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entitled 'Environmental Health: Action Needed to Sustain Agencies' 
Collaboration on Pharmaceuticals in Drinking Water' which was released 
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United States Government Accountability Office: 
GAO: 

Report to Congressional Requesters: 

August 2011: 

Environmental Health: 

Action Needed to Sustain Agencies' Collaboration on Pharmaceuticals in 
Drinking Water: 

GAO-11-346: 

GAO Highlights: 

Highlights of GAO-11-346, a report to congressional requesters. 

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. 

View [hyperlink, http://www.gao.gov/products/GAO-11-346] or key 
components. For more information, contact David Trimble at (202) 512-
3841 or trimbled@gao.gov. 

[End of section] 

Contents: 

Letter: 

Background: 

Pharmaceuticals Have Been Found in Drinking Water, but Their 
Prevalence and Effects on Human Health Are Largely Unknown: 

The United States and Other Countries Are Engaged in Take-Back 
Programs to Help Prevent Pharmaceuticals from Reaching Drinking Water: 

Data Gaps Make It Difficult for EPA to Identify Pharmaceuticals for 
Regulation; Sustained Collaboration May Help EPA Address Such 
Difficulties: 

Conclusions: 

Recommendation for Executive Action: 

Agency Comments and Our Evaluation: 

Appendix I: Objectives, Scope, and Methodology: 

Appendix II: Guidelines for Proper Disposal of Unused Pharmaceuticals: 

Appendix III: Comments from the Environmental Protection Agency: 

Appendix IV: Comments from the Department of the Interior: 

Appendix V: GAO Contact and Staff Acknowledgments: 

Table: 

Table 1: Pharmaceuticals on the Third Contaminant Candidate List: 

Figures: 

Figure 1: Examples of Pathways through which Pharmaceuticals May Enter 
Drinking Water Supplies: 

Figure 2: Locations at which USGS Sampled Untreated Sources of Public 
Drinking Water and Those at which It Detected Pharmaceuticals: 

Figure 3: Pharmaceuticals USGS Detected at Untreated Sources of Public 
Drinking Water. 

Figure 4: Five Take-Back Programs GAO Identified: 

Abbreviations: 

ADI: acceptable daily intake: 

BPA: bisphenol A: 

CENRS: Committee on Environment, Natural Resources, and Sustainability: 

DEA: Drug Enforcement Administration: 

DOI: Department of the Interior: 

DOJ: Department of Justice: 

EDC: endocrine disrupting chemical: 

EPA: Environmental Protection Agency: 

EU: European Union: 

FDA: Food and Drug Administration: 

HHS: Department of Health and Human Services: 

OSTP: Office of Science and Technology Policy: 

NSTC: National Science and Technology Council: 

PiE: Pharmaceuticals in the Environment: 

RCRA: Resource Conservation and Recovery Act of 1976: 

RUM: Return Unwanted Medicines: 

SDWA: Safe Drinking Water Act: 

USGS: U.S. Geological Survey: 

[End of section] 

United States Government Accountability Office: 
Washington, DC 20548: 

August 8, 2011: 

The Honorable Brad Miller: 
Ranking Member: 
Subcommittee on Energy and Environment: 
Committee on Science, Space and Technology: 
House of Representatives: 

The Honorable Edward J. Markey: 
House of Representatives: 

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.[Footnote 1] 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 
[Footnote 2]. 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. 

Background: 

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. 

Pharmaceuticals May Enter Drinking Water through Different Pathways: 

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. 

Figure 1: Examples of Pathways through which Pharmaceuticals May Enter 
Drinking Water Supplies: 

[Refer to PDF for image: illustration] 

Entering Drinking Water Supplies: 

Pharmaceutical manufacturer: Treated effluent; 
Agricultural run-off; 
Residential septic system (leaching into ground water); 
Wastewater treatment plant: Treated effluent: 
* Municipal sewer system; 
* Hospitals and nursing homes; 
Drinking water treatment plant (Intake). 

Source: GAO. 

[End of figure] 

Pharmaceuticals in Drinking Water Are a Contaminant of Emerging 
Concern: 

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)).[Footnote 3] 

The Degree to which Relevant Environmental Statutes Regulate 
Pharmaceuticals: 

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. 

The Safe Drinking Water Act: 

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.[Footnote 4] 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.[Footnote 
5] 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.[Footnote 6] 

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.[Footnote 7] 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.[Footnote 8] Table 1 identifies the 
12 pharmaceuticals. 

Table 1: Pharmaceuticals on the Third Contaminant Candidate List: 

Pharmaceutical: 17alpha-estradiol; 
Use: An estrogenic hormone used in pharmaceuticals. 

Pharmaceutical: Equilenin; 
Use: An estrogenic hormone used in pharmaceuticals. 

Pharmaceutical: Equilin; 
Use: An estrogenic hormone used in pharmaceuticals. 

Pharmaceutical: Erythromycin; 
Use: Used in pharmaceutical formulations as an antibiotic. 

Pharmaceutical: Estradiol (17-beta estradiol); 
Use: An estrogenic hormone used in pharmaceuticals. 

Pharmaceutical: Estriol; 
Use: An estrogenic hormone used in veterinary pharmaceuticals. 

Pharmaceutical: Estrone; 
Use: An estrogenic hormone used in veterinary and human 
pharmaceuticals. 

Pharmaceutical: Ethinyl estradiol (17-alpha ethynylestradiol); 
Use: An estrogenic hormone used in veterinary and human 
pharmaceuticals. 

Pharmaceutical: Mestranol; 
Use: An estrogenic hormone used in veterinary and human 
pharmaceuticals. 

Pharmaceutical: Nitroglycerin; 
Use: Used in pharmaceuticals, in the production of explosives, and in 
rocket propellants. 

Pharmaceutical: Norethindrone (19-norethisterone); 
Use: A progresteronic hormone used in pharmaceuticals. 

Pharmaceutical: Quinoline; 
Use: Used in the production of other substances, as a pharmaceutical 
(antimalarial), and as a flavoring agent. 

Source: EPA. 

Notes: According to FDA, estriol, estrone, ethinyl estradiol, and 
mestranol are not listed as approved for veterinary use in the United 
States but it is possible that these pharmaceuticals are or have been 
used as such, for example, for research purposes or as investigational 
new drugs. Although not identified as a use by EPA, according to FDA, 
estradiol and erythromycin are approved for veterinary use. 

[End of table] 

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.[Footnote 9] 
EPA did not agree to adopt these recommendations and generally took 
the position that no further steps are needed. 

Resource Conservation and Recovery Act: 

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.[Footnote 10] 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.[Footnote 11] 

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.[Footnote 12] 

Clean Water Act: 

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.[Footnote 13] 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[Footnote 14] 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.[Footnote 15],[Footnote 16] 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. 

