Environmental Health: Action Needed to Sustain Agencies' Collaboration on Pharmaceuticals in Drinking Water
Published: 2011-08-08T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.
section_title: What GAO Recommends
paragraphs: 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.

section_title: Letter
paragraphs: In 2008, in response to increasing information arising from the scientific  community, the news media reported that pharmaceuticals had been  detected in the drinking water of 24 major metropolitan areas across the  United States. The concentrations detected were measured most  frequently in parts per trillion. The reports raised concerns about the  potential impact of these pharmaceuticals on human health and the  environment. Pharmaceuticals are a particular concern because they are  designed to interact with human or animal physiology. Much is known  about the therapeutic uses of pharmaceuticals, but little is known about  their potential risk to human health from long-term exposure through  drinking water. According to scientists, pharmaceuticals may enter the  environment and ultimately drinking water supplies in various ways, such  as through the elimination of human and animal waste, disposal of  unused medicines down the toilet or drain, veterinary drug usage, hospital  waste disposal, and industrial discharges.
Federal, state, and local governments, and other countries have taken  actions to reduce the extent to which pharmaceuticals enter the  environment through programs that encourage the proper disposal of  unused and expired pharmaceuticals. These programs are known as  take-back programs and in the United States they are also tied to efforts  to reduce drug abuse or accidental poisoning by removing expired  medicines from homes.
The Environmental Protection Agency (EPA) has the authority to regulate  some pharmaceuticals under several statutes, including its responsibility  for regulating the nation’s drinking water under the Safe Drinking Water  Act (SDWA). Pharmaceuticals are regulated by other agencies, including  the Food and Drug Administration (FDA) and in some cases the Drug  Enforcement Administration (DEA), but not as contaminants in drinking  water.
To help understand the human health and ecological effects of  pharmaceuticals in the environment, a workgroup of federal scientists  was established in 2006 to identify and prioritize research to better  understand the risk from pharmaceuticals in the environment and to  recommend areas for federal collaboration to address those priorities.  The workgroup, known as the Pharmaceuticals in the Environment (PiE)  workgroup, produced a draft report in the spring of 2009 that was never  finalized or publicly released.
In this context, you asked us to review the scientific literature and assess  efforts to address pharmaceuticals in drinking water. Our objectives 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 EPA faces in  determining whether any pharmaceuticals should be regulated under  SDWA, actions EPA is taking to address these challenges, and options  for addressing such challenges in the future.
To identify the extent to which pharmaceuticals occur in drinking water  and their potential effects on human health, we reviewed federal and  peer-reviewed reports, including (1) studies by the U.S. Geological  Survey (USGS), (2) articles in scientific journals, and (3) the PiE  workgroup’s draft report. We also interviewed scientists and other officials  from federal agencies, as well as representatives from the pharmaceutical  industry. Additionally, we attended an October 2009 academic conference  on hormones and related compounds in the environment. To describe the  approaches taken in the United States and in other countries to reduce  the extent to which pharmaceuticals occur in drinking water; we reviewed  literature and spoke with experts; from these efforts, we identified  consumer take-back programs as the primary approach to reducing  occurrence in the United States. We selected a nonprobability sample of  five U.S take-back programs to provide geographic and program diversity;  the information from these programs is not generalizeable to all take-back  programs and offers examples of how these programs can operate . We  also chose to describe efforts by Sweden and Australia to reduce the  occurrence of pharmaceuticals in drinking water. We selected Sweden  because it engages in a variety of activities to reduce the occurrence of  pharmaceuticals in drinking water. We selected Australia because it has a  national take-back program. To identify challenges, if any, that EPA faces  in determining whether any pharmaceuticals should be regulated under  SDWA, actions EPA is taking to address these challenges, and options  for addressing such challenges in the future, we reviewed documentation  related to EPA’s implementation of SDWA and interviewed EPA and other  federal officials knowledgeable about challenges EPA is facing in  implementing SDWA. We also reviewed the PiE workgroup’s 2009 draft  report and interviewed workgroup members and Office of Science and  Technology Policy (OSTP) officials. We also reviewed our own work on  practices that can help enhance and sustain interagency collaboration. A  more detailed description of our scope and methodology is presented in  appendix I.
We conducted this performance audit from January 2010 through August  2011 in accordance with generally accepted government auditing  standards. Those standards require that we plan and perform the audit to  obtain sufficient, appropriate evidence to provide a reasonable basis for  our findings and conclusions based on our audit objectives. We believe  that the evidence obtained provides a reasonable basis for our findings  and conclusions based on our audit objectives.
subsections: section_title: Background
paragraphs: This section presents information on (1) the ways in which  pharmaceuticals may enter drinking water, (2) pharmaceuticals in drinking  water as a contaminant of emerging concern, (3) the degree to which  relevant environmental statutes regulate pharmaceuticals, and (4) the  establishment of the PiE workgroup.
subsections: section_title: Pharmaceuticals May Enter Drinking Water through Different Pathways
paragraphs: Scientists have identified numerous pathways by which pharmaceuticals  may enter the environment and ultimately drinking water supplies.  According to USGS scientists, the main source of human  pharmaceuticals in the environment is likely treated wastewater from  households, industry, and commercial facilities. Biosolids from  wastewater treatment plants applied to land as fertilizer may also be a  source of human pharmaceuticals in the environment. Septic systems  may be a source of human pharmaceuticals in ground water. A potential  source of veterinary pharmaceuticals is agricultural facilities where large  numbers of food-producing animals (such as chickens, cattle, and swine)  are treated with pharmaceuticals. The pharmaceuticals enter the  environment either directly from waste storage structures as a result of  accidents or weather conditions, or through the application of manure and  liquid waste to croplands.
Figure 1 illustrates the different pathways by which pharmaceuticals may  enter drinking water supplies.
EPA considers pharmaceuticals in drinking water to be a contaminant of  emerging concern (also called emerging contaminants). The term is not  defined in regulation, and EPA does not maintain a list of contaminants that  are considered contaminants of emerging concern. In this report, the term  refers to a wide range of contaminants for which the risk to human health  and the environment associated with their presence, frequency of  occurrence, or source may not be known. In some cases, the release of  contaminants of emerging concern into the environment has likely occurred  for a long time but may not have been recognized until new detection  methods were developed. In other cases, the synthesis of new chemicals  or changes in the use and disposal of existing chemicals can create new  sources of contaminants of emerging concern. Other contaminants of  emerging concern can include personal care products (e.g., sunscreen,  antibacterial soap, synthetic musks); chemicals used in industry (e.g., flame  retardants, stain resistant coatings); and chemicals used in agriculture  (e.g., pesticides that may act as endocrine disrupting chemicals (EDC)).
section_title: The Degree to which Relevant Environmental Statutes Regulate Pharmaceuticals
paragraphs: Most pharmaceuticals are not currently regulated under EPA programs  implementing key environmental laws. SDWA, the Resource  Conservation and Recovery Act of 1976 (RCRA) and the Clean Water Act  provide EPA with authority to regulate pharmaceuticals meeting certain  criteria in drinking water, waste, and wastewater discharges.
