this area is good and will contribute to understanding total 

maximum daily loads (TMDLs) and, ultimately, to assist in source water protection. 

Opportunities 

Water reuse continues to grow as an area of importance and potential for risk to human health. 

This is a future source of drinking water with broad applications in the South and Southwest. 

ORD should find water reuse to be an issue on the near-term horizon and, a strategic research 

plan for this area will have to be developed in the near- to mid-term. 

The research efforts in the area of source water protection are relatively small. Interagency 

collaborations (e.g., with the U.S. Geological Survey [USGS]) to address source water protection 

and assessment goals will be important toward meeting research goals. The SDWA well-head 

protection program is an important part of EPA’s efforts at source water protection; however, 

little documentation nor a description of this program were available; also, the obvious links to 

homeland security issues were not documented. The need for a thorough evaluation of this 

program for protecting ground water resources may be a priority item. Furthermore, it appears 

that ORD should not restrict research on source water protection to contaminants listed 

under LTG 2 as source water protection research is relevant to some regulated 

contaminants in LTG 1. 

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III. QUALITY

Scientific Quality Questions and Overview

A. What is the scientific quality of the DWRP’s research products (including consideration of 

peer-review process)? 

B. Is high quality research ensured through competitive merit-based funding? 

C. For non-competitive funds, what process is used to allocate funds, and does it ensure that 

quality is maintained? 

In general, the mechanisms for ensuring quality are relatively consistent, regardless of whether 

research is being directed toward LTG 1 or LTG 2. STAR grant support is through a peerreview process, with laboratory and program directors ultimately prioritizing and selecting 

projects for funding based on preconceived needs of the overall Agency research plan. 

Cooperative agreements resulting in intramural collaboration receive internal peer review but are 

not open to an extensive outside review process. This may tend to perpetuate some research 

efforts that are past their prime and may leave the Agency open to concerns of “cronyism.” 

ORD could consider a streamlined external review process that could make suggestions to 

improve the quality and/or timeliness of the cooperative venture. 

Candidate Contaminant List

Research related to the CCL is an applicable model for describing the overall objectives for 

insuring research quality. 

The scientific quality of the CCL research is good. High quality research is ongoing and is 

maintained through the use of partnering with other agencies, intramural research efforts, and the 

STAR grants program. CCL research is particularly challenging given the large number of 

contaminants to be evaluated and the mandatory timeline for review. The STAR program is a 

competitive, merit-based mechanism and has been used to develop important research areas with 

respect to CCL contaminants. ORD should consider more open-ended calls for STAR grants 

on CCL-related topics to provide quality research on emerging issues. 

The process of allocating non-competitive funds for CCL and source water protection research 

lies ultimately with the NPD for DW Research, who recommends budgetary allocations to the 

laboratories and centers. ORD Laboratory and Center Directors are responsible for 

implementing the research programs with their prescribed budgets. In addition, the Laboratory 

and Center Directors provide input as to the impact of the budget allocations on their research 

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and business plans. The overall requirement is that DW research must be focused on research 

products that address the MYP and other near-term needs of the program and the clients. 

Research plans to implement MYP research undergo extensive internal and external peer review. 

In general, this process appears to be working to produce high quality research in support of the 

CCL and, to a lesser extent, source water protection. ORD should consider that further efforts 

to integrate research on source water protection with the CCL research would be 

advantageous. 

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IV. SCIENTIFIC LEADERSHIP

Scientific Leadership Question A

Has the program played a leadership role in contributing to advancing the state-of-the-science 

and solving drinking water research problems? 

The issue of leadership relative to the charge question appeared to be perceived somewhat 

differently on the part of the Subcommittee compared to the Agency’s program directors who 

spoke to the issue. It was apparent that leadership from an Agency perspective was viewed in a 

management context. For example, it was argued that leadership is demonstrated by the Agency 

or individual directors in their ability to function as conveners to bring disparate or partner 

groups to the table to focus on overarching issues, perhaps even larger than the Agency’s agenda. 

An example provided was the Agency’s role in managing the perchlorate in drinking water issue, 

which extends into the interest area of many stakeholders, industry, government agencies, and 

the public. 