Workgroup Addressing Pharmaceuticals in the Environment Was 
Established within the National Science and Technology Council: 

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).[Footnote 17] NSTC is a council 
of cabinet-level officials chaired by the President and managed by the 
Director of OSTP.[Footnote 18] 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.[Footnote 19] The 
workgroup, which was intended to be temporary, was staffed by 
scientists from eight federal agencies.[Footnote 20] 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. 

Pharmaceuticals Have Been Found in Drinking Water, but Their 
Prevalence and Effects on Human Health Are Largely Unknown: 

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. 

Research Has Confirmed the Presence of Some Pharmaceuticals in 
Drinking Water: 

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. 

Studies Have Detected the Occurrence of Pharmaceuticals in Source 
Water: 

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.[Footnote 21] The study reported testing for the presence of 
100 contaminants, including 36 pharmaceuticals.[Footnote 22] 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 2: Locations at which USGS Sampled Untreated Sources of Public 
Drinking Water and Those at which It Detected Pharmaceuticals: 

[Refer to PDF for image: illustrated U.S. map] 

State: Alabama; 
Locations at which USGS detected pharmaceuticals: 1. 

State: California; 
Locations at which USGS did not detect pharmaceuticals: 1. 

State: Connecticut; 
Locations at which USGS detected pharmaceuticals: 1. 

State: Florida; 
Locations at which USGS detected pharmaceuticals: 2. 

State: Georgia; 
Locations at which USGS detected pharmaceuticals: 1. 

State: Hawaii; 
Locations at which USGS detected pharmaceuticals: 2; 
Locations at which USGS did not detect pharmaceuticals: 2. 

State: Idaho; 
Locations at which USGS detected pharmaceuticals: 2. 

State: Indiana; 
Locations at which USGS did not detect pharmaceuticals: 1. 

State: Kansas; 
Locations at which USGS detected pharmaceuticals: 2. 

State: Maryland; 
Locations at which USGS detected pharmaceuticals: 1. 

State: Massachusetts; 
Locations at which USGS detected pharmaceuticals: 2; 
Locations at which USGS did not detect pharmaceuticals: 2. 

State: Michigan; 
Locations at which USGS detected pharmaceuticals: 2. 

State: Minnesota; 
Locations at which USGS detected pharmaceuticals: 3; 
Locations at which USGS did not detect pharmaceuticals: 2. 

State: Mississippi; 
Locations at which USGS detected pharmaceuticals: 1. 

State: Montana; 
Locations at which USGS did not detect pharmaceuticals: 1. 

State: Nebraska; 
Locations at which USGS did not detect pharmaceuticals: 1. 

State: New Jersey; 
Locations at which USGS detected pharmaceuticals: 7; 
Locations at which USGS did not detect pharmaceuticals: 2. 

State: New Mexico; 
Locations at which USGS detected pharmaceuticals: 1. 

State: New York; 
Locations at which USGS detected pharmaceuticals: 3; 
Locations at which USGS did not detect pharmaceuticals: 1. 

State: North Carolina; 
Locations at which USGS detected pharmaceuticals: 3. 

State: North Dakota; 
Locations at which USGS detected pharmaceuticals: 1; 
Locations at which USGS did not detect pharmaceuticals: 1. 

State: Ohio; 
Locations at which USGS detected pharmaceuticals: 2. 

State: Oregon; 
Locations at which USGS detected pharmaceuticals: 1; 
Locations at which USGS did not detect pharmaceuticals: 2. 

State: Puerto Rico; 
Locations at which USGS detected pharmaceuticals: 1; 
Locations at which USGS did not detect pharmaceuticals: 2. 

State: South Dakota; 
Locations at which USGS detected pharmaceuticals: 2; 
Locations at which USGS did not detect pharmaceuticals: 1. 

State: Tennessee; 
Locations at which USGS detected pharmaceuticals: 1. 

State: Texas; 
Locations at which USGS did not detect pharmaceuticals: 1. 

State: Virginia; 
Locations at which USGS detected pharmaceuticals: 6. 

Source: GAO; map (MapArt). 

[End of figure] 

Figure 3 shows the pharmaceuticals that USGS reported detecting in its 
study of untreated sources of public drinking water. 

[Refer to PDF for image] 

[End of figure] 

Figure 3: Pharmaceuticals USGS Detected at Untreated Sources of Public 
Drinking Water. 

[Refer to PDF for image: illustrated table] 

Category of pharmaceutical: Nonprescription drugs; 
Number of sites with selected pharmaceuticals in untreated sources of 
public drinking water: 26; 
Type of pharmaceutical: Cotinine; 
Typical use: Nicotine metabolite. 

Category of pharmaceutical: Nonprescription drugs; 
Number of sites with selected pharmaceuticals in untreated sources of 
public drinking water: 17; 
Type of pharmaceutical: 1, 7-dimethylxanthine; 
Typical use: Caffeine metabolite. 

Category of pharmaceutical: Nonprescription drugs; 
Number of sites with selected pharmaceuticals in untreated sources of 
public drinking water: 6; 
Type of pharmaceutical: Acetaminophen; 
Typical use: Antipyrectic. 

Category of pharmaceutical: Nonprescription drugs; 
Number of sites with selected pharmaceuticals in untreated sources of 
public drinking water: 6; 
Type of pharmaceutical: Caffeine; 
Typical use: Stimulant. 

Category of pharmaceutical: Nonprescription drugs; 
Number of sites with selected pharmaceuticals in untreated sources of 
public drinking water: 1; 
Type of pharmaceutical: Ibuprofen; 
Typical use: Anti-inflammatory. 

Category of pharmaceutical: Prescription drugs; 
Number of sites with selected pharmaceuticals in untreated sources of 
public drinking water: 16; 
Type of pharmaceutical: Carbamazepine; 
Typical use: Anticonvulsant. 

Category of pharmaceutical: Prescription drugs; 
Number of sites with selected pharmaceuticals in untreated sources of 
public drinking water: 4; 
Type of pharmaceutical: Diphenhydramine; 
Typical use: Antihistamine. 

Category of pharmaceutical: Prescription drugs; 
Number of sites with selected pharmaceuticals in untreated sources of 
public drinking water: 3; 
Type of pharmaceutical: Dehydronifedipine; 
Typical use: Metabolite of nifedipine, an antianginal. 

Category of pharmaceutical: Prescription drugs; 
Number of sites with selected pharmaceuticals in untreated sources of 
public drinking water: 2; 
Type of pharmaceutical: Codeine; 
Typical use: Analgesic. 

