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Pharmaceuticals and
Personal Care Products
in Drinking Water
Pharmaceuticals and Personal Care Products in Drinking Water




Pharmaceuticals and Personal Care Products
in Drinking Water


Scientific advances in pharmaceutical therapies and the growing availability of
pharmaceutical drugs has done much to improve the overall health of the world’s
population. But the widespread use of pharmaceuticals and other personal care
products has increased concerns about concentrations of these substances throughout
the water cycle, including surface and ground waters, wastewater, and drinking water.
Despite seemingly small concentrations, the presence of pharmaceuticals in drinking
water has raised concerns about the potential risks to human health from exposure to
water-borne pharmaceuticals.

In part, the increased detection of pharmaceuticals in drinking water is due to advances
in analytical technology that support the measurement of concentrations to levels
as low as the nanogram per liter range. However, the effects of prolonged exposure
to even small concentrations of pharmaceuticals in water are not well understood.
Further, since the use of pharmaceuticals and other personal care products is expected
to increase, the risk from their introduction into the water system will also rise. As
such, water supply stakeholders, including government officials, drinking water
regulators, water suppliers and the general public, are focusing increased attention on
pharmaceutical concentration levels in drinking water.

This UL white paper provides an overview of the issues related to the presence of
pharmaceuticals and personal care products (PPCPs) in drinking water. The paper
discusses the possible effects of PPCPs on humans and on the environment and
summarizes recent research conducted by U.S. government agencies, UL and others on
PPCP concentrations found in public drinking water supplies and wastewater facilities.
The white paper also discusses available water treatment options for reducing PPCP
concentrations and their relative effectiveness. The paper concludes with areas for
further research and a preview of possible future regulatory actions.




page 2
Pharmaceuticals and Personal Care Products in Drinking Water




Types and Sources of PPCPs                     through bathing or showering, when             treated water. In addition, prolonged

in Drinking Water                              soaps and cosmetic creams are washed           multi-generational exposure can lead to
                                               from the body into the waste                   effects that accumulate over time. 4
In general, the term PPCP refers to any
                                               water system.
product used for either personal health                                                       Research on PPCPs in Water
or cosmetic reasons as well as any
                                               The Impact of PPCPs in                         Research on PPCPs in water has been
product used in the agricultural industry
                                               Drinking Water                                 ongoing for nearly 20 years, with
to maintain the health or enhance
                                               While there are no confirmed adverse           the first Environmental Protection
the growth of livestock. Specifically,
                                               human health effects associated                Agency (EPA) studies on conventional,
PPCPs comprise a diverse collection
                                               with PPCPs in drinking water, PPCP             nonconventional and toxic pollutants in
of thousands of chemical substances,
                                               contamination remains a significant            water dating to 1982. The EPA web-site
including prescription and over-the-
                                               concern. For example, pharmaceuticals          lists more than 100 separate research
counter therapeutic drugs for humans
                                               are designed to interact with cellular-level   projects related to PPCPs in which the
and animals, biopharmaceuticals,                                                              EPA has been or is currently involved,5
                                               receptors at low concentrations to
diagnostic agents, vitamins and other                                                         and the agency maintains an extensive
                                               induce specific biological effects, and the
nutritional supplements, cosmetics                                                            database of published literature on
                                               side effects caused by interaction with
and fragrances, and growth-enhancing                                                          PPCPs as environmental contaminants.6
                                               nonreceptor targets are unpredictable
chemicals used in livestock operations.1                                                      Here is a brief summary of some of the
                                               and poorly understood. Further, certain
PPCPs enter the water supply as a result                                                      key research that has been conducted
                                               strains of bacteria subject to prolonged
of multiple industrial, commercial and                                                        concerning PPCPs in water.
                                               exposure to antibiotics can develop
agricultural activities and pharmaceutical                                                    National Reconnaissance of
                                               resistance to those antibiotics, resulting
manufacturing (although the latter is                                                         Pharmaceuticals, Hormones and Other
                                               in strains of drug-resistant bacteria.
tightly regulated2). PPCPs also enter the                                                     Organic Wastewater Contaminants in
water supply in the form of residue from       Other PPCPs, such as steroid hormones
                                                                                              Streams of the U.S., 1999-2000
hospitals and other healthcare facilities      like estrone, progesterone and
                                               testosterone and fragrance additives           This important field study 7 was conducted
and as a byproduct of veterinary drug use,
                                               like galaxolide, have been identified as       by researchers at the U.S. Geological
most notably antibiotics and steroids.
                                               endocrine-disrupting compounds (EDCs).         Survey in 1999 and 2000 to provide
Water-born PPCPs can also result from
                                               EDCs are synthetic chemicals that block        baseline information on the occurrences
the surreptitious disposal of illegal drugs.
                                               or mimic natural hormones in the body,         of pharmaceuticals, hormones and other
Individual consumers are also an                                                              wastewater contaminants in water
                                               disrupting normal organ function. It is
important source, both intentionally                                                          resources. Concentrations of 95 separate
                                               important to note that EDCs, even at
and unintentionally, of PPCPs found                                                           organic wastewater contaminants
                                               extremely low concentrations, can have
in water. Consumers often dispose of                                                          (OWCs) were measured in water samples
                                               effects on the human endocrine system.3
unused prescription medications by                                                            taken from 139 streams in 30 states across
including them with household refuse           Beyond potential effects on human              the United States. Researchers found
or flushing them through their home            health from exposure the PPCPs in water,       OWCs in 80% of the streams sampled,
plumbing systems. But unintentional            there are also potential consequences for      with coprostanol (a fecal steroid),
PPCP contamination of water by                 aquatic life, where the exposure risk is       cholesterol (a plant and animal steroid),
consumers also occurs through the              potentially much greater. Fish and aquatic     tridosan (an antimicrobial disinfectant),
simple elimination of waste material           organisms can experience continual             4-nonylphenol (a non-ionic detergent
from the body, since drugs are not always      exposure to PPCP concentrations, often         metabolite) and caffeine as the most
fully metabolized by the body, and also        at higher concentrations than found in         frequently detected compounds.



page 3
Pharmaceuticals and Personal Care Products in Drinking Water




According to the results of this field study, the measured concentrations of OWCs found
were low - generally, less than one part per billion - and rarely in excess of drinking
water guidelines or health advisories. However, researchers noted that concentration
guidelines have been established for only 14 of the 95 identified compounds. The
study’s report recommended further research to “fully understand not only the fate
and transport of OWCs in the hydrologic system but also their ultimate overall effect on
human health and the environment.”