Clearly this is an important leadership area, and it may reflect a synthesis of science and risk 

management approaches noteworthy to the Agency. It does not necessarily speak to being the 

science leader per se. For example, in the area of DBPs, EPA has been viewed, internationally, 

as a science leader. As this is a maturing research area, EPA still holds some leadership 

credentials such as in the critical issue area of “mixtures.” In other areas, however, such as the 

occurrence of unregulated contaminants in drinking water sources (e.g., pharmaceutically active 

compounds), researchers from USGS, Western European agencies, and academia have taken 

leadership roles. It appears that where statutory mandate and rules require focused Agency 

resources, ORD can maintain a science leadership; however, in rapidly evolving fields in which 

regulations have not been promulgated, ORD may not be responsive enough to take on a 

leadership role. In light of the narrowing resource base (i.e., not keeping up with inflation) and 

an ever expanding problem set, it seems likely that the ORD research leadership will become

narrow compared to its former level of prominence. 

It also was noted by the Subcommittee that many of ORD’s key administrative and science 

managerial posts, including that of the NPD for the DWRP, are filled by interim or acting 

directors. This leads to some concerns over the long-term issues of leadership, morale, and 

program direction within the Agency, as well as the national science agenda. It is accepted that 

many of these positions are in somewhat continuous flux, and it is unknown as to the extent, if 

any, that this introduces uncertainty into the management structure and leadership. Although it is 

difficult to influence the process that leads to the formal appointment of research and 

administrative directors, ORD is strongly encouraged to continue to press for timely 

appointments to these key leadership positions.

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Scientific Leadership Question B

Have ORD scientists demonstrated leadership in the field of drinking water research? 

The Subcommittee was provided several sources of information as evidence of the manifestation 

of the scientific leadership of the DWRP scientists. The information included posters and poster 

abstracts, biosketches of the DWRP researchers and managers, biosketches of postdoctoral and 

visiting scholars, overview presentations, testimonial presentations, and scientific awards and 

leadership positions of DWRP researchers and managers. Examination of the material indicates 

the program has been a leader in the development of state-of-the-science research in areas that

are related directly to the SDWA and its amendments and mandates (e.g., arsenic, ground water 

pathogens, mixed contaminants). Several individuals and groups are known internationally for 

their work. The bibliometric analysis shows 19 publications during the past 10 years in the most 

highly cited category (i.e., the top 1%) per the Thomson’s Essential Science Indicators (ESI). 

Approximately one-half of the lead authors are internal researchers. This is indicative of

recognized good research across many aspects of the DWRP. 

The stellar performance and recognition of the research, however, is not uniform throughout the 

program. Although it is somewhat difficult to compute, an analysis of the publication records of 

the DWRP researchers, managers, and STAR grant participants indicates the average publication 

rate for peer-reviewed and total publications per person per year over the last 10 years is less 

than 1.0. The Subcommittee views this as below the expected publication rate of a program that 

aspires to be a leader in drinking water research. 

 

The Subcommittee is concerned about the potential conflict of the goal for scientific leadership 

in the DWRP and the need to be responsive to mandates per the SDWA and its amendments. If 

the goal of scientific leadership is to be achieved and maintained, the Subcommittee recommends 

consideration of a program that would allow a group of researchers to pursue fundamental 

research that may not be driven exclusively by the SDWA but is in the drinking water arena and 

the Agency’s long-term objective of providing safe drinking water. In such a program, the 

research would investigate emerging issues (e.g., indirect potable water reuse, seawater 

desalination), and the researchers would be expected to be nationally and internationally 

renowned for the work, as evidenced by publications, citations, invited talks, membership in 

honorific societies, etc. Models currently exist in other federal agencies, such as USGS. 

As an alternative, the DWRP could revise the goal of scientific leadership to something more in 

harmony with its need to respond to SDWA mandates. For example, the use of a modifier such 

as “in selected areas” could be inserted in the existing goal. 

The Subcommittee also is concerned about the program’s lack of stable leadership. The reason 

for this concern is the perception that uncertainties over changing authority or management may 

create difficulty in championing the program or capitalizing on opportunities, as well as 

protecting budgets and priorities in research direction. Currently, the NPD and the leaders of the 

LTGs are acting in their positions. The Subcommittee believes there is need to fill the acting 

positions to solidify the program’s leadership as soon as possible. 