Category of pharmaceutical: Prescription drugs; 
Number of sites with selected pharmaceuticals in untreated sources of 
public drinking water: 1; 
Type of pharmaceutical: Diltiazem; 
Typical use: Antihypertensive. 

Category of pharmaceutical: Prescription drugs; 
Number of sites with selected pharmaceuticals in untreated sources of 
public drinking water: 1; 
Type of pharmaceutical: Fluoxetine; 
Typical use: Antidepressant. 

Category of pharmaceutical: Veterinary and human antibiotics; 
Number of sites with selected pharmaceuticals in untreated sources of 
public drinking water: 6; 
Type of pharmaceutical: Erythromycin-H2O; 
Typical use: Erythromycin metabolite. 

Category of pharmaceutical: Veterinary and human antibiotics; 
Number of sites with selected pharmaceuticals in untreated sources of 
public drinking water: 5; 
Type of pharmaceutical: Enrofloxacin; 
Typical use: Antibiotic. 

Category of pharmaceutical: Veterinary and human antibiotics; 
Number of sites with selected pharmaceuticals in untreated sources of 
public drinking water: 5; 
Type of pharmaceutical: Trimethoprim; 
Typical use: Antibiotic. 

Category of pharmaceutical: Veterinary and human antibiotics; 
Number of sites with selected pharmaceuticals in untreated sources of 
public drinking water: 2; 
Type of pharmaceutical: Sulfamethoxazole; 
Typical use: Antibiotic. 

Category of pharmaceutical: Veterinary and human antibiotics; 
Number of sites with selected pharmaceuticals in untreated sources of 
public drinking water: 1; 
Type of pharmaceutical: Azithromycin; 
Typical use: Antibiotic. 

Category of pharmaceutical: Veterinary and human antibiotics; 
Number of sites with selected pharmaceuticals in untreated sources of 
public drinking water: 1; 
Type of pharmaceutical: Ciprofloxacin; 
Typical use: Antibiotic. 

Category of pharmaceutical: Veterinary and human antibiotics; 
Number of sites with selected pharmaceuticals in untreated sources of 
public drinking water: 1; 
Type of pharmaceutical: Sarafloxacin; 
Typical use: Antibiotic. 

Source: USGS. 

Notes: A metabolite is a substance that is the product of biological 
changes to a chemical. For example, cotinine is the metabolite 
produced in the body after nicotine has been consumed. According to 
FDA, while caffeine, caffeine metabolites, and nicotine are in 
nonprescription drugs, caffeine and its metabolites are most likely 
from the urine of persons imbibing caffeine-containing beverages and 
nicotine metabolites are most likely from the urine of smokers. Also, 
antipyretic medication reduces fever. 

[End of figure] 

The other three national reconnaissance studies that USGS conducted 
focused on (1) surface water,[Footnote 23] (2) ground water,[Footnote 
24] and (3) stream sedimentation.[Footnote 25] 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[Footnote 
26] 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.[Footnote 27] 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.[Footnote 28] 

* 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.[Footnote 29],[Footnote 30] 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. 

Studies Have Also Detected Occurrence of Pharmaceuticals in Treated 
Drinking Water: 

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.[Footnote 31],[Footnote 32] The study 
reported detecting 9 of the 20 pharmaceuticals and metabolites at all 
of the locations tested.[Footnote 33] 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.[Footnote 34] The analysis notes 
that of the 64 substances that have been detected, only 36 have 
corroborative data from at least a second study.[Footnote 35] 

Studies Have Also Detected Occurrence of Pharmaceuticals in Treated 
Wastewater: 

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.[Footnote 36] 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.[Footnote 37] 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.[Footnote 38] 

* 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.[Footnote 39] 

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. 

Research Has Not Determined the Human Health Effects of 
Pharmaceuticals in Drinking Water: 

Uncertainty persists regarding whether pharmaceuticals in drinking 
water pose a risk to human health, and research has pointed to 
different conclusions.[Footnote 40] For example, in its April 2008 
testimony before the Senate Committee on Environment and Public Works, 
[Footnote 41] 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.[Footnote 42], 
[Footnote 43] 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.[Footnote 44],[Footnote 
45] 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 
[Footnote 46] 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)? 

Some Research Has Raised Concerns about EDCs and Antibiotics: 

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.[Footnote 47] 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.[Footnote 48] The 
researchers reported a collapse in the population of fathead minnows 
in the experimental lake and concluded that the results from the study 
demonstrate that 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.[Footnote 49] 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.[Footnote 50] 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.[Footnote 51] 

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.[Footnote 52] 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.[Footnote 53] 

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. 

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. 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.[Footnote 54] 

Consumer Drug Take-Back Programs Are Found Across the United States, 
and Congress and Others Are Considering Additional Efforts: 

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.[Footnote 55],[Footnote 56] 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 (appendix 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. 

Figure 4: Five Take-Back Programs GAO Identified: 

[Refer to PDF for image: illustrated table] 

Program type: Ongoing; 
State: Utah; 
Coverage: Statewide; 
Program name: Proper Medication Disposal; 
Collection: 5,625 pounds (June 2009 to June 2010). 

Program type: Ongoing; 
State: Washington; 
Coverage: 6 counties; 
Program name: PH:ARM pilot - (Pharmaceuticals from Households: A Return
Mechanism); 
Collection: 15,134 pounds (June 2009 to June 2010). 

Program type: One-time; 
State: California; 
Coverage: San Francisco Bay Area; 
Program name: Bay Area Pollution Prevention Group Safe Medicine 
Disposal Days; 
Collection: 3,634 pounds (May 13-21, 2006). 

Program type: One-time; 
State: Texas; 
Coverage: Amarillo, Canyon, and their surrounding communities; 
Program name: Medication Cleanout™; 
Collection: 1,947 pounds (September 12, 2009; March 27, 2010; June 9, 
2010). 

Program type: Mail-back; 
State: Maine; 
Coverage: Statewide; 
Program name: Safe Medicine Disposal for ME; 
Collection: 2,373 pounds (May 2008 to October 2009). 

Sources: GAO; art (Art Explosion). 

Note: Data on the volume of pharmaceuticals collected generally 
include packaging. 

[End of figure] 

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. 
[Footnote 57] 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. 

Other Countries Also Support Take-Back Programs: 

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."[Footnote 58] 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. 

Data Gaps Make It Difficult for EPA to Identify Pharmaceuticals for 
Regulation; Sustained Collaboration May Help EPA Address Such 
Difficulties: 

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.[Footnote 59] 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. 

EPA Faces Challenges Because of Gaps in Occurrence and Health Effects 
Data: 

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. 