Study of Occurrence of Contaminants of Emerging Concern in Wastewater

This multi-stage study8 was conducted by the U.S. Environmental Protection Agency
(EPA) from 2005 through 2008 to identify contaminants of emerging concern (CECs)
found in untreated and fully treated wastewater at publically owned water treatment
facilities in the United States. The CECs evaluated in this study included PPCPs, steroids
and hormones, bisphenol A (BPA), commercial flame retardants, and pesticides. A total
of 72 different PPCPs were tested in both influent and effluent samples.

According to the final report issued in August 2009, detectible amounts of 44 different
PPCPs were identified in at least one influent sample collected, and 27 different PPCPs
were detected in 75% or more of the influent samples analyzed. For effluent samples,
33 separate PPCPs were detected in at least one sample, and 16 were detected in less
than 25% of the effluent samples analyzed. Pharmaceutical antibiotics represented the
category of PPCPs most frequently identified, accounting for half of the total PPCPs
identified in both influent and effluent samples.

EPA researchers cautioned that the results of this study were not statistically
representative of all public-owned treatment works. Further, although the study
measured PPCP concentrations in both influent and effluent samples from water
treatment facilities, researchers noted that the data were insufficient to draw any
conclusions about the effectiveness of various treatment methods.

An important byproduct of this EPA study was the development of new analytical
methods for detecting the occurrence of PPCPs and other contaminants in untreated
and fully treated wastewater and sludge. These methods include “Method 1694:
Pharmaceuticals and Personal Care Products in Water, Soil, Sediment, and Biosolids by
HPLC/MS/MS,”9 and “Method 1698: Steroids and Hormones in Water, Soil, Sediment,
and Biosolids by HRGC/HRMS.”10 The methods cover over 100 separate chemicals,
74 PPCPs, and 27 steroids and hormones.

“Pharmaceuticals in Drinking Water”

Published in June 2011 by the United Nation’s World Health Organization (WHO), this
technical report11 is based on work conducted by a WHO working group that included
experts in water quality and health, water treatment, drinking water regulation and
policy, and water quality and health. The chief goal of the working group was to review
and summarize available scientific knowledge about pharmaceuticals in drinking water,
and recommend steps for managing the problem.


page 4
Pharmaceuticals and Personal Care Products in Drinking Water




The WHO report determined that                least 41 million Americans. Specifically,    sensitivity when compared with the
concentration levels of pharmaceuticals       pharmaceuticals were found in the            parts per billion (ppb) concentration
in drinking water fall outside the            drinking water supplies of 24 major U.S.     range available with standard analytical
scope and sensitivity of the analytical       metropolitan areas. The AP investigation     equipment and methods.
methodologies that are prescribed             also tested samples from the watersheds
                                                                                           UL has leveraged these advanced
for compliance analysis of drinking           of 35 of the 62 major providers and found
                                                                                           analytical technologies to enable
water. However, WHO experts                   pharmaceutical concentrations in 28 of
                                                                                           increased understanding of the
acknowledged that there are “very few         those watersheds.
                                                                                           occurrence of PPCPs and EDCs in drinking
systematic monitoring programmes                                                           water. Table 1 lists the 10 most frequently
or comprehensive, systematic studies
                                              Research by UL
                                                                                           detected PPCPs submitted to UL from
on the occurrence of pharmaceuticals          As noted in the WHO technical study
                                                                                           various cities in 30 states between 2008
in drinking-water.” Further, according        discussed above, concentrations of
                                                                                           and 2009. A total of 57 different PPCPs
to the report, the “limited occurrence        pharmaceuticals in drinking water have
                                                                                           and 17 different EDCs were detected.
data present one of the key challenges        often been below levels detectable with
                                              most analytical testing equipment. But       While the concentrations of PPCPs found
in assessing the potential risks
                                              most studies on PPCPs also concede that      in drinking water supplies sampled by
associated with trace concentrations of
                                              the effects of prolonged exposure to even    UL were millions of times lower than the
pharmaceuticals in drinking-water.” The
                                              small concentrations of pharmaceuticals      concentrations prescribed for therapeutic
report concluded that “future research …
                                              in water are not well understood.            effect, additional research by the EPA
may be beneficial to better characterize
                                              Although the increased detection of          and others is underway to determine
potential health risks from long-term,
                                              PPCPs in drinking water in recent years      the potential health risk to humans and
low-level exposure to pharmaceuticals.”
                                              is due, in part, to advances in analytical   ecological systems of PPCPs at these
Research by the Associated Press              technology, continued technological          concentration levels.
Research into the presence of                 advances along with routine monitoring       More recently, UL has continued its
pharmaceuticals and other personal care       are necessary to fully understand the        efforts to further develop its own testing
products in drinking water has not been       occurrence of these contaminants and         methods for identifying PPCPs and other
limited to U.S. government agencies.          their relevance to human health and          contaminants in water. In 2009 and 2010,
A five-month long investigation in 2008       the environment.                             UL developed a specific method for the
by the Associated Press (AP) 12 analyzed
                                              UL has a long history of developing          analysis of PPCPs and EDCs based on prior
federal drinking water databases,
                                              analytical technologies for emerging         proprietary testing methods. The new
reviewed hundreds of scientific reports,
                                              contaminants in drinking water. During       method, L222, focuses on the detection
and interviewed more than 230
                                              the past decade UL has invested in           and analysis of almost 30 of the most
officials, scientists and academics. AP’s
                                              advanced analytical equipment such as        frequently detected and studied PPCP
investigatory team also surveyed drinking
                                              high performance liquid chromatograph        and EDCs, including acetaminophen,
water system providers in 50 of the
                                              with triple quadrupole mass spectrometer     bisphenol A, caffeine, DEET, estrone,
largest cities in the United States as well
                                              (HPLC/MS/MS). When coupled with              nicotine, nonylphenol and triclosan.
as small community water providers in all
                                              various sample preparation techniques,       UL also created method S190, which
50 states.
                                              this technology has enabled UL to develop    streamlined the analysis of selected
AP’s investigation determined that a          several analytical methods to detect a       semi-volatile organic compounds,
wide array of pharmaceuticals, including      wide range of emerging contaminants in       including sterols, phosphate flame
antibiotics, anti-convulsant drugs and        the parts per trillion (ppt) concentration   retardants, fragrances, polyaromatic
mood stabilizers, were found in the           range. This level of detection represents    hydrocarbons (PAHs), phenols
drinking water supplies that serve at         a thousand-fold increase in measurement      and pesticides.