Under SDWA, EPA is authorized to regulate contaminants, including  pharmaceuticals, meeting certain criteria in public drinking water systems.  In 1996, Congress amended SDWA to require EPA to select for  consideration those unregulated contaminants that present the greatest  public health concern, evaluate their occurrence and the potential health  risks associated with them, and decide whether a regulation is needed for  at least five contaminants every 5 years. This regulatory determination  process includes EPA’s publication in the Federal Register of a  preliminary decision on whether the agency will propose a drinking water  regulation for each contaminant evaluated—called a preliminary  regulatory determination—and provides for a public comment period,  followed by a final decision, or regulatory determination, also published in  the Federal Register. The 1996 amendments also require EPA to identify  and publish a list every 5 years of unregulated contaminants for drinking  water that may require regulation—called the Contaminant Candidate  List. The Administrator must decide whether to regulate at least five of the  contaminants on the candidate list every 5 years. These decisions are  called regulatory determinations. SDWA specifies that EPA is to regulate  a contaminant if the Administrator determines that  the contaminant may have an adverse effect on the health of persons;  the contaminant is known to occur or there is a substantial likelihood  that the contaminant will occur in public water systems with a  frequency and at levels of public health concern; and  in the sole judgment of the Administrator, regulation of such  contaminant presents a meaningful opportunity for health risk  reduction for persons served by public water systems.
Since 1996, EPA has completed two regulatory determination cycles—in  2003 and 2008. During this time, EPA conducted 20 regulatory  determinations and found that none met the criteria requiring regulation.  In 2011, EPA made an out-of-cycle regulatory determination, concluding  that perchlorate, an ingredient in rocket fuel and other products that can  interfere with the normal functioning of the thyroid gland, met the criteria  requiring regulation. EPA has made no regulatory determinations for  pharmaceuticals. EPA published the third candidate list in October 2009  but has not yet made any regulatory determinations or completed the  third regulatory determination cycle.
To determine which contaminants to include on the third candidate list,  EPA developed a multistep process, based on available data, to  characterize occurrence and adverse health risks a contaminant may  pose to consumers of public water systems. Starting with a list of almost  26,000 unique chemicals, EPA identified a universe of about 6,000  potential drinking water contaminants for consideration based on the  availability of occurrence and health effects data. Of these, 287 were  pharmaceuticals. Then, using the available data, EPA employed  successively more detailed evaluations—as well as expert opinions and  comments from the public—to identify the 116 contaminants that it  included on the third candidate list—12 of these contaminants are  pharmaceuticals. Table 1 identifies the 12 pharmaceuticals.
In a May 2011 report, we identified systemic limitations in EPA’s  implementation of the 1996 amendments’ requirements for determining  whether additional contaminants in public drinking water warrant regulation  and made 17 recommendations to EPA for implementing the requirements  in a way that better assures the public of safe drinking water. Among other  things, we recommended that EPA (1) develop criteria and a process for  identifying those contaminants on its candidate list that present the greatest  public health concern and (2) develop a coordinated process for obtaining  both the occurrence and health effects data that may be needed for the  agency to make informed regulatory determinations on these priority  contaminants. EPA did not agree to adopt these recommendations and  generally took the position that no further steps are needed.
RCRA established federal requirements and EPA regulatory authority for  “cradle-to-grave” management of hazardous wastes, as well as a program  for state oversight of nonhazardous solid waste with federal minimum  regulations for landfills. RCRA and its implementing regulations establish  several means by which waste may be deemed hazardous, including  specifically being listed by EPA as a hazardous waste or by exhibiting one of  the following four characteristics: toxicity, ignitability, corrosivity, or reactivity.  According to EPA’s August 2010 draft guidance and a proposed rule  concerning management of hazardous pharmaceutical wastes in the Federal  Register, more than 30 active pharmaceutical ingredients are considered  listed hazardous wastes under RCRA. In addition, other pharmaceuticals  may be considered to be hazardous waste when disposed if they have  certain characteristics (e.g., they are likely to leach concentrations of any 1 of  40 different toxic chemicals in amounts above the specified regulatory  levels). Examples of these chemicals that have pharmaceutical uses include:  arsenic, barium, cadmium, and chloroform. EPA has estimated that about 5  percent of all pharmaceutical waste is hazardous waste.
The disposal of pharmaceuticals meeting the RCRA hazardous definition is  generally subject to RCRA requirements, such as reporting, using a  manifest, and disposing of the waste in approved ways, such as through  hazardous waste incineration; however, household trash is exempted.  Noting that implementing existing regulations may be difficult for healthcare  facilities such as hospitals and nursing homes and that the streamlined  requirements would help avoid mismanagement, in 2008 EPA proposed to  add hazardous waste pharmaceuticals to the Universal Waste Rule, which  simplifies RCRA requirements for certain hazardous wastes. Under the  proposed rule, manifests would not be required and other requirements  may be simplified. EPA estimated the rule could affect over 600,000  entities. According to EPA’s Web site on the proposed rule, stakeholders  commenting on the proposal expressed concerns that including hazardous  pharmaceutical wastes under the Universal Waste Rule would eliminate  some requirements, such as notification and use of a manifest, that  currently apply to such wastes. EPA officials also told us the agency has  begun considering additional regulatory options to address these and other  issues but that EPA has no projected date for issuing a final rule.
The Clean Water Act is the primary federal law concerning pollution of the  nation’s waters. Under the act, EPA is required to establish and revise  national water quality criteria that accurately reflect the latest scientific  knowledge about the effects of pollutants on aquatic life and human  health. These criteria represent maximum concentrations that would not  cause an unacceptable effect on aquatic life and represent the levels at  which specific chemicals are not likely to adversely affect human health.  Criteria are elements of state water quality standards, expressed as  constituent concentrations, levels, or narrative statements, representing a  quality of water that supports a particular use. When criteria are met,  water quality will generally protect the designated use. States, or in  some instances EPA, use these criteria to adopt and revise water quality  standards for designated uses—such as drinking, swimming, or fishing— for water bodies. States may use EPA’s national criteria, modify them to  site-specific criteria, or adopt other scientifically defensible criteria. States  are required, as part of 3-year reviews, to adopt water quality standards  for each of the toxic pollutants for which EPA has promulgated water  quality criteria. Water quality standards play a critical role in the act’s  framework, potentially affecting effluent limitations dictated by permits  and requirements for state reporting and pollution control planning.
Regarding permits, EPA and delegated states administer the Clean Water  Act’s National Pollutant Discharge Elimination System program, which  limits the types and amounts of pollutants that industrial and municipal  wastewater treatment facilities may discharge into the nation’s surface  waters. Facilities such as municipal wastewater treatment plants and  pharmaceutical plants require a permit if they discharge into surface  waters. Certain agricultural facilities—known as concentrated animal  feeding operations—also need a permit, but other agricultural operations  do not. EPA and delegated states issue discharge permits that are to set  conditions in accordance with technology-based effluent limitations EPA  established for various categories of discharges. EPA has issued effluent  limitation regulations for pharmaceutical manufacturing facilities as well  as pretreatment regulations applicable when these facilities discharge into  a publicly owned wastewater treatment plant. These regulations currently  do not include limitations for any pharmaceutical constituents in  wastewater; rather, the regulations set limitations for conventional  pollutants, priority toxic pollutants, and selected nonconventional  pollutants—mainly solvents used in manufacturing. Similarly, EPA’s  regulation for concentrated animal feeding operations does not contain  specific limitations for veterinary pharmaceuticals.
At present, EPA has not developed specific water quality criteria under the  Clean Water Act for most pharmaceuticals; hence, there are no water  quality standards for most pharmaceuticals, and permits do not contain any  limitations for them. EPA’s current national criteria include one pollutant  identified as being used as a pharmaceutical—lindane. In January  2010, the Center for Biological Diversity, a nonprofit environmental  organization, petitioned EPA to revise its water quality criteria for lindane,  and to establish water quality criteria for 34 other pharmaceutical and  personal care products. EPA told us the agency is considering the petition  and expects to issue a response by mid 2011. If EPA were to establish  water quality criteria for one or more additional pharmaceuticals, then  states would need to adopt water quality standards reflecting the new or  revised criteria, and the standards would be considered in permit decisions  as well as in states’ water quality management plans.