Occurrence Data Were Limited for Pharmaceuticals Considered for the 
Most Recent Contaminant Candidate List: 

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.[Footnote 60] 

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. 
[Footnote 61] 

Health Effects Data Were Limited for Pharmaceuticals Considered for 
the Most Recent Contaminant Candidate List: 

According to the Federal Register notice for the draft 2009 
Contaminant Candidate List,[Footnote 62] 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,[Footnote 63] 
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.[Footnote 64] 

* 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.[Footnote 65] 

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.[Footnote 66] 
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. 

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: 

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.[Footnote 67] 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.[Footnote 68] Its draft report was neither 
approved by NSTC nor publicly released.[Footnote 69] 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. 

Key Practices Can Enhance and Sustain Coordination: 

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.[Footnote 70] 

* 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. 

Conclusions: 

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. 

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. 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. 

Agency Comments and Our Evaluation: 

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 [hyperlink, 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. 

Signed by: 

David C. Trimble: 
Director, Natural Resources and Environment: 

[End of section] 

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 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. 

[End of section] 

Appendix II: Guidelines for Proper Disposal of Unused Pharmaceuticals: 

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.[Footnote 71] 

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. 

[End of section] 

Appendix III: Comments from the Environmental Protection Agency: 

United States Environmental Protection Agency: 
Office Of Water: 
Washington, D.C. 20460: 

July 22, 2011: 

Mr. David C. Trimble: 
Acting Director: 
Natural Resources and Environment: 
U.S. Government Accountability Office: 
Washington, D.C. 20548: 

Dear Mr. Trimble: 

The U.S. Environmental Protection Agency (EPA) appreciates the 
opportunity to review and comment on the Government Accountability 
Office (GAO) draft report, "Action Needed to Sustain Agencies' 
Collaboration on Pharmaceuticals in Drinking Water" (Report Number
GA0-11-346). EPA agrees with the recommendation in the draft report 
with the caveat that level of engagement is dependent upon available 
resources. Brief comments on the EPA's position regarding the 
recommendation are provided below. In addition, EPA is providing 
clarifying language for two specific places in the draft report 
regarding responsibilities, accomplishments, and activities of the 
Interagency Pharmaceuticals in the Environment (PiE) workgroup. This 
additional language reflects clarification provided by the PiE 
workgroup co-chairs. Other technical comments and clarifications on 
draft report language have been provided in a separate document. 

GAO recommendation: 

To collect the 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, GAO made 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, the EPA should: 

- Define roles and responsibilities, including how the collaborative 
effort will be led; 

- Identify the expertise and other resources that each agency can 
bring to bear on the issue; and; 

- Develop a process for monitoring, evaluating, and reporting to the 
public the results of the collaborative research efforts. 

EPA response to recommendation: 

The EPA supports the establishment of an interagency workgroup or 
other formal mechanism to collaborate and coordinate research on 
pharmaceuticals and, as appropriate, other contaminants in drinking 
water that present the greatest public health concern. The EPA 
anticipates that the extent to which collaborative efforts are 
conducted may be dependent upon available resources. 

Clarifying language: 

The PiE workgroup co-chairs recommend that the following language 
should replace the paragraph that starts at the bottom of page 12 and 
ends on page 13, significant additions to the draft report language 
are underlined: 

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).[Footnote 13] NSTC is a council 
of cabinet-level officials chaired by the President and managed by the 
Director of Office of Science and Technology Policy (OSTP).[Footnote 
14] 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.[Footnote 15] The workgroup, which was 
intended to be temporary, was staffed by scientists from eight federal 
agencies.[Footnote 16] The EPA, FDA, and USGS scientists served as co-
chairs. In May 2009, the PiE workgroup produced a draft report [begin 
underline] that was reviewed and approved by the Toxics and Risk 
Subcommittee and then conveyed to OSTP. [end underline] OSTP officials 
told us they had several significant concerns with the draft report 
and indicated that it would not be approved or publicly released until 
the workgroup addressed these concerns. The workgroup co-chairs told 
us that the requested changes [begin underline] were shared with them 
after the workgroup had expired and, as a result, the document was not 
finalized. However, interagency collaborative efforts begun by the 
workgroup have continued. [end underline] 

Footnotes: 

[13] NSTC was established by Executive Order in 1993. NSTC has 
multiple committees to address its responsibilities regarding the 
scientific and technical work of the executive branch. For example, 
CENRS advises and assists NSTC on federal research and development 
related to environment, natural resources, and sustainability. The 
Toxic and Risks Subcommittee is one of several subcommittees of CENRS. 

[14] Congress established OSTP in 1976 to advise the President and 
others within the Executive Office of the President on considerations 
of science and technology in federal policy, plans, and programs. OSTP 
is also charged with leading interagency efforts to develop and 
implement sound science and technology policies, among other things. 

[15] Charter of the Working Group on Pharmaceuticals in the 
Environment, Toxics and Risk Subcommittee, Committee on Environment 
and Natural Resources, National Science and Technology Council (May 
26, 2006). 

[16] The eight agencies were the U.S. Department of Agriculture, the 
Department of Commerce 's National Oceanographic and Atmospheric 
Administration, U.S. Environmental Protection Agency (EPA), the 
Department of Health and Human Services' Centers for Disease Control 
and Prevention, US. Food and Drug Administration (FDA), National 
Institute for Environmental and Health Sciences; and the Department of 
the Interior's Fish and Wildlife Service and U.S. Geological Survey 
(USGS). 

The PiE workgroup co-chairs recommend that the following language 
replace the paragraph that starts at the bottom of page 38 and ends on 
page 39; significant additions to the draft report language are 
underlined: 

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.[Footnote 66] The draft report was neither 
approved by NSTC, nor publicly released. [begin underline] According 
to the NSTC 2008 Handbook, NSTC documents must be cleared by the White 
House Co-Chair of the Committee (in this case, CENRS), or by the OSTP 
Director, or, in the event that neither is available, by the OSTP 
General Counsel. [end underline] According to OSTP officials, the 
draft did not specifically outline how agencies would coordinate 
research and other long-term activities identified in the draft report 
once the workgroup disbanded. 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. 
[begin underline] The workgroup co-chairs told us that OSTP did not 
provide the workgroup with its concerns until after the workgroup
had expired. Nonetheless, the interagency activities begun by the 
workgroup were continued. [end underline] 

Footnote: 

[66] Charter of the Working Group on Pharmaceuticals in the 
Environment, Toxics and Risk Subcommittee, Committee on Environment 
and Natural Resources, National Science and Technology Council (May 
26, 2006). 

Once again, thank you for the opportunity to respond to this draft 
report. 

