JOINT TESTIMONY OF NORINE NOONAN, PH.D. and CYNTHIA C. DOUGHERTY
JOINT TESTIMONY OF
NORINE NOONAN, PH.D.
OFFICE OF RESEARCH AND DEVELOPMENT
CYNTHIA C. DOUGHERTY
DIRECTOR, OFFICE OF GROUND WATER AND DRINKING WATER
OFFICE OF WATER
U.S. ENVIRONMENTAL PROTECTION AGENCY
SUBCOMMITTEE ON HEALTH AND ENVIRONMENT
COMMITTEE ON COMMERCE
U. S. HOUSE OF REPRESENTATIVES
October 20, 1999
Thank you, Mr. Chairman, for providing this opportunity to address the Committee today concerning the Environmental Protection Agency's (EPA) drinking water research program. We would like to update you on the status of our research program to support the implementation of the Safe Drinking Water Act (SDWA) Amendments of 1996. We would also like to share with you the activities that have been initiated in recent months to assess future drinking water research needs and resource requirements, to improve internal tracking mechanisms, and to further strengthen our interactions with stakeholders.
The Amendments of 1996 identified a wide range of critical research requirements to improve the scientific foundation for decisions to protect the health of both the general public and subgroups that may be at greater risk than the general population. EPA has responded to these needs by establishing drinking water as one of our highest priority research programs. The annual investment in drinking water research in the Office of Research and Development has essentially doubled from a level of $20.8 M in 1995 to $41.5 M in the FY 2000 President's Budget. Research partnerships with outside research entities have been strengthened, and a strict adherence to the peer review process has been followed for all research plans and scientific products developed by the Office of Research and Development. These and other measures discussed below have enabled the Agency to improve the science and technologies needed to support priority rule makings and risk management decisions required by the 1996 SDWA Amendments.
RESEARCH TO SUPPORT PRIORITY REGULATORY ACTIVITIES
EPA has been highly successful in addressing the critical near-term research needs and requirements of the 1996 Amendments. A targeted research program has been implemented with an emphasis on health effects, analytical methods and exposure, risk assessment and risk management research. Research priorities have also been addressed through the use of interagency agreements, cooperative agreements, and grants with such federal and non-federal entities as the Centers for Disease Control and Prevention, the National Institute for Environmental Health Sciences, the U.S. Geological Survey, the American Water Works Association Research Foundation, and universities across the country.
Research on Microbial Pathogens and Disinfection By-Products
EPA's research activities on microbial pathogens and disinfection by-products (DBPs) in drinking water are consistent with the highest priorities identified in the Research Plan for Microbial Pathogens and Disinfection By-Products in Drinking Water. This research program represents hundreds of projects to support more informed risk management decisions for the Stage 1 and Stage 2 DBP rules and the new microbial rules that apply to surface water and ground water.
EPA research on waterborne pathogens in recent years has provided new information and methods to better characterize and control the risks posed by microbial contaminants in drinking water. Studies to determine the infectious dose of two important waterborne pathogens, Cryptosporidium and Norwalk virus, have demonstrated that exposure to low levels of these agents in drinking water may cause infection in healthy humans. Less conventional treatment methods such as membrane filtration and alternatives to chlorination have been evaluated to determine their effectiveness in removing or inactivating waterborne pathogens. New technologies have been developed for increasing the operational efficiency of treatment processes to control microbial and chemical contaminants, and new methods for monitoring and predicting disinfectant concentrations in the distribution system have been developed to help ensure the safety of drinking water delivered at the tap. Current areas of emphasis include research to determine the nature and magnitude of waterborne disease in the U.S., and the development of simple inexpensive and accurate detection methods for well-known waterborne pathogens such as Cryptosporidium and for emerging pathogens such as microsporidia. EPA researchers are also evaluating the effectiveness of water treatment systems for small communities, and are conducting research to better understand how microbial intrusion into the distribution system occurs and can be prevented.
EPA has been a leader in development of an expanding scientific data base to assess DBP health effects. New and improved tools for conducting toxicology and epidemiology research on these substances are being applied to better understand the mechanisms by which effects occur in laboratory animals and humans, and to characterize the nature and magnitude of the problem in both the general population and in subpopulations that may be more susceptible to harm. In addition to the long-standing research program addressing the carcinogenic potential of DBPs, a major new investment has been made to better understand whether adverse reproductive, immunological, or neurologic effects may also be of concern.