In August 2010, EPA’s Office of Water released a draft guidance  document for health care facilities, Best Management Practices for  Unused Pharmaceuticals at Health Care Facilities. The nonbinding  document recommends management practices, such as methods to  reduce the quantity of unused pharmaceuticals, and explains applicable  disposal requirements for those pharmaceuticals that are hazardous.  EPA’s goal for the guidance document is to keep pharmaceuticals out of  U.S. waters, particularly by minimizing their disposal into sewers.  According to agency officials, EPA expects to issue a final guidance  document by the end of 2011.
section_title: Workgroup Addressing Pharmaceuticals in the Environment Was Established within the National Science and Technology Council
paragraphs: The PiE workgroup was established in 2006 by the Committee on  Environment, Natural Resources, and Sustainability (CENRS), Toxics and  Risk Subcommittee, an executive branch entity under the National  Science and Technology Council (NSTC). NSTC is a council of cabinet- level officials chaired by the President and managed by the Director of  OSTP. The purpose of the workgroup was to identify and prioritize  research needed to better understand the risk from pharmaceuticals in  the environment and to recommend areas for federal collaboration to  address those priorities. The workgroup, which was intended to be  temporary, was staffed by scientists from eight federal agencies. EPA,  FDA, and USGS scientists served as co-chairs. In May 2009, the PiE  workgroup produced a draft report but it was never finalized because of a  disagreement between OSTP and the workgroup over what should be  included in the final report.
section_title: Pharmaceuticals Have Been Found in Drinking Water, but Their Prevalence and Effects on Human Health Are Largely Unknown
paragraphs: Although research has confirmed the presence of pharmaceuticals in  drinking water throughout the nation, the full extent of their occurrence is  unknown. Research on the human health effects of exposure to these  pharmaceuticals is largely unknown but the effects of some compounds  have raised concern among some scientists, the public, and policy  makers.
subsections: section_title: Research Has Confirmed the Presence of Some Pharmaceuticals in Drinking Water
paragraphs: Research has detected pharmaceuticals in the nation’s drinking water.  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.
As part of its Toxic Substances Hydrology Program, USGS conducted  four reconnaissance studies that were national in scope (national  reconnaissance studies) to study the occurrence and distribution of  emerging contaminants, including pharmaceuticals, in the environment.  For each study, USGS chose to sample water from locations that it  believed were more likely to have pharmaceuticals and other  contaminants present.
One study specifically focused on untreated source water used by public  drinking water systems. For example, samples were collected from wells  and near surface water intakes that supplied the water systems. For this  study, USGS collected water samples from 74 locations in 25 states and  Puerto Rico in 2001. These locations provide drinking water to  populations ranging from one family to over 8 million. The study  reported testing for the presence of 100 contaminants, including 36  pharmaceuticals. USGS found that 53 of the 74 locations had one or  more pharmaceuticals in the water, and 40 percent of the  pharmaceuticals analyzed were detected at one or more of these  locations. Figure 2 shows the location of sample sites and the sites at  which USGS detected pharmaceuticals.
Figure 3 shows the pharmaceuticals that USGS reported detecting in its  study of untreated sources of public drinking water.
The other three national reconnaissance studies that USGS conducted  focused on (1) surface water, (2) ground water, and (3) stream  sedimentation. The four USGS national reconnaissance studies tested  for a similar, but not identical, suite of pharmaceuticals and other  contaminants and all of the studies reported detecting pharmaceuticals  and other contaminants.
In addition to its national studies, USGS has undertaken a number of  local and regional studies as part of its reconnaissance effort to provide  information on the sources, occurrence, and transport of contaminants  of emerging concern, including pharmaceuticals. These studies have  reported similar results—finding pharmaceuticals in source water. For  example, in a 2009 study, USGS, in cooperation with the Oregon  Department of Environmental Quality and Deschutes County  Environmental Health Division, collected and analyzed water samples  from ground water near La Pine, Oregon. The study reported detecting  8 of the 18 pharmaceuticals for which it tested. The study also reported  testing for and finding other contaminants.
In addition to USGS, other research groups have conducted studies to  detect pharmaceuticals and other contaminants in source water, with  results that are similar to those of USGS. Specifically:    The New York City Department of Environmental Protection reported  finding pharmaceuticals and personal care products in the low, part- per-trillion range in a 2010 study of the Catskill, Croton, and Delaware  untreated source waters that contributed to New York City’s water  supply.    The National Water Research Institute funded a study testing for 50  contaminants such as pharmaceuticals and organic wastewater  contaminants in three watersheds supplying drinking water to more  than 25 million people in California. The study analyzed 126  samples taken from 32 locations at various points in the watershed,  including upstream and downstream from wastewater treatment plant  discharges over a 1-year period, from April 2008 through April 2009.  Overall, at least 1 contaminant was found in all but one of the  samples. The study further reported that concentrations of  contaminants were higher downstream of the wastewater treatment  plants and concluded that the plant discharges were likely the main  source of these contaminants in the environment.
Although USGS studies have focused on source water, other studies  have detected pharmaceuticals and other emerging contaminants in  treated drinking water. For example:    A 2008 study funded by the American Water Works Association  Research Foundation and the WateReuse Foundation tested for 51  potential contaminants including 20 pharmaceuticals and  pharmaceutical metabolites in drinking water in 19 drinking water  treatment plants across the United States. The study reported  detecting 9 of the 20 pharmaceuticals and metabolites at all of the  locations tested. These plants provide drinking water for over 28  million Americans.    EPA funded a 2010 meta-analysis of 48 publications and found that  54 active pharmaceutical ingredients and 10 metabolites have been  detected in treated drinking water. The analysis notes that of the 64  substances that have been detected, only 36 have corroborative data  from at least a second study.
In addition to source and treated drinking water, USGS and others have  tested the effluent of wastewater treatment plants and animal feeding  operations, two sources that are thought to be significant contributors of  contaminants to streams and other sources of drinking water. Specifically:    Treated wastewater. A 2005 study by USGS and EPA collected water  samples upstream and downstream of wastewater treatment plants at  10 different locations totaling 40 sampling sites across the United  States. The agency tested for the presence of 110 chemicals,  including industrial wastewater compounds and pharmaceuticals and  related chemicals. Specifically, the study reported finding  nonprescription pharmaceuticals in over 40 percent of the samples;  prescription, nonantibiotic pharmaceuticals in over 30 percent of  samples; and antibiotics in fewer than 10 percent of all samples. The  study’s results demonstrated an increase in the frequency of detection  and concentration of most of the pharmaceuticals, and other chemical  compounds, in the treatment plants’ effluent as compared to water  samples collected upstream of these plants; however, the chemical  concentrations and occurrences decreased downstream from the  treatment plants.    Animal feeding operations. A study published in 2002 reported finding  concentrations of antimicrobial agents in surface and ground water  near large-scale poultry and swine farms, and concluded that animal  waste likely acted as a source for antimicrobial residues in nearby  water resources. Specifically, the study noted that livestock receive  antimicrobials both in therapeutic and nontherapeutic doses (i.e., in  their feed), and that these compounds can be excreted into the  environment.    Pharmaceutical manufacturing facilities. A 2010 USGS study of  emerging contaminants in wastewater treatment plant effluents found  that wastewater treatment plants that receive discharge from  pharmaceutical manufacturing facilities had 10 to 1,000 times higher  concentrations of pharmaceuticals (including opioids, muscle  relaxants, and a barbiturate) than typically found in wastewater  effluents. Maximum concentrations of some pharmaceuticals were in  the part per million range.
section_title: Research Has Not Determined the Human Health Effects of Pharmaceuticals in Drinking Water, but Some Research Raises Concerns
paragraphs: 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.