Sincerely, 

Signed by: 

Nancy K. Stoner: 
Acting Assistant Administrator: 

Enclosure: 

[End of section] 

Appendix IV: Comments from the Department of the Interior: 

United States Department of the Interior: 
Office Of The Secretary: 
Washington, D.C. 20240: 

July 21, 2011: 

Mr. David Trimble: 
Acting Director, Natural Resources and Environment: 
U.S. Government Accountability Office: 
441 G Street, N.W. 
Washington, D.C. 20548: 

Dear Mr. Trimble: 

The Department of the Interior has reviewed the draft GAO report 
entitled Environmental Health: Action Needed to Sustain Agencies' 
Collaboration on Pharmaceuticals in Drinking Water (GAO-11-346). 

The Department of the Interior generally agrees with the findings and 
recommendation in the report. However, the description of the 
responsibilities, activities, and accomplishments of the 
Pharmaceuticals in the Environment (PiE) Working Group, 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), should be clarified. Language is provided to make that 
clarification in two specific places in the draft report. 

The following language should replace the paragraph that starts at the 
bottom of page 12 and ends on page 13; significant additions to the 
draft report language are underlined: 

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).[Footnote 13] NSTC is a council 
of cabinet-level officials chaired by the President and managed by the 
Director of Office of Science and Technology Policy (OSTP).[Footnote 
14] 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.[Footnote 15] The workgroup, which was 
intended to be temporary, was staffed by scientists from eight federal 
agencies.[Footnote 16] EPA, FDA, and USGS scientists served as co-
chairs. In May 2009, the PiE workgroup produced a draft report [begin 
underline] that was reviewed and approved by the Toxics and Risk 
Subcommittee and then conveyed to OSTP.[end underline] OSTP officials 
told us they had several significant concerns with the draft report 
and indicated that it would not be approved or publicly released until 
the workgroup addressed these concerns. The workgroup co-chairs told 
us that the requested changes [begin underline] were beyond the charge 
of the workgroup and would reflect a markedly different document. The 
workgroup expired in 2009 and the report was never finalized. However, 
interagency collaborative efforts begun by the workgroup have 
continued. [end underline] 

Footnotes: 

[13] NSTC was established by Executive Order in 1993. NSTC has 
multiple committees to address its responsibilities regarding the 
scientific and technical work of the executive branch. For example, 
CENRS advises and assists NSTC on federal research and development 
related to environment, natural resources, and sustainability. The 
Toxic and Risks Subcommittee is one of several subcommittees of CENRS. 

[14] Congress established OSTP in 1976 to advise the President and 
others within the Executive Office of the President on considerations 
of science and technology in federal policy, plans, and programs. OSTP 
is also charged with leading interagency efforts to develop and 
implement sound science and technology policies, among other things. 

[15] Charter of the Working Group on Pharmaceuticals in the 
Environment, Toxics and Risk Subcommittee, Committee on Environment 
and Natural Resources, National Science and Technology Council (May 
26, 2006). 

[16] The eight agencies were the U.S. Department of Agriculture, the 
Department of Commerce's National Oceanographic and Atmospheric 
Administration, U.S. Environmental Protection Agency (EPA). the 
Department of Health and Human Services' Centers for Disease Control 
and Prevention, U.S. Food and Drug Administration (FDA), National 
Institute for Environmental and Health Sciences; and the Department of 
the Interior's Fish and Wildlife Service and US. Geological Survey 
(USGS). 

We recommend that the following language replace the paragraph that 
starts at the bottom of page 38 and ends on page 39; significant 
additions to the draft report language are underlined: 

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.[Footnote 66] [The] draft report was neither 
approved by NSTC, nor publicly released. [begin underline] According 
to the NSTC 2008 Handbook, NSTC documents must be cleared by the White 
House Co-Chair of the Committee (in this case. CENRS), or by the OSTP 
Director. or. in the event that neither is available, by the OSTP 
General Counsel. [end underline] According to OSTP officials, the 
draft did not specifically outline how agencies would coordinate 
research and other long-term activities identified in the draft report 
once the workgroup disbanded. 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. 
[begin underline] The workgroup co-chairs told us that OSTP did not 
provide the workgroup with its 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 draft report with significant additional information, including 
agencies' roles and responsibilities, which they felt would be beyond
the purpose of the workgroup. Thus, the workgroup was not reactivated 
by the Toxics and Risk Subcommittee: however, the interagency 
activities begun by the workgroup were continued. 

Footnote: 

[66] Charter of the Working Group on Pharmaceuticals in the 
Environment, Toxics and Risk Subcommittee, Committee on Environment 
and Natural Resources, National Science and Technology Council (May 
26. 2006). 

We hope these comments will assist you in preparing the final report. 
If you have any questions, or need additional information, please 
contact lone Taylor (703) 648-6403 or Herbert Buxton at (609) 771-3944. 

Sincerely, 

Signed by: 

Anne J. Castle: 
Assistant Secretary for Water and Science: 

[End of section] 

Appendix V: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

David C. Trimble, (202) 512-3841 or trimbled@gao.gov: 

Staff Acknowledgments: 

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. 

[End of section] 

Footnotes: 

[1] This report uses the term "drinking water" to refer to treated 
drinking water--the water that has been treated before it enters homes 
or businesses. We use the term "source water" to refer to the water in 
rivers, lakes, ground water, and other water bodies that may be the 
source of drinking water before treatment or that may be consumed 
without being treated. We also use the term "effluent" to refer to 
treated wastewater. 

[2] This report uses the term "pharmaceutical" to refer to active 
pharmaceutical ingredients (API) and related chemicals such as 
metabolites. According to the Food and Drug Administration, an API is 
a substance that is intended to furnish pharmacological activity or 
other direct effect in the diagnosis, cure, mitigation, treatment, or 
prevention of disease, or to affect the structure or any function of 
the body. A metabolite is a substance that is the product of 
biological changes to a chemical. 

[3] EDCs are chemical compounds found in some pharmaceuticals, food, 
and consumer products, or occur naturally in the environment. EDCs can 
interfere with the functioning and development of hormones in humans 
and animals and can produce adverse developmental, reproductive, 
neurological, and immune effects. 

[4] The Administrator may also regulate contaminants not on the 
Contaminant Candidate List if the criteria for regulation are met, but 
to date has not done so. 

[5] 76 Fed. Reg. 7762 (Feb. 11, 2011). 

[6] 74 Fed. Reg. 51850 (Oct. 8, 2009). 

[7] EPA used a different approach to determine which contaminants to 
include on the first and second candidate lists. See 73 Fed. Reg. 
9628, 9631 (Feb. 21, 2008). 

[8] For additional information on the process EPA used to develop the 
third Contaminant Candidate List and the contaminants on that list, 
see [hyperlink, http://www.epa.gov/ogwdw/ccl/ccl3.html]. 