page 5
Pharmaceuticals and Personal Care Products in Drinking Water




   NAME                                 (# OF SAMPLES)                 USE                                                                MEDIAN LEVEL DETECTED (PPT)

   Carbamazapine                                  235                  Mood stabilizer                                                                10.3

   Cotinine                                       221                  Metabolite of nicotine                                                          3.4

   DEET                                           221                  Insect repellent                                                               15.2

   Galaxolide                                     134                  Synthetic fragrance used in cosmetics, cleaners & perfumes                     61.5

   Gemfibrozil                                    264                  Cholesterol lowering drug                                                       5.9

   Nicotine                                       221                  Tobacco products                                                               15.6

   Sulfamethoxazole                               219                  Antibiotic                                                                     34.9

   Paraxanthine                                   219                  Metabolite of caffeine                                                         20.7

   Acetaminophen                                  219                  Analgesic                                                                       8.1

   Caffeine                                       235                  Coffee, tea, soda                                                               104


Table 1: Top ten PPCPs found in drinking water samples tested at UL




Treatment Methods for PPCPs                                           of success in removing PPCPs in several                 •  More than 90% of lipid regulators
in Drinking Water                                                     classifications, as follows:                                  can be removed using activated
Most conventional water treatment                                                                                                   carbon, biologically activated
                                                                          •  More than 90% of steroids can
systems are not specifically engineered or                                   be removed from drinking water                         carbon, ozone/advanced oxidation
equipped to remove PPCPs from drinking                                       using activated sludge, activated                      processes, nanofiltration and
water. However, depending on the specific                                    carbon, biologically activated                         reverse osmosis
chemical class of the contaminant, there                                     carbon, ozone/advanced oxidation                 •  Less than 40% of listed PPCPs
is a range of treatment methodologies                                        processes, UV treatments and                           can be removed through the use
that have proven effective for removing                                      reverse osmosis                                        of coagulation/flocculation and
PPCPs or reducing their concentration.
                                                                          •  More than 90% of antibiotics,                          softening/metal oxides
Such methodologies include:
                                                                             antidepressants and antimicrobials           The EPA’s Office of Water maintains
      •  Activated carbon
                                                                             can be removed using activated               an inventory of scientific studies and
      •  Biologically activated carbon                                       carbon, biologically activated               literature on the treatment of CECs, which
      •  Ozone/advanced                                                      carbon, nanofiltration and                   includes abstracts of over 400 documents
         oxidation processes                                                 reverse osmosis                              available through the U.S. National
      •  Ultraviolet (UV) treatments                                      •  More than 90% of anti-                       Library of Medicine and other sources. The
                                                                             inflammatories can be removed                EPA’s 2010 report, “Treating Contaminants
      •  Nanofiltration
                                                                             using activated carbon, biologically         of Emerging Concern,”14 offers a detailed
      •  Reverse osmosis                                                     activated carbon, ozone/                     review of the effectiveness of various
According to some researchers, a             13                              advanced oxidation processes, UV             types of treatment methodologies, based
number of individual water treatment                                         treatments, nanofiltration and               on compiled data from a subset of the
methods have demonstrated high levels                                        reverse osmosis                              EPA’s research document inventory.


page 6
Pharmaceuticals and Personal Care Products in Drinking Water




Areas for Future Research and                   needed to understand both the scope of      Rule (UCMR 3). UCMR 3 will require all
Possible Regulation                             the problem and its implications for our    public water systems serving more than
                                                public drinking water supply. The EPA       10,000 people, as well as a representative
As authorized under the U.S. Safe
                                                has several research efforts currently      sample of the 800 systems serving
Drinking Water Act (SDWA), the EPA
                                                underway to strengthen the science for      10,000 or fewer people, to conduct
sets drinking water standards to control
                                                understanding the behavior of PPCPs         assessment monitoring for the presence
contaminants in the public drinking water
                                                in drinking water, including research,      of 28 separate chemicals during a
supply, and currently has drinking water
                                                methods development and occurrence          12-month period. The rule will require
regulations for more than 90 separate
                                                studies. Data from this research will       public water systems (PWS) to conduct
contaminants. To determine whether
                                                                                            this occurrence monitoring from January
a contaminant should be regulated,              assist the agency in determining whether
                                                                                            2013 through December 2015. Included
the EPA analyzes peer-reviewed science          regulations regarding acceptable
                                                                                            in UCMR 3 are a number of hormones,
addressing a number of variables,               concentrations of PPCPs in drinking water
                                                                                            including equilin and esteron (used in
including the occurrence levels of a            and the testing of public drinking water
                                                                                            estrogen replacement therapies) and
contaminant in the environment, routes          systems should be considered, even in the
                                                                                            testosterone. Although these substances
of human exposure and the health effects        absence of health-based standards.
                                                                                            are not currently regulated by national
of exposure, particularly the effects on
                                                As part of its ongoing research             primary drinking water regulations, the
vulnerable subpopulations.
                                                to determine the occurrence of              EPA will use the data from this and prior
The fact that contaminants are detected         contaminants of emerging concern,           UCMR assessment phases to determine
in trace amounts does not alone imply           the EPA has recently proposed the           whether further regulations are in the
risk to humans. Significant research is still   Unregulated Contaminant Monitoring          interest of public health.15