Uncertainty persists regarding whether pharmaceuticals in drinking water  pose a risk to human health, and research has pointed to different  conclusions. For example, in its April 2008 testimony before the Senate  Committee on Environment and Public Works, the Pharmaceutical  Research and Manufacturers of America, a trade association for the  leading research-based pharmaceutical and biotechnology companies,  cited a peer-reviewed study for which it provided financial support that  concluded there was no demonstrable health risk to exposure to 26  pharmaceuticals detected by USGS in one of its national reconnaissance  studies. The study reached its conclusions by comparing an estimate  of human exposure from drinking water and/or ingesting fish for each  pharmaceutical to the acceptable daily intake (ADI) for that pharmaceutical.  ADI is an estimate of the daily amount of pharmaceuticals that can be  ingested by a healthy adult of normal weight and that should not result in  an adverse health effect. In this instance, the ADI was derived from data  developed by pharmaceutical manufacturers when testing the effectiveness  and safety of a therapeutic dose of the pharmaceutical.
Other research has emphasized the absence of data and lack of  knowledge regarding the health effects of pharmaceuticals in the  environment. For example, research funded by EPA notes that risk  assessments based on benchmarks such as ADIs generally conclude that  there is negligible risk from exposure to pharmaceuticals through drinking  water but that benchmark levels such as ADI are orders of magnitude  higher than the exposure levels and may not take into account less  obvious, nontherapeutic effects. This research notes that despite the  lack of empirical data linking pharmaceuticals in drinking water to adverse  human health effects, the issue remains one of interest because of the  unanswered questions concerning low-dose exposure to contaminants of  emerging concern, including but not limited to pharmaceuticals. Some of  the most significant unanswered questions identified in the research are:    What is the potential for biological effects of long-term, low-dose  exposure to pharmaceuticals, including for sensitive subpopulations  such as children and in utero exposure?    What are the effects of mixtures of pharmaceuticals, both additive and  interactive?    How do pharmaceuticals interact with the many other contaminants— both man-made and naturally occurring—that may be present in  drinking water?    Are there transgenerational effects (i.e., present in successive  generations)?
The human health effects of pharmaceuticals in drinking water have not  been conclusively shown, but research showing an impact on aquatic life  raises concerns about two classes of pharmaceuticals—EDCs and  antibiotics. Some of the concern about EDCs in drinking water stem from  studies that have documented the abnormalities associated with aquatic  life exposed to EDCs in rivers and lakes. Specifically, scientists have  expressed concern because of both the significance of the abnormalities  and the effects of contaminants on animals, which can be indicative of  similar effects on humans. For example:    A 2007 study reported that 75 percent of male smallmouth bass in  certain areas of the South Branch of the Potomac River basin had  ovarian tissue in their gonads. The study concluded that a  combination of EDCs was likely to have caused the feminization of the  male fish. Although the authors note that the actual EDCs responsible  for the abnormalities could not be determined, they suggest that a  combination of contaminants could be the cause and noted that the  additive effects of many EDCs have been demonstrated even when  each compound present is below the threshold of detectable effects.
The authors further noted that reproductive abnormalities in fish are  frequently associated with human wastewater effluent, which contains  synthetic estrogens found in birth control and hormone replacement  medications.
In another 2007 study by EPA and the Canadian government,  researchers reported conducting a 7-year whole-lake experiment to  test the effects on fathead minnows of chronic exposure to a synthetic  estrogen used in some birth control pills. The researchers reported  a collapse in the population of fathead minnows in the experimental  that  lake and concluded that the results from the study demonstrate  continued introduction of estrogens and estrogen mimics to the  aquatic environment through municipal wastewaters could decrease  the reproductive success and sustainability of fish populations.    According to a 2004 research study, fish exposed to effluent from a  cattle feedlot in Nebraska experienced reproductive abnormalities,  including reduced testes size in male fish and a lower level of  estrogen in female fish. The study reported the use of androgens in  growth implants in the feedlot as one possible cause of the  abnormalities.
Not all EDCs found in drinking water, however, are pharmaceuticals.  Other contaminants, such as industrial chemicals and products, as well  as naturally occurring hormones found in plants and excreted by different  species, can also act as EDCs. Because other chemicals have also been  shown to have potential endocrine-disrupting effects, the extent to which  pharmaceutical EDCs contribute to detected abnormalities is unclear. For  example, bisphenol A (BPA), a nonpharmaceutical EDC, is used to make  polycarbonate plastics that are used in products such as compact disks,  baby bottles, plastic dinnerware, eyeglass lenses, and toys. In its paper  reporting 2003-2004 National Health and Nutrition Examination Survey  findings, the Centers for Disease Control and Prevention found BPA in  more than 90 percent of the urine samples representative of the U.S.  population 6 years of age and older. Another commonly occurring  nonpharmaceutical EDC is atrazine, the most commonly used herbicide  in the United States. In a 2003 study, scientists established a probable  chain of causation between exposure to small concentrations of atrazine  and the formation of female reproductive organs in frog testes.
A second class of pharmaceuticals that has raised concern about the  potential for health effects is antibiotics. In addition, some scientists are  concerned about antimicrobial resistance resulting from interactions  among chemicals, genes, microbes, animals, and humans in the  environment. For example, some studies have demonstrated that bacteria  exposed to pharmaceutical antibiotics and other antimicrobial agents in  the environment have increased resistance to pharmaceutical antibiotics.  However, the studies do not identify the extent to which pharmaceuticals  or other antimicrobial agents contribute to these resistant bacteria. For  example, triclosan and triclocarban, which are antimicrobials found in  antiseptics, can contribute to antimicrobial resistance. We recently  issued a report that, among other issues, discusses scientific evidence  supporting the association between antibiotic occurrence in the  environment and an increase in resistance among bacteria.
In addition to EDCs and antibiotics, other classes of pharmaceuticals  have been found in drinking water and garnered scientific attention.  Examples include chemotherapy drugs and selective serotonin reuptake  inhibitors, which are a class of pharmaceuticals used to treat depression.
section_title: The United States and Other Countries Are Engaged in Take-Back Programs to Help Prevent Pharmaceuticals from Reaching Drinking Water
paragraphs: 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. These efforts are often tied to efforts to reduce drug  abuse or accidental poisoning by removing expired medicines from the  home. Through outreach and education on proper drug disposal, EPA  has also taken steps to reduce the introduction of hazardous  pharmaceutical waste into water supplies. Other countries—including  Sweden and Australia—have undertaken additional efforts to reduce the  occurrence of pharmaceuticals in drinking water.
subsections: section_title: Consumer Drug Take-Back Programs Are Found Across the United States, and Congress and Others Are Considering Additional Efforts
paragraphs: Federal agencies do not have comprehensive data on the number of  take-back programs across the United States, but EPA and the Product  Stewardship Institute, Inc. collectively identified 25 states that have had  one or more take-back programs. In addition, DEA has held two  nationwide take-back programs—in September 2010 and April 2011— and a third is planned for October 29, 2011.
Take-back programs are organized by a wide variety of stakeholders,  including environmental groups, those with interests in preventing  prescription drug abuse, and government entities (app. II provides federal  guidelines on the proper disposal of pharmaceuticals). According to  experts and program organizers we interviewed, the goals for  implementing these programs include preventing drug abuse and  accidental poisoning, as well as preventing unused pharmaceuticals from  entering the environment. Pharmaceuticals collected through take-back  programs are incinerated.
Through a survey of the literature and interviews with experts, we  determined that take-back programs generally fall into one of three broad  categories: (1) ongoing, (2) one-time, and (3) mail-back. To illustrate the  three categories, we selected five take-back programs to review more  closely. Figure 4 describes these five programs.