[9] GAO, Safe Drinking Water Act: EPA Should Improve Implementation of 
Requirements on Whether to Regulate Additional Contaminants, 
[hyperlink, http://www.gao.gov/products/GAO-11-254] (Washington, D.C.: 
May 27, 2011). 

[10] EPA Office of Water, Guidance Document: Best Management Practices 
for Unused Pharmaceuticals at Health Care Facilities, Draft (August 
2010): table 1, 14-15. EPA, Proposed Rule, Amendment to the Universal 
Waste Rule: Addition of Pharmaceuticals, 73 Fed. Reg. 73520, 73522 
(Dec. 2, 2008). 

[11] EPA Office of Water, Guidance Document: Best Management Practices 
for Unused Pharmaceuticals at Health Care Facilities, Draft (August 
2010): 18. 

[12] EPA noted it has also funded and assisted in the development of a 
guidance document to help healthcare facilities develop and implement 
hazardous pharmaceutical waste management plans. 

[13] 40 C.F.R § 131.11 (2011). Most water quality criteria are 
expressed as numeric or quantitative-parameters. For example, national 
recommended water quality criteria for toxic pollutants are numeric 
and specify the precise, measurable levels of particular chemicals or 
conditions allowable in a water body. When numerical criteria cannot 
be established, such as when pollutants cannot be precisely measured, 
narrative criteria are used to express a parameter in a qualitative 
form. 

[14] Effluent refers to wastewater discharged into the environment. 
Typically, effluent is treated and discharged from wastewater 
treatment plants, which may receive wastewater from such entities as 
households, factories, or commercial establishments. 

[15] Lindane is also known as gamma-hexachlorocyclohexane (-HCH), 
gammaxene, and Gammallin. As a pharmaceutical, lindane is used in 
shampoos and creams to treat lice and scabies (mites). 

[16] According to EPA officials, another pollutant for which EPA has 
issued national criteria - malathion - has pharmaceutical applications. 

[17] NSTC was established by Executive Order in 1993. NSTC has 
multiple committees to address its broad responsibilities regarding 
the scientific and technical work of the executive branch. For 
example, CENRS advises and assists NSTC on federal research and 
development related to environment, natural resources, and 
sustainability. The Toxic and Risks Subcommittee is one of several 
subcommittees of CENRS. 

[18] Congress established OSTP in 1976 with a broad mandate to advise 
the President and others within the Executive Office of the President 
on considerations of science and technology in federal policy, plans, 
and programs. OSTP is also charged with leading interagency efforts to 
develop and implement sound science and technology policies, among 
other things. 

[19] Charter of the Working Group on Pharmaceuticals in the 
Environment, Toxics and Risk Subcommittee, Committee on Environment 
and Natural Resources, National Science and Technology Council (May 
2006). 

[20] The eight agencies were the U.S. Department of Agriculture, the 
Department of Commerce's National Oceanographic and Atmospheric 
Administration, EPA, the Department of Health and Human Services' 
Centers for Disease Control and Prevention, FDA, and National 
Institute for Environmental and Health Sciences; and the Department of 
the Interior's Fish and Wildlife Service and USGS. 

[21] Focazio, M.J.; Kolpin, D.W.; Barnes, K.K.; Furlong, E.T.; Meyer, 
M.T.; Zaugg, S.D.; Barber, L.B.; Thurman, M.E., "A National 
Reconnaissance for Pharmaceuticals and Other Organic Wastewater 
Contaminants in the United States - II) Untreated Drinking Water 
Sources," Sci Total Environ, 402(2-3) (2008): 201-216. 

[22] USGS selected these contaminants using the following criteria: 
known or suspected usage, toxicity, potential hormonal activity, 
persistence in the environment, and results from previous studies. 

[23] Kolpin, D.W.; Furlong, E.T.; Meyer, M.T.; Thurman, E.M.; Zaugg, 
S.D.; Barber, L.B.; Buxton, H.T., "Pharmaceuticals, Hormones, and 
Other Organic Wastewater Contaminants in U.S. Streams, 1999-2000: A 
National Reconnaissance," Environ. Sci. Technol., 36(6) (2002): 1202-
1211. 

[24] Barnes, K.K.; Kolpin, D.W.; Furlong, E.T.; Zaugg, S.D.; Meyer, 
M.T.; Barber, L.B., "A National Reconnaissance of Pharmaceuticals and 
Other Organic Wastewater Contaminants in the United States - I) 
Groundwater," Sci Total Environ, 402(2-3) (2008): 192-200. 

[25] Furlong, E.T.; Ferrer, I.; Glassmeyer, S.; Cahill, J.D.; Zaugg, 
S.D.; Werner, S.L.; Kinney, C.A.; Kolpin, D.W.; Kryak, D., 
"Distributions of organic wastewater contaminants between water and 
sediment in surface-water samples of the United States" (in 
Proceedings of the 3rd International Conference on Pharmaceuticals and 
Endocrine Disrupting Chemicals in Water, Minneapolis, Minn., National 
Ground Water Association, Mar. 19-21, 2003). 

[26] Transport refers to the movement of a contaminant within the 
environment. 

[27] Hinkle, S.R.; Weick, R.J.; Johnson, J.M.; Cahill, J.D.; Smith, 
S.G.; Rich, B.J., Organic Wastewater Compounds, Pharmaceuticals, and 
Coliphage in Groundwater Receiving Discharge from Onsite Wastewater 
Treatment Systems Near La Pine, Oregon: Occurrence and Implications 
for Transport, U.S. Geological Survey Scientific Investigations 
Report, 2005-5055 (2005): 98. 

[28] NYC Department of Environmental Protection, Occurrence of 
Pharmaceutical and Personal Care Products (PPCP) in Source Water of 
the New York City Water Supply (New York, N.Y.: May 26, 2010). 

[29] The National Water Research Institute (NWRI) is a nonprofit 
organization founded in 1991 by a group of California water agencies 
in partnership with the Joan Irvine Smith and Athalie R. Clarke 
Foundation to promote the protection, maintenance, and restoration of 
water supplies and to protect public health and improve the 
environment. NWRI's member agencies include Inland Empire Utilities 
Agency, Irvine Ranch Water District, Los Angeles Department of Water 
and Power, Orange County Sanitation District, Orange County Water 
District, and West Basin Municipal Water District. 

[30] Y. Carrie Guox and Stuart W. Krasner, Metropolitan Water District 
of Southern California, La Verne, California; Steve Fitzsimmons, Greg 
Woodside, and Nira Yamachika, Orange County Water District Fountain 
Valley, California. Source, Fate, and Transport of Endocrine 
Disruptors, Pharmaceuticals, and Personal Care Products in Drinking 
Water Sources in California. A special report prepared at the request 
of the National Water Research Institute Fountain Valley, California, 
May 2010. 