page 7
Pharmaceuticals and Personal Care Products in Drinking Water




Conclusion
The presence of PPCPs and other emerging contaminants in drinking water is not a
new issue, and significant research is still required to understand both the scope of the
problem and its implications for the safety of the public drinking water supply. However,
advancements in analytical technologies now make it possible to analyze a wider range
of contaminants in drinking water with greater specificity and sensitivity than at any
time in the past. Only a few laboratories, including UL, have developed methods to
detect pharmaceuticals and other compounds at ultralow levels.

UL is a recognized leader in drinking water analysis and has analyzed over 2.5 million
samples for thousands of water utilities, bottled water producers, engineering firms,
and state and federal governments, including the U.S. EPA and the U.S. military. UL
is one of only a few laboratories in the United States that can analyze a wide variety
of emerging contaminants in drinking water, including PPCPs, estrogens and other
hormones, phenolic endocrine disrupters, brominated and phosphate flame retardants,
herbicide degradates, and perfluorochemicals. With advanced detection methodologies,
UL can analyze drinking water for a broad range of contaminants using the most
efficient methods available, thereby streamlining the testing process and reducing
testing costs.

For more information about the “Pharmaceuticals and Personal Care Products in
Drinking Water” white paper, please contact Laura Snell, marketing manager –
Food & Water, at Laura.J.Snell@ul.com


THIS DOCUMENT IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND IS NOT INTENDED TO CONVEY ANY LEGAL ADVICE. USE OF
THE INFORMATION IN THIS DOCUMENT IS AT YOUR OWN RISK. PLEASE CONSULT WITH LEGAL COUNSEL FOR ADVICE ON COMPLYING
WITH THE REGULATIONS DESCRIBED ABOVE.




Copyright©2011 Underwriters Laboratories Inc. All rights reserved. No part of this document may be copied or distributed without the
prior written consent of Underwriters Laboratories Inc. 12/11




page 8
Pharmaceuticals and Personal Care Products in Drinking Water




1
    “Pharmaceuticals and Personal Care Products (PPCPs).” U.S. Environmental Protection Agency. Web. 4 Nov. 2011 www.epa.gov/ppcp
2
     For details on the EPA’s effluent requirements for pharmaceutical manufacturers, see “Effluent Guidelines: Pharmaceutical Manufacturing.” U.S. Environmental Protection Agency,
	 Jul, 1998. Web. 21 Nov 2011. http://water.epa.gov/scitech/wastetech/guide/pharm/pharmac.cfm
3
     Day, Rhonda, “Managing Micro-Pollutants.” Water and Wastewater International, Dec/Jan 2010-2011. Web. 21 Nov 2011.
     http://www.waterworld.com/index/display/article-display/8838408304/articles/waterworld/drinking-water/water-quality/2011/01/managing-micro-pollutants.html
4
     “Frequent Questions: Pharmaceuticals and Personal Care Products (PPCPs).” U.S. Environmental Protection Agency. 4 Nov 2011. www.epa.gov/ppcp/faq.html
5
     “EPA PPCP Research Areas.” U.S. Environmental Protection Agency. Web. 7 Nov 2011. http://www.epa.gov/ppcp/work2.html
6
     “Published Literature Relevant to Issues Surrounding PPCPs as Environmental Contaminants.” U.S. Environmental Protection Agency. Web. 7 Nov 2011. www.epa.gov/ppcp/lit.html
7
     Kolpin, D., Furlong, E., Meyer, M., and others. “Pharmaceuticals, Hormones, and Other Organic Wastewater Contaminants in U.S. Streams, 1999-2000: A National Reconnaissance.” published in Environmental
     Science & Technology, 15 Mar 2002. Web. 7 Nov 2011. An abstract of the study report is available at http://pubs.acs.org/doi/full/10.1021/es011055j. Additional information about this study, as well as study data,
     is available at http://toxics.usgs.gov/regional/emc_surfacewater.html
8
     “Occurrence of Contaminants of Emerging Concern in Wastewater from Nine Publically Owned Treatment Works.” U.S. Environmental Protection Agency, Aug. 2009. Web. 7 Nov 2011. http://tiny.cc/wn2fr
9
     “Method 1694: Pharmaceuticals and Personal Care Products in Water, Soil, Sediment, and Biosolids by HPLC/MS/MS.” U.S. Environmental Protection Agency. Dec. 2007 Web, 10 Nov 2011.
      http://water.epa.gov/scitech/methods/cwa/bioindicators/upload/2008_01_03_methods_method_1694.pdf
10
     “Method 1698: Steroids and Hormones in Water, Soil, Sediment, and Biosolids by HRGC/HRMS.” U.S. Environmental Protection Agency. Dec. 2007. Web. 10 Nov 2011.
     http://water.epa.gov/scitech/methods/cwa/bioindicators/upload/2008_01_03_methods_method_1698.pdf
11
     “Pharmaceuticals in drinking-water: Technical report.” World Health Organization. June 2011. Web. 4 Nov 2011.
     http://www.who.int/water_sanitation_health/publications/2011/pharmaceuticals/en/index.html
12
     Donn, J., Mendoza, M., Pritchard, J. “PharmaWater 1.” Associated Press. 9 Mar 2008. published as “AP: Drugs found in drinking water,” USA Today. Web. 8 Nov 2011.
     http://www.usatoday.com/news/nation/2008-03-10-drugs-tap-water_N.htm
13
     Snyder, S.A., Westerhoff, P., Yeomin, Y., Sedlak, D.L. “Pharmaceuticals, Personal Care Products, and Endocrine Disruptors in Water: Implications for the Water Industry.” Environmental Engineering Science.
     20:5:449, 2003. Web. 10 Nov 2011 http://www.mendeley.com/research/pharmaceuticals-personal-care-products-and-endocrine-disruptors-in-water-implications-for-the-water-industry
14
     “Treating Contaminants of Emerging Concern.” U.S. Environmental Protection Agency. Aug. 2010. Web. 10 Nov 2011. http://tiny.cc/5tg8k
15
     “Basic Information about the Unregulated Contaminant Monitoring Rule 3 (UCMR 3).” U.S. Environmental Protection Agency. Web. 23 Nov 2011.
     http://water.epa.gov/lawsregs/rulesregs/sdwa/ucmr/ucrm3/basicinformation.cfm