As the figure shows, the following two programs are ongoing:    Utah’s Proper Medication Disposal Program. Consumers can leave  unused pharmaceuticals in drop boxes at participating law  enforcement agencies. The program collected over 5,600 pounds of  pharmaceuticals, including packaging, from June 2009 to June 2010.  It received $70,000 in grants from EPA and the Utah Department of  Environmental Quality. The program costs, not including in-kind  donations, were $40,000 from May 2007 to June 2010. According to  program representatives, the program will seek additional grants to  continue its efforts once it has spent the money from its current  grants.    Washington State’s PH:ARM Pilot (Pharmaceuticals from  Households: A Return Mechanism). PH:ARM began as a pilot project  in 2006 with over 37 participating pharmacies in six counties.  Consumers drop off their unused pharmaceuticals in secure drop  boxes at pharmacies. From October 2006 to October 2008, the  program collected over 15,000 pounds of pharmaceuticals, including  packaging, at a cost of approximately $170,000. According to program  representatives, grant funding for the initial pilot project has ended,  but the pharmacies have chosen to continue to collect unused  pharmaceuticals on their own. Legislation proposed in the state  legislature would have required pharmaceuticals manufacturers to pay  for take-back programs in the state; however, the legislation failed a  state senate vote in 2011.
We also identified one-time take-back events. These events are often  organized by local communities and operate for a day, several days, or  several weeks. For example:    Bay Area Pollution Prevention Group. This group, a consortium of 43  wastewater agencies in the San Francisco Bay Area, piloted a week- long take-back program called “Safe Medicine Disposal Days” in May  2006. Consumers were invited to drop off pharmaceutical waste at 39  locations, including pharmacies, law enforcement offices, household  hazardous waste facilities, and senior and civic centers. Over the  course of the event, more than 1,500 residents disposed of over 3,600  pounds of pharmaceuticals. The event cost around $180,000,  including administrative costs, and was funded by local agencies,  cities, counties, and wastewater treatment plants.    Amarillo and Canyon, Texas, “Medication Cleanout™” (MCO)  program. Three 1-day events were conducted between September  2009 and July 2010. These events were organized and funded by the  Texas Panhandle Poison Center of Texas Tech University Health  Sciences Center School of Pharmacy, the Amarillo Independent  School District’s Safe Schools Healthy Students program, and the  Amarillo Police Department. Medication Cleanout provided consumers  with drive-through drop-off points in order to return their unused  pharmaceuticals without leaving their cars. The cost for the  September 2009 event—the only date for which cost data are  available—was approximately $44,000, and organizers reported that  approximately 1,900 pounds of pharmaceuticals, including some  packaging, were returned for all three events. Program organizers  indicated that similar 1-day, drive-through events would be planned  for the future.
Mail-back programs allow consumers to use the Postal Service to dispose  of unused pharmaceuticals. For example, in 2008, Maine implemented a  2-year mail-back pilot program—called “Safe Medicine Disposal for ME.”  The program distributed postage-paid return envelopes to pharmacies  and health and social service agencies across the state to be given to  consumers. The envelopes contained instructions for how to properly  return the pharmaceuticals, including how to remove personally  identifying information from prescription bottles before mailing the unused  pharmaceuticals. The pharmaceuticals were sent to the Maine Drug  Enforcement Agency for proper disposal. Between May 2008 and  October 2009, the program collected more than 2,600 pounds of  pharmaceuticals, including packaging. Organizers reported that some of  the prescriptions returned were over 20 years old. The program was  initially funded with a $150,000 EPA grant and has since received  $150,000 from the Fund for Healthy Maine that will allow the program to  operate into 2011. Program organizers stated that their main goals for  implementing the program were to prevent poisonings and drug abuse,  but that 77 percent of respondents to a survey included with the  envelopes distributed by the program reported that they participated  because they were concerned about the environment.
According to DEA, its two nationwide take-back events—in September  2010 and April 2011—collected more than 300 tons of pharmaceuticals at  thousands of sites across the country.
Although the U.S. take-back programs differ in how they are  implemented, organizers of the events have faced similar challenges. For  example, according to experts and organizers of the take-back programs  we spoke with, these programs have been hampered by legal restrictions  and limited funding, although the legal restrictions are being addressed.  These experts and organizers told us that collecting controlled  substances was resource intensive because, until recently, according to  DEA the Controlled Substances Act made it was unlawful for the recipient  of a controlled substance to give that substance to anyone other than law  enforcement, even for the purposes of disposal. Thus, consumers were  prohibited from returning unused controlled substances to their pharmacy  or doctor. Any take-back program that intended to collect controlled  substances had to arrange for law enforcement to receive the unused  controlled substances and maintain custody of them until they were  destroyed.
However, in October 2010 the Secure and Responsible Drug Disposal  Act was enacted amending the Controlled Substances Act. The act gives  DEA the authority to issue regulations allowing communities and others to  establish secure disposal programs for unused controlled substances. It  also authorizes DEA to permit long-term care facilities to dispose of  controlled substances on behalf of consumers who no longer need them.  According to the Deputy Assistant Director of DEA’s Office of Diversion  Control, DEA strongly supported this legislation and anticipates issuing a  notice of proposed rulemaking in the fall of 2011.
According to experts and program organizers, take-back programs are  also hampered by limited funding. Programs use a combination of in-kind  contributions, volunteer time, grants, and local funding sources to pay for  their programs. For example, between 2004 and 2008, EPA awarded 25  grants—totaling $926,972—to support take-back programs; these grants  ranged from approximately $10,000 to $150,000. In addition, at least one  state has previously proposed legislation that would require  pharmaceutical manufacturers to fund take-back programs. As of March  2011, no such state legislation had been enacted.
section_title: Other Countries Also Support Take-Back Programs
paragraphs: In 2004, the European Union (EU) issued a directive to its member states  to, among other things, ensure that appropriate collection systems are in  place for medicinal products that are unused or have expired in light of  the potential risks presented by these pharmaceuticals for the  environment.” Three years later, in 2007, the European Federation of  Pharmaceutical Industry Associations surveyed 27 EU member states on  their implementation of programs to collect unused pharmaceuticals. Of  the 22 national pharmaceutical associations responding to the survey, 19  reported they had a pharmaceutical waste collection program, and most  of these 19 associations reported that the programs operate nationwide.  In 6 of the 19 programs, the pharmaceutical industry funds all costs  associated with collecting and destroying unused pharmaceuticals.
Sweden is an example of an EU country that has taken additional steps to  reduce the occurrence of pharmaceuticals in drinking water. Sweden’s  efforts are supported by its government; pharmacies (most of which are  publicly owned) are now obligated to take back all unused or expired  pharmaceuticals and safely incinerate them. In 2009, 1,128 tons of  pharmaceuticals, including packaging, were returned and destroyed.  Sweden has also taken the following actions:    Classifying pharmaceuticals according to how toxic they would be if  they were released into the environment. According to a Swedish  official, in 2004, officials from pharmaceutical producers and  Sweden’s health care system created an environmental classification  system for pharmaceuticals to provide doctors and patients with  information about the environmental effects of pharmaceuticals.  Sweden developed this system by using risk and hazard data  submitted by pharmaceutical manufacturers on their products. These  data were then evaluated by an independent consulting firm, which  provided an approval or disapproval for the proposed risk and hazard  levels. The pharmaceuticals’ risk and hazard determinations used the  following criteria: biodegradability, potential to accumulate in the body,  and toxicity to aquatic organisms. Individual jurisdictions throughout  Sweden then used these results to compile lists of pharmaceuticals  recommended for specific ailments, and doctors may consider these  lists when prescribing pharmaceuticals. In addition, at least one  pharmaceutical company has indicated that it is pursuing initiatives to  produce less toxic and more environmentally friendly  pharmaceuticals.    Encouraging initial prescriptions in smaller amounts. According to  data from Sweden, in 2005 and 2006, nearly 40 percent of the  pharmaceuticals collected were unopened, and the remaining  packages were still nearly two-thirds full, suggesting that patients may  be buying more pharmaceuticals than they need. As a result, the  public providers of healthcare encourage doctors to prescribe smaller  initial prescriptions so that patients and their physician can determine  if the pharmaceutical will work for the patient. This practice may  reduce the amount of pharmaceuticals that are disposed of when  patients switch to different pharmaceuticals.