[31] According to its Web site, the American Water Works Association 
Research Foundation is a member-supported, international, nonprofit 
organization that sponsors research to enable water utilities, public 
health agencies, and other professionals to provide safe and 
affordable drinking water to consumers. Its stated mission is to 
advance the science of water to improve the quality of life. 

[32] According to its Web site, the WateReuse Foundation is an 
educational, nonprofit public benefit corporation that serves as a 
centralized organization for the water and wastewater community to 
advance the science of water reuse, recycling, reclamation, and 
desalination. 

[33] Benotti, M.J.; Trenholm, R.A.; Vanderford, B.J.; Holady, J.C.; 
Stanford, B.D.; and Snyder, S.A., "Pharmaceuticals and Endocrine 
Disrupting Compounds in U.S. Drinking Water," Environmental Science 
and Technology, 43(3) (2009): 597-603. 

[34] Daughton C.G., "Pharmaceutical Ingredients in Drinking Water: 
Overview of Occurrence and Significance of Human Exposure," in ACS 
Symposium Series 1048, Contaminants of Emerging Concern in the 
Environment: Ecological and Human Health Considerations, ch. 2, Rolf 
Halden (ed.) (Washington, D.C.: American Chemical Society, November 
2010). 

[35] The study's analysis cautioned that the data cannot be considered 
statistically representative of any particular locale and that with 
very few exceptions; each of the 48 publications was very limited in 
scope. The analysis further cautions that the published studies 
employed various methods of analysis and quality control measures; and 
that no attempt was made to determine the veracity of the actual 
identification of targeted pharmaceuticals. 

[36] Glassmeyer, S.T.; Furlong, E.T.; Kolpin, D.W.; Cahill, J.D.; 
Zaugg, S.D.; Werner, S.L.; Meyer, M.T.; Kryak, D.D., "Transport of 
Chemical and Microbial Compounds from Known Wastewater Discharges: 
Potential for Use as Indicators of Human Fecal Contamination," Environ 
Sci Technol, 39(14) (2005): 5157-5169. 

[37] Antimicrobials are drugs used to treat infections by micro- 
organisms such as bacteria and viruses and include drugs such as 
synthetic and natural antibiotics. 

[38] Campagnolo, E.R.; Johnson, K.R.; Karpati, A.; Rubin, C.S.; 
Kolpin, D.W.; Meyer, M.T.; Esteban, J.E.; Currier, R.W.; Smith, K.; 
Thu, K.M.; McGeehin, M., "Antimicrobial Residues in Animal Waste and 
Water Resources Proximal to Large-Scale Swine and Poultry Feeding 
Operations," Sci Total Environ, 299(1-3) (2002), 89-95. 

[39] Phillips, P.J.; Smith, S.G.; Kolpin, D.W.; Zaugg, S.D.; Buxton, 
H.T.; Furlong, E.T.; Esposito, K.; Stinson, B., "Pharmaceutical 
Formulation Facilities as Sources of Opioids and Other Pharmaceuticals 
to Wastewater Treatment Plant Effluents," Environ. Sci. Technol., 44 
(13) (2010): 4910-4916. 

[40] While each of the studies cited in this report are limited in 
geographic scope and not generalizable to all public drinking water 
systems or sources of drinking water in the country, they still offer 
valuable insights. Please see the specific research citation for 
additional information. 

[41] Statement by Alan Goldhammer, Ph.D., Deputy Vice President, 
Regulatory Affairs; Pharmaceutical Research and Manufacturers of 
America, before the Senate Environment and Public Works Committee, 
Subcommittee on Transportation Safety, Infrastructure Security, and 
Water Quality, "Pharmaceuticals in the Nation's Drinking Water: 
Assessing Potential Risks and Actions to Address the Issue" (Apr. 15, 
2008). 

[42] Schwab, B.W.; Hayes, E.P.; Fiori, J.M.; Mastrocco, F.J.; Roden, 
N.M.; Cragin, D.; Meyerhoff, R.D.; D'Aco, V.J.; Anderson, P.D., "Human 
Pharmaceuticals in U.S. Surface Water: A Human Health Risk 
Assessment," Reg. Toxicol. Pharmacol., 42(3) (2005): 296-312. 

[43] Kolpin, D.W.; Furlong, E.T.; Meyer, M.T.; Thurman, E.M.; Zaugg, 
S.D.; Barber, L.B.; Buxton, H.T., "Pharmaceuticals, Hormones, and 
Other Organic Wastewater Contaminants in U.S. Streams, 1999-2000: A 
National Reconnaissance," Environ. Sci. Technol., 36(6) (2002): 1202-
1211. 

[44] Daughton C.G., "Pharmaceutical Ingredients in Drinking Water: 
Overview of Occurrence and Significance of Human Exposure," in Rolf 
Halden (ed.), ACS Symposium Series 1048, Contaminants of Emerging 
Concern in the Environment: Ecological and Human Health 
Considerations, ch. 2, Rolf Halden (ed.) (Washington, D.C.: American 
Chemical Society, November 2010). 

[45] Daughton, C.G., "Pharmaceuticals as Environmental Pollutants: The 
Ramifications for Human Exposure," in the International Encyclopedia 
of Public Health, vol. 5, Kris Heggenhougen and Stella Quah (eds.) 
(Oxford: Academic Press, 2008): 66-102. 

[46] Such subpopulations, which may be at greater risk for adverse 
health effects from exposure to drinking water contaminants, may 
include infants, children, individuals with kidney or liver diseases 
or weakened immune systems, and the elderly. 

[47] Blazer, V.S.; Iwanowicz, L.R.; Iwanowicz, D.D.; Smith, D.R.; 
Young, J.A.; Hedrick, J.D.; Foster, S.W.; Reeser, S.J., 2007, 
"Intersex (Testicular Oocytes) in Smallmouth Bass from the Potomac 
River and Selected Nearby Drainages," Journal of Aquatic Animal 
Health, 19(4) (2007): 242-253. 

[48] Kidd, K.A.; Blanchfield, P.J.; Mills, K.H.; Palace, V.P.; Evans, 
R.E.; Lazorchak, J.M.; Flick., R.W., "Collapse of a Fish Population 
after Exposure to a Synthetic Estrogen," Proceedings of the National 
Academy of Sciences of the United States of America, 104(21) (2007): 
8897-8901. 

[49] Orlando, E. F.; Kolok, A. S.; Binzcik, G. A.; Gates, J. L.; 
Horton, M. K.; Lambright, C. S.; Gray, L. E.; Soto, A. M.; Guillette, 
L. J., "Endocrine-Disrupting Effects of Cattle Feedlot Effluent on an 
Aquatic Sentinel Species, The Fathead Minnow," Environ. Health Persp., 
112(3) (2004): 353-358. 