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V. COMMUNICATION AND COORDINATION

Communication and Coordination Questions 

A. To what extent has the program coordinated with and used other agencies (inside and outside 

the government) in advancing EPA’s research agenda? Are there important interagency 

collaborations that should and can be improved to advance the Agency’s research agenda? 

B. Does the program use effective mechanisms for communicating research activities and 

results, both internally and externally? 

Information on communication and coordination was provided to the Subcommittee both as a 

section of the notebook and in the form of presentations at the review meeting. From this 

documentation, it was clear that the DWRP has established internal efforts for coordination and 

communication, including the Water Research Coordination Team, to facilitate communications 

across the ORD laboratories and centers, OW, and the regional offices. Members of this team

have worked to develop the Drinking Water Research MYP, held annual DW progress reviews, 

held annual ORD/OW senior management meetings, held annual Deputy Assistant 

Administrators meetings, and have held at least 18 ad hoc meetings and conference calls. 

The DWRP also has established relationships with various outside organizations, including the 

Global Water Research Coalition, the AwwaRF, the WaterReuse Foundation, the Water 

Environment Foundation, the CDC (National Center for Environmental Health and National 

Center for Infectious Diseases), and the National Toxicology Program at the National Institute of 

Environmental Health Sciences (NIEHS). During the review, there were several testimonials 

about the interactions of the DWRP and other organizations (inside and outside the government). 

Work with OW was shown and involves ORD closely (e.g., arsenic, DBPs, Surface Water and 

Ground Water rules, CCL). OW is satisfied with interactions and outputs. Given the 

performance measures in place, the Subcommittee believes that ORD should develop a means to 

track and assess how outputs are used in the formulation of outcomes beyond ORD control. 

ORD’s work with AwwaRF has been “satisfying” to AwwaRF. The states (Texas was 

represented) are appreciative of the support and guidance provided by ORD; however, some

concern was expressed that the states’ needs and issues were not heard as well as they could be. 

The Subcommittee believes there is a need to develop partnerships with regard to CCL 

issues (e.g., selection, evaluation) with both governmental and non-governmental 

organizations. The Subcommittee also thinks that coordination with other governmental 

agencies can be enhanced to leverage the outputs of ORD efforts. For example, studies can 

be designed jointly with CDC, NIEHS, National Cancer Institute, and others to address an 

issue more completely than individual agencies could do alone. 

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Communication of research activities and results uses several mechanisms. Journal articles 

describing research results are published in peer-reviewed journals. DWRP scientists actively 

make oral and poster presentations at national and international conferences. At least 18 internal 

meetings and 35 meetings with external organizations or experts have been held since 1999. 

These meetings are designed to both provide and receive information. In addition, at least 17 

meetings have been hosted by EPA/ORD that indirectly support the DWRP. These meetings 

have included STAR seminars/program meetings and science forums. Several Web sites have 

been established to facilitate access to EPA activities, scientific/technical work products, 

publications, and EPA organizations. 

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VI. APPENDIX A: DRAFT CHARGE QUESTIONS FOR ORD’S 

DRINKING WATER RESEARCH PROGRAM REVIEW

The following charge questions were developed by ORD to help evaluate the relevance, design, 

performance, quality, and scientific leadership of its DWRP: 

1. Program Relevance Questions: 

A. Is the focus of ORD’s Drinking Water Research Program responsive to the Agency’s 

strategic goal for Clean and Safe Water?

B. Are potential public benefits of the program clearly evident?

2. Program Design Questions: 

A. Is the program design logical? Are the program goals and priorities clearly 

identified? 

B. Does the MYP describe an appropriate flow of work (i.e., the sequencing of related 

activities) that reasonably reflects the anticipated pace of scientific progress and the 

timing of client needs? 

C. Do the two LTGs provide a logical framework for organizing and planning the 

research and demonstrating outcomes of the program?

D. Does the research program use the MYP to help guide and manage its research?

3. Program Progress in Addressing Key Scientific Questions and Meeting Client Needs 

Questions: 

A. Has the program made significant progress toward each of the LTGs? 

B. How well has the research program addressed the key scientific questions?

C. Is the rationale for the research clearly articulated?

D. Has the program met client needs in a timely and useful way through its scientific 

products?

E. Have clients applied the program’s research in environmental decisions and 

regulations? 

