Figure 1 illustrates the different pathways by which pharmaceuticals may  enter drinking water supplies. Under SDWA, EPA is authorized to regulate contaminants, including  pharmaceuticals, meeting certain criteria in public drinking water systems. National and regional studies have generally detected pharmaceuticals in  source water, treated drinking water, and treated wastewater; but the full  extent of occurrence is unknown. The concentrations detected were  measured most frequently in parts per trillion. Research Has Not Determined the Human Health Effects of Pharmaceuticals in Drinking Water, but Some Research Raises Concerns

Research has not determined the human health effects of exposure to  pharmaceuticals in drinking water. However, some research has  demonstrated the potential impact to human health from exposure to  some pharmaceuticals found in drinking water, such as EDCs and  antibiotics. The United States and Other Countries Are Engaged in Take-Back Programs to Help Prevent Pharmaceuticals from Reaching Drinking Water

Some states and local governments, as well as DEA, have taken actions  to reduce the extent to which pharmaceuticals occur in drinking water— primarily through take-back programs to properly dispose of  pharmaceuticals. II provides federal  guidelines on the proper disposal of pharmaceuticals).   Encouraging initial prescriptions in smaller amounts. This practice may  reduce the amount of pharmaceuticals that are disposed of when  patients switch to different pharmaceuticals. EPA is collaborating with  other agencies on research to help obtain these data for use in  developing future candidate lists, but these efforts are largely informal  and EPA has not established a formal mechanism to sustain these  collaborative efforts. According to EPA officials, there is no formal mechanism, such as a long- term strategy or formal agreement, to manage and sustain these  collaborative efforts. Three of these practices  may help clarify how EPA and other agencies could coordinate their  research efforts. We have previously reported  on key practices for enhancing and sustaining interagency collaboration  efforts, such as (1) establishing roles and responsibilities, including how  the collaborative effort will be led; (2) identifying the expertise and other  resources that each agency can bring to bear on the issue, and (3)  establishing a process for monitoring, evaluating, and reporting to the  public the results of the collaborative research efforts. Recommendation for Executive Action

To collect the pharmaceutical occurrence and health effects data  necessary to better implement SDWA, and to address the broader issue  of pharmaceuticals and their relationship to other contaminants in the  nation’s waterways, we are making the following recommendation to the  Administrator of EPA:    Establish a workgroup or other formal mechanism that includes the  relevant federal agencies to collaborate and coordinate research on  pharmaceuticals and, as appropriate, other contaminants in drinking  water that present the greatest public health concern. GAO staff who made major contributions to  this report are listed in appendix V.

Appendix I: Objectives, Scope, and Methodology

The objectives of this study were to (1) provide information on the extent to  which pharmaceuticals occur in drinking water and the effects, if any, that  their occurrence has on human health; (2) describe the approaches taken  in the United States and in other countries to reduce the extent to which  pharmaceuticals occur in drinking water; and (3) identify challenges, if any,  that the Environmental Protection Agency (EPA) faces in determining  whether any pharmaceuticals should be regulated under the Safe Drinking  Water Act (SDWA), actions EPA is taking to address these challenges, and  options for addressing such challenges in the future. To identify the effects, if any, that the occurrence of pharmaceuticals in  drinking water has on human health, we also reviewed federal and peer- reviewed reports, including articles in peer-reviewed journals by federal  scientists and others; and the PiE workgroup’s draft report. We selected a nonprobability sample of  five programs to represent the three categories.
Why GAO Did This Study

Drinking water in some metropolitan areas contains concentrations of pharmaceuticals, raising concerns about their potential impact on human health. The Safe Drinking Water Act (SDWA) authorizes the Environmental Protection Agency (EPA) to regulate contaminants, including pharmaceuticals, in public drinking water systems if they may adversely affect human health among other criteria. Pharmaceuticals may enter drinking water supplies from several pathways, including discharge from wastewater facilities. GAO was asked to provide information on the (1) extent to which pharmaceuticals occur in drinking water and their effects, if any, on human health; (2) U.S. and other countries' approaches to reducing their occurrence; and (3) challenges, if any, that EPA faces in determining whether to regulate pharmaceuticals. GAO reviewed federal and peer-reviewed reports, and surveyed a nonprobability sample of five U.S. programs designed to properly dispose of pharmaceuticals. We selected these programs based on geographic diversity and program characteristics. We also researched such programs in two countries, and interviewed scientists and agency officials.

What GAO Found

Research has detected pharmaceuticals in the nation's drinking water. National and regional studies by the U.S. Geological Survey, EPA, and others have detected pharmaceuticals in source water, treated drinking water, and treated wastewater; but the full extent of occurrence is unknown. The concentrations detected for any one pharmaceutical were measured most frequently in parts per trillion. Research has not determined the human health effects of exposure to these concentrations of pharmaceuticals in drinking water. However, federal research has demonstrated the potential impact to human health from exposure to some pharmaceuticals found in drinking water, such as antibiotics and those that interfere with the functioning and development of hormones in humans. Some states and local governments as well as the Drug Enforcement Administration have taken actions that could reduce the extent to which pharmaceuticals occur in drinking water. These efforts have primarily been through drug take-back programs to encourage proper control and disposal of pharmaceuticals. Additional efforts have been adopted in Europe following the European Union's directive in 2004 requiring member states to have appropriate collection systems for unused or expired medicinal products. In addition to collection systems, Sweden also encourages actions such as writing small initial prescriptions to reduce the amount of pharmaceuticals that are disposed of if patients switch to a different pharmaceutical course. EPA faces challenges in obtaining sufficient occurrence and health effects data on pharmaceuticals and other contaminants in drinking water to support analyses and decisions to identify which, if any, pharmaceuticals should be regulated under SDWA. EPA is collaborating with the Food and Drug Administration and U.S. Geological Survey on research to help obtain such data but these efforts are largely informal. EPA officials said there is no formal mechanism, such as a long-term strategy or formal agreement, to manage and sustain these collaborative efforts. A recently expired interagency workgroup, which EPA co-chaired, initiated work on a research strategy to identify opportunities that will enhance collaborative federal efforts on pharmaceuticals in the environment, but its draft report did not contain key details about how the agencies will coordinate such collaborative efforts. GAO previously identified key practices for enhancing and sustaining collaboration among federal agencies, some of which may help clarify such coordination, such as establishing the roles and responsibilities of collaborating agencies; leveraging their resources; and establishing a process for monitoring, evaluating, and reporting to the public the results of the collaborative research efforts.

What GAO Recommends

GAO recommends that the Administrator of EPA establish a workgroup or other formal mechanism to coordinate research on pharmaceuticals and other contaminants in drinking water. EPA agreed with the recommendation.