page 9

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Pharmaceuticals and Personal Care Products in Drinking Water

  • 1. Pharmaceuticals and Personal Care Products in Drinking Water
  • 2. Pharmaceuticals and Personal Care Products in Drinking Water Pharmaceuticals and Personal Care Products in Drinking Water Scientific advances in pharmaceutical therapies and the growing availability of pharmaceutical drugs has done much to improve the overall health of the world’s population. But the widespread use of pharmaceuticals and other personal care products has increased concerns about concentrations of these substances throughout the water cycle, including surface and ground waters, wastewater, and drinking water. Despite seemingly small concentrations, the presence of pharmaceuticals in drinking water has raised concerns about the potential risks to human health from exposure to water-borne pharmaceuticals. In part, the increased detection of pharmaceuticals in drinking water is due to advances in analytical technology that support the measurement of concentrations to levels as low as the nanogram per liter range. However, the effects of prolonged exposure to even small concentrations of pharmaceuticals in water are not well understood. Further, since the use of pharmaceuticals and other personal care products is expected to increase, the risk from their introduction into the water system will also rise. As such, water supply stakeholders, including government officials, drinking water regulators, water suppliers and the general public, are focusing increased attention on pharmaceutical concentration levels in drinking water. This UL white paper provides an overview of the issues related to the presence of pharmaceuticals and personal care products (PPCPs) in drinking water. The paper discusses the possible effects of PPCPs on humans and on the environment and summarizes recent research conducted by U.S. government agencies, UL and others on PPCP concentrations found in public drinking water supplies and wastewater facilities. The white paper also discusses available water treatment options for reducing PPCP concentrations and their relative effectiveness. The paper concludes with areas for further research and a preview of possible future regulatory actions. page 2
  • 3. Pharmaceuticals and Personal Care Products in Drinking Water Types and Sources of PPCPs through bathing or showering, when treated water. In addition, prolonged in Drinking Water soaps and cosmetic creams are washed multi-generational exposure can lead to from the body into the waste effects that accumulate over time. 4 In general, the term PPCP refers to any water system. product used for either personal health Research on PPCPs in Water or cosmetic reasons as well as any The Impact of PPCPs in Research on PPCPs in water has been product used in the agricultural industry Drinking Water ongoing for nearly 20 years, with to maintain the health or enhance While there are no confirmed adverse the first Environmental Protection the growth of livestock. Specifically, human health effects associated Agency (EPA) studies on conventional, PPCPs comprise a diverse collection with PPCPs in drinking water, PPCP nonconventional and toxic pollutants in of thousands of chemical substances, contamination remains a significant water dating to 1982. The EPA web-site including prescription and over-the- concern. For example, pharmaceuticals lists more than 100 separate research counter therapeutic drugs for humans are designed to interact with cellular-level projects related to PPCPs in which the and animals, biopharmaceuticals, EPA has been or is currently involved,5 receptors at low concentrations to diagnostic agents, vitamins and other and the agency maintains an extensive induce specific biological effects, and the nutritional supplements, cosmetics database of published literature on side effects caused by interaction with and fragrances, and growth-enhancing PPCPs as environmental contaminants.6 nonreceptor targets are unpredictable chemicals used in livestock operations.1 Here is a brief summary of some of the and poorly understood. Further, certain PPCPs enter the water supply as a result key research that has been conducted strains of bacteria subject to prolonged of multiple industrial, commercial and concerning PPCPs in water. exposure to antibiotics can develop agricultural activities and pharmaceutical National Reconnaissance of resistance to those antibiotics, resulting manufacturing (although the latter is Pharmaceuticals, Hormones and Other in strains of drug-resistant bacteria. tightly regulated2). PPCPs also enter the Organic Wastewater Contaminants in water supply in the form of residue from Other PPCPs, such as steroid hormones Streams of the U.S., 1999-2000 hospitals and other healthcare facilities like estrone, progesterone and testosterone and fragrance additives This important field study 7 was conducted and as a byproduct of veterinary drug use, like galaxolide, have been identified as by researchers at the U.S. Geological most notably antibiotics and steroids. endocrine-disrupting compounds (EDCs). Survey in 1999 and 2000 to provide Water-born PPCPs can also result from EDCs are synthetic chemicals that block baseline information on the occurrences the surreptitious disposal of illegal drugs. or mimic natural hormones in the body, of pharmaceuticals, hormones and other Individual consumers are also an wastewater contaminants in water disrupting normal organ function. It is important source, both intentionally resources. Concentrations of 95 separate important to note that EDCs, even at and unintentionally, of PPCPs found organic wastewater contaminants extremely low concentrations, can have in water. Consumers often dispose of (OWCs) were measured in water samples effects on the human endocrine system.3 unused prescription medications by taken from 139 streams in 30 states across including them with household refuse Beyond potential effects on human the United States. Researchers found or flushing them through their home health from exposure the PPCPs in water, OWCs in 80% of the streams sampled, plumbing systems. But unintentional there are also potential consequences for with coprostanol (a fecal steroid), PPCP contamination of water by aquatic life, where the exposure risk is cholesterol (a plant and animal steroid), consumers also occurs through the potentially much greater. Fish and aquatic tridosan (an antimicrobial disinfectant), simple elimination of waste material organisms can experience continual 4-nonylphenol (a non-ionic detergent from the body, since drugs are not always exposure to PPCP concentrations, often metabolite) and caffeine as the most fully metabolized by the body, and also at higher concentrations than found in frequently detected compounds. page 3