F. Has the program been successful in providing technical assistance to the Office of 

Water, regional offices, states, municipalities and water utilities? 

4. Scientific Quality Questions: 

A. What is the scientific quality of the program’s research products? (This includes a 

consideration of the peer review process employed.) 

B. Does the program ensure high quality research through competitive, merit-based 

funding?

C. If funds are not competitively awarded, what process does the program use to allocate 

funds? Does this process ensure that quality is maintained?

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5. Scientific Leadership Questions: 

A. Has the program played a leadership role in contributing to advancing the state-ofthe-science and solving important drinking water research problems?

B Have ORD scientists demonstrated leadership in the field of drinking water research? 

6. Coordination and Communication Questions:

A. Has the program effectively engaged scientists and managers from ORD and the 

Office of Water in its planning?

B. Does the program identify key research gaps and update the research agenda through 

an established process that considers the input of the scientific community and 

stakeholders? 

C. To what extent has the program coordinated with and used other agencies (inside and 

outside the government) in advancing the EPA’s research agenda? Are there 

important interagency collaborations that should and can be improved to advance the 

Agency’s research agenda? 

D. Does the program use effective mechanisms for communicating research activities 

and results, both internally and externally?

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VII. APPENDIX B: DRINKING WATER RESEARCH SUBCOMMITTEE

BIOGRAPHIES

Gary S. Sayler, Ph.D.

Dr. Sayler is Distinguished University Professor of Microbiology, and Ecology and Evolutionary 

Biology, and Director of the Center for Environmental Biotechnology at the University of 

Tennessee. He received his Ph.D. in 1974 from the Department of Bacteriology and 

Biochemistry at the University of Idaho and did postdoctoral research at the University of 

Maryland. He received his B.S. in Bacteriology from North Dakota State University in 1971. 

Dr. Sayler has more than 30 years of experience in multidisciplinary laboratory and field 

environmental research and biodegradation of organic pollutants. He has pioneered the 

development of environmental molecular diagnostics, including the extraction and analysis of 

nucleic acids from soils, bioluminescent bioreporter technology, and the first field release of a 

genetically engineered microorganism for bioremediation purposes. This research has resulted in 

more than 275 technical publications and monographs, more than 350 invited presentations at the 

national and international level, and 9 patents. He is a member of American Society for 

Microbiology (ASM), American Chemical Society (ACS), American Association for the 

Advancement of Science (AAAS), Society for Industrial Microbiology (SIM), Society of 

Environmental Toxicology and Chemistry (SETAC), and SPIEE, has served on five editorial 

boards, and currently is an associate editor of the journal Environmental Science & Technology. 

Dr. Sayler is a Lifetime Fellow of the American Academy of Microbiology. He was the 

recipient of the 5-year U.S. Public Health Service Research Career Development Award from

NIEHS, the recipient of the Procter & Gamble Award in Applied and Environmental 

Microbiology from the ASM, The University of Idaho Distinguished Alumni Award, and the 

SPHERE award from the Dow Foundation. He has directed the research of more than 50 Ph.D. 

and M.S. candidates. Dr. Sayler currently serves on the Drinking Water Committee of the EPA 

Science Advisory Board (SAB) and is an Executive Committee member of the EPA/ORD 

BOSC. 

James H. Johnson, Jr., Ph.D. 

Dr. Johnson is a professor of Civil Engineering and Dean of the College of Engineering, 

Architecture and Computer Sciences at Howard University. Dr. Johnson received his B.S. from

Howard University, M.S. from the University of Illinois, and Ph.D. from the University of 

Delaware. Dr. Johnson’s research interests include the treatment and disposal of hazardous 

substances, the evaluation of environmental policy issues in relation to minorities, the 

development of environmental curricula and strategies to increase the pool of underrepresented 

groups in the science, technology, engineering, and math disciplines. He is the Chair of the 

EPA/ORD BOSC, a member of EPA’s SAB, and the co-principal investigator of the Department 

of Energy (DOE)-sponsored Historically Black Colleges and Universities/Minority Institutions 

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BOSC Drinking Water Research Program Review Final Report 

(HBCU/MI) Environmental Technology Consortium. Currently, he is a consultant to the Office 

of the President, University of California, as a member of the Environmental, Health, and Safety 

Panel monitoring activities at the three DOE national laboratories operated by the University of