According to one knowledgeable Swedish official, Sweden adopted these  policies—even though there is no scientific evidence that the occurrence  of pharmaceuticals in the environment is affecting human health—as a  result of its adherence to the “precautionary principle.” This principle  states that action should be taken without waiting for the certainty of  causation when an appropriate level of scientific evidence suggests an  association between hazardous environmental exposures and ill health.  According to the principle, action should be taken preventively because  definitive knowledge about causation might take decades of further  research.
Outside of the EU, Australia has a national take-back program—”Return  Unwanted Medicines” (RUM). RUM is a national, government-financed  program that allows consumers to return unwanted or expired  pharmaceuticals to participating pharmacies. Educational materials from  the RUM program instruct consumers that they should not dispose of  pharmaceuticals in the trash, in the toilet, or in the sink. According to  RUM data from July 2009 through June 2010, the RUM project collected  1,075,957 pounds of pharmaceutical waste, including packaging, that  might otherwise have been disposed of through wastewater or in the  trash and risk contaminating the environment. A program representative  stated that RUM has been an integral component of Australia’s efforts to  advise consumers on all aspects of pharmaceutical consumption and  disposal.
section_title: Data Gaps Make It Difficult for EPA to Identify Pharmaceuticals for Regulation; Sustained Collaboration May Help EPA Address Such Difficulties
paragraphs: EPA faces challenges in obtaining sufficient occurrence and health  effects data to support analyses and decisions about which  pharmaceuticals to include on the Contaminant Candidate List as well as  to make regulatory determination decisions. 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. We previously reported key practices for enhancing  and sustaining collaboration among federal agencies that may be an  option to help institutionalize an approach for conducting research that  leverages resources among the agencies. We recommended that the  Director of the Office of Management and Budget continue to encourage  interagency collaboration by among other things, promoting and  collaboration practices identified in GAO’s report; the Office of  Management and Budget agreed with the recommendation.
subsections: section_title: EPA Faces Challenges Because of Gaps in Occurrence and Health Effects Data
paragraphs: EPA faces significant data gaps concerning both the occurrence and  health effects of pharmaceuticals. Sufficient occurrence and health effects  data are critical for EPA to assess pharmaceuticals for possible regulatory  determinations under the criteria established by SDWA. The difficulties  EPA experienced in evaluating pharmaceuticals to include on its most  recent Contaminant Candidate List, in 2009, illustrate the challenges EPA  faces in obtaining these data.
To evaluate pharmaceuticals for inclusion on its 2009 Contaminant  Candidate List, EPA identified two general types of occurrence data: first,  data on the actual detection of pharmaceuticals in source and treated  drinking water, and second, data on environmental releases and  production volumes of pharmaceuticals developed by industry and  government.
Source and treated drinking water: EPA occurrence data on  pharmaceuticals detected in untreated source water came from USGS’s  national reconnaissance study on surface water and related efforts.  These efforts provided data on 123 contaminants, including  pharmaceuticals. The data contain measurements of contaminants in  water but the data were from sample sites often chosen because they  were predicted to be the most likely place that pharmaceuticals and other  emerging contaminants would enter the environment (e.g., downstream  from wastewater treatment plants). The sample sites are not statistically  representative of average conditions across the nation. However, the  sites were geographically distributed and included a mix of characteristics  that were intended to provide a basic understanding of whether  pharmaceuticals and other contaminants are in the nation’s waterways.  According to EPA, the most relevant occurrence data are for treated  drinking water, but these data are often not available. EPA told us it  evaluated the available studies from the scientific literature that included  occurrence data for pharmaceuticals from treated drinking water, but  there were only a limited number of studies available and the majority of  these studies only sampled a limited number of drinking water systems.  Thus, to identify pharmaceuticals for inclusion on the most recent  candidate list, EPA instead relied on data on untreated source water.  Most Americans consume treated drinking water.
Environmental release and production volumes: EPA also obtained  occurrence data on pharmaceuticals from the Toxics Release Inventory  and the High Production Volume Chemical List. The Toxics Release  Inventory contains industry- and government-reported information on  chemical releases into the environment—air, land, and water; the High  Production Volume Chemical List contains production volume information  for chemicals manufactured or imported into the United States in  quantities greater than certain threshold amounts. However, EPA  considered these data sources to provide less meaningful information on  a chemical’s potential to occur in drinking water than sources that actually  detect the presence of chemicals in the environment, such as the USGS  data that it did use.
For the 12 pharmaceuticals that it included on its 2009 Contaminant  Candidate List, EPA reported it does not have comprehensive occurrence  data for treated drinking water for any of them and does not have an  analytic method suitable for conducting national drinking water studies for  7 of them. For the remaining 5 pharmaceuticals, EPA reports that it has or  is developing a suitable analytic method.
According to the Federal Register notice for the draft 2009 Contaminant  Candidate List, the primary source of health effects information on  pharmaceuticals in drinking water was the FDA database on maximum  recommended daily doses. This FDA database includes the  recommended doses for the “average adult patient” for over 1,200  pharmaceuticals and is based on human clinical trials of daily exposure,  usually for 3 to 12 months. The maximum recommended daily dose is an  estimated upper dose beyond which a pharmaceutical is not more  effective and/or adverse effects begin to outweigh beneficial effects.  However, according to EPA-sponsored research, extrapolating health  effects data from data on the therapeutic doses of individual  pharmaceuticals does not address, among other issues, the following two  areas of concern about pharmaceuticals in drinking water: the health  effects of (1) long-term, low-dose exposure to pharmaceuticals and (2)  exposure to mixtures of pharmaceuticals.    Effects of long-term, low-dose exposure to pharmaceuticals.
According to the EPA-sponsored research, the health effects of long- term, low-dose exposure to a pharmaceutical may not be predictable  by extrapolating from an observed effect of shorter-term exposure to  much higher concentration of that pharmaceutical. The research  indicates that further complications arise when trying to predict the  effects of exposure on sensitive sub-populations. For example, a child  in the age group between birth and 1 month might be particularly  sensitive to a contaminant during this life stage, during which the child  experiences rapid growth, weight gain, and immature immune system  function, among other characteristics, which can influence a child’s  susceptibility to a particular chemical.    Effects of exposure to mixtures of pharmaceuticals. Also according to  the EPA-sponsored research, the simultaneous exposure to multiple  pharmaceuticals could result in an additive or interactive effect. In  particular, studies on occurrence data have found more than one  contaminant in a single water sample. For example, the USGS  national reconnaissance study on surface water that EPA used to  identify contaminants for the most recent candidate list found that  there was a median of 7, and as many as 38, of the tested  contaminants in a given sample.