[50] Calafat, A.M.; Ye, X.; Wong, L.Y.; Reidy, J.A.; Needham, L.L. 
"Exposure of the U.S. Population to Bisphenol A and 4-tertiary- 
Octylphenol: 2003-2004." Environ. Health Perspect., 116(1) (January 
2008): 39-44. 

[51] Hayes, T.; Haston, K.; Tsui, M.; Hoang, A.; Haeffele, C.; Vonk, 
A., "Atrazine-Induced Hermaphroditism at 0.1 Ppb in American Leopard 
Frogs (Rana Pipiens): Laboratory and Field Evidence," Environ. Health 
Persp., 111 (2003): 568-575. 

[52] According to studies published in 2008 and 2009, triclosan and 
triclocarban are also endocrine-disrupting chemicals. For example, 
see, Ahn, K.C.; Zhao, B.; Chen J.; Cherednichenko, G.; Sanmarti, E.; 
Denison, M.S.; Lasley, B.; Pessah, I.N.; Kultz, D.; Chang, D.P.Y.; 
Gee, S.J.; Hammock, B.D., "In Vitro Biologic Activities of the 
Antimicrobials Triclocarban, Its Analogs and Triclosan in Bioassay 
Screens: Receptor-Based Bioassay Screens," Environmental Health 
Perspectives, 116(9) (2008). Zorilla, L.M.; Gibson, E.K.; Jeffay, 
S.C.; Crofton, K.M.; Setzer, W.R.; Coper, R.L.; Stoker, T.E., "The 
Effects of Triclosan on Puberty and Thyroid Hormones in Male Wistar 
Rats," Toxicological Sciences, 107 (2009): 56-64. 

[53] GAO, Antibiotic Resistance: Gaps in Information Will Remain 
Despite HHS Taking Steps to Improve Monitoring, GAO-11-406 
(Washington, D.C.: June 1, 2011). 

[54] For additional details on pollution prevention, source control, 
and other environmental stewardship measures see: Daughton, C.G, 
"Drugs and the Environment: Stewardship & Sustainability," National 
Exposure Research Laboratory, Environmental Sciences Division, U.S. 
EPA. Las Vegas, Nevada, report NERL-LV-ESD 10/081, EPA/600/R-106 
(September 2010). Available at [hyperlink, 
http://www.epa.gov/nerlesd1/bios/daughton/APM200-2010.pdf]. 

[55] The Product Steward Institute, Inc. is a nonprofit environmental 
organization whose members include 45 states, 70 local governments, 
and other stakeholders, and whose mission is to reduce the adverse 
health and environmental impacts of consumer products. 

[56] The states are Arkansas, California, Colorado, Connecticut, 
Delaware, Florida, Idaho, Illinois, Indiana, Iowa, Kentucky, Maine, 
Massachusetts, Michigan, Missouri, New York, Oklahoma, Ohio, Oregon, 
Pennsylvania, Texas, Utah, Vermont, Washington, and Wisconsin. 

[57] According to DEA regulations and the Controlled Substances Act, 
controlled substances include narcotics, stimulants, depressants, 
hallucinogens, anabolic steroids, and chemicals used in the illicit 
production of controlled substances. This list includes 
pharmaceuticals that are considered to have a high potential for 
abuse, such as opium, morphine, and methadone. DEA officials we spoke 
with stated that about 10 percent to 12 percent of all pharmaceuticals 
dispensed in the United States are controlled substances. 

[58] Article 1, paragraph 87 of the European Union Directive 
2004/27/EC (2004). 

[59] GAO, Results-Oriented Government: Practices That Can Help Enhance 
and Sustain Collaboration among Federal Agencies, [hyperlink, 
http://www.gao.gov/products/GAO-06-15] (Washington, D.C.: Oct. 21, 
2005). 

[60] Production volumes include information on the volume of 
pharmaceuticals manufactured in or imported into the United States in 
amounts equal to or greater than 10,000 pounds per year. 

[61] In March 2011, EPA proposed the list of contaminants to be 
monitored under the third Unregulated Contaminant Monitoring Rule. EPA 
uses this rule to gather occurrence data on unregulated contaminants 
in drinking water. The proposed list of contaminants for monitoring 
includes five of the pharmaceuticals on the 2009 Contaminant Candidate 
List. 76 Fed. Reg. 11713 (March 3, 2011) 

[62] 73 Fed. Reg. 9628 (Feb. 21, 2008) 

[63] Daughton C.G., "Pharmaceutical Ingredients in Drinking Water: 
Overview of Occurrence and Significance of Human Exposure," in ACS 
Symposium Series 1048, Contaminants of Emerging Concern in the 
Environment: Ecological and Human Health Considerations, ch. 2, Rolf 
Halden (ed.) (Washington, D.C.: American Chemical Society, November 
2010). 

[64] EPA Risk Assessment Forum, Guidance on Selecting Age Groups for 
Monitoring and Assessing Childhood Exposures to Environmental 
Contaminants (Washington, D.C., 2005). 

[65] Kolpin, D.W.; Furlong, E.T.; Meyer, M.T.; Thurman, E.M.; Zaugg, 
S.D.; Barber, L.B.; Buxton, H.T., "Pharmaceuticals, Hormones, and 
Other Organic Wastewater Contaminants in U.S. Streams, 1999-2000: A 
National Reconnaissance," Environ. Sci. Technol., 36(6) (2002): 1202-
1211. 

[66] [hyperlink, http://www.gao.gov/products/GAO-11-254]. 

[67] GAO, Homeland Defense: U.S. Northern Command Has Made Progress 
but Needs to Address Force Allocation, Readiness Tracking Gaps, and 
Other Issue, [hyperlink, http://www.gao.gov/products/GAO-08-251] 
(Washington, D.C.: Apr.16, 2008); Live Animal Imports: Agencies Need 
Better Collaboration to Reduce the Risk of Animal-Related Diseases, 
[hyperlink, http://www.gao.gov/products/GAO-11-9] (Washington, D.C.: 
Nov. 8, 2010). 

[68] Charter of the Working Group on Pharmaceuticals in the 
Environment, Toxics and Risk Subcommittee, Committee on Environment 
and Natural Resources, National Science and Technology Council (May 
26, 2006). 

[69] According to the NSTC 2008 Handbook, NSTC documents must be 
cleared by the White House Co-Chair of the Committee or by the OSTP 
Director, or, in the event that neither is available, by the OSTP 
General Counsel. 

[70] [hyperlink, http://www.gao.gov/products/GAO-06-15]. 

[71] [hyperlink, 
http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesa
fely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm] 

[End of section] 

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