California. From 1989-2002, he was the Associate Director of the EPA-sponsored Great Lakes 

and Mid-Atlantic Center for Hazardous Substance Research; from 1996-2002, he oversaw the 

activities of the Engineering Coalition of Schools for Excellence and Leadership in Education, a 

National Science Foundation (NSF)-funded consortium. Dr. Johnson is a member of the NRC’s 

Board on Environmental Studies and Toxicology, SECME, and the Engineering Deans Council 

of the American Society for Engineering Education. Other recent service activities include 

NRC’s Board on Radioactive Waste Management, the Board of Directors of the Civil 

Engineering Research Foundation (CERF), and the Space Day Foundation. He also serves on 

several university and private sector advisory committees. Dr. Johnson has authored more than 

50 scholarly articles, contributed to three books, and co-edited two books. He is a fellow of the 

American Society of Civil Engineers (ASCE) and a member of the American Association of 

Environmental Engineering and Science Professors, American Water Works Association, 

American Society for Engineering Education, and Tau Beta Pi. Dr. Johnson is a registered 

professional engineer in the District of Columbia and a diplomate of the American Academy of 

Environmental Engineer. He is the 2005 recipient of the National Society of Black Engineers 

Lifetime Achievement Award in Academia. 

Chi-Hsin Selene Jen Chou, Ph.D. 

Dr. Chou is an Environmental Health Scientist at the Agency for Toxic Substances and Disease 

(ATSDR), Division of Toxicology and Environmental Medicine (DTEM), Prevention, Response 

and Medical Support Branch, Scientific Assessment and Consultation Team, in Atlanta, Georgia. 

Dr. Chou’s major activities include human health risk assessment, Chair of the ATSDR Minimal

Risk Level Workgroup, Co-Chair of the DTEM Health Effects Review Workgroup, and 

Chemical Manager of ATSDR’s toxicological profiles for arsenic, hydrogen sulfide, chloroform, 

and pyridine. Dr. Chou received her B.S. degree in chemical engineering from National Taiwan 

University, Taipei, Taiwan, and a Ph.D. in physical chemistry from Emory University, Atlanta 

Georgia. She also received postdoctoral training in biochemistry and neurochemistry at 

Northwestern University, Evanston, Illinois, and Emory University School of Medicine, Atlanta 

Georgia, respectively. 

David L. Sedlak, Ph.D. 

Dr. Sedlak is a Professor of the Department of Civil and Environmental Engineering at the 

University of California, Berkeley, Dr. Sedlak received his B.S. degree in Environmental 

Science from Cornell University in 1986. He received his Ph.D. in Water Chemistry from the 

University of Wisconsin in Madison in 1992, and served as a postdoctoral researcher at the Swiss 

Federal Institute for Environmental Science and Technology (EAWAG) from 1992-1994. He 

has received several notable awards, including the Paul Busch Award for Innovation in Water 

Quality Engineering in 2003, the NSF CAREER Award in 1997, and the Hellman Family 

Faculty Award in 1996. His areas of research interest include analytical methods for measuring 

organic compounds in water, fate of chemical contaminants in water recycling systems, metal 

speciation and its effect on metal uptake and reaction, and environmental photochemistry. 

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BOSC Drinking Water Research Program Review Final Report 

James H. Raymer, Ph.D. 

Dr. Raymer is Senior Program Director for the Exposure Analysis Research Program at RTI 

International, Research Triangle Park, North Carolina, and has been responsible for scientific 

and financial management of a variety of projects utilizing analytical chemistry for both 

government and commercial clients. These projects have involved the development and 

application of separation techniques, including capillary gas chromatography, supercritical fluid 

chromatography, supercritical fluid extraction, high performance liquid chromatography, liquid 

chromatography/mass spectrometry, capillary gas chromatography-Fourier transform infrared 

spectroscopy, and capillary gas chromatography mass spectrometry to the quantitative and 

qualitative analysis of various chemical classes, including pesticides, water DBPs, and volatile 

and semi-volatile analytes, in biological and environmental samples. Most of these projects have 

been geared toward a greater understanding of human exposure to toxic chemicals or the 

biological responses of animal models to such exposures and have included the development of 

methods for analysis that are then applied in the studies. Recent projects have focused on 

improving the understanding of exposures of children to environmental contaminants through 

air, food, water, and dust, including potential pesticide exposure via interactions with surfaces. 