For the 12 pharmaceuticals that it included on the most recent candidate  list, EPA reported that it has substantial data needs on health effects for 8  of them. For the remaining 4 pharmaceuticals, EPA reports that  information exists or there is an ongoing assessment. Furthermore, as we  recently reported, EPA has not identified the drinking water contaminants  of greatest public health concern. In many cases, gathering sufficient data  to make a regulatory determination has taken EPA more than 10 years,  and obtaining data on other contaminants on the current list may well take  decades. We made recommendations regarding the need for EPA to  develop criteria to identify contaminants that pose the greatest health  concern and a process to obtain data to support regulatory  determinations; EPA did not agree to adopt these recommendations and  generally took the position that no further steps are needed.
section_title: EPA Is Collaborating with Other Agencies to Obtain Needed Occurrence and Health Effect Data on Pharmaceuticals, but It Has not Established a Formal Mechanism to Sustain Future Collaboration
paragraphs: EPA is collaborating with other federal agencies to collect occurrence and  health effects data on pharmaceuticals and other contaminants that could  support decisions about which contaminants to include on future  candidate lists as well as regulatory determinations. As the following  examples demonstrate, collaboration is helping EPA leverage the  resources and expertise of other agencies to obtain results that may have  been more difficult for it to achieve on its own.    EPA and USGS are jointly developing occurrence data for over 230  contaminants, more than half of which are pharmaceuticals, in a study  designed to provide EPA with data for future candidate lists. The  agencies’ joint study will sample treated drinking water and source  water in about 25 drinking water treatment plants across the nation.  These plants were selected because they draw water from streams,  lakes, reservoirs, or ground-water aquifers affected by a variety of  waste sources (e.g., municipal waste, septic systems, livestock  production). EPA is providing expertise to analyze micro-organisms,  and has experience with drinking water treatment facilities and their  design. USGS is providing its expertise in the logistics of operating a  nationwide water sampling project. Both agencies have expertise in  detecting low concentrations of pharmaceuticals and other  contaminants of emerging concern. The study is expected to conclude  in September 2012.    EPA is working with FDA to develop a methodology to more efficiently  assess the health effects of pharmaceuticals in drinking water by  addressing groups of related pharmaceuticals, such as selective  serotonin reuptake inhibitors, instead of individual pharmaceuticals.  FDA is providing health effects data, and EPA plans to use the  methodology to support decisions about which pharmaceuticals to  include on future candidate lists. This effort is part of a larger EPA  initiative to better implement SDWA by focusing on assessing risk from  exposure to groups of contaminants instead of individual contaminants.
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. Agency officials and former members of the PiE  workgroup told us that interagency efforts such as those described above  are the result of informal collaborative relationships among agency  personnel, particularly those fostered by the PiE workgroup. As one  official from EPA’s Office of Water noted, the current interagency  collaboration is “ad hoc.” In 2008 and 2010, we reported that by using  informal coordination mechanisms, agencies may rely on relationships  with individual officials to ensure effective collaboration, but these  informal relationships could end if the responsible staff are not available  to continue the efforts. We recommended that those agencies develop  clear guidance for interagency planning efforts in the 2008 report, and  that roles and responsibilities be identified to support collaboration in the  2010 report; the agencies generally agreed with these recommendations.
The purpose of the PiE workgroup was to identify and prioritize research  needed to better understand the risk from pharmaceuticals in the  environment and to recommend areas for federal collaboration to address  those priorities. Its draft report was neither approved by NSTC nor  publicly released. According to OSTP officials, the draft report was not  approved or released because the workgroup did not address OSTP’s  concerns, including that the report did not specifically outline how  agencies would coordinate research and other long-term activities  identified in the draft report once the workgroup expired. For example,  OSTP officials stated that the draft report did not clarify collaborating  agencies’ roles and responsibilities by identifying which agencies are best  positioned to address specific issues identified in the report and which  existing or new programs would be most appropriate for addressing these  issues. OSTP officials told us that providing this additional information  was consistent with the purpose of the workgroup. The workgroup co- chairs told us that OSTP did not present the workgroup with its written  concerns until June 2010, about a year after the draft report was  approved by the Subcommittee on Toxics and Risk, and after the  workgroup had expired. According to the co-chairs, addressing OSTP’s  concerns would have required the workgroup to update the scientific data  included in the draft report and would have required the workgroup to  provide additional information regarding agencies’ roles and  responsibilities that was beyond the purpose of the workgroup. Thus, the  draft report was never finalized although, according to the co-chairs, the  interagency activities begun by the workgroup continued.
section_title: Key Practices Can Enhance and Sustain Coordination
paragraphs: In an October 2005 report, we identified key practices for enhancing and  sustaining collaboration among federal agencies. Three of these practices  may help clarify how EPA and other agencies could coordinate their  research efforts.    Establish roles and responsibilities: We reported that collaborating  agencies should work together to define and agree on their respective  roles and responsibilities, including how the collaborative effort will be  led. In doing so, agencies can clarify who will do what, organize their  joint and individual efforts, and facilitate decision making.    Leverage resources: We reported that collaborating agencies should  identify the human, information technology, physical, and financial  resources needed to initiate or sustain their collaborative effort.  Collaborating agencies bring different levels of resources and  capacities to the effort. By assessing their relative strengths and  limitations, collaborating agencies can look for opportunities to  address resource needs by leveraging each other’s resources, thus  obtaining additional benefits that would not be available if they were  working separately.    Establish mechanisms for monitoring, evaluating, and periodically  reporting results of the collaborative research efforts: We reported that  federal agencies engaged in collaborative efforts need to create the  means to monitor and evaluate their efforts to enable them to identify  areas for improvement. Reporting on these activities can help key  decision makers within the agencies to obtain feedback for improving  both policy and operational effectiveness.
section_title: Conclusions
paragraphs: There are basic questions about the potential health risks from exposure  to pharmaceuticals in the nation’s drinking water. Other contaminants  also have been detected in drinking water including personal care  products, and chemicals used in industry and agriculture, including some  that may act as EDCs. Some of these other contaminants may work in  tandem with pharmaceuticals to affect human health through additive or  interactive effects. Also of concern to government scientists are the health  effects of long-term low-dose exposure to pharmaceuticals and exposure  to mixtures of pharmaceuticals.
Since the 1996 amendments to SDWA, EPA has been required to publish  a list of currently unregulated contaminants including pharmaceuticals  that may require regulation in drinking water, and to make determinations  on whether or not to regulate at least 5 of the contaminants on the list  every 5 years. In 2009, EPA issued its third Contaminant Candidate List,  which consists of 116 contaminants, 12 of which are pharmaceuticals.  However, EPA continues to experience difficulty obtaining sufficient  occurrence and health effects data for making determinations on (1)  which contaminants present the greatest public health concern to include  on the list and (2) whether or not to regulate any of the contaminants on  the candidate list. It will continue to be difficult for EPA to prioritize  contaminants on the candidate list without the necessary information on  health effects and occurrence to determine the contaminants that present  the greatest public health concern. In many cases, gathering sufficient  data to address contaminants awaiting determinations has taken EPA  more than 10 years, and obtaining data on other contaminants on the  current list may well take decades. To collect occurrence and health  effects data on pharmaceuticals and other contaminants that could  support decisions about which contaminants to include on future  candidate lists, EPA is collaborating informally with USGS and FDA, but  does not have a formal mechanism for sustaining such collaboration in  the future. Furthermore, the PiE workgroup, which pulled together the  scientific expertise from eight federal agencies, has expired and its draft  report was neither finalized nor released.
However, neither EPA’s informal collaboration efforts nor the strategy  proposed by the PiE workgroup details how agencies could coordinate  their future interagency collaboration 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.
section_title: Recommendation for Executive Action
paragraphs: 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. In establishing  this mechanism, EPA should: (1) define roles and responsibilities,  including how the collaborative effort will be led; (2) identify the  expertise and other resources that each agency can bring to bear on  the issue; and (3) develop a process for monitoring, evaluating, and  reporting to the public the results of the collaborative research efforts.
section_title: Agency Comments and Our Evaluation
paragraphs: We provided a draft of this report to EPA, the Department of the Interior  (DOI), the Department of Health and Human Services (HHS), OSTP, and  the Department of Justice (DOJ) for review and comment.