  • 4. Pharmaceuticals and Personal Care Products in Drinking Water According to the results of this field study, the measured concentrations of OWCs found were low - generally, less than one part per billion - and rarely in excess of drinking water guidelines or health advisories. However, researchers noted that concentration guidelines have been established for only 14 of the 95 identified compounds. The study’s report recommended further research to “fully understand not only the fate and transport of OWCs in the hydrologic system but also their ultimate overall effect on human health and the environment.” Study of Occurrence of Contaminants of Emerging Concern in Wastewater This multi-stage study8 was conducted by the U.S. Environmental Protection Agency (EPA) from 2005 through 2008 to identify contaminants of emerging concern (CECs) found in untreated and fully treated wastewater at publically owned water treatment facilities in the United States. The CECs evaluated in this study included PPCPs, steroids and hormones, bisphenol A (BPA), commercial flame retardants, and pesticides. A total of 72 different PPCPs were tested in both influent and effluent samples. According to the final report issued in August 2009, detectible amounts of 44 different PPCPs were identified in at least one influent sample collected, and 27 different PPCPs were detected in 75% or more of the influent samples analyzed. For effluent samples, 33 separate PPCPs were detected in at least one sample, and 16 were detected in less than 25% of the effluent samples analyzed. Pharmaceutical antibiotics represented the category of PPCPs most frequently identified, accounting for half of the total PPCPs identified in both influent and effluent samples. EPA researchers cautioned that the results of this study were not statistically representative of all public-owned treatment works. Further, although the study measured PPCP concentrations in both influent and effluent samples from water treatment facilities, researchers noted that the data were insufficient to draw any conclusions about the effectiveness of various treatment methods. An important byproduct of this EPA study was the development of new analytical methods for detecting the occurrence of PPCPs and other contaminants in untreated and fully treated wastewater and sludge. These methods include “Method 1694: Pharmaceuticals and Personal Care Products in Water, Soil, Sediment, and Biosolids by HPLC/MS/MS,”9 and “Method 1698: Steroids and Hormones in Water, Soil, Sediment, and Biosolids by HRGC/HRMS.”10 The methods cover over 100 separate chemicals, 74 PPCPs, and 27 steroids and hormones. “Pharmaceuticals in Drinking Water” Published in June 2011 by the United Nation’s World Health Organization (WHO), this technical report11 is based on work conducted by a WHO working group that included experts in water quality and health, water treatment, drinking water regulation and policy, and water quality and health. The chief goal of the working group was to review and summarize available scientific knowledge about pharmaceuticals in drinking water, and recommend steps for managing the problem. page 4
  • 5. Pharmaceuticals and Personal Care Products in Drinking Water The WHO report determined that least 41 million Americans. Specifically, sensitivity when compared with the concentration levels of pharmaceuticals pharmaceuticals were found in the parts per billion (ppb) concentration in drinking water fall outside the drinking water supplies of 24 major U.S. range available with standard analytical scope and sensitivity of the analytical metropolitan areas. The AP investigation equipment and methods. methodologies that are prescribed also tested samples from the watersheds UL has leveraged these advanced for compliance analysis of drinking of 35 of the 62 major providers and found analytical technologies to enable water. However, WHO experts pharmaceutical concentrations in 28 of increased understanding of the acknowledged that there are “very few those watersheds. occurrence of PPCPs and EDCs in drinking systematic monitoring programmes water. Table 1 lists the 10 most frequently or comprehensive, systematic studies Research by UL detected PPCPs submitted to UL from on the occurrence of pharmaceuticals As noted in the WHO technical study various cities in 30 states between 2008 in drinking-water.” Further, according discussed above, concentrations of and 2009. A total of 57 different PPCPs to the report, the “limited occurrence pharmaceuticals in drinking water have and 17 different EDCs were detected. data present one of the key challenges often been below levels detectable with most analytical testing equipment. But While the concentrations of PPCPs found in assessing the potential risks most studies on PPCPs also concede that in drinking water supplies sampled by associated with trace concentrations of the effects of prolonged exposure to even UL were millions of times lower than the pharmaceuticals in drinking-water.” The small concentrations of pharmaceuticals concentrations prescribed for therapeutic report concluded that “future research … in water are not well understood. effect, additional research by the EPA may be beneficial to better characterize Although the increased detection of and others is underway to determine potential health risks from long-term, PPCPs in drinking water in recent years the potential health risk to humans and low-level exposure to pharmaceuticals.” is due, in part, to advances in analytical ecological systems of PPCPs at these Research by the Associated Press technology, continued technological concentration levels. Research into the presence of advances along with routine monitoring More recently, UL has continued its pharmaceuticals and other personal care are necessary to fully understand the