Both activities and metabolic effects have been considered in these recent studies as they relate 

to dose. Responsibilities also have included experimental design, modeling of experimental 

data, proposal and report preparation, and preparation of articles for publication. He received a 

B.A. in Chemistry at SUNY College at Brockport, Brockport, New York, in 1979, and a Ph.D. in 

Analytical Chemistry (Minor: Biochemistry), Indiana University, Bloomington, Indiana, in 1984 

Subcommittee Consultant: 

Mary H. Ward, M.S., Ph.D. 

Dr. Ward is an environmental epidemiologist and tenure-track investigator in the Occupational 

and Environmental Epidemiology Branch, Division of Cancer Epidemiology and Genetics, 

National Cancer Institute, National Institutes of Health, in Bethesda, Maryland. She received a 

M.S. degree in Ecology from the University of Tennessee in 1983. She received her doctorate in 

Epidemiology from Johns Hopkins University, School of Hygiene and Public Health, in 1994. 

Dr. Ward’s research has focused on environmental and occupational epidemiology, with special 

emphasis on pesticides and N-nitroso compounds (NOC). She has examined the role that NOC 

and NOC precursors, particularly drinking water and dietary sources of nitrate and nitrite, may 

play in the development of cancer through studies of non-Hodgkin’s lymphoma and cancers of 

the bladder, brain, colon, esophagus, stomach, and pancreas. She has developed interdisciplinary 

collaborations to use Geographic Information Systems for exposure assessment of environmental 

contaminants, including pesticides and nitrate and she received a Division of Cancer 

Epidemiology and Genetics Intramural Research Award in 1999 and a NIH Merit Award in 2000 

to continue her research in this area. 

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31

VIII. APPENDIX C: LIST OF ACRONYMS

AAAS American Association for the Advancement of Science

ACS American Chemical Society

ASCE American Society of Civil Engineers

ASM American Society for Microbiology

ATSDR Agency for Toxic Substances and Disease Registry

AwwaRF American Water Works Association Research Foundation

BOSC Board of Scientific Counselors

CCL Candidate Contaminants List

CDC Centers for Disease Control and Prevention

CERF Civil Engineering Research Foundation

DBP Disinfection Byproduct

DFO Designated Federal Officer

DHHS Department of Health and Human Services

DOE U.S. Department of Energy

DTEM Division of Toxicology and Environmental Medicine

DW Drinking Water

DWRP Drinking Water Research Program

EAWAG Swiss Federal Institute for Environmental Science and Technology

EPA U.S. Environmental Protection Agency

ESI Essential Science Indicators

FACA Federal Advisory Committee Act

GPRA Government Performance and Results Act

HBCU/MI Historically Black Colleges and Universities/Minority Institutions

IRIS Integrated Risk Information System

LTG Long-Term Goal

MAC Mycobacterium avium intercellulare

MCL Maximum Contaminant Level

MCLG Maximum Contaminant Level Goal

MTBE Methyl Tertiary-Butyl Ether

MYP Multi-Year Plan

NCER National Center for Environmental Research

NDWAC National Drinking Water Advisory Council

NERL National Exposure Research Laboratory

NGO Nongovernmental Organization

NHEERL National Health and Environmental Effects Research Laboratory

NIEHS National Institute of Environmental Health Sciences

NIH National Institutes of Health

NOC N-Nitroso Compounds

NPD National Program Director

NRC National Research Council

NRMRL National Risk Management Research Laboratory
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NSF National Science Foundation

OMB Office of Management and Budget

ORD Office of Research and Development

OW Office of Water

PART Program Assessment Rating Tool

PPCPs Pharmaceuticals and Personal Care Products

PVC Polyvinyl Chloride

QSAR Quantitative Structure-Activity Relationship

RFP Request for Proposals

SAB Science Advisory Board

SECME Science, Engineering, Communication, Mathematics Enhancement Program

SDWA Safe Drinking Water Act 

SETAC Society of Environmental Toxicology and Chemistry

SIM Society for Industrial Microbiology

STAR Science To Achieve Results

THM Trihalomethane

TMDL Total Maximum Daily Load

UCMR Unregulated Contaminated Monitoring Rules

USGS U.S. Geological Survey