In written comments, EPA agreed with our findings and recommendation  and noted that the extent of interagency collaboration may be dependent  upon available resources. EPA also provided clarifying language  regarding the responsibilities, accomplishments, and activities of the PiE  workgroup which, according to EPA, reflects clarification provided by the  PiE workgroup co-chairs. We modified our draft accordingly. EPA’s  comments are reprinted in appendix III. EPA also provided technical  clarifications and comments, which we incorporated as appropriate.
DOI also provided written comments on a draft of this report and stated  that it generally agrees with the findings and recommendation in the  report. Additionally, DOI provided clarifying language regarding the PiE  workgroup. DOI’s comments are reprinted in appendix IV. Additionally,  USGS, an agency within DOI, provided technical clarifications and  comments, which we incorporated as appropriate.
DOJ, HHS, and OSTP did not provide written comments but provided  technical clarifications and comments, which we incorporated as  appropriate.
As agreed with your offices, unless you publicly announce the contents of  this report earlier, we plan no further distribution for 30 days from the  report date. At that time, we will send copies to the appropriate  congressional committees, the Administrator of EPA, and other interested  parties. In addition, this report will be available at no charge on the GAO  Web site at http://www.gao.gov .
If you or your staff members have any questions on this report, please  contact me at (202) 512-3841 or trimbled@gao.gov. Contact points for  our Offices of Congressional Relations and Public Affairs may be found  on the last page of this report. GAO staff who made major contributions to  this report are listed in appendix V.
section_title: Appendix I: Objectives, Scope, and Methodology
paragraphs: 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 extent to which pharmaceuticals occur in drinking water,  we reviewed federal and peer-reviewed reports, including (1) studies by  the U.S. Geological Survey (USGS), (2) articles in peer-reviewed journals  by federal scientists and others, and (3) the Pharmaceuticals in the  Environment (PiE) workgroup’s draft report. We also selected a  nonprobability sample of scientific studies to review in our report. The  data from these studies are not generalizable beyond the scope of these  studies. We selected these studies on the basis of certain criteria,  including the source of the study (e.g., a peer-reviewed journal); the  geographic scope of the study; and whether the study focused on source  water, treated drinking water, or wastewater. We also discussed the  subject with scientists at USGS and other federal agencies as well as with  representatives from academia, trade associations, the environmental  community, and the pharmaceutical industry.
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 discussed  the subject with federal scientists and representatives from academia, the  environmental community, and the pharmaceutical industry. We also  attended an October 2009 academic conference on hormones and related  compounds in the environment that was hosted by Tulane University.
To describe the approaches taken in the United States to reduce the extent  to which pharmaceuticals occur in drinking water; we reviewed literature  and spoke with officials from federal agencies including the Drug  Enforcement Administration (DEA), EPA, and the Food and Drug  Administration (FDA), as well as experts from academia, industry and  nonprofit organizations that have ongoing work addressing  pharmaceuticals in the environment; from these efforts, we identified  consumer take-back programs as the primary approach to reducing  occurrence. We also determined that take-back programs could be  grouped into three broad categories based on common characteristics— mail back, one-time, and ongoing. We selected a nonprobability sample of  five programs to represent the three categories. The information from these  programs is not generalizable to all take-back programs. We selected the  programs because they provided geographic diversity and exemplified  certain characteristics. For example, we selected one program, in part,  because it was pharmacy-based. We did not attempt to evaluate the  programs. We collected information on each program through a survey,  follow-up interviews, and, where appropriate, additional documentation. To  describe approaches taken by other countries to reduce the extent to which  pharmaceuticals occur in drinking water, we chose to describe efforts in  Sweden and Australia. We selected Sweden because it is undertaking a  variety of stewardship activities. We selected Australia because it has a  nationwide take-back program. We obtained information on each country’s  efforts though interviews with knowledgeable officials and, where  appropriate, additional documentation.
To identify challenges, if any, that EPA faces in determining whether any  pharmaceuticals should be regulated under SDWA, actions EPA is taking  to address these challenges, and options for addressing such challenges  in the future, we reviewed agency documents and interviewed relevant  agency officials. Specifically, to identify challenges, we reviewed EPA’s  documentation on the process it used to develop the 2009 Contaminant  Candidate List under the authority of SDWA. We also reviewed some of  the sources of data that EPA relied upon to identify pharmaceuticals for  inclusion on the candidate list. To identify actions that EPA is undertaking  to address challenges we identified, we interviewed agency officials from  EPA, FDA, and USGS and, where appropriate, obtained and reviewed  additional documentation. To identify options to address these challenges  in the future, we obtained and reviewed a 2009 draft report produced by  the PiE workgroup. We also interviewed several of the workgroup  members, including the three co-chairs. We also reviewed our own work  on practices that can help enhance and sustain collaboration among  federal agencies.
We conducted this performance audit from January 2010 through August  2011 in accordance with generally accepted government auditing  standards. Those standards require that we plan and perform the audit to  obtain sufficient, appropriate evidence to provide a reasonable basis for  our findings and conclusions based on our audit objectives. We believe  that the evidence obtained provides a reasonable basis for our findings  and conclusions based on our audit objectives.
section_title: Appendix II: Guidelines for Proper Disposal of Unused Pharmaceuticals
paragraphs: According to FDA and the White House Office of National Drug Control  Policy, consumers are encouraged to properly dispose of unused  pharmaceuticals to avoid harm to others. In general, consumers should  not flush prescription pharmaceuticals down the toilet or sink drain unless  the label or accompanying patient information specifically instructs  consumers to do so. However, in some instances, it may be necessary to  dispose of unused pharmaceuticals by flushing. For a list of  pharmaceuticals that are recommended to be flushed, consumers should  visit FDA’s Web site.
Several disposal options are available to consumers for prescription  pharmaceuticals that are not specifically labeled to be flushed. For  example, other than the pharmaceutical take-back programs presented in  this report, programs such as household hazardous waste collection  events, which collect pharmaceuticals at a central location, can provide  consumers with proper disposal of unused pharmaceuticals.  Organizations such as the Product Stewardship Institute have information  on such events across the nation.
In addition, FDA and the White House Office of National Drug Control  Policy recommend that consumers consider the following steps to  dispose of unused pharmaceuticals:  1.  Take prescription pharmaceuticals out of their original containers.  2.  Mix pharmaceuticals (do NOT crush tablets or capsules) with an  undesirable substance, such as cat litter or used coffee grounds.  3.  Place the mixture into a disposable container with a lid, such as an  empty margarine tub, or into a sealable bag.  4.  Conceal or remove any personal information, including Rx number, on  the empty containers by covering it with black permanent marker or  duct tape, or by scratching it off.  5.  Place the sealed container with the mixture, and the empty  pharmaceutical containers, in the trash.
section_title: Appendix III: Comments from the Environmental Protection Agency
section_title: Appendix IV: Comments from the Department of the Interior
section_title: Appendix V: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: In addition to the contact above, Diane B. Raynes, Assistant Director;  Elizabeth R. Beardsley; Mark A. Braza; Tanya L. Doriss; Charles T. Egan;  Brynne Keith-Jennings; Amanda M. Leissoo; Carol Herrnstadt Shulman;  John B. Stephenson; and Kiki Theodoropoulos made key contributions to  this report. Also contributing to this report were Sandra J.G. Kerr,  Katherine M. Raheb, and Nicholas L. Weeks.