efforts to further develop its own testing products in drinking water has not been occurrence of these contaminants and methods for identifying PPCPs and other limited to U.S. government agencies. their relevance to human health and contaminants in water. In 2009 and 2010, A five-month long investigation in 2008 the environment. UL developed a specific method for the by the Associated Press (AP) 12 analyzed UL has a long history of developing analysis of PPCPs and EDCs based on prior federal drinking water databases, analytical technologies for emerging proprietary testing methods. The new reviewed hundreds of scientific reports, contaminants in drinking water. During method, L222, focuses on the detection and interviewed more than 230 the past decade UL has invested in and analysis of almost 30 of the most officials, scientists and academics. AP’s advanced analytical equipment such as frequently detected and studied PPCP investigatory team also surveyed drinking high performance liquid chromatograph and EDCs, including acetaminophen, water system providers in 50 of the with triple quadrupole mass spectrometer bisphenol A, caffeine, DEET, estrone, largest cities in the United States as well (HPLC/MS/MS). When coupled with nicotine, nonylphenol and triclosan. as small community water providers in all various sample preparation techniques, UL also created method S190, which 50 states. this technology has enabled UL to develop streamlined the analysis of selected AP’s investigation determined that a several analytical methods to detect a semi-volatile organic compounds, wide array of pharmaceuticals, including wide range of emerging contaminants in including sterols, phosphate flame antibiotics, anti-convulsant drugs and the parts per trillion (ppt) concentration retardants, fragrances, polyaromatic mood stabilizers, were found in the range. This level of detection represents hydrocarbons (PAHs), phenols drinking water supplies that serve at a thousand-fold increase in measurement and pesticides. page 5
  • 6. Pharmaceuticals and Personal Care Products in Drinking Water NAME (# OF SAMPLES) USE MEDIAN LEVEL DETECTED (PPT) Carbamazapine 235 Mood stabilizer 10.3 Cotinine 221 Metabolite of nicotine 3.4 DEET 221 Insect repellent 15.2 Galaxolide 134 Synthetic fragrance used in cosmetics, cleaners & perfumes 61.5 Gemfibrozil 264 Cholesterol lowering drug 5.9 Nicotine 221 Tobacco products 15.6 Sulfamethoxazole 219 Antibiotic 34.9 Paraxanthine 219 Metabolite of caffeine 20.7 Acetaminophen 219 Analgesic 8.1 Caffeine 235 Coffee, tea, soda 104 Table 1: Top ten PPCPs found in drinking water samples tested at UL Treatment Methods for PPCPs of success in removing PPCPs in several •  More than 90% of lipid regulators in Drinking Water classifications, as follows: can be removed using activated Most conventional water treatment carbon, biologically activated •  More than 90% of steroids can systems are not specifically engineered or be removed from drinking water carbon, ozone/advanced oxidation equipped to remove PPCPs from drinking using activated sludge, activated processes, nanofiltration and water. However, depending on the specific carbon, biologically activated reverse osmosis chemical class of the contaminant, there carbon, ozone/advanced oxidation •  Less than 40% of listed PPCPs is a range of treatment methodologies processes, UV treatments and can be removed through the use that have proven effective for removing reverse osmosis of coagulation/flocculation and PPCPs or reducing their concentration. •  More than 90% of antibiotics, softening/metal oxides Such methodologies include: antidepressants and antimicrobials The EPA’s Office of Water maintains •  Activated carbon can be removed using activated an inventory of scientific studies and •  Biologically activated carbon carbon, biologically activated literature on the treatment of CECs, which •  Ozone/advanced carbon, nanofiltration and includes abstracts of over 400 documents oxidation processes reverse osmosis available through the U.S. National •  Ultraviolet (UV) treatments •  More than 90% of anti- Library of Medicine and other sources. The inflammatories can be removed EPA’s 2010 report, “Treating Contaminants •  Nanofiltration using activated carbon, biologically of Emerging Concern,”14 offers a detailed •  Reverse osmosis activated carbon, ozone/ review of the effectiveness of various According to some researchers, a 13 advanced oxidation processes, UV types of treatment methodologies, based number of individual water treatment treatments, nanofiltration and on compiled data from a subset of the methods have demonstrated high levels reverse osmosis EPA’s research document inventory. page 6
  • 7. Pharmaceuticals and Personal Care Products in Drinking Water Areas for Future Research and needed to understand both the scope of Rule (UCMR 3). UCMR 3 will require all Possible Regulation the problem and its implications for our public water systems serving more than public drinking water supply. The EPA 10,000 people, as well as a representative As authorized under the U.S. Safe has several research efforts currently sample of the 800 systems serving Drinking Water Act (SDWA), the EPA underway to strengthen the science for 10,000 or fewer people, to conduct sets drinking water standards to control understanding the behavior of PPCPs assessment monitoring for the presence contaminants in the public drinking water in drinking water, including research, of 28 separate chemicals during a supply, and currently has drinking water methods development and occurrence 12-month period. The rule will require regulations for more than 90 separate studies. Data from this research will public water systems (PWS) to conduct contaminants. To determine whether this occurrence monitoring from January a contaminant should be regulated, assist the agency in determining whether 2013 through December 2015. Included the EPA analyzes peer-reviewed science regulations regarding acceptable in UCMR 3 are a number of hormones, addressing a number of variables, concentrations of PPCPs in drinking water including equilin and esteron (used in including the occurrence levels of a and the testing of public drinking water estrogen replacement therapies) and contaminant in the environment, routes systems should be considered, even in the testosterone. Although these substances of human exposure and the health effects absence of health-based standards. are not currently regulated by national of exposure, particularly the effects on As part of its ongoing research primary drinking water regulations, the vulnerable subpopulations. to determine the occurrence of EPA will use the data from this and prior The fact that contaminants are detected contaminants of emerging concern, UCMR assessment phases to determine in trace amounts does not alone imply the EPA has recently proposed the whether further regulations are in the risk to humans. Significant research is still Unregulated Contaminant Monitoring interest of public health.15 page 7