As with microbial issues, DBP methods development is an essential focus both to improve occurrence information, and to expand our knowledge about what DBPs are formed from different treatment processes. To address these needs, EPA is developing analytical methods to support large-scale exposure surveys and facilitate regulatory compliance monitoring. Researchers are applying highly sensitive analytical techniques to identify previously uncharacterized by-products that are formed with the use of alternative disinfectants. EPA is also conducting a range of studies to determine the effectiveness of various treatment processes in minimizing and controlling the formation of DBPs, with a special focus on the needs of small systems.
Finally, I am pleased to report to you on the success of the largest data collection effort in the history of the drinking water program, commonly referred to as ICR (Information Collection Rule) data. Working closely with industry and other stakeholders, we have recently completed 18 months of data collection from 500 plants across the country. These data provide essential new information on source water, treatment train, and distribution system concentrations of DBPs and pathogens. The data represent over a $130 million investment in good science by the drinking water industry and will play a central role in the ongoing development of Stage 2 DBP and microbial public health measures.
Research on Arsenic
The Safe Drinking Water Act Amendments of 1996 mandate that EPA promulgate a new regulation for arsenic by January 2001, and develop a plan for long-term research. The Agency's peer reviewed Research Plan for Arsenic in Drinking Water, which describes both short-term and long-term research activities to address key areas of scientific uncertainty, has guided the planning and implementation of research conducted by EPA scientists as well as by outside investigators. Researchers at EPA are conducting studies to better characterize the toxicity of arsenic and the factors that influence human susceptibility. Improved analytical methods are being developed to better distinguish toxic forms of arsenic in the diet and in biological materials. Another important area of research is the evaluation of cost-effective treatment technologies for small water systems.
We are pleased to report that EPA has completed or is on schedule to complete all of the short-term research that we made a commitment to finish in the Research Plan for Arsenic in Drinking Water. The EPA will consider the existing information on health effects, exposure and risk management, along with new information that is available, as we assess the risks and evaluate treatment options in support of a new rule for arsenic by the statutory deadline in 2001. As a practical matter, research initiated in late FY 1999 and in FY 2000 by EPA and outside sources will not be available in time to inform the final rule making in 2001. This is because of the long-term nature of some of the more complex research issues, particularly in the area of the health effects of arsenic at low doses. Many of the projects conducted or financed by EPA and outside organizations are long-term research activities that will support the required review and revision, as appropriate, of the arsenic standard subsequent to the establishment of a new rule in 2001.
Research on the Contaminant Candidate List
The Contaminant Candidate List (CCL) was established by EPA, with considerable involvement of outside technical groups and the stakeholder community, to aid in priority setting for the Agency's drinking water program. A number of contaminants on the CCL have already been identified as having sufficient data available, or limited data needs that can be quickly addressed. Regulatory determinations for the August 2001 statutory deadline will be made on contaminants selected from this category. Many other chemicals and microbial pathogens on the list may require additional data on health effects, monitoring methods, treatment or occurrence before a regulatory determination can be made.
The EPA has completed a draft CCL research plan that has been shared with stakeholders in a collaborative effort to identify and prioritize research needs (see additional discussion about stakeholder involvement below). Although the plan will not be finalized until mid-2000, research on a number of critical contaminants on the CCL (e.g., MTBE, perchlorate, and waterborne microbial pathogens such as Norwalk virus) is already being conducted by EPA or collaborating institutions, and general solicitations have been made under the Agency's external grants program. In the FY 2000 drinking water research program, there is an increased emphasis on addressing needs for CCL contaminants in the areas of health effects, analytical methods, treatment and occurrence, following the priorities outlined in the CCL research plan that is currently under development.
Research on Subpopulations at Greater Risk
The 1996 SDWA Amendments emphasize the importance of research to identify and characterize groups that may be at greater risk than the general population of adverse health effects from exposure to contaminants in drinking water. EPA is addressing this issue by developing health effects data in laboratory animals and conducting assessments in target populations (e.g., pregnant women and infants) that are exposed to chemical contaminants and waterborne pathogens. Studies are being conducted to evaluate biological factors, such as differences in metabolism, that may be responsible for greater susceptibility in selected subpopulations. Research is also directed at improving estimates of exposure to the general public and special subpopulations, using a more comprehensive consideration of such factors as personal activity factors and exposures through the diet. As required by the 1996 Amendments, these research activities will be summarized in a Report to Congress that will be submitted by August, 2000.