  • 8. Pharmaceuticals and Personal Care Products in Drinking Water Conclusion The presence of PPCPs and other emerging contaminants in drinking water is not a new issue, and significant research is still required to understand both the scope of the problem and its implications for the safety of the public drinking water supply. However, advancements in analytical technologies now make it possible to analyze a wider range of contaminants in drinking water with greater specificity and sensitivity than at any time in the past. Only a few laboratories, including UL, have developed methods to detect pharmaceuticals and other compounds at ultralow levels. UL is a recognized leader in drinking water analysis and has analyzed over 2.5 million samples for thousands of water utilities, bottled water producers, engineering firms, and state and federal governments, including the U.S. EPA and the U.S. military. UL is one of only a few laboratories in the United States that can analyze a wide variety of emerging contaminants in drinking water, including PPCPs, estrogens and other hormones, phenolic endocrine disrupters, brominated and phosphate flame retardants, herbicide degradates, and perfluorochemicals. With advanced detection methodologies, UL can analyze drinking water for a broad range of contaminants using the most efficient methods available, thereby streamlining the testing process and reducing testing costs. For more information about the “Pharmaceuticals and Personal Care Products in Drinking Water” white paper, please contact Laura Snell, marketing manager – Food & Water, at Laura.J.Snell@ul.com THIS DOCUMENT IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND IS NOT INTENDED TO CONVEY ANY LEGAL ADVICE. USE OF THE INFORMATION IN THIS DOCUMENT IS AT YOUR OWN RISK. PLEASE CONSULT WITH LEGAL COUNSEL FOR ADVICE ON COMPLYING WITH THE REGULATIONS DESCRIBED ABOVE. Copyright©2011 Underwriters Laboratories Inc. All rights reserved. No part of this document may be copied or distributed without the prior written consent of Underwriters Laboratories Inc. 12/11 page 8
  • 9. Pharmaceuticals and Personal Care Products in Drinking Water 1 “Pharmaceuticals and Personal Care Products (PPCPs).” U.S. Environmental Protection Agency. Web. 4 Nov. 2011 www.epa.gov/ppcp 2 For details on the EPA’s effluent requirements for pharmaceutical manufacturers, see “Effluent Guidelines: Pharmaceutical Manufacturing.” U.S. Environmental Protection Agency, Jul, 1998. Web. 21 Nov 2011. http://water.epa.gov/scitech/wastetech/guide/pharm/pharmac.cfm 3 Day, Rhonda, “Managing Micro-Pollutants.” Water and Wastewater International, Dec/Jan 2010-2011. Web. 21 Nov 2011. http://www.waterworld.com/index/display/article-display/8838408304/articles/waterworld/drinking-water/water-quality/2011/01/managing-micro-pollutants.html 4 “Frequent Questions: Pharmaceuticals and Personal Care Products (PPCPs).” U.S. Environmental Protection Agency. 4 Nov 2011. www.epa.gov/ppcp/faq.html 5 “EPA PPCP Research Areas.” U.S. Environmental Protection Agency. Web. 7 Nov 2011. http://www.epa.gov/ppcp/work2.html 6 “Published Literature Relevant to Issues Surrounding PPCPs as Environmental Contaminants.” U.S. Environmental Protection Agency. Web. 7 Nov 2011. www.epa.gov/ppcp/lit.html 7 Kolpin, D., Furlong, E., Meyer, M., and others. “Pharmaceuticals, Hormones, and Other Organic Wastewater Contaminants in U.S. Streams, 1999-2000: A National Reconnaissance.” published in Environmental Science & Technology, 15 Mar 2002. Web. 7 Nov 2011. An abstract of the study report is available at http://pubs.acs.org/doi/full/10.1021/es011055j. Additional information about this study, as well as study data, is available at http://toxics.usgs.gov/regional/emc_surfacewater.html 8 “Occurrence of Contaminants of Emerging Concern in Wastewater from Nine Publically Owned Treatment Works.” U.S. Environmental Protection Agency, Aug. 2009. Web. 7 Nov 2011. http://tiny.cc/wn2fr 9 “Method 1694: Pharmaceuticals and Personal Care Products in Water, Soil, Sediment, and Biosolids by HPLC/MS/MS.” U.S. Environmental Protection Agency. Dec. 2007 Web, 10 Nov 2011. http://water.epa.gov/scitech/methods/cwa/bioindicators/upload/2008_01_03_methods_method_1694.pdf 10 “Method 1698: Steroids and Hormones in Water, Soil, Sediment, and Biosolids by HRGC/HRMS.” U.S. Environmental Protection Agency. Dec. 2007. Web. 10 Nov 2011. http://water.epa.gov/scitech/methods/cwa/bioindicators/upload/2008_01_03_methods_method_1698.pdf 11 “Pharmaceuticals in drinking-water: Technical report.” World Health Organization. June 2011. Web. 4 Nov 2011. http://www.who.int/water_sanitation_health/publications/2011/pharmaceuticals/en/index.html 12 Donn, J., Mendoza, M., Pritchard, J. “PharmaWater 1.” Associated Press. 9 Mar 2008. published as “AP: Drugs found in drinking water,” USA Today. Web. 8 Nov 2011. http://www.usatoday.com/news/nation/2008-03-10-drugs-tap-water_N.htm 13 Snyder, S.A., Westerhoff, P., Yeomin, Y., Sedlak, D.L. “Pharmaceuticals, Personal Care Products, and Endocrine Disruptors in Water: Implications for the Water Industry.” Environmental Engineering Science. 20:5:449, 2003. Web. 10 Nov 2011 http://www.mendeley.com/research/pharmaceuticals-personal-care-products-and-endocrine-disruptors-in-water-implications-for-the-water-industry 14 “Treating Contaminants of Emerging Concern.” U.S. Environmental Protection Agency. Aug. 2010. Web. 10 Nov 2011. http://tiny.cc/5tg8k 15 “Basic Information about the Unregulated Contaminant Monitoring Rule 3 (UCMR 3).” U.S. Environmental Protection Agency. Web. 23 Nov 2011. http://water.epa.gov/lawsregs/rulesregs/sdwa/ucmr/ucrm3/basicinformation.cfm page 9