RESEARCH PLANNING AND BUDGETING,
EPA has an extensive, coordinated research planning process that involves a comprehensive consideration and prioritization of all of the Agency's research needs, including those to support drinking water decision making. This process ensures that the media-specific needs of one regulatory program are considered in the context of the needs identified by other programs, and that the areas of greatest need, such as drinking water, are given the highest priority. The Office of Research and Development works in close partnership with the Office of Water, as well as in consultation with scientific advisory groups and stakeholders, to evaluate and prioritize research needs. Planning activities are closely linked to the annual budget cycle. A new multi-year planning effort for drinking water has been initiated to link strategic, long-term research priorities with annual planning and budgeting.
Peer reviewed research plans and strategies provide a basis for planning and monitoring the progress of research on important programs such as drinking water. As described above, research plans have been finalized for M/DBPs and arsenic, and the CCL research plan will be finalized by mid-2000. A comprehensive research strategy that describes near- and long-term research needs for M/DBPs, arsenic, CCL contaminants, the review of existing standards, and other emerging issues will be completed by the end of 2000. The strategy will be used to guide discussions within the EPA and with stakeholders concerning research needs and resource requirements for the entire drinking water research program.
Yearly budget requests for drinking water reflect a careful analysis of the highest priority research needs, considering EPA's need for research across all environmental activities (e.g., Clean Air, Clean/Safe Water, Children's Health) and keeping balanced budget constraints in mind. EPA has determined that the level of funding for drinking water research that was received in FY 1999 and requested for FY 2000 is sufficient to meet the near-term regulatory requirements. The Agency is committed to ensuring that the budget request for FY 2001, which is currently being developed by the Administration, will also adequately address the highest priority research needs.
The EPA uses a comprehensive system to ensure fiscal controls and to track resources at the research project level. The management information system developed by the Agency was designed to produce accurate and timely reports for use by the Office of Research and Development's laboratories and centers according to: (1) fiscal year; (2) goal (e.g., air, water, waste); (3) program results code; (4) organization; (5) research area; and (6) task. The system was not designed to track resources by individual regulation. Recognizing the importance of research to future drinking water regulatory decisions, EPA is currently examining ways to provide information that is more closely aligned with the rule making efforts so that we can better track and communicate the status of our priority drinking water research activities that will feed into the regulatory decision making process.
INVOLVEMENT OF STAKEHOLDERS
EPA places a high priority on sharing information with stakeholders regarding the status and plans for research on drinking water contaminants. Representatives from EPA participate regularly in numerous stakeholder meetings and other public events to share information on research that is being planned or conducted in support of the Agency's rule makings. In addition, EPA staff work closely with other federal agencies and serve on numerous research coordination committees and advisory groups with stakeholder groups. These efforts offer opportunities for more coordinated utilization of resources and to ensure that research conducted or supported by these organizations is complementary, not duplicative.
EPA is taking steps to further strengthen these interactions to ensure that all groups are fully informed and have an opportunity to provide input concerning research needs and activities. One recent example of a highly successful effort to involve stakeholders early in the research planning process was the Drinking Water Research Needs Workshop, co-sponsored by EPA and the American Water Works Association Research Foundation on September 27-29, 1999. The goals of this expert workshop, which involved participants from the water industry, academia, various government agencies and the private sector, were to: (1) identify and prioritize the research needs related to unregulated drinking water contaminants; (2) describe the proper sequencing for the studies; and (3) develop resource needs estimates. Contaminants on the CCL were the major focus of the workshop, and EPA's draft CCL research plan was used as a starting point of the discussions. The EPA considers this workshop to be a excellent model for involving stakeholders early in the process of identifying and prioritizing research needs relating to future drinking water issues.
ENSURING SUCCESS IN MEETING THE RESEARCH CHALLENGE
EPA has made considerable progress in meeting the research challenges posed by the 1996 Amendments. We have significantly increased the research budget for drinking water over the past five years. We have developed peer reviewed research plans to guide research supporting the current major rule makings, and we are developing new research plans to support future regulatory activities. EPA has initiated a new multi-year planning effort for drinking water research that will facilitate the linkage of strategic, long-term research planning to the yearly budget cycle. We have conducted and are now refining a comprehensive resource needs assessment to address future requirements. A priority has been placed on strengthening partnerships with outside research entities and involving the academic community in helping to address critical research needs. We have made extensive efforts to share information with stakeholders about the status and plans for research to support drinking water regulations, and we have initiated new activities to make further improvements in this area. Taken together, these measures have enabled us to successfully meet the near-term needs and requirements of the 1996 Amendments, and will position us to meet the challenge of providing a sound scientific foundation for future drinking water regulatory decisions.